cyrilzakka/clinical-trials huggingface dataset:
A Nested Case-control Study on the Secondary Prevention of Ischemic Stroke and TIA by Hypertension Health Education Protocol (HHEP): The Post-Stroke Preventive Trial

Patients with a diagnosis of ischemic stroke or TIA (ISTIA), who are treated at hospital are asked to participate in our pre specified hypertension health education protocol (HHEP) after discharge from our hospital.HHEP was used as secondary prevention treatments of stroke and cardiovascular diseases.

HHEP consists of several items such as controlling the patient's hypertension level, monitoring the adherece of antihypertensive agents, reducing risk factors of hytertension like tobacco smoking, obesity, and motivating the patient to physical activity and to a healthy diet.

Patients will receive visits by a study nurse with the aim of supervising, monitoring, and recording the adherence of HHEP. The patients will be classified as different adherence level at the end of the study according to their adherence condition.

This study is aimed at testing the hypothesis that controlling hypertension and its risk factors was more effective than those do not receive HHEP in reducing the recurrence of stroke and cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

Participants were eligible for this observational cohort study if they were age 18 years or older; Hospitalized for a primary diagnosis of acute ischemic stroke or Transient Ischemic Attack (TIA) and concurrently diagnosed as hypertension; Provided consent to participate, and their data can be collected from Medical Record System of our hospital.

Exclusion Criteria:

We will exclude people who are onset of symptoms 3 months after their ischemic stroke or TIA; The stroke events occurred before the baseline survey were identified from the Hospital Discharge Register retrospectively and excluded from the analyses.
Retrospective Study to Capture Dosing and Treatment Outcome Data in Participants With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND

This is a data collection study with the purpose of capturing dosing and treatment outcome data in participants with severe congenital protein C deficiency who were treated with protein C concentrate under an Emergency Use Investigational New Drug Application (IND).


Eligibility Criteria:
Inclusion Criteria:

* Participant treated with protein C concentrate under a Baxter Healthcare Corporation Emergency Use IND.
* Participant with diagnosis of severe congenital protein C deficiency.
* Participant or parent/legally authorized representative has provided written informed consent.
Biomarker for Krabbe Disease (BioKrabbe)

Development of a new MS-based biomarker for the early and sensitive diagnosis of Krabbe Disease from blood

Krabbe disease is a rare, hereditary degenerative disorder of the central and peripheral nervous systems. It is characterized by the presence of globoid cells (cells that have more than one nucleus), the breakdown of the nerve's protective myelin coating, and destruction of brain cells. Krabbe disease is one of a group of genetic disorders called the leukodystrophies. These disorders impair the growth or development of the myelin sheath, the fatty covering that acts as an insulator around nerve fibers, and cause severe deterioration of mental and motor skills. Myelin is a complex substance made up of at least 10 different enzymes. Each of the leukodystrophies affects one (and only one) of these substances. Krabbe disease is caused by a deficiency of galactocerebrosidase, an essential enzyme for myelin metabolism. The disease most often affects infants, with on-set before age 6 months, but can occur in adolescence or adulthood.

Symptoms include irritability, unexplained fever, limb stiffness, seizures, feeding difficulties, vomiting, and slowing of mental and motor development. Other symptoms include muscle weakness, spasticity, deafness, and blindness.

Overall calculated European frequency is 1 case per 100,000 populations, with a higher reported incidence in Sweden of 1.9 cases per 100,000 populations. An unusually high incidence, 6 cases per 1000 live births, is reported in the Druze community in Israel.

New methods, like mass-spectrometry give a good chance to characterize in the blood (plasma) of affected patents specific metabolic alterations that allow to diagnose in the future the disease earlier, with a higher sensitivity and specificity. Therefore it is the goal of the study to develop new biochemical markers from the plasma of the affected patients helping to benefit the patient by an early diagnose and thereby with an earlier treatment.

