cyrilzakka/clinical-trials huggingface dataset:
CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)

The aim of this study is to compare the effects of two different protein supplements (partially hydrolyzed whey protein, PHWP vs. partially hydrolyzed gelatin, PHG) on weight loss in obse individuals with metabolic syndrome (METS). These two supplements will contain equal amounts of protein but differ considerably in their amino acid contents. Whey protein is rich in essential amino acids whereas gelatin is rich in proline.

In obese individuals with METS, the hypotheses are:

* PHWP will augment fat-mass loss and increase lean-mass to fat-mass ration more than PHG.
* PHWP will improve insulin action more than PHG.
* PHWP will decrease cardiovascular disease risk more than PHG.

The Metabolic Syndrome (METS) is a clinical disorder characterized by the following problems: Obesity, especially located in the waist area, elevated blood fats (lipids), high blood pressure and insulin resistance. The METS affects one third of the adult population in the USA and increases the risks for both diabetes and hardening of the arteries, leading to heart attacks and strokes.

The best treatment for improving the symptoms of METS is weight loss. In previous studies, it has been demonstrated that whey protein (WP) supplementation increased weight loss and especially fat-mass loss in obese, insulin resistant women when compared to carbohydrates. We now propose to compare WP to another protein source in patients with the METS during weight loss. In addition, we will use a special preparation called partially hydrolyzed whey protein, which may have specific properties that increase fat mass loss.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnoses of Metabolic Syndrome (at least 3/5 of the following)

  * Waist Circumference: men: \>40 in women: \>35 in
  * Blood Pressure: \>135/\>85 mm Hg
  * Triglycerides: \>150 mg/dl
  * HDL-cholesterol: men: \<40 mg/dl women: \<50 mg/dl
  * Fasting Glucose: \>100 mg/dl
* Ages 18 to 65 Years
* BMI range of 27 to 42 kg/m\^2
* Body weight \<300 lbs
* Weight Stable for 3 Months

Exclusion Criteria:

* Subjects who habitually consume protein supplements or have eating disorders
* Recent delivery (within 12 months), lactation, pregnancy or intention to become pregnant
* Type 2 diabetes, kidney disease, liver disease, anemia, gout, cancer, untreated thyroid disease, gastrointestinal disease, other metabolic diseases or malabsorption syndromes
* Triglyceride \>500 mg/dl, Cholesterol \>260 mg/dl
* Use of insulin sensitizers, lipid lowering medication or ACE inhibitors
* Use of anti-obesity medications or supplements for at lease 6 months prior to start of study
* Known allergy or adverse reaction to protein and dairy products (including lactose)
Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension

Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.

It is a prospective, randomized, double-blind, placebo controlled trial to assess the effect of 3 months treatment with sildenafil (20 mg/8 h), added to a pulmonary rehabilitation program, on exercise tolerance. Subjects: 60 patients (30 by treatment group). Main end-point variable: endurance time in constant work exercise test (CWET). Other measurements: 6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* COPD, FEV1 \< 80% ref. and FEV1/FVC \< 0.7 post bronchodilator
* Age 40-80 years
* Pulmonary hypertension
* Consent to participate in the study

Exclusion Criteria:

* Pulmonary or extrapulmonary disease that modifies gas exchange or pulmonary hemodynamics
* Recent exacerbation (\<4 weeks) (temporally)
* Patients treated with nitrates or CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir)
* Ischemic optic neuropathy
* Patients treated with phosphodiesterase-5 inhibitors
* Patients with ischemic cardiopathy
* Systemic disease that could modified the results
* Patients unable to practise exercise
Reducing Problematic Substance Use in Youth With Chronic Medical Conditions

The investigators goal is to pilot a substance use-related brief intervention (BI) for youth with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability and impacts of the approach for reducing substance use among this group.


