cyrilzakka/clinical-trials huggingface dataset:
Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis

A clinical trial to asses efficacy and safety of Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use associated standard antimonial in the treatment of Cutaneous Leishmaniasis in Bahia, Brazil.

The treatment of cutaneous leishmaniasis caused by L. braziliensis in Brazil with pentavalent antimony is associated with a high rate of failure, reaching up to 45% of cases. Additionally, pentavalent antimony is only administered by parenteral route with important toxicity and ulcer lesion healing takes a long time, from 2 to 3 months.

So, this randomized and controlled clinical trial was designed to compare the efficacy and safety of standard antimonial (20mg/day /kg for 20 days) associated with Transition-state Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use versus standard antimonial (20mg/kg/day for 20 days) associated with placebo for topical use in the treatment of Cutaneous Leishmaniasis and Early Cutaneous Leishmaniasis caused by L. braziliensis in the endemic area of Corte de Pedra, Bahia, Brazil.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed (untreated) cutaneous leishmaniasis or early cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
* Number of lesions: 1 to 3 ulcerative lesions.
* Lesion´s diameter: 1 to 5 cm.
* Disease duration: up to three months.

Exclusion Criteria:

* Aspartate aminotransferase, alanine aminotransferase \>3 times upper limit of normal range
* Serum creatinine or blood urea nitrogen \>1.5 times upper limit of normal range
* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
* Immunodeficiency or antibody to HIV
* Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months
* Negative parasitology (aspirate/biopsy/PCR) or negative Montenegro test
* Any history of prior anti-leishmania therapy
* Any condition which compromises ability to comply with the study procedures
* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
* Anticipated non-availability for study visits/procedure
Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed

Staying confined in the bed is frequent at the end of life. The cancer patients can also experiment this situation, and consequences are painful, with pain increasing with the time. This pain are related to the joints stiffing , muscles mass decreasing, and tendons retractions . The non pharmacological approach associated with the conventional treatments can be interesting to assess in this frails patients.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* Aged 18 years or older
* Having signed informed consent to participate in the study
* Patient affiliated to a social security scheme
* Patient with pain affecting the musculoskeletal system following prolonged bed rest
* Capable to understand French
* Capable of completing self-assessment scales

Exclusion Criteria:

* Patients with bone metastases at risk for the use of osteopathy
* Patients under legal protection measures
* Patients with cognitive impairment preventing self-evaluation
* Patient who is considered too fragile or with a clinical condition too unstable by the doctor refer to be included in the study
* Patients in the pre-agonic or agonic phase
EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients

The purpose of this study is to evaluate the prognostic value of early focal lesions and early diffuse lesions on ambulatory disability progression within 5 years after clinical onset.

Prospective, multicentric study

Eligibility Criteria:
Patients with multiple sclerosis:

Inclusion Criteria:

* Relapsing Remitting Multiple Sclerosis patients (Mac Donald 2010 criteria)
* First clinical event \< 1 year
* Brain MRI \> 9 lesions or/and spinal cord attack with focal lesion on spinal cord MRI
* Score Expended Disability Status Scale \< 3
* Age between 18 and 40 years

Exclusion Criteria:

* Multiple Sclerosis progressive
* Patients treated with immunosuppressive therapy
* Pregnancy

Healthy volunteers:

Inclusion Criteria:

-Age between 18 and 40 years

Exclusion Criteria:

-Pregnancy
Capturing Physiologic Autonomic Data from Clinically Indicated Magnetic Resonance Imaging Scans in Children

The Fontan Procedure is a palliative surgical procedure used in pediatric patients with one functional ventricle. The procedure, a series of stepwise operations that alter cardiorespiratory physiology, separate the systemic and pulmonary circulations to create Fontan physiology, where the systemic venous blood flows passively and without ventricular thrust into the pulmonary circulation. The hallmark of the Fontan circulation is a sustained, abnormally elevated central venous pressure combined with decreased cardiac output, especially during periods of increased demands. Results of several studies in Fontan patients have shown reduced parasympathetic and sympathetic activity compared to controls. In children with congenital heart disease, a differential diagnosis of autonomic dysfunction may be part of their pathophysiology, a compensatory mechanism, a consequence of surgical procedures or a combination of these.

In children, measurement of ANS function is equally important. Children with single ventricle physiology (and other cardiac conditions) have routine surveillance and cardiac magnetic resonance (CMR) imaging to monitor for disease progression. While autonomic data is routinely collected and is available from these scans, these data are rarely, collected and analyzed; however, our group has shown feasibility. Therefore, autonomic data is usually unavailable in children. Despite the availability of agerelated normal values, the predictive power of autonomic activity is understudied in children and there are no published studies of quantification of autonomic data in this population.


