cyrilzakka/clinical-trials huggingface dataset:
The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose

This study is being done to see if the blood pressure and metabolic effects of an approved drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and placebo in hypertensive patients.

This study is double blind (neither you nor the physician will know when you are receiving placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol or hydrochlorothiazide).

All participants will also receive lisinopril, an angiotensin converting enzyme, or losartan, an angiotensin receptor blocker. All medications are approved and marketed for the treatment of hypertension.This study is being conducted in about 500 patients at approximately 80 research centers in the United States.

The study consists of approximately 9 study visits over a period of 5 months. During these visits, patients will undergo routine health exams and some special laboratory tests such as an oral glucose tolerance test.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ambulatory outpatients 18-80 years old at screening.
* Have a history of hypertension and taking up to 2 medications for high blood pressure.
* Qualifying laboratory results confirming impaired fasting glucose or impaired glucose tolerance
* Vision and hearing (hearing aid permissible) sufficient for compliance with questionnaire completion

Exclusion Criteria:

* Have clinically significant respiratory, liver or cardiovascular disease
* Presence of coronary artery disease requiring treatment with a beat blocker, calcium channel blocker or nitrates
* Use of niacin or antidiabetic drugs (oral or injectable) within 6 months before study entry
* Have a history of hypersensitivity to nebivolol, other beta-blockers, hydrochlorothiazide, or other sulfonamide-derived drugs.
SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate.

Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable results to that of Holmium laser enucleation of the prostate and subjective improvement of prior device limitations

Thulium laser is continuous wave laser which offers numerous potential benefits compared to alternative lasers and surgical procedures used for BPH. The SOLTIVE Laser system is a compact system which is significantly smaller than Holmium laser systems. The laser fiber is also smaller in diameter allowing for improved maneuverability with decreased fiber degradation and endoscope damage. The continuous wave pattern produces fast, hemostatic cuts during the removal and furthermore the associated hemostasis improves the visual field. Additionally, based on the 1940nm wavelength is absorbed nearly five times more in water. For all the stated reasons, the SOLTIVE Thulium Laser should improve the enucleation efficiency and warrants further investigation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be 18 years of age or older
2. Patients must be diagnosed with benign prostatic hyperplasia
3. Patients must opt for surgical management of their BPH with laser enucleation

Exclusion Criteria:

1. Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
2. Patients with prostate glands greater or equal to 200 grams
3. Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.
Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants

The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier.

This is a prospective, randomize, double-blinded study in preterm infants born between 28-34 weeks gestation admitted to the NICU at the University of Kansas Hospital. After obtaining informed consent, babies will be randomized to either liquid or powdered HMF using opaque, sealed envelopes with preassigned randomization. The feeding protocol as established in the KU NICU will be followed, beginning with initiation of trophic feeds, and advancement of enteral feeds depending on the gestational age and preceding illnesses. Once infants reach 80ml/kg/day of enteral feeds, human milk will be fortified to 22 kilocalories by adding either liquid or powdered fortifier. The beginning of the study(Study day 1) will be defined as reaching and tolerating 100ml/kg/day of 24 kilocalorie human milk fortified with either liquid or powdered fortifier. Enteral feeds will be advanced per unit protocol until they reach 150-160ml/kg/day and 110-120 kcal/kg/day. the volume of feeds will be adjusted based on the documented weight to provide energy and protein requirements as recommended by the ESPGHAN guidelines. Babies will be followed up until the time of NICU discharge.

Eligibility Criteria:
Inclusion Criteria:

* Inborn preterm infants born between 28 0/7 and 34 0/7 weeks gestation and fed either mother's own milk or donor human milk

Exclusion Criteria:

* Newborn infants \<28 weeks and \>34 weeks gestation, those with life threatening illness, congenital and chromosomal anomalies, gastrointestinal anomalies or necrotizing enterocolitis and fed premature formula
Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids

To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients.


