cyrilzakka/clinical-trials huggingface dataset:
Testing a New Therapy for Trichotillomania

This study will test the effectiveness of a new behavioral therapy for adults with trichotillomania (compulsive hair pulling).

Trichotillomania (TTM) is a disorder in which people compulsively pull out their own hair. Treatments for TTM sometimes do not have long-term effectiveness. Acceptance and commitment therapy (ACT) is a therapeutic approach thought to have longer lasting effects than standard cognitive behavioral therapy (CBT) approaches, because ACT focuses on accepting thoughts and behaviors as opposed to changing them. Previous research indicates that a combination of ACT and habit reversal behavioral therapy is more effective than no treatment. This study will test whether a combination of ACT and behavioral therapy, called acceptance enhanced behavioral therapy (AEBT), is more effective than the current standard treatment for TTM.

Participation in this study will last 12 weeks, and follow-up assessments will last for 6 months. At study entry, participants will complete a brief intelligence test and an in-person interview about their medical history, psychiatric history, and hair pulling. At their second visit, participants will have digital pictures taken of their hair-pulling sites and complete two computer tasks measuring their response inhibition and cognitive flexibility. After the second visit, participants will be randomly assigned to receive either AEBT or psychoeducation and supportive therapy (PST)-a standard treatment for TTM. Both treatments will involve ten 1-hour sessions completed over 12 weeks. Assessments of participants will occur after 6 weeks of treatment, at treatment completion, and after 6 months. These assessments will measure treatment effectiveness, based on several clinical scales and measures of TTM symptoms. Participants who receive PST during this study will be offered AEBT afterward.

Eligibility Criteria:
Inclusion Criteria:

* Current DSM-IV diagnosis of trichotillomania
* Massachusetts General Hospital Hair Scale score greater than 12
* Wechsler Test of Adult Reading score greater than 85
* Fluent in English
* Outpatient status
* Agreement to not alter the dosage of any psychotropic medication throughout the course of the study, or, if such a dosage change is required, understanding that the participant will continue to receive treatment, and data will continue to be collected on him or her
* Individuals who eat their hair after pulling will be eligible for participation only after they have received a physical exam from their primary care physician to determine whether there is any gastrointestinal blockage due to hair pulling, which would require more immediate clinical care.

Exclusion Criteria:

* Diagnosis of bipolar disorder, psychotic disorder, mental retardation, pervasive developmental disorder, or current substance dependence (with the exception of nicotine dependence)
* Current mood or anxiety disorder with an active suicide risk
* Currently receiving psychotherapy for trichotillomania or another psychiatric condition
* Initiation or change in the dosage of any psychotropic medication for up to 8 weeks preceding participation in the study
Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is characterized by the progressive increase in pulmonary vascular resistance leading to shortness of breath and exercise intolerance. Exercise capacity has been used as the primary endpoint in most recent randomized controlled trials evaluating PAH-specific therapies as it correlates with functional class and survival in PAH. Exercise test is commonly assessed by the six-minute walk test (6MWT). However, there is commonly some discrepancy between significant clinical improvement and minor changes (generally \<10% from baseline) in 6WMT following therapy. Because important clinical decisions are based on patients' functional capacity, a reproducible and sensitive exercise test is needed in PAH. The aim of this study was to compare the reproducibility and the responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance test (CET) following pharmacological therapy in this disease.


Eligibility Criteria:
Inclusion Criteria:

* WHO functional class II or III
* Idiopathic PAH, familial PAH, or associated PAH due to connective tissue disease patients
* Mean pulmonary artery pressure ≥25 mmHg at rest
* Pulmonary capillary wedge pressure ≤15 mmHg

Exclusion Criteria:

* Prior use of phosphodiesterase type-5 inhibitors
* Unstable clinical condition over the last 4 months
* Recent syncope
* WHO functional class IV
* Left ventricular ejection fraction \<40%
* Restrictive or obstructive lung disease
* Intrinsic musculoskeletal abnormality precluding exercise testing
* Patients with a pacemaker
* Treatment with systemic corticosteroids
Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry

We examine patients with different autonomic neuropathies and Ehlers Danlos syndromes compared to healthy controls at three different points over time (baseline, after 3 months and after 1.5 years) to gain knowledge about the course of this disease and understand its pathophysiology, with a focus on Small Fiber neuropathy. Moreover we will validate the german version of the Malmö POTS Score and establish an easy diagnostic scheme for patients in outpatient care.

Inclusion of patients with autoimmune autonomic neuropathies/ pure autonomic failure, postural orthostatic tachycardia syndrome, small fiber neuropathies, Ehlers-Danlos syndromes, Mast cell activation syndrom, Chronic fatigue syndrome and PostCOVID syndrome in our Registry study with follow up visits. Comparison to healthy controls concerning selected examinations.

