cyrilzakka/clinical-trials huggingface dataset:
Duration of Brace Wear in Clubfoot Treatment - A Prospective Randomized Trial

The goal of this multi-center, randomized, controlled trial is to evaluate the effectiveness of a 2 year versus 4 year bracing protocol in preventing isolated clubfoot recurrence within the first year post-treatment, and to evaluate factors associated with recurrence in isolated clubfoot.

The study is based on the hypothesis that prolonged bracing will reduce clubfoot recurrence. In addition to bracing length, the study will determine if other factors in addition to duration of brace wear are associated with recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Subject \< 1 year of age when treatment initiated at local site
* Confirmed diagnosis of Isolated Clubfoot
* At least one foot demonstrates fixation of the foot in equinus, forefoot adduction, cavus and hindfoot varus
* Deformity was present at birth

Exclusion Criteria:

* Previous foot abduction bracing
* Previous surgical correction (excluding Tenotomy)
* Dysmorphic features, additional anomalies (i.e. congenital heart disease, hypospadias, a genetic syndrome), or developmental delay
* Neurologic cause for clubfoot (i.e. myelomeningocele or sacral agenesis)
Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.

A pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender aged 50 years or older with high risk intermediate AMD defined as the following criteria:

\>4 areas of at least iRORA or iORA (incomplete RPE and outer retinal atrophy and incomplete outer retinal atrophy).

1 area of cRORA + 2 \> areas of iRORA. \< 1 mm2 of cRORA (complete RPE and outer retinal atrophy). No exudative neovascular AMD.

Exclusion Criteria:

Best corrected visual acuity in the study eye less than 20/400 by ETDRS. Not ability to provide written informed consent. Not ability to return for all trial visits. if subject cannot attend all trial required visits. GA secondary to any condition other than specified. Any ocular condition in the study eye that would progress during the study that could affect central vision or otherwise be a confounding factor.

Concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina or optic nerve. Anti -VEGF therapy is allowed in Cohort B.

Presence of intraocular inflammation (≥ trace cell or flare), macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-retinal traction maculopathy, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an exclusion criteria).

Presence of idiopathic or autoimmune-associated uveitis in either eye. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, fundus photography or fundus autofluorescence. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the following year.

Any intraocular surgery or thermal laser within three (3) months of trial entry.

Any prior thermal laser in the macular region, regardless of indication. History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.

Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.

Pregnant or nursing women. Additionally, women with childbearing potential must be using at least two effective contraception methods.
Predicting Medication Response for Autoimmune Disease

Coral is conducting a large study comparing and predicting the relative effectiveness of different medications for autoimmune patients.

Patients with Inflammatory Bowel Disease (IBD) who have been diagnosed with either Ulcerative Colitis or Crohn's Disease and are undergoing treatment are eligible to participate.

Patients with Rheumatoid Arthritis (RA) and Psoriasis (Ps) will also be enrolled.

A novel clinical test will be performed to predict the responsiveness of a particular patient to different immune modulating therapies used in these conditions.


Eligibility Criteria:
Inclusion Criteria:

* Ulcerative Colitis, Crohn's Disease, Rheumatoid Arthritis, Psoriasis diagnosis
* On or about to begin a treatment for condition above
Low Fructose Diet in Diabetes Type 2

Diabetes is one of the most common and chronic diseases in the world, with the prevalence and incidence of this disease rising in most societies, especially in Iran. Suitable treatments for type 2 diabetes include changing lifestyle with exercise, nutrition, and drug use. New research suggests that added sugar, especially fructose, is the main trigger for diabetes and pre-diabetes even more potent than other carbohydrates. Fructose has a low glycemic index (23μg =) and slowly increases blood glucose levels. Therefore, it is thought that replacing fructose instead of glucose can have a positive effect on glycemic control of diabetic patients..


Eligibility Criteria:
Inclusion Criteria:

1. Age of 70-40 years
2. body mass index(BMI) between 18.5 and 27
3. Type 2 diabetes People who only control their diabetes by using glucose lowering tablets Type 2 diabetes (1 to 10 years)

Exclusion Criteria:

1. Pregnancy and lactation
2. Thyroid gland disorders
3. Kidney disease and inflammation
4. Follow the weight loss regimen 6 months before starting the study
5. Usage of fatty and fatty foods, fiber powder Vitamin A Mineral Supplements, Omega 3
6. Taking glucocorticoid drugs and non-steroidal anti-inflammatory drugs
Vitamin D Production Levels Achieved by Sunbed Tanning

