cyrilzakka/clinical-trials huggingface dataset:
Medication-Assisted Treatment Implementation in Community Correctional Environments (MATICCE)

The goal of this study is to see whether or not a strategic planning process is able to introduce and sustain improvements in the working relationship between probation/parole departments and community-based addiction treatment agencies that provide medication assisted therapy (MAT) for individuals with opioid or alcohol dependence. In addition, this study seeks to improve probation/parole agency personnel's knowledge and perceptions about MAT, and increase the number of appropriate referrals to community treatment agencies that provide MAT. There are three phases to this study. Phase 1 includes a pilot study to determine the quality and availability of client level records and the collection of baseline data (the pilot study protocol was previously submitted to TMH IRB). Phase 2 will consist of a Knowledge, Perceptions and Information (KPI) intervention during which probation/parole agencies will undergo training to increase knowledge about the effectiveness of MAT, and complete a post training assessment to evaluate the effectiveness of the KPI intervention. During Phase 3, probation/parole agencies will be randomly assigned to a 12-month Organizational Linkage Intervention (OLI) condition or to control (no further intervention). Agencies assigned to the OLI will establish a Pharmacotherapy Exchange Council (PEC) that consists of staff from both the probation/parole and community treatment agencies. The PEC will undergo a strategic planning process to increase the availability of MAT for opiate and/or alcohol dependent individuals who are on probation/parole.


Eligibility Criteria:
Probation/parole or community treatment agency staff.
ULTIVA Post Marketing Surveillance

This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of remifentanil in real clinical practices after marketing.

The subjects are patients prescribed for remifentanil by the investigators at the sites based on prescription information in normal clinical practices.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring general anesthesia

Exclusion Criteria:

* According to precautions or warnings on PI, remifentanil should not be administered to the following patients
* Patients with any allergic reaction to any ingredients of remifentanil or other fentanyl analogues
Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings

The purpose of this study is to evaluate if it is possible to use a new 3D imaging method to guide Botulinum neurotoxin (BTX) injection for muscle spasticity management after stroke. This imaging method is called three dimensional innervation zone imaging, or 3DIZI.


Eligibility Criteria:
Inclusion Criteria:

* a history of not more than one stroke which occurred at least 6 months prior to study enrollment;
* elbow flexor spasticity rated at 2 or 3 on Modified Ashworth scale (MAS);
* receiving repeated botulinum toxin injection every 3-4 months;
* absence of excessive pain in the paretic upper limb;
* capacity to provide informed consent, with Mini-Mental State Examination (MMSE) must be 25 or higher;

The following modified Ashworth scale (MAS) will be used for spasticity assessment:

0 -No increase in muscle tone; 1 -Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ -Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 -More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3 -Considerable increase in muscle tone, passive movement difficult; 4 -Affected part(s) rigid in flexion or extension.

Exclusion Criteria:

* recent botulinum toxin injection \< 4 months;
* recent changes in antispastic medications \<3 weeks (i.e., the antispastic medication regime is not stable;
* Changes in antispastic medications (such as baclofen, tizanidine, dantrolene etc) during the followup research visits. (NOTE: it is clinically rare for patients who receive repeated injections to change their antispastic medications);
* history of spinal cord injury or traumatic brain damage;
* history of serious medical illness such as cardiovascular or pulmonary complications;
* any condition that, in the judgment of a physician, would prevent the person from participating.
Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-933043 in Healthy Subjects

Includes a placebo-controlled sequential, ascending multiple-dose panels (10 panels, 8 ascending doses, and 2 fixed Japanese Panels exploring safety, tolerability, and Pharmacokinetic (PK) measures


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2
* Normal Neurological Exam (LP subjects only: to rule out focal CNS lesions that would render LP unsafe)
* Men and women, ages 18 to 55 years, inclusive.
* Women who are not of childbearing potential (WOCBP) \[ie, who are postmenopausal or surgically sterile\] and men
* Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
* Women must not be breastfeeding
* Sexually active fertile men must use effective birth control if their partners are WOCBP throughout the study and for 90 days after last dose

