cyrilzakka/clinical-trials huggingface dataset:
Physical Exercise and Coronary Artery Plaque Composition

The purpose of this study is to examine the effect of two different physical exercise protocols on changes in coronary artery plaque composition and development of in-stent restenosis in patients treated with percutaneous coronary intervention with stent implantation. The investigators will compare aerobic interval training and moderate continuous training. Both exercise protocols have a duration of 12 weeks. The investigators hypothesize that aerobic interval training is superior to moderate continuous training regarding effects on the composition of coronary artery plaques and a reduction in the development of in-stent restenosis.


Eligibility Criteria:
Inclusion Criteria:

* stable or unstable coronary artery disease treated with percutaneous coronary intervention with stent implantation,
* informed patient consent

Exclusion Criteria:

* ST-elevation myocardial infarction,
* inability to give informed consent,
* inability to participate in regular training due to residency, work situation or comorbidity,
* any known chronic inflammatory disease other than atherosclerosis,
* planned surgery within the next four months
Safety and Efficacy of a New Approach to Delineating Clinical Target Volume of Glioblastoma

Radiotherapy (RT) is one of the most important local treatments besides surgery, but currently, no consensus has been made regarding the optimal radiation volume for high grade gliomas. The most main growth characteristics of glioblastoma is infiltrative growth through the white matter tracts, regions along the white matter tracts especially at the direction of the main fiber bundles would have a higher risk of microscopic tumor cell dissemination. However, in current practice, recommends for the CTV definition is adding a 2 cm symmetrical margin to GTV or peritumoral edema in all directions, which hardly account for the growth characteristics of gliomas that are known from histopathological findings.

Patients with glioblastoma were recruited for this study based on the following eligibility criteria: Age between 18 and 70, performance status of 0-1 (Eastern Cooperative Oncology Group performance status), histologically confirmed glioblastoma, no cerebrospinal fluid and distant metastatic disease. All patients had adequate hematologic, hepatic, and renal function. Patients younger than 18 years; patients with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities were excluded.

Eligible patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT）, followed by 6 additional cycles of TMZ. (150 mg/m2 for the first cycle and 200 mg/m2 for the 2-6th cycles, on days 1-5, every 4 weeks) .

The investigators established a detailed protocol for target delineation of the CTV based on brain anatomy, white mater fiber tracts distribution and the growth patterns of tumor. Briefly, along the directions of the main nerve fiber bundles ，the CTV is defined as peritumoral edema plus 1cm. while in other directions, the CTV is defined as GTV plus 2cm and should be adjusted to anatomical borders such as the skull (0 mm, using bone window), ventricles (5 mm), falx (0 mm), tentorium cerebelli (0 mm), visual pathway/optic chiasm and brainstem (each 0 mm) and modified to include all regions of abnormal T2/FLAIR MRI signal. Deep brain white matter is the focus for RT target contour, regions of normal uninvolved gray matter should be modified to be protected.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70 years
* performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
* histologically confirmed glioblastoma
* no cerebrospinal fluid and distant metastatic disease
* All patients had adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

* younger than 18 years;
* patients with a prior (i.e. within 5 years) or synchronous malignancy, other than non-melanoma skin cancer; and those with significant comorbidities
Misoprostol Prior to Intrauterine Device (IUD) Insertion in Nulliparous Women

Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.

There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization\[1\], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.

Eligibility Criteria:
Inclusion Criteria:

* 18 years
* negative pregnancy test
* no prior pregnancy beyond 19 6/7 weeks
* no pelvic inflammatory disease in last 3 months
* no current cervicitis
* willing to follow up in 1-2 months

Exclusion Criteria:

* active cervical infection
* current pregnancy
* prior pregnancy beyond 19 6/7 weeks
* uterine anomaly
* fibroid uterus distorting uterine cavity
* copper allergy or wilson's disease for ParaGard
* undiagnosed abnormal uterine bleeding
* cervical or uterine cancer
* sepsis associated with the most recent pregnancy
* current breast cancer for levonogestrel IUD
* inflammatory bowel disease
* allergy to misoprostol
Physical Fitness and Cardiovascular Mortality in Firefighters

To study prospectively the interrelationships among physical fitness, activity, other measured risk factors, coronary heart disease (CHD) and all-cause mortality in a cohort of 3,403 firefighters.

