cyrilzakka/clinical-trials huggingface dataset:
The Effect of an Inpatient Home-work Exercise Program on Leg Function After Stroke

This study would focus on a new method of adding extra leg homework exercises to the usual therapy delivered in the hospital. We propose to design an exercise program for the affected leg that would be given to the client as homework and done in the client's hospital room or ward. The program would be designed and monitored by a therapist that works in the hospital.

In total 120 participants admitted for stroke rehabilitation in the province British Columbia, Canada will be randomly assigned to either the Leg Exercise group or Leg Management group. The extra leg exercise group (experimental group) will receive usual therapy plus 60 minutes per day of self-directed leg exercises. This program will last for 4 weeks while the participant is in the hospital. The Leg Exercise program will include exercises of range of motion, leg strengthening, weight-bearing, and walking. The family will be encouraged to participate in the program with the participant. The control group (Leg Management group) will receive usual therapy and stroke education.

Eligibility Criteria:
Inclusion Criteria:

* Have been admitted to a hospital unit for stroke treatment
* 19 years or older
* Are experiencing difficulty using legs
* Able to understand and follow instructions

Exclusion Criteria:

* Have uncontrolled hypertension or unstable cardio-vascular condition
* Injuries to muscles, bones, or joints of the leg
* Unable to verbally speak or understand the investigators when asked questions
The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer

This is a phase II, prospective, multicenter, study to evaluate the recurrence gene profiles of adjuvant osimertinib therapy in resected EGFR-mutated NSCLC.

This is aprospective, multicenter, phase II study to evaluate the recurrence gene profiles of adjuvant osimertinib therapy in resected EGFR-mutated NSCLC. Approximately 60 NSCLC patients with EGFR-sensitive mutations (19del, L858R) who received adjuvant osimertinib after complete resection were enrolled. The primary endpoint was to assess the recurrence gene profiles of adjuvant Osimertinib therapy. The secondary endpoint was to explore of subgroups recurrence gene profiles of different recurrence types (local /distant) after adjuvant Osimertinib therapy and to describe the diverse treatment patterns in real clinical practice after the disease progressed.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent signed;
2. Age ≥ 18 years;
3. Histologically confirmed diagnosis of non-squamous non-small cell lung cancer;
4. Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection;
5. Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy;
6. Recurrence after/on Osimertinib treatment according to RECIST 1.1;
7. NGS gene test report (tumor or blood sample) at the time of recurrence;
8. Receiving or not receiving neoadjuvant treatment before surgery.

Exclusion Criteria:

1. Patients with stage I-III NSCLC whose surgical resection cannot be confirmed;
2. Received adjuvant therapy other than that specified in the ADAURA study;
3. No NGS test report at recurrence;
4. History of other malignant tumors within 2 years;
5. Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has treatment-related complications High risk etc.
Delivery Optimization for Pre-Exposure Prophylaxis (DO PrEP) Study

The overall goal is to determine whether an end-to-end decentralized delivery service for PrEP is more effective, safe, acceptable, and cost-effective than facility-based PrEP delivery.

Optimizing pre-exposure prophylaxis (PrEP) delivery with a focus on priority populations is critical to realize the enormous potential of PrEP for HIV prevention. HIV incidence remains relentlessly high among young women and sexual minority men and primary prevention is critical to achieving control of the HIV epidemic. With effective and persistent use, oral pre-exposure prophylaxis (PrEP) for HIV prevents 75%-100% of HIV cases among cisgender women and men, gay and bisexual men, and transgender women. Despite the high efficacy, uptake throughout the PrEP prevention cascade remains low.

South Africa is expanding PrEP provision but requires evidence-based strategies on how to achieve access, effective use, and persistence. The current clinic-based requirement of PrEP to persons at risk for HIV acquisition requires that clients self-identify their exposure to HIV and visit the clinic regularly for initiation, monitoring and refills. Barriers to PrEP access include clinic level factors (i.e. staff training, brief visits) and individual level factors including logistics such as transportation for clinic visits. The priority is to determine how to deliver PrEP in a scalable way and achieve high PrEP access and effective, persistent use.

PrEP is a highly efficacious HIV prevention strategy but requires effective strategies that streamline delivery and engage users for scale-up. Community-based strategies for HIV testing, ART initiation, and monitoring successfully reach people living with HIV for treatment and have made marked improvements to viral suppression.

This protocol describes a randomized clinical study to test an end-to-end decentralized delivery service for PrEP. It aims to safely increase PrEP access and use among priority populations in South Africa. Participants will include 16-30 year old HIV negative women and sexual minority men at high risk for acquiring HIV. As a critical component of decentralized delivery, we will also evaluate the safety and efficacy of HIV self-testing compared to rapid diagnostic tests.

