cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Caffeine, With and Without Biperiden, in the Detoxification of Cocaine Dependent Patients

The aim of this study is to assess the efficacy of caffeine compared to placebo in detoxifying cocaine dependent patients. Caffeine potentiation with biperiden will be also studied.

108 with cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) or caffeine (300 - 1200 mg t.i.d.) with placebo or placebo during 6 months.

Primary efficacy outcomes will be 1) patient comfort assessed with abstinence symptomatology, craving for cocaine and mental status during detoxifying period, 2) study retention and 3) cocaine use.

Brain dopamine system will be assessed thru IBZM-SPECT and the apomorphine test.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of intranasal cocaine dependence, according to DSM-IV-TR criteria
* age between 18 and 60 years
* current cocaine use, confirmed by a positive urine drug screen for cocaine the week prior to admission.
* demonstrated capacity to grant informed consent and sign the pertinent informed consent form.
* place of residence compatible with attendance at the centre.
* for women, willingness to use effective contraceptive measures during the study.

Exclusion Criteria:

* diagnosis of a severe medical disorder that could interfere with the study
* presence of an organic pathology for which methylxanthines or biperidene, iodine or apomorphine administration is contraindicated
* serum liver transaminase levels 3 times higher than normal values
* pregnancy and breast-feeding
* neuroleptic medication treatment in the past 6 weeks
* current treatment, or anticipation that the patient may need to initiate treatment during the study with drugs that may interact with study medication.
* current diagnosis of a major mental disorder.
* awareness of a situation that could prevent the patient's participation in the study (e.g. serving a sentence)
* current participation in another research project.
Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo

The exact mechanism of impairment of autophagy in vitiligo has not yet been determined.


Eligibility Criteria:
Inclusion Criteria:

* • Patients with non-segmental vitiligo whether active or stable.

  * Age above 12 years.
  * Both sexes.

Exclusion Criteria:

* • Patients should not use any topical or systemic treatment at least 6 weeks before inclusion into the study.

  * Patients having other autoimmune disease, heart disease, liver disease, kidney disease, neurological disorder, cancer, active infection or any chronic disease.
  * Pregnancy or breast feeding for female patients.
The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration

This study aims to investigate the influence of desensitizing agents on reducing post-operative sensitivity in posterior composite.


Eligibility Criteria:
Inclusion Criteria:

* Patients having active primary class I carious lesions on vital molar teeth either in the middle or the inner third of dentin in the three quadrants of each patients.
* Teeth having a positive reaction to vitality test (cold test), no signs of pulp inflammation, or spontaneous pain before treatment.
* Preoperative radiographic record of the carious lesions.
* Buccolingual width is no more than half the inter-cuspal distance

Exclusion Criteria:

* Excessive tooth wear due to clenching or abnormal habits.
* Patients with direct occlusal contact by antagonist cusp (traumatic occlusion).
* Patients with periodontal or gingival disease.
* Patients using analgesics and/or anti-inflammatory medicine.
A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane

Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain, superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but clinical experience suggests that most epidermise in less than a month. Some, however, for unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined for this study as lasting more than three months are a source of major discomfort and could play a decisive role in the morbidity and mortality of the disease.

The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3) from the start of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age between 2 years and 60
* REBD clinically evident with immunohistological confirmation and / or genetic
* REBD with at least two chronic ulcers (\> 3 months) comparable
* Signing the informed consent of the patient and / or (children) of parents holding parental authority
* Affiliation to a social security scheme (beneficiary or legal)

Exclusion Criteria:

* Epidermoid carcinoma on the target or chronic ulcers
* Budding excessive requiring the application of a topical corticosteroid on the target or chronic ulcers
* Skin bacterial superinfection clinically overt requiring oral antibiotics
* Herpes simplex virus superinfection
* major evolutionary and malnutrition defined as a BMI \<12 or more than 2 variant between screening and randomization OR a serum albumin \<20 g / l or more ranging from 5 g / l between screening and randomization
* major and progressive anemia defined by a Hb \<6 g / liter or variant more than 4 g / l between screening and randomization
* Life expectancy estimated at less than 3 months
* Pregnancy
* Inability to understand or observance of the rules of protocol
* Participation in another interventional therapeutic biomedical research whose treatment is not yet completed or the primary endpoint is not yet measured at the time of inclusion in Mabul
Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac Surgery

