cyrilzakka/clinical-trials huggingface dataset:
Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study

The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).

The treatment guidelines for valvular heart disease indicate that surgical correction of primary mitral valve regurgitation (MR) is a Class I recommendation. Further, recent evidence indicates that valve replacement is at least as effective as repair in both primary and secondary MR patients. However, many patients are not referred for surgery as they are considered to be too high of a risk to undergo on pump, open-heart procedures. Percutaneous aortic valve replacement has made treatment of stenosed aortic valves available to high-risk surgical patients who would have otherwise been medically managed. Percutaneous mitral valve (MV) replacement offers similar advantages. Currently, the only approved percutaneous treatment for MR is MitraClip. MitraClip is limited to a specific population of high risk surgical patients with valvular prolapses that are amenable to repair by the edge to edge technique. The feasibility of percutaneous MV replacement has been shown in animal studies, the implantation of aortic valves at the mitral position, and early evaluations of purpose made transcatheter MVs in humans. To meet this medical need, Caisson Interventional has developed a percutaneous delivery system for a bioprosthetic mitral valve. As with patients with aortic valve (AV) deficiencies, this device can be used to provide needed therapy to patients who might not otherwise receive treatment beyond medical therapy. This study will provide initial information on the safety and performance of this system.

Eligibility Criteria:
Inclusion Criteria:

* Has severe mitral regurgitation
* New York Heart Association (NYHA) Class II, III, IVa or heart failure
* High risk for cardiovascular surgery

Exclusion Criteria:

* Excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass
* Left ventricular end diastolic dimension \> 7cm
* Left ventricular outflow tract obstruction
* Severe right ventricular dysfunction
* Stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index procedure
the Effect of Transcutaneous Electrical Acupoint Stimulation on the Quality of Oocyte on Poor Ovarian Response(POR)

Patients in experimental group will be given transcutaneous electrical acupoint stimulation (TEAS) treatment for 12 weeks prior to controlled ovarian stimulation (COS).The patients will be given three times acupuncture every week except menstruation.Patients in no intervention group will not be given any interventions for 12 weeks prior to COS. The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes.

The patients will be randomly recruited into two groups. Patients in experimental group will be given TEAS treatment for 12 weeks prior to COS.The patients will be given three times acupuncture every week except menstruation. One treatment lasts for 30 minutes. The acupoints used for the TEAS treatment included head acupoint Baihui(DU20), abdominal acupoint Zhongji (RN3), Guanyuan (RN4), Zigong(EX-CA1), leg acupoint Sanyinjiao(SP6), waist acupoint Shenyu (BL23) and Guanyuanyu(BL26). Patients in no intervention group will not be given any intervention for 12 weeks prior to COS. When at least one dominant follicle is greater than 18 mm then injection a GnRH agonist (Triptorelin, Ferring, Switzerland) 0.2mg. 36 hours later transvaginal oocyte retrieval will be taken. After 3 hours of incubation, each egg will be transferred with a density of about 100,000/mllive sperm. The fresh embryo transfer is performed 72 hours after embryo culture in vitro. The whole embryos will be frozen.

The primary outcome measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures are the lab and clinical reproductive outcomes,including basic endocrine, serum Anti-Mullerian Hormone （AMH）, antral follicle counts, fertilization rate, cleavage rate, number of D3 embryos, the clinical pregnancy rate and early abortion rate.

Eligibility Criteria:
Inclusion Criteria:

1. The poor ovarian response patients compliance with Bologna consensus
2. Age：20-45 year
3. Women undergoing IVF-ET because of infertility for more than one year.

