cyrilzakka/clinical-trials huggingface dataset:
Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C

This study is designed to provide a preliminary assessment of the safety and effectiveness of the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the treatment of chronic hepatitis C virus infection.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 to 65 years of age; if females are of childbearing potential, then they must be willing to use two non-hormonal methods of birth control
2. Body weight greater than 40 kg and less than 125 kg
3. Clinical diagnosis of chronic hepatitis C
4. Treatment-naïve for hepatitis C: no previous treatment with interferon, pegylated interferon, ribavirin, telaprevir, boceprevir, or any investigational therapies for hepatitis C
5. No symptoms or signs of intercurrent illness at Screen (other than those attributable to hepatitis C)
6. No clinically significant abnormalities in the 12-lead electrocardiogram at Screen
7. Signed informed consent prior to trial participation.

Exclusion Criteria:

1. Seropositive for HIV antibody or Hepatitis B Surface Antigen at Screen
2. Liver disease due to causes other than chronic HCV infection
3. Symptoms or signs of decompensated liver disease, or evidence of cirrhosis
4. Any medical condition that may interfere with the absorption, distribution or elimination of study drugs
5. Poorly controlled or unstable hypertension at Screen.
6. Clinically significant, unstable cardiovascular or pulmonary disease, including cardiovascular or pulmonary disease requiring pharmacologic intervention other than anti-hypertensive medications, statins, and/or prophylactic aspirin (or similar anticoagulant).
7. Red blood cell disorder, including (but not limited to): thalassemia major or minor, sickle cell anemia.
8. Diabetes Mellitus treated with insulin or hypoglycemic agents
9. History of asthma requiring hospital admission within the preceding 12 months
10. History of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements, or with the safety or efficacy assessments in this study
11. Patients requiring treatment, during this study, with any of the medications on the restricted medications list (provided in the investigator site file), are not eligible for this study due to considerations of possible drug interactions with the study drug regimen.
Optimizing Treatments for Heart Failure During Hospitalization

Heart failure reaches 1.5 million people in France and is responsible for 200,000 hospitalizations per year.

Over the past ten years, new therapies have emerged (treatment of martial deficiency, Entresto, iSGLT2).

Hospitalization in a context of acute heart failure is a moment of choice in the history of the disease to introduce recommended treatments under closer supervision (clinical, biological) than in ambulatory, and allows a decrease in hospitalizations, morbidity and mortality.

The purpose of this study is to describe the introduction of heart failure drugs (including iSGLT2) in real-life settings in patients hospitalized for decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years
* Hospitalized (≥24h) for decompensated heart failure in cardiology.

Exclusion Criteria:

* Patient opposition participation in research and use of data.
Optimizing Tobacco Treatment Delivery for People Living With HIV

The purpose of this study is to conduct a randomized trial to evaluate a proactive, opt-out model of provider contact to deliver smoking cessation support for people living with HIV compared to standard care support delivered through traditional clinic pathways. Investigators will also evaluate implementation outcomes to identify barriers and facilitators towards future implementation. Investigators hope to define best practices and optimize the delivery of smoking cessation interventions for people living with HIV.

This hybrid effectiveness-implementation trial presents on opportunity to optimize tobacco treatment delivery for people living with HIV (PLWH), and identify barriers and facilitators towards future implementation. We are proposing a comparison of Treatment As Usual (TAU; reactive, opt-in tobacco treatment using standard clinical pathways) vs Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Participants will be randomized in a 1:1 allocation. The primary aim is to compare rates of cessation and quit attempts at the Week 12 follow-up between participants who received TAU versus PrOMOTE. As a secondary aim we will characterize key determinants of PrOMOTE reach, implementation fidelity, adherence, and acceptability. We hypothesize that the PrOMOTE intervention will increase cessation rates and number of quit attempts, and that it will result in greater reach and pharmacotherapy delivery compared to TAU. Key determinants of PrOMOTE implementation outcomes will also be characterized. An exploratory assessment of CD4 cell count and HIV viral load, in addition to durability of smoking cessation outcomes, will also be assessed. By optimizing the delivery of effective tobacco treatments for PLWH, we hope to increase the number of people receiving tobacco treatment, increase tobacco cessation rates, and reduce the risk of morbidity and mortality from smoking-related causes.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 and older
* Current diagnosis of HIV
* Current smoker (defined as self-report of current smoking)
* Willing to be randomized
* English speaking

Exclusion Criteria:

* Currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking nicotine replacement therapy or other cessation medications, enrolled in the Quitline, or in another study)
* Currently imprisoned
* Pregnant women
* Non-English speaking persons
Comparison of Abdominal Draw-in Maneuver With Real-time Ultrasound Imaging Biofeedback vs Conservative Physical Therapy in Patients With Chronic Low Back Pain

The aim of this study is to compare the effectiveness of abdominal drawing-in maneuver with real-time ultrasound biofeedback to conservative treatment in patients with chronic nonspecific low back pain.

