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4,919 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Must be ≥22 and ≤80 years of age
- Competent and willing to provide written, informed consent to participate in the study
- A diagnosis of essential tremor as confirmed from clinical history and examination by
a movement disorder neurologist
- Postural, action or intention tremor severity score of 2 or above in the dominant
hand/arm as measured by the CRST rating scale
- Significant disability due to essential tremor (Bain & Findley score of 3 or above in
any one of the hand items)
- Currently or previously prescribed either propranolol or primidone for the treatment
of essential tremor
- Stable dose of tremor medications for 30 days prior to study entry
- Stable dose of antidepressant medications for 90 days prior to study entry
- Willing to comply with study protocol requirements including: remaining on a stable
dosage of tremor and antidepressant medications, if applicable, during the duration of
the study; no significant alcohol or caffeine consumption within 12 hours of study
visits; and no significant alcohol or caffeine consumption within 4 hours of
twice-daily at home assessments during the controlled phase of the study
Exclusion Criteria:
- Moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5
(score of 4 or higher)
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain
stimulator
- Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife
radiosurgical thalamotomy, and focused ultrasound for the treatment of tremor
- Suspected or diagnosed epilepsy or other seizure disorder
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous
lesions of skin at stimulation site
- Peripheral neuropathy affecting the tested upper extremity
- Presence of any other neurodegenerative disease like Parkinson-plus syndromes
suspected on neurological examination. These include: multisystem atrophy, progressive
supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
- Anyone suspected to have the diagnosis of idiopathic Parkinson's disease (PD). This
includes excluding anyone with the presence of parkinsonian features including
bradykinesia rigidity, or postural instability. Subjects who exhibit only mild resting
tremor but no other symptoms or signs of PD may be included.
- Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
- Are participating or have participated in another interventional clinical trial in the
last 30 days which may confound the results of this study, unless approved by the
Sponsor
- Are participating or have participated in another Cala Health clinical trial
- Significant alcohol or caffeine consumption within 12 hours of study enrollment, which
may confound the results of the study, where significant caffeine is considered more
than 95 mg (equivalent to a cup of coffee), and significant alcohol is considered more
than 14 g (equivalent to 5 oz of wine, 12 oz of beer, or 1.5 oz of distilled spirits).
- Subjects unable to communicate with the investigator and staff
- Any health condition that in the investigator's opinion should preclude participation
in this study
- Pregnancy or anticipated pregnancy during the course of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
Subject must be at most 80 Years | A Pilot Study of the Cala ONE Device for Essential Tremor | NCT03152136 | Entailment |
4,605 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
Patients:
• Patients ≥5 years of age undergoing surgery at Mbale Regional Referral Hospital, who
receive post-operative care in one of four main surgical wards, with a family carer
prepared to participate in the trial intervention.
Carers:
- All carers will be included in the trial if they feel they are capable of performing
and documenting the basic vital signs provided they agree to participate in the trial.
- The ability to speak English, Luganda, Lugisu, Ateso or Lugwere
- The ability to read a digital clock (to measure vital signs)
- Numeracy sufficient to write numbers on the basic observation chart
Exclusion Criteria:
Patients:
- Refusal of informed consent.
- Identification of potential participant >24hours after operative procedure has taken
place
Carers:
• Refusal of informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
| Family SuppleMented pAtient monitoRing afTEr suRgery: A Pilot Trial | NCT04341558 | Entailment |
4,357 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Has had an oculo-visual examination in the last two years
- Is at least 18 years of age and has full legal capacity to volunteer
- Has read and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/50 or better (in at least one eye) with their
habitual vision correction
- Currently wears soft contact lenses
- They should require contact lens powers between -12.00 and -20.00D or between +8.00
and +15.00D
- Has clear corneas and no active ocular disease
- Demonstrates an acceptable fit with the study lenses.
Exclusion Criteria:
- Has any systemic disease affecting ocular health
- Is taking medication, such as antihistamine eye drops, oral and ophthalmic
betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any
prescribed or over-the-counter eye medication, except artificial tears or eye
lubricants
- Have any active ocular disease and/or infection that would contraindicate contact lens
wear.
- Active ocular disease is defined as infection or inflammation which requires
therapeutic treatment. Mild (i.e. not considered clinically relevant) lid
abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and
conjunctival staining and dry eye are not considered active ocular disease.
Neovascularization and corneal scars are the result of previous hypoxia, infection or
inflammation and are therefore not active.
- Has worn gas permeable contact lenses within the last month.
- Is aphakic
- Has undergone corneal refractive surgery.
- Is participating in any other type of clinical research study
- Female who is currently pregnant or is breast-feeding.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Multicenter Dispensing Study of Biofinity Lenses in Extended Range | NCT02060539 | Entailment |
460 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Each subject must be willing and able to provide written informed consent for the
study.
- Each subject must be female with years of age ≥35 to ≤42 at the time of recruitment..
- Each subject must have an indication for controlled ovarian stimulation and IVF
- Each subject must have a body weight ≥ 50.0 kg, with a body mass index (BMI) ≥18.0 to
≤32.0 kg/m2.
- Each subject must have a regular spontaneous menstrual cycle with an intra-individual
variation not outside the 24 to 35 days range.
- For each subject, ejaculatory sperm must be available (use of donated and/or
cryopreserved sperm is allowed; sperm obtained via surgical sperm retrieval is not
allowed).
- Each subject must have results of clinical laboratory test (complete blood count,
blood chemistries, and urinalysis) within normal limits or clinically acceptable to
the investigator, as measured by the local laboratory at screening. A normal cervical
smear result, obtained within 12 months, otherwise it must be obtained during
screening.
- Each subject must have results of a physical examination, including blood pressure,
within normal limits or clinically acceptable limits to the investigator.
- Each subject must have normal ovarian reserve, based on anti-Mullerian hormon (AMH) of
1.38 - 3.25ng/ml or an antral follicle count (AFC) of 7-20, taken within 2 months
prior to corifollitropin alfa start.
- Each subject must be able to adhere to dose and visit schedules and willing to
disclose any medical events to the investigator.
Exclusion Criteria:
- The subject has a recent (ie, within 3 years) history of/ or any current endocrine
abnormality (irrespective whether the patient is stabilized on treatment).
- The subject has a history of ovarian hyper-response (ie, previous IVF cycle with more
than 30 follicles ≥11 mm on ultrasound) or ovarian hyperstimulation syndrome (OHSS).
- The subject has a history of/or current polycystic ovary syndrome (PCOS)
- The subject has more 20 basal antral follicles <11 mm (both ovaries combined) as
measured on ultrasound in the early follicle phase (menstrual cycle day 2-5).
- The subject has less than 2 ovaries in any other ovarian abnormality (including
endometrioma > 10 mm; visible on ultrasound).
- The subject has unilateral or bilateral hydrosalpinx (visible on ultrasound, less
clipped).
- The subject has any intra-uterine fibroids >5 cm or any clinically relevant pathology,
which could impair embryo implantation or pregnancy continuation.
- The subject has more than three unsuccessful treatment cycles for IVF/ICSI.
- The subject has a history of non- or low avarian response to FSH / Human Menopausal
Gonadotropin (hMG) treatment (ie, previous COS cycle cancelled due to insufficient
ovarian response or ≤3 oocytes obtained).
- The subject has a history of current miscarriage (3 or more, even when explained).
- The subject has FSH > 15.0 IU/L or LH > 12 .0 IU/L as measured by the local laboratory
(sample taken during the early follicle phase: menstrual cycle day 2 to 5).
- The subject has tested positive for human immunodeficiency virus (HIV) or Hepatitis B
(results obtained within one year) .
- The subject has contra-indications for the use of gonadotropins (eg, tumors,
pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, or ovarian cysts)
or GnRH antagonist (eg, hypersensitivity, pregnancy/lactation).
- The subject has a concomitant use of either LH or hMG/urinary FSH preparations in
study cycle.
- The subject has a recent history of/or current epilepsy, thrombophilia, diabetes,
cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease
requiring regular treatment.
- The subject or the sperm donor has known gene defects, genetic abnormalities, or
abnormal karyotyping, relevant for the current indications or for the health of the
offspring.
- The subject smokes or has recently stopped smoking (ie, within the last 3 months prior
to signing ICF).
- The subject has a history or presence of alcohol or drug abuse within 12 months prior
to signing informed consent.
- The subject has an allergy/ sensitivity to investigational drugs or their excipients.
- The subject has used any experimental drugs within 3 months prior to signing informed
consent.
- The subject is participating in any other clinical study (excluding surveys).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 42 Years | Efficacy of Corifollitropin Alfa Versus Follitropin Beta in Aged IVF (In-vitro Fertilization) Patients | NCT02466204 | Contradiction |
6,173 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Age 18 years or older
- Negative RT-PCR test at the beginning of the study.
- Negative SARS-CoV-2 serological Elecsys Anti-Sars-CoV-2 test at the beginning of the
study.
- Living in a geographic area with active COVID-19 transmission (number of
- cases reported locally).
- Living in a geographic area that has been determined by the Colombian National
Statistics Department (DANE) to have a medium, medium-high, and high vulnerability
index (higher prevalence of comorbidities and social and economic vulnerabilities.
- Working outside the home for at least two days a week, during the last week.
- Acceptance to participate in the study regardless of the trial arm assignment through
verbal informed consent.
Exclusion Criteria:
- Retired adults or unemployed
- Adults referring previous diagnosis of COVID-19 confirmed by RT-PCR tests or
serological antibody tests.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Effectiveness and Adherence to Closed Face Shields to Prevent COVID-19 Transmission | NCT04647305 | Contradiction |
2,581 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- unilateral inguinal hernia
- age between 2 years and 17 years
- no history of abdominal or inguinal operations
- the age range was based on the day surgery criteria of our hospital
- of male patients, only those with completely descended testes were included
Exclusion Criteria:
- the bilateral hernia
- the recurrence hernia
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
Subject must be at most 17 Years | Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children | NCT01377181 | Contradiction |
2,299 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Diagnosed with one of four specific muscle diseases on the basis of diagnostic
criteria:
1. Limb girdle muscular dystrophy; symptomatic limb girdle muscular dystrophy
genetically or pathologically proven
2. Dystrophinopathies resulting in a Becker' muscular dystrophy phenotype (excluding
Duchenne muscular dystrophy) with pathology or genetic diagnosis
3. Facioscapulohumeral muscular dystrophy diagnosed clinically with specific genetic
abnormality in the subject or their family
4. Inclusion body myositis clinic-pathologically defined, clinically defined or
probable IBM based on ENMC research diagnostic criteria 2013 (submitted)
2. duration of muscle disease greater than six months
3. over the age of 18 years
4. access to the internet and a computer on which they can receive the intervention
materials
5. HADS scores > 8 for depression or >8 for anxiety
Exclusion Criteria:
1. Major active co-morbidities unrelated to muscle disease such as arthritis, respiratory
disease, cardiovascular disease
2. Unstable complications of muscle disease including:
1. neuromuscular respiratory weakness
2. cardiomyopathy
3. Cognitive impairment that prevents comprehension of the questionnaires; assessed using
the Montreal Cognitive Assessment
4. Unable to read English questionnaires
5. Major diagnosed active mental health co-morbidities e.g. psychosis, major depression,
obsessive compulsive disorder, active suicide risk
6. Current or recent participation in other treatment intervention studies (< 4 weeks
after completion)
7. Currently receiving psychological support or psychotherapy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Acceptance and Commitment Therapy for Muscle Disease | NCT02810028 | Contradiction |
4,881 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | PROTOCOL ENTRY CRITERIA:
Suspected adrenocorticotropin hormone (ACTH)-dependent Cushing's syndrome No pregnant women
Effective contraception required of fertile women
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Study of Hypercortisolism in Cushing's Syndrome and Stress-Induced Pseudo-Cushing's Syndrome | NCT00004343 | Entailment |
6,644 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Male subjects
- Any ethnicity
- Age <6 years
- Severe haemophilia A (FVIII:C <1%), as confirmed at enrolment by the central
laboratory.
o Those patients diagnosed locally as severe but subsequently found to have FVIII
levels >= 1% on testing at the central laboratory will be separately recorded in the
screening list.
- Previously untreated (0 EDs to any FVIII concentrates or blood products) or minimally
treated (<5 EDs) with blood components, namely whole blood, fresh frozen plasma,
packed red blood cells, platelets or cryoprecipitate.
o Patients not meeting these criteria will be separately recorded in the screening
list.
- Negative inhibitor measurement at both local and central laboratory at screening
- Ability to comply with study requirements
- Signed informed consent of legal tutors o Patients who will not accept to enter into
the study or to be randomized will be separately recorded.
Exclusion Criteria:
- Previous history of FVIII inhibitor
- Other congenital or acquired bleeding defects
- Plasma FVIII level >= 1%, as assayed at the central laboratory
o Those patients originally diagnosed locally as severe but subsequently found to have
FVIII levels ranging from 1% to 2% on testing at the central laboratory will be
separately recorded in the screening list.
- Concomitant congenital or acquired immunodeficiency
- Concomitant treatment with systemic immunosuppressive drugs
- Concomitant treatment with any investigational drug
Male
No healthy subjects accepted to join the trial.
Subject must be at most 6 Years | Survey of Inhibitors in Plasma-Product Exposed Toddlers | NCT01064284 | Contradiction |
1,000 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
To be included in the study, participants needed to suffer knee osteoarthritis with
osteoarthritis levels 2 - 4 according to Kellgren-Lawrence grade12, be aged between 50 and
75 years and suffer knee pain and functional disability for at least three months,
according to the criteria of the American College for Rheumatology (ACR)13. Participants
from both genders were included. The Kellgren and Lawrence grading of knee osteoarthritis
is as follows: none (0), doubtful (1), minimal (2), moderate (3) and severe (4).
The ACR criteria of knee osteoarthritis are as follows:
- Using history and physical examination: knee pain and three of the following - over 50
years old; less than 30 minutes of morning stiffness; bone tenderness; bone
enlargement; no palpable warmth of synovial.
- Using history, physical examination and radiographic findings: knee pain and one of
the following - over 50 years old; less than 30 minutes of morning stiffness; crepitus
on active motion; and osteophytes.
- Using history, physical examination and laboratory findings: knee pain and five of the
following - over 50 years old; less than 30 minutes of morning stiffness; bone
tenderness; bone enlargement; no palpable warmth of synovial; crepitus on active
motion; ESR <40 mm/h; rheumatoid factor <1: 40; synovial fluid sign of osteoarthritis.
Exclusion Criteria:
- Participants were excluded if they had cancer, diabetes, symptomatic hip
osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics
during six months prior to enrollment.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 75 Years | Ultrasound and Exercises in Knee Osteoarthritis | NCT03676790 | Entailment |
1,797 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Patients who present to the KCVA GI endoscopy unit with symptoms of reflux,upper
abdominal pain, anemia (patients referred by their primary care physicians with a
diagnosis of low hemoglobin (< 10 G/DL, and or dyspepsia
Exclusion Criteria:
- Weight loss (Weight loss of > 10% of their mean body weight over last 6 months)
- Dysphagia
- Gastrointestinal bleeding
- Gastrointestinal malignancy
- Recent EGD (in the past 5 years)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Demographics and Findings of Upper Endoscopy Patients | NCT00576992 | Contradiction |
4,136 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- the patient was admitted to a general department of Rambam Medical Center for any
reason from March to May 2008
- the patient is 65 years old or older
- the patient is in a good health, based on medical history, physical examination and
laboratory screening evaluation.
Exclusion Criteria:
- renal failure with creatinine level more then 1.3 mg/dL or nephritic syndrome.
- liver disease with transaminase rise three times from normal level.
- nephrolithiasis in the last fife years.
- primary hyperparathyroidism, hypoparathyroidism or pseudohypoparathyroidism.
- advanced cancer.
- chronic diarrhea or malabsorption.
- granulomatous disease (sarcoidosis, tuberculosis, lymphoma).
- patients, who are receiving barbiturates, rifampin, anticonvulsants.
- patients, who are receiving digitalis.
- patients, who are receiving glucocorticoids for more than two weeks during the study.
- advanced dementia.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Interventional Trial of Vitamin D Deficiency in the Patients of General Departments | NCT00640237 | Contradiction |
4,918 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Age: 20-80 years
- Patients with tremor (involuntary, rhythmic, oscillatory movement in one or more body
part)
- Subject who signed an informed consent
Exclusion Criteria:
- Pregnant or nursing woman.
- Comorbid neurologic illnesses that impact the ability to perform the study tasks.
