cyrilzakka/clinical-trials huggingface dataset:
Ethanol Sclerotherapy Prior to ART

The goal of this randomized controlled trial is to assess the impact of ethanol sclerotherapy on ART cycle outcomes. The main questions it aims to answer are:

1. Does ethanol sclerotherapy before ART cycle has any impact on cumulative live birth rate in patients with endometrioma?
2. Does ethanol sclerotherapy improve chronic pelvic pain, dysmenorrhea, complications during oocyte retrieval, response to ovarian stimulation (number of mature oocytes retrieved), and pregnancy loss rates?

Infertile patients with endometrioma between 4-10 cm who are scheduled for ART within 2 cycles will be randomized to ethanol sclerotherapy or no intervention.

The effect of ethanol sclerotherapy before assisted reproductive technology (ART) cycle in patients with endometrioma on reproductive outcomes will be investigated. While endometrioma may result in technical difficulties in the ART process, the superiority of ethanol sclerotherapy has yet to be examined before the ART procedure in randomized controlled studies and meta-analyses. The negative effect of ethanol sclerotherapy on ovarian reserve was found to be less than other existing interventions such as cyst stripping. However, randomized controlled studies did not determine its direct effect on ART outcome. Our current study aimed to assess the effect of ethanol sclerotherapy on ART outcomes.

Infertile patients aged 18-40 years with at least one endometrioma 4-10 cm and scheduled for ART will be included in the study. Patients with any untreated thyroid dysfunction or additional disease, such as hyperprolactinemia, those who did not accept the study information and consent, and patients younger than 18 or older than 40 will not be included. Those who underwent surgery for endometrioma within 3 months before ART will be excluded. In addition, patients with an anti-mullerian hormone value below 0.3 ng/ml will not be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* AMH\>0.3 ng/ml
* unilateral/bilateral endometrioma
* Endometrioma diameter 40-100 mm

Exclusion Criteria:

* 3 or more IVF/embryo transfer failure
* Menstrual cycle abnormalities
* Male Factor infertility
* Presence of uterine fibroids
* Presence of hydrosalpinx
* Presence of uterine abnormalities
* Suspicion of malignancy according to International Ovarian Tumor Analysis criteria
Early CPAP in COVID-19 Patients With Respiratory Failure.

The study aims at clarifying whether early treatment with continuous positive airway pressure (CPAP) ventilation is able to reduce the need for intubation or death in patients visiting an emergency department (ED) with known or suspected COVID-19 infection and insufficiency respiratory.

Eligible patients will be randomized to two treatment arms: current clinical practice (control arm) and early treatment with CPAP in addition to current clinical practice (experimental arm). To deal with the current emergency situation, the study will adopt an adaptive design with a Bayesian continuous monitoring. Such design allows to stop the study as soon as the data provide sufficient evidence of efficacy or ineffectiveness of the studied treatment.

The primary endpoint of the study is the combination of intubation or death within 7 days of randomization. The secondary endpoint is 30-day mortality.

All patients arriving at the ED will be evaluated to verify the presence of inclusion and exclusion criteria. Randomization will be performed through an ad-hoc electronic case report form (eCRF). Eligible patients should be randomized as soon as possible, possibly immediately after the ED triage.

Patients randomized to the control arm will be treated according to current clinical practice, which currently does not involve the use of CPAP. Therefore, these patients should not start treatment with CPAP immediately after randomization. CPAP treatment, however, is allowed at a later stage, if deemed appropriate according to clinical judgment.

Patients randomized to the experimental arm should begin treatment with CPAP as soon as possible. CPAP should only be performed with a helmet, using a positive end-expiratory pressure (PEEP) between 8 and 14 cmH2O and an inspired oxygen fraction (FiO2) between 40 and 60%. FiO2 and PEEP must be modulated, within the limits indicated above, so as to obtain a saturation \> 94%. Whenever this goal cannot be achieved, the patient should be referred to the intensivist.