Eligibility Criteria:
Inclusion Criteria:

* 14-18 years old
* Currently being treated for diabetes, rheumatologic disorders, asthma, or ulcerative colitis (UC) at Boston Children's Hospital with a duration of chronic illness of at least one year
* Previous participation in the screening validation study
* Evidence of problems related to substance use

Exclusion Criteria:

* Medically or emotionally unstable or otherwise unable to provide assent/consent
* Unable to speak/read English
* Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire
A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T

Radiation in combination with Provenge based immunotherapy may improve outcomes seen on imaging as well as immunologic monitoring. This study will assess the effect of radiation therapy to augment anti-tumor responses from immune therapy with Provenge.

It is common knowledge that the host can make anti-tumor immune responses, although often these are ineffective in causing tumor regression. Boosting these responses with immunotherapy is therefore an attractive, relatively benign adjunctive cancer treatment. Little is known in regards to how standard anti-cancer therapies like radiation therapy might interact with immunotherapy in a clinical setting. We are interested in knowing if the tumor cell death occasioned by radiation therapy might augment anti-tumor responses from the immune therapy, Provenge.

The tentative assumption is that cell death following radiation therapy will stimulate anti-tumor immunity, which could provide a more permanent solution to curing cancer and discouraging tumors from spreading throughout the body. In order to find out if this assumption is correct, for patients undergoing radiation 28 days prior to Provenge, highly developed, laboratory analyses for tumor-specific immunity and imaging will be performed.

Eligibility Criteria:
Inclusion Criteria: Subjects will be recruited from the population of patients who are castrate refractory metastatic prostate cancer (mCRPC) and have made the decision to be treated with radiation therapy to one or more metastatic sites of concern followed at least 28 days later by Provenge.

Exclusion Criteria: The potential subject is unwilling or hesitant to participate for any reason and/or fails to complete the appropriate Informed Consent Form.
Operative Versus Non-operative Management of Subacromial Impingement

The study aims at determining the effectiveness and cost-effectiveness of surgical management of subacromial impingement (including partial tears) compared to conservative treatment. The research setting is prospective, randomised, and controlled.

The aim of the study is to search out evidence based data of indications for subacromial decompression. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when subacromial impingement is suspected.

The investigators hypothesise that there are subgroups of patients suffering from subacromial impingement that benefit from surgery whereas other subgroups are best treated conservatively.

Subgroup analysis:

* age
* sex
* duration of symptoms
* presence of trauma before symptoms
* presence of partial tear
* degenerative findings
* other findings in MRI or arthroscopy
* type of operation
* co-morbidities
* occupation
* pain (VAS)
* objective shoulder function
* activities of daily living

Eligibility Criteria:
Inclusion Criteria:

* age over 35 years old
* duration of symptoms at least three months despite non-operative treatment
* accepts both treatment options (operative and physical therapy)
* must have pain in abduction of the shoulder
* must have painful arc
* must have pain in two of the three isometric tests (0 and 30 degrees of abduction, or external rotation)
* a positive result in the impingement test (a subacromial injection of lidocaine reduces pain)

Exclusion Criteria:

* previous shoulder operations
* too high risk for operation
* any disease or social problem reducing the ability to co-operate
* rheumatoid arthritis
* severe arthrosis of the glenohumeral or acromioclavicular joint
* a full-thickness rotator cuff tear in MRI arthrography
* a progressive malign disease
* adhesive capsulitis
* high-energy trauma before symptoms
* cervical syndrome
* shoulder instability
Evaluation of the Fluoride Dose Response Using In Situ Caries Model

The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 85 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two 4 mm round enamel specimens and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth;
* Be willing and capable of wearing their removable partial denture 24 hours a day for four (4), three-week treatment periods;
* Be willing to allow study personnel to drill specimen sites (as described in #iv) in their mandibular partial denture;
* Be in good medical and dental health with no active caries or periodontal disease (NOTE: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1);
* Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).

Exclusion Criteria:

* Currently being pregnant, intending to become pregnant during the study period, or breast feeding;
* Currently having any medical condition that could be expected to interfere with the subject's safety during the study period;
* Currently taking antibiotics or having taken antibiotics in the two weeks prior to beginning treatment 1;
* Having participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
* Taking fluoride supplements, required to use a fluoride mouth rinse, or have received a professional fluoride treatment in the two weeks preceding specimen placement;
* Currently taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis.
Effects of Oral Care in the Neuroscience ICU

The purpose of this study is to compare how effective different ways of mouth cleaning are for patients in a neuroscience intensive care unit with a breathing tube in their mouth.