Eligibility Criteria:
Inclusion Criteria:

* Ages 0 to ≤ 30 years
* Baseline sinus rhythm (interventricular conduction delays and bundle branch blocks allowed); and undergoing CMR scan in which sequences containing timing of aortic valve opening (cine), vector cardiogram (VCG) and respiratory bellows use will be obtained
* Fontan physiology - only for the Fontan group. Chest wall deformity or arrhythmogenic right ventricular cardiomyopathy for the healthy control group

Exclusion Criteria:

* Patient or family refusal;
* Contraindication to study procedures
* Prior participation in the study (ie, we plan to sample without replacement)
CPAP and Nebivolol in Hypertensive Obstructive Sleep Apnea (OSA) Patients.

The aim of this study is to examine how effective CPAP treatment and treatment with nebivolol are respectively on reducing blood pressure and on endothelial dysfunction in patients suffering from obstructive sleep apnea and hypertension.


Eligibility Criteria:
Inclusion Criteria:

* male/female ≥ 18 years old
* patient with obstructive sleep apnea (apnea-hypopnea index ≥ 20) naïve for CPAP treatment
* patient with weak or moderate hypertension (140 \<= systolic blood pressure (SBP) \< 180 mmHg and 90 \<= diastolic blood pressure (DBP) \< 110 mmHg naïve for any antihypertensive treatment
* negative pregnancy test
* ambulatory patient
* patient who have signed the informed consent form
* patient affiliated to social security

Exclusion Criteria:

* pregnant or nursing woman
* acute hepatic failure, biliary cirrhosis, cholestasis
* clearance of Cockcroft \< 30 ml/min/1.73m2
* sick sinus syndrome, including sino-atrial block
* second and third degree heart block (without a pacemaker)
* history of bronchospasm and bronchial asthma
* bradycardia (heart rate\< 60bpm prior to start therapy)
* severe peripheral circulatory disturbances
* acute hypertension (SBP\>= 180 mmHg and/or DBP \>= 110 mmHg)
* severe daytime sleepiness (Epworth rating scale \> 15)
* known cardiovascular pathologies
* contraindication to CPAP
* allergy to nebivolol
* patient treated with antihypertensive drug(s), with class I antiarrhythmics (quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone)
* patient treated with CPAP
* patient kept in detention, major protected by the law, hospitalised person
* patient currently participating in another clinical trial
The Effectiveness of The Training Program Given to Midwives and Nurses to Prevent Obstetric Violence

In the study, 84 midwives and nurses working in hospital delivery and puerperal services and family health centers in Adiyaman province constituted the experimental group, and the control group of 84 midwives and nurses working in the delivery room and postpartum services of hospital Child and Gynecology Hospital in Malatya and family health centers', determined by randomization in the study. While the training program for the prevention of obstetric violence consisting of 16 sessions was applied by the researcher to the midwives and nurses in the experimental group, no intervention was applied to the midwives and nurses in the control group. The second phase of the study was conducted with women who received care from the hospital delivery and postpartum services and family health centers in Adiyaman province before and after the training program applied to the midwives and nurses in the experimental group (158 women before the training, 158 after the training). Data were collected with Introductory Information Forms, Caring Behaviors Inventory-30, Communication Skills Scale and Care Satisfaction Evaluation Form.

The research was conducted between November 2020 and December 2021. In the study, 84 midwives and nurses working in hospital delivery and puerperal services and family health centers in Adiyaman province constituted the experimental group, and the control group of 84 midwives and nurses working in the delivery room and postpartum services of hospital Child and Gynecology Hospital in Malatya and family health centers', determined by randomization in the study. While the training program for the prevention of obstetric violence consisting of 16 sessions was applied by the researcher to the midwives and nurses in the experimental group, no intervention was applied to the midwives and nurses in the control group. The second phase of the study was conducted with women who received care from the hospital delivery and postpartum services and family health centers in Adiyaman province before and after the training program applied to the midwives and nurses in the experimental group (158 women before the training, 158 after the training). Data were collected with Introductory Information Forms, Caring Behaviors Inventory-30, Communication Skills Scale and Care Satisfaction Evaluation Form.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* Those who do not have any problems during pregnancy, birth and postpartum period (such as heart disease, preeclampsia, diabetes, difficult birth, fetal anomaly),
* No psychological health problems according to medical records,
* Those who are open to communication and cooperation.

Exclusion Criteria:

* Not meeting the inclusion criteria
Growth and Body Composition in Children

This study is planned to measure and compare body composition indexes and growth between typically developing children and those with disabilities in South Korea for understanding the nutritional and growth status.

