cyrilzakka/clinical-trials huggingface dataset:
The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss

The purpose of this study is to determine whether ovarian reserve is related to recurrent pregnancy loss

This study will be conducted at the gynecology and infertility department of Kanuni Sultan Süleyman Training and Research Hospital from 2016 to 2017. The approval of the local Institutional Review Board (KAEK/2016.22.31) was obtained in June 2016 and informed consents of all subjects have been prepared. RM is defined as three or more pregnancy losses at \<20 weeks of gestation or fetal weight \<500 g. Women with history of RM for whom routine workup for RM (chromosomal analyses of both partners; levels of prolactin and TSH; anticardiolipin antibody, lupus anticoagulant, antinuclear antibody, and coagulation studies; and pelvic ultrasonography) is negative are assigned to the RM group. The control group consists of healthy women with no history of RM who are seeking contraception in the center's family planning unit. To keep the power of the study at 80% with an alpha-level of 0.05, a sample size of minumum 60 patients in each group was required.

Demographic data (age,gravidity,parity,pregnancy loss,bmı) ovarian reserve parameters(AMH,FSH,LH,E2,AFC) will be recorded and then two groups will be compared.

Data will be analyzed with the use of medcalc version 16.4.8 by Gökhan Yıldırım. Mean,median,SD,lowest and highest frequency ,and ratio values are used at statistical complementary of data .Quantitative data will be analyzed with the use of the Student t test and the Mann-Whitney U test. A chisquare test will be used for analyses of qualitative data

Eligibility Criteria:
Inclusion Criteria:

* Women with RM between 20-40 years old

Exclusion Criteria:

* Anovulation or PCOS
* Presence of endometrosis by laparoscopy or ultrasonography
* History of ovarian surgery
* Tobacco use
* Systemic chemotherapy
* Pelvic irradition
* Genetic abnormalities
* Irregular menstruel cycle
* family history of premature ovarian failure
Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)

There have been growing interest in identifying Parkinson's disease (PD) patients with mild cognitive impairment (MCI) which is susceptible to progress to PD dementia(PDD). PD-MCI is known to significantly correlates with low cerebrospinal beta-amyloid 1-42 and 1-40 levels, in which suggest the existence of something common with Alzheimer's dementia. PDD have showed more cholinergic deficits than Alzheimer's dementia and responds to donepezil. The investigators assume that PD-MCI patients also have cholinergic deficits. Donepezil improves cognition, and seems to be well tolerated and not to worsen parkinsonism in patients with cognitive impairment. Donepezil produced similar improvements in cognition and behaviour in DLB and PDD. This supports the hypothesis that the two disorders are closely related clinically and neurobiologically. Larger scale, placebo controlled clinical trials are needed to provide an evidence base to guide the clinical use of cholinesterase inhibitors in Lewy body disease.

It is believed that earlier intervention, later appearance of dementia should be needed to lower the socioeconomic costs and to improve the quality of life on patients and caregivers. The investigators anticipate that donepezil may delay the development of dementia in patients with PD-MCI.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 40 years old
* Clinical diagnosis of PD established by Queen Square Brain Bank Criteria
* Stable dose of levodopa at least 3 months before the study enrollment
* Diagnosis of MCI in PD according to the Movement Disorder Society (MDS) task force guideline

Exclusion Criteria:

* Diagnosis of Dementia
* Hypersensitivity to piperidine derivatives
* Concomitant anticholinergics and cholinergic agents
* Severe cardiac arrhythmia: Sick sinus syndrome, complete AV block, Uncontrolled arrhythmia, history of ventricular fibrillation
Moxibustion in a Randomized Trial for Version of Breech Position From Week 32

Moxibustion was tested for version of a breech position in singleton pregnancies. The women were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20 minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic version was offered for those still in breech position. The randomization was stratified for primigravida and multiparae separately. The randomization was made with a random number even and odd numbers indicating moxibustion or not. The randomization result was hidden in a sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave informed consent to the study.

