cyrilzakka/clinical-trials huggingface dataset:
Cognitive Testing in Diverse Populations to Further the Objective and Clinical Understanding of Cognivue Study

An open-label, multi-site, validity and reliability study to obtain data on the Cognivue 5-Minute Screening and Cognivue 10-Minute Assessment tests to assess scoring and normative ranges and compare against other cognitive tests within a diverse population.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Fluent in English
* Full vision in at least one eye
* Full use of at least one functional hand
* In overall good health, not experiencing any acute symptoms
* Agrees to cognitive examinations administered by research team

Exclusion Criteria:

* Age under 18
* Not fluent in English
* Blind in both eyes (any level of diagnosed blindness)
* Lacking a functional hand
* Those entering or in hospice
* Inability to agree to cognitive examinations administered by research team
Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai

A study to evaluate the efficacy and safety of maralixibat in infants with Biliary Atresia (BA) after Hepatoportoenterostomy (HPE, also known as the Kasai procedure).

This is a double-blind randomized, placebo-controlled study in subjects with Biliary Atresia with a primary endpoint at Week 26 followed by long-term open-label period during which all subjects will receive maralixibat to Week 104.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects with body weight ≥2500 g, who are ≥21 days old and \<90 days old at the time of HPE (Kasai)
2. HPE or Kasai Procedure within 3 weeks prior to randomization
3. Clinical diagnosis of biliary atresia

Exclusion Criteria:

1. Subjects with intractable chronic diarrhea at randomization
2. Subjects not tolerating enteral feeds at randomization
3. History of ileal resection
4. Diagnosis of biliary atresia splenic malformation syndrome or cystic biliary atresia
5. Evidence of another non-biliary atresia pathology involving the intrahepatic bile duct (e.g., paucity, sclerosing cholangitis)
6. Evidence of liver failure (e.g. significant ascites)
Effects of Dry Heat Application for Menstrual Symptoms

This randomized controlled trial was to determine the effect of dry heat applied on foot base of the 65 nursing students on menstrual symptoms and pain. A statistically significant difference was found between the three-day Visual Analog Pain Scale in both intervention and control groups. However, there was no difference between Menstruation Symptom Scale subscale and total score avg of the intervention and control groups. Applying hot pack to the sole of the foot can be expressed as an effective method to reduce pain. However, due to premenstrual syndrome is a complex process, the reduction of pain in the later days of the menstrual cycle in both groups can be psychological or be explained for physiological reasons.

The study was conducted as a randomized controlled trial, a non-blinded between 30 September 2019 and 29 November 2019. In the first stage of the present study, the Premenstrual Syndrome Scale was used for all participants and the study was continued with the students with premenstrual syndrome symptoms based on the data acquired from the Premenstrual Syndrome Scale. This stage was used only for restricting the sample group, rather than diagnosing or treating the students. In the second stage, the randomization of students included in the sample group was presented according to the CONSORT diagram. The population of the study consisted of 452 female nursing students studying in the faculty of health sciences in a university. The students (n=75) who were absent in the school, took analgesics during the study, and did not agree to participate in the study, were excluded from the study. The students, who had no diagnosis of psychiatric disorder and history of endometriosis, stated that they menstruated regularly (between 22-35 days), did not use complementary and alternative treatments such as analgesics or massage throughout the study, had no diabetes or neuropathic problem causing nerve injury, did not take oral contraceptives, were over 18 years, and agreed to participate in the study, were included in the study.

Eligibility Criteria:
Inclusion Criteria:

* having no diagnosis of psychiatric disorder and history of endometriosis
* stated that they menstruated regularly (between 22-35 days),
* not use complementary and alternative treatments such as analgesics or massage throughout the study,
* having no diabetes or neuropathic problem causing nerve injury,
* not take oral contraceptives,
* were over 18 years,
* agreed to participate in the study

Exclusion Criteria:

* analgesics during the study
* not agree to participate in the study
Fuzeon Viral Decay Pilot Study

In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (\> 5 years).


