cyrilzakka/clinical-trials huggingface dataset:
Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration

Endothelin receptors antagonists (ERA), such as bosentan and ambrisentan, are a class of vasoactive drugs that have been developed for the treatment of pulmonary arterial hypertension. It has been anecdotally reported that ERA is frequently used among top-level athletes to counteract exercise-induced rise in pulmonary vascular pressures and increase exercise performance. Yet, the effects of ERA on exercise capacity in healthy humans are puzzling, with the drugs not included in the current Prohibited List, since the ergogenic potential is yet to be fully understood and determined. Furthermore, the urinary excretion of ERA metabolites following administration has not been studied systematically at rest and during exercise in athletes, as a way to detect its intake if performance-enhancing potential is confirmed. In the planned study ERA will be administered in newly approved doses for 8 weeks in order to assess the presumed doping potential for both male and female athletes, and to monitor serum and urinary ERA excretion dynamics after single- and multiple-dose administration. The possible effects of prolonged ERA administration in higher doses on exercise performance may be relevant, if further confirmed, in terms of their possible fraudulent utilization to influence exercise performance in sports, raising the difficult question of whether, particularly in some circumstances, the ERA might be considered as prohibited substances in athletes.

Preliminary findings of our research group indicated that ERA enhances exercise performance (particularly aerobic) after 7-day intake of higher doses of non-selective ERA bosentan (doses used were approved for pulmonary arterial hypertension treatment). This is in part in accordance with results of previous research (Faoro et al. 2009), although authors administered regular single dose (62.5 mg) of bosentan in hypoxic healthy subjects. Our study should examine metabolic profiles of athletes after receiving significantly higher doses of two oral ERA as compared to previous research, along with assessment of ergogenic potential with 8 weeks of administration in placebo-control and randomized design. We expect that ERA will increase time to exhaustion during endurance test, increase the maximal oxygen uptake and rate of ultra-short term heart rate recovery after exercise, and affecting blood and urine cortisol, testosterone and dehydroepiandrosterone following administration. Moreover, we will clearly evaluate 24-h pharmacokinetic profile of ERA in blood and urine and collect data for concentration-time profiles of ERA and main active metabolites, in aim to provide more rationale basis for identification and detection for doping control.

Eligibility Criteria:
Inclusion Criteria:

* male and female volunteers
* experienced in athletic training (\> 5 years of experience)
* aged 20 to 30 years
* free from musculoskeletal dysfunctions
* free from metabolic and heart diseases

Exclusion Criteria:

* pregnancy
* use of hormonal contraceptives
* use of dietary supplement that contains any ergogenic agent
Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer

In this study, we propose to use the combination of ET-SPACE NIR irradiation whole-body thermal stimulation, ICI (Tislelizumab), and RTK inhibitor (Anlotinib) in the multimodal treatment of CRPC.

The initial efficacy and safety of the multimodal therapy will be evaluated at the animal level to fully validate the potential feasibility of the therapy. Subsequently, the efficacy of the multimodal therapy will be verified at the organoid level, and based on which a translational randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the multimodal therapy at the human level, and the patients will be followed up for a long period of time, so as to collect detailed data on improvement of the quality of life. Finally, the synergistic effect of the multimodal therapy will be analyzed at the molecular and cellular levels.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed diagnosis of PC and clinically confirmed diagnosis of CRPC;
* Complete and reliable medical history and medical records;
* No other primary tumors except CRPC;
* Blood tests, liver function, renal function and electrocardiogram are basically normal;
* Patients with ECOG score 0\~3, aged ≥18 years and \<90 years old;
* Patients with good compliance, able to accept regular follow-up.

Exclusion Criteria:

* History of malignant tumor other than PC within the past 5 years;
* Severe abnormalities in the patient's laboratory indices may jeopardize patient safety or compromise this study;
* Accompanied by severe underlying diseases that cannot tolerate this therapy;
* With acute diseases, such as acute infection, active bleeding;
* Those who have recently participated in other clinical trials and have not passed the washout period;
* Those who cannot tolerate systemic heat stress, such as claustrophobic patients;
* Those who have a history of allergy to the drugs used in the trial;
* Patients with other reasons for not being able to be enrolled in the study, according to the study doctor.
Effects of Retinoids on CYP2D6 Activity During Pregnancy

Prospective drug interaction study during pregnancy.

