cyrilzakka/clinical-trials huggingface dataset:
NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome)

The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respiratory distress syndrome (RDS).

A Randomized Control Trial (RCT) conducted in two tertiary level Neonatal Intensive Care Unit (NICU). Ethical approval is needed. Informed and written consent will be obtained prior the delivery from the parents of the babies before the inclusion in the study. All inborn Very Low Birth Weight (VLBW) infants (Birthweight less than 1500 g and Gestational Age \< 32 weeks) with signs of RDS, spontaneously breathing and only supported by nasal-Continuous Positive Airway Pressure (NCPAP) in NICU, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies: Nasal Synchronized Intermittent Positive Pressure Ventilation (N-SIPPV) or Bilevel Continuous Positive Airway Pressure (BiPAP).

Eligibility Criteria:
Inclusion Criteria:

* All inborn VLBW infants (birthweight less than 1500 g and Gestational Age \< 32 wks) with signs of RDS, spontaneously breathing and only supported by N-CPAP, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies.

Exclusion Criteria:

* Apneic or severely depressed newborns requiring invasive ventilation, within two hours from birth
* Newborns with genetic disease and/or with major congenital malformations
* Newborns for whom it was not obtained informed consent within two hours from birth
Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

Pneumonia is a major cause of mortality and morbidity in patients with acute stroke fed via nasogastric tubes and may be because of vomiting and gastro-esophageal regurgitation. The aim of the study was to assess whether regular treatment with metoclopramide, a D2-receptor antagonist with antiemetic and gastric prokinetic actions, could reduce the rate of pneumonia.

Patients admitted with no signs of pneumonia within 7 days of stroke onset and 48 hours of insertion of a nasogastric tube will be recruited into a single-blind randomized placebo-controlled study who will admit in Neurology Department, PIMS. Participants will receive metoclopramide 10 mg or placebo 3 times daily via the nasogastric tube for 4 days. Clinical signs of pneumonia will be recorded on alternate days. Pneumonia will be diagnosed if the patient has relevant clinical signs, high inflammatory markers, and new infiltrates on the chest radiograph. A sample size of 106 patients is calculated, 53 patients in each group. Non-probability consecutive sampling will be used for recruitment of participants. Study duration will be six months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of either gender.
2. Patients within 7 days of acute ischemic or hemorrhagic stroke confirmed by computed tomographic scan of the brain who required nasogastric feeds for \>24 hours, and could be recruited within 48 hours of NGT insertion
3. Age above 13 years.

Exclusion Criteria:

* Patients with aspiration pneumonia at the time of presentation.
* Patients with a history of chronic neurodegenerative diseases that could affect swallowing (e.g. Parkinson disease and motor neuron disease)
* Poor postural control (unable to sit up for swallowing assessment).
* Esophageal disorders,
* Contraindications to metoclopramide.
The Effect Of Antiplatelets Therapy On Saphenous Vein Coronary Artery Bypass Graft Patency

This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG.

Coronary artery bypass graft (CABG) surgery is a commonly used revascularization strategy in patients with severe coronary artery disease. Saphenous vein grafts (SVGs) are the most frequently used conduits for this procedure. Unlike arterial grafts, SVGs are particularly susceptible to occlusive thrombosis during the first post-operative year, which exposes patients to increased risks of death, myocardial infarction, and repeat revascularization.

This study is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG. Patients will undergo planned cardiac Computed tomographic angiography (CTA) predischarge (at 1 week) and CTA/coronary angiography (CAG) at 6 months to 1 year follow-up. CTA at baseline (predischarge) and follow-up CTA/CAG at 6-12 months after CABG will be used to evaluate graft patency.

Eligibility Criteria:
Inclusion Criteria:

* All comer study where all patients undergoing coronary bypass surgery (CABG) will be randomized to one of the four treatment groups

Exclusion Criteria:

* Acute myocardial infarction (AMI) or cardiogenic shock
* Aortic dissection
* Mechanical valves.
* Contraindication to antiplatelets or aggrastat.
* Active bleeding or high risk of bleeding.
* History of hemorrhagic stroke any time.
* Recent history of embolic stroke or transient ischemic attack (TIA) less than 3 months.
* Active peptic ulcer disease (PUD).
* Liver derangement.
* Warfarin use.
* Heparin-induced thrombocytopenia (HIT) syndrome.
* Thrombocytopenia (platelet count \<100,000/mm3), disorders of platelet function
Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS

Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in patients with coronary artery disease. In the proposed study we wish to prospectively assess the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients who demonstrate non-responsiveness to clopidogrel.

