cyrilzakka/clinical-trials huggingface dataset:
Phase I Interaction Study of Istaroxime and Digoxin in Subjects With Stable Heart Failure

This study explores a potential drug-drug interaction between istaroxime and digoxin in patients with stable CHF on chronic oral digoxin treatment.

This is a single center, randomized, double blind, placebo controlled, escalating dose phase I interaction study. The three dose levels of istaroxime or placebo will be randomized sequentially to three cohorts (I to III) of 16 patients each (12 patients on istaroxime and 4 patients on placebo). Digoxin will be administered non blinded in all patients, once daily in the morning after a standardized breakfast, continuing with previously personalized dosage schedule during the screening period, treatment period, post treatment period and follow up period. Prior to accrual of cohorts II and III, a Data Monitoring Committee (DMC) will advise on the continuation to the next istaroxime dose, based on a predetermined safety review.

This 37 day study includes a screening period (Days -21 to -1), a treatment period (Day 1), a post treatment period (Days 2-4), and a follow up period (which includes one patient visit on Day 14). Patients will be confined in the phase I research center from Day -2 to Day 4.

Eligibility Criteria:
Inclusion Criteria:

Main screening inclusion criteria :

* Signed informed consent;
* Male or female patients ≥18 years;
* Female patients of childbearing potential must not be pregnant;
* Chronic stable cardiac function impairment (no change in heart failure medication over the last 3 months and without any dosage adjustment in the last 4 weeks);
* Systolic blood pressure (SBP) of ≥ 90 mmHg and ≤ 140 mmHg;
* LVEF ≤ 35% by any method (to be performed at screening if not measured within the last 12 months);
* Chronic treatment (i.e. once daily dosing without interruption) with oral digoxin started at least 3 months prior to study entry and without any concomitant administration of other positive inotropic drugs;

Exclusion Criteria:

Main screening exclusion criteria :

* Need for current or intermittent intravenous positive inotrope administration within the preceding 6 months, or hemodynamic support devices;
* Acute coronary syndrome within the past 3 months;
* Coronary artery bypass graft or percutaneous coronary intervention within the past 3 months;
* Stroke within the past 6 months;
* Atrial fibrillation or uncontrolled heart rate (HR) (\> 100 beats per minute \[bpm\]);
* Significant arrhythmia or second or third degree atrio-ventricular block;
* Valvular disease as the primary cause of HF;
* Significant ECG abnormalities as assessed by appropriately qualified physician or investigator including QTcF \>450;
* Positive testing for Human Immunodeficiency Virus (HIV), Hepatitis B and/or Hepatitis C;

Main randomization exclusion criteria:

* HR \> 100 bpm or \< 50 bpm;
* Serum potassium \> 5.3 mmol/L or \< 3.8 mmol/L and magnesium \> 1.1 mmol/L or \< 0.6 mmol/L,
* TN I \> ULN.
Study to Test the Usefulness of Magnetoencephalography (MEG) Imaging of Cognition in Children and Adolescents

The primary objective of this protocol is to test the feasibility and utility of obtaining magnetoencephalography (MEG) recordings in healthy children and also in children who have a psychiatric or developmental disorder. Secondary objectives are to examine and compare typical and atypical motor, sensory, and cognitive functioning as recorded by MEG, and to identify subpopulation groups for which MEG may be optimal in order to establish feasibility of future hypothesis-driven MEG research.

Healthy children and those who have a psychiatric or developmental disorder will undergo MEG recording to evaluate whether such children are candidate MEG subjects. Essentially, this feasibility study will examine whether children can remain still enough, complete simple tasks, and produce neurophysiologically consistent responses that would warrant full size studies.

Eligibility Criteria:
Inclusion Criteria:

* May or may not have a psychiatric or developmental disorder diagnosis.
* Outpatient at study entry.
* Age 4-18 (inclusive).
* Male or female.
* Have ability to sit still for 5 minutes or longer.
* Have ability to comply with basic instructions.
* Provide written informed assent if willing and able, per local IRB requirements before any study specific procedures are performed.
* Parent or legal guardian provide written informed consent before any study specific procedures are performed.

