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3,630 | 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:
- Women between the ages of 18-45 (inclusive) not intending to get pregnant during the
next year
- Women complaining of heavy menstrual bleeding over several consecutive cycles
- Women without structural or histological abnormality of the uterus, or with fibroids
less than 3 cm in diameter which are causing no distortion of the uterine cavity
(eligible for pharmaceutical treatment according to the NICE guideline 2007)
- Informed consent (where required by laws or regulations)
Exclusion Criteria:
- The contraindications and warnings of the respective Summary of Product
Characteristics (Mirena, combined oral contraceptives, oral/injectable progestogens,
non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed.
- Women taking hormone replacement therapy
- Women with symptoms such as intermenstrual or post-coital bleeding, unless an
endometrial biopsy has been performed and pathology excluded
- Women with fibroids that are palpable abdominally or who have intra-cavity fibroids
and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than
12 cm (NICE guideline 2007)
- Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use)
known to cause menorrhagia
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Mirena or Conventional Medical Treatment for Menorrhagia | NCT00864136 | Entailment |
2,426 | 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. | DMD-Patients
Inclusion Criteria:
- Histologic or genetically proven DMD
- Age 3-10 years
Exclusion Criteria:
-
Healthy controls
Inclusion Criteria:
- Male
- Age 3-10 years
Exclusion Criteria:
- Suspected muscular disease/myopathia
- missing informed consent
Male
Accepts Healthy Volunteers
Subject must be at least 3 Years old.
Subject must be at most 10 Years | Non-invasive Imaging of Muscle Structure in Duchenne Muscular Dystrophy Using Multispectral Optoacoustic Tomography | NCT03490214 | Entailment |
1,617 | 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:
- Age between 40-70 years at screening
- Proven hand OA by clinical examination and/or ultrasound
1. Clinical examination criteria: Heberden/Bouchards nodes and/or bony enlargement,
squaring and/or deformity of the thumb base and no clinical signs of inflammatory
arthritis (e.g. soft tissue swelling of two or less metacarpophalangeal (MCP)
joints, and no soft tissue swelling of the wrist).
2. Ultrasound criteria: Osteophytes in the interphalangeal joints and/or the thumb
base, and no signs of inflammatory arthritis (e.g. synovitis with power Doppler
activity in two or less MCP joints and no synovitis with power Doppler activity
in the wrist).
- Capable of understanding and signing an informed consent form
- Provided a written informed consent to participate in the study
Exclusion Criteria:
- Diagnosis of inflammatory arthritic disease, e.g. seropositive or seronegative
rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthritis or
arthritis related to connective tissue disorders
- Diagnosis of psoriasis
- Erythrocyte sedimentation rate (ESR) > 40 mm/hour and/or C-reactive protein (CRP) >20
mg/L, without a known ongoing infection
- Anti Cyclic Citrullinated Protein (anti-CCP) and/or rheumatoid factor positivity
- Ferritin >200 microgram/L for women and >300 microgram/L for men and s-iron/s-total
iron binding capacity (TIBC) above 50%
- Major co-morbidities (e.g. severe malignancies, severe diabetes mellitus, severe
infections, uncontrollable hypertension, severe cardiovascular disease or severe
respiratory disease)
- Mental or psychiatric disorders, alcohol or drug abuse, language difficulties or other
factors that make compliance to the study protocol difficult.
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 | The Nor-Hand Study | NCT03083548 | Contradiction |
79 | 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:
- Successful completion of ZA-203
- Ability to understand and provide written informed consent
- Agreement to use a condom, and with a fertile female partner, another form of
contraception
- Agreement to provide semen samples in the clinic
Exclusion Criteria:
- Any condition which, in the opinion of the Investigator, would make the Subject an
unsuitable candidate for enrollment in the study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 65 Years | A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203 | NCT01386567 | Contradiction |
3,933 | 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:
- Primary diagnosis of Functional Class I-III OA of the hip or knee
- Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen for
OA pain
- Discontinued all analgesic therapy at Screening
- For women of child-bearing potential: a woman who is not pregnant and not nursing, and
who is practicing an acceptable method of birth control
Exclusion Criteria:
- History of allergic reaction or clinically significant intolerance to acetaminophen,
aspirin, or any NSAIDs, including meloxicam
- Requires continuous use of opioid or opioid combination products to control OA pain of
the knee or hip
- Clinically significant unstable cardiac, respiratory, neurological, immunological,
hematological, or renal disease
- Significant difficulties swallowing capsules or unable to tolerate oral medication
- Previous participation in another clinical study of Meloxicam Capsules or received any
investigational drug or device or investigational therapy within 30 days before
Screening
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.
| Study of Meloxicam Capsules to Treat Osteoarthritis Pain | NCT01787188 | Entailment |
1,142 | 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. | Group 1:
HCM patients, aged grater than 20 years of either gender who received DDD pacemakers at the
NIH at least 4 years ago, for relief of LVOT obstruction and drug-refractory symptoms.
Group 2:
HCM patients selected from Group 1 who at the follow-up cardiac catheterization are
demonstrated to have either (1) no significant LVOT obstruction (less than 30mm HG at rest
and less than 50mm HG with Isuprel); or (2) a substantial reduction of the LVOT obstruction
(greater than 50% reduction in LVOT gradient).
Patient who have developed a heart block will be excluded from group 2.
Females must have a negative pregnancy test.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy | NCT00001530 | Entailment |
5,393 | 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:
- Diagnosed with VWD
- Desmopressin acetate (DDAVP) treatment is ineffective or contraindicated or not
available
- Evidence of vaccination against hepatitis A and B (or presence of antibodies against
hepatitis A and B) within 10 years prior to their first dose of Biostate®
- Written informed consent given
Exclusion Criteria (for participation in the PK component):
- Actively bleeding immediately prior to initial PK period
- Have received DDAVP or a VWF product in the 5 days prior to their first dose of study
product
- Have Type 2B, 2N or 2M VWD
Exclusion Criteria (for all subjects):
- Requiring a VWF product for a planned surgical procedure at enrolment
- Have received aspirin or other non-steroidal anti-inflammatory drugs within 7 days
prior to their first dose of study product
- Known history of, or are suspected to have, VWF or FVIII inhibitors
- Suffering an acute or chronic medical condition, other than VWD, which may affect the
conduct of the study
- Known or suspected hypersensitivity or previous evidence of severe side effects to
Biostate®, VWF/FVIII concentrates, or human albumin
- Impaired liver function at screening
- Evidence or a history (within the previous 12 months) of abuse of any drug substance,
licit or illicit
- Participation in a clinical study or use of an investigational compound in the 3
months preceding the first day of study drug administration, or plans to enter such a
study during the study period.
- Females who are pregnant, breast-feeding or who have a positive pregnancy test at
screening
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.
| Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease | NCT00941616 | Entailment |
3,832 | 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. | Main Inclusion Criteria:
- Diagnosed with knee osteoarthritis based on clinical and radiographic criteria of
American College of Rheumatology
- Grade 2 or 3 according to the criteria of Kellgren & Lawrence knee osteoarthritis
radiographic examination scale.
- Minimum score of 4 cm in Visual Analogue Scale (total 10 cm)
- Medical prescription, showing that the participant is capable of performing physical
activities
Main exclusion Criteria:
- Physical therapy within 3 months prior to the research project
- Corticosteroid injection in the knee (in the previous 6 months)
- Medical condition (cardiorespiratory, neurological and / or musculoskeletal)
- Previous ankle, knee or hip surgery
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 75 Years | Cryotherapy Associated With Exercise in Pain Control and Physical Function in Individuals With Knee Osteoarthritis | NCT03360500 | Entailment |
6,196 | 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:
- Tests negative for current or previous SARS-CoV-2 infection by RT PCR and serology
(Pre-exposure population only)
- Is at high risk of SARS-CoV-2 infection as assessed by the Investigator:
1. Post-exposure population: including, but not limited, to household contact or
occupational/recreational exposure to an individual with a diagnosis of
SARS-CoV-2 infection (index case). Note: Participants with recent exposure to a
laboratory-confirmed index case must be asymptomatic and randomized within 5 days
(120 hours) of collection of the index case's positive SARS-CoV-2 diagnostic
test.
2. Pre-exposure population: Occupational, housing, recreational and/or social
conditions that are likely to increase risk of exposure to SARS-CoV-2.
- Agrees to defer receipt of COVID-19 vaccination for minimum of 180 days (6 months)
after dosing
Exclusion Criteria:
- Has received (1) a SARS-CoV-2 vaccine, (2) mAb or (3) convalescent plasma from a
person who has recovered from COVID-19 or prior participation in SARS-CoV2 vaccine,
convalescent plasma, or mAb clinical trial any time prior to participation in the
study.
- Receipt of any investigational product within 30 days or 5 half lives before the day
of enrollment.
- Is acutely ill or febrile 72 hours before or at Screening or has other COVID-19
symptoms including cough, fatigue, muscle or body aches, headache, or loss of taste or
smell. Fever is defined as a body temperature ≥38.0°C (≥100.4°F).
- Has received or plans to receive a non-COVID-19 vaccine within 28 days before or after
dosing (except for seasonal influenza vaccine, which is not permitted within 14 days
before or after dosing).
NOTE: Other protocol defined inclusion/exclusion criteria apply
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.
| Evaluation of ADG20 for the Prevention of COVID-19 | NCT04859517 | Contradiction |
1,744 | 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:
- Dyspeptic adult outpatients
- Characteristic dyspeptic symptoms according to Rome III criteria (bothersome
postprandial fullness, early satiation, epigastric pain, or epigastric burning)
- Upper gastrointestinal endoscopy excluding structural diseases
Exclusion Criteria:
- aged less than 20 years old,
- organic lesions such as peptic ulcer, tumor of any kind, stricture or structural
deformity, erosive esophagitis, or vasculopathy on endoscopy
- typical and predominant reflux symptoms (heartburn or acid regurgitation)
- comorbidity with malignancy, diabetes mellitus, liver cirrhosis, renal failure, or
porphyria
- history of intra-abdominal surgery
- concurrent use of aspirin, non-steroidal anti-inflammatory drug or proton pump
inhibitor
- history of allergy or severe side effects to lansoprazole
- pregnant or lactating 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.
| Lansoprazole for Subgroups of Functional Dyspepsia | NCT01040455 | Contradiction |
4,897 | 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:
- Participants must have been implanted with the DBS
- Participants must have been diagnosed with Essential Tremor
- Participants must experience negative side effects from their DBS which limit control
over their tremor
- Participants must be able to receive benefit from their stimulator, but at the cost of
negative side effects
Exclusion Criteria:
- All individuals who meet criteria outlined in "inclusion criteria" may be 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 18 Years old.
Subject must be at most 80 Years | Relief From Side Effects: Clinical Use of Electrodes With Direction | NCT03795935 | Contradiction |
2,324 | 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:
- To be a Duchenne Muscular Dystrophy diagnosis,
- Being in the ambulatory period and climbing four steps independently,
- to be Level 1 and Level 2 according to Brooke Lower Functional Classification Test
- To be able to cooperate
- No any severe contracture in the lower limbs which may prevent assessments,
Exclusion Criteria:
- Children who fail to meet these criteria study.
Male
Subject must be at least 5 Years old.
Subject must be at most 14 Years | Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy | NCT03589612 | Entailment |
5,502 | 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:
- Patients admitted to the Fondation Ophtalmologique Adolphe de Rothschild and suspected
to suffer from Horton disease, based on the presence of 3 or more major criteria, or 2
major criteria and at least one minor criteria.
Major criteria : Age > 50 ans ; headache ; intermittent jaw or tongue pain ; visual
impairment ; ESR > 50 mm at 1h and/or CRP > 8mg/l.
Minor criteria: temporal artery or scalp tenderness ; facial pain or tenderness ; fever
>38°C, weight loss >10%, anorexia, fatigue.
Exclusion Criteria:
- Autoimmune disease
- Active infectious condition
- Malignant disease
- Condition counterindicating one or several of the protocol's imaging procedures :
allergy to iodine and/or renal insufficiency and/or claustrophobia and/or metallic
foreign body...
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.
| Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease | NCT02473029 | Entailment |
2,941 | 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:
- Clinical diagnosis of ALS
- Taiwanese and used traditional Chinese(Mandarin).
- If they were older than age 20 years.
Exclusion Criteria:
- Frontotemporal dementia, severe depression, or schizophrenia.
- If they cannot complete the questionnaire with researchers or family members help.
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.
| Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS (Part 1) | NCT03806647 | Entailment |
3,750 | 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:
- 18-70 years
- Radiographic evidence of OA in the tibiofemoral compartment (minute or definite
osteophytes and a measurable joint space)
- Pain on walking (Visual Analogue Scale 0-10). Minimum of 4 and maximum of 9.
- Oxford knee score (OKS) of above 12 but below 36 (0-48, 48 no problem)
- Pain score of 1, 2 or 3 on Q1 (pain) of OKS.
- Suitable for viscosupplementation
Exclusion Criteria:
- OKS of below 12 and above 36 (0-48, 48 no problem)
- Pain score of 0 or 4 on Q1 (pain) of OKS.
- Grade 3 or 4 patellofemoral degeneration (Kellgren-Lawrence classification).
- Grade 3 or 4 tibiofemoral degeneration (Kellgren-Lawrence classification).
- A clinically apparent tense effusion of the target knee.
- Significant valgus/varus deformities.
- Ligamentous laxity or meniscal instability.
- Viscosupplementation history in any joint in the past 9 months.
- Previous surgery at the target knee in the past 6 months.
- Concomitant inflammatory disease (rheumatoid arthritis) or other condition that
affects the joints.
- Use of prohibited medication/treatment for chronic pain.
- Pregnancy or new mothers who are breastfeeding.
- Systemic or intra-articular injection of corticosteroids in any joint within 3 months
prior to screening.
- Obvious cartilage defects producing mechanical symptoms (i.e. locking).
- Listed for a knee replacement procedure for osteoarthritis of the knee.
- Have a history of failed conservative treatment (exercise therapy, physiotherapy).
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 | The Efficacy of Viscosupplementation for Early Knee Osteoarthritis | NCT01210742 | Contradiction |
5,465 | 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:
- Signed informed consent by the patient or next of kin or legally acceptable
representative to collect data on treatment of a given bleeding episode, surgical
event or prophylactic regimen as specified in the protocol.
- If informed consent is provided by the next of kin or legally acceptable
representative, consent must also be obtained from the patient as soon as he/she is
able to do so.Informed consent should preferentially be obtained before initiation of
treatment or as a minimum before entry of data into the database. 2.Males and females
0 to 90 years of age. 3. Any patient with a FVII deficiency for whom treatment of
bleeding episodes, prevention related to surgery and primary/secondary prophylaxis is
considered necessary by the treating physician can be enrolled.
