cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure

The objective of this study is to conduct a population pharmacokinetic analysis of caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis or liver disease with Child-Pugh score B and C in order to better characterize pharmacokinetic parameters in case of moderate and severe liver dysfunction.

patients admitted for alcoholic hepatitis or decompensated cirrhosis and Child-Pugh score 7-9 and 10-15 will be included; all patients without invasive aspergillosis.

Eligibility Criteria:
Inclusion Criteria:

* Liver failure Child-Pugh B and C

Exclusion Criteria:

* Cachexia (BMI \< 15 kg/m²)
* Pregnancy
* HIV
* Hepatitis C patients
Teen Video Study to Reduce Risky Driving and Sexual Behavior in Adolescents

The purpose of this study is to measure the effects of an interactive video on adolescent risky behaviors and outcomes, with one video intended to reduce teen pregnancies and the other intended to reduce automobile accidents.

Motor vehicle crashes cause one-third of teenage deaths and many serious injuries. Teen drivers ages 16 to 19 are four times more likely than older drivers to crash. Death and injuries could be reduced with a change in behaviors that include improved visual and attention skills while driving, more seat belt use, appropriate speed control, and not combining drinking or texting with driving. Sexually transmitted infections (STIs) and unplanned pregnancies are particularly common among adolescents. The U.S. adolescent birthrate is by far the highest among industrialized nations. These problems can be decreased by less sexual activity and better protection.

This study uses a randomized controlled trial to measure how well interactive video interventions can reduce these common risks to adolescents. Adolescent females will be invited to participate if they are currently seeking care at a participating clinic. They will answer survey questions about their driving and sexual behaviors, and then a computer will determine whether they will be given a video about driving or a video about sexual behavior. Participants will have unlimited access to their video, which they can watch at their clinic or from any Internet-enabled computer, and will be followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patient at participating healthcare facility
* Unmarried at time of enrollment
* Not pregnant at time of enrollment
* Available for contact over ensuing 6 months

Exclusion Criteria:

* Apparent or stated inability to comprehend consent or assent form (e.g., language barrier or cognitive ability)
* No ability to provide at least 2 methods of contact
* Married or pregnant at time of enrollment
Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma

The goal of this clinical trial is to determine the maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy in nasopharyngeal carcinoma. Researchers will observe the toxicity response of patients receiving nab-paclitaxel at 180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m².


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed nasopharyngeal carcinoma
* III-IVa (AJCC8th)
* age 18-70
* PS score 0-1
* normal functions to tolerate chemotherapy and radiotherapy

Exclusion Criteria:

* The presence of other malignant neoplasms within the preceding five years, with the exception of carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer, is permitted.
* Symptomatic heart failure, unstable angina, myocardial infarction, active infections requiring systemic therapy, psychiatric disorders, or family and social factors
Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.

Patients will be randomized to receive either prophylactic antibiotic \[a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)\] or placebo using identical sealed envelopes.Included cases are those with early miscarriage (within the first trimester 12 6/7 weeks of gestation) , missed or incomplete miscarriage, undergoing surgical management will be included in the study.

Technique:

The investigators will prepare 138 identical envelops, half of them filled with a label group(1) who are the group to receive the antibiotic prophylaxis with all instruction details, while the other half filled with a label identifying ( group 2) who are the placebo group. All envelops will be prepared by the investigator and sealed before starting enrollment. After enrollment, each participant will be allowed to choose one envelop to determine to which group the patient will be assigned to.

Eligibility Criteria:
Inclusion criteria:

* Maternal age :18-35 years
* Gestational age: up to 12 6/7 weeks of gestation (confirmed by a reliable date for the last menstrual period or /and 1st trimester ultrasound scan).
* Singleton miscarriage
* Type of miscarriage: Incomplete or Missed miscarriage
* Surgical evacuation will be done within 2 weeks of diagnosis of miscarriage .

Exclusion criteria:

* Maternal age: younger than 18 years
* Induced miscarriage of pregnancy
* Septic miscarriage
* Evidence of infection
* Morbid obesity (BMI≥40kg/m2)
* Allergy to prophylactic antibiotics (i.e., doxycycline or metronidazole)
* Antibiotics use within 7 days before randomization
Effects of Combined Grape Seed Extract and L-citrulline Supplementation on Hemodynamic Responses in Young Males

This study was to examine the additive benefits with combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study.