- Subjects with medical condition that in the opinion of the investigator would affect
his/her ability to participate in this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | Assessment of Tremor Using SNUMAP Motion Sensing System | NCT01731145 | Entailment |
550 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
Patients with poor ovarian response (POR) diagnosis according to the POSEIDON
stratification system (as POSEIDON group 1) with following criteria :
- Women' age under 35 years;
- Previous unexpected poor or suboptimal ovarian response after using conventional
protocols (subgroup 1a: < 4 oocytes ) and (subgroup 1b: 4-9 oocytes retrieved)
- Adequate ovarian reserve (antral follicle count ≥5 on menstrual cycle day 2-3; and
basal serum AMH ≥ 1.2 ng/ml)
Exclusion Criteria:
- Ovarian failure including basal FSH above 20 IU/l or no antral follicle by ultrasound
examination;
- Endometriosis grade 3 or higher;
- Severe male infertility (surgical sperm extraction: TESE, PESA)
- Body mass index >30 kg/ m2
- History of uterine surgery as well as sub-mucosal and intramural fibroids greater than
5 cm or uterine polyps
- Treatment cycles with pre-implantation genetic diagnosis, blastocyst and donation
embryo transfer indications
- Cigarette and drug addiction
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 35 Years | The Effect of Dual Trigger for Final Oocyte Maturation on IVF/ICSI Outcomes in Patients With Suboptimal Ovarian Response | NCT04549649 | Contradiction |
5,143 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal women (natural or surgically induced menopause)
- Low bone mineral density (BMD), as defined by a T score or equivalent BMD absolute
value (g/cm2) for lumbar spine of between -2.0 and -3.5, inclusive
- Body mass index (BMI) must be within the range of 18 to 35kg/m2. Subjects must weigh
between 45 and 120kg inclusive to participate.
- 25-(OH) vitamin D serum level of ≥ 15ng/ml
- Serum calcium within normal limits
Exclusion Criteria:
- Subjects with suspected neural foraminal stenosis (e.g., cervical, spinal, lumbar), or
history of Bell's palsy, cranial nerve disorders, temporomandibular joint and muscle
disorders.
- Subjects who have an increased baseline risk of osteosarcoma: Paget's disease of the
bone or unexplained and clinically significant elevations of alkaline phosphatase
and/or subjects who have received radiation therapy involving the skeleton.
- Subjects with any known bone diseases other than postmenopausal osteoporosis.
- Subjects with a history of an osteoporotic fracture (e.g., vertebral fracture,
fragility fracture of the wrist, radius, humerus, hip, or pelvis).
- Subjects who are regularly using or have regularly used agents affecting bone
metabolism:
- Calcitonin, estrogen, SERMs (raloxifene, Tamoxifen, etc.), Tibolone progestin, or
androgens within the last three (3) months prior to screening.
- Any oral bisphosphonate, lithium chloride, fluoride or systemic
glucocorticosteroids (p.o. or i.v.) where the total dose exceeds 750 mg of
prednisone or equivalent within the last year prior to screening.
- Any previous use of denusomab (ProliaTM), parathyroid hormone (ForteoTM), and/or
PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
- Current disease(s) known to influence calcium metabolism including
hyperparathyroidism, hypoparathyroidism, hypocalcemia or hypercalcemia.
- Any disease, abnormality or deformation of the spine (e.g., scoliosis, ankylosing
spondylitis, osteophytes) or hip (e.g., joint prosthesis) which would preclude the
proper acquisition of a lumbar spine DXA (L1-L4) or femur DXA, respectively.
Other protocol-defined inclusion/exclusion criteria may apply
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years | Safety and Efficacy of Multiple Dosing Regimens of BPS804 in Post Menopausal Women With Low Bone Mineral Density | NCT01406548 | Contradiction |
1,232 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignant pleural effusion (MPE)
- Symptomatic disease
- Candidate for thoracoscopic surgery for treatment of MPE
- No known or suspected ipsilateral pleurodesis that would preclude surgery
- No bilateral MPEs
- No progressive extrapleural disease that is untreatable and/or resistant to systemic
treatment
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
Hepatic
- ALT and/or AST ≤ 1.5 times upper limit of normal (ULN) (if alkaline phosphatase
normal) OR
- Alkaline phosphatase ≤ 2.5 times ULN (if ALT and/or AST normal)
- Bilirubin normal
- INR ≤ 1.5
Renal
- Creatinine ≤ 1.8 mg/dL
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 1 month after
completion of study treatment
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
with polysorbate 80
- No peripheral neuropathy > grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No concurrent systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion | NCT00114205 | Entailment |
6,981 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Diagnosis of probable AD based upon the National Institute on Aging-Alzheimer's
Association (NIA-AA) Criteria
- MMSE Score 12-24 inclusive
- Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4
- Provided a signed and dated informed consent form (either the subject and/or subject's
legal representative as well as the trial partner)
Exclusion Criteria:
- Evidence of clinically relevant neurological disorder(s) other than probable AD
- History of blood coagulation disorders or hypercoagulability; any concurrent use of an
anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa
inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
- Initiation or change in the dosage of cholinesterase inhibitors (AChEI), memantine,
Axona, vitamin E supplementation or selegiline within 3 months prior to screening.
- Heart disease (or history thereof), as evidenced by myocardial infarction, unstable,
new onset or severe angina, or congestive heart failure (New York Association Class
II, III or IV) in the 6 months prior to dosing; uncontrolled high blood pressure
(systolic blood pressure of 160 mmHg or higher and/or diastolic blood
- Prior hypersensitivity reaction to any human blood product or intravenous infusion;
any known clinically significant drug allergy.
- Treatment with any human blood product, including transfusions and intravenous
immunoglobulin, during the 6 months prior to screening.
- History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke,
anaphylaxis, or thromboembolic complications of intravenous immunoglobulins.
- Hemoglobin <10 g/dL in women; and <11 g/dL in men.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 90 Years | A Randomized Study to Assess the Safety of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease | NCT03520998 | Entailment |
3,297 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- children aged from 7-12 years old;
- children with spherical equivalent ranged from -0.5D to -6.0D;
- children without other eye diseases except for ametropia
Exclusion Criteria:
- children with other eye diseases: amblyopia, strabismus, eye trauma, etc;
- children with cycloplegia contradictions;
- children who have used atropine;
- children who are severly allergic with atropine;
- children who are using other eye drops for treatment;
- children with severe heart, lung, liver and kidney diseases.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 12 Years | Atropine for Children and Adolescent Myopia Progression Study | NCT03949101 | Contradiction |
1,325 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- All patients who receive easypod GH of age 1-14 years will be approached for consent
to participate in the study. Patients may have any valid cause for short stature.
These may include children with
- isolated growth hormone deficiency
- multiple pituitary hormone deficiencies
- non-growth hormone deficient conditions such as
- Small for gestational age with postnatal failure of height gain
- chronic renal failure and
- Turner syndrome. Patients will be recruited to the study irrespective of diagnosis and
will not be stratified by diagnosis at entry to the study. However, in analysis of
data, subgroup analysis may be performed on groups such as those with isolated growth
hormone deficiency, dependent on the frequency of recruitment.
All patients will be identified at the start of the study. A one month period will be
considered before the study commences to contact families for potential recruitment. Each
patient will remain in the study for 12 months. The active study duration will be 18 months
whereby all eligible patients will be recruited and followed up for a 12 month period. This
period will be followed by a buffer period to gather necessary data for analysis.
Exclusion Criteria:
- Patients on growth hormone treatment but using other growth hormone devices Patients
who are younger or older than the age limits.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 14 Years | Web-based Adherence Information Integrated Nurse-led Monitoring Clinic | NCT04244123 | Contradiction |
328 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Woman may be on birth control pill (OC), patch or NuvaringTM (vaginal ring) taken in
the traditional 21/7 or 24/4 manner, which means ever month they have a period. If
they are taking it continuously (without a period), you must be willing to take your
birth control 24/4 (4 days taking hormone free interval, HFI) for 2 months.
- If you are not on OCs, patch or NuvaringTM you must have a period every 21-40 days.
- You must not want to get pregnant for 12 months.
- Women have headaches around the time of their period.
Exclusion Criteria:
- BMI > 38
- If you smoke and are age 35 years old or greater or if are under 35 years old and
smoke over 10 cigarettes a day
- If you have or had an aura with your headaches (An aura is a temporary sensation, like
bright lights that come before you experience the headache.)
- Headaches are not occurring during the time of your period.
- Blood Pressure > 140/90 or you take more than a single antihypertensive medication
(excluding diuretics) and are age 40 or greater.
- Contraindications to combination estrogen/progestin hormonal contraception.
- Desire to become pregnant in the next 12 months.
- Refuse to avoid any ergot-based medication, triptan medication or isometheptene/midrin
during their hormone free interval or the one day before the hormone free interval
- Stroke
- Breast Cancer
- Blood clots in your legs, lung or anywhere else in your body
- Diabetes mellitus
- Heart attack
- Liver disease
- Lupus Erythematosus
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Prevention of Menstrual Migraines: Using Frovatriptan or Placebo During Hormone Free Intervals | NCT00700128 | Contradiction |
1,141 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Diagnosed HCM
- Documented history of sustained ventricular tachyarrhythmia or resuscitated sudden
cardiac arrest
- Maximal left ventricular wall thickness of > 30mm
- Extensive fibrosis on cardiac MRI (>15% of total myocardial volume)
- >7.5%/5-year risk of sudden cardiac death as determined by HCM risk-SCD
Exclusion Criteria:
- age < 18 years
- Pregnancy
- Atrial Fibrillation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years | Hypertrophic Cardiomyopathy Pilot Study | NCT02806479 | Entailment |
1,368 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Children between 2 and 16 years and referral to our out patient clinic with either
constipation or fecal incontinence.
- Patients must fulfill the Rome III criteria of constipation, which mean they must have
at least 2 of the following characteristics: fewer than 3 bowel movements weekly, more
than 1 episode of fecal incontinence weekly, large stools in the rectum by digital
rectal examination or palpable on abdominal examination, occasional passing of large
stools, display of retentive posturing and withholding behavior, and painful
defecation.
Exclusion Criteria:
- Children with known organic causes of constipation, including Hirsprung disease,
spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory
bowel disease, allergy and metabolic or endocrine diseases.
- Children receiving drugs known to affect bowel function during a 2 month period before
initiation.
- The healthy control group consists of children with no history of constipation (Rome
III), urinary incontinence, urinary tract infections, fecal incontinence, laxative use
or any other disease affecting the digestive system.
- Children receiving medications known to affect bowel function are excluded from the
study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 16 Years | Maintenance Treatment for Children With Constipation | NCT01566409 | Contradiction |
5,463 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Healthy adults
- Able to perform their own oral hygiene
- Dental students
Exclusion Criteria:
- Active Dental Caries
- Uncontrolled chronic medical conditions
- History of drug and/or treatment that reduces salivary flow
- Currently undergoing orthodontic treatment
- Missing index teeth #16, #12, #24, #36, #32, #44
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 25 Years | Efficacy of Miswak in Oral Hygiene Maintenance | NCT04561960 | Entailment |
2,329 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Diagnosis of DMD confirmed by
1. clinical history with features before the age of five
2. physical examination
3. elevated serum creatine kinase level
4. absence of dystrophin expression, as determined by immunostain or Western blot
(<2%) and/or DNA confirmation of dystrophin mutation.
- Age 7 to 10.5 years: a lower age limit of 7 years was selected, since in our
experience children younger than 7 years are likely unable to cooperate and comply
with all of the exercise measures as needed. An upper age limit of 10.5 years has been
set as boys with DMD tend to reach a rapid progression into a late ambulatory phase
soon after this age.
- Ambulatory at the time of the first visit, defined as the ability to walk for at least
100 m without an external assistive device and able to climb four stairs.
- Currently using corticosteroids (prednisone or deflazacort) as prescribed by a
physician.
Exclusion Criteria:
- Contraindication to an MR examination (e.g. aneurysm clip, severe claustrophobia,
magnetic implants)
- Presence of a condition in control subjects or a secondary condition in boys with DMD
that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine
disorder, mitochondrial disease)
- Secondary condition leading to developmental delay or impaired motor control (e.g.
cerebral palsy)
- Secondary condition that impacts muscle function or muscle metabolism (e.g. myasthenia
gravis, endocrine disorder, mitochondrial disease)
- Unstable medical condition (e.g. uncontrolled seizure disorder)
- Behavioral problems causing an inability to cooperate during testing
Male
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 10 Years | Strength Training in Duchenne Muscular Dystrophy | NCT02421523 | Entailment |
615 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Female with a persisting pregnancy of unknown location:
1. A pregnancy of unknown location is defined as a women with a positive pregnancy
test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound
imaging (Ultrasound must be performed within 7 days prior to randomization)
2. Persistence of hCG is defined as 3 serial hCG values over 4-14 days or 2 serial
hCG values over 7-14 days, showing less than 30% rise, or less than 30% fall
between the first and last value. (This abnormal pattern of serial hCG confirms
that the gestation is nonviable.)
2. Patient is hemodynamically stable, hemoglobin greater than 10 mg/dL,
3. Greater than or 18 years of age
Exclusion Criteria:
1. Hemodynamically unstable in need of acute treatment
2. Most recent hCG greater than 5000 IU/mL
3. Patient obtaining care in relation to a recently completed pregnancy (delivery,
spontaneous or elective abortion),
4. Diagnosis of gestational trophoblastic disease,
5. Subject unwilling or unable to comply with study procedures,
6. Presence of clinical contraindications for treatment with methotrexate (ACOG
guidelines, Appendix B),
7. Prior medical or surgical management of this gestation.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| RCT for Women With a Persisting Pregnancy of Unknown Location | NCT01800162 | Entailment |
4,183 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Age 18-45 years, inclusive, of both genders
2. Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
3. Forced expiratory volume at one second (FEV1) of at least 75% of predicted (without
use of bronchodilating medications for 12 hours), consistent with lung function of
persons with no more than mild intermittent or mild persistent asthma.
4. Oxygen saturation of <93% and blood pressure within the following limits: (Systolic
between 150-85 mmHg, Diastolic between 90-50 mmHg).
5. Ability to provide an induced sputum sample.
6. Subject must demonstrate a ≥10% increase in sputum neutrophils following inhaled WSP
exposure, when compared to baseline sputum (to be completed in a separate protocol).
7. Ability/willingness to discontinue inhaled corticosteroids, montelukast, and cromolyn
for 2 weeks without increased symptoms or increased need for beta agonist rescue
medication prior to screening and through the course of the study.
Exclusion Criteria
Patients who meet any of these criteria are not eligible for enrollment as study
participants:
1. Clinical contraindications:
1. Any chronic medical condition considered by the PI as a contraindication to the
exposure study including significant cardiovascular disease, diabetes, chronic
renal disease, chronic thyroid disease, history of chronic
infections/immunodeficiency.
2. Viral upper respiratory tract infection within 4 weeks of challenge.
3. Any acute infection requiring antibiotics within 4 weeks of exposure or fever of
unknown origin within 4 weeks of challenge.
4. Abnormal physical findings at the baseline visit, including but not limited to
abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or
< 85 mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry
saturation reading less than 93%.
5. Physician directed emergency treatment for an asthma exacerbation within the
preceding 12 months.
6. Moderate or severe asthma
7. Exacerbation of asthma more than 2x/weeks which would be characteristic of a
person with moderate or severe persistent asthma as outlined in the current
National Asthma Education and Prevention Program (NAEPP) guidelines for diagnosis
and management of asthma
8. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest
tightness) which would be characteristic of a person with moderate or severe
persistent asthma as outlined in the current NHLBI guidelines for diagnosis and
management of asthma (not to include prophylactic use of albuterol prior to
exercise).
9. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not
during a clearly recognized viral induced asthma exacerbation) which would be
characteristic of a person of moderate or severe persistent asthma as outlined in
the current NHLBI guidelines for the diagnosis and management of asthma.
10. History of intubation for asthma
11. If there is a history of allergic rhinitis, subjects must be asymptomatic of
allergic rhinitis at the time of study enrollment.
12. Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study
requirements.
13. Cigarette smoking > 1 pack per month
14. Unwillingness to use reliable contraception if sexually active (IUD, birth
control pills/patch, condoms).
15. Abnormal prothrombin time (PT) or activated partial thromboplastin time (aPTT)
values at screening or during the treatment period. Normal values will be those
published by the clinical lab (Labcorp, INC).
16. Use of immunosuppressive or anticoagulant medications including routine use of
NSAIDS. Oral contraceptives are acceptable, as are Antidepressants and other
medications may be permitted if, in the opinion of the investigator, the
medication will not interfere with the study procedures or compromise safety and
if the dosage has been stable for 1 month.
17. Orthopedic injuries or impediments that would preclude bicycle or treadmill
exercise.
18. Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.
19. Allergy/sensitivity to study drugs or their formulations
20. Known hypersensitivity to methacholine or to other parasympathomimetic agents
21. Unwillingness to avoid coffee, tea, cola drinks, chocolate, or other foods
containing caffeine after midnight on the days that methacholine challenge
testing is to be performed.
2. Pregnant/nursing women and children (< 18 years as this is age of majority in North
Carolina) will also be excluded since the risks associated with woodsmoke exposure to
the fetus or child, respectively, are unknown and cannot be justified for this
non-therapeutic protocol. Individuals over 45 years of age will not be included due to
the increased possibility of co-morbidities and need for prohibited medications.
3. Inability or unwillingness of a participant to give written informed consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | A Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults | NCT03444298 | Contradiction |
5,707 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | PROTOCOL ENTRY CRITERIA:
- Girls aged 8 and 12 years with Turner's syndrome-compatible karyotype
- Age-matched girls without Turner's syndrome entered as controls
- Concurrent registration on Thomas Jefferson University growth study required of
subjects with Turner's syndrome
Female
Accepts Healthy Volunteers
Subject must be at least 8 Years old.
Subject must be at most 12 Years | Effect of Estrogen on Mental and Social Functioning in Girls With Turner's Syndrome | NCT00004274 | Entailment |
2,817 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Patients with diagnosis of familial or sporadic ALS, defined as meeting the possible,
laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS
according to the revised World Federation of Neurology El Escorial criteria [Rix
Brooks 2000].