Eligibility Criteria:
INCLUSION CRITERIA:

* Informed consent will be obtained from the patient or the parents before any study related procedures.
* Patients of both gender from one year old
* The patient has a diagnosis of Krabbe Disease

EXCLUSION CRITERIA:

* No Informed consent from the patient or the parents before any study related procedures.
* Patients younger than one year
* The patient has no diagnosis of Krabbe Disease
Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-005)

The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or other autoimmune disease

Exclusion Criteria:

* Intraocular or refractive surgery in the study eye within 3 months prior to study start
* Unwilling to discontinue use of contact lenses during the run-in and duration of the study
* Pregnancy or lactation
COVID-19 Ad Intervention

This study will provide advertisements to (de-identified) participants and track (de-identified) movement patterns to learn whether the ads increase adherence to stay-at-home orders.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older (as identified by company running advertisements); recent visit to a non-essential location; agreed to terms and conditions of websites allowing advertisements

Exclusion Criteria:

-
Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

The purpose of this study is:

1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion.
2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen.
4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.


Eligibility Criteria:
Inclusion Criteria:

Phase I portion:

* Relapsed or refractory acute myelogenous or lymphoid leukemia.
* Chronic myelogenous leukemia in accelerated phase or blast-crisis.
* Recurrent or refractory malignant lymphoma or Hodgkin's disease
* Recurrent or refractory multiple myeloma.
* Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
* Myeloproliferative disorder (polycythemia vera, myelofibrosis) with transformation
* Myelodysplastic syndromes with more than 5% blasts.

Phase II portion:

* AML with active disease or beyond CR2.
* MDS with more than 5% blasts.

Exclusion Criteria:

* Clinical progression. Such patients may be treated on other treatment protocols or at the investigator's discretion. Such patients will continue to be monitored for survival and, may be asked to continue to provide specimens for studies of minimal residual disease and immune reconstitution as other treatments are recommended.
Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

Three different antibiotics are used to prevent infection in case of neurosurgery - this study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal fluid (surrounding the brain).


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Already having an external CSF drain
* Scheduled for neurosurgery requiring antibiotic prophylaxis (most commonly placement of an internal drain ("shunt")

Exclusion Criteria:

* Infection or colonization requiring other than standard prophylactic antibiotics
Ezetimibe for Patients With Chronic Hepatitis D

Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry that include two hydrophobes and one hydrogen bond acceptor. Therapy with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to evaluate the utility of Ezetimibe in patients with chronic HDV infection


Eligibility Criteria:
Inclusion Criteria:

* Treatment experienced patients; non-responders of relapsers of pegylated interferon therapy
* Age 18 years or above
* Presence of anti-HDV in serum
* Presence of quantifiable HDV RNA in serum
* Elevated ALT \> ULN

Exclusion Criteria:

* Decompensated liver disease
* Patients with ALT levels greater than 10 times ULN (400 U/L)
* Pregnancy or inability to practice adequate contraception.
* Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR\<50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease.
* Systemic immunosuppressive therapy
* Evidence of another form of liver disease in addition to viral hepatitis
* Active substance abuse, such as alcohol or injection drugs
* Hepatocellular carcinoma
* Concurrent hepatitis C infection or HIV coinfection
* Diagnosis of malignancy in the five years
* Concurrent usage of statins
* Concurrent use of any other drug known to inhibit NTCP
* Inability to understand or sign informed consent
* Any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study
Medical Treatment for Acute Appendicitis

Medical treatment for acute appendicitis

Patients with clinically and radiologically approved acute appendicitis will be treated medically. The main aim of the study is to define the long term results of medical treatment for acute appendicitis. Patients will be followed by clinical visits and recurrences will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* clinically and radiologically approved acute appendicitis
* approved and signed the informed consent form

Exclusion Criteria:

* perforated cases
* cases with peritonitis
* patient wish for surgical treatment
* allergy to drugs used in medical treatment of acute appendicitis
Expanded Population Health Model Evaluation

This study will evaluate the impact of a comprehensive wellness and social determinants of health intervention on cardiovascular health in a community setting of the Bonton neighborhood. Participants will not be assigned to intervention activities, but health and wellbeing indicators will be collected in relation to how they choose to participate in activities over the year.

The specific aims of this study are to 1) evaluate whether a population health model integrated into a community setting improves cardiometabolic health and quality of life in adults 18 years or older and 2) evaluate which programs and services provide the most impact for specific sub-groups of individuals, e.g., elderly, individuals with diabetes, etc.