Eligibility Criteria:
Inclusion Criteria:

1. Patient must be HIV infected
2. Patient must be \> 18 years old
3. Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years
4. Patient must have a viral load \< 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load
5. Patient must have a CD4 count above 400 cells/mm3 in last 3 months
6. Female patient must agree to use two methods of birth control or abstinence during the period of the study
7. Patient has to have signed full informed consent

Exclusion Criteria:

1. Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
2. Patient who have taken mono or dual antiretroviral therapy
3. Patient who have had a viral load \> 50 copies/mL on any antiretroviral regimen
4. Patient with any of the following abnormal laboratory test results in screening:

   * Hemaglobin \< 100 g/L
   * Neutrophil count \< 750 cells/uL
   * Platelet count \< 50,000 cells/L
   * AST or ALT \> 5X the upper limit of normal
   * Creatinine \> 250 umol/L
5. Patient with a malignancy
6. Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
7. Patient with an active AIDS-defining illnesses in the past six months
8. Patients who are pregnant
Assessment of Pelvic Floor Strength Variables in Female Nulliparous Athletes

Functional Fitness Training (FFT) is a modality that seeks to improve physical fitness and performance within several functional tasks by conducting a variety of training activities such as aerobic and metabolic conditioning, resistance training, and high impact exercises. Although there are many benefits of FFT for improving fitness and body composition, their effects on the pelvic floor are not clear, as high-impact exercises performed in FFT have been shown to cause an increase in intra-abdominal pressure. When these exercises are performed repeatedly, fatigue can occur within the pelvic floor muscles (PFM), which can increase the risk of developing pelvic floor dysfunctions. However, currently little is known about how FFT activities acutely affect the PFM and whether such training regimes may contribute to long-term urinary incontinence in female FFT athletes. Therefore, this study aimed to analyse the acute effects of a FFT.workout on pelvic floor strength and muscle activation in nulliparous female FFT athletes. It is hypothesized that both strength and PFM activation of the female athletes would be reduced after a FFT workout due to PFM fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous
* Have been practicing FFT or weightlifting for at least 2 years
* Train a minimum of 3 days/week that did not include pelvic floor exercises
* Have no medical contraindications or previous pelvic floor surgeries

Exclusion Criteria:

* Any criterion that fails to meet the inclusion criteria
Stress Reduction After Use of a Haptic Vibrotactile Trigger Technology Patch: Analysis and Assessment

The purpose of this research study is to collect subject perceptions or feelings about their treatment. Participation includes a survey from individuals who are receiving a stress or anxiety-relieving topical patch \[Super Patch PEACE Patch with Haptic Vibrotactile Trigger Technology (VTT)\] and assigned to a Treatment Group or given a Sham patch, assigned to the Control Group, to address symptoms or stress and anxiety symptoms using validated scales \[for example, The Perceived Stress Scale (PSS) or Medical Outcomes Study Short Form-20 (SF-20)\].

This minimal risk observational study, will evaluate an over the counter (OTC) non-invasive, non- pharmacological patch (Super Patch PEACE Patch; The Super Patch Company Ltd LLC., SRYSTY Holding Co., Toronto, Canada) that is embedded with a proprietary sensory pattern and incorporates haptic vibrotactile trigger technology (VTT) and designed to trigger neural pathways and circuits associated with stress, anxiety, and other cortical networks, with other study participants who receive an 'inactive' (Sham) patch without the embedded VTT technology. The sensory patterns within the active patches are in close symmetry between known EEG patterns and their role in modulating EEG and neuronal circuits within higher brain centers.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 to 85, inclusive
2. Able to provide written informed consent
3. Have received a PEACE Patch from their treating clinician if in treatment group.
4. Is a patient who has been diagnosed with experienced stress or anxiety related issues.
5. Have received a Sham Patch if assigned tot eh Control Group

Exclusion Criteria:

1. Use of drugs of abuse (illicit or prescription)
2. Pregnancy
3. Existing or planned implantation of Pacemaker or other electrical devices
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome

This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of interstitial cystitis or bladder pain syndrome

Exclusion Criteria:

* Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
* Previous treatment with LiRIS®
Computer Screen Properties Study

The purpose of this study is to identify how various popular methods of changing computer screen settings affect dry eye symptoms (eye pain, grittiness, tearing, burning, etc.). Specifically, this study will examine if there are differences in effects of blue light blocking (F.lux app or night shift) versus reducing screen brightness on the symptoms of dry eye.

After the initial survey, participants will be randomized by a randomization tool internal to Redcap to be in one of three arms of intervention: no intervention, screen brightness reduction to 50%, and tone modulator application. Instructions will be e-mailed to participants to explain the steps they must take depending on which treatment arm they are randomized to. Adherence will be monitored and assessed at the time of post-intervention survey. If participants have issues with the software of complying, they will be able to contact the research team at any point.