Eligibility Criteria:
Inclusion Criteria:

ED patients positive to or suspected of COVID-19 infection with at least one of the following symptoms:

* fever
* cough/dyspnea
* respiratory symptoms or ED arrival for respiratory reason and for whom there are the following conditions:
* SpO2 \< 95% in ambient air or positive Quick Walk Test
* PaO2/FiO2 \> 200 in ambient air or with Venturi mask, evaluated in 1 hour from ED arrival.

Exclusion Criteria:

* BPCO patients
* Age \> 70 years
* Pregnant status
* Contraindications for CPAP
Prospective Evaluation of Jugular Vein Thrombi After CPB Cervical Cannulation

The primary objective of the study is to prospectively analyse the occurrence of post-interventional internal vena jugularis (VJI) thrombi after minimally invasive cardiac surgery using a VJI cannula to perform cardiopulmonary bypass (CPB). The study follows the question whether the performance of a jugular cannulation for the operation under CPB regularly causes wall thromboses despite continuous anticoagulation and a short length of stay of a few hours. The thromboses to be assessed for the study will be obtained by bedside (Doppler) sonography by experienced intensive care physicians in the cardiac surgery intensive care unit. A prospective analysis of all minimal invasive procedures performed with regard to thrombi in the VJI.


Eligibility Criteria:
Inclusion Criteria:

- Minimally invasive cardiac surgery carried out using complete cardiopulmonary bypass.

Exclusion Criteria:

* Postoperative support by veno-venous or veno-arterial extracorporeal membrane oxygenation.
* Complications of neck cannula placement or removal.
* Pre-existing occlusion of the vena jugularis interna
* Pre-existing thrombosis of the vena jugularis interna
* Pre-existing prothrombotic coagulation disorder
* Existing catheterisation of the vena jugularis interna within 14 days
* Pre-existing anatomical anomaly of the vena jugularis interna
Bringing Parkinson Care Back Home

SUMMARY

Rationale: For persons with Parkinson's disease (PD), medical decisions are based almost exclusively on periodic in-clinic evaluations by a neurologist or a nurse. For a variety of reasons, such "snapshots" are unable to capture the actual impact of PD on the patient's functioning in their own home environment. Outpatient evaluations cannot detect rare and typically domestic events, such as falls. In addition, episodic visits are not well suited to detect changes in important lifestyle issues, such as gradual declines in physical activity.

Objective: To objectively, continuously and accurately collect detailed information on (changes in) physical activity and fall patterns among patients with PD in daily life.

Study design: Observational cohort study in 200 patients with PD, with a 12 month follow-up period.

Study population: Patients with PD (n=200), with an increased fall risk (i.e. at least one fall within the last six months).

Intervention (if applicable): This study does not include an intervention. After a baseline assessment on demographics and PD symptoms, patients will use a remote monitoring system at home (a pendant falls detector) combined with an smartphone application aimed at falls self-reporting, and an application to report medication intake for 12 months. A similar set up (i.e.Vital@Home) has been previously tested on feasibility (Dossiernummer: 2017-3382). Additionally, patients will report sleep patterns through paper-based diaries.

Main study parameters/endpoints: The main study parameters are physical activity and number of falls. They are remotely registered by the pendant falls detector.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, no invasive measurements will be performed. The participation is free of risks. Subjects could potentially benefit personally from participating in this study, as they can use the devices for free during the study and receive periodically feedback about physical activity and the occurrence of falls.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must confirm that they have been diagnosed with Parkinson's Disease by a neurologist (self-reported)
* Age 18 or older
* At least 1 fall incident in the previous 6 months. A fall is defined as any unexpected event that caused the person to unintentionally land on any lower surface (object, floor, or ground), regardless of any sustained injury (self-reported)
* Able and willing to provide written informed consent in accordance with Good Clinical Practice, and national and local regulation
* Fluent in Dutch

Exclusion Criteria:

* The patients receives advanced therapy for their Parkinson's disease (deep brain stimulation, duodopa pump, apomorphine pump);
* The patients shows cognitive of psychiatric impairments that may hinder successful completion of the study protocol (as judged by the researcher running the recruitment).
Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention

The pilot prospective randomized trial is designed to determine the safety and feasibility of enrolling patients to surgically correct residual Mitral Regurgitation (MR) following Percutaneous Coronary Intervention (PCI) for Myocardial Infarction (MI) verses ongoing medical management of MR. The investigators hypothesize that if moderate MR is corrected in this patient subset, the patients will have improved outcomes as measured by decreased number of major adverse cardiac events, including death, congestive heart failure requiring hospitalization, atrial fibrillation, deterioration of New York Heart Association (NYHA) functional status and improved quality of life.

Mitral regurgitation (MR) is a frequent complication of myocardial infarction. Ischemic MR portends a poor prognosis on long term follow up. This pilot prospective randomized trial is a safety and feasibility trial to evaluate mitral valve repair versus surgical management in patients with residual MR after primary percutaneous coronary intervention (PCI). Patients will be screened for possible inclusion to identify those that have first MI treated with primary PCI. Patients with moderate MR at 6 or more weeks following first primary PCI will be randomized to continued medical management versus surgical mitral valve repair. Patients with previous or subsequent coronary artery bypass surgery and patients with severe ventricular dysfunction will be excluded. Patients will be followed for one year from the time of randomization. The safety and feasibility data will be used to design a large trial powered to detect a difference in mortality between treatment arms.

Results of this study could lead to a radical change in the treatment paradigm for patients with ischemic MR following PCI for acute MI. In addition, insight gained from this study could advance our understanding of the interrelationship between LV remodeling and MR and shed some light into the mechanism of ventricular function deterioration following MI. Moreover, it may provide a framework for the development of further recommendations with respect to the indications for surgical intervention in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone PCI for first acute MI (index MI) since 7/1/09 at MMC and STJ
* documented moderate mitral regurgitation on follow up echocardiography six or more weeks after PCI procedure
* English speaking

Exclusion Criteria:

* CABG after PCI for acute MI
* History of previous MI prior to index MI
* History of previous PCI or CABG prior to index PCI
* EF \<30 % on the echocardiogram at 6 weeks after PCI for MI
Assistance Multidisciplinary in Hypertensive Patient: Randomized Clinical Trial

The purpose of this study is to determine if multidisciplinary care improves the health condition of hypertensives.

A multidisciplinary approach in managing hypertensive patients has shown benefits in reducing blood pressure and risk factors for hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Diagnosis of hypertension

Exclusion Criteria:

* Secondary hypertension
* Hypertensive patients with congenital cardiopathy
* Surgical patients
* Proven myocardial infarction
Efficacy and Safety Study of ATG for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT

The purpose of this study is to determine the efficacy and safety of combined ATG （antithymocyte globulin ） regimen for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).

Transplantation with G-CSF （Granulocyte colony stimulating factor ）mobilized peripheral blood stem cell (PBSCT) has been a stable transplant setting with matched sibling donor transplantation. Unmanipulated haploidentical donor PBSCT (haplo-PBSCT) has been applied in patients with hematologic malignancies. In our previous cohort study, haplo-PBSCT was associated with lower incidence of severe acute GVHD and extensive chronic GVHD compared with matched sibling donor PBSCT (MSD-PBSCT). Haplo-PBSCT has the same GVHD prophylaxis regimen with MSD-PBSCT, except ATG. It suggested the potential advantage of ATG in prophylaxis of GVHD and improvement of long-term quality of life of the transplant recipients, which motivate us to observe the efficacy of combined ATG regimen for GVHD prophylaxis in MSD-PBSCT.

