cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)

Randomized, controlled, double-blind intervention study, with four parallel branches depending on the product consumed, to analyze the efficacy of different types of milks on the improvement of sleep quality.

The duration of the study will be 90 days (12 weeks). Each day they will have to consume the product under investigation. The subjects who meet the selection criteria will be randomly distributed in each of the study groups (A, B, C or D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary on sleep quality and concomitant medication.

They will make a total of two visits to the research laboratory and the tests preestablished in the protocol will be performed. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (\> 18 years).
* Low sleep quality by Pittsburgh Sleep Quality Questionnaire (PSQI).
* Volunteers able to understand the clinical study and willing to comply with the study procedures and requirements.

Exclusion Criteria:

* Subjects with serious or terminal illnesses.
* Subjects with known allergy or hypersensitivity to any of the components of the investigational product.
* Participation in another study involving blood draws or dietary intervention.
* Subjects with body mass index above 32 kg/m2.
* Pregnant or lactating women.
* Use of medications that alter cognitive functions or sleep, such as barbiturates, anticonvulsants, benzodiazepines, antidepressants, neuroleptics, alcohol and illicit drugs.
* Organic dementias such as Alzheimer's, Huntington's disease, Parkinson's and senile dementia.
* Inability to understand informed consent (IC).
Reducing Aggression in Children and Adolescent on an Inpatient Unit

The purpose of this study is to determine whether Anger Control Therapy (ACT) with Regulate and Gain Emotional-Control (RAGE-Control) is a feasible behavioral therapy to provide on a pediatric inpatient psychiatric unit.

Aggression and disruptive behavior are the most common reasons for child and adolescent inpatient psychiatric hospitalization. Aggressive children and adolescents who merit admission to inpatient psychiatric hospitals for treatment typically display dramatic problems with self-regulation that interfere with global adaptive functioning. The goal of this study is to teach self-regulation techniques by combining Cognitive Behavioral Therapy with a biofeedback video game in effort to motivate patients to learn and practice these coping skills, which will translate to decreased feelings of anger and aggression while hospitalized.

Eligibility Criteria:
Inclusion Criteria:

* consecutive admissions to the psychiatric inpatient unit between the ages of 9 and 17 years of age
* who were not expected to begin or undergo a change \>25% to their antipsychotic or mood stabilizing medications
* elevated levels of anger as demonstrated by baseline score on the State Trait Anger Expression Inventory - Child and Adolescent (STAXI-CA) combined State-anger and Trait-anger score greater than 30.

Exclusion Criteria:

* Inability to consent, comprehend, and effectively participate in the study.
* Gross cognitive impairment due to mental retardation, dementia, or intoxication.
* Started on an antipsychotic or mood stabilizing drug within 5 days of beginning the study
MeMed BV® Test Evaluation in Adult Emergency Department Patients

The goal of this observational study is to compare the results of a serum biomarker called the MeMed BV®, which is approved to help differentiate between bacterial and viral respiratory infections, to clinical diagnoses of adult emergency department patients presenting with recent fever and signs or symptoms of a respiratory infection. Active participation is completed during the emergency department visit and includes drawing blood, obtaining a sputum sample, and answering survey questions.

The MeMed BV® is a diagnostic test newly approved by the FDA to assess the likelihood of bacterial vs. viral respiratory infections based on protein biomarkers in blood. This study aims to identify the level of agreement between the results of the MeMed BV® (bacterial/viral) and the standard of care treatment received by the participant (e.g. antibiotics for patient diagnosed with bacterial pneumonia) in order to see if implementing the MeMed BV® into standard clinical care would potentially change diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Adults presenting to the emergency department
* Subjective or objective fever within the past 7 days
* Signs or symptoms of upper or lower respiratory tract infection within the past 7 days

Exclusion Criteria:

* Prisoner
* Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis
* Active inflammatory disease
* Congenital or acquired immune deficiency
* Chronic fungal or parasitic infection
* Infection with human immunodeficiency virus (HIV)
* Hepatitis B virus (HBV)
* Hepatitis C virus (HCV)
* Infection with active tuberculosis (TB)
* Significant trauma or burns in the last 7 days
* Patients that have undergone major surgery in the last 7 days
* Pregnancy
* Active malignancy
Nutrition and Growth in Very Preterm Infants

This study aims to explore the relation of early nutritional intake, especially oral nutrition intake, with growth and body composition among very preterm or very low birth weight infants.