Exclusion Criteria:
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 90 Years | Treatment of Inherited Factor VII Deficiency | NCT01269138 | Entailment |
2,307 | 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:
- Molecular diagnosis of DMD
- Patients 7 - 10 years of age at time of screening
- Ambulant
Exclusion Criteria:
- Previous (3 months or less) or concomitant participation in another therapeutic trial
- Use of L-arginine, L-citrulline or metformin within the last 3 months
- Known individual hypersensitivity to L-citrulline or metformin
- Other chronic disease or clinical relevant limitation of renal, liver, heart function
according to discretion of the investigator
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 10 Years | Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin | NCT02516085 | Entailment |
256 | 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:
- Age: ≥18 and <35 years old
- AFC: ≥5 and <20
- AMH: ≥1.1 ng/mL and <2.5 ng/mL
- BMI: ≥18.5 Kg/m2 and <29 Kg/m
- First or second ART cycle
- Regular menstrual cycles (between 22 and 35 days)
- Two ovaries present
- Planned for single or double day 3 transfer
- Infertile couples scheduled for their first IVF/ICSI cycle with fixed antagonist
protocol.
- Informed consent obtained.
Exclusion Criteria:
- Women with contraindication for IVF or ICSI, such as poorly controlled type 1 or type
2 diabetes mellitus; undiagnosed liver disease or dysfunction (based on serum liver
enzyme test results); renal disease or abnormal serum renal function; significant
anemia; history of deep venous thrombosis, pulmonary embolus or cerebrovascular
accident; uncontrolled hypertension or known symptomatic heart disease; history of (or
suspected) cervical carcinoma, endometrial carcinoma or breast carcinoma; and
undiagnosed vaginal bleeding.
- Previous history of poor ovarian response (<4 oocytes retrieved) with a maximal dose
of OS (≥300 IU/day) or OHSS, regardless of gonadotropin dose
- Known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the
endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis)
- Repeated miscarriages (>2 previous biochemical pregnancies or >2 spontaneous
miscarriages)
- Recurrent implantation failure (>3 failed cycles with good quality embryos)
- PCOS
- Untreated thyroid disfunction
- Administration of exogenous E2, P4 or gonadotropins in the preceding menstrual cycle
- Active female smoking
- Ongoing pregnancy
- Women who have previously enrolled in the trial
- Those unable to comprehend the investigational nature of the proposed study
- either male partner or female partner has to receive donor sperm or donor eggs.
- Either male partner or female partner has to receive PGD and PGS.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Trigger Timing in Ovarian Stimulations | NCT04163133 | Contradiction |
70 | 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 males
Exclusion Criteria:
use of anabolic steroids, use of narcotics,
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 30 Years | Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males | NCT03541395 | Contradiction |
4,208 | 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. | No eligibility criteria
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 21 Years | Effects of Chronic Ozone Exposure on Lung Function | NCT00006306 | Contradiction |
6,866 | 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:
- Male or female subjects aged 50-80 years.
- Lives with a significant other.
- Has subjective memory complaints. Verbal verification of this subjective memory
complaint will be obtained from the significant other.
- Has no severe, uncontrolled medical condition.
- If receiving treatment for a medical condition, that treatment has been stable for at
least 2 months before entering the trial and to remain stable throughout the trial.
Exclusion Criteria
- Aged less than 50 years or greater than 80 years.
- Lives alone.
- Has any medical condition not adequately controlled, or likely to interfere with
performance of the study procedures.
- Medication for a medical condition has been changed in the last 2 months or during the
trial.
- Administration of acetylcholinesterase inhibitors and gingko biloba within 2 months
prior to entering the study.
- Has evidence of depression or anxiety
- Meets DSM-IV criteria for Alzheimer's or vascular dementia.
- Has participated in an investigational drug trial in the previous 30 days.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 80 Years | A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI) | NCT00109564 | Contradiction |
6,640 | 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 for Part 1:
1. Be male and ≥18 years of age;
2. Have clinically severe hemophilia A, defined as:
1. <1% (<1 IU/dL) endogenous FVIII activity levels as historically documented by a
certified laboratory or screening data results; OR
2. 1-2% (1-2 IU/dL) endogenous FVIII activity levels and > 10 bleeding events per
year (in the last 52 weeks prior to screening); OR
3. 1-2% (1-2 IU/dL) endogenous FVIII activity levels and on prophylaxis;
3. Have had >150 exposure days (EDs) to any recombinant and/or plasma-derived FVIII
concentrates or cryoprecipitates
4. Have no prior history of hypersensitivity or anaphylaxis associated with any FVIII or
IV immunoglobulin administration
5. Have no measurable inhibitor against FVIII as assessed by central laboratory, have no
confirmed history of clinically significant FVIII inhibitor, and no clinical signs or
symptoms of decreased response to FVIII administration (Note: family history of
inhibitors will not exclude study participation)
6. Agree to use reliable barrier contraception after the administration of SPK-8016 until
notified by the Investigator.
Exclusion Criteria for Part 1:
1. Have active hepatitis B or C
2. Have significant underlying liver disease.
3. Have serological evidence of HIV-1 or HIV-2 with CD4 counts ≤200/mm3. Participants who
are HIV-positive and stable, with an adequate CD4 count (>200/mm3) and undetectable
viral load, and are on an antiretroviral drug regimen are eligible to enroll
4. Have detectable antibodies reactive with AAV-Spark capsid
5. Have history of chronic infection or other chronic disease
6. Have been dosed in a previous gene therapy research trial within the last 52 weeks or
with an investigational drug within the last 12 weeks
7. Any concurrent clinically significant major disease (such as liver abnormalities or
type I diabetes) or other condition that, in the opinion of the Investigator and/or
Sponsor, makes the subject unsuitable for participation in the study;
8. Unable or unwilling to comply with the schedule of visits and study assessments
described in the clinical protocol.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors | NCT03734588 | Contradiction |
5,924 | 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:
- Danish adult patient with GERD-diagnosis verified by upper endoscopy 1997-2014
Exclusion Criteria:
- Any diagnosis of cancer in the gastrointestinal tract during follow-up
- Patients with GERD-diagnosis within previous four years or with concomitant diagnosis
requiring independent anti-secretory treatment will be excluded (DK25.0-9, DK26.0-9,
DK27.0-9, DK22.7 & DE16.4B).
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.
| Treatment of Newly Diagnosed Gastroesophageal Reflux Disease in a National Population-based Cohort | NCT03524781 | Contradiction |
1,100 | 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. | Patients of either gender, aged 18-80 years.
NYHA functional class III/IV, or syncope, or greater than or equal to 2 presyncope despite
verapamil and/or Beta-blocker therapy.
LV outflow tract gradient greater than or equal to 30 mm Hg at rest or greater than or
equal to 50 mm Hg following isoproterenol infusion to a heart rate of greater than 100 bpm.
No patients with mid-cavity obstructive HCM.
No patients with LV septal wall thickness less than 15 mm estimated by echocardiography.
No patients with greater than 50 percent luminal narrowing in a major coronary artery
vessel.
No patients with chronic atrial fibrillation.
No patients with a positive pregnancy test.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| A Comparison of Two Treatments: Pacemaker and Percutaneous Transluminal Septal Ablation for Hypertrophic Cardiomyopathy | NCT00001894 | Entailment |
3,455 | 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:
- Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol
- Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride
levels of <400 mg/dL
Exclusion Criteria:
- Type I diabetes mellitus
- Secondary causes of high cholesterol
- Elevated liver enzymes
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 | A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol | NCT00645424 | Entailment |
5,341 | 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:
- Female gender - to evaluate effects in the target population for clinical trials
- History of abnormal uterine bleeding documented by menorrhagia impact questionnaire
(MIQ) and menstrual calendar
- Anovulatory and ovulatory women will be included
- In good health. Chronic medication use is acceptable except for glucocorticoid use.
Other chronic medication use may be acceptable at the discretion of the research team.
Interval use of over-the counter drugs is acceptable but must be recorded.
- Ovulatory women will be defined as those who have menstrual cycles of 24 35 days and a
progesterone value > 3.0 pg/mL between 5 and 9 days after in-home documentation of an
LH surge
- Anovulatory women will be defined as those without an in-house LH surge in whom
progesterone values 3 and 4 weeks after menses are < 3.0 ng/mL
- Hemoglobin > 10 g/dL (for those wishing surgery); iron may be administered to improve
red blood cell counts
- Willing and able to comply with study requirements
- Age 25-40
- Using mechanical (condoms, diaphragms), sterilization or abstinence methods of
contraception for the duration of the study
- Negative urine pregnancy test
- BMI less than or equal to 33, if a surgical candidate or less than or equal to 35, if
not a surgical candidate.
- Creatinine less than 1.3 mg/dL
- Liver function tests within 130 percent of upper limit
- Women who elect surgery must state that they do not desire further fertility.
- Endometrial biopsy without endometrial hyperplasia or neoplasia
- Normal cervical cytology screening within the last 12 months
EXCLUSION CRITERIA:
- Significant abnormalities in the history, physical or laboratory examination
- Pregnancy
- Lactation
- Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year
- History of malignancy within the past 5 years
- Vaginal Bleeding in context of anatomic abnormality, endometrial neoplasia or
hyperplasia, cervical, vaginal, or vulvar neoplaisa or preneoplastic pathology
- Use of estrogen or progesterone-containing compounds, such as oral contraceptives and
hormone replacement therapy, within 8 weeks of study entry, including transdermal,
injectable, vaginal and oral preparations
- Current use of agents known to induce hepatic P450 enzymes; use of imidazoles
- Current use of GnRH analogs or other compounds that affect menstrual cyclicity
- Use of herbal medication having estrogenic or antiestrogenic effects within the past 3
months
- FSH > 20 IU/mL
- Untreated cervical dysplasia
- Need for interval use of narcotics
- Abnormal adnexal/ovarian mass
- Contradiction to anesthesia, for women planning surgery
- Leiomyomata, polyps or other anatomic causes of vaginal bleeding
- Previous participation in the study
- Thrombocytopenia defined as platelets < 150,000
- Patients with known abnormal breast pathology
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 50 Years | CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women | NCT01493791 | Contradiction |
6,601 | 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 ≥18 years of age
- Severe hemophilia A (past evidence of circulating FVIII activity of < 1% normal)
- Treated or exposed to FVIII concentrates or cryoprecipitate for at least 150 exposure
days
- ≥12 bleeding episodes if receiving on-demand therapy over the preceding 12 months
- Agree to use double barrier contraceptive until at least 3 consecutive semen samples
are negative for AAV 2/6 after SB-525 infusion
Exclusion Criteria:
- Presence of neutralizing antibodies
- Current inhibitor, or history of FVIII inhibitor (except for transient low titer
inhibitor detected in childhood)
- History of hypersensitivity response to FVIII
- History of Hepatitis B or HIV-1/2 infection
- History of Hepatitis C, unless viral assays in two samples, collected at least 6
months apart, are negative
- Evidence of any bleeding disorder in addition to hemophilia A
- Markers of hepatic inflammation or overt or occult cirrhosis
- History of chronic renal disease or creatinine ≥ 1.5 mg/dL
- Presence of liver mass on magnetic resonance imaging (MRI), or, positive alpha
fetoprotein
- Presence of > grade 2 liver fibrosis on elastography for subjects with history of
treated Hepatitis C or suspicion of chronic liver disease
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A | NCT03061201 | Contradiction |
3,150 | 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:
1. 18 years old
2. Both sexes
3. Patients that diagnosis in sjogren in treated in Meir Medical center in the years
2003-2014 And treated in Hydroxychloroquine at least a month.
Exclusion Criteria:
1. Minors and special populations
2. Patients that treated in Hydroxychloroquine at less than a month.
3. Patient that participate in clinical trial and treat with investigational product
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.
| the Effect of HCG Treatment as a Cardiovascular Disease Morbidity Factor in Sjogren Syndrome Patients | NCT02381587 | Contradiction |
2,749 | 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:
- Male patients over 18 years of age who applied for inguinal hernia surgery
Exclusion Criteria:
- Patients under the age of 18
- Complicated hernias
- Recurrent hernias
- Those undergoing laparoscopic hernia repair
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Can Ideal Mesh Size be Standardized in Open Inguinal Hernia Repair | NCT04280094 | Entailment |
2,452 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- I1. Sufficiently conversant in the English language to satisfy I3.
- I2. Able and willing to comply with all study requirements.
- I3. Able and willing to provide written informed consent to participate (including by
parent or legal guardian if under 16 years old).
Exclusion Criteria:
- There are no exclusion criteria.
No condition on gender to be admitted to the trial.
Subject must be at least 3 Years old.
| Vital Sign Comparison Between Lifelight and Standard of Care - Development | NCT04003662 | Entailment |
1,610 | 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:
- Chronic periodontitis (AAP 1999);
- ≥35 years of age;
- Presence of at least 15 teeth;
- Minimum of 6 teeth with at least one site each with PD and clinical attachment level
(CAL) ≥5 mm;
- At least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).
- Smokers: had smoked at least 10 cigarettes per day for a minimum of 5 years;
- Non-smokers: had never smoked.
Exclusion Criteria:
- Previous subgingival periodontal therapy;
- Pregnancy;
- Nursing;
- Systemic diseases that could affect the progression of periodontal disease (e.g.
diabetes, osteoporosis);
- Long-term administration of anti - inflammatory medications;
- Need for antibiotic pre-medication for routine dental therapy;
- Continuous use of mouthrinses containing antimicrobials;
- Antibiotic therapy in the previous 6 months
- Allergy to MTZ or AMX.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 75 Years | MTZ Plus AMX in the Treatment of Smokers and Non-smokers | NCT01837199 | Contradiction |
6,346 | 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:
For Phase A:
1200 persons who are recovering from an acute COVID-19 infection will participate.
Inclusion criteria for Phase A:
Post-COVID-19 Convalescence (n=1000)
1. Participants 18 and older
2. Ability to provide informed consent
3. Stated willingness to complete telephone interviews
4. Reports having begun recovery from an acute COVID-19 infection within the last six
months
5. Provides documentation of a positive COVID-19 PCR or antibody test
OR
Post-COVID-19 Neurological Sequelae (n=100)
1. Participants 18 and older
2. Ability to provide informed consent
3. Stated willingness to complete telephone interviews
4. Reports having developed neurological symptoms as a consequence of an acute COVID- 19
infection
5. Provides documentation of a positive COVID-19 PCR or antibody test
OR
Test-Negative COVID-19 with Persistent Symptoms (n=100)
1. Participants 18 and older
2. Ability to provide informed consent
3. Stated willingness to complete telephone interviews
4. Reports having developed persistent symptoms as a consequence of an acute COVID-19
infection
5. Provides documentation of a clinical diagnosis of an acute COVID-19 infection from a
medical practitioner OR meets the Clinical Criteria of the 2020 CDC Interim Case
Definition for Probable COVID-19 infection.
6. Has either negative or absent COVID-19 PCR testing for the documented COVID-19
infection.
7. Provides documentation of a negative COVID-19 antibody test.
The elements of the 2020 CDC Interim Case Definition for Probable COVID-19 Infection used
for this protocol will be the Clinical Criteria:
Clinical Criteria:
At least two of the following symptoms: fever (measured or subjective), chills, rigors,
myalgia, headache, sore throat, new olfactory and taste disorder(s)
OR
At least one of the following symptoms: cough, shortness of breath, or difficulty breathing
OR
Severe respiratory illness with at least one of the following:
1. Clinical or radiographic evidence of pneumonia, OR
2. Acute respiratory distress syndrome (ARDS).
AND
No alternative more likely diagnosis.
