cyrilzakka/clinical-trials huggingface dataset:
RIS International Cohort

The Radiologically Isolated Syndrome (RIS) corresponds to the discovery of white matter (WM) abnormalities suggestive of multiple sclerosis (MS) by their location, size, and appearance, on the brain or spinal cord Magnetic Resonance Imaging (MRI). This imaging is performed for a reason other than for suspicion of demyelinating disease in subjects without a history of neurological symptoms and a strict routine clinical neurological examination. It was defined and named in 2009 (Okuda et al.) after publishing 3 case series (French, USA, Turkey). The Radiologically Isolated Syndrome Consortium (RISC) published a cohort of subjects with an extended follow-up after the first brain MRI of MS, with 34% presenting an event (clinical conversion) at five years, 51.2 % of these subjects showed an event at ten years. The patients who offer a higher risk of developing a first clinical demyelinating event were identified such as male sex, young age, the presence of oligoclonal bands (BOCs) in the Cerebrospinal Fluid (CSF), the presence of infratentorial lesions and spinal cord lesions on the first MRI suggestive of RIS. The location and morphology of the lesions appear to be decisive for studying the risk of conversion. Our first objective is to prospectively collect data to identify the subjects who present a higher risk of developing a first clinical demyelinating event and the progression of the disease in these subjects.

Among the objectives of this worldwide cohort is the analysis of (1) environmental factors (Vit D, EBV, tobacco...), (2) MRI biomarkers, including atrophy, central veins signs, paramagnetic rings, and DTI.

(3) digital biomarkers (4) oculography (5) biological markers To summarize, this cohort will allow for analyzing features in imaging, biology and the exploration of digital and oculographic characteristics to identify predictive factors of clinical evolution of a large cohort of subjects presenting WM abnormalities suggestive of multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* white matter T2 lesions suggestive of demyelination
* asymptomatic
* normal neurological exam

Exclusion Criteria:

* abnormal neurological exam,
* suspicion of another disease explaining MRI lesions.
The Use of Non-ICG-Enhanced Lymphatic Vessels for LVA

The aim of the present study was to investigate the impact of non-ICG(+) LVs on the outcomes after LVA compared to ICG(+) LVs with propensity-score-match analysis.

It is a common belief among lymphatic supermicrosurgeons that LVA should only be performed with indocyanine green-enhanced (ICG(+)) LVs since such LVs are considered functional and are suitable for achieving better outcomes. However, in moderate to advance lymphedema patients, the use of non-ICG(+) LVs are inevitable despite efforts to identified ICG(+) LVs with ICG lymphography10, magnetic resonance (MR) lymphangiography11, or ultrasound12. In a previous study, it was suggested that a non-ICG(+) but flow-positive LV should also be considered functional because the functionality of an LV should be determined by its capability to transport lymph instead of ICG(+) lymph. Therefore, non- ICG(+) but flow-positive LVs should also be used for LVA to maximize the outcome13. This hypothesis was further supported by a recent article emphasizing the concept of a lymphatic-based lymphosome14, where it has been demonstrated that a functional LV will not become ICG(+) when ICG is not injected in the region being drained by this particular LV. It offers an explanation as to why a supposedly functional LV is not enhanced by ICG.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from September 2015 to March 2023.
* Patients who underwent LVA for unilateral lower-limb lymphedema.

Exclusion Criteria:

* Primary lymphedema
* Bilateral lower limb lymphedema
* History of previous treatment for lymphedema (LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure) - Those that were lost to follow-up.
Study of NPL-2003 in Adolescents With Obsessive Compulsive Disorder (OCD)

The purpose of this study is to investigate the effect of NPL-2003 on the symptoms of Obsessive Compulsive Disorder (OCD) in an adolescent population.


Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for Obsessive Compulsive Disorder.
* CY-BOCS score of greater or equal to 16 at screening.
* NIMH Global OC Scale score of 7 or higher at screening.

Exclusion Criteria:

* Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
* Autistic Disorder or Pervasive Developmental Disorder.
* Moderate or severe mental retardation.
* Severe renal insufficiency.

