cyrilzakka/clinical-trials huggingface dataset:
Effects of Supplementation With Ginseng and BCAA Improved Central Fatigue and Enhanced Attention During Exercise

The main purpose of the present study is to determine the effects of acute and short-term (14 days) ginseng combined with branch chained amino acids supplementation on endurance exercise performance and the ability of anti-fatigue. In addition, this study also measured the performance of continuous attention during recovery period to examine the effect of supplementation on central fatigue.

Muscle fatigue was a common problem after exercise. When fatigue occured, body functions were affected and changed. Changbai Mountain ginseng had higher anti-fatigue substances than general commercial ginseng. And recent studies had showed that the supplementation of branched chain amino acids (BCAA), including leucine, isoleucine and valine, can increase attention and reduce fatigue. However, its effect on Changbai Mountain ginseng combined with BCAA was still unclear. Subjects were allocated to Gojinsen® drinks and placebo group (1:1 ratio) for 14 days, and then examined by maximal oxygen consumption, time to exhaustion, rating of perceived exertion (RPE), oxygen saturation (SPO2) , blood lactate concentration, and continuous attention performance test (CPT II). The Gojinsen® group significant increased maximal oxygen consumption, time to exhaustion, and attention compared to placebo group. Moreover, the Gojinsen® group significant decreased lactate concentration and fatigue compared to placebo group. By this study, Gojinsen® drinks did not showed absolute anti-fatigue effect but provided the objective evidence of fatigue-related measurement and the therapeutic potential for people suffering from exercise fatigue.

Eligibility Criteria:
Inclusion Criteria:

1. healthy male and female adults aged 20-25 years old .
2. without heart, liver, kidney, endocrine or other major organic diseases).
3. had at least 3 months experience in performing exercise

Exclusion Criteria:

1. BMI of the study subjects must be less than 25.
Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center

Evaluation of functional improvement after spa therapy in Fontcaude center, for knee osteoarthritis Background. Knee osteoarthritis is the first indication of spa therapy in rheumatology. This therapeutic represents a non pharmacological treatment and is recommended by OARSI.

In order to obtain agreement for spa therapy, the center Fontcaude, needs to show clinical improvement for patients, as demonstrated in the Thermarthrose study. This center is near Montpellier and could improve patients localised in this area.

Methods: randomised prospective clinical trial of patients with knee osteoarthritis.

The spa therapy group received 18 days of therapy over 3 weeks. Patients in the control group received 18 days of therapy over 3 weeks after the 6-month follow-up visit.

Follow-up was at 3 and 6 months, by a visit to the examination.

The hypothesis of our study is to demonstrate clinical improvement at six months. The main endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defi ned as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score.

Eligibility Criteria:
Inclusion criteria:

* Patient aged 40 to 75 years with radiologic and gonarthrosis radiologic et painful gonarthrosis, unilateral ou bilateral, whatever is the radiographic stage
* Patient presenting a EVA ≥3 with a corresponding radiology at least of 1year
* Patient affiliated with a social security system

Exclusion criteria:

* Realization of a water cure in the last 6 months
* Infiltration of the knee of less than 3 months
* Impossibility to sign the informed consent or which for reasons geographical, social or psychological could not be regularly followed,
* Person major placed under guardianship or trusteeship,
* Private person of freedom by court or administrative order, nobody being the object of a legal protective measure,
* Patient already included in an interventional clinical protocol,
* Pregnant women
* Contraindication in the water cure:

  * Severe change of the general state or debilitating afflictions
  * Acute affections and pushed acute(sharp) of the chronic affections
  * Grave cardiac insufficiency, unstable arterial high blood pressure
  * Severe renal or hepatic insufficiency
  * Not healed cutaneous hurts
  * Contagious or evolutionary diseases
  * Evolutionary Cancers
  * Current immunomodulator or immunosupressor Treatment, waves of inflammation.
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Eligibility Criteria:
Inclusion Criteria:

* Male and female residents of LTCFs at least 55 years of age.
* Willing and able to provide written informed consent and comply with the requirements of the protocol.
* At least one symptomatic laboratory-confirmed COVID-19 illness identified among residents or staff of the LTCF within 10 days prior to randomization.

