cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)

A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

1-year mortality after the study valve implantation will be compared to the performance goal based on the literature review of clinical outcomes for dialysis patients who underwent surgical aortic valve replacement. Data will be collected from all patients for up to five years following the index valve replacement procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation.
* Patient has senile degenerative aortic valve stenosis
* Patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months.
* Patient has appropriate aortic valve annulus size measured by TEE or 3D-CT.

Exclusion Criteria:

* Patient has evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
* Patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve.
* Patient has severe aortic valve regurgitation.
* Patient has severe mitral valve regurgitation.
* Patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. Implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary.
* Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis

Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard procedure after obtaining informed consent.

Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard procedure after obtaining informed consent. Demographic profile of the patients will be recorded like gender and age. And baseline TEE will be interpreted and parameters such as mean MVO (cm2), mean MPG (mmHg), and mean LA size (AP diameter, cm) will be recorded. LAA morphologies will be classified as per the operational definition. All the patients will be put on oral anticoagulation with Warfarin. The international normalized ratio (INR) will be maintained between 2.5 and 3.5. Patients will be prescribed with warfarin initial with 5 mg of daily dosage. Weekly INR monitoring will be performed via weekly calls to each and every patients and their INR level will be obtained. Warfarin daily dosage will be adjusted after every month based on target INR range. Repeat TEE will be performed after three (3) months in all the patients. And presence and absence of clot in different types of LAA will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 65 years.
* Both male and female.
* Patients with server mitral stenosis.
* Patients with LAA clot on TEE.
* Patients prescribed with anticoagulation (warfarin therapy).

Exclusion Criteria:

* Patients with severe MR
* Patients with severe AS
* Patients with NYHA class IV
* Patients whose valve morphology precluded PTMC
Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

The objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (IIS) to send seasonal influenza vaccine reminders from Local Health Departments (LHDs), targeting children with high-risk conditions.


Eligibility Criteria:
Inclusion Criteria:

* children, 24-60 months
* current or previous enrollment in Medicaid (Michigan)
* presence of at least 1 chronic condition, as indicated by the Michigan Care Improvement Registry (MCIR)
* resident of Kalamazoo, Ottawa, or Kent counties (Michigan)

Exclusion Criteria:

* receipt of influenza prior to notification date
* ineligible for reminder/recall notification in the Michigan Care Improvement Registry (MCIR)
A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors

This is an open label, dose-escalation and expansion, single centre, phase Ia study . In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection were studied in patients with advanced solid tumors, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease;
2. Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy;
3. ECOG: 0-1;
4. Adequate organ and bone marrow function;
5. sign an informed consent.

Exclusion Criteria:

1. Patients with brain malignant tumor, lymphoma or other malignant hematologic diseases;
2. Active CNS metastasis;
3. Clinically significant GI disorders;
4. Significant cardiovascular disease;
5. Active infection or uncontrolled fever;
6. Pregnant or breast feeding patients;
7. Allergic to a drug ingredient or component;
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma

A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different Combinations (with chemotherapy or AZD5069) in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

This is a Phase Ib and II open-label, multi-center study to evaluate the safety, tolerability, pharmacodynamics, and antitumor activity of MEDI4736 in combination with chemotherapy or AZD5069 in patients with pancreatic ductal adenocarcinoma (PDAC). This study will consist of 2 independent cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen or treatment-naïve patients
2. Eastern Cooperative Oncology Group 0 or 1
3. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan and that is suitable for accurate repeated measurements
4. MEDI4736 + nab-paclitaxel + gemcitabine chemotherapy cohort: treatment-naïve patients with metastatic PDAC who have received no previous systemic chemotherapy 5 MEDI4736 + Cohort: Patient should receive no more than 1 prior systemic chemotherapy regimen.

6. Life expectancy ≥ 12 weeks. 7. ECOG PS of 0 or 1 8. Adequate organ and bone marrow function 9. Ability to undergo during screening a tumor biopsy that is adequate for biomarker analysis.

Exclusion Criteria:

1. Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy for cancer treatment.
2. Receipt of any investigational anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of study treatment.
3. Major surgical procedure within 21 days prior to the first dose of IP.
4. Patients weighing less than 30 kg
5. History of leptomeningeal carcinomatosis
6. Ascites requiring intervention
7. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy
8. Current or prior use of immunosuppressive medication within 14 days of first dose
9. Brain metastases or spinal cord compression.
10. Medi4736+AZD5069 Cohort only: received any potent and moderate cytochrome CYP3A4 inhibitors, potent and moderate CYP3A4 inducers, P-gp substrates, BCRP substrates, sensitive CYP2B6 substrates, warfarin and coumarin derivatives, or herbal supplements within 14 days of the first dose of study treatment
11. Uncontrolled intercurrent illness
12. Other malignancy within 5 years except for noninvasive malignancies
13. Mean QT interval ≥470 ms
14. Active infection
15. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP
16. Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not employing an effective method of birth control
17. Prior exposure to immune-mediated therapy
18. Known allergy or hypersensitivity to IP formulations or to other human monoclonal antibodies
Mindfulness Meditation for Cognition and Mood