EXCLUSION CRITERIA:
Exclusion criteria for Phase A:
- Not willing to provide personal identifying information to investigative team
- Cognitive impairment that is severe enough to limit consent capacity
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.
| Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health | NCT04573062 | Entailment |
4,291 | 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:
- Men with Obstructive/Non-Obstructive Azoospermia who turned to sperm cell aspiration
for IVF and were found suitable for TEFNA and signed consent form.
Exclusion Criteria:
- healthy, non-azoospermic men
- men who are unsuitable for the TEFNA procedure
- men who don't sign the Informed Consent
Male
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 80 Years | Testis Needle Aspiration of Sperm in Men With Azoospermia | NCT02418832 | Entailment |
5,875 | 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:
1. Age 18-80 years;
2. GERD for > 1 year;
3. History of daily PPIs for > 6 months;
4. At least daily bothersome medically refractory GERD symptom(s) other than heartburn on
PPIs;
5. Hill grade I and II at gastroesophageal junction;
6. Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow
testing;
7. Willingness to undergo pH testing;
8. Willingness to cooperate with the postoperative diet;
9. Availability for follow-up visits at 6, 12, 24, and 36 months;
10. Willingly and cognitively signed inform consent
Exclusion Criteria:
1. BMI > 35 Hiatal hernia > 2c m in axial height and > 2 cm in greatest transverse
dimension;
2. Esophagitis grade C and D;
3. Barrett's esophagus > 2 cm;
4. Esophageal ulcer;
5. Fixed esophageal stricture or narrowing;
6. Portal hypertension and/or varices;
7. Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis;
8. Gastroparesis;
9. Coagulation disorders;
10. History of any of the following: resective gastric or esophageal surgery, antireflux
surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical
spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia,
scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis;
11. Pregnancy or plans of pregnancy in the next 12 months;
12. Enrollment in another device or drug study that may confound the results
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 80 Years | The EndoGastric Solutions TEMPO Trial | NCT01647958 | Contradiction |
375 | 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:
- Aged 18 years or more
- Menstruating women with regular menstrual cycle between 24 and 35 days and
intra-individual variations less than or equal to 5 days
- Request emergency contraception between 48 hours and 120 hours after unprotected
intercourse as defined by lack of contraceptive use, or condom breakage (including
condoms lubricated with spermicide) or other barrier contraceptive method failure
- No current use of hormonal contraception and having had at least one complete
menstrual cycle (2 menses) since having stopped hormonal contraception
- For women with a recent history of Depo Provera use, the most recent injection must
have been at least 9 months before study entry and followed by at least one complete
menstrual cycle (2 menses)
- Willing to not use hormonal methods of contraception until study completion
- At least one complete menstrual cycle (2 menses) post delivery, miscarriage or
abortion
- Able to provide informed consent in English
- Give voluntary, written informed consent, and agree to observe all study requirements
(the subject needs to be available for follow-up over the next 6 weeks)
- Willing to abstain from further acts of unprotected intercourse during participation
in the study and until pregnancy status has been ascertained
Exclusion Criteria:
- One or more acts of one unprotected intercourse more than 120 hours before requesting
emergency contraception in the current cycle
- All acts of unprotected intercourse (in the current cycle) within 48 hours of
presentation
- Currently pregnant as confirmed by positive HSUP test performed at screening
- Currently breast-feeding
- Current use of hormonal contraception
- Use of hormonal emergency contraception since last menstrual period
- Current use of IUD
- Tubal ligation
- Partner with a vasectomy
- Unsure about the date of the last menstrual period
- Severe asthma insufficiently controlled by oral glucocorticoid
- Currently enrolled in any other trial of an investigational medicine
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety and Efficacy of CDB-2914 for Emergency Contraception | NCT00411684 | Contradiction |
6,170 | 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. Adults ≥18 years of age.
2. COVID-19 positive by PCR and hospitalized for respiratory infection with a range of
respiratory severity as follows.
Moderate ● Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent
testing
● Symptoms of moderate illness with COVID-19, which could include:
o Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal
symptoms; shortness of breath with exertion
- Clinical signs suggestive of moderate illness with COVID-19, such as:
o RR ≥ 20, HR ≥ 90, SaO2 ≥93% on room air or requires ≤2L oxygen by nasal cannula
(NC) in order maintain SaO2 ≥93%, fever >38.3 Celsius
- No clinical signs indicative of Severe or Critical Illness Severity
Severe
- Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent
testing
- Symptoms suggestive of severe systemic illness with COVID-19, which could
include:
o any symptom of Moderate Illness; shortness of breath at rest or respiratory
distress
- Clinical signs indicative of severe systemic illness with COVID-19, such as
o RR ≥ 30, HR ≥ 125, requires > 2L oxygen by NC in order maintain SaO2 ≥93%,
PaO2/FiO2 <300
- No criteria for Critical Severity
Critical ● Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent
testing
- Evidence of critical illness, defined by at least 1 of the following:
- Respiratory failure defined based on resource utilization requiring at least
1 of the following:
◙, Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen
delivered via reinforced nasal cannula at flow rates >20L/min with fraction
of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, ECMO,
or clinical diagnosis of respiratory failure (i.e., clinical need for one of
the preceding therapies, but preceding therapies not able to be administered
in setting of resource limitation)
- Shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg or requiring
vasopressors)
- Multiple organ dysfunction/failure
3. Able to give written informed consent in English to participate in the study by
patient.
-
Exclusion Criteria:
- Exclusion Criteria:
1. Inability to swallow or ingest oral medication in either tablet form or in
suspension form.
2. Patient is known to be pregnant
3. Patients with a history of allergy or hypersensitivity to dipyridamole
4. Patient is unable to consent -intubated, on mechanical ventilation
5. Bleeding disorders (e.g. thrombocytopenia with platelet counts < 50,000)
6. Existing severe medical illnesses unrelated to Covid-19 infection such as end
stage heart, kidney, liver disorders;
or hepatic insufficiency defined as liver enzymes ≥5 times upper limit normal if
baseline is normal or 5 times baseline if baseline is abnormal.
Metastatic cancer as well as those with severe coronary artery disease, unstable
angina, STEMI, NSTEMI, hypotension (systolic blood pressure <90mmHg),
myocarditis, bradycardia with resting heart rate less than 60 bpm,
atrioventricular block without pacemaker.
Those with myasthenia gravis and those treated with cholinesterase inhibitors
7. Patient is enrolled in a clinical trial for another investigational drug designed
to test for efficacy for SARS-CoV-2
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.
| Trial of Open Label Dipyridamole- In Hospitalized Patients With COVID-19 | NCT04424901 | Contradiction |
5,756 | 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 proven painful Bullous/erosive or atrophic forms of OLP
Exclusion Criteria:
- lichenoid lesions
- Presence of systemic conditions
- Smoking
- Known hypersensitivity or severe adverse effects to the treatment drugs or to any
ingredient of their preparation
- Pregnancy or breast-feeding
- History of previous treatments potentially effective on OLP in last 3 months
- Loss of pliability or flexibility in the tissues involved by the oral lesions of
lichen planus
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 | Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus | NCT02858297 | Contradiction |
2,214 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Male or female subjects aged 18 to 75 years (time of get informed consent)
- Meet the American College of Rheumatology/The European League Against Rheumatism
criteria (2015) for the classification of acute arthritis of primary gout
- Pain Visual Analogue Scale Score (VAS) ≤ 3 at screening
- Serum uric acid ≥7 mg/dL (420μmol/L) at screening
- Self-reported history of at least 2 gout flares within 12 months prior to screening
- Normal electrocardiogram (ECG), or no clinical significant at screening
- Be capable of understanding and complying with protocol requirements
Exclusion Criteria:
- Occurrence of an acute gout flare ongoing at screening or within 2 weeks prior to
screening
- Known or suspected of secondary hyperuricemia (e.g. due to renal disorder,
hematological disorder, drugs, radiotherapy, chemotherapy or organ transplant)
- Use of colchicine, allopurinol, probenecid, benzbromarone, febuxostat or history of
intra-articular steroid injection within 4 weeks prior to screening
- Use of glucocorticoids, nonsteroidal antiinflammatory drugs (NSAIDs), or
cyclooxygenase-2 (COX-2) inhibitors within 1 week prior to screening
- History of stroke, transient ischemic attack (TIA), acute myocardial infarction (MI),
heart failure (NYHA Class II-IV), coronary intervention procedure (including but not
limited to angioplasty, stent placement, coronary revascularization) prior to
screening
- History of gastrointestinal (GI) bleeding, peptic ulcer disease prior to screening
- History of malignancy and/or mental disorder prior to screening
- Active infection with hepatitis B, hepatitis C, or has aspartate transaminase (AST),
alanine aminotransferase (ALT) or gamma-glutamyl transpeptidase (GGT) values ≥1.2
times the upper limit of normal (×ULN) during the screening period
- Presence of severe renal function impairment, or has serum creatinine (sCr) values
≥1.2 (×ULN) during the screening period
- History of allergy or intolerance to febuxostat, diclofenac sodium, simiaowan and/or
the placebo
- History of aspirin-induced asthma, or any other form of allergy to aspirin and other
NSAIDs
- Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases
with arthritis at screening
- Being treated with simiaowan at screening
- Being treated with azathioprine, mercaptopurine, theophylline, cytotoxic agents at
screening
- Diagnosis of drug or alcohol dependence or abuse or any condition requiring chronic
daily use of pain medication
- Pregnant or nursing, or planning to become pregnant or father a child within 3 months
after receiving the last dose of study drug
- Subjects who participated in another clinical study or clinical trial within 3 months
prior to screening
- Any other condition(s) that will compromise the safety of the patient, prevent
compliance with the study protocol, or compromise the quality of the clinical study,
as judged by the investigator
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 | Efficacy and Safety of Simiaowan in Prevention of Acute Flares in Chronic Gout Patients Initiating Febuxostat Therapy | NCT04069325 | Contradiction |
81 | 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 aged 20 to 40 years.
- Fluent in English.
Exclusion Criteria:
- Currently receiving hormonal therapy or testosterone boosting supplement.
- Has received hormonal therapy or testosterone boosting supplement within 3 months
prior to study.
- Has experienced adverse event following previous exposure to testosterone boosting
supplements.
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 40 Years | EndogenousTestosterone Response to a Testosterone Boosting Supplement | NCT02600650 | Contradiction |
2,506 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- Patient oral and written informed consent
- Adult Caucasian patients (male and female) aged 18-69 years (both included);
- Patients smoking ≤ 10 cigarettes/day
- Patient has confirmed diagnosis of atopic dermatitis using the diagnostic features as
described by Hanifin and Rajka, initial diagnosis made at least 12 weeks before first
treatment;
- SCORAD (12) between 20 and 50 (mild to moderate atopic dermatitis);
- Two comparable lesional areas of approximately 50 cm2 each (difference in modified
local SCORAD not greater than 2) on the arms, legs, chest, stomach or neck (distance
between the lesions at least 5 cm), clinical condition of atopic eczema mild to
moderate defined by a modified local SCORAD between 7 and 10 with 2 parameters scored
at least 2 one being the erythema score;
- Patient has to have an increased total IgE;
- Patient has to have an increased specific IgE of at least 1 of the sx1 allergens with
CAP classification II [>0.7 KU/l];
- Erythema score from modified local SCORAD for both lesional areas of at least 2;
- TEWL in the lesional areas at least 12 g/m²h, TEWL value differences ≤ 30 % are
allowed between both lesional areas (related to the higher TEWL value);
- Except for atopic diseases or asthma like atopic dermatitis or allergic rhinitis
assessed as healthy based on a screening examination including medical history,
physical examination of the skin, vital signs, and clinical laboratory results;
- The male patient must agree:
- to use two methods of contraception in combination with his female partner, if she is
of childbearing potential (At least one of the contraception methods must be a barrier
contraception method)
- The female patient must agree:
- to use two methods of contraception in combination with her male partner, if she is of
childbearing potential;
Exclusion Criteria:
- History of allergic reactions to any active or inactive component of the IMP;
- Presence of clinically significant diseases other than asthma or atopic diseases
(cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological,
genitourinary, autoimmune, endocrine, metabolic, etc.) which in the opinion of the
investigator, influence the results of the trial or the patient's ability to take part
in it;
- Inherent or acquired immune deficiency, immune deficiency in consequence of drug use;
- Immune mediated diseases;
- Suntan, hyperpigmentation or tattoos in the test fields;
- Dark-skinned persons whose skin colour prevents ready assessment of skin reactions;
- Systemic bacterial or mycotic as well as severe viral systemic infections;
- Severe systemic other disease;
- Patients with a resting heart rate <50 and >100 bpm, systolic blood pressure <100 and
>150 mmHg, diastolic blood pressure <60 and >95 mmHg;
- UV-therapy within 6 weeks before first treatment and during the trial;
- History or current evidence of a malignant tumour (an excised basal cell carcinoma
distant from target lesion with at least 14 days after surgery will be allowed);
- Clinically relevant abnormalities in serology, clinical chemical, haematological or in
any other laboratory variables;
- Chronic or acute infections (a small lesion of non-treated onychomycosis will be
allowed in the opinion of the investigator);
- Pregnancy or nursing
- Signs of secondary infections on the lesions to be treated;
- History of previous administration of SB011 or any other registered or investigational
oligonucleotide-based drug;
- History or presence of alcohol or drug abuse;
- Consumption of alcohol within 48 h before administration of IMPs and during the trial;
- Use of any medication (including over-the-counter medication such as herbal products)
except allowed concomitant medication within 2 weeks (for biologics: 6 months, for
systemic treatment of atopic dermatitis 4 weeks) before administration of the IMPs or
within <10 times the elimination half-life of the respective drug, or the duration of
the pharmacodynamics effect, whatever is longer, or anticipated concomitant medication
during the treatment period (exception: asthma may be found in patients with AD,
therefore the continuation of inhalative treatment with corticosteroids in patients
with asthma accompanying AD that began at least four weeks prior to randomisation will
be allowed; dose limited: ≤ 300 μg/d fluticasone propionate or equivalent);
- Treatment with known cytochrome P450 enzyme inducing or inhibiting agents (St. John's
Wort ("Johanniskraut"), barbiturates, phenothiazines, cimetidine, ketoconazole) within
30 days before administration of the IMPs or during the trial;
- Consumption of grapefruit, grapefruit juice within 14 days prior to the IMP
administration or during the trial;
- Need for additional skin care products in the treatment area(s);
- Use of skin care products with anti-septic components during the last four weeks
before first treatment and during the trial or anti-septic textiles with contact to
the target lesions;
- Proneness to orthostatic dysregulation, faintings, or blackouts;
- Planned donation of germ cells, blood, organs, bone marrow during the course of the
trial or within 6 months thereafter;
- Participation in another clinical trial with an investigational drug or device within
the last 3 months. For biologics, the minimum exclusion period is at least 6 months or
the time of duration of the pharmacodynamics effect or 10 times the half-life of the
respective drug whatever is longer before inclusion in this trial;
- Lack of ability or willingness to give informed consent;
- Anticipated non-availability for trial visits/procedures;
- Anticipated lack of willingness or inability to cooperate adequately;
- Close affiliation with the investigators (e.g. a close relative) or with persons
working at bioskin GmbH or with persons working at the study site or with employees of
sterna biologicals GmbH & Co. KG;
- Vulnerable patients (e.g., persons kept in detention)
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 69 Years | Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of the Topical Formulation SB011 Applied to Lesional Skin in Patients With Atopic Eczema | NCT02079688 | Contradiction |
2,850 | 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:
- Age: 25 to 80 years, inclusive
- Male or female subjects with probable or confirmed ALS (revised international El
Escorial criteria, Forbes et al., 2001).
