cyrilzakka/clinical-trials huggingface dataset:
SexoMBC2 Non Interventional Study

The study is composed of three paper self-questionnaires to be filled in by the patients included at distance (\> 6 months) from their diagnosis of metastatic breast cancer, in order to limit the impact of the announcement on the filling out the questionnaires.

After verification of the eligibility criteria, the medical oncologist will present the study to patients coming to the ICL for a follow-up consultation as part of their regular care. The patients will meet with a clinical research nurse so that she can explain the again and answer any questions they may have. She will also give the patients the questionnaires questionnaires and will give a presentation of the questions asked. After this meeting, the patients will be given sufficient time to reflect on, which may extend until their next visit to the ICL, in order to express, if they wish, their opposition to participating in the study. If she agrees to participate, the patient can then complete the questionnaires as well as the complementary questionnaire and place them in a closed envelope to be given to the clinical research nurse. The completion of the questionnaires will be completely anonymous. The data of those who object to the use of their data will be deleted from the database.

After the completion of the questionnaires, and in order to allow a benefit for the patient, a semi-directive interview in the form of a teleconsultation with a psycho-oncologist and sexologist will be offered. The interviews are not mandatory.

The time to fill in the self-questionnaires is estimated at 30 minutes and the semi-directive interview can last up to one hour. Finally, at the end of the study, as part of her subsequent care, each patient participating in the study will have the possibility to renew a teleconsultation with the psycho-oncologist and sexologist if she feels the need. As the subject of the study may generate personal questions and lead to a request for psychological and/or sexological care.


Eligibility Criteria:
Inclusion Criteria:

* Major woman
* Patient with metastatic breast cancer, either initially or secondary metastatic breast cancer
* RH+/HER2- tumor
* Patient starting first line metastatic therapy or currently undergoing 1st line metastatic treatment
* Patient diagnosed with metastatic breast cancer 6 months or more
* WHO 1 or 2 patient
* Postmenopausal or not
* Patient able to understand the French language

Exclusion Criteria:

* Patient WHO\>2
* Patient undergoing chemotherapy
* HER2+ or triple negative tumor
* Male
* Patient diagnosed with breast cancer less than 6 months ago
* Patient under guardianship, curatorship or safeguard of justice
A Study to Investigate Pharmacokinetic Drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin

This is a phase 1, open label, two-cohort, single-sequence, crossover study

This is a phase 1, open label, two-cohort, single-sequence, crossover study to investigate the pharmacokinetic drug interaction and safety of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male with body mass index(BMI) between 18.5 and 28 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing
* Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
* Sitting blood pressure meeting the following criteria at screening: 160 ≥ systolic blood pressure ≤100 (mmHg) and 95 ≥ diastolic blood pressure ≤ 60 (mmHg)
Comparison of Infection Rates Among Patients Using Two Catheter Access Devices

Intravenous catheters are placed in nearly every hospitalized patient. These catheters, since they are breaks in skin integrity, are potential sources of infection that occur in the bloodstream. Bloodstream infections can result in higher rates of death and lengths of hospital stay, as well as increase healthcare costs. Blood is drawn or medications delivered through a catheter access device attached to the catheter. In looking at new ways to decrease infections associated with healthcare, the investigators plan to test whether the use of a silver-coated catheter access device (VLINK) compared to the standard, non-coated device (CLEARLINK) can reduce infection rates. These devices are identical in design other than the silver coating of the VLINK, that imparts a brown color to the device. Silver can prevent the growth of bacteria inside the device (biofilm formation) in the laboratory, but this has never been proven in patients.

The investigators propose to do a crossover study in two Emory-owned hospitals (Emory University Hospital and Emory University Hospital at Midtown), anticipated to last 10 months. Currently, both types of devices, (standard and silver-coated) are FDA approved for clinical use and are in use at both hospitals. The investigators plan to have each hospital use only one type of catheter access device for a period of time (approximately 5 months), and then switch ("crossover") to other type of device for the rest of the study. All patients admitted to either hospital (excluding newborns and patients with infections attributed to hemodialysis catheters) will be enrolled since both devices meet the standard of care. During the study, the infection prevention department, as a continuing part of their regular duties will measure infection rates. A small subset of catheters that are removed during routine clinical care (none will be taken out solely for the study) will be sent to CDC to determine the amount of bacteria inside catheters and catheter access devices (look for biofilm). Finally, the microbiology lab, again as part of its routine function will determine the rate at which blood cultures are falsely positive. All of these measures will be compared using statistical methods to see if there is a difference between the standard and silver-coated catheter access devices.

