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5,811 | 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:
- a history of minor recurrent aphthous stomatitis (RAS) lesions occurring at least 3-4
time/ year, and usually requiring 5 or more days to resolve
- presence of an active ulcer of less than 48 hours duration on either the buccal or
labial mucosa (making them more easily accessible for powder application)
- willing and able to give informed consent
Exclusion Criteria:
- pregnant or lactating
- if ulcers were manifestations of a systemic disease process such as ulcerative
colitis, Crohn's disease, Behcet's syndrome, or anemia;
- concurrent clinical conditions that could either pose a health risk to the patient by
being involved in the study or potentially influence the outcome of the study
- hypersensitivity to dexamethasone, diphenhydramine, tetracycline, metronidazole,
nystatin, karaya gum, or zinc oxide
- having used corticosteroids, oral retinoids, or other immunomodulatory agents within
one month of participation in the study; non-steroidal anti-inflammatory agents (e.g.,
aspirin, ibuprofen, etc.), acetaminophen, or oral antihistamines chronically within
one month of participation in the study or any use within five days of participation
in the study; topical medication (including steroids, retinoids, and anti-microbial
drugs) within two weeks of participation in the study, systemic antibiotics within two
weeks of participation in the study; any preparation or medication (OTC or
prescription) applied to the ulcer within 48 hours of participation in the study
- history of drug or alcohol abuse
- having had any dental work within 2 weeks of study entry
- having had any orthodontic or oral appliances (that could cause oral trauma) within 1
cm of the ulcer or any recollection of trauma in the area of the ulcer
- participating in any other study involving investigational or marketed products within
1 month of study entry or plans to participate in such an investigation during this
study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 12 Years old.
Subject must be at most 55 Years | The Effect of 2-DeNT Oral Topical Powder on Minor Recurrent Aphthous Ulcer | NCT02142543 | Entailment |
6,361 | 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:
- All humans seeking prevention or treatment of the COVID-19 pandemic.
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Treatment of Covid-19 Using Infrared and/or Vitamin C | NCT04584437 | Entailment |
2,966 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Diagnosis of ALS or a related disorder (e.g. primary lateral sclerosis, progressive
muscular atrophy).
- Receiving care at a clinical center that uses Epic as its EHR.
- Able and willing to provide informed consent (or informed consent obtainable from a
designated proxy).
Exclusion Criteria:
- Inability to understand English and/or Spanish
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.
| Clinical Procedures to Support Research in ALS | NCT03489278 | Entailment |
3,281 | 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:
- Diagnosis of a primary Sjögren´s Syndrome
- ESSDAI score ≥ 6
- Liver values above 1,5 ULN
- Stable low dose systemic use of Glucocorticoids（<=7.5mg） in the last 4 weeks before
begin with Study medication
Exclusion Criteria:
- Secondary Sjögren's Syndrome
- Pre-treatment with Cyclosporine A
- Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab,
belimumab, other immunosuppressives
- Infection
- Neoplasia
- Relevant cardiac, pulmonary, neurologic or psychiatric disease
- Life-Vaccination within 4 weeks before begin with study medication
- Pregnant or breast-feeding
- Weight under 45kg or more than 80kg
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome | NCT02464319 | Entailment |
5,047 | 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:
1. Men and women, between 18 and 80 years, inclusive
2. Patients who are able and willing to give consent and able to attend all study visits
3. A diagnosis of ET as confirmed from clinical history and examination by a movement
disorder neurologist
4. Tremor refractory to adequate trials of at least two medications, one of which should
be either propranolol or primidone. An adequate medication trial is defined as a
therapeutic dose of each medication or the development of side effects as the
medication dose is titrated.
5. Vim nucleus of thalamus can be target by the ExAblate device. The Vim region of the
thalamus must be apparent on MRI such that targeting can be performed with either
direct visualization or by measurement from a line connecting the anterior and
posterior commissures of the brain.
6. Able to communicate sensations during the ExAblate MRgFUS treatment
7. Postural or intention tremor severity score of greater than or equal to 2 in the
dominant hand/arm as measured by the CRST rating scale.
8. Stable doses of all medications for 30 days prior to study entry and for the duration
of the study.
9. May have bilateral appendicular tremor
10. Significant disability due to essential tremor despite medical treatment (CRST score
of 2 or above in any one of the items 16-23 from the Disability subsection of the
CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene,
dressing, writing, working, and social activities])
11. Inclusion and exclusion criteria have been agreed upon by two members of the medical
team.
Exclusion Criteria:
1. Patients with unstable cardiac status including:
1.1 Unstable angina pectoris on medication 1.2 Patients with documented myocardial
infarction within six months of protocol entry 1.3 Congestive heart failure requiring
medication (other than diuretic) 1.4 Patients on anti-arrhythmic drugs
2. Patients exhibiting any behavior(s) consistent with ethanol or substance abuse as
defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the
following occurring within a 12 month period:
- Recurrent substance use resulting in a failure to fulfill major role obligations
at work, school, or home (such as repeated absences or poor work performance
related to substance use; substance-related absences, suspensions, or expulsions
from school; or neglect of children or household).
- Recurrent substance use in situations in which it is physically hazardous (such
as driving an automobile or operating a machine when impaired by substance use)
- Recurrent substance-related legal problems (such as arrests for substance related
disorderly conduct)
- Continued substance use despite having persistent or recurrent social or
interpersonal problems caused or exacerbated by the effects of the substance (for
example, arguments with spouse about consequences of intoxication and physical
fights).
3. Severe hypertension (diastolic BP > 100 on medication)
4. Patients with standard contraindications for MR imaging such as non-MRI compatible
implanted metallic devices including cardiac pacemakers, size limitations, etc.
5. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or
Magnevist) including advanced kidney disease
6. Severely impaired renal function (estimated glomerular filtration rate < 45ml/min/1.73
m2) or receiving dialysis
7. History of abnormal bleeding and/or coagulopathy
8. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within
one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
(e.g. Avastin) within one month of focused ultrasound procedure
9. Active or suspected acute or chronic uncontrolled infection
10. History of intracranial hemorrhage
11. Cerebrovascular disease (multiple CVA or CVA within 6 months)
12. Individuals who are not able or willing to tolerate the required prolonged stationary
supine position during treatment (can be up to 4 hrs of total table time.)
13. Symptoms and signs of increased intracranial pressue (e.g. headache, nausea, vomiting,
lethargy, and papilledema)
14. Are participating or have participated in another clinical trial in the last 30 days
15. Patients unable to communicate with the investigator and staff.
16. Presence of any other neurodegenerative disease like parkinson-plus syndromes
suspected on neurological examination. These include: multisystem atrophy, progressive
supranuclear palsy, dementia with Lewy bodies, and Alzheimer"s disease.
17. Anyone suspected to have the diagnosis of idiopathic Parkinson"s disease. This
includes excluding anyone with the presence of parkinsonian features including
bradykinesia rigidity, or postural instability. Subjects who exhibit only mild resting
tremor but no other symptoms or signs of PD may be included.
18. Presence of significant cognitive impairment as determined with a score ≤ 24 on the
Mini Mental Status Examination (MMSE)
19. History of immunocompromise, including patient who is HIV positive
20. Known life-threatening systemic disease
21. Patients with a history of seizures within the past year
22. Patients with current or a prior history of any psychiatric illness will be excluded.
Any presence or history of psychosis will be excluded. Patients with mood disorders
including depression will be excluded. For the purpose of this study, we consider a
significant mood disorder to include any patient who has:
- been under the care of a psychiatrist for over 3 months
- taken antidepressant medications for greater than 6 months
- has participated in cognitive-behavioral therapy
- been hospitalized for the treatment of a psychiatric illness
- received transcranial magnetic stimulation
- received electroconvulsive therapy
23. Patients with risk factors for intraoperative or postoperative bleeding (platelet
count less than 100,000 per cubic millimeter, PT > 14, PTT > 36 or INR > 1.3) or a
documented coagulopathy
24. Patients with brain tumors
25. Any illness that in the investigator's opinion preclude participation in this study.
26. Pregnancy or lactation.
27. Legal incapacity or limited legal capacity.
28. Patients who have had deep brain stimulation or a prior stereotactic ablation of the
basal ganglia
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 | ExAblate Transcranial MR Guided Focused Ultrasound in the Treatment of Essential Tremor | NCT02037217 | Entailment |
5,716 | 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. | Patients and their families with known or suspected genetic disorders within the following
categories will be recruited:
Hereditary connective tissue disorders;
Phacomatoses;
Chromosomal disorders;
Dysmorphic syndromes;
Neuromuscular or neurological disorders;
Inherited immunological and hematologic disorders.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Study of Clinical and Molecular Manifestations of Genetic Disorders | NCT00001466 | Entailment |
5,721 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- All children of selected sample with an approved consent by their parents
Exclusion Criteria:
- Children with malformations that not permit take anthropometric measures.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Years old.
Subject must be at most 9 Years | Obesity Childhood in Cuenca-Ecuador: Prevalence and Risk Factors | NCT01381978 | Entailment |
2,358 | 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:
- Be able to provide written informed consent/assent as per local requirements.
- Be male.
- Have phenotypic evidence of dystrophinopathy based on the onset of characteristic
clinical symptoms or signs (e.g., proximal muscle weakness, waddling gait, and Gowers'
manoeuvre), an elevated serum creatinine kinase level, and ongoing difficulty with
walking.
- Have prior confirmation of the duchenne muscular dystrophy (DMD) diagnosis through:
Documentation of the presence of a mutation in the dystrophin gene as determined by gene
sequencing from a laboratory certified by the College of American Pathologists, the
Clinical Laboratory Improvement Act/Amendment or an equivalent organisation or
documentation of the absence of dystrophin in the muscle (via biopsy).
- Be able to undergo MRI examination.
- Participants must have used stable systemic corticosteroids (prednisone, prednisolone
or deflazacort) for a minimum of 6 months immediately prior to the start of the
Treatment Phase, with no significant change in dosage or dosing regimen (not related
to body weight change) and a reasonable expectation that dosage and dosing regimen
will not change significantly for the duration of the study.
- Confirmed screening laboratory values within the central laboratory ranges
(haematology, renal and serum electrolyte parameters and serum chemistry parameters)
or considered not clinically significant in the opinion of the Investigator.
Variations in specific parameters expected in a DMD population classed by the
Investigator as not clinically significant will not exclude the participant.
- Be willing and able to comply with scheduled visits, drug administration plan, study
procedures, laboratory tests and study restrictions.
Cohort 1 and 2 Specific Inclusion Criteria:
- Be aged ≥5 years to <10 years of age (from 5th birthday to 10th birthday).
- Be willing and able to comply with 2 muscle biopsy procedures.
- Have the ability to walk at least 300 meters unassisted during the screening 6 minute
walk distance (6MWD) and be below the protocol-specified threshold for 80%-predicted
6MWD.
- Have results of 2 6MWD by Baseline determined as valid. The results of the second 6MWD
(baseline) must be within 20% of the first 6MWD (screening).
- Have cardiac echocardiogram (ECHO) measurements showing an ejection fraction of ≥55%
and fractional shortening of ≥28%.
Cohort 3 Specific Inclusion Criteria:
- Have taken part in a prior SMT C1100 study.
Exclusion Criteria:
- Have physical exam findings that in the Investigator's opinion should be exclusionary
e.g., lower limb injury that may affect 6MWD performance.
- Have any change (initiation, change in type of drug, dose modification, schedule
modification, interruption, discontinuation or reinitiation) in prophylaxis/treatment
for congestive heart failure (CHF) within 3 months prior to the start of study
treatment.
- Have uncontrolled clinical symptoms and signs of CHF (American College of
Cardiology/American Heart Association Stage C or Stage D).
- Have abnormal glutamate dehydrogenase (GLDH) at baseline (>1.5 x upper limit of normal
[ULN]).
- Have abnormal coagulation times at baseline (>1.5 x ULN).
- Have an abnormal electrocardiograms (ECG).
- Use herbal supplements and be unwilling to stop these for the duration of the study.
- Have been exposed to another investigational drug or DMD interventional agent within 3
months prior to start of the Treatment Phase. Prior exposure to SMT C1100 or
participation in an approved deflazacort access program within this period would not
exclude the participant (provided they have been on stable treatment for 6 months).
- Have a history of major surgical procedure within 12 weeks prior to the start of the
Treatment Phase (Week 1).
- Be undertaking ongoing immunosuppressive therapy (other than corticosteroids).
- Require daytime ventilator assistance.
- Have a prior or ongoing medical condition, medical history, ECG findings, or
laboratory abnormality that, in the Investigator's opinion, could adversely affect the
safety of the participant, makes it unlikely that the course of treatment or follow-up
would be completed, or could impair the assessment of study results.
- Be dairy or lactose intolerant or have any other dietary restrictions that might
interfere with the conduct of the study.
- Be a smoker, use other tobacco or nicotine products or be exposed to daily passive
smoking (including parent/legal guardian, siblings) so as to minimise environmental
factors causing CYP1A induction.
- Be using an approved DMD medication or anticipates using one during the duration of
the study. Participants who are taking part in the FOR-DMD and ACCESS DMD studies will
be allowed to take part.
- Be using an inducer of CYP1A1 or CYP1A2.
- Be using a substrate of CYP2B6.
- All prescription, over the counter, and herbal products that are known CYP2B6
sensitive substrates will be excluded 14 days prior to study conduct (beginning at
screening) through 14 days after study conduct completion. Please note, this is not an
exhaustive list of CYP2B6 substrates and a discussion with the Medical Monitor may be
warranted.
- Be using drugs that have serotonergic, norepinephrinergic or dopaminergic activity, or
treatments used in attention deficit hyperactivity disorder.
- Use of substrates of BRCP.
Cohort 1 and 2 Specific Exclusion Criteria:
- Use beta blockers (however, if during the course of the study they are clinically
indicated they can be initiated).
Cohort 1 and 3 Specific Exclusion Criteria:
- Have a known hypersensitivity to any of the ingredients or excipients of the
investigational medicinal product: Poloxamer 188, Methylparaben, Propylparaben,
Hydroxypropylmethyl cellulose, Glycerol, Non-crystallising sorbitol [70%], Xanthan
gum, Strawberry cream flavour [PHS-132963].
Cohort 2 Specific Exclusion Criteria:
- Have a known hypersensitivity to any of the ingredients or excipients of the
investigational medicinal product: hypromellose acetate succinate.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
| Proof of Concept Study to Assess Activity and Safety of SMT C1100 (Ezutromid) in Boys With Duchenne Muscular Dystrophy (DMD) | NCT02858362 | Entailment |
3,294 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria for Normal Group
1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as
evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes (eyes without pathology)
4. lOPs 21mmHg bilaterally
5. BCVA 20/40 or better (each eye)
6. Both eyes must be free of eye disease
Exclusion Criteria for Normal Group
1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
2. Subjects unable to tolerate ophthalmic imaging
3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
4. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT
'Outside Normal Limits' and/or PSD < 5%
5. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on
manufacturer's recommendation), defined as fixation losses> 33% or false positives >
25%, or false negatives > 25%
6. Presence of any ocular pathology except for cataract
7. Previous ocular surgery or laser treatment, other than uncomplicated refractive
procedure or cataract surgery, performed within six months prior to study scanning
8. Narrow angle
9. History of leukemia, dementia or multiple sclerosis
10. Concomitant use of hydroxychloroquine and chloroquine
Inclusion Criteria for Glaucoma Group
1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as
evidenced by signing the informed consent
3. Subjects presenting at the site with glaucoma
4. BCVA 20/40 or better in the study eye
5. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT
'Outside Normal Limits' and/or PSD < 5% in the study eye
Exclusion Criteria for Glaucoma Group
1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
2. Subjects unable to tolerate ophthalmic imaging
3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
4. HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as
fixation losses > 33% or false positives > 25%, or false negatives > 25% in the study
eye
5. Presence of any ocular pathology except glaucoma in the study eye
6. Previous ocular surgery or laser treatment, other than uncomplicated refractive
procedure or cataract surgery, performed within six months prior to study scanning in
the study eye
7. History of leukemia, dementia or multiple sclerosis
8. Concomitant use of hydroxychloroquine and chloroquine
Inclusion Criteria for Retinal Group
1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as
evidenced by signing the informed consent
3. Subjects presenting at the site with retinal disease
4. lOP <= 21mmHg in the study eye
5. BCVA 20/400 or better in the study eye
6. Diagnosis of some type of retinal pathology by investigator, may include, but not
limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy,
Macular Hole, Epiretinal Membrane, Cystoid Macula Edema, and others
Exclusion Criteria for Retinal Group
1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
2. Subjects unable to tolerate ophthalmic imaging
3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
4. Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g.,
cornea pathology) in the study eye
5. Previous ocular surgery or laser treatment other than uncomplicated refractive
procedure or cataract surgery performed within six months prior to study scanning in
the study eye
6. Narrow angle in the study eye
7. History of leukemia, dementia or multiple sclerosis
8. Concomitant use of hydroxychloroquine and chloroquine
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Clinical Study of the Optic Disc Parameters | NCT02277119 | Contradiction |
6,403 | 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:
- Samples with positive RT-PCR results with Ct value ≤30 for the COVID-19 gene(s) at
IEDCR will be selected as COVID-19 positive.