A randomized pharmacokinetic study to evaluate CYP2D6 activity with and without vitamin A administration during pregnancy and compared to postpartum control.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* Extensive metabolizers

Exclusion Criteria:

* Chronic or persistent cough accompanying asthma, smoking or chronic obstructive pulmonary disease
* Productive cough
* Fever
* Known kidney disease
* Known liver disease
* Diabetes
* Obesity
* Bipolar disease
* Attention deficit disorder
* Social phobia
* Allergy or history of adverse event with dextromethorphan
* Drugs, foods, beverages or dietary supplements that interact with CYP2D6 or dextromethorphan
* dextromethorphan
* Unable to give written informed consent
* Inability to fast
* Concurrent use of vitamin A supplementation
HAIC of Oxaliplatin, and 2400 mg/m² 5-fu vs HAIC of Oxaliplatin, and 1200 mg/m² 5-fu for Unresectable HCC: a Randomised Phase 3 Non-inferiority Trial

Hepatic artery infusion of oxaliplatin, leucovorin and 2400 mg/m² fluorouracil is effective in hepatocellular carcinoma. However, SILIUS study showed that sorafenib plus hepatic artery infusion of cisplatin and fluorouracil did not significantly improve overall survival compared with sorafenib alone. Whether fluorouracil is effevtive is known.


Eligibility Criteria:
Inclusion Criteria:

* Age range from 18-75 years;
* KPS≥70;
* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
* Patients must have at least one tumor lesion that can be accurately measured;
* Diagnosed as unresectable with consensus by the panel of liver surgery experts;
* No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin

  ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine

  ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) \>1,500/mm3;
* Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Evidence of bleeding diathesis.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
Step Test and Six Minute Walk Test in Stroke

The purpose of this study is to investigate the viability of using the Step Test (ST) in stroke patients, and to compare the functional performance of the physiologic variables in stroke patients during ST and Six Minute Walk Test (6MWT).

To accomplish the study it was assessed a group of 12 post-stroke patients who were admitted in the Rehabilitation Clinic inside the University. As inclusion criteria it was established to be able to walk alone without supervision and with no aids.

Eligibility Criteria:
Inclusion Criteria:

* To be able to walk alone without supervision and with no aids.

Exclusion Criteria:

* There were no.
Effect of BT and PFET on Urinary Symptoms and Quality of Life in Patients With OABS

The aim of this study was to examine the effects of bladder training and pelvic floor exercise training programs given in addition to Botulinum Toxin-A (BTx-A) application on urinary symptoms and quality of life in patients with Overactive Bladder Syndrome (AAMS) who do not respond to conservative treatments.

Individuals who meet the criteria for inclusion in the study and agree to participate in the study will be divided into 2 separate research branches.The patients to be included in the study will be divided into two groups as "Group 1=Botox + physiotherapy " or "Group 2=Botox group ". In addition to the BTx-A application, bladder training and pelvic floor exercise training will be applied to patients in the first group, while standard patient training will be provided to patients in the second group.

Severity of urinary symptoms, quality of life and subjective perception of improvement Before BTx-A application, 2 weeks and 12 weeks after BTX-A application, International Incontinence Consultation Questionnaire - Women's Lower Urinary Tract Symptoms (ICIQ-FLUTS), 1-hour ped test, International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS) and Global Perception of Improvement will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* over the age of 18 (those with a Mini Mental Test score of 24 and above for individuals over the age of 65),
* Who has Non-Neurogenic Overactive Bladder Syndrome,
* Patients who received Routine Botulinum Toxin-A administration because they did not respond to conservative treatment,
* Patients who volunteer to participate in the study will be included.

Exclusion Criteria:

* Patients with Neurogenic Overactive Bladder Syndrome,
* Pregnant Women,
* Lack of cooperation in evaluation and/or treatment and lack of literacy status,
* Patients with urogynocological/anatomical abnormalities,
* Patients receiving pelvic radiation therapy,
* Patients with psychiatric or neurogenic disorders and
* Patients who have not given consent to the study and do not have an informed consent form (BGOF).
Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)

This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and induction of labor.

