cyrilzakka/clinical-trials huggingface dataset:
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery

The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total hip replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects is scheduled for elective primary total hip replacement surgery
* Written informed consent obtained before screening

Exclusion Criteria:

* Subject has history of deep vein thrombosis and/or pulmonary embolism
* Subject has a hemorrhagic disorder and/or coagulation disorder
* Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
* Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia
* Subject is receiving anticoagulants/antiplatelet agents
Relationship Between OCT Coronary Plaque Morphology and Clinical Outcome

The multicenter observational CLIMA registry has been conceived to explore correlation between OCT morphology of atherosclerotic plaques located in the left anterior descending artery with mid and long term clinical outcome.

Acute myocardial infarction (MI) is commonly caused by plaque ulceration and subsequent local thrombosis. Plaques that tend to rupture are typically characterized by a large superficial lipid pool, delimited by a thin fibrous cap and often exhibit local signs of inflammation. Such atherosclerotic lesions are commonly described as vulnerable plaques (1-4).

Identification of these plaque features with imaging modalities is potentially a valid approach to identify patients at increased risk of M (5). Optical coherence tomography is capable of visualizing superficial plaque components at a high resolution (in the range of 10-15 microns) and can depict all the features of plaque vulnerability or thrombogenicity (6,7).

The aim of the study is to relate presence of multiple OCT criteria of plaque vulnerability with following clinical events in a subset of coronary lesions. For this purpose all plaques in the proximal-mid portion of the left anterior descending artery will be evaluated with FD-OCT assessing the following criteria:

* minimum lumen area (MLA) \<3.5 mm2:
* fibrous cap minimum thickness \<75 µm:
* lipid arc extension \>180°;
* presence of macrophages;

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years;
* Patients with clinical indication to coronary angiography undergoing OCT evaluation of the left anterior descending artery regardless of the clinical syndrome;
* Patients with at least 30 mm of naïve OCT-assessable proximal-mid left anterior descending artery;
* Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent to the procedure;

Exclusion Criteria:

* Female with childbearing potential or lactating;
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
* Advanced heart failure (NYHA III-IV)
* Previous Coronary artery by-pass surgery
* Previous stenting of proximal-mid left anterior descending artery with residual untreated segment \<30mm.
* Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study;
* Heavily calcified vessel and/or lesion which cannot be successfully imaged by OCT
Overall Survival and Disease-free Survival in Breast Cancer Patients Under COS

The main objective of the study is to evaluate the overall survival and disease-free survival in breast cancer patients under 40 years old. They underwent controlled ovarian stimulation (COS) for fertility preservation versus women of the same age, type and stage of breast cancer, who have not been subjected to COS.

Breast cancer is a disease where the tumor size, lymph node involvement and histological grade provide rich information about prognosis and enable to stage the disease. As in any other oncological pathology, stage of disease at diagnosis is the major determining factor for estimating survival. Ovarian stimulation for fertility preservation is performed in this study, in patients with stage I-II (TNM) after the neoplasia is treated (surgical removal of the tumor) prior to systemic therapy, when indicated.

Among young women there is a greater incidence of basal type tumors and HER2 (human epidermal growth factor receptor 2), which do not always express hormone receptors. In early stages of the disease, the controlled ovarian stimulation procedure, after removal of the tumor, has not revealed any worsening in the prognosis of the disease, in terms of overall survival and disease-free survival (absence of local or distant recurrence).

It is a study that aims to collect data retrospectively from 2008 to 31 December 2015. To this end, we will collect the follow-up data, up to 5 years for patients from 2008, 2009 and 2010. Four years for patients in 2011, 3 years for 2012, 2 years for 2013, one year for those included until 31 December 2014 and patients followed until 31 December 2015. Each patient is called in order to request data authorization, to complete and track information.