As the survival of very preterm infants increases, it is important to evaluate their long-term outcomes. Nutritional intake during early life was important to the growth and development in infants, especially in preterm infants. Studies found that early nutrition exposure in preterm infants can effect scored of Griffith Mental Development Scales and body fat percentage at later life. Insulin-like growth factor-1, leptin, Ghrelin, C-Peptide are associated with fat mass in children. And accumulation of fat and insulin resistance (IR) in the early postnatal period are related to metabolism diseases in adulthood. However, previous studies on nutrition and growth or the body composition of preterm infants were mostly completed in developed countries, and no relevant data were available in China. Therefore, this study aims to establish a prospective cohort of very preterm infants to observe the effects of nutritional exposure in early life on growth and body composition in later life.

Eligibility Criteria:
Inclusion Criteria:

* infants born with a gestational age \>=28 weeks and \<32 weeks and/or a birth weight \>=1000g and \<1500g;
* infants admitted to neonatal intensive care unit (NICU) of Children's hospital of Fudan University within 24h after birth.

Exclusion Criteria:

* major congenital anomalies or heredity metabolic diseases;
* severe disease or abdominal surgery during hospitalization;
* death during hospitalization or discharge without medical advice;
* small for gestational age.
A Prospective, Cohort Study of Hyperpolarized 3He MRI in Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine the MRI characteristics of Chronic Obstructive Pulmonary Disease subjects both at baseline and yearly for a period of 5 years, and to correlate these biomarkers with pulmonary function tests, CT scan, 6 Minute-walk tests, and respiratory questionnaires.

The central hypothesis is that quantitative assessment of the lung through magnetic resonance imaging of hyperpolarized 3He can detect early alterations in structure and function which are precursors to clinically apparent COPD and that these precursors can be used to predict progression of disease earlier and better than established clinical methods.

Novel assessments using 3He MRI will lead to new information about COPD and will be critical for characterizing disease response to therapy. A secondary hypothesis is that a variety of technical improvements in the techniques of hyperpolarized gas MRI will accelerate the translation of this relatively new modality to clinical use.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent was obtained and documented (after the investigator has given oral and written information about the study to the subject).
* The subject was conscious, co-operative, and agreed to return for the scheduled visits and tests and any visits required to obtain additional safety information.
* The subject's medical history, physical examination (including vital signs, pulse oximetry, PFT's, and 12-lead electrocardiogram \[ECG\]), and clinical laboratory tests (hematology, serum chemistry) obtained at the screening visit were within acceptable limits for entry into the study, as judged by the investigator.

Exclusion Criteria:

* Subject is \<40 or \>70 years old
* Subject known to be pregnant
* Subject with a baseline oxygen requirement \> 2 l/min via nasal cannula
* Any known contraindication to MRI examination
* Inability to provide informed consent
* A language, communication, cognitive or behavioral impairment that might interfere with fully informed consent
* Active drug or alcohol dependence
* Homelessness or other unstable living situation
* Active drug or alcohol dependence
* Significant co-morbidities such as heart disease, kidney disease, liver disease, hematologic or neurological disease that require continuing treatment.
Left Bundle Branch Area Pacing 3D Guidance System

The investigator's project proposes the development of a 3D hybrid guidance system which has the aim of avoidance of scar and septal perforation through targeted lead deployment via a personalised septal real time image overlay onto x-ray fluoroscopy imaging during left bundle branch pacing. The investigators hypothesise that the use of cardiac anatomy and myocardial scar distribution derived from cardiac magnetic resonance imaging (MRI) as well as 3D position of the pacing lead, may improve LBBAP lead deployment success and improve clinical outcomes by guiding the physician towards optimal lead positioning.

The study will use anonymised imaging data from the TACTIC-CRT (IRAS 250715) , Cardiac CT to guide Cardiac Resynchronisation Therapy (CRT) implantation (IRAS 150161) study (IRAS 150161) and anonymous cardiac MRI, CT and fluoroscopy imaging data from patients who underwent LBBA pacing to develop a 3D hybrid guidance system using machine learning methods. The developed 3D hybrid guidance system will be tested on anonymised retrospectively collected x-ray fluoroscopy images from patients who underwent LBBAP and had a cardiac MRI. The 3D hybrid guidance system will collect data from the retrospective anonymised X-ray fluoroscopic images, detect the pacing lead and reconstruct the 3D position of the pacing lead and test the accuracy of the 3D hybrid guidance system.