Prior studies have demonstrated significant variability in platelet response to clopidogrel in patients with coronary artery disease (CAD). Up to 25% of patients have been shown to be non-responders to a conventional dose of clopidogrel. This phenomenon has been associated with higher incidence of recurrent cardiovascular (CVS) adverse events in patients with acute coronary syndrome (ACS), and higher incidence of peri-procedural myocardial damage, thrombotic complications, and ischemic events in patients undergoing elective percutaneous coronary intervention (PCI). Both the ex-vivo anti-platelet effect and the clinical benefit of clopidogrel are dose related. Moreover, in patients sustaining ACS while on maintenance clopidogrel treatment, reloading with 600 mg clopidogrel, resulted in further reduction in platelet aggregation, although the patients were not non-responders. Despite this, the effect of dose escalation has never been examined in patients resistant to clopidogrel. In the present study we wish to assess prospectively the effect of reloading with 600 mg clopidogrel, and double dose maintenance treatment (150 mg/day) for one month in acute myocardial infarction (AMI) patients who demonstrate non-respondese to clopidogrel.

Eligibility Criteria:
Inclusion Criteria:

* age equal or over 18 years
* acute coronary syndrome
* Clopidogrel non-responsive
* signed an informed consent

Exclusion Criteria:

* Bleeding disorder
* hypersensitivity to aspirin or clopidogrel
* any contraindication to anti-thrombotic or anticoagulant therapy
* active neoplastic disorder
Mobile Cognitive Behavioral Therapy for Stroke

This study aims to assess the feasibility and acceptability of "MAYA", a mobile cognitive behavioral therapy app for anxiety and mood disorders, in adults who have had a stroke.

The primary objective of this study is to assess the feasibility and acceptability of "MAYA", a mobile CBT application, in adults who have had a stroke. Feasibility will be measured by the total number of sessions completed and acceptability will be measured by scores on the Mobile Application Rating Scale-User Version (uMARS). Qualitative feedback will also be collected with a questionnaire using open-ended questions.

A secondary objective will be to evaluate preliminary efficacy of the mobile CBT application on symptoms of depression and anxiety assessed using (1) interview-based measures (the Montgomery Asberg Depression Rating Scale \[MADRS\] and the Hamilton Anxiety Rating Scale \[HAM-A\]), and (2) a patient reported outcome measure (the 21-item Depression, Anxiety, and Stress Scale \[DASS\]).

This study will collect pilot data over the course of 8 weeks. Because this is a pilot study, all participants will use the same version of the app and there will be no control group. Primary outcome measures will be collected at baseline (pre-intervention) and at the endpoint (week 8). Participants will be asked to use the mobile app for at least two days a week, for 30 minutes on each day, for 8 weeks. Participants will have weekly check-ins in person or via a HIPAA compliant virtual meeting platform (Zoom) with a study staff member to assess intervention adherence and answer brief questionnaires designed to assess feasibility, acceptability, and mood symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-79
* Presence of clinically-significant anxiety and/or depression (as determined by an eligibility evaluation)
* Stroke that occurred 1 month or more prior to study initiation
* Capacity to provide consent
* No greater than mild cognitive difficulties based on an eligibility evaluation conducted as part of the study
* If taking medication for depression and/or anxiety, must be on a stable dose for a minimum of 8 weeks prior to study initiation
* Ability to use iPhone or iPad independently
* Home internet access
* Willingness to participate in the full study duration.

Exclusion Criteria:

* Aphasia of moderate or greater severity (as determined during an eligibility evaluation)
* Non-fluency in English
* History of a bipolar or psychotic disorder
* Current alcohol or substance use disorder
* Active suicidal ideation
* Current engagement in psychotherapy is not grounds for exclusion unless the individual's psychotherapy is primarily focused on CBT
* Severe depression and/or anxiety based on the initial evaluation and clinical judgment of the study doctor, which warrants a higher level of care and/or immediate referral to psychiatric services
* Any other clinical or medical reason in the study doctor's initial screening evaluation that suggests the study is not appropriate for the participant
XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer

This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.


Eligibility Criteria:
Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate that is refractory to hormone therapy and previously treated with a Taxotere®-containing regimen.
2. Documented progression of disease (demonstrating at least one visceral or soft tissue metastatic lesion, including a new lesion). Patients with non-measurable disease must have documented rising prostate-specific antigen (PSA) levels or appearance of new lesion.
3. Surgical or hormone-induced castration
4. Life expectancy \> 2 months
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

Exclusion criteria

1. Previous treatment with mitoxantrone
2. Previous treatment with \<225 mg/m\^2 cumulative dose of Taxotere (or docetaxel)
3. Prior radiotherapy to ≥ 40% of bone marrow
4. Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
5. Other prior malignancy, except for adequately treated superficial basal cell skin cancer, or any other cancer from which the patient has been disease-free for less than 5 years
6. Known brain or leptomeningeal involvement
7. Other concurrent serious illness or medical conditions
8. Inadequate organ function evidenced by unacceptable laboratory results

The investigator will evaluate whether there are other reasons why a patient may not participate.
Benefits of Endoscopic Bariatric Procedures

This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty \[ESG\] or transoral outlet reduction \[TORe\]) as clinically indicated, and subsequent follow up clinic visits for up to one year.

