cyrilzakka/clinical-trials huggingface dataset:
Completion of OST - a Prospective Study

Only limited information on the process of completing long-term opiate substitution treatment (OST) with substances like methadone exist. Furthermore, systematic knowledge from scientific studies is scarce, there are only few studies with respect to treatment completion or regular termination (mainly catamnestic analyses). Studies by Nordt et al. (2004) or Nordt \& Stohler (2006) show an estimated rate of 10% of patients per year who terminate OST by means of tapering the substitution agent or changing into withdrawal treatment in specialized clinics. It is state of the art that an indication for termination of OST has to be based on a common agreement between the patient and the doctor. Furthermore, the patient should live in a stable social situation and the state of health had markedly improved. Finally, the patient has to be free of (illegal) drug use for at least 6 months and the individual aims of treatment should have been reached (Vader et al. 2003).

The main objective of the prospective and explorative study is the systematic description of the process of termination of OST. With a comparison between patients who complete OST regularly and patients who terminate treatment prematurely (or are still in treatment) predictors of positive termination of OST can be identified.

Patients treated with methadone or levomethadone of 5 general practitioners' practices and 2 specialized clinics who might be able to terminate OST during the next 12 months from the doctors' perspective can take part in the study. In addition to baseline examination further assessments take place every 3 months (i.e. after 3, 6, 9 and 12 months). The questionnaires include state of health, well-being, social situation as well as drug and alcohol use. Furthermore, the treating doctors are asked every 3 months to fill out questionnaires on infections and other disorders, clinical characteristics, dosage process and drug use (measured by urine samples).

Patients who will be successful in completing OST during the observational period will be compared with the remaining cases.

Finally, a 6-month follow-up is planned in order to investigate the stability and maintenance of the situation at month 12.


Eligibility Criteria:
Inclusion Criteria:

* opioid dependence according ICD-10
* Minimum age of 18 years
* In OST with methadone or levomethadone
* Expected or planned treatment completion during the next 12 months
* Informed consent to participate in the study

Exclusion Criteria:

* Patients with planned hospitalisation during the next 12 months
* Patients who are likely or it is save to assume that they will be incarcerated or imprisoned during the next 12 months
* Disability to take part in the study or follow the study conditions
Parents and Tots Together: A Family-Based Obesity Prevention Intervention

The obesity epidemic has spared no age group, including our youngest children. My and others' formative research shows that ethnically-diverse, low-income parents of young children are enthusiastic about learning general parenting skills, such as discipline strategies, but less interested in nutrition and physical activity. To capitalize on this enthusiasm, I will create and test an intervention that embeds strategies to improve child weight-related behaviors within a general skills parenting program.

The overall goal of this study is to assess Parents and Tots Together (PTT), a family-based intervention to prevent obesity among children age 2 through 5 years. To achieve this goal, my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically diverse, primarily low-income families. Our specific aims are to:

1. Determine the extent to which the intervention, compared with a control condition, results in a smaller age-associated increase in body mass index (BMI) among children after a 3- month intervention and a 9-month follow-up period (primary outcome).
2. Determine the extent to which the intervention, compared with a control condition, results in:

   1. Improved parent general parenting behaviors, i.e., increased use of positive discipline strategies.
   2. Improved parent feeding practices, i.e., increased responsiveness to child satiety cues.
   3. Improved child weight-related behaviors, i.e., increased sleep duration and physical activity, and reduced sugar-sweetened beverage intake and television/video viewing.


Eligibility Criteria:
Inclusion Criteria:

* parents who have a child aged 2-5 years
* respond to interviews and questionnaires in English or Spanish

Exclusion Criteria:

* any families who plan to move during the study period
* children or parents with severe health conditions that would prohibit them from participating in study activities
Varenicline and Nicotine Interactions in Humans (VA)

To examine the effects of varenicline on the subjective, physiological and cognitive responses to intravenous nicotine. Varenicline is a partial nicotine agonist and it is approved as a treatment for smoking cessation. We predict that varenicline treatment will modify subjective, physiological and cognitive responses to IV nicotine.