Planned examinations are laboratory tests, questionnaires on mental and physical health status and circulatory disorders, attention tests, tilt table testing, standing test, sweat function, investigation of small fiber function via quantitative sensory testing as well as the density of nerve fibers in the skin. Measurements are performed at baseline mostly in clinical routine and follow up visits are offered.

Eligibility Criteria:
Inclusion Criteria:

* autonomic neuropathy
* Postural orthostatic tachycardia syndrome
* hypermobile or classical Ehlers Danlos syndromes
* Chronic fatigue syndrome, mast cell activation syndrome and/or PostCOVID
* healty controls
* between 18-80 years
* in patients: diagnosis and clinical testing in our outpatient clinic
* German speaking

Exclusion Criteria:

* pregnancy
* Pacemaker or Deep brain Stimulation
* sensory or motor Polyneuropathy
* neurodegenerative disease
Niclosamide With Etanercept in Rheumatoid Arthritis

Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis

In this randomized double blind placebo-controlled pilot study (Phase I study) we will assess the efficacy and safety of adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with RA, as defined by the American College of Rheumatology (ACR) 1987 revised criteria or ACR/EULAR 2010,
* Severly Active RA by calculating either DAS28 or SDAI or CDAI.
* Patient selected are those who started etanercept for less than 3months and still active.

Exclusion Criteria:

* Patients on nonsteroidal anti-inflammatory drugs (NSAID) 2 days before entry into this study. or methotrexate (MTX)..
* Patients with hypersensitivity or severe adverse effects to niclosamide .
* Renal impairment.
* Hepatic impairment.
* Pregnancy or a desire to become pregnant.
* Breast feeding.
* Patients with Juvenile RA \[16 years old or younger\].
* Patients using other conventional disease modifying antirheumatic drugs (DMARDs).
* Patients on steroid.
* Patients with coexistence other connective tissue diseases or hypothyroid disease.
* Patient with mild or inactive RA.
Optimizing the Treatment Strategy for Age-related Macular Degeneration

The purpose of this study is to compare two different treatment protocols for wet macular degeneration; the new protocol called "Observe and Plan" against the current standard protocol "Treat and Extend". Studies suggest that patients achieve equally good visual acuity with fewer controls and that they are more satisfied with the new protocol.

The purpose of the study is to test a new treatment protocol for wet macular degeneration, called "Observe and Plan", against today's standard protocol "Treat and Extend". Studies suggest that the individual treatment interval can be achieved earlier with "Observe-and-Plan" and that a proportion of patients do not need more than 3 injections, ie the loading dose. The other advantages seem to be that patients achieve good visual acuity with fewer controls and are more satisfied with the new protocol, which will be beneficial to both patients and health care. To our knowledge, no randomized controlled trial has tested this before.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed age-related macular degeneration according to criteria.
* new diagnose of active CNV verified with OCTA or FA / ICGA.
* BCVA ≥ 20/200 measured with ETDRS visual acuity chart
* written informed consent

Exclusion Criteria:

* Eyes formerly treated with anti-VEGF, photodynamic therapy, radiation therapy, transpupillary thermotherapy or focal laser photocoagulation involving the macular area.
* Geographic atrophy and subretinal fibrosis affecting the patient's visual acuity.
* Any other ongoing eye disease that influences patient's visual acuity, such as glaucoma with central vision loss, proliferative diabetic retinopathy, diabetic macular edema or chronic uveitis.
Arrhythmias in Patients With COVID-19

The study is a prospective clinical cohort study of consecutive patients hospitalized at all hospitals of greater Copenhagen with a laboratory confirmed diagnosis of COVID-19. The investigators aim to examine if continuous ECG monitoring can be used to understand the contribution of COVID-19 infection in the acute phase to the development of cardiac arrhythmias, especially focusing on cardiovascular outcomes. In all patients included, the investigators aim to examine if continuous ECG monitoring - alone and in combination with biomarkers - can be used to detect early signs of cardiac complications and predict long-term risk of cardiovascular morbidity and mortality following COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized at hospitals of greater Copenhagen area and Zealand with a laboratory confirmed diagnosis of COVID-19 \> 18 years of age.

