cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Implantation of the End-vascular Creation of the Arteriovenous Fistulas in Patients in the University Hospital of Araba. Pilot Study.

In last few years, there is a new technology that permits the endovascular fistula creation with a minimum vascular trauma and the first results show encouraging results with high technical success rate, low resurgent and failure rates and good usability for hemodialysis.

The implementation of the endoFAVI realization in dialysis patients is an emergent procedure that in our hospital can contribute important benefits to the patients, savings to the health system, as well research and innovation in the implicate services.


Eligibility Criteria:
Inclusion Criteria:

* Adult (older than 18).
* Currently be receiving chronic dialysis, or be waiting to start the chronic dialysis in the next six months.
* Have veins with diameter \>= 2.0mm to the creation of the fistula, established by Duplex ultrasound or venogram.
* Have arteries with diameter \>= 2.0mm to the creation of the fistula, established by Duplex ultrasound or venogram.
* Cubital and radial arterial flow for the hand, confirmed with Duplex Ultrasound and/or Allen test.
* Dismissed the realization of cephalic-radius FAVI for surgical technical problems.
* Informed Consent to participate in the study.

Exclusion Criteria:

* Known central venous stenosis or narrowing of the central vein \> 50% according to images on the same side as the creation of the planned FAV.
* Absence of perforator that feed the target cannulation, by venogram.
* Occlusion or stenosis \> 50% of the cephalic basilica vein of the target cannulation.
* Cannulation target vein of less than 2.0 mm of diameter.
* Significantly compromised flow (\>= 50% of stenosis) in the treatment arm as determined by the doctor and the images.
* Ejection fraction documented \<= 35% in the last 6 months.
* Pregnant women.
* Heart failure Class III or IV of the New York Heart Association (NYHA).
* Hypercouagulability status demonstrated ( Antiphospholipid Syndrome, Leiden factor V, Protein deficit S, ...).
* Known hemorrhagic diathesis.
* Documented history of drug abuse including intravenous drugs within six months of FAV creation.
* Concomitant major surgical procedure "planned" within three months of recruitment or major previous surgery within 30 days of recruitment.
* Known iodine contrast allergy that cannot be properly premedicated.
* Known adverse effects for sedation and/or anesthesia that cannot be properly premedicated.
* Evidence of active infections on the day of the index procedure.
* Life expectancy \< 1 year.
* The patient is not willing to provide an written informed consent, is not geographically stable and/or is not willing to cmply with the required follow-up.
* Patient with an objective cannulation vein of more than 6 mm of deep that would require a transposition procedure, defined as the elevation of an objective cannulation vein nad the creation of a new fistula AV.
* The patient is nit willing to undergo of second stage, defined as a conversion to surgical FAVI, central catheter arrangement, thrombectomy/rescue fibrinolysis, stenoic area angioplasty, ...
Active Commuting To Improve Well-being and Health in Everyday Life

The aim of present randomized controlled trial is to evaluate the health effects of physical activity in transport and leisure time domains of everyday life and to develop durable physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle routine, in overweight individuals.

Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4: a non-intervention control group


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* No engagement in habitual structured physical activity
* Body mass index 25-35 kg/m2
* Body fat percentage \>32% for women and \>25% for men
* Maximum oxygen uptake (VO2max) \<40 ml O2/kg/min for women and \<45 ml O2/kg/min for men
* Ethnicity: Caucasian

Exclusion Criteria:

* Chronic use of medicine
* Smoking
* Fasting plasma glucose \> 6,1 mmol/L
* Blood pressure \> 140/90 mm Hg
* Abnormal resting and working ECG
* Parents or siblings with diagnosed type 2 diabetes
* For women: Follicle stimulating hormone (FSH) concentration \> 35 milliunits/ml, pregnancy or planning of pregnancy within the coming year
A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants

The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.

The drug being evaluated in this study is called Enantone (leuprorelin). Enantone is used to treat children who have CPP. This study will look at long term safety and efficacy of leuprorelin in the treatment of Chinese participants with CPP.

The study will enroll approximately 300 participants.

All participants who have received leuprorelin 30 mcg/kg to \<90 mcg/kg or 90 mcg/kg to 180 mcg/kg per body weight, injection, subcutaneously, every 4 weeks up to at least 9 continuous months during the index period from September 1st 1998 to September 30th 2018 will be observed.

This multi-center trial will be conducted in China. Data will be collected over period of 20 months.

Eligibility Criteria:
Inclusion Criteria:

1. Has diagnosis of idiopathic CPP.
2. Has been treated with leuprorelin acetate (Enantone) for at least 9 continuous months of therapy with either a stable dose of high dose (greater than or equal to \[\>=\] 90 mcg/kg up to 180 mcg/kg) or low dose (\< 90 mcg/kg down to 30 mcg/kg).
3. Has initiated and completed treatment during the index period from September 1st 1998 to September 30th 2018.
4. Have the following information prior to initiation of enantone and at least one record of each of the following parameters at the end of enantone treatment in the medical records: Tanner staging, estradiol or testosterone level, and FSH and LH level. The participant should have at least one record of bone age prior to the initiation gonadotropin releasing hormone analogs (GnRHa) therapy with enantone to support the diagnosis of CPP. In addition, should have at least one record of bone age during treatment with enantone.

Exclusion Criteria:

1. Has been treated with leuprorelin acetate or any other GnRHa for conditions other than CPP.
2. Has used any other GnRHa products for CPP treatment prior to initiation of enantone therapy.
3. CPP participants with identified etiology, such as brain tumor or cranial irradiation.
Safety and Feasibility of the XFLO Expander System (Mercury)

To demonstrate the safety and feasibility of the Mercury Expander system and procedure to treat patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia.

A prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the safety and feasibility of the Mercury Expander system in patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia (BPH).

Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Age ≥ 50 years
* Prostate volume 30 - 80 cc by Abdominal Ultrasound (AUS) or Trans Rectal Ultrasound (TRUS)
* Prostatic urethra length of 2.0-6.0 cm, as measured from bladder neck to verumontanum, using cystoscopy (or prostate length from bladder neck to external sphincter of 2.0-8.0 cm during screening visit, using ultrasound).
* Medication history

  * Not on BPH related medication for the past 6 months.
  * If on BPH related medication:

    * On 5-alpha-reductase inhibitors (ARIs), the patient must be on the medication for at least 3 months with a stable voiding pattern
    * On alpha-blockers, the patient must be on the medication for at least 3 weeks with a stable voiding pattern
* Patients with symptomatic BPH and related lower urinary tract symptoms (LUTS):

  * With International Prostate Symptom Score (IPSS) \> 13; Qmax \< 12 mL/sec on a voided volume ≥125 mL; Post-void residual (PVR) \< 250 mL; QoL score ≥ 3

Exclusion Criteria:

* Previous BPH procedure
* Median prostatic lobe or high bladder neck
* Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
* Elevated Prostate Specific Antigen (PSA) ≥ 10 ng/mL unless negative biopsy within last 6 months, or a positive biopsy showing cancer
* Cystolithiasis within the prior 3 months
* History of neurogenic bladder or urinary retention with PVR \>1000mL.
* Serum creatinine \>1.8 mg/dl or upper-tract disease which compromises renal function
* Current or recent Urinary Tract Infection (UTI) or disease
* Known allergy to nickel
* Life expectancy of less than 24 months
* Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
* Anticipated need for additional surgery or treatments for comorbidities during the study period.
* Current gross hematuria
* Other co-morbidities that could impact the study results
* Unable or unwilling to complete all required questionnaires and follow-up assessments
* Unable or unwilling to sign informed consent form
* Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
Gastric Cancer Complicated With Bleeding

To investigate the impact of bleeding on the survival and treatment-related adverse events (TRAEs) of gastric cancer patients.

We will retrospectively enroll patients diagnosed with advanced or metastatic gastric cancer at the Department of Medical Oncology and Radiation Sickness of Peking University Third Hospital. The retrospective study aims to investigate the impact of bleeding on treatment-related adverse events (TRAEs) for gastric cancer patients receiving systematic anticancer treatment, assess the influence of bleeding on the survival of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years;
2. A histologically confirmed diagnosis of advanced or metastatic gastric cancer;
3. The initial anticancer treatment was systematic therapy, including chemotherapy, targeted therapy or immune checkpoint inhibitor (ICI);
4. No history of gastrectomy before systematic therapy.

Exclusion Criteria:

1. Incompletable clinical data;
2. Siewert I type esophagus cancer.
L-citrulline Supplementation During Sepsis

The purpose of this study is to study the stimulating effects of prolonged (8h) enteral L-citrulline supplementation on the normalisation of the plasma citrulline concentrations and the Arginine-NO metabolism, the microcirculation, the systemic hemodynamics, vascular permeability, and organ function and disease severity scores.

NO synthesis is compromised during sepsis through lack of arginine de novo synthesis and may thereby contribute to impaired microcirculation and organ dysfunction. Supplementation of L-citrulline in septic patients will increase NO production without increased arginase activity and these effects will be studied on arginine-NO metabolism,improved organ function, vascular permeability and microcirculation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from close relative
* Age \> 18 years
* Patient meets the general criteria for severe sepsis or septic shock, diagnosed less than 48 h prior to study inclusion.
* Patient must be relatively hemodynamically stable, defined as stable blood pressure (variation in mean arterial pressure \<15 mm Hg) during 2h without necessity of increasing the vasopressor dose, inotropic support or rate of fluid administration.
* Systemic arterial catheter in place with continuous pressure monitoring.
* Patients in whom the clinician is prepared to provide full life support during the duration of the study

Exclusion Criteria:

* Shock due to any cause other than sepsis (e.g. drug reaction or drug overdose, pulmonary embolus, burn injury etc.)
* Prolonged or high dose corticosteroid use
* Liver cirrhosis
* Chronic pancreatitis
* Insulin-dependent diabetes mellitus
* Metastases, haematological malignancies or chemotherapy
* Patients on dialysis (CVVH or other)
* Pre-existent renal failure (on dialysis)
A Comparison of the Effect of Warm and Cold Water Exercise Training on Vascular Function in Type 2 Diabetic Patients

Warm water based cycling exercise training would more favorable than cold water based cycling exercise training and land based cycling exercise in vascular function in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria included type 2 diabetes (as defined by the American Diabetes Association), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, and no previous exercise training in the past 6 months. All participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.

Exclusion Criteria:

* Participants were excluded if they dropped out or completed less than 80% of the training schedule.
Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men

Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese and normal-weight men subjects, to research a dysfunction in the negative feed-back between pregnenolone and CB1 ligand in obese subjects. This dysfunction could participate to the hyperactivity of endocannabinoid system saw in obesity.

Endocannabinoid system is an orexigenic key system, controlling the energy balance. It is composed of receptors (ex: CB1), of endogenous ligands, the endocannabinoids (ex: anandamide and 2- arachidonoylglycerol) and of enzymes implied in the synthesis and the degradation of the endocannabinoids. Researches resulting from our group highlighted anomalies of the plasmatic concentrations of endocannabinoid, in obese subject compared to normal-weight subject. Those being higher in obese subject with a flatness of post prandial reduction of AEA, so maintenance of elevated levels which can facilitate the food catch and create a metabolic vicious circle. In addition, prestigious research resulting from our collaborators highlighted in the animal that exposure to tetrahydrocannabinol (THC, ligand exogenic of CB1) induced the synthesis of pregnenolone (neurosteroid) which, by an autocrine effect on the CB1, inhibited the effects of the THC. In particular one of the principal behavioural effects: the food intake.

We want to measure pregnenolone and endocannabinoid concentrations in men blood samples, to observe if this association exists in fasting conditions and over a meal in normal-weight and obese subjects. Obese subjects will be recruited during an hospitalization, while normal subject will be recruited by a poster at Bordeaux university and Haut-Leveque hospital. They will be included at Haut-Leveque hospital during morning at hospital.

Eligibility Criteria:
Inclusion Criteria:

* Obese subjects:

  * men,
  * aged between 18 and 65 years,
  * BMI\>30kg/m2.
* Normal-weight subjects:

  * men,
  * aged between 18 and 65 years,
  * BMI\<25kg/m2.

Exclusion Criteria:

* For all subjects:

  * cannabis detected by urinary tetrahydrocannabinol presence,
  * treatment which can interfere with endocannabinoid system (antidepressant, antipsychotics, anxiolytics).
Diabetes Strengths Study - Pilot of Provider-delivered Strengths-based Intervention

The purpose of this study is to determine whether a newly developed intervention is feasible and acceptable to adolescents with type 1 diabetes and their families and diabetes care providers, and to evaluate trends in whether the intervention impacts important diabetes outcomes. The intervention involves diabetes care providers discussing and reinforcing individuals' and families' diabetes management strengths during routine, outpatient diabetes care appointments.

The purpose of this study is to pilot test a newly developed strengths-based clinical intervention delivered by diabetes care providers in the context of routine ambulatory diabetes care, designed to promote resilience and support diabetes management among adolescents with type 1 diabetes and their families. The emphasis of the intervention is shifting the tone of clinical encounters for diabetes care to emphasize and reinforce youths' and families' current diabetes strengths and positive diabetes management behaviors. Youth with type 1 diabetes are seen routinely in clinic every 3-4 months, and this intervention will occur at two consecutive clinic visits. The intervention consists of (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique "diabetes strengths profile" generated from the strengths and adherence assessments.

Outcome assessments are conducted at baseline (prior to the start of the intervention) and immediately following the conclusion of the intervention (approximately 6-8 months later). The primary outcome is feasibility and acceptability, measured by qualitative feedback from participants and providers, as well as quantification of recruitment and enrollment, provider adherence to intervention protocol, and time to completion. Secondary (exploratory) outcomes include diabetes regimen adherence, glycemic control, family conflict, diabetes burden, diabetes strengths, and satisfaction with the diabetes care provider relationship. Strengths and adherence assessments are also completed prior to the second clinic visit to generate the diabetes strengths profile.

Eligibility Criteria:
Inclusion Criteria:

1. At least one parent of each adolescent, self-identified as the primary caregiver most involved in diabetes care, will also be enrolled with each adolescent participant. When present, secondary caregivers involved in diabetes management will be invited (not required) to participate.
2. Youth type 1 diabetes diagnosis for at least 12 months, to allow ample opportunity for adjustment to diabetes management
3. Youth and parent fluency in written and spoken English because assessment measures are not available in other languages.

Exclusion Criteria:

(1) Presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.
An Investigational Study of BGB-58067 in Participants With Advanced Solid Tumors

This is an open-label, multicenter, first-in-human dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-58067 as monotherapy in participants with advanced solid tumors and with methylthioadenosine phosphorylase (MTAP) deficiency.

BGB-58067 is a new drug designed to target a specific protein called protein arginine methyltransferase 5 (PRMT5). This protein is involved in many cell activities and can promote cancer growth when it is overactive. High levels of PRMT5 are linked to poor outcomes in several types of cancer.

This new study will check how safe and helpful a potential anticancer drug called BGB-58067 is. This drug will be tested as monotherapy in participants with advanced solid tumors and with MTAP deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Participants must sign the ICF and be capable of giving written informed consent
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Scale (KPS) ≥ 70
* Life expectancy ≥ 3 months
* Evidence of homozygous loss of MTAP or lost MTAP expression in the tumor tissue
* Able to provide tumor sample to meet the minimum tissue requirement for central MTAP deficiency testing
* Participants with advanced, metastatic, or unresectable solid tumors, who have previously received standard systemic therapy or for whom treatment is not available or not tolerated
* Adequate organ function

Exclusion Criteria:

* Prior treatment with any PRMT5 inhibitor or methionine adenosyltransferase 2a (MAT2A) inhibitor
* Active leptomeningeal disease or symptomatic spinal cord compression
* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
* Any malignancy ≤ 2 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively
* Significantly impaired pulmonary function
* Clinically significant infections
* Serologically active hepatitis B or C infection
* Known HIV infection
* High cardiovascular risk factors
* QTcF \> 470 ms based on the screening triplicate 12-lead ECG records
* Toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized
* Participants who are unable to swallow or with disease/procedure significantly affecting gastrointestinal function
* Female participants who are pregnant or are breastfeeding
* Concurrent participation in another therapeutic clinical study (participation in observational or noninterventional studies is allowed)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sleep Disturbance and Bipolar Disorder

The study aims to evaluate a psychological intervention for individuals who suffer from sleep disturbance and bipolar disorder. We are hoping that this treatment will: (1) improve the quality of life of individuals with bipolar disorder who are suffering from sleep disturbance and (2) reduce the risk of, or help prevent, episodes.


Eligibility Criteria:
Inclusion Criteria:

Bipolar disorder patients with sleep disturbance

1. Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Text Revision (DSM-IV-TR; APA, 2000) diagnostic criteria for bipolar disorder type 1 (established with the SCID: Structured Clinical Interview for DSM-IV).
2. Being inter-episode throughout the experiment as defined by cutoffs widely used in previous research. On the basis that a drug-free group would likely be unfeasible and unrepresentative, participants will not be excluded on the basis of medications prescribed for bipolar disorder. Comorbidity will be allowed as long as bipolar disorder is the primary diagnosis. However, it is necessary to assess comorbidity for reporting purposes.
3. Participants who have a history of bipolar 1 or suicidal ideation must be under the care of a psychiatrist.
4. Experience distress related to significant sleep disturbance.

Exclusion Criteria:

1. Presence of an active and progressive physical illness (e.g., congestive heart failure, cancer, COPD) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) directly related to the onset and course of insomnia;
2. Alcohol or drug abuse (except nicotine) within the past year
3. Active posttraumatic stress disorder
4. Evidence of sleep apnea, restless legs syndrome or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)
5. Patients who pose a current suicidal risk or homicidal risk (assessed by treating psychiatrist) or who have made a suicide attempt within the past 6 months.
6. Pharmacotherapy for sleep defined as the benzodiazepine and non-benzodiazepine hypnotics that operate via the GABA A receptor complex and are FDA approved for the treatment of insomnia, selective melatonin agonists, benzodiazepine anxiolytics and over the counter medications with proven efficacy such as melatonin or herbs such as St. Johns wort.
7. Use of certain medications known to alter sleep (e.g., steroids, theophylline, propranolol, antihistamines that cause drowsiness).