cyrilzakka/clinical-trials huggingface dataset:
Pilot Study On The Role Of Nitric Oxide In Alpha 1-Adrenergic Vasoreactivity

This is a research project to test two study techniques among healthy adults. The procedures look at how blood flow is controlled by substances in blood vessels.

Most patients with chronic kidney disease (CKD) have high blood pressure and are at high risk for cardiovascular disease. High blood pressure can be partly caused by narrowing of blood vessels from high activity of the alpha1-adrenoceptor system in blood vessels. On the other hand, nitric oxide (NO), produced by the body, opposes the alpha 1-adrenoceptor system. NO widens blood vessels and prevents high blood pressure. We hypothesize that low availability of NO may be responsible for high activity of alpha 1-adrenoceptor system in patients with CKD. This protocol is a pilot study in healthy subjects to guide us in performing future studies in patients with CKD.

The specific aims of the pilot study, in healthy people, are to 1) determine whether alpha 1-adrenoceptor vasoreactivity is reproducible and 2) determine alpha 1-adrenoceptor vasoreactivity with the NO clamp technique. To carry out these specific aims, we will consent and enroll healthy people with normal blood pressure. After a screening visit to confirm eligibility, subjects will be admitted to the General Clinical Research Center overnight for a study the following day.

We will constrict the forearm blood vessels by giving different amounts of phenylephrine into the artery through a catheter. We will measure the subjects blood flow with venus plethysmography ( a measuring tool like a blood pressure cuff) while giving the phenylephrine. We will repeat the tests to see if we get the same results.

Then, a research medication, L-NMMA, which blocks NO in the blood vessel, will be dripped into the same artery followed by another medication nitroprusside, which gives back NO, to restore normal forearm blood flow. This procedure is called the NO clamp technique and is used to measure the effects of NO. The phenylephrine concentrations and plethysmography will be repeated again to compare vessel narrowing before and during the NO clamp. This research will teach us how to perform future studies on the relationship between NO and the alpha 1-adrenoceptor system in patients with kidney disease.

Eligibility Criteria:
Inclusion Criteria:

Healthy men and women:

* Age 18 to 55 years
* Who have Blood Pressure less than or equal to 120/80.

Exclusion Criteria:

Individuals with:

* Diabetes, lung disease
* Stomach disease, liver disease
* Blood vessel disease
* Kidney disease
* High blood pressure
* Heart disease
* Hereditary blood disorders
* Hematocrit (amount of red blood cells) less than 30%,
* Who smoke
* Women who are pregnant or lactating
An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years

This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, \>/= 18 years of age
* HER2-positive metastatic breast cancer or locally advanced breast cancer
* Systemic treatment included Herceptin as 1st line therapy
* Without progression for at least 3 years after the beginning of Herceptin treatment
* Alive or not alive and treated or not treated with Herceptin at the time of inclusion

Exclusion Criteria:

* Disease progression \<3 years after beginning 1st-line therapy with Herceptin
Acute Effects of Gabapentin in Sleep Parameters and Hormonal Release During Sleep in Older Men

The primary objective of this study is to evaluate the effects of gabapentin in sleep polysomnography parameters and in nocturnal secretion of endogenous hypothalamic-pituitary-adrenal (HPA), hypothalamic-pituitary-gonadal (HPG) and somatotropic axes hormones and basal IGF-1 in older men.

The influence of sleep variables on muscle protein anabolism is little studied, but data on the effects of slow-wave sleep and the syndrome of obstructive sleep apnea on the hypothalamic-pituitary axis indicate that interventions in the sleep structure and disorders impact on the age-related muscle loss. Thus, we propose to assess the acute effects of a drug potentially capable of increasing slow wave sleep, and consequently growth hormone release during sleep, on the physiological release of growth hormone, testosterone and IGF-1 during the night in older healthy men.

Eligibility Criteria:
Inclusion Criteria:

* 60 years old or more,
* healthy men

Exclusion Criteria:

* Basal Apnea-Hypopnea index (aHI)\>=15
* Restless Legs Syndrome Symptons
* BMI less than 18.5 kg/m2 or greater than 30 kg/m2
* Less than 30 min. of regular physical activity (at least walking inside home, etc.)
* Plasma albumin below 3.5 mg/dL
* Psychoactive drugs use
* Drugs with muscle anabolic potential
* Current treatment for obesity or weight gain
* Enteral or parenteral feeding
* Inability to walk without assistance,
* Loss of independence in any activity of daily living
* Nocturia above 2 episodes
* Smoking more than 2 cigarettes per day
* Alcoholism (more than 2 doses a day)
* Prior epilepsy diagnosis
* Clinically evident atherosclerotic disease
* Dementia
* Depression
* Rheumatic diseases
* Cancer
* Diabetes (poorly controlled, HbA1C \> 7,0, requirement of insulin)
* Thyroid dysfunction without treatment
* Advanced stages in COPD, HF, liver or renal failure
Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function