Exclusion Criteria:

* Alzheimer's disease, dementia, or other mental incapacity which precludes comprehension of the study requirements or symptom diary.
* Subjects expected to require hospitalization within the 8-week treatment and follow-up period.
* Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies.
* Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions or antiviral therapy for influenza within two weeks prior to and including study day 1.
* Receipt of any dose of NTZ within 7 days prior to screening.
* Treatment with any investigational drug or vaccine within 30 days prior to screening or unwilling to avoid them during the course of the study.
* Known sensitivity to NTZ or any of the excipients comprising the study medication.
* Subjects unable to swallow oral tablets or capsules.
* Subjects taking medications considered to be major CYP2C8 substrates.
* Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.
Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy

This study will evaluate the effects of mindfulness and concentration meditation on pain, fatigue, and physical functioning in patients with either multiple sclerosis or peripheral neuropathy.

We propose a prospective, randomized controlled study evaluating the effects of mindfulness meditation and concentration meditation on pain, fatigue, and physical functioning in patients with either multiple sclerosis MS or a generalized polyneuropathy (PN). A secondary endpoint for the MS arm will include spasticity and for the PN arm will be the physical examination findings of sensory changes and weakness. Meditation classes of 90 minutes duration will be led by a Buddhist monk with over 20 years experience in meditation. Sessions will be held once weekly over a 3-month period. There will be an initial introduction session that will last approximately 180 minutes for the adminsitration of formal instructions and a training session on how to do the meditation. Outcome assessments will be answered electronically on a secure system or in written form that will be able to be completed at home or at the site of the meditation class. The data will be directly downloaded into a queriable database. Outcome assessments will be based on the Short Form (SF)-36 health survey and Visual Analog Scale (VAS) for pain at baseline and at 3 months. Additionally, the Neuropathy Impairment Score (NIS) will be used for the PN pts. The PDDS spasticity questionnaire and the fatigue portion of the MSQLI for fatigue will be used for the MS patients. We plan to recruit adult patients with either MS or PN through the current patient population in the Mellen Center and Neuromuscular Center and flyers placed throughout the Cleveland Clinic. Patients will be excluded if they have performed meditation within the last 6 months, are cognitively impaired, or have an underlying illness that would preclude comprehension of the instructions. Other exclusion criteria include a history of symptomatic cardiopulmonary disease, uncontrolled HTN, current alcohol or drug abuse, and kidney or renal failure. Patients must be ambulatory and able to toilet themselves.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis OR peripheral neuropathy

Exclusion Criteria:

* Unable to walk without the assistance of others
* Unable to toilet independently
* Currently abusing drugs or alcohol
* Have performed meditation within the last 6 months
* Cognitive impairment or an underlying illness which would prevent the comprehension of instructions
* History of symptomatic/unstable heart or lung disease
* Uncontrolled high blood pressure
* Kidney or renal failure
2BALANCE: Cognitive-motor Dual-tasking in Persons with Vestibular Disorders

The overall aim of this study is to elucidate the impact of a vestibular dysfunction on the cognitive and motor performance by means of an extensive test protocol, evaluating the vestibular, cognitive and motor function using single as well as dual-task paradigms.

The test protocol consists of five cognitive tasks, all assessing a different cognitive domain: executive function, working memory, processing speed, and visuospatial abilities (mental rotation and visuospatial memory). These cognitive tasks will be performed separately (in single task condition, while seated), as well as while performing different motor tasks (in dual-task condition). These motor tasks will also be performed in single task condition (without performing the cognitive tasks).

The study consists of the establishment of normative age-related data for the single as well as dual-task protocol in healthy adults, age ranging from 18 to 65 years old (objective 1). Subsequently, the test protocol will be validated in persons with bilateral vestibulopathy (objective 2). Finally, a cross-sectional study in persons with unilateral vestibular impairment will take place, and the results on the single as well as dual-task components will be compared to normative data, as well as to persons with bilateral vestibulopathy (objective 3).

Eligibility Criteria:
For healthy controls:

Exclusion Criteria:

* Vestibular disorders or subjective dizziness complains (past or present)
* Hearing loss
* Mild Cognitive Impairment (Montreal Cognitive Assessment, MOCA)
* Visual impairment (Snellen Chart)
* Motor abnormalities (anamnestic questionnaire)

For bilateral vestibulopathy (BV):

Inclusion criteria:

* Bilaterally reduced vestibular function, as defined by the Bárány Criteria for BV(Michael Strupp 2017):
* the horizontal vestibulo-ocular reflex (VOR) gain should be \<0.6 bilaterally and/or
* the sum of the maximal peak velocities of caloric response for stimulation with warm and cold water should be \<6◦/s bilaterally and/or
* the horizontal angular VOR gain should be \<0.1 upon sinusoidal stimulation on the rotation test

For unilateral vestibulopathy:

Inclusion criteria:

* the horizontal VOR gain should be \<0.6 unilaterally and/or
* the slow component velocity of the caloric response should be below the age-dependent normative data unilaterally, established by Maes et al. (2010)
Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD

prescription opioid misuse in chronic pain is a growing public health concern. few studies got interested in prevalence of misuse and of opiate use disorder in a population of patients with a non cancer chronic pain.

the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a population of patients consulting a center specialized in pain management.


