cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men

Survey of fifty new psychoactive substances consumers in a context of MTM sexual intercourse.

Evaluation using an hetero-assessment questionnaire about the link between hypersexual disorder and the use of synthetic cathinone.

Evaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and the medico-psycho-social consequences of those practices.


Eligibility Criteria:
* Inclusion Criteria:

  * Patients ≥ 18 years
  * Male homosexual and / or bisexual who come to the CSAPA at the Croix-Rousse Hospital, Lyon France following the use of psychostimulants products in sexual contexts
  * Patients who have received clear information and not opposed to participate in the study
  * Patients affiliated to a social security scheme or similar
  * Patients not undergoing a measure of legal protection
* Exclusion Criteria:

  * Opposition to participation in the study
  * Patients \< 18 years
  * Pregnant women or breastfeeding
  * Deprived of individual liberty
Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia or PFM

The aim of is to compare the survival rate and technical outcomes of cantilever implant-supported fixed denture prosthetics (cFDPs) made either out of monolithic zirconia bonded to a titanium base in a digital workflow, or porcelain fused-to metal using a gold abutment in a conventional workflow. In addition, biological outcomes, wear patterns, PROMs and time efficiency will be recorded. The null hypothesis is: the reconstruction type does not influence the survival rate and technical outcomes of 2-unit implant-supported cFDP.


Eligibility Criteria:
Inclusion Criteria:

* Minimal age of 22 years old.
* No general medical condition which represents a contraindication to implant treatment
* Good oral hygiene (PII ≤ 20%), and healthy periodontal tissues (BOP≤ 20%)
* Two adjacent-teeth gap in posterior maxilla or mandible arch (first premolar, second premolar, first molar, second molar) with an osseointegrated regular or wide-diameter bone-level implant in a prosthetically correct position to allow occlusal screw-retention. Free-end edentulous gaps can also be included
* Presence of antagonist occlusal units

Exclusion Criteria:

* Severe bruxism or clenching habits
* Patients with inadequate oral hygiene or persistent intraoral infection
* Women who are pregnant or breast feeding at the day of inclusion
* Smokers exceeding 15 cigarettes / day, or equivalent; patients chewing tobacco
* Unable or unwilling to cooperate for the trial period
* Estimated cantilever crown mesial-distal length \> 10 mm
* Estimated implant crown height (from implant platform to occlusal contact points) \> 15 mm
Study Using WST11 in Patients With Obstructing Endobronchial Non-Small Cell Lung Cancer

The aim of this study is to determine the dose of WST11 and light energy necessary to obtain desobstruction of the bronchial lumen using Vascular Targeted Photodynamic therapy in obstructive Non-Small Cell Lung Cancer.

This study is designed as a multicentre, exploratory phase IIa, open label, single intravenous (IV) dose, escalating treatment regimen (Treatment regimen = a single dose of WST11 associated with a particular laser light energy) with a one month follow-up.

Six escalating treatment regimens will be followed: 3 WST11 doses (5 mg/kg; 7.5 mg/kg and 10 mg/kg) combined with 2 light energies (200 Joules/cm and 300 Joules/cm)

The patient will be treated under local anesthesia. The light is produced using a specific laser at a wavelength of 753 nm at a fixed power of 250 mW/cm and locally delivered to the obstructing tumor through an optical fiber placed, during endoscopy, in the endoscope operating channel with visual control, possibly video-transmission assisted. The fiber illuminating diffusion length is fixed (2 cm).

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven lung cancer
* Inoperable
* Non-Small Cell Cancer
* Partial or total bronchial obstruction responsible for functional signs
* T1 to T4, N0-N3, M0-M1
* Patients with functional signs: hemoptysis, infection, cough and, above all, dyspnea
* Contralateral metastases not representing a contraindication insofar as they do not represent a risk of impairment of respiratory function during treatment
* The Karnofsky index should be greater than or equal to 40
* Patients should agree to and tolerate repeated bronchial endoscopy (a disadvantage of all endoscopic treatments)
* Male or female patients aged over 18 years, female patients should not be pregnant (menopause or contraception)
* Patients should have given their written consent to take part in the study

Exclusion Criteria:

* Tracheal lesions and lesions affecting the carina tracheae
* Patients with painful bone metastases (not an absolute criterion since the extent of dyspnea is the decisive element)
* Patients with brain metastases
* Patients having undergone pneumonectomy
* Patients undergoing chemotherapy or radiotherapy or having undergone chemotherapy less than 4 weeks before the procedure or radiotherapy less than 4 weeks before the procedure
* Patients with risk of large vessel erosion or perforation resulting from lesion topography
* In case of allergy to the photosensitizer
* Leukopenia (WBC\<2000), Thrombocytopenia (\< 100 000), PT \> 1.5 normal, Fibrinogen \< 2g/l, a PTT \> 1.5 ULN (Upper Limit of Normal)
* Renal insufficiency
* Hepatic insufficiency
* Patients having already received 70 Gy on the lesion
* Existing tracheoesophageal or bronchoesophageal fistula
* Emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion
Evaluation of Multi-Organ Metabolism and Perfusion in NAFLD by Total Body Dynamic PET Scan on EXPLORER

Evaluation of Multi-Organ Metabolism and Perfusion in Non-Alcoholic Fatty Liver Disease (NAFLD) by Total Body Dynamic PET Scan on EXPLORER

You are invited to participate in a research study that seeks to understand the effect of non-alcoholic fatty liver disease (NAFLD) on organs other than the liver. One of the most common organs affected in patients with NAFLD is the heart. We expect to have about 88 people participate in this study at University of California (UC), Davis. About three-fourths (66) of the participants will be patients who have been diagnosed with NAFLD. The other one-fourth (22) will be healthy individuals with no known liver disease. These healthy subjects will allow researchers to compare healthy organs or body functions with those of persons with NAFLD. The healthy participants are called the "Healthy Control" group. All participants will undergo the same testing.

If you agree to participate in this study, researchers will first interview you and review your medical records in order to document your medical (clinical) history. You will also have a physical examination by a doctor and a blood test. You will then undergo a series of imaging tests to determine the status of your liver, heart and other internal organs.

All participants will have a PET/CT Scan (Positron Emission Tomography), and an MRI (Magnetic Resonance Imaging). All participants will also have an Electrocardiogram and an Echocardiogram. All Electrocardiogram tests are the same, but there are two types of Echocardiogram tests. One is like a standard ultra-sound imaging of your heart. The other is a "Stress Cardio" that will require you to increase your heart rate on a treadmill before the ultra-sound test. Your study doctor will determine which test you have.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals of 18 years and older
2. NAFLD patients with diagnosis of non-alcoholic fatty liver disease will be eligible for enrollment or healthy controls without any history of fatty liver disease or risks association with fatty liver will be eligible

Exclusion Criteria:

1. History of other liver diseases including viral hepatitis B or C (except those cured \> 3 years), autoimmune hepatitis, cholestatic diseases, significant alcohol use or known alcoholic liver disease
2. Participation in a blinded investigational study for NAFLD
3. Pregnant women
4. Prisoners
5. Claustrophobic to MRI and/or PET Scan (EXPLORER)
6. Inability to lie or to maintain posture in the scanner for one hour
7. Hgb A1c \>9%
8. Underwent dynamic FDG PET as part of another study, Non-Invasive Evaluation of Liver Steatosis, Inflammation and Fibrosis (IRB 840422) within 12 months
A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This study is divided into three periods:

* Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
* Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
* Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology
2. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
3. Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one prior line of systemic therapy are eligible if they present with high risk features. Patients that received two or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2)
4. Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) or relapsed after hematopoietic stem cell transplant
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate organ function
7. Adequate vascular access for leukapheresis procedure

Exclusion Criteria:

1. Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL
2. WHO subclassification of duodenal-type FL
3. Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study)
4. History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies
5. Prior CAR T-cell or other genetically-modified cell therapy
6. History of or active human immunodeficiency virus (HIV)
7. Active hepatitis B or active hepatitis C
8. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment
9. Active autoimmune disease requiring immunosuppressive therapy
10. Presence of acute or chronic graft-versus-host=disease
11. History of significant cardiovascular disease
12. History or presence of clinically relevant central nervous system pathology
13. Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis
Evaluation of Microvolt T-Wave Alternans(MTWA) Testing for the Detection of Active Ischemia

MTWA-CAD is a feasibility study designed to evaluate Microvolt T-Wave Alternans (MTWA) testing for the purpose of detecting active ischemia in patients with known or suspected coronary artery disease (CAD). MTWA is a subtle, alternating pattern in the T wave portion of the surface electrocardiogram (ECG) that is associated with increased risk of ventricular tachyarrhythmias and sudden cardiac arrest (SCA).