Other protocol-defined Inclusion/Exclusion criteria may apply.
Free From Abuse: The Booster Project

This project is designed to develop and test a brief internet-delivered intervention to promote healthy relationships among young adults.

In spite of the fact that young adults are at an increased risk of experiencing and perpetrating intimate partner violence (IPV), there is a lack of universal and widely accessible prevention programmes targeted at this age group. One of the reasons for this may be that it is difficult to deliver a universal prevention to individuals who are not formally grouped through one organisation, such as employed young adults. Those who are formally grouped, such as university students, are unlikely to take part in a lengthy prevention programme which is not a part of an official curriculum. Therefore, there is a need for widely available, accessible, and efficacious IPV prevention programmes that could be appropriate for all young adults regardless of gender. Since many young adults in contemporary Western societies were exposed to some kind of relationship education in schools, it may be that a brief programme will suffice to further boost their awareness of IPV and reduce IPV perpetration and victimisation risk. Therefore, we propose a brief internet-based intervention, Free From Abuse - The Booster Project, to achieve these objectives.

Primary objectives:

1. To investigate the acceptability and feasibility of the internet-delivered intervention to university students (determined using the 1 and 4-week follow-up rates, % of participants who correctly answered control questions assessing compliance);
2. To assess the acceptability and feasibility of the outcome measures as methods to measure effectiveness of the intervention within a definitive trial (determined using % of missing data);
3. To estimate the standard deviation (SD) for the continuous outcomes to inform sample size calculations for a definitive trial.

Secondary objective:

1. To evaluate the potential effectiveness of the brief internet-delivered intervention, Free From Abuse - The Booster Project, in increasing recognition of abusive behaviour, as well as reducing acceptance of myths about domestic violence, abuse perpetration, and abuse victimisation among young university students compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be university students aged between 18-24 years, reside in the UK, have access to a computer and internet connection, and be fluent in English.

Exclusion Criteria:

* Participants will not be eligible to enrol in the trial if they have visual and/or auditory deficits with regards to watching video clips.
The Effect of Progesterone Levels on Pregnancy

The aim of this study is to investigate the effect of progesterone levels on pregnancy occurrence on the 3rd and 5th days after insemination.

Ovarian stimulation with gonadotropins is a frequently used method in patients with unexplained infertility undergoing intrauterine insemination.

Pregnancy and live birth rates after ovarian stimulation; The number of follicles in ovulatory size and responsive to ovarian stimulation is affected by many factors such as the age of the woman and the duration of infertility. Progesterone production in the luteal phase is necessary to achieve successful treatment results by increasing the receptivity of the endometrium in the secretory phase.

In assisted reproductive techniques, exogenous progesterone support in the luteal phase is a routinely used method due to higher pregnancy rates, but there is no consensus with the use of progesterone in IUI applications. In a recent meta-analysis, a positive relationship was found between gonadotropins and progesterone support when ovulation induction and intrauterine insemination were performed, while this relationship was not found with clomiphene citrate, and although letrozole and gonadotropin were used together, no significant statistics were found.

The relationship between luteal phase hormone dynamics and pregnancy outcomes in IUI is not fully understood. Although luteal phase failure is mentioned, there is no accepted definition of luteal phase failure worldwide. In one study, progesterone concentrations in the midluteal phase and pregnancy outcomes were investigated in 188 IUI cycles, predicting that low levels could predict treatment failure. In another study, a positive relationship was found between luteal phase progesterone levels and clinical pregnancy outcomes.However, the relationship between blood progesterone levels and pregnancy rates in a small number of IUI cycles has been investigated in the literature. Considering all these studies, there is no Level 1 evidence regarding the benefit of providing progesterone support in groups where the progesterone level is below a certain threshold value. In this study, we aimed to investigate the relationship between gestational outcomes by looking at progesterone values on the 3rd and 5th days after IUI in patients who were decided to be treated with IUI. By looking at these progesterone levels, we aimed to determine a threshold value for the ideal level of progesterone in the luteal phase and to be a guide in terms of possible results and methods of shaping the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been decided for intrauterine insemination
* Patients under the age of 40
* Patients with a BMI of less than 40 kg / m2
* Cycles triggered by rhCG
* Those who have a signed and dated informed consent document that they have been informed about the study and that their consent has been obtained