This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female smokers will have two 4-day treatment periods, in which they will be randomized to varenicline (1 mg/day) or placebo. During the first 3 days of each treatment period, smokers will have daily clinic visits and receive their study medication. On Day 4, subjects will come to the laboratory, where they will receive ascending doses of intravenous (IV) nicotine (0.1, 0.4, and 0.7 mg per 70kg). This procedure will allow accurate assessment of varenicline effects on the subjective, physiological and cognitive responses to nicotine. Following a washout period, subjects will be crossed over to the alternative treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female and male smokers, aged 18 to 55 years
* History of smoking daily for the past 12 months, at least 15 cigarettes daily
* Carbon Monoxide (Alveolar) level \> 10ppm
* For women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods

Exclusion Criteria:

* History of heart disease, renal or hepatic diseases
* other medical conditions that the physician investigator deems as contraindicated for the subject to be in the study
* Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
* recent psychiatric diagnosis and treatment for Axis I disorders including
* major depression, bipolar affective disorder,
* schizophrenia and panic disorder within the past year
* Current dependence on alcohol
* drugs or treatments for drug
* alcohol addiction within the past 5 years
* Allergy to varenicline
A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX

To assess whether high dose or low dose atovaquone suspension is more effective than aerosolized pentamidine as prophylaxis against Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients. To compare the safety of chronic administration of the three regimens in patients with advanced HIV disease. To determine the relationship between steady state atovaquone plasma concentrations and prophylactic efficacy against PCP.

Patients are randomized to receive oral atovaquone at 1 of 2 doses once daily or aerosolized pentamidine once every 4 weeks. Treatment continues until 18 months after the last patient is enrolled. Patients are stratified into primary or secondary prophylaxis strata based on prior occurrence of a PCP episode.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antimicrobial agents not specifically prohibited.

Concurrent Treatment:

Allowed:

* Transfusion.

Patients must have:

* HIV positivity.
* Prior PCP (histologically confirmed) OR documented CD4 count \< 200 cells/mm3 OR constitutional symptoms such as thrush or unexplained fever (\> 100 F) for 2 or more weeks.
* No current or suspected active PCP, and no signs of active PCP on chest x-ray.
* Prior intolerance to TMP/SMX or other trimethoprim or sulfa-containing regimens.
* Life-expectancy of at least 6 months.

NOTE:

* Pregnant women are eligible at the discretion of the investigator.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Significant psychosis or emotional disorder that would preclude study compliance.
* Severe chronic diarrhea (e.g., \> five stools/day) that may negatively affect absorption of oral medication.
* Unable to take oral medication or unable or unwilling to take medication with food.

Concurrent Medication:

Excluded:

* Rifampin.
* Other investigational agents except for drugs available through Treatment INDs or expanded access programs.
* Medications likely to have anti-pneumocystis effect (e.g., dapsone, trimethoprim, pyrimethamine, trimetrexate, other DHFR inhibitors, sulfadiazine, sulfamethoxazole, other sulfonamides, primaquine, clindamycin, and sulfonylureas.
* Corticosteroids in greater than physiologic replacement doses for more than 21 consecutive days.
* Systemic therapy for CNS toxoplasmosis, Kaposi's sarcoma, lymphoma, other active malignancies, or other disease that may decrease life expectancy or confound assessment.

Patients with the following prior conditions are excluded:

* History of severe or intractable intolerance to atovaquone or aerosolized pentamidine.
* Prior hypoglycemia, pancreatitis, arrhythmias, or severe hypotension associated with any form of pentamidine.
* Prior enrollment in this protocol. Active substance abuse that would preclude study compliance.
MRgLITT for TLE: A PROBE Trial

How does magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) impact clinical prognosis in temporal lobe epilepsy (TLE)?

1. Compare the clinical prognosis between magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) and traditional open surgery (OS) on patients with temporal lobe epilepsy (TLE).
2. Explore the factors associated with seizure outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Drug-resistant epilepsy.
* Temporal lobe epilepsy.
* Participants approved.

Exclusion Criteria:

* Individuals with significant medical comorbidities or conditions that pose an excessive risk for surgery, such as severe cardiovascular disease, respiratory disorders, or uncontrolled systemic infections.
* Brain surgery histroy.
Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Female Patients With Lower Urinary Tract Syndrome

The purpose of this study is to determine whether Tamuslosin is effective in the treatment of lower urinary tract syndrome with female patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with urination disorder not accompanied by apparent organic or neurologic abnormality(lower urinary tract syndrome: LUTs)．

Exclusion Criteria:

* Patients with urination disorder accompanied by apparent organic or neurologic abnormality, active urinary tract infections, severe cardiovascular, hepatic and/or kidney complications.
Real-time Deflectable Guidewire in Neuro-interventions Study