- Samples with negative RT-PCR results with no amplification for the COVID-19 gene(s) at
IEDCR will be selected as COVID-19 negative.
Exclusion Criteria:
- Samples with equivocal/ambiguous RT-PCR results in terms of sigmoidal curve and Ct
value will be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 65 Years | Performance Evaluation of RealDetect™ COVID-19 RT-PCR Kit for the Detection of SARS-CoV-2 Virus | NCT04403672 | Entailment |
5,229 | 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:
- Clinical diagnosis of a metabolic bone disorder
Exclusion Criteria:
- none
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Preliminary Study for Identification of Calcium-Binding Proteins in the Serum in Various Metabolic Bone Disorders | NCT00403598 | Entailment |
5 | 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:
- Patients of secondary hypogonadism on testosterone replacement therapy, newly
diagnosed patients of secondary hypogonadism.
Exclusion Criteria:
- Regular strength training, medical treating osteoporosis, abnormal digital rectal
results, conditions which are medical contraindications (without adjusting state):
diabetes mellitus, severe cardiac arrhythmia, uncontrolled hypertension, unstable
angina pectoris, chronic obstructive pulmonary disease, epilepsy, unstable bone
lesions with high risk of fracture, prostate cancer or abnormal serum PSA levels
without adverse histological examination.
Male
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 60 Years | Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male (ADAM) | NCT03282682 | Contradiction |
6,448 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Patient must sign an Institutional Review Board (IRB) approved written informed
consent for this study.
2. Male and female 18 years of age and older.
3. Patients must have clinical diagnosis of moderate to severe rosacea.
4. Have a minimum total of 15.
5. Have two nodules or less .
Exclusion Criteria:
1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of
their study participation or were found to have positive pregnancy test at baseline or
screening visits.
2. Presence of more than 2 facial nodules or any nodule greater than 1 cm.
3. Current or past ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of
sufficient severity to require topical or systemic antibiotics.
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.
| A Study of S5G4T-1 in the Treatment of Papular-Pustular Rosacea | NCT03564119 | Entailment |
4,755 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
-Age ≥ 18
- Ability to provide informed consent
- English speaker
- Falls under one of the four groups a. Normal Hearing without Tinnitus (NH/T-) i.
Normal Hearing as defined as pure tone thresholds of 25 dB or less across all tested
frequencies ii. Subjective confirmation of lack of tinnitus* 1. Never or rarely b.
Normal Hearing with Tinnitus (NH/T+) i. Normal Hearing Normal Hearing as defined as
pure tone thresholds of 25 dB or less across all tested frequencies ii. Subjective
confirmation of tinnitus* 1. Often, always c. Unilateral hearing loss and ipsilateral
unilateral tinnitus (uHL/uT+) i. Unilateral hearing loss as defined by pure tone
thresholds of 50 dB or greater across 3 frequencies in the bad ear and 25 dB or less
in good ear ii. Subjective confirmation of tinnitus in the good ear* 1. Often, always
d. Bilateral hearing loss and bilateral tinnitus (bHL/bT+) i. Bilateral hearing loss
as defined by pure tone thresholds of 50 dB or greater across 3 frequencies in both
ears ii. Subjective confirmation of tinnitus in both ears*
1. Often, always
- Tinnitus will be confirmed via Likert-scale: Never - Rarely - Sometimes -
Often - Always
Exclusion Criteria:
- Currently undergoing tinnitus treatment with other pharmacologic agents
a. Patients may be eligible if they complete a 60 day washout period from
pharmacologic agents treating tinnitus
- Inability to tolerate fMRI or other contraindications of fMRI including claustrophobia
or presence of ferromagnetic objects in the body that cannot be removed.
- Contraindications to IV lidocaine administration such known allergy to lidocaine
- History of myocardial infarction or cardiac arrhythmias including
Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart
block in the absence of a pacemaker
- History of seizure disorder
- Resting BP of <100/50
- Currently taking antiarrhythmics
- Have taken antibiotics within 48 hours of infusion
- Known hepatic failure
- Pregnant or lactating women
- Patient with other neurological or psychiatric disorders, such as stroke, brain tumor,
schizophrenia, bipolar disorder.
- Patients who cannot fill out the questionnaires
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus | NCT04192773 | Entailment |
3,417 | 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:
- Cohort 1 Osia:
- Willing and able to provide written informed consent.
- Proficient in English.
- Hearing loss etiology of Conductive or Mixed Conductive loss.
- Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the
treatment ear.
- Aged 18 years and older.
Exclusion Criteria:
- Cohort 1 Osia:
- Unwilling to wear the treatment device or comply with the surgical and
rehabilitation requirements of the study.
- Unable or unwilling to comply with the requirements of the clinical investigation
as determined by the Investigator.
- Medical, audiological or psychological conditions, as judged by the investigator
that might contraindicate participation in the clinical investigation.
- Investigator site personnel directly affiliated with this study and/or their
immediate families; immediate family is defined as a spouse, parent, child, or
sibling.
- Cochlear employees or contractors engaged by Cochlear for the purposes of this
investigation.
- Currently participating, or participated within the last 30 days, in another
interventional clinical investigation/trial involving an investigational drug or
device.
- Prior experience with a surgical bone conduction treatment option
- Insufficient bone quality to support the BI300 implant as determined by the
surgeon
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.
| Osia CPT Code Study | NCT04320407 | Entailment |
2,011 | 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. Patients must have histologically or cytologically confirmed gastric adenocarcinoma,
including Siewert III gastroesophageal junction adenocarcinoma, confirmed by the NCI
Laboratory of Pathology, and have provided a block or unstained slides of primary or
metastatic tumor tissue or newly obtained fresh biopsy of a tumor lesion in case
archival tissue sample is not available.
2. Patients may be treatment na(SqrRoot) ve or have received systemic chemotherapy prior
to enrollment:
- Trastuzumab allowed as prior treatment for HER2/neu over-expressing cancers as
clinically indicated.
- Last dose of chemotherapy at least 4 weeks prior to enrollment with recovery to
Grade 1 from chemotherapy-related toxicities.
3. Radiographic evidence of peritoneal carcinomatosis and/or sub-radiographic evidence of
peritoneal carcinomatosis found at staging laparoscopy.
4. Age >=18 years. Children under the age of 18 will not participate in this study as
gastric cancer is rare in this population.
5. ECOG performance status <=1
6. Patients must have normal organ and marrow function as defined below:
hemoglobin >=8.0 g/dL
absolute neutrophil count >=1,000/mcL
platelets >=100,000/mcL
total bilirubin <=1.5 X institutional upper limit of normal
AST(SGOT)/ALT(SGPT) <=2.5 X institutional upper limit of normal
creatinine <1.5 mg/dl
OR
creatinine clearance >=60 mL/min/1.73 m^2 for patients with creatinine levels above
institutional normal.
7. Physiologically able to undergo laparoscopy and systemic chemotherapy.
8. Ability of subject to understand and the willingness to sign a written informed
consent document.
9. Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage
is permitted.
10. Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study treatment. Should a woman become pregnant or suspect she is
pregnant while she or her partner is participating in this study, she should inform
her treating physician immediately.
11. Patients must be co-enrolled in protocol 13C0176 (NCT01915225) and 17C0044
(NCT03027427) for sample collection.
12. HIV-positive patients may be considered for this study only after consultation with a
NIAID physician.
EXCLUSION CRITERIA:
1. Patients who are receiving any other investigational agents.
2. Previous cytoreductive surgery or intraperitoneal chemotherapy.
3. Disseminated extra-peritoneal or solid organ metastases:
- Excludes greater omentum and ovarian metastases.
- Radiographic signs or clinical symptoms consistent with malignant bowel
obstruction.
4. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Paclitaxel or Capecitabine or other agents used in study.
5. Previous treatment with paclitaxel or nab-paclitaxel resulting in progression of
disease.
6. Existing peripheral neuropathy, Grade 3 or greater.
7. Past medical history of dihydropyrimidine dehydrogenase deficiency.
8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.
9. Patients on therapeutic anticoagulation; Note: Prophylactic anticoagulation (i.e.
intralumenal heparin) for venous or arterial access devices is allowed.
10. Pregnant women are excluded because paclitaxel and capecitabine can cause fetal harm
when administered to pregnant women. Because there is an unknown but potential risk
for adverse events in nursing infants secondary to treatment of the mother with
paclitaxel and capecitabine, breastfeeding should be discontinued if the mother is
treated with paclitaxel and capecitabine.
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.
| Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis | NCT04034251 | Entailment |
2,826 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Patients with definite ALS
- Males or females
- Age > 18
Exclusion Criteria:
- Patients with other neuromuscular affections
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.
| A Study of the Expression of Nogo and Reticulon Genes in Skeletal Muscle of Patients With Amyotrophic Lateral Sclerosis | NCT00213824 | Entailment |
6,959 | 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 according to the National
Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and
Related Disorders Association (NINCDS-ADRDA) criteria (including patients living
independently in residential homes for the elderly or day patients)
- have mild to moderate dementia, as evidenced by a Mini-Mental Status Examination
(MMSE) score of 11 - 24, and a score of at least 12 on the cognitive portion of the
Alzheimer's Disease Assessment scale (ADAS-cog)
- history of at least a 6 months of gradual and progressive cognitive decline
- have a consistent informant to accompany the patient on scheduled visits
Exclusion Criteria:
- Neurogenerative disorders such as Parkinson's disease
- dementia caused by small strokes or cerebrovascular disease
- cognitive impairment resulting from acute cerebral trauma, cerebral damage due to a
lack of oxygen, vitamin deficiency, infections such as meningitis or AIDS, significant
endocrine or metabolic disease, mental retardation, or a brain tumor
- having epilepsy, significant psychiatric disease, active peptic ulcer, clinically
significant liver, kidney or lung disorders, or heart disease
- females of child bearing potential without adequate contraception
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.
| A Study of the Safety and Effectiveness of Two Doses of Galantamine Versus Placebo in the Treatment of Patients With Alzheimer's Disease | NCT00253201 | Entailment |
3,707 | 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:
- Diagnoses of knee osteoarthritis:( American College of Rheumatology (ACR) criteria
(see below) - possibilities:ACR1: Fulfilled at least one of the classification
criteria of the American College of Rheumatology ACR2: KOA verified with the American
College of Rheumatology criteria using a history and physical examination, i.e. knee
pain and at least three of the following: 50-85 years old, ≤ 30 minutes of morning
stiffness, crepitus on active range of motion, bony tenderness, bony enlargement, and
no palpable warmth of synovia Radiographic evidence of knee osteoarthritis between 2-3
in Kellgren and Lawrence classification
- KOA grade 2-3
- Knee pain on movement 40 to 90 mm Visual Analog Scale
- Knee pain for the last ≥ 3 months
- Functional reduction in the last three months
- Agrees not to use NSAIDs throughout the experiment
- Agrees not to use any other treatment (except rescue drugs) for KOA during
participation in this study.
Exclusion Criteria:
- Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, etc) have been
ruled out by physical examinations
- Knee surgery for KOA
- Intra-articular steroid injection and/or oral steroid treatment within the last six
months
- Rheumatoid arthritis;
- Symptomatic OA in other joints (i.e. hip, hand)
- Use of analgesics on the day of evaluation
- Use of NSAIDs 2 weeks before the beginning of the treatment
- Active malignancy
- Uncontrolled diabetes mellitus
- Neurological conditions: sciatica, neuropathy, multiple sclerosis
- Other chronic pain conditions: Fibromyalgia, back pain, hip pain
- Enrolled in any other clinical trial within the last 6 weeks or enrollment in another
clinical trial during participation in this trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Prospective Double Blind, Randomized, Sham-Controlled Clinical Study | NCT04276038 | Contradiction |
2,423 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Diagnosis of Duchenne muscular dystrophy confirmed by at least one of the following:
- Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin
deficiency, and clinical presentation consistent with typical DMD
- Positive gene deletion test (missing one or more exons) in the central rod domain
(exons 25-60) of dystrophin, where reading frame can be predicted as
"out-of-frame", and clinical presentation consistent with typical DMD
- Complete dystrophin gene sequencing showing an alteration (point mutation,
duplication, or other mutation resulting in a stop codon mutation) definitively
associated with DMD, and clinical presentation consistent with typical DMD
2. Age between 5 - 14 yrs old (inclusive)
3. Positive Gower sign (indicating ability to rise from the floor & presence of proximal
muscle weakness).
4. Able to walk 10 meters in <12 seconds
5. Able to stand upon WBVT plate (with knees flexed) for entire treatment protocol (i.e.
15-minutes)
6. Stable absolute dose of glucocorticoids (i.e. prednisone or deflazacort) for at least
3 months prior
7. Stable absolute doses of all medication that may affect muscle function (i.e. coenzyme
Q10, green tea extract, creatine, arginine, glutamine, nutritional supplements, etc.)
for at least 3 months prior
8. Stable absolute dose of all medication that may affect bone metabolism (i.e. vitamin D
and calcium supplementation) for at least 3 months prior
Exclusion Criteria:
1. Clinical presentation, genetic testing and/or muscle biopsy consistent with Becker
muscular dystrophy
2. History of recent surgery (within past 6-months)
3. History of a recent fracture (long-bone or vertebral) within past 6-months.
4. Acute inflammatory processes of lower extremities (e.g. cellulitis, etc) due to risk
of pain and/or worsening inflammatory process
5. History of venous thrombosis (theoretically risk of inducing thromboembolic event).
6. History of kidney or bladder stones
7. History of uncontrolled seizures or severe migraines
8. History of cardiac arrhythmia
9. Intracranial pathology or hardware (e.g. ventriculoperitoneal shunt, cochlear
implant).
10. Use of any investigational or experimental products within last 6-months and/or
concomitant participation in another study
11. Inability or refusal to follow the study requirements (e.g. autism, severe cognitive
or behaviour problems)
12. Inability or refusal to provide informed consent (parent) and/or assent (child)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 14 Years | Whole Body Vibration Therapy in Boys With Duchenne Muscular Dystrophy | NCT01954940 | Entailment |
1,948 | 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. Histologically confirmed adenocarcinoma of the stomach, T1-T4 stages.
2. Eastern Cooperative Oncology Group performance status of 0 or 1.
3. Adequate organ function.
Exclusion Criteria:
1. Patients had distant metastasis.
2. oesophageal invasion of more than 3 cm.
3. Borrmann type 4 or large (more than 8 cm) type 3 carcinoma.
4. Previous chemotherapy or radiation therapy for any other malignancies.
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 | Reduced Port Laparoscopic Gastrectomy for Gastric Cancer | NCT04295473 | Entailment |
6,136 | 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:
- Cohort 1:
Index case - Individuals ≥ 5 years of age with confirmed COVID19 mild disease or moderate
pneumonia defined as:
- Mild disease - Influenza like illness, with any of the following symptoms cough,
fever, headache, sore throat, nasal congestion/runny nose, body pains (myalgia),
fatigue (malaise), diarrhoea, abdominal pain, anorexia, nausea or vomiting without
evidence of pneumonia or hypoxia
- Moderate pneumonia -Clinical signs of pneumonia (fever, cough, dyspnoea, fast
breathing) with no need for supplemental oxygen (oxygen saturation ≥90%% on room air
or RR between 20 and 30bpm).
Household contacts - Individuals ≥ 5 years of age living in the same household with the
index cases from cohort 1 will be offered to participate into the study. Living in the same
household is defined as those individuals who are planning to sleep in and eat from same
'cooking pot' during the following 2 weeks.
Cohort 2:
Individuals ≥12 years of age with suspected or confirmed COVID-19 associated severe
pneumonia defined as signs of pneumonia (fever, cough, dyspnoea or fast breathing) plus one
of: oxygen saturation (SpO2) <90% on room air OR respiratory rate > 30 breaths/minute
Suspected COVID-19 disease is defined as clinically or radiologically suspected as
determined by the most senior clinician available:
1. Clinically suspected Signs and symptoms of pneumonia (as defined above) AND patient
living in or recent travel to region with community transmission OR close contact with
known COVID-19 patient AND no alternative diagnosis to explain the clinical picture OR
2. Radiologically suspected Typical radiological signs of COVID-19 on chest X-ray or lung
ultrasound
Exclusion Criteria:
- Pregnant women will be excluded from both Cohort 1 and Cohort 2. Patients with
allergies to the investigational products will be excluded Cohort 1 (Ivermectin)
Lactating mothers will be excluded
Cohort 2 (aspirin):
- Taking aspirin or other non steroidal anti-inflammatory drugs for any reason.
- Any bleeding disorder (e.g. frequent nose bleeds, haemophilia)
- Active or recurrent peptic ulcer disease (defined as currently on triple therapy or
had more than 1 course of triple therapy in the past 12 months. Do not count symptoms
of gastritis or on omeprazole as peptic ulcer disease)
- Current active gastrointestinal haemorrhage
- Severe liver disease or severe kidney disease (severe liver disease defined as
cirrhosis with portal hypertension and history of variceal bleeding; severe kidney
disease defined as stage 4/5 KD, eGFR <30ml/min)
- Gout
- Suspected intra-cerebral haemorrhage
- Diagnosed with a stroke on this admission
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
| Prevention and Treatment for COVID -19 (Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV-2) Associated Severe Pneumonia in the Gambia | NCT04703608 | Contradiction |
3,778 | 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:
- 40 years of age or older
- Meet the American College of Rheumatology (ACR) clinical criteria for a diagnosis of
knee OA. The ACR clinical criteria for knee OA includes knee pain plus 3 of the
following 6 criteria:
- age > 50 years,
- morning stiffness of < 30 minutes,
- crepitus on active movement,
- tenderness of the bony margins of the joint,
- bony enlargement of the joint noted on exam,
- lack of palpable warmth of the synovium. Based on this criteria, a subject who is less
than 50 years but has knee pain and 3 of the other 5 criteria would also be classified
as having knee OA.