- Onset of muscle weakness within 60 months of study entry.
- Patients who have low Slow Inspiratory Vital Capacity (SVC) below that what is
predicted for age and sex can be included into the study at the discretion of the
investigator as long as they are NOT respiratory insufficient.
- If on any medication (including riluzole), these must have been stable within the
previous one month. (See also 'Concomitant Medications' - Section 8).
- Age 18 - 80 years inclusive.
- Male or Female of non-childbearing potential (NCBP) defined as follows:
Pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal
defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with
simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and oestradiol < 40 pg/ml (<140
pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal
status is in doubt will be required to use one of the contraception methods in Section
7.1.1, if they wish to continue their HRT during the study. Otherwise, they must
discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and
the blood draw; this interval depends on the type and dosage of HRT. Following confirmation
of their post-menopausal status, they can resume use of HRT during the study without use of
a contraceptive method.
- Male subjects must agree to use one of the contraception methods listed in Section
7.1.2. This criterion must be followed from the time of the first dose of study
medication until the last follow-up visit.
- QTcB < 500 msec or uncorrected QT <600msec (machine or manual overread). If subject
has bundle branch block then criteria is QTcB < 530 msec.
- A Body Mass Index that at the discretion of the investigator is acceptable for
inclusion into the study.
- Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.
Exclusion Criteria:
- Patients with other neuromuscular disorders (in addition to their ALS diagnosis),
unless the investigator determines that such additional disorder will not affect
safety or other measures in this study.
- Patients with evidence of dementia or psychiatric illness which, in the investigator's
opinion, is likely to prevent them from a full understanding of and/or compliance with
the study requirements and procedures.
- Patients with abnormalities detected during the screening evaluations which, in the
investigator's medical judgement, are sufficiently significant to exclude them from
participation in the study.
- Patients who have participated in a clinical trial involving receipt of a
biopharmaceutical product within 6 months prior to the first dosing day.
- Exposure to more than four new investigational products within 12 months prior to the
first dosing day.
- The subject has a positive drugs of abuse test at the screening or pre dose visit. A
minimum list of drugs that will be screened for include amphetamines, barbiturates,
cocaine, opiates and benzodiazepines. Subjects who are on any of these drugs by
prescription for medical reasons may be considered by the investigator for inclusion
if they fulfil other entry criteria.
- The subject has a positive alcohol test at the pre-dose visit. History of regular
excessive alcohol consumption within 6 months of the study defined as:
- For European sites: an average weekly intake of > 28 units for males or >21 units for
females. One unit is equivalent to 8g of alcohol: a half-pint (~240mL) of beer, 1
glass (125mL) of wine or 1 (25mL) measure of spirits.
- For North American sites: an average weekly intake of >21 drinks for males or >14
drinks for women. One drink is equivalent to 12 g alcohol: 12 ounces (360mL) of beer,
5 ounces (150mL) of wine or 1.5 ounces (45mL) of 80 proof distilled spirits.
- History of sensitivity to GSK1223249, or components thereof, or a history of drugs or
other allergies that, in the opinion of the investigator or GSK Medical Monitor,
contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
- Females of childbearing potential, pregnant females as determined by positive serum or
urine beta hCG test at screening or prior to dosing, or lactating females.
- Patients who have received any type of vaccination in the last 3 weeks before study
drug administration.
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subjects who will undergo muscle biopsies (cohorts 3-optional 5, 6, 7 and 8 will not
be eligible for inclusion, if any of the following criteria apply:
Patients with wasted deltoids (MRC score ≤ 2) and patients with normal deltoids (MRC score
5).
Patients who cannot achieve normal coagulation in the peri-operative period and those who
may otherwise be at higher risk of bleeding complications
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | First Time in Human Study of GSK1223249 in Amyotrophic Lateral Sclerosis | NCT00875446 | Entailment |
5,262 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion criteria :
- Postmenopausal women with menopause duration more than 5 years and with age between
45-75 years old (menopausal age ≥40), or if hysterectomy operated before natural
menopause, the age of women between 60-75 years old.
- Subject with BMD (L2-4 or neck of femur) being more than 2 Standard Deviation (SD)
below the young female adult mean (According to the standard of each center)
- BMI between 18 kg/m2-30 kg/m2.
- The anatomic structure of lumbar spine must be available for Dual-energy X-ray
Absorptiometry (DEXA) examination, patient with serious scoliosis, bone trauma or
sequela after orthopedics surgery, which makes BMD measurement difficult, should be
excluded
- Subject who have given informed consent prior to participation in the trial and who
undertake to comply with the protocol.
Exclusion Criteria
- Subject with conditions that are considered to effect osteoporosis, such as clear
definite diabetes mellitus, rheumatoid arthritis, rheumatoid arthritis,
hyperparathyroidism or other bone metabolic diseases.
- Subjects who have received treatment with active-type vitamin D3 preparation, other
vitamin D preparations (>1000IU per day）, calcitonin, corticosteroid hormone,
androgen, estrogen, other hormone, vitamin K preparation, in the 3 months prior to
inanition of this study; Subjects who have received treatment with bisphosphonate
preparation or Sodium Fluoride in the 1 year prior to inanition of this study;
Subjects who have received treatment with Selective Estrogen Receptor Modulator (SERM)
in the 6 months prior to inanition of this study
- Concurrent serious renal disease, hepatic disease, uncontrolled hypertension
（≥150/100mmHg）, symptomatic ischemic heart disease, cerebral infarction or
arteriosclerosis obliterans.
- Cancer history within 5 years.
- Subjects who take antacid containing aluminum in the preparation, warfarin or
thrombolytic agents.
- Subject with any known abnormality in laboratory tests, which is deemed to be
clinically significant by the investigator, which include:
- Serum alkaline phosphatace (ALP) > upper normal limit 10% (calculated according to the
range of normal values of each center);
- Glutamic Oxalacetic Transaminase (AST)/ Glutamic Pyruvic Transaminase (ALT) > upper
normal limit 50％(calculated according to the range of normal values of each center);
- Serum creatinine >1.5mg/dL (133μmol/L);
- Blood-fasting sugar ≥ 7mmol/L (126mg/L)
- Inability of subject to return for scheduled visits or to comply with any other aspect
of the protocol.
- Subject who, in the opinion of the investigator, are poor medical candidates or pose
any other risk for therapy with an investigational drug.
Female
Subject must be at least 45 Years old.
Subject must be at most 75 Years | Efficacy and Safety Study on Menatetrenone in the Treatment of Postmenopausal Osteoporosis Women | NCT00165698 | Entailment |
5,543 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
1. Patients >18 years
2. Diagnosis of large vessel vasculitis based on Ultrasonographic and/or Computed
Tomography Angiography and/or Magnetic Resonance Angiography findings or biopsies of
the temporal arteries
3. Fulfill the classification criteria for Giant Cell Arteritis /Takayasu Arteritis
Exclusion Criteria:
1. Patients <18 years
2. Moderate to severe kidney failure
3. Known allergic reactions to contrast agents
4. Inability to give informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Magnetic Resonance Angiography vs Ultrasonography in Systemic Large vEssel vasculitiS | NCT02042092 | Entailment |
213 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
Healthy men:
Good general health,
- Normotensive,
- Normal testosterone levels,
- No medications known to influence glucose homeostasis or testosterone levels
IHH men:
- Good general health;
- Normal thyroid, adrenal, and GH axes;
- Normal prolactin levels;
- No abnormalities on imaging of the hypothalamic-pituitary region;
- No medications known to influence glucose homeostasis;
- Must have been off hormone therapy for a suitable washout period depending on the type
of prior androgen replacement
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Effect of Varying Testosterone Levels on Insulin Sensitivity in Normal and IHH Men | NCT00470990 | Entailment |
3,155 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
To be included in the study, participants needed to suffer knee osteoarthritis with
osteoarthritis levels 2 - 4 according to Kellgren-Lawrence grade12, be aged between 50 and
75 years and suffer knee pain and functional disability for at least three months,
according to the criteria of the American College for Rheumatology (ACR)13. Participants
from both genders were included. The Kellgren and Lawrence grading of knee osteoarthritis
is as follows: none (0), doubtful (1), minimal (2), moderate (3) and severe (4).
The ACR criteria of knee osteoarthritis are as follows:
- Using history and physical examination: knee pain and three of the following - over 50
years old; less than 30 minutes of morning stiffness; bone tenderness; bone
enlargement; no palpable warmth of synovial.
- Using history, physical examination and radiographic findings: knee pain and one of
the following - over 50 years old; less than 30 minutes of morning stiffness; crepitus
on active motion; and osteophytes.
- Using history, physical examination and laboratory findings: knee pain and five of the
following - over 50 years old; less than 30 minutes of morning stiffness; bone
tenderness; bone enlargement; no palpable warmth of synovial; crepitus on active
motion; ESR <40 mm/h; rheumatoid factor <1: 40; synovial fluid sign of osteoarthritis.
Exclusion Criteria:
- Participants were excluded if they had cancer, diabetes, symptomatic hip
osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics
during six months prior to enrollment.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 75 Years | Ultrasound and Exercises in Knee Osteoarthritis | NCT03676790 | Contradiction |
5,239 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Over 50 years of age
- Fragility fracture
- Consulting an orthopedic surgeon at the CHUS for treatment of the fracture
Exclusion Criteria:
- No Primary Care Practitioner
- Severe co-morbidity requiring specialized care
- Failure to consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 95 Years | Strategies to Treat Osteoporosis Following a Fragility Fracture | NCT00512499 | Entailment |
4,531 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- • Menstrual cycle ranging between 21-42 days
- At least 3 cycles after cessation of breastfeeding
Exclusion Criteria:
- • Not currently on medications that affect ovulation and 3 months prior
- Not currently pregnant or breastfeeding
- No known fertility problems
- Not planning on achieving pregnancy during the 3 menstrual cycles of the study
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 42 Years | Quantum Natural Family Planning Pilot | NCT03908697 | Contradiction |
3,231 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Men and women from 18 to 80 years old
- Patients recruited during the multidisciplinary consultation of Sjogren's Disease,
filling the criteria of Sjogren's Disease or patients having a salivary recidivate
pathology and selected players on the basis of their voluntary service to benefit from
an ultrasound of the main salivary glands
- The patients will have to be capable of adhering to the protocol of study and of
having understood it.
- The patients will have to be capable of giving a signed informed consent, the latter
being obtained before the inclusion
Exclusion Criteria:
- Not cooperative patient and having refused to sign the informed consent.
- Patient incapable to understand the protocol, under guardianship or under
guardianship.
- Unaffiliated patients to the Social Security.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Evaluation of the Reproducibility Inter-observer of the Ultrasound Anomalies of the Salivary Glands in Sjogren's Disease | NCT02358213 | Entailment |
5,075 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- post-menopausal women
- with a normal Bone Mineral Density (T-score >-1.5) at the 3 sites (lumbar spine, total
hip and femoral neck) or with osteoporosis (T-score ≤ -2.5) at least at one of the 3
sites.
Exclusion Criteria:
- Current antibiotherapy or in the last 6 months or repeated antibiotherapy
- Current corticotherapy or stopped for less than 6 months
- Current treatment of osteoporosis or having lasted more than 3 months in the last 5
years
- Current hormonal treatment for menopause
- Current or discontinued drugs that may affect bone metabolism (eg anti-aromatase)
- Known hepatic, cardiac or respiratory insufficiency
- Pathologies that may affect bone metabolism, particularly severe renal insufficiency
- Serious illnesses, particularly disabling and chronic diseases of the gastrointestinal
tract
- Diseases characterized by substantial disorders of the gut microbiota (eg severe
obesity, BMI> 40 kg / m2, depression, poorly controlled diabetes)
- Psychiatric pathology hindering understanding
- Difficulty understanding oral French
- Person protected by law, unable to express her consent, subject to a protective
measure or deprived of liberty.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Microbiota and Bone Fragility:Study of the Relation Between Gut Microbiota and Bone Microarchitecture | NCT04265742 | Contradiction |
690 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
1. Diagnosis
- Individuals who art homozygous for C282Y or H63D or "compound heterozygous" for
these tow variants and have ferritin levels higher than 300 micrograms/L or
transferrin saturation higher than 50%.
- Individuals heterozygous for C282Y or H63D if ferritin levels higher than 500
micrograms/L or transferrin saturation higher than 50%.
2. Requirements to the patient Body weight higher than 65 kg and initial hemoglobin level
higher than 12 g/dL.
Exclusion Criteria:
1. Contra-indications to either treatment modality
2. Patients who are not able to co-operate
3. Lack of informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Erythrocyte Apheresis Versus Phlebotomy in Hemochromatosis | NCT00509652 | Entailment |
4,066 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
To be considered eligible for enrolment into the study, subjects must;
1. Be aged 30 to 75 years (inclusive),
2. Be willing to provide informed consent,
3. Have a BMI between 18.5 and 32 kg/m2,
4. Have documented diagnosis of primary osteoarthritis (OA) of the target knee made at
least 12 months prior to Screening,
5. Have radiographic evidence of OA in the tibio-femoral compartment of the target knee
with at least 1 definite osteophyte and a measureable joint space, as diagnosed by
standard X-rays taken no longer than 18 months,
6. Have mild to moderate pain not adequately or completely controlled with
anti-inflammatory drugs,
7. Be able to perform the 20-meter walking test and to understand all questions from the
WOMAC questionnaire.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria;
1. Females are pregnant, lactating or wish to become pregnant during the study. Female
subject is currently either of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant,
including any female who is post-menopausal or any female who is surgically sterilized
(via documented hysterectomy or bilateral tubal ligation). (For purposes of this
study, postmenopausal is defined as one year without menses), OR
- child bearing potential, the subject is eligible to enter and participate in this
study if she is not lactating and has a negative urine pregnancy test at the screening
visit, visit 2 and upon completion of the study at visit 5. The subject must also
agree to one of the following methods of contraception: i. Complete abstinence from
intercourse two weeks prior to administration of study drug, throughout the clinical
trial, until the completion of follow-up procedures or for two weeks following
discontinuation of the study medication in cases where subject discontinues the study
prematurely. (Subjects utilizing this method must agree to use an alternate method of
contraception if they should become sexually active and will be queried on whether
they have been abstinent in the preceding 2 weeks when they present to the clinic for
the Final Visit.) or, ii. Has a male sexual partner who is surgically sterilized prior
to the Screen Visit and is the only male sexual partner for that subject or, iii.
Sexual partner(s) is/are exclusively female or, iv. Oral contraceptives (either
combined or progestogen only) with double-barrier method of contraception consisting
of spermicide with either condom or diaphragm. (Women of child-bearing potential using
an oral contraceptive in combination with a double-barrier method of contraception are
required to continue to use this form of contraception for 1 week following
discontinuation of study medication).
v. Use of double-barrier contraception, specifically, a spermicide plus a mechanical
barrier (e.g. male condom, female diaphragm). The subject must be using this method
for at least 1 week following the end of the study or, vi. Use of any intrauterine
device (IUD) with published data showing that the highest expected failure rate is
less than 1% per year. The subject must have the device inserted at least 2 weeks
prior to the first Screen Visit, throughout the study, and 2 weeks following the end
of the study.
1. Patient with secondary OA (due to a known disorder)
2. Has modified Kellgren-Lawrence Numerical Grading System of grade IV in the
patello-femoral compartment of the target knee confirmed by standard X-rays taken
no longer than 12 months prior to Screening, and before any baseline assessment,
3. Has clinically apparent tense effusion of the target knee or other joint,
4. Has had viscosupplementation in any joint including the target knee or other
joint within 9 months prior to Screening,
5. Subject is taking any anti-inflammatory steroid medications, salicylates
(aspirin) or Propionic acid derivatives (ibuprofen), for 2 weeks prior to study
entry,
6. Has concomitant inflammatory disease or other condition that affects the joints
(e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic
chondrocalcinosis and active infection, etc.),
7. Symptomatic OA of the contralateral knee that is not responsive to paracetamol
and requires other therapy,
8. Taking any calcium supplements (4-week washout) or other supplement e.g.
glucosamine, chondroitin,
9. Any medical condition deemed exclusionary by the Principal Investigator/Study
doctor,
10. Subject has a history of drug and / or alcohol abuse at the time of enrolment,
11. Change of dietary habit within the preceding month,
12. Subject with known organic disease, including an inflammatory bowel disease, a
benign or malign tumour of intestine or colon and significant systemic disease,
13. Subject currently involved in any other clinical trial or having participated in
a trial within the preceding 90 days,
14. Subject with known allergy to components of the test product,
15. Subject has any concurrent medical or psychiatric condition that, in the opinion
of the Investigator, would compromise his/her ability to comply with the study
requirements,
16. Subject has a history of cancer within the last 5 years, except basal cell
carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with
no significant progression over the past 2 years,
17. Subject has a significant cardiovascular, pulmonary, renal, liver, infectious
disease, immune disorder, or metabolic/endocrine disorders or other disease that
would preclude supplement ingestion and/or assessment of safety and the study
objectives,
18. Current illnesses which could interfere with the study (e.g. prolonged severe
diarrhea, regurgitation/severe, difficulty swallowing).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 75 Years | An Intervention Study Evaluating the Effects of a Raspberry Leaf Extract in an Osteoarthritic Population. | NCT03703024 | Entailment |
869 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Age 40-80
- Knee Pain
Exclusion Criteria:
- Inability to read, understand and give effective English consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Stated-Preferences in Knee Arthroplasty | NCT03058380 | Entailment |
890 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Male or female subjects in the age range of 40 - 70 years (both inclusive).
