cyrilzakka/clinical-trials huggingface dataset:
PrEP Readiness Interventions for Sustained Motivation (PRISM)

This is a hybrid type I, factorial randomized controlled trial to test the comparative and combined effectiveness of contingency management (CM), motivational interviewing (MI), and MI+CM for optimizing entry or re-entry into the PrEP care continuum. A total of 840 participants will be randomized to CM (n = 280), MI (n = 280), or MI+CM (n = 280), all delivered via Telehealth. Monthly follow-up assessments will be completed over 12 months to examine differential effectiveness for the primary outcome - filling a PrEP prescription (verified using a digital photo or detectable tenofovir diphosphate). Secondary outcomes will include: self-reported PrEP clinical evaluation by a PrEP provider; self-reported meth and other substance use severity (ASSIST), and self-reported receptive and insertive condomless anal sex (CAS).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Sexual or gender minority (SGM) person
* Assigned male at birth
* Self-reported methamphetamine use (past 3 months)
* Non-reactive HIV antibody test results (past 3 months)
* Not on PrEP

Exclusion Criteria:

* Unwilling or unable to provide informed consent
Evaluation of Metionac for the Modulation of Metabolic and Endocrine Parameters in Patients With PCOS.

Evaluate the efficacy of the combination of antioxidants ALA, NAC, Vit. B6 and SAMe as a dietary supplement, in the improvement of metabolic and endocrine parameters and clinical manifestations of PCOS.

The investigators will explain the study to all patients who meet the inclusion and exclusion criteria during the study period. After signing the informed consent patients will be randomized 1:1 to oral contraceptive 4 mg drospirenone once daily or oral contraceptive 4 mg drospirenone + combination of 200 mg S-adenosylmethionine, 100 mg N-acetylcisteine, 75 mg Alpha lipoid acid and 0,65 mg vitamin B6 (Metionac) twice daily. Patients for whom oral contraceptive is not indicated will be enrolled in third study group of Metionac twice daily. 2 study visits will be carried out, Baseline (Visit 0) and after 6 months therapy (Visit 1).

Eligibility Criteria:
Inclusion Criteria:

1. Women newly diagnosed with PCOS with at least 2 of the following symptoms:

   * Oligo/Anovulation \< 21 or \> 35 days \> 90 days (any cycle) \< 8 periods / year
   * Hyperandrogenism (clinical symptoms or laboratory results)
   * Polycystic ovary morphology (NHMRC guideline): In any ovary:

     20 follicles\* and/or ovarian volume greater than or equal to 10ml and no corpus luteum, cysts or dominant follicles

     \*number of follicles per ovary measuring 2-9 mm
2. \> 18 years old
3. Overweight defined as BMI\>25
4. Normal prolactin levels
5. Women with altered coagulation factors or a personal history of thromboembolism for whom OAC is contraindicated (they will be included in the control group without randomization)
6. Written inform consent

Exclusion Criteria:

1. Diabetic women
2. Adrenal enzyme deficiency and/or other endocrine disease
3. Pregnant or lactating women.
4. Women under treatment with SNRIs (serotonin reuptake inhibitors)
5. Other serious illness
Does Neuromuscular Electrical Stimulation Benefit the Functional Ability of Elderly Patients With Chronic Obstructive Lung Disease

Background: Patients with COPD often experience skeletal muscle dysfunction. For those who are unable or unwilling to undertake physical training, neuromuscular electrical stimulation (NMES) may provide an alternative method of exercise training.

Objective: To investigate the effects of adding neuromuscular electrical stimulation of gluteus maximus, quadriceps and calf muscles to chest physiotherapy, compared to chest physiotherapy alone, on muscles strength (gluteus max., quadriceps, calf muscles), femoral blood flow physical and pulmonary function in severe COPD Patients.

Material and methods: This study include a group of 60 patients (30 males and 30 females) diagnosed with severe COPD), their age is ranged 65-75 years, they will be randomly divided into two groups; study group (A) 30 patients and study group (B) 30 patients. Study group (A): The patients in this group will receive the chest physiotherapy program for 20 min each day, for five days a week for three consecutive weeks. Study group (B): The patients in this group will receive the same chest physiotherapy program combined with neuromuscular electrical stimulation of gluteus max., quadriceps, calf muscles, performed for 30 min /day for five days a week for three consecutive weeks. Femoral blood Flow, gluteus maximus, quadriceps and calf muscles strength and pulmonary function (FEV1/FVC) will be measured for both groups pre and post treatment.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of COPD with FEV1/FVC \<50% predicted as per the GOLD guidelines.
* Self-reported dyspnea and/or arm fatigue during at least one activity of daily living that required arm exercise.
* Dyspnea and/or physical activity fatigue were self-reported by the Borg Scale.
* Before entering in the study, all patients had their pulmonary function optimized with long-acting bronchodilators and corticosteroids.

