cyrilzakka/clinical-trials huggingface dataset:
Salvage: Postconditioning With Adenosine for STEMI

Investigate the effect of selective intracoronary administration of adenosine on myocardial salvage and microvascular integrity in the setting of acute myocardial infarction.

Prospective, single center, randomized clinical study. Study design is random patient assignment to selective intracoronary administration of adenosine or control immediately before restoration of coronary artery patency in patients presenting with an acute ST segment-elevation myocardial infarction (STEMI). Randomisation will be stratified for the duration of symptoms (\< 4 hours vs \> 4 hours).

Eligibility Criteria:
Inclusion Criteria:

* Myocardial infarction of less than 12 hours duration with symptoms lasting at least 20 minutes.
* ECG-criteria: ST-segment elevation of \> 0.1 mV in 2 or more limb leads or \> 0.2 mV in 2 or more contiguous precordial leads or presumed new left bundle branch block.
* Written informed consent prior to inclusion in the study. If this is not possible, verbal informed consent from the patient or written assent of a legally acceptable representative should be obtained, to be followed by written informed consent by the patient at the earliest subsequent opportunity.
* Adequate vascular access seems possible (femoral pulsation palpable).

Exclusion Criteria:

* Contra-indication to heparin, LMWH, clopidogrel.
* Anticipated difficulty with vascular access.
* Cardiogenic shock.
* Inability to give informed consent (or assent).
* High grade atrioventricular block; severe asthma; treatment with theophylline, glibenclamide (Diamicron) or dipyridamole.
* Prior CABG.
* Participation in an investigational drug or device study within the past 30 days.
The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation

The objective of the study is to demonstrate the effects that lasofoxifene has on serum markers of bone metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women over 50 years who have low bone mineral density.

Exclusion Criteria:

* Women who are under 50 years of age, are premenopausal, or who currently have osteoporosis are excluded.
Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy

Esophageal cancer imposes a significant burden in China, accounting for over 60% of the global disease burden. While surgery remains a common and highly effective treatment for esophageal cancer, patients often experience multiple physical and psychological symptoms postoperatively, severely affecting their recovery outcomes and quality of life. Although existing exercise or psychological intervention programs have shown some effectiveness, issues such as relatively singular intervention content, imprecise intervention timing, and vague intervention details persist.

This project, based on previous research foundations (including the development of symptom measurement tools and the identification of key recovery periods), is guided by symptom management theory and knowledge translation models. Taking a perspective of the synergistic impact of physical and psychological symptoms, the study focuses on patients undergoing esophageal cancer surgery. Initially, evidence-based literature review, focus group interviews, and expert consultations were conducted to develop a combined exercise and psychological intervention program, integrating subjective (CSCA_EC) and objective (6MWT) measurement indicators, named "Recovery For EC." Subsequently, the program was preliminarily applied in clinical settings using a mixed-methods approach, combining quantitative quasi-experimental design (108 cases) and qualitative interviews to assess its acceptability. The final clinical trial version of the Recovery For EC program was developed to provide patients with a tool for self-monitoring recovery outcomes and offer clinical healthcare professionals guidance for implementing precise and personalized rehabilitation management.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of esophageal cancer by pathological biopsy.
2. Undergoing surgical treatment.
3. Age ≥ 18 years old.
4. The patient is able to communicate effectively in language.
5. The patient is fully aware of their condition and willingly participates in the investigation.

Exclusion Criteria:

1. Patients with consciousness disorders.
2. Patients with severe physical illnesses who are unable to cooperate with the investigation.
3. Participation in other studies.
Early rhBNP on Myocardial Remodeling and Reperfusion in Patients With STEMI

The study intends to evaluate the efficacy of early rhBNP on myocardial remodeling and reperfusion in patients with ST-segment elevation myocardial infarction after percutaneous coronary intervention

As prospectively observational study，it brings anterior acute myocardial infarct patients from 2018 JAN. to 2019 JAN, whose predefined time between symptom onset and percutaneous is not more than 12 hours. The door-to-balloon time, present to balloon time and first medical contact-to-balloon time will be documented. ECG in FMC and 90min after PCI also will be record. Patients assigned to the rhBNP group will receive intravenous rhBNP before PCI，and the variety of heart rate and blood pressure will be record. Routinely evaluation of corrected TIMI frame counting（CTFC）, TIMI myocardial perfusion frame counting and TIMI myocardial perfusion grade(TMPG).Blood tests including BNP, CK-MB and CRP are measured at admission and6, 12, 24, 48 hours after PCI. Both Cardiovascular magnetic imaging and echocardiography will be applied in Day 30 and 12 months. The composite endpoint is incidence of all-cause mortality, reinfarct, stroke and target vessel revascularization at hospitalization and follow-up. Principally patients are prevented from any drug affecting microcirculation (GPIIb/IIa receptor agonist, vascular dilation drug, etc.), otherwise it is necessary, which should be documented.

