cyrilzakka/clinical-trials huggingface dataset:
ADR-002K for Patients With Ischemic Cardiomyopathy Who Undergo Coronary Artery Bypass Surgery

Ischemic cardiomyopathy undergoing coronary artery bypass surgery


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG
2. Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
3. Others

Exclusion Criteria:

1. Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure
2. Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
3. Others
Femtosecond Laser-Assisted Keratoplasty

The purpose of this study will be to determine optimal surgical technique for performing FLAK including laser parameters, keratoplasty shape and suture technique in order to standardize surgical technique and to collect safety and efficacy data. This will be compared to data of patients with full thickness PKP to measure visual outcomes, refraction, astigmatism, surgical methods and wound healing.

FLAK Instrument: The Femtosecond Laser (IntraLase Corporation, Irvine, CA) is a focusable infrared laser, similar to the more familiar neodymium-yttrium-aluminum-garnet (YAG) laser, but uses shorter pulses in the hundred-femtosecond (100 X 10-15 seconds) duration range. There is minimal postoperative inflammation and collateral tissue damage.

Subjects: We will be enrolling subjects 18 years or older that need keratoplasty based on clinical findings. Subjects will be enrolled regardless of race or gender on a first come first serve basis. Subjects will be recruited from the physicians own clinic.

PKP Subjects: We will do a retrospective chart review on subjects who have undergone traditional PKP. FLAK eyes will be age and gender matched to these PKP eyes to compare visual outcomes, wound healing and complications.

Eligibility Criteria:
Inclusion Criteria:

1. Corneal opacification.
2. Reduced ETDRS-measured, best corrected, distance visual acuity to 20/40 or worse.
3. Ability to participate in follow-up visits..

Exclusion Criteria:

1. Corneal opacification adequately dense to obscure visualization of iris.
2. ETDRS-measured, best-corrected, distance visual acuity of 20/30 or better.
3. Corneal thickness greater than 1200 µm at the 9 mm peripheral zone.
4. Severe corneal thinning including descemetocoele with impending corneal rupture.
5. Prior PKP or incisional surgery that may provide a potential space into which the gas produced by the procedure can escape.
6. Poor visual potential in the non-study eye (VA of 20/100 or less, without potential for improvement by the examining ophthalmologist's judgment).
7. History of glaucoma, including steroid response rise in intraocular pressure.
8. Active intraocular inflammation or infection.
9. Age 18 or younger (consideration will be given to an upper age limit).
10. Unable to return for scheduled follow-up examinations.
11. Other medical condition(s) that will likely prevent long term follow-up.
The Effectiveness of Cow's Milk Immune Globulin in the Treatment of AIDS-Related Diarrhea

To examine the efficacy of cow's milk immune globulin in the treatment of diarrhea due to chronic intestinal cryptosporidiosis in patients with AIDS. The secondary end points of the study involve functional improvement which will be determined from nutritional and absorption studies.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Diagnosis of diarrhea associated with intestinal cryptosporidiosis.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Survival time projected to be \< 9 weeks.
* Inability to tolerate any oral intake.
* Known allergy or intolerance to milk products.
* Organic mental syndrome precluding informed consent or following directions.

Patients with the following are excluded:

* Survival time projected to be \< 9 weeks.
* Inability to tolerate any oral intake.
* Known allergy or intolerance to milk products.
* Organic mental syndrome precluding informed consent or following directions.
Superior Capsule vs Bridging Study

Randomized controlled trial examining superior capsule reconstruction versus tendon repair with graft interposition in "irreparable" rotator cuff tears.

RCT n = 50

Groups:

1. bridging
2. SCR

Outcomes:

1. WORC
2. ASES
3. QuickDASH
4. MRI at 12 months post-op

Eligibility Criteria:
Inclusion Criteria:

1. Large to massive rotator cuff tear (with or without subscapularis tear) that may possibly be irreparable without the use of graft materials (confirmed intra-operatively)
2. Either primary tear or re-tear after previous repair
3. Radiographic evidence of Hamada stage 1-3, with or without Samilson \& Prieto mild osteoarthritis (\<3mm inferior osteophyte)

Exclusion Criteria:

1. Primary glenohumeral osteoarthritis: radiographic evidence of Samilson \& Prieto classification moderate or greater
2. Cuff tear arthropathy (CTA): radiographic evidence of Hamada stage 4 or above
3. Inflammatory joint disease of the shoulder (e.g. rheumatoid arthritis)
4. Medical issues precluding surgery
5. Unwilling or unable to complete study outcomes
6. Worker's Compensation Claim or litigation
Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia

This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare disease with unmet clinical need.

