cyrilzakka/clinical-trials huggingface dataset:
Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL

This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.


Eligibility Criteria:
Inclusion Criteria:

1. Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned;
2. Preoperative corneal astigmatism of one diopter or more in the operative eye;
3. Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better;
4. Clear intraocular media other than cataract in each eye;
5. Ability to understand, read and write English in order to consent to study participation;
6. Availability, willingness, sufficient cognitive awareness to comply with examination procedures;
7. Signed Informed Consent Document (ICD) and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Exclusion Criteria:

1. Recurrent severe anterior or posterior segment inflammation or uveitis;
2. Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible;
3. Circumstances that would result in damage to the endothelium during implantation;
4. Suspected ocular microbial infection;
5. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;
6. Known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, \[macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.\];
7. Planned monovision correction;
8. Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.
An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)

The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol in adults with moderate to severe chronic plaque psoriasis when administered every 2 weeks.

This study consists of the following Periods:

* Initial Treatment Period from Week 0 to Week 16
* Maintenance Treatment Period from Week 16 to Week 48
* Open-label Treatment Period from Week 48 to Week 144
* Safety Follow-Up Period from Week 144 to Week 152

Eligibility Criteria:
Inclusion Criteria:

* Provided informed consent
* Adult men or women \>= 18 years
* Chronic plaque psoriasis for at least 6 months
* Baseline psoriasis activity and severity index \>= 12 and body surface area \>= 10 % and Physician's Global Assessments score \>= 3
* Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Erythrodermic, guttate, generalized pustular form of psoriasis
* History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
* Congestive heart failure
* History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
* Concurrent malignancy or a history of malignancy as described in the protocol
* History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis)
* Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug (in Czech Republic and Germany) and within 3 months for all other countries. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose of study drug
* Any other condition which, in the Investigator's judgment, would make the subject unsuitable for participation in the study
* Other protocol-defined exclusion criteria may apply
High Fat - High Protein Diet in the Treatment of Obesity

The purpose of this study is to examine the effects of a low calorie high fat/protein diet on body fat and body composition in overweight and obese subjects. The investigators will also test the effects of this diet on secondary outcomes such as: fluid and electrolyte balance, cholesterol, inflammation, sugar and insulin metabolism, fat hormones, blood pressure and feelings of fullness.

Participation in this study requires 2 screening visits to the outpatient clinic, and if participants qualify, 10 inpatient study weeks.

Subjects will be admitted to the Rockefeller University Hospital for the 10 week in-patient phase of the study. The first 2 weeks consist of a weight stabilization period, during which subjects will be required to eat an average American diet. This is followed by the 6 week weight loss period where subjects will be put on a low calorie high fat/protein diet. During the weight loss period, calories will be cut by 50% compared to the weight stabilization period. This will be followed by a 2 week weight maintenance period during which calories will be added to the diet to maintain the new weight. Appropriate adjustments will be made to keep the subject's weight stable.

During the entire inpatient study, subjects will consume one multivitamin per day (Centrum, always complete, from A to Zinc) and one iron supplement per day. In addition, unlimited access to zero calorie liquids (water/diet soda) will be available and subjects will be encouraged to maintain their usual activity level.

Females of reproductive age need to make sure that they do not become pregnant during the inpatient study. Urine will be tested for pregnancy once during each phase of the study.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 30 to 34.9 or
* BMI of 25 to 29.9 and a waist circumference \> 88cm (35in)
* Pre-menopausal-

Exclusion Criteria:

* High Blood Pressure
* High Cholesterol
* Diabetes
* Anemia
* Liver disease
* Kidney disease
* HIV positive
* Syphilis
* Hepatitis B/C positive
Effect of Allopurinol on Left Ventricular Function in Children With Dilated Cardiomyopathy

The aim of this study is to detect effect of allopurinol supplementation in pediatric patients with dilated cardiomyopathy.

DCM as a serious cardiac disorder in which structural or functional abnormalities of the heart muscle can lead to substantial morbidity and mortality owing to complications such as heart failure and arrhythmia Among patients with heart failure (HF), elevated serum uric acid levels and increased oxidative stress have been associated with increased mortality, implicating xanthine oxidase as a possible therapeutic target Xanthine oxidase (XO), a superoxide-generating enzyme, is up regulated in animals (6,7) and in humans with heart failure. Acute administration of the XO inhibitor allopurinol improves the mechanical efficiency of the failing heart ), whereas oxygen consumption paradoxically decreases. Direct XO inhibition in cardiac muscle leads to increased force generation by the myofilaments at any given level of activator calcium(10).