Eligibility Criteria:
Inclusion Criteria:

* All patients who took part in the TACTIC-CRT (IRAS 250715) and Cardiac CT to guide Cardiac Resynchronisation Therapy (CRT) implantation (IRAS 150161) study.
* All patients who received a LBBA pacing device from the GSTT/RBH/ICH database in the last 10 years (from 01/01/2014) and had a cardiac MRI for assessment of scar.
* All patients who are \>18 years old.
* Male and Female

Exclusion Criteria:

* All patients \<18 years old
* Patients with congenital heart disease
* Patients who did not have a cardiac MRI before receiving a LBBA pacing device
Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy

Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.

Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T2DM for ≥10 years determined by electrophysiological measurements were enrolled.
* The participants regularly took their diabetes medications during the assessment and treatment period.

Exclusion Criteria:

* Uncontrolled T2DM and diagnosed with T2DM for \< 10 years.
* Patients with neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.
What the Body Does to Foliglurax in Healthy Volunteers

This study evaluates how the body takes up and gets rid of foliglurax after swallowing a liquid dose.

Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of radioactive tracer. Blood, urine and faeces will be collected to measure how much of the radioactivity gets into the blood stream and ends up in the urine and faeces. It is also measured how the body gets rid of the radioactivity and how quickly.

Eligibility Criteria:
Inclusion Criteria:

- Healthy men with a body mass index (BMI) of 19-30 kg/m2 (inclusive), and with a body weight of minimum 60 kg at the Screening Visit.

Exclusion Criteria:

- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Other inclusion and exclusion criteria may apply.
One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays

the aim of present study is to evaluate clinically the fracture liability , marginal adaptation , and patient satisfaction of conservative versus conventional ceramic Onlays use e-max press to restore defective restored molar with old restoration or caries. with one or more cusp defect


Eligibility Criteria:
Inclusion Criteria:Inclusion criteria:

All subjects are required to be:

1-From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for onlay restoration:

1. Decayed teeth
2. Teeth restored with defected filling restorations
3. Teeth with occlusal defect 5- Able to return for follow-up examinations and evaluation Exclusion criteria

   1. Patient less than 18 or more than 50 years
   2. Patient with active resistant periodontal diseases
   3. Patients with poor oral hygiene and uncooperative patients
   4. Pregnant women
   5. Patients in the growth stage with partially erupted teeth
   6. Psychiatric problems or unrealistic expectations
   7. Lack of opposing dentition in the area of interest

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Pre-operative Education Modalities to Decrease Opioid Use

This is a triple-armed, randomized, controlled, non-blinded trial to study the effect of preoperative patient education in conjunction with a limited opioid peri-operative analgesia program on post-operative opioid use following radical prostatectomy. Patients will be randomized into three education arms: usual care (variable provider-dependent education), text handout, or text handout and pre-recorded video. The impact of patient education on outcomes of in-hospital, post-discharge, and persistent opioid use will be studied.

This is a triple-armed, randomized, controlled, non-blinded trial that will be conducted at Virginia Mason Medical Center (VMMC). Men of age 18 or older undergoing robotic assisted radical prostatectomy (RARP) for prostate cancer will be approached to participate in the study. Recruited patients will be randomized into three main groups based upon opioid education given to the patient before surgery: usual care group, text handout group, and text handout with pre-recorded video group.

During their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider. The study group will receive additional standardized pre-operative education including the topics of:

1. Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP.
2. Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids.
3. Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction.

Patients in both usual care and study groups will receive standardized multimodal analgesia program with minimal opioids used.

Primary outcomes measured will include in-hospital and post-discharge opioid use, pain levels and time to return of bowel function. Secondary outcomes will include daily measures of patient satisfaction and quality of life, feeling of preparedness to manage post-operative pain, as well as incidence of prolonged opioid use at 90 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Undergoing RARP at VMMC
* Consent to participate in the study

Exclusion Criteria:

* Long-term opioid use defined as use of opioids on most days for \>3 months
* History of drug or alcohol dependence
* Concurrent surgery during radical prostatectomy
* History of allergy to opioid analgesics, NSAIDs, acetaminophen or local anesthetics
* Inability or unwillingness to give written informed consent
Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty

This prospective randomized controlled study will be aimed to evaluate the effect of preoperative oral carbohydrate loading on the elderly patient's quality of recovery and satisfaction in undergoing knee arthroplasty (TKA) surgery with spinal anesthesia.