Eligibility Criteria:
Inclusion Criteria:

1. acute myeloid leukemia (AML) in CR1 (complete remission 1) or CR2 (complete remission 2) phase regardless of cytogenetics;
2. CML CP(chronic myelogenous leukemia , chronic phase); NHL (non-Hodgkin's lymphoma )
3. MDS-RAEB(myelodysplastic syndrome -refractory anemia with excess blasts ).
4. All patients should aged 40 to 70 years
5. Have matched sibling donor.
6. Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases .

Exclusion Criteria:

1. Patients aged less than 40 years old ;
2. Patients with any uncontrolled infections or with severe pulmonary, renal, hepatic or cardiac diseases;
3. AML patients with t (15;17);
Development of the Leeds Food Preference Questionnaire in Spanish

The Leeds Food Preference Questionnaire (LFPQ) is a computer-based task used to measure reward responses and preferences for images of food. The present study aims to develop a Spanish version of the LFPQ (ES-LFPQ) by examining its validity and repeatability under fasted and fed states.

The Leeds Food Preference Questionnaire (LFPQ) is a computer-based task for measuring reward responses (liking/wanting) and preferences for images of food. There are no cultural adaptation studies for the Spanish population to date in order to address its validity and repeatability in a test-retest design. The present study aim to develop a Spanish version of the LFPQ (ES-LFPQ), examine its outcomes under fasted and fed states; and test its reproducibility after one week.

An online survey containing foods that were either low-fat sweet, high-fat sweet, low-fat savoury or high-fat savoury was first conducted among a sample of 96 Spanish adults (60.4 % women) to develop and validate a culturally appropriate food image database. 50 participants (25 men and 25 women) will participate in two identical trials where they will completed the ES-LFPQ under fasted and fed states (immediately after a standardised meal), at least one week apart.

Eligibility Criteria:
Inclusion Criteria:

* Being able to understand instructions, programs and questionnaires.
* Being able to recognize the foods presented in at least 4 of the 5 photographs available for each category that make up the ES-LFPQ.
* Living in Spain for at least 2 years

Exclusion Criteria:

* Being intolerant, allergic and/or having an aversion to the foods contained in the standardized meal.
* Never eat the foods presented in at least 4 of the 5 photographs available for each category that make up the ES-LFPQ
Study to Evaluate Efficacy, Safety and Tolerability of PENNEL Capsule in the Patients With Chronic Liver Disease

The test agent in this study is a product of biphenylmethyl dicarboxylate (BDD) with garlic oil. The two components were confirmed to have complementary effects because of different operational mechanism in animal experiments, and were examined on humans in this study. Both BDD and garlic oil are expected to show better protection and treatment on hepatotoxicity caused by toxic substances, and the purpose of this study is to confirm efficacy of and safety on human body of the agent and to determine its optimal dose.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic liver disease.
* Patients over 20, under 65 years of age.
* Patients with abnormal transaminase levels.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients who have any history of esophageal bleeding, hepatic encephalopathy, ascites.
* Diabetes, thyroid dysfunction, fatty liver, liver cancer patients.
* Toxic hepatitis, alcoholic hepatitis.
* Total bilirubin value more than 3.0 mg/dl.
* Albumin value less than 3.0 g/dl.
* Patients who participating in other study about drug.
Optimizing Meal and Snack Timing to Promote Health

This study will be conducted using standardized techniques to collect blood samples via an acute, randomized, cross-over design. Subjects will be provided all of their meals the day prior to testing and participate in 3 testing days with a minimum of 1 week break between testing days and a maximum time commitment of 7 weeks. A trained phlebotomist will place a catheter and collect blood samples from an antecubital vein using sterile techniques.


Eligibility Criteria:
Inclusion Criteria:

25-39 years old

* BMI between 22-37 kg/m2
* Weight stable (± 4.5 kg) for the previous 3 months
* Not currently (or within the past 6 months) following a vigorous exercise regimen or weight loss program
* No acute illness
* Not smoking
* Not diabetic
* Not pregnant or planning pregnancy in the next 3 months
* Lactose tolerant
* Willing to limit purposeful activity for 48 hours prior to each testing day
* Willing to consume study foods and beverages.