- Patients presenting first motor deficits due to ALS for a maximum of three years at
the first consultation in an ALS centre.
- Patients monitored for at least 6 months in an ALS centre or for whom the previous
monitoring parameters are available (excepted for MIP and SNIP).
- Patients who have lost at least 5 points on the ALSFRS-R (ALS functional rating scale)
during the last 12 months or at least 2 points during the preceding 6 months
- Patients who have been treated with riluzole for at least 3 months at a stable dose.
In case of intolerance to this product or refusal for this treatment, patients who
have not been treated with riluzole for at least 1 month before inclusion
- For patients with spinal form (onset of the disease affecting limbs) or respiratory
form, slow vital capacity > 60% of predicted value.
- For patients with a bulbar form, slow vital capacity > 60% of theoretical value or, if
spirometry not assessable (severe bulbar disability), patient should not have
significant abnormality in both nocturnal capnography and nocturnal oximetry (median
pCO2 (carbon dioxide partial pressure ) < 52 mmHg, SaO2 (arterial oxygen saturation )
< 90% less than 5% of the time during night) less than 3 months prior inclusion.
- Patients who are willing to give written consent (or oral consent in the presence of a
trusted person if the patient is no longer able to write)
- Patients likely to be able to participate in all scheduled evaluation and complete all
required study procedures (except for spirometry in bulbar patients with severe
disability).
Exclusion Criteria:
- Patients on non-invasive ventilation for respiratory insufficiency due to ALS for more
than 10 hours a day
- Patients with an ALSFRS-R score at inclusion of < 20 (maximum score without disability
= 48)
- Patients who have lost less than 5 points on the ALSFRS-R during the last year or less
than 2 points during the preceding 6 months
- Patients with a gastrostomy
- Patients who have lost more than 15% of their reference weight (defined as weight
before disease onset)
- Patient with dyspnoea at rest or with the least effort (score < 3 on the dyspnoea item
of the ALSFRS-R)
- Patients with dementia
- Patient with severe or rapidly progressive form of ALS for whom the investigator
estimates the life expectancy less than 3 months
- Patients with another progressive disease that has not been stabilized at the time of
inclusion
- Patients with cancer, except basal cell carcinoma, for less than 5 years, or who
require continuous treatment for cancer even if it is older
- Pregnant women.
- Subject who are not covered by a social security scheme.
- Subject under temporary or permanent Judicial Protection.
- Contraception: Both male subjects, and female subjects who are not either surgically
sterile (tubal ligation/obstruction or removal of ovaries or uterus) or
post-menopausal (no spontaneous menstrual periods for at least one year confirmed by a
negative hormone panel), must commit to using two highly effective method of birth
control for the duration of the study and for two months after the treatment
termination.
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 80 Years | Effect of MD1003 in Amyotrophic Lateral Sclerosis | NCT03114215 | Entailment |
4,410 | 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:
- spontaneous local pain over lateral epicondyle of the affected elbow for more than six
months and failure to respond to previous physical therapy or oral medications,
- local tenderness around the lateral epicondyle, and
- pain elicited or aggravated by resisted contraction of the wrist or middle finger
extensors.
Exclusion Criteria:
- local steroid injection within the past six months,
- coexisting elbow arthritis or arthralgia,
- previous trauma or surgery history over the lateral epicondyle,
- pregnancy or lactation, and
- other systemic, neuromuscular or bleeding disorders that are contraindicated to Botox
injection.
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 | Comparison Between Steroid and Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia | NCT02767635 | Contradiction |
1,794 | 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:
1. Age over or equal to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy, including
gastric multiple primary carcinoma
3. cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the
American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. expected to perform distal, total or proximal gastrectomy to obtain R0 resection
sugicall results.
5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Written informed consent
Exclusion Criteria:
1. Severe mental disorder
2. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
3. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal
Dissection/Endoscopic Mucosal Resection )for gastric cancer)
4. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative
imaging
5. History of other malignant disease within the past 5 years
6. History of previous neoadjuvant chemotherapy or radiotherapy
7. History of unstable angina or myocardial infarction within the past 6 months
8. History of cerebrovascular accident within the past 6 months
9. History of continuous systematic administration of corticosteroids within 1 month
10. Requirement of simultaneous surgery for other disease
11. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
12. FEV1<50% of the predicted values
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 75 Years old.
| Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer | NCT03290209 | Contradiction |
1,697 | 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:
- HV aged between 18 - 60 years
Exclusion Criteria:
- history of psychiatric disease or a positive first degree psychiatric family history
- pregnancy or lactation
- concomitant administration of any centrally activating medication (anti-depressive
medication, hypnotics, sedatives, anxiolytics, …)
- medication affecting esophageal motility
- significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary,
endocrine, autoimmune, renal and hepatic)
- prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
- history of gastrointestinal disease
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 60 Years | Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers | NCT04355455 | Entailment |
4,262 | 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:
- Azoospermia
Exclusion Criteria:
- Absent or surgical removed testes
Male
No healthy subjects accepted to join the trial.
| Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia | NCT02008799 | Entailment |
1,028 | 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. Patients referred to the Leeds Community Healthcare Musculoskeletal service aged 45
years or over with primary symptoms suggestive of degenerative intraarticular knee
pain with a dominant mechanical presentation (i.e. activity related pain, functional
limitation, morning stiffness not exceeding 30 minutes) AND
2. Limitation in weightbearing range of motion of the knee joint (tibiofemoral joint
limitation in flexion or extension)
Exclusion Criteria:
1. Subjects with cognitive impairment or medical conditions preventing understanding or
participation in the study
2. Subjects with symptoms requiring surgical evaluation or other intervention
3. Knee symptoms related to pathology other than degenerative intraarticular pathology
4. Subjects who are contraindicated from kneeling or crouching
5. Subjects unable to attend the full study programme
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.
| Joint Loading vs Normal Physiotherapy Care in Degenerative Knees (V1) | NCT02454374 | Entailment |
4,852 | 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. | Inclusion Criteria:
- Major Inclusion Criteria:
- Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing
syndrome with at least 80% compliance with the dosing schedule.
- According to the Investigator's opinion will benefit from continuing treatment
with relacorilant
Exclusion Criteria:
- Major Exclusion Criteria:
- Premature discontinuation from a relacorilant parent study.
- Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
- Has poorly controlled hypertension
- Has Stage ≥ 4 renal failure
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | NCT03604198 | Contradiction |
5,281 | 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. | Osteoporosis suspicion
Inclusion Criteria:
- Age: 50 - 59 years (n = 500) and 60-79 years (n = 500).
- Post-menopausal status.
- At least one of the clinical risk factors for fracture:
- Low body mass index (< 19kg/m2)
- Previous fragility fracture
- Parental history of hip fracture
- Glucocorticoid treatment (≥ 5mg prednisolone daily or equivalent for 3 months or
more)
- Current smoking
- Alcohol intake 3 or more units daily
- Causes of secondary osteoporosis:
- Untreated hypogonadism
- Inflammatory bowel disease
- Prolonged immobility
- Organ transplantation
- Type 1 and type 2 diabetes
- Thyroid disorders
- Chronic obstructive pulmonary disease
- A Physician has referred the woman to axial DXA investigation.
Exclusion Criteria:
- Treatment: osteoporosis medication.
- Obesity: body mass index BMI > 30kg/m2
- a refusal to participate in the study
Healthy
Inclusion Criteria:
- Age: 50 - 59 years (n = 50) and 60-79 years (n = 50).
- Post-menopausal status.
- No diseases or treatments which may affect to bone health.
Exclusion Criteria:
- Treatment: osteoporosis medication.
- a refusal to participate in the study
- Obesity: body mass index BMI > 30kg/m2
Female
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 79 Years | Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX | NCT01998737 | Entailment |
4,215 | 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:
- Adult patients with intractable dyspnea and PaO2>55mmHg in the setting of terminal
illness where the underlying cause has been maximally treated; a medical specialist
must document that all identified reversible causes of the dyspnea have been treated;
PaO2 measurement must be in the last month
- Dyspnea at rest or with minimal exertion, as measured by a score of ≥ 3 on the Medical
Research Council categorical dyspnea exertion scale
- On stable medications over the prior week except routine "as needed" medications.
- Survival of at least 1 month in the opinion of the treating physician
Exclusion Criteria:
- Meets international guidelines for long-term oxygen therapy with PaO2 56-59mmHg, i.e.
symptomatic pulmonary hypertension with cor pulmonale
- Hemoglobin<10.0g/dL as measured within one month of baseline evaluation
- PaCO2 >50 mm Hg.
- Confusion as measured by Folstein Mini-mental Status Exam <24/30
- Current oxygen therapy or continuous oxygen therapy in previous week
- Actively smoking
- Active respiratory or cardiac event in the previous 2 weeks, not including upper
respiratory tract infections; illness must be resolved for at least 2 weeks prior to
baseline evaluation, as judged by a doctor involved in the care of the patient
- Previous respiratory failure induced by oxygen
- Unable to give informed consent or complete diary entries
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.
| Palliative Oxygen for the Relief of Breathlessness | NCT00327873 | Contradiction |
490 | 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. | IVF
Inclusion criteria:
- Women aged <43 years at the time of IVF treatment
Exclusion criteria:
- Preimplantation genetic diagnosis treatment
- Use of donor oocytes or donor embryos
- Hydrosalpinx shown on pelvic scanning and not surgically treated
- Women at risk of OHSS
FET
Inclusion criteria:
- Women aged <43 years at the time of IVF treatment
- Replacing early cleavage embryos or blastocysts after thawing
- FET in natural cycles
Exclusion criteria:
- Frozen early cleavage embryos thawed and cultured to blastocysts prior to transfer as
requested by the patient
- Preimplantation genetic diagnosis treatment
- Use of donor oocytes or donor embryos
- Hydrosalpinx shown on pelvic scanning and not surgically treated
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 42 Years | GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FET | NCT04064840 | Contradiction |
268 | 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:
- Women of good general health aged 18 - 35 years
- Not at risk of pregnancy
- Regular menstrual cycles of 24-35 days duration
- Not pregnant
- Intact uterus and ovaries
- Haemoglobin ≥ 11 g/dl
- Normal laboratory tests and normal TSH
- Willing to abstain from any use of hormonal contraception until study completion
- No current use of hormonal contraception and having had at least one complete
menstrual cycle (2 menses) since termination of previous hormonal contraception
- Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage
or induced abortion
- Able to give voluntary, written informed consent, and agreeing to observe all study
requirements for 5 complete menstrual cycles
Exclusion Criteria:
- Current participation in any other trial of an investigational medicine
- Known hypersensitivity to the ingredients of the test active substances or excipients
- Suspected hyperplasia or carcinoma of the endometrium
- Current pregnancy as confirmed by positive serum beta-hCG at screening
- Desire to get pregnant before the planned end of the study participation
- Currently breastfeeding
- Abnormal Pap smear
- Cancer (past history of any carcinoma or sarcoma)
- Known or suspected alcoholism or drug abuse
- Abnormal thyroid status
- Body mass index > 32
- Current use of hormonal contraception
- Use of hormonal emergency contraception since last menstrual period
- Severe asthma insufficiently controlled by oral glucocorticoids
- Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose
malabsorption
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge | NCT01107093 | Contradiction |
2,779 | 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:
1. 21 years or older
2. No prior open abdominal surgery at or below the umbilicus
3. Primary or recurrent unilateral inguinal hernia repair
4. No previous preperitoneal mesh placement
5. BMI less than or equal to 40kg/m2
Exclusion Criteria:
1. Need for an open inguinal hernia repair
2. Patients presenting for evaluation of bilateral inguinal hernias
3. Patients requiring surgical repair of a strangulated inguinal hernia
4. Patients with liver disease defined by the presence of ascites
5. Patients with end-stage renal disease requiring dialysis
6. Patients who are unable to give 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 21 Years old.
| The Role of the Robotic Platform in Inguinal Hernia Repair Surgery | NCT02816658 | Entailment |
4,038 | 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:
- Patients diagnosed with knee osteoarthritis. The patients should have most problem
with their knees, but are allowed to have osteoarthritis in other lower extremity
joints.
- Independent in walking, with or without walking aids.
- Understand test instructions verbally and in writing.
Exclusion Criteria:
- Neurological disorders that affects the patients balance or gait.
- Severe somatic or mental illness that affect the physical functional performance or
the ability to understand test instructions verbally or in text.
- Knee or hip replacement the past six months.
- Other knee surgery the past six months that could affect the physical functional
performance.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Intra and Inter Reliability of 30 Seconds Chair Stand Test as Self-test for Patients With Knee Osteoarthritis. | NCT03855813 | Entailment |
4,528 | 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. Healthy sexually active women who have ever used an FC and using condoms (male or
female) as their current method of contraception.
2. Be 18 to 40 years at enrolment (inclusive).
3. Have a negative urine pregnancy test at enrolment visit.
4. Is HIV negative
5. Have a history of regular cyclic menses (usual length of 21 to 35 days) when not using
hormonal contraception.
6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that
ended at 14 or more weeks gestation.
7. Have at least one cycle (two menses) after an abortion at less than 14 weeks
gestation.
8. Be willing to accept a risk of pregnancy.
9. Reporting to have at least four acts of heterosexual vaginal intercourse per month for
a period of 6 months.
10. Be willing to only use the study product (Cupid or FC2 female condom) as the primary
method of contraception over the course of the study.
11. Be capable of using the study product properly and agree to observe all study
directions and requirements.
12. Be willing to keep a daily diary to record menstrual pattern, acts of intercourse, and
details of condom use and any condom failures.
13. Be willing to state that, to her best knowledge, her sexual partner:
- Has not had a vasectomy or been previously diagnosed as infertile.
- Is HIV negative
- Has no known history of allergy or sensitivity to natural rubber latex,
water-based or silicone lubricants
- Does not want her to become pregnant in the next 7 months
14. Agree to have fingerprint identity check
15. Be willing to give written informed consent to participate in the trial.
16. Intend to stay in the area for the next 6-7 months
17. Be willing to be randomized
Exclusion Criteria:
1. Have a history of allergy or sensitivity to rubber latex or water-based /silicone
lubricants
2. Have evidence of sexually transmitted infections on syndromic assessment and / or
vaginal examination
3. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course
of the study.
4. Have a history of infertility or pelvic inflammatory disease without a subsequent
spontaneous intrauterine pregnancy.
5. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent
intrauterine pregnancy.
6. Be in a monogamous relationship of less than 4 months with their partner.
7. Have any contraindications to pregnancy (medical condition) or regularly use
medications that are unsafe to use in pregnancy
8. Have shared injection drug needles in the past unless has a negative HIV test at least
6 weeks since last use.