Eligibility Criteria:
Inclusion Criteria:

* Aged 16 years - 30 years old,
* Men in serodifferent relationships or those reporting male to male sex,
* Heterosexual cis-gender females
* Interested in use of PrEP for HIV prevention
* Able and willing to provide informed consent for study procedures

Exclusion Criteria:

* HIV infection based on negative HIV rapid tests
* Clinically ineligible for PrEP
* The participant doesn't reside in the study community for the duration of follow-up
Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders

Both patients and remitters ask for treatment with Botulinumtoxin A (BTX) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent.

The aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect of BTX is dose dependent.

The primary goal with this study is to expand treatment modalities for patient with myogenous TMD, and to develop clinical protocols with adequate doses for myogenous TMD. A secondary goal is to study if there are differences in treatment effect between sub-groups of myogenous TMD for more personalised pain-treatment.

Hypothesis The investigators hypothesis is that application of BTX into the masseter and temporalis muscle will reduce pain and increase quality of life in patients with myogenous TMD, and that the reduction of pain is only to a certain degree due to the dose. High doses of BTX does not necessarily entail increased reduction of pain or better quality of life. The investigators also hypotheses that the effect may differ in sub-groups of myogenous TMD.

Eligibility Criteria:
Inclusion Criteria:

* Has given a written consent
* Diagnose of myalgia, myofacial pain or myofascial pain with referred pain according
* Average pain due to NRS ≥ 3 for more than three months
* Palpationpain in masseter or temporalis.
* Eventual treatment for orofacial pain \> three months ago.
* Adequate contraceptives and a negative pregnancy test.

Patients will still be included even if they have one or more co-diagnoses

* Discdisplacement with or without reduction
* Degenerative joint disease
* Arthralgia

Exclusion Criteria:

* Treatment with BTX during the last 12 months
* Treatment for orofacial pain within the last 3 months.
* Systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)
* Widespread pain e.g., fibromyalgia
* Neuropathic pain
* Neurologic disease (myasthenia gravis)
* Pain of dental origin
* Use of muscle relaxants, or aminoglycoside antibiotics
* Pregnancy or nursing
* Hypersensitivity to BTX
* Neuropsychiatric conditions.
* Difficulties understanding the Swedish language
Endoscopic Robot-Assisted Simple Enucleation Versus Standard Robot-Assisted Partial Nephrectomy in the Treatment of T1 Renal Cell Carcinoma

This is a non-inferiority, randomized controlled trial to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation(ERASE) and standard robot-assisted partial nephrectomy(RAPN) in the treatment of T1 renal cell carcinoma.

Simple enucleation (SE) consists of excising the tumor by blunt dissection following the natural cleavage plane between the peritumoral capsule and the renal parenchyma without removing a visible rim of healthy renal tissue, which appears to reserve more renal parenchyma without compromising oncologic safety, may be an alternative to standard partial nephrectomy (PN). Although published studies showed excellent long-term oncologic results, many urologists still consider SE an unsafe technique with a high risk of incomplete tumor excision. The aim of this study is to compare the peri-operative, renal functional and oncologic outcomes of endoscopic robot-assisted simple enucleation(ERASE) and standard robot-assisted partial nephrectomy(RAPN) in the treatment of T1 renal cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. patients with sporadic, unilateral, newly diagnosed T1 presumed renal cell carcinoma
2. ECOG score \<=1
3. RENAL score \<=9
4. patients with normal contralateral renal function
5. patients giving consent to the participation in the current clinical trial

Exclusion Criteria:

1. intolerance of robotic surgery
2. metastastic renal cell carcinoma
3. RENAL score \>=10
4. entry into collection system or hematuria
5. patients with a history of other renal diseases, such as urinary lithiasis
6. patients with a history of renal surgery
Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy

The purpose of this study is to evaluate the flow of oxygen and blood necessary for nutrient transfer across the placenta during the second and third trimesters in pregnancy in women who are obese before pregnancy compared to women who have an average weight before pregnancy. This study will evaluate blood flow across the placenta by functional Magnetic Resonance Imaging (fMRI) using arterial spin labeling (ASL). The investigators hypothesize that there will be differences in placental oxygenation and blood flow among women with obesity as compared to those with normal weight. Participants will be asked to complete Magnetic Resonance Imaging scans (MRIs), the first in the second trimester at 20-24 weeks and the second in the third trimester at 30-34 weeks.

The transfer of oxygen and nutrients from the mother to the baby across the placenta is essential to successful pregnancy outcomes. Conversely, poor transfer of oxygen from the mother to the baby through the placenta is associated with adverse outcomes, including poor fetal growth, preterm delivery, and stillbirth. Babies need oxygen to maintain good health. Babies born to women who are obese before pregnancy have a higher risk of experiencing health problems in pregnancy and long-term health problems such as metabolic syndrome, obesity, and diabetes. Obesity has continued to increase in the United States over the past decades, and a quarter of pregnancy complications, such as preterm birth, gestational diabetes, hypertension, and large gestational infants, can be attributed to maternal obesity.