The investigators aimed the additive effects of combined grape seed extract (GSE) and L-citrulline supplementation on hemodynamic responses to dynamic exercise, 11 young, healthy males were recruited for this study. Effects of 7 days of combined GSE with L-citrulline supplementation on systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), cardiac output (CO), total vascular conductance (TVC), and oxygen consumption (O2) were examined at rest and during cycling exercise.

Eligibility Criteria:
Inclusion Criteria:

* healthy males

Exclusion Criteria:

* cardiovascular and/or pulmonary disease, musculoskeletal disorders, or medications that prevent the safe completion of the exercise protocol
Quality of Life After Laparoscopic Removal of Essure®

A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and 12 months after Essure® removal.


Eligibility Criteria:
Inclusion Criteria:

* women aged 18 years or more
* patients with Essure® sterilization device
* surgical removal of Essure® with bilateral salpingectomy by laparoscopy

Exclusion Criteria:

* interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
* impaired lower-limb range of motion preventing positioning for surgery
* inability to understand information provided
* prisoner or under administrative supervision.
Evaluation of Lymphedema Patients Status During Covid-19 Pandemic

The pandemic, which started in China at the end of 2019, appeared in our country in a short time. Most hospitals and physicians were only concerned with the treatment of these patients. One of the most victimized patient groups in this duration was lymphedema patients who were in need of continuous follow-up and rehabilitation at necessary periods, but were also at risk in terms of covid-19 infection and could not go to hospitals unless necessary. The treatment of both primary and secondary lymphedema patients has been interrupted or delayed. This process has affected the health status, treatment processes and quality of life of the lymphedema patient group. The current situation may have caused them anxiety and depression as a result of infection fear. In this study, we aimed to evaluate the treatment processes, health status, coronavirus phobia, anxiety, and depression states of the lymphedema patients .

60 primary and secondary lymphedema male and female patients with stage I,II,III lymphedema older than 18 years old over who were followed up in the lymphedema outpatient clinic of the Physical Medicine and Rehabilitation Clinic were included in the study.They were called by phone. Permission was asked for questioning from the patients reached. A hundred lymphedema patients were called and 60 patients were reached or agreed to be interviewed. The questions on the form and scales were read clearly to the patients who accepted the interview and were asked to be answered by the patient. The health status of the admitted patients during the covid-19 pandemic period and the treatment processes were questioned with the form we prepared.These forms were included socio-demographic features, physical, and detailed medical histories.Edema staging was evaluated by the International Society of Lymphology (ISL) lymphedema staging classification.This information was filled in from patients' files. The pandemic process was evaluated in the other part of the form. Working status, mobilization during the pandemic process, whether he/she or his/her relative was diagnosed with coronavirus infection, whether he/she received suplemental treatment, how much he/she paid attention to hand-foot hygine, whether his/her swelling increased, whether he/she had a cellulite attack, whether he/she regular self-manual lymphatic drainage and/or exercise, It was questioned whether there was an increase in a different symptom other than swelling, eating habits and weight gain, most recently whether he used pressure stocking regularly.In addition, the fear because of the covid-19 virus was questioned with the coronavirus-19 phobia scale (CP19-S), quality of life with lymphedema quality of life arm / leg (LYMQOL), and anxiety and depression with the hospital anxiety and depression scale (HADS).

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary lymphedema patients with stage I,II,II stage
* Aged over 18 years old
* Upper or lower extremity lymphedema

Exclusion Criteria:

* Patients under the age of 18
* Patients who do not accept phone calls.
Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates

Cardiac resynchronization therapy (CRT) is a recommended treatment for selected patients with symptomatic heart failure (HF). Although most treated patients show a benefit from CRT, a lack of response is observed for about 25-30% of them whatever the response criteria used either based on the clinical status (NYHA class, Packer clinical composite score) or on ventricular remodeling parameters assessed by echography (Left ventricle end of systole volume). This rate has remained remarkably stable since the therapy started and has motivated many studies to better understand the underlying physiopathology and the CRT action mechanisms.

Among the various research axes to improve CRT response and responders rate, increasing the number of pacing sites in an attempt to better homogenize the cardiac mechanical activity has been evaluated. A configuration with two RV leads and one LV lead was tested acutely in three studies. In all cases, it demonstrated a significant improvement of cardiac performance whether assessed by echographic parameters or LV dp/dt measurements. Additionally feasibility of this approach for long term CRT delivery was demonstrated during a previous study. First results with triple-site ventricular stimulation are encouraging and its clinical efficacy should now be tested on a larger population in order to conclude on its interest for CRT candidates.


