cyrilzakka/clinical-trials huggingface dataset:
Can Hypothermia be Incorporated Into Primary Angioplasty for Heart Attack?

The hypothesis of this study is that consciously sedated patients suffering from ST-elevation myocardial infarction can be rapidly and safely cooled to a state of therapeutic hypothermia (32 to 34 degrees C) using the LRS ThermoSuit System prior to percutaneous coronary intervention.

This clinical study will investigate the safety and feasibility of cooling heart attack (STEMI) patients with the LRS (Life Recovery Systems)ThermoSuit System, a cooling device which uses the principle of cold water immersion to rapidly reduce patient temperature. The study will enroll a total of up to 20 patients, and will be a cooperative effort between LRS and LSU Health Sciences Center - Shreveport.

The study is being conducted under an IDE (Investigational Device Exemption) that was granted to LRS by FDA (G070141). The primary goal of this trial is to demonstrate the feasibility of cooling AMI patients pre-reperfusion with the ThermoSuit cooling device. The safety of this treatment will be determined by review of a composite of serious adverse events.

Consciously sedated patients will be cooled after entry into the emergency room and prior to percutaneous coronary intervention in the catheterization laboratory. It is hypothesized that the ThermoSuit System will enable cooling of the patient to 34ºC after a treatment of 30 minutes or less. Previous research has suggested that cooling of ST-elevation myocardial infarction patients before coronary reperfusion could result in a significant reduction in myocardial infarct size.

If successful, this study will lead to a pivotal clinical study to investigate the potential for the ThermoSuit cooling treatment to reduce myocardial infarct size. The ultimate goal of these studies is to determine the safety and effectiveness of the use of the ThermoSuit device for the treatment of AMI patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Duration of MI symptoms ≥ 30 minutes to ≤ 6 hours.
* ST-segment elevation of ≥ 1mm or more in two or more contiguous leads.
* Eligible for PCI.
* Willingness of patient or legal guardian to provide written, informed consent.
* Patient dimension criteria:
* Height: 147-190 cm (58 - 75 in)
* Width: ≤73 cm (29 in) (elbow to elbow)

Exclusion Criteria:

* Cardiac arrest or previous MI within one month.
* Administration of thrombolytics.
* Cardiogenic shock (systolic blood pressure (SBP) \< 80 mmHg for \> 30 minutes or SBP \< 100 mmHg on vasopressors or IABP) in the absence of bradycardia or other correctable causes.
* Known hypersensitivity to hypothermia including Raynaud's disease or cryoglobulinemia.
* Severe allergy or contraindication to aspirin, Plavix, heparin, or contrast media which cannot be adequately pre-medicated.
* History of bleeding diathesis or coagulopathy or refusal of blood transfusions.
* Pregnancy.
* Known hypersensitivity midazolam, meperidine, buspirone, or magnesium sulfate.
* Current enrollment in another clinical trial (other than registry).
* Temperature \< 35°C on admission to Emergency Department.
* Recent (\< 1 week) surgical incisions.
Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation

The investigators sought to evaluate the incidence and influence of vagal response observed during cryoballoon-based pulmonary vein isolation on the cardiac autonomic nervous system (CANS) and ablation outcomes in paroxysmal atrial fibrillation cohort. 296 patients were treated with a 28-mm second-generation cryoballoon (Arctic Front Advance, Medtronic). Preprocedural pulmonary veins anatomy and their ostial dimensions were acquired with a computed tomography. 74 patients without structural heart disease and with no concomitant diseases were chosen for a detailed CANS assessment with heart rate variability analysis. All patients were screened over a 2-year post-ablation period.

An interplay between left atrial (LA) ganglionated plexi (GP), a part of the intrinsic cardiac autonomic nervous system (CANS), and pulmonary veins (PVs) is considered to be an important mechanism related with the initiation and maintenance of atrial fibrillation (AF). Therefore additional GP ablation has been reported with better ablation outcomes when added to RF-based PV isolation (PVI). A cryoballoon ablation (CBA) is an anatomically based approach which allows PVI that is highly safe and efficacious. The extension of the scar created by the cryoballoon frequently extends beyond the PV orifice in the acute and chronic post-ablation phase creating a set of lesions that are near the LA-GP area and inadvertent damage. A marked vagal response (VR) observed during CBA is considered a marker for the CANS modification. However, changes in the autonomic tone were independently noted from the presence of VR in several studies. Moreover, it is not clear if these changes are transient or long-lasting, and it has been shown that the presence of VR increases ablation success although with conflicting results. In previous studies assessing the influence of CBA on the autonomic balance, CANS modulation was appraised with different surrogates, a small number of individuals were usually recruited and both paroxysmal and persistent AF populations were included. Therefore, the investigators sought to evaluate the incidence of VR observed during CBA-based PVI, its impact on CANS assessed with widely accepted heart rate variability (HRV) analysis, and in relation to ablation outcomes in a large paroxysmal AF (PAF) cohort.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of paroxysmal atrial fibrillation