Exclusion Criteria:

* Ferrous metal permanently attached on or implanted in their body.
* Metal braces on teeth (i.e. Invisalign braces and cavity fillings are permitted).
* Has major medical condition, including cancer or hepatitis.
* Has confounding multiple psychiatric and/or developmental diagnoses, as judged by the principal or co-investigator.
* Known history or diagnosis of alcohol or substance abuse/dependence.
* Unable or unwilling to comply with the protocol.
* Anyone deemed as not appropriate for study participation, as deemed by the principal investigator.
Post Marketing Surveillance For General Drug Use To Assess the Safety And Efficacy Profile Of Viviant In Usual Practice

This survey is conducted for preparing application material for re examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, and assessing the safety and efficacy profiles of VIVIANT in usual practice according to the Re-examination Regulation for New Drugs

continuous enrollment

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal osteoporosis and osteopenia patients

Exclusion Criteria:

* Patients with active or past history of venous thromboembolic events including deep vein thrombosis,
* Patients with pulmonary embolism and retinal vein thrombosis
Optimizing Ventilation to Improve Health

Our overall goal is to optimize preferred, ventilating windows/apertures/vents in low-income neighborhoods of Dhaka, Bangladesh. We will:

I. Collect baseline data on housing types and finalize windows/vents protoypes.

II. Measure the impact of improved ventilation on air exchange rates in houses in low-income neighborhoods of Dhaka and characterize the current and potential market for windows/vents in households in low-income neighborhoods of Dhaka, Bangladesh.

III. Understand recipients' (tenants and landords) perceived benefits of installed window/vent designs and difficulties faced with adoption of each design


Eligibility Criteria:
Inclusion Criteria:

* 1) lack cross-ventilation at the time of enrollment
* 2) have obtained landlord permission to make adjustments to their dwelling,
* 3) have a free roof where a window can be installed

Exclusion Criteria:

* 1) Household reports receiving dust from nearby machine that pulverizes materials for making roads
Adherence to Opioids in Oncology Out Patients

Cancer pain is undertreated despite a good access to opioids in France. Although many factors are involved, the barriers related to the patient (and his family) are often reported .the reluctance of the patient or the family to take the prescribed medication is linked to misconceptions about the opioids , cultural barriers; or the lack of explanations provided by the physician. Some patients can have undiagnosed slight cognitive impairment .The situation is now more complicated as appear on the market the new form of opioids for the cancer breakthrough pain drug, adding one more opioid formulation in the prescription. The goal of the study is to measure the adherence to opioids in cancer out patients and the associated factors.


Eligibility Criteria:
Inclusion Criteria:

* Cancer out patients with opioids by mouth prescription
* Prescription than more than 8 days

Exclusion Criteria:

* Patient not at home, but in nursing home or other setting were the treatment are given by medical staff
* Patient unable to answer at the questionnaire
* Opoids given Intravenous or other way than mouth.
Real World Prostate Cancer Registry

Prostate cancer is the most common cancer diagnosed in men in the USA with 268,490 cases diagnosed in 2022 constituting 27% of male cancers and 34,500 deaths (11%) occurred in same year.1 Prostate cancer is a very heterogeneous disease that has different presentations, molecular and pathological features, stages, and disease biology. The treatment options are dependent on the disease stage, its features, and the patient's condition and preferences. The disease outcome also varies significantly due to the previous heterogeneity of the features in addition to other social determinants of health.

Therefore, it is critical to obtain real-world data that reflects the actual patterns of prostate cancer presentation, work up, management, and outcome. Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome.

Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome.

Primary Objectives: Describing the patterns of prostate cancer presentation, management, and outcome in the studied population Identify any impact of the compiled variables on treatment selection, work up and outcome.

Secondary Objectives: Identify any gaps and variations in the delivery of care, challenges and needs to optimize management of the disease and improve patient's outcome.

Improve awareness and facilitate enrollment into clinical trials and research studies.

Data will be collected directly from patients. This data will be collected over 10 years with three years of enrollment and seven years of follow-up. Patients provide e-consent and then get login credentials to complete the e-forms which can be edited and updated by the patient. 6 monthly reminders will be sent to the patients to complete 6 monthly follow-ups

Research staff may contact patients to offer opportunities to participate in clinical trials if eligible. A gift card will be provided to the patient for the initial survey submission. A gift card will also be provided to the patient for each 6 month follow up submission.

Eligibility Criteria:
Inclusion Criteria:

All patients with pathologically confirmed primary prostate cancer

Diagnosis within 12 months of the study enrollment.

Acceptance to sign the consent form.

