cyrilzakka/clinical-trials huggingface dataset:
Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep

To demonstrate the influence of a herbal preparation containing hypericum, passionflower, and valerian on sleep structure, improvement of attention, and well-being in comparison to placebo.

To demonstrate the influence of the herbal combination preparation Neurapas® balance on the objective sleep structure in comparison with placebo. A further aim was to investigate whether treatment with Neurapas® balance versus placebo brings about an improvement in attention and well-being and whether these changes are related to the improvement in the sleep structure.

1. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in continuity of sleep?
2. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in sleep architecture, especially an increase in deep sleep?
3. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning attentional performance?
4. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days vs. placebo lead to an improvement in morning well-being?

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged between 18 and 55 years
* Normal sleeping times (at least 6 hours a night), going to sleep between 22.00 and 1.00 hours, getting up between 6.00 and 9.00 hours
* Written informed consent
* The volunteer is willing and able to cooperate fully
* The volunteer agrees not to drink any alcohol for the duration of the study

Exclusion Criteria:

* Participation in another study in the last 30 days or participation in this study at an earlier date
* Lack of verbal or intellectual ability to communicate adequately and to understand the information to volunteers
* Legal incompetence
* Smoker
* Shift worker
* Transatlantic flight in the last 4 weeks
* Taking psychotropic drugs within the last 4 weeks
* Taking medicines that influence the EEG within the last 4 weeks
* Diseases that influence the sleep EEG
* History of known medication / drug / alcohol misuse according to ICD-10 coding F10 - F19
* Known intolerance/hypersensitivity/allergy to St. John's wort, valerian or passionflower
* Taking inadmissible concomitant medication (anxiolytic, neuroleptic or hypnotic drugs, cyclosporin, sedative, sleep-promoting or mood-enhancing medicines, antidepressants other than the trial medication, coumarin-type anticoagulants, oral contraceptives, tranquillisers, homeopathic remedies, digoxin, theophylline, indinavir, nortriptyline, amitriptyline)
* Known light-sensitivity
Bioengineered Collagen Implant for Urethral Stricture Repair

The field of research for this study is tissue engineering and the utilization of a bioengineered collagen implant as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of distal urethral strictures.

Urethral stricture is defined as the abnormal narrowing of the urethral lumen in the area of the corpus spongiosum. A stricture is the result of ischemic spongiofibrosis manifesting as scar tissue in the corpus spongiosum. Long-term consequences are chronic fistulation through the skin, recurrent sepsis, bladder stones, obstructive uropathy, obstructive nephropathy, and finally renal failure.

Current available surgical techniques for urethral stricture repair require harvesting of grafts from autologous sites resulting in additional risks of complications at the tissue harvest site and additional pain to the patient.

The hypothesis of this study is that the developed bioengineered collagen implant can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients.

Eligibility Criteria:
Inclusion Criteria:

Adult males with urethral stricture less than 3 cm (anywhere from penile to bulbar urethra not including the membranous urethra) with existing lumen of at least 6 Fr suitable for augmentation urethroplasty. The stricture may be due to trauma or infection.

Exclusion Criteria:

* Known bovine collagen allergy
* Current urinary tract infection
* Chronic renal failure
* Diabeted
* Neurological diseases
* Chronic obstructive pulmonary diseases
* Sleep disturbances
* Depression
* Former cancer treatment
* Smokers
* Recurrent stricture
Evaluation of the Role of Plasma Procalcitonin in Prediction of Intra-amniotic Infection in Preterm Premature Rupture of Membrane

It is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic subclinical infection.

Study population

* This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital from Mars2014.
* This study will include 100 pregnant women these cases will be divided into 2 groups:
* Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age .
* Group 2: Preterm premature rupture of membrane Group: will include 50 pregnant females all at 24-34 weeks of gestational age

Eligibility Criteria:
Patients are with singleton pregnancies. Rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal and ultrasound to confirm oligohydraminos.

Subclinical infection will be detected with laboratory indices (WBC count of ≥15, 000 c/mm3, CRP of ≥1 mg/dL) without any clinical symptoms and signs of infection as urinary tract infection in group 1 patients.

Women with multiple pregnancies. Clinical signs of infection as (fever,abdominal tendernes). Cervical dilatations of 2 cm or more. Maternal disease like diabetes or fetal complications like intra-uterine fetal death.

Inclusion Criteria:

-

Exclusion Criteria:

-
Insulin Resistance in Women With Prolactinoma

Prolactin is suggested to influence insulin resistance, but scarce data is available on the metabolic profile of patients with prolactinoma.

The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with prolactinoma treated with dopamine agonists and to study the influence of disease control and anthropometry on their metabolic profile.