Patients with neurological dysfunction requiring intubation and ventilation are at risk for developing ventilator acquired pneumonia. Several studies have suggested that oral hygiene plays a role in the subsequent development of pneumonia for patients in the intensive care unit requiring intubation and mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* \> or equal 18 years old
* Intubated within 24hours of admission to the Neuroscience ICU
* Intubation anticipated to continue for approximately 72 hours

Exclusion Criteria:

* Minors
* Pregnancy
* Acute cervical spinal cord injury
* Severe facial trauma
* Family not present for consent
Development, Implementation and Evaluation of the Impact of a Guideline in Clinical Practise for Cardiovascular Risk

The aim of this study is to evaluate the impact of a clinical guideline in cardiovascular risk, with a local adaptation model of the existing guidelines in clinical practise at present, of each of the different cardiovascular risk factors, and the implementation strategy.

With this objective this study will be developed in three diferent phases. The guideline in clinical practice elaboration. It will be based in evidence medicine and it will be adapted based in the cardiovascular risk factors guidelines published at the present.

The spreding and implementation of the guideline between the sanitarians, as much in primary medicine as in specialised area, involved in the care of the patient in cardiovascular risk, in the Area 2 in Madrid.

And the evaluation of the implementation strategy, used between the primary care physicians.

For the local adaptation, will be used a systematic review of the different guidelines in the Spanish and international literature, published in the last years about this topic.

The ones with better quality criteria will be selected and doctors and nurses related from different specialities, involved in the cardiovascular illness, as much as members of the staff of the medical management an nursery, will be invited to participate in the selection of the recommendations of the guides and in the search of the consensus. After that, this guide will be given to a group of patients, who will be asked for a critical approach and their suggestions will be applied.

The evaluation will be done with a clinical trial designe , testing the use of the guide and its results on health intermediary variables. With this objective the results with an implementation technique based on opinion leaders plus computer reminder, will be evaluated, instead of using the standard implementation.

Eligibility Criteria:
Inclusion Criteria:

* patients whose health cards showed them to belong to the studied health area

Exclusion Criteria:

* Clinical history have not opened in the health center or this one is empty
Disclosure of Genetic Risk for Salt Sensitivity

The global burden of cardiovascular disease (CVD) has decreased over the past 10 years. Nevertheless, the disease still kills one in three people. Hypertension is one of the leading causes of cardiovascular disease, with salt in the diet being a main contributor. Depending on an individual's DNA, participants may or may not be salt sensitive. Genotyping individuals for variants in a salt sensitivity gene (SLC4A5) may identify salt sensitive individuals which may benefit from a personalised dietary advice to reduce salt intake. Adherence to such advice can then be assessed which may aid in prevention of hypertension and CVD.

Salt sensitivity is a key risk factor for hypertension. However, population decrease in salt intake is less than optimal. Research suggests genetics-based personalised nutrition can positively impact health behaviours aiding in the prevention of chronic disease development. However, the effects of communicating such information are unclear. The aims of this study will be to analyse the impact of communicating genetic susceptibility to salt sensitivity on salt intake by assessing dietary salt intake before and after disclosure of genetic risk for hypertension according to the polymorphism in the SLC4A5. Participants will be normotensive, aged 18-35 years. All individuals will receive genetics-based personalised nutritional information. Participants displaying the risk genotype (AA + AC) will be advised to decrease salt intake to less than 4g/d and non-risk will be advised to adhere to government recommendations (6g/d). Dietary recall (24hrs) and 24-hour urine collection will be collected at baseline and four-weeks post-intervention to assess salt intake and excretion.

Eligibility Criteria:
Inclusion Criteria:

* healthy males and females, aged 18-35

Exclusion Criteria:

* pregnant, CVD events (Angina, myocardial infarction, heart failure) or stage 2, hypertension, a BMI ≥30kg/m2, or experiencing mental anguish.
Investigation of Q Angle in Osteoporosis Patients

Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).