2. Body mass index (BMI) must be ≥ 25 and < 29.9 kg/m2.
3. Radiographic evidence of grade I- II osteoarthritis of knee joint, based on the
Kellgren and Lawrence radiographic entry criteria with WOMAC pain score in range of
10-16.
4. History of primary idiopathic osteoarthritis of the knee characterized by pain of mild
to moderate intensity which requires intake of analgesics.
5. Self-reported difficulty in at least one of the following activities attributed to
knee pain: walking a distance of 400 metres, getting in and out of the car, going up
and down the stairs or stiffness observed in the knee if > 30 minutes in the same
position.
6. Female subjects of child-bearing age must be willing to use the accepted methods of
contraception during the course of the study.
7. Ability to provide written informed consent.
Exclusion Criteria:
1. Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric condition,
alcoholism, drug abuse), medical history, physical findings, ECG findings or
laboratory abnormalities that in the investigator's opinion could adversely affect the
safety of the subject, makes it unlikely that the course of treatment or follow-up
would be completed or could impair the assessment of study results.
2. History of surgery or major trauma to the study joint.
3. History of arthroscopic surgery or intervention on the study joint.
4. Subjects who have received intra-articular steroids or hyaluronic acid within the last
three months.
5. Signs of active study joint inflammation including redness, warmth, and/or, if
qualifying with osteoarthritis of the knee, a large, bulging effusion of the study
knee joint with the loss of normal contour of the joint at the screening visit or at
the baseline examination after the washout period.
6. Subjects awaiting a replacement of knee or hip joint.
7. Subjects with other conditions that cause pain.
8. Subjects with deformity of the knee joint.
9. Subject who are significantly incapacitated or disabled and would be categorized as
ACR Functional Class IV (largely or wholly incapacitated), or unable to walk without
assistive devices.
10. Subjects with other known rheumatic or inflammatory disease such as rheumatoid
arthritis, osteomyelitis and bone metastasis.
11. Other pathologic lesions on X-rays of knee.
12. Positive hepatitis B surface antigen, Hepatitis C antibody, Anti human
immunodeficiency virus (HIV) antibody test, or VDRL.
13. History of bleeding disorders.
14. Inability to comply with the protocol requirements.
15. Participation in any other clinical trial within 3 months of registering in this
trial.
16. Women of child-bearing potential with a positive pregnancy test or who are lactating.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Assessment of the Efficacy of ParActin® in Subjects With Mild to Moderate Osteoarthritis | NCT03262792 | Entailment |
69 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
decreased serum testosterone concentration below the normal range (serum T < 300ng/dL), FSH
and LH levels within or below the normal range, absence of a pituitary or hypothalamic mass
lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH, normal smell
test and normal karyotypes
Exclusion Criteria:
previous androgen treatment, history of smoking, presence of bilateral anorchia,
intellectual deficiency, diabetes mellitus, arterial hypertension or dyslipoproteinemia,
medication of any kind and drug abuse. Because of possible confounding effects, patients
with other hormone deficiencies were excluded.
-
Male
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 26 Years | Plasma RBP Levels in Patients With Idiopathic Hypogonadotrophic Hypogonadism | NCT01758094 | Contradiction |
3,619 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Any patient consulting in the emergency department during the study period
Exclusion Criteria:
- Patients attending the emergency departments as part of dressing or trauma follow-up
consultations
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
| Impact of Biological Point of Care Devices Implementation on the Length of Stay of Patients in Emergency Room | NCT03840564 | Entailment |
1,346 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Boys and girls.
- Aged from 0 to 18 years old.
- Subjects with an Achondroplasia diagnosis.
- Patients or parents/ legal guardian must provide non opposition prior to participation
in the study.
Exclusion Criteria:
- Patients or patient's parents or legal guardian whose have an objection for using their
data.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | Radiological Analysis on Patients With Achondroplasia Disorder | NCT04184817 | Entailment |
6,228 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
Each subject must meet all of the following inclusion criteria to be randomized to
treatment:
1. Willing and able to provide written informed consent
2. Aged ≥ 18 years
3. SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization
4. Currently hospitalized due to SARS-CoV-2 infection with fever, defined as body
temperature ≥ 37.8 °C
5. Modified World Health Organization (WHO) Ordinal Scale for Clinical Status Patient
state in Covid-19: score 4 i.e. hospitalized, virus-positive, oxygen by mask or nasal
prongs
Exclusion Criteria:
The subject is excluded from the trial if any of the following criteria apply:
1. Concurrent treatment with other agents with actual or possible direct acting antiviral
activity against SARS-CoV-2 is prohibited < 24 hours prior to start of IMP treatment
2. Requiring mechanical ventilation at screening or it is expected within 24 h after
inclusion
3. Expected survival time < 72 hours for any reason
4. Positive pregnancy test
5. Breastfeeding woman
6. Presence of renal dysfunction defined as estimated glomerular filtration rate (eGFR)
<60 mL/min, total bilirubin ≥ 2.0 mg/dL, Thyroid stimulating hormone (TSH) outside
normal range and / or Aspartate aminotransferase (ASAT)/ Alanine aminotransferase
(ALAT) above threefold upper limit of normal range (known from patients medical
history)
7. Known hypersensitivity to the trial drug, the metabolites, or formulation excipient
8. History or presence of drug or alcohol abuse
9. History or presence of diseases of thyroid gland
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years | A Clinical Study to Assess the Efficacy and Safety of Amizon® Max in the Treatment of Moderate Covid-19 | NCT04682873 | Contradiction |
4,197 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Couples Inclusion Criteria:
1. Heterosexual couples in a committed relationship with a female partner aged 18-45
years and male partner aged 18 years and older attempting to conceive and seeking
assisted reproduction at participating fertility clinics.
2. Couples actively trying to conceive.
3. Couples who are planning ovulation induction (OI), natural fertility optimization
methods, or intrauterine insemination (IUI) should be willing to be on the study
dietary supplement for at least 3 weeks before starting the next assisted reproduction
cycle.Women with regular periods may initiate their fertility therapy at the start of
the woman's menstrual cycle following randomization if randomization occurred within
the first 10 days of the cycle, but must wait one menstrual cycle if the visit
occurred after day 10 of the cycle). For women with irregular periods or amenorrhea,
the male must be on the study supplement for 3 weeks prior to initiation of any
ovulation induction medication (e.g., clomid, letrozole, gonadotropins).
Couples Exclusion Criteria:
1. Female partner unwilling to participate (e.g., no abstraction of her assisted
fertility treatment record or unwilling to complete baseline visit).
2. Couples using donor, cryopreserved sperm, or sperm obtained via microsurgical or
percutaneous epididymal sperm aspiration.
3. Couples attempting to conceive with a gestational carrier (surrogate).
4. Positive urine pregnancy test at screening.
Male Inclusion Criteria:
1. Willing to provide semen samples according to the proposed schedule at baseline, 2, 4,
and 6 months of follow-up.
2. Able to complete regular study questionnaires and daily journals aimed at capturing
ejaculation, sexual intercourse and lifestyle factors considered to affect male
fecundity (e.g., cigarette smoking, fever, high temperature environment and other
environmental exposures) and other data collection instruments (e.g., physical
activity, food frequency questionnaire, stress).
Male Exclusion Criteria:
1. Age <18 years.
2. Unwilling to abstain from use of non-study approved dietary supplements or medications
containing folic acid or oral preparations containing zinc throughout the study.
3. Unwilling to abstain from use of testosterone supplementation throughout the study.
4. Diagnosis of Vitamin B12 deficiency or pernicious anemia.
5. Consuming a vegan diet.
6. A known genetic cause of male factor subfertility, including chromosomal disorders
related to subfertility (e.g., Y chromosome deletions).
7. Males currently using and unwilling (or unable) to discontinue the following drugs
known to interact with folic acid or interfere with the biosynthesis of folic acid
will be excluded.
1. Dihydrofolate reductase inhibitors: Trimethoprim, Triamterene, Bactrim, Iclaprim
2. Sulfonamides: Hydrochlorothiazide (HCTZ), Metolazone, Indapamide, Lasix, Bumex,
Torsemide, Chlorthalidone, Acetazolamide, Mefruside, Xipamide
3. Sulfonylureas: Glipizide, Glyburide
4. Cox-2 inhibitors: Celecoxib
5. Others: Valproic acid, Probenecid, Sulfasalazine, Sumatriptan, Mafenide,
Ethoxzolamide, Sulfiram, Zonisamide, Dorzolamide (optic), Dichlorphenamide,
Fluorouracil, Capecitabine, Methotrexate
8. History of organ transplantation.
9. Physician diagnosed:
1. Current poorly controlled chronic diseases such as heart disease, diabetes
mellitus, hypertension, cancer, inflammatory diseases, autoimmune, thyroid
disease, endocrine dysfunction, liver disease, kidney disease, or HIV/AIDS or
other immune-insufficient related illnesses.
2. Crohn's disease, celiac disease, ulcerative colitis, gastric bypass surgery, lap
band surgery or history of intestinal surgery to remove a portion of small bowel.
History of diseases/symptoms that require folic acid dietary supplementation,
such as megaloblastic anemia, homocystinemia, and homocystinuria.
3. History of alcohol dependency disorder and/or other drug/substance dependency in
the past 180 days.
4. History of psychoses or other mental conditions that would result in cognitive
impairment and inability to participate in any part of this study including the
informed consent process, as diagnosed by a physician within the past year.
10. History of vasectomy without reversal, obstructive azoospermia such as Congenital
Bilateral Aplasia of Vas Deferens (CBAVD), or ejaculatory duct obstruction.
11. Known allergy to folic acid or zinc dietary supplements.
Female Exclusion Criteria:
Age <18 or >45 years.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Folic Acid and Zinc Supplementation Trial (FAZST) | NCT01857310 | Contradiction |
1,414 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Nonsmoker >= 6 months prior to first dose
- body mass index (BMI) <= 36 kg/m2
- Meet American College of Rheumatology (ACR) clinical classification criteria for
osteoarthritis of knee by meeting at least 3 of the following: age > 50, morning
stiffness < 30 minutes, crepitus on active motion, bony tenderness, bony enlargement,
no palpable warmth of synovium
- Has Functional Class I-III osteoarthritis (OA) of knee with continuing OA-knee joint
pain >= 5 days/week x 3 months prior to screening, and has been taking a non-opioid
analgesic for OA knee pain daily for >=5 days prior to screening with benefit
- Otherwise healthy based on physical exam, medical history, vital signs, 12-lead
electrocardiogram (ECG), can clinical laboratory tests
- Women must be postmenopausal or surgically sterile.
Exclusion Criteria:
- Oral temperature >37.5 deg C at Screening or Day -1
- Failure of burn prevention measures quiz at Screening
- patients with occupations or hobbies in which they are routinely exposed to situations
in which they could sustain burns
- orthopedic and/or prosthetic device on target knee joint
- Significant pain outside the target knee, including significant hip or back pain
(bilateral knee OA is permitted)
- Unable to discontinue prior analgesic medications/non-steroidal antiinflammatory drugs
(NSAIDS) other than paracetamol during the study
- Surgical intervention for any pain within 3 months prior to screening or has plans for
surgical intervention while in the study
- History of prior diagnosis of inflammatory arthritis (including rheumatoid arthritis)
- Treatment with local corticosteroid injections or viscosupplementation in target
joint, or use of oral or intramuscular corticosteroids, within 3 months prior to
Screening
- History of active peptic ulceration, active dyspepsia, gastrointestinal bleeding,
Crohn's disease, ulcerative colitis, chronic diarrhea esophageal, and gastric or
duodenal ulcer within 3 months prior to screening or any other condition, which in the
Investigator's opinion, precludes use of an NSAID.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis | NCT01343303 | Contradiction |
6,342 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Patients who had fever (central temperature ≥38°C) or acute upper respiratory symptoms
and laboratory confirmation (rRT-PCR) for COVID-19, with available same type of upper
respiratory tract specimens from screening evaluation to the initial testing within 4
days of initial testing
2. Patients have mild (no pneumonia) to moderate disease (pneumonia without respiratory
distress) according to the following World Health Organization (WHO) definition of
COVID-19 clinical syndromes:
- Mild (Mild illness):
Patients with uncomplicated upper respiratory tract viral infection, may have
non-specific symptoms such as fever, fatigue, cough (with or without sputum
production), anorexia, malaise, muscle pain, sore throat, dyspnea, nasal congestion,
or headache. Rarely, patients may also present with diarrhoea, nausea and vomiting.
- Moderate (Pneumonia):
Adult with pneumonia but no signs of severe pneumonia and no need for supplemental
oxygen.
3. Willing and able to comply with the study procedure and sign a written informed
consent
Exclusion Criteria:
1. Patients with the medical history of hypersensitivity to chloroquine, chloroquinine,
or hydroxychloroquine
2. Patients with retinal disease, hearing loss, severe neurological and mental illness
3. Patients with pancreatitis
4. Patients with severe lung, liver (alanine aminotransferase (ALT)/aspartate
aminotransferase (AST) elevation more than 3 times the normal upper limit), kidney
(estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2, using the MDRD or
CKD-EPI methods), brain, haematological diseases or other important systemic diseases
5. Medical history of uncontrolled but clinically significant abnormal cardiac conduction
abnormalities at electrocardiogram (ECG) at screening, any history or evidence of long
QT syndrome or QTcF interval >450 msec for males and >470 msec for females (according
to Fridericia's correction) at screening
6. Known HIV infection; active hepatitis B or C without concurrent treatment (positive
tests for hepatitis B [both HBsAg and HBeAg], or high titer of hepatitis C ribonucleic
acid [RNA] >800,000 IU/ml)
7. Uncontrolled and unstable concurrent medical condition including psychiatric disorders
and alcohol/substance dependence/abuse that will jeopardize the safety of the patient,
interfere with the objectives of the study, or affect the patient compliance with
study requirements, as determined by the Investigator
8. Patients with concomitant use of medications that alter the absorption or excretion of
hydroxychloroquine
9. Patients were considered to be unable to complete the study, or not suitable for the
study judged by Investigators
10. Pregnant or breast-feeding women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 79 Years | Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19 | NCT04384380 | Entailment |
5,662 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- All students who accept to participate in the study
Exclusion Criteria:
- Students who refused to participate in the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
Subject must be at most 17 Years | Evaluation of the Effectiveness of Internet Based Nutrition and Physical Activity Education Programme in Adolescents | NCT02297919 | Contradiction |
6,893 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
1. Older than 55-year-old，male or female.
2. patients meet the diagnosis of mild cognitive impairment (MCI) or Alzheimer's
disease(AD) or whose family members were diagnoed with AD
3. Complete self-rating scale for memory impairment (AD-8 scale)
4. Those who agree to participate in clinical research and sign informed consent.
Exclusion Criteria:
1. Patients with acute cardiovascular and cerebrovascular diseases, acute infections
(pneumonia, urinary tract infection, oral infection, digestive tract infection),
severe renal dysfunction, and uremia;
2. Pregnant or lactating women;
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
| Proteomics Study of Mild Cognitive Impairment and Alzheimer's Disease | NCT04804618 | Entailment |
970 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Enrolled to receive medical care at the Michael E. DeBakey VA Medical Center
- At least 3 joints affected by distal interphalangeal (DIP) nodal hand OA
- DIP nodal hand OA will be defined as Heberden's nodes on physical exam.
- Sufficiently severe frequent pain of at least one DIP
- Frequent pain: pain on most days of the month for at least one month in the last year.
- Minimum VAS pain severity of 40 on a 0 - 100 scale
Exclusion Criteria:
- History or current inflammatory arthritides (examples: gout, psoriatic arthritis, and
rheumatoid arthritis)
- Prior surgery on the DIP joints
- Planned surgery for the DIP joints
- Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| A Pilot Randomized Controlled Trial for Hand Osteoarthritis | NCT04784065 | Entailment |
4,129 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Subjects must be aged between 18 to 35 years
2. Have a diagnosis of atopic asthma (based on at least one positive skin prick test and
methacholine PC20 ≤16 mg/ml)
3. FEV1 ≥ 70% of predicted
4. Demonstrate a cough response to capsaicin with a minimum of 3 coughs during the
screening capsaicin challenge
Exclusion Criteria:
1. Subjects who are in a pollen season that affects their asthma
2. Subjects who report allergies to capsaicin or bronchoconstrict at the end of the full
dose capsaicin cough challenge and require short acting bronchodilator therapy (assess
after visit 1)
3. Subjects who do not display evidence of airway hyper-responsiveness (methacholine
PC20>16mg/ml) (assess after visit 1)
4. Symptoms of upper respiratory tract infection in the last 1 month which have not
resolved.
5. Lower respiratory tract infection or pneumonia in the last 6 weeks.
6. Current smoker or ex-smoker with ≥10 pack year smoking history and abstinence of ≤6
months
7. Asthma exacerbation in the previous month requiring a start of inhaled or oral
corticosteroids.
8. Any asthma medication with the exception of infrequent (less than twice weekly)
short-acting β2-agonist.
9. Subjects who have changed asthma medication within the past 4 weeks prior to screening
10. A previous asthma exacerbation requiring Intensive Care Unit admission.
11. Significant other primary pulmonary disorders in particularly; pulmonary embolism,
pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis,
emphysema or bronchiectasis.