Exclusion Criteria:
- do not meet the ACR clinical criteria for knee OA,
- are scheduled for total knee arthroplasty (TKA) surgery,
- have undergone TJA surgery on any lower extremity joint,
- exhibit uncontrolled hypertension (i.e. individuals not currently taking medication
for hypertension whose systolic blood pressure is greater than 140 mm Hg or diastolic
blood pressure greater than 90 mm Hg at rest),
- have complaints of low back pain or other lower extremity joint pain that affects
function at the time of recruitment,
- have a history of neurological disorders that would affect lower extremity function
(stroke, peripheral neuropathy, parkinson's disease, multiple sclerosis, etc.),
- are women who are pregnant.
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.
| Enhancing the Effectiveness of Physical Therapy for People With Knee Osteoarthritis | NCT01314183 | Entailment |
1,193 | 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 a new lesion in the lung
Exclusion Criteria:
- a prior diagnosis of cancer in the past
- Not fasted for at least 6 hours
- Plasma glucose concentration ≥ 200 mg/dl
- Intake of medication at the day of investigation
- History/treatment of cancer in the previous 5 years
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| LC-NMR Study Biomarkers to Detect Lung Cancer | NCT02024113 | Entailment |
3,789 | 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:
- men and women between 35 and 80 years of age
- radiographically verified degenerative osteoarthritis of the knee (grade II or III
according to the Kellgren and Lawrence classification)
- pain of at least 40 mm on a 100 mm visual analogue scale (VAS) at initial examination
- persisting pain for at least 6 months
- Lequesne-Score of at least 10 points
- good physical and mental status
- good compliance and agreement to participate in this study
Exclusion Criteria:
- non-degeneratively induced osteoarthritis
- rheumatoid arthritis
- ligamentous instability or complete resection of the meniscus
- Sudeck´s disease
- operations of the affected knee within the last three months
- varus or valgus deformity of more than 15 degrees
- patellofemoral arthritis
- intraarticular therapy of the affected joint within the last 6 months with hyaluronan
and three months with glucocorticoids
- severe systemic diseases (tumor, exacerbated diabetes mellitus, hyperthyroidism)
- anti-thrombotic medication or regular medication with NSAID/psychiatric
pharmaceuticals
- infectious diseases
- alcohol abuse
- drugs
- psychiatric diseases or suicidal tendencies
- involvement in another study
- non-compliance
- acute hemarthrosis or joint effusion
- allergic predisposition
- skin infections or skin diseases around the knee
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 80 Years | Gait Patterns After Intraarticular Treatment of Patients With Osteoarthritis of the Knee | NCT00731289 | Entailment |
3,595 | 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:
- BMI between ≥18 kg/m² and <30 kg/m² at time of screening
- Body weight between ≥45 kg and <100 kg
- Baseline vWF:Ag between ≥60% and <170% (0.6-1.7 IU/mL)
Exclusion Criteria:
- History of and/or any sign or symptom indicating current abnormal hemostasis or blood
dyscrasia, including but not limited to thrombocytopenia, thrombocytopathy,
thromboasthenia, hemophilia, von Willebrand's disease, vascular purpura, bleeding gums
and/or frequent nose bleeding, easy/spontaneous bruises, meno- or metrorrhagia,
history of gastrointestinal bleeding or excessive bleeding after minor injury such as
shaving.
- Family history of congenital vascular malformation (e.g., Marfan's Syndrome) and/or
bleeding disorder (e.g., hemophilia, von Willebrand's disease, Christmas disease)
- Any surgical intervention (including tooth extraction) or trauma within the 4 weeks
preceding screening for the study or any planned surgical intervention during the
participation in the study
- Treatment with vitamin K, direct oral anticoagulant (DOAC), warfarin, high dose
heparin within 2 weeks before screening
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 65 Years | Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects. | NCT03172208 | Contradiction |
1,366 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
Male and female patients of any ethnic origin will be eligible to participate in the study
if all of the following criteria are fulfilled.
- informed consent having been obtained from the patient's parent or guardian and assent
from the child if they are capable of understanding the study
- aged 24 months - 11 years
- experiencing constipation as defined as:
- ≤2 complete bowel movements per week, and at least one of the following:
- pain on defaecation on ≥1 in 4 days
- 1/4 or more of bowel movements with straining
- 1/4 or more of bowel movements with hard or lumpy stools
- patients in whom these symptoms have been present for ≥3 months
- available to complete the study and able to comply with requirements and restrictions
listed in the patient's/parent's information documents.
Exclusion Criteria:
Patients will not be eligible to participate in the study if any of the following
conditions apply:
- faecal impaction or history of faecal impaction
- history of intestinal perforation or constipation
- paralytic ileus
- toxic megacolon
- Hirschsprungs disease
- severe inflammatory conditions of the intestinal tract
- severe gastro-oesophageal reflux - that which is complicated by anaemia, haematemesis,
respiratory aspiration, failure to thrive or other recognised complications of
gastro-oesophageal reflux
- patients currently receiving over 0.5mg/kg/day of senna or over 1/2 sachet of sodium
picosulphate per day for children <6 years and over 1 sachet sodium picosulphate per
day for children > 6 years (i.e. high doses of stimulant laxatives)
- any other significant medical condition that in the investigator's opinion would
effect their suitability for entry into the study
- patients who have previously received Movicol or previously participated in the study
- known hypersensitivity to polyethylene (PEG) 3350 or any of the constituents of
Movicol
- patients with diabetes as the placebo to be used in this study is sucrose
- patients who have received any investigational drug in the last 3 months
- patients and/or parents who the investigator thinks could not comply with the
requirements of the protocol for any reason (particularly in relation to reliable
completion of diary cards)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 24 Months old.
Subject must be at most 11 Years | Study to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children | NCT00403819 | Contradiction |
4,560 | 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:
- Healthy women
- Self-reported menstrual cycle length of 25-35 days within the past 2 months
- Nonsmoker
- Sedentary (exercise < 3 times weekly within the past 6 months)
- Intact ovaries and uterus
- No history of gynecological problems (e.g., fibroids, endometriosis, polycystic ovary
syndrome)
- Female
- Premenopausal
- Body mass index 18.5 to 40
- Stable weight (no changes ≥ 10% within the past year)
Exclusion Criteria:
- No pregnancy or breast feeding within the past 6 months
- No plans to become pregnant during study treatment
- No cancer within the past 5 years except for nonmelanoma skin cancers
- No medical condition that would prohibit participation in a vigorous program of
weight-bearing aerobic exercise including, but not limited to, any of the following:
- Fibromyalgia
- Chronic fatigue syndrome
- Metabolic disorders
- Recent cardiovascular event
- Orthopedic limitations
- Psychiatric disorders requiring antipsychotic drugs
- No uncontrolled hypertension (systolic blood pressure [BP] > 160 mm Hg and/or
diastolic BP > 99 mm Hg)
- No more than 7 alcoholic beverages per week
- No injected hormonal contraceptive use within the past year
- More than 6 months since prior use of intrauterine device
- More than 3 months since prior oral or patch hormone contraceptives
- No medication that would prohibit participation in a vigorous program of
weight-bearing aerobic exercise
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years | Women in Steady Exercise Research [Formerly Women, Oxidative Stress, Exercise and Estrogens (WOSEE)] | NCT00393172 | Contradiction |
6,384 | 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:
- Subject provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
- Male or non-pregnant female adult ≥18 years of age at time of enrolment.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR and fulfils the
case criteria of COVID-19 (One or more of the following must be met in lieu of a
positive PCR test: fever [defined as a temperature ≥ 100.0°F / 37.8°C documented
within 24 hr. of randomization] , absolute and relative lymphopenia and leukopenia,
new typical infiltrates in x-ray of the chest or chest CT scan [only if obtained for
clinical reasons; not required by study], no improvement on antibiotics).
- Scoring a "3" or "4" (or "5", at the Investigator's discretion) on the 7-Point Ordinal
Scale (see Outcome Measures) at enrolment. Note, if scoring a "2" at screening,
inclusion will be met if the patient is in the process of being hospitalized or
admitted to an inpatient setting. Such a patient would be assigned a "3" at enrolment
for Baseline assessment purposes.
- No participation in other clinical trials according to the German Medicines Act (AMG)
(3 months before) at the time of this trial.
Exclusion Criteria:
- ALT/AST > 5 times the upper limit of normal.
- Patients with severe hepatic impairment (defined as liver cirrhosis Child stage B or
C)
- Stage 4 chronic kidney disease or requiring dialysis (i.e. eGFR < 30 ml/min)
- Advanced cardiac (eg, severe heart failure [NYHA III-IV]) or pulmonary diseases which,
in the Investigator's judgment, would not make participation appropriate.
- Pregnancy or breast feeding.
- Anticipated transfer to another hospital which is not a study site within 72 hours.
- Known allergy or hypersensitivity to CVC or its components.
- Use of medications that are contraindicated with CVC and that could not be replaced or
stopped during the trial period
- Administration of specified drugs which interfere with the metabolism of CVC.
- Patients immediately or imminently requiring mechanical ventilation.
- Patients unwilling to consent to saving and propagation of pseudonymised medical data
for study reasons.
- Subjects who are legally detained in an official institution.
- Subjects that are unsuitable to understand or to comply with the study requirements in
the opinion of the investigator.
- Subjects who may be dependent on the sponsor, the investigator or the trial sites.
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.
| Charité Trial of Cenicriviroc (CVC) Treatment for COVID-19 Patients | NCT04500418 | Entailment |
3,589 | 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
- Males and females aged 18 to 60 years
- Current non-smokers for last 6 months (<5 cigs per week), with a smoking history of <5
pack years
- BMI 20-30 kg/m2
EXCLUSION CRITERIA
- History of allergy
- Upper airway infection in 2 weeks before screening
- Lower respiratory tract infection in past 3 months
- Treatment with local or systemic corticosteroids during previous 2 months
- Signs or symptoms of chronic rhinitis, hypertrophy of turbinates, major septum
deviation, nasal polyposis or recurrent sinusitis
- Previous nasal or sinus surgery
- Clinically significant cardiovascular, hepatic, GIT, renal, endocrine, infective,
haematological, neurological, dermatological, neoplastic conditions,
gastro-oesophageal reflux, depression, TB
- Participation in a therapeutic drug trial in the prior 30 days.
- Medical therapy other than that permitted for contraception.
- Positive pregnancy test
- Inability or unwillingness to use contraception if the patient is a female of
child-bearing age.
- History of drug abuse or urine test showing evidence of recreational drug abuse
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 | Nasal LPS Challenge in Healthy Volunteers | NCT02284074 | Contradiction |
3,338 | 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:
- Hearing loss at the better ear between 35dB and 50dB (PTA1/2/4)
- Active lifestyle
- No language problems
- No medical contra-indications
- Age: between 18 and 75 years
- About 50% experienced users and 50% new users
- Willing to participate in the trial with one three hour visit to the AMC.
Exclusion Criteria:
- Conductive hearing loss in the middle ear
- Severe hearing loss
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Study of SelfFit Mobile Medical App for Hearing Loss Diagnostics and Hearing Device Fitting / Fine Tuning | NCT01877317 | Contradiction |
6,076 | 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:
- History of physician diagnosed GERD
- Heartburn and Regurgitation 3 Days during the week prior to screening
Exclusion Criteria:
- History of erosive esophagitis, Barrett's esophagus, esophageal stricture,
scleroderma, Zollinger-Ellison Syndrome, known primary disorder
- History or presence of infection or inflammation of the small or large intestine,
gastrointestinal malignancy, history of upper GI surgery
- Use of PPI during the last four weeks prior to screening
Other protocol-defined inclusion/exclusion criteria may apply.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD) | NCT00149851 | Entailment |
5,734 | 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:
1. Patients clinically & histopathologically diagnosed to be suffering from oral lichen
planus.
2. Patients who had symptoms i.e. pain and/or burning sensation secondary to oral lichen
planus.
3. Patients not on any treatment for the same. In case they were, then such treatment was
stopped and a washout period of two weeks was given.
Exclusion Criteria:
1. Patients suffering from any systemic disease/s like
2. Patients with any other mucosal disease or any other skin disease which may be
associated with oral lesions.
3. Patients on any drug therapy which may cause lichen planus like lesions.
4. Patients with findings of any physical or mental abnormality, which would interfere
with or be affected by the study procedure.
5. Patients with a known allergy or contraindication to study medications
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treat Oral Lichen Planus | NCT02421770 | Contradiction |
5,570 | 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:
Volunteers will qualify for participation in the study if they meet the following criteria:
1. <TAB>Age 13-17 years.
2. <TAB>Good general health as indicated by medical history and physical examination.
3. <TAB>Negative urine glucose and normal electrolytes, hepatic, and thyroid function.
4. <TAB>For the fMRI portion only: right handedness (required for standardization of
responses).
5. <TAB>For the fMRI portion only: female.
6. <TAB>For the fMRI portion only: overweight (BMI greater than or equal to 85th
percentile for age and sex).
EXCLUSION CRITERIA:
Volunteers will be excluded if they have any of the following:
1. <TAB>Medical problem likely to affect caloric intake.
2. <TAB>History of any condition including psychiatric disorders in either child or their
responsible parent that in the opinion of the investigators would impede competence to
sign consent, interfere with adherence to procedures, or possibly hinder completion of
the study.
3. <TAB>Pregnancy.
4. <TAB>Use of medication likely to affect caloric intake.
5. <TAB>History of significant neurological injury or insult.
6. <TAB>For the fMRI portion only: braces (or other metal) that would interfere with the
fMRI procedure.
7. <TAB>For the fMRI portion only: non-native English speakers (required for
standardization of responses).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 13 Years old.
Subject must be at most 17 Years | Eating Behavior in Adolescents | NCT00631644 | Contradiction |
5,603 | 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 for participants at the intervention group (segments 1&2):
1. Girls aged 3-7 years old and boys aged 3-8 years old
2. Prepubertal - tanner stage 1
3. Height, weight and BMI < 10th percentile for age and gender
4. Availability of growth velocity data for at least 4 months prior to study entry.
5. Signing inform consent forms
Exclusion Criteria for participants at the intervention group (segments 1):
1. Diagnosis of GH Deficiency or treatment with GH
2. Any known chronic disease or dysmorphic syndrome including: bone diseases, organic
brain diseases, neurological disease, past or current malignancy, chronic cardial,
renal or pulmonary problems
3. Any known gastrointestinal problem including absorption problems
4. Any known organic reason for slow growth
5. Any chronic treatment with medication that might effects appetite (for example
SSRI's), weight or Growth.
Inclusion Criteria for participants at the control group (segments 2):
1. Girls aged 3-8 years old and boys aged 3-9 years old
2. Prepubertal - tanner stage 1
3. Height ≥ 25th percentile for age and gender
4. Proper proportion between weight and height- 5th ≤ BMI ≤ 85th
5. Signing inform consent forms
Exclusion Criteria for participants at the control group (segments 2):
1. Diagnosis of GH Deficiency or treatment with GH
2. Any known chronic disease or dysmorphic syndrome including: bone diseases, organic
brain diseases, neurological disease, past or current malignancy, chronic cardial,
renal or pulmonary problems
3. Any known gastrointestinal problem including absorption problems
4. Any known organic reason for slow growth
5. Any chronic treatment with medication that might effects appetite (for example
SSRI's), weight or Growth
6. Children with growth faltering during the previous year
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 8 Years | Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children | NCT01158352 | Contradiction |
6,105 | 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:
- Confirmed COVID 19 infection (positive PCR, elevated ESR, leucopenia)
- Clinical picture of COVID 19 infection including fever, malaise, sore throat,
coughing, dyspnea, and runny nose
Exclusion Criteria:
- Mild cases of COVID 19 that do not require hospitalization
- Pregnant & lactating women
- Children with other comorbidities
- People who received previous treatment for COVID 19 in the last 2 weeks N.B. Diabetes
and hypertension not excluded
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 90 Years | Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial | NCT04383717 | Contradiction |
868 | 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:
- Subjects having at least one or more sign and symptoms of Osteoarthritis like Pain in
joints (at Knee, Hip, Ankle, Elbow and Shoulder), stiffness, difficulty in flexion and
extension, crepitus, swelling etc for more than 3 months prior to the study.
- Pain score of at least 4 cm on a 10-cm linear visual analogue scale.
- Are free of any systemic or dermatologic disorder, which, in the opinion of the
investigator, will interfere with the study results or increase the risk of adverse
events.
- Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation
(natural or artificial) for the duration of the study.
- Are willing to refrain from using any lotions, gel, balm, moisturizer, cleansers,
cosmetics or creams, other than those issued as part of the study, on the treatment
areas during the treatment period.
