cyrilzakka/clinical-trials huggingface dataset:
Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study (Phase 1)

This phase of the project aims to analyze the interaction between physical exercise and the phases of the menstrual cycle, evaluating its impact on fatigue, functional capacity, and exercise perception in women with and without Multiple Sclerosis. To achieve this, a controlled, single-blind, prospective, 2x3 crossover, randomized clinical trial will be conducted, involving women with Multiple Sclerosis (MS), matched by age, lifestyle habits (smoking, physical activity), and geographic location with a group of women without MS. This study, aligned with previous findings, seeks to deepen the understanding of the role of exercise in managing Multiple Sclerosis symptoms and to promote greater adherence to personalized physical activity programs adapted to the phases of the menstrual cycle.


Eligibility Criteria:
Inclusion criteria include:

* Women of reproductive age (18-50 years) with MS will be included, with the upper age limit adjusted to reflect the reproductive phase;.
* No iron-deficiency anemia.
* Stable disease phase.
* Independent walking ability for over 10 meters.

Women will be recruited first and later matched with men based on age, EDSS, and lifestyle habits (physical activity, smoking, and alcohol consumption).

Exclusion criteria will include participants with MS who:

* Score \<1 or \>6 on the EDSS.
* Report a relapse within 12 months before the study begins.
* Have taken corticosteroid treatment within the last 2 months.
* Have participated in a structured training program in the previous 6 months.

Once all women with MS are recruited, male participants will be recruited following a 1:1 matching methodology based on age, geographic region, and lifestyle habits.
Joint Pain Occurring During Anti-TNF Therapy in Chronic Inflammatory Bowel Disease

IBD (inflammatory bowel disease) are associated with various types of joint manifestations, especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint symptoms, with variable expressions and aetiologies, possibly responsible for impaired quality of life, and possibly leading to discontinuation of an effective and validated treatment.


Eligibility Criteria:
Inclusion Criteria:

* Males or females over the age of 18 years at the time of inclusion
* Patients with IBD (Crohn's disease or ulcerative colitis), diagnosed by a set of compatible clinical (chronic diarrhoea, haematochezia, anoperineal lesions, etc.), laboratory, histological and endoscopic arguments. Patients will be included regardless of the severity of their disease, its clinical course, the type of lesions, and the presence or absence of associated manifestations.
* Patients treated with anti-TNF: infliximab or adalimumab.
* Informed patients not refusing to participate.
* Patients covered by French national health insurance.

Exclusion Criteria:

* Patients under the age of 18 years at the time of inclusion.
* Patients previously treated with anti-TNF, but no longer treated with anti-TNF at the time of inclusion.
* Protected majors (under permanent or temporary guardianship).
Study on the Chromatic Perception of Digital Systems in Aesthetic Field

The study under consideration aims to evaluate differences in chromatic perception among three distinct color acquisition methodologies. Specifically, recruited patients will undergo testing with three different color detection systems, including two intraoral photography methodologies and one digital intra oral scanning. All procedures conducted are part of normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with good oral health
* Age over 18 years old
* Signing of an informed consent form according to the protocol

Exclusion Criteria:

* Any type of restoration on the upper central and lateral incisors
Brain Genomics Superstruct Project

The purpose of this study is to explore the effects of genes and genetic variation on brain structure and function. Investigators at Harvard plan to explore the relationship between candidate genes that affect cognitive performance and brain structure/function. Since brain phenotypes reflect more proximal sequelae of gene activity, neuroimaging measures may show greater sensitivity than cognitive performance to measure gene effects.


Eligibility Criteria:
Inclusion Criteria:

1. 13 years or older
2. Subject must have a current DSM-IV diagnosis of high functioning ASD, based on past evaluations at the Bressler Clinic.
3. Subjects must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
4. Each subject must understand the nature of the study. The subject must sign an IRB approved informed consent.

Exclusion Criteria:

1. IQ \< 70 bassed on evaluation in the Bressler Clinic.
2. Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items).
3. Neuropsychiatric conditions (such as dementia) which sufficiently impair cognition such that a surrogate consent would be required.
4. Neurological disorders associated with gross brain pathology (other than atrophy), e.g., stroke, tumors, or demyelinating diseases.
5. Pregnancy.
Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer

In this phase II trial, we will evaluate the weekly schedule of topotecan in the second-line treatment of patients with small cell lung cancer

Upon determination of eligibility, all patients will be receive:

* Topotecan

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Small Cell Lung cancer
* Progression after one previous regimen
* Measurable or evaluable disease
* Able to perform activities of daily living with assistance
* Adequate bone marrow, liver and kidney function
* No more than three previous courses of radiation therapy
* Accessible for treatment and follow up
* Must give written informed consent prior to study entry

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Central nervous system involvement
* Serious or active infection
* Serious underlying medical condition
* Other active neoplasms

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man

This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.

The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.

