cyrilzakka/clinical-trials huggingface dataset:
Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer

The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate adenocarcinoma
* Clinical stage T1a-T3, N0-Nx, M0-Mx
* Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA\<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA\<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 \& \<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20
* Karnofsky performance status 70-100
* Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy
* Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment
* High risk group: three hormone therapy regimens are allowed
* 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed

Exclusion Criteria:

* Prior prostatectomy or cryotherapy of the prostate
* Prior high-dose radiotherapy to the prostate or lower pelvis
* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis

A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients


Eligibility Criteria:
Inclusion Criteria:

* Patient has a diagnosis of Atopic Dermatitis rated mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area, and the maximum of 20% of the body surface area
* If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study

Exclusion Criteria:

* Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated
* Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
* Patient has clinically infected Atopic Dermatitis at baseline
* Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
* Patient has a known hypersensitivity to macrolides or any excipient of either study medication
* Patient has a chronic condition which is either not stable or not well controlled
* Patient is pregnant or breast feeding an infant
Continuous Intraosseous Vascular Access Over 48 Hours

A prospective study to determine the safety of intraosseous (IO) access for a period up to 48 hours in healthy adult volunteers and volunteers with a history of mild to moderate renal disease and/or controlled diabetes.

A prospective, study to determine the safety of intraosseous (IO) access for a period up to 48 hours, in healthy adult volunteers and volunteers with a history of being health-compromised, including patients with mild to moderate renal disease (National Health and Nutrition Examination Survey Stage 1 to 3) and/or patients with controlled diabetes. Subjects will be randomized to receive IO access in the proximal tibia insertion site or the proximal humerus insertion site using the EZ-IO intraosseous vascular access system. The hypothesis is that there will be no serious complications for the subjects during a 48 hour IO catheter dwell time in either place.

Eligibility Criteria:
Inclusion Criteria:

* 21 years or older
* Self Identifying as having poor vascular access
* Healthy or Having at least one of the following conditions:
* Controlled diabetes, as evidenced by a glycosylated hemoglobin A1c (HbA1c) value of less than or equal to 8% at the time of screening. or
* Renal disease, Stages 1 to 3, as evidenced by the presence of albuminuria at the time of screening. Subjects albumin-creatinine ratio (ACR) must fall within the microalbuminuria or macroalbuminuria values: Microalbuminuria - ACR 17-250 mcg/mg for men; 25-355 mcg/mg for women or, Macroalbuminuria- ACR \>250 mcg/mg for men; \>355 mcg/mg for women

Exclusion Criteria:

* Imprisoned
* Self identifying as pregnant
* Cognitively impaired
* Fracture in target bone
* Excessive tissue and/or absence of adequated anatomical landmarks in target bone
* Signs and symptoms of infection in target area
* IO insertion in past 48 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
* Intravenous infusion within the past 30 days
* Current use of anti-coagulants
* Previous adverse reaction or known allergy to Lidocaine
* Current cardiac condition requiring pacemaker
* Currently taking beta blockers or calcium channel blockers for heart arrhythmia (use of beta blockers or calcium channel blocker for hypertension is allowed when indication of hypertension can be confirmed by physician
* Previous surgery for peripheral arterial disease
* History of ulcers to the extremities
* History of bilateral lymph node dissection in the arms or legs
* Known sickle-cell disease
* signs or symptoms of vascular disease or vascular insufficiencies to the extremities, as identified upon physical examination
* History of peripheral vascular disease
* Hyperkalemia as evidenced by potassium level greater than 5.1 mmol/L the upper limit of hte normal reference range at screening
Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea

The study objectives are to demonstrate the ease and safety of bilateral cervically implanted phrenic nerve stimulators for Central Sleep Apnea in patients with Heart Failure. To demonstrate the efficacy, both in the short and long term, of implanted phrenic nerve stimulators in patients with Central Sleep Apnea and Heart Failure. Central Sleep Apnea is a form of hypoventilation syndrome, for which this device is FDA approved. We will also determine if the patient's quality and duration of life is improved by using the PNS to treat CSA in heart failure patients.