The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery

Patients with severely reduced left ventricular ejection fraction (LVEF) face a high risk of morbidity and mortality after cardiac surgery. Impaired cardiac function preoperatively predisposes patients to low cardiac output syndrome. Levosimendan acts by a different mechanism than traditional inotropes and its preoperative use could improve the outcome of patients with cardiac failure. Specifically, it promotes vasodilation of coronary, pulmonary and systemic vessels, has an anti-inflammatory and anti-oxidant effect and enhances cardiac contractility by improving the response of the myofilaments to intracellular calcium.

The aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* elective cardiac surgery
* cardiac surgery under cardiopulmonary bypass
* low ejection fraction (\<40%)

Exclusion Criteria:

* age \<18 years old
* urgent operation
* glomerular filtration rate\<30 ml/min
* hepatic dysfunction preoperatively
* side effects (hypotension, tachycardia, ST segment abnormalities during levosimendan administration
* redo surgery
The Effect of Home-Based Monitoring, Exercise Training

Chronic obstructive pulmonary disease (COPD); From time to time, significant involvement in dusts or gases and abnormal disease outbreaks are observed, which are observed throughout life in the period when the cause has just emerged, interruption of air flow with disruptions in air flow, shortness of breath, increase in the amount of secretion. Directly or indirectly, very high costs are incurred in COPD care and promotion. While mild stages are treated without directed hospitalization, hospitalizations become more frequent as the disease progresses, and the duration of hospitalization in each acute attack increases compared to the next attack. Acute exacerbations of COPD negatively affect the rates of rehospitalization and emergency service admissions, and the living conditions of this condition, whose long-term cause of death and morbidity has not yet been revealed, do not lead to negative aspects. Exercise programs applied in chronic diseases should include stopping their illnesses, increasing sleep during the disease, stopping inflammatory acuteness, and in addition to treatment, the rest of the patients should be normal. It has been stated that it is more effective than home-based hospital system applications in pulmonary regulation, and it has been taken positively from applications compatible with the basic field, as everywhere in the world. In this direction, the effect of home-based monitoring, education and exercise training applied to individuals with COPD via tele-consultancy method on repeated hospitalization and quality of life is revealed.


Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research,
* Diagnosed with COPD,
* Able to use a smartphone,
* Oriented and cooperative,
* Does not have a psychiatric disorder that impairs verbal communication, such as schizophrenia or dementia,
* Having no communication problems.

Exclusion Criteria:

* Having alcohol or drug addiction,
* Those with physical disabilities,
* Illiterate.
The Construction of Bidirectional Column Study of Acute Osteoporotic Vertebral Compression Fractures

Our research group plans to establish a disease specific bidirectional cohort study on prognosis prediction of acute osteoporotic vertebral compression fracture based on imaging and clinical data, and to establish a comprehensive bioinformation database on OVCFs, including patient status, clinical data, laboratory examination, and imaging examination database


Eligibility Criteria:
Inclusion Criteria: all patients who suffer a acute osteoporosis vertebral compression fractures -

Exclusion Criteria: those who have endocrine disease which have impacts on the bone density

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A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT

The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.

Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.


