cyrilzakka/clinical-trials huggingface dataset:
Reduction in Infarct Size by Remote Per-postconditioning in Patients With ST-elevation Myocardial Infarction

* Trial objective: To test the hypothesis that remote per-postconditioning in connection with primary PCI will reduce myocardial infarct size patients with STEMI.
* Trial Design: Placebo controlled randomized study with parallel groups
* Primary Endpoint: Myocardial infarct size expressed as a percentage of the myocardium at risk determined by Cardiac Magnetic Resonance (CMR) day 4-7
* Efficacy Parameters: Myocardial infarct size expressed as a percentage to the myocardium at risk determined by CMR at 6 months.
* Global left ventricular function determined by left ventricular ejection fraction determined by CMR.
* Microvascular obstruction determined by CMR day 4-7. Quantified ECV (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180.
* Safety Parameters: Major adverse cardiovascular events.

See above. 3 patients left to include.

Eligibility Criteria:
Inclusion Criteria:

* Patient planned for primary PCI.
* Chest pain indicating myocardial ischemia with a duration \>30 minutes and \< 6 hours prior to randomization.
* ST elevations \>0.1 mV (\>0.2 mV in V2-V3) in \> two contiguous leads in V1-V6.
* Informed consent.

Exclusion Criteria:

* Previous myocardial infarction based on medical history or Q-wave on ECG in other area
* Left Bundle Branch Block on ECG.
* Previous CABG
* Cardiac arrest
* Any contraindication for CMR.
* Clinical symptoms of claudication
* Treatment with glibenclamide or cyclosporine on admission.
* Any condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
Everolimus Stent in Patients With Coronary Artery Disease (CAD)

Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients

Compared with the currently available first-generation drug-eluting stents (DES), second-generation DES have been designed with the goal of improving safety and efficacy. Everolimus, a sirolimus analogue, is released from a open cell, thin-strut, cobalt-chromium frame. A significant reduction in cardiac events was noted in patients with the everolimus-eluting stent compared with those who had a paclitaxel-eluting stent. Sirolimus eluting stent was the first available drug eluting stent and is the most tested. Therefore the investigators compared the safety and efficacy of the everolimus-eluting and sirolimus eluting stents in unselected patients in real world practice.

Eligibility Criteria:
Inclusion Criteria:

* All patients with coronary artery disease eligible for percutaneous coronary intervention (PCI)

Exclusion Criteria:

* Contraindication to dual antiplatelet therapy for 12 months
* Known allergy to sirolimus or everolimus
* Major surgical procedure planned within 1 month
* History, symptoms, or findings suggestive of aortic dissection.
* Participation in other trials
* Pregnancy
Exploratory Study Using a New Head-only PET Scanner

The "BPET prototype" is a small aperture PET scanner. The BPET prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the BPET prototype without the need for an additional radioactive tracer dose.

The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the BPET prototype.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving Informed Consent as documented by signature (Appendix Informed Consent Form)
* ability to sit still in the head-only PET scanner for 15 minutes
* Are scheduled to receive a regular brain PET scan as part of clinical routine.
* Male and Female patients 18 years to 80 years of age

Exclusion Criteria:

* Contraindications to PET examination,
* Patient height smaller than 160 cm or taller than 200 cm,
* Patient weight more than 120 kg,
* Patient cannot sit upright for at least 15 minutes,
* Metal implants in the head,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, severe dementia, etc. of the participant,
* Participation in another study with investigational drug/device within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
Describing the Clinical-laboratory Aspects of Diabetes Through the Creation of a Registry

The main objective of the study is to describe the clinical-laboratory aspects of diabetes by creating a registry in which to census all newly diagnosed or already diagnosed cases after 1/1/2000 at the O.U. of Endocrinology and Diabetes Prevention and Care.

The main objective of the study is to describe the clinical-laboratory aspects of diabetes by creating a registry in which to census all newly diagnosed or already diagnosed cases after 1/1/2000 at the O.U. of Endocrinology and Diabetes Prevention and Care.

The clinical-laboratory aspects covered by this study also include family history, survival, comorbidities, psychological aspects, and in any case all those data that add relevant scientific information. This registry may be used to review the OU's case history and to confirm or obtain new scientific evidence on diabetes through cohort studies conducted using the data that will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Newly or previously diagnosed patients with diabetes mellitus at any stage of disease
* Obtaining informed consent

Exclusion Criteria:

- Patients whose diagnosis of diabetes mellitus is uncertain
An Evaluation of a Fibrillar Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds

Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.