BACKGROUND:

From 1971-1991 the Occupational Health Service of Los Angeles Country measured physical fitness and other CHD risk factors (including physical activity, anthropometric measures, blood pressure, smoking, family history of CHD, and levels of total cholesterol, uric acid, and glucose) in Los Angeles County firefighters at application and routine intervals (approximately every three years). The entire cohort of 3403 firefighters is now followed for mortality up to 1996.

DESIGN NARRATIVE:

The entire cohort of 3,403 firefighers is followed up to 1996 in this longitudinal study. The investigators are using a variety of tracing sources, including the National Death Index, and obtaining death certificates to determine date and cause of death. Cohort data will be analyzed to address the following aims: (1) To provide a longitudinal description of and determine the interrelationships among physical fitness, physical activity, and other measured risk factors; (2) to determine whether levels of physical fitness are related, independently of other known and measured risk factors, CHD and all-cause mortality; (3) To determine whether there is a gradient of decreasing CHD risk with increasing levels of physical fitness, or whether there appears to be some threshold of physical fitness, above which CHD risk stabilizes; (4) To determine whether the relationship between physical fitness and CHD and all-cause mortality varies by such cardiovascular risk factors as age, cholesterol levels, blood pressure, smoking, and obesity.

Eligibility Criteria:
No eligibility criteria
Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients

A prospective, longitudinal study meant to compare blood levels of I-FABP in pediatric celiac patients during diagnosis to levels under gluten free diet, it's correlation with traditional serology testing and questionnaire regarding patient responsiveness to the gluten free diet, and in comparison to a control group.

I-FABP is a reliable marker for intestinal damage and has been proved to respond more swiftly than traditional serology to enterocyte injury in celiac patients who do not a gluten free diet. In this study a pediatric population of celiac patients will be tested for I-FABP levels during initial endoscopic diagnosis and during one year of follow up. Their levels will be compared to a control group of pediatric patients undergoing endoscopy for reasons other than suspicion of celiac disease. During the period of follow up, the test group will undergo repeat testing for I-FABP levels, as well as the traditional follow up testing for serology in celiac patients and a questionnaire regarding. The results will be analyzed in the hope of finding a way to use I-FABP as a more direct, accurate marker of disease activity, and of correlations between it's level and the patient's Marsh score at diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing endoscopy for diagnosis of celiac disease, with elevated serology (TTG more than 3 times the norm), and whose histological Marsh score is 2 or higher.

Exclusion Criteria:

* Diseases known to cause elevation in I-FABP levels: Bowel ischemia, inflammatory bowel disease, Primary Biliary Cholangitis, liver failure, biliary duct obstruction, liver malignancy.
* Bowel trauma or abdominal surgery or acute gastroenteritis in the last 3 months
* NSAID use in the last week.
* Intensive daily physical activity (over 1 hour) in the 2 days prior to endoscopy.
* Known genetic disorders (such as Down's syndrome).
* Patients whose TTG was elevated but lower than 3 times the normal range.
Evaluation of Left Ventricular Function and Therapeutic Effect of CPAP in Patients With OSAS by 3D STE

The changes of left ventricular function in patients with sleep apnea were studied by three-dimensional speckle-tracking echocardiography to evaluate the changes of left ventricular function after CPAP treatment

Research purposes: (1) Use 3D speckle tracking echocardiography to measure the diastolic and systolic strains of the left atrium and left ventricle of OSAS patients, in order to evaluate the impact and degree of OSA on left ventricular function.

(2) By comparing the changes in the three-dimensional ultrasound strain index of the left ventricle of patients before and after CPAP treatment, and in patients receiving and not receiving CPAP treatment, to evaluate whether CPAP treatment contributes to the improvement of cardiac function in patients with OSAS, and to infer the best suitable intervention population and using time, providing reference basis for clinical treatment.

(3) Discovery of serological indicators that predict the severity of the disease and predict the impairment of heart function Study design: This study is a prospective, observational controlled study. It is planned to include 30 cases of newly diagnosed OSAS patients in the Peking University Third Hospital and a control group selected according to age and gender matching. The three-dimensional strain of the left atrium and left ventricle of the crowd is measured by the 3D speckle tracking technology, and the serological indicators are detected. The OSAS group and the control group were followed up during the course of receiving or not receiving CPAP.