Exclusion Criteria:

* Previous atrial fibrillation ablation
Evaluation of NICHE Programme Activities in Kenya

This study evaluates the impact of additional cash and nutritional counselling on nutrition outcomes in pregnant women and children up to the age of two years in CT-OVC (cash transfer- orphan and vulnerable children) households in Kitui and Machakos counties of Kenya. The control arm households will receive their normal CT-OVC cash payment and the intervention arm will receive an additional cash payment and nutritional counselling.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women and children aged up to 23 months of age in households receiving CT-OVC cash transfers in Kitui and Machakos counties of Kenya

Exclusion Criteria:

* not residing in CT-OVC households
Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication

Rosie the Chatbot is an educational chatbot that moms can have on their computers or cellphones and will work by moms typing in their questions about pregnancy, health, infant milestones, and other variety of health related topics and receiving back a response immediately. Rosie only provides information from verified sources such as children's hospitals, health organizations and government agencies. Rosie does not ask moms to provide any personal information on her or her child, her chat is completely confidential, it works in English and Spanish and will be free.

This study will examine whether the use of a chatbot to impart health information to minority women during pregnancy and postpartum period improves health care seeking behavior and maternal and infant health outcomes. This study does not involve administration of an investigational intervention and therefore poses minimal risk to participants.

Aim 1: Develop technology for a "chatbot" that will provide health information support to vulnerable mothers the moment they need it.

Aim 2: Evaluate the use of Rosie on maternal and infant outcomes. Aim 3: Release an open-source packet for the construction of a chatbot.

* Participants in the study will be randomly assigned into one of two groups, Rosie the Chatbot group (treatment group) and Book Club group (control group).
* Participants in the Rosie the Chatbot Group will be taking a pre-test health survey, mid-test health survey, and post-test health survey. In addition, they will be expected to actively use the chatbot app by asking questions related to maternal and infant health and selecting "thumbs up or thumbs down" to provide feedback for questions' response and use the features (video library, resources page, frequently asked questions (FAQ), and daily syllabus).
* Participants in the Book Club Group will be taking a pre-test health survey, mid-test health survey, and post-test health survey. In addition, they will receive a monthly children's book, which they are expected to read with baby if parenting or individually if pregnant.

Eligibility Criteria:
Inclusion Criteria:

* Age 14 years and older
* Racial minority women
* Pregnant or has an infant \< 6 months
* Must be able to read English or Spanish

Exclusion Criteria:

* Mother younger than 14 years of age at time of child's birth.
* Non-hispanic white
Multimodal Prehabilitation for Colorectal Surgery

Despite advances in surgical care, the incidence of postoperative complications and prolonged recovery following colorectal surgery remains high. Efforts to improve the recovery process have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural blockade) and post-operative periods (eg, "fast track" early nutrition and mobilization. The pre-operative period may in fact be a better time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". Based on the notion that preoperative exercise would have an impact on recovery of functional capacity after colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup analysis identified that patients whose functional exercise capacity improved preoperatively, regardless of exercise technique, recovered well in the postoperative period. However, one-third of patients deteriorated preoperatively despite the exercise regimen, and these patients were also at greater risk for prolonged recovery after surgery. These results suggested that exercise alone is not sufficient to attenuate the stress response in all patients. In the present trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be compared to one begun in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* referred for scheduled surgery for nonmetastasized colorectal cancer
* age \> 18 years old

Exclusion Criteria:

* asa 4-5
* Poor English or French comprehension
* severe co-morbid disease interfering with ability to perform exercise at home or complete testing
Neoadjuvant Ifosfamide, Doxorubicin, Gemcitabine, and Cisplatin in Treating Patients Who Are Undergoing Radical Cystectomy for Locally Advanced Carcinoma (Cancer) of the Urothelium

RATIONALE: Drugs used in chemotherapy, such as ifosfamide, doxorubicin, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant combination chemotherapy works in treating patients undergoing radical cystectomy for locally advanced carcinoma of the urothelium.

OBJECTIVES:

Primary

* Determine the response rate and 4-year disease-free survival of patients with locally advanced carcinoma of the urothelium undergoing radical cystectomy treated with neoadjuvant chemotherapy comprising ifosfamide, doxorubicin, and gemcitabine followed by cisplatin, gemcitabine, and ifosfamide.