Moxibustion was tested for version of a breech position in singleton pregnancies.

The women were randomized in week 32 to either moxibustion on acupuncture point Bl 67 daily in 15-20 minutes or no moxibustion. In week 36-37 the fetal position was checked and external cephalic version was offered for those still in breech position. The randomization was stratified for primigravida and multiparae separately. The randomization was made with a random number even and odd numbers indicating moxibustion or not. The randomization result was hidden in a sealed, non-transparent envelope on the obstetrical department and drawn when the woman gave informed consent to the study.

Sample size calculation gave 45 women in each group, based on alfa 0.05 and beta 20 under condition of a 30 % effect of moxibustion vs. 20 % of spontaneous version in the control group in primiparae and 60 % in multiparae, respectively. Thus, 4 times 45 women in each group were sought. Only women who had performed three treatments were judged under the principle of intention to treat.

Exclusion criteria at inclusion in week 32 was bleeding in 2nd and 3rd trimester, placenta insufficiency, cervical shortening, premature rupture of membranes, preeclampsia, elevated blood pressure, pelvic insufficiency, low placental position, uterine malformations, former uterine corrective surgery and known fetal morbidity

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with singleton breech position of their babies

Exclusion Criteria:

* vaginal bleeding in 2nd and 3rd trimester, placental insufficiency, cervical shortening, premature rupture of membranes, preeclampsia, high blood pressure, pelvic insufficiency, low placental position, placenta praevia, uterine malformations, previous corrective uterine surgery, known fetal morbidity
Assessment of Skin Perfusion Pressure as an Indicator of Tissue Oxygenation in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass

This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac surgery. Association of the intraoperative and postoperative 6hr skin perfusion pressure with perioperative serum lactate level is going to be assessed.


Eligibility Criteria:
Inclusion Criteria:

* age \> 20 yrs, scheduled for elective on-pump cardiac surgery

Exclusion Criteria:

* known peripheral arterial occlusive disease, patients without swan ganz catheter insertion, heart transplantation, infective endocarditis, emergency surgery, hemodynamic instability requiring vasopressor, preoperative lactate \> 2mmol/L, known liver cirrhosis, pregnant, cognitive dysfunction, being unable to communicate
A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. Male or female ≥ 18 years old and ≤75 years old.
3. ECOG performance status of 0-1.
4. With a life expectancy of ≥12 weeks.
5. With unresectable locally advanced or metastatic solid tumors harbouring with KRAS G12D mutation confirmed by central laboratory testing.
6. Need to provided tumor tissue samples for genetic testing.
7. Have at least one measurable lesion according to RECIST1.1, and the dose-escalation phase allows no measurable lesion.
8. Adequate laboratory parameters during the screening period.

Exclusion Criteria:

1. Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis.
2. Systemic antitumor therapy was received 4 weeks before the start of the study.
3. Palliative radiotherapy was completed within 14 days before the first dose.
4. Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria.
5. Subjects with known or suspected interstitial pneumonia.
6. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
7. Have poorly controlled or severe cardiovascular disease.
8. Subjects with active hepatitis B or active hepatitis C.
9. A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
10. The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
11. Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.
A Bleeding-Model Clinical Study

The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 20 gradable teeth;
* Have established gingivitis with ≥10 % bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

* Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
* Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Having known hypersensitivity to the test products;
* Having removable oral appliances;
* Having fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Having any diseases or condition that might interfere with the safe participation in the study;
* Having an inability to undergo study procedures.
Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis

The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease.

In addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.


