cyrilzakka/clinical-trials huggingface dataset:
Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Hypothesis: Gastroschisis is a localised disruption of the abdominal layer. It occurs early in gestation, and the bowel is therefore bathing in the amniotic fluid and can be constricted at the level of the abdominal hole. The bowel is therefore submitted to different injuries partly attributable to the contact with amniotic fluid contaminated by digestive compounds and inducing an inflammatory reaction. Experimental studies on animal models and preliminary data in humans indicate that changing regularly the amniotic fluid (i.e. AMNIOECHANGE) would improve the outcome of theses fetuses and then neonates.

Primary Objective: To compare prospectively the effect of AMNIOECHANGE against classical care on the delay of full enteral feeding in gastroschisis affected foetuses

Study:

* Multicenter, Randomized.
* Inclusion at 20 GA (gestational age) weeks.
* AMNIOECHANGE every 2 weeks from 30 GA weeks

Subject: 140 inclusion during 3 years

Analysis: Triangular Sequential Evaluation

Eligibility Criteria:
Inclusion Criteria:

* Seen before 30 GA weeks
* Normal karyotype
* Single pregnancy
* Isolated gastroschisis
* No associated disease (maternal)
* Accept randomization and understand the study

Exclusion Criteria:

* Maternal diabetes
* Maternal infection with HIV, hepatitis
* Preexistent oligohydramnios before inclusion
The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot Environment

The purpose of this preliminary experiment is to measure the effect of a novel ventilation system on the physiological strain during exercise in high heat load while wearing ballistic protective vest. Ten young and healthy participants will participate in the study. They will all go through a six days heat acclimation period in a heat chamber according to a valid protocol. Afterwards they will be randomly exposed to 4 conditions during four separate consecutive days.

Ten young and healthy civilian participants will participate in the study. They will all go through a six days heat acclimation period in a heat chamber according to a valid protocol. After heat acclimation the participant will be randomly exposed to 4 conditions during four separate consecutive days: 1) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest (control group); 2) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest (control group); 3) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest with a ventilator (experimental group); 4) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest with a ventilator (experimental group). During the heat exposures, rectal temperature, skin temperature and heart rate will be continuously monitored. Subjective comfort measures, heat strain indices, sweat rate and sweat evaporation will be also measured/calculated. The differences in the above measures, during exposure to exercise in the heat between ventilator and no ventilator will be then analyzed.

Eligibility Criteria:
Inclusion Criteria:

* age 21-28
* healthy
* after medical checkup
* after signing concent form

Exclusion Criteria:

* heart disease
* respiratory disease
* baseline bp above 140/90 mmHg
* sleep disorders
* diabetes
* anhydrosis
* skin disease
* acute illness in last 3 days prior to the examination
Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta

An in-house calculator was developed to calculate the appropriate contrast dose, rather than standardly administering a 120ml dose. This study aims for a more uniform contrast enhancement in patients by means of adjusting (lowering) contrast dose to patient parameters.

Until now, CT scans in our and many other institutions are being performed with a fixed standard contrast dose specific for every protocol, independent of patient characteristics. However, many if not all patients would benefit from a contrast dose reduction, as long as image quality is not impaired. This is especially beneficial to patients with impaired renal function.

For this purpose, we researched previous literature as well as data from previously scanned patients with standard dose, to formulate a contrast dose calculation adapted to patient parameters.

An in-house calculator was developed to calculate the optimal contrast dose dependent on patient length, weight and heartrate.

A total of 60 CT-scans will be performed and retrospectively collected. Patients are randomly assigned to one of three groups : 1/ Standard dose of 120ml; 2/ Calculated dose (40-150ml) 3/ Calculated dose -50% (20-120ml). In case of reduced kidney function, patients were randomly divided between group 2 and 3 (reduced contrast dose).

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring CT-angiography of the aorta as requested by clinician
* For aneurysm detection or follow-up
* Or for dissection follow-up
* Thoraco-abdominal aorta or abdominal aorta

Exclusion Criteria:

* Contra-indications for contrast administration (severe renal impairment or adverse reactions)
* Previously endovascular repair of the aorta
* Only thoracic aorta
* No informed consent
* Contrast injection at 4cc/second not possible
Safety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)

The goal of this study is to evaluate the safety and efficacy of LX102-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 to evaluate its safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.