Secondary

* Compare perioperative morbidity and mortality of patients treated with this regimen vs historical standards.

OUTLINE: Patients receive neoadjuvant chemotherapy comprising ifosfamide IV over 3 hours on days 1-4, doxorubicin IV on day 3, gemcitabine IV over 30 minutes on days 2 and 4, and filgrastim (G-CSF) subcutaneously on days 7-12 or until blood counts recover. Treatment repeats every 3 weeks for a total of 3 courses. Patients then receive cisplatin IV, gemcitabine IV over 90 minutes, and ifosfamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for a total of 4-6 courses. Four to six weeks after the completion of all neoadjuvant chemotherapy, patients undergo cystectomy.

Patients are followed at 9, 12, 15, 18, 24, and 30 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 31-49 patients will be accrued for this study within 16-25 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed carcinoma of the urothelium, meeting 1 of the following criteria for locally advanced disease:

  * Clinical stage T3b disease, defined by presence of a mass on examination under anesthesia
  * Clinical stage T4a disease, defined by direct invasion of prostatic stroma, vagina, or rectum
  * Lymphovascular invasion on transurethral resection specimen
* Upper tract disease or micropapillary histology allowed
* No evidence of disease outside the pelvis

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* 0-2

Life expectancy

* Not specified

Hematopoietic

* Bone marrow function adequate

Hepatic

* Liver function adequate

Renal

* Creatinine clearance ≥ 45 mL/min

Cardiovascular

* Ejection fraction ≥ 50%

Other

* Not pregnant
* No other malignancy likely to be life-threatening within the next 4 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* See Disease Characteristics
Cardiometabolic Risk in Children With Type 1 Diabetes.

To access the relationship between metabolic control of children and adolescents with type 1 diabetes and cardiometabolic risk through noninvasive imaging modalities to assess the early vasculature changes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for more than 0.5 year
* Age ≥ 10 years up to 25 years (inclusive)
* The subject/carer is willing to follow study specific instructions

Exclusion Criteria:

* Youth with maturity-onset diabetes of the young, hybrid, other, or missing type
* Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study
* Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy

Hypocalcemia is one of the most frequent complications of total thyroidectomy, a procedure used for benign as well as malignant conditions of the thyroid gland. Postoperative hypocalcemia is usually caused by hypoparathyroidism. Vitamin D is implicated in calcium metabolism as it increases intestinal calcium transport and regulates parathormone production. Aim of the present study is to evaluate preoperative vitamin D levels as a prognostic factor for postoperative hypocalcemia and hypoparathyroidism.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is over 18 years old
2. Patient scheduled for total thyroidectomy
3. Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Exclusion Criteria:

1. Primary hyperparathyroidism
2. Primary hypoparathyroidism
3. Chronic Renal Failure
4. Hypoalbuminemia
5. Neck irradiation
6. Systematic Diseases (e.g., infections)
7. Thyroid or parathyroid cancer
8. Osteoporosis
9. Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)
Periventricular White Matter Hyperintensities in Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy

White matter hyperintensities (WMH) are one of the small vessel disease-related MRI characteristics of both cerebral amyloid angiopathy (CAA) and hypertensive arteriopathy (HA). WMH tend to show a peri-basal ganglia pattern in HA, whereas a multiple subcortical spots pattern can be observed in CAA. Periventricular WMH (PVWMH) have been reported to be posterior predominant using a semiautomated segmentation method and logarithmic transformation, not used in daily clinical practice. In these studies including CAA patients, patients initially presented with haemorrhage-related symptoms. In another study analysing PVWMH and cerebral amyloid evidence in patients with mild cognitive impairment, frontal PVWMH burden was associated with high uptake on florbetapir-PET whereas parietal and occipital PVWMH burden was associated with low CSF-amyloid-beta.

The aim of this study is the descriptive comparative analysis of the distribution of PVWMH between CAA and HA patients with radiological tools available in daily practice.


Eligibility Criteria:
Inclusion Criteria:

CAA and HA patients, managed at Nîmes University Hospital between January 2015 and March 2022.

Exclusion Criteria:

CAA and HA patients, treated at the CHU of Nîmes between January 2015 and March 2022, not objecting to the use of their health data
Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients

Glutamine-induced recovery in intestinal barrier function by reducing bacterial translocation was demonstrated in previous studies. In this trial, intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 10 days and the effects of the intervention on intestinal permeability will be assessed.