- If female of childbearing potential, must be willing to practice an acceptable form of
birth control for the duration of the study.
- Are able to give written informed consent in a manner approved by the Institutional
Ethics Committee and comply with the requirements of the study.
- Are willing to avoid participation in any other interventional clinical trial for the
duration of this study.
Exclusion Criteria:
- Are pregnant, breast-feeding, or planning to become pregnant during the study.
- Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis,
Gouty Arthritis.
- Complications of OA, like Pseudogout, Spontaneous osteonecrosis of the knee, Ruptured
Baker cyst, Bursitis, Anserine bursitis (knee)interfere with the disease and
treatment.
- Severe Stomach infection.
- Severely traumatised and/or very severe or mucosal inflammation
- Peritonsillar abscess
- Long term use (≥ 3 times per week within the last month or regular intake within the
last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow
release analgesic intake including Non Steroidal Anti-Inflammatory Drugs
(NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)
- Any anti-inflammatory drugs intake by systemic route within 12 hours before
randomization
- Any paracetamol intake within 6 hours before randomisation
- Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6
hours before randomisation
- Heavy smokers (>10 cigarettes/day)
- Have open sores or open lesions in the treatment area(s).
- Have any condition that, in the opinion of the investigator, would confound the safety
and/or efficacy assessments of plaque Arthritis.
- Have participated in any interventional clinical trial in the previous 30 days.
- Have a known sensitivity to any of the constituents of the test product
- Have used, are using, or are planning to use immunosuppressive or immunomodulatory
medication (i.e., biologics), including oral or parenteral corticosteroids.
- Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or
illegal drug/substance abuse in the past 2 years.
- Plan to seek alternative treatment of any kind for their Arthritis, in the eligible
treatment areas or otherwise, during the trial period.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 80 Years | NGA-01 Gel for the Treatment of Osteoarthritis With Joint Pain | NCT04612283 | Entailment |
4,606 | 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:
- Patient undergoing hysterectomy for benign indication
- Age 18 or greater
- English speaking
- Access to communication via telephone
Exclusion Criteria:
- Patient undergoing hysterectomy for malignant or pre-malignant condition
- Non-english speaking patient
- Patient without telephone access
- Patient undergoing emergent or unplanned hysterectomy
- Vulnerable populations
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Goal Achievement and Patient Satisfaction in Benign Hysterectomy | NCT02621710 | Entailment |
2,379 | 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:
- ≤18 years
- Neuromuscular weakness or central hypoventilation
- Established nocturnal or intermittent daytime ventilatory support
Exclusion Criteria:
- Unable to sit in the plethysmograph
- Cardiac anomaly with right-to-left shunt
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | 'Fitness To Fly' Tests In Children With Type II Respiratory Failure | NCT03824223 | Entailment |
80 | 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:
- Male veterans only
- 35 to 65 years old
- With an average fasting morning T level from 2 measurements of <300 ng/dl taken at
least a day apart
- symptoms of hypogonadism as assessed using the androgen deficiency in aging male
(ADAM) questionnaire
- Participants should have
- T2D
- an A1C of <10.5 %
- a fasting blood sugar of 180 mg/dl
- body mass index (BMI) <35 kg/m2
- with DM of 15 years duration or less to target men who have relatively less
complications from long-term DM
Exclusion Criteria:
- history of prostate or breast cancer
- history of testicular disease
- untreated severe sleep apnea
- ongoing illness that could prevent the subject from completing the study
- a hematocrit of >50%
- prostate-related findings as:
- a palpable prostate nodule on digital rectal exam (DRE)
- serum PSA of 4.0 ng/ml
- International Prostate Symptom Score (IPSS) >19 (severe)
- on androgen therapy or selective androgen receptor modulators
- on medications that affect bone metabolism such as:
- estrogen
- selective estrogen receptor modulator as:
- raloxifene
- aromatase inhibitors
- GnRH analogs
- glucocorticoids with prednisone equivalent of least 5 mg daily for 1 month
- anabolic steroids
- phenobarbital and Dilantin
- use of bisphosphonates within two years of study entry, i.e.:
- risedronate
- alendronate
- zoledronic acid
- pamidronate
- diseases that interfere with bone metabolism, as:
- hyperparathyroidism
- untreated hyperthyroidism
- osteomalacia
- chronic liver disease
- renal failure
- hypercortisolism
- malabsorption
- immobilization
- current alcohol use of > 3 drinks/day
- those with a history of:
- deep vein thrombosis
- pulmonary embolism
- stroke or recent diagnosis of coronary artery disease
- because of the potential of being randomized to placebo, subjects with osteoporosis or
a BMD T-score by DXA of -2.5 in the lumbar spine, total femur or femoral neck and
those with a history of fragility fractures
- spine
- hip
- wrist
Male
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 65 Years | Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism | NCT03887936 | Contradiction |
5,382 | 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:
Patients who are presenting for gynecologic visits or well-woman examinations who still
have an intact uterus and are between the ages of 18 and 51 years, have abnormal uterine
bleeding, and can read and write in English.
Exclusion Criteria:
- Women who are presently on a treatment for abnormal uterine bleeding.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 51 Years | HMB- Data Collection Methods | NCT02001324 | Entailment |
3,063 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Diagnosis of a rare disease, a disease of unknown prevalence, undiagnosed or an
unaffected carrier of a rare/uncommon disease
Exclusion Criteria:
- Diagnosis of a disease which is not rare
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford | NCT01793168 | Entailment |
4,637 | 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:
- Born female. Note: Participants who were female at birth, who now identify as male,
will not be excluded so long as they are not on female-to-male transition therapy.
- Age 18 through 45 years (inclusive) at screening, verified per site SOPs (standard
operating procedures)
- Able and willing to provide written informed consent to be screened for and take part
in this study (MTN-028)
- Able and willing to provide adequate locator information, as defined by the site SOPs
- HIV-uninfected, based on testing performed by study staff at screening and enrollment
(per applicable algorithm in Appendix II of the protocol) and willing to receive
results
- In general good health at screening and enrollment, as determined by the site
Investigator of Record (IoR) or designee
- At screening, participant states willingness to abstain from receptive sexual activity
(including penile-vaginal intercourse, anal intercourse, receptive oral intercourse,
finger stimulation, and the use of sex toys) for the 5 days prior to the enrollment
visit and for the duration of study participation
- Per participant report, using an effective method of contraception at enrollment, and
intending to continue the use of an effective method for the duration of study
participation. Effective methods for MTN-028 include: hormonal methods (except
contraceptive IVRs), intrauterine device (IUD) inserted at least 28 days prior to
enrollment, engages in sex exclusively with women, sterilized (self or partner),
and/or sexually abstinent for the past 90 days
- Women over the age of 21 (inclusive) must have documentation of a satisfactory Pap
within the past 3 years prior to enrollment consistent with Grade 0 according to the
Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS
Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004
(Clarification dated August 2009), or satisfactory evaluation with no treatment
required of Grade 1 or higher Pap result. If otherwise eligible women do not have
documentation of a recent Pap test, one may be performed at the screening visit.
- Per participant report at screening and enrollment, agrees not to participate in other
research studies involving drugs, medical devices, or vaginal products for the
duration of study participation
- Per participant report at screening, regular menstrual cycles with at least 21 days
between menses. Note: This criterion is not applicable to participants who report
using a progestin-only method of contraception at screening (e.g., Depo-Provera or
levonorgestrel-releasing IUD) nor to participants using continuous combination oral
contraceptive pills, as the absence of regular menstrual cycles is an expected, normal
consequence in this context.
- At screening, participant states a willingness to refrain from inserting any non-study
vaginal products or objects into the vagina, including but not limited to,
spermicides, female condoms, diaphragms, contraceptive IVRs, vaginal medications,
menstrual cups, cervical caps (or any other vaginal barrier method), douches,
lubricants, sex toys (vibrators, dildos, etc.) for the 5 days prior to enrollment and
for the duration of their study participation
Exclusion Criteria:
- Participant report of any of the following at screening or enrollment:
- History of adverse reactions to any of the components of the study products
- Non-therapeutic injection drug use in the 12 months prior to screening and
enrollment
- Post-exposure prophylaxis (PEP) for HIV exposure within 6 months prior to
enrollment
- Pre-exposure prophylaxis (PrEP) for HIV prevention within the 6 months prior to
enrollment
- Regular use and/or anticipated regular use during the period of study
participation of CYP3A inducer(s) and/or inhibitor(s)
- Use and/or anticipated use during the period of study participation of
female-to-male transition therapy
- Chronic and/or recurrent candidiasis
- Gonorrhea, chlamydia and/or syphilis diagnosis in the 6 months prior to
enrollment
- Last pregnancy outcome 90 days or less prior to screening
- Currently breastfeeding
- Has had a hysterectomy
- Intends to become pregnant within the next 3 months
- Has plans to relocate away from the study site area in the next 3 months
- Current sexual partner is known to be HIV-positive at screening or enrollment
- Reports participating in any other research study involving drugs, medical devices, or
vaginal products within 60 days or less prior to enrollment
- At screening or enrollment, as determined by the IoR/designee, any significant
uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic,
gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or
infectious disease
- Has any of the following laboratory abnormalities at screening:
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher
- Calculated creatinine clearance less than 60 mL/min by the Cockcroft-Gault
formula, where creatinine clearance (female) in mL/min = (140 - age in years) x
(weight in kg) x (0.85)/72 x (creatinine in mg/dL)
- Hemoglobin Grade 1 or higher
- Platelet count Grade 1 or higher
- White blood count Grade 2 or higher
- Positive hepatitis B surface antigen (HBsAg) test result
- Positive anti-hepatitis C virus (HCV) test result
- International normalized ratio (INR) greater than 1.5 × the site laboratory upper
limit of normal (ULN)
- Note: Otherwise eligible participants with an exclusionary test result (other
than HIV, hepatitis B virus [HBV], or HCV) can be re-tested during the screening
process. If a participant is re-tested and a non-exclusionary result is
documented within 45 days of providing informed consent for screening, the
participant may be enrolled.
- Pregnant at either screening or enrollment. Note: A documented negative pregnancy test
performed by study staff is required for inclusion; however a self-reported pregnancy
is adequate for exclusion from screening/enrollment into the study.
- Diagnosed with urinary tract infection (UTI) at screening or enrollment. Note:
Otherwise eligible participants diagnosed with UTI during screening will be offered
treatment. If within the 45 day screening window treatment is complete and symptoms
have resolved the participant may be enrolled.
- Diagnosed with pelvic inflammatory disease, reproductive tract infection (RTI) or a
sexually transmitted infection (STI) requiring treatment per current Centers for
Disease Control and Prevention (CDC) guidelines (http://www.cdc.gov/std/treatment/) at
screening or enrollment. Note: With the exception of gonorrhea, chlamydia and/or
syphilis, otherwise eligible participants diagnosed with a RTI during screening will
be offered treatment. If within the 45 day screening window treatment is complete and
symptoms have resolved, the participant may be enrolled.
- At enrollment, has a clinically apparent Grade 1 or higher pelvic exam finding
(observed by study clinician or designee) per the Division of AIDS Table for Grading
the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004
(Clarification dated August 2009), Addendum 1, Female Genital Grading Table for Use in
Microbicide Studies. Note: Cervical friability bleeding associated with speculum
insertion and/or specimen collection judged to be within the range of normal according
to the clinical judgment of the IoR/designee is considered expected non-menstrual
bleeding and is not exclusionary.
- At screening, severe pelvic relaxation such that either the vaginal walls or the
uterine cervix descend beyond the vaginal introitus with valsalva maneuver or has
pelvic anatomy that compromises the ability to adequately assess vaginal safety
- Has any other condition that, in the opinion of the IoR/designee, would preclude
informed consent, make study participation unsafe, complicate interpretation of study
outcome data, or otherwise interfere with achieving study objectives
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Pharmacokinetics of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048 | NCT02419456 | Entailment |
4,943 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Age range 18 to 95 years,
- Clinical diagnosis of essential tremor for at least a year,
- A +2 or worse action or kinetic tremor of one or both upper limbs involving at least
the forearm and/or hand
Exclusion Criteria:
- Dermatologic lesions in upper limbs (e.g. skin cancer, eczema, fresh or healing
wounds, abrasions, acne, pustules, abscesses, or skin rash),
- Sensory loss in the upper limbs,
- Known history of sensitivity to cold (i.e., cold urticaria),
- Known peripheral vascular disease,
- Raynaud's phenomenon,
- Scleroderma
Healthy normal controls will be enrolled through advertisements. All controls will be
examined to ensure that they are neurologically healthy.
The exclusion criteria for controls will remain same as those for patient subjects.
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 95 Years | Limb Cooling in Essential Tremor | NCT02067702 | Entailment |
4,076 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria: 1) Sleep onset latency > 30 min for at least 3 nights per week
Exclusion Criteria: 1) Unable to perform tests due to inability to communicate
verbally/blindness, inability to write and read in English (the study questionnaires are in
English and do not exist in validated form for other languages). 2) Cognitive impairment;
cognitively impaired patients may not be able to comply with the protocol). 3) History of a
diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder 4)
Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
| Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults-2 | NCT03187340 | Contradiction |
3,091 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Students enrolled in the St. Louis Special School District.
- Teachers/Staff working at the 6 St. Louis Special Schools dedicated to teaching
children with IDD.
or
- Parents/ of students, teachers and/or staff employed by the St. Louis Special School
District or Kennedy Krieger Institute schools in Maryland or
- Families, teachers, and staff of the 67 University Centers for Excellence in
Developmental Disabilities (UCEDD) which is sponsored by the Association of University
Centers for Disability (AUCD).
Exclusion Criteria:
- Members of the research team will not be eligible to participate in the focus groups.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 90 Years | Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic | NCT04565509 | Entailment |
4,787 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
Locally referred Patients to an ear-nose-and throat (ENT) clinic at an University Hospital
for dizziness symptoms.
Exclusion Criteria:
Any severe neurologic or orthopedic disease affecting gait.
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 67 Years | Dynamic Neck Function During Gait in Patients With Dizziness | NCT04626544 | Entailment |
6,266 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Age ≥ 18
- ECOG 0-3
- For patients who have not started radiation at the time of screening: patients are
required to have a plan in place for a minimum of 10 radiation treatments with or
without concurrent systemic therapy
- For patients who have already started radiation at the time of screening: patients
must complete enrollment such that they are able to receive at least 10 radiation
treatments with hydroxychloroquine.
- Disease Site
- Mandatory inclusion criteria:
- No COVID-19 symptoms within 14 days of enrollment:
- (Temp >38C in addition to sore throat, cough, wheezing, chest tightness,
shortness of breath, body aches, chills, diarrhea, and anosmia)
- If symptoms are present within 14 days of enrollment, patients with a negative
COVID-19 PCR or COVID-19 serology assay are eligible for inclusion.
- No close contact with confirmed COVID-19 person
- Close contact defined as:
- Within 6 feet for prolonged period
- Cohabitating
- Optional laboratory criteria (Recommended if available)
- Negative pre-treatment SARS-CoV-2 rapid antigen test result (within 1 week of
enrollment)
- Negative pre-treatment SARS-CoV-2 PCR test result (within 1 week of enrollment)
using MSKCC laboratory or outside laboratory assay
- Negative pre-treatment Standard Q COVID-19 IgM/IgG rapid serology result (within
1 week of enrollment)
- Blood serum for SARS-CoV-2 serology tests (being validated by MSKCC)
- Disease site meets following criteria:
- Head and Neck / High-Risk Skin Cancer
- Lung Cancer
- Breast Cancer
- Prostate Cancer
- Central Nervous System Tumors
- Gastrointestinal System Cancer
- Gynecologic cancer
- Other disease sites permitted at PI discretion
Exclusion Criteria:
- Previous positive test for SARS-CoV-2
- Previous positive serology test for SARS-CoV-2
- Recent Chest CT meeting CT exclusion criteria
- Live in a skilled nursing facility with COVID-19 symptoms (Temp >38 C in addition to
sore throat, cough, wheezing, chest tightness, shortness of breath, body aches or
chills, diarrhea, anosmia)
- Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
- Pre-existing retinopathy
- Known chronic kidney disease, stage 4 or 5, or receiving dialysis
- Breast Feeding
- Tamoxifen
- Absolute neutrophil Count <1,000/ml at registration
- Concurrent use of any other quinine derivative
- Antiarrhythmic medications: amiodarone, sotalol, dofetilide, procainamide, quinidine,
flecainide
- Glucose-6-phosphate dehydrogenase deficiency
- Pre-treatment corrected QT interval (QTc) ≥470 milliseconds**
- Prisoners
- Inability to participate
- Psoriasis
- History of suicidal ideation
- CT Criteria for Enrollment Exclusion (Optional - only for patients who received a
diagnostic CT as part of standard of care or a thoracic CT as part of radiation
simulation): All patients with COVID-19 typical radiographic findings on CT Chest as
defined by the RSNA will be excluded. Patients with any NEW COVID-19 indeterminate
radiographic findings on CT Chest that are concerning for COVID-19 will be excluded.
COVID-19 indeterminate features are permitted if they can be demonstrated as STABLE on
prior (>14 calendar days) CT Chest or PET/CT. If no prior comparison is available AND
any intermediate or typical feature is present, the patient is not eligible.