Post-Bariatric Hypoglycemia (PBH) is a rare, but increasingly reported disease occurring after bariatric surgery, characterized by severe hypoglycemic episodes accompanied by symptoms of hypoglycemia. At the moment, no medical therapies have been developed for this disorder, but the clinical need is great. The major contributory factor is thought to be an exaggerated secretion of glucagon-like peptide-1 (GLP-1) due to altered nutrient transit after bariatric surgery. GLP-1 is an incretin hormone secreted primarily by the distal ileum that contributes to postprandial glucose regulation. Exendin (9-39) is a specific GLP-1 receptor antagonist, that when given via continuous IV infusion, has been shown to effectively prevent postprandial hypoglycemia and reduce symptoms of hypoglycemia in patients with PBH. This study is designed to assess the efficacy, safety and pharmacokinetic profile of a novel subcutaneous formulation of exendin (9-39).

Eligibility Criteria:
Inclusion Criteria:

* Post-bariatric surgery more than 6 months prior to signing the informed consent
* Reported history of Whipple's triad: the occurrence of hypoglycemic symptoms associated with a capillary blood glucose of ≤55 mg/dL, and resolution with glucose or carbohydrate administration.
* Symptomatic hypoglycemia during the baseline/screening oral glucose tolerance test (OGTT), as defined by the presence of plasma glucose ≤55 mg/dL with concomitant autonomic and/or neuroglycopenic symptoms.

Exclusion Criteria:

* Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
* Participation in any clinical investigation within 4 weeks prior to dosing
* History of or current insulinoma
* Active infection or significant acute illness within 2 weeks prior to dosing
* Female patients who are pregnant or lactating
* Women of childbearing potential and not utilizing effective contraceptive methods
* Inadequate end organ function
Development and Validation of a Real-time Prediction Model for Acute Kidney Injury in Hospitalized Patients

Early prediction of acute kidney injury (AKI) may provide a crucial opportunity for AKI prevention. To date, no prediction model targeting AKI among general hospitalized patients in developing countries has been published. We developed a simple, real-time, interpretable AKI prediction model for general hospitalized patients from a large tertiary hospital in China, and validated it across five independent, geographically distinct, different tiered hospitals.

Early prediction of acute kidney injury (AKI) may provide a crucial opportunity for AKI prevention. To date, no prediction model targeting AKI among general hospitalized patients in developing countries has been published. We developed a simple, real-time, interpretable AKI prediction model for general hospitalized patients from a large tertiary hospital in China using the machine learning technique, and then validated the performance of the prediction model across five independent, geographically distinct, different tiered hospitals in China.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years and older) admitted to five hospitals during the study period

Exclusion Criteria:

* Have less than 2 documented serum creatinine (Scr) measurements during hospitalization
* Being diagnosed with end-stage renal disease (ESRD)
* Maintained on dialysis or had an initial Scr greater than or equal to 4.0 mg/dL at admission
* Developed AKI prior to admission or within 24 hours after admission
* Length of stay shorter than 24 hours
* Underwent kidney transplantation or nephrectomy during hospitalization
* With all Scr measurements lower than or equal to 0.6 mg/dL from 90 days prior to admission until discharge.
Effects of High-intensity Inspiratory Muscle Training in Patients Undergoing Coronary Artery Bypass Grafting Surgery

Even with the advances in clinical therapy and percutaneous interventions, coronary artery bypass grafting (CABG) is still widely used in the treatment of patients with coronary artery disease (CAD). However, it is a complex procedure that triggers important organic implications especially on pulmonary function. In relation to the treatment of patients undergoing CABG, the recovery is linked to the cardiac rehabilitation programs. These programs can also be associated with other muscle training measures, among these there is inspiratory muscle training (IMT). Most studies has been implemented moderate-intensity IMT daily, but there are few studies about the effects of high intensity training loads performed on alternate days. In this context, is justified the use of a device such as the recent Powerbreathe, which uses higher training loads that would provide greatest benefits, whereas the magnitude of the response to training tends to increase with load.

OBJECTIVE: To investigate the efficiency of high intensity IMT associated with combined aerobic and resistance training on maximal exercise capacity, submaximal exercise capacity, respiratory muscle strenght, pulmonary function, oxidative stress, quality of life and endothelial function in patients who underwent CABG in phase II cardiac rehabilitation program.

