cyrilzakka/clinical-trials huggingface dataset:
Latin America Real World Study With Inspiron Drug Eluting Stent - INSPIRON LATITUDE

Prospective, multicenter, single arm registry to monitor post-market clinical outcomes of patients treated with Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer.

Prospective, multicenter, single arm registry to assess the safety and performance of Inspiron Sirolimus-Eluting Stent with Biodegradable Polymer for the treatment of "real world" patients.

Eligibility Criteria:
Inclusion Criteria:

* All individuals aged over 18 years who signed the informed consent and had lesions in native coronary arteries treated only with Inspiron Sirolimus-Eluting stent.

Exclusion Criteria:

* Saphenous vein grafts or Mammary lesions;
* Individuals who have been treated within the last 6 months with another stent;
* Acute myocardial infarction with ST segment elevation;
* Chronic Total Occlusion
Dose Escalation for SBRT of Recurrent VT Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial

The objective of this study is to demonstrate that higher radiation doses are necessary to induce transmural scar formation which is currently assumed to be the underlying mechanism of successful long-term efficacy of VT treatment and therefore dose-escalation will lead to a significantly reduced long-term VT recurrence rate compared to the currently applied single dose of 25 Gy.


Eligibility Criteria:
Inclusion Criteria:

Patients with structural heart disease, in particular ischemic and non-ischemic cardiomyopathy: Implanted ICD and/or CRT-D. Prior ≥1 failed catheter ablation (with endocardial ± epicardial approach based on the substrate location and the ECG morphology of clinical VTs) procedure to control sustained monomorphic VT using currently recommended mapping and ablation techniques,2 or patients in whom ablation is not feasible. Reasons for lack of epicardial ablation and non-feasibility of catheter ablation must be specified. Sustained VT recurrence after catheter ablation on optimised antiarrhythmic medication.

Age ≥18 years. IRB-approved, written informed consent must be provided

Exclusion Criteria:

Patients with only premature ventricular contractions.

Patients with sustained VT/VF who demonstrate:

Acute myocardial infarction; Primary electrical disease (channelopathy); Reversible and treatable cause (e.g., drug-induced or intoxication) of VT that can be adequately addressed otherwise; A target that cannot be safely and precisely defined based on stereotactic radiotherapy accuracy requirements (e.g., anatomical interference from OARs, overlapping prior radiation therapy to the thoracic region); Pregnancy or breastfeeding; Inability to provide informed consent.
Cilostazol After Lower Extremity Arterial Revascularization Trial

Twenty patients will be recruited to CLEAR. Ten will be randomized to the treatment arm (Cilostazol) and tenwill be randomized to the control group. Patients randomized to the treatment arm will receive Cilostazol for 90 days. The primary purpose of this study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required to adequately power a trial of Cilostazol versus usual care without Cilostazol and its effect on quality of life.

Cilostazol is the only medication approved for use in peripheral arterial disease (PAD) patients to reduce claudication symptoms. Contemporary data has demonstrated that Cilostazol improves patency after endovascular interventions in multiple randomized trials and retrospective studies done in Japan in both critical limb ischemia and claudication patients. However, Cilostazol use after peripheral revascularization has been sporadic and there has been no research to estimate patient quality of life with use of Cilostazol after open or endovascular lower extremity revascularization.

This is a prospective investigator initiated single-center open-label, non-placebo controlled pilot study. Eligible patients would be randomized to either the Cilostazol treatment or the non-Cilostazol treatment groups using a closed envelope randomization technique. Twenty patients will be recruited and randomized; Ten to the treatment group and tento the control group.

The primary purpose of this pilot study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required for adequate powered trial of Cilostazol versus usual care without Cilostazol and its effect on Quality of Life.

Eligibility Criteria:
Inclusion Criteria:

* At least 35 years of age
* Atherosclerotic peripheral arterial disease
* Able to provide informed consent
* Lower extremity open or endovascular revascularization.

Exclusion Criteria:

* Known CHF (class III/IV)
* Allergic reaction to phosphodiasterase inhibitors
* Intracranial bleeding within 3 months or active bleeding peptic ulcer disease
* Traumatic vascular injuries requiring revascularization
* Pregnant or breast feeding women or women who plan to get pregnant over the study period
* Planned ipsilateral major amputation within 30 days of index procedure
* Moderate to severe hepatic impairment.
Dual-echo and Inversion Recovery Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders. Diagnostic Accuracy Study

In the present study, investigators are going to investigate the potential of inversion recovery (fluid attenuated inversion recovery -FLAIR and short-TI Inversion Recovery -STIR) sequence images to demonstrate joint effusion, compared to T2-weighted images.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pain related to temporomandibular joint.
* Patients with limited mouth opening.

