cyrilzakka/clinical-trials huggingface dataset:
Pharmacodynamic and Pharmacokinetic Study of 2 Different Dose Regimen of Clopidogrel in CYP2C19 Genotyped Healthy Subjects

Primary Objective:

* Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects

Secondary Objectives:

* Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg loading dose followed by 150 mg/day for 4 days)
* Compare the pharmacokinetic profiles of clopidogrel active metabolite between the selected groups of genotyped subjects and the 2 dose regimen

The total study duration per subject is 10-12 weeks broken down as follows:

* Screening: 2 to 40 days before the first dosing
* Period 1: 7 days including 5 days treatment
* Washout: At least 14 days after the last dosing
* Period 2: 7 days including 5 days treatment
* End of study: 7 to 10 days after the last dosing

Eligibility Criteria:
Inclusion criteria:

Healthy subject in good health, as determined by a medical history, physical examination including vital signs and clinical laboratory tests:

* with a body weight between 45 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a Body Mass Index (BMI) between 18 and 30 kg/m²
* classified into one of the 4 groups of metabolizers according to his/her CYP2C19 genotype:

  * Ultrarapid Metabolizers (UMs, CYP2C19\*1/\*17 and CYP2C19\*17/\*17)
  * homozygous Extensive Metabolizers (homoEMs, CYP2C19\*1/\*1)
  * heterozygous Extensive Metabolizers (heteroEMs, CYP2C19\*1/\*2 and CYP2C19\*1/\*3)
  * Poor Metabolizers (PMs, CYP2C19\*2/\*2 and CYP2C19\*2/\*3)

Exclusion criteria:

* Evidence of inherited disorder of coagulation/hemostasis functions
* Subject smoking more than 10 cigarettes or equivalent per day
* Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" Under Fed Conditions in Healthy Adult Volunteers

The purpose of this clinical trial is evaluate the pharmacokinetics and safety between single administration of "BR6002" and coadministration of "BR6002A" and "BR6002B" under fed conditions in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those who weigh 55 kg or more for men and 50 kg or more for women and have body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 at screening.
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception (In the case of a female subject, hormone drugs is excluded) accepted in clinical trial from the date of the first administration of the investigational products to 7 days after the last administration and disagrees to provide their sperm or ovum.

  * Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc.

Exclusion Criteria:

* Those who have clinically significant diseases or past history of the gastrointestinal system, cardiovascular system, endocrine system, respiratory system, hemato-oncologic disease, infectious disease, kidney \& genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, ENT system, skin system, ophthalmic system.
* Those who have a medical history of gastrointestinal surgery (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 1month prior to the first day of administration or have taken ETC, OTC, herbal medicine and health functional foods concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs)
* Those who have participated in other clinical trials or bioequivalence tests and administered their investigational products within 6 months prior to the first administration date.
* Those who are unable to consume high-fat meals provided during this clinical trial.
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain

The purpose of this study is to explore the cortical regulation of the paraspinal muscles in chronic low back pain. These (possible) changes in regulatory mechanisms are being compared to other motor control tests in order to determine whether correlations are found. Furthermore the patients are being treated with repetitive transcranial magnetic stimulation (rTMS) and tested afterwards. The purpose is to find out if rTMS-therapy is capable of normalizing motor control deficits.


Eligibility Criteria:
Inclusion Criteria:

* chronic nonspecific low back pain for at least six months
* male gender
* age 25-50 yrs
* average pain during last week 4-8/10 by VAS
* Oswestry disability index 20-80 %

Exclusion Criteria:

* former spinal operations
* rheumatic disease, marked spondylolysis and -olisthesis, other diseases that markedly reduce physical or psychological performance, history of epilepsy, history of taking epileptic or strong opioid drugs
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 in participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.