9. HIV positive.
10. Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
(initial episode) within 3 months prior to screening or have clinical evidence of HSV
on exam.
11. Be lactating or breastfeeding.
12. Have any clinically significant abnormal vaginal bleeding or spotting within the month
prior to screening.
13. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to
screening.
14. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to
screening or enrollment.
15. Have received a Depo-Provera® injection in the 6 months prior to enrolment or
Nur-Isterate in the last 4 months prior to enrolment
16. Have a past (within 12 months) or current history of alcohol or drug [recreational,
prescription or over-the-counter (OTC)] abuse.
17. Have taken an investigational drug or used an investigational device within the past
30 days.
18. Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Randomized Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom | NCT04233632 | Contradiction |
5,650 | 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:
- Children ages 4 to 14 years with a height less than the 5th percentile for age and sex
or having a decelerated across two major percentiles (5th, 10th, 25th, 50th, 90th, and
95th) on standard pediatric growth curves, poor growth velocity (less than 5
centimeters/year), radiographic evidence of delayed bone age (i.e. greater than 1 SD
below the mean for chronological age) and a documented diagnosis of idiopathic growth
hormone deficiency [as determined by failure to raise serum GH concentrations 10
microgram/Liter following provocative testing with two growth hormone
secretagogues(e.g. insulin, arginine, or clonidine)].
- All subjects will be prepubertal, as determined by Tanner staging.
Exclusion Criteria:
- Children receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO,
CYP2D6 or CYP3A4 activity.
- Subjects with a history of smoking (including exposure to second hand smoke > 8 hours
per day) or illicit drug use.
- Subjects with a history of hepatic, renal, cardiac or thyroid disorders. Presence of
hepatic, renal, cardiac or thyroid disease will be established based on clinical
history and results of recent laboratory tests conducted as part of the routine
medical evaluation of children who are being considered for rhGH therapy.
- Children experiencing fever or acute viral illness
- Children who have a history of a hypersensitivity reaction to dextromethorphan or
caffeine
- Children who have received prior treatment with rhGH
- Children who are receiving corticosteroids or thyroid hormone
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 14 Years | rhGH Therapy on Hepatic Drug Metabolism | NCT00458991 | Contradiction |
6,265 | 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:
- Institutionalized people in nurswing homes since the beginning of the COVID19 epidemic
who do not have the infection present at the time of entering into the study.
- Healthcare professionals who provide direct care (nursing assistants and registered
nurses) to institutionalized older people in nursing homes with confirmed cases of
COVID19 during the past 8 days.
- Subjects that give their consent to participate in the study or that it be obtained
from their representative / legal guardian.
Exclusion Criteria:
- Staff members who do not provide direct care to residents.
- Residents with active SARS-CoV-2 infection present, or with symptoms compatible with
COVID19 confirmed by PCR test.
- Staff members with present or past SARS-CoV-2 infection, or with PCR-confirmed
symptoms consistent with COVID19.
- History of QT interval prolongation or arrhythmias of any etiology.
- Presence of retinopathy of any etiology, changes in acuity or visual field.
- Severe hearing loss (requires the use of hearing aids).
- Structural heart disease.
- History of non-structural heart failure, ischemic heart disease, SCASEST, or SCACEST
- Chronic liver disease.
- Alcoholism.
- Epilepsy.
- For the participating professionals, pregnancy or suspected pregnancy (if they are
planning pregnancy, or in fertilizer treatment, they must abandon the study).
- Subjects with known HDQ hypersensitivity.
- Subjects diagnosed with G6PDH deficiency.
- Taking other medicines that prolong QT: domperidone, ondansetron, cilostazol,
antiarrhythmics (procainamide, amiodarone, flecainide, sotalol), macrolides
(azithromycin, clarithromycin, erythromycin), quinolones (ciprofloxacin,),
moxofloxacin,) neuroleptics (haloperidol, chlorpromazine, pimozide), antidepressants
(citalopram, escitalopram), sulpiride, anticholinesterase drugs (donepezil)
- Denial to participate in the study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM) | NCT04400019 | Contradiction |
576 | 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:
- Singleton pregnancy.
- Primigravida or multigravida.
- Gestational age ≤ 20 weeks.
- Missed abortion.
Exclusion Criteria:
- Maternal age < 18 years.
- Twin pregnancy.
- Previous cesarean section.
- Allergy to letrozole or misoprostol.
- Liver cirrhosis or severe liver impairment.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Effectiveness of Pretreatment Letrozole Versus Misoprostol Alone in Missed Abortion | NCT04194658 | Entailment |
4,049 | 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:
- age between 45 and 65.
- Participants having Knee osteoarthritis grade 2 or higher "Kellgren and Lawrence
scale"
- Participants had an average pain intensity of grade 4 or more on a 10-point visual
analog for at least one year.
Exclusion Criteria:
- Patient with history of rheumatic or chronic inflammatory diseases
- Patient poorly controlled diabetes,
- Patient who currently on OA treatment such as corticosteroids, chondroitin sulfate,
glucosamine or hyaluronic acid.
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 65 Years | Knee Osteoarthritis Treatment With Adipose-derived Stem Cells: Phase II Clinical Trial | NCT03308006 | Entailment |
5,947 | 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:
- Symptoms suggestive of GERD, with heartburn as their predominant symptom (described as
a burning feeling, rising from the stomach or lower part of the chest up towards the
neck), for longer than 6 months.
- Heartburn occurring for 4 days or more during the last 7 days prior to endoscopy. Or,
if PPI treatment has been started within the last 7 days prior to endoscopy, then
heartburn occurring for 4 days or more during the last 7 days prior to start of PPI
treatment
- Male or female, at least 18 years of age (for Austria, at least 19 years of age)
- Have given written informed consent
- Ability to read and write (literate)
- 7 symptom free (from heartburn) days in the last week prior to randomisation (day of
visit not included)
Exclusion Criteria:
- Documented esophageal mucosal break
- History of esophageal, gastric or duodenal surgery, except closure and oversewing of
an ulcer
- Chronic or recurrent abdominal pain associated with a chronic or recurrent bowel
disturbance and/or bloating, that in the opinion of the investigator is likely to be
due to irritable bowel syndrome or two or more of the following criteria:
- Symptoms relieved by defecation
- Symptoms associated with change in frequency of stools
- Symptoms associated with change in form of stools
- Any significant "alarm symptoms" such as unintentional weight loss, haematemesis
melaena, jaundice or any other sign indicating serious or malignant disease.
- Subjects with current or historical evidence of the following diseases/conditions
- Zollinger Ellison syndrome
- Primary esophageal motility disorder(s) i.e. achalasia, scleroderma, esophageal
spasm
- Complications of GERD such as esophageal stricture, ulcer and/or macroscopic
Barrett's metaplasia (longer than 3 centimetres) or significant dysplastic
changes in the esophagus
- Evidence of upper gastrointestinal malignancy at the screening endoscopy
- Gastric and/or duodenal ulcers within the last 2 years
- Malabsorption
- Malignancy, or significant cardiovascular, pulmonary, renal, pancreatic or liver
disease as judged by the investigator
- Unstable diabetes mellitus. Stable diabetes controlled on diet, oral agents or
insulin is acceptable
- Cerebrovascular disease, such as cerebral ischemia, infarction, haemorrhage or
embolus
- Subjects using a PPI for more than 10 days in the last 28 days, prior to endoscopy
- Use of PPIs for more than 5 days in the last 7 days prior to endoscopy
- Subjects using daily H2-receptor antagonist, prokinetics recommended in the treatment
of reflux symptoms or sucralfate during the 2 weeks prior to endoscopy and between the
endoscopy and visit 1 and throughout the study
- Need for continuous concurrent therapy with
- NSAIDs (including selective COX II antagonists, salicylates (unless<165 mg daily
for cardiovascular prophylaxis)
- anticholinergics
- prostaglandin analogues
- phenytoin
- ketoconazole
- itraconazole
- warfarin and other vitamin K antagonists
- Pregnancy or lactation. Women of childbearing potential must maintain effective
contraception during the study period as judged by the investigator (for Austria:
Women of child-bearing potential may only be included when their pregnancy status is
assessed by the investigator prior to entry and then at monthly basis. For
South-Africa and Spain:
Women of child-bearing potential may only be included when their pregnancy status is
assessed by the investigator prior to endoscopy)
- Use of any other investigational compound 28 days prior to start and during the study
- Requirement of an interpreter (illiterate)
- Alcohol and/or drug abuse or any condition associated with poor compliance, including
expected non-co-operation, as judged by the investigator
- Previous participation in this study
- Contra-indications to study drugs, e.g. known or suspected allergy to esomeprazole and
any other constituents of the formulation. Known hypersensitivity to substituted
benzimidazole
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.
| Open, Randomised, Multi-center Study of on Demand Versus Continuous Esomeprazole Treatment in Patient With GERD | NCT02670642 | Contradiction |
4,533 | 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:
- Aged 18 years or more
- Menstruating women with regular menstrual cycle between 24 and 35 days and
intra-individual variations less than or equal to 5 days
- Request emergency contraception between 48 hours and 120 hours after unprotected
intercourse as defined by lack of contraceptive use, or condom breakage (including
condoms lubricated with spermicide) or other barrier contraceptive method failure
- No current use of hormonal contraception and having had at least one complete
menstrual cycle (2 menses) since having stopped hormonal contraception
- For women with a recent history of Depo Provera use, the most recent injection must
have been at least 9 months before study entry and followed by at least one complete
menstrual cycle (2 menses)
- Willing to not use hormonal methods of contraception until study completion
- At least one complete menstrual cycle (2 menses) post delivery, miscarriage or
abortion
- Able to provide informed consent in English
- Give voluntary, written informed consent, and agree to observe all study requirements
(the subject needs to be available for follow-up over the next 6 weeks)
- Willing to abstain from further acts of unprotected intercourse during participation
in the study and until pregnancy status has been ascertained
Exclusion Criteria:
- One or more acts of one unprotected intercourse more than 120 hours before requesting
emergency contraception in the current cycle
- All acts of unprotected intercourse (in the current cycle) within 48 hours of
presentation
- Currently pregnant as confirmed by positive HSUP test performed at screening
- Currently breast-feeding
- Current use of hormonal contraception
- Use of hormonal emergency contraception since last menstrual period
- Current use of IUD
- Tubal ligation
- Partner with a vasectomy
- Unsure about the date of the last menstrual period
- Severe asthma insufficiently controlled by oral glucocorticoid
- Currently enrolled in any other trial of an investigational medicine
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Safety and Efficacy of CDB-2914 for Emergency Contraception | NCT00411684 | Contradiction |
2,456 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
1. Histologically proven sarcoidosis from any site (noncaseating granulomas without other
causes).
2. Diagnosis of active sarcoidosis (Sec. 5.5.4.t) clinical stage II by Chest X-ray (CXR).
3. Forced Vital Capacity (FVC) >45% and Diffusing Capacity for Carbon Monoxide (DLCO)
>50% of predicted values.
4. Evidence of active sarcoidosis (see criteria above)
5. Able and willing to complete all study procedures (e.g., bronchoscopy, post-drug
surveillance)
6. Age: 18+ years old (prevalence greatest in young adults; pediatric maraviroc safety
not established).
7. Not on immunosuppression for sarcoidosis at the time of recruitment, (e.g., steroids,
tumor necrosis factor alpha (TNF-a) blockade)
8. Liver function (transaminases, bilirubin), coagulation (International Normalized Ratio
(INR), partial thromboplastin time (PTT), platelet count), blood urea nitrogen (BUN),
creatinine, and white blood count (WBC) within normal limits.
9. If female: negative pregnancy test, agreement to use reliable contraception if of
childbearing potential 30 days prior and for 30 days after study completion (drug
safety during pregnancy not established).
10. Negative HIV and HBsAg tests
Exclusion Criteria:
1. Diagnosis of infection based upon clinical evaluation and/or microbial testing.
2. The diagnosis of any disease involving the heart, lungs, liver (HVC), kidney,
hematologic, endocrine, or Gl systems which, in the judgment of the PI, would pose an
undue risk to the subject if they participated in this study. This includes but is not
limited to diabetes, uncontrolled hypertension, liver disease (HVC), or history of
malignancy.
3. Medications that will either inhibit or induce CYP3A4 (including St John's Wort)
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 | Impact of Chemokine Receptor 5 (CCR5) Inhibition on Sarcoidosis Immunophenotypes | NCT02134717 | Entailment |
3,689 | 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:
- 60 years or older
- Having difficulty sleeping over the past three months (Insomnia Severity Index ≥ 8)
- Having osteoarthritis pain (Brief Pain Inventory Worst pain ≥ 4)
Exclusion Criteria:
- Working night shift
- Previously diagnosed with a primary sleep disorder (Sleep Apnea or Restless Leg
Syndrome).
- Seizure disorder
- Photosensitivity
- Dementia
- Diagnosis or other significant chronic illness beyond OA that would impact sleep
- Severe psychiatric disorder including a history of or current diagnosis of psychosis
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.
| Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain | NCT03441191 | Contradiction |
5,060 | 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:
for the application with Dynaflex®:
- central or foraminal lumbar stenosis, Claudicatio spinalis pathology
- degenerative lumbar instability (e.g. Spondylolisthesis) with lumboischialgia or
Claudicatio spinalis pathology
- herniated vertebral disk with forms of ischialgia pain
- age: 18-80 years
additionally for the application with LumboSensa®:
- scoliosis
- osteoporosis
- inflammatory rheumatic back pain
- Failed Back Surgery Syndrome
- painful conditions after stabilizing or reinforcing surgeries
Exclusion Criteria:
- paresis of the lower extremity
- contact allergy to orthotic material
- diseases in body regions with contact to orthosis, which become manifest
neurologically/dermatologically
- acute Spondylodiscitis
- tumor diseases
- recent vertebral body fractures
- pregnant and lactating females
- subject has been committed to an institution by legal or regulatory order
- dependency or working relationship with the investigator
- participation in a parallel interventional clinical 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 80 Years | "Examination of the Impact of a Dynamic Flexion Orthosis (Dynaflex®Ottobock) or of a Back Bandage (Lumbo Sensa®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Back Pain" | NCT02536274 | Contradiction |
2,887 | 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:
- definite and/or probable diagnosis of ALS
- early stages of the disease
Exclusion Criteria:
- history of neuromuscular dysfunction not related to ALS
- active, confounding medical conditions
- unwillingness or inability to comply with the protocol
- FVC of less than 90% predicted
- ALSFRS score of less than 30
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 | Study of the Effects Strengthening Exercises in Individuals With ALS | NCT00204464 | Entailment |
3,494 | 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:
1. Subject is willing to give consent and comply with evaluation and treatment schedule;
2. 18 to 65 years of age (inclusive);
3. Have a BMI > 27 with one or more significant co-morbid medical conditions which are
generally expected to be improved, reversed, or resolved by weight loss. These
conditions may include but are not be limited to -
- Hyperlipidemia
- Type 2 diabetes
- Mild obstructive sleep apnea
- Hypertension
- Osteoarthritis of the hip or knee
4. Agree to refrain from any type of weight-loss drug (prescription or OTC) or elective
procedure that would affect body weight for the duration of the trial;
5. HbA1C < 11%
6. For subjects who have Type 2 diabetes, the anti-diabetic medication regimen is no more
complex than oral metformin plus one oral sulfonylurea plus once daily insulin
injection.
7. Ability to self pay for the procedure and follow up.
Exclusion Criteria:
1. Previous malabsorptive or restrictive procedures performed for the treatment of
obesity;
2. Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
3. Women of childbearing potential who are pregnant or lactating at the time of screening
or at the time of surgery;
4. Any condition which precludes compliance with the study;
5. History or presence of pre-existing autoimmune connective tissue disease
6. Use of prescription or over the counter weight reduction medications or supplements
within thirty days of the Screening Visit or the duration of study participation.
7. Psychiatric disorders that may affect compliance with the clinical trial, including
dementia, active psychosis, severe depression requiring > 2 medications, or history of
suicide attempts. Any condition which places the subject at undue risk for the
procedure (surgeon's discretion).
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 | Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients. | NCT01512940 | Entailment |
164 | 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:
1. Patients with ED over 3 months (specify using IIEF score)
2. Age >= 18 years.
3. Stable sexual relationship
4. With low or low normal serum testosterone level (either total or bioavailable
testosterone) TT <= 4 ng/ml and/or BT <= 1 ng/ml
5. Aging Male Symptom scale with total score starting at 37 points (must not replace TT <
4 ng/ml)
6. Eligible subjects who previously took the oral androgen or PDE5 inhibitor must have
discontinued their use for 1 month
Exclusion Criteria:
1. Contraindication to treatment with Testosterone according to the SPC
2. Hypersensitivity to the active substances or any of the excipients of Nebido
3. Diagnosed or suspected carcinoma of the prostate or the male breast cancer
4. Past or present liver tumors
5. Acute or chronic hepatic diseases
6. Severe cardiac, hepatic or renal insufficiency
7. History of penile implant or significant penile deformity
8. Diagnosed sleep apnea
9. Polycythemia (Hematocrit >50%)
10. Prolactin >25 ng/ml
11. Organic hypothalamic-pituitary pathology
12. Any unstable medical, psychiatric or drug/alcohol abuse disorder
13. Prostate specific antigen (PSA)>= 4 ng/ml
14. Severe symptomatic benign prostatic hyperplasia (IPSS) sum score >=20)
15. Diabetes mellitus which is uncontrolled (HbAlc level >10%)
16. Epilepsy not adequately controlled by treatment
17. Patients requiring fertility treatment
18. Hypertension which is not adequately controlled on therapy
19. Clinically significant chronic hematological disease which may lead to priapism such
as sickle cell anemia, multiple myeloma or leukemia
20. Hypersensitivity to PDE-5 inhibitors
21. Concomitant Medication:
- Nitrites or Nitric oxide donors
- Anti-androgens
- anti-coagulants, with the exception of anti-platelet agents
- Any of potent inhibitors of cytochrome P-450 3A4:such as HIV protease inhibitors
(Ritonavir or Indinavir); Anti-mycotic agent (Itraconazole and
Ketoconazole)-topical application allowed; or Erythromycin.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Therapy of Nebido as Mono or in Combination With PDE-5 Inhibitors in Hypogonadal Patients With Erectile Dysfunction | NCT00421460 | Entailment |
3,415 | 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:
- 18 - 60 years old
- ASA (I and II)
- Hb level > 10 mg/dl
- elective ear exploratory tympanotomy surgery under general anesthesia.
Exclusion Criteria:
- Allergy to TXA
- bleeding/coagulation disorders
- psychiatric illness
- acute and chronic renal failure
- heparin use within 48 hrs or aspirin use within seven days before surgery,
- pregnancy
- liver cirrhosis
- color blindness
- cardiac stent.
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 60 Years | Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy | NCT04188184 | Entailment |
1,714 | 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:
- ≥18 years of age
- Own an iOS or Android device
Exclusion Criteria:
- Inability to give informed consent
- <18 years of age
- Inability to understand written English language
- Hypertensive urgency or emergency as an admission diagnosis
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Role of Wrist Based Blood Pressure Monitoring in Clinical Practice | NCT03862742 | Entailment |
1,283 | 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. | Inclusion Criteria:
- Diagnosis of pleural effusion based on the presence of a consistent radiological
finding on simple posteroanterior and lateral chest X-rays, and decubitus lateral in
cases of small PE.
Exclusion Criteria:
- Non diagnosis of pleural effusion
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 | Effects of Respiratory Physiotherapy on Pleural Effusion | NCT01756742 | Entailment |
2,360 | 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:
- Diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist,
- Being volunteer,
- Being between 6 and 15 years old,
- Being between levels 1-5 according to the Brooke Lower Extremity Functional
Classification developed to classify lower extremity functions in children with DMD,
- Being able to cooperate with the physiotherapist's directives.
Exclusion Criteria:
- Being between levels 6-10 (children who do not have independent ambulatory ability)
according to the Brooke Lower Extremity Functional Classification,
- Not being able to cooperate with the physiotherapist's directives,
- End of the volunteering.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 15 Years | Effects of Fear of Falling on Physical Performance and Quality of Life in Children With Duchenne Muscular Dystrophy | NCT03507530 | Entailment |
1,713 | 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:
- Is the individual a healthy, normal adult man or woman who volunteers to participate?
- Is s/he within 18 to 45 years of age, inclusive?
- Is his/her BMI between 19 and 30 inclusive?
- Is she willing to avoid pregnancy by abstaining from sexual intercourse with a
non-sterile male partner, or by the use one of the following methods: diaphragm +
spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine
contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or
has she been surgically sterile or post-menopausal at least six months prior to
entering into the study?
- Is s/he considered reliable and capable of understanding his/her responsibility and
role in the study?
- Has s/he provided written informed consent?
Exclusion Criteria:
- Does the individual have a history or allergy or hypersensitivity to desloratadine or
pseudoephedrine, milk or eggs?
- Does s/he have clinically significant laboratory abnormalities that would interfere
with the conduct or interpretation of the study or jeopardize his/her safety?
- Does s/he have significant history or clinical evidence of auto-immune,
cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological,
ongoing infection, pancreatic, or renal disease that would interfere with the conduct
or interpretation of the study or jeopardize his/her safety?
- Is she nursing?
- Does s/he have serious psychological illness?
- Does s/he have significant history (within the past year) or clinical evidence of
alcohol or drug abuse?
- Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C
screen, or a positive pregnancy test?
- Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or
beverages during periods beginning 48 hours prior to study drug administration and
ending when the last blood sample has been taken in each study period?
- Has s/he used any prescription drug, other than hormonal contraceptives, during the 14
day period prior to study initiation, or any OTC drug during the 72 hour period
preceding study initiation?
- Is s/he unable to refrain from the use of all concomitant medications, other than
hormonal contraceptives, during the study?
- Has s/he donated or lost blood or participated in a clinical study which involved the
withdrawal of a large volume of blood (480 mL or more), during the six week period
preceding study initiation?
- Has s/he donated plasma during the two week period preceding study initiation?
- Has s/he received an investigational drug during the 30 day period preceding study
initiated?
- Has s/he used any tobacco products in the 3 months preceding drug administration?
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 | Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions | NCT01506791 | Entailment |
5,645 | 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:
- Females with BMI >25 kg/m2.
- Females not engaged in routine exercise programs in last 6 months
Exclusion Criteria:
- Females who are using weight loss products.
- Females having uncontrolled diabetes, thyroid disease, arthritis, cardiac diseases,
asthma, hypertension, and recent trauma would not be included in the study.
- Females who are pregnant would not be included in the study.
Female
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 HICT and LIIT on Functional Strength and Weight Efficacy in Overweight and Obese Females | NCT04812340 | Contradiction |
822 | 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:
- Presence of osteophytes or sclerosis at the carpometacarpal (CMC) joint
- Complaint of unacceptable pain despite modification of activity and a therapeutic dose
of nonsteroidal anti-inflammatory drugs (NSAIDS), if tolerated
- If bilateral disease, only the most severely involved hand (as defined by the visual
analog scale [VAS] for pain) will be entered in the study
- Able to follow instructions and complete questionnaires
- Failed conservative therapy with NSAIDS or COX-2 inhibitors
- Unable to tolerate COX-2 inhibitors
Exclusion Criteria:
- Previous traumatic dislocation, ligament tear, or fracture of the thumb in the
affected hand
- Previous hand surgery on the affected hand
- Known hand comorbidities (e.g., active carpal tunnel syndrome, de Quervains
tenosynovitis, etc.)
- Systemic rheumatic disease
- Bleeding diatheses or anti-coagulation
- Allergies to steroids, chicken products, bupivicaine, or adhesive (e.g., double-sided
tape)
- Current use of oral or intravenous steroids
- Active systemic malignancies
- Hyaluronan injection in the target CMC joint in the last 6 months
- Steroid or hyaluronan injection in any other joint in the last 6 months
- Insulin dependent diabetes mellitus (IDDM)
- Active infection
- Pain in the index joint that is more than 40 out of 100 on a VAS Pain scale
- End Stage CMC osteoarthritis, equivalent to bone on bone, Kellgren and Lawrence Stage
IV
- Grade 3 or 4 Eaton and Litter (E+L) Classification
- E+L 3: Advanced joint distraction, subchondral cysts, and sclerosis
- E+L 4: Involvement of several joint surfaces
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 95 Years | A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb | NCT00398866 | Entailment |
4,024 | 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;
- Male or female, 40 years to 85 years old (inclusive);
- Must be ambulatory;
- Index knee must be symptomatic for greater than 6 months with a clinical diagnosis of
OA and supported by radiological evidence (Kellgren Lawrence Grade II to IV) read by a
central reader;
- WOMAC 5-point Likert pain subscale <1.5 in the contralateral knee;
- Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the
WOMAC Index 3.1 5-point Likert Pain Subscale);
- Moderate to moderately-severe OA pain in the index knee (even if chronic doses of
nonsteroidal anti-inflammatory drug (NSAID), which have not changed in the 4 weeks
prior to screening, have been/are being used);
- Ability to discontinue 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 is allowed
during the study);
- No analgesia (including acetaminophen [paracetamol]) 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 patient 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
index knee for the duration of the trial (e.g. cancer, congenital defects, spine
osteoarthritis)
- Major injury to the index knee within the 12 months prior to screening
- Severe hip osteoarthritis ipsilateral to the index knee
- Any pain that could interfere with the assessment of index 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:
- No IA injected pain medications in the study knee during the study
- No analgesics containing opioids.
- NSAIDs are not permitted during the study; acetaminophen is available as a rescue
medication during the study from the provided supply.
- No topical treatment on osteoarthritis index knee during the study
- No significant anticoagulant therapy (e.g. Heparin or Lovenox) during the study
(treatment such as low dose Aspirin and Plavix are allowed)
- No systemic treatments that may interfere with safety or efficacy assessments during
the study
- No immunosuppressants
- No use of 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-B Study to Evaluate the Efficacy And Safety Of An Intra-Articular Injection Of Ampion™ In Adults With Pain With Osteoarthritis Of The Knee | NCT02556710 | Entailment |
4,888 | 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:
- Patients aged 20 to 60 with spontaneous active Cushing's syndrome
- At least 2 weeks since medication with psychoactive effects or influence on cortisol
metabolism by hepatic hydroxylating enzyme induction
- Antihypertensives allowed for severe hypertension
- No barbiturates
- No phenytoin
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 60 Years | Study of Depression, Peptides, and Steroids in Cushing's Syndrome | NCT00004334 | Entailment |
1,575 | 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:
1. Age ≥ 21 years and ≤ 85 years
2. Able to understand and give informed consent.
3. Subject is presenting for the following planned procedures:
3.1 Group A (25 subjects): Subjects presenting for catheter ablation for cardiac
arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular
tachycardia) 3.2 Group B (25 subjects): Subjects judged based on the clinical evaluation of
high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing
dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2)
implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac
resynchronization therapy with or without defibrillator (single or dual chamber plus left
ventricular pacing).
3.3 Group C (5 subjects): Subjects for clinically indicated defibrillation threshold
testing (DFT) (with a transvenous or subcutaneous ICD lead system)
Exclusion Criteria:
1. Age < 21 years and > 85 years
2. Unable to or refuse to give written informed consent
3. Unwilling or unable to wear the smartwatch device on at least one wrist
4. Uncorrected severe aortic stenosis or subaortic stenosis (including hypertrophic
cardiomyopathy) with outflow tract obstruction > 50 mm
5. New York Heart Association Class IV Heart Failure
No condition on gender to be admitted to the trial.
Subject must be at least 21 Years old.
Subject must be at most 85 Years | iBeat Wristwatch Validation Study | NCT03711695 | Contradiction |
4,351 | 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:
- 18 to 39 years of age
- Best corrected visual acuity of at least 20/30
- Spherical equivalent refractive error in each eye of between -0.75 and -6.00 diopters
sphere after vertexing to the corneal plane
Exclusion Criteria:
- Greater than -1.00 diopter of refractive astigmatism at the corneal plane
- Any active anterior segment disease, pathology, or surgery affecting vision,
refraction, or the ability to wear a soft contact lens
- History of ocular trauma or surgery causing abnormal or distorted vision
- Current Rigid Gas Permeable (RGP) contact lens wearers
- Unwilling to have eyes photographed or video recorded
- Pregnant and/or lactating females, by self-report
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 39 Years | Evaluation of Visual Performance With Contact Lenses | NCT03705130 | Entailment |
3,491 | 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:
- Sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's
disease patients with 25dB HL in pure tone audiometry
- Patients whose hearing has not been restored after standard treatment
- Patients do not participate in clinical trials within 6 months
Exclusion Criteria:
- Patients with retrocochlear lesion
- Patients with history of hypersensitivity to the substance of this drug
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
| Verification of the Efficacy/Safety of the Dual Drug Delivery for Hearing Loss | NCT04766853 | Entailment |
3,284 | 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:
- Patients: cross sectionally patients will be included for clinical suspicion of
primary SS or with the diagnosis already established in Rheumatology unit.
The following inclusion criteria will be applied to the study:
- Age > 18 years
- Informed consent of the patient.
Exclusion Criteria:
- Impossibility of obtaining consent (cognitive impairment, other causes).
- Associated systemic autoimmune or rheumatological diseases.
- Chronic viral infections (HCV, HBV, HIV).
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.
| Biomarkers in Primary Sjögren's Syndrome | NCT03765593 | Entailment |
6,852 | 49 | A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating. She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications. Vital signs are normal. Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive. Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels. | I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive. I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these. | Inclusion Criteria:
- referral by a physician for swallowing evaluation because of suspected dysphagia
- complaint of difficulty swallowing
- aspiration or penetration of the laryngeal vestibule with liquids or semisolids OR
post-swallow residue visible in the oral cavity, valleculae, or pharynx that is
instrumentally documented by a participating SLP during a standard clinical
videofluoroscopic swallowing study
- between the ages of 21 and 95
- ability to perform the exercise protocol independently or with the assistance of a
caregiver
- physician approval of medical stability to participate
- decision-making capacity to provide informed consent (confirmed through discussion
between the participating SLP and the subject's primary physician)
Exclusion Criteria:
- degenerative neuromuscular disease
- poorly controlled psychosis
- patient unable to complete the exercise program
- allergy to barium (used in videofluoroscopic swallowing assessment)
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.
Subject must be at most 95 Years | Study of Tongue Strengthening for Swallowing Problems | NCT01570023 | Entailment |
3,571 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- erythema migrans in patients > 18 years
Exclusion Criteria:
- pregnancy or immunocompromising conditions
- taking antibiotic with antiborrelial activity within 10 days
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.
| Inflammatory Mediators in Erythema Migrans | NCT03956212 | Entailment |
2,531 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | - INCLUSION CRITERIA:
1. Subject or unaffected relatives must:
1. Be at least 2 years of age and less than or equal to 21 years of age at the
time of enrollment and have documented history of AD, by modified Hanifin
and Rajka criteria, that began in the first 5 years of life, that is
moderate to severe, and with continued active flares in the preceding 3
months. Patients greater than 21 years of age with active moderate to severe
AD may be enrolled, at the discretion of the PI or AIs, if they have a
history of AD in the first 5 years of life and/or, if in the opinion of the
PI or AIs, the patient would be of interest to fulfill the objectives of the
study.
OR
2. Be 2-80 years of age with a suspected genetic or congenital disorder
associated with atopy or affecting an atopic pathway, as determined by the
PI or AIs.
OR
3. Be an unaffected relative of a patient enrolled in the protocol.
2. Have a private physician to provide local continuity of care.
3. Provide a letter of referral, with copies of pertinent medical history and
laboratory studies as indicated, from prospective study participant s referring
physician; this is not a requirement for healthy relatives.
4. Be willing to donate blood, buccal swabs, saliva, skin and nasal swabs for
research and clinical studies and for storage to be used for future research; for
unaffected relatives, be willing to donate blood and/or undergo allergy skin
testing, in addition to having blood samples stored for future research.
5. Pregnant women or women who become pregnant are eligible to participate or
continue participation on the study.
Healthy Volunteer must:
1. Be at least 18 years old and no greater than 80 years old.
2. Have no history of recent, active, moderate to severe atopic dermatitis.
3. Be willing to have samples stored for research and genetic testing.
4. For a subset of subjects participating in the cooling cuff procedure, be willing to
have research skin biopsies performed.
EXCLUSION CRITERIA:
Any subject with any of the following criteria will be excluded:
1. Presence of conditions that, in the judgment of the investigator or the referring
physician, may put the subject at undue risk or make them unsuitable for participation
in the study.
2. Inability or refusal to undergo study procedures.
3. Inability to participate for the duration of the study.
Any unaffected relative or healthy volunteer with any of the following criteria will be
excluded:
1. Presence of conditions that, in the judgment of the investigator or the referring
physician, may put the subject at undue risk or make them unsuitable for participation
in the study.
2. Inability or refusal to undergo study procedures.
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 80 Years | Natural History of Diseases Associated With Allergic Inflammation: Atopic Dermatitis and Genetic and Congenital Diseases Associated With Atopic Pathways | NCT01164241 | Entailment |
1,621 | 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:
- Participation in the NLM / NAO Teen Health Information Literacy Project
EXCLUSION CRITERIA:
-NA
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 18 Years | Educational Impact of the NLM/National Area Health Education Center Organization (NAO) Project-SHARE Based Teen Health Information Literacy Curriculum | NCT02769988 | Contradiction |
2,829 | 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:
- ALS patients diagnosed according to El Escorial / Awaji criteria for ALS
- patients should have the ability to comprehend the full nature and purpose of the
study, to cooperate with the investigator, to understand verbal and written
instructions, and to comply with the requirements of the entire study.
Exclusion Criteria:
- patient's request or if patient compliance with the study protocol is doubtful
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 90 Years | Evaluating the Potential of the Diet as Disease Modifier in Amyotrophic Lateral Sclerosis (JERN_ALS) | NCT02572479 | Entailment |
6,375 | 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:
- Male or female, aged ≥18 years of age;
- Laboratory confirmed infection with COVID-19 virus by an FDA-authorized SARS-Cov-2
RT-PCR;
- Able and willing to give written informed consent.
- Willing to keep an electronic diary from Study Day 1 to Study Day 13 (± 1 day) and
Study Day 15 (± 1 day) to Study Day 28 (± 1 day)
- Willing to have daily phone or videoconferences with study team personnel from Study
Day 1 to Day 13 (± 1 day) and Day 28
- At least one of the following clinical symptoms of COVID-19 infection within the 4
days prior to and inclusive of the day of screening:
1. Respiratory rate ≥ 24/min
2. New cough or shortness of breath that has presented within the last 4 days
3. Fever - temperature 37.7°C [oral or skin surface]
- Must agree not to enroll in another study of an investigational agent prior to
completion of Day 28 of the study.
- Able to take ARAKODA or KODATEF according to Prescribing Information
- Have been symptomatic no longer than 5 days when the first dose of study medication is
administered.
- If female, agree to use an acceptable method of birth control from the time of consent
through 56 days after the last dose of study drug.
Exclusion Criteria:
- Have one of the contraindications for ARAKODA or KODATEF in the prescribing
information (section 16.1) including:
1. G6PD deficiency
2. Breastfeeding
3. Psychotic disorder or current psychotic symptoms
4. Known hypersensitivity reaction to TQ
- Evidence of severe or critical illness, defined by at least one of the following:
1. Clinical signs indicative of severe systemic illness with COVID-19, such as
respiratory rate ≥30 breaths per minute, heart rate ≥ 125 beats per minute, SpO2
≤93% on room air
2. Respiratory failure defined based on resource utilization requiring at least one
of the following:
i. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow
nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at
flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive
pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical
diagnosis of respiratory failure (i.e., clinical need for one of the preceding
therapies, but preceding therapies not able to be administered in setting of resource
limitation) ii. Shock (defined by systolic blood pressure < 90 mmHg, or diastolic
blood pressure <60 mmHg or requiring vasopressors) iii. Multi-organ
dysfunction/failure
- Any other clinically significant acute illness unrelated to COVID-19 within seven days
prior to first study drug administration
- Receipt of any experimental treatment for COVID-19 (off-label, compassionate use, or
study-related) within the 30 days prior to the time of the screening evaluation
- Any excluded concomitant medication as described in the ARAKODA package insert
[Section 16.1]
- Any COVID-19 symptoms which, in the opinion of the investigator, is suggestive of
possible requirement to hospitalize within 48 hours of enrollment
- Positive pregnancy test
- Have been symptomatic for more than five days when the first dose would be
administered
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.
| Tafenoquine in Patients With Mild to Moderate COVID-19 | NCT04533347 | Entailment |
313 | 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:
- Regular menstrual cycles
- Age 18-50
- Normal Baseline ultrasound
- No intra-uterine procedures in prior 90 days
Exclusion Criteria:
- Any contraindications to undergoing estrogen stimulation of the endometrium
- Age ≥35 years and smoking ≥15 cigarettes per day
- Multiple risk factors for arterial cardiovascular disease (smoking, diabetes, and
hypertension)
- Hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Venous thromboembolism (current or history of)
- Known thrombogenic mutations
- Known ischemic heart disease
- History of stroke
- Complicated valvular heart disease (pulmonary hypertension, risk for atrial
fibrillation, history of subacute bacterial endocarditis)
- Systemic lupus erythematosus (positive or unknown antiphospholipid antibodies)
- Migraine with aura at any age
- Breast cancer
- Cirrhosis
- Hepatocellular adenoma or malignant hepatoma
- History of undiagnosed abnormal uterine bleeding.
- Allergic reaction to any study drug
- Known pregnancy or delivery within the past 6 months
- Breastfeeding
- Obesity >35 kg/m2
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Effects of Varied Estrogen Doses on Endometrial Receptivity | NCT02458404 | Contradiction |
5,156 | 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:
Caucasian
BMI of 18.5 kg/m2 or above
Ages 25 to 40 years (and premenopausal if female) or 55 to 75 years (and postmenopausal (at
least 5 years since last menstrual period) if female)
Sufficiently mobile to undergo scanning
Able to remain motionless for the duration of the scans
Able and willing to participate in the study and provide written informed consent
Exclusion criteria:
Previous orthopaedic surgery or fractures which preclude imaging at all sites
History of any long term immobilization (duration greater than three months)
High trauma fracture or low trauma fracture less than one year prior to recruitment
Current pregnancy or trying to conceive
Delivery of last child less than one year prior to recruitment
Breast feeding less than one year prior to recruitment
Pre-diagnosed diabetes mellitus
History of or current conditions known to affect bone metabolism including:
- Diagnosed skeletal disease
- Osteoarthritis at study measurement sites
- Chronic renal disease
- Malabsorption syndromes
- Diagnosed endocrine disorders
- Hypocalcemia or hypercalcemia
- Diagnosed restrictive eating disorder
Conditions which prevent the analysis of the DXA scans or the interpretation of their
result
Use of medications or treatment known to affect bone metabolism including Depot
medroxyprogesterone or the combined oral contraceptive pill
Alcohol intake of greater than 21 units per week
Competitive athlete, defined as participating in competitive sport at amateur or
professional level
Markedly abnormal clinical laboratory parameters that are assessed as clinically
significant by the PI.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 75 Years | The Effects of Obesity on Bone Structure and Strength | NCT02629185 | Contradiction |
6,533 | 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:
- Willingness to adhere to the clinical protocol and 15-year long-term follow-up as
evidenced by written informed consent
- Adult males at least 18 years of age
- A. Severe FIX deficiency (<1% normal circulating FIX) or B. Moderately severe FIX
deficiency (1-2% normal circulating FIX, inclusive) and a severe bleeding phenotype as
defined by at least one of the following: i. On prophylaxis for a history of bleeding
or ii. On demand therapy with a current or past history of frequent bleeding [4 or
more bleeding episodes in the last 12 months or chronic hemophilic arthropathy (pain,
joint destruction, and loss of range of motion) in one or more joints]
- No history of inhibitor against FIX
- No history of an allergic reaction or anaphylaxis to FIX products
- Greater than 20 exposure days of treatment with FIX protein
- Anti-AAV8 neutralizing titer measured at < 1:5
- Acceptable laboratory values: hemoglobin ≥ 11% gm; WBC ≥ 3,500/μL; platelets ≥
100,000/μL; AST, ALT, alkaline phosphatase ≤ 2x ULN; bilirubin ≤ 1.2 gm/dL; and
creatinine ≤ 1.5 gm/dL
- Subject agrees to use barrier contraception until at least two consecutive semen
samples after vector administration are negative for vector sequences (may be for up
to several months)
Exclusion Criteria:
- Subjects with active hepatitis B or C, and HBsAg or HCV RNA viral load positivity,
respectively. Negative viral assays in two samples, collected at least six months
apart, will be required to be considered negative. Both natural clearers and those who
have cleared HCV on antiviral therapy are eligible.
- Subjects currently on antiviral therapy for hepatitis B or C
- Subjects with significant underlying liver disease, as defined by presence of portal
hypertension, splenomegaly, varices, ascites, edema, gastrointestinal bleeding,
encephalopathy, reduction below normal limits of serum albumin, or prior liver biopsy
demonstrating significant fibrosis, specifically ≥ Metavir 3 fibrosis
- Subjects with serological evidence of HIV who have CD4 counts ≤ 200/mm3. Subjects who
are HIV-positive and stable, with an adequate CD4 count (> 200/mm3) and undetectable
viral load (< 50 gc/mL) measured twice in the six months prior to enrollment, on an
antiretroviral drug regimen are eligible to enroll.
- History of inhibitor against FIX
- Anti-AAV8 antibody titers ≥ 1:5
- History of chronic infection or other chronic diseases which the investigators
consider to constitute an unacceptable risk
- Subjects who have participated in a previous gene therapy research trial within one
year of enrollment
- Subjects who have participated in a clinical study with an investigational drug within
six months of enrollment
- Any other condition that would not allow the potential subject to complete follow-up
examinations during the course of the study or, in the opinion of the investigator,
makes the potential subject unsuitable for the study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Hemophilia B Gene Therapy With AAV8 Vector | NCT01620801 | Contradiction |
3,559 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- age 18-35 years
- female
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Exclusion Criteria:
- itchy skin diseases
- hay fever
- asthma
- chronic venous insufficiency
- peripheral artery disease
- musculoskeletal diseases or injuries affecting the legs, hips and pelvis
- BMI < 17 and > 35 kg/m2
- pregnancy
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise | NCT03455036 | Contradiction |
3,216 | 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:
Male and female subjects.
All subjects will have first participated in screening protocol 84-D-0056 to confirm their
diagnosis and assess salivary function.
Subjects must have dry mouth symptoms (xerostomia) and a diagnosis of primary or secondary
SS, incomplete SS, or radiation-induced salivary gland dysfunction (as determined in
protocol 84-D-0056).
Diagnostic criteria for SS are the American-European Consensus Group Classification
Criteria: For primary Sjogren s syndrome, any 4 of the 6 criteria, must include item IV
(Histopathology) or VI (Auto-antibodies) or any 3 of the 4 objective criteria (III, IV, V,
VI). For secondary Sjogren s syndrome, must have established connective tissue disease, one
symptom (I or II) plus 2 of the 3 objective criteria (III, IV, VI).
Ocular symptoms (at least one)
Daily persistent dry eyes for greater than 3 months?
Recurrent sensation of sand or gravel in the eyes?
Use of tear substitutes greater than 3 x/day?
Oral symptoms (at least one)
Daily feeling of dry Mouth greater than 3 months
Recurrent or persistently swollen salivary glands as an adult?
Frequently drink liquids to aid in swallowing dry foods?
Ocular signs (at least one)
Schirmer s test, (without anesthesia) greater than or equal to 5mm/5 minutes
Positive vital dye staining (van Bijsterveld greater than or equal to 4)
Histopathology: Lip biopsy showing focal lymphocytic sialadenitis (focus score greater or
equal to 1 per 4mm squared)
Oral signs (at least one)
Unstimulated whole salivary flow (greater or equal to 1.5 ml in 15 minutes)
Abnormal parotid sialography
Abnormal salivary scintigraphy
Auto-antibodies (at least one)
Anti-SSA (Ro) or Anti-SSB (La)
EXCLUSION CRITERIA FOR DIAGNOSIS OF SS:
Past head and neck radiation treatment
Hepatitis C infection
Acquired Immunodeficiency Syndrome (AIDS)
Pre-existing lymphoma
Sarcoidosis
Graft versus host disease
Current use of anticholinergic drugs
EXCLUSION CRITERIA:
Failure to complete evaluation procedures as specified in 84-D-0056.
Diagnosis of drug-related xerostomia.
Age less than 4 years.
There are no exclusions based on gender, race, or ethnicity. Salivary gland dysfunction is
uncommon in children and exceedingly rare in those less than 4 years old. Additionally, the
evaluation method described in the protocol cannot be used in this age group.