1. Age ≥ 50
2. Diagnosis of active CNV secondary to neovascular AMD
3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.
4. Subjects must have received a minimum of 2 injections within 6 months prior to screening.
5. Demonstrated a meaningful response to anti-VEGF therapy

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to diseases other than nAMD
2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
5. Uncontrolled diabetes defined as HbA1c \>7.5%
Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)

To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 30 years old with a diagnosis of Possible or Probable MSA of the parkinsonian subtype (MSA-P) according to The Gilman Criteria (2008).
* Subjects who are less than 3 years from the time of documented MSA diagnosis.
* Subjects with an anticipated survival of at least 3 years in the opinion of the investigator.
* Subjects who are willing and able to give informed consent. Subjects who are not able to write may give verbal consent in the presence of at least one witness, and the witness should sign the informed consent form.

Exclusion Criteria:

* Subjects receiving treatment with midodrine or other sympathomimetics within 4 weeks prior to baseline visit.
* Subjects with severe orthostatic symptoms as assessed by a score of ≥ 3 on Unified Multiple System Atrophy Rating Scale (UMSARS) question 9.
* Subjects who meet any of the following criteria which tend to suggest advanced disease:

  1. Speech impairment as assessed by a score of ≥ 3 on UMSARS question 1
  2. Swallowing impairment as assessed by a score of ≥ 3 on UMSARS question 2
  3. Impairment in ambulation as assessed by a score of ≥ 3 on UMSARS question 7
  4. Falling more frequently than once per week as assessed by a score of ≥ 3 on UMSARS question 8
* Subjects taking disallowed medications according to the locally approved Azilect® label.
* Subjects taking monoamine oxidase (MAO) inhibitors within 3 months prior to baseline visit.
* Subjects with hypertension whose blood pressure, in the investigator's opinion, is not well controlled.
* Subjects who, based on the investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Subjects with moderate or severe hepatic impairment.
* Subjects who have taken any investigational products within 60 days prior to baseline.
* Women of child-bearing potential who do not practice an acceptable method of birth control \[acceptable methods of birth control in this study are: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy, a double-protection method (condom or diaphragm with spermicide)\].
* Pregnant or nursing women.
A Pilot Study of Roadmap 2.0 in Oncology Caregivers and Patients

This study will investigate the use of a mobile health app (Roadmap 2.0) intervention in caregivers of patients with cancer. In this study participants will be given the Roadmap 2.0 app, with a focus on the positive aspects of caregiving (positive activity components), and a Fitbit. The primary objective of this pilot study is to test the feasibility and acceptability of using the mobile health app.

Health information technology tools may enable caregivers and patients to become more active participants in their healthcare.This study is not to provide any treatment, but rather to investigate the use of this mobile health technology-mediated intervention (Roadmap 2.0).

Eligibility Criteria:
Inclusion Criteria:

1. The caregiver must have an eligible patient (defined in items 5 - 9, below)
2. The caregiver must be of age ≥18 years.
3. The caregiver should be comfortable in reading and speaking English and signing informed consents.
4. The caregiver should provide at least 50% of care needs.
5. An eligible patient is one who identifies the eligible caregiver as their primary caregiver (i.e., provides at least 50% of care needs). The caregiver who provides consent will be deemed the caregiver who participates in the study. In adolescents who are at the age to provide assent, she/he will designate the caregiver who provides \>50% of their care, and that caregiver will sign the consent document.
6. An eligible patient is age ≥5 years.
7. An eligible patient is able to sign informed consent/assent forms.
8. Patients and caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved.
9. The caregiver and patient must have his/her own smartphone or tablet to participate.
Validating the Digital Virginia Tech Carilion Cognitive Examination

Currently, cognitive screening is performed in-person after the individual expresses symptoms or it is noticed by someone close to them and are largely done in clinical settings. The digital Virginia Tech Carilion Cognitive Examination (VTC-Cog) utilizes smart devices and allows for the early establishment of an individual's cognitive baseline. VTC-Cog has been designed to test all major aspects of cognition, as currently assessed using the Montreal Cognitive Assessment (MoCA) and Mini-Mental Status Examination (MMSE) but on a digital platform. The VTC-Cog allows for standardized scoring with no clinician bias and provides a clinician report that breaks down distinct changes in different areas of cognition (executive, visuospatial, memory, etc.) in order to refine clinician analysis.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-80 years
* No current diagnosis of dementia
* Current stable mental health
* English speaker
* Carilion Clinic Medical Provider