Rescue therapy (defined as alternative antihyperglycemic medication use or dose modification of oral antihyperglycemic medication \[OAM\]) may have been initiated during the planned treatment period if the participant discontinued study drug or met prespecified thresholds for severe, persistent hyperglycemia. Efficacy data, as well as data for hypoglycemic episodes from participants who permanently discontinued study treatment but switched to another diabetes medication and remained in the study, were censored from the point of initiating new treatment onwards.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have had a diagnosis of type 2 diabetes mellitus before screening.
* Participants who have been Oral Antihyperglycemic Medication (OAM)-naïve (diet and exercise only) or been taking OAM monotherapy except for thiazolidinedione (TZD) and are willing to discontinue this medication. Participants taking OAM monotherapy must complete 8-week washout period prior to randomization.
* Participants who are OAM naïve with a screening glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% and randomization HbA1c value of 7.0% to 10.0%, or who are taking OAM monotherapy with screening HbA1c value of 6.5% to 9.0% and randomization HbA1c value of 7.0% to 10.0%.
* Participants who have a body mass index (BMI) of 18.5 kilograms per meter squared (kg/m\^2) to 35.0 kg/m\^2.

Exclusion Criteria:

* Participants who have a diagnosis of type 1 diabetes.
* Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog.
* Participants who have been receiving more than half of the maximum dose of sulfonylureas at screening.
* Participants who have been currently taking insulin or TZD, or have had previous insulin or TZD treatment within 3 months before screening.
* Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening.
* Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC).
A Chart Review Study of Adults With Advanced NSCLC

The main aim is to see how treatment patterns and drugs might improve care for adults with advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon-20 driven mutations. Past medical records will be reviewed. No clinic visits or procedures will be required.

This is a retrospective, observational study in participants with advanced NSCLC with EGFR exon-20 driven mutations. This study will look at clinical outcomes, patterns of care and disease management strategies and healthcare resource utilization (HCRU) in a routine clinical practice setting in the real world.

The study will enroll approximately 218 participants. Participants who were treated at the participating sites between 01 January 2017 and 30 November 2021 will be included. The data will be collected retrospectively at the specialized centers from the participants medical records and notes. All the participants will be assigned to a single observational cohort:

• Participants With Advanced NSCLC With EGFR Exon-20 Mutations

This multi-center study will be conducted in Canada, France and Hong Kong. The overall duration of the study will be 6 months.

Eligibility Criteria:
Inclusion Criteria

1. Histologically/cytologically confirmed diagnosis of locally advanced or metastatic (Stage IIb to IV) NSCLC with EGFR ex20ins mutations (based on the evaluation by the treating center) between 01 January 2017 and 30 November 2021.
2. Followed-up at the site between 01 January 2017 and 30 November 2021 for his/her advanced NSCLC, irrespective of their current survival status.

Exclusion Criteria

1. Participants whose investigator has access to fewer than two registered visits for his/her advanced NSCLC between 01 January 2017 and 30 November 2021.
Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.

This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged ≥ 40 years
* Current or ex-smokers of ≥ 10 pack-year
* Clinical diagnosis of severe stable COPD

Exclusion Criteria:

* History or current diagnosis of asthma, allergic rhinitis, or atopy
* Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
* Hospitalised for an acute COPD exacerbation in the last 3 months
* Evidence of contraindicated use of anticholinergic drugs
Prepulse Inhibition of Startle in Cocaine Dependence - 7

The purpose of this study is to assess the effects of chronic cocaine use on the acoustic startle response and on gating of this response in humans.

The objective of this study is to assess the effects of chronic cocaine use on the acoustic startle response and on gating of this response in humans.

Eligibility Criteria:
Inclusion Criteria:

Cocaine dependence. Male. Right handed. Negative urine for cocaine

Exclusion Criteria:

Positive urine for cocaine. History of head trauma. Significant medical disease.
The Effects of Virtual Natural Environments on Residents' Health

This randomized controlled trial aims to explore the impact of virtual natural environments on the mental and physical health of older adults in long-term care facilities. A total of 120 participants will be divided into three groups: a virtual reality (VR) group, a tablet screen-based natural environments group (Tab), and a control group (C) receiving routine care. The intervention involves viewing virtual natural landscapes for 10 minutes, three times a week, over eight weeks. The study will evaluate the effectiveness of these virtual environments in enhancing the quality of life for elderly residents, with data collection occurring at multiple time points. Additionally, qualitative interviews will be conducted with VR group participants to capture their experiences and emotional responses.