Health Canada's Radiation Emitting Devices (RED) Act provides exposure time guidelines for sunbed use. These guidelines are intended to protect sunbed users from overexposure to UV radiation. Overexposure is defined as "exposure that exceeds the amount needed for vitamin D production and could lead to skin or eye damage. Acute overexposure induces sunburn." However, the effect of the recommended time exposure schedule on serum 25(OH)D response has not been characterized. Further, it is unknown if the maximum time exposures are required to reach and/or maintain optimal 25(OH)D levels. The aim of the current study is to characterize serum 25(OH)D response to regular sunbed use following the time exposure schedule recommended by Health Canada.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older, male or female

Exclusion Criteria:

* History of skin cancer, granulomatous disease, liver disease, or kidney disease
* Photosensitive medications
* Pregnancy
* Vitamin D supplementation within last 60 days
* Sunbed use within last 60 days
* Planned travel to sunny destination during study period (January to April 2014)
A Causal Relationship Study Between Anxiety, Depression, and Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic chronic inflammatory disease, and depression and anxiety are among the most common comorbidities in RA patients, with a high prevalence rate. Epidemiological studies have found that joint deformities, severe pain, positive serum RF titers, as well as comorbidities such as hypertension, insomnia, pain, and fatigue are significantly associated with depression and anxiety in RA patients.

Currently, clinical studies have found that the relief of depression or anxiety is one of the expected treatment goals for RA patients. Due to the unclear pathogenic factors of depression or anxiety in RA patients, there is a lack of effective clinical treatment options. Therefore, this study will use a "causal inference model" to identify possible "mediating variables" that may lead to the comorbidity of RA and emotional disorders through clinical investigation, aiming to improve the precision of treatment for physicians.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with RA.

Exclusion Criteria:

* Patients diagnosed as non-RA.
Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19

The purpose of this study is to determine whether hydroxychloroquine is an effective prophylactic regimen to prevent SARS-CoV-2 infection among healthcare workers. Participants will be randomized into two parallel groups. The first arm will evaluate the use of hydroxychloroquine every-other-day plus standard measures of protection for the prevention of SARS-CoV-2. The second arm will evaluate the use of standard measures of protection for the prevention of SARS-CoV-2. The target enrollment is 320 participants. Each study participant will be monitored for SARS-CoV-2 seroconversion in weekly visits or for the development of COVID-19 symptoms for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Healthcare workers in service during the COVID-19 outbreak including medical, nurse, technical, and auxiliary staff.
2. Negative rapid serologic and molecular testing for SARS-CoV-2.
3. Written informed consent.

Exclusion Criteria:

1. Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell, and taste.
2. Prior (last 30 days), current or planned use (during study period) of hydroxychloroquine, chloroquine sulfate, or azithromycin.
3. Known cardiac disease or a history of prolonged QT syndrome.
4. Known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate.
5. Use of concomitant medications that are contraindicated with the use of hydroxychloroquine.
6. Other reported medical conditions, such as glucose-6-phosphate dehydrogenase deficiency, hepatic or renal insufficiency, or visual acuity or field disturbances, that make study participation not in the individual's best interest.
Coronavirus-19 (COVID-19) and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)

This is a prospective, observational study with a primary objective of determining the incidence of non-severe and severe COVID-19, including MIS-C, among eligible children who are diagnosed with COVID-19 and consent (or assent) to collection of data on risk factors using a unique direct-to-participant, direct-to-family, and direct-to-community approach. Secondary and exploratory objectives include risk factors of severe disease and quality of life (QoL).


Eligibility Criteria:
Inclusion Criteria:

* Participant is ≤ 21 years of age at time of enrollment
* Participant or their parent/guardian has downloaded the "ABC Science" App from the App store as a part of the ABC Science Collaborative (Pro00107785) and has agreed to the App's Terms of Use
* Participant has a positive COVID-19 diagnosis, defined as one or more of the following:

  1. A positive COVID-19 test; or
  2. Clinical diagnosis of COVID-19 based on symptoms, as documented by a medical provider, in the absence of a positive influenza test; or
  3. Retrograde diagnosis based on presence of COVID-19 antibodies

Exclusion Criteria:

* N/A
The Norwegian Cervical Arthroplasty Trial

The study will compare cervical arthroplasty with cervical discectomy and fusion, in the treatment of cervical radiculopathy. The 0-hypothesis is that there is no difference between the two methods, when comparing primary and secondary outcome variables.

Anterior discectomy and fusion (ACDF) is in Norway currently the most common operative method against cervical radiculopathy, caused by disc herniation and/or spondylosis. In the last decade cervical arthroplasty has emerged as a new alternative operative method. Arthroplasty is claimed to preserve the natural motion of the spine, thereby preventing adjacent level disc disease and providing better clinical results. However, this hypothesis has not yet been adequately proven. In our study, we will prove if there is any real difference in terms of clinical effect between cervical arthroplasty and ACDF.We will also compare the overall costs of the two methods, including cost-utility analyses. Moreover, we will study the development of adjacent level disease by use of MRI scans, and analyze cervical spine motion and disc height by use of Distortion Compensated Roentgen Analysis (DCRA).