In this study, it will be investigated how psychological stress evoked by skydiving affects the intestinal permeability in 20 healthy subjects. Participants attend two visits: 1) Skydiving visit, 2) Negative control visit. At all visits, saliva samples, blood samples, and faecal samples are collected, and the multi-sugar permeability test is performed. In this test, participants drink a sugar solution and then collect urine for 5 and 24 h. The ratio of the sugars detected in the urine is a reflection of the intestinal permeability. Saliva samples are collected for assessment of cortisol, a stress marker. Blood and faecal samples are collected for assessment of markers of intestinal barrier function and inflammation.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent prior to any study related procedures
2. Age \> 18 till \<50
3. Novice skydivers (first or second tandem jump)
4. Signed up for tandem skydive
5. Willing to abstain from probiotic products or medications known to alter gastrointestinal function throughout the study

Exclusion Criteria:

1. Abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy.
2. Current diagnosis of hypertension.
3. Current diagnosis of psychiatric disease.
4. Over 100kg or with a body mass index over 35.
5. Systemic use of steroids in the last 6 weeks.
6. Use of antibiotics or antimicrobial medication in the last month.
7. Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening.
8. Usage of medications that could affect the barrier function, except oral contraceptives, during the 14 days prior to screening.
9. Diagnosed inflammatory gastrointestinal disease.
10. Regular use of probiotics in the last 6 weeks.
11. Smoking and/or chewable tobacco.
12. Planned changes to current diet or exercise regime.
13. Use of laxatives, anti-diarrhetics, anti-cholinergics within last 4 weeks prior to screening.
14. Use of immunosuppressant drugs within last 4 weeks prior to screening.
15. Women: Pregnancy, lactation.
16. Abuse of alcohol or drugs.
17. Any disease/condition which in the investigator's opinion could interfere with the intestinal barrier function.
18. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial.
Evaluation of Noise Induced by Ceramic-ceramic Friction Torques of Total Hip Prostheses With Customized Femoral Stem

Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem.

Retrospective and prospective multicentric study.

On a series of patients operated on for more than two years after a total hip arthroplasty that resulted in the implantation of a ceramic-on-ceramic prosthesis with a customized femoral stem:

Primary objective: To assess the frequency of occurrence of joint noise.

Secondary objectives:

* To describe the characteristics of the noise nuisance (date of onset, frequency, intensity, impact...)
* To evaluate the individual and surgical factors associated with the occurrence of noise pollution.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older, who has been informed of the research
* Patient who has had a fourth generation ceramic/ceramic hip replacement implanted for at least two years as a first-line replacement
* Patient who has had a three-dimensional preoperative examination leading to the design and implantation of a custom femoral stem
* Patient regularly monitored since surgery and for whom all clinical and radiological data are available at the three-month and two-year follow-up visits

Exclusion Criteria:

* Patient operated for revision
* Patient under legal protection, guardianship or curators
* Patient who has indicated his opposition to the use of his medical data (by completing and returning the non-opposition form which will be sent to him)
A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer

The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
* Age 18-70
* No evidence of distant metastasis
* No previous therapy
* Normal hematologic function
* No abnormality of renal or liver function
* Written informed consent

Exclusion Criteria:

* With allergic constitution or possible allergic reflection to drugs to be used in this study
* Any concurrent uncontrolled medical or psychiatric disorder
* History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
* Being pregnant or nursing
Intestinal Microbiota and Postoperative Ileus After Colorectal Surgery

Postoperative ileus (POI) after colorectal surgery is frequent and is a burden for national health authority because it increases the morbidity and the length of hospital stay.

Some of the stage of the mechanism of POI are known and are now targeted to reduce its occurence but despite these measures, POI still happens in 10-30% of surgeries.

The role of the intestinal microbiota in POI is unknown while it could be a new target to reduce its duration or its occurence.


Eligibility Criteria:
Inclusion Criteria:

* laparoscopic colorectal resection with anastomosis and without diverting stoma

Exclusion Criteria:

* risk of modification of the microbiota (terminal enterostomy, chronic inflammatory bowel disease, oesophageal or gastric surgery, vagal nerves lesion, beta lactamin allergy, bowel cleansing)
* postoperative complication
Denosumab and Osteoporotic Vertebral Compression Fracture

This study aimed to investigate the effect of denosumab on bone mineral density(BMD), bone turnover markers(BTMs), functional status, secondary fracture rate, and adverse effects in osteoporotic vertebral compression fracture (OVCF) patients after vertebroplasty during a 12-month follow-up period.