Eligibility Criteria:
Inclusion Criteria:

* patient with a non cancer chronic pain
* consulting a CETD center

Exclusion Criteria:

* non understanding of french
Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Orthopedic Surgical Operations

The aim of this study is to assess the effect of pregabalin administration on catheter-related bladder discomfort (CRBD). The study group includes patients that are about to be subjected to orthopedic operations.


Eligibility Criteria:
Inclusion Criteria:

* All patients about to be subjected to urinary operations
* Signed informed consent

Exclusion Criteria:

* Preoperative urinary bladder/kidney dysfunction as a result of spinal cord pathology
* History of overactive ((urinary frequency\>3 times at night and \>8 times in 24 hours), neurogenic bladder
* End stage renal failure
* Central nervous system dysfunction
* Mental illness/ substance abuse
* Sensitivity to pregabalin
* Preoperative administration of pregabalin for other indications
* Recent bladder catheterization \<3 months
Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations

This is a single-center, open-label, randomized crossover study being conducted in three cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.


Eligibility Criteria:
Inclusion:

* Healthy males or females,
* ages 18 to 55 years
* Body mass index (BMI) \&gt;
* 18 and 32 kg/m2 at Screening

Exclusion:

* Female subjects who are nursing
* Subjects with a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profiles of E2006
* Subjects with a known history of clinically significant drug or food allergies
* Subjects with a known allergy or hypersensitivity to capsule or tablet ingredients
Interactive Care Coordination and Navigation:RCT To Assess the Impact of a mHealth Intervention for Homeless Individuals

People experiencing homelessness (PEH) are at exceptionally high risk of frequent emergency department (ED) and hospital use, poor functional outcomes, and increased morbidity and mortality from poorly managed chronic health conditions and complex social needs. Evidence-based interventions of particular promise for reducing ED and hospital utilization and improving health outcomes and meeting social needs involve:1) providing care in the community to overcome barriers including transportation and fear of stigmatization; 2) coordination of care transitions following ED or hospital discharge to improve access to needed community supports and reduce the risk of readmission; and 3) using mHealth technology to link PEH with appropriate community-based health and social services. This project builds on evidence from two feasibility studies in order to integrate and test a mHealth intervention, comprised of GPS technology and text messaging components, into a community setting to connect PEH with a community-based case manager and healthcare and social services. Our hypothesis is that integrating the mHealth intervention into an established, trusted navigation center for PEH will mitigate barriers to care and gaps in the care continuum resulting in decreased ED and hospital use and improved health outcomes and attainment of social needs. The study aim is to conduct a stratified RCT to compare a mHealth intervention with usual care community-based case management to examine the impact on healthcare utilization (primary outcome), medication adherence, social support, psychological distress and social needs attainment (secondary outcomes) in PEH.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old Homeless (defined as where the person slept most nights in past 30 days (street, shelters, transitional housing, doubling-up with family or friends) Currently own a cell phone with service or use phone with wifi (when available) at baseline Currently prescribed ≥ 2 medications for chronic medical conditions (self-report) Diagnosis of at least two chronic health conditions (self-report): e.g., hypertension, diabetes, depression
* 2 hospitalizations or ED visits in the last 6 months (self-report) Score of at least 4 on the REALM-SF health literacy measure Score \> 17 on the Mini-Mental State Exam

Exclusion Criteria:

Unable to communicate verbally in English. This is an exclusion criteria because the text messaging, apps, procedures and measures are not validated in in other languages.
Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm

This study evaluates the cognitive and behavioral outcomes including image findings of school-aged children who were born preterm compared with who were born term gestational age.

There are lots of studies published that school-aged children who were born preterm has some behavioral problems in school and they also have poor academical achievement.