Eligibility Criteria:
Inclusion Criteria

* BMI 18 - 28 kg/m2
* SBP 90-140
* DBP 50-90

Exclusion Criteria

* Seizures,
* Orthostatic hypotension
A Study of the Performance of Certain Prevail Implants Used in Short Fixed Cases

This prospective, randomized study evaluates the performance and crestal bone changes difference between the Osseotite Certain Prevail vs the non-lateralized design of the implant.

Study (null) hypothesis: the crestal bone changes that take place after placement and loading of the Osseotite lateralized implants will be the same as for similar but non-lateralized Osseotite Certain implants.

This is a prospective, randomized-controlled study where patients with qualifying partial edentulism received a short fixed bridge restoration. Each implant site was randomized to receive either the test (Osseotite Certain Prevail) or the control non lateralized version of the Osseotite Certain implant. All implants were placed in a single-stage manner with temporary provisionalization taking place two months after implant placement. Enrollment continued until 10 patients (approximately 30 implants) were treated at each participating study center.

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and any race greater than 18 years of age
* patients for whom a decision has already been made to use dental implants for treating an existing dental condition specifically: a partially edentulous short fixed case of less than 4 implants in the maxilla or mandible; no cantilevers are allowed, but one interior crown may be a pontic
* patients must be physically able to tolerate conventional surgical and restorative procedures
* patients must agree to be evaluated for each study visit, especially the yearly follow-up visit

Exclusion Criteria:

* patients with active infection or severe inflammation in the areas intended for the implants
* patients with more than 10 cigarette per day smoking habit
* patients with uncontrolled diabetes mellitus
* patients with metabolic bone disease
* patients who have had treatment with therapeutic radiation to the head within the past 12 months
* patients in need of allogenic bone grafting at the site of the intended study implant
* patients who are pregnant at the screening visit
* patients with evidence of severe para-functional habits such as bruxing or clenching
* patients with cantilevers and more than one pontic per bridge
Intravenous Cannulation In Children During Sevoflurane Induction

This interventional simple-blind,randomized trial has included 90 children of American Society of Anesthesiologist (ASA) physical status I or II aged between 1 to 12 years of either sex, scheduled for for outpatient minor surgery under general anesthesia. This study examined whether one should make iv attempts during the early induction period (at 60 seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.

We conducted a prospective randomized study, after obtaining Institutional review board approval, which didn't require written parental consent. Children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L) following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were determined. Difficulty with iv placement was also recorded. Statistical analysis included contingency testing, ANOVA, and non parametric testing. A P-value \<0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* children with American Society of Anesthesiologist (ASA) physical status I or II
* age between 1 and 12 years of either sex,
* were scheduled for outpatient minor surgery under general anesthesia

Exclusion Criteria:

* age \<1 and \>12 years
* patients with full stomach
* a history of gastric reflux
* history of convulsions, cardiovascular or neuromuscular disease
* suspected difficult airway and hyper-reactive airway disease
The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis

The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.

F-18 florbetapir is currently used for the early detection of brain amyloid (Alzheimer's disease). The hypothesis is that F-18 florbetapir will detect amyloid deposition in myocardium prior to current non-invasive diagnostic measures, particular electrocardiography with strain and technetium pyrophosphate scintigraphy. The investigators intend to use F-18 florbetapir and assess its correlation between standard non-invasive diagnostic modalities.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis
2. Patients with a ratio of affected to unaffected free light chains \>5 or free light chain difference of \>50

Exclusion Criteria:

1. Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm
2. Contraindication to florbetapir or its components
3. Refusal to participate in the study
Drug Wastage : Observational Study in the Operating Rooms of France

Environmental awareness is leading medical field to question its responsibility and possibilities for action.

Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice this is not systematic. Moreover, data on drug wastage in the operating rooms by anesthesia department are rare.

The GAME-OvBLOC observational study aim to evaluate drug wastage in the operating rooms by anesthesia department in France and to propose ways of improving health care practices.

Observational study with data collection over a 24-hour business day. Data collected refer to healthcare team's practices and patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients who will need an anesthesia act in operating room during a 24 hours period

Exclusion Criteria:

* Patient opposition to participate in the study or parents opposition if the patient is a child or patient family opposition if the patient is not capable of being informed
Melatonin Use After Primary Total Joint Arthroplasty

The purpose of this study is to determine the effect of melatonin supplementation on patient sleep quality, length of stay, and opioid consumption following primary, unilateral, elective total hip or knee arthroplasty.