Eligibility Criteria:
Inclusion Criteria:

* Age 25 - 60 years
* Clinical C6 or C7 root radiculopathy with corresponding radiologic findings with or without neurological symptoms
* Mechanical provoked pain which aggravate with physical activity or positive Spurling test
* Radiological nerve root compression on the basis of disc herniation or spondylosis
* NDI =/\> 30 percent
* The patient has not responded to non-operative treatment and shown no sign of improvement during the last 6 weeks

Exclusion Criteria:

* Significant spondylosis involving more than one level
* Intramedullary changes on MRI
* Ankylosis at adjacent level
* Clinical suspicion of myelopathy
* Chronic generalised pain syndrome
* Infection
* Active cancer
* Rheumatoid arthritis involving the cervical spine
* Previous trauma involving the cervical spine
* Pregnancy
* Allergy against contents in cage/artificial disc
* Previous neck surgery
* Psychological or somatic illness that causes the patient not to be suitable for the study
* The patient does not understand Norwegian orally or in writing.
* Abuse of medication/narcotics
The Influence of Ageing on Muscle Quality

The purpose of the present study is to evaluate the influence of the ageing process on muscle quality. Therefore, muscle mass, muscle density and force-velocity characteristics are measured after a 5-yr interval in older adults (65+).


Eligibility Criteria:
Inclusion Criteria:

* male, +65 years
* participation in previous study "De effecten van oefenprogramma's op gezondheids- en fitheidsgerelateerde parameters in een groep van 60-plussers"
* able to perform a maximal strength test on a dynamometer

Exclusion Criteria:

* pathologies that prohibit a maximal strength test on a dynamometer
A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome

This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group study designed to evaluate the effects of RO5459072 treatment on disease activity and symptoms of Sjogren's syndrome in adult participants with moderate to severe primary Sjogren's syndrome. The total duration of the study for each participant will be approximately 18 weeks (including screening).


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of primary Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
* ESSDAI score greater than or equal to (\>/=) 5
* ESSPRI score \>/=5
* Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening
* Negative pregnancy test at screening and baseline (for women only)
* Willing to comply with the study procedures and restrictions, including measures to prevent pregnancy and restrictions on sperm donation

Exclusion Criteria:

* A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria
* Severe complications of Sjogren's syndrome
* Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy within 6 months prior to the screening visit
* Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day
* A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal, yeast or bacterial infection at screening
* A history suggesting reduced immune function or any other conditions predisposing participants to serious infection
* A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance (MGUS), or any other malignancies within the past 5 years
* A diagnosis of fibromyalgia or significant depression
* Having any concomitant disease or condition that could interfere with the conduct of the study, or that would pose an unacceptable risk to the individual
* Participation in an investigational drug or device study within 3 months prior to screening
* Inability to comply with the study protocol for any other reason
* Women who are lactating, breastfeeding or planning to nurse
* Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein \[P-gp\]; sensitive substrates of CYP3A4 with a narrow therapeutic index)
Pain Measurement in Healthy Volunteers

This study will attempt to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in patients.

Normal healthy volunteers and dental patients undergoing third molar extraction may be eligible for this study. Participants will undergo the following procedures:

Volunteers: Volunteers will participate in two 90-minute sessions in which they will receive and rate four heat stimuli per minute applied to the skin for a maximum of 36 minutes. The heat stimuli range from 37° (Degree)C to 51° (Degree)C (99° (Degree) F to 124° (Degree) F) and last 2 to 3 seconds. A drug commonly used in dental treatments may be administered during the second session. This will be either a maximum of 0.15 mg fentanyl, a short-acting narcotic pain killer, or a maximum of 5 mg saline, an inactive substance (placebo).

Dental patients: Dental patients will participate in two 60-minute sessions. The first session will be on the day before the third molar extraction, and the second session will be immediately before the dental procedure. The heat stimulus procedure will be identical to that described above for normal healthy volunteers.

Mismanaged pain is still a major medical problem. Many pain syndromes have no effective treatment, and many are managed poorly. Basic and applied research on pain treatment is hampered by the unobservable nature of pain sensation and the lack of validated measures of this perception.

The purpose of this protocol is to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in clinical populations. Normal volunteers rate experimentally-evoked pain sensations before and after double-blind administration of the opioid fentanyl or saline placebo. Patients rate experimentally-evoked pain sensations without any drug administration.