This is a multi-center prospective cohort study to monitor the effect of bilateral phrenic nerve stimulation for treatment of central sleep apnea (CSA) in patients with heart failure. There will be 2 groups of study patients, both with CSA and heart failure. One group will receive the phrenic nerve pacer, and one will not. Both groups will have the same medical oversight, management, and assessment of heart health whether they receive the pacer or not.

Subjects will have a physical exam, review of medications, New York Heart Association (NYHA) functional classification assessment for heart failure, Minnesota Living With Heart Failure (MLWHF) Questionnaire for quality of live assessment and blood test for Pro-BNP. In-lab sleep study will be required if subject haven't had one within 3 months, and Echocardiogram, if subjects haven't had one within 30 days. If subjects are willing to have stimulator placement procedure, they'll have an ENT consult. Subjects in the procedure arm will have Phrenic Nerve Stimulator placement procedure, and 3 weeks after procedure follow up visit with ENT doctor to activate the device and have sleep study to confirm proper settings.

Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female, age 18 to 80 years inclusive.

  2. New York Heart Association (NYHA) class III or IV, or NYHA class II with an episode of heart failure requiring hospitalization in the past 24 months.

  3. Stable on guide line directed medical therapy (GDMT) for 30 days prior to enrollment.

  4. Moderate or severe sleep apnea, that is an Apnea Hypopnea Index (AHI) of \>15/hour with \>50% being central apneas.

  5. Willing and able to provide written informed consent in compliance with the regulatory requirements. If a subject is unable to provide written informed consent, written informed consent may be obtained from the subject's legal representative.

Exclusion Criteria:

1. Phrenic nerve palsy.
2. Baseline hypoxia (oxygen saturation \<90% on room air).
3. On supplemental oxygen.
4. Severe COPD.
5. Unstable angina, MI or cardiac procedure within 3 months of phrenic nerve stimulator placement.
6. Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
7. Any other reasons that, in the opinion of the Investigator, the candidate is determined to be unsuitable for entry into the study.

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Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Elderly Healthy Subjects

The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. Recent evidence in young healthy subjects suggest that the sleep-associated consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If elderly, healthy subjects benefit from transcranial slow oscillatory stimulation (tSOS) during nocturnal sleep as well has not been studied so far. The primary aim of the present study is to investigate the influence of a weak slow oscillating brain stimulation (tSOS) on declarative memory consolidation applied during periods of nocturnal SWS in elderly healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* elederly, healthy Subjects
* unobtrusive, neuropsychological screening
* age: 50-90 years
* right handed

Exclusion Criteria:

* untreated severe internal or psychiatric diseases
* epilepsy
* other severe neurological diseases eg., previous major stroke, brain tumour, dementia
* contraindications to MRI
Prescribing Practice of Medication - Patient View.

In the clinical routine of a hospital, there are often problems dealing with medication that has already been prescribed at the time of admission due to incomplete or missing medication lists from the family doctor. Often patients forget this list at home.

This pilot study focuses on the medication process from admission to discharge and patient health literacy.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalised at the clinical ward of Endocrinilogy and Diabetology and plastic Surgery
* Patient with an minimum of 2 days hospitalisation
* good knowledge of German
* Age 18 to 99 Years
* Male/female

Exclusion Criteria:

* Neurological or psychiatric primary disease e.g. Dementia
* Rehospitalisation 7 days after discharge from hospital
* Patients who need intensive care
A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study

The purpose of the study is to collect acoustic, ECG, and clinical data from consenting participants, so that AusculSciences can perform analysis on the sounds produced by the heart and determine the accuracy of the CAD-det System for detecting CAD.

This is a prospective multi-center clinical trial. Using the CAD-det, acoustic and electrical cardiac data will be collected from participants with intermediate pretest probability of CAD who are referred to invasive coronary angiography (ICA). The CAD-det recording will be administered prior to the scheduled ICA procedure. The data collected by CAD-det will be processed using AusculSciences' Data Analysis Application (DAA) to produce a patient's indication for CAD.