Eligibility Criteria:
Main Inclusion Criteria:

* Insulin dependent type 1 diabetes mellitus diagnosed within the previous 3 months at time of screening
* Fasting C-peptide level at time of screening above 0.1 nmol/L
* Elevated GAD65 antibodies (GADA) at time of screening
* Male and female patients between 10 and 20 years of age

Main Exclusion Criteria:

* Treatment with immunosuppressants or any anti-diabetic medications other than insulin
* A history of certain diseases or conditions (e.g. anemia, HIV, hepatitis, epilepsy, head trauma, neurological diseases or cerebrovascular accident, alcohol or drug abuse etc)
* Treatment with any vaccine within 1 month prior to planned first Diamyd dose or planned treatment with vaccine up to 2 months after the last injection with Diamyd, excluding the influenza vaccine
* Participation in other clinical trials with a new chemical entity within the previous 3 months
* Pregnancy or planned pregnancy within 1 year after the last Diamyd dose
* Presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study
Effects of Sensory Motor Training on Balance and Proprioception Among Post-Menopausal Obese Women

Postmenopausal obese women often have difficulties with balance and proprioception. Sensorimotor training is an important part of physical therapy interventions, with emerging evidence that it could be beneficial for postmenopausal obese women.

Objective: To find the impact of sensorimotor training on balance and proprioception among postmenopausal obese women.

Randomized clinical trial was conducted on postmenopausal obese women population with impaired balance and proprioception on inclusion \& exclusion criteria, sample size of 40, ages ranged from 45 to 65 years included. Group A received SMT and Group B received CT. The interval of treatment was 6 weeks. Data is collected from THQ Samundri. FRT, TUG, OLS utilized to assess the pre-and post-estimations of postural strength.

Eligibility Criteria:
Inclusion Criteria:

* • Post-menopausal obese women

  * BMI ≥30
  * Participants independent in ADLs
  * self-ambulatory
  * healthy (having no known condition in which sensorimotor exercises would be contraindicated.)

Exclusion Criteria:

* • History of ankle sprain

  * Uncontrolled diabetes mullites
  * Presence of orthopaedic problems.
  * Neurological disorders.
  * Psychological problems.
  * Cognitive issues.
  * People with severe visual issues
Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.

This study used a 6 treatment arm, parallel-group, randomized, double-blind study design. 974 male and female COPD patients were randomized into the trial. The study consisted of four distinct study periods:

* Screening (Weeks -3 to -2): Participants underwent a screening period of 1 week where were assessed for eligibility and tapered off disallowed medications.
* Run-in (Days -14 to 1): Subsequently, participants entered the run-in period of up to 2 weeks to establish baseline values for symptom assessments, to standardize the COPD background therapy (triple combination LABA/LAMA/ICS), and to complete eligibility assessments.
* Treatment (Day 1 to Week 24): Eligible participants moved into the Day 1 visit where they were stratified according to their smoking status (current or ex-smoker) and severity of airflow limitation (FEV1 ≥ 30% to \< 50% and ≥ 50% to \< 80%) and then randomized into 1 of 6 treatment arms with a randomization ratio of 2:2:1:1:1:2 (450 mg b.i.d., 300 mg b.i.d., 150 mg b.i.d., 75 mg b.i.d., 25 mg b.i.d., placebo). The treatment period consisted of 24 weeks, during which the participant returned to the site for regular visits (Day 1 - Week 24). QBW251 450 mg arm was discontinued early based on a pre-defined pharmacokinetic exposure stopping rule.
* Follow-up (Weeks 25-28): Upon completion of the treatment period, participants were followed up for safety assessments for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
* Current or ex-smokers who have a smoking history of at least 10 pack years.
* Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last 3 months prior to screening.
* Patients featuring chronic bronchitis

Exclusion Criteria:

* Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection in the 4 weeks prior to screening, or between screening and randomization.
* Patients with any documented history of asthma, or with an onset of chronic respiratory symptoms, including a COPD diagnosis, prior to age 40 years.
* Patients with a body mass index (BMI) of more than 40 kg/m2.
* Use of other investigational drugs (approved or unapproved) within 30 days or 5 half-lives prior to screening, or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations.
* Pregnant or nursing (lactating) women, and women of childbearing potential not willing to use acceptable effective methods of contraception during study participation.
A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen

The purpose of this study is to find out the frequency of the I50L substitution among patients experiencing treatment failure on an atazanavir-containing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Atazanavir - containing antiretroviral regimen
* Confirmed virologic failure defined as either:

  1. HIV RNA by PCR greater than or equal to 1000 copies/mL after achieving a value of \<400 copies/mL on at least 2 consecutive measurements or
  2. HIV RNA greater than or equal to 1000 copies/mL after 24 weeks of continuous therapy
* At least 18 years old

Exclusion Criteria:

* Unable to give informed consent
* Prisoners or subjects involuntarily incarcerated for treatment of psychiatric or physical illness
European Sepsis Care Survey

The objective of this survey is to investigate the current state of sepsis care around Europe. The study is aiming at hospital structure, emergency departments, wards, intensive care units and clinical diagnostic and microbiological service.