18 years old or older

Resident in Tristate area including Greater Cincinnati Area, Northern Kentucky, and Southeast Indiana

Exclusion Criteria:

Having diagnosis of other cancer except squamous cell cancer of the skin

Refusal to sign a consent form.
TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)

The purpose of this study is to assess the treatment effect of intravenous TAK-954 in improving the average daily protein adequacy received through enteral nutrition in critically-ill participants developing EFI.

The drug being tested in this study is called TAK-954. The study will assess the treatment effect of intravenous TAK-954 in improving average daily protein adequacy received through enteral nutrition in critically ill participants with EFI.

The study will enroll approximately 200 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 4 treatment groups -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

* Group A: TAK-954 0.1 mg
* Group B: TAK-954 0.3 mg
* Group C: TAK-954 1 mg
* Group D: Metoclopramide 10 mg

This multi-center trial will be conducted in the United States, United Kingdom, Australia and Canada. The overall duration of treatment in this study is maximum of 14 days while in hospital. Participants will be contacted by telephone 30 and 90 days after receiving their last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Has at least a size 12-(french size) Fr nasogastric or orogastric tube with its tip at least 10 centimeter (cm) below the esophagogastric junction confirmed radiologically (the tip of the tube must be in the body or the antrum of the stomach and not in the fundus).
2. Is intubated and mechanically ventilated in the ICU.
3. Is expected to remain alive, mechanically ventilated, and receive continuous enteral feeding for \>=48 hours following randomization.
4. Have EFI, defined as a single GRV measurement of \>=250 mL with vomiting/retching within the last 24 hours, or a single GRV measurement of \>=500 mL with or without vomiting/retching within the last 24 hours.

Exclusion Criteria:

1. Is under consideration for withdrawal of life-sustaining treatments within the next 72 hours.
2. Has had major esophageal or gastric surgery or direct luminal trauma on this admission (participants with lower abdominal surgery are not excluded unless enteral feeding is contraindicated).
3. Has mechanical bowel obstruction, short bowel syndrome, or the presence of an active gastric pacemaker.
4. Have pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).
5. Has been admitted primarily for treatment of a drug overdose.
6. Has a presence of a post-pyloric tube in place at Randomization that may be used for enteral nutrition.
7. Is receiving parenteral nutrition (PN) at Screening.
8. Is in diabetic ketoacidosis or non-ketotic hyperosmolar coma.
9. Has a different nutrient requirement than allowed in feeding protocol.(outside a range of 1.2 to 2 gram per kilogram per day \[g/kg/day\] of proteins and up to 1.5 kilocalorie per milliliter \[kcal/mL\]).
The Effect of Music on Pain and Anxiety During Diagnostic Outpatient Hysteroscopy in Postmenopausal Women

This study aims to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' level of pain and anxiety in postmenopausal women

This study aims to demonstrate the value of music in diagnostic outpatient hysteroscopy on patients' levels of pain and anxiety in postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding
Operation of a Mobile Telemedicine System in the EMS

The aim of the study is to investigate the safety and efficacy of the operation of a prehospital teleconsultation system in the Emergency Medical Service.

Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. The paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. Also 12-lead-ECGs can be transmitted to the tele-EMS physician. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, ECG diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The safety and efficacy of the introduction and operation of this system should be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* prehospital emergency
* consent of the patient for teleconsultation was obtained or patient is unable to consent due to the severity of the emergency

Exclusion Criteria:

* patient refuses consent for teleconsultation
* psychiatric emergency
Neuropsychiatry and Cognition in SCA3/MJD

This research investigates how cognitive-affective aspects evolve during the course of SCA3/MJD. Due to COVID-19 pandemics, this study protocol was adapted for online-only consultations. Evaluations happening after March 2020 have been done by videocall with patients, and no neurological evaluation was thus performed on these patients. A scale on Activities of Daily Living was added to the online protocol to replace SARA, SCAFI and CCFS scales.

By the end of this study, the evaluated population will be composed of 144 participants: 36 ataxic SCA3/MJD carriers, 72 at 50% risk of carrying the SCA3/MJD mutation and 36 healthy controls. Ataxic subjects are invited to participate if they have an established molecular diagnosis of SCA3/MJD and have a SARA score greater than 2.5 points. At risk subjects are composed by the offspring of molecularly diagnosed SCA3/MJD subjects that have a SARA\<3. Healthy controls belonging either to families living with the disease or to the general population are invited to participate according to how well they match with ataxic subjects included in the study. Subjects are invited to participate in the study and, after constentment procedures, cognitive-affective assessments and a scale on Activities of Daily Living (ADL) are performed on a videocall. At risk subjects collect a blood sample for double bilnd determination of their carrier status. Before March 2020, all procedures were performed in person and, instead of ADL, SARA, SCAFI and CCFS were obtained.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic:
* older than 18 year old;
* molecular diagnosis of SCA3/MJD;
* SARA\>2.5.
* At 50% risk:
* older than 18 year old;
* have a parent with molecular diagnosis of SCA3/MJD;
* SARA\<3.
* Healthy Controls
* older than 18 year old;
* no genetic relationship with a SCA3/MJD carrier.