Eligibility Criteria:
Inclusion Criteria:

* Age under 40 years ( at the time of diagnosis)
* TNM stage I- II
* Authorization of the fertility preservation multidisciplinary committee

Exclusion Criteria:

* Contraindications for pregnancy
* previous history of infertility
* Previous history of ovarian surgery
* Prior chemotherapy
* History of pelvic radiation
* Diabetes Mellitus
* Hypertension
* renal failure
* liver failure
* autoimmune disease.
Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken Separately

The purpose of this study is to investigate whether treatment with a combination capsule of Esomeprazole 40 mg and Aspirin (ASA) 325 mg is bioequivalent (i.e.has the same effect within the body) as these medications taken separately. Two different forms of esomeprazole (tablets and capsules) will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking male or female within the age range of 20 to 50 years
* Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2

Exclusion Criteria:

* Documented upper gastrointestinal surgery
* Use of any proton pump inhibitors or any bismuth preparations (e.g. Pepto-Bismol®) within 14 days preceding the screening visit
Lateral Rectus Muscle and Anterior Segment Optical Coherence Tomography (AS-OCT) in Two Recession Surgeries

* Background and study aims : The investigators conducted this study to compare the movement of extraocular muscle after two types of recession surgery with non-invasive tool called AS-OCT.
* Who can participate? patients who will undergo two types (conventional method and hang-back method) of typical bilateral lateral rectus recession surgery for correcting intermittent exotropia
* What does the study involve? Volunteers will attend a clinic for four visits over three months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is non-invasive test to evaluate operation site. The test only requires their cooperation when they undergo AS-OCT.
* What are the possible benefits and risks of participating? This is non-invasive test for your postoperative follow up. Therefore, there will be no risks about this test.
* Where is the study run from? Samsung Medical Center
* When is the study starting and how long is it expected to run for? From April 2015 to Dec 2015

This study is a following study of our prior study about AS-OCT in strabismus. The aim of this study is to compare the longitudinal changes of lateral rectus (LR) muscle insertion between two types of bilateral recession surgery. An AS-OCT scan of the LR muscle was performed every visits. Data on gender, age, degree of deviation (prism diopter), and spur-LR insertion distance using AS-OCT were collected at postoperative months 1,3 in each group.

Eligibility Criteria:
Inclusion Criteria:

* patients who will undergo bilateral lateral rectus recession surgery for correcting intermittent exotropia

Exclusion Criteria:

* previous ocular surgery
* other ocular diseases except intermittent exotropia
* amblyopia
Study of Home-Based Exercise to Alleviate Postpartum Depression

The purpose of this study is to evaluate the effectiveness of an aerobic home-based exercise program for the treatment of postpartum depression.

Postpartum depression occurs in 10-16% of women, with depressive symptoms lasting up to one year post delivery. Women affected by depression in the postpartum have been shown to be at higher risk for developing a recurrent depressive disorder. While the direct and indirect costs associated with postpartum depression are unknown, those associated with depression have been found to exceed 43 billion dollars in the United States alone. Moreover, maternal depression can negatively impact the mother-infant relationship and infant development. Despite the high prevalence of postpartum depression, the condition often goes undiagnosed and untreated by primary care providers. Alternative non-medical interventions for treating postpartum depression have not been widely investigated, leaving women and health care providers with few evidence-based options for treatment. If this exercise program is shown to be effective, then this intervention can be an alternate treatment option for alleviating depressed mood for women in the postpartum period. This nonpharmacological approach may be particularly attractive as many women are reluctant to take medication in the postpartum.

Eligibility Criteria:
Inclusion Criteria:

* women 4 to 38 weeks following childbirth
* score of 10 or more on the Edinburgh Postpartum Depression Scale
* understand English or French
* no current alcohol or substance abuse,
* not currently participating in regular moderate or high intensity exercise (30 minutes, at least 3 times per week)

Exclusion Criteria:

* obstetrical or concomitant diseases which would have precluded participation in an exercise program.
Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia

Schizophrenia is a psychiatric disorder, affecting 600,000 patients in France. Patients with schizophrenia have life expectancy decrease from 10 to 20 years because of cardiovascular death. Cardiovascular risk factors are numerous: inadequate diet, smoking, alcohol consumption, diabetes, obesity. Primary prevention of cardiovascular risk in patients suffering from schizophrenia is difficult because of understaff in general practitioners and psychiatrists.