This study investigates whether virtual natural environments can improve the mental and physical health of older adults living in long-term care facilities. The trial will involve 120 participants randomly assigned to one of three groups: a virtual reality (VR) group, a tablet screen-based natural environments group (Tab), and a control group (C) receiving routine care. The intervention consists of viewing virtual natural landscapes for 10 minutes, three times a week, over an eight-week period.

The study's primary focus is to assess the impact of these virtual environments on participants' overall well-being and quality of life. Data will be collected at multiple stages throughout the intervention, and statistical analysis will be conducted to determine the effectiveness of the virtual nature sessions. In addition to the quantitative analysis, qualitative interviews will be carried out with participants in the VR group to gather deeper insights into their experiences and the emotional benefits they may derive from the intervention. These interviews will provide valuable context to the quantitative findings, helping to understand the broader implications of using virtual natural environments in long-term care settings.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* Residency in a long-term care institution for more than 1 month
* Clear consciousness

Exclusion Criteria:

* Blindness
* Presence of an infectious disease
* Inability to wear glasses
Urodynamic Assessment of the Lower Urinary Tract: Water vs. Air

Comparison of water-perfused (WP) and air-charged (AC) catheters for invasive urodynamic investigation (UDI) regarding consistency, features and artifacts.

UDI is the gold standard to assess refractory lower urinary tract symptoms (LUTS), i.e. to detect and specify lower urinary tract dysfunction (LUTD). Therefore, UDI findings lead to diagnosis and decision-making for further non-invasive and invasive therapies. For UDI pressure recordings, the use of WP catheters is recommended by the International Continence Society (ICS).

Currently AC catheters have been marked for pressure recording as an alternative to WP catheters. However, the number of comparative studies is very limited. Nevertheless, since release, AC catheters have gained popularity due to their omnidirectional detection of pressure, and claimed reduction in movement artefacts (due to weight-less air column vs weighted water column), lack of external reference level, and ease of set-up/use. Still, there is debate whether AC catheters are an acceptable alternative to fluid-filled lines for measuring intravesical and intra-abdominal pressure in UDI. Based on the available literature, an appropriate conclusion, whether both systems can be used as equivalents and interchangeably, cannot be drawn.

In this study we compare both systems regarding consistency, features and artifacts.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with LUTD
* Age: minimum 18 years
* Informed consent
* Competent German language skills

Exclusion Criteria:

* Age \<18 years
* Pregnancy or breast feeding (see chapter 3.6.)
* Symptomatic UTI
* Individuals especially in need of protection
* No informed consent
* Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on.
* Earlier participation in this clinical trial
Probiotics and Recovery From Gastrointestinal Surgery - 2

This prospective randomized trial is designed to test a pragmatic simple intervention in a community hospital. The trial will test the hypothesis whether patient recovery after a major elective abdominal operation can be improved and/or accelerated with postoperative use of probiotics.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥18 years undergoing elective major abdominal operation
* Functional GI tract expected after operation

Exclusion Criteria:

* Current episode of acute necrotizing pancreatitis as defined by surgeon
* Palliative decompressive GI tube
* Life expectancy ≤ 6 months
* Systemic immune-mediated disease active requiring systemic therapy:
* Prednisone ≥20 mg QD
* IV immunoglobulins
* Anti-rejection medication
* Presence of functional transplanted organ
* Systemic collagen-related disease treated with immunomodulating agents, including rheumatoid arthritis, SLE, scleroderma, etc.
* Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed
* Patient taking probiotics, synbiotics, or cobiotics as part of their lifestyle
* Need for full systemic anticoagulation postoperatively.
Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes

The primary objectives of the study are

* to perform a survey on the clinical management of unintentional hypothermia during surgery in France.
* to assess the impact of perioperative hypothermia on anemia and myocardial injury.

100 investigation centers in metropolitan France will participate in the study, targeting 2000 included patients (20 surgical interventions in each center). The duration of inclusion in each center should last at most 2 weeks.

The selected surgical interventions will be those performed with a high frequency, practiced in all types of hospitals (public, private, university hospital or not), and requiring anesthesia of at leat 30 minutes (general, epidural or intrathecal anesthesia).

Eligibility Criteria:
Inclusion criteria:

* Non-ambulatory surgery.
* Duration of anesthesia \> 30 minutes.
* Type of surgery: urology, gynecological, gastrointestinal, vascular and orthopedics surgery.
* Type of anesthesia: general, intrathecal or epidural anesthesia.
* patient ≥ 45 years.
* No opposition of patient to participate in the study.