The purpose of this pilot study is to collect feasibility and acceptability of an internet mindfulness meditation intervention for older adults and to collect preliminary data on mood and cognition changes from before to after the intervention. Up to 32 older adults will be randomized to receive a mindfulness meditation intervention or a time and attention control, both delivered over the internet (16 completers). Participants will have a one-hour session weekly for six weeks with daily home practice between sessions. Participants will complete the sessions online with a study iPad. Their home practice will also be installed on the study iPad as well as an objective adherence monitoring program that the investigators developed to track actual home practice between sessions. The feasibility and acceptability measures are enrollment rate, completion rate, and participant satisfaction. Self-report mood questionnaires and cognitive tasks will be measured before and after the intervention period and data used to conduct power analyses and sample size estimation for a larger clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Age 65 - 90 years old
* Baseline Perceived Stress Scale1 score ≥ 9
* Stable on medications six weeks prior to and during study
* Willing to learn and use study technology
* Can hear and understand instructions
* Willing to accept randomization scheme and agrees to follow the study protocol

Exclusion Criteria:

* Cognitive impairment limiting ability to give consent or follow the protocol (≤26 on the mTICS)2
* Significant acute medical illness that would decrease likelihood of study completion (self-report).
* Significant, untreated depression, as assessed by CESD-5 \>16 during screening.
* Current daily meditation practice (≥5 min/day daily for at least 30 days in the last 6 months. Past practice not exclusionary but will be recorded)
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation

This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation.

This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, PK and PD effects of SP-304 in patients with chronic idiopathic constipation. Patients diagnosed with chronic idiopathic constipation (CIC) will be screened for the anticipated 4 cohorts, to yield 80 randomized patients for enrollment. Four dose cohorts are planned (0.3 mg, 1.0 mg, 3.0mg, and 9.0 mg) with 20 patients per dose cohort \[randomization ratio 3:1 (15 receive SP-304:5 receive placebo)\]. Patients who continue to meet all the entry criteria and complete the pre-treatment bowel movement (BM) diary will receive, in a double-blind, randomized fashion, SP-304 or matching placebo. It is expected that each patient will complete all 14 days of dosing (including making accurate BM diary entries for all 14 days in the treatment period). All patients receiving at least one dose of SP-304 or matching placebo will be considered evaluable for the safety endpoints. If a patient receives at least 5 doses per treatment week (1 dose per day for 7 days) and has completed BM diary entries for those 5 dosing days in each corresponding treatment week, he/she will be considered evaluable.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act \[HIPAA\]).
* Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.
* Subject has a body mass index (BMI) between 18 and 35 kg/m2.
* Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset \> 6 months prior to diagnosis.

Exclusion Criteria:

* Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the absence of any laxative, enema, suppository or prohibited medicine for \> 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.
* Subjects who meet the Rome III criteria for IBS.
* Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.
ALI (Acute Lung Injury) /ARDS (Acute Respiratory Distress Syndrome) in Oncologic Pediatric Patients

Identify pediatric oncologic patients with ALI/ARDS at GRAACC (Grupo de Apoio ao Adolescente e a Criança com Câncer) /IOP's (Instituto de Oncologia Pediátrica) Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.

Evaluate adequate mechanical ventilation based on protective ventilation protocols for children available so far.

Evaluate and describe the subjects. Evaluate the necessity and outcome of rescue therapies (surfactant, prone position, corticosteroids, alveolar recruitment) Obtain data about ALI/ARDS' etiology, mortality rates and predictive factors related to the outcomes (PICU/ hospital discharge or death)

Eligibility Criteria:
Inclusion Criteria:

* patients admitted at the intensive care unit with diagnosis of acute lung injury or acute respiratory distress syndrome and submitted to mechanical ventilation for over 24h

Exclusion Criteria:

* mechanical ventilation less than 24h
* absence of ALI/ARDS criteria
* no neoplasm diagnosis
Drug-Drug Interaction Study of Evobrutinib and Transporter Substrates