The aim of the study is to describe prevalence of cardiovascular disorders in patients aged 40 and more with schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* aged of 40 and more
* with schizophrenia
* agreeing to participate in the study
The Bern Perioperative Biobank

The goal of the research is to define clinically relevant molecular markers for increased risk of peri-/ postoperative organo-dysfunctions, inflammation, adverse events and disease progression. To better understand the perioperative impact the investigators aim to determine perioperative levels of molecular markers over time in the available samples and clinical data of the Bern perioperative Biobank (BPBB) cohort to finally increase quality of perioperative care of patients by permitting preventive measures to be taken early in patients at risk.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Written informed consent
* Non-emergency surgery

Exclusion Criteria

* Transient incapacity to consent or insufficient time (\< 6h) to consider study participation
* No informed consent
* Cognitive impairment/Patients unable to consent
* Patients who retrospectively expressed their wish to be excluded
The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension

The purpose of this study is to determine the effects of yoga on blood pressure and quality of life in patients in primary health care diagnosed with hypertension within the last year. Another purpose is to examine whether the possible effect on blood pressure differs if patients practice yoga in a group lead by a yoga-trainer or receive a few yoga-exercises from their doctor to be practiced individually at home.

Hypertension is one of the most common diseases in the industrialized world. In Sweden alone approximately 1.8 million persons, 25% of the adult population, have hypertension. Hypertension is a common diagnosis in primary health care and the costs of investigating and treating hypertension and its consequences are considerable. We know that stress can affect blood pressure, but it is hard to measure and control.

Previous studies have separately shown that yoga can reduce levels of cortisol in saliva and lower blood pressure. However, few studies have investigated the effects of yoga on hypertension and we lack information about the possibility of using yoga in primary health care to reduce hypertension.

If yoga can be used to complement antihypertensive medicines, it could reduce medicine intake and thereby possibly reduce side effects and lower medicine costs. It is to be hoped that patients will also experience a higher quality of life if they perform yoga on a regular basis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with hypertension since at least one year.
* Blood pressure 120/80-160/100 mmHg at the last blood pressure control by doctor or nurse.

Exclusion Criteria:

* Blood pressure \>180 systolic and/or \>110 diastolic by the initial control in the study.
* Blood pressure \<120 systolic by the initial control in the study.
* Medical adjustments regarding hypertension within 4 weeks prior to begin of study.
* Expected inability to understand instructions about yoga exercises (e.g dementia and mental retardation) or physical or psychical inability to carry out yoga exercises (e.g severe physical or psychical handicap).
* Need for interpreter. Linguistic/language difficulties
* Older than 80 years
Implication of Stiffness of the Hamstrings, Achilles Tendon and Calf Muscles for Jumping Performance

For optimal jumping performance an adequate interaction of muscles and tendons is required. A parameter in the functional evaluation of both structures is their stiffness (resistance of the tissue against deformation by external forces). It is unclear so far if higher stiffness values of tendon or muscle or a specific stiffness relation of both tissues is the cause of better jumping performance. The present study examines this based on the Achilles tendon and the calf muscles or the patellar tendon and the hamstrings by three different forms of jumps (squat jump, counter-Movement Jump, Drop-Jump).

The plan is to include young healthy volunteers aged 18 to 40 years. In a cross-sectional study, the jump height of the participants will be measured for each jump form: squat jump (jump from a squatting position), Counter-Movement Jump (jump with backswing by going into the knees) or drop jump (jump from small box with direct re-jump). The order of the jump form is determined randomly. The measurements are carried out within one day. Furthermore the international physical activity questionnaire will be used in order to assess the level of physical activity.

As primary outcome the stiffness of the calf muscles, achilles tendon, hamstring and patellar tendon will be detected. The measurement is carried out before the jumps (there are three jumps after one sample jump performed). The measurement is executed non-invasively and completely painless using Indentometers and MyotonPro. With both devices, minimal pressure on the examined tissue will be exerted and measured how much of this can be compressed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Drug intake in the past 48 hours
* Pregnancy
* Muscle soreness
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis

The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance which does not have any action).


Eligibility Criteria:
Inclusion Criteria:

* Male or post-menopausal or surgically sterile female patients
* Have a clinical diagnosis of Cystic Fibrosis with lung function tests greater or equal to 40% of normal
* Have normal renal function

Exclusion Criteria:

* Lung transplant patients
* Significant liver disease
* Any other non-CF-related lung disease that may interfere with study assessments
The Brain Structure and Neural Network Changing the Before and After Ventriculo-peritoneal Shunting in the Normal Pressure Hydrocephalus Patients

With the advent of the aging society, dementia becomes the focus of common people. As for the neurodegeneration dementia, no disease modifying treatments have been discovered. Idiopathic normal pressure hydrocephalus (iNPH) is considered as one of reversible dementia, which can be hint by the surgery. In addition, dementia of iNPH is the typical subcortical dementia. Therefore exploring the pathogenic mechanism is conducive to the early diagnosis and treatment. This research is to monitor the changing of iNPHGS, cognitive function, walking ability as well as brain construction imaging and neural network before and after ventriculo-peritoneal shunting in order to demonstrate the pathogenesis of triads. In the process, the supplementary test, for instance, CSF tap test, will be validated the predictive value.