Eligibility Criteria:
Inclusion Criteria:

* Age 13 years and weight 40 kg
* End-stage renal disease, with patients receiving a primary or secondary renal allograft from a living-unrelated donor, or from a living-related donor.
* Women who are of childbearing potential must have a negative pregnancy test before enrollment in the study and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation from the study.
* Total white blood cell count 4.0 x 109/L (4,000/mmP3P), platelet count 100 x 10P9P/L(100,000/mmP3P), fasting triglycerides ≤ 4.6 mmol/L (400 mg/dL), fasting cholesterol ≤ 7.8 mmol/L (300 mg/dL). If it is not possible to obtain fasting triglycerides and cholesterol before surgery, historical values (within 1 year) may be used.
* Signed and dated informed consent (parent or legal guardian must provide consent for patients \<18 years of age). An assent form will be signed by patients \< 18 years of age enrolled in the study.

Exclusion Criteria:

* Evidence of active systemic or localized major infection at the time of initial Sirolimus administration.
* Cadaveric donors
* History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin)
* Use of any investigational drug other than specified in the protocol during the 4 weeks before enrolling in the study.
* Use of planned antibody induction therapy at the time of transplantation.
* Active gastrointestinal disorder that may interfere with drug absorption.
* Known hypersensitivity to Sirolimus, MMF or Cyclosporine or its derivatives.
* Multiple organ transplants (2 or more organ transplant e.g. Kidney and Pancreas).
* Patient with high risk of rejection (eg. Patients with a PRA \>50%, black patients and patients with 2nd transplant who lost their first graft within the first 6 months).
* Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.


Eligibility Criteria:
Inclusion Criteria:

- 1)18≤age≤60 years old, no gender limit; 2) Patients receiving routine gastroscopy diagnosis and treatment; 3) ASA score is I or II; 4) 18 kg/m2\<BMI\<28kg/m2； 5) It is estimated that the operation time of gastroscope will not exceed 30 minutes; 6) Clearly understand, voluntarily participate in the research, and be signed and informed consent.

Exclusion Criteria:

1. Need to perform complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography Surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa Stripping, oral endoscopic muscle dissection, etc.);
2. Patients who intend to undergo tracheal intubation;
3. It is judged to be difficult to manage the respiratory tract (modified Mallampati score is IV)patient;
4. Anemia or thrombocytopenia,( Hb\<90g/L, PLT\<80×109/L);
5. Diagnosed lung diseases (asthma, bronchitis, COPD, Pulmonary bullae,pulmonary embolism, pulmonary edema, lung cancer);
6. Liver and kidney disease;( AST and/or ALT≥2.5×ULN,TBIL≥1.5×ULN, blood creatinine is greater than the upper limit of normal);
7. There is a history of drug and/or alcohol abuse within 2 years before the beginning of the screening period.The average daily alcohol consumption exceeds 2 units of alcohol (1 unit = 360 mL beer Liquor or 45 mL liquor with 40% alcohol content or 150 mL grapes liqueur);
8. Hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs(Sitting systolic blood pressure ≥160 mmHg during screening period, and/or diastolic pressure during screening period Pressure ≥100 mmHg);
9. Sitting systolic blood pressure ≤90 mmHg during the screening period;
10. Women who are pregnant or breastfeeding;
11. Benzodiazepines, opioids, propofol, lidoca Those who are allergic or contraindicated due to their drug components;
12. Participated in other drug clinical trials as subjects in the past 3 months;
13. The investigator believes that it is not appropriate to participate in this trial;
14. A well-diagnosed heart disease (heart failure, angina pectoris, myocardial infarction, heart rhythmabnormalities etc.).
Auditory Training and Hearing Aid Satisfaction

Although hearing aids are the most common treatment for hearing loss, and have the potential to help seniors stay active and productive, almost 50% of them who receive hearing aids rarely if ever use them, a state of affairs sometimes referred to as "the hearing aid in the drawer" syndrome. clEAR's customized auditory brain training has been shown to be effective in improving adults' abilities to recognize speech, in reducing their perceptual effort associated with listening with a hearing loss, and in increasing their confidence to engage in everyday conversations. In the proposed research, we will determine whether older adults who receive hearing aids for the first time report higher satisfaction with their new hearing aids and have longer daily use time as a result of having completed clEAR's auditory brain training program for new hearing aid users.

Auditory training as the potential to dramatically affect older persons' adjustment to a new hearing aid and to maximize the benefits they receive from wearing one. In turn, by wearing hearing aids, they experience easier and more successful communication patterns. They enhance their ability to engage in everyday conversations and will be able to become more socially involved with their family and friends. In this study we will try to determine the extent to which web-based clEAR auditory brain training, with concomitant support from a clEAR in-house audiologist, affects satisfaction with new hearing aids and increases daily use time. The study will include thirty adults over the age of 60 years who have received hearing aids for the first time. After an adjustment period, half will complete clEAR's auditory brain training program right away and the other half will complete it after a delay period, and both will complete a control condition. To establish the level of feasibility and clinical utility. We will measure hearing aid satisfaction, benefit ratings, and hearing aid use time.

Eligibility Criteria:
Inclusion Criteria:

* Must be a native English speaker
* Must have a mild to severe bilateral sensorineural hearing loss
* Must be a candidate for new hearing aid(s) (have never used hearing aids)

Exclusion Criteria:

* Cognitive impairment or any factors that would prohibit a participant from completing questionnaires
* Cognitive or speech production factors that would prohibit a participant from repeating words during a speech perception test.
Plant Pigments for Human Health: Impact of Lycopene and Anthocyanins on Bioefficacy of Provitamin A Carotenoids From Carrots

The proposed research will help characterize the impact that simultaneous consumption of anthocyanins and carotenoids has on the bioavailability of the provitamin A carotenoids a-carotene and b-carotene and the non-provitamin A carotenoid lycopene, and on their respective antidiabetic activity in humans. The central hypothesis is that provitamin A carotenoids will be bioavailable from purple-red multicolored carrots in humans, and the co-ingestion of carotenoids and anthocyanins from these carrots will have synergistic impacts on their respective antioxidant and antidiabetic effects. This hypothesis will be assessed through a 53 day randomized crossover time course study that consists of three arms in which healthy males and females ages 18-40 (n = 12) will consume carrot juice prepared from red, purple-red, or purple carrots. During each arm, participants will switch the type of juice they consume and by the end of the third arm, all participants will have ingested juice made from all three carrot varieties. Blood will be collected at multiple time points over 72 hours following consumption.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smoking
* Not pregnant (or planning to become pregnant)
* Body Mass Index (BMI) greater than 18.5 and less than 30

Exclusion Criteria:

* Major comorbidities (cardiovascular disease (CVD), diabetes, cancer, kidney/liver/bowel disease)
* History of malabsorptive/GI disorders
* Abnormal diet
* BMI less than 18.5 or greater than 30
* Food intolerances/allergies/hypersensitivities
* History of substance abuse or alcoholism
* Unwilling to restrict consumption of specific foods prior to study
* Unwilling to participate in blood draws
* History of difficulty drawing blood/health issues associated with blood draws (gets dizzy, etc).
Clinical Trial of Teriparatide in Japan

The purpose of this study is to assess the Efficacy and Safety of Teriparatide in Japanese Postmenopausal Women with Osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Japanese women with primary osteoporosis
* Postmenopausal women aged at least 55 years
* Patients with a high risk for fracture

Exclusion Criteria:

* History of metabolic bone disorders other than osteoporosis
* History of any secondary causes of osteoporosis
* History of malignant neoplasm within the last 5 years except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated
* Severe or chronically disabling conditions other than osteoporosis
Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.