- COVID-19 Atypical Features
- Isolated lobar or segmental consolidation without GGO
- Discrete small nodules (centrilobular, "tree-in-bud")
- Lung cavitation
- Smooth interlobular septal thickening with pleural effusion
- COVID-19 Indeterminate Features
- Multifocal, diffuse, perihilar, or unilateral GGO with or without consolidation
lacking a specific distribution and are non-rounded or non-peripheral
- Few very small GGO with a non-rounded and non-peripheral distribution
- COVID-19 Typical Features
- Peripheral, bilateral GGO with or without consolidation or visible intralobular
lines ("crazy paving")
- Multifocal GGO of rounded morphology with or without consolidation or visible
intralobular lines ("crazy paving")
- Reverse Halo sign or other findings of organizing pneumonia ** If pre-treatment
QTC can be decreased to <470, the patient can be re-considered for trial.
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.
| A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy | NCT04381988 | Contradiction |
4,257 | 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:
- Azoospermic patients
Exclusion Criteria:
- Patients with sperm cells
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Spermatogonial Stem Cells in Azoospermic Patients: a Comparison Between Obstructive and Non-obstructive Azoospermia | NCT01178463 | Entailment |
5,901 | 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. In the opinion of the investigator, the participant and parent(s) or legal guardian
are capable of understanding and complying with protocol requirements.
2. Prior to any study-specific procedures being performed, the informed consent and the
assent form, according to local country requirements, must be signed and dated by
parent(s) or legal guardian and by the participant respectively.
3. The participant has a medical history of symptoms of Gastroesophageal Reflux Disease
(GERD) for at least 3 months prior to Screening (signed informed consent form and
assent, if applicable) as assessed by the investigator.
4. The participant has met the electronic diary qualification criteria as assessed by the
electronic daily diary defined as follows: heartburn (burning or hurting in your
throat, chest, or stomach) on at least 3 of 7 days.(Note: if an endoscopy done within
1 week of signing informed consent and assent is used to confirm diagnosis of EE, the
subject does not need to meet this criterion).
5. The participant has endoscopic evidence of EE (LA Grade A-D) based on the screening
endoscopy.
6. The participant is male or female and aged 12 to 17 years, inclusive.
7. A male participant who is nonsterilized and sexually active with a female partner of
childbearing potential agrees to use adequate contraception from signing of informed
consent and assent throughout the duration of the study and for 30 days after last
dose of study medication.
8. A female participant of childbearing potential who is or may become sexually active
agrees to routinely use adequate contraception from the time of signing the informed
consent and assent until 30 days after the last dose of study medication.
Exclusion Criteria:
1. Participant has evidence of cardiovascular, pulmonary, central nervous system,
hepatic, hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or
serious allergy, asthma, or allergic skin rash that suggests clinically significant,
uncontrolled underlying disease or condition (other than the disease being studied),
which may impact the ability of the participant to participate or potentially confound
the study results.
2. The participant has a co-existing disease affecting the esophagus (eg, esophageal
varices, scleroderma, viral or fungal infection, or esophageal stricture), history of
radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma
such as sclerotherapy to the esophagus.
3. The participant has known history of Barrett's with dysplastic changes in the
esophagus.
4. The participant has a known history of eosinophilic esophagitis (EoE) or endoscopic
findings suggestive of EoE.
5. The participant has a history of celiac disease or participant tests positive for
tissue transglutaminase (tTG) antibody.
6. The participant has active gastric or duodenal ulcers within 4 weeks prior to Day -1.
7. Participant has any finding in his/her medical history, physical examination, or
safety clinical laboratory tests giving reasonable suspicion of underlying disease
that might interfere with the conduct of the trial.
8. Participant has taken any proton pump inhibitor (PPI) within 1 week (7 days) prior to
the Screening Visit.
9. Participant tests positive for H. pylori.
10. The participant has a history of hypersensitivity or allergies to dexlansoprazole or
any component of dexlansoprazole or any PPI (including lansoprazole, omeprazole,
rabeprazole, pantoprazole, or esomeprazole) or antacid containing Mg(OH)2 and/or
Al(OH)3 or simethicone.
11. The participant is required to take excluded medications or it is anticipated that the
participant will require treatment with at least one of the disallowed concomitant
medications during the study evaluation period as specified in the Excluded
Medications and Treatments Section 7.3.
12. The participant has a history of malignant disease (except basal cell carcinoma)
within 5 years prior to Screening.
13. The participant has a condition that may require inpatient surgery during the course
of the study.
14. The participant requires dilatation of esophageal strictures and/or strictures
preventing passage of the endoscope during the Screening endoscopy. Schatzki's ring (a
ring of mucosal tissue near the lower esophageal sphincter) is acceptable.
15. The participant is known to be human immunodeficiency virus (HIV) positive.
16. The participant has current or clinical history of Zollinger-Ellison syndrome or other
hypersecretory condition.
17. The participant has a history of gastric, duodenal or esophageal surgery except simple
oversew of an ulcer. A history of gastric tube and/or percutaneous endoscopic
gastrostomy (PEG) placement is allowed.
18. The participant had an acute upper gastrointestinal hemorrhage within 4 weeks prior to
endoscopy.
19. The participant has donated or lost ≥300 mL blood volume, undergone plasmapheresis, or
has had a transfusion of any blood product within 90 days prior to the first dose of
study drug.
20. The participant has a known history of alcohol abuse or illegal drug use within the
past 12 months prior to the first dose of study drug.
21. The participant has any Screening Visit 1 abnormal laboratory value that suggests a
clinically significant underlying disease or condition that may prevent the
participant from entering the study; or the participant has: creatinine >1.5 mg/dL,
alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times the
upper limit of normal (×ULN), or total bilirubin >2.0 mg/dL with AST/ALT elevated
above the limits of normal values.
22. If female, the participant is pregnant or lactating or intending to become pregnant
before, during or within 30 days after last dose of study medication; or intending to
donate ova during such time period.
23. If male, the participant intends to donate sperm during the course of this study or
within 30 days after last dose of study drug.
24. The participant, participant's Parent(s) or Legal Guardian is an immediate family
member, study site employee, or is in a dependent relationship with a study site
employee who is involved in the conduct of this study or may consent and assent under
duress. Students of the institution/research facility who are under the supervision
of, or in a subordinate role to, the investigator are also ineligible.
25. The participant or participant's Parent(s) or Legal Guardian, in the opinion of the
investigator, is unlikely to comply with the protocol requirements or is unsuitable
for any other reason.
26. The participant has participated in another clinical study and/or has received any
investigational compound within 30 days prior to 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.
Subject must be at most 17 Years | Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents | NCT01642615 | Contradiction |
1,300 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Parent(s) or guardian(s) willing and able to provide signed informed consent after the
nature of the study has been explained and prior to performance of any research
related procedure.
- Have ACH, documented by genetic testing.
- Are willing and able to perform all study procedures as physically possible.
- Age 0 to ≤ 12 months, at study entry (Day 1). Given that any potential impact of
vosoritide therapy on the foramen magnum is dependent on treating as early as possible
and as long as possible while the synchondroses at the base of the skull are still
open. For subjects > 6 months of age at enrollment, a discussion between the
investigator and the Medical Monitor should occur with the goal of limiting the number
of subjects in the range of > 6 months to ≤ 12 months of age.
- Parent(s) or caregiver(s) are willing to administer daily injections to the subject
and complete the required training.
- Have evidence of CMC that "may" require surgical intervention
Exclusion Criteria:
- Have hypochondroplasia or short-stature condition other than achondroplasia (eg,
trisomy 21, pseudoachondroplasia, etc).
- Have CMC that either does not require surgical intervention (for example foramen
magnum narrowing with preservation of the cerebrospinal fluid space) or does require
immediate surgical intervention .
- Have any of the following: Untreated congenital hypothyroidism or maternal history of
hyperthyroidism, Insulin-requiring neonatal diabetes mellitus, Autoimmune inflammatory
disease, Inflammatory bowel disease, Autonomic neuropathy.
- Have a history of any of the following:Renal insufficiency, Chronic anemia,Baseline
systolic blood pressure below age and gender specified normal range or recurrent
symptomatic hypotension (defined as episodes of low blood pressure generally
accompanied by symptoms eg, pallor, cyanosis, irritability, poor feeding) and Cardiac
or vascular disease.
- Have a clinically significant finding or arrhythmia that indicates abnormal cardiac
function or conduction or QTc-F ≥ 450 msec on screening ECG.
- Have been treated with growth hormone, insulin-like growth factor 1, or anabolic
steroids in the 6 months prior to Screening, or long-term treatment (> 3 months) at
any time.
- Have ever had prior cervicomedullary decompression surgery.
- Have had a fracture of the long bones or spine within 6 months prior to Screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 12 Months | A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With Achondroplasia | NCT04554940 | Contradiction |
1,511 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- 30-80 years old
- Diagnosed with hypertension since at least one year
- Blood pressure 130-160 mm Hg systolic and/or 85-100 diastolic at the last blood
pressure control by doctor or nurse.
- Blood pressure within inclusion- and exclusion-limits at baseline control
Exclusion Criteria:
- Blood pressure outside the range of 120-180 systolic and 80-110 diastolic at the last
blood pressure control or at baseline control.
- Medical adjustments regarding hypertension within 4 weeks prior to begin of study.
- Expected inability to understand instructions about yoga exercises (e.g dementia and
mental retardation) or physical or psychical inability to carry out yoga exercises
(e.g severe physical or psychical handicap).
- Need for interpreter. Linguistic/language difficulties
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 80 Years | Impact of Yoga on Blood Pressure, Quality of Life and Stress in Patients With Hypertension | NCT01984593 | Entailment |
2,167 | 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:
1. Subjects capable of giving informed consent.
2. Male or non-pregnant, non-nursing female
3. ≥ 18 years of age
4. eGFR < 60mls/min/1.73m2 and ≥ 30mls/min/1.73m2 as calculated using serum creatinine
and modified MDRD formula as per renal association guidelines.
5. Diagnosis of gout arthritis as defined by the American College of Rheumatology 1977
preliminary criteria (this criteria is currently endorsed by NICE guidelines).
6. Gout flare less ≤ 36 hours
7. Baseline pain intensity > or equal to 50mm on the 0-100 mm VAS. In the case of
multiple joints (≤ 3), the most affected joint will be assessed.
Exclusion Criteria:
1. Treatment with NSAIDS in last 48 hours, systemic steroids in last 4 weeks or
colchicine within 7 days.
2. Polyarticular gout, i.e. affecting four or more 4 joints
3. Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
acute inflammatory arthritis such as systemic lupus erythematosus, mixed connective
tissue disease, scleroderma, polymyositis, or significant systemic involvement
secondary to rheumatoid arthritis.
4. Con-current immunosuppression/immunomodulatory treatment (Calcineurin inhibitor,
anti-proliferative or biologic) therapy for other reason i.e. organ transplant.
5. Prior history or current inflammatory joint disease other than gout (e.g. rheumatoid
arthritis (RA), reactive arthritis, psoriatic arthritis, seronegative
spondyloarthropathy, Lyme disease). Concurrent medication for RA like methotrexate and
anti-TNF treatment has been associated with increased risk of neutropenia and
infection.
6. Current active malignancy (with the exception of basal cell or squamous cell carcinoma
of the skin, cervical intraepithelial neoplasia and non-metastatic/advanced prostate
cancer).
7. Any patients with contra-indication to intramuscular injection such as coagulopathy or
thrombocytopenia (Platelet count<100 x 109/L (100,000/mm3)).
8. Abnormal liver function tests: Total bilirubin>upper limit of normal, Alanine
aminotransferase (ALT) or Aspartate Aminotransferase (AST) >2 times upper limit of
normal.
9. Haemoglobin <85g/L (8.5 g/dL)
10. White blood cell (WBC) count<1.5 x 109/L (1000/mm3), absolute neutrophil count<1.5 x
109/L (1000/mm3)
11. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary
(including obstructive pulmonary disease), hepatic, endocrine (including uncontrolled
diabetes) or gastrointestinal disease.
12. Known positive hepatitis B virus surface antigen (HBsAg), hepatitis C (HCV) antibody
or HIV.
13. Females of child bearing potential who are not willing to use highly effective birth
control methods from the time of consent to one week after treatment discontinuation.
Highly effective method of contraception (hormonal or barrier method of birth control;
abstinence) consist of:
- Combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation; oral, intravaginal, transdermal.
- Progestogen-only hormonal contraception associated with inhibition of ovulation;
oral, injectable, implantable.
- Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion or vasectomised partner
- Sexual abstinence
14. Females of childbearing potential must have a negative pregnancy test (highly
sensitive urine or serum pregnancy test after a confirmed menstrual period) within 7
days prior to treatment initiation. Subjects are considered not of child bearing
potential if they are surgically sterile (i.e. they have undergone a hysterectomy,
bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
15. Females must not be breastfeeding.
16. Patients who have had treatment as part of this trial cannot have repeat treatment for
another flare as part of the trial.
17. Patient with allergies to excipients of IMPs: citric acid, anhydrous, sodium chloride,
disodium edetate dehydrate, polysorbate 80, sodium hydroxide. Hypersensitivity to E.
Coli derived proteins, egg proteins and soy proteins. Patients with a latex allergy
are also not eligible as the inner needle cover of the pre-filled syringe contains dry
natural rubber (a derivative of latex).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Anakinra vs. Steroids for the Treatment of Gout Attacks in Patients With Renal Disease (ASGARD): A Feasibility Study | NCT02578394 | Contradiction |
2,132 | 13 | A 24-year-old man comes to the office complaining of infertility. He and his wife have been trying to conceive for the last 18 months. Medical records of his wife showed no abnormalities. The patient doesn't smoke and takes no medications. Height is 185 cm and weight is 77 kg. Heart and lung sounds are normal. There is bilateral gynecomastia and bilateral descended firm testes. The lower extremities appear abnormally long. His karyotype evaluation shows 47, XXY consistent with Klinefelter syndrome. | I'm only a 24 year old man but I’m already struggling with infertility. I went to a clinic with my wife the other day because we've been trying to have a baby for at least 18 months. The medical records of my wife are totally normal. For me I don't smoke or take any medication. I'm 185 cm and 77 kg. Everything was normal when the doctor inspected my lungs and my heart. The doctor said that I have enlarged breasts for a man. My testicles seem normal. The doctor noticed that my legs were abnormally long compared to the rest of my body. I also had a karyotype evaluation which led the doctor to diagnose me with Klinefelter syndrome. | Inclusion Criteria:
- all patients undergoing fertility care
Exclusion Criteria:
- none
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 50 Years | Study of Gene Associations and Infertility | NCT01223092 | Entailment |
2,639 | 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:
- Signed informed consent obtained from the subject prior to participation in the study
- Active males over the age of 18 years and below 80 years
- Experiencing an uncomplicated unilateral primary inguinal hernia or experiencing an
uncomplicated bilateral hernia provided that only one hernia is operated during the 12
months of study follow-up
- Subjects eligible for elective inguinal hernia repair using Lichtenstein technique.
Exclusion Criteria:
- Recurrent, scrotal, incarcerated or femoral hernias
- Hernia types L3 and M3 according the EHS classification
- BMI equal or more than 35
- Concomitant abdominal surgery
- Ongoing long term analgesic or steroid treatment
- Patients under Clopidogrel or Warfarin (can be switched to LMW sub-cutaneous heparin)
- Known abuse of alcohol or drugs
- Liver cirrhosis (Child C)
- Previous treatment or Hypersensitivity to bovine aprotinin
- Known immunodeficiency
- Severely compromised physical or psychological health, that in the investigator's
opinion will affect patient compliance
- Concurrently participating in another clinical trial and having received another
investigational drug or device within the last 30 days
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Efficacy Study of Tissucol/Tisseel Fibrin Sealant to Treat Inguinal Hernia | NCT00306839 | Entailment |
3,804 | 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:
1. Adults between the ages of 25-65 years
2. Body Mass Index (BMI) less than 40 kg/m2
3. Ambulatory and in good general health as described by vital signs (blood pressure
90/60 mm Hg to 120/80 mm Hg, pulse rate 60-100 beats per minute, temperature 97.2-99.1
°F) and normal blood chemistry.
4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score of ≥
11 (worst possible = 20) over the previous 7 days
5. OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4
inclusive) within the last 6 months
6. Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain.
7. Patients who have failed to adequately respond for at least 6 months to at least 2 OA
therapies that include conservative, non-pharmacological therapy and simple analgesics
(e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of
activities that cause joint pain; exercise; weight loss; physical therapy; and removal
of excess fluid from the knee.
8. Have suitable knee joint anatomy for intra-articular injection.
9. For adults of reproductive potential: use of effective contraception for at least 1
month prior to screening and agreement to use such a method during study
participation.
Exclusion Criteria:
1. Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,
or arthritis associated with inflammatory bowel disease.
2. Subject with an infection that requires parenteral antibiotic administration.
3. Active infection or crystal disease in the index joint within 1 month of screening
4. History of fracture in the index limb, joint instability, or history of acute
dislocation within 12 months of screening, or fracture with sequelae at any time
5. Intra-articular treatment of any joint with any of the following agents within 6
months of screening: Any corticosteroid preparation (investigational or marketed),
sodium hyaluronate, any biologic agent (e.g., platelet rich plasma (PRP) injection,
stem cells, prolotherapy, amniotic fluid injection); investigational six months prior
to enrollment.