Eligibility Criteria:
Inclusion Criteria:

* Hospitals of all strata

Exclusion Criteria:

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Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B.

This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in NN7999-3747 (NCT01333111) and/or NN7999-3773

Exclusion Criteria:

* Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
* Current FIX inhibitors above or equal to 0.6 BU (Bethesda Units)
* Congenital or acquired coagulation disorders other than haemophilia B
* Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
* Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's (trial physician) judgement, could imply a potential hazard to the patient, interfere with trial participation, or interfere with trial outcome
Zoledronate for Osteopenia in Pediatric Crohn's

Background:

* Up to 30% of children and adolescents with Crohn's disease have decreased bone strength, or decrease bone density, called osteopenia.
* Bisphosphonates are a group of drugs that have been well studied and found to be effective in the treatment of osteopenia in menopausal women.
* Zoledronate is a very potent third generation bisphosphonate, that is safe and easy to administer, and has been found effective in the treatment of menopausal women with osteopenia.

Hypothesis: The investigators hypothesize that zoledronate can improve bone density in children and adolescents with Crohn's disease with osteopenia.

* This study is recruiting 40 children and adolescents, aged 6 to 18, who have a proven abnormal bone density as measured on a special type of x-ray called a DEXA-scan.
* Participants are allocated at random to one of two groups: either treatment with zoledronate, or a placebo.
* Neither the participants or the physicians are aware of which group each participant is in.
* Participants are followed every three months for one year, and assessed with blood tests, urine tests, physical examination, diet questionnaire and exercise questionnaire.
* Participants have a repeat DEXA scan at 6 and 12 months after beginning the study.
* Once all participants are enrolled and followed for one whole year, we will compare the bone density of the group treated with zoledronate with the group treated with placebo.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 6 to 18,
* diagnosed with Crohn's disease with osteopenia,
* a minimum of 6 months of adequate calcium and vitamin D intake. (Osteopenia was defined for the purposes of this study as: Z-score lumber spine BMD by DEXA of -2.0 or less, or -1.5 and a risk factor (either steroid use for 6 months or more or decrease of 0.5 z-score in the preceding 12 months).)

Exclusion Criteria:

* renal dysfunction,
* insufficient calcium or vitamin D intake,
* current medication or condition affecting bone metabolism,
* documented fracture, previously diagnosed bone disease,
* documented intolerance/hypersensitivity to bisphosphonates,
* previous treatment with bisphosphonates within the last 6 months.
Single Dose and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4

A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. Cohorts of healthy adults (female and male) will participate in:

single dose escalation study of increasing doses of MRX-4 given by mouth others will participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.

other cohorts of subjects will participate in the study to evaluate the impact of concomitant food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder
The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing breast reconstruction

Exclusion Criteria:

* Diabetes mellitus
* Kidney or liver disease
* Use of immunosuppressants
Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management

The purpose of this study is to evaluate the efficacy of an online virtual intervention in optimizing adherence to antiretroviral medication intake among Persons Living with HIV (PLHIV).


Eligibility Criteria:
Inclusion Criteria:

* have to be under ART for at least six months¸
* have internet access

Exclusion Criteria:

* be pregnant
* active IV drug user
* actual diagnosis of psychiatric health problem
DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor

The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.


Eligibility Criteria:
* Diagnosed (or previously diagnosed) with lymphoma or a solid tumor (not leukemia)
* Diagnosed with neoplastic meningitis
* If female, not pregnant and will not become pregnant while on-study
* No other experimental therapy within 21 days of participation