cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Nalmefene in Patients With Alcohol Dependence

The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the efficacy and safety of as-needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 6 months in adult patients with alcohol dependence.

Eligibility Criteria:
Inclusion Criteria:

In- and outpatients who:

* had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - Text revision (DSM-IV-TR) criteria
* had had ≥6 HDDs in the 4 weeks preceding the Screening Visit
* had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit

Exclusion Criteria:

The patient:

* had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
* had an antisocial personality disorder
* had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
* had a history of delirium tremens or alcohol withdrawal seizures
* reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
* reported current or recent treatment with antipsychotics or antidepressants
* was pregnant or breast-feeding

Other protocol-defined inclusion and exclusion criteria may apply.
The T1D Exchange Registry

The T1D Exchange Registry is a research study, conducted over time, for individuals with type 1 diabetes and their supporters. Participants volunteer to provide their data for research (for example, by answering questions in annual surveys). Once enrolled, Registry participants have the opportunity to sign up for other studies on various topics related to type 1 diabetes.

To participate, you will be asked to:

* Read and sign an online informed consent form
* Take a survey describing specific demographic and type 1 diabetes management information
* Update your information annually
* Periodically opt in for additional research opportunities (if you choose), i.e. taking new surveys or uploading health device data


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes.
* Individuals younger than 18 years of age must have parent/guardian consent.
* Must be able to read and understand English.
* Currently living in the United States

Exclusion criteria:

* Does not use insulin and has not had a pancreatic or islet cell transplant.
* Cannot fully read and understand English.
* Does not currently live in the United States.
Acute Effects of Fitness Drink Formulas on Energy Expenditure and Fat Metabolism

The purpose of this investigation was to examine the acute effects of consuming two different fitness drink formulas on the physiological response at rest and to exercise in healthy men and women.

Thermogenic fitness drinks containing \~200mg of caffeine have been reported to accelerate the metabolism, increase energy, and consequently promote increased fat oxidation. However, determination of the efficacy of lower caffeine concentrations may provide additional options for individuals with preferences for reduced caffeine intake. Therefore, the aim of this study was to evaluate different fitness drink formulas containing a total of 100mg and 140mg of caffeine on the physiological response at rest and to exercise.

This study utilized a randomized, double-blind, placebo-controlled design. All participants completed three testing visits during which they consumed the placebo, the 100mg caffeine formula, and the 140mg caffeine formula. Blood samples, blood pressure, heart rate, resting energy expenditure, substrate oxidation, and neurocognitive assessments were collected at baseline and repeated 30, 60, and 90 minutes post-ingestion. Immediately following the last cognitive assessment, a maximal graded exercise test with gas analysis was conducted on a cycle ergometer to evaluate physical performance and maximal fat oxidation during exercise as well as the physiological response prior to and following exercise.

Eligibility Criteria:
Inclusion Criteria:

* Young adult men and women between the ages of 18 and 35 years old.
* Participant is deemed by the investigator to be healthy and free of any physical limitations determined by physical activity readiness questionnaire (PAR-Q+) and medical and activity history questionnaire (MHQ).
* Participants will be required to be recreationally-active (defined according to American College of Sports Medicine standards of at least 150 minutes exercise per week and verified by information provided in the MHQ).
* Participant is willing to abstain from dietary supplementation throughout the duration of the study as indicated in the Informed Consent.
* Participant understands the study procedures and signs forms providing informed consent to participate in the study.

Exclusion Criteria:

* Inability to perform physical exercise, as determined by the PAR-Q+.
* Any "Yes" response in the PAR-Q+.
* History of hypertension, metabolic, hepatorenal, musculoskeletal, autoimmune or neurological disease, as determined by the MHQ.
* Regular consumption of greater than 250 mg per day of caffeine
* Currently taking thyroid, antihyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications.
* Taking any other nutritional supplement or performance-enhancing drug (determined from MHQ) that may interfere with the outcome variables of the study.
* Pregnancy (determined from MHQ).
Nonpharmacological Methods in Heel Stick Pain

In the present study, the randomized controlled and experimental design is used because it was aimed to determine the effects of two different warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick intervention on pain levels and duration of crying in healthy term newborns.

Study hypotheses are; Hypothesis 1. Using the thermophore pad warming method in newborns before heel prick reduces the newborn's pain level.