Low back pain is a common clinical condition among musculoskeletal disorders. It can be classified into two main categories: acute and chronic. Acute low back pain is usually limited to a duration of 6 weeks or less, whereas chronic low back pain refers to pain lasting 12 weeks or longer. Chronic low back pain is characterized by persistent and untreated pain, which can significantly affect individuals' physical and psychological health. A multidisciplinary approach is required for its treatment. Physical therapy, pharmacological approaches, psychotherapy, and exercise are the main treatment methods.

Exercise plays an active role in both the prevention and treatment of the disease. Among many exercise methods, the abdominal drawing-in maneuver has been proven effective in the literature. Biofeedback is a technique that helps individuals consciously control their physiological processes. Real-time ultrasound biofeedback stands out as a technique that directly visualizes musculoskeletal system functions. This method uses high-frequency sound waves to assess the dynamic movements of internal organs and muscle structures. Through this technology, individuals can visualize their movements in real time and consciously adjust their muscle activity or posture. It offers significant advantages, particularly in clinical and sports applications such as pelvic floor rehabilitation, postural balance training, and motor control skill development.

The aim of our study is to compare the effectiveness of exercises performed with real-time ultrasound biofeedback with those in patients receiving conservative treatment. Patients will be randomly assigned to two groups: Group 1: Patients receiving conservative treatment and performing the abdominal drawing-in maneuver with real-time ultrasound imaging biofeedback. Group 2 (Control Group): Patients receiving conservative treatment and performing the abdominal drawing-in maneuver with only verbal instruction. A total of 40 patients are planned to be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* The duration of low back pain is at least 3 months.
* Low back pain with or without radiation to the lower extremities.
* Age between 18-65 years.
* Chronic nonspecific low back pain patients.

Exclusion Criteria:

* Neuropathic pain complaints.
* Pregnancy status.
* History of infection, cancer, or trauma.
* Neurological abnormalities.
* History of lumbar spine surgery.
* History of conservative physical therapy and/or injections in the lumbar region within the last 6 months.
* Neurological diseases such as Parkinson's or Multiple Sclerosis.
* Systemic diseases that prevent exercise.
* Patients with a Mini-Mental Test score below 24.
2 Courses of Concurrent Cisplatin Chemoradiotherapy After Surgery for High-risk Head and Neck Squamous Cell Carcinoma

The main objective of this trial was to determine the value of 2 courses of cisplatin concurrent chemotherapy in postoperative adjuvant radiotherapy for high-risk head and neck squamous cell carcinoma.

The main objective of the trial was to evaluate whether the 3-year failure-free survival (FFS) rate in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant radiotherapy and 2 courses of concurrent cisplatin chemotherapy after surgery was no less than 10% compared with 3 courses of concurrent cisplatin chemotherapy. The secondary objective was to evaluate efficacy and toxicity of 2 courses of concurrent cisplatin chemotherapy (100mg/m2, days 1 and 22) during adjuvant intensity-modulated radiation therapy will be compared with 3 courses of concurrent cisplatin chemotherapy (100mg/m2, days 1, 22 and 43).

Eligibility Criteria:
Inclusion Criteria:

A. The pathological type is head and neck squamous cell carcinoma

* Stages III and IV

B. Radical surgery has been performed with high risk factors (one of below)

* extracapsular invasion of cervical metastatic lymph nodes
* positive incisional margin or inadequate incisional margin safety distance

C. No evidence of distant metastasis (M0).

D. Functional status: Karnofsky scale (KPS) \> 70.

E. Normal bone marrow function:

* white blood cell count \> 4×109/L
* hemoglobin \> 120g/L in males, 110g/L in females
* platelet count \> 100×109/L

G. Normal liver function:

* alanine aminotransferase (ALT), aspartate aminotransferase (AST) \< 1.5 times the upper limit of normal (ULN)
* alkaline phosphatase (ALP) \< 2.5×ULN
* bilirubin \< ULN.