Eligibility Criteria:
Patients are eligible for enrollment if they are suspected as anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom, and no contraindication for rhBNP. The coronary angiography (CAG) proves left anterior descending (LAD) as culprit vessel, which was totally or nearly occlusion with TIMI 0-1 grade and resulted in TIMI 3 grade after PCI.

Exclusive criteria:

1. Killips grade III-IV.
2. unstable hemodynamic; with A-V block or atrial fibrillation;
3. Contraindication of magnetic resonance, such as history of metal, ICD or paceman implant;
4. history of myocardial infarct;
5. pregnancy or breeding;
6. combined with other serious diseases: severe renal dysfunction (creatinine clearance\<30ml/min;), liver failure, neutropenia, thrombocytopenia, acute pancreatitis；
7. life expectancy≤12 months
Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes

Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. The indication for SCS is an ineffective conservative treatment of chronic pain syndromes. The effectiveness of SCS in the case of neuropathic pain is high. The positive result of SCS treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. Long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain.

The efficacy of SCS in different modes of stimulation is evaluated. Patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. It is said that in one type of stimulation they would feel parestesias and in other three they would not. Patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. The test is double-blinded

Patients with FBSS and CRPS are evaluated for VAS,, dissability scale, Quality of Life (QoL), sleep disorders and mental disorders.

All patients undergo percutaneus (1 or 2) 8-contact SCS electrode implantation with trial.

All patients are blindly randomized to tonic or burst or high frequency or off stimulation. After 2-week period each participant is adequately switched to another type of stimulation for next 2 weeks. Alltogether crossover takes 8 weeks: four 2-week periods of tonic, burst, HF and off stimulation. At the end of trial period patients are subjected to the mode of stimulation which is the most efficent. The final 2-week stimulation is performed with final renewed evaluation for VAS, amount of taken medications, dissability scale, Quality of Life (QoL), sleep disorders and mental disorders. Follow-up observation will last up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. FBSS, CRPS patients with neuropathic and mixed pain in low-back and/or legs refractory to conservative therapy
2. Chronic pain as a result of FBSS that exists for at least 6 months
3. ≥ 18 years of age
4. Written consent of the patient to participate in study procedures.

Exclusion Criteria:

1. Active malignancy
2. Addiction to any of the following: drugs, alcohol and/or medication
3. Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
4. Local infection or other skin disorder at site of surgical incision
5. Pregnancy
Operative Treatment of Traumatic Anteroinferior Shoulder Instability in Young Male Patients

Glenohumeral joint is prone to instability, i.e. the humeral head may dislocate off the scapular glenoid plate especially in the anteroinferior direction. Surgical treatment of shoulder instability aims at restoration of shoulder stability. The purpose of this trial is to investigate the difference in outcome after arthroscopic Bankart operation compared with open Latarjet operation in the treatment of a residual instability after a traumatic primary dislocation in young males.


Eligibility Criteria:
Inclusion Criteria:

1. Subluxation or fear of shoulder dislocation after a previous, reduced and primarily conservatively treated (for more than 3 months) traumatic anteroinferior shoulder dislocation, or redislocation after a primary shoulder dislocation.
2. Clinically documented anteroinferior instability (ie. a positive apprehension and relocation test (Jobe)).
3. X-ray (true ap, 30 degrees oblique ap, Y- and axillary projections), 2- and 3-dimensional computed tomography (2D and 3D CT) and magnetic resonance imaging arthrography (MRA) documentation of the joint.
4. Congruency of the shoulder joint on imaging investigations.
5. Young adult male patient 16-25 years of age (15 years \< patient \< 26 years ).
6. Patient's willingness for operative treatment.
7. Written informed consent from participating subject.

Exclusion Criteria:

1. Non-congruency of the glenohumeral joint on imaging investigations.
2. Concomitant dislocated fractures (requiring operative treatment) of the humerus or the scapula (other than Hill-Sachs lesion or bony Bankart lesion)
3. Severe grade 2 or above (Samilson et Prieto) osteoarthrosis of the glenohumeral joint detected in X-ray investigation.
4. A humeral avulsion of glenohumeral ligaments (HAGL) detected in MRA investigation.
5. Concomitant ipsilateral plexus or axillar nerve injury affecting motor function.
6. Life threatening other concomitant injuries (i.e. multitrauma patient).
7. Stiffness of the glenohumeral joint (restricted passive external rotation less than 30 degrees measured in standing position, arm at side).
8. Age under 16 or above 25 years.
9. Open physis with significant growth expectation.
10. Intellectual disability, history of seizures with high risk of recurrence, existing significant malignant, haematological, endocrine, metabolic, or rheumatoid disease.
The Effects of Long-term Consumption of Full-fat Dairy Products on Satiety, Body Weight and Glycemic Control

The proposed study looks at the effect of long-term diet modification with or without full-fat dairy products or restrictive eating on body weight, body composition and cardiometabolic markers in healthy overweight/obese men and women.