Eligibility Criteria:
Inclusion Criteria:

1. Stable
2. \>/= 19 years old
3. Suspected obstructive CAD
4. Referred to ICA

Exclusion Criteria:

1. Documented CAD or coronary revascularization
2. Age \< 19 years old
3. Acute coronary syndromes
4. Congenital heart disease or heart transplantation
5. Dextrocardia
6. Uncontrolled irregular heart rhythm (atrial arrhythmia (fibrillation, flutter) or frequent PACs or PVCs (\>10/minute))
7. Resting heart rate \> 110 bpm
8. Known hemodynamically-significant valvular heart disease, audible diastolic murmurs, or hypertrophic or non-ischemic cardiomyopathy
9. Chest wall deformity or wounds in adhesive application areas
10. Pregnancy
11. Unwillingness or inability to provide informed consent or to comply with the study protocol
Iodine I-131 Iodocholesterol, Its Use in Adrenal Screening

This is a clinical research study using I-131 Iodocholesterol which is an experimental radioactive chemical that when injected into the vein, is picked up in the adrenal glands and permits visualization with gamma imaging devices. These images are used in diagnosing a variety of adrenal abnormalities.Prior to the injection of I-131 Iodocholesterol, the patient will receive perchlorate capsules to block any uptake of I-131 by the thyroid gland if this is deemed important. The patient will continue to take these capsules throughout the period of imaging, which may last up to 1 week. The injection of I-131 Iodocholesterol will be given into a vein and the patient will return for images on at least 1 and possibly 2 occasions between 3-7 days after injection. If the case requires it, the patient may also be given a steroid in tablet form, dexamethasone, to take orally prior to and after the injection to suppress normal adrenal function so that the abnormal tissues can be more easily detected.


Eligibility Criteria:
Adults with suspected adrenal disease, such as adrenal adenoma, carcinoma, hyperplasia, or Addison's Disease.
Biological Therapy in Treating Women With Metastatic Breast Cancer

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of T cells and interleukin-2 combined with peripheral stem cell transplantation or bone marrow transplantation in treating women who have stage IIIB or metastatic breast cancer.

OBJECTIVES: I. Evaluate the toxicities of the combination of low dose interleukin-2 (IL-2) sargramostim (GM-CSF), and multiple doses of activated T cells (ATC) following peripheral blood stem cell transplantation in women with stage IIIB or metastatic adenocarcinoma of the breast. II. Evaluate the efficacy of this regimen in these patients.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days prior to peripheral blood stem cell (PBSC) collection or for 2 days prior to bone marrow harvest. Following PBSC collection or bone marrow harvest, patients receive high dose chemotherapy consisting of cyclophosphamide IV, carboplatin IV, and thiotepa IV over days -6 through -3. Patients undergo PBSC transplantation on day 0. Following PBSC transplantation, patients receive multiple doses of monoclonal antibody OKT3 activated T lymphocytes IV over 1 hour between days 1 and 65, continuous low dose interleukin-2 (IL-2) IV over days 1-65, and sargramostim (GM-CSF) subcutaneously on days 5-21. Patients are followed at day 100, as clinically indicated, and then annually.

PROJECTED ACCRUAL: Approximately 40-60 patients will be accrued for this study within 1-2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically documented metastatic adenocarcinoma of the breast Concurrent intraductal or lobular carcinoma in situ allowed Bilateral disease allowed Measurable or evaluable recurrent metastatic disease (Stage IIIB or IV) documented by radiograph, CT scan, nuclear medicine scan, or physical exam Tumor must be clinically chemosensitive as documented by a reduction in tumor burden No clinical evidence of brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin less than 1.5 times normal Hepatitis B surface antigen negative Renal: Creatinine less than 1.8 mg/dL Creatinine clearance normal Blood urea nitrogen (BUN) less than 1.5 times normal Cardiovascular: Ejection fraction at least 45% by MUGA No uncontrolled or significant cardiovascular disease including myocardial infarction (less than 1 year) or congestive heart failure Pulmonary: PFT-FEV1 at least 60% of predicted DLCO and FVC at least 60% of predicted Other: Not pregnant Negative pregnancy test HIV negative No serious medical or psychiatric illness No prior or concurrent malignancy, other than curatively treated carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent hormonal therapy for breast cancer
The Study of Mechanism of Alzheimer's Disease Using Acupuncture Based on fMRI