ULTRASOUND GUIDED CORE NEEDLE BIOPSY OF THE PAROTID GLAND
Adult subjects already enrolled in this protocol and healthy volunteers will be eligible
for this research procedure if they fulfill the criteria below and sign the parotid biopsy
consent form. Healthy volunteers will be recruited only for the ultrasound guided core
needle biospy of the parotid gland. They will sign the parotid biopsy consent form only.
INCLUSION CRITERIA:
Age 18 years or older.
Ability to give informed consent.
EXCLUSION CRITERIA:
History of bleeding diathesis or the current use of anticoagulants.
Any uncontrolled or severe chronic disease.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 4 Years old.
| Natural History of Salivary Gland Dysfunction and Sjogren's Syndrome | NCT00001852 | Entailment |
411 | 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:
- healthy, non-pregnant, pre-menopausal female who is not using NuvaRing.
- must meet one of the two following criteria: 1) has not taken a combined hormonal
contraceptives for at least 3 months prior to screening and has normal predictable
menstrual cycles ranging from 26 to 35 days in length with no history of
intermenstrual bleeding in the past 6 months; or 2) has been taking a combined
hormonal contraceptive for >3 months and has not experienced unscheduled bleeding for
the past 3 months.
- willing to abstain from vaginal penetration, including during sexual intercourse and
masturbation, from the time of randomization (Visit 2) to the end of the follow-up
period.
- willing to abstain from vaginal penetration with any objects other than the applicator
and placebo rings (including but not limited to tampons, douching, use of vaginal
applicators for medication, medication, diaphragms, cervical caps, male and female
condoms, lubricants, sex toys) from the time of randomization (Visit 2) to the end of
the follow-up period.
- good physical and mental health, based upon the medical judgment of the investigator.
Exclusion Criteria:
- current use or has used within past 3 months any of the following: NuvaRing,
progestin-only contraceptives (including pills, injection, or implant), oral or
transdermal combined hormonal contraceptives with extended or continuous hormonal
regimens that prevent monthly withdrawal bleeding by omitting monthly progestin-free
intervals. Note: Current use of oral or transdermal combined hormonal contraceptives
with 4 to 7 progestin-free days per 28-day cycle for >3 months is permitted.
- has stopped use of any hormonal contraceptive, including NuvaRing, <3 months prior to
screening; previous use (≥3 months prior to screening) is permitted.
- history of difficulty retaining NuvaRing in the vagina and therefore could not
continue on it as a contraceptive method or difficulty retaining other products (e.g.,
tampons) in the vagina.
- is pregnant or within 2 months of last pregnancy outcome (delivery, spontaneous or
induced abortion, medical or surgical management of ectopic pregnancy).
- is breastfeeding.
- diagnosed or treated for a sexually transmitted disease within the past 6 months.
- current complaints of vaginal or vulvar irritation, discomfort, abnormal
bleeding/spotting, or abnormal discharge.
- abnormal cervical Pap smear documented within 12 months of screening.
- genital herpes outbreak in the past 3 years.
- has received any investigational drug or device in the 30 days prior to screening
and/or plans to receive any investigational drug or device at any time up to the last
protocol-required visit.
- known current gynecological disorder which, in the opinion of the investigator,
interferes with the objectives of the study.
- known allergy/sensitivity or contraindication to the investigational product
(applicator) or ethylene vinyl acetate.
- current or recent history (within the last six months) of drug or alcohol abuse or
dependence.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063) | NCT02275546 | Contradiction |
855 | 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:
- Patient suffering with Osteoarthritis knee for three months at least
- Age ranges from 40-70
- knee OA as per the American College of Rheumatology clinical and radiographic
diagnostic criteria will participate
- 1-3 radiographic grades on the Kellgren-Lawrence scale
- Both genders will be included
- being able to cooperate
- Bilateral knee osteoarthritis
Exclusion Criteria:
- Traumatic knee pain, fractures or ruptured ligaments, meniscopathy of knee joint
- Inflammatory and Infectious knee conditions (RA, gout, psoriatic arthritis)
- Balance problem
- Any recent surgical intervention of knee joint or those who had undergone arthroplasty
- Surgeries in hip or knee
- Tumors/malignancy of bone
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Retro-walking in Knee Osteoarthritis | NCT04546659 | Entailment |
927 | 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:
- Hand OA diagnosis according to the criteria of the American College of Rheumatology
(ACR )
- Be properly registered in the rheumatology clinic of Hospital das Clínicas
Exclusion Criteria:
- Surgical treatment or infiltration in the hands, in the last 6 months;
- Treatment of occupational therapy and / or physical therapy, or use of any TA feature
(assist device or stent) in the last 6 months;
- Diagnosis of another rheumatologic disease or musculoskeletal system that compromise
the hands associated.
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 90 Years | Assistive Device for Hand Osteoarthritis | NCT02667145 | Entailment |
6,292 | 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:
- Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)
- Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat,
malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with
exertion. (Not applicable to participants in treatment arm 22.)
- Must have sample taken for test confirming viral infection no more than 3 days prior
to starting the drug infusion
- Are males or females, including pregnant females who agree to contraceptive
requirements
- Understand and agree to comply with planned study procedures
- Agree to the collection of nasopharyngeal swabs and venous blood. (Not applicable to
participants in treatment arms 20-21.)
- The participant or legally authorized representative give signed informed consent
and/or assent
Participants in treatment arms 7-9, 13-14, and 18-21 ONLY
- Are greater than or equal to (≥)18 years of age and must satisfy at least one of the
following at the time of screening
- Are pregnant
- Are ≥65 years of age
- Have a body mass index (BMI) ≥35
- Have chronic kidney disease (CKD)
- Have type 1 or type 2 diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment or
- Are ≥55 years of age AND have:
- cardiovascular disease (CVD), OR
- hypertension, OR
- chronic obstructive pulmonary disease (COPD) or other chronic respiratory
disease
- Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the
time of screening
- Are pregnant
- Have a body mass index (BMI) ≥85th percentile for their age and gender based on
CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm
- Have sickle cell disease
- Have congenital or acquired heart disease
- Have neurodevelopmental disorders, for example, cerebral palsy
- Have a medical-related technological dependence, for example, tracheostomy,
gastrostomy, or positive pressure ventilation (not related to COVID-19)
- Have asthma or reactive airway or other chronic respiratory disease that requires
daily medication for control
- Have type 1 or type 2 diabetes
- Have chronic kidney disease
- Have immunosuppressive disease, or
- Are currently receiving immunosuppressive treatment
Participants in treatment arm 22 ONLY
- Are 0 (≥ 32 weeks gestational age AND ≥ 1.5 kilograms [kg]) to 17 years of age
(inclusive) AND satisfy at least one of the following risk factors at the time of screening
- Are pregnant
- Have a BMI ≥85th percentile for their age and gender based on CDC growth charts,
https://www.cdc.gov/growthcharts/clinical_charts.htm
- Have sickle cell disease
- Have congenital or acquired heart disease
- Have neurodevelopmental disorders, for example, cerebral palsy, autism, or Down
syndrome (FAIR Health 2020; Spreat et al. 2020)
- Have a medical-related technological dependence, for example, tracheostomy,
gastrostomy, or positive pressure ventilation (not related to COVID-19)
- Have asthma, cystic fibrosis, reactive airways disease or other chronic respiratory
disease that requires daily medication for control
- Have type 1 or type 2 diabetes
- Have chronic kidney disease
- Have immunosuppressive disease, or
- Are currently receiving immunosuppressive treatment, or
- Are less than (<) one year of age.
- Have one or more COVID-19 symptoms
- Shortness of breath/difficulty breathing
- Fever
- Sore throat
- Nausea
- Diarrhea
- Tiredness
- Headache
- New loss of taste
- Nasal congestion/runny nose
- Chills
- Stomachache
- Vomiting
- Cough
- Muscle/body aches and pain
- New loss of smell
- Poor appetite or poor feeding (in babies)
Exclusion Criteria:
- Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at
sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of
mercury) to fractional inspired oxygen (FiO2) less than (<)300, respiratory rate
greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19
- Require mechanical ventilation or anticipated impending need for mechanical
ventilation due to COVID-19
- Have known allergies to any of the components used in the formulation of the
interventions
- Have hemodynamic instability requiring use of pressors within 24 hours of
randomization
- Suspected or proven serious, active bacterial, fungal, viral, or other infection
(besides COVID-19) that in the opinion of the investigator could constitute a risk
when taking intervention
- Have any co-morbidity requiring surgery within <7 days, or that is considered
life-threatening within 29 days
- Have any serious concomitant systemic disease, condition or disorder that, in the
opinion of the investigator, should preclude participation in this study
- Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility
for this study
- Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30
days before dosing
- Have received treatment with a SARS-CoV-2 specific monoclonal antibody
- Have received convalescent COVID-19 plasma treatment
- Have participated, within the last 30 days, in a clinical study involving an
investigational intervention. If the previous investigational intervention has a long
half-life, 5 half-lives or 30 days, whichever is longer, should have passed
- Are concurrently enrolled in any other type of medical research judged not to be
scientifically or medically compatible with this study
- Mothers who are breast feeding
Participants in Treatment Arm 22 ONLY
- Have a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) in the
opinion of the investigator
- Are currently hospitalized for treatment of COVID-19. Other reasons for
hospitalization are acceptable.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness | NCT04427501 | Entailment |
2,691 | 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:
- ages must be upper 18
Exclusion Criteria:
- Morbit obesity (BMI>40)
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 | Normal and Small Size Mesh in Open Inguinal Herni Repair | NCT04269330 | Entailment |
6,960 | 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:
- Outpatients with a diagnosis of Alzheimer's disease.
- Exhibiting an onset and progression of cognitive dysfunction during at least 3 months
prior to the screening period.
Exclusion Criteria:
- Patients with neurodegenerative diseases other than Alzheimer's disease.
- Patients with cognitive dysfunction due to cerebral damage resulting from a lack of
oxygen, a brain injury, etc.
- Patients with clinically significant cardiovascular disease.
- Patients with history of clinically-evident stroke.
- Patients with history of cancer in the last 5 years.
- Patients with clinically-significant systemic illness that may affect safety or
completion 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 65 Years old.
| Effects of Chromium on Insulin Resistance in Alzheimer Disease Patients | NCT03038282 | Entailment |
1,002 | 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:
- patients with grade I or grade II knee OA (based on the Kellgren-Lawrence
classification;
- which was diagnosed by a medical traumatologist;
- radiographic changes that demonstrated a reduced joint space in at least one of the
compartments of the knee;
- subchondral bone sclerosis;
- consent to participate in the study
Exclusion Criteria:
- patients who had grade III and grade IV knee OA (based on the Kellgren-Lawrence
classification);
- who were involved in another rehabilitation program outside the center;
- who presented with clinical symptoms that would prevent them from participating in the
exercises;
- who had heart disease;
- cardiac pacemakers;
- periarticular metal implants;
- who experienced changes in sensitivity;
- who had a previous history of knee injury (meniscus, ligaments, sprains);
- who had uncontrolled diabetes;
- neurological disorders with cognitive impairments;
- rheumatic diseases;
- history of knee trauma in the last six months;
- prior knee surgery;
- three consecutive unexcused absences.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Exercise and Muscle Stimulation in Patients With Knee Osteoarthritis | NCT01320904 | Entailment |
5,079 | 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:
Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral
density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip,
or femoral neck)
Exclusion Criteria:
- Severe osteoporosis
- Use of agents affecting bone metabolism
- History of metabolic or bone disease (except osteoporosis)
- Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
- Current hyper- or hypocalcemia
- Current, uncontrolled hyper- or hypothyroidism
- Current, uncontrolled hyper- or hypoparathyroidism
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years | Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis | NCT01992159 | Contradiction |
1,935 | 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:
1. Age from over 18 to under 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT1-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the
American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. expected to perform distal gastrectomy with D1+/D2 lymph node dissction to obtain R0
resection sugicall results.
5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Written informed consent
Exclusion Criteria:
1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal
Dissection/Endoscopic Mucosal Resection )for gastric cancer)
5. Gastric multiple primary carcinoma
6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative
imaging
7. History of other malignant disease within the past 5 years
8. History of previous neoadjuvant chemotherapy or radiotherapy
9. History of unstable angina or myocardial infarction within the past 6 months
10. History of cerebrovascular accident within the past 6 months
11. History of continuous systematic administration of corticosteroids within 1 month
12. Requirement of simultaneous surgery for other disease
13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
14. FEV1<50% of the predicted values
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 | Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer | NCT03313700 | Entailment |
2,935 | 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]
1. Subjects who show both upper motor neuron signs and lower motor neuron signs at the
same time in neurological tests.
2. Among subjects diagnosed with familial or sporadic ALS, subjects falling into
clinically definite ALS, probable ALS and probable ALS-lab supported according to The
revised World Federation of Neurology El Escorial Criteria[Rix Brooks, 2000], during
17-weeks period prior to the administration and ALSFRS-R score (progression rate) of
1.03 ± 50%/month (meaning mean value in that total period).
3. For subjects who are under Riluzole treatment, those who have received stable dose of
Riluzole for more than 28 days before screening visit.
4. Subjects with duration of disease of no more than 2 years from the first diagnosis
date.
5. Subjects whose ALSFRS-R scores are in the range of 31~46 at the time of screening
(P-V0).
[Exclusion Criteria]
1. Subjects who received tracheostomy or use ventilators (including positive pressure
ventilators; subjects who use non-invasive ventilation for sleep apnea may be allowed
after review) at the time of screening (P-V0).
2. Subjects who received gastrotomy at the time of screening (P-V0).
3. Subjects for whom clinical efficacy evaluation is not possible because pulmonary
functional tests cannot be conducted at the time of screening (P-V0) or subjects whose
forced vital capacity is found to be not greater than 40%of the expected value.
4. Subjects who fall into above Class II according to the New York Heart Association's
functional classification, who have showed myocardial infarction, unstable arrhythmia
and/or other significant cardiovascular diseases such as unstable angina in the past 3
months, or who show electrocardiographic signs of myocardial infarction or angina at
the time of screening (P-V0) or who received stent insertion or coronary artery bypass
grafting.
5. Subjects who have received other investigational products or edaravone within 3 month
or 5 half-lives at the time of screening (P-V0) and lead in period visit L-V1
(evaluated by whichever is longer).
6. Subjects who have experienced epileptic seizure.
7. Subjects with severe renal disorder (serum creatinine: not less than 2.0 mg/dL).
8. Subjects with severe hepatic disorder (ALT, AST, or bilirubin: over 2.0 times of the
normal upper limit).
9. Subjects who show hemorrhagic tendency at the time of screening (PT and aPTT > 1.5 x
ULN)
10. Subjects who are found to have active viral infections (HBsAg, HCV Ab, HIV Ab, CMV
IgM, EBV IgM, HSV IgM and Treponema pallidum) at the time of screening.
11. Subjects with hypersensitivity to antibiotics (penicillin or streptomycin).
12. Subjects who have ever received any cell therapy product for the same disease.
13. Subjects with any malignant tumor in the past 5 years before screening, except
malignant tumors with very low risk of metastasis or death.
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 75 Years | Evaluatiton the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALS | NCT04745299 | Entailment |
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