A total of 93 males and females will participate in the study at the University of Toronto.

At the beginning and after 12 weeks, body weight, composition will be measured through Bodpod scans. Resting metabolic rate and thermogenesis will be measured by indirect calorimetry. Also, fecal samples will be collected for gut microbiome profiling along with blood for glucose, insulin, hormones, triacylglycerol, HbA1c, short-chain fatty acid, red blood cells and FGF21. Urine samples will be collected throughout the study.

A followup session at 16 weeks will reassess previous measures.

Eligibility Criteria:
Inclusion Criteria:

* BMI: ≥ 27 and ≤ 34.9 kg/m2
* Fasting serum glucose: ≤ 7 mmol/L
* Low ≤1 serving of dairy consumption
* Waist circumference \>88cm (women) and \>102cm (men)
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
* Willing to maintain current dietary supplement use throughout the trial. On test days, participant agrees not to take any dietary supplements until dismissal from the study. Failure to comply will result in a rescheduled test visit.
* Willing to abstain from alcohol consumption for 24 h prior to all test visits.
* Willing to avoid vigorous physical activity for 24 h prior to all test visits.
* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator

Exclusion Criteria:

* Fasting blood glucose \> 7 mmol/L
* Triglycerides ≥ 2.3 mmol/L
* Smoking tobacco products and marijuana
* Thyroid problems
* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
* Presence of gastrointestinal disorder or surgeries within the past year.
* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement.
* Known to be pregnant or lactating, or planning on becoming pregnant in the next 12 months.
* Irregular menstrual cycles (i.e. frequent missed cycles), menopausal or post- menopausal
* Unwillingness or inability to comply with the experimental procedures
* Known intolerance, sensitivity or allergy to dairy products
* Consumption of protein powders/protein supplements
* Extreme dietary habits
* Uncontrolled hypertension as defined by the average blood pressure measured at screening.
* Weight gain or loss of at least 10 lbs in previous three months, and history of childhood overweight or obesity
* Excessive alcohol intake
* Restrained Eaters
Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer

This study aims to investigate the effect of involved-field radiotherapy for recurrent ovarian cancer after primary standard treatment. We will investigate whether the addition of involved-field RT improves 2-year PFS in those patients than that of historical data (only with other standard salvage treatments as systemic chemotherapy ± maximum tumor resection).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed ovarian carcinoma
* Patients who received "standard treatment" for each stage as a primary treatment
* No. of recurrent lesions:

If, all in lung, or intra-abdominal or pelvis organs - ≤ 5 If, any in liver, bone, or spinal cord - ≤ 2

* Size of recurrent lesions ≤5 cm
* All recurrent lesions are available for involved-field radiotherapy
* Within 60 days before enrollment:
* Absolute neutrophil count ANC ≥ 500 / mm3
* Platelet ≥ 50,000 / mm3
* Hb ≥ 8.0 g / dl
* Good performance status (ECOG 0-1)

Exclusion Criteria:

* Brain metastasis
* Diffuse peritoneal carcinomatosis
* Malignant pleural effusion
* History of previous salvage radiotherapy for recurrent lesions
* History of other malignancy or severe/unstable medical condition
Smartphone Technology: Young Adult Drinking

Exploring technology based tools to reduce drinking is important. The purpose of this research study is to compare different BAC monitoring apps for their effects on alcohol drinking and ratings of usability among young adults.This study will be conducted in six phases: a web-based and in-person screening assessment; brief counseling session on the day before the alcohol drinking session; brief appointment on the day of the alcohol drinking session; alcohol drinking session; two-week field period; and a follow-up appointment. Participation in this study will last approximately two months.