Exclusion Criteria:

* Patients over the age of 40
* Patients with BMI over 40 kg / m2
Alberta Hip Improvement Project

A study to determine the effectiveness and safety of the use of metal-on-metal hip resurfacing (for example the birmingham hip) when compared to conventional total hip replacement.

This study is designed to provide orthopedic surgeons and decision makers with evidence-based health measures for patients that are treated by orthopedic surgeons for degenerative joint disease of the hip in Alberta. This study is provincial initiative to determine whether new alternative hip bearing surfaces improve patient outcomes and/or decrease health resource utilization in patients with degenerative joint disease of the hip in Alberta. The primary objective is to compare time to revision for patients receiving alternative hip bearing surfaces to patients receiving conventional total hip replacements. Secondary objectives are to evaluate long-term safety; to evaluate costs; to determine if alternative hip bearing surfaces improve patient function; to develop evidence base guidelines for the implementation of alternative hip bearing surfaces in Alberta; do develop a modal to assess other technologies and health advances; to develop an Alberta HIP registry

Eligibility Criteria:
Inclusion Criteria:

* documentation of DJD of hip
* patient at least 18 years
* patient able to provide written consent
* Male under 65 years, female under 56 years
* Orthopedic surgeon has received appropriate training to implant an alternative device

Exclusion Criteria:

* renal failure (MOM only)
* child bearing potential (MOM only)
* inappropriate femoral anatomy, including evidence of osteoporosis
* inflammatory arthritis (MOM)
* Unwilling to consent
Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor

This study seeks to verify the analgesic efficacy of TENS during the first stage of labor applying TENS parameters that, according to with the evidence, can be effective for this application and discarding the placebo effect according to the methodological recommendations.

TENS is a non-pharmacological alternative for pain control during labor. Although it's a method that has been used for decades, there is not enough evidence on its efficacy, so it's considered ineffective in the Spanish and British guidelines of clinical practice. The present study seeks to verify the analgesic efficacy of TENS by applying the electrodes in the spinal nerve roots associated with labor pain and using conventional TENS with parameters that, according to the evidence, may be effective for this application.

Eligibility Criteria:
Inclusion Criteria:

- Women attending routinary fetal monitoring before labor

Exclusion Criteria:

* Multiparous
* Scheduled cesarean
* Implantable Cardioverter Defibrillator (ICD) or pacemaker
* Epilepsy
* Fetal malformation
* Language barrier
Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome.

The primary objective is to test the hypothesis that enoxaparin efficacy is reduced in severe nephrotic syndrome. Another purpose is to compare two dosing regimens.

Nephrotic syndrome (NS) is a rare clinical condition characterized by proteinuria exceeding \>3.5 g/24h, hypoalbuminemia, dyslipidemia and edema and is associated with hypercoagulable state. In severe cases, with serum albumin ≤2.5 g/dL, the risk of venous thromboembolic events (VTE) is particularly high, and pharmacological prophylaxis is recommended. However, there is a limited evidence of its efficacy and optimal dosing.

The study is designed as 3 arms clinical trial, with 2 study groups and a single control group. The study groups will include patients with severe NS parallelly, alternately assigned (1:1) into two enoxaparin dosing regimens. The control group will consisted of individuals without proteinuria and edema, similar in terms of age, anthropometric features and renal function to NS patients, who will be administered a standard enoxaparin dose. A peak anti-Xa activity at the steady state will be measured to determine the plasma concentration of enoxaparin. Additional laboratory tests for markers of NS severity, renal function and coagulation system proteins will be performed. The overhydration and body water compartments will be assessed using bioimpedance spectroscopy technique. Nephrotic patients will be followed up by 12 months to assess overt VTE and adverse events associated with enoxaparin use.