12. Pregnancy or breast-feeding
13. Use of ACE inhibitors
14. Any centrally acting medication (opioids, gapapentin, pregabalin, amitriptyline) which
in the view of the investigator could alter the sensitivity of the cough reflex
15. History of psychiatric illness, drug or alcohol abuse which may interfere in the
participation of the trial.
16. History of current or previous anabolic steroid use in men.
17. For the natural cycle group, the female patients must have regular (24 to 35 day)
natural cycles and no oral contraceptive use for ≥6 months
18. For female's taking the oral contraceptive pill they must be taking this ≥6 months
19. Use of B-blockers
20. Patients with clinically significant cardiovascular disease
21. Patients with known allergy to any of the study medications or excipients
22. Patients with a known potentially life threatening allergy (e.g. food allergy,
stinging insect allergy), history of anaphylaxis, mastocytosis, angioedema
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Effect of Sex Hormone During the Menstrual Cycle on Capsaicin Evoked Cough Responses | NCT04233762 | Contradiction |
651 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- Male,
- At least 18 years old
- BMI > 25 Kg/m2
- Serum ferritin level between 100 et 300 µg/L
- Written informed consent
Exclusion Criteria:
- Blood donations in the past two years
- Alcohol consumption more than 30 g/day
- Inflammatory syndrome (CRP > 10 mg/L)
- Inflammatory, dysimmunitary or cancerous disease
- Hepatic cytolysis
- Transferrin saturation > 45%
- Person involved in another clinical trial
- Person with a measure of legal protection (guardianship)
- Person who reached the annual limit for compensation provided by biomedical research
- Hemoglobin < 13 g/dL
- Uncontrolled heart failure or coronary insufficiency
- Abnormal ECG
- Echocardiographic abnormalities contraindicating phlebotomy
- Hepatic, renal or respiratory insufficiency
- Superficial venous network insufficiency
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Evaluation of Body Iron Stores in Overweight Healthy Volunteers | NCT02304874 | Contradiction |
1,524 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- All the patients who referred for video-fluoroscopic-swallowing study
Exclusion Criteria:
- none
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
| Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation | NCT03598491 | Entailment |
109 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Men, 40-70 years of age, in a stable relationship, with mild to moderate erectile
dysfunction for at least 6 months; defined as an IIEF-EF domain score between 11 and
25 (mild to moderate ED)
- Neutral or extremely dissatisfied with one's sex life
- Presence of androgen deficiency defined as serum total testosterone level less than
300 ng/dL (measured by LC-MS/MS) and/or free testosterone level (measured by
equilibrium dialysis) less than 50 pg/ml.
- Able to understand the nature of the study and provide written, informed consent
Exclusion Criteria:
- Contraindication for use of testosterone, e.g., history of prostate or breast cancer
- benign prostatic hyperplasia with AUA/IPSS symptom scores of 21 or greater
- erythrocytosis (hematocrit >50% at baseline)
- untreated, severe sleep apnea
- serum PSA levels >4 ug/L will be excluded unless they have had a urologic evaluation
in the past three months to exclude prostate cancer.
- Contraindication for use of sildenafil, e.g., symptomatic coronary artery disease
taking long-acting or short-acting nitrate drugs on a regular basis.
- Symptomatic postural hypotension
- Congestive heart failure with class III or IV symptoms
- History of myocardial infarction or stroke within the past six months
- Primary diagnosis of another sexual disorder such as premature ejaculation
- AST, ALT, alkaline phosphatase elevation greater than three times the upper limit of
normal, creatinine greater than 2 mg/dL.
- Currently taking testosterone or oral androgen precursors; unless willing to
discontinue their use for 4 weeks (oral precursors or transdermal testosterone patch
or gel) or 6 weeks (if injectable testosterone) before the initial screen visit.
- Currently taking medications that affect androgen metabolism, action, or clearance
(dilantin, phenobarbital, aldactone, flutamide, finasteride).
- Uncontrolled diabetes mellitus or diabetes mellitus, e.g., if their baseline
hemoglobin A1C is less than 8.5%.
- Structural abnormalities of the penis, including Peyronie's disease, will be excluded.
- Men who are taking medications for erectile dysfunction, including sildenafil, must
stop using these medications for at least 4 weeks before starting Visit 2.
- DSM-IV criteria for an Axis I psychiatric disorder within the past year, including
depression; use of psychotropic medication for at least six months, or dementia is
also an exclusion.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Effect of Testosterone in Men With Erectile Dysfunction | NCT00512707 | Contradiction |
1,330 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Achondroplasia without epiphyseal line closure
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 15 Years | Special Survey for Long Term Application | NCT01516229 | Contradiction |
3,227 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Subject is female between the ages of 18 and 49 years (at lease 21 subjects) or 50-60
years (no more than 9 subjects);
- Subject is using adequate non-barrier method of birth control [established us of
hormonal methods of contraception (oral, injected, implanted, or patch), intrauterine
device (IUD) or intrauterine system (IUS), surgical sterilization (e.g. in a
monogamous relationship with male partner with vasectomy];
- Subject is free of any vaginal disorders;
- Subject is sexually active and in a monogamous, heterosexual relationship, and whose
male partner is willing and able to give informed consent and agrees to engage in
sexual intercourse at least twice each week during the two-week study (at least 50%
and up to 100% of the study population) or is not sexually active (no more than 50% of
the population);
- Subject is a personal lubricant user and agrees to replace her usual personal
lubricant with the investigational product;
- Subject has normal menstrual cycle and is not expected to menstruate 2-4 days before
or after the examination days;
- Subject agrees to use the provided investigational product at least four times weekly
(including at least twice weekly during sexual intercourse for subjects with
monogamous, male partners) over the two-week study period;
- Subject exhibits no clinically significant evidence of vulvar or vaginal irritation,
as determined by a study doctor, and no reports of sensory irritation at the baseline
examination;
- Subject is willing to refrain from introducing any new vaginal products, or using
vaginal medication or local contraceptives (including condoms and hormonal rings),
during the course of this study;
- Subject agrees to refrain from douching or using any medications, powder, lotions or
personal care products in the vulvar or perianal area for the duration of the study
(Note: subjects may continue to use their usual pantyliner, if any);
- Subject is willing to use a urine pregnancy test provided to them at baseline and on
the third visit (Week 2, day 14);
- Subject has a standard Clinical Research Laboratories, Inc. (CRL) Medical History form
on file at CRL and has completed study specific Medical History and Screener/Inclusion
forms;
- Subject has signed and, if sexually active and in a monogamous relationship, whose
partner has signed, an Informed Consent Form (ICF) in compliance with 21 CFR Part 50:
"Protection of Human Subjects";
- Subject (and male partner, if applicable) has completed a HIPAA Authorization Form in
conformance with 45 CFR Parts 160 and 164;
- Subject is dependable and able to follow directions as outlined in the protocol;
- Subject receives a score of 0 or 0.5 for erythema and edema, and 0 for sensorial
irritation (burning, stinging, itching, and dryness) during the first examination.
Exclusion Criteria:
- Subject is pregnant, nursing, or planning a pregnancy;
- Subject is post-menopausal or has had a hysterectomy;
- Subject is currently using, or has used within two weeks prior to study initiation,
any systemic or topical corticosteroids, vasoconstrictors, antibiotics,
anti-inflammatories, or antihistamines;
- Subject has known allergies to vaginal or any cosmetic products (including lotions,
moisturizer, powder, sprays, etc.);
- Subject reports a history of recurrent bladder, vaginal infection, or incontinence;
- Subject exhibits or reports gynecological abnormalities or has had vaginitis within 60
days prior to study initiation.
- Subject is expected to menstruate 2-4 days before or after the time of the first,
second, and third examination;
- Subject uses a vaginal ring, diaphragm or cervical/vault caps, condoms, or condoms
with spermicide as a means of contraception;
- Subject has participated in a study involving the vaginal area or in an
investigational systemic drug study within two weeks of study initiation;
- Subject receives a score higher than 0.5 for erythema, edema, or >0 for burning,
stinging, or itching, during the first examination or shows any other sign of mucosal
irregularities (dryness, papules, vesticulation, fissure).
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | A Single-Center, Clinical Study to Evaluate the Safety of a Fragranced Personal Lubricant in Healthy Female Subjects | NCT02320214 | Entailment |
6,118 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Adults (˃18 years) COVID-19 positive patients (confirmed by PCR).
- Moderate infection ( pneumonia ± leucopenia or lymphopenia ).
Exclusion Criteria:
- Severe or life threatening COVID infection: Severe disease is defined as: dyspnea,
respiratory frequency ≥ 30/min, blood oxygen saturation ≤ 93%, partial pressure of
arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates >
50% within 24 to 48 hours. Life threatening disease is defined as: respiratory
failure, septic shock, and/or multiple organ dysfunction or failure .
- Pregnant or lactating females.
- Participation in any investigational clinical study, other than observational, within
the past 30 days; or plans to participate in such a study at any time from the day of
enrollment until 30 days post-treatment in the current study.
- Allergy or hypersensitivity to sirolimus.
- Taking immunosuppressive drugs.
- Glomerular filtration rate (GFR) < 30 ml/min by CKD-EPI equation.
- liver cirrhosis .
- Decompensated heart failure.
- known active tuberculosis (TB) or history of incompletely treated TB.
- Uncontrolled systemic bacterial or fungal infections.
- Drugs that may affect sirolimus level: antifungals, diltiazem, verapamil, nicardipine,
phenytoin, phenobarbital, rifampicin, carbamazepine.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy and Safety of Sirolimus in COVID-19 Infection | NCT04461340 | Contradiction |
6,088 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | - INCLUSION CRITERIA:
- Adults (at least 18 years of age) with a diagnosis of DS (including mosaic DS or
partial trisomy 21) who are capable of providing consent to participate, or for whom a
legally authorized representative (LAR) may give permission on behalf of the
individual to participate. Adults with DS who cannot consent for themselves but can
provide assent would need to provide assent to their LAR.
- Children (up to age 18 years of age) with a diagnosis of DS. Parents/guardians may
enter registry information and give permission to participate on behalf of their
child; if the child is over 7 years of age and able to provide assent, they must do
so. (Note: Once a child has reached age 18, he or she will be prompted to re-enroll
into the registry as an adult, if he/she is able to provide informed consent or with
the consent of his/her LAR if unable to re-enroll themselves.)
- Children with DS (between the ages of 7 and 18 years) will be asked to provide their
assent to register.
No individuals with DS will be excluded from taking part in DS-Connect based on age, race,
ethnicity, or gender.
EXCLUSION CRITERIA:
- A person who does not have a diagnosis of DS (or mosaic DS or partial trisomy 21)
- Adults with DS who are not capable of providing informed consent or assent to
participate and do not have a Legally Authorized Representative who can do so. In the
case where an adults with DS is able to provide assent but does not do so, that adult
will be excluded.
- A participant, parent, and/or LAR who cannot provide consent or does not read or
understand a language that is available for the registry, either English or Spanish.
- A child with DS (between the ages of 7 and 18 years) who is capable of providing
assent but does not do so.
- A child under the age of 18 years whose parents share joint custody and one parent
indicates that they do not consent to the child s participation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
| DS-Connect {TM}: The Down Syndrome Registry | NCT01950624 | Entailment |
4,134 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Non-smoking healthy male firefighters or volunteers
Exclusion Criteria:
- Current smoker or regular users of snus
- History of lung or ischaemic heart disease
- Malignant arrhythmia
- Systolic blood pressure >190mmHg or <100mmHg
- Renal or hepatic dysfunction
- Previous history of blood dyscrasia
- Unable to tolerate the supine position
- Blood donation within the last 3 months
- Recent respiratory tract infection within the past 4 weeks
- Routine medication including aspirin and NSAIDs
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Effect of Woodsmoke on Vascular Function | NCT01495325 | Contradiction |
4,456 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Cases diagnosed with lateral epicondylitis by the physician and decided to receive
conservative treatment
- Not receiving NSAID or other medical treatment
- Untreated Lateral Epicondylitis for the last 6 months
- Cases with age range 18-75
- Patients with pain and tenderness for at least 3 months
Exclusion Criteria:
- People with pacemakers or cardiac arrhythmias
- Tumoral disease
- Pregnant women
- Head and neck, elbow, scapula joint pathologies
- Acute infection
- Nerve or nerve root compression
- Other musculoskeletal problems
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 68 Years | Examining The Efficacy Of Scapular Exercises On Pain And Function İn Patients With Lateral Epicondylitis | NCT04141488 | Contradiction |
3,093 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Being between the ages of 12-18
- Mild to moderate intellectual disability
- Parents agree to participate in research.
- Lack of speech and vision impairment
- Completing all trainings and follow-ups during the research period
Exclusion Criteria:
- Not being between the ages of 12-18
- Having several intellectual disability
- Parents not agree to participate in research.
- Having speech and vision impairment
- Not completing all trainings and follow-ups during the research period
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 12 Years old.
Subject must be at most 18 Years | Determining the Effectiveness of Sexual Health and Development Education for Children With Intellectual Disability | NCT04635969 | Entailment |
1,691 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:- Potential participants will be any patient that is seen at Stanford
Dermatology or LPCH that has a cyst, nodule, vesicle, tumor, or possible pilomatricoma
Exclusion Criteria:- Inability of subject or subject's guardian to understand informed
consent form.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Use of Otoscope as a Non-Invasive Tool for Diagnosis of Pilomatricoma | NCT00715819 | Entailment |
6,811 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
Inclusion criteria for patients/caregivers in the Patient/Caregiver Study:
- Patients with hemophilia A (≥ 18 years of age) or caregivers of children with
hemophilia A (≥12-<18 years of age)
- Group 1: Hemophilia A patients/caregivers who have switched to FVIII products with
improved half-life for the treatment of hemophilia A during the eligibility period.
These patients can also include those who have switched back from FVIII products with
improved half-life to conventional FVIII replacement therapy within the Data
Collection Period
- Group 2: Hemophilia A patients/caregivers who are considering switching to FVIII
products with improved half-life within 12 months of the Start of the Documentation
period and have been prescribed prophylaxis regimen of at least 2x/week
- Able to understand, read, write and speak English
- Provide electronic informed consent
- Able to access the Internet for at least 20 minutes per day during the Data Collection
Period
Inclusion criteria for physicians:
- At least 60% of time spent in direct patient care
- Board-certified or eligible with a Specialty in Hematology or Hematology-Oncology
- Physicians with a specialty in Hematology-Oncology must have at least 10% of their
practice dedicated to treatment of hemophilia
- A minimum of 2 years' experience treating hemophilia A patients
Inclusion criteria for patients in the physician chart study:
- Hemophilia A patients age 12 year and over
- Prior treatment with one of the following FVIII replacement products: Adynovate,
Afstyla, Eloctate, or Kovaltry
- Patients that have 12 months of medical chart data available; 6 months on conventional
therapy and 6 months after switching to FVIII products with improved half-life.
Exclusion Criteria:
Exclusion criteria for patients/caregivers in the Patient/Caregiver Study:
- Hemophilia A patient initiated FVIII products with improved half-life for the treatment
at time of diagnosis with hemophilia A.
Exclusion criteria for physicians:
- Unwilling to comply with the study protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Evaluation of Patient and Physician Reported Reasons for Switching Factor VIII Replacement Therapies | NCT03405337 | Entailment |
6,771 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
Diagnosis of hemophilia or other severe bleeding disorders. Signed inform consent
Exclusion Criteria:
None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Swiss Hemophilia Registry | NCT02512250 | Entailment |
4,300 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Heterosexual, monogamous couples, of any race or ethnicity, who are sexually active
- 20 - 50 years of age
- Signed Informed Consent
- Past experience with using condoms
- Trying to conceive or using a non-vaginal birth control with which they do not
normally use a condom.
Exclusion Criteria:
- Vaginal tract medical interventions with the last three (3) month
- Vaginal prolapse
- Full Hysterectomy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 50 Years | Usability Study of the Focus Touch™ Conception System: Semen Collection | NCT01585012 | Entailment |
2,033 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- gastric adenocarcinoma proven by endoscopic biopsy;
- application of both computed tomography and diffusion weighted magnetic resonance
imaging;
- standard gastrectomy and a D2 lymph node dissection;
- desire to attend the study protocol
Exclusion Criteria:
- preoperative neoadjuvant therapy;
- metastatic disease;
- undesired reaction to attend the study protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Diffusion Weighted Magnetic Resonance Imaging for Preoperative Staging in Gastric Adenocarcinoma Patients | NCT01794026 | Entailment |
3,637 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- All patients presenting to the EDs during the study period will be included as far as
they do not actively ask to not be included in the study. Patients presenting during
the control period, will be allocated to the control group, while patients presenting
during the intervention period will be allocated to the intervention group,
indeependently of whether they receive clinical pharmacist services or not.
Exclusion Criteria:
- Patients for whom data is not available retrospectively.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Integrating the Clinical Pharmacists Into Emergency Department Teams | NCT04722588 | Entailment |
2,732 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- any type of inguinal hernia
Exclusion Criteria:
- active urinary tract infection,
- previous BPH, neurological disease or significant systemic disease,
- medications that could interfere voiding function
- history of prostate, bladder or urethral surgery or traumatic urethral
catheterisation.