Eligibility Criteria:
Inclusion Criteria:

* Be able to read/write English and complete study assessments
* Drink alcohol regularly

Exclusion Criteria:

* Test positive on a urine test for use of certain illegal drugs
* Undergraduate student enrolled at the University of Florida
* Graduate students from the College of Health and Human Performance at the University of Florida
* Pregnant, or currently breast feeding
Extended Long-Term Safety Study of KW-6500

This is a extended long-term safety study in Parkinson's disease patients who have motor response complications on levodopa therapy and completed 12 weeks administrations of KW-6500 in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of KW-6500 are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given written informed consent
* Patients who have completed the 6500-004 study
A 48 Week Study to Evaluate the Efficacy and Safety of Two (2) EYS606 Treatment Regimens in Subjects With Active Chronic Non-infectious Uveitis (CNIU)

The objective of the study is to evaluate the efficacy and safety of two different treatment regimens of EYS606.

This is a Phase 2, multi-center, randomized open-label interventional study of EYS606 in subjects with active chronic non-infectious uveitis.

The maximum study duration per patient is 51 Weeks (including an up to 3 week screening period + 48 weeks follow-up after treatment).

The study will be conducted in 2 parts. Part I is a safety cohort phase that will enroll up to 6 subjects, Part II is the randomized comparison phase that will enroll up to an additional 50 subjects.

Eligibility Criteria:
Key Eligibility Criteria:

1. Subject must be 18 years of age or older.
2. Subject must have a diagnosis of chronic non-infectious uveitis of any anatomic subtype (anterior, intermediate, posterior or panuveitis).
3. Subject must have a history of chronic or recurrent non-infectious uveitis requiring or having required treatment with corticosteroids (systemic, periocular or intraocular) and/or systemic immunosuppressive medication(s) in the 12 months prior to the screening visit.
4. Best corrected visual acuity of

   * Study Part I: ≥ 5 and \< 67 ETDRS letters in the study eye (equivalent to less than or equal to 20/50 but better than or equal to 20/800 Snellen).
   * Study Part II: ≥ 5 and \< 77 ETDRS letters in the study eye (equivalent to less than or equal to 20/32 but better than or equal to 20/800 Snellen).
5. At the screening and baseline visits subject must have active chronic non-infectious uveitis as evidenced by at least one or more of the following in the study eye:

   * Active retinal vasculitis (retinal vascular leakage) involving the posterior pole confirmed by the reading center.
   * Vitreous haze grade ≥ 2+ (SUN classification).
   * Anterior chamber cell grade ≥ 2+ (SUN classification); anterior chamber cells must be present for subjects with a diagnosis of chronic anterior non-infectious uveitis.
   * Persistent macular edema (defined as central retinal thickness (CRT) \> 300 microns or \> 320 microns using Zeiss Cirrus and Topcon or Heidelberg Spectralis spectral domain ocular coherence tomography (SD-OCT) instruments, respectively) despite treatment with corticosteroids and/or immunosuppressive therapy for at least 4 weeks prior to screening.
6. Subject receiving concomitant topical and/or systemic corticosteroids or allowed systemic immunosuppressive medications must have maintained the same treatment regimen (dosage/frequency) for at least 2 weeks prior to the baseline (V1) visit, (if applicable).
n-3 Fatty Acid Effects in T2DM After Acute High Intensity Exercise

The aim of this study was to verify the effect of a combined supplementation \[n-3 PUFA (known to induce anti-inflammatory effects) plus vitamin E (known for its antioxidant properties)\] on lipidic, glycemic, redox status and inflammatory parameters in type 2 diabetic patients. In addition, considering that exercise, at high intensities, can induce a transient inflammatory state and increase oxidative stress (OS) markers, the investigators tested if our nutritional intervention could attenuate this response within this population (thus, using high intensity exercise as inductor of acute inflammatory/OS state).

Herein the investigators tested the effect of eight weeks of omega-3 polyunsaturated fatty acid (n-3 PUFA) and vitamin E supplementation before and after an acute high intensity exercise bout on lipid profile, glycemic, redox and inflammatory parameters in type 2 diabetic (T2DM) patients. Thirty T2DM patients, without chronic complications, took part in this study. Blood and urine samples were collected after 12 h-fasting state for baseline biochemical analysis. Thereafter, subjects performed an incremental workload VO2max test on a cycle ergometer to determine the load of the high intensity submaximal exercise. On the following week, blood samples were collected before and immediately after the exercise test for measurements of oxidative stress (OS) and high-sensitivity C-reactive protein (hs-CRP). Afterwards, participants were randomly allocated into two groups: placebo (gelatin) and n-3 PUFA (capsules containing 180 mg of eicosapentaenoic acid, 120 mg of docosahexaenoic acid and 2 mg of vitamin E). Three capsules were ingested daily for eight weeks. Then, the examination protocol and the exercise test were repeated and the samples collected.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 2 Diabetes
* Male and female
* Age between 40 and 60 years old.
* Must be able to do exercise

Exclusion Criteria:

* Smoking;
* Clinical diagnosis of kidney, pulmonary or heart diseases