The aim of the study is to assess the safe and successful use of the SmartGUIDE guidewire in neuro interventions and to compare to standard of care guidewires on the market.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Informed consent signed by patient
* Confirmed cerebral unruptured aneurysm treatable via transcatheter approach

Exclusion Criteria:

* Pregnancy or lactation
* Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome)
* Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures
* Acute phase myocardial infarction or uncontrolled cardiac arrhythmia
* Uncontrolled serum electrolyte imbalance
* Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy
* Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
* Known hypersensitivity to Nickel
* Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints
Characterization of Phenotype and Genotype of Early Onset Enteropathies

This study has been set up in order to characterize phenotypes and genotypes of patients with early onset enteropathies.

In that goal, Investigators will collect biological samples (mainly blood) of patients suffering from early onset enteropathies and their healthy relatives.

This study specifically aims at the genetic analysis of early onset enteropathies with the goal in mind to delineate human pathways necessary to maintain intestinal homeostasis despite the considerable density of microbes colonizing the distal part of the human intestine.

Eligibility Criteria:
Main Inclusion Criteria:

* Severe chronic enteropathy
* Patients developing their first symptoms within the first 6 years of life and, in priority within the first two years of life, or patients with a disease of later onset, in case of a familial history suggestive of inherited mutations notably in families comprising several affected members
* OR : Be a patient's relative, even if presenting with enteropathy of later onset.

Main Exclusion Criteria:

* Subject having participated to any therapeutical clinical study in the 30 days preceding the inclusion in this study,
Association Between Telomere Length and Risk of Acute Coronary Syndrome

Compelling epidemiological evidence indicates that alterations length of telomere, are associated with the initiation and development of ischemic heart disease. This study was undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be used as a risk predictor for acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

-1.History of documented myocardial infarction; 2.Prior coronary revascularization intervention (coronary artery bypass graft surgery or percutaneous coronary intervention); 3.The presence of≥50% stenosis in one or more coronary arteries identified during cardiac catheterization;

Exclusion Criteria:

-1.History of malignancy or end-stage renal disease; 2.Blood transfusion within one month or prior bone marrow transplantation 3.Patients who reluctant to sign informed consent
The Food Effect on Pharmacokinetics and Safety of Fixed-dose Combination of CJ-30056 in Healthy Male Subjects

This study evaluate the food effect on pharmacokinetics and safety of fixed-dose combination of "CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)" in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

1. Willing to adhere to protocol requirements and sign a informed consent form
2. Male volunteers in the age between 20 and 45 years old and have the weight range is not exceed ±20% of ideal weight
3. Subjects with no history of any significant chronic disease
4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data

Exclusion Criteria:

1. Use of barbital inducer or inhibitor medication within the 4 weeks before dosing
2. Symptom of an acute illness within 4 weeks prior to drug administration
3. History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
5. History of clinically significant allergies including drug allergies
6. History of clinically significant allergies about atorvastatin or metformin
7. Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration
8. History of myopathy
9. Clinical laboratory test values are outside the accepted normal range

   * AST or ALT \>1.25 times to normal range
   * Total bilirubin \>1.5 times to normal range
   * e-GFR \<90 mL/min
10. History of drug, caffein(caffein \> 5 cups/day), smoking (cigarette \> 10/day) or alcohol abuse(alcohol \> 30 g/day)or Subjects who have ever drink within 7 days prior to drug administration
11. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
12. Donated blood within 60 days prior to dosing
13. Participated in a previous clinical trial within 60 days prior to dosing
14. Use of any other medication, including herbal products, within 10 days before dosing
15. Subjects considered as unsuitable based on medical judgement by investigators
Impact of the COVID-19 Pandemic on Drug Use and Monitoring of Cancer Patients

The COVID-19 pandemic has profoundly changed the organisation of care. Teleconsultation has replaced hospital medical consultations in order to reduce the risk of patient exposure to the virus.

Within the framework of the Oncoral multidisciplinary outpatient / hospital program of follow-up, carried out by the Hospices Civils de Lyon for ambulatory patients treated with oral anticancer drugs, interviews with the pharmacist and/or nurse, which were previously organised face-to-face, have been replaced by telephone interviews, ensuring continuity of follow-up for patients without having to come to the hospital.