Exclusion Criteria:

* Persons not able to cooperate
* Persons unable to understand and sign "informed consent"
Natural History Study of Patients With Centronuclear Myopathies

This is a prospective, longitudinal study of the natural disease course intended to recruit approximately 60 patients with centronuclear myopathies (CNM) in Europe and the United States. The duration of the study, including the enrollment period, will be approximately 4 years. Data from the study will be used to characterize the natural disease course of CNM, to identify prognostic variables of the disease and to determine the best outcome measure(s) for the evaluation of future therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

* 1. Clinically symptomatic male or female subjects of all ages (newborns included) with a CNM resulting from a documented mutation in the MTM1 or DNM2 gene.
* 2. A written, signed and dated informed consent must be provided to participate in the study. For subjects \<18 years, consent of parent(s)/legal guardian(s) is required; informed assent can be obtained from the child according to local regulations.
* 3. Willing and able to comply with all protocol requirements and procedures.

Exclusion Criteria:

* 1. Participation in any other interventional study. Participation in a previous study should be completed at least 4 weeks before the first study visit.
* 2. Currently undergoing or has undergone previous gene therapy or other therapy for CNM.
* 3. Current or past abuse of alcohol or recreational/narcotic drugs (with the exception of caffeine and nicotine), which in the investigator's opinion would compromise the subject's safety and/or compliance with the study procedures.
* 4. Current or relevant history of physical or psychiatric illness, that would make the subject unlikely to comply with the study procedures. (Note: Subjects in a wheelchair are not to be excluded).
* 5. Subject is mentally incapacitated, or parent(s)/legally-authorized representative are legally incapacitated or have limited legal capacity, or have lack of mental capacity to fully understand the protocol requirements and complete all study required procedures.
Gender in Face-Voice Integration

Bayesian models of perception represent a promising approach to describe information processing by the brain. Predictive coding hypothesizes a process in which top-down expectations are continuously compared across multiple hierarchical levels with bottom-up sensory inputs and the differences or error signals are propagated in a bottom-up direction. The investigators hypothesize that strong expectations, are best investigated in expert processes such as face and voice recognition in humans. Individuals in complex social systems need to extract socially relevant information in a fast and efficient manner; hence, the majority of humans constitute face, voice and gender experts. Nevertheless, linking such combined abilities to brain activity with regards to the predictive coding hypothesis has not been attempted.Our results suggest asymmetric contributions of visual and auditory signals to the gender classification task. This sensitive psychophysical procedure is implemented in a decoding approach using fMRI and multi-voxel pattern analysis (MVPA). The investigators plan to test whether cortical areas implicated in processing auditory and visual gender signals show similar asymmetries.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women, right-handed
* No neurological antecedent
* Signed informed consent

Exclusion Criteria:

* Pregnant women
* Volunteers with MRI contraindications: persons using a pacemaker or insulin pump, persons with a metallic prosthesis or an intracerebral clip, as well as claustrophobic subjects, neurosensory stimulator or implantable defibrillator, cochlear implants, body Foreign ferromagnetic ocular or cerebral close to nerve structures, agitation of the subject (non-cooperating or agitated subjects), ventriculoperitoneal neurosurgical bypass valves, dental apparatus.
* Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty, as well as persons of legal age protected by law.
* Participants refusing to be informed of the results of the medical examination (inclusion).
* Participants refusing to be informed of the possible detection of an anomaly.
Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).

This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US

Eligibility Criteria:
Inclusion Criteria:

1. Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logarithm of the Minimum Angle of Resolution (logMAR) or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
2. Have a documented history of DED in both eyes supported by a previous clinical diagnosis.
3. Have ongoing DED, as defined by at least one eye (if one eye, the same eye) meeting all the following criteria:

   * A symptom severity score of ≥30 for Eye Dryness on a Visual Analog Scale (VAS) (0-100)
   * An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤10 mm per 5 minutes (Note: STT Score obtained at Visit 1)
   * Evidence of ocular surface staining (total fluorescein staining score of at least 3 \[0-15 scale\]).
4. Have normal lid anatomy.

Exclusion Criteria:

1. Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
2. Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
3. Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
4. Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit 1.
5. Have used Restasis® for more than 1 month (if prior use is reported).
6. Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit 1.
7. Have had corneal graft surgery in either eye within 1 year.
8. Have recent or current evidence of ocular infection or inflammation in either eye.
9. Have current evidence of clinically significant blepharitis (defined as requiring lid hygiene therapy), conjunctivitis, or a history of herpes simplex or zoster keratitis in either eye.
Impact of Isotretinoin in Different Doses on Quality of Life

The Cardiff Acne Disability Index is a short five-item questionnaire derived from the longer Acne Disability Index.It is designed for use in teenagers and young adults with acne. It is self explanatory and can be simply handed to the patient who is asked to complete it without the need for detailed explanation( .Abdelrazik etal., 2021).

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Lower doses of isotretinoin can be effective in terms of cost and decreasing systemic side effects. Therefore, other regimens may be used instead of daily conventional dose as alternate, pulse and low doses of oral isotretinoin in acne vulgaris( Agarwal et al., 2011).