6. Presence of surgical hardware or other foreign body in the index joint
7. Subjects who were administered with immunosuppressants such as cyclosporin A or
azathioprine within 6 weeks before screening.
8. Planned or anticipated surgery of the joint during the study period
9. Allergies to anesthesia
10. Subjects who tested positive for HIV, HCV, WNV, CMV, HBV, HTLV, ZIKA, syphilis, flu or
COVID-19. Note: CMV is not a relevant communicable disease agent. A subject who tests
positive or reactive for CMV is not necessarily ineligible. Physicians will determine
donor eligibility for subjects with positive CMV test results.
11. History of lipid disorders: lipedema, lipomatosis, or lipodystrophies.
12. Active cancer, chemotherapy, or other malignancies in the last 6 months.
13. Recent history of DVT or pulmonary embolism requiring anticoagulants or other
medicines per the hematologist.
14. Subject who participated in another clinical trial within 3 months before the
screening visit
15. Any illness which, in the Investigator's judgment, will interfere with the subject's
ability to comply with the protocol, compromise patient safety, or interfere with the
interpretation of the study results.
16. Subjects who are breastfeeding
17. Subjects with uncontrolled arrhythmias
18. Subjects with hemophilia; factor II, V, VII, X, or XII deficiencies; or Von
Willebrand's disease.
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 65 Years | Safety and Tolerability of StroMel™ in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint | NCT04750252 | Entailment |
6,418 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Subjects 18 years of age and older of any race.
2. Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based
on physician evaluation.
3. Willing and able to understand and sign informed consent.
4. Able to complete study and comply with study procedures.
Exclusion Criteria:
1. Severe self reported facial sensitivity
2. History of allergy to fish
3. Severe sun sensitivity
4. Severe erythematotelangiectatic rosacea requiring systemic treatment
5. Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
6. Unwilling to undergo facial biopsies
7. Concomitant use of medications that are reported to exacerbate rosacea, such as
topical and systemic steroids
8. Use of topical rosacea treatments in the past 2 weeks.
9. Use of systemic antibiotics in the past 4 weeks.
10. Use of systemic retinoids within the past 6 months.
11. Use of topical retinoids within the past 3 months
12. Use of laser or light based rosacea treatments within the past 2 months.
13. Cosmetic procedures (e.g., superficial chemical peels, exfoliation or
microdermabrasion of the face) within the past two months
14. Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid,
beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
15. Other dermatologic conditions that require the use of interfering topical or systemic
therapy or that might interfere with study assessments.
16. Clinically significant abnormal findings or conditions (other than rosacea), which
might, in the opinion of the Investigator, interfere with study evaluations or pose a
risk to subject safety during the study.
17. If female, Subjects who are either of non-child bearing potential (defined as
postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone
bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of
childbearing potential, Subjects who have had a negative urine pregnancy test at the
beginning of the study, and have agreed to practice appropriate birth-control to
prevent pregnancy during the study.(The type and dose of birth control must have been
stable for at least 2 months prior to study entry and not be expected to change during
the study).
18. Subjects who are lactating.
19. Use of any investigational therapy within the past 4 weeks.
20. Known hypersensitivity or previous allergic reaction to retinoids
21. Carcinoid, Pheochromocytoma or other systemic flushing causes
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.
| Atralin Gel for the Treatment of Rosacea | NCT01125930 | Contradiction |
2,895 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- Patients will be adults with a diagnosis of ALS.
- Healthy controls will also be recruited and will be age- and gender-matched to
patients.
- Patients able to undergo a brain MRI for approximately an hour.
Exclusion Criteria:
- Subjects with other psychiatric or CNS or PNS diseases.
- Subjects ineligible for MRI investigation due to a pacemaker or other metallic foreign
body, or significant claustrophobia that could affect the ability to have an MRI scan.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| New Magnetic Resonance Imaging Biomarkers in Amyotrophic Lateral Sclerosis | NCT04691011 | Entailment |
4,669 | 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:
- The study included 80 women with ASA I-II,
- Aged 18 to 45 years, who were accepted to participate in the study,
- were smoking,
- did not use oral contraceptives,
- had no menstrual irregularity (regular 28 ± 2 days menstrual cycle)
Exclusion Criteria:
- In preop evaluation patients had difficulties in communication,
- amenorrhea,
- pregnancy,
- delirium,
- psychological illness,
- major depressive disorder,
- patients with a history of acute illness (such as in intensive care unit follow-up),
- which may affect cognitive function and daily life activities in the last 6 months,
- malignancy,
- acute renal failure,
- substance abuse and patients older than 45 years and male sex will be excluded from
the study.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Effects of Menstrual Cycle on Preoperative Anxiety | NCT03708679 | Entailment |
330 | 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:
- Maternal age ≥20years old.
- No vaginal bleeding.
- No dilation of internal os.
- Gestational age: from 8-11weeks.
- Gestational sac with a mean gestational sac diameter (MGD) greater than 25 mm and no
yolk sac, or an MGD >25 mm with no embryo.
Exclusion Criteria:
- Patients with excessive vaginal bleeding (soaking more than a pad per day).
- Patients with dilated cervix.
- Patients with allergy either to misoprostol or isosorbide mononitrate.
- Those who will be insisted on D and C will be excluded from the study.
- Women will be excluded from the study if they are anemic (hemoglobin less than 11
g/dl).
- Hemo-dynamically unstable with signs of pelvic infection and/or sepsis.
- Suffering from a clotting disorder or using anticoagulants.
- Women with uterine pathology such as myomas or malformation.
- Women had previous caesarian section.
- Asthmatic patients.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Termination Of Anembryonic Pregnancy | NCT02573051 | Contradiction |
1,265 | 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:
- Patients with radiographic evidence of pleural lesions or effusion
Exclusion Criteria:
- Age < 20 y/o
- Patients who cannot hold their breath for 5 seconds
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.
| Application of Transthoracic Shear-wave Ultrasound Elastography in Pleural Lesions | NCT04781894 | Entailment |
3,299 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | - INCLUSION CRITERIA:
To be eligible for this protocol, participants must:
- Have a molecular diagnosis of HPS-1 or HPS-4
- Be 18-70 years of age
- Have the expectation to live more than 3 months, i.e., an FVC greater than or equal to
30% of predicted
- Have evidence of severe pulmonary fibrosis, i.e.:
1. A FVC less than or equal to 45% of predicted
2. Reduced exercise tolerance lasting longer than 1 week on the Dyspnea Perception
Scale
3. No evidence of improvement in pulmonary fibrosis within the past year, as defined
by an FVC increase of 10% or a DLco increase of 15%.
- Be available, willing, and able to come to the NIH Clinical Center for admission every
3 months.
EXCLUSION CRITERIA:
- An explanation for interstitial lung disease other than HPS, including but not limited
to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans
organizing pneumonia, cancer
- Pregnancy or lactation
- History of ethanol abuse or recreational drug use in the past two years
- History of human immunodeficiency virus (HIV) or chronic viral hepatitis infection
- Chronic use of high-dose steroids (greater than 10 mg prednisone/day) intended for
ongoing treatment of their interstitial lung disease
- Use of any of the following within 28 days of enrollment: investigational therapy,
cytotoxic/immunosuppressive agents other than corticosteroids, including but not
limited to azathioprine, cyclosphosphamide, methotrexate, cyclosporine, colchicine,
interferon gamma-1b, bosentan;
- Any severe medical complication including but not be limited to uncontrolled seizures,
repeated transient ischemic attacks, severe ataxia, uncontrolled migraine headaches,
diplopia, repeated episodes of syncope, an untreated psychiatric disorder, recent
myocardial infarction (past 6 months), unstable angina, clinically relevant and
untreated arrhythmias, uncontrolled hypotension or hypertension (systolic blood
pressure less than 80 or greater than 180 mm Hg), myocarditis, severe congestive left
sided heart failure, hepatomegaly not due to right heart failure, renal glomerular
impairment (creatinine clearance less than 35 ml/min/1.73 m(2)), pancreatitis, toxic
thyroiditis, life-threatening malignancy;NOTE: right sided heart failure due to
pulmonary hypertension as a result of pulmonary fibrosis will not be considered an
exclusion criteria.
- Significant laboratory abnormalities, including but not limited to serum potassium
less than 3.0 or greater than 5.4 mEq/L, SGPT greater than 100 U/L, CK greater than
700 U/L, hemoglobin less than 9.0 g/dL, platelets less than 70 k/mm(3), leukocyte
count less than 2.0 k/microL;
- For women of child-bearing age, failure to have an effective method of birth control.
Oral contraceptives will be considered inadequate without a second method due to risk
of reduced efficacy of BCP while taking Zileuton.
- Severe psychiatric disease untreated. Inability to give informed consent after reading
or having the consent read to the participant in their native language. Any concern
that there is a therapeutic misconception will be evaluated by genetic counselor
and/or appropriate mental health professionals prior to acceptance into the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome | NCT00467831 | Contradiction |
5,265 | 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:
- Any subjects who give written informed consent
Exclusion Criteria:
- Any individual who is not willing or able to give written informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Osteoporosis Research Registry | NCT01223300 | Entailment |
881 | 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. | Key Inclusion Criteria:
- Generally in good health at the screening visit
- Body mass index (BMI) ≤39 kg/m2 at the screening visit
- Clinical diagnosis of OA of the knee on the American College of Rheumatology criteria
(Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the
screening visit
- Moderate-to-severe pain in the index joint
- A history of inadequate pain relief from or intolerance to analgesics used for OA
Key Exclusion Criteria:
- Diagnosis of systemic diseases that may affect joints
- History or presence of osteonecrosis, destructive arthropathy, neuropathic joint
arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip
dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella
dislocation is eligible) at the screening visit. Presence of subchondral insufficiency
fracture on screening films or MRI as assessed by the central imaging reader.
- Is scheduled for a joint replacement surgery to be performed during the study period
- Received an intra-articular injection of hyaluronic acid in any joint within 90 days
prior to the screening visit
- Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the
screening visit. Intra-articular corticosteroids in the index joint within 12 weeks
prior to the screening visit, or to any other joint within 30 days prior to the
screening visit (topical, intranasal, or inhaled corticosteroids are permitted).
- History or presence at the screening visit of multiple sclerosis, autonomic
neuropathy, diabetic neuropathy, or other peripheral neuropathy
- Significant concomitant illness including, but not limited to, psychiatric, cardiac,
renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that,
in the opinion of the investigator, would adversely affect the patient's participation
in the study
- History of myocardial infarction, acute coronary syndromes, transient ischemic attack,
or cerebrovascular accident within 12 months prior to the screening visit
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 40 Years old.
| A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee | NCT03956550 | Entailment |
6,414 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
- Fitzpatrick Skin Type I - III
- Post-menopausal or surgically sterilized, or using a medically acceptable form of
birth control at least 3 months prior to enrolment and during the entire course of the
study.
- Clinical diagnosis of Erythematotelangiectatic Rosacea stade II
- Homogeneous extend and staining telangiectasia in each half face
- Patient never treated with laser for Rosacea
- Patient doesn't wish to use systemic corticosteroids or retinoids; or topical
corticosteroids or retinoids on the treated area.
- Patient agreeing to have limited exposure to the sun and use of a protective screen
(index 50 or higher) every day of the study and throughout its duration if it takes
place from May to September.
- Patient must be able to read, understand and sign the Informed Consent Form
- Patient able to adhere to the program of visits of the study and the other imperatives
of the protocol
- Patient accepting to have photographs taken on the face
- Quality of social insurance or social security entitlement
Exclusion Criteria:
- Pregnant and/or breastfeeding woman or childbearing age without effective
contraception
- Alcohol abuse assessed at the discretion of the investigator
- History of prior laser or light based procedures for any other pathology for the face
within 6 months of study participation Fitzpatrick Type IV à VI
- Systemic use of isotretinoin in the 6 months prior to inclusion in the study.
- Topical use of retinoids and / or corticosteroids in the 4 weeks prior to inclusion in
the study.
- Patient under photo sensitization treatment
- Patient suffering from significant concurrent illness such as type 1 diabetes,
cardiovascular disease, uncontrolled hypertension, neurological disease, lupus
erythematosus, scleroderma.
- Patient subject to hypertrophic or abnormal scarring
- Patient presenting or having a malignant tumor or skin cancer in the area to be
treated.
- Having a known anticoagulative condition or taking prescription anticoagulation
medications.
- Participation to another clinical study involving a laser or drug within three months
of inclusion in the study.
- Smoker or former smoker in the 12 months prior to inclusion in the study.
- Patient with excessive tattoos in the area to be treated and / or wishing to tattoo
the treated area during the study.
- Patient treated for cancer by chemotherapy or radiotherapy
- Patient with hyper or hypo pigmentation
- Patient unable to understand protocol or give consent
- Legal incapacity (persons deprived of their liberty or under guardianship or
curatorship)
- Patient in emergency or in detention
- Clinical follow-up impossible for psychological, family matters, social or
geographical reasons
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 | Evaluation of the New Laser PHOTOLASE PLV-585nm for the Treatment of Rosacea | NCT03708263 | Contradiction |
910 | 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:
- Knee pain, or taking NSAIDs/ analgesia for knee pain on most days past month
- Knee pain 4-10 on 10cm VAS
- Medial tibio-femoral compartment joint space narrowing in symptomatic knee
Exclusion Criteria:
- Unstable diabetes
- <2mm medial tibio-femoral compartment joint space width
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 45 Years old.
Subject must be at most 75 Years | The Long-term Evaluation of Glucosamine Sulphate Study | NCT00513422 | Entailment |
4,298 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Age 18-50 years old.
2. Ability and willingness to provide informed consent.
3. Assessment of understanding: completion of a questionnaire prior to first screening
procedure; verbally demonstrate understanding of all questionnaire items answered
incorrectly.
4. Available for the duration of the trial.
5. Good general health as shown by medical history, physical exam, and screening
laboratory tests.
6. The following laboratory parameters:
- Hematology
- Hemoglobin ≥10.5 g/dL for women; ≥11 g/dL for men
- Absolute Neutrophil Count (ANC): ≥1000/mm3
- Platelets: 125,000 to 550,000/mm3
- Chemistry
- Creatinine: <1.1 x upper limit of normal (ULN)
- AST: <1.25 x ULN
- ALT: <1.25 x ULN
- Normal urinalysis
- Negative urine glucose.
- Negative or trace urine protein.
- Negative or trace urine hemoglobin (if trace hemoglobin is present on
dipstick, a microscopic urinalysis within institutional range).
7. All female participants must be willing to undergo serum or urine beta human chorionic
gonadotropin pregnancy tests at time points indicated in the Schedule of Procedures
and must test negative prior to vaccination.
8. All sexually active males (unless anatomically sterile) must be willing to use an
effective method of contraception (such as consistent condom use) from the day of
first vaccination until Week 12.
9. If a woman of child-bearing potential, committed to use an effective method of
contraception when sexually active with men until Week 12, including:
- Condoms (male or female) with or without spermicide.
- Diaphragm or cervical cap with spermicide.
- Intrauterine device.
- Hormonal contraception.
- Successful vasectomy in the male partner (considered successful if a woman
reports that a male partner has [1] documentation of azoospermia by microscopy,
or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite
sexual activity post-vasectomy).
- Not be of reproductive potential, such as having undergone hysterectomy,
bilateral oophorectomy, or tubal ligation.
Exclusion Criteria:
1. History of known flavivirus infection or previous receipt of flavivirus vaccine.
2. Positive serology for HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus
antibodies prior to enrollment.
3. Planned travel to areas with active Zika virus transmission during the study period.
4. Recent (within 3 weeks) travel to an area with active Zika virus transmission.
5. Current or planned participation in another clinical trial of an experimental agent
during the study period.
6. Pregnant or lactating.
7. Any condition, including any clinically significant acute or chronic medical
condition, for which, in the opinion of the investigator, participation would not be
in the best interest of the subject (eg, compromise the well-being) or that could
prevent, limit, or confound the protocol-specified assessments.
8. Use of anticancer, antituberculosis or other medications considered significant by the
investigator within the previous 6 months.
9. Receipt of live-attenuated vaccine within the previous 60 days or planned receipt
within 60 days after vaccination with Investigational Product (within 14 days for live
attenuated influenza vaccine [LAIV]); or receipt of other vaccine (e.g., influenza,
pneumococcal), allergy treatment with antigen injections or tuberculin skin test
within the previous 14 days or planned receipt within 14 days after vaccination with
Investigational Product
10. Receipt of blood transfusion or blood-derived products within the previous 3 months.
11. Previous severe local or systemic reactions to vaccination.
12. History of splenectomy
13. History of seizure in the last 3 years (participants with a history of seizures who
have neither required medications nor had a seizure for 3 years are not excluded)
14. Known autoimmune disease
15. Asthma other than mild, well-controlled asthma. Exclude participants who:
1. Use a bronchodilator (beta 2 agonist) daily, or
2. In the past year have (any of the following):
i. Had > 1 exacerbation of symptoms treated with oral steroids ii. Routinely used
moderate to high dose inhaled corticosteroids (e.g., more than the equivalent of 250
mcg fluticasone; 400 mcg budesonide; 500 mcg beclomethasone; or 1000 mcg
triamcinolone/flunisolide, as a daily dose) or theophylline iii. Needed emergency
care, urgent care, hospitalization, or intubation for asthma c. Prophylactic
bronchodilator use prior to exercise is not exclusionary
16. Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not
excluded: history of isolated gestational diabetes.)
17. Thyroidectomy, or thyroid disease requiring medication during the last 12 months
18. Angioedema within the last 3 years if episodes are considered serious or have required
medication within the last 2 years
19. Uncontrolled Hypertension:
1. If a person has been diagnosed with hypertension during screening or previously,
exclude for hypertension that is not well controlled. Well- controlled
hypertension is defined as blood pressure consistently ≤ 140 mm Hg systolic and ≤
90 mm Hg diastolic, with or without medication, with only isolated, brief
instances of higher readings, which must be ≤ 150 mm
2. If a person has NOT been diagnosed with hypertension during screening or
previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or
diastolic blood pressure ≥ 90 mm Hg at enrolment
20. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or
platelet disorder requiring special precautions)
21. Malignancy (Not excluded: a participant with a surgical excision and subsequent
observation period that in the investigator's estimation has a reasonable assurance of
sustained cure or is unlikely to recur during the study period)
22. Psychiatric condition that compromises safety of the participant or precludes
compliance with the protocol, specifically excluding persons with psychoses within the
past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture
within the past 3 years
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Zika Virus Purified Inactivated Vaccine (ZPIV) Accelerated Vaccination Schedule Study | NCT02937233 | Entailment |
637 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
1. Informed consent from patient or patient representative.
2. Trauma patient
3. Anemia (hemoglobin < 12 g/dL).
4. Functional iron deficiency:
1. Serum iron concentration < 40 ug/dL
2. TSAT < 25%
3. Serum ferritin concentration > 28 ng/mL
5. < 72 hours from ICU admission.
6. Expected ICU length of stay ≥ 7 days.
Exclusion Criteria:
1. Age < 18 years.
2. Active bleeding requiring pRBCs transfusion.
3. Iron overload (serum ferritin concentration ≥ 1,500 ng/mL). The serum ferritin
concentration is an acute phase reactant that is increased during critical illness
regardless of total body iron. Substantial levels of hyperferritinemia (serum ferritin
concentration > 1,000 ng/dL) were observed in both NCT00450177 and NCT01180894 without
increased risk of infection and despite both low TSAT and IDE. For these reasons, we
believe that relative hyperferritinemia (serum ferritin concentration 500 - 1,500
ng/dL) is neither harmful nor indicative of bone marrow iron availability.
4. Infection, defined using US Centers for Disease Control and Prevention (CDC)
guidelines, with the exception of ventilator-associated pneumonia (VAP), which is
defined as clinical suspicion for pneumonia along with a lower respiratory tract
culture with ≥ 105 colony forming units per mL.
5. Chronic inflammatory conditions (e.g., systemic lupus erythematosis, rheumatoid
arthritis, ankylosing spondylitis).
6. Pre-existing hematologic disorders (e.g., thalassemia, sickle cell disease,
hemophilia, von Willibrand's disease, or myeloproliferative disease).
7. Pre-existing hepatic dysfunction (cirrhosis, non-alcoholic steatohepatitis, hepatitis)
8. Current or recent (within 30 days) use of immunosuppressive agents.
9. Use of any recombinant human erythropoietin formulation within the previous 30 days.
10. Known or suspected carcinoma of the breast or prostate.
11. Nephrosis, the nephrotic phase of nephritis.
12. Hypercalcemia (serum calcium concentration > 10.5 mg/dL).
13. Pregnancy or lactation.
14. Legal arrest or incarceration.
15. Prohibition of pRBCs transfusion.
16. Stay of ≥ 48 hours duration in the ICU of a transferring hospital.
17. History of intolerance or hypersensitivity to either iron or oxandrolone.
18. Moribund state in which death was imminent.
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.
| RCT of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients, With and Without Oxandrolone | NCT02047552 | Contradiction |
2,189 | 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:
- At least one prior International Classification of Disease (ICD) 9 code for gout
(274.xx)
- Received a new prescription for allopurinol, defined as no prior allopurinol
prescription in the preceding 12 months
Exclusion Criteria:
- No prior ICD9 code for gout (274.xx)
- Did not receive a new prescription for allopurinol, defined as no prior allopurinol
prescription in the preceding 12 months
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.
| Virtual Gout Clinic | NCT02790463 | Contradiction |
4,017 | 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 referrals to one of two orthopedic department's outpatient clinics due to knee
osteoarthritis
Exclusion Criteria:
- previous total or unicompartmental knee replacement
- osteotomy around the study knee
- unable to read or write Danish
- patients who decline to answer the questionnaire at inclusion
No condition on gender to be admitted to the trial.
| The Right Treatment for the Right Patient at the Right Time. A Study Following 5,000 Patients With Knee Osteoarthritis | NCT03746184 | Entailment |
6,607 | 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:
- Severe Hemophilia A with an inhibitor level of 0.6 B.U. or higher
Exclusion Criteria:
- Severe Hemophilia A with a negative inhibitor
Male
No healthy subjects accepted to join the trial.
Subject must be at most 99 Years | Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia | NCT00178607 | Contradiction |
4,434 | 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:
The inclusion criteria for the study are
- provision of informed consent by patient
- adult men or women aged > 18 and < 65 years
- Patients had a clinical diagnosis of lateral epicondylitis based on local tenderness
to palpation at lateral epicondyle and pain in that area elicited with active
extension of the wrist in pronation and elbow extension
- History of pain >3 months and <2 years, failed each of the following conservative care
modalities: relative rest, physical/occupational therapy, non-steroidal
anti-inflammatorydrugs and two corticosteroid injections.
- Baseline elbow pain > 50 mm/100 mm using a visual analog scale (VAS) with resisted
active extension of the wrist in pronation and elbow extension
- All affected elbows were screened with radiography and all proved to be normal, except
for some calcifications of the common extensor origin.
- documented sonographic diagnosis of common extensor tendinosis was based on tendon
echogenicity, loss of the normal echotexture and tendon thickening. We also performed
the sonographic assessment of the extensor carpi radialis brevis, extensor digitorum
communis and radial collateral ligament; tendinosis defined as ill- or well-defined
focal/generalized hypoechogenic swollen tendon with loss of normal fibrillary pattern
and focal tear defined as well-defined anechoic cleft
Exclusion Criteria:
- History of narcotic use for pain management > 1 mo, narcotic abuse
- History of alcoholic abuse
- any recent febrile or infectious disease
- corticosteroid injection within the past 3 months
- Signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment,
fracture or osteochondral lesion)
- History of carpal tunnel syndrome, cervical radiculopathy or neurologic disorder
- Other chronic widespread pain syndromes
- History of bleeding disorder, anemia
- Systemic disorders such as diabetes, rheumatoid arthritis,or hepatitis
- Intolerance/allergy to local anesthetics or injection corticosteroids
- history of vasovagal shock
- Pregnancy/lactation
- history of any malignancy (including hematologic and non hematologic malignancies)
- Hypotension, systolic BP <100mmHg, diastolic BP < 60mmHg
- Systemic disorders such as diabetes, rheumatoid arthritis, or hepatitis, nephropathy,
Hypothyroidism.
- History of receiving a PDRN injection at any site
- Allergic reaction or hypersensitivity for PDRN
- Workers compensation or worker using both upper extremities, especially elbow and hand
for most labor activity
- history of acute elbow trauma (<1 week)
- patients requiring antiplatelet medications for the treatment of heart attack, stroke,
or other medical condition
- Previous surgery for elbow tendinosis or other disease at affected side
- Active bilateral elbow tendinosis within 4 weeks before randomization
- Tendon echogenicity, grade 0 and 4 were excluded; The degree of tendinosis is grade
based on changes in tendon echotexture at sonographic assessment, Diagnostic
ultrasound features for the RISEe
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.
Subject must be at most 64 Years | Bundang Rehabilitative Impact Study of the Elbow Epicondylitis | NCT02492945 | Contradiction |
4,743 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- Patient older than 18 years and younger than 81 years and
- Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physical
examination, history, audiology, speech interpretation tests and tinnitus evaluation
and
- Seen in the clinic within the first 14 days after the onset of symptoms. and
- Mean hearing threshold equal to or worse than >30 dB averaged across three consecutive
frequencies.
- Excellent English Speaking and Comprehension
Exclusion Criteria:
- Children
- Prisoners
- Pregnant women
- Patients who have experienced similar prior events of SSNHL
- Patients with bacterial infections, mycoplasma, Lyme disease, tuberculosis, syphilis,
fungal infections,
- Autoimmune inner ear disease
- Middle ear inflammation or effusion
- Ototoxic medication such as chemotherapy, loop diuretics, high dose aspirin, etc.
- Head Trauma, lead poisoning
- Genetic disorders affecting hearing
- Mitochondrial disorders, including MELAS (metabolic encephalopathy, lactic acidosis,
and stroke-like episodes), stroke, Cogan's syndrome
- Neoplastic (neurofibromatosis II, bilateral vestibular schwannomas, carcinomatous
meningitis, intravascular lymphomatosis, others)
- Sarcoidosis
- Hyperviscosity syndrome
- Diabetes
- Use of statins within the last 12 months
- Allergy, hypersensitivity or intolerance to any components of the study medication
- Prior tinnitus
- Prior otologic surgery other than ventilation tubes
- History of drug abuse or alcoholism within the prior 2 years
- Any psychiatric syndrome requiring treatment with neuroleptics, antidepressants,
hypnotics or anxiolytics
- Severe systemic neurologic disease (epilepsy, Parkinson's, dementia/Alzheimers,
multiple sclerosis
- Oral steroid treatment within the preceding 30 days
- Heart disease or TIAs
- Chronic kidney failure
- HIV, Hepatitis B or C
- Active shingles
- Skull, facial or temporal bone anomalies
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 | Oral Statins and Protection From Hearing Loss | NCT04826237 | Contradiction |
3,493 | 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. | Key Inclusion Criteria:
- Medically healthy, with no clinically significant medical history, physical
examination findings, vital signs, or ECG findings
Key Exclusion Criteria:
- Estimated creatinine clearance <90 mL/min
- Use of tobacco- or nicotine-containing products
- History in the past 90 days of prior trauma to the outer or internal structures of the
ear or tinnitus
- History or family history of vestibular disorder, chronic vertigo (sensation of
spinning), chronic dizziness
- History of hearing loss or a family history of hearing loss, or a prior diagnosis of
sensorineural hearing loss or Ménière's disease
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 55 Years | A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin | NCT03270553 | Entailment |
2,078 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- patients with interstitial lung disorders including IPF
Exclusion Criteria:
- patients younger than 18 years or older than 85,
- pregnant women,
- patients that present with medical conditions contra -indicated for performing
bronchoscopy including sedation
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 85 Years | The Role of Gastric Content Microaspirations in the Pathogenesis of Idiopathic Pulmonary Fibrosis | NCT01714934 | Entailment |
1,883 | 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 between 18 to 75 years old
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
3. Locally advanced tumor in the upper third stomach（cT2-4a, N-/+, M0 at preoperative
evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging
Manual Seventh Edition）
4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby
in the preoperative examinations
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. Pregnant and lactating women
2. Suffering from severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal
Dissection/Endoscopic Mucosal Resection )for gastric cancer)
5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative
imaging including enlarged or bulky No.10 lymph node
6. History of other malignant disease within the past 5 years
7. History of previous neoadjuvant chemotherapy or radiotherapy
8. History of unstable angina or myocardial infarction within the past 6 months
9. History of cerebrovascular accident within the past 6 months
10. History of continuous systematic administration of corticosteroids within 1 month
11. Requirement of simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
13. FEV1<50% of the predicted values
14. Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen
blood vessels.
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 | Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Gastric Cancer | NCT02845986 | Entailment |
1,699 | 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:
- Male or female, aged 18 to 60 years, inclusive.
- Body mass index 19.0 to 35.0 kg/m2
- Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on
the upper back in the area intended for infusion
- Free from any clinically significant abnormality on the basis of medical/medication
history or physical examination
- Vital signs and clinical laboratory parameters within normal range or, if outside
normal range, deemed not clinically significant
- Negative urine drug and alcohol screens.
Exclusion Criteria:
- Upper back pathology that could interfere with study outcome.
- History of congestive heart failure, known coronary heart disease, active or recent
pulmonary disease, or renal insufficiency.
- Rales on lung auscultation.
- Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex
recombinant
- Treatment with furosemide, benzodiazepines, or phenytoin.
- Pregnancy or breastfeeding.
- Exposure to any experimental drug within 30 days prior to study admission, or previous
participation in this study.
- Any other reason which, in the investigator's opinion, would prevent the safe
participation in the 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 60 Years | Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A) | NCT01116102 | Entailment |
2,014 | 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. aged 20 years or older
2. endoscopy indicated for reflux symptoms (heartburn, epigastric soreness and/or
regurgitation), dyspepsia (epigastric discomfort, bloating, early satiety), or
non-cardiogenic chest pain, or known or suspected to have esophageal varices,
infectious esophagitis, or other esophageal disease based on their medical history
3. a written informed consent form
Exclusion Criteria:
1. history or symptoms of severe rhinitis and sinusitis
2. symptoms of acute respiratory inflammation at the time of examination
3. abnormal anatomy of the nasal cavity or nasopharynx due to nasal tumors or previous
nasopharyngeal surgery
4. taking anticoagulants such as coumadin
5. patients for whom a EGD could not be performed
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
| A Study of Disposable Transnasal Esophagoscope | NCT01360515 | Entailment |
5,200 | 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:
- Age >50 years old
- Patient must have a diagnosis of osteoporosis on dual energy x-ray absorptiometry
(DEXA),
- Patient must have an acute or subacute single level vertebral compression fracture
between T10 - L3 as confirmed via magnetic resonance imaging (MRI) or nuclear medicine
bone scan,
- Patient must have an initial pain score of greater than or equal to five using a
standard 0-10 Visual Analog Scale subjective pain score upon initial consultation.
Exclusion Criteria:
- Pathologic compression fracture, such as due to metastatic disease
- Age >90 years old or <50 years old
- Pregnancy
- Diagnosed Anxiety Disorder
- Diagnosed Depression Disorder
- Diagnosed Psychotic Disorder
- Diagnosed Mental Disease Disorder
- Diagnosed Parkinson's disease/other movement disorders/or cerebellar dysfunction
- Eastern Cooperative Oncology Group (ECOG) score at baseline prior to compression
fracture >1
- Back Pain scores at time of initial consult <5, using a standard Visual Analog Scale
- Illicit drug dependence or abuse
- Alcohol dependence or abuse
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 100 Years | Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management | NCT04774029 | Entailment |
3,439 | 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. Written informed concent obtained
2. At the time of obtaining informed consent, Ages ranged from over 20 to 80
3. At the time of obtaining informed consent, only those with tympanic membrane
perforation in 1 ear (not both) for over 6 months (perforation in both ears is
excluded)
Exclusion Criteria:
1. TMP caused by burn or radiation therapy
2. In patients with chronic otitis media with ear drum perforation, tympanic cavity are
not dry
3. Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and
tympanic cavity
4. No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated
edge
5. History of tympanoplasty
6. A Part of the eardrum adhered to tympanic cavity
7. By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT
image of less than 12 wks before patients registration)
8. Abnormality in the chain and ear ossicles
9. Air-bone gap difference more than 25dB by patch hearing test
10. Unable to see whole edge of TMP due to narrow external auditory canal
11. Unable to wash out Ear drops during the treatment period
12. Presenting with uncontrolled diabetes (NGSP HbA1c 6.9% and more)
13. Presenting with autoimmune disease
14. History of malignancy within 3 years prior to obtained informed concent
15. Administration of immunosuppressive agent or anti-cancer-agent
16. History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray),
fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and
others
17. Though out the period from screening to treatment, patient who is unable to wash out
"Thrombolytic agent", "Anticoagulant", "Anti-platelet agent", "Procoagulant agent",
"anti-line solvent"and"aprotinin formulation"
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 80 Years | A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18 | NCT02550314 | Entailment |
260 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Age ≥18 - ≤40 years
2. Normal serum prolactin level.
3. Tubal factor of infertility.
4. Unexplained infertility.
5. BMI ≥ 30 kg/m2.
6. Estradiol (E2)>3,500 pg/ml on day of ovulation trigger.
7. Patients who underwent coasting for OHSS prevention.
8. More than 20 follicles ≥11 mm on the day of final oocyte maturation.
Exclusion criteria:
1. Contraindication of pregnancy e.g.: Somatic and mental diseases, which are
contraindications for carrying of a pregnancy and childbirth, inborn malformations or
acquired deformations of uterus cavity which make embryo implantation or carrying of a
pregnancy impossible ,ovarian tumors.