Ischemia, a common trigger for arrhythmias, is a well-documented cause of repolarization alternans. Human studies have shown that active ischemia can be associated with visible as well as microvolt-level T-wave alternans. While MTWA testing is traditionally used to evaluate arrhythmic risk, this known association with ischemia may allow MTWA testing to be used as a diagnostic tool to detect underlying CAD. The MTWA-CAD study will assess the feasibility of this concept by measuring MTWA during routine nuclear stress testing or stress echocardiography with treadmill exercise. This is a feasibility study designed to verify preliminary observations under controlled environments and to generate hypotheses, endpoints, and sample sizes for future investigations.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Willing and capable of providing informed consent
* Willing and capable of undergoing a SPECT MPI exercise test (or stress echo) at an approved clinical investigational center
* In normal sinus rhythm at the time of the exercise test
* A life expectancy of more than 6 months

Exclusion Criteria:

* In atrial fibrillation at the time of the exercise test
* Left bundle branch block (precludes ST segment measurement)
* Pacemaker-dependent
* Life expectancy of less than 6 months
* Pregnancy
Antidiabetic Effects on Intrahepatic Fat

This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide, liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.

Following enrollment, eligible participants were randomized (1:1:1) using computer-generated random numbers to the metformin (Glucophage, Bristol-Myers Squibb), liraglutide (Victoza, Novo Nordisk), or gliclazide (Diamicron, Servier) groups. All patients were informed about a proper diet and exercise. For the metformin group (n = 31), the dosage was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study. For the gliclazide group (n = 31), the initial dosage was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of \<7.0 mmol/L. For the liraglutide group (n = 31), the dosage was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study.At the end of the study, data will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-70 years;
2. Type 2 diabetes mellitus;
3. Not used antidiabetic drugs within 3 months;
4. HbA1c(7-10%);
5. Presence of fatty liver disease (hepatic fat content ≥ 20% by quantitative ultrasonography);
6. Female subjects：post-menopausal women, take contraceptive measures three months before the test screening and can persist throughout the experimental period;
7. Body mass index (BMI) 20-35kg/m2, and stable Weight 3 months(less than 10% volatility);
8. patients signed the informed consent.

Exclusion Criteria:

1. Used antidiabetic drugs or any other possible hepatic steatosis associated with drugs within the past three months;
2. Suffering from pancreatitis or other pancreatic diseases or have other similar history;
3. GLP-1 analogs or sulfonylurea allergy history;
4. Liver dysfunction (aspartate aminotransferase ≥ 2.5 times of the normalupper limit);
5. Moderate to severe renal insufficiency (eGFR\<60ml/min/1.73m2,calculated according to MDRD);
6. Female subjects drinking\> 14 units / week; male subjects drinking\> 21 units/week;
7. A history of metabolic or autoimmune liver diseases or viral hepatitis diseases;
8. A history of medullary thyroid carcinoma, multiple endocrine neoplasia 2 or family history;
9. Congestive heart failure (NYHA grade Ⅲ - Ⅳ grade);
10. Severe gastrointestinal diseases;
11. Other serious concomitant diseases;
12. Pregnant or planning pregnancy;
13. The researchers believe that the subjects with proliferative retinopathy or macular degeneration need urgentl treatment;
14. Subjects are using unknown ingredients or non herbal medicine preparations or local medicine, researchers believe that during the test the dose of traditional Chinese medicines can not be adjusted or disabled.
An Epidemiological Study to Assess the Psychosocial and Symptomatic Remission and Community Integration Status in Patients With Schizophrenia

The purpose of this study is to estimate the level of symptomatic and psychosocial remission of patients with schizophrenia and schizoaffective disorder in standard clinical practice as a function of the degree of adherence to antipsychotic treatment. The secondary objectives are to study the level of community integration of the patients included in the study, and its influencing factors, to analyze the role of various sociodemographic factors, factors related to the course of disease and the psychopathological status of the patient in community integration and remission, to analyze the potential predictors of a favorable course (symptomatic and psychosocial remission) and a poor course (no symptomatic or psychosocial remission), to assess the impact of treatment adherence on the change in the functional and community integration status of patients (based on the occupation, independence level, and degree of disability variables), to assess the significance of premorbid (academic and social) adjustment in the symptomatic and functional remission and the community integration status of patients and to correlate the level of insight to the remission and integration status of patients.