Exclusion Criteria:

1. Patients with genital tract malformation. Uterine malformation (single uterus, double uterus, double uterus, untreated mediastinal uterus) and other effects affecting uterine cavity disease (adenomyosis, submucosal uterine fibroids, intrauterine adhesions and scar uterus)
2. Complicated with other medical diseases（Hypertension, diabetes, psychosis, hereditary diseases）
Clinical Trial of Transtek Body Fat Analyzer (GBF-1251-B & Other 3 Models)

The clinical protocol of the clinical testing of this device:

1. Objective of the test: To verify the functions and efficiency of devices.
2. Test methods and procedures: Comparison Test.
3. Device Under Test (DUT): Transtek Body Fat Analyzer, Model: GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B.
4. Comparison device: Transtek, Glass Body Fat Analyzer, GBF-950-D.
5. Study endpoints: DUT and the comparison device are substantial equivalence.
6. Statistical methodology used: Description of statistical methods.

1. Test Purpose:

   The aim of clinical test is to collect weight, body fat, total body water, bone mass, and muscle mass reading value which measured by DUT and reference device.
2. Target Subject:

   The subject database shall contain at least 25 male and 25 female subjects and all above 18 years old.
3. Test procedures:

   1. Record the name, age, gender, and height of each subject.
   2. Let subject seated calmly for two minutes before test, dry the feet.
   3. Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value.
   4. For each subject, repeat 3) to get 3 pairs measurements.
   5. Repeat step 1) to 4) for every device (DUT: GBF-1251-B, BF-1255-B, BF-1256-B, and GBF-1257-B; and reference device: GBF-950-D).
   6. Repeat step 1) to 5) for each subject.
4. Note:

   1. No motion and speaking are allowed during the measurement.
   2. All DUT use the same algorithms and contact the patient at the same body locations (feet), and operate on the same frequency.
   3. Test environment: Temperature: 22±1℃; Relative humidity: 40\~70%.

Eligibility Criteria:
Inclusion Criteria:

* male,female

Exclusion Criteria:

* below 18 years old
Development of Compensation-Based Problem Solving Therapy

The aim of the study was to develop a Compensation-Based Problem-Solving Therapy and to examine its effects on activities of daily living, participation, self-efficacy, and quality of life in individuals with stroke.

The study was designed as a randomized controlled trial. A simple randomization method was employed to randomly assign individuals to two groups (intervention and control groups). A simple randomization method was employed, whereby the intervention and control group papers were selected from a closed envelope. Following the initial evaluation of each participant, one of the papers bearing the designation "intervention" or "control" was selected at random. This decision determined whether the individual would be included in the intervention or control group. The study was conducted in the occupational therapy department of the physical therapy and rehabilitation clinic of Etlik City Hospital. The study was approved by the Ethics Committee of Etlik City Hospital on May 17, 2023, and was assigned the code AEŞH-EK1-2023-176. Following approval from the ethics committee, the Compensation-Based Problem Solving Training (CBPST) was developed. The training program was developed in accordance with the tenets of the Occupational Adaptation Model. All subsequent steps were conducted in accordance with the aforementioned model. The adaptive response, as outlined in the model, encompasses the occupational adaptation that is anticipated to occur at the conclusion of the training program. The therapy was then trialled with a pilot group of five individuals, with the aim of refining the content. Subsequently, the final iteration of the training program was established. All individuals included in the study signed a consent form indicating their willingness to participate. This was completed at the outset of the study. All individuals were provided with a standard rehabilitation program comprising five days a week (40 minutes) of routine therapy. In addition to this, the intervention group received CBPST in the form of five days a week (20 minutes) sessions. The evaluations completed at the beginning of the training were repeated one month later.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with ischemic stroke due to middle cerebral artery lesion 18-64 years of age Stroke time between 3-12 months Scoring 24 and above on the Standardized Mini Mental Test Scoring 16 and below on the NIH Stroke Scale Receiving service in the inpatient service at Etlik City Hospital

Exclusion Criteria:

* Having any psychiatric or neurological disease that may affect the study Individuals whose affected hand is not their dominant hand Individuals who tend to neglect their affected hand
Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer

Hypothesis: In selected patients external hyperthermia will be used in combination with intravesical Mitomycin-C (MMC) to treat recurrent transitional cell carcinoma (TCC) of the bladder after local resection and standard adjuvant therapy and thus prevent or delay recurrence and the need for radical cystectomy.