Eligibility Criteria:
Inclusion Criteria:

* children former preterm infants \< 32 weeks of gestation or 1,500gm of birth weight
* children former normal term infants

Exclusion Criteria:

* major congenital anomaly
* neuromuscular disease
* chromosomal anomaly
A Longitudinal Observational Follow-up of the PRECEPT Study Cohort

The purpose of this study is to longitudinally follow consenting clinical trial participants who participated in PRECEPT (A Randomized, Double Blind, Placebo Controlled, Dose Finding Study to Assess the Efficacy and Safety of CEP 1347 in Patients With Early Parkinson's Disease). The study will assess the clinical and imaging outcomes relevant to the natural history of Parkinson's disease (PD), as well as determine early biomarkers of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the PRECEPT study
* Willing and able to give informed consent

Exclusion Criteria:

* Patients will be excluded from participating in the the study if either of the criteria stated above is not met
A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea

This is an open label, prospective, multicenter, non-comparative study to assess the safety and effectiveness of Tabrecta® (Capmatinib) in real world setting. Also, this study is to fulfill the regulatory requirements as part of the RMP (Risk Management Plan) for Tabrecta® (Capmatinib), as requested by Korea Health Authority, MFDS (Ministry of Food and Drug Safety).

The study is a post approval surveillance so there will be no comparator arm/drug nor blinding process.

Dose/regimen should follow locally approved label and it could be adjusted as per the decision from treating physician during treatment period, under their routine clinical practice. Treatment duration is deemed to the decision from treating physician under their routine clinical practice, since this study is a post approval surveillance and to look for safety profiles happening under real world practice. There will be no intervention from Novartis regarding dose/regimen and treatment duration.

This study will be completed after data collection of the last subject during the follow up period. The follow up period is recommended for up to 24 weeks after enrollment or up to the time of discontinuation of study drug (in case of early discontinuation) as per linical judgement of treating physician.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent must be obtained prior to participation in the study.
* Subject who are diagnosed as exon 14 skipping mutated NSCLC from tissue or plasma(ctDNA) sample analysis by treating physician (i.e. Any kind of diagnostic methods the institution currently has. Diagnostic modalities for research purpose would be also allowable.)
* Subject who plan to receive Tabrecta® (Capmatinib) as per locally approved label

Exclusion Criteria:

* Subject with contraindication according to the locally approved label
* Subject whose medical record is not accessible
* Subject who are not willing to provide informed consent
Visual Outcomes of Topography Guided Photorefractive Keratectomy (PRK) for Treatment of Patients With Irregular Cornea

Irregular astigmatism is one of the most serious and frequent complications of corneal refractive surgery and one of the worst sequelae of other forms of corneal surgery . It is also considered as one of common, serious complications of corneal injuries .

Spectacle correction is usually not useful in the correction of corneal irregular astigmatism. Contact lenses represent a good alternative, but their adaptation and stability are limited by the irregular corneal surface and patient discomfort.

In recent years, advancements in laser technology have offered better tools for dealing with irregular astigmatism with finding new surgical methods to improve corneal regularity for the correction of irregular astigmatism.

Topography-linked excimer laser is a potentially effective technique in the treatment of irregular astigmatism after keratoplasty . In fact, customized ablation was shown to be an effective means of treatment of irregular astigmatism due to different etiologies Such as corneal Injuries , scar , or postoperative.

Some of the theoretical advantages of topography-driven photorefractive keratectomy (PRK) are a better astigmatic correction, the possibility of correcting irregular astigmatism, and a smaller ablation volume compared with standard treatments, resulting in better visual performance.

Aim of the work To evaluate the efficacy, safety, and predictability of topography-guided photorefractive keratectomy (PRK) to improve refractive status of patient with irregular Cornea.


Eligibility Criteria:
Inclusion Criteria:

* Patients with irregular corneal astigmatism caused by:

  * Trauma.
  * Non - Central Corneal Scars.
  * Previous corneal surgery.
* With No other abnormalities in the eye.
* Patient is willing to enter the study and sign a consent.

Exclusion Criteria:

* Patients with central corneal scars.
* Patients with central haze interfering with visual acuity.
* Patients with ectasia at corneal graft margins.
* Patients with irregular astigmatism caused by corneal ectasia or keratoconus.
* Patients had refractive surgery with ablations leaving a residual corneal thickness less than 250 μm.
Single and Multiple Ascending Doses of AZD1981 in Japan

The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese and Caucasian males

Exclusion Criteria:

* Other clinically relevant disease or disorders