Eligibility Criteria:
Inclusion Criteria:

* Severe NS, defined as proteinuria exceeding 3.5 g/24h or 50 mg/kg/24h and serum albumin ≤2.5 g/dL;
* eGFR ≥30 mL/min/1.73 m2.

Exclusion Criteria:

* Body mass index (BMI) ≥40 kg/m2;
* Low body mass (\<45 kg for female, \<57 kg for male);
* Acute VTE;
* Previously introduced anticoagulation (due to comorbidities);
* Contraindications for enoxaparin;
* Pregnancy.
Safer Aging With Diabetes Monitoring

Older adults with type 2 diabetes are at higher risk for severe hypoglycemia and its related complications (including hospitalization and death) when taking insulin. This study proposes to evaluate, in a randomized clinical trial, a strategy of safe insulin prescribing based on an educational program that leverages continuous glucose monitoring to support older adults at high risk for hypoglycemia. If the aims of this project are achieved, this novel care strategy could be widely applied to reduce severe hypoglycemia episodes in older, high-risk adults with type 2 diabetes.

The overarching goal of this pragmatic randomized clinical trial is to support safer diabetes care in older adults (age ≥ 75) with type 2 diabetes (T2D) who require insulin therapy. Many of these older adults are at high risk for severe hypoglycemia due to symptom unawareness and/or nocturnal hypoglycemia. Effective and safe management in this population requires close glucose monitoring coupled with proactive medication and diet adjustment to avoid severe iatrogenic consequences. This study proposes to achieve this goal through a patient-oriented intervention program that incorporates the use of alarm-enabled continuous glucose monitoring (CGM). There are currently no major randomized trials directly assessing the use of CGM to reduce severe hypoglycemia among the oldest adults with T2D. The study team will conduct a 2-arm trial: 1) Group-based, three-session education intervention (CGM provided to participants) vs. 2) usual care (no CGM provided to participants). The primary outcome is an aggregate measure of clinically significant hypoglycemia. The study will also examine differences in patient-reported diabetes distress, fear of hypoglycemia, and self-efficacy using validated survey measures.

Eligibility Criteria:
Inclusion Criteria:

* Age 75 years and older
* Diagnosis of Type 2 Diabetes
* Current treatment with insulin
* Increased hypoglycemia risk (prior year hypoglycemia by self-report or utilization)
* Able to communicate in English
* Able to access email and the Internet

Exclusion Criteria:

* On renal dialysis
* Dementia
* Pacemaker or Automatic Implantable Cardioverter Defibrillator
* Using insulin pump
* Severe Mental Illness
* Severe Visual Impairment
* In Hospice
* Current or recent CGM use
Safety and Efficacy Study of Prosaptide to Treat Neuropathic Pain in HIV-Positive Patients

This is a double-blind, placebo-controlled, parallel groups study to determine whether prosptide is effective in relieving pain in patients who have sensory neuropathic pain related to their HIV infection or the drugs used to treat it.

Sensory neruopathies are the most frequent neurological complicaton of HIV infection and its treatmet with antiretrovirals. To date, there are few effective treatments, and all are symptomatic treatments for pain. Management typically involves the intiation and adjustment of pain-modifying therapies, and the adjustment or discontinuation of potentially neurotoxic antiretrovirals, thereby limiting the choice of HAART regimens.

In precinical animal models,prosaptide has been shown to be efficacious in the treatment of neuropathic pain caused by a variety of different mechanisms.

Hypothesis: Prosaptide will improve neuropathic pain in HIV-associated sensory neuroathies,and will be safe and well tolerated in subjects.

Comparisons: 4, 8, or 16 mg prosaptide vs. placebo

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years and older
Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue.