* Inclusion criteria for typically developing children

  1. typically developing children in 5th and 6th grades of elementary schools
  2. children whose parents checked the agreement form distributed by schools
* Inclusion criteria for children with disabilities

  1. children and adolescent who are in special schools
  2. children whose parents checked the agreement form distributed by schools
  3. children who were able to cooperate during the body composition analysis
* Exclusion criteria for both groups

  1. those whom do not have written informed consent
  2. who are not able to stay calmly during the body composition analysis
* All measurements done at two elementary schools on the day of the annual physical examination
* Measurement of height and body weight for growth
* Measurement of body composition index: Inbody 770 and Inbody S10, body composition analyzers

Eligibility Criteria:
Inclusion Criteria:

* Those who agreed to participate both parents and a child
* Typically developing children: among the 5th and 6th grade of two elementary schools.
* Children with neurodevelopmental disabilities: among the students in a special school.

Exclusion Criteria:

* Who do not want to participate
* Who are not possible to do the Inbody examination
Internet-based Pain Self-management for Persons With Acute Recurrent and Chronic Pancreatitis Pain

Pain is the cardinal symptom of acute recurrent and chronic pancreatitis, and available medical treatments have limited efficacy. Pain self-management programs equip patients to minimize the impact of chronic painful conditions on activity, health, and psychosocial functioning. The purpose of the current study is to pilot the use of Internet-delivered pain self-management course in adults with chronic and acute recurrent pancreatitis to generate preliminary feasibility and acceptability data to inform design of a subsequent large randomized controlled trial.

Acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) are associated with high disease burden across the lifespan. Recurring abdominal pain is the most prevalent and distressing symptom. Pain severity reduces health-related quality of life for individuals with CP and is associated with increased fatigue, anxiety and depressive symptoms, lower general health status, and reduced physical and role functioning. Medical therapies for CP pain have limited efficacy. Cognitive-behavioral interventions (CBT) offer safe and effective alternatives to pharmacological treatments for pain management. In other chronic painful conditions including gastrointestinal disorders, CBT interventions have been effective for reducing pain and pain impact including disability and depressive symptoms. CBT is traditionally provided by trained psychologists working with individual patients one-on-one or in small groups. Access to CBT is limited by availability of providers, with long waiting lists at centers offering CBT. The Internet is an ideal medium to provide pain self-management interventions that are low-cost and sustainable, and internet-based CBT has shown efficacy in children and adults with chronic pain, allowing clinics to greatly extend their reach to patients. The purpose of this study is to test the acceptability, feasibility, and preliminary efficacy of an Internet-delivered CBT pain self-management course for adults with acute recurrent and chronic pancreatitis pain.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Able and willing to provide informed consent for participation in this study
3. Meet CPDPC criteria for diagnosis of either suspected CP (CPDPC "yellow zone") or definite CP (CPDPC "red zone")
4. Have personal internet access on any device (e.g., phone, tablet, computer)
5. Has experienced pain intensity rated as 4 or higher on a 0-10 scale in the last month

Exclusion Criteria:

1. Currently undergoing treatment for cancer
2. Inability to understand English well enough to complete questionnaires or to participate in treatment
3. Severe depression (i.e., indicated by a score \> 22 on the Patient Health Questionnaire (PHQ-9)
4. Significant suicidal ideation (i.e., indicated by a score \> 2 to Question 9 of the PHQ-9)
5. Acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months)
6. Currently receiving treatment with a psychologist
Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)

The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset.

Participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 156 patients are planned in this study.

This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, approximately 36 participants will be randomized in a 3:1 ratio (investigational drug: placebo) into 1 of 3 planned ascending dose groups to determine the dose levels to be studied in Part B. Two dose levels will be chosen based upon a review of all available data including safety, PK, PD and preliminary efficacy. In Part B, approximately 120 participants will be randomized in a 1:1:1 ratio to receive a single dose of two dose levels of study drug or placebo.

All participants will be screened for participation after confirmed diagnosis of an anterior circulation ischemic stroke by neurovascular imaging. Enrolled participants will be followed for 90 days. Radiological outcomes will be assessed by a central blinded reviewer. A Data Safety Monitoring Committee will review safety and preliminary efficacy data throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute ischemic stroke
* 18 years or older
* Anterior circulation intra-cranial occlusion
* Onset of stroke symptoms within 24 hours of enrollment

Exclusion Criteria:

* Large volume ischemic stroke
* Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage
* Chronic intracranial occlusion
* Weight \>125kg
* Administration of thrombolytic drug or glycoprotein IIb/IIIa inhibitors
* Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding
* Prior stroke within 90 days
* Unable to undergo a contrast brain perfusion scan with either MRI or CT
Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes

The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.