This is a retrospective, cross-sectional, non-interventional observational, cohort epidemiological study conducted in the outpatient mental health facility setting in patients with schizophrenia. The inclusion of two patient cohorts is contemplated, recruited in mental health facilities. One cohort will involve patients estimated to have inadequate adherence to antipsychotic treatment, while the other will consist of patients with adequate adherence to such treatment. N/A

Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenia or schizoaffective disorder being followed-up at a mental health facility
* Whose clinical records of recent years may be accessed
* Who has signed informed consent, stating that he/she understands the study purpose and requirements and gives consent to participate in the study
* In whom the psychiatrist and main caregiver may estimate the degree of adherence to antipsychotic treatment during the last two years
* Not hospitalized in acute disorder units in the last 12 months

Exclusion Criteria:

* Patients with psychiatric disease other than schizophrenia or schizoaffective disorder who have been diagnosed with severe to moderate mental retardation, organic disorders of personality, and/or severe and/or disabling neurological disease
* Patients who are actively participating in any clinical trial/study
Hub Cleansing to Prevent Hub Infection

Central venous catheter infections are common preventable adverse events among hospital patients. Microbes may enter catheter hubs, also known as needleless connectors, and result in downstream contamination. This study aims to compare alcohol disinfection of catheter hubs to disinfection with chlorhexidine gluconate in alcohol, which has been proven to be a superior disinfectant at the site of central venous catheter insertion. Scrub duration of central venous catheter hubs will also be evaluated.

A prospective randomized blinded crossover clinical trial will be performed in the medical intensive care unit at Rush University Medical Center. The intensive care unit will be divided into two regions (A\&B). Hub disinfectants and duration of disinfection will be randomly assigned to these regions. After 1/2 of the study period, the agents will crossover, but the duration of scrubbing will remain the same, analogous to a 2 by 2 factorial design. Our primary endpoint will be internal contamination of hubs and catheters.

In February 2012 it was determined that the supplier of chlorhexidine and alcohol pads could not completely blind each pad. It was decided that a plain white sticker would be affixed to the front of each pad, but the safety information on the back of each pad would remain visible.

3/27/12-Internal hub contamination (yes/no)was clarified as the primary outcome.

On 5/10/12 a new sample size calculation adjusted the hub sample size needed to power the main effects based on more accurate information regarding the expected hub contamination rate. The expected hub contamination rate changed because of the more sensitive hub culture method that was adopted before the study began. This more sensitive method also allowed for a new secondary outcome of number of microbial colony forming units per hub.

The first crossover time selected was 6/11/12, prior to the midpoint of the study. This was done to try to improve a large imbalance in the group sizes.

On 6/11/12 a hold was placed on the catheter tip component of the study, because of an inability to collect tips.

On 8/7/12 the catheter tip outcome was dropped because of an inability to collect tips.

On 1/11/13 a second crossover was implemented in an effort to balance the sizes of the study groups.

Eligibility Criteria:
Inclusion Criteria:

* Medical intensive care unit patients with non-tunneled central venous catheters

Exclusion Criteria:

* Dialysis catheters
* Antibiotic-impregnated catheters
* Introducer sheaths
* Tunneled catheters
Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer

The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of small-cell lung cancer
* Extensive disease (i.e. a disease with distant metastases or that cannot be included in a single irradiation field incorporating primary tumour, mediastinum and supraclavicular lymph node(s))
* Availability for participating in the detailed follow-up of the protocol
* Presence of an evaluable or measurable lesion
* Informed consent

Exclusion Criteria:

* Prior treatment with chemotherapy, radiotherapy or surgery
* Performance status \< 60 on the Karnofsky scale
* A history of prior malignant tumor, except non-melanoma skin cancer or in situ carcinoma of the cervix or a cured cancer (defined as a disease-free interval \> 5 years)
* White blood cells \< 4000/mm3
* Platelets \< 100000/mm3
* Serum bilirubin \> 1.5 mg/100 ml
* Serum creatinine \> 1.3 mg/100 ml and creatinine clearance \<60 ml/min
* Recent myocardial infarction (less than 3 months prior to date of diagnosis)
* Congestive cardiac failure or cardiac arrhythmia uncontrolled by medical treatment
* Uncontrolled infectious disease
* Serious medical or psychological factors which may prevent adherence to the treatment schedule