As an essential aspect of enhanced recovery after surgery, the advantages of preoperative oral carbohydrate loading (eg, improving patients' comfort during preoperative preparation, reducing nausea and vomiting, and reducing insulin resistance) have been shown by a large number of studies.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Elderly ( \> 65) patients scheduled for elective TKA will be screened for enrollment in the study. Patients will be randomized into an oral carbohydrate group (Group OC), and an oral placebo group (Group OP). Solid food will be forbidden starting at 20:00, and drinking will be banned after 22:00 the day before surgery. Oral carbohydrate preload will be administered to the Group OC. In Group OP, the blinded researcher will give an equal volume of placebo fluid orally at 22:00 and 2 hours before the operation in the ward. The participant will record that the liquid has been completely consumed

Eligibility Criteria:
Inclusion Criteria:

* Physical status according to the American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for total knee arthroplasty

Exclusion Criteria:

* Previous operation on same knee
* Hepatic or renal insufficiency
* Younger than 65 years old
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* ASA IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month)
* impaired gastrointestinal motility
* Fasting glucose \>200
* Acquired immunodeficiency
* Severe malnutrition
Evaluation of Periodontal Response to Non Surgical Therapy in Pre and Post Menopausal Women With Periodontitis

The present study was evaluated periodontal status in pre and post-menopausal women with periodontitis following non-surgical therapy.

AIM: The aim of the present study was to evaluate periodontal status in pre and post-menopausal women with periodontitis following non-surgical therapy.

MATERIALS AND METHODS: Periodontal status was measured by Periodontal index (PRI), and oral hygiene status was measured by plaque index (PI). Both the parameters were measured at baseline i.e before Scaling and Root Planing (SRP) and after 3 months intervals post treatment. SRP was done in both pre\&post menopause groups.

Eligibility Criteria:
Inclusion Criteria:Patients should have at least 15 natural teeth remaining

* Non smokers
* Systemically healthy from past 6 months

Exclusion Criteria:Present or past smokers

* Below 40 years of age
* With gross oral pathology or tumors
* Patients on long term steroid medication
* Undergoing Hormone replacement therapy (HRT)
* Pregnant women or planning for pregnancy
* Those who have received periodontal therapy in the preceding 6 months
* Those that are under medication in the preceding 6 months
* Any systemic disorders or any medication that affects the periodontal status was excluded from this study.
The Effect of Endoscope Water Pump Flow Rates on Successful Unsedated Colonoscopy by Water Immersion Method: a Randomized Controlled Trial

The purpose of this study is to compare the cecal intubation rate between two endoscopy water pump with different flow rates (1.7 ml/sec vs 10.4 ml/sec) in water immersion colonoscopy examination in unsedated patients undergoing diagnostic colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Adult \> 18 years old with indication for colonoscopy, such as chronic diarrhea, chronic constipation, hematochezia, chronic lower abdominal pain, positive fecal occult blood test, and other change of bowel habit symptoms indicative of need for diagnostic colonoscopy examination

Exclusion Criteria:

* Patients refuse to participate, patient with obstructive lesion in the colon distal of the cecum, patients with experienced of colon resection, hemodynamically unstable, severe cardiac disorders (such as acute myocardial infarction, unstable angina, malignant arrhythmia, and moderate to severe congestive heart failure), patients with fecal obstruction (whatever the causes) so that impossible to pass the scope through the obstructed segment.
Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Enhanced MRI Techniques to Increase Resolution

This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI.

This study will assess the distribution of topical gel in the human vagina, using enhanced MRI techniques. The number and size of uncovered areas will be studied, and the upper genital tract will be examined for the presence of topical gel using MRI. MRIs will be performed with both a standard pelvic coil and an enhanced resolution endo-rectal coil in order to obtain maximal resolution. MRI images will be acquired before and after simulated coitus.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 year old women
* not pregnant
* willingness to use effective method of contraception
* regular menstrual cycle
* normal Pap test result

Exclusion Criteria:

* abnormal pelvic exam
* pregnant or breastfeeding
* claustrophobia or other MRI contraindications
* hypertension, hemolytic anemia,latex allergy
* history of hemorrhoids or irritable bowel syndrome
Effect of NO Precursors on Physiological Responses to Exercise

NO is an ubiquitous molecule contributing to many physiological functions such as vasodilation, immune and oxidative stress responses. NO production can be supplemented either by providing substrate to the NO-synthase (L-Arginine and L-Citruline) or by providing nitrate which can lead to NO. In the present project the investigators evaluate the effect of various acute and chronic oral NO precursors supplementation on exercise performance and responses in healthy young and older subjects.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary subjects
* No cardiovascular, respiratory, metabolic and neurological disorders

Exclusion Criteria:

* Body mass index \> 28 kg.m-2
* Smoker
* Alcool intake \> 10g/day
* Psychiatric diseases
* Subjects under treatment able to interfere with their cardiovascular, metabolic and neurological status