Exclusion criteria:

* Emergency surgery.
* Cardiac surgery, proctology surgery or thoracic surgery.
* Digestive endoscopy or surgical radiology.
* Septic surgery.
* Patient with at least one organ failure.
Intermittent Ropivacaine Bolus for Epidural Labor Analgesia

Enhanced patient safety and satisfaction have contributed to growing use of epidural labor analgesia. Epidural analgesia appears to be currently the most effective technique in reducing pain during labor. However, reduction in total dose of local anesthetic and thus motor blockade is crucial to improve the obstetric outcome. This technique has evolved from intermittent boluses by anesthesiologists to the current standard labor epidural analgesic regimens in many institutions in North America and Europe that consist of a local anesthetic in combination with an opioid delivered via continuous epidural infusion (CEI) with or without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of administration has been used: regular bolus of low concentration local anesthetic + intermittent bolus (PIEB). This technique would offer safe and superior quality labor analgesia and greater maternal satisfaction by reducing total amount of the drug combination.

The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes, total drug dose and incidence of pain that required top-up administration (breakthrough pain)

Patients were explained about the procedure and written informed consent was obtained. Healthy term primi or second gravid parturients (aged \>18 years) with a singleton, live fetus in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm were recruited in the study after they requested epidural for pain relief. PIEB epidural analgesia was used.

Primary outcome was maternal satisfaction during labor and delivery. Our hypothesis was that patients would have a greater level of satisfaction when using PIEB technique. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes.

Eligibility Criteria:
Inclusion Criteria:

* healthy term primi or second gravid parturients
* aged 18-30 years
* singleton, live fetus
* vertex presentation
* active stage of labor with cervical dilation of 3-5 cm parturients

Exclusion Criteria:

* Hypertension
* no vertex presentation
* contraindications to neuraxial blockade
Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)

Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject.

The objective of this study is to perform a first assessment of the range of most potentially clinically relevant indications for use of the Gabi system for children \< 6 years old with underlying medical conditions.

This is performed by asking HCPs to review the data measured by the Gabi system after taking a medical decision independently from the Gabi data and to assess the potential clinical utility of the Gabi system.

The usability of the system will also be assessed throughout questionnaires filled out by the HCPs and by the caregivers.

\*During this study, the data collected by the Gabi system are not intended to be used by caregivers or HCPs to take any (medical) decisions.


Eligibility Criteria:
Inclusion Criteria:

1. Infants and children \< 6 years old.
2. Subjects who present at least one of the following underlying medical conditions:

   1. Subjects who underwent a congenital cardiac or cardiopulmonary surgery recently and could benefit from an additional post-surgery monitoring at home, per the investigator's opinion.
   2. Subjects at risk awaiting surgery.
   3. Subjects hospitalized following a severe respiratory condition within the past 2 weeks requiring invasive or non-invasive ventilation or oxygen therapy.
   4. Subjects hospitalized following a severe cardiovascular condition within the past 2 weeks, including severe heart failure, tachycardia or bradycardia.
   5. Subjects with chronic respiratory disease, such as asthma, developmental or cardiovascular conditions who could benefit from medical monitoring at home, per the investigator's opinion.
   6. Subjects with chronic respiratory support at home.
   7. Premature babies who required intensive neonatal care.
   8. Subjects hospitalized following a Brief Resolved Unexpected Event (BRUE) within the past 2 weeks.
   9. A clinical risk identified by the investigator which justifies the potential benefit of having a Gabi system used by the subject
3. Subject is (or is willing to be) followed up by an HCP of the investigation site during the duration of the study.
4. Signed informed consent form prior to performing any study specific procedure.
5. Willing and likely (based on the investigator's judgement) to comply with all study requirements.

Exclusion Criteria:

1. Weight \< 2.5 kg.
2. Subject presenting an anatomical limitation that would prevent the use of the Gabi system.
3. Subjects presenting a motor disorder that would prevent the use of the Gabi system (with the exception of epilepsy ).
4. Subjects participating in another interventional clinical study (with the exception of registries), which may have an impact on this study outcomes, based on the investigator's judgement.