Exclusion Criteria:

* Non agreement in signing the informed consent;
* Healthy Controls: having any history of genetic disorders in their families or any psychiatric or neurologic disorder.
Delayed Start to Ovarian Stimulation

In couples with infertility secondary to Diminished Ovarian Reserve, the investigators hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.

Over the past two decades, the success rate of assisted reproductive technology (ART) has dramatically increased. This increase is attributed to improvements in embryo culture, laboratory conditions, and optimization of ovarian stimulation protocols. Over the past years, there has been more interest in altering the ovarian stimulation protocol to improve outcomes. For example, recently our group found that a modification of ovulation trigger toward a more physiologic process improves oocyte quality and pregnancy outcomes. Others have suggested minimal stimulation improves in vitro fertilization (IVF) outcomes. The investigators propose to further investigate modifying the ovarian stimulation for women who have "decreased" ovarian reserve. The investigators propose that a delayed start to ovarian stimulation will improve oocyte maturation and quality and pregnancy outcomes. No published studies to date have evaluated if a delayed start to ovarian stimulation improves pregnancy outcomes. However, the investigators hypothesize that the use an antagonist for a delayed start of stimulation will work by one of two mechanisms:

I. The partial suppression of FSH will allow for further recruitment of early antral follicles.

II. The partial suppression of FSH will allow for further FSH responsiveness in existing follicles to synchronize the primary cohort, thereby increasing the total number of follicles.

Eligibility Criteria:
Inclusion Criteria:

* Antral Follicle Count (AFC) less than or equal to 4 as measured by transvaginal ultrasound (TVUS), or
* Cancellation of a prior IVF cycle due to poor ovarian response.
* Patients will receive an antagonist stimulation protocol for IVF, or IVF with Intracytoplasmic Sperm Injection (ICSI).

Exclusion Criteria:

* Severe male factor infertility requiring surgical intervention to obtain sperm
* Major uterine abnormality,
* Preimplantation genetic diagnostic (PGD) testing,
* Planned cycles without embryo transfer (for example, freeze-all, donor, or surrogate cycles).
Dragon III-Phase 3: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer

DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase 3, open label, multi-center randomized controlled study.

Non inferiority of SOX will be tested against FLOT. This study will be conducted at multiple center of China and will invite international centers to join it.The sponsor of this study is Ruijin Hospital and the project is supported by the Shanghai Key Laboratory of Gastric Neoplasms and Institute of Digestive Surgery, Shanghai.

Eligibility Criteria:
Inclusion Criteria:

* Histology confirmed non-obstructive adenocarcinoma of stomach or esophago-gastric junction.
* Clinical stage: Clinical Tumor-Node-Metastasis (cTNM:) stage III
* Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
* Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic and pulmonary function.
* Written informed consent

Exclusion Criteria:

* Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
* Distant metastases (including retroperitoneal lymph node)
* Locally advanced inoperable disease (Clinical assessment)
* Relapse of gastric cancer
* Malignant secondary disease
* Prior chemo or radio therapy
* Inclusion in another clinical trial
* Known contraindications or hypersensitivity for planned chemotherapy
Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin

This trial is conducted in Europe. This is a single-centre, retrospective trial aiming at comparing the antibody levels in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Any subjects at onset of Type 1 Diabetes
* Treatment with either Insulin Aspart and Soluble Human Insulin or Soluble Human Insulin and Isophane Human Insulin / Mixtard® for at least 9 months from the time of diagnosis of diabetes

Exclusion Criteria:

* Treatment with immunosuppressive agents
* For the Insulin Aspart + Isophane Human Insulin: Treatment with insulin analogues other than Insulin Aspart or treatment with fast acting human insulin for a period of 7 days or more during the treatment period
* For the Soluble Human Insulin and Isophane Human Insulin group: Treatment with insulin analogues
* Other diseases influencing immune response
* Unable or unwilling to provide consent