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 90 Years | Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres | NCT03450811 | Entailment |
4,377 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
- Body mass index ≥ 18 and ≤ 30 (kg/m2)
- Medically healthy with normal screening results, or in the case of results that are
abnormal; the abnormal results are clinically insignificant (eg, medical history,
physical examination, neurological assessment, vital signs, oxygen saturation,
laboratory profiles)
- 12-lead ECGs (calculations by the electrocardiograph) which have no clinically
significant findings
- Vital signs which are within normal range
- No tobacco/nicotine-containing product use for a minimum of 6 months
- If female, must be able to adhere to acceptable methods of contraception or be
postmenopausal or surgically sterile
Exclusion Criteria:
- History or presence of significant cardiovascular, hepatic, renal, hematological,
gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease
- History or presence of any degree of chronic obstructive pulmonary disease
- History of suicidal ideations or depression requiring professional intervention
including counseling or antidepressant medication
- Any history of drug or alcohol abuse
- Positive drug (urine)/alcohol (breath) testing at screening or check-in
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg), or hepatitis C antibodies (HCV)
- History of hypersensitivity or allergy to propoxyphene or any opioid compound,
naloxone, naltrexone, palonosetron (Aloxi®), glycerin, senna, or bisacodyl (Dulcolax®)
- Use of any prescription medication (with the exception of hormonal contraceptives for
females) within 2 weeks of enrollment
- Use of any over-the-counter medication, including herbal products, within 1 week of
enrollment
- Use of any drugs known to significantly inhibit or induce liver enzymes involved in
drug metabolism [CYP P450]) within 30 days of enrollment
- Blood donation or significant blood loss within 30 days of enrollment
- Plasma donation within 7 days of enrollment
- Participation in another clinical trial within 30 days of enrollment
- Females who are pregnant or lactating
- Any other condition or prior therapy, which, in the opinion of the PI, would make the
subject unsuitable for this study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Multiple-Ascending-Dose Study to Evaluate the Safety of Propoxyphene Napsylate In Healthy Adult Subjects | NCT01133873 | Entailment |
5,483 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Male or female age 18-75
- If female, subject is not of child bearing potential. Defined as females who have
- had a hysterectomy or oophorectomy.
- bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year
since last menstruation).
- Female subject of childbearing potential must agree to use a medically approved method
of birth control and have a negative urine pregnancy test result. Acceptable methods
of birth control include: Hormonal contraceptives including oral contraceptives,
hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing),
injectable contraceptives (Depo--Provera, Lunelle), or hormone implant (Norplant
System), Intrauterine devices, Vasectomy of partner, Total Abstinence
- Subject has unresolved persistent muscle or nerve pain (muscle or nerve pain
population)
- Subjects using other therapies for nerve/muscle pain (e.g., exercise, TENS,
acupuncture, exercise, psychotherapy, massage, physiotherapy, etc), must be used at a
stable schedule for 1 month prior to the trial and subject agrees to continue these
therapies at the same schedule during the trial avoiding changes in frequency or
intensity and to record therapies in the study diary
- Agrees to comply with study procedures
- Has given voluntary, written, informed consent to participate in
- the study
Exclusion Criteria:
- Women who are pregnant, breastfeeding, or planning to become pregnant during the
course of the trial
- Planned surgery during the course of the trial
- Use of prescription drugs for fibromyalgia or nerve pain (e.g.Lyrica, Cymbalta and
Savella and others).
- Use of prescription medications for depression, anxiety or other mental disorders
- Requires the use of prescription drugs to control pain (other than provided rescue
medication)
- Use of oral or topical prescription or over the counter medications or natural health
products for pain relief 3 days prior to randomization and during the trial (other
than provided rescue medication)
- Use of natural health products including vitamins and minerals within 3 days prior to
randomization and during the trial
- Use of blood thinning medications (e.g. warfarin)
- Chronic lyme disease or chronic parasitic infections
- Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg
and/or diastolic blood pressure > 100 mmHg
- Subjects with diabetes
- History of bleeding disorders, or significant blood loss in the past 3 months
- Alcohol use >2 standard alcoholic drinks per day and/or alcohol or drug abuse within
the past year
- Allergy or sensitivity to study supplement ingredients or acetaminophen
- Participation in a clinical research trial within 30 days prior to randomization
- Individuals who are cognitively impaired and/or who are unable to give informed
consent
- Any other condition which in the Investigator's opinion may adversely affect the
subject's ability to complete the study or its measures or which may pose significant
risk to the subject
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain | NCT04737278 | Contradiction |
6,563 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Healthy volunteers
Inclusion Criteria:
- Age 18 - 60 years,
- Non smoker,
- Good general health and physical fitness
- Informed Consent
Exclusion Criteria:
- Current or history of tobacco smoking (> 5 py)
- Current alcohol or drug abuse
- Heart disease or untreated arterial hypertension
- Pulmonary disease
- Epilepsy or other major neurologic disease
- Dark skin colour
- Known anemia
- Severe metabolic disease (e.g. diabetes)
- Pregnancy
Patients
Inclusion Criteria:
- Age ≥ 18 years
- Long term oxygen therapy at rest and/or on physical effort
- Hypoxemia in arterial blood gas analysis at rest PaO2 ≤ 55 mmHg or < 60 mmHg with PHT
or polycythemia (men Hb > 174 g/L, women Hb > 140 g/L) or:
Oxygen desaturation on effort (SpO2 < 90%)
- Pulmonary disease including Chronic Obstructive Pulmonary Disease, Interstitial Lung
Disease and Sarcoidosis
- Informed Consent
Exclusion Criteria:
- Severe hypoxemia (pO2 <40 mmHg)
- Severe hypercapnia (pCO2 >55 mmHg)
- Acute respiratory infection or systemic infection,
- Severe systolic heart disease (LVEF < 25%)
- Myocardial infarction during the last month before inclusion
- Unstable angina pectoris
- Severe aortic stenosis (mean gradient > 40mmHg, valve area <1 cm2)
- Rhythmogenic heart disease
- Severe or untreated arterial hypertension (blood pressure > 180mmHg systolic, >100mmHg
diastolic)
- Anemia (Hb < 120 g/l)
- Known or suspected coagulation disorder (e.g. INR > 4)
- Severe or untreated metabolic disorder
- Neurologic disease or dementia
- Pregnancy
- History of non-compliance to medical treatment
- Current alcohol, drug abuse or current tobacco smoking
- Dark skin color
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. | NCT02723032 | Contradiction |
3,391 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Diagnosed with ear fluids (OME) according to a doctor's examination for at least 4-6
weeks. There is a progressive hearing impairment and a matching tympanum.
- In principle, these children (with OME and hearing impairment) meet the criteria and
candidates for the analysis of inserting tubes of incontinence (buttons).
Exclusion Criteria:
- First encounter: acute ear infection or Proper Otoscopy
- Second session: First review: Otoscopy / Timpneometry / Hearing test.
- Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up -
cessation of the experiment initiated by parents
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 10 Years | A Non-invasive Device to Remove Fluid From the Middle Ear | NCT03978195 | Contradiction |
5,630 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Both parental guardians (mother and father) and target child must be of Hispanic or
African American descent
- Child must be between the ages of 9-14 years
- Child must be overweight/obese as defined by a body mass index percentile for age-
gender specific between the 85th-100th percentile
- Child must have no physical disability or medical conditions that interfere with their
participation in an exercise program
- Children must have no extensive diet restrictions that would hinder their
participation in the BOUNCE nutrition component (e.g., unable to eat solid foods)
- All children will be required to submit evidence of a medical examination conducted by
a health professional
- Parental guardians and child must be available to participate for the duration of the
BOUNCE summer
Exclusion Criteria:
- Child and parental guardians are not Hispanic or African American
- Child is not between the ages of 9-14 years
- Child is underweight or normal weight (BMI < 85 percentile) or are morbidly obese (BMI
> 100 percentile)
- Child or mother are pregnant or physically unable to participate
- Child has extensive diet restrictions that would hinder their participation in the
BOUNCE nutrition component (e.g., unable to eat solid foods)
- Child does not have submitted evidence of a medical examination conducted by a health
professional
Note: We will encourage both maternal and paternal guardians to participate in the
measurements and interventions. However, if the paternal guardian refuses to participate or
there is no father figure present in the family, maternal guardian-child pairs will be
still eligible to participate in this study. If the children are of mixed race, but
identify themselves as Hispanic or African American and at least one of their parents is
either Hispanic or African American, they will be still eligible to participate.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 9 Years old.
Subject must be at most 14 Years | BOUNCE to Health: A Healthy Lifestyle Program | NCT03925012 | Contradiction |
812 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. KOA according to the clinical American College of Rheumatology (ACR) criteria. The
clinical ACR criteria for KOA are: knee pain and at least 3 of the 6 following
features: age ≥50, morning stiffness <30 minutes, crepitus, bony tenderness, bony
enlargement, no palpable warmth. KOA will be confirmed with radiographs, including
anterior-posterior (AP) and medio-lateral (ML) radiographs for imaging the
tibiofemoral joint, and an axial view for imaging the patellofemoral joint. Kellgren
and Lawrence (K&L) grading system for OA will be applied, with K&L grade 2 or higher
defined as OA; radiographic KOA is defined as definite osteophytes and possible joint
space narrowing.
2. pain, nominated by the patient as 3 /10 or higher on a visual analogue scale on most
days of the last 3 months
3. aged ≥ 50 years.
Exclusion Criteria:
1. treatment with exercise therapy or joint infiltrations (e.g., corticosteroids,
hyaluronic acid) in the preceding 6 months;
2. being on a waiting list for knee replacement;
3. any contra-indication for exercise therapy as established by the treating physician;
4. corticosteroid infiltrations in the last 6 months;
5. cognitive impairment (unable to understand the test instructions and/or Mini Mental
State Examination score <23/30);
6. unable to understand the Dutch language;
7. inflammation unrelated to OA (e.g. due to acute or chronic infection) established by
CRP>10mg/L.
8. presence of a disorder and/or medication that influences pain and/or the immune system
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Exercise Therapy for Osteoarthritis Pain: How Does it Work? | NCT04362618 | Entailment |
6,519 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Diagnosis of severe hemophilia A defined as <1% FVIII:C documented in medical records.
- Males between 18 and 65 years of age (Parts 1 and 2).
- Males between 12 and 65 years of age (Part 3).
- Subjects who have received or are currently receiving FVIII products (plasma-derived
and/or recombinant FVIII) and have had >150 exposure days (EDs) with a FVIII product
- Written informed consent for study participation obtained before undergoing any study
specific procedures.
Exclusion Criteria:
- Any history of or current FVIII inhibitors
- Any first order family history of FVIII inhibitors
- Use of an Investigational Medicinal Product within 30 days prior to the first
rVIII-SingleChain administration.
- Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to
administration of rVIII-SingleChain or reference product.
- Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or
hamster protein.
- Any known congenital or acquired coagulation disorder other than congenital FVIII
deficiency.
- Platelet count < 100,000/µL at screening.
- Human immunodeficiency virus (HIV) positive subjects with a CD4 count < 200/mm3, in
their medical history or at screening if available results are older than one year.
(HIV positive subjects may participate in the study and antiviral therapy are
permitted, at the discretion of the Investigator).
- Subject currently receiving IV immunomodulating agents such as immunoglobulin or
chronic systemic corticosteroid treatment.
- Subject with serum aspartate aminotransferase (AST) or serum alanine aminotransferase
(ALT) values > 5 times (x) the upper limit of normal (ULN) at Screening.
- Subjects with serum creatinine values > 2 x ULN at Screening.
- Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism,
myocardial infarction and arterial embolus within 3 months prior to Day 1.
- Experienced life-threatening bleeding episode or had major surgery or an orthopedic
surgical procedure during the 3 months prior to Day 1.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A | NCT01486927 | Contradiction |
6,336 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patients presenting with COVID symptoms to hospitals.
- Patients >18 years old
Exclusion Criteria:
- Patients without capacity to consent
- Pulmonary oedema secondary to decompensated cardiac, renal or liver disease at the
time of admission
- Interstitial lung disease at the time of presentation
- Known lymphangitis carcinomatosis
- Morbidly obese patients with BMI more than 40
- Patients with known pulmonary hypertension or if the clinician feels there are other
reasons for pulmonary hypertension than cardiomyopathy secondary to COVID 19.
- Pregnant women
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| COVID-19 Pathophysiology of Long Term Implications | NCT04813575 | Entailment |
2,030 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Key Inclusion Criteria:
- provide archive tumor tissue samples or accept fresh tumor tissue biopsy(Sample
requirements are: formalin-fixed and paraffin-embedded wax blocks of tumor tissue or
at least 20 unstained tumor specimen slides).
- assessed by the surgery can be removed, histology/confirmed HER2 positive cytology and
the integration of a stomach esophagus carcinoma.
- CT2-4CN any C M0 or T any CN +M0, AJCC/UICC TNM staging of gastric cancer (8th
edition).
- The HER2 receptor protein status was assessed by immunohistochemistry (IHC) and
fluorescence in situ hybridization (FISH) using the following methods.Tumors with
an IHC 3+ score are considered HER2-positive.Patients with immunohistochemical 2+
tumors were given FISH tests to determine FISH positive samples.
- Abdominal computed tomography (CT), abdominal, pelvic, and/or echo-endoscopy were
performed 2 weeks before surgery to assess resectability.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.
- have no received no any anti-tumor treatment, including surgery, chemotherapy,
targeted therapy, immune therapy.
- Adequate organ function (No blood transfusion or hematopoietic stimulating factor
therapy was received within 14 days. Absolute neutrophil count (ANC) ≥1.5×109/L
Platelet count ≥75×109/L Hemoglobin ≥80 g/L. Serum total bilirubin ≤1.5×ULN. total
bilirubin must be <3×ULN) Prothrombin time/international normalized ratio (PT/INR)
≤1.5×ULN and activated partial thromboplastin time (aPTT) ≤1.5×ULN.Aspartate
transaminase (AST) and alanine aminotransferase (ALT) ≤3×ULN. For subjects with liver
metastases, AST and ALT must be ≤5×ULN for subjects with liver metastases. Creatinine
clearance rate (Ccr) ≥50ml/min（according to the Cockcroft-Gault formula）. Urine
protein qualitative≤1+ ;Or urinary protein qualitative ≥2+, 24 hours urinary protein <
1g)
Key Exclusion Criteria:
- A history of any other malignancy in the past 5 years (except carcinoma in situ or
basal cell carcinoma of the skin or squamous cell carcinoma of the skin)
- Received other unmarketed investigational drug or therapy within 4 weeks prior to
initial investigational drug use.
- A major organ surgery (excluding needle biopsy) or significant trauma occurred within
4 weeks prior to initial investigational drug use.
- Requires systemic treatment with either corticosteroids (>10 mg daily prednisone
equivalents) or other immunosuppressive medications within 14 days of study drug
administration to treat a current condition.
Exceptions include: topical, ocular, intraarticular, intranasal, and inhaled
glucocorticoids;Short-term use of glucocorticoids for preventive treatment (e.g. to prevent
contrast allergy)
- Use of immunoregulatory drugs, including but not limited to thymosin, interleukin-2,
interferon, etc., within 14 days prior to initial use of the study drug.
- Has been administered a live vaccine within 4 weeks prior to Cycle1 Day 1.
- Previous recipient of allogeneic hematopoietic stem cell transplantation or organ
transplantation.
- Previous adverse reactions to other medications have not recovered to CTCAE 5.0 level
≤1 (Other toxicities, such as hair loss, were not considered to pose a safety risk).
- Symptomatic peripheral neuropathy was evaluated as > 2 with CTCAE 5.0.
- Has central nervous system metastases or meningeal metastases.
- Inability to swallow medications orally, or other gastrointestinal diseases (such as
total intestinal obstruction, etc.) that may affect the absorption of oral
medications.
- Patients who had an active infection within 1 week prior to the first use of the study
drug and who currently require systemic anti-infective therapy.
- has a history of alcohol or drug abuse or dependence.
- Known history of Human Immunodeficiency Virus (HIV).
- Untreated chronic hepatitis B viral (HBV) infection or chronic HBV carrier with HBV
DNA ≥200 IU/mL (or 1000 copies/mL),prophylaxis antiviral therapy other than interferon
is allowed ,or active hepatitis C virus (HCV) should be excluded.
- Current patients with interstitial lung disease.
- Has a history of severe cardiovascular and cerebrovascular disease, including but not
limited to: has serious heart rhythm or abnormal conduction;Acute coronary syndrome,
congestive heart failure, aortic dissection, stroke, or other grade 3 or higher
cardiovascular and cerebrovascular events occurred within 6 months prior to D1 ;New
York heart association (NYHA), cardiac function class II or higher and left
ventricular ejection fraction (LVEF) < 50%; clinical uncontrol of high blood pressure.
- Patients with active, or previous and recurrent autoimmune diseases (such as systemic
lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) were excluded from
patients with clinically stable autoimmune thyroid disease.
- Grade 3 or higher arteriovenous thromboembolism events or bleeding events occurred
within 6 months prior to the first use of the study drug;Or present with grade ≥2
bleeding or factors determined by the investigator to have a higher blood risk (such
as active gastrointestinal ulcer or esophageal varicose veins or tumor invasion of
major blood vessels).
- Gastrointestinal perforation, abdominal fistula or intraperitoneal abscess occurred
within 6 months prior to the first use of the study drug;Or a risk factor for cavity
perforation/fistula formation (e.g., tumor infiltration of the outer wall of the
cavity wall) currently identified by the investigator.