H. Normal renal function: creatinine clearance \> 60 ml/min.

I. Patients must be informed of the basic contents of this study and sign informed consent.

Exclusion Criteria:

A. Age \>70 years or \<18 years.

B. Treatment is palliative.

C. Previous chemotherapy (except induction chemotherapy prior to surgery).

D. Previous radiation therapy.

E. Women who are pregnant or breastfeeding

F. Previous history of malignant tumor.

G. With other serious medical conditions that may pose a greater risk or affect compliance with the test. Examples include:

* unstable heart disease that requires treatment
* kidney disease
* chronic hepatitis
* poorly controlled diabetes (fasting blood glucose \> 1.5×ULN)
* mental illness.
Assessment of the Quality of Life of Multiple Sclerosis Patients Treated With Ofatumumab in Real-life in France

SEPROS is a non-interventional study, based on primary data collection of MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol.

This is a non-interventional, prospective (primary data), multicenter study conducted in metropolitan France. The primary objective of this study is to describe the quality of life of MS patients after initiation of treatment with ofatumumab.

In order to form a representative sample of MS patients taking into account the terms of care in France, free or practicing neurologists in healthcare institutions (public or private) in different regions of France will be selected to participate in this study.

The study will enroll adult patients with MS who initiated ofatumumab according to the physician's advice and independently of the study. Patients will be followed from initiation of ofatumumab either until (i) 12 months (± 1month) after initiation of ofatumumab (End of Study), or until (ii) discontinuation of treatment with ofatumumab prior to the completion of the 12-month follow-up (early termination); whichever occurs first (end of study or early termination).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 years of age or older
2. Patient with confirmed MS diagnosis
3. Patient initiating treatment with ofatumumab for the first time
4. Patient for which the decision to initiate treatment with ofatumumab was made by the doctor (investigator) in accordance with his/her usual practices independently of the study
5. Patient not opposed to participation in this study
6. Patient willing and able to complete patient questionnaires

Exclusion Criteria:

1. Patient treated with ofatumumab in the context of a clinical trial
COVID-19 Seroprevalence in Pregnant Women and Blood Donors

The study aims to measure the SARS-CoV-2 seroprevalence (ie. the proportion of people with antibodies against the virus) in pregnant women and blood donors in an administrative area of France, and to determine whether these measures are representative of the general population.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women

  * Adult female
  * Admitted to hospital for live birth
  * Informed consent
  * Affiliated to the French social security health insurance scheme
* Blood donors

  * Adult male or female
  * Qualified for whole blood donation (up to 70 years old in France)
  * Informed consent
  * Affiliated to the French social security health insurance scheme

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Subject without health insurance coverage
* Exclusion period of another study or exclusion period of the French national healthy volunteer registry
The Effect of rPMS on Motor Skill Performance in Persons With a Stroke.

In the past two decades, even as stroke cases increase around the world, advances in motor rehabilitation have been limited. Clinical trials of stroke rehabilitation have examined the therapeutic utility of several neuromodulatory devices to improve efficacy of motor training. However, there is limited knowledge on the effects of sensory-based priming techniques using repetitive peripheral magnetic stimulation (rPMS) post stroke. This project focuses on understanding the effect of rPMS on motor skill performance in persons with stroke.

The central hypothesis of this study is that rPMS is a suitable priming technique for enhancing motor skill performance in individuals with stroke. The investigators plan to test our hypothesis by pursuing the following specific aim:

To determine whether rPMS can facilitate lower limb's motor skill performance more than sham rPMS in individuals with stroke.

Hypothesis: The effect of stimulation on lower limb's motor skill performance will be measured using a visuomotor tracking task at different time points: baseline, immediately after, at 30 minutes, and 60 minutes after stimulation. Individuals with stroke during the rPMS condition will demonstrate greater motor skill performance following rPMS and will be able to sustain the enhanced performance at 30 and 60 minutes after the stimulation, compared to sham condition.

This study will improve our understanding of the effects of rPMS, thus encouraging the use of a single session of rPMS as a priming tool to enhance motor skill performance. The proposal is important as it is the first to study the time course effects of rPMS on lower limb's motor skill performance in stroke populations.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed mono-hemispheric stroke
* More than 3 months since stroke onset.
* Participants must demonstrate adequate cognitive abilities to be able to follow the protocol (21\>MMSE).