This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing primary elective total hip and the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Patient are current candidates for elective primary total hip and total knee arthroplasty.
* Patients ≥18 years of age but ≤ 95
* Patients have been medically cleared and scheduled for surgery

Exclusion Criteria:

* Non-elective conversion arthroplasty
* Bilateral total joint arthroplasty
* Contraindications to use of melatonin (diabetes, calcium channel blocker use, depression)
* Conditions and medications likely to confound results due to impact on subjective and/or objective sleep quality (insomnia, drug/alcohol abuse, and use of benzodiazepines, and prescription sleep aids)
* Conditions likely to impair capacity to adhere to protocol (mental impairment, psychiatric disorders other than anxiety/depression)
Clinical Study of CS-001 As a Treatment for Canities (Grey Hair)

Clinical Study to Assess the Safety and Efficacy of CS-001 as a treatment for Canities (Grey Hair)

CS-001 is a small molecule that affects lysosomal storage and transfer of melanin from hair follicle melanocytes. In vitro and a small pilot study demonstrated re-pigmentation of grey hair following CS-001 application. The aim of this study is to assess the safety and efficacy of CS-001 as a treatment for grey hair.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 65
* Diagnosed with Grey Hair (Canities)
* Willing and able to apply the treatment as directed, comply with study
* Otherwise healthy
* Able to give informed consent

Exclusion Criteria:

* A medical history that may interfere with study objectives
* Women who are pregnant, lactating, or planning to become pregnant during the study period
* Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
* Subjects who have known allergies to any excipient in CS-001
* Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
* Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
* Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
* Subject is unable to provide consent or make the allotted clinical visits
A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan

This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases. Phase I is a qualitative study using semi-structured in-depth interviews in participants with hypertrophic cardiomyopathy. Phase II is a quantitative study using questionnaires in participants with hypertrophic cardiomyopathy and a control group of participants who do not have hypertrophic cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria - hypertrophic cardiomyopathy group

* Participants diagnosed with non-obstructive or obstructive HCM in Japan
* Participants aged ≥18 years of age
* Participants who have been attending outpatient visits for HCM and who are referred to the study by the physician treating HCM
* Participants with HCM who are diagnosed as New York Heart Association (NYHA) functional classification 2-3 at enrolment
* Participants experiencing burden in their daily lives because of HCM (self-reported)

Inclusion Criteria - control group

* Participants aged ≥18 years of age
* Individuals from the general population who are enrolled in 3H Clinical Trial's consumer panel

Exclusion Criteria - hypertrophic cardiomyopathy group

* Participants who have ever been diagnosed with dilated cardiomyopathy or secondary cardiomyopathy, including cardiac amyloidosis, Fabry disease, or mitochondrial myopathy
* Participants who have previously participated or are currently participating in another clinical trial (not including observational studies)

Exclusion Criteria - control group

* Participants who have ever been diagnosed with non-obstructive or obstructive HCM
* Participants who have ever been diagnosed with either dilated cardiomyopathy or secondary cardiomyopathy, including cardiac amyloidosis, Fabry disease, or mitochondrial myopathy
* Participants who have previously participated or are currently participating in another clinical trial (not including observational studies)
A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
* Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
* HbA1c: 7.0-10.0 % (both inclusive)
* Body weight between 60 kg and 110 kg

Exclusion Criteria:

* Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
* Impaired liver or kidney function
* Proliferative retinopathy or maculopathy requiring acute treatment
* Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
* Recurrent major hypoglycaemia or hypoglycaemic unawareness
* Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)
Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation

Heart failure is the most rapidly rising cardiovascular disease and has come to be recognized as a growing epidemic. Digital health interventions are the most recent iteration of an effort to promote individualized outpatient care through positive behaviour change theory. The UHN team has developed a highly automated and user-centered smartphone-based system, Medly, which allows for the telemonitoring of patients diagnosed with heart failure. The purpose of this study will be two-fold: 1) to determine if the introduction of Medly within two weeks of discharge will improve self-care management, quality of life, and clinical status, 2) to assess whether Medly will lead to a potential reduction in 30 day readmission rates amongst HF patients in the Toronto Central Local Health Integration Network (TC LHIN), without increasing the average length of stay or visits to the emergency department. These parameters will be measured as secondary outcomes.

Heart failure is the most rapidly rising cardiovascular disease and has come to be recognized as a growing epidemic. Digital health interventions are the most recent iteration of an effort to promote individualized outpatient care through positive behaviour change theory. The UHN team has developed a highly automated and user-centered smartphone-based system, Medly, which allows for the telemonitoring of patients diagnosed with heart failure

Patients with heart failure will be provided with a smartphone and commercial home medical devices, such as a blood pressure monitor and weight scale. The measurements from the medical devices will be automatically sent to the smartphone, and from there to a data server at the hospital for analysis and storage. Both clinicians and patients will be able to access these data and will be sent alerts by the system if the measurements are outside of the normal range. The system will be evaluated through interviews and comparing outcomes between the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years or older)
* Hospitalization for decompensated HF \> 48 hours
* Patient speaks and reads English adequately to provide informed consent and understand the text prompts in the application (or has an informal caregiver who can translate for them)
* Ability to comply with using Medly (ex. able to stand on the weight scale, able to answer symptom questions, etc.)

Exclusion Criteria:

* Dementia or uncontrolled psychiatric illness
* Residents of long-term care facilities
* Terminal diagnosis of any health condition with a life expectancy \< 1 year
* Patients who will require inpatient rehabilitation after discharge
* Participating in another clinical trial that may confound the results