Eligibility Criteria:
Inclusion Criteria:

* The patient has been correctly informed.
* The patient must have given their informed and signed consent.
* The patient must be insured or beneficiary of a health insurance plan.
* The patient is at least (≥)15 years old.
* The patient has MS according to diagnosis criteria (Thompson et al. 2017) and:

  * Participates to the OFSEP-HD cohort (ancillary study);
  * Has a Expanded Disability Status Scale score comprised between 0 - 7.0;
  * With or without Disease Modifying Drug;
  * For Work Package 3: patients enrolled in any OFSEP-HD centre that meet landmark criteria for an active MS (relapse, or Expanded Disability Status Scale progression, or active MRI) during follow-up;
  * For Work Package 4: patients with a stable disease enrolled in OFSEP-HD study in Nîmes or Nantes University Hospitals.

Exclusion Criteria:

* Within the past three months, the patient has participated in another interventional study that may interfere with the results or conclusions of this study.
* The patient is in an exclusion period determined by a previous study.
* The patient is under judicial protection.
* The patient refuses to sign the consent.
* It is impossible to correctly inform the patient (inability to understand the study, language problem).
* The patient is pregnant or breast-feeding.
* The patient is under 15 years old.
* Inability to answer questionnaires.
* Clinically isolated syndrome (CIS) that does not meet the criteria of MS.
* Radiologically isolated syndrome (RIS).
* Patient with Neuromyelitis optica spectrum disorder.
MitraClip NT System Post-marketing Surveillance Study - Japan

The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.

This study is a prospective, mutli-center, single-arm post-marketing clinical use surveillance study. The Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted. Patients registered in the AVJ-514 clinical trial who received additional MitraClip procedures will be excluded from the Surveillance.

Patients will be evaluated at Baseline, Procedure, Discharge, 30 days, 1 year, 2 years and 3 years in Japanese medical centers.

Eligibility Criteria:
Inclusion Criteria: Refer to MitraClip IFU

Exclusion Criteria: Refer to MitraClip IFU
Mental Visualization as a Learning Tool in Anesthesia

The purpose of this study is to evaluate the benefit of adding mental visualization to a training program in medical education. Undergraduate medical students will be randomized before participating in a training program on airway management during rapid sequence induction. In the control group, participants will receive traditional teaching including theoretical courses and procedural simulation. In the intervention group, in addition to traditional teaching, participants will be trained and encouraged to practice mental visualization. The main outcome will be clinical performance during a standardized high-fidelity simulation of rapid sequence induction assessed using a specific pre-established checklist.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate medical students from the Grenoble Alps university hospital
* From the 2nd to the 6th year
* Volontary

Exclusion Criteria:

* /
NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators

The primary objective is to demonstrate the safety and efficacy of a non-awake implantation method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter, parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will be implanted from up to 4 active sites, coordinated by a single lead investigator.

Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had a successful spinal cord stimulation trial and are indicated for permanent implantation at a participating facility.
* Sign informed consent

Exclusion Criteria:

* \< 18 years of age
Occlusion and Temporomandibular Joint(TMJ) Disorders: A Study

The study "Exploring the Relationship Between Occlusion and Degenerative TMJ Disorders: A Comparative Clinical Study" investigated the efficacy of occlusal therapy in managing degenerative temporomandibular joint (TMJ) disorders. Conducted over 6 months with 150 patients, it compared three groups: occlusal therapy (Group 1), conventional treatment (Group 2), and routine care (Group 3). Group 1 showed significant improvements, including a 65% pain reduction, 51% better jaw function, slower joint degeneration, 64% less muscle tension, 24% improved jaw mobility, and enhanced quality of life, outperforming the other groups. The findings support occlusal therapy's role in multidisciplinary TMJ management, though long-term studies are needed.