It is well established that tumor cells are sensitive to heat and when combined with a chemotherapeutic agent, drug uptake and intracellular distribution of drug within malignant cells is improved due to increased cellular permeability. Further, hyperthermia inhibits deoxyribonucleic acid (DNA) repair as a result of increased reaction between DNA and chemotherapy. By heating bladder tissue and accelerating the necessary series of reactions to link agents such as mitomycin C to cell DNA, this effect may be optimized. Depending on the extent of resection (and location, size, and depth of invasion of remaining tumor) after transurethral resection of the bladder tumor(TURBT), recommended adjuvant therapy consists of intravesical chemotherapy. MMC has been studied at doses as high as 80 mg without producing significant or irreversible side effects. The most commonly used dose of mitomycin is 40 mg.2

This pilot study proposes to use Mitomycin C at a dose of 40 mg in conjunction with deep hyperthermia to enhance the effect intravesical chemotherapy as second-line treatment of recurrent TCC (Stage Ta, T1, or Tis) of the bladder after surgical resection and standard adjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

* Non-muscle invasive transitional cell carcinoma (TCC) of the bladder (Ta, T1, Tis) recurrent after initial surgery and at least one round of adjuvant treatment (i.e. 6 weeks of intravesical biological therapy with Bacillus Calmette Guerin (BCG) solution); or
* An inability to tolerate BCG
* Age \> 18
* Eastern Cooperative Oncology Group(ECOG) Performance Status 0-2
* Laboratory tests performed within 14 days of study enrollment:

  * Leukocytes ≥ 3,200, Absolute Neutrophil count ≥ 1,500, Platelets ≥ 100,000
  * Hemoglobin ≥ 9.0 gm/dL, Total bilirubin ≤ institution upper limit of normal \*(ULN), Asparate Aminotransferase(AST) and Alanine Aminotransferase(ALT) ≤ 2.5 times ULN, Alkaline phosphatase ≤ 2.5 times ULN
  * Creatinine ≤ 1.5 times ULN
* Women of child bearing potential must have a negative pregnancy test
* If post-menopausal - Amenorrhea for ≥ 12 months

Exclusion Criteria:

* Pregnancy or breastfeeding
* Muscle invasive disease (T2-T4)
* Prior radiation to the pelvis
* Peripheral neuropathy (any grade)
* Thrombocytopenia, coagulation disorder or an increase in bleeding tendency due to other causes
* Known bladder fistula
* Hypersensitive or idiosyncratic reaction to mitomycin-C or its components in the past
End-expiratory Transpulmonary Pressure-guided vs Electrical Impedance Tomography-guided PEEP Titration Methods in Patients With Intra-abdominal Hypertension Combined With Acute Respiratory Distress Syndrome: a Randomized Crossover Controlled Study

This study aims to adopt a randomized crossover design to compare the effects of end-expiratory transpulmonary pressure-guided PEEP titration and EIT-guided PEEP titration on local lung ventilation, shunt, dead space, and ventilation-perfusion (V/Q) ratio as monitored by EIT. Additionally, it will evaluate their impact on respiratory mechanics, chest wall mechanics, mechanical power, hemodynamics, gas exchange, intra-abdominal pressure, abdominal perfusion pressure, and renal perfusion. By identifying an optimal PEEP titration strategy for patients with intra-abdominal hypertension (IAH) and acute respiratory distress syndrome (ARDS), this study aims to develop a mechanical ventilation approach that maintains lung recruitment and minimizes lung injury while avoiding adverse effects on other organs. The findings could facilitate the clinical application of this strategy and benefit a broader population of patients with IAH and ARDS.