Eligibility Criteria:
Inclusion Criteria:

* Adult person (18+) with intact vision who uses computers

Exclusion Criteria:

* Children (\<18 years)
* Adult person without intact vision
* Adult who does not use computer screens
Shared Decision Making in Hospitalized AECOPD

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Patients require good communication with the physician to improve control illness. Shared decision making is a promising opportunity for chronic disease management due to the relative cost, medicine optimization and decreases hospital admissions/re-admissions

Chronic obstructive pulmonary disease (COPD) is the leading one on hospital care cost, physician services, and prescription drugs. Additionally to the disease progression with the reduction in lung function, COPD patients experiment a progressive decline in functional capacity and health-related quality of life (HRQoL) with a significant burden in terms of disability. Shared Decision Making is defined as an approach where clinicians and patients share the available information to making clinical decisions, and where patients are counseled. SDM is a way to empower patients when decisions are made about treatment as a determinant factor in patient-centered care. Decision aids have been proven effective in improving disease knowledge, decision making, and self-care.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were COPD patients hospitalized due to acute exacerbation

Exclusion Criteria:

* Exclusion criteria were the inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, organ failure, cancer, or inability to cooperate. Patients who had experienced another exacerbation of COPD in the previous month were also excluded.
A Study to Document Long-Term Safety and Continued Benefit of Irinotecan and Carboplatin or Irinotecan in Subjects With Refractory Solid Tumors (Rollover Study -001, -002)

The purpose of this study is to determine the long term safety of patients with refractory solid tumors who have experienced clinical benefit after at least 6 cycles of treatment in BMS Protocol CA124-001 or CA124-002.


Eligibility Criteria:
Inclusion Criteria:

* Completion of at least 6 cycles of therapy on BMS clinical protocol CA124-001 or CA124-002 and who continue to derive clinical benefit and are not experiencing intolerable toxicity from the therapy
* Karnofsky score of at least 50 for subjects \> 10 years of age; Lansky play scale of at least 50 for children 10 years of age and younger
* Recovery to baseline or Grade 1 from toxicities (except alopecia or asthenia) resulting from previous therapies
* Males and females, ages 1 - 21 years of age at the time of consent into CA124-001 or CA124-002

Exclusion Criteria:

* A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
* Requirement to receive concurrent chemotherapy, immunotherapy, radiotherapy, or any other investigational drug while on study
* Inadequate bone marrow and renal function
* Concurrent receipt of Dilantin®(phenytoin), phenobarbital, primidone, Tegretol®(carbamazepine), Depacon®, Depakene®, Depakote®, and Deproic®(valproic acid)
Fingolimod -Response According to Coping - Evaluation

This is a prospective, open-label, multi-center phase IV study to assess response to fingolimod initiation according to coping profile in adult patients with highly active relapsing remitting multiple sclerosis in France.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 year-old male \& female with RRMS (2005 revised McDonald criteria) corresponding to fingolimod indication (in Europe) and EDSS score 0 - 5.5 inclusive

Exclusion Criteria:

* History of immune system chronic disease other than MS or known immunodeficiency syndrome; increased risk for opportunistic infections, including immunocompromised patients; severe active infections, active chronic infections; negative for varicella-zoster virus IgG antibodies; live or live attenuated vaccines;
* Active malignancies; Macular edema; Cardiac disease or medicines decreasing heart rate; severe liver impairment; lymphocyte count \<800/mm3;
* Pregnant or nursing (lactating) women /child-bearing potential UNLESS they are using an effective contraceptive method;
* Hypersensitivity; participation in any clinical research study within 6 months prior to baseline; prior participation in a trial with fingolimod

Other protocol-defined inclusion/exclusion criteria may apply
Universally Delivered Interventions for Young People

Mental health problems are amongst the major contributors to disease burden globally.

According to a recent study, 34% of young people worldwide (aged 10-19) suffer from depression and more than half of this population belongs to Southeast Asia such as Pakistan, India, and China.

Existing evidence shows that the access to mental health services in LMICs is limited and even fewer child psychiatric services are available.

One approach to overcome barriers such as limited availability of trained mental health professionals and risk of stigma may involve the use of simple, brief, scalable interventions based on basic psychological principles rather than treatment of psychopathology.