Eligibility Criteria:
Inclusion Criteria:

* Patient who signed the MEC approved informed consent
* Patient older than 18
* Patient with a CRT (CRT-P or D) indication as per ESC guidelines 2013
* Left Ventricular Ejection Fraction (LVEF) ≤ 35%
* NYHA class II/III/IV despite optimal medical treatment
* Left Bundle Branch Block (LBBB) and QRS ≥ 120 ms (class IA and IB indications) or in the absence of LBBB QRS \> 150 ms (class IIA indication)
* De novo implantation
* Sinus rhythm

Exclusion Criteria:

* Permanent supra ventricular tachycardia
* Pacing indication for 3rd degree AV block
* Impossibility to perform FU at the investigative center
* Pregnancy
* Adults under legal protection
* Heart transplant candidates
* Concomitant pathology that may interfere with the study results
Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)

To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

- 1.18≤ age ≤75, no gender limitation; 2.patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance; 3.RV/LV ratio ≥0.9; 4.Patients who agreed to participate in the study and voluntarily signed the informed consent.

Exclusion Criteria:

1. Patients with systolic blood pressure\<90 mmHg and lasting for 15 minutes or requiring maintenance of systolic blood pressure ≥ 90 mmHg;
2. Patients with known severe pulmonary hypertension;
3. Patients with Hematocrit \<28%;
4. Patients with known structural heart disease;
5. Patients with left bundle branch block;
6. Patients with history of chronic left heart failure and left ventricular ejection fraction ≤30%;
7. Patients with abnormal renal function (serum creatinine \> 1.8 mg/dL or \>159 umol/L);
8. Patients with known coagulopathy or bleeding tendency (platelet \<100×109/L, or INR\> 3);
9. Patients who cannot receive antiplatelet or anticoagulant therapy;
10. Patients who underwent cardiovascular or pulmonary open surgery within 7 days before peocedure;
11. Patients with intracardiac thrombosis;
12. Patients treated with extracorporeal membrane oxygenation;
13. Patients known to be allergic to contrast agents;
14. Patients with diseases that may cause difficulty in treatment or evaluation (such as malignant tumor, acute infectious disease, sepsis, general condition that cannot tolerate procedure, life expectancy less than one year, etc.);
15. Females who are pregnant or in lactation;
16. Patient is currently enrolled in another investigational study protocol;
17. Other conditions not suitable for inclusion judged by the researcher.
The Effects of Water-only Fasting and Refeeding on Body Composition

This observational pilot study will assess the effects of water-only fasting on body composition and insulin resistance

This pilot study will explore the effects of water-only fasting followed by an exclusively whole-plant-food diet free of added salt, oil, and sugar on body composition with a particular focus on visceral adipose tissue (VAT). The study will also extend a previous study assessing the effects of fasting and refeeding on Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) values and markers of cardiovascular health and inflammation by following participants for an additional 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Any gender
* 40-70 years old
* Fasting plasma glucose \<126mg/dL and/or hemoglobin A1c \<7%
* BMI between 25 and 40 kg/m2
* Elect and qualify for a water-only fast of at least 10 consecutive days
* Provide informed consent
* Internet and computer access
* Able to return for 6-week follow-up visit

Exclusion Criteria:

* Active malignancy
* Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's)
* Stroke or heart attack within the last 12 months
* Break water-only fast before 10 days with juice or food.
* Break water-only fast after 10 days with juice or food before end-of-fast blood draw occurs.
* Leave center before completing at least 5 days of refeeding
* Unable to lay still on the back for at least 10 min
* Abdominal metal implants
Observational Study Evaluating Rituximab Use and Use of the Patient Alert Card in Participants Receiving Rituximab Infusion for a Non-Oncology Indication at Infusion Centers in Europe

This study is to characterize the indications for which rituximab is being used and to evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for non-oncology conditions at infusion centers. The study involves the retrospective chart review of rituximab users' medical records in non-oncology indications as well as a survey to collect information on participant characteristics, and will include questions about participant knowledge on the risk of infections, participant receipt and review of the PAC, and any actions the participant has taken as a result of receiving the PAC.