A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 60 eligible hospitalized patients with enteral feeding in ICU, aged ≥ 18 years. Intervention patients will be received 0.3 g/kg/day of glutamine along with enteral formula for 10days and control patients will be received maltodextrin along with enteral formula for 10 days. Patients will be evaluated for plasma endotoxin and plasma zonulin.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old) admitted to ICU
* Start of study intervention within 48 hours after ICU admission
* Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour
* Written informed consent of patient or written informed consent of legal representative

Exclusion Criteria:

* Enrollment in a related ICU interventional study
* Requiring other specific enteral nutrition for medical reason
* Death or Discharge before 5th day
* Having any contra-indication to receive enteral nutrition
* Pregnant patients or lactating with the intent to breastfeed
* BMI \<18 or \> 40.0 kg/m2
* Have life expectancy of \<6 mo
* Patients who are moribond
* Liver cirrhosis- Child's class C liver disease
* Have seizure disorder requiring anticonvulsant
* History of allergy or intolerance to the study product components
* Receiving glutamine during two weeks before start study product
* Have other reasons
Progesterone vs Clobetasol Propionate in Vulvar Lichen Sclerosus

This is a randomized trial comparing progesterone with conventional clobetasol propionate in patients with vulvar lichen sclerosus.

Background

A total of 62 female patients with first diagnosis of lichen sclerosus will be treated daily with either topical progesterone 8% or clobetasol propionate 0.05% for 12 weeks. Response to the treatment will be evaluated by macroscopic description of the dermatologic phenotype by using a specific lichen sclerosus score and photography-documentation. The symptoms and quality of life of the patients will be evaluated by standardized questionnaires. Additionally, tissue samples will be taken before and again after 12 weeks of treatment to evaluate the response status.

Objective

The purpose of this study is to compare progesterone with conventional clobetasol propionate in a superiority trial.

Methods

Prospective, randomized, controlled, superiority phase II pilot trial. Patients will be randomized 1:1 to either progesterone or clobetasol propionate, with patients, physicians, assessors and analysts being blinded.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Consent to biopsy at start and end of therapy
* Suspicion of Lichen sclerosus
* Pre-menopausal
* Age ≥18 years

Exclusion Criteria

* Prior surgery at the vulva, with exception of episiotomy
* Pregnancy
* Signs of infection with human papilloma virus at the vulva
* Vulvar intraepithelial neoplasia (VIN)
* Known generalised autoimmune disease
* Lichen sclerosus since childhood
* Prior therapy with topic clobetasol propionate or other immunosuppressives (tacrolimus or pimecrolimus) at the vulva
* Atopic diathesis and/or contact allergy
* Systemic immunosuppressive therapy
* Genital infection within the last four weeks (eg., condyloma acuminata, candidiasis)
A 2-part Study to Investigate the Effect of Macitentan in Healthy Male Participants

The purpose of this study is to evaluate the effect of macitentan at steady state on the pharmacokinetic (PK) of a single dose of riociguat and sildenafil (Part A); and rosuvastatin (Part B) when co-administered to healthy male participants under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male (according to their reproductive organs and functions assigned by chromosomal complement)
* Healthy on the basis of physical examination, medical history, and 12 lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
* Body mass index (BMI; weight per height\^2) between 18.0 and 30.0 kilogram (kg)/meter square (m\^2) (inclusive), and body weight not less than 50.0 kg at screening and on Day -5
* Blood pressure (after the participant is supine for 5 minutes) between 100 and 140 millimeters of mercury (mmHg) systolic blood pressure (SBP), inclusive, and between 60 and 90 mmHg Diastolic blood pressure (DBP), inclusive, at screening and on Day -5. If blood pressure is out of range, up to 2 repeated assessments are permitted
* Heart rate between 45 and 90 beats per minute (bpm, inclusive) at screening and on Day -5

Exclusion Criteria:

* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen) within 14 days before the first dose of the study drug is scheduled until completion of the study
* A participant who has been on a known cytochrome P450 (CYP) inhibitor or inducer or transport inhibitor or inducer should be excluded from the study based upon the duration of the inhibitor or inductive effect and also at least 5 terminal half-lives of the drug, vitamin or herbal supplements
* Orthostatic hypotension (greater than \[\>\] 20 mmHg decrease in SBP or \>10 mmHg decrease in DBP after 2 minutes of standing compared to supine blood pressure)
* One or more of the following lab abnormalities at screening, defined as grade 1 or more by the World Health Organisation (WHO) Toxicity Grading Scale for Determining the Severity of Adverse Events, February 2003: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (\>=) 1.25 \* upper limit of normal (ULN), total bilirubin \>=1.25 \* ULN, and Hemoglobin less than or equal to (\<=) 10.5 gram per deciliter (g/dL)