METHODOLOGY: This is a clinical trials, controlled, randomized,double-blind being developed in partnership with Cardiology Clinic of Hospital Universitário de Santa Maria (HUSM), Santa Maria, RS, Brazil. Patients will undergo the evaluation of pulmonary function and respiratory muscle strength (spirometry and digital manovacuometry), as well on the maximal exercise capacity (Ergospirometry), submaximal functional capacity (6MWT and 6MST), of quality of live (MLHFQ) of Oxidative stress and endothelial function (blood biomarkers). After the evaluation will be randomly allocated into two groups: the control group will perform cardiac rehabilitation associated with the Sham of IMT, and the experimental group cardiac rehabilitation associated with the IMT High-intensity. The intervention will last twelve weeks for both groups and after this phase patients will be submitted again to the assessment tools.

EXPECTED RESULTS: The high intensity IMT potentiates the effects of cardiac rehabilitation (phase II) after coronary artery bypass surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing CABG up to three weeks before the initiation of the study, a clinical course without complications during hospitalization
* Clinically stable
* The absence of smoking (previous or current).

Exclusion Criteria:

* Unstable angina
* Myocardial infarction and heart surgery up to three months before the survey;
* Chronic respiratory diseases
* Hemodynamic instability
* Orthopedic and neurological diseases that may preclude the achievement of the cardiopulmonary test and Cardiac Rehabilitation exercises
* Psychological and / or cognitive impairments that restrict them to respond to questionnaires.
Low Intensity Shockwaves Therapy for the Treatment of Erectile Dysfunction. 12- Month Follow-Up

The purpose of this study is to evaluate the safety and effectiveness of the shockwave therapy to treat Erectile Dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be able willing and able to provide informed consent.
* The patient is a male between 30 and 70 years of age (inclusive).
* The patient has erectile dysfunction (ED) based of IIEF scores.
* The patient has been in a stable relationship for over 3 months prior to enrollment.
* A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by International Index of Erectile Dysfunction (IIEF)
* The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years as per history provided by patient.
* IIEF-EF score between 16 and 25.
* Testosterone level 300-1000 ng/dL within 1 month prior to enrollment. A1C level ≤ 7% within 1 month prior to enrollment

Exclusion Criteria:

* The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study.
* The patient is under judicial protection (prison or custody).
* The patient is an adult under guardianship.
* The patient refuses to sign the consent.
* History of radical prostatectomy or extensive pelvic surgery.
* Evidence of venous leak.
* Past radiation therapy of the pelvic region within 12 months prior to enrollment.
* Recovering from any cancer within 12 months prior to enrollment.
* Neurological disease such as Alzheimers or Parkinson's disease which affects erectile function at the discretion of the investigator.
* Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator.
* Anatomical malformation of the penis, including Peyronie's disease.
* Testosterone level \<300 or \>1000 ng/dL within 1 month prior to enrollment.
* A1C level \> 7% within 1 month prior to enrollment or history of Insulin dependent diabetes.
* The patient is taking blood thinners and has an international normalized ratio \>3.
* Received shockwave treatment at least 6 months before enrollment.
Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia

Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS with intensive language therapy as a way of enhancing language outcomes in aphasia

Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS supplementing clinically determined intensive language therapy as a way of enhancing language outcomes in aphasia. Eligible clients enrolled in the University of Michigan Aphasia Program (UMAP) will be invited to participate in the study. Clients will receive 20 minutes of tDCS every day along with their usual treatment protocol. Pre and post testing will be completed to assess for improvement in language functioning. This is a feasibility and proof of concept study to determine if a randomized control trial should be pursued

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of aphasia
* Enrolled in intensive therapy program at the University of Michigan Aphasia Program.
* Ability to understand and give consent to treatment.

Exclusion Criteria:

* No metal implants or surgical devices
* History of seizures
* History of significant cognitive or psychiatric disturbance
* Participant cannot be pregnant at the time of study
3D Printed Advanced Cardiac Models for Transseptal Puncture, Cardiac Ablation, and Cardiac Tamponade Simulation Training

The objective of this study is to develop advanced cardiac models using 3D printing technology for teaching complex cardiology procedures such as (1) transseptal puncture, (2) cardiac ablation, and (3) ultrasound scanning and drainage of cardiac tamponade. By implementing this study, the investigators aim to transform the teaching methods for cardiology students at our hospital.

Background： The standard methodology for education in medicine, particularly in cardiology, still follows the apprenticeship model, where trainees observe, gradually take over, and practice under supervision until they can independently perform procedures. The traditional pedagogical strategy for complex medical procedures, like cardiac catheterization, emphasizes the "see one, do one, teach one" doctrine. Studies have revealed the superior efficacy of 3D printing in medical education, particularly in enhancing learning skills and knowledge among medical students. The demand for 3D printed models in medical education is increasing continuously.

Study Design：

This study is a single-center, pilot, prospective, randomized controlled educational trial.