In undertaking this study, the investigators will be using a type of vascular access device (valve, not positive pressure) already in use in both hospitals and not changing the delivery of care to patients while, in a rigorous, systematic manner, obtaining samples and data for analysis.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to the two participating hospitals.

Exclusion Criteria:

* Catheter-associated infections attributed to hemodialysis catheters.
* Neonates and children.
* Known silver allergy or hypersensitivity.
Bread Daily Intake Enriched With Mix Fibers in Metabolic Subjects: Intestinal Microbiota and Metabolic Profile Impact

The level of fibre consumption in France is lower than the national and international recommendations (mean 18.8 g/d for men, 16.4 g/d for women (INCA 2007 Study) instead of 30g/d recommended). Fibre have beneficial effects on health and interact with the intestinal microbiota diversity: a diet fortified with different structure fibres increase of 25 % the dysbiotic intestinal microbiota in obese patient (Cotillard et al, Dietary intervention impact on gut microbial gene richness. Nature, August 2013). The study aim is to evaluate the impact of daily consumption of bread (150 g ) enriched with a mixture of fibres of different structure (15g) during two months on the intestinal microbiota composition in metabolic risk subjects (abdominal overweight or obese) and also, to assess the correlation between the microbiota change and their metabolic profile improvement.It is a mono centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes)


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index of 25 to 35 kg/m2
* Waist circumference greater than 80 cm for women and than 96 cm for men
* Low level of fibre intake (\<20 g /d) and low level of fibre nature diversity
* Daily bread consumption

Exclusion Criteria:

* Bread products allergy or intolerance
* Digestive surgery history except appendicectomy
* Metabolic or gastrointestinal disease history
* Medication that could interfere with glucose and lipid metabolism or intestinal microbiota (for example, no antibiotics within the 3 months before the study)
* Smokers (5 cig/d or more)
Pharmacokinetics of Implanon in Obese Women

Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. population, studies of Implanon in obese women are essential. The proposed study represents an important first step in addressing the lack of data on Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women during the first 6 months of use and to provide data on the acceptability, side effect profile, and ease of insertion, palpation, and removal in these women. We also aim to collect samples for future validation studies of the use of the blood spot (finger-stick blood sample on filter paper) as a method of determining plasma etonogestrel.


Eligibility Criteria:
Inclusion Criteria:

* premenopausal with a uterus and at least one ovary
* willing and able to sign the informed consent
* willing to comply with the study protocol and visit schedule
* have a body mass index of less than 25, or greater than or equal to 30
* weight stable

Exclusion Criteria:

* known or suspected pregnancy
* delivery (vaginal or cesarean) within 4 months of device insertion
* abortion (first or second trimester) within 4 months of device insertion
* contraindications to Implanon use
* hemophilia
* undiagnosed abnormal genital bleeding
* hypersensitivity or allergy to any components of Implanon
* personal or family history of thrombosis or thromboembolic disorders
* hepatic tumors or active liver disease
* known or suspected carcinoma of the breast or history of breast cancer
* more that one cardiovascular risk factor such as hypertension or diabetes
* known history of PCOS, diabetes, or glucose abnormality
* present use or use within 2 months of device insertion of a CYP3A4 inducer
* breastfeeding women
* use of an investigational drug within 2 months of device insertion
* use of injectable contraception within 6 months of device insertion
* planning a pregnancy in the next 12 months
* known HIV infection
* smoking over the age of 35
Obstetrics , Prenatal Outcomes in Recurrent Miscarriage

The effect of recurrent miscarriage on the outcome of the current pregnancy and if there's a relation between it and adverse out come


Eligibility Criteria:
Inclusion Criteria:

1- patients who had ≥2 abortions during early pregnancy 2.patients had no abnormal reproductive tract anatomy 3. Pregnant in single fetus

Exclusion criteria:

chronic hypertension, chronic kidney diseases autoimmune diseases multiple pregnancy
Hearing Aid Performance Study for Different Spatial Configurations

This clinical investigation will extend the evaluation of perception of speech in different listening environments with hearing aids available on the market (from Phonak). The clinical investigation is divided in three parts addressing different challenges met by hearing aid users.

Hearing aids are designed to amplify and transmit sound to compensate for impaired hearing. The main objective of this medical device is to improve the perception of speech, which can be defined among many attributes by intelligibility or listening effort. Evaluating the performance of the hearing aid or different features reasonably assumes that the talker location should be in front and close of the hearing aid user. However, listening situations in daily life might show much more variability regarding the spatial configuration of the talker, listener and noise sources.