In this study, the investigators propose using a novel method, arterial spin labeling (ASL)) to measure placental blood flow. The study aims to evaluate the feasibility and reliability of assessing placental blood flow by this novel method. The investigators will also evaluate the mean global placental perfusion of second and third trimester placentas among obese women as compared to those with a normal weight before pregnancy. To provide an innovative and comprehensive evaluation of placental oxygen delivery and insights into the delivery of nutrients, investigators will compare global placental perfusion of second and third trimester placentas with measurements of placental oxygenation by R2\* relaxation rates.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy

Exclusion Criteria:

* multifetal gestation
* congenital anomaly
* claustrophobia, or ineligible for MRI (incompatible implanted medical device)
Description of the Short-term Effects of KAFTRIO® by Continuous Monitoring With the PHEAL-CR-K Application in Real Life in Patients With Cystic Fibrosis Eligible for KAFTRIO® Treatment

This is a prospective, open-label, multicenter study (1 year) with 50 patients with cystic fibrosis for whom treatment with KAFTRIO® is prescribed.Cystic fibrosis is a rare autosomal recessive hereditary disease linked to a mutation of the CFTR (Cystic Fibrosis Transmembrane Regulator) protein gene. For the majority of patients, no treatment with a CFTR protein modulator was available until the arrival of the KAFTRIO® triple therapy (ivacaftor/tezacaftor/elexacaftor). Clinical studies on this triple therapy demonstrate significant improvements in FEV (forced vital capacity) and also very rapid health improvement of patients. However, there is a lack of data recorded in real life at home by patients to trace the evolution curves of health parameters and patient perceptions from the first days after initiation of treatment. The PHEAL-CR-K application, specially developed for the study, makes it possible to collect physiological parameters and perceptions collected via connected objects or declared manually in the application. These data will reflect the evolution of the parameters from the start of the treatment and over a period of 3 months. In addition, the composition of volatile organic compounds (VOCs) of the air exhaled in the early phase of treatment with KAFTRIO® will be monitored for the group of patients followed at Foch Hospital. Exhaled air is an ideal biological fluid for clinical monitoring (non-invasive collection and real-time analysis). In cystic fibrosis, biomarkers in the exhaled air have been correlated with functional and clinical parameters. The objective is to collect the air exhaled before initiating treatment with KAFTRIO® and during treatment, to identify VOCs whose expression would be modified early. Changes in the composition of the exhaled air will be correlated with follow-up clinical data collected with the PHEAL-CR-K application and with functional data obtained during measurements of breath by spirometry (FEV) and sweat concentrations of chloride ions collected at the during a sweat test. The identified COVs could become early predictive biomarkers of clinical response.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over
* Patients with Cystic Fibrosis eligible for KAFTRIO®
* Patients for which KAFTRIO® treatment is prescribed, including patients previously treated with other CFTR modulators (ORKAMBI®, KALYDECO®, SYMKEVI®)
* Patients who signed the informed consent form
* Patients affiliated to a health insurance plan
* Patients equipped with a smartphone and having a Wifi connection at home

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patient who does not speak or understand French
* Patient deprived of liberty or under guardianship
Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD

This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD).

Current front-line treatments for Posttraumatic stress disorder (PTSD) are ineffective for up to half of patients, with serious medical and societal consequences. It is imperative to improve the efficacy of front-line treatment options, such as cognitive processing therapy (CPT). CPT is an effective treatment for PTSD, including when delivered intensively (i.e., multiple sessions over 7 days). However, a substantial proportion of patients continue to meet criteria for PTSD or have residual PTSD symptoms post-treatment. Psilocybin-assisted CPT may be a potential solution, as preliminary evidence supports the potential of psilocybin to alleviate symptoms of PTSD.

Fifteen participants will receive a single dose of psilocybin 25mg combined with 12 sessions of massed CPT, and 2 psychotherapy sessions related to psilocybin over 7 days. Participants will complete clinician-administered scales, self-reported mental health questionnaires, and use a wearable device. After the 1-week interventional period, participants will enter a 12-weeks follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a duration of 6 months or longer assessed by study psychiatrist;
2. Have a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 50 or higher, indicating moderate to severe PTSD symptoms;
3. Are willing to refrain from taking any psychiatric medications during the study period.