Exclusion Criteria:

* Patients with pain related to temporomandibular joint for less than one month duration.
* Patients with limited mouth opening for less than one month duration.
* Patients with history of TMJ surgical intervention.
* Patients with history of TMJ arthrocentesis.
A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients

The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Central subfiled macular thickness greater than or equal to 250 microns
* CME in either eye.
* Other protocol-defined exclusion criteria may apply.
Zoladex® 10.8 BC RWS

This is a multi-center, retrospective-prospective, observational, active-control, non-inferiority, real world study using hospital medical record data, with objectives to evaluate E2 suppressive effect of Zoladex® 10.8 mg is non-inferior to Zoladex® 3.6 mg. Eligible breast cancer patients who received Zoladex® from January 1st, 2015 till December 31st, 2021(including December 31st, 2021) will be identified and included for retrospective data collection and analyses in this study. And prospective data will be monthly collected of eligible patients receiving Zoladex® after January 1st, 2022 (including January 1st, 2022) until approximately 1000 patients being included in this study for analysis. (If site has specific identification of retrospective data and prospective data, it will be subject to the requirement of site). The first date of the presence of Zoladex® treatment or prescription record for breast cancer during the study period will be considered the index date for patients. According to the Zoladex® treatment at the index date, patients will be categorized into two cohorts: Zoladex® 10.8 mg or Zoladex® 3.6 mg.

About 10-15 hospitals will be included in this study. To be considered, the hospitals need to have relatively large number of eligible patients, geographic representativeness and willingness to participate in this study. Approximately 1000 eligible patients from selected hospitals during the study period will be included and matched with propensity scores. It is expected that at least 150 matched patients in each of the two cohorts will eventually be included in the primary endpoint analysis. The final subject number will be based on the actual situation of the study.


Eligibility Criteria:
Inclusion Criteria

* Diagnosed with primary breast cancer
* Female, ≥18 years old (at index date)
* HR positive
* Receive Zoladex® 10.8 mg or Zoladex® 3.6 mg treatment
* Premenopausal status prior to the treatment of Zoladex®. Baseline premenopausal status will be confirmed if the patient's last E2 measurement within 180 days prior to the index date indicated premenopausal status or there was a recorded menstrual history within 180 days prior to the index date
* At least one actual or expected E2 testing measurement within 8-28 weeks of the index date Exclusion Criteria
* Patients received concurrent treatments that may affect E2 testing results
Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes

This trial is conducted globally. The aim of the trial is to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. The trial is event-driven, i.e. the maximum trial duration (up to max. 148 weeks) will depend on the accrual of major adverse cardiovascular events (MACE) in this trial and the remaining research programme. The incidence of MACE will be monitored throughout the trial which will be terminated according to plan when pre-specified stopping criteria are met.


Eligibility Criteria:
Inclusion Criteria: - Men and women with type 2 diabetes mellitus - Age above or equal to 50 years at screening and clinical evidence of cardiovascular disease or age above or equal to 60 years at screening and subclinical evidence of cardiovascular disease - Anti-diabetic drug naïve, or treated with one or two oral antidiabetic drug (OADs), or treated with human Neutral Protamin Hagedorn (NPH) insulin or long-acting insulin analogue or pre-mixed insulin, both types of insulin either alone or in combination with one or two OADs - HbA1c above or equal to 7.0% at screening Exclusion Criteria: - Type 1 diabetes mellitus - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (exenatide, liraglutide, or other) or pramlintide within 90 days prior to screening - Use of any dipeptidyl peptidase 4 (DPP-IV) inhibitor within 30 days prior to screening - Treatment with insulin other than basal and pre-mixed insulin within 90 days prior to screening - except for short-term use in connection with intercurrent illness - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (eg diabetes ketoacidosis) within 90 days prior to screening - History of chronic pancreatitis or idiopathic acute pancreatitis - Acute coronary or cerebro-vascular event within 90 days prior to randomisation - Currently planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure New York Heart Association (NYHA) class IV - Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma - Personal history of non-familial medullary thyroid carcinoma - Screening calcitonin above or equal to 50 ng/L
Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings

Nearly half of the adult population in Latin American urban settings has abnormally high blood pressure. Although half of these subjects with high blood pressure are still in the pre-hypertensive stage (systolic blood pressure values in the 120-139 mmHg range or diastolic blood pressure in the 80-89 mmHg range), the rate of progression to hypertension is high (10-20% per year), according to studies done in other settings. The main objective of this proposal is to evaluate the effectiveness of an affordable and sustainable primary health care intervention to reduce blood pressure and prevent progression from pre-hypertensive status to hypertension in individuals at poor urban clinics in Argentina, Guatemala, and Peru. Our primary hypotheses are that pre-hypertensive subjects who receive mHealth (mobile health) support for 12 months (intervention group) will have lower blood pressure compared to individuals who receive the usual primary health care (control group); and that pre-hypertensive subjects will maintain lower blood pressure six months after receiving mHealth support. The investigators will determine the effects of an intervention using mHealth technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants. The intervention also aims to help participants become better informed, motivated, and encouraged to practice self-management of their own health; to improve patient satisfaction levels; provide tailored targeted interventions; and to improve patient-provider relationships. The proposal is designed as a proof-of-concept intervention in three Latin American countries that encompass a wide range of environments and health care settings. A total of 212 subjects (30-60 years old) per country will be recruited in primary health clinics and randomized to study groups. Blood pressure, anthropometry, and behavioral risk factors (physical activity, diet, stress, alcohol and tobacco use) will be measured at baseline and at months 6 and 12 during the intervention, and six months after the end of the intervention. The investigators will also evaluate feasibility, acceptability, cost-effectiveness, and process implementation of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure values in the 120-139 mmHg range or diastolic blood pressure in the 80-89 mmHg range
* No current anti-hypertensive medication
* Own a personal cellular phone

Exclusion Criteria:

* Previous diagnosis/treatment hypertension
* Illiteracy
* Another household member already in the study
Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS

Study to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet in benign prostatic hyperplasia patients with lower urinary tract symptomatic

GL2702 GLARS-NF1 tablet is controlled released formation which is made by GL Pharm Tech

Eligibility Criteria:
Inclusion Criteria:

* Over 50 years old, BPH diagnosted, Adult Male Subject
* IPSS ≥ 13 point
* PSA \< 4ng/mL
* 5ml/sec \< Qmax ≤ 15ml/sec

Exclusion Criteria:

* Prostatic cancer
* 250ml \< PVR
* ALT or AST \> 2 times (Upper Normal Range)
* Total Bilirubin \> 1.5 times (Upper Normal Range)
* Treated with α-adrenalin receptor blocker within 2weeks before screening
* Treated with 5Alpha-Reductase Inhibitor within 6 months before screening
* Treated with phytotherapy within 2weeks before screening
* Treated with Anabolic Steroid within 6 months before screening
An Efficacy and Safety Trial of Serostim® in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome

This is an open-label, multi-center, randomized, parallel-group, maintenance trial of Serostim® in subjects who have completed a prior Serostim® Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) trial (Study 22388). The subjects, who encountered toxicity during the antecedent protocol, will be assigned to a 1 milligram (mg) dose. All other subjects will be randomized in 1:1 ratio, to receive up to 2 mg or 4 mg of Serostim®, beginning from Day 1 of Week 1. Doses will be adjusted downward in subjects weighing less than 55 kilogram (kg). Serostim® therapy will be continued at the assigned doses through Week 12 (Period 1). Subjects, who will encounter toxicity during Period 1, will be assigned to the 1 mg group for Period 2. All other subjects will be randomized in a 1:1 ratio to receive up to 2 mg or 1 mg of Serostim® on a weight adjusted basis. Period 2 therapy will begin on Day 1 of Week 13, continuing through Week 36. Study visits are required at Screening (that is, Final Visit of the antecedent trial), Day 1 of Week 1 (Baseline), and at Weeks 2, 6, 12, 14, 24, 30 and 36.


Eligibility Criteria:
Inclusion Criteria:

* Complete all treatments prescribed by the antecedent protocol (Study 22388)
* Be able and willing to comply with the protocol for the duration of the study, including concomitant therapy restrictions
* Have given written informed consent
* If female, be post-menopausal, surgically sterile, or using adequate contraception

Exclusion Criteria:

* Experienced a protocol defined toxicity or any other adverse event, which caused premature withdrawal from the antecedent study (Study 22388)
* Withdrew from the antecedent study or was discontinued prematurely for any other reason
* Based on the Final Visit evaluations from the antecedent trial, would be required to withdraw from the antecedent protocol, if (theoretically) the antecedent trial continued beyond the Final Visit
* Based on the Final Visit evaluations from the antecedent trial, would be required to temporarily stop or reduce the dose of study drug, if (theoretically) the antecedent trial continued beyond the Final Visit. This does not apply to subjects whose study drug was temporarily stopped or whose study drug dose was reduced prior to the Final Visit (Screening), provided they continued in the antecedent protocol and are stable at the time of the Final Visit (Screening)
Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

The purpose of this study is to determine if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs.