A cross-sectional study was performed in non-obese premenopausal women with prolactinoma treated with dopamine agonists evaluated regarding glucose, insulin, Homeostasis Model Assessment (HOMA), lipid profile, C reactive protein (CRP), body mass index (BMI), waist circumference, prolactin, estradiol, testosterone, and sex hormone binding globulin (SHBG). They were compared with control women of similar age and BMI distribution.

Eligibility Criteria:
Inclusion Criteria:

* Prolactinoma
* Female gender
* Premenopausal

Exclusion Criteria:

* Obesity (BMI ≥ 30 kg/m²)
* Diabetes mellitus
* Hypertension
* GH deficiency
* Hypothyroidism
* Primary hypogonadism
* Adrenal insufficiency
* Pituitary surgery
Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®

The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux

Exclusion Criteria:

* IMRT; Concomitant chemotherapy
Physiopathology of Sodium Retention in Acromegaly

Acromegaly is a disease due to an excess of growth hormone that abnormally occurs in adulthood. It is due to a benign (non cancerous) tumor located in a particular part of the brain that secretes several hormones, the hypophysis. The excess of growth hormones in adults induces an increase in bone (resulting in large enlargement of extremities), and organs. The disease is complicated by the apparition of cardiovascular events including retention of water, salt in the tissues and increase in blood pressure, that altogether might major the mortality of the patients. The investigators recently got experimental data suggesting that the retention of water and salt is mainly due to the activation by the growth hormone of a renal transporter of sodium. Because this transporter is highly sensitive to amiloride, a well know diuretic, the investigators hypothesize that this drug will be very efficient in treating the hypertension in patients, as compared to another diuretic, furosemide.

To prove this, we compared the response to amiloride administrated before and after treatment of acromegaly in the same subject. We will also compare the response to furosemide administrated before and after treatment of acromegaly in the same subject. We expected that the response to amiloride will be greater before than after treatment, while the response to furosemide will be lesser before than after treatment.

Detailed Description:

Definition: Extended description of the protocol, including information not already contained in other fields, such as comparison(s) studied.

Patients will be recruited in the Department of Endocrinology and Reproductive diseases in BICETRE University Hospital and will be explored in the Centre for Clinical Investigation of HEGP. Investigations will be performed during 4 separate day-hospital stays (2 pre-treatment and 2 post treatment) in the CIC of HEGP. The tests will consist of blood and urine sample collections before and after a single dose administration of furosemide or amiloride. The tests will be performed before treatment of acromegaly in random order and separated by 48hours, interval performed before treatment, and repeated in the same order after normalization of IGF1 by appropriate treatment.

The study will last for 2 years, with a 12 months maximal participation of each patient

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 75 yrs
* proven evolutive acromegalia with indication of treatment (surgical or medical)
* controlled blood pressure (systolic BP \< 140 mmHg et diastolic BP \< 90 mmHg)
* signed informed consent
* efficient contraception in women

Exclusion Criteria:

* edematous state unrelated to acromegaly
* history of sulfamide intolerance
* hemoglobin \< 8g/dL
* pregnant or breastfeeding women
* inability to give informed consent
* blood donation in the preceding 3 months
Community and Clinician Partnership for Prevention

The purpose of this study is to evaluate the impact of strategies to develop and foster the relationship between primary care practices and community resources to address specific unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity).

Tobacco use, poor diet, and lack of physical activity are associated with the leading causes of significant morbidity and mortality, including coronary heart disease, hypertension, cancer, stroke, diabetes, and respiratory dysfunction. One solution to decreasing unhealthy behaviors would be to better integrate primary care providers with community resources, including community and public health organizations that already have the capacity and expertise to deliver effective interventions. This project is a randomized trial to evaluate different practice-level interventions to link practices to community resources to decrease unhealthy behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Internal medicine and family practices in Durham and Orange counties, North Carolina

Exclusion Criteria:

* None
The Mediterranean Full-Fat Dairy Study

A Mediterranean dietary pattern emphasizing an abundance of plant-based foods including nuts, moderate intakes of fish, poultry and low-fat dairy products, and use of extra virgin olive oil as the main source of fat has been associated with reduced risk of cardiovascular disease (CVD), and such a pattern has been advocated by the 2015 U.S. Dietary Guidelines Advisory Committee. The strongest experimental support for this recommendation derives from the success of the recent PREDIMED CVD outcomes trial, and studies indicating that a Mediterranean-style diet improves lipoprotein and oxidative markers of cardiovascular disease risk in comparison to either low-fat or Western dietary patterns. However, in none of these studies were comparisons made between the effects of Mediterranean-style diets with low-/nonfat vs. full-fat dairy foods. The overall objective of the present proposal is to determine whether the inclusion of full-fat rather than low- and nonfat dairy foods in a Mediterranean dietary pattern based on that used in the PREDIMED study results in similar improvements in biomarkers of CVD risk. Specifically, we will test the hypotheses that 1) a standard Mediterranean diet will lower LDL-C and apoB compared to a Western diet; 2) modification of the Mediterranean diet by replacing low-fat dairy products with high-fat dairy (3 servings/day; high-dairy fat Mediterranean diet) will not significantly increase LDL-C and apoB but may raise large buoyant LDL particles compared with a standard Mediterranean diet; and 3) the high dairy fat and standard Mediterranean diets will result in comparable reductions in levels of inflammatory markers and oxidized LDL, and improvements in endothelial function compared to a Western diet.


Eligibility Criteria:
Inclusion Criteria:

* BMI 25-35 kg/m2
* Weight stable for \> 3 months
* Agrees to abstain from alcohol or dietary supplements during the study

Exclusion Criteria:

* History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
* Current use of hormones or drugs knowns to affect lipid metabolism
* Use of nicotine products or recreational drugs
* Abnormal TSH
* Pregnant or breastfeeding
* Total- and LDL- cholesterol \> 95th percentile for sex and age
* Fasting triglyceride \> 500 mg/dl
* Fasting blood sugar \> 126 mg/dl
* Blood pressure \>160/95 mm Hg
* Allergy to or unwillingness to consume study foods
Neoadjuvant ECS Versus ECF in Local Advanced Breast Cancer

S-1 is a newly developed novel oral dihydrouracil dehydrogenase inhibiting fluoro-pyrimidine drug consisting of i M tegafur (FT), 0.4 M 5-chloro-2, 4-dihydroxypyrimidine (gimeracil), and 1 M potassium oxonate (oteracil), with efficient antitumor activity and low gastrointestinal toxicity. Several studies have proved the safety and efficacy of single agent S-1 in metastatic breast cancer. This study is designed to further investigate and compare the efficacy and safety of Epirubicin-cyclophosphamide-S-1(ECS) vs. Epirubicin-cyclophosphamide-5-fluorouracil (ECF) as neoadjuvant chemotherapy in patients with local advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Disease characteristic:

  * Histologically confirmed primary breast cancer by core biopsy (Mammotome or bard needle)
  * Disease stage appropriate for neoadjuvant chemotherapy (T≥3cm, N0 or T（2-3cm）N1 or any T, N2)
  * Her-2(-); Ki67≥14%
  * No previous treatment for breast cancer (chemotherapy, endocrinotherapy, radiotherapy)
* Patients characteristic:

  * Female patients, age 18 to 70 years old
  * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2
  * Life expectancy of at least 12 weeks
  * Willing to be kept follow-up
  * Functions below are maintained in major organs:
  * Cardiac status:

LVEF: 50% 45% • Haematopoietic status: Leukocyte count: ≥4.0×109/L Neutrophil count: ≥2.0×109/L Platelet count: ≥100×109/L Hemoglobin: ≥80g/L

• Hepatic status: Total Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 times ULN(no liver metastasis) bilirubin:

• Renal status: BUN ≤ 1.5 x times ULN Creatinine ≤1.5 times ULN or calculated creatinine clearance, using the Cockcroft-Gault formula, ≥50 mL/min; Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85

• Written informed consent (both biopsy and neoadjuvant chemotherapy) will be obtained for patients for entering this study

Exclusion Criteria:

* Previous treatment for breast cancer (neither local nor systemic therapy)
* Known or suspected distant metastasis
* Potentially pregnant, pregnant, or breast-feeding
* Drug allergy
* Concurrent malignancy or history of other malignancy (except Hodgkin lymphoma)
* Currently active severe infection (Hepatitis included)
* History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures
* Known history of uncontrolled severe heart disease, myocardial infarction within 6 months, congestive heart failure, unstable angina pectoris, clinically significant hydropericardium or unstable arrhythmias
Evaluation of the Prognostic Value of Preoperative Quadriceps and Respiratory Muscle Thickness by Ultrasound Measurement in Cardiac and Thoracic Surgery Patients

Cardiac and thoracic surgery are major procedures. In order to estimate the operative risk, many scores have been developed, including the Euroscore 2 in cardiac surgery. However, the Euroscore has limitations since it does not assess all the parameters that may influence postoperative complications, such as the patient's general condition or the status of his or her functional reserves.