This study focuses on a telephone survey to describe the impact of the COVID-19 pandemic health crisis on the drug exposure of cancer patients followed in the Oncoral program, their treatment management, their perception of teleconsultation and their IT resources for remote monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 and over
* Ambulatory patients treated with oral anticancer drugs and benefiting from the ONCORAL multidisciplinary outpatient / hospital program
* Having benefited from a remote monitoring between March 16, 2020 and May 11, 2020 (the COVID-19 pandemic-related containment period)
* Patients who do not object to participating in the survey and to the use of the data collected

Exclusion Criteria:

* Patients who do not speak French
* Patients living in an institution
* Patients protected by law
* Patients included in a drug clinical trial
* Patients refusing to participate in the survey and / or not responding to the 2 telephone calls requesting their participation and / or not responding to any of these calls
* Patients choosing to stop the interview and no longer answering to the questions asked
Behavioural Text Messages to Improve Retention in Care in South Africa

The proportion of South Africans aware of their HIV status and on treatment remains lower than optimal. The goal of this study is to rapidly determine whether text messages framed according to behavioural economics principles increase clinic attendance among recipients of care on antiretroviral therapy in South Africa. We hypothesize that messages incorporating behavioural economics principles will increase the likelihood of recipients of care attending clinic appointments and returning within 28 days of a missed appointment.

The objective of this study is to rapidly determine whether text messages framed according to behavioural economics principles increase the likelihood that recipients of care attend their clinic appointment and return to clinic within 28 days of a missed appointment. The study will be nested in a routine HIV program, in approximately 5 selected Aurum Institute clinics based in Ekurhuleni district, Gauteng province, South Africa.

Intervention arms will include voice call attempts and one-way text messages sent by clinic staff to recipients of care in two scenarios: 1) Approximately 3-7 days in advance of a clinic appointment for collecting antiretroviral medication supplies or collection of a specimen for viral load testing and 2) Approximately 24 hours after a missed clinic appointment.

This individually randomised trial will have four arms. Each time there is an upcoming or missed clinic visit clinic staff will randomly assign recipients of care to one of the following study arms: 1) Standard of Care 2) Loss aversion framed messaging 3) Social norms framed messaging or 4) Altruism framed messaging.

Eligibility Criteria:
Inclusion Criteria:

* Registered to receive ART (this includes patients receiving ART through multi-month scripting) at selected study sites.
* Aged ≥18 years.
* Have a documented cell phone number in their clinic records
* Are eligible to receive appointment reminders as part of routine care OR eligible to receive follow-up text messages as part of routine care for missed clinic appointments.

Exclusion Criteria:

* Do not have contact details in their clinic records.
* Have contact details on record that are established to belong to someone else upon follow-up (i.e., wrong number).
* Have contact details that are deactivated/non-functional (i.e., voice notification that the number does not exist).
* Are documented to have self-transferred out of the clinic.
* Are known to have been deceased.
Precision Medicine for Preterm Birth

This project is examining genetic and metabolic markers for the use of 17 hydroxyprogesterone caproate (17OHPC) in pregnant women with a history of preterm birth (PTB). 17OHPC has been associated with a 30-35% reduction in repeat PTB in women carrying a singleton gestation. However, it is not well known why it works for some women but not for others. There are limited available interventions for the prevention of recurrent PTB. This study will enroll 150 women at risk for PTB and eligible to receive 17OHPC, and expect that 80% will use 17OHPC and 20% will decline use. We will obtain blood samples and samples of cervical cells and cervical vaginal fluid. The objective of the study is to identify genetic, microbial and molecular markers that help to identify which women at risk for recurrent preterm birth will respond to 17OHPC and which women will not. The ultimate goal is to develop a personalized screening test based on these markers.

Women with a prior preterm birth will be recruited between 16 and 22 weeks gestation. At this initial time point, samples of cervical epithelial cells and cervicovaginal fluid will be collected. Approximately 8 weeks later, those samples will be collected a second time, along with a blood sample. Outcome data will be collected after delivery.

Eligibility Criteria:
Inclusion Criteria:

* Women with a prior spontaneous preterm birth of a singleton pregnancy (delivered at 16-36 6/7 weeks gestation)
* Singleton in the current pregnancy
* Eligible to use 17 hydroxyprogesterone caproate (17OHPC) in this pregnancy for clinical indications
* 16-22 weeks gestation at the time of visit 1 assessments

Exclusion Criteria:

* Major fetal anomaly
* Allergy to 17OHPC