This study consists of 2 parts: Part 1 and 2. The purpose of this study is to evaluate the pharmacokinetic, safety and tolerability of multiple doses of evobrutinib on single doses of digoxin, metformin and rosuvastatin in Part-1 and sumatriptan in Part-2 of the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
* Participants have a body weight within 50.0 and 100.0 kilograms \[kg\] (inclusive) and body mass index within the range of 19.0 and 30.0 kilograms per square meter \[kg/m\^2\] (inclusive)
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as determined by medical evaluation
* Individuals with diagnosis of hemochromatosis, Wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including Gilbert's disease will be excluded from the study
* Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to Screening
* History of any malignancy
* History of chronic or recurrent acute infection or any bacterial, viral, parasitic or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening
* History of shingles within 12 months prior to Screening
* History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion
* History of alcoholism or drug abuse within 2 years prior to Screening, or positive for drugs of abuse, nicotine/cotinine or alcohol by the laboratory assays conducted during Screening and Day -1
* History of residential exposure to tuberculosis, or a positive QuantiFERON® test within 4 weeks prior to or at the time of Screening
* Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to Screening
* Moderate or strong inhibitors or inducers of Cytochrome P450, family 3, subfamily A (CYP3A4/5) within 4 weeks prior to the first administration of study intervention
* Other protocol defined exclusion criteria could apply
External Pop-Out Technique Versus Classic Head Extraction During Cesarean Section

Caesarean section is one the most common operations worldwide, its rates are globally increasing. A multitude of efforts had been done aiming at reduction of Caesarean section related maternal morbidities; most of them are related to technical modifications of how to open and how to close the abdominal and uterine incisions . The comparative studies of blunt versus sharp extension of the uterine incision showed a reduction of the incidence of unintended extension from 8.8% to 4.8% .

The vulnerability of the lower uterine segment for tears are related to stage of labor. The frequency of unintended extension was reported to be 15.5%, and 35.0% in cases operated in first and second stages of labor respectively.

The original techniques of fetal head extraction entail the introduction of the obstetricians hand or other instruments into the lower uterine segment . This puts the lower uterine segment at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time, infection adhesions and blood transfusion. Adherence to the available the generated good quality evidence bases practice in Caesarean section is anticipated to decease such morbidities.

The idea of the present technique was derived from the fact that during vaginal delivery the main task of obstetrician is to support the perineum while the fetal head extends to get out through birth canal.


Eligibility Criteria:
Inclusion Criteria:

* single fetus
* more than 37 weeks of gestation
* elective Caesarean section

Exclusion Criteria:

* non-cephalic presentation
* placenta previa
* hydrocephalus
* Multiple pregnancy
Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya

Transactional sex is widely believed to be among the driving factors for the high HIV rates among adolescent girls and young women in Kenya. We will pilot a randomized trial among men in Kenya to assess whether prize-linked savings opportunities reduce spending on transactional sex. The project will randomize men to the savings intervention and assess changes in key economic and self-reported health outcomes over a 3-6 month period.

Despite a large decline in new adult HIV infections in eastern and southern Africa from 2005-2015, progress has slowed in recent years. In particular, HIV risk among adolescent girls and young women remains high. Transactional sex, or the exchange of material support in non-commercial sexual relationships, is widely believed to be among the main driving factors for the HIV risk in this population. There is a large gap when it comes to interventions targeting men who engage in transactional sex. The proposed pilot project seeks to fill this important gap by using behavioral economic principles to promote behavior change among men.

The project will assess a novel prize-linked savings intervention designed to shift men's income away from alcohol and transactional sex and towards saving for the future. Prize-linked savings accounts offer savers a random, lottery-like payout proportional to the amount participants save, instead of traditional interest income. A number of banks, employers, and policymakers have promoted this low-cost, scalable approach to increasing savings among low-income individuals. However, there have been no assessments of whether prize-linked savings interventions can induce changes in key health-related behaviors as well. We will conduct a pilot randomized trial among men in Kenya to assess whether offering prize-linked savings opportunities leads to reduced spending on alcohol and transactional sex. The project will enroll men who in communities with high HIV risk, randomize them to the savings intervention, and assess changes in key economic and self-reported health outcomes over a 3-month period with baseline and follow-up surveys. We hypothesize that men randomized to the prize-linked savings intervention will have higher savings, lower expenditure on transactional sex, alcohol, and gambling, and lower rates of participation in risk behaviors such as transactional sex, relative to men randomized to the standard bank account control group.

Eligibility Criteria:
Inclusion Criteria:

* Resident in selected shoreline communities and their hinterlands in Siaya County, Kenya
* Male
* Age 21 years and above
* Primary or secondary occupation is fishing or transportation (i.e. motorbike taxi driver)
* Owns mobile phone
* Is willing to open savings account with a local bank and has, or is willing to obtain, the necessary documents (national identification card, Kenya Revenue authority PIN) to do so

Exclusion Criteria:

* Planning to relocate from study communities in the next 6 months
* Does not express willingness to open a savings account