To study the impact of different protocols of systemic isotretinoin in acne treatment on quality of life among egyptian patients using Cardiff Acne Disability Index (CADI) and dermatology life quality index (DLQI)questionnaires.

To assess validity and reliability of the translated Arabic version of CADI. To compare the clinical efficacy and tolerability of different protocols of systemic isotretinoin in acne treatment.

Eligibility Criteria:
Inclusion Criteria:

Patients with clinically diagnosed acne vulgaris older than 18 years of age

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Exclusion Criteria:

Patients having personal or family history of hyperlipidemia. Pregnancy and lactation. Newly married female desiring to get pregnant or using temporary method of contraception.

Patients with a history suggestive of any psychic disturbance -
Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

The purpose of this pilot study is to provide an initial assessment of the feasibility, safety and efficacy of Polar Wand carbon dioxide cryotherapy for treatment of Barrett's low grade and high grade dysplasia by use in a small number of patients so as to support, or otherwise, the development of a full-scale trial.

Prospective pilot study to be performed in 14 Barrett's Esophagus patients with low grade and high grade dysplasia, referred for standard of care treatment. Patients will receive treatments with carbon dioxide Polar Wand cryotherapy at 0, 2 and 4 months, followed by surveillance endoscopy with four quadrant biopsies throughout the entire Barrett's esophagus (BE)segment at 6 months, followed by endoscopy with additional treatments (if needed) at 8 and 10 months, followed by a final surveillance endoscopy at 12 months, with four quadrant biopsies throughout the entire initial BE segment length.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for treatment with Barrett's esophagus with dysplasia as the original indication for ablative treatment.
* Previous fundoplication surgery is permitted
* Age 18 years to 98 years
* Ability to provide written, informed consent

Exclusion Criteria:

* Inability to obtain biopsies due to anticoagulation, varices, etc.
* Previous ablation therapy, wide area mucosal resection or external beam radiation to the thorax.
* Intolerance to twice daily proton pump inhibitor medication or inability to undergo sedation or endoscopic procedures.
* Worse than Grade B erosive esophagitis
* Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (resection).
Texture and Colour Enhancement Imaging in Improving Detection and Miss Rate of Premalignant Lesions

Texture and Color Enhancement Imaging (TXI) is a newly developed image-enhancing endoscopy technology that has show potential in improving detection of colorectal lesions. This multicenter, randomized, tandem trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of diagnosis of premalignant lesions.


Eligibility Criteria:
Inclusion Criteria:

patients aged 45-85 years and scheduled for screening colonoscopy who provided written informed consent

Exclusion Criteria:

Surveillance, diagnostic or therapeutic colonoscopy

Patients with an already known or suspected colorectal tumour

Patients with alarming symptoms and signs, including haematochezia, melena, weight loss or anaemia without specific causes, an abdominal mass and positive digital rectal examination

Pregnant or lactating women

Patients with gastrointestinal tract obstruction

Patients with inflammatory bowel diseases, hereditary CRC syndromes or serrated polyposis syndrome

Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy

Patients with failed cecal intubation

Patients with poor bowel preparation quality that necessitated a second bowel preparation

Patients with a history of colonic resection
Registry for Primary Ciliary Dyskinesia

Primary Ciliary Dyskinesia (PCD) is a rare disease, which means that any single PCD center has experience with a limited number of patients. PCD Registry is the collection of data about PCD from many centers and countries who treat children with PCD. Collecting data about PCD increase the knowledge on PCD, better describe the course of the disease, and help to better understand the progression of the disease and be used to develop new treatments.

In the PCD registry of Alberta, important information about PCD such as time of diagnosis, symptoms, and tests which led to the diagnosis, state of health at diagnosis, the progression of lung function, the occurrence of severe infections, tests and treatments data will be collected from the patients' medical records.

In order to better characterize the clinical course, and improve the diagnosis and treatment of PCD, the investigators propose to establish a provincial PCD registry in Alberta. This registry will be securely linked to the currently existing International Registry for PCD and will allow more researchers to use the information to do research on PCD.

The investigators will collect demographic data: current age, sex, age, diagnostic findings and symptoms at diagnosis; in addition, clinical data about PCD which are recorded during the past and future clinical visits and encounters (e.g. lung function, weight, height, infections, treatments, and complications) will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PCD
* Abnormal findings in at least two of the following tests:

High-frequency video microscopic finding, transmission electron microscopy finding, immunofluorescence finding, low nasal NO concentration/production, demonstration of biallelic disease-causing mutations by genotyping.

Exclusion Criteria:

• Failure or unwillingness to give written informed consent.