Hypothesis 2. Using the warm towel warming method in newborns before heel prick reduces the newborn's pain level.

Hypothesis 3. Using the thermophore pad warming method in newborns before heel prick reduces the duration of crying.

Hypothesis 4. Using the warm towel warming method in newborns before heel prick reduces the duration of crying

Heel prick, intervention performed to take blood sample from the heel, which is frequently performed in newborns, is a more painful intervention than are other methods of taking blood samples. In several studies, it has been indicated that the use of various non-pharmacological methods such as sucrose administration, breastfeeding, skin-to-skin care, acupressure, swaddling, positioning, non-nutritive sucking, foot reflexology, vibration, laser acupuncture, warming the baby's heel reduce infants' pain during heel prick.

This study is a prospective, randomized and controlled trial. In this study aim, was aimed at determining the effects of two different heel warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick on healthy term newborns' pain levels and duration of cryingin newborns will be examined.

The minimum number of newborns to be included in the study was calculated as 150 using the G\*Power (3.1. 9.7) program (margin of error: 5%, confidence interval: 0.95, power: 0.80). The 150 newborns in the sample were randomly assigned into the following three groups in equal numbers via an internet-based program (http://www.randomizer.org): control group (n = 50), thermophore-warming group (n = 47) and warm towel-warming group (n = 50).

Data Collection Tools To collect the study data, the "Descriptive Information Form", "Follow-up Form", and "Neonatal Infant Pain Scale" were used.

Eligibility Criteria:
Inclusion Criteria:

* Having been born at 38-42 weeks of gestation,
* having a birth weight of 2500 g and above,
* having a 5-min APGAR score of 7 and above,
* having stable health,
* having been fed within an hour before the intervention, being calm and not crying before the intervention,
* having a postnatal age of 24-72 hours, and
* undergoing heel prick for the first time

Exclusion Criteria:

* Parents with any mental problems
* Infants with any chronic disease and congenital anomalies.
Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis

The purpose and objectives of the study is to establish the feasibility of the simultaneous PET/MR in patients with cardiac sarcoidosis, determine relationships between various imaging biomarkers like extracellular volume (ECV) and standardized uptake values (SUV) from FDG-PET and to evaluate the diagnostic accuracy of the simultaneous method in comparison to the PET/CT and cardiac MRI.

Patients who meet the inclusion criteria and agree to the study will be recruited from the Kirklin Clinic and UAB hospitals who will be undergoing FDG-PET/CT for cardiac study as part of their standard of care to diagnose cardiac sarcoidosis. MRI and FDG-PET screening questionnaire will be completed. A chart review will be completed to obtain data from patient medical records pertaining to study including age, gender, race, weight, height, vital signs, social and family history, past medical history especially if there is any history of hypertension, diabetes, high cholesterol levels, heart failure or history of lung diseases, lab results including brain natriuretic peptide levels, creatinine, hemoglobin, coagulation parameters, results of stress test/left heart catheterization, prior echocardiography if available. The CMR will be done solely for research purposes. The patient will be in the PET/MRI scanner for cardiac study only for 60-90 minutes, Finally, multi-sequence, multi-planar cardiac MR images will be acquired to assess cardiac chamber size, regional wall motion abnormalities, ejection fraction, left ventricular perfusion(using gadolinium-based agent) and late gadolinium enhancement.

The investigators will also conduct MRI examinations on 5 healthy volunteers to establish cardiac MRI protocol for the PET/MRI scanner. These scans will not involve any FDG administration to the healthy volunteers. These will involve cardiac MRI examinations to determine the feasibility and quality of MRI scans with the new scanner.

Eligibility Criteria:
Inclusion Criteria:

1.Subjects older than 18 years of age with high suspicion of cardiac sarcoidosis and/or biopsy proven extracardiac sarcoidosis and/or positive HRS criteria will be enrolled.

Exclusion Criteria:

1. Coronary artery disease
2. Insulin dependent diabetes
3. Claustrophobia
4. Pregnancy/nursing
5. Presence of pacemaker or automatic implantable cardioverter-defibrillator
6. Impaired renal function (estimated glomerular filtration rate \<45 ml/min/1.73 m2) will be excluded.
7. Inability to undergo PET/MRI due to any other condition.
Nurse-led Intervention to Improve Phosphate Binder Adherence

The study aim is to test the efficacy of one-year nurse-led interventions to improve the medication intake behaviour of chronic dialysis patients. The investigators hypothesis is the interventions leading to a 15% mean increase in intake, compared to standard care.