However, it has been shown that the preoperative functional reserves have a significant impact on the patient's risk of developing postoperative complications following major surgery. In addition, there is a strong association between cardiac failure and a well-described decrease in peripheral muscle lean mass (sarcopenia) in patients older than 65 years.

Usually, a nutritional assessment is performed during the pre-anesthesia consultation. This assessment is based on clinical and biological criteria that are not totally predictive of the patient's functional reserve status.

Lean body mass (muscle) is a well-validated marker for the assessment of patients' functional reserves. However, the techniques used to date are complex and require radiation.

This study aims to use ultrasound of muscle groups (respiratory muscles - Quadriceps muscle - Diaphragm) to study the relationship between preoperative muscle mass and postoperative complications in patients over 65 years of age undergoing cardiac or thoracic surgery.

This is a prospective observational study to be conducted at the Dijon University Hospital by the cardiovascular anesthesia-intensive care department. A total of 300 patients will participate in this study, and we have planned to complete the project over a 2-year period. The participating patients (if they do not present any exclusion criteria and are not opposed to inclusion) will be included and undergo a muscle ultrasound in the cardiovascular surgery department or the thoracic and pulmonary surgery department the day before their intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patient 65 years or older
* Patients who have not objected to their inclusion in the study
* Any patient requiring elective cardiac surgery, with extracorporeal circulation extracorporeal circulation OR
* Any patient requiring lung surgery with resection of at least one lobe

Exclusion Criteria:

* pneumectomy
* Person who is not affiliated to national health insurance
* Person subject to a measure of legal protection (curatorship, guardianship)
* Pregnant, parturient or breastfeeding women
* Major unable to express consent
* Persons with amputations of the proximal segment of a lower limb
* Persons suffering from a pre-existing neuromuscular pathology, tetra or paraplegia
* Person who must undergo emergency surgery
Interventions for Lifestyle Changes to Promote Weight Reduction, a Randomized Controlled Trial in Primary Health Care

The purpose of this study is to examine the effects of a weight reduction program in adults, seen in a primary care setting, with overweight/obesity perceived as a health problem or with diseases related to overweight/obesity and ambitions to achieve weight reduction as part of treatment.

Patients seeking advice for overweight/obesity or illness related to overweight/obesity at eight primary health care centers in Sweden were randomized either to intervention or control care groups with both dietary advice and individualized advice on increased regular physical activity. Main outcome measures were reduction in body weight of 5 percent or more from study start.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients between 18 and 70 years of age who consulted or were in care for overweight/obesity with or without type 2 diabetes
* Hypertension, CVD
* Coronary heart disease (CHD)
* Dyslipidemia
* Gallstone or musculoskeletal disorders

Exclusion Criteria:

* Patients were not eligible if they were already taking part in another weight control program
* Understood the Swedish language poorly
* Were mentally ill or had an alcohol or drug addiction.
* Nor were they eligible if they had a physical disability preventing intensified physical activity or were pregnant at study start.
Risk Factors for Falls After Intervention of the Urgent Medical Assistance Service (SAMU) in the Elderly Person at Home

In this project, the investigators are interested in a particular population, that of elderly subjects who used the SAMU after a fall and who are not hospitalized or are hospitalized less than 24 hours. The scientific literature concerning this population is poor . However, this is a particularly vulnerable population. The Direction of research, studies, evaluation and statistics (DREES) report notes that in 2005 in metropolitan France, 24% of people aged 65 to 75 said they had fallen in the last 12 months. Home falls among seniors may require emergency medical services (EMS).

The first cause of accidental death in people over 65, the fall often has a pejorative impact on the physical, psychological and quality of life . It is also predictive of entry into an institution.

In this project, the investigators propose to evaluate the patient at home with a Gerontological Assessment Nurse working in collaboration with the attending physician, whenever the fall triggers a call to the SAMU (without hospitalization or with hospitalization of less than 24 hours). In addition to the evaluation, the nurse will propose a personalized intervention plan (PIP) based on targeted and prioritized actions.

The Main objective is to study the effect of a personalized intervention plan (PIP) proposed by a Gerontological Assessment Nurse at home in the elderly who used the SAMU for a fall (with on-site care or hospitalization inferior to 24h), on the delay institutionalization or death before institutionalization compared to standard care.

Eligibility Criteria:
Inclusion Criteria:

* Living at home
* Living at maximum 45 minutes from a hospital center participating in the study (for logistical reasons and practices of study organization)
* Intervention of the SAMU for a fall at home without there being hospitalization or with hospitalization lasting less than 24h
* Patient or trusted person capable of giving telephone information
* Patient or his / her trusted person who has agreed to participate in the study
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Total dependency (ADL at 0)
* Entry in nursing home already scheduled within 3 months