cyrilzakka/clinical-trials huggingface dataset:
A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria

* Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.
* Subject age range: male and female subjects 50 to 90 years of age, inclusive
* Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* MMSE 1 to 12 inclusive, at both Screening and Baseline
* SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline
* Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified.

Exclusion Criteria

* Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD
* Evidence of focal disease to account for dementia on any cranial image MRI or CT.
* Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria
* Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed
* Illiteracy prior to AD
* Subjects who are unwilling or unable to fulfill the requirements of the study
* Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening
* Subjects with a poor response (tolerability) to prior exposure to donepezil
Preemptive Analgesic Effects of Rectus Sheath Block in Laparoscopic Cholecystectomy Patients

The purpose of this study was to investigate the effectiveness of preemptive effect of rectus sheath block (RSB) and intercostal nerve block (ICNB) on postoperative visceral pain in laparoscopic cholecystectomy (LLC).

After induction of general anesthesia, group of patient is decided randomly. In Group pre, RSB and ICNB are performed with 0.25% Ropivacaine 40ml before the operation. In Group post, RSB and ICNB are performed with 0.25% Ropivacaine 40ml after the operation.

Measure the NRS and compare the rescue analgesic dose used at 0, 0.5, 1, 2, 6, 9, 18, and 24 hours after arrival at the recovery room.


Eligibility Criteria:
Inclusion Criteria:

1. adults between the ages of 20 and 80
2. scheduled laparoscopic cholecystectomy patient
3. ASA class 1 or 2
4. Patients who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

1. Patient with side effects on local anesthetics or steroids
2. Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
3. Patients with uncontrolled medical or psychiatric problem
4. Patient does not agree to participate in the study
5. Patients who are pregnant or lactating
6. Patients whose visceral pain is expected to be too severe
7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)
The Growth and Development of Breast and Formula Fed Term Asian Infants

Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia


Eligibility Criteria:
Inclusion Criteria:

* Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4 months; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg.
* Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial infant formula for 12 months.

Exclusion Criteria:

* 1. Severe congenital or metabolic disease likely to affect infant feeding or infant growth.
* 2. Multiple birth
Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF

The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the CONTAK® RENEWAL™ 2/4/4HE cardiac resynchronization therapy defibrillator (CRT-D) family and EASYTRAK® 2 lead in delivering LV-CRT or BiV-CRT with an LV Offset for patients with heart failure and an indication for an ICD.

This clinical investigation is a prospective, multi-center, randomized, double-blind study design enrolling 360 patients at 57 centers to demonstrate the safety and effectiveness of the therapy, the CONTAK RENEWAL 2/4/4HE devices and the EASYTRAK 2 lead.

Eligibility Criteria:
Inclusion Criteria:

* Meet the general indications for a CRT-D device
* Moderate or severe heart failure, defined as NYHA Class III-IV despite optimal pharmacological heart failure therapy.
* A 12-lead electrocardiogram (ECG) obtained no more than 90 days prior to enrollment documenting a sinus rate \> 50 bpm, QRS duration ³ 150 ms, and PR interval £ 320 ms measured from any two leads, and a P-wave duration \< 150 ms measured from lead V1
* Creatinine £ 2.5 mg/dL obtained no more than 14 days prior to enrollment
* Left ventricular ejection fraction £ 35% \[measured by echo, multiple gated acquisition (MUGA) scan, cardiac catheterization, etc.\] no more than 14 days prior to enrollment
* Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
* Have a life expectancy of more than 180 days, per physician discretion
* Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Right bundle branch block morphology (per World Health Organization Guidelines) on a 12-lead ECG obtained no more than 90 days prior to enrollment.
* Have had previous cardiac resynchronization therapy, a previous coronary venous lead, or meet the general indications for antibradycardia pacing
* Have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
* Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 180 days prior to enrollment
* Have a hypersensitivity to a 0.7 mg dose of dexamethasone acetate
* Have surgically uncorrected primary valvular heart disease
* Currently requiring dialysis
* Have chronic obstructive pulmonary disease (COPD), defined as FEV1/FVC \< 60%
* Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the 30 days prior to enrollment
* Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
* Have a mechanical tricuspid prosthesis
* Enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study.
Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.

The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).