Background Phosphate binder nonadherence is ubiquitous. The results of adherence enhancing interventions are often disappointing. The aim is to test a nurse-led multifactorial intervention to enhance phosphate binder adherence.

Methods In a quasi-experimental clinical trial, phosphate binder adherence was measured electronically in 135 hemodialysis patients for one year and phosphatemia measured monthly. For all patients, months 1-2 were baseline (no interventions were performed). The intervention arm was given 1 "preparatory" intervention and then monthly 8 "maintenance" individualized management sessions. The control arm received standard of care.

Eligibility Criteria:
Inclusion Criteria:

* adult (≥18)
* chronic hemodialysis ≥1 month
* treated with phosphate binders
* Dutch-speaking

Exclusion Criteria:

* receiving professional medication care
* cognitive impairment
* nursing home residents
Multi-center Study on Therapy-oriented Molecular Subtyping of Hepatocellular Carcinoma

The purpose of this study is to establish molecular subtyping of HCC.

Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Liver transplantation is the most effective treatment for HCC and is in high demand in China. However, recurrence of HCC among liver transplantation recipients is still a great challenge and threat to the survival of recipients. So it is of great significance to establish molecular subtyping of HCC and achieve precise selection of recipients. Based on large scales of samples, the investigator's study aims to establish multi-omics characteristic profiles of liver transplantation for HCC in integration of apparent biological characteristics, clinical management and prognostic information by utilizing genomics, transcriptomics and proteomics, etc. This study will contribute to the therapy-oriented molecular subtyping of HCC.

Eligibility Criteria:
Inclusion Criteria:

Liver transplantation due to HCC within Hangzhou criteria

Exclusion Criteria:

Liver transplantation due to HCC beyond Hangzhou criteria Liver transplantation due to other disease except HCC Multiple organ transplantation
Myopia Control Using Soft Bifocal Lenses

The purpose of this study is to evaluate whether bifocal soft contact lenses (CLs) with low addition and nasally decentered optical zone are effective in controlling myopic progression in children. Visual manipulations induced by multifocal soft CLs with high addition have been shown to inhibit eye growth and myopia development in children by recent studies. Several theories have been proposed including alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations. However, those theories remain to be proven and the optical properties and performance of multifocal soft CLs have not been investigated in children.

Visual manipulations induced by multifocal soft contact lenses (CLs) with high addition (+2.00 D or above) have been shown to inhibit eye growth and myopia development in children with up to 25-50% efficacy by recent studies. Several theories have been proposed including; alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations, which remain to be proven. However, the effect of controlling myopic progression by bifocal CLs with low addition has not been studied.

Several studies have shown that multifocal soft CLs can induce changes in ocular aberrations and degradation of image qualities in adults, whereas the optical properties and performance of multifocal soft CLs have not been investigated in children. Due to the differences in ocular structure and function, for instance, the pupil size and accommodation response, the performance of multifocal CLs in children may vary compared with that in adults. As a result, it is essential to assess the optical quality of these lenses worn by children for myopia control, through COAS (Complete Ophthalmic Analysis System).

The aim of this randomized clinical trial is to evaluate myopic progression in children wearing soft bifocal with low addition CLs (Menicon 2 week Duo \*\*) used as daily disposable lenses, compared to control subjects wearing single-vision spectacles. Myopia progression quantified by changes in axial length (AL) and cycloplegic refractive error (Rx) will be monitored for 2 years with single-masking. The optical performance of bifocal CLs worn by children will also be investigated.

(\*\*this lens is currently commercially available in Japan only. The oxygen permeability (Dk) is 34 with 72% water content, FDA group Ⅱ.)