The purpose the research is to better understand the effects of endoscopic bariatric therapy (EBT) on the weight change, hormonal changes and changes in the quality of life parameters for patients undergoing endoscopic bariatric procedures.

The primary research procedures are:

* EBT procedure (endoscopic sleeve gastroplasty \[ESG\] or transoral outlet reduction \[TORe\])
* Behavioral intervention consisting of diet therapy, exercise therapy, and behavior modification
* Collection of blood to evaluate changes in hormonal profiles

Eligibility Criteria:
Inclusion Criteria:

* Patients who are considering undergoing EBT for weight loss
* Patients with a BMI \>30 kg/m2 (without obesity related comorbidities)
* Patients with a BMI \>27 kg/m2 (with obesity related comorbidities)
* Patients willing and able to comply with study requirements for follow-up
* Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight
* Individuals 18 years old or older are included

Exclusion Criteria:

* Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
* Esophageal, gastric or duodenal malignancy
* Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
* Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
* Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
* General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation at the discretion of the investigator
* Pregnant or planning to become pregnant during period of study participation
* Patient refuses or is unable to provide written informed consent
* Prior surgical or endoscopic anti-reflux procedure
* Patients who are unwilling or unable to comply with the follow-up study schedule
A Preliminary Randomized Study of Tianjiu (Auto-moxibustion) Effects in Patients With Intradialytic Hypotension

Intradialytic hypotension (IDH) is a most frequent complication of hemodialysis (HD) and may contribute to cardiovascular events and high mortality. The etiology of IDH is multifactorial; therefore, it remains a challenging problem in the management of HD patients. Because moxibustion (MO) at specific points can influences hemodynamics, we hypothesize that Tianjiu (auto-MO) at the traditionally used meridian points will reduce the severity of hypotension in patients who undergo HD.

In this clinical trial, 45 patients had IDH were divided randomly into two (auto-MO therapy and control) groups for 4 weeks. In the Tianjiu (auto-MO) group, the patients were applied at 3 points (Conception Vessel 4, and Kidney 1) for 3-4 h during HD sessions. All number of episodes complicated by symptomatic IDH during HD sessions and the number of IDH-related nursing interventions (Trendelenburg position, manual reduction of ultrafiltration rate, infusion of isotonic saline or hypertonic fluid, lowering of dialysate temperature) in a session were recorded. Pre- and post-dialysis systolic and diastolic BP, pre- and post-dialysis body weights, interdialytic weight gain, percentage of target ultrafiltration achieved, patient's subjective assessment of the degree of fatigue after dialysis (scale from 0 to 10; 0, not at all, 10, extremely) and recovery time from fatigue after dialysis were measured at the 0, 2nd, 4th and 6th week.

Eligibility Criteria:
Inclusion Criteria:

* The subjects enrolled in the study were patients undergo regular hemodialysis, ranging from 20-75 years of age, at nephrologic clinic in KCGMH. These patients have experienced \> 3 episodes of intradialytic hypotension in recent two months.

Exclusion Criteria:

* (1)confounding diseases such as sepsis, cancer, decompensated liver cirrhosis, respiratory failure, and heart failure(NYHA\>3), (2) disturbed consciousness, (3) pregnancy, (4) can't tolerate the heat and allergy to automoxibustion,
Impact on Management of the HEART Risk Score in Chest Pain Patients

Aim of this study is to quantify the impact of the use of the HEART risk score on patient outcome and on costs in patients with chest pain presenting at the emergency room, as compared to not using the score.

During 14 months, patients presenting with chest pain to the Emergency Department (ED) of participating hospitals will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital will sequentially start to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 will not be admitted to the hospital (in accordance with the results of our validation studies), and patients with a HEART score above 3 will be treated according to current guidelines.

Eligibility Criteria:
Inclusion Criteria:

* All patients presenting with chest pain to the (cardiac) ED of ten participating Dutch hospitals, older than 18 years.