We performed a single-center, placebo-controlled, randomized clinical trial in the Department of Spinal Surgery located at the First Affiliated Hospital of Southern University of Science and Technology (Shenzhen People's Hospital). All patients underwent vertebroplasty and randomly received denosumab treatment or placebo control after surgery. The BMDs (lumbar, total hip, and femoral neck) and BTMs were assessed at baseline, 6, and 12 months post-operation. The visual analog scale (VAS) score for back pain, and function status questionnaires, including EuroQol five-dimension (EQ-5D), the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31), and the Roland-Morris Disability Functioning Questionnaire (RMDQ),secondary fracture rate, and adverse effects in OVCF patients after vertebroplasty during a 12-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Must be age between 50 and 90 years old
* X-ray diagnosis of 1 or 2 segment vertebral compression fractures from T4 to L5
* Bone mineral density T value less than -1 via dual-energy X-ray
* A recent fracture history less than 6 weeks
* MRI show bone marrow edema of fractured vertebrae
* low back pain, local paravertebral tenderness

Exclusion Criteria:

* Must be able to have no intervertebral fissure
* Must be able to have no infection
* Must be able to have no malignancy
* Must be able to have no neurological dysfunction
* Must be able to have no previous use of anti-osteoporosis drugs
* Must be able to have no inability to perform magnetic resonance imaging
* Must be able to have no prior back open surgery
* Must be able to have no other established contraindications for elective surgery
An Innovative Gait Training Program in Immersive Virtual Reality for Healthy Older Adults

Background Impaired gait adaptability is one of the major causes of falls among older adults by producing inappropriate gait adjustments in cluttered environments. Training programs designed to improve gait adaptability behavior in a systemic approach may prevent falls in older adults. Recently, the technology of virtual reality has appeared as a relevant gait training tool based on its training implementation potential. The present study was designed to compare the effectiveness of a virtual reality gait training program (VR group) for improving gait adaptability behavior and thus, reducing the risk of falls relative to a conventional training program of Nordic walkway (NW group). We hypothesize that the virtual reality gait training program will lead to greater gait adaptability improvements.

Methods The protocol describes a randomized controlled trial with pre-tests, post-tests, retention tests and follow-up. Forty healthy independent living community dweller participants (65-80 years) will be allocated, after a general medical examination, to the VR or the NW group for a training program of six weeks. Primary outcome related to gait adaptability capacities and acceptance of the virtual reality device will be assessed in pre- and post-intervention and one month after the completion of the training program (retention). A follow-up will be done during the 12 months after the completion of the gait training program.

Discussion This study will demonstrate the relative relevance of a gait training program in virtual reality versus a conventional one for improving gait adaptability behavior in healthy older adults and thus preventing falls.


Eligibility Criteria:
Inclusion Criteria:

* aged between 65 and 80
* with weekly moderate to vigorous physical activity

Exclusion Criteria:

* inability to practice activity at a moderate or vigorous intensity
* moderate or severe cognitive impairments
* severe non-corrected visual impairments
* uncontrolled psychiatric disorders
Automated Inhaler Monitoring for Asthma Medication Usage

The goal of this clinical trial is to evaluate the aflo™ digital platform's ability to improve asthma control and inhaler technique for children, adolescents, and adults with uncontrolled asthma. The main questions the trial aims to answer are:

1. Does the aflo™ platform improve asthma control, as measured by changes in the Asthma Control Test (ACT) and lung function tests (FEV1, PEF)?
2. Does the platform improve medication adherence and inhaler technique, as measured by the Inhaler Proficiency Score (IPS)?

Participants will:

* Use the aflo™ sensor with their asthma inhaler to receive real-time feedback on technique and medication adherence reminders.
* Track asthma symptoms and quality of life through a mobile app.
* Complete assessments and surveys at the start and end of the 3-month study and 2 interim asthma assessment phone calls.


Eligibility Criteria:
Inclusion Criteria:

* Youth or adult with a diagnosis of persistent asthma by a physician
* Participants must have uncontrolled asthma, defined as an ACT score of less than 19, FEV1 less than 80% of the predicted value, and an FEV1/FVC ratio less than 70%, all while on controller therapies.
* Females or males between the ages of 10 years of age and older
* Participant or caregiver must have an Apple and/or Android smart phone with operating system 4.3 or above and data plan for the duration of the study period

Exclusion Criteria:

* Participants with other cardiac, pulmonary with exception of asthma, neuromuscular disorders that impact breathing, or other conditions that hinder patient to perform spirometry.
* Participants with documented developmental delays or impairments that would interfere with ability to use aflo™ system
* The participant's guardian or the patient has comprehension or language difficulties that prevent understanding of study materials (available in English) or effective training on the app or device.
* Patients are currently receiving biologic therapies for asthma management or other allergic diseases.
Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization

A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid can harm the tubes and uterus making implantation more difficult or harm the embryo.


Eligibility Criteria:
Inclusion Criteria:

* Are willing to participate in this clinical study
* Are able to comprehend and give informed consent for participation in this study
* Have read, understood and signed an informed consent form
* Have been unable to achieve pregnancy after trying for 1 year or greater and who have unilateral or bilateral hydrosalpinges as evidenced by laparoscopy or ultrasound or HSG
* Have a Day #3 serum FSH\<10, and Day #3 Estradiol\<80
* Recipient women undergoing a ovum donor cycle the donor must have a Day 3 serum FSH \< 10 and Day 3 Estradiol \< 80
* Have an antral follicle count 10 or greater for both ovaries combined, if women using ovum donor (follicle count) will be based on eligible donor
* Have a desire to receive treatment for their HS
* Are willing to undergo a hysterosalpingogram (HSG) 3 months after ADIANA placement to confirm proximal tubal occlusion

Exclusion Criteria:

* Active or recent upper or lower pelvic infection
* Known hypersensitivity to nickel as confirmed by skin test
* Known allergy to contrast media
* Pregnancy or suspected pregnancy
* Delivery or termination of pregnancy less than six weeks prior to Adiana placements
* BMI \> 35
* Abnormal pap smear (CIN2 or greater abnormality) within the past year
* Pelvic malignancy
* Severely retroverted uterus
* Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum
* Abnormal Clomid Challenge Test or abnormal lab values on Day #3 serum FSH and Estradiol
* Antral follicle count less than 10 (both ovaries combined)
* Poor general or gynecologic health
* Inability or refusal to provide informed consent
Assessment of Hydration Status Using Bioelectrical Impedance Vector Analysis

The state of hyperhydration in critically ill patients with acute kidney injury (AKI) is associated with increased mortality. Bioelectrical impedance vector analysis (BIVA) appears to be a viable method to access the fluid status of critical patients but has never been evaluated in critical patients with AKI. The objective of this study is to evaluate the hydration status using BIVA in critical patients under intensive care at the time of AKI diagnosis and to correlate this measurement with mortality. A sample of 224 patients with AKI will be evaluated by BIVA and followed until they are discharged or death in intensive care unit and the BIVA vectors will be analysed to define differences in hydration characteristics from each group.

Patients admitted to Intensive Care Unit (ICU) will be assessed by BIVA at the moment of the AKI diagnosis. They will be followed up to 12 weeks, until hospital discharge or death. The association between survival and hydration status, as assessed by BIVA in the first AKI day, will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years who developed acute kidney injury after admission in Intensive Care Unit

Exclusion Criteria:

* Chronic kidney injury, dialysis-dependent chronic kidney injury, acute kidney injury before ICU admission, kidney transplant, morbidity obesity and limb amputation.
Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?

The potential clinical implications of this study are to optimise the selection of a population at risk for developing a diabetic cardiomyopathy among diabetic patients in order to develop early therapeutic strategies to prevent the left ventricular remodelling.

Therefore, the originality of this project is to hypothesize that :

* Diabetes mellitus is often associated with a premature aging syndrome
* Cellular senescence may potentiate the mechanisms that are involved in decreasing myocardial contractility in DM and,
* DM associated to premature aging may increase the risk of developing a cardiomyopathy Thus, the modulation of telomerase activity and the control of telomere length, together with the attenuation of the formation of reactive oxygen species, might represent important new targets in order to develop therapeutic tools in prevention of diabetic cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes mellitus
* 40 \< Age \< 55 years old
* oral antidiabetic or insulin treatment
* No symptoms
* Sinus rhythm
* no sign or history of heart disease
* LVEF \> 55%
* Absence of regional left ventricular motion abnormalities.

Exclusion Criteria:

* absence of sinus rhythm,
* silent ischemia defined as positive exercise test or positive stress echocardiography,
* history of cardiomyopathy or CAD,
* valvular heart disease hemodynamically significant,
* severe renal insufficiency defined as creatinine clearance \< 30 mL/min,
* echocardiographic images unsuitable for quantification,
* type 1 diabetes mellitus,
* Important diabetes mellitus imbalance defined as glycated hemoglobin \> 9% or glycemia \> 3g/L uncontrolled hypertension (\> 180/100 mmHg).