This investigation is designed to extend the evaluation of hearing aid features to different spatial configuration and also to evaluate the benefit of the investigational device. The investigational device is European conformity (CE) marked and will be used within its defined use and on the intended population. The investigation is divided into three independent parts:

* Beamformer (BF) benefit: the first part of the study will evaluate the effect of a wider beamformer on intelligibility and listening effort for a speech-in-noise condition when the talker is not in front of the listener in comparison to a narrower beamformer,
* Speech Enhancer benefit: the second part of the study will evaluate the effect of the Speech Enhancer algorithm on distant speech in quiet and when speech in quiet is coming from an adjacent room with different measures such as listening effort, objective and subjective speech intelligibility,
* Hearing aid benefit: the third part of the study will evaluate the benefit provided by amplification with a speech-in-noise test where the talker is in front and close to the hearing aid user

Eligibility Criteria:
Inclusion Criteria:

* Experienced (minimum use duration 6 months)
* Adult (minimum age: 18 years) hearing aid users,
* Written and spoken German,
* Ability to understand instruction,
* Ability to describe listening experiences,
* Ability to attend to the appointments,
* Healthy outer ear,
* Hearing loss within the fitting ranges of the investigational product,
* Informed consent as documented by signature.

Exclusion Criteria:

* Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
* Known hypersensitivity or allergy,
* Not willing to wear the hearing aid,
* Fluctuating hearing that could influence the results.
Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study

The LockeT II study is a single center, prospective randomized study. It is intended to study the effectiveness of using LockeT device to gain hemostasis after venous procedures as compared to Manual Compression (MC). Approximately 110 patients will be enrolled.

The volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the United States and worldwide. Despite decrease in complication rates due to refinement in ablation tools and techniques, achieving vascular hemostasis following large-bore sheath femoral access remains a challenge. Thus, MC remains the current standard of care. However, MC requires up to 8 hours of prolonged bedrest, which is associated with longer length of stay and complications from indwelling catheters.

Another method of vascular closure is the figure-of-eight (FoE) stitch - a subcutaneous suture that has been evaluated to achieve homeostasis following major cardiovascular procedures.

In recent years, invasive, vascular closure devices have become popular. However, results continue to suggest that the risk versus benefit has not been definitively demonstrated. Instead, the LockeT is a new suture retention device designed to closely mimic manual compression by distributing the tension of a FoE stitch over a larger surface area. In such a way, patients can have the benefits of MC without a healthcare professional to stand bedside.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Be able to provide consent
* Presenting for planned procedures that require percutaneous venous punctures, such as atrial fibrillation radiofrequency ablation, and where the physician utilizes a LockeT device or MC to close the wound.

Exclusion Criteria:

* Under the age of 18
* Unable to or unwilling to provide consent
* Cannot comply with study requirements
* Not undergoing procedures that require a percutaneous venous puncture or planned access to the left atrium and/or ventricle
* Subjects whose physician does not use LockeT or MC to close the venous puncture.
* Patient is currently pregnant, as evidenced by positive urine Beta-HCG. (Urine Beta Human chorionic gonadotropin (HCG) will be checked in all females of the reproductive age group).
* If the physician detects a formed hematoma prior to venous closure, that patient will be excluded from the study.
Temporomandibular Joint and COVID-19

There is evidence that CV-19 is associated with joint symptoms, but there are no specific data on the temporomandibular joint (TMJ). It is also known that the systemic health status can impact the immune system. Given all this, this study aimed to investigate the effect of CV-19 and systemic health status, as determined by the American Society of Anesthesiologists (ASA) Physical Status Classification System 12, on TMJ in patients with TMJ complaints using the DC/TMD scale.

This study investigates the effect of systemic status, according to American Society of Anesthesiologist (ASA), and COVID-19 on temporomandibular joint (TMJ) disorders using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) scale, shown to be valid for assessing TMJ disorders. The study included 76 patients who presented to our clinic with TMJ. Participants were divided into two groups: those with COVID-19 (CV-19, study group) and those without (non-CV-19, control group). These two groups were both further divided into subgroups according to ASA 1 and ASA 2 classification. Power analyses were performed using G\*Power software to determine the required number of patients. Groups were compared using the Symptom Questionnaire, a demographics survey, the Graded Chronic Pain Scale (GCPS), and the Jaw Functional Limitation Scale-20 (JFLS-20) of the DC/TMD. The statistical software program version 1.6.23 was used for statistical analysis. Although joint complaints were more common in ASA 2 patients with CV-19, the groups were not significantly different. The CV-19 ASA 2 group had the highest JFLS-20 score (mean: 1.3±1.5) and the non-CV-19 ASA 1 group had the lowest JFLS-20 score (mean: 0.7±0.8), but the differences were again not significant. Joint complaints were more common and more severe in ASA 2 patients with CV-19, albeit not with statistical significance. More studies are needed to better understand our results.