Exclusion Criteria:

1. Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control;
2. Have a history of or a current primary diagnosis of psychotic disorder, schizophrenia, delusional disorder, borderline personality disorder, schizoaffective disorder, bipolar disorder or, dissociative identity disorder;
3. Have evidence or history of coronary artery disease or cerebral or peripheral vascular disease, hepatic disease with abnormal liver enzymes, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration;
4. Have hypertension using the standard criteria of the American Heart Association (values of 140/90 or higher assessed on three separate occasions;
5. History of seizure disorder;
6. Uncontrolled insulin-dependent diabetes;
7. Recent stroke, intracranial or subarachnoid hemorrhage (\< 1 year from signing of informed consent form \[ICF\]), recent myocardial infarction (\< 1 year from signing of ICF), clinically significant arrhythmia (\< 1 year from signing of ICF);
8. Have liver disease with the exception of asymptomatic subjects with Hepatitis C who have previously undergone evaluation and successful treatment;
9. Lifetime history of substance-induced psychosis;
10. Lifetime history of substance use disorder with a hallucinogen;
11. History of alcohol use disorder in the past 3 months.
Mechanical Stimulation on Pain Level and Functional Discomfort After Breast Cancer Surgery

This study evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months, in breast cancer needing physiotherapy, following a total mastectomy and exploratory axillary surgery.

A prospective, monocentric, randomized, open-labelled in two parallel groups study that evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months in breast cancer patients needing physiotherapy, following a total mastectomy and exploratory axillary surgery.

Other objectives of the study include:

* Evaluate the efficacy of mechanical stimulation technique compared to massages on pain and functional discomfort (on the mobility of the shoulder) 15 days after the end of physiotherapy.
* Evaluate the impact of mechanical stimulation on the quality of life of patients, in comparison to those receiving massages

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient who had total mastectomy for a breast cancer or pre-cancerous lesions
* Associated with axillary dissection or removal of the sentinel lymph nodes
* Presenting with functional discomfort and/or pain at the control consultation, 3 weeks after the mastectomy and justifying the prescription of physiotherapy
* Possibility to be treated by a physiotherapist who can carry out both techniques and accepts to perform either one of the techniques according to the randomized allocation of the treatment
* Patient covered by the French social security regime
* Signed and informed consent

Exclusion Criteria:

* Immediate breast reconstruction
* Total bilateral mastectomy
* Contraindication to mechanical stimulation technique
* Patient who are planning to move houses in the next 6 months
* Patients under guardianship
Canadian Trial of Dietary Carbohydrates in Diabetes

A long-term low carbohydrate, high monounsaturated fat diet, compared to a high carbohydrate, low glycemic index diet, results in more rapid progression of diabetes; i.e. increased fasting glucose and glycated hemoglobin, reduced beta-cell function and insulin sensitivity and increased free fatty acids. The deleterious effects of a high carbohydrate diet on plasma lipids are only temporary and do not persist beyond 6 months. A long-term high carbohydrate, low glycemic index diet, compared to a high carbohydrate, high glycemic index diet, improves glycemic control and beta-cell function


Eligibility Criteria:
Inclusion Criteria:

* male or non-pregnant/non-lactating females with type 2 diabetes treated by diet alone
* age 53-75y
* body mass index 25-40kg/m\^2 (Caucasian) or 23-40kg/m\^2 (other)
* HbA1c \<=130% of upper limit of normal of local hospital lab

Exclusion Criteria:

* use of any hypoglycemic or anti-hyperglycemic drug within 6 months of randomization
* major cardiovascular event or major surgery within 6 months of randomization
* serum triglycerides \>10mmol/L
* presence of other major debilitating disorder such as liver disease, renal failure or cancer
* presence of gastrointestinal disorder or use of drug which is likely to alter gastrointestinal motility or nutrient absorption
* use of oral steroids
* substance or alcohol abuse
* simultaneous participation in another clinical trial
* allergy or intolerance to more than one of wheat, barley, corn, oats, potato, legumes, nuts, psyllium, olives, avocado or canola
* unwilling or unable to follow the protocol and/or give informed consent
* subjects planning to be on holiday for more than 8 weeks in a row or a total of 12 weeks in the year in locations to which they will not take study food
Bacterial Ano-rectitis Sexually Transmitted in a Specialized Consultation Center

Infectious ano-rectitis is poorly described. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly corrected in gastroenterology and new diagnostic tools are now available) and therapeutic aspects.

Analysis of data from this large population of patients referred to the proctology center for suspicion of Neisseria gonorrhoeae and / or Chlamydia trachomatis ano-rectitis will help identify risk factors and target prevention strategies and optimized therapeutic management.


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18
* Patient consulting or hospitalized in the proctology center
* Patient for whom an anorectal sampling will be performed for suspicion of sexually transmitted infectious ano-rectitis

Exclusion Criteria:

* Patient's opposition to participate
* Patient deprived of liberty
* Patient under guardianship