Exclusion Criteria:

* \<50 years old or \>80 years old
* Current diagnosis of dementia
* Unstable mental health
* Non-English speaker
* Medical provider outside the Carilion Clinic system
SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma

The study is evaluating the efficacy, and safety of SHR1459 combined with YY-20394 for Recurrent and refractory B-cell non-Hodgkin's lymphoma in adults.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of B-cell NHL such as DLBCL, FL and MCL
2. Patients received at least 2 lines of systemic therapy
3. Previously received anti- CD20 treatment
4. Patients in stage II should also be unsuitable or unwilling to receive allogeneic hematopoietic stem cell transplantation
5. Patients must have an acceptable organ function

Exclusion Criteria:

1. Previously treated with PI3K inhibitors or BTK inhibitors
2. Unresolved toxicity of CTCAE grade \> 1 from prior anti-lymphoma therapy
3. Chemotherapy or other investigational therapy within 28 days (or 5 times the half-life time, whichever is shorter) before starting cycle 1
4. Significant concurrent medical disease or condition which according to the investigators' judgement
5. Active hepatitis B, C or HIV infection
6. Infection requiring treatment 2 weeks prior to the first dosing
Predictive Urodynamic Parameters for The Treatment Efficacy of Onabotulinum A Toxin in Neurogenic Lower Urinary Tract Dysfunction

Purpose: To evaluate urodynamic parameters predicting the treatment efficacy of onabotulinumtoxin A (onaBoNT-A) in patients with neurogenic lower urinary tract dysfunction (NLUTD).

Methods: Patients with NLUTD who received 200 IU onaBont-A injections at Gaziantep University, Faculty of Medicine, Department of Urology between September 2013 and September 2023 were included in the study. Urodynamic parameters, including cystometric capacity, detrusor pressure (Pdet), and compliance, detrusor leak point pressure (DLPP), phasic or terminal neurogenic overactivity were assessed. Additionally, the correlations between these parameters and treatment outcomes were analyzed.

Changes in the number of pads used per day due to UI were assessed every 3 months during the postoperative period. The time lapsed to return to the pad usage levels before onaBoNT-A injections was recorded as the duration of the benefit.

Preoperative urodynamic data of the patients were compared between groups. Additionally, a subgroup analysis was conducted in patients who benefited from treatment to evaluate the correlation between treatment efficacy, duration of benefit from treatment, and urodynamic parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Neurogenic Lower Urinary Tract Disorder
* Aged \>18 years
* Patients who did not respond adequatel to antimuscarinics or could not tolerate their side effects
* Antimuscarinic treatment failure with at least two different antimuscarinic agents for a minimum of 3 months.

Exclusion Criteria:

* Patients with Lower Urinary Tract Disorder due to functional or non-neurogenic etiologies
* Patients who received onaBoNT-A doses either other than 200 IU or its multiple doses
* In the 12-month period designated for patient follow-up, patients who did not attend their check-ups
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration


Eligibility Criteria:
Inclusion Criteria:

* ≥50 years of age at time of consent
* Treatment naïve MNV secondary to nAMD in the study eye
* Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT), in the study eye, at the Screening Visit confirmed by the Reading Center
* Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center
* BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit

Exclusion Criteria:

Ocular Conditions:

* MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter))
* History of retinal detachment in the study eye
* History of or presence of active inflammation in either eye
* Glaucoma or intraocular hypertension requiring more than 2 topical medications for control

Systemic Conditions and Considerations:

* Major illness or major surgical procedure in the 28 days prior to the Screening Visit
* Uncontrolled blood pressure
* Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit
* History of autoimmune condition that may predispose to the development of uveitis
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure

The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure.