Eligibility Criteria:
Inclusion Criteria:

* Has one of the following types of wounds below the knee: diabetic ulcers, pressure ulcers, venous ulcers, ulcers of mixed-vascular origin, traumatic wounds, or post-surgical wounds
* Wound has been present for at least four weeks
* Wound is free of necrotic tissue or debridement practices will take place prior to initial visit in order to remove necrotic tissue
* Wound has failed at least one wound care treatment
* Wound size is between 1 and 100 square centimeters
* Patient has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
* Wound is confirmed as being free of infection and absence of osteomyelitis

Exclusion Criteria:

* Pregnant, planning to become pregnant during the study timeframe, or breast feeding
* Unable or unwilling to receive porcine collagen
* Wound is infected or presence of osteomyelitis
* Allergy or sensitivity to collagen
* Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol
Closed-loop DBS in Parkinson's Disease

Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of primary Parkinson's disease: Diagnosis of primary Parkinson's disease should meet the diagnostic criteria outlined in the "Diagnosis Standards for Parkinson's Disease in China" published in 2016 or the diagnostic criteria for primary Parkinson's disease by the International Parkinson and Movement Disorder Society (MDS) published in 2015.
2. Good response to levodopa combination therapy.
3. Significant reduction in drug efficacy or significant impact on the patient's quality of life due to prominent motor complications.
4. Intolerable adverse reactions to medication affecting its efficacy.
5. Presence of uncontrollable tremors despite medication.

Exclusion Criteria:

1. Patients who have undergone pallidotomy or other brain surgeries.
2. Patients with secondary Parkinson syndromes or Parkinson plus syndromes.
3. Patients with concurrent central nervous system and peripheral nervous system diseases.
4. Patients with severe systemic diseases, unstable vital signs, or those who cannot tolerate clinical assessments.
5. Patients with severe psychiatric disorders.
6. Patients who are unable to provide informed consent due to cognitive or communication impairments or those who refuse to sign the informed consent form.
The Use of Electrical Stimulation to Increase Anal Pressures

The goal of this clinical trial is to learn about the feasibility of inducing contraction of the anal sphincter by transcutaneous neuromuscular electrical stimulation in patients with fecal incontinence.

The main questions it aims to answer are:

* Efficacy of the specific stimulation protocol to increase anal pressures
* Tolerability and safety Participants will be exposed to the stimulation with the changes in pressure will be studied using high resolution anorectal manometry


Eligibility Criteria:
Inclusion Criteria:

* Undergoing anorectal manometry for the evaluation of fecal incontinence indication
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* \>18 years old

Exclusion Criteria:

* Pregnant or attempting to become pregnant. The safety of electronic muscle stimulators during pregnancy has not been established.
* An electronic implant (e.g. cardiac pacemaker, implanted defibrillator) or suffer from heart problems.
* Conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine
* Cancer, epilepsy, or cognitive dysfunction.
* Pelvic floor surgery within the last six weeks.
* Complete denervation of the pelvic floor.
* Advanced full thickness rectal prolapse.
* Injured, inflamed or any significant disease in the peri-anal skin.
* Allergy to any component of the device, either known of developed during testing.
* Moderate to severe proctitis of any etiology.
* Skin irritation at the site of the stimulating electrodes
Microcirculation of Patients With Kidney Transplant

This study measures the sublingual microcirculation of patients with kidney transplant using MicroScan. The data will be compared with data of health volunteers and end stage renal disease patients on hemodialysis.

This study measures the sublingual microcirculation of patients with kidney transplant using MicroScan. The data will be compared with data of health volunteers and end stage renal disease patients on hemodialysis. The microcirculation date includes total small vessel density, perfused small vessel density, proportion of perfused vessels, microvascular flow index, and heterogeneity index.

Eligibility Criteria:
Inclusion Criteria:

* patients with kidney transplant for more than one month

Exclusion Criteria:

* Body mass index (BMI) \< 18.5 or \> 30
* diagnosis of sepsis or trauma, or admitted to intensive care unit within one month before enrollment
* body temperature \< 35.5 or \> 37.5 Celsius
* patients with tongue resection
* non-native speaker
The Effectiveness Yoga@Work Among Office Workers With Chronic Nonspecific Neck Pain (CNNP)

Chronic nonspecific neck pain (CNNP) is a public health issues with a 50% life prevalence. CNNP is a leading cause of disability which contributes to higher costs due to loss of productivity, disability, and increased absenteeism from work. Yoga has been found effective managing neck pain but there has been no study at work setting for chronic non-specific neck pain.