Participants will receive programs from the existing population health model from Baylor Scott \& White Health and Wellness Center with additional programs from a local community organization. Individuals will complete study measures at baseline, 6 months, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Ability to alter diet and/or physical activity
* Willing to participate in a 12-month study
* Willing and able to participate in programs at Bonton Farms
* Cannot have participated in an intensive lifestyle change program (Group Lifestyle Balance, Health Eating and Lifestyle Program, or first cohort of apprenticeship) in the last 6 months or have attended more than two weeks of an intensive lifestyle change program
* Cannot be diagnosed with a terminal illness
* Cannot be pregnant or planning to get pregnant in the next 12 months

Exclusion Criteria:

* Below the age of 18 years
* Unable to alter diet and physical activity due to medical condition
* Not willing to participate in a 12-month study
* Not willing and unable to participate in programs at Bonton Farms
* Participated in an intensive lifestyle change program (Group Lifestyle Balance, Health Eating and Lifestyle Program, or first cohort of Bonton Farms' apprenticeship) or has attended more than two weeks of an intensive lifestyle change
* Be diagnosed with a terminal illness
* Currently pregnant or planning to get pregnant in the next 12 months
A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis

The purpose of this study is to evaluate the safety and efficacy of glycopyrrolate compared to vehicle for the treatment of axillary hyperhidrosis.

This is a randomized, vehicle controlled, dose-ranging study enrolling subjects with axillary hyperhidrosis and designed to assess the safety and efficacy of four doses of glycopyrrolate compared to vehicle. There are 5 arms in this study.

Efficacy will be assessed through the Hyperhidrosis Disease Severity Score (HDSS), Dermatology Life Quality Index (DLQI) and a gravimetric assessment of sweat production.

Safety will be assessed, at specified times during the study, through adverse events, local skin responses, serum chemistry and hematology laboratory testing, ECGs, physical examination and vital signs.

PK samples will be taken from 20 to 30 subjects participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older.
* Primary, axillary hyperhidrosis of at least 6 months duration.
* A Hyperhidrosis Disease Severity Score (HDSS) of 3or 4.
* A gravimetric measurement of sweat production of at least 50 mg over 5 minutes in each axilla (total of 100 mg) while at rest at room temperature.
* Male or non-pregnant, non-lactating females.

Exclusion Criteria:

* Prior surgical procedure for hyperhidrosis.
* Any prior treatment with an axillary anti-hyperhidrosis medical device (approved or investigational)
* Prior treatment with botulinum toxin for axillary hyperhidrosis within 1 year.
* Treatment with cholinergic, serotonergic antagonists, and dopamine partial agonists thought to relieve antidepressant-induced hyperhidrosis. Treatment with psychotherapeutic medications for less than 4 months prior to study enrollment. - Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 4 weeks prior to enrollment.
* Prior axillary treatment with axillary iontophoresis within 4 weeks.
* Axillary use of nonprescription or prescription antiperspirants within 2 weeks of study enrollment.
* Known history of a condition that may cause secondary hyperhidrosis.
* Known history of Sjögren's syndrome or Sicca syndrome.
* Abnormal findings on screening ECG deemed clinically significant by the Investigator.
RCT of Ghrelin in Stroke Patients

About half of the patients with acute ischemic stroke treated with endovascular thrombectomy (EVT) remain dependent on the help of others or die in the first 90 days. We hypothesize that treatment with ghrelin, started in the first six hours after stroke onset, improves early recovery and long-term functional outcome in these patients. Ghrelin is a naturally occurring hormone and mildly excitatory neurotransmitter also known as the 'hunger hormone.' Treatment with acylated ghrelin consistently improved functional and histological recovery in in vitro and in vivo models of ischemic stroke.

We will include 80 patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation, eligible for EVT. The study population will be drawn from adult patients with acute ischemic stroke treated with EVT at UMC Utrecht, Rijnstate, MST or Isala.

Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.

Eligibility Criteria:
Inclusion Criteria:

* a clinical diagnosis of acute ischemic stroke, caused by intracranial large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle (M1/proximal M2) cerebral artery) confirmed by neuro-imaging (CTA or MRA),
* treatment with EVT, defined as groin puncture in the angio suite,
* CT or MRI ruling out intracranial hemorrhage,
* a pre-EVT score of at least 10 on the NIHSS,
* age of 18 years or older,
* written informed consent (deferred).

Exclusion Criteria:

* pre-stroke disability defined as mRS ≥ 2,
* life expectancy shorter than one year,
* child-bearing potential.
Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect

The primary purpose of this substudy is to determine if collagen-targeted PET using the type 1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can inform as to drug effect of EGCG and assist in dose selection.