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery that could impact upon the absorption of study drug
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration
* Blood transfusion within 4 weeks of study drug administration
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access
* Smoking more than 1 cigarette/cigar per week, within 3 months prior to screening
* Regular daily use of nicotine products or Varenicline (Chantix® or Champix®) within 3 months prior to screening
* Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (4th Edition) \[DSM IV\], Diagnostic Criteria for Drug and Alcohol Abuse
* History of cardiac arrhythmias, or palpitations associated with presyncope or syncope or history of unexplained syncope
Study of Lurbinectedin (PM01183) in Combination With Cisplatin in Patients With Solid Tumors

Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Cisplatin in Patients with Advanced Solid Tumors to determine the recommended dose (RD) of PM01183 in combination with cisplatin, to characterize the safety profile, the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity and to conduct an exploratory pharmacogenomic (PGx) analysis.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed written informed consent
* Age ≥ 18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 1.
* Life expectancy ≥ 3 months.
* Patients with confirmed diagnosis of advanced solid tumors.
* Patients may have received ≤ 2 chemotherapy-containing lines in the advanced setting.
* Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ seven days before inclusion in the study)
* Recovery or stabilization to grade ≤ 1 from any adverse event derived from previous treatment (up to grade 2 alopecia or asthenia/fatigue are allowed).
* No clinically significant changes in ECG.
* At least four weeks since the last monoclonal antibody containing therapy or definitive radiotherapy (RT)
* At least two weeks since the last biological/investigational single-agent therapy (excluding MAbs) and/or palliative RT (≤10 fractions or ≤30 Gy total dose)
* Fertil women must have pregnancy excluded by appropriate testing before study entry

Exclusion Criteria:

* Prior treatment with PM01183 or trabectedin.
* Concomitant diseases/conditions:

  * History within the last year or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically relevant valvular heart disease or symptomatic arrhythmia or any asymptomatic ventricular arrhythmia requiring ongoing treatment.
  * Ongoing, non-neoplastic, chronically active liver disease of any origin.
  * Active infection.
  * Patients who are requiring any ongoing oxygen support.
  * Known human immunodeficiency virus (HIV) infection.
  * Any other major illness.
* Symptomatic or corticosteroid-requiring brain metastases or leptomeningeal disease involvement. Patients with asymptomatic documented stable brain metastases not requiring corticosteroids during the last three months are allowed.
* Peripheral sensory/motor neuropathy grade \>1. Hearing impairment grade \>1.
* Fertile men or women not using an effective method of contraception.
* History of bone marrow or stem cell transplantation
* Radiotherapye to \>35% of the bone marrow.
Prenatal Pelvic Floor Prevention (3PN)

Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group.

Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.

Justification:

Pelvic floor disorders lead to handicap and medical care consumption. Pregnancy and delivery are the main etiologies. Pelvic floor exercises are proposed for prevention and may reduce immediate postpartum incontinence but we do not know if this preventive effect persists at 1 year.

Principal criteria:

* Urinary incontinence score at 12 months post-partum (ICIQ-SF)

Secondary criteria:

* Urinary incontinence prevalence at pregnancy end, 2 and 12 months post-partum
* Other pelvic floor disorders at pregnancy end, 2 and 12 months post-partum: symptoms questionnaires, QOL questionnaire, Pad-test, POP-Q.
* Mode of delivery, length of active second phase, perineal tears, Apgar score.
* Number of postpartum pelvic floor session, number of medical consultations, Kegel exercises.

Progress:

* Inclusion between 20 and 28 weeks, initial assessment, randomization.
* 8 sessions of pelvic floor exercises with a physiotherapist between 24 and 36 weeks versus written information only.
* Assessment at pregnancy end, 2 and 12 (+/-1) month post-partum

Study length:

* For each women 18 months.
* For each center 30 months.

Number of subjects:

* To show a 1 point difference on ICIQ-SF score, we need 182 subjects (sd=2,4, a=0,05, β=0,20 bilateral test).
* Taking in account lost of follow-up (estimated 1/3) we are going to include 280 women.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous
* aged 18 years or more
* pregnant between 20 and 28 weeks
* French language reader

Exclusion Criteria:

* No medical insurance
* multiple or pathologic pregnancy
* Previous pelvic floor exercises with a physiotherapist less than 6 months before pregnancy
Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty

The goal of this prospective, open label study is the construction and the evaluation of a composite score evaluating the residual instability in patients who have undergone an ankle's ligamentoplasty (the Ankle Go Test score).

The main hypothesis of this study is based on the fact that the composite score "Ankle Go Test" would allow a global validation of all the criteria of scores of 4 tests and 2 questionnaires, which are performed in common pratice, evaluating the instability of the ankle after an ankle ligamentoplasty.

Participants will have to complete 2 questionnaires (FAAM, ALR RS) and to undergoe 4 tests (Single Leg Stance Test, Side Hop Test, Start Excursion Balance Test, La figure of 8), at 4, 6 and 12 months post surgery.

Researchers will compare the group of participants who undergone ankle's ligamentoplasty with a group of healthy volunteers to assess the discriminant validity of the Ankle Go Test score


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients who underwent arthroscopic ankle ligamentoplasty or healthy volunteers with no previous knee or ankle history.
2. Age ≥ 18 years
3. Patients who's been informed about the study and who didn't express their opposition to participate

Exclusion Criteria:

1. Patients with chronic ankle instability, operated or not, contralateral
2. Patients under legal protection
CKD-504 in SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects

To assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of CKD-504 compared to placebo in healthy Korean and Caucasian adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult Korean or Caucasian aged 19 to 45 (inclusive) years, at the time of screening.
* Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
* Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study.
* Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.

Exclusion Criteria:

* Subjects with a history of hypersensitivities to the drug, including investigational drugs or other drugs or with a history of clinically significant hypersensitivities.
* Subjects with a history of drug abuse or a positive urine screening for drug abuse.
* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within three months prior to study drug administration.
* Subjects who have donated a unit of whole blood within 60 days or blood components within 30 days prior to study drug administration.
* Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.
Astaxanthin Supplementation in Cyclists

Background of the study:

Astaxanthin has been shown to be a powerfull anti-oxidant. Health benefits have been shown in animals and humans. Exercise enhancing effects have been shown in animals via enhancement of fat oxidation. We want to examine the effects of 4 weeks of astaxanthin supplementation on fat oxidation and cycling performance in trained cyclists

Objective of the study:

To test the hypothesis that 4 weeks supplementation with astaxanthin will improve fat oxidation and improve exercise performance in trained cyclists

Study design:

Double blind, placebo controlled study.

Study population:

Well trained cyclists between 18-30 years old

Intervention (if applicable):

astaxanthin (20 mg/day) or placebo for 4 weeks

Primary study parameters/outcome of the study:

performance on a time trial after 90 min steady state exercise.

Secundary study parameters/outcome of the study (if applicable):

substrate use plasma glucose plasma lactate plasma free fatty acid plasma astaxanthin

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):

The risks involved in participating in this experiment are minimal. Astaxanthin has been shown to be safe. Insertion of the catheters in a vein is comparable to a normal blood draw and the only risk is of a small local haematoma.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Male
* Age between 18 and 30 years
* Endurance trained (≥3 sessions of endurance exercise per week)
* VO2 max ≥ 50 ml/kg/min
* Training history of more than one year of ≥3 sessions of endurance exercise per week
* BMI \<25 kg/m2

Exclusion Criteria:

* Use of medication
* Smoking
Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among HSCT Patients

Primary Objective:

- To understand the importance of receiving information on fertility- and menopause-related treatment effects for female patients undergoing hematopoietic stem cell transplantation.

Researchers are currently conducting a survey on how important it is to women who are having a stem cell transplant to have information about the effects of the treatment on their fertility (their ability to have children) and on the risk of early menopause. Researchers know that some women who had transplants think that the information that they received may have been lacking or was not appropriate for their needs. Therefore, researchers would like to ask women who have had stem cell transplants at M. D. Anderson Cancer Center to report what kind of information they got and would like to have gotten before or during their treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center.
* Age 16 to 50 years at the time of the transplant.

Exclusion Criteria:

* History of ovarian cancer.
* History of hysterectomy/oophorectomy
* Non-English speaking patients
STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin \& simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.


Eligibility Criteria:
Inclusion Criteria:

* Discontinuation of all previous lipid lowering therapy.
* Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 \& 3 for subjects not on lipid lowering therapy at Visit 1.
* Other lipid parameters as specified in the protocol.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Abnormal laboratory parameters as defined in the protocol.
Studies of the Prevention of Atrial Fibrillation by ALA

An alpha-linolenic acid (ALA) rich diet in the Lyon Heart Study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994). Since then, there has been a growing interest in ALA as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of ω-3 fatty acids, especially the longer chain ω-3 fatty acids, DHA and EPA, derived from fish. We therefore concluded it important to test whether the shorter chain ω-3 vegetable oil ALA also had antiarrhythmic effects, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Heart Study.

Objective: We determined the effect of an ALA rich diet in reducing recurrence of atrial fibrillation as a further example of a cardiac arrhythmia.

Design: Randomized parallel design efficacy study. Setting: Three university hospital centers in the Bordeaux region, France. Patients: 98 successive patients successfully underwent electro cardioversion of whom 75 completed the study without major deviations according to the protocol.

Intervention: A canola margarine and oil together with a Mediterranean diet (ALA ω-3, 1.4 g/d) versus a conventional diet (control), with a one year follow-up.

Main outcome measure: Length of time to first recurrence of atrial fibrillation.

Significance: If ALA is antiarrhythmic this action may explain its cardioprotective effect in clinical trials and cohort studies.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized in one of the three centers in the Bordeaux region, and who subsequently underwent successful electrocardioversion for atrial fibrillation.

Exclusion Criteria:

* included patients who were unable to receive electrocardioversion or those who were already enrolled in another trial
* patients who were unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements
* patients with clinically significant cardiac disease, advanced heart failure, cardiac cachexia, thyroid disease, treated or untreated, clinically significant hepatic or renal disease or a history of malignant disease or alcohol abuse were not included
* Taking ALA rich foods or recording intakes of ALA \>2g/d on the control diet or reporting using \<1g/d on the ALA diet was considered a major deviation from the protocol.
Nutritional Transition in the Maghreb and Prevention of Obesity and Non-communicable Diseases

Problematic and state of the art Obesity and its associated non communicable diseases (NCDs) are rising rapidly in middle income countries, such as those in the Maghreb (North Africa). This progression is related to the context of a nutrition transition (changing food and physical activity environment) and profound changes in technological advances and in society. These societies and their health systems are insufficiently prepared for this evolution, which has enormous health and socioeconomic consequences. In the context of limited resources, the priority has been given on an international level to prevention. But several problems arise: - these countries are still confronted by undernutrition in terms of micronutrient deficiencies, which coexist with obesity and NCDs, including at a family level and also individual level. Known as the 'double burden', this coexistence is relatively new and has been rarely documented until recently. Educational measures could be ineffective in a society where cultural norms do not recognise obesity and where changes in lifestyle are possibly not seen as acceptable. As well as information about citizen's knowledge of risk factors, data on their perceptions and attitudes are indispensable. Policies that involve changing the 'obesogenic' environment that individuals occupy is a priority.

Objectives of the project Overall aim: to contribute to the development of preventive strategies for obesity and chronic NCDs in the context of a nutrition transition.

Specific objectives: characterise the nature and size of the double burden (obesity/undernutrition) in regions, families and individuals; estimate the prevalence of biological and behavioural risk factors; characterise the psycho-sociocultural determinants of behaviour.


Eligibility Criteria:
Inclusion Criteria:

* To live in the region of the capital city
* To give free informed consent

Exclusion Criteria:

* Pregnancy