- Patients who allergies to the study drugs.
- People with mental disorders or poor compliance.
- Women who are pregnant or lactating.
- The investigator considers the subject to have a history of other serious systemic
disease or for other reasons unsuitable for participation in this clinical study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study of Perioperative Chemotherapy Combined With Tirelizumab and Trastuzumab in the Treatment of GC/EGC | NCT04819971 | Entailment |
924 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Male or female subjects may be recruited in to the Investigation.
- Age - The subject must be at least 21 years of age and skeletally mature as
demonstrated radiographically by complete closure of the distal femoral and proximal
tibial epiphyses.
- Subjects who are able to give voluntary, written informed consent to participate in
this investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Investigators and Approved Study Staff, are able
to understand this Investigation and cooperate with the Investigation procedures and
are willing to comply with all the required post-operative follow-ups.
- Subjects who require a total knee arthroplasty for primary surgical management of
osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, moderate deformities
or femoral condyle osteonecrosis as defined below.
- Osteoarthritis: Kellgren-Lawrence Grade 3 or higher, with clinical history of an
absence of major trauma to the joint; symptoms of pain, stiffness, swelling, and/or
loss of motion; and with radiographic evidence of joint space narrowing, sub-chondral
sclerosis, or peripheral osteophytes.
- Post-Traumatic Arthritis: Kellgren-Lawrence Grade 3 or higher, with a clinical history
of trauma to the targeted knee and subsequent pain, stiffness, swelling and loss of
motion; and with radiographic evidence of joint space narrowing, sub-chondral
sclerosis, or peripheral osteophytes.
- Rheumatoid Arthritis: American College of Rheumatology classification score of 6 or
higher, with a clinical history that demonstrates the following: morning stiffness for
at least 1 hour and present for at least 6 weeks, swelling, loss of motion, and/or
serum rheumatoid factor; and radiographic findings of narrow joint space,
peri-articular osteopenia, and/or per-articular erosions.
- Moderate Deformities: Moderate varus, valgus, flexion, or post-traumatic deformities
of no more than 15° assessed radiographically. Moderate recurvatum of no more than 8°
assessed radiographically.
- Femoral Condyle Osteonecrosis: Loss of blood supply in the femoral condyle
characterized by sudden onset of pain, possibly triggered by a specific seemingly
routine activity or minor injury. Pain is often increased with activity and at night
time and may cause swelling of the knee and sensitivity to touch and pressure and may
result in limited motion. Confirmed by a bone scan, MRI, and/or x-ray.
- Subjects whose anatomy is appropriate for the available range of implant sizes.
Exclusion Criteria:
- Patients who have had previous surgical procedures requiring implantation of hardware
in their operative side knee, hip, or ankle that would result in metal artifact
scatter in a CT scan.
- Patients who have a fracture malunion of the distal femur or proximal tibia within
12cm of the knee center, assessed radiographically.
- Patients who are pregnant, may become pregnant during the course of the Investigation,
or are currently lactating.
- Patients with allergies or suspected sensitivity to any patient-contacting component
of the investigational device or the implant to be used in the study as listed below:
- Femoral component: Cobalt Chromium alloy (CoCr)
- Tibial component: Titanium alloy (Ti6Al4V)
- Tibial inserts and patella component: Vitamin E infused ultra-high molecular weight
polyethylene (UHMWPE)
- Saw blade: 440C Stainless Steel
- Patients who require bilateral total knee arthroplasty.
- Patients who are currently on medical leave from their employment due to Workmen's
Compensation.
- Patients who are currently state or federal prisoners.
- Patients who are currently Wards of the state.
- Patients who are at high risk for poor healing or confounding outcomes or at excessive
risk for surgery i.e.: clinically significant/being actively treated for renal,
hepatic, cardiac, hematologic, or neurologic disease or poorly controlled diabetes
(HbA1c > 10 mg/dL) or previous history of joint infection.
- Patients who are known drug or alcohol abusers or with psychological disorders as
defined by DSM V that could affect follow-up care or treatment outcomes.
- Patients who are currently involved in another clinical study with an investigational
device.
- Patients with current litigation pending related to medical treatment of any sort.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Robotic Arm Assisted Total Knee Arthroplasty | NCT02058069 | Entailment |
6,792 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- 18-75 years of age, of either sex or any race
- Clinical history of at least 2 lipomas for at least one year
- Lipomas diagnosed as benign
- Two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart,
with easily definable edges
- Each lipoma is a single mass with easily definable edges
- Lipomas are 5 to 24 cm squared
- Women of childbearing potential must use an acceptable method of birth control
Exclusion Criteria:
- Lipomas on the head, neck, hand or foot, or female breast
- Women who are nursing or pregnant
- Multi-lobular lipomas
- Subjects who have received an investigational drug within 30 days before receiving the
first dose of study drug in this study
- Subjects with a known allergy to collagenase or any of the inactive ingredients in
XIAFLEX
- Subjects with uncontrolled diabetes, hypertension, or thyroid disease, or any medical
condition that would make the subject unsuitable for enrollment
- Subjects having prior treatment or trauma of the lipoma that could interfere with
study assessments
- Subjects with a history of connective tissue diseases, rheumatological diseases
- Subjects taking anticoagulants or planning to receive anticoagulants (except for lo
dose aspirin and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days
of injection of study drug
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma | NCT02249052 | Entailment |
4 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Adult male subject aged 18 to 65 years inclusive
- BMI > 30 kg/m2 and < 50 kg/m2
- Serum total testosterone concentration below the normal range
- LH levels below the upper limit of normal
- Oestradiol levels within or above the normal range of approved assay
- At least two symptoms of androgen deficiency present for at least 2 months prior to
the first Screening Visit, with at least one of these being a sexual dysfunction
Exclusion Criteria:
- Evidence of clinically significant endocrinopathy at screening that may interfere with
the study assessments
- Other types of hypogonadotropic hypogonadism or primary hypogonadism
- Any other pituitary or hypothalamic disease
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Phase IIb Multicentre, Double-Blind, Dose-Ranging, Randomised, Placebo-Controlled Study Evaluating Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism | NCT02730169 | Contradiction |
5,797 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- clinically and histologically confirmed painful Erosive or Atrophic OLP
- free from any systemic diseases using medical questionnaire guided by Cornell Medical
Index
Exclusion Criteria:
- history of drug induced lichenoid lesions
- potential treatment of OLP for less than 2 weeks by topical and 4 weeks systemic
therapy before study start
- pregnant or breast-feeding women,
- smoking and
- known hypersensitivity or severe adverse effects to the treatment drugs or to any
ingredient of their preparation
- loss of paliability or flexibility in the tissues involved by the oral lesions or
histological signs of epithelial dysplasia or lichenoid lesions within the biopsied
sites.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 60 Years | Clinical and Immunohistochemical Effect of Topical Pimecrolimus in Treatment of Oral Lichen Planus | NCT02443311 | Contradiction |
1,538 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- patients with established RA
- age between 18 and 65 years
- disease modifying anti-rheumatic drugs (DMARDs) stable for at least 3 months
- synovitis in wrist with pain visual analogic scale (VAS) between 4 and 8cm
Exclusion Criteria:
- patients with overlap syndromes
- polyarticular synovitis
- diabetes mellitus or uncontrolled hypertension and those with suspected local or
systemic infection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Effectiveness Intraarticular Corticosteroid | NCT01851278 | Contradiction |
148 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Overweight/obese (BMI = or > 27 kg/m2)
- Older (65-85 yr)
- Male veteran patients being seen at the PI's endocrine clinic and receiving standard
of care consisting of diet and regular exercise counseling
- Diagnosed with hypogonadism on current or previous testosterone replacement at the
PI's endocrine clinic
- Willing to provide informed consent
Exclusion Criteria:
- Failure to provide informed consent
- Unstable cardiopulmonary disease (e.g. recent MI, unstable angina, stroke) or unstable
disease (Class III or IV congestive heart failure).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
Subject must be at most 85 Years | Long-term Lifestyle Change and Testosterone Replacement | NCT03256292 | Contradiction |
1,829 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion criteria:
A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in
the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point
categorical scale), which has been present at least 3 times per week for 12 weeks,
unrelated to exercise.
C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating
(abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea;
however, the dominant symptom must be epigastric pain/discomfort.
D. Capable of and willing to give informed consent and comply with all study requirements.
Exclusion criteria:
A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C.
Patients requiring chronic treatment with any medication inducing GI symptoms (e.g.,
certain antibiotics, codeine, etc.).
D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or
presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions.
G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable
bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria.
I. History or presence of other known organic disease that might explain the dyspepsia
symptoms (e.g., symptomatic gallstones).
J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater
than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of
beer or 16 fluid ounces of wine) per day.
M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence
of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors
(PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks
maximum).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients | NCT00222131 | Entailment |
4,294 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
One of the following conditions:
- Sexually transmitted disease evaluation or prior history of sexually transmitted
disease
- Pregnancy
- Clinical condition that suggests possible immunodeficiency
- History of illicit drug use
- History of chronic viral hepatitis
- Patients with unexplained pneumonia or recurrent pneumonia
- Male patients who have a history of sex with men
- Abdominal pain in a sexually active woman or urethritis in a man
- Trauma.
- Age 18 years old or older.
Exclusion Criteria:
- Age less than 18 years.
- None of the above conditions.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Rapid HIV Testing Program in the Emergency Department | NCT00548041 | Entailment |
6,316 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- >= 60 years of age
- COVID-19 infection, confirmed by polymerase chain reaction (PCR) test <=5 days from
enrollment done in the ambulatory setting
- Able to provide informed consent
- Symptom related to COVID-19. This includes: fever or chills, cough, shortness of
breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of
taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea or
other symptom recognized by the Centers for Disease Control to be a symptom of
COVID-19.
Exclusion Criteria:
- Patients who undergo asymptomatic screening test that is positive and remain
asymptomatic during the eligible time window
- Patients who have had one or more positive more than 5 days prior to enrollment but
within 60 days of enrollment (ex. if a patient has a positive test 10 days prior to
enrollment and then a second positive test the day referred for enrollment, that
patient would be excluded. If a patient had a positive test 5 months ago, and then
another positive test the day he/she was referred for enrollment, that patient would
be eligible)
- Unable to take oral medication
- Male patients with female partners of reproductive potential who are unable to
maintain effective contraception during the recommended time period (during treatment
and for 130 days after the final dose)
- Symptoms requiring hospitalization or immediate referral to hospital
- Taking bicalutamide, any systemic hormonal therapy, or camostat within one month of
study entry
- Known hypersensitivity to bicalutamide, or camostat, or its components.
- On coumadin anticoagulation (because of drug-drug interaction with bicalutamide)
- Self-reported past medical history of chronic liver disease or cirrhosis
- Self-reported myocardial infarction within 6 months or past medical history of
congestive heart failure with known ejection fraction < 40%
- Taking any other investigational treatment for COVID-19 or COVID-19 prophylaxis
(COVID-19 vaccines and treatments allowed under FDA Emergency Use Authorization are
allowed.)
Women and people from all ethnic and race groups are eligible for this study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Camostat With Bicalutamide for COVID-19 | NCT04652765 | Entailment |
5,242 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- patients with a diagnosis of osteoporosis and with or without fracture
- post- menopausal women
- age > 48 years
Exclusion Criteria:
- vitamin D supplementation in recent 6 months
- patients on steroid
- age < 48 years
- patients with chronic diseases such as liver cirrhosis, renal failure, hypertension,
hyperparathyroidism
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 48 Years old.
| Study on the Correlation of Free Vitamin d With BMD and Fracture | NCT03605173 | Entailment |
2,977 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Moderate or severe intellectual disability
- Availability of patient and parent DNA
- No etiologic diagnosis with standard approaches: negative fragile X, normal pangenomic
180K and 1M array-CGH
- Informed consent of person having parental authority
Exclusion Criteria:
- Non availability of parent DNA
- Patient lost to follow-up
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Targeted Next Generation Sequencing and Intellectual Disability | NCT02889068 | Contradiction |
3,659 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE
IN ORDER TO PARTICIPATE IN THIS STUDY.
Inclusion:
DoD beneficiaries between the ages of 18-65 years old Symptoms of Low Back Pain greater
than 12 weeks duration Patients with a history of lower back surgery may be included
Exclusion:
DoD beneficiaries less than 18 years old or greater than 65 years old
Lower back pain caused by any of the following:
Infection Tumor Osteoporosis Ankylosing spondylitis Fracture Deformity Inflammatory process
Cauda equina syndrome Treated or untreated central nervous system impairment
Meeting the criteria for surgery, including:
progressive motor deficit sphincter impairment from neurological cause disabling sciatic
pain (in the absence of backache) lasting 6 weeks or more that is attributed to a
compromised nerve root and demonstrated by magnetic resonance imaging or computed
tomography Oncologic disease during the previous 5 years Unexplained weight loss, fever, or
chills Diagnosed upper urinary tract infection within last 28 days Patients identified
during standard of care interview to have a history of intravenous drug use.
Immunocompromised host
A severe comorbidity to include:
determining overall well-being (e.g. painful disabling arthritic hip joints) Cirrhosis
Ongoing dialysis Radiating symptoms to lower extremities (sciatica) History of bleeding
disorders History of high blood pressure History of heart, kidney, liver or ulcer disease
Allergic to analgesics or Non-steroidal anti inflammatory agents (NSAIDs) Pregnant or
breastfeeding Initial pain rating of greater than 8/10 on initial intake evaluation If any
of the components of the comprehensive metabolic panel are outside the Nellis clinical
laboratory reference ranges, the subject will be excluded from the study
If any of these four components of the complete blood count are outside of the Nellis
clinical laboratory reference ranges, the subject will be excluded from the study:
White blood cell count Hemoglobin Hematocrit Platelets
Patients taking any of the following medications are excluded from participating, unless
they agree to wash out for two weeks prior to entering the study:
Muscle relaxers of any type Non-steroidal anti-inflammatory agents (NSAIDs) * Patients
taking naproxen must agree to wash out for two weeks prior to entering the study, but can
begin taking it again, as prescribed, after Visit 1 where a baseline pain assessment is
performed.
Tramadol Gabapentin Pregabalin Glucosamine Narcotic pain medications
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | The Use of Methylsulfonylmethane (MSM) in the Treatment of Low Back Pain | NCT02268305 | Contradiction |
2,816 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Diagnosis of possible or more definite ALS according to the El Escorial criteria
- SVC >50% of predicted for age, height and gender.
- At least four of 12 ALSFRS-R questions scored as 2 or 3 at screening.
- Diminished but measurable grip strength (1) in at least one hand (females:10-50
pounds; males, 10-70 pounds).
- Taking riluzole at a stable dose or not taking riluzole at screening.
- On Radicava at a stable dose for at least 30d or not taking this
- Life expectancy at least 6 months
- Able to swallow tablets without crushing.
- Age: 18+ years at enrollment.
- Subjects are capable of giving written consent.
- If sexually active, must agree to use contraceptive or abstinence for duration of
treatment
- Females of child bearing age must have negative pregnancy test at screening
Exclusion Criteria:
- Concurrent illness or laboratory abnormalities that could confound the measurement of
ALS progression or interfere with the ability to complete the study.
- Taking any investigational study drug within 30 days of screening or five half-lives
of the prior agent.
- No previous exposure to clenbuterol.
- Pregnancy
- Clinically relevant EKG abnormality (arrhythmia, cardiomyopathy)
- Tachycardia (resting heart rate greater than 100 beats per minute)
- History of seizure disorder
- Hyperthyroidism
- Pheochromocytoma
- Pregnancy
- Have any other co-morbid conditions that in the opinion of the study investigator,
places the participant at increased risk of complications, interferes with study
participation or compliance, or confounds study objectives
- History of hypersensitivity to 2-agonist drugs such as albuterol, levalbuterol
(Xopenex), bitolterol (Tornalate), pirbuterol (Maxair), terbutaline, salmeterol
(Serevent).
- The use of the following concomitant meds is prohibited during the study:
diuretics (furosemide, Lasix), digoxin (digitalis, Lanoxin);blockers such as atenolol
(Tenormin), metoprolol (Lopressor), and propranolol (Inderal); tricyclic antidepressants
such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine,
Tofranil), and nortriptyline (Pamelor); MAO inhibitors such as isocarboxazid (Marplan),
phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine
(Parnate); or other bronchodilators such as albuterol (Ventolin), levalbuterol (Xopenex),
bitolterol (Tornalate), pirbuterol (Maxair), terbutaline (Brethine, Bricanyl), salmeterol
(Serevent), isoetherine (Bronkometer), metaproterenol (Alupent, Metaprel), or isoproterenol
(Isuprel Mistometer).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Clenbuterol on Motor Function in Individuals With Amyotrophic Lateral Sclerosis | NCT04245709 | Entailment |
6,285 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Patient with symptoms of COVID-19 (fever, headache, cough, sore throat, myalgias,
arthralgias, shortness of breath, anosmia, fatigue, diarrhea, vomit, or
conjunctivitis) meeting criteria for mild or moderate COVID-19 according to the
following criteria:
1. Mild COVID-19: With or without mild pneumonia. Peripheral oxygen arterial
saturation (SaO2) greater than or equal to 94% (90% in Mexico City and
Guadalajara) at room air. Does not meet criteria of moderate, severe, or critical
COVID-19.