Exclusion Criteria:

* Children (age \<18 years) are excluded from study participation. Subjects who are (for whatever reason) not able to fill in questionnaires are excluded from study participation. Legal incapacity of every patient will be assessed by the attending doctor, according to the guidelines of legal incapacity. In case of doubt, consultation of the cardiologist (primary local investigator) will be possible.
Evaluation of Vitamin A Absorption From Fortified Bouillon

The goal of this clinical trial is to measure how well different formulations of vitamin A (VA) are absorbed by the body when they are added to bouillon (broth) as vitamin A palmitate (VAP). Fortifying bouillon cubes with VA is one potential approach to addressing VA deficiency, which is a major public health issue in many low- and lower-income countries. The main question this study aims to answer is to compare the amount of VA that is absorbed by the body from three different VAP formulations that are added to bouillon.

Participants will consume different formulations of VA and have multiple blood collections.

This study is being conducted to help characterize the absorption of 3 different formulations of VAP (PFH-VAP and BASF-VAP250 vs a positive control) when prepared as broth with an oil dose containing VAP or placebo (referred to as the "study treatments") and consumed by healthy adult women of reproductive age (ages 18 - 49 years).

Participants will undergo 3 treatment periods and will be blinded to treatment sequence using a 3-period, 3-treatment crossover design to receive all 3 treatments. All 3 treatment periods will include blood sampling to measure VA levels from pre- through 24 hours post-broth consumption.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, nonpregnant women
* ≥18 and \<49 years of age
* Able and willing to provide informed consent
* Body mass index (BMI) between 18.5 to 30.0 kg/m2
* Willing and able to undergo study procedures, including: repeated blood sampling, a baseline hemoglobin and pregnancy test, adherence to a low-vitamin A diet at specified times throughout the study, consumption of provided meals (specifically, a breakfast of bouillon, peanut butter, and a bagel or bread), and, except for the Screening visit, foregoing alcohol for at least 2 days before each visit and fasting for ≥8 hours before each visit

Exclusion Criteria:

* Currently pregnant
* Breastfeeding a child under 1 year of age
* Allergic to soy or peanut butter
* Current use of smoking tobacco products or any other form of nicotine
* Active eating disorder diagnosis
* Current diagnosis of acute or chronic illness, including hepatitis, Celiac's disease, Crohn's disease, and cystic fibrosis
* Moderate or severe anemia according to World Health Organization guidelines (i.e., hemoglobin ≤10.9 g/dL)
* Unable or unwilling to refrain from consuming alcohol when required
* Unable or unwilling to discontinue consumption of foods that are high in vitamin A and of vitamin A supplements when required during the study
* Taking prescription oral medication that includes a retinoid, e.g., isotretinoin/ Accutane
* Taking proton pump inhibitors.
* Unable/unwilling to avoid taking antacids during the fasting period prior to sample collection
* Unable/unwilling to fast for periods of at least 10 hours at a time
* Status relationship with a member of the study team.
* Unable to fulfill study requirements per the judgment of the investigator
Towards Optimal Prescription of Chemotherapy in Prostate Cancer

This study will examine the impact of modern treatments for metastatic Castrate Resistant Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function, objective physical function, and falls. Additionally, the investigators study whether frailty is associated with worse outcomes, and whether it is possible to predict the risk of severe chemotherapy toxicity in older men.

Our primary aims are (a) to examine the impact of pre-treatment frailty on 'elder-relevant' outcomes including daily function, objective physical function, falls, quality of life (QOL), and early treatment discontinuation; (b) to determine whether the Hurria/Cancer and Aging Research Group (CARG) tool is able to predict severe (grade 3+) chemotherapy toxicity in men starting chemotherapy. Our secondary aim is to understand the impact of abiraterone and enzalutamide on 'elder-relevant' outcomes.

This is a prospective multicentre observational study. The investigators will enroll men age 65 or older with mCRPC who are starting (a) first-line chemotherapy; (b) abiraterone; or (c) enzalutamide. Assessments will occur prior to starting treatment and every 2 months thereafter until the end of treatment.

As treatment options become more complex in older men with mCRPC, understanding and predicting a wide range of treatment toxicities is important and will aid decision-making and management.

Eligibility Criteria:
Inclusion Criteria:

1. At least 65 years of age
2. Diagnosed with prostate cancer with evidence of clinical and/or radiographic evidence of progression despite adequate androgen deprivation therapy and achievement of castration (total testosterone level \<1.7 nmol/L measured within 6 months of enrollment)
3. Among men starting either abiraterone or enzalutamide, no prior chemotherapy/abiraterone/enzalutamide. Among men starting first-line chemotherapy, commencing docetaxel but can have had either prior abiraterone or enzalutamide

Exclusion Criteria:

1. Unable to speak English fluently.
2. Severe neuropsychiatric abnormalities that prevent study participation.
3. Limited life expectancy (\<3 months) as estimated by the primary oncologist.