Exclusion Criteria:

* • Patients with unstable angina pectoris.

  * Progressive ventricular dysrhythmia.
  * Intermittent claudication.
  * Implanted cardiac pacemakers.
  * Uncontrolled diabetes mellitus.
  * Peripheral vascular disease.
Short Term Effects of Probiotics in the Human Micro-vascular Physiology

While the beneficial properties of kefir consumption have been thoroughly studied for many years, very little research has been conducted to explore the potential protective properties of kefir consumption to the endothelium in humans. Therefore, the aim of the current study is to explore the short-term efficacy of kefir consumption in improving endothelial function in older and younger healthy, sedentary adults.


Eligibility Criteria:
Inclusion Criteria:

All recruited participants were either 18-35 yrs. or 55-75 yrs.

Exclusion Criteria:

Pregnancy; chronic diseases with the potential to influence vascular function; smoking status; sedentary (defined via the completion of the international physical activity questionnaire; IPAQ); regular consumption of probiotic-containing products; any overt chronic diseases.
Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke

The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Currently, evidence regarding the safety and efficacy of urinary kallidinogenase treatment in patients with acute ischemic stroke lacks, and few of related studies were large-scale and high-quality. Thus, this study was designed to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15;
3. Moderate to severe stenosis or occlusion of offending vessels;
4. The mRS Score ≤2 before onset;
5. Subjects or their legal representatives agreed to the treatment and signed the informed consent form.

Exclusion Criteria:

1. Transient ischemic attack;
2. Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);
3. Severe disturbance of consciousness:GCS ≤8;
4. Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;
5. Refractory hypertension: systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg; hypotension: systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg;
6. Liver dysfunction (ALT/AST \>1.5 × upper limit of normal \[ULN\]), renal dysfunction (Cr \>1 × ULN);
7. Coagulopathy (prolonged INR (\>1.5) or prolonged APTT (\>2 folds);
8. Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.);
9. Special populations such as pregnant and lactating women, patients with life expectancy less than 3 months, or patients unable to complete the study for other reasons;
10. Unwilling to be followed up or poor treatment compliance;
11. Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment;
12. Other conditions considered by the investigator to be inappropriate for enrollment.
Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration

Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspension compared to the reference product, Faslodex in healthy female subjects.

This is a Phase 1, open-label, parallel group study in healthy female subjects. The study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of Fulvestrant for Injectable Suspension vs. the reference drug, Faslodex, administered in the gluteal muscle.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 18 kg/m2 to 32 kg/m2
* Body weight of at least 50 kg at screening
* Good health as determined by evaluations
* Negative serum pregnancy test
* Subjects who are naturally postmenopausal for at least 12 consecutive months with a follicle-stimulating hormone level at Screening of ≥40 mIU/mL
* Subjects who are peri-menopausal and experiencing at least one of specified symptoms of menopause (eg, hot flashes, mood swings, night sweats, and others)
* Negative urine test for drugs of abuse
* Negative urine test for HIV antibody, HBsAG, and HCV at Screening
* Women of child-bearing potential must agree to consistently practice contraception throughout the duration of the study and continue to do so for 1 year after receiving study drug by one of the following methods: abstinence, condom, diaphragm or cervical cap with spermicide, intrauterine device or male partner had previously undergone a vasectomy as declared in medical history

Exclusion Criteria:

* Recent history (6 months) or current evidence of any clinically significant (uncontrolled) disorder including hepatic, renal, cardiovascular, psychological, pulmonary, metabolic, endocrine, neurologic, infectious, gastrointestinal, hematologic or oncologic disease, or other medical conditions that may interfere with the subject completing the study
* Lab test results outside the normal range at Screening or Day 1 considered clinically significant by the Investigator
* Use of hormonal replacement therapy within 6 months prior to randomization an/or current use of oral contraceptive pill or patch as contraceptive method throughout the study
* Concomitant medication that can affect bleeding
* Recent history (6 months) or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant
* Subjects with QTcF interval duration \>470 milliseconds
* History of alcoholism or drug addiction within 1 year prior to Day 1
* History of allergy or a known sensitivity to product components of fulvestrant Test and Reference formulations
* Creatinine clearance \<60 mL/minute based on the Cockcroft-Gault equation
* Blood donation of 500 mL or more or a significant loss of blood within 56 days prior to Day 1
* Previous exposure to fulvestrant
* Familial relationship with another study participant
A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas

The purpose of this study is to determine the safety and tolerability of XL765 in combination with Temozolomide in adults with anaplastic gliomas or glioblastoma on a stable Temozolomide maintenance dose. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Temozolomide (TMZ, Temodar®) is an orally administered alkylating agent with activity against malignant gliomas. It is approved by the Food and Drug Administration for the following indications: 1) treatment of newly diagnosed glioblastoma multiforme (GBM) patients when given concomitantly with radiotherapy and then as maintenance treatment; 2) refractory anaplastic astrocytoma (AA), ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. Temozolomide is commonly used in the treatment of other anaplastic gliomas (AG) including oligodendroglial tumors and mixed gliomas.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed intracranial Grade 3 or 4 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma)
* Received prior standard radiation for a Grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 Gy administered
* Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression
* Karnofsky performance status of 60 or more
* Adequate organ and bone marrow function as defined by hematological and serum chemistry limits
* At least 18 years old.
* Both men and women must practice adequate contraception
* Informed consent

Exclusion Criteria:

* Progressed while on temozolomide
* Evidence of acute intracranial or intratumoral hemorrhage \> Grade 1
* Restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including cytotoxic chemotherapy other than temozolomide, biologic agents, nitrosoureas or mitomycin C, small-molecule kinase inhibitors, non-cytotoxic hormonal agents, prior therapy with a PI3K inhibitors, radiation therapy, enzyme-inducing anti-convulsants, valproic acid
* Not recovered from the toxic effects of prior therapy
* Pregnant or breast feeding
* History of diabetes mellitus
* Uncontrolled intercurrent illness
* Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
* HIV positive
* Diagnosis of another malignancy may exclude subject from study
The Prevalence of Secondary Adrenal Insufficiency in Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene

To investigate the correlation between four well-known polymorphisms of the glucocorticoid receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with exacerbation of COPD.

COPD patients who have received systemic glucocorticoid exceeding the equivalent of 180 mg prednisolone which are homo / heterozygous for the BclI and / or N363S polymorphisms (associated with increased glucocorticoid sensitivity) will have a lower cortisol response in a synacthen® test (greater suppression of adrenal corticosteroid) than the corresponding patients there are wild-type or homo- or heterozygous for the polymorphic ER22 / 23EK and / or 9β (associated with decreased sensitivity). Information from the results of the investigation will be able to help clinicians to identify patients with acute exacerbation of COPD (AECOPD) at risk of of secondary adrenal insufficiency.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 18 years
* Caucasian classified with COPD
* Patients with AECOPD being treated with at least 5 days of glucocorticoid (minimum of 180 mg)

Exclusion Criteria:

* Treated with estrogen-containing medications, including anticonceptiva 6 weeks prior to Synacthen®
* Pregnancy or lactation
* on regular systemic glucocorticoid therapy before admission to the hospital
* People who are detained under the act on the use of coercion in psychiatry
* Severe language problems or inability to provide written informed consent
The Effect of Respiratory Training on Exercise Tolerance in COPD

Exercise intolerance is one of the key disabling factors in patients with chronic obstructive pulmonary disease (COPD). Although multifactorial, exercise intolerance involves physiological interactions between respiratory and locomotor muscles that may contribute to further reducing exercise tolerance in COPD. The respiratory muscle work during exercise is closely related to breathing and could induce respiratory muscle fatigue in patients with COPD.

Respiratory muscle training is an intervention strategy that is sometimes proposed for some patients with COPD, especially whose with inspiratory muscle weakness. It was reported that inspiratory muscle training improves inspiratory muscle endurance and strength, dyspnea and exercise tolerance. There are two types of inspiratory muscle training, inspiratory muscle training against a resistive loading and normocapnic hyperpnoea. The advantage of normocapnic hyperpnoea compared to resistive training is the possibility to simulate the exercise ventilation level while maintaining stable the partial pressure of arterial carbon dioxide and end-tidal pressure of carbon dioxide and to solicit the inspiratory and expiratory muscles together, which could increase respiratory muscle tolerance and avoid their fatigue during whole-body exercise.

Therefore, the aim of this project is to study the effect of normocapnic hyperpnoea training on exercise tolerance in patients with COPD.

We hypothesize that greater improvement in cycling exercise tolerance will be observed following 6-weeks normocapnic hyperpnoea training compared to a sham intervention in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years;
* Chronic airflow obstruction : FEV1/FVC \< 0.7, FEV1 of 30 to 80% predicted, after bronchodilation;

Exclusion Criteria:

* Inability to perform a cycling exercise;
* Diagnosed of one of more comorbidities that may limit exercise tolerance : cardiovascular, metabolic, endocrine, gastrointestinal, renal, neurological or rheumatologically disease;
* Recent COPD exacerbation (\< 3 months);
* Recent cancer;
* A daily dose of Prednisone \> 10 mg;
* Hypoxemia at rest or during exercise: PaO2 \< 60 mmHg or SpO2 ≤ 88%;
* Body mass index \> 30 kg/m²;
* Pregnancy;
* Skinfold at intercostal or vastus lateralis muscle \> 1.5 cm.
Can an Educational Intervention Targeting General Practitioners Increase HPV Vaccination Coverage in AuRA_Lyon (France)

The PAPRICA implementation trial aims to test the efficacy of an educational intervention about HPV vaccination and targeting general practitioners in Lyon

The PAPRICA study aims to test if an intervention directed to General Practitioners (GP) to train them in methods for recommending HPV vaccine with greater confidence and efficiency is effective to increase HPV vaccination coverage in France. As each health professional is associated in France to a specific reference number i.e. "RPPS number", RPPS numbers for all General Practitioners (GP) from the city of Lyon will be randomly allocated either to the intervention arm or to the control arm to ensure that each arm contains 50% of the total number of GPs. After allocation, GPs in the allocation arm will be identified and invited to attend the intervention i.e. a 3-hour workshop at IARC in the presence of HPV vaccination specialists. The effect of the intervention on the HPV vaccination coverage in Lyon will be measured through HPV vaccines reimbursement data extracted from the Inter-Scheme National Information System within the National Health Insurance System (SNIIR-AM : Système National d'Information Inter-Régimes de l'Assurance Maladie ). Linkable data between girls and General Practitioners (GP) via RPPS numbers will allow us to allocate girls either in the intervention or the control arm. Vaccination coverage will be estimated within each of these cohorts.

Eligibility Criteria:
Inclusion Criteria:

* general practitioners (GP) from Lyon (69001-69009) from private practice

Exclusion Criteria:
Gene Expression Profiles in Generalized Aggressive Periodontitis: A Gene Network-based Microarray Analysis

In this study, the investigators evaluated molecular biomarkers which play a role in the development of generalized aggressive periodontitis (GAgP) using gingival tissue samples through omics-based whole-genome transcriptomic while using healthy individuals as background controls.

Aggressive periodontitis (AgP) is an inflammatory periodontal disease which is complex, multifactorial, and destructive. Progression and severity of the disease depend on interacting risk factors such as: immunological, microbiological, environmental, and genetic factors, as well as age, sex, and race.Some patients are genetically predisposed to AgP; they have immunological abnormalities, which are thought to be under genetic control. However, high susceptibility for periodontal destruction and the relationship between inflammatory changes, and genetic factors remain unclear.

Gene expression profiling is a powerful means of generating comprehensive genome-level data sets on diseases such as cancer, asthma, rheumatoid disorders and periodontitis, and provides significant insight information for these diseases. Gene expression profiling may provide an evidence for involving genes in the pathogenesis of AgP and generate further information other than clinical signs and symptoms of AgP.

The aim of this study was to identify gene-expression patterns of patients with generalized aggressive periodontitis by whole-transcriptome gene-expression analyses.

Eligibility Criteria:
Inclusion Criteria:

* The periodontal diagnosis of subjects with GAgP was established on the basis of clinical and radiographic criteria and was defined by the 1999 International World Workshop for a Classification of Periodontal Diseases and Conditions.(Lang et al., 1999) Patients were included if they were between 18 and 35 years of age and otherwise healthy. The bone loss estimation was radiographically performed in each patient for the assessment of the extent and severity of alveolar bone loss.

Exclusion Criteria:

* Subjects were excluded if they had any known systemic diseases or conditions that can/could influence the periodontal status (cancer, cardiovascular and respiratory diseases), any history of hepatitis and/or HIV infection, immunosuppressive chemotherapy, current pregnancy, planning a pregnancy or lactation, requirement for antibiotic prophylaxis, oral diseases other than GAgP, ongoing orthodontic therapy, a history of antibiotic therapy, or periodontal treatment within the preceding six months.
Clareon IOL Retrospective Data Collection

The purpose of this study is to provide real world evidence (RWE) on the performance of the Clareon ultraviolet absorbing (UVA) intraocular lenses (IOLs) to support the overall body of evidence on the Clareon IOL family.

In this retrospective postmarket study, the WaveTec AnalyzOR Database will be reviewed. All available data that meet the data selection criteria as of the data cutoff will be analyzed.

Eligibility Criteria:
Data Selection Criteria (eyes):

* Must have undergone cataract extraction by phacoemulsification with implantation of a Clareon UVA IOL (CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, or CCA0T0) using the WaveTec ORA System.
* Must have a BCDVA in the WaveTec AnalyzOR Database from ≥ 10 days after surgery.
* Predicted residual refractive error spherical equivalent (SE) ≤ 0.75 D.