Eligibility Criteria:
Inclusion Criteria:

ncluded will be subjects with a probable diagnosis of NPH. The diagnosis will be based primarily on presence of gait impairment plus at least one other impairment in urinary symptoms, cognition impairment or both.

1. Are 50 years old or older
2. Patients who understand the study protocol
3. Patients who meet the criteria for NPH

   1. A typical personal history
   2. A typical brain imaging on head CT or MRI
   3. Normal LP findings excluding other conditions
   4. Exclusion of other conditions causing the symptomatology

Exclusion Criteria:

1. Patients below the age of 50 years.
2. Patients who underwent shunt surgery before
BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma

The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven esophageal cancer of the mid or distal esophagus
* Scheduled for external-beam photon radiotherapy with curative intention.
* WHO 0-2.
* Age \>= 18 years
* Written informed consent.

Exclusion Criteria:

* Serious respiratory distress
* Contra-indication for fiducial marker placement
* Noncompliance with any of the inclusion criteria
Hepatic Mitochondrial Function in Youth

Assess the impact of bariatric surgery on hepatic energy metabolism and glucose and insulin dynamics in obese youth

A metabolic study that will be performed prior to and 12 months following bariatric surgery. The study will include 31-phosphorus magnetic resonance spectroscopy to measure phosphate concentrations in the liver; a 4 hour mixed meal tolerance test, an intravenous arginine test, Abdominal Magnetic Resonance Imaging (MRI) for visceral and hepatic fat, Magnetic Resonance (MR) Elastography of the liver, indirect calorimetry, body composition assessment with Bodpod, serum metabolomics and hepatic tissue mitochondrial measures from the time of surgery only.

Eligibility Criteria:
Inclusion Criteria:

1. Obese youth ages 13-20 years, scheduled for bariatric surgery at Children's Hospital Colorado
2. BMI 35-55 m2/kg
3. Maximal body circumference \<200 cm

Exclusion Criteria:

1. Use of medications known to affect insulin sensitivity: oral glucocorticoids within 10; days, atypical antipsychotics, immunosuppressant agents, HIV medications.
2. Infectious hepatitis
3. Alcohol abuse
4. Mitochondrial disease
5. Type 2 diabetes
6. Medications that affect hepatic outcomes (e.g. PPAR-γ or PPAR-α, metformin)
7. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
8. Severe illness requiring hospitalization within 60 days
9. Diabetes, defined as Hemoglobin A1C \> 6.4%
10. Anemia, defined as Hemoglobin \< 10 mg/dL
11. Diagnosed major psychiatric or developmental disorder limiting informed consent
12. Implanted metal devices that are not compatible with MRI
A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women

The objective of this study is to determine the safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0.625 mg.

The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10, and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin® 0.625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with an intact uterus
* Body mass index (BMI) between 18.0 - 33.0
* Good general health
* Endometrial thickness ≤ 4 mm by TVU
* No history or suspected endometrial hyperplasia
* Negative urine pregnancy test
* Pap smear in last 6 months with no evidence of malignancy or pre-malignant changes
* Mammogram without suspicion of malignancy within last 6 months
* Endometrial biopsy with no evidence of pathologic changes within last 6 months

Exclusion Criteria:

* Any abnormal lab result the study-doctor considers significant
* History of severe reaction to hormone therapy
* Receiving hormone therapy
* Currently using phytoestrogenic compounds, such as red clover, black cohosh (Promensil and Remifemin), dong quai, ginseng and soy isoflavones
* History or known or suspected cancer other than basal cell carcinoma
* Stenosis of the cervix
* History of reproductive endocrine disorder
* Washout requirement for hormonal therapy not met
* Ovarian mass
* Submucus or other symptomatic fibroid which would confound efficacy