Allopurinol, an inhibitor of xanthine oxidase, may be a novel therapeutic agent for HF. Allopurinol reduces uric acid levels, prevents acute gout, and acts as an anti oxidant, which could be beneficial among HF patients(5)

Eligibility Criteria:
Inclusion Criteria:

1 - children (1-16) year's age with impaired left ventricular systolic function due to dilated cardiomyopathy, who attend pediatric cardiology unit 2-children attend to pediatric cardiology out patient clinic in Assiut university children hospital 3-children with no allergic reaction from allopurinol

Exclusion Criteria:

1. children with impaired left ventricular systolic function due to other causes like congenital heart diseases
2. children with acquired heart diseases
3. patients with allergic reaction or contra indicated from Allopurinol
This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made \> 6 months prior to study entry
* Screening HbA1c \> 7.0%
* Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione

Exclusion Criteria:

Smoking within last 6 months PFTs outside of range

* Type 1 diabetes mellitus
* Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
* Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit 1. However, patients with elevated ALT \>1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial

This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT01828957) will be followed-up until 60 months of corrected age.

Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: corrected age of 6, 12,18, 24, 36, 48, and 60 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject who completed the safety and efficacy evaluations in Pneumostem Phase II clinical trial
* Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

Exclusion Criteria:

* Subject whose parent or legal representative does not agree to participate in the study
* subject who is considered inappropriate to participate in the study by the investigator
Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer

The purpose of this study is to learn more about the factors that influence decision-making before surgery (distress about cancer and/or reproductive concerns) and the possibility of regret after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥ 18 and ≤ 50 years
* Premenopausal
* Endometrioid histological diagnosis
* Scheduled for surgical intervention at MSKCC
* FIGO grade 1-2, clinical stage I
* Disease confined to uterus, no clear evidence of deep (≥50%) myoinvasion on imaging (MRI preferred, ultrasound optional)
* Normal ovaries on preoperative imaging
* Able to provide informed consent
* English-speaking

Exclusion Criteria:

* Known Lynch syndrome
* Prior bilateral oophorectomy
* Personal history of hormone receptor-positive breast carcinoma
* Increased risk of ovarian cancer identified on the basis of family or personal history
* Women currently on hormonal contraception, letrozole, or tamoxifen may not opt-in to AMH
* Women who recently underwent ovarian stimulation within the past 3 months may not opt-in to AMH
* Women who have pituitary dysfunction (or any pituitary disorders) may not opt-in to AMH
* Women who completed chemotherapy within \<12 months may not opt-in to AMH
Measuring Upper Extremity Functional Movement with Accelerometry: FitBit® Vs Actigraph®

To determine the criterion validity of the FitBit® Flex™ compared to the ActiGraph's Bluetooth® Smart wGT3X-BT wireless activity monitor, and contribute to the clinical utility of accelerometry measurement of UE movement.

Participants will wear two different accelerometers (FitBit and Actigraph) to record normal, everyday movement. Data from each accelerometer will be compared to determine similarity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults with no upper extremity limitations

Exclusion Criteria:

* Upper extremity limitations
Integrated Depression Care

The Integrated DEpression CAre (IDECA) Programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure).

The following deliverables apply:

1. Development and implementation of a shared care protocol for depression management involving primary, secondary and tertiary care levels;
2. Training module for physicians and other care providers in population health management for patients with depression;
3. Training module for case managers/integration of a case management function into existing depression service offerings;
4. A patient education module for depression self-management;
5. A financing model for integrated depression care.

Eligibility Criteria:
Inclusion Criteria:

* persons between 18-65
* presenting to the general practitioner's office
* with depressive symtomatology

Exclusion Criteria:

* Severe depression warranting direct referral to specialized services

Inclusion criteria are kept broad on purpose as it's one of the research questions to define for which patients the intervention (namely the case management) is appropriate.
Survey Study for Velaglucerase Alfa (VPRIV) in Japan

The objective of this post-marketing survey study is to collect data to determine the safety and efficacy of velaglucerase alfa (VPRIV) in participants with Gaucher disease who are new to therapy or have been switched from another therapeutic agent for Gaucher disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants with a confirmed diagnosis of Gaucher disease
* Participants who are either naïve to treatment or participants that have been treated with another therapeutic agent for Gaucher disease
* Participants who start VPRIV treatment or transition from VPRIV clinical studies during the enrollment period

Exclusion Criteria:

-
Effect of Olmesartan and Nebivolol on Ambulatory Blood Pressure and Arterial Stiffness in Acute Stage of Ischemic Stroke

Single-blind, randomized, active-treatment controlled clinical study evaluating the effect of omesartan and nebivolol versus no treatment on 24-hour brachial and central aortic blood pressure in hypertensive patients with acute ischemic stroke

A total of 60 patients with hypertension and acute ischemic stroke (clinic BP \>160/100 mmHg and \<220/120 mmHg at day 3 of stroke onset) will be randomly allocated to therapy with olmesartan (20 mg/day) or nebivolol (5 mg/day) or no treatment between the 3rd to 7th day of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a first diagnosis of an acute ischemic stroke (permanent or transient)
2. BP levels \>160/100mmHg at start of the third day of hospitalization
3. BP levels \>160/100mmHg and \<220/120mmHg at start of the fourth day of hospitalization

Exclusion Criteria:

1. Patients with confirmed hemorrhagic stroke with computer tomography at hospital admission.
2. Patients with chronic atrial fibrillation or other cardiac arrhythmia.
3. Patients with BP levels \>220/120 mmHg during the hospitalization or patients with other hypertensive emergency situation (i.e. acute myocardial ischemia, aortic dissection, acute pulmonary edema, acute renal failure, hypertensive encephalopathy) which demands fast BP reduction with the use of intravenous antihypertensive drugs, according to current guidelines {Jauch, 2013 340 /id}.
4. Patients with specific indication for treatment with blockers of the renin-angiotensin-aldosterone system (RAAS) other than hypertension (i.e., congestive heart failure, acute myocardial ischemia).
5. Patients with specific indication for treatment with β-blockers other than hypertension (i.e., heart failure, tachyarrhythmia or angina pectoris).
6. Patients with specific contra-indications for RAAS blockers (hyperkalemia, history of angioedema) and patients with a history of allergic reaction or severe hypotension after olmesartan treatment.
7. Patients with specific contra-indications for β-blockers (heart rate \<60/min without a treatment with bradyarrhythmic drugs), chronic obstructive pulmonary disease or asthma and patients with history of allergic reaction after nebivolol treatment.
Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)

The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.

The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or cytologically proven NSCLC
* Unresectable disease
* Stage IIIA except T3N1M0 and IIIB which does not have disease extended to any contralateral hilar nodes, atelectasis of the entire lung or malignant pleural effusions
* A required radiation field of less than one half of one lung
* Measurable disease
* No previous chemotherapy or radiotherapy
* Age \>= 71
* Unable to receive cisplatin-based combination chemotherapy
* ECOG performance status (PS) of 0-2
* Adequate bone marrow, lung, hepatic, and renal function
* Written informed consent

Exclusion Criteria:

* Active infection, diarrhea, ileus, uncontrolled diabetes, myocardial infarction within three months, or severe other comorbidity
* Synchronous cancer or metachronous (within 5 years) malignancy
* Interstitial pneumonia or active lung fibrosis on chest X-ray
* Severe chronic obstructive pulmonary disease, chronic bronchitis, or bronchial asthma
* Pleural or pericardial effusion
* A history of severe hypersensitivity
* Mental disorder
* Judging of inappropriate condition for this study by physician
External Physical Vibration Lithecbole(EPVL) Versus Traditional Treatment for 4-10 mm Ureteral Stone

The investigator aims to perform a prospective and randomized controlled trial evaluating the safety and efficacy of External Physical Vibration Lithecbole(EPVL) in treating 4-10 mm ureteral stone.

Patients with ureteral stones less than 10 mm, would receive observation for stone passage, not requiring immediate surgery. There are many studies evaluating the effect of Medical expulsive therapy in treating ureteral stones, including a-blockers, and calcium channel blockers. Most of shuties concluded that the benefit of a-blockers might be among those with larger (distal) stones. There is no good method for the removal of upper ureteral calculi, except drinking water and exercising.

Recently, a new extracorporeal physical vibrational lithecbole (EPVL) device named Friend-I EPVL (Zhengzhou Fu Jian Da Medical Instrument Co., Zhengzhou, China) has proven to be an effective treatment for upper urinary tract residual calculi. The device was approved by the Chinese food and drug administration in 2012. A Simple harmonic motion technology in multi-direction was applied. The Lateral acceleration was provided by the physical vibration device in the base through the harmonic vibration wave in the horizontal direction, which induces the urinary stone separate with the kidney or ureter, and expands a moving space for the stone. Meanwhile, an axial effect was produced to push the stone by the physical vibration device in the handle through the harmonic vibration wave in the multi- direction. So, we think that EPVL may be effective in treating ureteral stones.

Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18 to 70 years
2. 4-10 mm single ureteral calculi
3. Normal serum creatinine
4. ASA grading: 1-2 levels.

Exclusion Criteria:

1. Pregnant or isolated kidney patients
2. Moderate or severe hydronephrosis
3. History of ureteral stricture
4. Multiple ureteral stones;
5. Acute urinary tract infection
6. Those who are taking α-receptor, calcium channel blocker or chinese medicine stone shovel
7. Dysfunction of blood coagulation
8. Obese patients (body mass index \> 28 kg / m2);
Effect of Green Tea in Obese Pre-hypertensive Women

The purpose of this study is to evaluate the effects of green tea on body weight, waist circumference, metabolic profile, inflammation, blood pressure and endothelial function in obese pre-hypertensive women.

Crossover randomized controlled double-blinded trial. Twenty women with obesity and pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a daily supplement of 3 capsules that contained either 500mg of green tea extract (GTE) or a matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments. Endothelial function was evaluated by peripheral arterial tonometry method, using Endo-PAT 2000®.

Eligibility Criteria:
Inclusion Criteria:

pre-hypertensive women obese adult

Exclusion Criteria:

pregnant smoker elderly
Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study

The purpose of this study is to assess the interobserver agreement (IOV) for pancreatico-biliary Volumetric Laser Endomicroscopy (VLE) de-identified clips using the new VLE criteria.

This is an Interobserver study to validate VLE criteria for indeterminate biliary and pancreatic duct strictures and evaluate impact on clinical management.

Objective: Validate diagnostic impact of VLE diagnostic accuracy on clinical management

Primary Objectives:

1. Interobserver study for criteria validation and accuracy, Positive predictive value (PPV) and Negative predictive value (NPV), sensitivity and specificity.
2. Evaluation of VLE diagnostics on clinical management (increased accuracy/faster detection)
3. Determination of learning curve to standardize credentialing for endoscopists to use and interpret VLE imaging for biliary/pancreatic treatment management.

B. Hypotheses / Research Question(s) The new VLE criteria for biliary and pancreatic duct strictures increase accuracy, thus leading to substantial impact on clinical management (Screening and Treatment)

Study Design (2 phase):

* Phase 1: Primary Objective 1 and 2 part of the study will be completed.
* Phase 2: Primary Objective 3 of the study will be conducted within 1 month.

Study Timeline: 3 months post WIRB approval. Sample size: 40 VLE Clips of at least 20 seconds featuring one or more the VLE criteria. All clips will have confirmed diagnosis for accuracy analysis. All clips will be de-identified. All clips will be removed from RedCAP and other secure cloud storage upon completion of study.

Clips will be supplied by NinePoint Medical, the company behind VLE OCT. All VLE clips will be from a dataset of clips collected from adults \> 18 and who underwent Endoscopic retrograde cholangiopancreatography (ERCP) with indeterminate biliary stricture indications. The clips are chosen based on the quality of the clips, duration, final diagnosis and presence of either benign or malignant criteria.

Investigators: Up to 30 Expert and non-expert endoscopists currently using VLE

Eligibility Criteria:
Inclusion Criteria:

VLE clips featuring indeterminate biliary or pancreatic duct stricture with confirmed diagnosis on pathology -

Exclusion Criteria:

-