Eligibility Criteria:
Inclusion Criteria:

1. OSA met the diagnostic criteria of obstructive sleep apnea in the United States Classification of Sleep Diseases in 2014
2. Between the ages of 18 and 80, regardless of gender
3. Sign informed consent

Exclusion Criteria:

1. previously diagnosed patients with heart failure,
2. coronary artery disease,
3. valvular disease,
4. cardiomyopathy,
5. arrhythmia,
6. chronic obstructive/ restrictive pulmonary disease,
7. thyroid dysfunction (including hypothyroidism or hyperthyroidism),
8. already treated with CPAP,
9. poor image quality of echocardiography.
Genetic Inclusion by Virtual Evaluation

This study aims to transform the current clinical practice paradigm by leveraging an internally designed web-based model of delivery of care called Consultagene to provide remote evaluation and genomic sequencing for improving genetic health of less resourced children with rare disorders living along the Texas-Mexico border.

Inadequate access to genetics evaluation and genomic testing in the Hispanic minorities living along the Texas-Mexico has marginalized the most vulnerable pediatric group. In this study, we will (1) implement a virtual web-based service, called Consultagene for simplifying patient pathways and deliver virtual genetics evaluation in Rio Grande Valley (RGV) (2) provide rapid genetic diagnoses through whole genome sequencing and interpretation of diagnostic studies for medical decision-making and improving health outcomes for the minorities, and (3) build genomic competency of front-line healthcare providers through education and machine learning to expedite referral of pediatric patients with suspected rare diseases for shortening diagnostic odyssey.

Eligibility Criteria:
Inclusion Criteria:

Pediatric patients with undiagnosed rare genetic diseases residing in the Rio Grande Valley and El Paso in Texas

Exclusion Criteria:

Children with known genetic diseases
RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care

This clinical investigation is designed to demonstrate the performance characteristics of the RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the point-of-care when compared to the results for the same samples analyzed on the RAMP® Reader.


Eligibility Criteria:
Inclusion Criteria:

Study Arms A - Troponin I (ACS/MI)

1. Males or Females, 18 years of age or older, of any race
2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
3. Willing to voluntarily agree to sign a consent form (if applicable)

Study Arms B - Myoglobin (ACS/MI)

1. Males or Females, 18 years of age or older, of any race
2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
3. Myoglobin test result falls within the reportable range of the test as reported in the RAMP® Myoglobin IFU.
4. Willing to voluntarily agree to sign a consent form (if applicable)

Study Arms C - CK-MB (ACS/MI)

1. Males or Females, 18 years of age or older, of any race
2. Has had a routine test order of Troponin for suspected Acute Coronary Syndrome / Myocardial Infarction (ACS/MI) - as per institutional guidelines
3. CK-MB test result falls within the reportable range of the test as reported in the RAMP® CK-MB IFU.
4. Willing to voluntarily agree to sign a consent form (if applicable)

Study Arm D - NT-proBNP (HF)

1. Males or Females, 18 years of age or older, of any race
2. Has had a routine test order of NT-proBNP or BNP for suspected Heart Failure (HF) - as per institutional guidelines
3. Willing to voluntarily agree to sign a consent form (if applicable)

Exclusion Criteria:

Study Arms A, B, C - Troponin I, Myoglobin, CK-MB (ACS/MI)

1. Healthy Subjects
2. Pregnant or lactating
3. Subjects not having a cardiac marker test ordered
4. Blood sample collected \>24 hours prior to screening
5. Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing
6. Non-compliance to the protocol or the inclusion criteria

Study Arm D - NT-proBNP (HF)

1. Healthy Subjects
2. Pregnant or lactating
3. Subjects not having a cardiac marker test ordered
4. Blood sample collected \>24 hours prior to screening
5. Subjects without adequate volumes of surplus EDTA whole blood available for all required trial testing
6. Non-compliance to the protocol or the inclusion criteria
Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a NHS-PEG Coated Collagen Patch.

The aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable NHS-PEG collagen patch.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old.
* Ability to understand and make their own decision to participate in the study.
* Pre-surgery right colon adenocarcinoma pathological diagnosis.
* Patient with a mechanic, intra or extracorporeal ileocolic anastomosis.