Eligibility Criteria:
Inclusion Criteria:

1. age: 18-80 years;
2. meets IAH ≥12 mmHg;
3. meets the diagnostic criteria of the new global definition of ARDS in the 2023 edition;
4. PaO2/FiO2 ≤ 150;
5. within 36 hours of invasive mechanical ventilation;
6. patients or their family members were consulted, agreed to participate in the trial, and signed an informed consent form.

Exclusion Criteria:

1. Age \<18 years or age \>80 years;
2. uncorrected shock of any type;
3. chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, right heart failure, pulmonary hypertension, or severe cardiac arrhythmia;
4. pneumothorax or bronchopleural fistula or lobectomy or other surgery of the lungs within 2 weeks of surgery;
5. non-invasive ventilation or transnasal high-flow oxygen;
6. with relevant contraindications to the application of EIT (large chest skin injuries, infections, pacemaker implanters, in vivo automatic defibrillator implantation, etc.) pneumothorax, mediastinal emphysema, massive pleural effusion;
7. oesophageal obstruction, oesophageal perforation, severe oesophageal variceal bleeding, upper gastrointestinal surgery, and other factors that make it impossible to place an oesophageal pressure catheter;
8. diaphragmatic hernia, thoracic deformity; patients with obvious pulmonary hernias;
9. prolongation of prothrombin time (PT), activated partial thromboplastin time (APTT) to two times the high limit of normal values or with active bleeding in the nasopharynx;
10. severe neurological disease: intracranial hypertension or neuromuscular disease, etc;
11. pregnant and lactating women;
12. patients to be treated with ECMO;
13. re-admission to the ICU of patients who have already been included in this study, or who are participating in other clinical studies;
MILES-4: Study Comparing Gemcitabine and Pemetrexed, With or Without Cisplatin, in Patients With Nonsquamous Lung Cancer

The purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cytologically or histologically confirmed non-small cell lung cancer.
* Non squamous tumor type (including those with a non-specified tumor type).
* Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
* Both patients at first diagnosis or those with disease recurrence after former surgery are eligible.
* At least one target or non-target lesion according to RECIST revised version 1.1.
* Male or female \> or = 70 years of age.
* ECOG PS 0 or 1.
* Life expectancy \> 3 months.
* Neutrophils \> or = 1500 mm3, platelets \> or = 100000 mm3, and haemoglobin \> or = 9 g/dL.
* Bilirubin level either normal or \< 1.5 x ULN.
* AST (SGOT) and ALT (SGPT) \< or = 2.5 x ULN (\< or = 5 x ULN if liver metastasis are present).
* Serum creatinine \< 1.5 x ULN.
* Signed written informed consent.

Exclusion Criteria:

* Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior adjuvant chemotherapy is permitted if it did not contain gemcitabine and pemetrexed and if at least 6 months elapsed from the end of adjuvant chemotherapy.
* Any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications.
* Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).
* Patients with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation; patients with CNS metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require steroids (anti-seizure medications are allowed).
* Known or suspected hypersensitivity to any of the study drugs
Fecal Microbiota Transplantation for Liver Failure

To investigate the safety, adverse reactions and therapeutic effects of fecal microbiota transplantation on patients with liver failure;to investigate the effect of fecal microbiota transplantation on the intestinal microecology and "gut-liver axis immune system" of liver failure, and further optimization of fecal microbiota transplantation technology.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing to sign informed consent
* Patients aged 18-65
* According to the diagnosis standard of liver failure in the guide for diagnosis and treatment of liver failure (2018 Edition), the eligible patients are included, that is, on the basis of chronic liver disease, the syndrome with acute jaundice deepening and coagulation dysfunction as the manifestation of liver failure caused by various inducements can be combined with complications such as Hepatoencephalopathy, ascites, electrolyte disorder, infection, hepatorenal syndrome, hepatopulmonary syndrome, etc And extrahepatic organ failure. The patient's jaundice deepened rapidly, the serum TBIL ≥ 10 × ULN or the daily rise ≥ 17.1 μ mol / L; there was bleeding, PTA ≤ 40% (or INR ≥ 1.5)