Methods：

The trial will be conducted in the Department of Cardiovascular Medicine at Fu Jen Catholic University Hospital. The investigators plan to enroll 50 participants, who will be randomly assigned to either the 3D model training group (n=25) or the conventional curriculum group (n=25) in a 1:1 ratio. All participants will undergo pre- and post-training assessments, including a knowledge test (structured written questionnaire), an attitude assessment (semi-structured satisfaction questionnaire), and a skills evaluation (direct observation of procedural skills, DOPS).

Effect：

The investigators anticipate the development of a set of advanced 3D cardiac models for teaching cardiology procedures. It is expected that combining classroom learning with the viewing and interactive practice of 3D printed models will significantly improve the learning outcomes of the trainees.

Key words：

Clinical simulation-based education, advanced cardiology procedures, transseptal puncture, cardiac ablation, cardiac tamponade.

Eligibility Criteria:
Inclusion Criteria:

* Medical student, nurse practitioner and Resident in Fu Jen Catholic University Hospital

Exclusion Criteria:

* Refused to participate in the study.
Metabolomics in Occupational Asthma

The project aims to increase the diagnostic accuracy in occupational asthma (OA), with emphasis on Irritant Induced Asthma (IIA). Currently, most patients are evaluated in occupational medicine by comparing the exposure and symptom characteristics with epidemiological data. Biological markers may be present in AA, but presently not in IIA. The majority of cases evaluated are considered as possible IIA, i.e. low-dose multiple exposures. VOC features will be analyzed with the Breath Biopsy® and TD-GS-MS (Owlstone Medical Ltd, UK).


Eligibility Criteria:
Inclusion Criteria:

* capable of informed consent.
* asthma diagnosis established by lung specialist or healthy control.

Exclusion Criteria:

* skin allergy towards plastics or rubber.
* immunocompromised by oral medication.
* contagious respiratory disease.
* biopsy of lung parenchyma within the last 36 hours.
UCB Stem Cells for Autism Spectrum Disorders

Purpose. The goals of the study are to assess the safety of the intravenous infusion of umbilical cord blood (UCB) cells in patients with autism and to confirm changes in social/ communicative skills and cognitive functioning after four infusions of ABO/Rh-matched UCB stem cells.

Material and methods. The sample comprises 30 patients (27 males, 3 females) aged between 3 and 11 years with ASD under the care of the National Medical Research Center for Psychiatry and Neurology (Saint-Petersburg, Russia). Participants are randomly assigned to either the control group (14 males, 1 female) or the experimental group (13 males, 2 females). The experimental group receives intravenous injections of UCB cells four times with a two-week gap between injections. The control group receives standard therapy.

The dynamic of cognitive functions and social/communicative skills assess with Checklist for autism spectrum disorders (CASD), Autism treatment evaluation checklist (ATEC), subscales of Wechsler Intelligence Scale for Children (WISC) - "Digit Span", "Picture completion", "Block design", "Coding".


Eligibility Criteria:
Inclusion Criteria:

* diagnosed ASD by ICD-10 criteria

Exclusion Criteria:

* acute somatic diseases
* indication for surgical (neurosurgical) therapy
* acute or chronic infectious diseases
* history of acute allergic reactions
The Importance of Wnt-signaling After Cardiac Surgery

Cardiac surgery saves lives when patients suffer from cardiac disease. Local inflammation is important for tissue repair and wound healing after such an operation. Inflammation starts already when the patient is treated in the intensive care unit. When inflammatory proteins (cytokines) are released into the circulation, they cause also a systemic inflammation, which alerts the immune system of the body and activates defence mechanisms (=adaptive response). In some patients, systemic inflammation is out of control thereby causing organ dysfunctions, shock, and in the most severe cases even death (=maladaptive response). The aim of this study is to investigate the early phase of inflammation after the operation. Repeated blood samples will be taken of patients undergoing cardiac surgery to describe the patterns and dynamics of inflammation proteins. A better understanding of these mechanisms will potentially lead to improved treatment of patients after cardiac surgery.

The aim of this project is to understand early inflammation mechanisms after cardiac surgery. Therefore, repeated blood samples of patients undergoing cardiac surgery will be taken. Patients are selected after "open" cardiac surgery (via sternotomy), when when they require postoperative care in the cardiovascular intensive care unit. The blood samples will be analysed in collaboration with the Inflammation Research Unit of the Department of Internal Medicine at the University Hospital Zurich.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery via sternotomy
* Coronary-bypass bypass surgery with or without valve surgery
* Postoperative hospitalisation in the cardio-surgical ICU
* Available informed consent

Exclusion Criteria:

* Preoperative infections (e.g. endocarditis)
* Preoperative use of steroids or other immunosuppression