PK study in women requiring cervical ripening.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at ≥36 weeks 0 days inclusive gestation;
* Aged 18 years or older;
* Candidate for pharmacologic induction of labor;
* Singleton pregnancy;
* Baseline modified Bishop score \<4 (see Appendix B);
* Nulliparous (nulliparous is defined as no previous births live or dead after 24 weeks gestation);
* Written informed consent.

Exclusion Criteria:

* Women with hemoglobin level \< 11.0 g/dL (confirmed within one week of study drug insertion);
* Women in active labor;
* Presence of uterine or cervical scar or uterine abnormality e.g. bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
* Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or pregnancy inducted hypertension;
* Severe pre-eclampsia marked by CNS findings, HELLP syndrome, or other end-organ affliction;
* Suspected or confirmed cephalopelvic disproportion and/or fetal malpresentation;
* Diagnosed fetal abnormalities;
* Suspected or confirmed intrauterine growth retardation (less than 10% estimated fetal weight for dates);
* Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
* Receipt of NSAID (including aspirin) within 4 hours of study treatment;
* Ruptured membranes ≥48 hours prior to the start of treatment or suspected chorioamnionitis;
* Fever (oral or aural temperature \> 37.5C);
* Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
* Known or suspected allergy to misoprostol, dinoprostone, other prostaglandins or any of the excipients;
* Any condition urgently requiring delivery;
* Unable to comply with the protocol.
Evaluate the Performance of Genetic Amplification by Polymerase Chain Reaction (PCR) and the "Mannan Antigenemia and Antimannan Antibodies Couple as a Means of Diagnosis and a Marker of Follow-up in Invasive Candidiasis.

The study consists in taking 4 tubes of blood at different times over a period of 10 days, via a catheter (central venous or arterial catheter) already in place in the usual therapeutic management. These samples will make it possible to measure blood levels of certain markers specific to invasive candidiasis. PCR will be used to quantify fungal load precisely, that is to say the quantity of yeast present in the blood and to monitor this quantity over time.

These samples will be transferred to a specialized unit and stored for a maximum of three years for use at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patient informed about the study
* Patients aged at least 18 years admitted to a medical Intensive Care or general intensive care
* Patients with suspected invasive candidiasis - that is to say:
* Presenting persistent sepsis despite broad-spectrum antibiotherapy for at least 48 hours or targeted antibiotherapy for a documented bacterial infection (sepsis will be defined according to:

  * the usual SIRS criteria, at least 2 of the following 4: temperature \> 38°C or \< 36°C, tachycardia \> 90/min, respiratory rate \> 20/min or blood pressure carbon dioxide (PaCO2 ) \< 32 mmHg, leukocytosis \> 12000/mm3 or \< 4000/mm3 or \> 10% of immature forms.
  * Persistent hemodynamic instability (impossibility to significantly diminish catecholamine requirement, need for rapid vascular resuscitation \> 1000 ml over the previous 24 hours)
* Candida score ≥ 3 with multifocal colonization
* Decision to initiate echinocandin therapy made by the clinician in charge of the patient

Exclusion Criteria:

* Treatment with echinocandin \> 1 day in the week preceding inclusion
* Patients not covered by national health insurance
* Pregnant or breast-feeding women
An Extension (Rollover) Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first.


Eligibility Criteria:
Inclusion Criteria:

* BRAF V600 mutation-positive malignancy
* Prior eligibility for and on study treatment from an antecedent vemurafenib protocol
* Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol
* Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use 2 adequate methods of contraception as defined by protocol during the course of this study and for at least 6 months after completion of study treatment

Exclusion Criteria:

* Adverse event requiring discontinuation of vemurafenib in the antecedent protocol
* Progressive disease during the antecedent protocol. If approval to treat beyond progression was already given in the antecedent protocol, the participant may roll over into the current protocol without sponsor approval. Under special circumstances, enrollment into this protocol and dosing beyond progression may be considered and will require approval of the sponsor

Participants meeting any of the following exclusion criterion of the antecedent study at the time the participant is considered for the extension (rollover) study:

* Current, recent (within 28 days prior to Day 1), or planned use of any antitumor therapy outside this study
* Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the study
* History of malabsorption or other clinically significant metabolic dysfunction
* History of clinically significant cardiac or pulmonary dysfunction as specified in antecedent study
The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making

An anal fistula is an abnormal communication between the luminal surface of the anorectal canal and the perianal skin. Fistulas can vary in their complexity and can be challenging to treat, due to the anatomical relation to the anal sphincter complex that controls continence. In addition, fistulas can display complex features such as branches, cavities and horseshoes; where the tract travels radially around the anal canal. All these features have a role in determining the most appropriate surgical treatment option, and are key to understanding the surgical decision-making process. This study will determine patient understanding of fistula anatomy, their perception of their own understanding, their rating of how good their clinician's explanation is and how this impacts the decision-making process using standard explanation with 2D images, versus a 3D printed model of a fistula.

Previous work has established a method of using traditional two-dimensional MR images to construct and print 3D models of perianal fistula, however the clinical utility of these models in the outpatient setting and their impact on patient knowledge of disease have not yet been assessed. This study is aimed at understanding how the use of 3D printed models can influence patient understanding of disease and support them in making decisions regarding treatment.

Participants attending routine outpatient appointments will have their fistula explained to them using either a standard explanation, or a 3D printed model of a fistula. They will complete a short series of questionnaires and their answers will be analysed to determine if there is any benefit of using 3D models in a clinical consultation.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* Aged ≥18 years old
* Patients who are new referrals to complex fistula clinic
* Patients with an idiopathic or Crohn's perianal fistula
* Patients with an intersphincteric or transsphincteric fistula according to Park's classification
* Patients who have had MR imaging of their anal fistula prior to consultation
* Able to give full informed consent

Exclusion Criteria:

Patients \< 18 years

* Patients with a rectovaginal or pouch fistula
* Fistula secondary to malignancy or radiation
* Suprasphincteric or extrasphincteric fistulas
* Follow up patients
* Patients who have no prior MR imaging of their fistula Patients who do not have the capacity to consent
Povidone Iodine and Cesarean Section Wound Infections

The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section wound infections \& compare side effects of both agents.

For centuries, hand washing with soap and water has been considered the main approach for personal hygiene. In the community, hand hygiene has been known to prevent infectious diseases and to decrease the burden of disease. Currently, hand hygiene is considered the most important measure for preventing the spread of pathogens in health-care settings.

There are multiple agents used for surgical hand scrubbing as alcohol, chlorhexidine, iodine/iodophors, para-chloro-meta-xylenol \& triclosan. Ideally, the optimum antiseptic used for scrub should have broad spectrum of activity, persistent effect \& fast acting. Unfortunately most studies evaluating surgical scrub antiseptics have focused on measuring hand bacterial colony counts. No randomized clinical trials have evaluated the impact of surgical scrub choice on surgical site infection risk \& proven its efficiency.

Eligibility Criteria:
Inclusion Criteria:

* elective caesarian section (CS)

Exclusion Criteria:

* diabetes,
* immuno-compromised patients
High PEEP Application Following Pulmonary Thromboendarterectomy; Does it Have Any Impact on Outcome?

Investigation of the effect of intraoperative lung protection high PEEP maneuver on ischemic reperfusion injury in patients undergoing pulmonary endarterectomy.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease characterized by progression of thromboembolism obstructing pulmonary arteries as an organized tissue. Pulmonary thromboendarterectomy (PTE) is a treatment option for chronic thromboembolic pulmonary disease. However, PTE is associated with specific postoperative complications, such as pulmonary edema and right ventricular failure due to reperfusion injury, with a significant mortality rate of 7% to 24%. Some strategies have been proposed to reduce lung injury after PTE, such as rectification maneuvers and high PEEP. The aim of this study was to investigate the effect of intraoperative lung protection high PEEP maneuver in patients undergoing pulmonary endarterectomy for ischemic reperfusion injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective PTE operation due to CTEPH,
* 20-70 years old

Exclusion Criteria:

* Patients with chronic inflammatory disease,
* liver and renal failure,
* heart failure (\<EF: 40%),
* intraoperative bronchial hemorrhage,
* patients undergoing postoperative revision.