Eligibility Criteria:
Inclusion Criteria:

* Refractive sphere: -0.75 D to -4.50 D
* Refractive cylinder: not exceed 1.00 D
* Spherical equivalent: -0.75 D to -5.00 D
* Best corrected distance VA (LogMAR): 0.14 or better in each eye and 0.10 or better in both eyes
* Difference in refractive error (spherical equivalent) in the two eyes: not exceed 1.00 D

Exclusion Criteria:

* Prior history of myopia control treatment
* Contraindication to contact lens wear
* Binocular anomalies (e.g. strabismus)
Nottingham Osteoarthritis Biomarker Study 2011

Osteoarthritis is by far the most common joint condition and the single largest cause of disability in the older population. The investigators still have a poor understanding of the nature of osteoarthritis and factors that influence its development and progression. Identification of biochemical markers that relate to cartilage loss, bony overgrowth and other features that occur with osteoarthritis will advance our understanding. Over the last 5 years analytical methods have developed to measure a range of different biomarkers. This pilot study will use these analytical methods to measure biomarker levels in joint fluid, urine and blood of 50 participants with Osteoarthritis (OA) and 50 healthy volunteers.

This study will provide novel pilot data on the changes in the composition of the synovial fluid, urine and blood in patients with OA. Apart from being a key target site for OA, the knee is a suitable joint for study because of its accessibility to clinical assessment, joint aspiration and imaging.


Eligibility Criteria:
Inclusion Criteria:

All participants:

* Be able to provide written informed consent
* Aged 30 and over

Knee OA patients:

• Radiographic signs of OA - that is definite joint space narrowing plus osteophyte in at least one compartment of the knee

Normal controls:

* No knee pain
* No clinical or radiographic changes of knee OA
Sleep Disturbances and Pulmonary Artery/Aorta Diameter in Scleroderma Patient

To determine sleep disturbance, pulmonary function test, 6 minute walk, echocardiogram abnormality, arterial blood gas, ventilation/perfusion scan of the chest in Scleroderma patient with Pulmonary Hypertension.

As above

Eligibility Criteria:
Inclusion Criteria:

* Patient must have Scleroderma

Exclusion Criteria:

* Patients who do not have Scleroderma
Prediction of Acute Rejection in Renal Transplant

Acute rejection is still a major risk factor affecting the prognosis of kidney transplant patients. Alloreactive cells of the recipient infiltrate the kidney graft and cause inflammatory reaction which damages the graft structure and function. Conventional diagnosis of acute rejection is based on clinical symptoms and kidney biopsy examination. The clinical symptoms are a result of the kidney damage, which occurs days after the initiation of the rejection reaction. Kidney biopsy is an invasive and expensive procedure. It has been wished to have new parameters that can replace/supplement the conventional procedures. Chemokines are small molecules that attract inflammatory cells. Changes of chemokine levels in the urine may correlate with the immune status in the kidney. A systematic study to evaluate the chemokine levels in urine and correlation with the kidney biopsy pathology will answer the question whether monitoring of urinary chemokines would be useful in predicting graft rejection/damage.


Eligibility Criteria:
Inclusion Criteria:

* One hundred subjects undergoing kidney biopsy for suspected rejection
* Forty subjects that have stable graft function with normal level of blood creatinine (No biopsy is needed at the time of sample collection).

Exclusion Criteria:

* Subjects under the age of 18
* Gender of potential subjects male or female
* Age Limits greater than 18 years of age
Gerofit Exercise Intervention for Older Adults With Sickle Cell Disease (SICKLE-FIT Study)

The purpose of this study to assess the feasibility, acceptability, and safety of a personalized exercise training program adapted from Gerofit to improve physical health and quality of life for adults with SCD

The purpose of this study is to adapt and pilot the Gerofit personalized exercise intervention for older adults with sickle cell disease (age ≥ 40 years). The Sickle Cell Disease Functional Assessment (SCD-FA) will be performed at steady state at baseline and every 3 months to track progress. Endpoints include feasibility, acceptability, and safety. All participants will be interviewed to identify barriers and facilitators to exercise and how to better optimize the exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of sickle cell disease (any genotype) confirmed by hemoglobin electrophoresis, high performance liquid chromatography, or genotyping
* Understand and speak fluent English.

Exclusion Criteria:

* Diagnosed with moderate or severe cognitive impairment based on ICD-10 codes or report from their outpatient provider
* Unable to self-consent
* Wheelchair-bound
* Successfully treated with hematopoietic stem cell transplantation for SCD
* Have moderate to severe uncorrected visual or auditory impairment
* Oxygen-dependent
* Pregnant
* Have severe avascular necrosis requiring an assist device
* Unstable cardiac disease.