To determine the effectiveness of Yoga@work program for chronic non specific neck pain among office workers, present randomised controlled trial was undertaken.


Eligibility Criteria:
Inclusion Criteria:

* Participants who gave written informed consent
* Having neck pain for more than 3 month

Exclusion Criteria:

* Systematic disorder
* Neck or spine injuries
* Recent surgery
A Comparison of Pregabalin (Lyrica®) to Placebo in Pain Relief After Photorefractive Keratectomy (PRK) Surgery

The purpose of this study is to compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.

Study subjects will be taken from a standard group of typical candidates for PRK surgery including active duty and DoD (Department of Defense) beneficiaries. Prior to being approached for the study, all patients will have had a previous desire for surgery and had a pre-operative evaluation indicating healthy ocular status.

Patients scheduled for PRK surgery will be briefed on the purpose of the study and invited to participate at the preoperative appointment. After the consent process, patients will be randomized in a 1:1 fashion to receive either oral pregabalin 75mg twice daily or placebo for pain control, in addition to the standard care treatment of as needed Percocet and tetracaine ophthalmic drops. Subjects will be evaluated daily for 4 days post-operatively for subjective pain assessment, adverse drug events and compliance, use of concomitant medications as well as monitoring of healing time. Quality of life will be measured at baseline and post-op day 2 when the peak of pain is anticipated. Analysis will be performed to detect an approximate 10% improvement in pain scores. Secondary outcomes will include measuring healing time, quality of life and use of rescue medications.

Eligibility Criteria:
Inclusion Criteria:

* Healthy ocular status
* Stable preoperative refractive anisometropia
* Consented to the PRK surgical procedure

Exclusion Criteria:

* Pregnant or breastfeeding
* Diagnosed with autoimmune disease or diabetes
* Patients with a known adverse reaction or hypersensitivity to gabapentin or pregabalin
* Patients only desiring PRK on one eye
* Patients with history of drug use/abuse/addiction
* Patients who are on chronic pain medications
* Patients currently taking anti-epileptic, antidepressant and/or anti-psychotic medications
* Patients with a history of suicidality
* Patients with chronic renal insufficiency (defined as estimated creatinine clearance less than 30ml/min or Scr ≥ 2.0) 10) Patients who have experienced angioedema, or have heart failure
Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).


Eligibility Criteria:
Inclusion Criteria:

* Competent and willing to voluntarily provide informed consent
* 18 years of age or older
* In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia
* Other inclusion criteria to be evaluated by the investigator

Exclusion Criteria:

* No allergies to the medications and/or the active ingredients of any of the study medications
* No medications with the same activities as the of the active ingredients in OMS302 for defined time intervals prior to and after surgery
* No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
* Other exclusion criteria to be evaluated by the investigator
The Clinical Outcomes of the Arthroscopic and Open Modified Broström Operation in CLAI and GJL

Investigators designed this randomized controlled trial to compare the clinical outcomes of open and arthroscopic modified Broström operation for the treatment of CLAI and GJL.

The open modified Broström operation is the first line to treat chronic lateral ligament instability (CLAI). Arthroscopic techniques gain popularity for less invasivity, quick recovery to normal and sports activities, and the possibility to treat other intraarticular disorders. Studies have shown significantly poor clinical and radiological outcomes and a higher rate of failure in patients with generalized joint laxity (GJL) than patients without after open modified Broström operation. However, there is no study to compare the open and arthroscopic modified Brostrom operation for patients with GJL and CLAI. So, investigators designed this randomized controlled trial. The primary outcomes are Karlsson, American Orthopaedic Foot \& Ankle Society, and visual analogue scales. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years

Exclusion Criteria:

- Patients with an acute or subacute ankle injury (within 3 months) Injury of the deltoid ligament Alignment of lower extremity greater than 5 degrees Fractures of the lower extremity Stage III or IV osteoarthritis Patients who refused to participate in the study
Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency

This study is conducted in China only. The purpose is to demonstrate the efficacy and safety of once weekly dosing of TransCon hGH, a long-acting growth hormone product, compare to once-daily dosing of human growth hormone (hGH) after 52 weeks of treatment in prepubertal children with growth hormone deficiency (GHD).