2. Severe Male factor infertility.
3. Hyperprolactinemic patients.
4. Frozen embryo transfer cycles
5. Uterine Anomalies.
6. Uterine synechia.
7. History of Genital Tuberculosis.
8. Repeated implantation failure in ICSI.
9. On medication that is known to alter prolactin levels e.g antipsychotics, Atypical
agents and risperidone
10. Thyroid dysfunction.
11. Medical disorders affecting serum prolactin eg acromegaly ,chronic renal failure and
hypothyroidism
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Effect of Cabergoline on Endometrial Vascularity During IntraCytoplasmic Sperm Injection | NCT02306564 | Contradiction |
6,180 | 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:
- Laboratory-confirmed COVID-19 infection by real-time polymerase chain reaction
(RT-PCR) assay
- Hospital admission
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
| Characteristics and Outcomes of Hospitalized Patients With COVID-19 in Spain | NCT04355871 | Contradiction |
2,778 | 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:
- men
- 18-69 years
- uni- or bilateral hernia
- ASA I-II
- Danish speaking
Exclusion Criteria:
- bad compliance
- acute operation
- daily intake of opioids
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 69 Years | Detailed Pain Pattern After Laparoscopic Inguinal Hernia Repair | NCT01105039 | Entailment |
1,086 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
1. Ages 18 - 80 years old.
2. Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained
left-ventricular hypertrophy (wall thickening) > 13 mm in any wall segment.
3. Exercise £ 30 minutes, 1 day per week for the previous 3 months.
4. Agreement to be a participant in the study protocol and willing/able to return for
follow-up.
Exclusion Criteria:
1. History of exercise-induced syncope or arrhythmias (ventricular tachycardia or
non-sustained ventricular tachycardia).
2. Medically refractory LV outflow tract obstruction being evaluated for septal reduction
therapy.
3. Less than 3 months post septal reduction therapy (surgery or catheter based
intervention).
4. Hypotensive response to exercise (> 20 mmHg drop in systolic blood pressure from peak
blood pressure to post exercise blood pressure).
5. Pregnancy.
6. ICD placement in last 3 months or scheduled.
7. Life expectancy less than 12 months.
8. Inability to exercise due to orthopedic or other non-cardiovascular limitations.
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 | Exercise Study Including Patients With Hypertrophic Cardiomyopathy | NCT01165749 | Contradiction |
174 | 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:
- Testosterone deficiency
- Normal BMI
Exclusion Criteria:
- Previous treatment with testosterone replacement therapy within 4 weeks
- Moderate-severe benign prostatic hypertrophy, or prostatic cancer
- Haematocrit >50%
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Study of 3 Doses of ARD-0403 in Testosterone Deficient Men | NCT00597051 | Entailment |
3,546 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
1. clinical diagnosis of primary adrenal insufficiency
2. Written informed consent
Exclusion Criteria:.
1. Diabetes mellitus
2. Severe cardiovascular disease
3. Active malignant disease
4. Pregnancy or breast feeding
5. treatment with interfering drugs
6. Intake of grapefruit juice
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 | Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia | NCT02096510 | Entailment |
5,827 | 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:
- Minimum of 12 months history of heartburn as the predominant symptom with at least 2
symptomatic episodes
- Negative endoscopy (no erosive lesions according to the Modified Savary-Miller scale)
within 7 days prior to acute treatment
- at least 3 days with moderate to very severe heartburn within one week prior to acute
treatment
Exclusion Criteria:
- No known gastro-duodenal ulcer
- no infections, inflammations, or obstruction of the small or large intestine
- no history of gastrointestinal cancer, or prior surgery of the stomach or intestine
- no stomach or abdominal pain or discomfort as the predominant symptom or that requires
treatment
- no history of erosive reflux causing inflammation of the esophagus
- no stricture of the esophagus, stomach, or any condition that causes difficulty in
swallowing
- no history of non-erosive reflux disease (NERD) that is or was refractory to an
adequate treatment course (1 month) with proton pump inhibitors
- no females who are pregnant or those lacking adequate contraception
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.
| A Study of Efficacy and Safety of "On-demand" Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease (NERD) | NCT00236392 | Contradiction |
2,844 | 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. Women and males over 18-year-old.
2. Good understanding of the protocol and aptitude to grant the informed assent.
3. Diagnosis of sporadic ALS, with diagnosis of certainty, that is to say, definite or
probable, in agreement with the criteria of "El Escorial", of the World Federation of
Neurology.
4. Forced vital capacity of at least 50 % of the one that would correspond to them for
sex, height and age.
5. More than 6 and less than 36 months of evolution of the disease (from the beginning of
the symptoms).
6. Possibility of obtaining, at least, 50gr of adipose tissue.
7. Treatment with riluzole, for at least, a month before the inclusion.
Exclusion Criteria:
1. Any concomitant disease that under investigator's criteria could concern the measures
of the clinical variables of the trial (hepatic, renal or cardiac insufficiency,
diabetes mellitus, etc).
2. Previous therapy with stem cells.
3. Participation in another clinical trial during 3 months previous to the entry in this
trial.
4. Any disease lymphoproliferative
5. Tracheostomy and /or gastrostomy.
6. Haemophilia, diathesis hemorrhagic or anticoagulative current therapy.
7. Hypersensitivity known to the bovine foetal whey or the gentamicin.
8. Medical precedents of infection of the HIV or any serious condition of
immunocompromised.
9. Positive HBV or HCV serology
10. Levels of creatinine in whey > 3.0 in subjects not submitted to haemodialysis.
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.
| A Multicenter Phase I/II Clinical Trial to Evaluate Safety of Mesenchymal Stem Cell in Patients With Amyotrophic Sclerosis Lateral | NCT02290886 | Entailment |
6,858 | 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:
- Parent diagnosed with Alzheimer's disease
- Age 40-72
Exclusion Criteria:
- Active liver disease
- History of adverse reaction to statins
- Contraindication to lumbar puncture
- Elevated creatine kinase and creatinine lab values
- Use of medications known to interact with statins
- History of dementia or mild cognitive impairment
- Currently pregnant or planning to become pregnant
- Use of large quantities of grapefruit juice (more than 1 quart per day)
- Contraindications to MRI (for MRI sub-study)
- Currently on cholesterol-lowering medication or use in past 4 months
- History of heart attack, heart problems, stroke and/or diabetes
- Drinking more than a quart of grapefruit juice per day
- Metal implants, or metal debris in body (MRI)
- List of medications that interact with simvastatin
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 72 Years | Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease | NCT00939822 | Contradiction |
4,699 | 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:
- Healthy
- Regular menstrual cycles
Exclusion Criteria:
- No medications affecting the menstrual cycle or sleep
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years | Impact of Sleep Disruption on the Menstrual Cycle | NCT00456222 | Entailment |
1,071 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
Men and women 18 years of age or older and less than 65 years of age.
Able to read and understand English.
HIV infected on stable ART regimen for 5 months or greater, and not likely to change
regimen for the duration of the study.
Significant dementia but able to give consent (International HIV Dementia Scale score <10).
Significant cognitive slowing on screening, defined as 1 SD below normal (t-score >60) on
the Conner's CPT-II reaction time test.
Beck Depression Inventory score <16.
Documented HIV-1 RNA PCR <50 copies/mL and documented CD4 count >200 within 3 months of
entry visit.
Baseline CBC and chemistry panel Grade 1 or normal.
For females of reproductive potential (women who have not been post-menopausal for at least
24 consecutive months, i.e., who have had menses within 24 months prior to study entry), or
women who have not undergone surgical sterilization, specifically hysterectomy or bilateral
oophorectomy or tubal ligation) will require a negative serum or urine pregnancy test
within 48 hours prior to entry.
NOTE: Subject reported history is considered acceptable documentation of hysterectomy,
bilateral oophorectomy, tubal ligation, tubal micro-inserts, menopause, and
vasectomy/azoospermia.
All subjects must agree not to participate in the conception process (e.g., active attempt
to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if
participating in sexual activity that could lead to pregnancy, the subject/partner must use
at least two reliable methods of contraception, (condoms, without a spermicidal agent; a
diaphragm or cervical cap without spermicide; an IUD; or hormone-based contraceptive), for
2 weeks before study treatment, while receiving study treatment, and for 6 weeks after
receiving study treatment.
Ability and willingness of subject to provide informed consent.
Exclusion Criteria:
Inability to give informed consent. No proxy consent allowed.
Uncontrolled hypertension (SBP >140 and DBP >90 at screening and baseline).
Untreated hypogonadism, hypothyroidism or hyperthyroidism.
Initiation of antidepressants, thyroid medication or anabolic steroids within 6 weeks of
screening visit.
Pregnancy or breast feeding.
Clinically significant EKG abnormalities at screening.
History of coronary artery disease, atherosclerotic disease, left ventricular hypertrophy,
cardiomegaly, syncope, congestive heart failure, myocardial infarction, pacemaker,
clinically significant arrhythmia, angina, history of treatment for arrhythmia.
Brain related opportunistic infections, stroke, intracranial lesions/disease, or
meningitis.
History of epilepsy.
Untreated depression.
Uncontrolled diabetes (glucose <70 or >200 at screening).
Use of interferon or ribavirin during study and for 1 month prior to screening.
History of bipolar disorder, Alzheimer's dementia, ALS, Parkinson's disease or other
medical dementias other than HIV-related.
History of schizophrenia, mania or other serious mental illness.
History of methylphenidate allergy.
Other serious concurrent medical illness other than HIV.
History of radiation therapy to the brain or brain injury.
History of crystal methamphetamine, cocaine, LSD use or other recreational substance use
other than marijuana within the 12 months prior to screening and for the duration of the
study.
Plan to use marijuana or marinol during the entire study duration and one month prior to
screening visit.
Plan to drink 7 or more alcoholic drinks per week during the 4 weeks prior to screen visit
and for the duration of the study.
History of alcohol dependence, alcohol abuse, cocaine addiction, crystal methamphetamine
addiction or other recreational drug addiction or treatment for addiction or dependence
within 5 years of screening visit.
If subject is using prescription narcotics, should be on a stable dose for at least 1 month
prior to screening and throughout the study.
Previous use of Concerta™, Ritalin™, atomexitine or Adderall™ or other psychostimulants
(e.g. modafinil, armodafinil) for 3 months prior to screening visit and for duration of the
study.
History of tic disorders in the past 3 months or any history of Tourette's syndrome.
Greater than 10% below ideal body weight (IBW for men = 50 kg + 2.3 kg per inch over 5 feet
of height, and IBW for women = 45.5 kg + 2.3 kg per inch over 5 feet of height)
Uncontrolled migraine headaches.
History of short gut syndrome, Meckel's diverticulum, or cystic fibrosis.
Family history of sudden cardiac death in a young relative.
History of fainting with exercise.
History of attention deficit disorder will be excluded, defined as a score greater than 6
on the Childhood ADHD Symptoms Scale.
-
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 64 Years | A Study Comparing Long-acting Methylphenidate (ConcertaTM) vs. Placebo in the Treatment of Memory Loss Due to HIV | NCT01599975 | Contradiction |
1,924 | 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. Histologically confirmed gastric adenocarcinoma
2. Patients were diagnosed during 2006-2013
3. HER2 expression status was evaluated in primary gastric cancer or metastatic lesion.
Exclusion Criteria:
- Patients with second primary cancer within 5 years
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Investigation of the Proportion of Human Epidermal Growth Factor Receptor 2 Protein Overexpression of Gastric Adenocarcinoma and Prognostic Effect of HER2, and Analysis of Practice Pattern of Herceptin Use in Stage IV Gastric Cancer | NCT02136836 | Entailment |
4,339 | 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:
- Signed informed consent
- Medical examination carried out before the participation in the research
- Age between 18 and 55 years
- Minimum level of studies
- Obligation to join the social security system
- normal or corrected vision normal
Exclusion Criteria:
- Subject included in another clinical and / or therapeutic experimentation in progress
- Major vision disorder
- Past or current neurological or neuropsychiatric pathologies
- History of cranial trauma with loss of consciousness.
- Medication treatments likely to modulate brain activity: benzodiazepine,
antidepressants, neuroleptics, lithium, etc.
- Diabetes, cardiac pathology, immunodeficiency.
- Medication treatments likely to modulate the activity of the cardiovascular system.
- History of abuse or recent ingestion of alcohol, hard drugs or doping products.
- Consumption of more than 15 cigarettes per day
- Subject deprived of liberty by a judicial or administrative decision (L1121-6 CSP)
- Major subject subject to a legal protection measure or unable to express their consent
(L1121-8 CSP)
- Pregnant, parturient and nursing mothers (L1121-5)
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 55 Years | Multistability: Perception is Inspired by Noise | NCT03723044 | Entailment |
5,245 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal women
- More than one day of follow up
- Dietary information on soft drinks
Exclusion Criteria:
Previous hip fracture
Female
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 79 Years | Soft Drinks and Osteoporosis in WHI Participants | NCT03371433 | Entailment |
4,764 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
- 18 years of age or older at time of surgery
- The poorer ear (implant ear) will have a severe-to-profound hearing loss and meet
current cochlear implant candidacy criteria.
- The better ear (contralateral ear) will have hearing levels less than current cochlear
implant candidacy criteria and stable/non-fluctuating hearing levels for at least the
previous year
- Normal/patent cochlear anatomy
- Fluent in English
- Desire to have more functional binaural hearing and willingness to comply with all of
the study requirements
Exclusion Criteria:
- Medical or psychological conditions that contraindicate undergoing surgery
- Additional handicaps that would prevent or restrict participation in the audiological
evaluations
- Ossification or any other cochlear anomaly that might prevent complete insertion of
the electrode array
- Hearing loss of neural or central origin, including auditory neuropathy
- Chronic and severe tinnitus in the ear to be implanted
- Unwillingness or inability to comply with all investigational requirements
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.
| Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss | NCT02004535 | Entailment |
5,582 | 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 aged 7 to 18 years
- BMI > 85 percentile
- Signed informed consent
Exclusion Criteria:
- Overweight / obesity secondary to genetic syndromes and/or endocrine diseases
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 7 Years old.
Subject must be at most 18 Years | The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children | NCT01673152 | Contradiction |
3,269 | 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:
- Diagnosed with primary Sjögren's syndrome
Exclusion Criteria:
- Having neurological and cognitive disorders,
- Having another rheumatological diseases
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Reliability, Validity of the Turkish Version of the Primary Sjögren Syndrome Quality of Life (PSS-QoL) Questionnaire | NCT04858464 | Entailment |
3,332 | 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 for normal-hearing participants :
- consenting to and available for the study
- age ≥ 18 years and ≤ 25 years
- right-handed
- native French speaker
- pure-tone air-conduction audiometric thresholds at .5, 1, 2, and 4 kHz all ≤ 20 dB
hearing loss (HL)
Exclusion criteria for normal-hearing participants :
- score at the Tinnitus Handicap Inventory > 56
- uncorrected visual impairment
- pregnancy
- subject placed under legal authority (guardianship, tutorship)
Inclusion criteria for hearing-impaired participants :
- consenting to and available for the study
- age ≥ 55 years
- native French speaker
- pure-tone air-conduction average hearing thresholds (PTA) for frequencies of .5, 1, 2,
and 4 kHz ≥ 30 dB HL and ≤ 70 dB HL
- right-ear PTA for low frequencies (< 2 kHz) lower than the right-ear PTA for high
frequencies (> 4 kHz). The difference between the two PTAs must be ≥ 20 dB
- the difference between the PTA for frequencies of .5, 1, 2, and 4 kHz (PTA.5-4kHz) in
the right ear and the left-ear PTA.5-4kHz must be ≤ 10 dB
Exclusion criteria for hearing-impaired participants :
- score at the Tinnitus Handicap Inventory > 56
- history of a hearing impairment that was left uncorrected for more than 10 years
- uncorrected visual impairment
- congenital hearing impairment
- Ménière's disease
- auditory neuropathy
- mixed hearing loss
- fluctuating hearing impairment
- sudden hearing loss
- hearing impairment concomitant with other symptoms (e.g. vertigo)
- score at the Montreal Cognitive Assessment (MoCA) < 27
- subject placed under legal authority (guardianship, tutorship)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons | NCT04775810 | Contradiction |
798 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Age of eighteen or older
- Diagnosis of symptomatic knee osteoarthritis
- Radiographic evidence of knee osteoarthritis. Note: For the purposes of this study,
radiographic evidence of knee osteoarthritis is defined as any one or more of the
following: osteophytes, joint space narrowing, loss of articular cartilage thickness,
subchondral sclerosis or cysts.
Exclusion Criteria:
- History of treatment with any intra-articular knee injection
- Current ligament instability as demonstrated by a positive Lachman Test, Anterior or
Posterior Drawer Test, or positive Valgus or Varus Stress Test.
- Known allergy to lidocaine
- Under 18 years of age
- Pregnant women
- Prisoners
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Efficacy of Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis. | NCT03379168 | Entailment |
5,254 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal women or men aged 50 years or older
Conform to the diagnosis of osteoporosis or osteopenia as followings:
1. Bone mineral density measured by dual-energy X-ray absorptiometry show a T-score ≤
-1.0 at neck of femur or total hip or lumber 1-4 OR
2. Have at least once major osteoporotic fracture
Exclusion Criteria:
- Screened people who do not meet the inclusion criteria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| A Tiered Management System of Osteoporosis in China | NCT03916289 | Entailment |
Subsets and Splits