Eligibility Criteria:
Inclusion Criteria:

Adults aged 18 to 65 years

Clinical diagnosis of moderate to severe degenerative temporomandibular joint (TMJ) disorder, confirmed by:

Radiographic evidence (e.g., cartilage thinning, joint space narrowing)

Symptoms such as jaw pain, restricted jaw movement, or muscle tension

Ability to provide written informed consent

No recent trauma to the TMJ or oral structures

Exclusion Criteria:

Diagnosed rheumatoid arthritis or other autoimmune joint conditions

Serious cardiovascular, neurological, or systemic disorders

Pregnant women

Patients with contraindications for orthodontic procedures or occlusal splint use

History of TMJ surgery

Uncontrolled bruxism or other parafunctional habits that require alternative treatment strategies
Efffectiveness of a Roller Intervention in Anterior Knee Pain

Anterior knee pain is one of the most frequent reasons for consultation within knee conditions in adolescents and young adults. However, despite the high prevalence of this disorder, its pathogenesis and therefore its treatment are not clearly understood. Foam rolling has become a common intervention to enhance joint mobility and muscle recovery after exercise. the aim of this study is analyze the effectiveness of a roller intervention in patients with anterior knee pain.

Randomized controlled trial. patients were divided into two groups, intervention and control.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 65 years.
* Knee anterior pain diagnosis

Exclusion Criteria:

* Concomitant somatic or psychiatric disorder
* Previous knee surgery
* Other lower limb traumatological pathologies
GLP-1 Receptor Agonist Use and Incidence of Retained Gastric Food on Endoscopy

This study will enroll patients ages 18 and over who are in one of the following groups 1) taking a GLP-1 receptor agonist medication 2) not taking a GLP-1 receptor agonist (control group), are undergoing EGS and have appropriately fasted. Study data will be collected in the form of qualitatively observing whether the stomach is empty as expected, or contains solid or clinically relevant liquid contents.


Eligibility Criteria:
Inclusion Criteria

* Adults 18 years of age and older presenting for esophagogastroduodenoscopy (EGD)
* One of the following groups:

  * GLP-1 receptor agonist cohort: active treatment with any GLP-1 receptor agonist therapy within prior 30 days
  * Control cohort: not taking a GLP-1 receptor agonist medication
* Appropriately fasted per ASA Fasting Guidelines

Exclusion Criteria

* Simultaneous bowel preparation/planned dual endoscopy with colonoscopy
* Any pre-planned alteration to standard fasting guidelines (ASA NPO guidelines)
* Emergency endoscopic procedure
* Concern for active GI bleeding
* Food impaction/foreign body as indication for procedure
* Gastric outlet obstruction/bowel obstruction
* Achalasia
* Zenker's diverticulum
* History of esophageal or gastric surgery
* Active pregnancy
* Chronic daily opioid therapy ≥ 15 MMEs per day
* Prokinetic agent use (i.e. metoclopramide)
* Inability or unwillingness of subject to give informed consent
The Possible Role of Thyroxine in Keratoconus Development

Keratoconus (KC) is a corneal ectatic disorders, with incidence rate 1 per 50,000 among the population. Hormonal imbalances may be associated with KC as it affects the corneal metabolism. In this study, we aim to examine this clinical association between thyroid gland dysfunction (TGD) and KC.

Keratoconus (KC) is a corneal ectatic disorders, with incidence rate 1 per 50,000 among the population. Moreover, the pathophysiological processes underlying KC have not been fully elucidated with proposed mechanisms to include proteolytic degradation in the corneal stroma, oxidative damage, epithelial mechanical injury, immunological factors, and genetic factors. However, Hormonal imbalances may be associated with KC as it affects the corneal metabolism. Furthermore, thyroid gland dysfunction (TGD) can frequently associated with eye diseases such as Graves disease. Previous studies investigated the association between TGD and KC. Interestingly, thyroxine (T4) is important for corneal dehydration and transparency during embryonic development and regulates the synthesis of keratin sulfate proteoglycan in the chicken. T4 receptors (T4Rs) have been found in the lacrimal gland, confirming that the tear producing gland is a target organ of T4. T4 level was elevated in the tears of patients with KC. Hence, in this study, we aim to investigate the clinical association between TGD and KC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with KC.

Exclusion Criteria:

* Patients who cannot give an informed consent.
* Patients who cannot provide needed samples for any reason