Cancer survivors are at increased risk of gut bacteria communities that can negatively impact health and energy level and it is possible that exercise can cause healthy changes in these communities. Through careful design, this study will use a controlled-feeding diet and 10 weeks of exercise training to determine exercise effects on the number, distribution, and types of bacteria in the gut of breast cancer survivors. These changes will then be linked to fatigue and physiologic effects of exercise to determine how the information can be used to enhance exercise benefits and identify new treatment strategies leveraging changes in gut bacteria communities.

Eligibility Criteria:
Inclusion criteria:

* Women ages 18 to 74 years with a history of breast cancer stage 0, I, II, or III,
* ≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation),
* Average fatigue over the past week rated as ≥3 on a 1 to 10 Likert scale, cut point chosen because it is a clinically meaningful cutpoint,93
* English speaking,
* Physician medical clearance for study participation,
* Able to ambulate without assistance,
* No antibiotics for the past 90 days,
* Willing to avoid taking probiotics for the duration of the study
* Peak VO2 \<30 ml/kg/min (note: will measure peak VO2 if the participant meets all other criteria and consents to lab-based screening).

Exclusion criteria:

* Metastatic or recurrent cancer
* Another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ), 3)
* Unstable angina
* New York Heart Association class II, III, or IV congestive heart failure
* Uncontrolled asthma
* Interstitial lung disease
* Current steroid use
* Having been told by a physician to only do exercise prescribed by a physician
* Dementia or organic brain syndrome
* Schizophrenia or active psychosis
* Connective tissue or rheumatologic disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, CREST syndrome, polymyositis, dermatomyositis, progressive systemic sclerosis, vasculitis, polymyalgia rheumatic, temporal arteritis)
* Anticipate elective surgery during the study period
* Anticipate changes in usual medications during the study period
* Plan to move residence out of the local area during the study period
* Plan to travel out of the local area for \>1 week during study participation
* Contraindication to engaging in moderate-to-vigorous intensity aerobic exercise
* Currently pregnant or anticipate pregnancy during study participation
* Live or work \>50 miles from study site or do not have transportation to study site
* BMI \>50
* Anticipate needing antibiotics during the study period
Ophthalmic Manifestations of Patients With Mucopolysaccharidosis

Mucopolysaccharidosis (MPSs) are a group of disorders caused by inherited defects in lysosomal enzymes resulting in widespread intra- and extra-cellular accumulation of glycosaminoglycan(1,2). They have been subdivided according to enzyme defect and systemic manifestations and include MPS IH (Hurler)(3) , MPS IS (Scheie), MPS IH/S (Hurler/Sheie), MPS II(4,5) (Hunter), MPS III (Sanfilippo)(6) , MPS IV (Morquio)(7,8), MPS VI (Maroteaux-Lamy)(9), MPS VII (Sly)(10,11) and MPS IX (Natowicz)(12). Mucopolysaccharidosis have a spectrum of systemic manifestations, including airway and respiratory compromise, skeletal deformities, intellectual and neurological impairment, cardiac abnormalities, gastrointestinal problems and ocular manifestations(13). Ocular manifestation are common in the mucopolysaccharidosis and may result in significant visual impairment(14). Corneal opacification of varying severity is frequently seen, as well as retinopathy, optic nerve swelling and atrophy, ocular hypertension, and glaucoma(14). New treatment modalities for the systemic manifestations of the mucopolysaccharidosis include bone marrow transplant and enzyme replacement therapy have resulted in an improved prognosis in many cases(15).


Eligibility Criteria:
Inclusion Criteria:

* All patients at any age up to 18 years with any type of MPS confirmed by the enzymatic assay

Exclusion Criteria:

* Any patient other than MPS
Blade Finger Technique for Safe Laparoscopic Entery

blade-finger technique is a new technique for laparoscopic access which is safe

after optaining irb approval and patients consented, they were divided into 3 groups to whom one of the techniques of laparoscopic entery was applied and there was a comparison between these groups

Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 year-old.
* underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to May, 2022.

Exclusion Criteria:

* Patients with one or more previous abdominal surgery (upper, lower or upper and lower midline scars).
* Patients with distended abdomen due to bowel obstruction.
* Patients with uncorrected coagulopathy.