This study adapts and evaluates two brief interventions called behavioral activation single session intervention (BA-SSI) and 4-session Mindset intervention (MI) for teenage depression and anxiety in Pakistan, where access to mental health care is constrained by societal stigma and a shortage of clinicians.

A 3-arm multi-center cluster exploratory Randomized Controlled Trial to determine the feasibility, acceptability and preliminary effectiveness of a universally delivered, culturally adapted, potentially low cost, 4-session Mindset intervention (MI) and behavioral activation single session intervention (BA-SSI) for school going young persons (YP) (12-15 years) in Pakistan.

Proposed study is designed using the updated Medical Research Council (MRC) Framework for the development and evaluation of complex interventions.

Three public schools will be recruited from each of 10 cities across Pakistan: Karachi, Hyderabad, Nawabshah, Thatta, Lahore, Gujrat, Rawalpindi, Multan, Quetta, and Peshawar.

All the participants, regardless of their treatment arm, will be assessed at baseline, 1 month post-baseline and at 3-month.

Eligibility Criteria:
Young persons (YP)

Inclusion Criteria:

* Youth is between the age 12-15 years (inclusive) at the time of study enrollment.
* Youth has one parent or legal guardian to give consent.
* Youth speaks Urdu well enough to complete the paper based intervention.

Exclusion Criteria:

* Intellectual disability, as this may undermine comprehension of intervention material.
* Adolescent with history of hospitalization or those who received inpatient treatment for a mental health problem within the past two months as the intervention being tested and this study is not designed for adolescent with acute medical and/or psychiatric treatment needs (if identified with any acute medical and/or psychiatric problem, they would be referred to appropriate health services through parents).

Schools Inclusion Criteria

Schools in the study areas are eligible to participate if they meet all the following criteria:

1. the school authority agrees to participate;
2. the schools shall be non-specialist public schools;
3. school contains at least 80 students; Exclusion criteria

If the school meet the following exclusion criteria, they are ineligible to participate:

1. the school authority refuses to participate;
2. a specialist and/or independent or private school;
Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes

This pilot randomized trial will compare the preliminary effect of a regular physiotherapy (PT) program to a regular PT combined with a progressive walking program (PT+) in patients with and without diabetes who have adhesive capsulitis. After signing the consent form, recruited participants will be randomized into either PT group (control) or PT+ group (experimental). Participants in both groups will be referred to a physical therapy facility. The intervention will be chosen by treating physical therapist. In PT+ group, participants will also be asked to perform free walking at their own pace. Outcomes measures for the primary outcome (shoulder functional performance) will be evaluated at baseline and after 6 weeks. Secondary outcomes (shoulder ROM, pain and function, muscle strength, and physical activity level) will be evaluated at baseline, at 3 and 6 weeks, and again at 12 weeks after enrolment. We expect adding a progressive walking program to regular PT will result in better outcomes.

In this pilot randomized clinical trial, participants will be recruited from an Orthopedic clinic at St. Joseph's Health Care Centre via surgeon referrals and from local primary health care clinics via posters advertising the study. Potential participants will be contacted by the research team at Hand and Upper Limb Centre (HULC) to arrange for their initial evaluation and sign a consent form. Participants who agree to participate in this study will be asked to complete 2 outcomes questionnaires (i.e. SPADI, RAPA) and Katz comorbidity scale.

Next, patients will be randomly assigned to one of the two groups: regular Physical Therapy program (PT) or regular PT which add a progressive walking program (PT+). Stratified randomization by diabetic status and sex will be used. All participants will be referred to a physical therapy facility according to their preferences and the intervention will be chosen by the treating physical therapist. In PT+ group, participants will be asked to perform free walking at their own pace for 30-45 min, 5 days per week for 6 consecutive weeks and to record their walking date/time on a diary form provided by the research team before commencing the study. Participants in PT+ group will also be provided with accelerometer to accurately estimate their physical activity level. Outcomes measures for the shoulder functional performance test (primary outcome) will be evaluated at baseline and after 6 weeks. Secondary outcomes (shoulder ROM, pain and function, muscle strength, and physical activity level) will be evaluated at baseline, at 3 and 6 weeks, and again at 12 weeks after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with and without diabetes who have adhesive capsulitis

Exclusion Criteria:

* Previous shoulder surgery or dislocation
* Shoulder severe osteoarthritis