Exclusion Criteria:

* Urgent intervention.
* Simultaneous colon cancer.
* M1 pre-surgery staging.
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years or older
* And with a diagnosis of dysfunctional uterine bleeding without organic pathology
* And with at least one of the following symptoms: prolonged, frequent or excessive bleeding.

Exclusion Criteria:

* The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
* Women with a history of endometrial ablation or dilatation and curettage within 2 months prior to study start will be excluded.
Three Nerves Versus Suprascapular Nerve Radiofrequency Combined With Hydrodissection in Adhesive Capsulitis

comparison between effect of three nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up.

comparison between effect of three nerves suprascapular,axillary,lateral pectoral nerves pulsed radiofrequency combined with hydro-dissection versus suprascapular nerve Pulsed Radiofrequency combined with hydrodissection on pain control in adhesive capsulitis within six months follow up.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adult patients aged 30-80 years old 2. Shoulder pain existing for more than one month and reduction range of motion in at least two planes (flexion, abduction, external rotation...)

Exclusion Criteria:

1. Patient refusal
2. malignancy
3. Pre-existing neurological deficits or neuropathy
4. Significant concomitant shoulder pathology as instability of shoulder joint, labral tears, labral tears, rotator cuff calcific tendinopathy, infectious arthritis, and rheumatological disease of the shoulder
5. Previous history of fracture or shoulder dislocation, or cerebrovascular accidents.
6. Known allergic history to local anesthetic
7. Known contraindications to peripheral nerve block, including local skin infections in the block procedure area, bleeding diathesis, and coagulopathy.

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Quantification of Ketosis After Intake of Coconut Oil and Caprylic Acid-With and Without Glucose-After a 12-hour Fast

In a cross-over design, 15 participants, age 65-75, will be tested in six different arms in a randomised order. After a 12-hour fast participants will be served 2.5 dl coffee with 15 g cream + 30-50 g of different fatty acids, with or without 50 g glucose. Blood ketones and other biomarkers will be measured during 4 hours.

In the metabolic state ketosis, beta-hydroxybutyrate (BHB) and acetoacetate are synthesised from fatty acids in the liver, resulting in higher circulating levels. Ketosis can be induced by fasting or adherence to a low-carb-high-fat diet, but also by intake of-at least some-medium-chain-triglycerides (MCT). MCT are built from fatty acids with a chain of 6-12 carbon atoms. Caprylic acid (C8) is well known to be ketogenic, but the effect of lauric acid (C12)-constituting about 50% of coconut oil-is less clear.

The aim of this study is to assess ketosis, as a combined effect of an extended overnight fast, and intake of coconut oil or C8, and to study how ketosis is affected by simultaneous glucose intake. Sunflower oil is used as control, expected to not break fasting ketosis, although not being ketogenic in itself. Some sunflower oil is also added to C8 to make that arm isocaloric with coconut oil, with a roughly similar proportion of MCT.

Coffee with cream will be used as a vehicle, and although coffee has been reported to be mildly ketogenic, this effect is expected to be negligible and equally distributed between arms.

Eligibility Criteria:
Inclusion Criteria:

* Daily consumption of coffee
* Written informed consent

Exclusion Criteria:

* Smoker
* Weight \<50 kg
* Diagnosed diabetes
* History of heart disease
* History of disease related to internal organs or metabolism
* Experience of "sensitive gut", or known intolerance to the test ingredients
* Medication expected to affect glucose- or lipid-metabolism
* Fasting during study or one month before
* High intensity physical activity \> 3 times/week
* Dementia
* Severe psychiatric conditions
* Hb\<125 g/L
* Participation in other lifestyle intervention last 6 months
Microwave Ablation of Breast Tumors

The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.

Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy due to improvements in technology, reduced costs and reduced morbidity. The main objective of this protocol is to determine the extent of ablation based on time and power parameters of the MedWaves in breast cancers. This would be accomplished in patients diagnosed with breast cancer who are already scheduled for breast cancer surgery. Prior to the surgical removal of the cancer, the microwave antenna would be inserted into the tumor under ultrasound guidance (either percutaneously or open). The tumor would be ablated, and then surgically resected in a standard, curative fashion.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.
* Tumor is palpable or visible on ultrasound or both
* All participants need to be fully able to give informed consent

Exclusion Criteria:

* Gender: male
* Mental or legal incompetence
* Impaired decision-making capacity
* Pregnant women may not participate
* Implanted Pacemaker