Eligibility Criteria:
Inclusion Criteria:

* Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97)
* Healthy babies aged between 0 - 4 months of age
* Babies exclusively fed with an infant formula on enrolment into the study

Exclusion Criteria:

* The presence of an infection at the moment of the recruitment or 1 week before recruitment
* The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.)
* Any other diseases related to the immune system (primary immunodeficiency)
* Parents not able to comply with the study follow up (according to physician criteria)
Effects of Arm Cycling and Leg Cycling on Postprandial Blood Glucose Levels in Healthy Persons

The literature has shown that exercise is effective in decreasing blood glucose levels. However, it remains less clear if there is any difference between muscle groups regarding the glucose-lowering effects of exercise. The purpose of this study is to examine the differences in blood-glucose level changes in response to exercise that involves different muscle groups.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy persons
* Age 18 years or above

Exclusion Criteria:

* Cardiovascular diseases
* Pulmonary diseases
* Metabolic diseases
* Other contraindications to exercise
IT Matters: The Erectile Restoration Registry

The objective of the It MATTERS registry is to collect Real-World Data (RWD) to monitor the safe and effective use of commercially available Boston Scientific Corporation (BSC) penile prostheses

IT MATTERS is a prospective, multicenter, observational registry that is part of planned, active post market clinical follow-up (PMCF) activity associated with each device.

The study will include adult males who undergo penile prothesis implantation with a market approved BSC device to treat erectile dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age.
2. Males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved BSC penile prothesis by their physician.
3. Willing and able to complete the informed consent process.
4. Willing and able to comply with the follow-up requirements.

Exclusion Criteria:

1. Males who are deemed by their physician as not suitable candidates for a penile prosthesis.
2. In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.
Evaluation of Screening for Visual Disorders of the Old Subject in Consultation Memory

Visual disorders are often overlooked in the treatment of cognitive disorders of the elderly. Yet the visual deficit impacts the quality of life, the evolution of the autonomy and psycho-behavioral disorders in cognitive diseases. The main objective of the study is to evaluate the prevalence of visual disorders among elderly patients at consultant outpatient center of Nantes clinical gerontology as part of the consultation geriatric memory. Secondary objectives are to describe ophthalmological diseases detected and taken into the proposed ophthalmic load, to determine if there are associations between eye diseases and cognitive disorders, to estimate the proportion of patients who may have an ophthalmologic evaluation to determine the cognitive profiles and geriatric evaluation and ocular pathological, depending on the assessment of arterial stiffness. The results of this study will build a testing strategy to promote access of older patients with cognitive impairment to vision care.


Eligibility Criteria:
Inclusion Criteria:

* Elderly over 65 years,
* Subject to consultation from memory Clinical Gerontology ambulatory center Nantes University Hospital
* Current use of spoken French
* Patient (or legal guardian, if applicable) has given its written consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Life expectancy lower 1 year
* Mobility limitation preventing the installation retinal
* Major disorders and productive behavior does not allow participation in diagnostic procedures.
* Inability to respond to instructions when performing ophthalmological examinations.
Eversion in Dermatologic Surgery: Is Cosmetic Appearance Improved?

The investigators hypothesize that everting wound edges while suturing surgical sites will result in more aesthetic scars. Additionally, we also hypothesize that small to moderate wound irregularities present at 3 months will resolve by 6 months after surgery with no intervention


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Able to give informed consent themselves
* Willing to return for follow up visits

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Unwilling to return for follow up
* Pregnant Women
* Wounds less than 3 cm in length
Pilot of Pragmatic SBIRT Study

Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. This study is designed to pilot test the Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) intervention. SBIRT-PM is designed to reduce pain and reduce risky substance use among veterans applying for VA Benefits for a musculoskeletal condition, in part by helping Veterans get connected to comprehensive pain treatment. This pilot will involve a 2-year period to arrange for SBIRT Counselors at a single site to counsel Veterans throughout New England by phone with SBIRT-PM to test the acceptability and feasibility of the intervention.

In 2015 alone, 97,223 new Veterans under age 35 began receiving compensation for injuries related to their military service. In total, there are 559,999 post-9/11 Veterans being compensated for back or neck conditions, and a partially overlapping 596,250 for limitation of flexion in joints. Veterans seeking compensation for musculoskeletal conditions often develop chronic pain and are at high risk for substance misuse. Early intervention is needed to arrest worsening pain and risky substance use, particularly among post-9/11 Veterans for whom engagement in non-pharmacological pain treatment has the potential to improve their overall quality of life and spare them the complications of opioid treatments. The service-connection application is an ideal point-of-contact for initiating early intervention treatments for these at-risk Veterans.

This study is designed to pilot test the Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) intervention. SBIRT-PM is designed to reduce pain and reduce risky substance use among veterans applying for VA Benefits for a musculoskeletal condition, in part by helping Veterans get connected to comprehensive pain treatment. This pilot will involve a 2-year period to arrange for SBIRT Counselors at a single site to counsel Veterans throughout New England by phone with SBIRT-PM to test the acceptability and feasibility of the intervention.