Eligibility Criteria:
Normal Volunteers, including NIH employees, will serve as subjects.

No subjects with any painful disease or diseases in which altered pain sensitivity is suspected.

No subjects will be included with poor general health, history of significant illness, history of psychotic disorder or recent emotional distress, serious heart, lung, or liver disease, or pregnancy.

Subjects also will be excluded on the basis of history of allergy to any of the medications, history of chronic or recent drug use that may alter pain response, or chronic drug abuse.
Parental Attitudes to Neoanus Dilatations Post-reconstruction in Anorectal Malformations

The goal of this qualitative clinical trial is to learn about parental attitudes and experiences of performing post-operative dilatation anal dilatations for their child with an anorectal malformation. The main question it aims to answer are:

1. What are parental experiences/attitudes towards performing anal dilatations post-operatively.

In the first part of the study, participants will take part in a small virtual focus group discussion to identify themes to aid design of a semi-structured interview for part 2. In part 2, participants will undergo a virtual semi-structured interview. The answers will be recorded, anonymised, transcribed and undergo thematic analysis.

Babies born without an anal opening require reconstructive surgery to create one, allowing them to pass stools. After the procedure, some surgeons recommend that parents perform routine dilatation of the anal opening using a metal rod dilator called a Hegar dilator. Recent studies have shown no difference in clinical outcomes for patients who have routine anal dilatation and those who do not. This study will look to find out the parental experiences and attitudes towards performing anal dilatation for their child.

The study will be formed of 2 parts. Participants will all be parents who were asked to perform routine anal dilatation post-operatively for their child born with an anorectal malformation. In part 1, a focus group will be conducted via Microsoft teams to ascertain themes to formulate the questions for part 2. In part 2, individual semi-structured interviews will be performed via MS teams. The interviews will be recorded, anonymised, transcribed and undergo analysis to assess for common themes.

The results will be published to guide professionals with regards to best practice and help inform parental discussions for new patients.

Eligibility Criteria:
Inclusion Criteria:

The parent of any patient who has:

* Undergone a posterior sagittal anorectoplasty for anorectal malformation and been recommended post-operative anal dilatations
* AND operation performed prior to November 2020
* AND able to understand and communicate in English
* AND with access to a mobile/computer with MS Teams

Exclusion Criteria:

The parent of any patient who had has:

* NOT undergone a posterior sagittal anorectoplasty for anorectal malformation
* AND/OR, NOT been recommended post-operative anal dilatations
* OR operated on after to November 2020
* OR unable to understand and communicate in English
* OR without access to a mobile/computer with access to MS Teams
Favipiravir Therapy in Adults With Mild COVID-19

Favipiravir is a selective and potent inhibitor of inﬂuenza viral RNA polymerase. It acts as a purine analogue, which selectively inhibits viral RNA-dependent RNA polymerase (RdRps). It has the characteristic of acting on RNA viruses including Ebola and Coronaviruses especially novel coronavirus (2019-nCoV). The purpose of this study is to evaluate the clinical efficacy and safety of Favipiravir in comparison to placebo in the treatment of mild COVID-19 cases. It is a Multicenter, randomized double-blinded, parallel-group trial.


Eligibility Criteria:
Inclusion Criteria

Patients must be eligible according to the following criteria for enrollment

1. Should be at least 18 years of age
2. Male or non-pregnant female (pregnancy testing is not mandatory. If the patient requests or is not sure, the study team will provide it)
3. Diagnosed with mild COVID-19\* confirmed by positive PCR test for SARS-CoV-2 at the time of recruitment, a result within the last five days
4. Patients have to be enrolled within 5 days of disease onset.

Exclusion criteria

Patients meeting any of the following criteria will be excluded from trial enrolment:

1. Patients with concomitant documented bacterial pneumonia established through positive sputum cultures
2. Patients who are pregnant or breastfeeding
3. Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the patient previously for influenza)
4. Major comorbidities increasing the risk of study drug including

   * Hematologic malignancy
   * Advanced (stage 4-5) chronic kidney disease or dialysis therapy
   * Severe liver damage (Child-Pugh score C, AST\> 5 times the upper limit)
   * HIV
   * Gout/history of Gout or hyperuricemia (two times above the ULN)

(6) Having used Favipiravir or participated in any other interventional drug clinical study within 30 days before the first dose of study drug (i.e., the patient received it for influenza previously) (7) The investigator believes that participating in the trial is not in the best interests of the patient, or the investigator considers unsuitable for enrollment (such as unpredictable risks or subject compliance issues) (8) Clinical prognostic non-survival, palliative care, or in a deep coma and have no response to supportive treatment within three hours of admission.

(9) Hospitalized patients for mild, moderate, or severe COVID-19