Osteoporosis (OP) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. According to Calis et al; it was found that patients with hip fracture had a significantly higher Q angle compared to patients without hip fracture. According to You et al; contraction of the quadriceps muscles corrects the Q angle, therefore sports that use high amounts of quadriceps (strength) training are associated with lower Q angles due to the pulling effect of the quadriceps muscle. There are no studies evaluating Q angle in patients with OP and Osteopenia (OPN) in the literature. Therefore, the aim of this study was to examine the Q angle in patients diagnosed with OP and OPN and to compare it with patients diagnosed with OA. The study will be carried out by measuring the Q angle measurement with a goniometer. Pain assessment will be done with Visual Analog Scale (VAS). Lower extremity muscle strength will be assessed with the Medical Research Council (MRC) Scale. Foot posture will be assessed with the Foot Posture Index (FPI).

Eligibility Criteria:
Inclusion Criteria:

* Be willing to participate in the study.
* Being between the ages of 40-65.
* Being a woman.

Exclusion Criteria:

* Patellofemoral abnormalities during examination.
* Acute traumatic patellofemoral dislocations
* Surgical revision around the knee
* History of any previous lower extremity surgery
* Serious trauma
Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations

Exclusion Criteria:

1. Unwilling or unable to give written informed assent or consent to participate in the study.
2. Perceived to be unreliable or unavailable for the duration of the study period.
3. Previous confirmed or suspected disease caused by N. meningitidis.
4. Previously immunized with a meningococcal vaccine (licensed or investigational).
5. Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
6. Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.

   (certain exceptions influenza vaccines apply)
7. Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.
8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components
10. Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):

    * receipt of immunosuppressive therapy,
    * receipt of immunostimulants,
    * receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
11. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Effect of Xylitol Gum Chewing on Postoperative Bowel Activity

Altogether, 75 patients undergoing elective laparoscopy cholecystectomy were randomly divided into 3 groups (final numbers, xylitol chewing gum: 24 controls, xylitol free chewing gum:25 and control 25 patients). Controls underwent a routine postoperative regimen. Both groups chewed gum 3 times a day except the control group. Other postoperative management was routine. First flatus, first bowel movement, first defecation, first mobilization time, and discharge time from hospital were recorded. Symptoms included nausea, and vomiting.

Purpose: Laparoscopic cholecystectomy (LC) has become the standard treatment for gallbladder surgery due to its advantages over open surgery. However, postoperative ileus (POI) remains a common complication. Gum chewing has been proposed to stimulate bowel function post-surgery, but it's unclear whether xylitol in gum influences outcomes. Our objective was to evaluate the effects of postoperative xylitol gum chewing on gastrointestinal functional recovery after laparoscopy.

Design: A Three-Arm Randomized Controlled Trial Methods: Altogether, 75 patients undergoing elective laparoscopy cholecystectomy were randomly divided into 3 groups (final numbers, xylitol chewing gum: 24 controls, xylitol free chewing gum:25 and control 25 patients). Controls underwent a routine postoperative regimen. Both groups chewed gum 3 times a day except the control group. Other postoperative management was routine. The first flatus, first bowel movement, first defecation, first mobilization time, and discharge time from the hospital were recorded. Symptoms included nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Turkish-speaking,
* Verbal communication,
* Cognitive abilities are normal,
* No psychiatric diagnosis,
* 40 to 65 years old,
* He's having a laparoscopic cholecystectomy,
* ASA (American Society of Anaesthesiologists) Score-I and II,
* who has no problem chewing gum,
* who's going to have scheduled surgery,
* The prescribed duration of surgery not exceeding 100 minutes,
* Patients whose oral intake was to be opened after 6 hours.

Exclusion Criteria:

* Having emergency surgery,
* Liver failure,
* Kidney failure,
* Muscle disease
* Those with a known allergy to the anesthesia drugs used and morbidly obese,
* The one with the walking problem,
* The one with the jaw problem,
* Patients who cannot be contacted,
* With a post-operative nasogastric tube,
* Patients whose oral intake would be opened less than 6 hours were excluded from the study.