cyrilzakka/clinical-trials huggingface dataset:
Observational Study of Corneal Opacities in Adults

A prospective observational study on corneal opacities (scar and stromal dystrophy) in adults (n=150) will be conducted at OHSU. The Optovue anterior segment OCT will be used to perform 3-D corneal scans. These scans will be used to assess opacity depth and measure corneal thickness (pachymetry), corneal topography (anterior and posterior), and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A comprehensive eye examination, Placido-ring corneal topography, ultrasound pachymetry, and Scheimpflug camera imaging, will be performed for comparison.


Eligibility Criteria:
Inclusion Criteria:

• Adult (18 \& older) patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy)

Exclusion Criteria:

* Inability to give informed consent.
* Inability to maintain stable fixation for OCT imaging.
* Inability to commit to required visits to complete the study.
Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531

RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well patients will respond to treatment. It may also help doctors learn more about how gemtuzumab ozogamicin works in the body.

PURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from patients with acute myeloid leukemia treated on COG-AAML0531.

OBJECTIVES:

* To genotype the genomic DNA from acute myeloid leukemia (AML) patients treated on COG-AAML0531 clinical trial for CD33 (and PgP and SOC3) single nucleotide polymorphisms (SNPs).

OUTLINE: Archived DNA samples are analyzed for single nucleotide polymorphisms in CD33, PgP, and SOC3 genes by Sequenome platform. Results are then compared with patients clinical outcomes, including minimal-residual disease levels post induction I (chemotherapy and gemtuzumab ozogamicin), complete remission rates, refractory disease with various levels of bone marrow blasts, development of CNS/persistent disease, event-free survival, overall survival, and toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with acute myeloid leukemia
* DNA samples from patients treated on COG-AAML0531

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery

The purpose of this study is to compare the clinical outcomes, safety and efficacy in patients randomized to receive either ketorolac or nepafanac following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* · Male or female \> 18 years of age scheduled to undergo cataract surgery

  * Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to any study medication or any of their components

  * Uncontrolled systemic disease
  * Required use of ocular medications other than the study medications during the study
  * Abnormal pre-operative OCTs if obtainable
  * Diabetic patients
  * Use of oral NSAIDS
  * Patients with ocular disease (macula degeneration, glaucoma, corneal disease) which reduces the potential visual rehabilitation (patients will ocular disease that will no preclude achievement of a 20/20 visual outcome may be included)..
Safety and Efficacy of Aliskiren + Hydrochlorothiazide (± Amlodipine 5 mg) in Patients With Moderate Hypertension

This study will assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. There was an optional study extension for the first eligible 60 patients who wanted to participate that contains the triple therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.

Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg plus hydrochlorothiazide 25 mg

Eligibility Criteria:
Inclusion Criteria for Core Study:

- Patients with mean sitting diastolic blood pressure ≥ 100 mmHg and \< 110 mmHg

Inclusion criteria for the Extension:

- msSBP ≥ 140 mm Hg and/or msDBP ≥ 90 mm Hg at Visit 5 of the core study

Exclusion Criteria for Core Study:

* Patients with mean diastolic blood pressure ≥ 110 mmHg or mean systolic blood pressure ≥ 180 mmHg
* Patients with prior stroke, hypertensive encephalopathy or heart attack
* Patients with type 1 diabetes mellitus
* Patients with type 2 diabetes mellitus with poor glucose control

Exclusion criteria for the Extension:

* Premature discontinuation in the core study or failure to comply with the core study protocol
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures, known or suspected contraindications to diuretics as described in the SmPC (particularly amlodipine 5 mg), e.g. severe hypotension, shock - including cardiogenic shock, obstructions impairing the flow out of the left ventricle (e.g. significant aortic stenosis)
* Any patient that the investigator decides should not participate in the extension study for medical reasons

Other protocol-defined inclusion/exclusion criteria applied to the study.
Chinese Sports Injury Treatment Situation and Development Trend of Big Data Research

This project is planned to be based on the medical insurance database collected by the China Health Insurance Research Association (CHIRA). As a national academic research institution, CHIRA collects medical insurance patient data, covering more than 20 provinces across the country. The data of more than 60 municipalities, provincial capitals, and prefecture-level cities are unique and authoritative in my country. Based on the CHIRA database, big data analysis for Chinese sports medicine patients, starting from the names of medical institutions, admission/discharge diagnosis and classification of medical items, etc., to investigate the development trend of arthroscopic surgery in China and understand my country's arthroscopic diseases The distribution characteristics and changing trends of the quantity.

Sports medicine is a multidisciplinary comprehensive discipline, and is positioned as a secondary discipline in the country. It is a clinical application-based discipline that combines medicine and sports to solve sports-related diseases from a medical perspective. The treatment range is centered on the joints. The main treatment method is arthroscopic technology to solve sports-related injuries. Together with postoperative rehabilitation, the goal is to achieve the greatest recovery of motor function. This project is planned to be based on the medical insurance database collected by the China Health Insurance Research Association (CHIRA). As a national academic research institution, CHIRA collects medical insurance patient data, covering more than 20 provinces across the country. The data of more than 60 municipalities, provincial capitals, and prefecture-level cities are unique and authoritative in my country. Based on the CHIRA database, big data analysis for Chinese sports medicine patients, starting from the names of medical institutions, admission/discharge diagnosis and classification of medical items, etc., to investigate the development trend of arthroscopic surgery in China and understand my country's arthroscopic diseases The distribution characteristics and changing trends of the quantity.

Eligibility Criteria:
Inclusion Criteria:

1. Discharge diagnosis of patients with sports injury-related injuries (ICD codes are M12, M13, M15-M19, M20-M25, M65-67, M70, M71, M75, M76, M94 and S33, S40, S43, S46, S51, S53, S63, S8, S73, S93)
2. Patients whose service item name in the detailed database contains the keyword "arthroscope". Any one of the above will be included in this topic.

Exclusion Criteria:

1. After the data is cleaned, it does not meet the requirements of sports injury patients;
2. The data content contains obvious defects and cannot be backfilled.
Postmarketing Surveillance Study of Anticholinergics - Prescribing Pattern and Therapeutic Long Term Value in Patients Suffering From Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD)

To obtain further information on the prescribing pattern and therapeutic long term value in patients suffering from moderate or severs Chronic Obstructive Pulmonary Disease under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders older than 40 years, who suffer from moderate or severe Chronic Obstructive Pulmonary Disease
* Only patients who showed following diagnosis parameters were to be considered for inclusion

  * FEV1 (Forced expiratory volume in 1 second) and FEV1/VC (vital capacity) \<70%
  * Reversibility FEV1 \<12% in the last 6 months
  * Smoker or Ex-smoker (\>10 Pack years)
  * Asthma to be excluded

Exclusion Criteria:

• Contraindications listed in the Instructions for Use/Summary of Product Characteristics
Factors Associated With CPC 1-2 in 110 Patients Admitted in French ICU for a Myocardial Infarction Complicated by an OHCA.

This study evaluate the association of some in-ICU factors with the neurological prognosis of patients admitted for an out-of-hospital cardiac arrest due to a myocardial infarction.

Pre-hospital factors associated with poor neurologic outcome are well known. Meanwhile, in-ICU factors for the first 24 hours may impact neurologic outcome.

This observational study aim to study the factors such as ECLS, NSE dosage, therapeutic hypotermia... and their association with neurologic outcome in patient with myocardial infarction due to instable coronaropathy complicated by an out-of-+hospital cardiac arrest.

This is designed to be a observationnal, prospective, multicentric national french study

Eligibility Criteria:
Inclusion Criteria:

* aged of 18 years old or more
* non opposition of the patient, or his family if he is unable to consent, after loyal and comprehensive explanation
* patient admitted in ICU
* the reason for admission is a resurected out-of-hospital cardiac arrest
* the cause of the cardiac arrest is a type 1 myocardial infarction

Exclusion Criteria:

* refractory cardiac arrest (no flow \> 30 minutes in normothermia)
* in-hospital cardiac arrest
* pregnancy
* patient under juridic protection
* opposition of the patient, or of his family is he is unable to consent.
Lived Experiences of Adolescents in the Treatment Process of Cancer and the Impact on Occupations

The purpose of this phenomenological study is to discover and illuminate the experiences of adolescents in the treatment process of cancer and the meanings they attach to these experiences, while maintaining their daily routines. The focus area of interest lies in the impact side-effects (psychological and physical) which these treatments may have on an individual's ability to participate with peers, maintain social activities, and be involved in daily occupation(s).

This study will explore the following research questions: 1. How do adolescent patients in the treatment process of cancer perceive and describe their experience of engaging in occupational routines? 2. What effect does the treatment process of cancer have on an adolescent's ability to participate in life situations such as creating and maintaining relationships with family, friends, peers, students, or people with similar backgrounds?

By doing this study, researchers hope to gain information so that occupational therapists can increase the profession's present body of knowledge and better understand these individuals at a transitional period in their lives.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric cancer patients
Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection

After performing VATS pulmonary wedge resections, a chest tube is routinely left in the pleural cavity to drain possible air leaks and fluid accumulations. Chest tubes after VATS pulmonary wedge resections are left in place a minimum of 1 day. However, this practice has no scientific foundations. The investigators believe it is possible to avoid the placement of a chest tube after this procedure in a great amount of patients. This is a randomized controlled clinical trial with analysis blinding in which the investigators want to compare the outcomes between installing a chest tube or not after VATS pulmonary wedge resections. The investigators will include consecutively patients with interstitial lung disease or indeterminate pulmonary nodules undergoing this procedure, at the participating institutions. The investigators calculated a sample size of 50 subjects in each group using pneumothorax \< 10% data from Luckraz et al and to determine a difference of hospital stay of 2 versus 1 day; DS(1.5), power = 0.9 and alpha = 0.05.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing video-assisted thoracoscopic surgery pulmonary wedge resections at the participating institutions.
* No evidence of air leak at the end of the surgical procedure.
* No active bleeding at the end of the surgical procedure.

Exclusion Criteria:

* Pleural effusion previous to the procedure requiring drainage after it.
* Bullous or emphysematous changes in lung parenchyma.
* Patients going to positive pressure in the airways after the procedure.
Utility of MRI With Doppler Ultrasound Gating for Advanced Fetal Monitoring

We will test an ultrasound device that uses sound waves to detect the fetal heart beat, and use this device to tell the MRI scanner when to collect pictures of the fetal heart. This will help freeze motion of the fetal heart, to make MRI pictures sharper. This will be important for assessing human fetal heart disease, an active area of research at our institution.


Eligibility Criteria:
Inclusion Criteria:

* pregnant adults (age 18 and up) with fetus affected by congenital heart disease
* singleton pregnancy in their 2nd and 3rd trimesters
* scheduled for a clinical fetal ultrasound examination at the Fetal Echocardiography Clinic at SickKids

Exclusion Criteria:

* claustrophobia
* cardiac pacemaker
* non-MRI compatible implants
* non-singleton pregnancy
* obesity (BMI \> 30)
Below-elbow or Above-elbow Cast for Extra-articular Distal Radius Fractures

The aim of this prospective randomised study was to shed more light on the issue by comparing the capacity of long plaster casts (above-elbow, LC) and short plaster casts (below-elbow, SC) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (2R3A2.2, according to the AO/OTA classification). The initial hypothesis was that the short cast would be equally as effective as the long cast in treating this type of fracture. The secondary objective of the study was to determine whether or not there is a direct correlation between radiological parameters and functional outcomes in such patients.

Distal radial fractures are common traumatic injuries, but their management remains controversial, Hence, we conducted a two-arm, parallel-group, prospective randomised trial to compare the capacity of long casts (above-elbow) and short casts (below-elbow) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (AO/OTA classification: 2R3A2.2). Eligible patients with AO/OTA 2R3A2.2 fractures treated with closed reduction and cast immobilization were randomized to the long cast group or to the short cast group. Baseline radiological parameters, radial inclination (RI), radial height (RH), ulnar variance (UV) and palmar tilt (PT) were taken, and compared with clinical (DASH, Mayo Wrist and Mayo Elbow) and radiological scores taken at 7-10 days, 4 weeks and 12 weeks. Furthermore, to evaluate correlations between radiological parameters and functional outcomes, patients were divided into two groups according to whether or not their radiological parameters at Follow-ups 2 and 3 were acceptable, i.e. within the range 11-12 mm for RH, 16°-28° for IR, -4-+2 mm for UV, and 0°-22° for PT.

Eligibility Criteria:
Inclusion Criteria:

* extra-articular fractures of the distal radius with dorsal displacement (type 2R3A2.2 according to the AO classification).
* eligible for conservative treatment with plaster

Exclusion Criteria:

* open fractures
* extra-articular distal radius fracture with volar displacement
* a history of allergy to the cast material
* patients scheduled for surgical treatment
Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children

Zinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to determine how best to integrate programs designed either to prevent zinc deficiency or to treat diarrhea.

The overall objective of this project is to determine the most effective approach to prevent zinc deficiency and treat diarrhea, such that a single approach could provide the maximal beneficial impact on the health and nutritional status of young children and greatest simplicity of implementation.

This is a single-center cluster- and household-randomized, partially masked, community-based efficacy trial of zinc supplementation. The study sample consists of 5 study groups in one region, with 34 clusters randomly assigned to 3 types of intervention communities.

Communities will be randomly assigned to 1) early intervention communities, 2) later intervention communities, 3) non-intervention communities. Within each intervention cluster, children will be randomly assigned to the intervention group at the household level. Children aged 6-27 months at enrollment will be eligible. The study duration is 12 months.

The investigators will assess the relative impact of daily preventive zinc supplementation (7 mg zinc/d for one year), intermittent preventive supplementation (10 mg zinc/d for 10 days every three months for one year), and zinc treatment during episodes of diarrhea (20 mg zinc/d for 10 days beginning with each episode of diarrhea during one year). Outcomes that will be assessed include the incidence and duration of all episodes of diarrhea, the incidence of malaria, physical growth, and (in a sub-group) biochemical indicators of zinc, iron and vitamin A status.

Eligibility Criteria:
Inclusion Criteria:

* 6-27 months of age
* Plan to remain in study area for 1 year

Exclusion Criteria:

* Evidence of congenital abnormalities and chronic infection
* Severe anemia and severe acute malnutrition
* Consumption of micronutrient supplementation including zinc
The Link Between BRCA Mutation and Endothelial Function

This study evaluates the effect of BRCA1\&2 mutations on cardiovascular diseases by to comparing the endothelial function of male BRCA mutation carriers with that of age matched non-BRCA mutation carriers.


Eligibility Criteria:
Inclusion Criteria:

* Known carrier or non-carrier, confirmed by genetic testing of BRCA 1/2 mutation
* Able and willing to sign an informed consent

Exclusion Criteria:

* History of, or current, malignancy
* History of:

  * Myocardial infarction
  * Ischemic or Hemorrhagic cerebrovascular conditions
  * Arterial embolic and thrombotic events
  * Ischemic heart disease
  * Prior coronary artery or ilio-femoral artery revascularization (percutaneous or surgical procedures)
  * Peripheral vascular disease (e.g. claudication, prior vascular surgery/intervention)
Tumor Necrosis Factor-alpha Levels and Cardiac Functions in Type 1 Diabetes Mellitus

The goal of this clinical trial is to learn about the effect of type 1 diabetes mellitus on cardiac functions and evaluate the correlation of the dysfunction with the tumor necrosis factor-α (TNF-α) an inflammation-related factor. The study population will be the patients with the diagnosis of type 1 diabetes mellitus and the healthy children es the control group. The main question\[s\] it aims to answer are:

* Is diabetes affecting the systolic and diastolic cardiac functions
* Is diabetes affecting the left and the right ventricles equally?
* Does diabetes status, as assessed by HbA1c, have an impact on the occurrence of cardiac dysfunction?
* Is TNF-α can be a marker for early diagnosis of cardiac dysfunction? Diabetic patients will be examined by both a pediatric endocrinologist and a pediatric cardiologist. Transthoracic echocardiography will be performed and TNF-α will be evaluated for both the diabetic patients and the healthy children.

Type 1 Diabetes Mellitus (T1DM) patients are at risk of developing cardiac dysfunction, a serious complication. Conventional echocardiography and tissue Doppler echocardiography are the most commonly used methods to evaluate cardiac functions. This study aims to prospectively assess the cardiac functions of pediatric patients diagnosed with T1DM. After routine pediatric endocrinology assessments, including anthropometric measurements, monitoring of blood glucose charts, and inquiring about complications related to diabetes, patients will be referred for pediatric cardiology evaluation. Standard pediatric cardiac examination, electrocardiographic evaluation, and echocardiography, including conventional transthoracic echocardiography and tissue Doppler echocardiography, will be performed.

Patients with a T1DM diagnosis typically provide blood samples for standard tests (HgA1c, blood glucose, routine biochemistry, etc.) following each pediatric endocrinology visit. In this study, an additional blood sample will be taken during blood collection to measure tumor necrosis factor-alpha (TNF-α) levels. Previous studies have shown elevated TNF-α levels in T1DM patients. This study aims to investigate its potential impact on cardiac function. Similarly, an age- and gender-matched control group of healthy children without T1DM will be established. This control group will also undergo echocardiographic evaluation, and TNF-α levels in their blood will be measured. Subsequently, statistical analysis will be conducted.

Through these assessments, this study aims to determine whether there is a deterioration in systolic and diastolic heart functions in the pediatric T1DM patient group compared to the control group and to evaluate the effect of TNF-α levels on these results.

Eligibility Criteria:
Inclusion Criteria:

-Patients with a diagnosis of Type 1 Diabetes Mellitus (T1DM) who have been under follow-up for at least 1 year (for the patient group)

Exclusion Criteria:

* Having an additional cardiac anomaly
* Having an additional chronic medical condition