Not Provided

Eligibility Criteria:
Inclusion Criteria:

* Prepubertal children with GHD in Tanner stage 1, aged of 3 years and below 17 years;
* Impaired HT defined as at least 2.0 standard deviations (SD) below the mean height for chronological age and sex (HT SDS≤-2.0) according to the Chinese 2005 standard；
* Diagnosis of GHD confirmed by 2 different GH stimulation tests, defined as a peak GH level of ≤10 ng/mL, determined with a validated assay. Bone age (BA) at least 6 months less than the chronological age；
* Baseline IGF-1 level of at least 1.0 SD below the mean IGF-1 level standardized for age and sex (IGF-1 SDS ≤-1.0)；
* Written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is 8 years old or above).

Exclusion Criteria:

* Children with a body weight below 12 kg；
* Prior exposure to recombinant hGH or IGF-1 therapy；
* Children with past or present intracranial tumor growth as confirmed by a sellar MRI scan (with contrast dye recommended) at Screening
* Children born SGA (birth weight ≤10th percentile for gestational age according to the Chinese reference)；
* Children with psychosocial dwarfism；
* Children with idiopathic short stature；
* Other causes of short stature such as coeliac disease, hypothyroidism, or rickets；
* History or presence of malignant disease; any evidence of present tumor growth;
* Subjects with diabetes mellitus；
* Closed epiphyses；
* Major medical conditions and/or presence of contraindication to hGH treatment；
* Participation in any other trial of an investigational agent within 3 months prior to Screening.
Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid

In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways. The study will enroll adult patients suffering from coronary artery disease (narrowing or blockage of vessels that supply the heart with blood) or peripheral artery disease (narrowing or blockage of vessels that supply the legs or head with blood). The study will focus on information on when and why physicians are starting to treat patients with Xarelto in addition to ASA, treatment duration, reasons to discontinue treatment and previous therapies. The study will also look into treatment outcomes for patients being treated with a combination of Xarelto and ASA by their physicians.

The study aims to collect real-world data on treatment patterns and decision points for treatment in patients with coronary artery disease (CAD) and/ or peripheral artery disease (PAD) treated with rivaroxaban 2.5 mg \[twice daily\] for the prevention of major cardiovascular events in adult patients with CAD at high risk of ischemic events and/ or documented PAD and to describe outcomes of an antithrombotic regime based on dual pathway inhibition (vascular dose of rivaroxaban 2.5 mg \[twice daily\] plus low-dose ASA \[once daily\]) across the broad range of patient risk profiles encountered in routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Adults with diagnosis Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD).
* Treatment according to local marketing authorization, rivaroxaban 2.5 mg twice daily started within 4 weeks prior to enrolment. Only in those countries with a marketing authorization of rivaroxaban in the acute coronary syndrome (ACS) indication, also patients already on rivaroxaban treatment for ACS, who are subsequently fulfilling criteria for CAD, are allowed to be enrolled within 4 weeks of this decision being made.

Exclusion Criteria:

* Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
* Participation in an interventional trial.
Reliability and Validity of the Turkish Version of the Coping Strategies Questionnaire

Chronic musculoskeletal pain is a major health problem in 35% of the general population in most developed countries. In addition to interventional therapies, the cognitive and behavioral abilities of the patient, are important for the solution of chronic pain. All of these abilities of patients are called coping strategies of pain.

The Coping Strategies Questionnaire (CSQ) is commonly used to measure methods of coping with various forms of chronic pain, including musculoskeletal pain. CSQ aims to evaluate the frequency and success of coping strategies with cognitive and behavioral pain. The validity and reliability of the questionnaire was tested and satisfactory results were obtained and it became a widely used tool in pain studies. The aim of this study was to translate and culturally adapt the original English version of the CSQ into Turkish version and to assess the validity and reliability of this instrument in patients with chronic musculoskeletal pain.

Eligibility Criteria:
Inclusion Criteria:

* Being eighteen years old or older,
* being diagnosed with chronic musculoskeletal pain (at least 6 months),
* Being a native Turkish speaker and being able to read Turkish,
* Receiving no treatment between test-retest assessments.

Exclusion Criteria:

* Inability to complete the form due to significant psychiatric or psychological disorder,
* having a neurological disease,
* Pregnant women.