Alzheimer's disease (AD) is one of the major brain diseases which received more attention in recent years. The disconnection syndrome is the main pathophysiological mechanism leading to cognitive decline in AD patients. Both animal experiment and clinical observation have demonstrated that acupuncture can generate treatment effect on AD patients by moderating the neural pathway directly. However, the underlying mechanism remains unclear. By using resting state functional magnetic resonance imaging (fMRI) method, as well as acupuncture and neurology sciences, investigators will explore the multi-modality data analysis; compare brain connectivity and network parameters changes between pre- and post- acupuncture treatment; analyze the correlation between fMRI changes and neuropsychology test. The present study aims to elucidate the neural mechanism of acupuncture therapy on early AD, provide theoretical evidence from the perspective of functional connectivity.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Alzheimer's Disease Clinical diagnosis of MCI due to Alzheimer's Disease Drug therapy regularly

Exclusion Criteria:

Frontotemporal dementia Lewy body dementia Vascular dementia Severe depression Brain vascular disease Metabolic disease
Characterization of the Mechanical Properties of the Hamstring Muscle Group in Female.

The goal of this clinical trial is to precise the impact of menstrual cycle and physical activity on the hamstrings muscle function in healthy active women. The main question it aims to answer is : is there a moment of the menstrual cycle when the muscle is better able to recover from a strenuous exercise ? Three appointments will be conducted to evaluate the hamstring muscles at difference moments of the menstrual cycle. Echographic and maximal force production measures will be done.

Researchers will compare these results with a group taking oral contraceptives.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged between 18 and 35 years.
* Subjects who practice at least 2 hours of sport per week with a competitive aim.
* Subject who has not presented any musculo-tendinous pathology to the hamstrings in the last 6 months.
* Subject with no musculoarticular pathology having a prolonged (more than 2 weeks) interruption of sports activities in the last 2 years.
* Subject with no muscular pain or pathology currently.
* Subject with no known cardiac disorders or family history that could present a risk known family history that could present a risk in case of intense physical effort.

physical exertion.

* Subjects not taking any medication, which in the opinion of the that, in the opinion of the coordinating investigator, may interfere with the evaluation of the study criteria.
* Subject able and willing to comply with the protocol and agreeing to give written informed consent.
* Subject affiliated or benefiting from a Social Security plan.

Menstrual cycle group:

* Subject whose last 3 menstrual cycles are of a regular duration (± 4 days maximum difference between 2 consecutive menstrual cycles).
* Subject whose last 3 menstrual cycles are of a duration between 24 and 32 days (including milestones).
* Absence of any contraceptive method likely to modulate the hormonal variations linked to the menstrual cycle.

hormonal variations related to the menstrual cycle, during the duration of the duration of the protocol and during the last 6 months after the participant's inclusion.

the participant. Mechanical contraception such as the diaphragm is permitted.

Oral contraceptive group:

- Taking oral contraception, 2nd generation monophasic pill estrogen-progestin pill (Optilova®, Optidril®, Leeloo®, Minidril®, Ludeal®, Zikiale®, Lovavulo®, Lovapharm®) for at least 6 months.

Exclusion Criteria:

* Subjects with a medical contraindication to intense physical activity.
* Subject with a positive pregnancy test result.
* Subject with a medical or surgical history deemed by the coordinating investigator as being incompatible with the study.
* Subjects under guardianship.
* Subjects in a period of exclusion from another study.
* Decision of the volunteer, whatever the reason.
* Adverse event or effect affecting the safety of the volunteer in the opinion of the coordinating investigator.
* Major deviation from the protocol.
* Illness or injury interfering with the normal course of the protocol.
Efficacy of Kyphoplasty With a New Intervertebral Expander

Balloon kyphoplasty is a well-established treatment option to achieve pain relief and to correct kyphotic deformity caused by osteoporotic vertebral compression fracture. However, it has been demonstrated that reduction is partly lost as balloon is deflated in the vertebral body. An intravertebral expander was developed for better reduction and maintenance of vertebral body height while cement is injected. This study evaluates the efficacy of kyphoplasty with a new intravertebral expander with regard to correction of kyphosis angel and to restoration of vertebral body height.


Eligibility Criteria:
Inclusion Criteria:

* Osteoporotic vertebral body fractures that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification

Exclusion Criteria:

* More than 2 vertebral body fractures
* Fractures of vertebral body based on malignancy
* Previous spinal operation
* Spinal infection
* Spinal deformity (scoliosis)