During the two-years pilot trial, the team will prepare SBIRT-PM for implementation by establishing communication (Relational Coordination is the theoretical framework) between the "hub" where the SBIRT-PM clinician is sited and the "spoke" sites, establishing study-related procedures, and piloting the intervention at each of the eight VA medical centers in New England.

Eligibility Criteria:
Inclusion Criteria:

* Post-9/11 Veteran applying for MSD-related compensation, as ascertained from filed claim,
* Reports pain ≥4 on the pain Numerical Rating Scale (threshold for moderately severe pain);
* Availability of a landline or cellular telephone for SBIRT-PM.

Exclusion Criteria:

* Reports inability to participate during the study enrollment call
* Received three or more non-pharmacological pain treatment modalities (as previously categorized within the last 12 weeks from VA.
Calibration and Validation of the Masimo Temperature Device in Febrile Patients

The goal of this clinical trial is to test the performance of the Masimo noninvasive temperature device in patients with fever. The main question it aims to answer is whether the Masimo temperature device is comparable to standard methods of taking temperature such as inserting a probe under the tongue or using a forehead thermometer.

Participants will be asked to sit still while rounds of measurements are taken using the Masimo temperature device and the reference temperature device. Researchers will compare the measurements taken with the Masimo device with the measurements taken with the reference device.

Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05787782, NCT05674344, and NCT05779397)

Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥ 1year old
* Febrile at time of enrollment: ≥ 99.5oF/37.5oC for patients ages 1-5 years; ≥ 100.4oF/38oC for patients older than 5 years old.
* English- or Spanish-speaking patient or parent/LAR

Exclusion Criteria:

* Patients deemed not suitable for the study at the discretion of the investigator
* Patients who are rated as a 1 or 2 Emergency Severity Index
Quality Control of CE-Certified Phonak Hearing Aids - 2017_27

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature
* Smartphone user

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders
A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.

The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.

A Phase 1, multicenter, pharmacokinetic/Pharmacodynamic and safety study in which infants will be randomized in an open-label fashion to receive 5 days of open-label treatment with lansoprazole pediatric suspension 1 mg/kg/day oral, or lansoprazole pediatric suspension 2 mg/kg/day oral. On Dosing Days 1 and 5, blood samples will be obtained for drug assay. All subjects will be evaluated for inclusion in the pH monitoring portion of the study and will undergo pH monitoring, provided it is clinically indicated, at the discretion of the investigator. Intragastric pH monitoring (up to 24 hours) will be performed at Baseline, on Dosing Day 1 (or Day 2) and on Dosing Day 5 (or Day 6). Intraesophageal pH may be done in addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated for safety, including a follow-up visit on Post-Dosing Day 14.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized or outpatient male or female, term or post-term infants beyond the neonatal period (\>28 days) but less than 12 months of age, OR a preterm infant with a corrected age of at least 44 weeks but less than 12 months on Dosing Day 1.
* Clinically-evident Gastroesophageal Reflux Disease (feeding intolerance, regurgitation, wheezing or stridor with feedings)
* At least 7 days post-surgery without anticipated need for surgery during study
* No significant laboratory abnormalities

Exclusion Criteria:

* Unstable, clinically significant disease or abnormality
* Congenital anomaly of the upper gastrointestinal tract
* Clinical evidence of acute sepsis
* Cystic fibrosis
* Medical condition requiring subject to not be fed by mouth/gastric tube
The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty

Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative pain and swelling, protection of the healing graft, restoration of full range of motion symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee, hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional activities that are required for return to the normal daily life. The effects of concomitant injuries and surgical procedures must also be considered in planning an individualized rehabilitation program. However, it is still unclear regarding the optimal exercise prescription after TKA. In the current study, the investigators plan to develop an exercise protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density assessment. The exercise prescription consisted of cyclic exercise, aerobic exercise and resistant training exercise for first, second and third year, respectively. Cyclic exercise is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the exercise can be quantitatively determined. Aerobic exercise is privileged by the cardiopulmonary endurance improvement, along with muscle strengthening in the associated muscle groups. Resistance exercise is specified for the indicated muscle groups, especially knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed patients. The investigators hypothesis that using this cyclic exercise process can improve the body composition, muscle strength, bone mass density, level of oxidative damage indicators, gait performance, quality of life, knee joint range of motion, function of cardiopulmonary and fitness. This project will establish the scientific basis for rehabilitation protocol involving knee surgery.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (OA) and recommended to receive TKA surgery.

Exclusion Criteria:

* The exclusion criteria were the patients with Diabetes, Neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training