Eligibility Criteria:
Inclusion Criteria:

* Participant is in the center to receive an infusion for rituximab for a non-oncology indication during the study period
* Aged 18 years or older

Exclusion Criteria:

* Has previously already completed the rituximab survey
* Has participated in the past 12 months in a clinical trial in which rituximab was one of the treatments being evaluated.
An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer

This study will evaluate the anti-tumour activity, safety and tolerability of RO4929097 as monotherapy in patients with recurrent or refractory non-small cell lung cancer. Patients will receive oral doses of RO4929097 of 80mg (cohort 1) or recommended Phase II dose (cohort 2) on a 3 days on 4 days off schedule. Anticipated time on study treatment is until disease progression or unacceptable toxicity. Target sample size is \<50.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/= 18 years of age
* stage IIIB/IV recurrent or refractory non-small cell lung cancer
* at most 2 lines of prior therapy in the metastatic setting (first line: platinum containing regimen and bevacizumab; second line: EGFR-targeted therapy)
* ECOG performance status 0-2
* adequate liver, renal and bone marrow function

Exclusion Criteria:

* prior chemotherapy or radiotherapy \</= 4 weeks before first dose of study drug
* history of other malignancy within the past 2 years, except for basal cell skin carcinoma or in situ cervical carcinoma
* history of CNS metastases or leptomeningeal metastases, except for clinically stable disease
* serious cardiovascular illness
Effectiveness of Pilates Exercises Applied to Violinists With Nonspecific Neck Pain

The aim of this study is to examine the effects of different Pilates exercises on violinists experiencing non-specific neck pain

This study is planned as a randomized controlled study. Participants will be divided into two groups, mat pilates and reformer pilates, between the ages of 18-50. Participants will be asked to do the specified exercises for 6 weeks, 2 days a week and 45 minutes each session. Individuals with psychological and physical disabilities to do regular exercise will not be included in the study. The researcher will prepare a personal information form to collect the sociodemographic characteristics of the participants. A visual analog scale will be used to measure pain intensity and recovery process, a neck pain and disability scale to evaluate neck function and disability status, and a neck disability questionnaire to determine the effect of neck pain on daily life activities. These questionnaires will be repeated at the beginning and end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-50
* Individuals who play the violin with neck pain
* Having received professional instrument training

Exclusion Criteria

* Using medication
* Having any pathology that prevents exercise
* Having previously undergone upper extremity surgery
ECG Changes in Children and Adolescents With Type 1 Diabetes

Diabetes Mellitus type 1 is characterized by an absolute insulin deficiency caused by T-cell-mediated autoimmune destruction of pancreatic β-cells . It is the predominant form of diabetes mellitus during childhood and adolescence. Hyperglycemia is a major cause of vascular and neuropathic complications that are seen in patients with diabetes mellitus type 1.

Cardiovascular risk factors remain the most controversial chronic complication in diabetes mellitus type 1 Neuropathy in diabetes mellitus type 1 can lead to abnormalities in the response of the coronary vasculature to sympathetic stimulation, which may manifest clinically as resting tachycardia or bradycardia, exercise intolerance, orthostatic hypotension, loss of the nocturnal decline in blood pressure, or silent myocardial ischemia on cardiac testing. These abnormalities can lead to delayed presentation of cardiovascular disease. An early indicator of cardiac autonomic neuropathy is reduced heart rate variability, which can be assessed qualitatively in the clinic. Limited data suggest silent myocardial ischemia is more common in the presence of cardiac autonomic neuropathy . Cardiovascular mortality is a leading cause of death in Type 1 diabetic patients, in particular in patients with nephropathy.QT dispersion defined as the difference between maximal and minimal QT intervals from different electrocardiogram leads ( the QT interval was defined as the time between the first deflection from the isoelectric PR interval and the visual return of the T wave to the T-P segment ) ,Because these electrocardiogram abnormalities may confer an increased risk of ventricular arrhythmias and sudden cardiac death , early identification may have prognostic value .

Eligibility Criteria:
Inclusion Criteria:

* All children and adolescents with type 1 diabetes

Exclusion Criteria:

1. Cornary artery disease .
2. Heart failure , congenital heart disease ,
3. Rheumatic valve disease .
4. Primary cardiomyopathy .
5. Thyroid dysfunction .
6. Bundle branch block and atrioventricular conduction abnormalities .
7. Anti arrhythmic drugs .