This is a single center, open-label, three-group dose-escalation (phase I) study followed by dose-extension (phase IIa) study in up to 36 severe ischemic heart failure patients. It is estimated that up to 18 phase I patients will be received HiCM-188 intramyocardial injection during CABG surgery. The maximum number of subjects after dose escalation and dose extension studies in each dose group is 12. All the subjects need take immunosuppressant after transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. 35-75 years of age (including 35 and 75 years)
2. Willingness and ability to give written informed consent
3. Patients with severe chronic ischemic heart failure
4. New York Heart Association (NYHA) Class III or IV under optimal medical therapy
5. Weakening or absence of segmental regional wall motion as determined by standard imaging.
6. LVEF≤40% as assessed by MRI
7. Nuclide-myocardial metabolic perfusion imaging revealed infarcted myocardium in the left anterior descending branch (LAD) coronary artery supply area
8. Patients have indications for Coronary Artery Bypass Grafting

Exclusion Criteria:

1. Patient with pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) treatment.
2. Patients with severe valvular heart disease
3. Patients had acute myocardial infarction or underwent percutaneous coronary intervention (PCI) surgery within 1 month
4. Patients with non-ischemic heart failure, acute viral myocarditis.
5. Patients had acute cerebrovascular events within 1 month before screening.
6. Diagnosed with malignancy within 5 years
7. Autoimmune disease or long-term therapy with immunosuppressant
8. Recipients of organ transplant.
9. Patients undergoing other surgical operations (excluding resection of ventricular aneurysm).
10. Severe ventricular arrhythmia
11. Contraindication to CABG surgery
12. Serum-positive for HIV, hepatitis BsAg, HCV and TP.
13. Contraindication to performance of MRI or PET/CT scan.
14. Contraindication to use immunosuppressant
15. Be allergic to immunosuppressant
16. Patients who had participated in other clinical trials within 3 months
17. Women are pregnant, breastfeeding or blood pregnancy test positive
18. Patients with other conditions are not eligible to participate in this clinical trial
Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)

The purpose of this prospective randomized clinical trial is to compare the clinical outcomes according to the duration of aspirin and clopidogrel or prasugrel with dual anti-platelet therapy after percutaneous coronary intervention in patients with advanced chronic kidney disease using a new generation drug eluting stents.

Prospective, open label, multicenter randomized clinical trial

Eligibility Criteria:
Inclusion Criteria:

1. Over 19 years old
2. Chronic Renal Failure Stage IIIb, IV, V (CKD-EPI eGFR \<45 / \<30 / \<15 or dialysis)
3. Patients treated with a new generation drug eluting stent.
4. Patients who signed consent form

Exclusion Criteria:

1. Over 85 years old
2. Patients with high risk of bleeding 1) History of hemorrhagic stroke 2) Stroke, dementia or central nervous system damage within 1 year 3) Head trauma or brain surgery within 6 months 4) Tumor in the skull 5) If aortic dissection is suspected 6) Internal bleeding within 6 weeks 7) In case of active bleeding or bleeding disorder 8) In case of major surgery, trauma or bleeding within 3 weeks
3. Patients who need oral anticoagulant
4. Pregnant women or women of childbearing age
5. Life expectancy is less than 1 year
6. Patients with a history of intracranial bleeding
7. Moderate to severe hepatic impairment (Child-Pugh class B or C)
A Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter for Reduction of CAUTI.

The primary objective of this pilot study is to demonstrate the feasibility of recruiting eligible patients for the purposes of assessing the temporal aspects and rates of Catheter Associated Urinary Tract Infection (CAUTI), based on the agreed-upon case definition so that the numbers needed for a pivotal study can be better estimated.

This pilot study will be a prospective, single site, randomized clinical investigation comparing the safety and effectiveness of the ICET TIC antimicrobial Foley catheter, against the infection control standard-of-care, the BARD ® LUBRI-SIL® I.C. Foley catheter.

Approximately 160 patients will be screened. The study has been designed to enroll approximately 120 eligible subjects to obtain about 60 evaluable subjects (30 in each arm). Subjects who meet the eligibility criteria will be enrolled into the study and randomly assigned to the experimental or standard-of-care group in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age
2. Subject is expected to be catheterized with 14 or 16 French Foley catheters for at least 72 hours.
3. Subject (or a legally authorized representative) has provided written informed consent for study participation and procedures to be performed.
4. Life expectancy at least 3 months or more in the judgment of the investigator

Exclusion Criteria:

1. Subjects who present with previously known, symptomatic UTI
2. Subjects with a positive urine dipstick at the time of enrollment
3. Subjects who are on systemic antibiotics within 48 hours prior to enrollment
4. Subjects with a known of suspected allergy to silicone, silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis.
5. Subjects who have had an indwelling catheter removed less than 48 hours before study enrollment.
6. Current genitourinary tract surgery or known infection
7. Subject requires use of a non-study urinary catheter
8. Subjects known to be pregnant or breast feeding at the time of enrollment