Exclusion Criteria:

* Individuals with lesions affecting the brainstem or cerebellum.
* Other musculoskeletal or neurological impairments such as (Alzheimer, Parkinson, etc.).
* Complete paralysis that would limit the participant's' ability to perform motor skill tasks.
A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)

The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD) to each other and also to that of healthy matched control participants. This study will also evaluate the safety and tolerability of a single oral 120 mg dose of belzutifan in participants with ESRD and the extent of belzutifan removed by HD.


Eligibility Criteria:
Inclusion Criteria:

For Participants With Healthy Renal Function

* Is in good health based on the opinion of the investigator.
* Male participants agree to remain abstinent from heterosexual intercourse on a long-term basis or must agree to use contraception as instructed.
* Female participants must be of nonchildbearing potential.

For Participants With end stage renal disease (ESRD)

* With exception of the renal impairment, is in good health based on the opinion of the investigator.
* Has ESRD maintained on stable regimen of at least 3 times per week hemodialysis (HD) for at least 3 months prior to the initial administration of the study intervention.
* Male participants agree to remain abstinent from heterosexual intercourse on a long-term basis or must agree to use contraception as instructed.
* Female participants must be of nonchildbearing potential.

Exclusion Criteria:

For Participants With Healthy Renal Function

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* Has a history of cancer (malignancy).
* Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
* Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
* Has received any non-live vaccine starting from 14 days prior to study intervention or is scheduled to receive any non-live vaccine through 30 days following study intervention (except coronavirus disease 2019 \[COVID-19\]).

Participants With ESRD

* Has a history of cancer (malignancy).
* Has required frequent emergent HD (≥3) within a year prior to the initial dose of study intervention.
* Is positive for HBsAg, hepatitis C antibodies, or HIV.
* Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
* Has received any non-live vaccine starting from 14 days prior to study intervention or is scheduled to receive any non-live vaccine through 30 days following study intervention (except COVID-19)
Characterizing Response to Antipsychotics in Schizophrenia

The goal of this research project is to develop MRI-based biomarkers to identify patients with schizophrenia who are most likely to benefit from first-line antipsychotic or clozapine treatment. The MRI sequences (NM-MRI, MRS and rsfMRI) will be created by translating the best scientific evidence into a potential clinical product that has the highest chance of being clinically relevant predictor of treatment response. This study has the potential to significantly improve patient outcomes and reduce unnecessary interventions and costs at the Royal's Integrated Schizophrenia Recovery Program.

Currently, we cannot predict who will get better on first-line antipsychotic versus clozapine treatment. Although much evidence shows that dopamine and glutamate function are related to treatment response in schizophrenia, the utility of neuromelanin sensitive MRI (NM-MRI) as a measure of dopamine and magnetic resonance spectroscopy (MRS) as a measure of glutamate \& glycine (a co-agonist of glutamate receptors) in predicting response to treatment have never been measured in the same sample. The evidence suggests that the function of these two neurotransmitter systems partially determines the response to antipsychotic medications. Additionally, an emerging type of resting-state functional MRI (rsfMRI), naturalistic movie-watching, has been shown to outperform traditional rsfMRI for functional connectivity-based prediction of behaviour and will be explored in the current study. Given the background information, our hypotheses are:

1.1) First-line antipsychotic users will have higher dopamine turnover resulting in a higher NM-MRI signal in the substantia nigra relative to clozapine users.

1.2) First-line antipsychotic users will have lower glutamate and/or glycine concentration as indicated by the MRS signal in the dorsal anterior cingulate relative to clozapine users.

Eligibility Criteria:
Inclusion Criteria:

* Are voluntary and competent to consent to the study
* Are between the ages of 18-55
* Are English literate
* Have a diagnosis of schizophrenia or schizoaffective disorder
* Are currently taking primarily olanzapine or clozapine

Exclusion Criteria:

* Medication for the treatment of schizophrenia or schizoaffective disorder has changed in the past month
* Have a significant neurologic, neurodevelopmental, cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, or metabolic-endocrine disorder
* Are pregnant or breastfeeding
* Acquire positive urine test result for all drugs of abuse including cannabis
* Have met DSM-5 criteria for substance use disorder other than tobacco in the last 6 months
* Have a history of significant head trauma with loss of consciousness for more than 5 minutes
* Have any contraindication to MRI
* Have any other condition that in the opinion of the investigator(s) could create a hazard to the subject's safety, endanger the study procedures, or interfere with the interpretation of study results