The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of Informed Consent.
2. 18 -75 years at enrollment.
3. In need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws).
4. History of edentulism in the planned implant area of at least 3 months (at Visit 2).
5. At least 4 months of healing after last grafting procedure in the planned implant area (at Visit 2).
6. Deemed by the investigator to be suitable for one stage surgery and be likely to present an initially stable implant situation i.e. have a bone height and bone width suitable for the chosen study implants.
7. Deemed by the investigator to be suitable for loading after 6-8 weeks.
8. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants i.e. an even distribution of contacts between the teeth in the opposite jaw and the planned permanent crown/bridge.

Exclusion Criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator.
2. Uncontrolled pathological processes in the oral cavity.
3. Untreated, uncontrolled caries and/or periodontal disease.
4. Known or suspected current malignancy.
5. History of radiation therapy in the head and neck region.
6. History of chemotherapy within 5 years prior to surgery.
7. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration, as deemed by the investigator.
8. Uncontrolled diabetes mellitus.
9. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration.
10. Smoking more than 10 cigarettes per day.
11. Present alcohol and/or drug abuse.
12. Current need for bone grafting and/or augmentation in the planned implant area. Local, minor soft tissue grafting will be allowed.
13. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site).
14. Previous enrollment in the present study.
15. Simultaneous participation in other clinical studies at enrollment (Visit 1) and during the subject's first year of this study.
Effect of Balanced Hypocaloric Diet Associated With Supplementation of Eggplant Meal in the Remission of Cardiovascular Risk Factors

Cardiovascular diseases (CVD) prevail as the main cause of death in developed and developing countries and are among the most frequent causes of disabilities in Brazil and in the world.

Economic alternatives have been studied to assist in reducing cardiovascular risk factors. Within this context, the Solanum menogena, whose fruit known as eggplant is widely consumed in Brazil, is being used in alternative medicine with the purpose to reduce the concentrations of cholesterol, glucose and promote loss of body weight.

Aubergine (eggplant) stands out for its high fibre content (approximately 40%) and low fat content. In addition, it is popularly known for its functional properties, aiding in reducing the risk of coronary diseases. The purplish coloring of the eggplant peel is attributed to the large amount of flavonoids, which have antioxidant properties and contribute to the flavor of eggplant.

The investigators hypothesis is that the eggplant flour associated with a restricted calorie diet has effect in reduction in waist circumference, reduction of body fat and increasing HDL-cholesterol; this way, contributing to the reduction of cardiovascular risk factors

All participants will be informed about the research and they will have to sign a consent form. The volunteers will be divided into two groups: one group will receive a restricted-calorie diet and supplementation with eggplant flour; and the other will receive a diet plus a placebo for 120 days, being both groups evaluated monthly. In each consultation, evaluation of weight, body composition, fulfillment of the diet and blood pressure measurement will be performed. In addition, blood will also be collected in order to determine glucose, insulin, total cholesterol, LDL, HDL, triglycerides, oxidized anti-LDL antibodies, 15-isoprostane and minerals (selenium, zinc, iron, manganese, magnesium and copper). The results will be analyzed by statistical program.

The investigators expect that with the results obtained, the eggplant flour can be used as an ally in the prevention of cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

adults (aged\> 20 years) body mass index (BMI)\> 25 kg/m2 for both sexes, of any ethnicity.

Exclusion Criteria:

smokers, pregnant women, nursing mothers and that are performing diets and / or using drugs for weight reduction and supplements of any kind.
Accuracy of Non Invasive Hemoglobin Measure by SpHb Device in Post Operative Anemia Diagnosis

Non invasive Hemoglobin monitoring by SpHb device had been developed to assess Hemoglobin level during hemorrhagic surgery. It's accuracy to detect post operative anemia on a single post operative measure has been recently demonstrated on a cohort of post operative orthopedic patient and it's routine use has been generalized to other surgical department. This study aims to valid these finding on a cohort of post operative patients from gynaecological department.


Eligibility Criteria:
Inclusion Criteria:

* being hospitalized for gynecological procedure: hysterectomy or cancer related annexectomy
* \> 18 years

Exclusion Criteria:

* non french speaker
* being under a legal individual protection measure
* not being able to consent
* being opposed to data collection