Eligibility Criteria:
Inclusion Criteria:

* applied to our clinic with TMJ discomfort
* ASA 1 and ASA 2 patients

Exclusion Criteria:

* patients with acute CV-19
* Patients who are not in ASA 1 or ASA 2 classification
* Patients under 18 year-old
* Pregnants
Simultaneous or Sequential Multipoint Pacing

The purpose of this study is to compare electrical acute changes between simultaneous and sequential LV pacing and to assess the paced QRSd over a range of inter- and intra-ventricular programmable delays setting during MPP pacing.

The study will be a prospective, single-arm, non-randomized, non-blinded, acute study conducted at CRT device implant and prior to subject discharge. Subjects scheduled to be implanted with a Quadripolar Pacing System who provide informed consent will undergo "Enrollment" and participate in "SCOPE-CRT" study. Enrollment and device implant can occur in the same day. Including Enrollment, each subject's participation is expected to be 1-2 days. The total duration of the study is expected to be 12 months, including Enrollment. Enrollment will include the Informed Consent process, physical examination, and collection of demographics, cardiovascular history, medical history, and medications.

During CRT implant, surface ECG and PV loop recordings will be taken over the different programmable MPP settings. Following data collection, CRT device programming will be left to the discretion of the physician.

Eligibility Criteria:
Inclusion Criteria:

* Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA)
* QRS duration \> 130 ms
* Ability to provide informed consent for study participation
* At least 18 years of age

Exclusion Criteria:

* Myocardial infarction within 40 days before enrolment

  * NYHA Class IV
  * Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction
  * Such frequent VT or VF that the therapies would cause an unacceptably rapid depletion of the device batteries
  * VT with few or without clinically relevant symptoms
  * VT or VF treatable by surgery
  * Concomitant diseases that would substantially limit a positive prognosis
  * Accelerated intrinsic rhythm
  * Women who are pregnant
Comparing Intravenous and Oral Paracetamol for Cholecystectomy

To determine the amount of paracetamol in the blood when given in either intravenous or oral forms prior to cholecystectomy. The clinical effectiveness of each form will also be evaluated with pain scores and the use of other pain relief drugs.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-75
* Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia

Exclusion Criteria:

* Inadequate English comprehension (difficult to obtain informed consent and cooperation), and when interpreters are not available.
* History of allergy or sensitivity to paracetamol
* Administration of oral paracetamol within previous 8 hours
* American Society of Anesthesiologists (ASA) grade IV or V, indicating serious cardio-respiratory co-morbidity
* Not suitable for protocol anaesthetic technique (eg: history of nausea and vomiting with morphine)
Reliability of Rimegepant or Triptans for the Acute Treatment of Migraine

This protocol describes the analysis of the Adelphi Real World (ARW) Migraine Disease Specific Programme(TM) 2022, a cross-sectional study which used both physician and patient surveys to assess the perception of the acute treatment for migraine attacks.

This is a retrospective database study that aims to explore the reliability of effect with acute use of Rimegepant or triptans, to evaluate the satisfaction with Rimegepant or triptans, to evaluate willingness to continue using Rimegepant or triptans, and to explore proportion optimized on treatment with Rimegepant or triptans. The data will be extracted from the Adelphi Real World (ARW) Migraine Disease Specific ProgrammeTM (DSP) 2022 database, which was conducted across a number of countries including United States, between May 2022 and November 2022. The DSP was an observational study of clinical practice. Treatment practice data were collected by physicians (physician survey) who were asked to provide information for the next 10 patients consulting for migraine. These patients were then invited to fill out a self-completion form (patient survey) providing their own assessment on the disease and treatments.

Eligibility Criteria:
Inclusion criteria

* Patients who have episodic and/or chronic migraine
* Patients age \> 18
* Currently prescribed rimegepant OR triptans for the acute treatment of migraine

Exclusion criteria

* currently prescribed rimegepant for prevention of migraine or for both the acute treatment \& prevention of migraine
* Rimegepant group: currently prescribed an acute treatment for migraine and other than rimegepant
* Triptan Group: currently prescribed an acute treatment for migraine other than triptans
Baduanjin Program Effect on Geriatric Functional Dyspepsia

functional dyspepsia is very common between geriatric population

Forty Egyptian geriatrics with functional dyspepsia, after randomization, will be divided to 2 groups; the first 20-geriatric group will receive 5-session per-week 40-minute baduinjuin for 8 weeks plus the daily dose of pantoprazole (40 mg orally administered tablet drug. in the other 20-geriatric group, the daily dose of drug will be administered only for 8 weeks .

Eligibility Criteria:
Inclusion Criteria:

* functional dyspepsia complaints
* geriatric population

Exclusion Criteria:

* cardiac complaints
* respiratory complaints
* articular complaints