Exclusion Criteria:

* Patients with severe heart failure, COPD, cerebrovascular accident, nephrotic syndrome, etc;
* Patients with gastrointestinal bleeding, pulmonary infection, septicemia, etc
* Patients with liver cancer, lung cancer, lymphoma and other malignant tumors
* Patients taking anticoagulants, mental diseases and immune diseases for a long time
* Pregnant or lactating women.
Hearing and Cognition in Aging Adults

This cohort study is expected to provide valuable insights into the complex interplay between auditory and cognitive functions and how they change over time. The results of this study will have important implications for the prevention, diagnosis, and treatment of age-related hearing and cognitive disorders

The aim of the study is to identify the early perceptual and cognitive alterations related to age-related hearing loss or presbycusis, establish a correlation between the degree of hearing loss and the deterioration of cognitive functions, and examine the effectiveness of hearing loss management in reversing observed cognitive impairments. This project has the potential to shed light on the importance of early detection of hearing impairments in preventing cognitive decline. The data collected from this cohort, rigorously assessed for both auditory and cognitive functions, could serve as the basis for several high-level scientific investigations.

Eligibility Criteria:
Inclusion Criteria:

* Normal hearing (Pure Tone Audiometry \< or = 20 dB)
* Residency in one of the three neighborhoods :
* Affiliation with a social security system

Exclusion Criteria:

* Individuals under guardianship, trusteeship or curators
* History of neurological pathologies
* Taking of psychotropic medication.
Detection of Plasma DNA Methylation in Peripheral Blood from Patients with Resectable Liver Cancer

This study explores the potential values of a new blood test approach to detect measurable residual disease or early coming back of cancer (recurrence)/cancer growing, spreading, or getting worse (progression) in patients with liver cancer that can be removed by surgery (resectable). The development of novel cancer biomarkers for liver cancer may help in clinical decision making and lead to improvements in patient outcomes by facilitating prediction of the response to specific treatments, improved monitoring of patients on treatment, and better prognostication of patient outcomes, thus improving stratification for clinical trials.

PRIMARY OBJECTIVES:

I. To isolate plasma deoxyribonucleic acid (DNA) methylation panel from the peripheral blood of treated patients with hepatocellular carcinoma that will correlate with disease progression or measurable residual disease.

II. To correlate the mutations/ DNA methylation in peripheral blood with those identified in parallel tumor samples from the same patients with hepatocellular (HCC).

OUTLINE:

Patients undergo collection of blood samples at 4-6 weeks prior to surgery/ablation and at 12 weeks, 6, 12, 18 and 24 months after surgery/ablation. Patients' previously collected tissue samples are analyzed. Patients' medical records are also reviewed at baseline, 4-6 weeks prior to surgery/ablation, 12 weeks, 6, 12, 18 and 24 months after surgery/ablation, and then every 6 months for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient has planned resection or ablation of suspected hepatocellular carcinoma
* Patient is classified as resectable T1/T2 hepatocellular carcinoma (HCC) (solitary tumors less than or equal to 2 cm OR solitary tumors without vascular invasion \> 2cm or solitary tumor with vascular invasion \> 2cm, or multiple tumors, none \> 5cm) OR BCLC stage A (Single lesion of ANY size or 3 nodules or less with each being 3cm or less)

Exclusion Criteria:

* Patient is younger than 18 years of age
* Females who are pregnant or attempt to become pregnant
* Patient with significant anemia (hemoglobin \[Hb\] \< 7g/dL)
* Patient has known cancer outside of the liver 5 years prior to current blood collection (not including basal cell or squamous cell skin cancers)
* Patient has had a biopsy to the target organ and/or lesion within 3 days before blood collection
* Patient has had an intervention to completely remove current target pathology
* Target pathology is a recurrence of previously treated HCC
* Patient has had prior resection or ablation for target lesion
* Patient has had prior or active chemotherapy or radiation for target lesion