Stress shielding related bone resorption in the proximal femur after total hip arthroplasty continues to be a problem. The purpose of this prospective, randomized study was to evaluate which of the two anatomical stem designs achieved a more physiological load transfer by assessing bone mineral changes in the proximal femur after stem implantation.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of hip joint requiring total hip arthroplasty

Exclusion Criteria:

* Neurologic disorders affecting motor function of lower extremity
* foot and ankle disorders limiting ambulation of the patient
* Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
* Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study

The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Nonalcoholic fatty liver disease (NAFLD) patients who are scheduled for liver biopsy for the differential diagnosis of NASH and/or NAFLD patients who are scheduled for the MR elastography (MRE) and MRI-proton density fat friction (MRI-PDFF).
* Without a history of alcohol use, which lead to alcoholic hepatic involvement (pure alcohol below 30 g/day for male, 20 g/day for female).

Exclusion Criteria:

* Patients with endocrine disorder (hypopituitarism, growth hormone deficiency, hyperthyroidism etc.), serious nutrition disorder, and drug-induced hepatic involvement (steroid, tamoxifen, valproic acid, amiodarone etc.), which may lead to the steatosis
* Hepatitis B, Hepatitis C and HIV patients
* Primary biliary cholangitis, Primary sclerosing cholangitis, and Autoimmune hepatitis patients
* Wilson's disease, α1-antitrypsin deficiency, and hemochromatosis patients
* Malignant liver tumor, common bile duct stone, and jaundice patients
* Patients after jejunoileal bypass surgery or massive intestinal resection surgery
* Patients whose treatment changes during the period between imaging examination and liver biopsy, including medications such as antidiabetic drugs and other treatments which may change the fat deposition or inflammation of liver.
Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization

The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac catheterization.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female;
* The subject is of any racial or ethnic group;
* The subject is between 0 days and 12 years of age;
* Is less than 40 kg;
* The subject is scheduled for a cardiac catheterization for treatment or diagnosis of a cardiovascular disease;
* The scheduled cardiac catheterization includes catheter placements in the central venous circulation and central arterial circulation, or catheter placement in the central venous circulation with a pre-existing arterial catheter;
* The subject is American Society Anesthesiologist (ASA) status 1 through 4; and
* The subject's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate.

Exclusion Criteria:

* Is greater than twelve (12) years of age;
* Has pre-existing allergies to adhesive tapes or adhesives on neonatal ECG pads;
* Has pre-existing skin condition at the site where the Nonin cerebral oximeter sensor will be placed (e.g., eczema, dermatitis);
* Has craniofacial disease preventing application of the sensor to the forehead;
* Has sickle cell anemia or other hemoglobinopathy;
* Has disease of the cerebrovasculature including the jugular or carotid vessels;
* Was previously on ECMO involving the carotid or jugular vessels that could have resulted in disease or ligation;
* Is not able to be in a supine position with cardiac catheterization laboratory table angle zero degrees with a neutral neck position at zero degrees rotation;
* Has acute neurological injury (seizure, stroke, encephalopathy, meningoencephalitis currently or within the past 10 days), or a structural brain lesion (eg, arteriovenous malformation, cyst) in the optical field beneath the sensor;
* Has an emergency, life-threatening condition (American Society of Anesthesiologists Physical status 5 or 6) impacting the ability to obtain informed consent;
* Or has another condition, which in the opinion of the principal investigator would not be suitable for participation in the study.
Beta-CIT-SPECT and Neurophysiology in Depression

Aim of this project is to investigate the effects of escitalopram on monoamine transporter (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients with depression.


Eligibility Criteria:
Inclusion Criteria:

* Psychiatric in or outpatients with acute depressive episode
* Indication for pharmacological treatment

Exclusion Criteria:

* Acute suicidality
* Neurological or severe somatic disorders
* Occupational exposition to radiation \>15 mSv per year
* Women during pregnancy or lactation