The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia. Participants will all be taking an antipsychotic medication and half will have a diagnosis of Tardive Dyskinesia and half will not. Participant responses to interview questions and elements of the Abnormal Involuntary Movement Scale will be collected on video. The videos will be rated by trained observers. Machine learning methods will be used to develop an algorithm to detect abnormal movements in individuals with a known Tardive Dyskinesia diagnosis. The trained rater results will be compared to the algorithm to determine the accuracy of the algorithm.

Eligibility Criteria:
Inclusion Criteria:

For the non-TD group:

1. Prescribed and taking an antipsychotic medication for 90-days or longer.
2. Tardive Dyskinesia symptoms if present are not from Parkinsons, Tourette's syndrome, Huntington disease.
3. Signed an informed consent.
4. Speaks English fluently.

Exclusion Criteria:

1. Suffered a moderate or severe head injury in the last year;
2. History of a learning disorder or developmental disability that would inhibit a patient from completing the TD protocol.
3. Severe visual impairment that is cannot be corrected by glasses or contacts.
Justice-Involved Veterans and Moral Reconation Therapy

The purpose of this study is to determine whether Moral Reconation Therapy (MRT) is effective for reducing risk of criminal recidivism and improving other health-related outcomes (substance use, mental health, housing, and employment problems) among justice-involved Veterans entering residential mental health treatment programs in the Department of Veterans Affairs (VA).

Approximately 146,000 Veterans are released each year from correctional settings; however, two thirds will likely reoffend and return to the justice system. Antisocial cognitions and behaviors are the strongest predictors of reoffending and are highly prevalent among justice-involved Veterans (JIVs). However, in the absence of treatments with demonstrated effectiveness with JIVs, no systematic approach to address antisocial cognitions and behaviors has been implemented in VA. Moral Reconation Therapy (MRT) is a cognitive-behavioral intervention that aims to reduce antisocial cognitions and behaviors. MRT has the best empirical support for reducing risk for criminal recidivism among civilian offenders, and its associated mechanisms (improvements in interpersonal functioning and impulse control) have been linked to improvements in health-related outcomes that are also risk factors for recidivism (substance use, mental health, housing, and employment problems). However, no trials have been conducted with JIVs. Differences between JIVs and justice-involved civilians (e.g., prevalence of traumatic brain injuries; interpersonal problems) suggests prior research on MRT with civilians may not be generalizable, and prompted the VA's Veterans Justice Programs (VJP) and the developers of MRT to develop a Veteran-specific curriculum of this intervention.

Using the new Veteran-specific manual, the overarching objective of the current proposal is to implement and evaluate MRT as an intervention to reduce risk for criminal recidivism and improve health-related outcomes among JIVs in VA Mental Health Residential Rehabilitation Treatment Programs (MH RRTPs). Using a Hybrid Type 1 design, this project will test the effectiveness of MRT in a multisite Randomized Controlled Trial (RCT) (Palo Alto, Little Rock, and Bedford VAs) and conduct a formative evaluation to facilitate future implementation of MRT in VA.

Eligibility Criteria:
Inclusion Criteria:

* Veterans who

  * (a) are entering a mental health residential rehabilitation treatment program (MH RRTP) at one of three study sites (Palo Alto, Little Rock, or Bedford VA), and
  * (b) had been arrested and charged and/or released from incarceration in the past 5 years prior to MH RRTP admission will be eligible for participation

Exclusion Criteria:

* The only exclusion criterion is being too cognitively impaired to understand the informed consent process and other study procedures.
Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance

The primary objective of this pilot study aims to describe the modifications of subcutaneous impedancemetry induced by dialysis.

As secondary objectives, the study aims to 1) describe the modifications of cutaneo-muscular impedancemetry induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events. 3) describe the relationship between modifications of cutaneo-muscular impedancemetry induced by dialysis and 1) describe the modifications of cutaneo-muscular impedance induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events.

The study will be realized in dialysis facility of Ambroise Paré hospital, APHP. The duration of enrollment of subjects will be 3 months, each enrolled patient will has 2 or 3 week's follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient ⩾ 18 years;
* Patient undergoing chronic dialysis in hemodialysis facility of Ambroise Paré hospital;
* Patient has been informed and given no-opposition for participating to the study.

Exclusion Criteria:

* Patient with a pacemaker or an implantable cardioverter defibrillator;
* Patient under guardianship or curatorship;
* Foreign patient under french AME scheme.