Exclusion Criteria:

* \<25 or \>39 years old, BMI \<22 or \>37 kg/m2
* Currently (or within the past 6 months) following a vigorous exercise regimen greater than -3 - 45 minute exercise sessions per week
* Currently following a weight loss program where subject has lost greater than 4.5 kg
* Acute illness
* Smoking
* Diabetic
* Pregnant or planning pregnancy in the next 3 months
* Lactose intolerant
* Unwilling to consume study foods and beverages
* Peri and post-menopausal women.
A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA).


Eligibility Criteria:
Inclusion Criteria:

* LDL \>70md/dL
* Total coronary plaque \> 75mm3
* BMI 18-40
* Max tolerated lipid modifying therapy
* eGFR greater/equal to 40

Exclusion Criteria: - HbA1c \>10

* Contraindications for CCTA
* History of coronary artery bypass graft
* Active liver disease
A Cohort Study on the Efficacy of Bariatric Surgery for Rapidly Progressing Diabetic Nephropathy

Establish a cohort of diabetic kidney disease(DKD) patients with intensive weight loss treatment to evaluate the impact of intensive weight loss treatment on the renal prognosis of DKD and construct a prediction model for the improvement of renal outcomes after weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years old;

  * BMI\>25Kg/m2 or abdominal obesity (i.e. waist circumference\>90cm for men and\>85cm for women);

    * eGFR\<30ml/min/1.73m2 or urinary microalbumin≥300mg/g, eGFR\<60ml/min/1.73m2.

Exclusion Criteria:

* Patients who are taking glucocorticoids;

  * Combined with tumors; ③Combined with autoimmune diseases; ④Serum albumin\<25g/L.
Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma

To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of GSK3845097 in HLA-A\*02:01, HLA-A\*02:05 and/or HLA-A\*02:06 positive participants with New York esophageal squamous cell carcinoma (NY-ESO)-1 and/or Cancer testis antigen 2 (LAGE-1a) positive, previously treated, advanced (metastatic or unresectable) Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCLS).

This study is a substudy of the Master record - (209012) NCT04526509.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be \>=18 years of age and weighs ≥40 kg on the day of signing informed consent
* Participant must be positive for HLA-A\*02:01, HLA-A\*02:05, and/or HLA-A\*02:06 alleles
* Participant's tumor must have tested positive for NY-ESO-1 and/or LAGE-1a expression by a GSK designated laboratory
* Performance status: Eastern Cooperative Oncology Group of 0-1
* Participant must have adequate organ function and blood cell counts 7 days prior to leukapheresis
* Participant must have measurable disease according to RECIST v1.1.
* Participant has advanced (metastatic or unresectable) SS or MRCLS confirmed by local histopathology with evidence of disease-specific translocation
* Participant has completed at least one standard of care (SOC) treatment including anthracycline containing regimen unless intolerant to or ineligible to receive the therapy.
* Participants who are not candidates to receive anthracycline should have received ifosfamide unless also intolerant to or ineligible to receive ifosfamide. Participants who received neoadjuvant/adjuvant anthracycline or ifosfamide based therapy and progressed will be eligible

Exclusion Criteria:

* Central nervous system (CNS) metastases, with certain exceptions for CNS metastases in NSCLC as specified in the protocol
* Any other prior malignancy that is not in complete remission
* Clinically significant systemic illness
* Prior or active demyelinating disease
* History of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments
* Previous treatment with genetically engineered NY-ESO-1-specific T cells, NY-ESO-1 vaccine or NY-ESO-1 targeting antibody
* Prior gene therapy using an integrating vector
* Previous allogeneic hematopoietic stem cell transplant within the last 5 years or solid organ transplant
* Washout periods for prior radiotherapy and systemic chemotherapy must be followed
* Major surgery within 4 weeks prior to lymphodepletion
* Pregnant or breastfeeding females