2. Moderate COVID-19: Patient with pneumonia and risk factors for disease
progression; meeting all the following: Shortness of breath, peripheral oxygen
arterial saturation (SaO2) greater than or equal to 94% (90% in Mexico City and
Guadalajara) with a maximum 3 L/min of supplementary oxygen, does not meet
criteria for severe, or critical COVID-19.
2. Patient with less than or equal to 5 days from symptom onset
3. Participant understands the intervention and procedures and accepts randomization.
Exclusion Criteria:
1. Suspected or confirmed pregnancy at evaluation
2. Severe decompensation of any of the patient's underlying diseases
3. Previous diagnosis of COVID-19 with complete resolution of symptoms for at least 2
days.
4. Patients meeting criteria for severe or critical COVID-19 at evaluation:
1. Severe COVID-19 - Patient with ≥1 of the following: tachypnea (≥30 breaths per
minute), peripheral oxygen arterial saturation (SaO2) less than or equal to 93%
(89% in Mexico City and Guadalajara) with a maximum 3 L/min of supplementary
oxygen (patients requiring ≥4 L/min will be considered to have progressed to
severe COVID-19), or PaO2/FiO2 ratio <300.
2. Critical COVID-19 - Patient with ARDS, shock, multiorgan failure, or any other
condition requiring admission to an intensive care unit.
Elimination Criteria:
1. Participant retires consent to participate in the study
2. Patient requiring ≥4 L/min of supplementary oxygen in the 24 hours of hospitalization
(in the case that randomization occurred in the first 24 hours of hospitalization)
3. Two negative tests against SARS-CoV-2 (a sequential diagnostic strategy will be
implemented to reduce losses due to false negative tests).
4. Patient that do not tolerate thermotherapy and requests to stop receiving the
intervention.
5. Transfer to another medical unit in the first 5 days of inclusion in the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Local Thermotherapy for Patients With Mild-to-moderate COVID-19 | NCT04363541 | Entailment |
5,909 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- age more than 20 years old and less than 70 years old
- typical gastroesophageal reflux symptoms (heart burn and acid reflux)
- outpatient
- complete upper gastrointestinal endoscopy
Exclusion Criteria:
- age less than 20 years or more than 70 years old
- receive medication for reflux disease (including proton pump inhibitor, histamine type
2 receptor blocker, prokinetic agents) in previous one month
- pregnant women
- history of abdominal surgery
- severe comorbidity with cirrhosis, end-stage renal disease, heart failure
- no written informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 70 Years | Waist Circumference Versus Body Mass Index to Predict Severity of Gastroesophageal Reflux Disease | NCT00698178 | Contradiction |
4,041 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Able to provide written informed consent to participate in the study;
- Willing and able to comply with all study requirements and instructions of the site
study staff;
- Must be ambulatory;
- Study knee must have a clinical diagnosis of osteoarthritis (OA) supported by
radiological evidence (Kellgren Lawrence Grade 4) which is assessed locally (x-rays
within the past 6 months of screening are acceptable);
- Moderate to moderately-severe OA pain in the study knee (rating of at least 1.5 on the
WOMAC A, 5-point Likert Pain Subscale);
- Moderate to moderately-severe OA function in the study knee (rating of at least 1.5 on
the WOMAC C, 5-point Likert Function Subscale);
- WOMAC A, 5-point Likert pain subscale <1.5 in the contralateral knee;
- Ability to discontinue non-steroidal anti-inflammatory drug (NSAID) use at Screening
visit and/or 72 hours prior to the Baseline visit and for the duration of the clinical
study (low-dose aspirin (81 mg) is allowed during the study);
- No analgesia (including acetaminophen) taken 24 hours prior to an efficacy measure;
- No known clinically significant liver abnormality (e.g. cirrhosis, transplant, etc.).
Exclusion Criteria:
- As a result of medical review and screening investigation, the Principal Investigator
considers the subject unfit for the study
- A history of allergic reactions to human albumin (reaction to non-human albumin such
as egg albumin is not an exclusion criterion)
- A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan,
sodium caprylate)
- Presence of tense effusions
- Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis or
joint replacement in the affected knee, as assessed locally by the Principal
Investigator
- Isolated patella femoral syndrome, also known as chondromalacia
- Any other disease or condition interfering with the free use and evaluation of the
study knee for the duration of the trial (e.g. cancer, congenital defects, spine
osteoarthritis)
- Major injury to the study knee within the 12 months prior to screening
- Severe hip osteoarthritis ipsilateral to the study knee
- Any pain that could interfere with the assessment of study knee pain (e.g. pain in any
other part of the lower extremities, pain radiating to the knee)
- Any pharmacological or non-pharmacological treatment targeting OA started or changed
during the 4 weeks prior to randomization or likely to be changed during the duration
of the study
- Pregnancy or planning to become pregnant during the study
- Use of the following medications:
1. No intra-articular (IA) injected medications in the study knee during the study
(or 12 weeks prior to Baseline).
2. No analgesics containing opioids.
3. NSAIDs are not permitted during the study; acetaminophen is available as a rescue
medication during the study from the provided supply.
4. No topical treatment on the study knee during the study
5. No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study
(treatment such as low-dose Aspirin (81 mg) and Plavix are allowed)
6. No systemic treatments that may interfere with safety or efficacy assessments
during the study
7. No immunosuppressants
8. No use of systemic or intra-articular corticosteroids
- No human albumin treatment in the 3 months before randomization or throughout the
duration of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee | NCT03182686 | Entailment |
5,219 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Primary complaint of back pain
- Modified Oswestry Disability Index > 10 points=20%
Exclusion Criteria:
- Red flags noted in the patient's Low Back Medical Screening (i.e. tumor, fracture,
metabolic diseases, Rheumatoid Arthritis, prolonged history of steroid use, pregnancy,
ankylosing spondylitis, cauda equina).
- Use of high doses of blood thinners
- Evidence of central nervous system involvement, to include hyperreflexia, sensory
disturbances in the lower extremity, intrinsic muscle wasting of the hands,
unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of
the face, altered taste, the presence of pathological reflexes (i.e. positive
Hoffman's and/or Babinski reflexes), etc.
- Workers compensation or pending legal action regarding their back pain
- Insufficient English language skills to complete all questionnaires
- Inability to comply with treatment and follow-up schedule
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Dry Needling for Patients With Back Pain | NCT03586778 | Entailment |
6,326 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Age >18 years
- COVID PCR + patient: Patient screened positive by PCR on nasopharyngeal swab
- or COVID-like patient: Patient not screened, but considered COVID + because contact
with a COVID PCR + person, and presenting symptoms suggestive of COVID-19 among:
- Influenza-like illness (fever, body aches, arthralgia, etc.)
- Respiratory form: dyspnea, cough, rhinitis
- Gastrointestinal form: diarrhea, nausea, vomiting
- Anosmia and / or ageusia
- or patient COVID PCR-: If patient tested negative by PCR on nasopharyngeal swab, but
showing signs suggestive of COVID-19.
Exclusion Criteria:
- Patient objecting to the use of their data for research purposes
- Patient under justice or deprived of liberty.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Observational Study in Diagnosed Patients COVID-19, Supported on an Outpatient Basis. (COVID-PSL) | NCT04402905 | Entailment |
6,246 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Laboratory diagnosis:
- Respiratory specimen is positive for SARS-CoV-2 nucleic acid by RT-PCR; OR,
- The viral gene sequencing of the respiratory specimen is highly homologous to
known novel coronavirus.
2. Fever:
Axillary temperature >37.3℃
3. Respiratory variables (meets one of the following criteria):
- Respiratory rate: RR ≥25 breaths/min
- Oxygen saturation ≤93% at rest on room air
- PaO2/FiO2 ≤300 mmHg（1 mmHg=0.133 KPa）
- Pulmonary imaging showed that the lesions progressed more than 50% within 24-48
hours, and the patients were managed as severe
4. HBsAg negative, or HBV DNA ≤10^4 copy/ml if HBsAg positive; anti-HCV negative; HIV
negative two weeks prior to signed Informed Consent Form (ICF)
5. Appropriate ethics approval and
6. ICF
Exclusion Criteria:
- Age <18 years; Age >80 years
- Pregnant or breast feeding woman or with positive pregnancy test result
- P/F <100 mmHg
- Moribund condition (death likely in days) or not expected to survive for >7 days
- Refusal by attending MD
- Not hemodynamically stable in the preceding 4 hours (MAP ≤65 mmHg, or SAP <90 mmHg,
DAP <60 mmHg, vasoactive agents are required)
- Patient on invasive mechanical ventilation or ECMO
- Patient in other therapeutic clinical trial within 30 days before ICF
- Receive any other ACE inhibitors (ACEI), angiotensin-receptor blockers (ARB) treatment
within 7 days before ICF
- Chronic immunosuppression: current autoimmune diseases or patients who received
immunotherapy within 30 days before ICF
- Hematologic malignancy (lymphoma, leukemia, multiple myeloma)
- Other patient characteristics (not thought to be related to underlying COVID-19) that
portend a very poor prognosis (e.g, severe liver failure, and ect)
- Known allergy to study drug or its ingredients related to renin-angiotensin system
(RAS), or frequent and/or severe allergic reactions with multiple medications
- Other uncontrolled diseases, as judged by investigators
- Body weight ≥85 kg
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19 | NCT04287686 | Contradiction |
2,476 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- Patients with retina, glaucoma and neuroophthalmic disorders
- Patients with normal eye exams to act as controls
- Must be able to comprehend instructions and perform visual fields
Exclusion Criteria:
- Patients <18years old
- Patients unable to comprehend visual field instructions or unwilling to participate
- Patients lacking a complete clinical file or lacking a specific diagnosis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Assessment of Visual Function in Ophthalmic Disorders Using Virtual Visual Field Analysis | NCT04110015 | Contradiction |
4,678 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Age of 18 through 45 years at screening, verified per site SOP
2. Female participants, born female
3. Not pregnant or breastfeeding
4. Availability to return for all study visits, barring unforeseen circumstances
5. Willing and able to
- communicate in English
- provide written informed consent to take part in the study
- provide adequate locator information, as defined in site SOP
- complete all required study procedures, including phone surveys, daily vaginal
swabs, and reliably store swabs in freezer
6. Must agree
- not to participate in other concurrent interventional and/or drug trials
- to use study-provided condoms for vaginal or anal intercourse for the duration of
the study
- to abstain from use of any vaginal products (e.g., lubricants, feminine hygiene
products, vaginally administered contraceptive products, sex toys) other than
study products for the duration of the study beginning at enrollment Note:
Tampons may be used during menses, but must be discontinued 72 hours prior to
study visits and for 7 days after biopsy procedures. Menstrual pads will be
provided to participants.
- to abstain from receptive oral, vaginal, or anal intercourse during the first
week after each pod-IVR insertion and for 2 days before and 7 days after biopsy
procedures
- to abstain from insertion of anything in the vagina (e.g., tampon, finger, sex
toy, lubricants, medication, douche) during the first week after each pod-IVR
insertion and for 2 days before and 7 days after biopsy procedures
7. Understands and agrees to local STI reporting requirements
8. HIV-1 seronegative at screening
9. Must be in general good health in the opinion of the investigator
10. Regular menstrual cycles of approximately 21 to 35 days apart with no untreated
intermenstrual menstrual bleeding Note: This criterion is not applicable to
participants using continuous combination oral contraceptive pills or progestin-only
methods (such as Depo-Provera or levonorgestrel-releasing IUD), as the absence of
regular menstrual cycles is an expected, normal consequence in this context.
11. Satisfactory cervical Pap result in the 36 calendar months prior to Enrollment
consistent with Grade 0 according to the Female Genital Grading Table for Use in
Microbicide Studies [Addendum 1, Dated November 2007], or if Grade 1 or higher Pap
result has had a satisfactory evaluation with no treatment required per American
Society for Colposcopy and Cervical Pathology (ASCCP) guidelines in the 12 calendar
months prior to Enrollment
12. Using an effective method of contraception and intending to continue use of an
effective method for the duration of study participation. Acceptable methods include:
- hormonal methods (except contraceptive vaginal rings)
- IUD
- sterilization of participant or partner
In addition to the criteria listed above, participants who agree to have rectal
biopsies collected must meet the following criteria:
13. Must agree to abstain from insertion of anything in the rectum (e.g., finger, sex toy,
lubricants, medication, enema) during the first week after each pod-IVR insertion and
for 2 days before and 7 days after biopsy procedures
Male sexual partner(s) who meet the following criteria are eligible for inclusion in the
study:
1. Age of 18 years or over
2. Has a female sexual partner enrolled in the study
3. Willing and able to
- communicate in English
- provide written informed consent to take part in the study
- provide adequate locator information, as defined in site SOP
- complete in-depth interview via video conference
Exclusion Criteria:
Individuals who meet any of the following criteria will be excluded from the study:
1. Undergoing or completed gender reassignment
2. Participant reports any of the following at Screening:
1. Has plans to relocate away from the study site area during the period of study
participation
2. Pregnant, less than 3 months post-partum, or lactating
3. Intends to become pregnant during the period of study participation
4. Current or planned use of an IVR
5. Known HIV-infected partners
6. Non-therapeutic injection drug use in the 6 months prior to screening
7. History of autoimmune disease
8. History of toxic shock syndrome
9. History of adverse reaction to TDF, FTC, silicone, or microcrystalline cellulose
10. PrEP or Post-exposure prophylaxis for HIV exposure within 6 months prior to
screening
11. Use of systemic immunomodulatory medications within the 4 weeks prior to the
Enrollment
12. Use of vaginally or rectally administered medications or products (including
condoms) containing Nonoxynol-9 (N-9) within the 4 weeks prior to the Enrollment
13. Participating in another research study involving drugs or medical devices within
the 4 weeks or 5 half-lives (if known) prior to the Enrollment
14. Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage,
piercing) within 60 days prior to Enrollment
Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap smear as well
as IUD removal are not exclusionary
3. Per participant report at screening, anticipated use and/or unwillingness to abstain
from the following medications during the period of study participation:
1. Heparin, including Lovenox® (enoxaparin sodium)
2. Warfarin
3. Plavix® (clopidogrel bisulfate)
4. Any other drugs that are associated with increased likelihood of bleeding
following mucosal biopsy (e.g., daily high dose aspirin, Pradaxa®)
5. NSAID use for 5 half-lives prior to biopsy (e.g. ibuprofen for 1 day, naproxen
for 4 days).
6. Rectally or vaginally administered medications (including over-the-counter
products)
4. History of significant gastrointestinal bleeding in the opinion of the investigator
5. Abnormalities of the cervical, vaginal, or colorectal mucosa, or significant
symptom(s), which in the opinion of the clinician represents a contraindication to
protocol-required biopsies (including but not limited to presence of any unresolved
injury, infectious or inflammatory condition of the local mucosa, and presence of
symptomatic external hemorrhoids). Erythema is not exclusionary.
• Includes any clinically apparent Grade 2 or higher pelvic examination finding
(observed by study staff) at Screening or Enrollment, as per the Female Genital
Grading Table for Use in Microbicide Studies [Addendum 1, Dated November 2007]
6. At screening: participant-reported symptoms and/or clinical or laboratory diagnosis of
active rectal or reproductive tract infection requiring treatment per current CDC
guidelines or symptomatic urinary tract infection (UTI). Infections requiring
treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis,
trichomoniasis, chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions,
chancroid, pelvic inflammatory disease, genital sores or ulcers, cervicitis, or
symptomatic genital warts requiring treatment (i.e., those that cause undue burden or
discomfort to the participant).
Note:
- An HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since
treatment is not required
- One re-screening after documented treatment will be allowed
7. Has any of the following laboratory abnormalities at Screening:
Note: Grade is per Version 2.1 of the DAIDS Toxicity Table
1. Hemoglobin Grade 1 or higher
2. Platelet count Grade 1 or higher
3. International Normalized Ratio (INR) Grade 2 or higher
4. White blood cell count Grade 2 or higher
5. Calculated creatinine clearance ≤ 80 mL/minute using the Cockcroft-Gault equation
6. Grade 2 or higher ALT and/or AST (i.e., ≥ 2.5x the site laboratory upper limit of
normal [ULN])
7. Positive for Hepatitis B surface antigen (HBsAg)
8. Positive for Hepatitis C antibody (HCV Ab)
8. Has any other condition that, in the opinion of the Principal Investigator or
designee, would preclude informed consent, make study participation unsafe, complicate
interpretation of study outcome data, or otherwise interfere with achieving study
objectives
Male sexual partner(s) who meet the following criteria are not eligible for inclusion in
the study:
1) Female partner did not utilize study product
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study) | NCT03255915 | Entailment |
856 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- radiographically assessed osteoarthritis of the knee graded 1 to 4 according to the
Kellgren and Lawrence scale
- self reported moderate to severe level pain
Exclusion Criteria:
- acute septic arthritis
- predisposition to a tendency to fall
- lack of physical or mental ability to perform or comply with the treatment procedure
- diabetes mellitus
- history of pathological osteoporotic fracture
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years | The Effect of Neuromuscular Training on Osteoarthritis: A Comparative Prospective Randomized Study | NCT00457132 | Entailment |
3,744 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- symptomatic knee osteoarthritis
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 75 Years | Motivators and Barriers to Physical Activity in Knee Osteoarthritis Patients: a Qualitative Study | NCT02777684 | Contradiction |
Subsets and Splits