cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of URGOBD001 Compression System

Evaluation of the efficacy (wound epithelialization and time to closure) and safety (emergence and nature of adverse event) of the new URGO BD001 compression system versus a reference compression in the local treatment of venous or mixed predominantly venous leg ulcers: prospective multicenter, randomized controlled, open-label clinical study

This is a prospective, randomized, controlled, open-label, multicenter clinical trial conducted in patients with a leg ulcer of venous or mixed predominantly venous origin of stage C6 / C6r of the CEAP classification.

This study is carried out in around 55 French investigational centers. A total of 178 patients meeting the eligibility criteria will be included. The patients will be followed for 12 weeks and a total of 5 clinical evaluations will be carried out by the investigating centers.

A planimetric survey of the studied VLU is carried out during the initial assessment of the wound (Day 0) and at each assessment provided for in the protocol (Week 2, Week 4, Week 8 and Week 12).

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥ 18 years old), having given free, informed and written consent
* Patient affiliated to a social security scheme
* Patient agreeing to wear the study compression system daily
* Patient with an ankle circumference between 18 and 25 cm
* Target wound: stage C6 / C6r leg ulcer of the CEAP classification with a 0.8≤ ABPI≤1.3
* Target wound with an area between 1 and 20 cm2
* Target wound with age of ≤24 months

Criteria exclusion:

* Patient with a systemic infection not controlled by appropriate antibiotic therapy
* Patient having presented in the 3 months preceding his inclusion, a deep vein thrombosis
* Patient with advanced stage II or stage III lymphoedema
* Patient bedridden or spending less than an hour per day standing
* Clinically infected target wound
* Cancerized target wound
Does Intra-operative MarginProbe Use Reduce Re-excision Rates?

The new device we are looking at is called the MarginProbe. It is a disposable probe which measures the margins of tissue removed to check they are clear of cancer cells, during breast conservation surgery. After specimen radiology, allows the Surgeon to remove further tissue if necessary, during the same operation if any involved margins are identified. This minimises the need for further repeat operations.

Previous studies carried out elsewhere in the world (USA and Israel) have identified that the probe reduces re-excision rate but there has never been a study in the UK.

The trial involves randomly allocating patients once they are in theatre, to either the MarginProbe procedure after breast conserving surgery and radiology has been completed, or not.

Almost 60% of all patients diagnosed with breast cancer (48000 annually in the UK) undergo breast conserving surgery (BCS. Surgical removal of the cancer aims to reduce the risk of local recurrence and patient mortality. In order to minimise the amount of tissue removed, excision up to the cancer-free area (margins) is undertaken. Further surgery, following initial breast cancer surgery, is required in 25% - 30% of patients because of disease found at the edges of the tissue removed.

Reducing the need for further operations benefits patients (by reducing the number of operations required, improving cosmetic outcome and minimising anxiety) and the NHS (by realising economic benefits).

MarginProbe, a disposable probe which measures the margins of tissue removed during breast cancer surgery, allows the surgeon to remove further tissue during the same surgical procedure to clear any involved margins, minimising subsequent re-operations. Four hundred and sixty patients in 6 specialist Breast Units will be randomly allocated after BCS (and specimen radiology), by telephone randomisation, to either:

* MarginProbe assessment of the surgical specimen with re-excision of margins if required;
* Standard BCS (clinical and radiological clear margins) whereby the wound will be closed and the surgery completed (standard UK practice).

Eligibility Criteria:
Inclusion Criteria;

* Women aged 18-90 years with DCIS or Invasive Breast cancer containing DCIS diagnosed histopathologically.
* Histologically diagnosed DCIS or invasive lobular cancer in core biopsy (B5a or B5b).
* Tumour size 1.5cm - 4cm and undergoing breast cancer surgery. Written informed consent.

Exclusion Criteria;

* Unsuitable for BCS on basis of tumour size (\<1.5cm or \>4cm) or stage.
* Radiotherapy contraindicated.
* No histopathological evidence of DCIS or invasive lobular cancer.
* Neoadjuvant chemotherapy.
Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients

The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an optimal dose of sublingual (Under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.


Eligibility Criteria:
Inclusion Criteria:

* Pain due to cancer or its treatment; controlled baseline pain;
* episodes of breakthrough pain every day that are "4/10" in severity or greater, ;
* ast 10 minutes or longer, and
* are responsive to short acting oral opioids such as morphine or hydromorphone;
* are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent;
* are able to fill out the study forms

Exclusion Criteria:

* Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid;
* prior sensitivity to methadone;
* currently are being administered methadone;
* have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain,
* new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain);
* are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely
Hypnosis, Self-hypnosis and Weight Loss in Obese Patients

High food impulsiveness, impaired food reward and stress response are involved in the phenomena of weight gain and resistance at weight loss. Henceforth, hypnosis is a complementary medicine which is recognized as effective for defined indications. Complexity and diversity of methodological studies with hypnosis does not allow to conclude on its efficacy in treating this disease.

In obese subjects with high food impulsiveness, it is expected that Erickson's hypnosis and self-hypnosis practice would improve food disinhibition assessed by an adapted questionary (TFEQ 51).

Obese failing patients are recruited in an university hospital. Half of the subjects will be randomised to practice hypnosis and will learn to practice self-hypnosis to reduce food impulsivity and specially disinhibition. In the same time, all the included patients will follow therapeutic workshops based on current recommendations of the High Health Authority of France (HAS) for physical activity and the dietetic.

In the hypnosis group, eight workshops are planned during six months. Furthermore, patients have to practice daily self-hypnosis. In the same time, all the patients included will participate in eight dietetic workshops.

It is expected an improvement in patient involvement in personalized care plan, that eating behavior is more suited and consequently a significant decrease in weight.

Eligibility Criteria:
Inclusion criteria :

* subjects adult volunteers under 70 years old
* high score of disinhibition (D\> 8)
* obesity grade 1 and 2 (BMI between 30 and 40 kg m ²)
* no previous practice of hypnosis

Exclusion criteria :

* weight change of more than 3 kg peak to peak in the last 6 months
* psychiatric illness known
* craniopharyngioma
* treatment with a significant influence on the weight and / or eating behavior: steroids, hyperthyroidism, uncontrolled hypothyroidism,
* bariatric Surgery
* major TCA according to DSM IV
* sensory impairments (hearing, visual skills) and cognitive impairing its award of rating scales
* planned or ongoing pregnancy
* refusal of hypnosis.
Supplemented Very Low Protein Diet and the Progression of Chronic Kidney Disease

This is a prospective single center randomized controlled trial with a total duration of 18 months aiming to evaluate the effectiveness and the safety of a very low protein diet supplemented with ketoanalogues of essential aminoacids in reducing the progression of chronic kidney disease (CKD) in patients with advanced CKD.

All eligible patients who will give informed consent will be screened. Those meeting the selection criteria will be enrolled and will enter a 3-month run-in phase during which a conventional LPD will be prescribed in all patients.

At the end of this phase, the subjects still fulfilling all the selection criteria will be randomized in a 1:1 ratio to receive the KD or to continue the conventional LPD for a total duration of 15 months.

Nineteen blood and urine samplings are scheduled for each patient, to be drawn monthly. The laboratory reports include the nitrogen compounds, calcium-phosphorus metabolism parameters, acid-base balance, biochemical nutritional markers, serum C-reactive protein, hemoglobin, blood cell count, and biochemical safety parameters (sodium, potassium, liver enzymes, and bilirubin).

The anthropometric measurements and subjective global assessment will be evaluated at enrolment, at randomization, and every 3 months thereafter.

The compliance with the prescribed diet (protein and energy intake) will be assessed monthly during the run-in phase, weekly for the first month after randomization, every 4 weeks during the next 6 months, and every 3 months thereafter.

The blood pressure levels, drugs required for the therapy of hypertension, acidosis and mineral metabolism disorders, and occurrence of adverse events will be recorded monthly.

Eligibility Criteria:
Inclusion Criteria:

* adult non-diabetic patients
* stage 4-5 CKD not on dialysis (estimated glomerular filtration by Modification of Diet in Renal Disease formula \< 30 mL/min per year
* stable renal function at least 12 weeks before enrollment
* well-controlled arterial blood pressure
* proteinuria less than 1 g/g urinary creatinine
* good nutritional status
* declared and anticipated good compliance with the prescribed diet

Exclusion Criteria:

* poorly controlled arterial blood pressure (≥145/85 mm Hg)
* relevant comorbid conditions (diabetes mellitus, heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)
* uremic complications (pericarditis, polyneuropathy)
* feeding inability (anorexia, nausea)
Pilot Testing of an Online Rehabilitation Intervention for People With Heart Failure (PORIAS-HF).

The inability of the heart to pump out blood to the rest of the body organs is called heart failure (HF). HF affects almost 920,000 people in the UK, costing the NHS up to £2.33bn/year. Physical exercise programmes aiming to improve the heart's ability to pump out blood are used to a) reduce the risk of life-threatening events (e.g., heart attack), b) reduce admissions to hospital and c) improve individual's physical independence (e.g., walking unsupported, being able toperform daily essential activities). However, these physical exercise programmes have been cut short under the current COVID-19 pandemic, with support in most UK regions being restricted to online videos and advice. With many people with HF being asked to be "shielded" or "self-isolate" for an unknown duration, it is important to develop a reliable and cost-effective physical exercise service to support this clinical group. The research team has developed a novel physical exercise programme, fully-delivered online. Before assessing if it could improve clinical outcomes (e.g., heart's ability to pump out blood) and how cost-effective it could be, a 10-month pilot study is proposed that will assess if the proposed online physical exercise programme could be performed in people with HF. Thirty participants will be allocated at random into two groups: Group A will receive up to 24 exercise sessions and up-to 3 lifestyle workshops, in addition to usual care over a 2-month period. Group B will receive a self-care exercise programme (≥3 sessions per week) for a two-month period in addition to usual care. Prior to the group random allocation, online assessments will be performed including demographics and clinical history, the ability to perform daily activities, sedentary or physical activity habits and quality of life. The assessments including interviews to assess participant's experiences will be repeated at 2 months


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yrs. of either gender
* Confirmed diagnosis (by echocardiography) of HF reduced left ventricular ejection fraction
* Sinus rhythm N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) is \>400 ng/L at the time of referral to the diagnostic clinic if in sinus rhythm.
* Ability to exercise

Exclusion Criteria:

* Non-ambulant status
* Current pregnancy
* Scheduled major cardiac surgery
* The presence of an ICD or CRT-D device
* Severe pulmonary hypertension defined as systolic PAP of \>60 mmHg
* NYHA function class IV
* Lack of internet connection
* Inability/unwillingness to give informed consent
Udall Project 1 Aim 4

By defining the strength and direction of connectivity patterns at rest and during movement across the basal ganglia-thalamocortical (BGTC) network we will characterize the role of individual circuits in motor performance and cognitive function, paving the way for future development of optimization algorithms for DBS that take advantage of this understanding.


Eligibility Criteria:
Inclusion Criteria:

* Implanted with a DBS system
* Existing 7T imagery (either done as standard-of-care or done as part of Noam Harel's study, IRB #1210M22183)
* Diagnosed with idiopathic Parkinson's Disease
* Minimum age 21 years

Exclusion Criteria:

* Other significant neurological disorder, as determined by PI
* Diagnosis of dementia
* Pregnant
Safety and Clinical Efficacy of Local Topical Treatment for Erectile Dysfunction

VL#FIA3-30 is a preparation intended for topical use, applied on the penis, for the treatment of ED.

VasoLead's preparation to treat erectile dysfunction (ED), VL#FIA3-30, is composed of 2 active pharmaceutical ingredients, both act as vasodilators via different mechanisms. Both are currently used orally in the USA and Europe for the treatment of hypertension, angina pectoris and other diseases.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* ED for more than six months in duration.
* IIEF-EF domain score at baseline from 11 to 19 .
* Willingness for a minimum of two sexual attempts during the short period of this study.
* At least 50% unsuccessful sexual intercourse for 4 attempts on 4 different days.
* A stable heterosexual relationship with the same partner for more than six months.
* Age 25 to 75 years old.

Exclusion Criteria:

* Neurological pathology;
* Prior radical prostatectomy;
* Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities;
* Clinically significant chronic hematological disease;
* Cardiovascular conditions that prevent sexual activity (CHF or severe coronary artery disease);
* History of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to enrollment into the study;
* Use of anti-androgens, or oral or injectable androgens;
* Documented hypotension (BP below 100 systolic or 70 diastolic) or known orthostatic hypotension;
* Routine use of more than 2 antihypertensive medications;
* Use of oral nitrates within 3 months prior to enrollment into the study;
* Cancer within the last 3 years;
* Documented allergic reaction;
* Investigators impression for patient non-compliance;
* Hepatic or renal failure;
* History of HIV, hepatitis B, hepatitis C;
* Is an immediate family member of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site;
* Subject has taken any investigational medication within 30 days prior of entry into the study
* Employed by VasoLead (2012) Ltd.
Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer

To evaluated the efficacy and safety of caldonirimab plus nimotuzumab as second-line or later therapy for recurrent or metastatic cervical cancer

Caldonirimab, a PD-1/CTLA-4 bispecific antibody, has shown promising efficacy and tolerable toxicity in the first-line treatment of recurrent or metastatic cervical cancer. In this study, patients with recurrent or metastatic cervical cancer, after failure of first-line platinum-containing chemotherapy or intolerance to chemotherapy, will be included in this study according to the prescribed criteria in the protocal. Nimotuzumab 400 mg/time, intravenous injection, q2w, a total of 8 times; Caldonirimab 6 mg/Kg, q2w. Assess objective response rate; disease control rate; duration of overall response and safety ( adverse event).

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 \& ≤80.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.
3. Subjects must have histologically or cytologically confirmed recurrent or metastatic carcinoma of the cervix
4. Patients have received at least one systemic therapy or who cannot tolerate chemotherapy in the recurrent or metastatic setting
5. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
6. Has adequate organ function.
7. Life expectancy ≥3 months.

Exclusion Criteria:

1. Concurrent enrollment in another clinical study;
2. Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent;
3. Had received caldonirimab or nimotuzumab before;
4. Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.
5. Known active hepatitis B or C infections (known positive hepatitis B surface antigen \[HBsAg\] result or positive hepatitis C virus \[HCV\] antibody with detectable HCV ribonucleic acid \[RNA\] results).
6. Patients with clinically significant cardio-cerebrovascular disease
7. Known allergy or reaction to any component of the two drugs.
Effects of Ischemic Preconditioning on Conditioned Pain Modulation and Heart Rate Variability in Knee Osteoarthritis

Introduction: Musculoskeletal disorders have affected approximately 1.3 billion people worldwide. Evidence shows that chronic diseases and musculoskeletal conditions often occur together, and among them it is estimated that more than 240 million people worldwide have symptomatic osteoarthritis (OA) and activity limitation, which is a major contributor to chronic pain and changes central in pain processing. It is known that physical exercise (active approach to treatment) and manual therapy (passive approach) are capable of intervening in the pain processing system, but passive approaches have been little investigated. Among them, little is known about the effect of ischemic preconditioning (IPC) for pain management and its impact on conditioned pain modulation (CPM) and cardiac autonomic control. There is no evidence that IPC causes systemic hypoalgesia and increased vagal modulation, so this provides a rationale for study. Objectives: To analyze the acute effect of IPC on local pain, CPM and cardiac autonomic control in women with knee OA and observe whether there is a correlation between them. Methods: Double-blind, placebo-controlled, randomized clinical trial. Participants will be divided into IPC or placebo groups. Outcomes evaluated: CPM and cardiac autonomic modulation. Comparisons will be performed using Generalized Mixed Linear Models fitted to the data. For correlation, the Pearson or Spearman correlation test will be used according to the normality of the data. All analyzes will assume a significance level of p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis for uni or bilateral OA of the tibiofemoral joint (grade II or superior Kellgren-Lawrence radiographic changes);
* Not having systemic rheumatic diseases such as fibromyalgia, rheumatoid arthritis, systemic lupus erythematosus;
* Not having total knee arthroplasty, knee ligament injury, history of knee surgery;
* Not having heart disease, congestive heart failure, or a history of acute myocardial infarction (except those with hypertension);
* Not having diagnosis of neurological, metabolic, endocrine disorder, respiratory disease;
* Not being an alcoholic or smoker;
* Not use drugs that influence cardiac autonomic modulation (beta-blocker);
* Not having one or more predisposing risk factors for thromboembolism.

Exclusion Criteria:

* Use anti-inflammatory drugs or analgesics 24 hours before the test;
* Perform physical activity;
* Consume alcohol;
* Perform therapeutic treatments for pain relief;
* Errors in capturing the RR intervals;
* Want to leave the study.
Maraviroc Efficacy for Hepatitis C

This is a single-site, longitudinal, open-label, interventional study for evaluating the effect of maraviroc on hepatitis C viral levels in patients infected with both hepatitis C and human immunodeficiency virus (HIV) and taking antiretroviral therapy for HIV.

Recently, in-vitro studies (experiments performed in a laboratory, not on a person) have demonstrated that maraviroc, a medication that is used in human immunodeficiency (HIV) therapy, appears to have significant hepatitis C antiviral effect, comparable to sofosbuvir-a potent anti-hepatitis C medication. In this study, the investigators will evaluate the antiviral effect of maraviroc on hepatitis C virus in people infected with both hepatitis C and HIV, and whom have never been treated for hepatitis with direct antiviral agents. Participants will take maraviroc for 4 weeks in addition to their regular HIV antiretrovirals (ART). The investigators will measure the hepatitis C viral load before, during, and after the 4-week maraviroc time.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old
2. Hepatitis C-infected without plans to undergo hepatitis C treatment for duration of the study
3. Human immunodeficiency virus (HIV) infected
4. Currently receiving anti-retroviral therapy with HIV viral load \<50 IU/ml for ≥ 12 months

   a. One virologic blip ≤ 400 copies/ml permissible within the 12 months
5. CD4 T cell counts \> 100 cells/mm3
6. Non-cirrhotics and cirrhotics can be included
7. Willing to sign informed consent

Exclusion Criteria:

1. Age \< 18
2. Unable to comply with study visits, research study visits, or is planning to relocate during the study.
3. Have any condition that the investigator considers a contraindication to study participation
4. Pregnancy or breast feeding
5. Decompensated liver disease (Child-Pugh C)
6. Imminent treatment for hepatitis C infection
7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times the upper limits of normal
8. Concomitant use of drugs known to impact or be impacted in terms of pharmacokinetics or drug-drug interactions with either raltegravir, dolutegravir, or maraviroc. This includes:

   * Inducers of UGT1A1 (such as rifampin, phenytoin, phenobarbital rifabutin, St. John's wort)
   * Cytochrome P3A inhibitors (such as ketoconazole, itraconazole, clarithromycin, nefazodone, and telithromycin)
   * Cytochrome P3A inducers (such as rifampin, carbamazepine, phenobarbital and phenytoin)