This is an optional sub-study of the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, pharmacokinetic (PK) interactions with standard of care drugs, and biomarkers of drug effect." Up to twenty-two participants participating in the aforementioned study will be enrolled into this sub-study. This substudy will be conducted at a select number of sites with capabilities for performing \[68Ga\]CBP8 PET.

Eligible participants who consent to the substudy will undergo \[68Ga\]CBP8 PET-CT or \[68Ga\]CBP8 PET-MRI at two time points. Participants will undergo 68Ga-CBP8 PET within 7 days prior to randomization and then again within 7 days prior to day 84 of the phase I study.

The hypothesis is that \[68Ga\]CBP8 PET will detect decreased collagen deposition in individuals treated with EGCG compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in and eligible (based on screening procedures - Visit 1) for the main EGCG Phase 1 study, "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect
2. Signed informed consent

Exclusion Criteria:

1. Pregnant or breastfeeding (a negative quantitative serum human chorionic gonadotropin (hCG) pregnancy test is required for females having child-bearing potential before the participant can participate)\*
2. Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior 12 months
3. Determined by the investigator to be clinically unsuitable for the study

Additional exclusion criteria for participants undergoing PET-MRI:

1. Electrical implants such as cardiac pacemaker, defibrillator, or perfusion pump
2. Metallic or electric implants contraindicated for magnetic resonance-PET (MR-PET) scanning
3. Claustrophobic reactions
4. Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 within the prior 30 days
5. Known allergy to gadolinium

   * Women of childbearing potential (WCBP) are defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if \< 55 years or 12 months if ≥ 55 years.
Comparison of the Administration of Levosimendan and Placebo in the Preparation of Critical Patients for Heart Surgery

This study aims to examine the efficacy of levosimendan in terms of reducing postoperative mortality and severe morbidity in patients undergoing non-emergent surgery for coronary revascularisation with or without ischaemic mitral regurgitation and who may or may not require repair or replacement of the mitral valve and have a LVEF \< 35%.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 years and \< 85 years.
* LVEF ≤ 35%
* Indication for elective surgery for coronary revascularisation, with or without mitral valve repair.
* Freely choose to participate in trial and sign an informed consent

Exclusion Criteria:

* The patient does not accept the protocol.
* Allergy (hypersensitivity) to levosimendan, any of its components or to riboflavin.
* Severe hypotension or severe tachycardia prior to entering study.
* Significant mechanical obstruction affecting ventricular filling and/or emptying.
* History of Torsades.
* Requirement for inotropic or vasoactive drugs or any type of mechanical assistance for 48 hours prior to surgery.
* Onset of angina or acute myocardial infarction within 48 hours prior to surgery, or cardiogenic shock.
* Surgery needs that are different from those planned.
* Chronic or severe kidney failure requiring haemodialysis or peritoneal dialysis or creatinine clearance values below 30ml/min or presence of nephrotic syndrome.
* Liver failure with transaminases 4 times above the normal maximum value.
* The patient must undergo a concurrently scheduled surgery, such as for a valve other than the mitral.
* When a screening cannot be performed at least during the 24 hours before surgery.
* Uncontrolled diabetes mellitus (blood glucose \> 24mmol/l or 432mg/dl).
* History of any disease over the last five years that may compromise the patient's life, other than their heart disease.
* The patient is currently abusing alcohol or toxic substances.
* Presence of any other medical or psychiatric condition that the researcher believes makes a candidate ineligible for the study.
* Women with childbearing potential who are not using an effective contraception method.
* Participation in the last 30 days in any other study with either experimental drugs or devices.
* Body Mass Index (BMI) greater than 35.
* Administration of levosimendan in the last 30 days.
A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission

This is a first in human, prospective, multicenter, nonrandomized, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of repeat doses of CSL362.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or older.
* Previous diagnosis of CD123+ acute myeloid leukemia (AML), de novo or secondary.
* Completed and recovered from all planned induction and consolidation therapy according to the institution's standard of care, and achieved a complete remission (CR)/CR with incomplete platelet recovery (CRp); either first or second CR.
* Has factors conferring high risk of relapse.
* No plans for additional post-remission chemotherapy.
* Not currently a candidate for allogeneic hematopoietic stem cell transplant (HSCT).

Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia (APL).
* Known leukemic involvement of the central nervous system.
* Life expectancy 4 months or less as estimated by the investigator.
* Concurrent treatment or planned treatment with other anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy).