cyrilzakka/clinical-trials huggingface dataset:
Effect of Huperzine A on Cognitive Function and Perception of Effort During Exercise

This study evaluates the effects of acute huperzine A ingestion prior to exercise on cognitive function and perceived effort in exercise-trained individuals. Huperzine A has shown the ability to improve cognitive function in dementia patients, and is currently marketed as a cognitive enhancing supplement. Study participants will receive either huperzine A or placebo during the first experimental session, and will receive the other substance during the second session.

Huperzine A improves cognitive function by inhibiting the enzyme acetylcholinesterase. This enzyme is responsible for the degradation of the neurotransmitter acetylcholine. inhibition of acetylcholinesterase may allow for greater availability of acetylcholine, which may allow for better nerve conduction and therefore enhanced cognitive function and possibly muscular contraction.

Huperzine A (200 mcg, Swanson®, Fargo, North Dakota) and placebo capsules will be administered in a single oral dose. The dose of Huperzine A to be used is comparable to previous research (Xu et al, 2011). Placebo capsules will consist of rice flour. The participants will ingest the capsules with 250 mL of water 30-45 minutes before exercise is initiated.

A paired-sample t-test with alpha set to p ≤ 0.05 for statistical significance will be used to analyze the data. Outcomes measured during the first and second experimental sessions will be compared to each other. The participants will be compared to themselves during previous sessions, so a paired sample t-test will be used to calculate the difference between the sessions. Data will be presented as means ± SE. Data analyses will be performed with Microsoft Excel; and other analyses may be performed as needed to gain further insights about the data.

A statistical power analysis was performed (G\*Power software, version 3.1.5, University of Kiel, University of Dusseldorf, and University of Mannheim, 157 Germany) based on the following inputs: two-tailed paired t-test, alpha=0.05, desired power=0.80, sample size=15 subjects. The results indicated that a standardized effect size of 0.78 (i.e. large effect) will be detectable. As many as 20 subjects will be recruited and enrolled to ensure that complete data on 15 subjects are available in the event of screen fails and dropouts.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of all ethnic and racial groups that participate in endurance exercise of moderate to vigorous intensity at least three days per week, for at least 20 minutes per session, for at least six months prior to this study

Exclusion Criteria:

* Anyone not within the age range listed in section 8a will be excluded. Individuals who require medical clearance to participate in vigorous exercise based on ACSM's risk assessment algorithm will be excluded from the study. The participant screening form will be used to identify signs and symptoms or medical conditions that require medical clearance to participate in vigorous exercise.
Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants

OBJECTIVES: I. Determine whether infants treated with tauroursodeoxycholic acid (TUDCA) have a lower peak direct bilirubin, ALT, AST, glutamyltranspeptidase levels and a reduced duration of cholestasis compared to the nontreatment arm.

II. Determine the significance of lower birth weight and longer duration of total parenteral nutrition (TPN) on increasing risk of TPN associated cholestasis and increasing benefit from TUDCA therapy.

III. Determine whether TUDCA therapy leads to significant reduction in the appearance of biliary tract sludge and/or stone formation in these infants.

IV. Determine whether TUDCA therapy leads to reduced urinary excretion of potentially hepatotoxic bile acids as compared to the untreated arm matched for birth weight and duration of TPN.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by birth weight.

Patients are randomized in pairs by birth weight to receive either a placebo in arm I or tauroursodeoxycholic acid (TUDCA) in arm II. TUDCA is administered by mouth, nasogastric tube, or gastrostomy tube twice daily. After 2 weeks of therapy, a bile sample is obtained via a duodenal tube. An ultrasound examination of the liver and biliary tract is performed after 2 weeks and every 3 weeks thereafter until discontinuation of therapy or until presence of biliary tract sludge is noted on 2 consecutive examinations.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Hospitalized infants who are anticipated to require total parenteral nutrition for greater than 2 weeks and have: Major gastrointestinal anomalies (gastroschisis, ruptured omphalocele) OR Resection (necrotizing enterocolitis, volvulus)
* No evidence of biliary tract abnormalities
* No evidence of other forms of cholestatic liver disease

--Patient Characteristics--

* Renal: No life threatening renal disease
* Cardiovascular: No life threatening cardiovascular disease
* Other: No multiple congenital abnormalities
Effect of an Antiseptic Solution on the Skin Microbiome

The objective of this study is simulate the clinical use of an antiseptic solution in a 24 hour window and the recovery to baseline conditions at 1 month following application. Efficacy will be simulated as the capacity of the material to reduce or clear the skin bacterial population from a representative skin area: the anteromedial forearm.


Eligibility Criteria:
Inclusion Criteria:

A subject may be eligible for study participation if all of the following criteria are met:

1. Subject is male or female greater than 18 years of age.
2. Subject does not have a history of skin allergies/atopia (e.g. atopic dermatitis).
3. Subject does not have a history of skin disease (e.g scleroderma, vitiligo, psoriasis) or a chronic systemic disease affecting the skin (e.g systemic lupus erythematosus).
4. Subject is willing to have materials applied and follow the protocol.
5. Subject agrees to avoid exposure of the test sites to the sun, chemical product, clothes and to refrain from touching the area of application (for T0 \[baseline\], T1 \[5 minutes\], T2 \[2 hours\]).
6. Subject agrees to refrain from getting a bath/shower before T3 (24 h).
7. Subject agrees to avoid scrubbing, applying, and/or washing the test area with new soap, moistures, powders, lotions, cosmetic or toiletry products during the study.
8. Subject is able to follow directions as outlined in the protocol and anticipates being available for all study visits.
9. Subject is willing to participate in all study evaluations.
10. Subject is in generally good health.
11. Subject is willing to sign the Informed Consent form prior to study participation

Exclusion Criteria:

1. Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control.
2. Subject is immunologically compromised or has received specific topical treatment (antimicrobial or not-antimicrobial), during the last month.
3. Subject reports a history of allergies to antiseptics.
4. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study.
5. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
Neoadjuvant Chemotherapy in Non Small Cell Lung Cancer (NSCLC) Stages IB, IIA, IIB, and IIIA/T3

Randomised trial of chemotherapy or not before surgery in early resectable stages of NSCLC (IB, IIA, IIB, and IIIA/N2).

Randomisation between 3 courses of neoadjuvant Carboplatin plus Paclitaxel or no chemotherapy before surgery.

Eligibility Criteria:
Inclusion Criteria:

* NSCLC
* Stages IB, IIA, IIB, IIIA/T3
* Lung function test allowing surgery
* Age 18-75 years

Exclusion Criteria:

* Poor lung function
* Performance status 3-4
* Mediastinal lymph node involvement
Fatigability in Persons With Multiple Sclerosis: Inputs From Cognition, Walking and Coordination

Walking impairments occur in 93% of persons with MS (pwMS) within 10 years of diagnosis. Besides the impact of muscle weakness or hypertonia, one is increasingly aware about the symptom of fatigability. Motor and cognitive fatigability is a change in performance over time depending on the tasks and circumstances. It was shown that up to half of disabled pwMS slow down during walking, impacting on real life mobility. Walking function is related to functional muscle strength, balance and centrally mediated coordination deficits but also cognitive function. Preliminary data conducted by our research group has shown that people with MS with walking fatigability had a significant decrease in movement amplitude during a bipedal coordination task in sitting position. However, the psychometric properties such as within-session and test-retest reliability of bipedal function has not yet been determined. In addition, so far, no interventional research has included exclusively people with MS with walking-related fatigability. It is unknown if the downward curve in walking speed and coordination can be reversed by multi-model interventions.

The study will have two parts (A and B). Part A investigates psychometric properties of outcome measures related to fatigability in healthy controls, persons with MS with and without fatigability during walking. Part B is an intervention study in persons with MS and fatigability, comparing dance with a sham intervention, and its effects primarily on fatigability outcomes.

The study will have two parts (A and B). Part A includes 60 persons with Multiple Sclerosis (pwMS) and 30 healthy controls. The study consists of 2 test sessions, separated by 5-7 days of interval. The sessions 1 and 2 will be composed of cognitive test battery, questionnaires to be filled, information about the use of actigraph, clinical outcomes and interlimb coordination tests.

In the Part B the investigators propose a pilot randomized controlled trial with dance therapy to improve fatigability in pwMS. The study includes 24 pwMS presenting walking fatigability. The participants will be randomly allocated by group (n=3-4), by a person independent from the research, into the intervention group (Dance Therapy) or the active control group (control exercise). Interventions take place in groups of 3 or 4 people with MS, twice a week for eight weeks, complementary to their usual care or conventional physiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Persons with MS presenting walking-related fatigability (Distance walk index ≤-10);
* age between 30 and 70 years old;
* a diagnosis of MS (2017 revisions of the McDonalds criteria) with Expanded Disability Status Scale (EDSS) 4 up to 6.5.
* no relapses \>1 month preceding the start of the study
* ability to walk for 6 minutes without rest.

Exclusion Criteria:

* Cognitive impairment hindering understanding of study instructions,
* pregnancy
* musculoskeletal disorders in the lower limbs not related to MS.
Efficacy of Two Oral Hygiene Regimens in the Reduction of Dentin Hypersensitivity After Periodontal Treatment

This study aim is to determine the efficacy of two Oral Hygiene Regimens in the reduction of dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a period of 8 weeks.

This study aim was to determine the efficacy of two Oral Hygiene Regimens in the reduction of dentin hypersensitivity on subjects undergoing non-surgical periodontal treatment, over a period of 8 weeks. The study was conducted in Piracicaba Dental School, Piracicaba, São Paulo, Brazil, using a double-blind/two treatment design. Sixty subjects (30 per group) that meet the inclusion and exclusion criteria were assigned to the groups: Test group (Non-surgical periodontal treatment + In-office application of Colgate Sensitive Pro-Relief - CSPR + tooth brushing with at home CSPR toothpaste) and Control group (Non-surgical periodontal treatment + In-office application of a fluoride-free prophy paste + tooth brushing with a Colgate Cavity Protection Toothpaste). Air blast sensitivity assessments were used to compare the efficacy of the two approaches using both the Schiff scale. The sensitivity parameters were measured at baseline, 1, 4 and 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, between 30-75 years of age;
2. Availability for the duration of the study;
3. Individuals diagnosed with moderate chronic periodontal disease (4-5 mm loss of clinical attachment, according to AAP), and indication for non-surgical periodontal therapy;
4. Diagnosis, by air blast, of at least two (2) hypersensitive teeth with a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale;
5. Subjects in good general health and no allergies to products that are being tested.

Exclusion Criteria:

1. Oral pathology, chronic disease, or a history of allergy to testing products;
2. Qualifying sensitive teeth with extensive/defective restorations, pulpitis, caries, cracked enamel, or these teeth used as abutments for removable partial dentures;
3. Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
4. Subject regularly using desensitizing toothpaste;
5. Current smokers;
6. Subject pregnant or breast feeding;
7. Allergies to oral care products, personal care consumer products, or their ingredients.
Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea

Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.


Eligibility Criteria:
Inclusion Criteria:

* 18 \< Age \< 70
* HBV DNA \> 100,000 copies/mL and increased ALT over 2 times compared with normal range if HBsAg (+), HBeAg (+)
* HBV DNA \> 10,000 copies/mL and increased ALT compared with normal range if HBsAg (+), HBeAg (-)

Exclusion Criteria:

* With HCV or other liver disease
* With kidney disease
* decompensated liver cirrhosis
* with hepatocellular carcinoma
* refuse this clinical trials
Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia.

The purpose of this study is to explore the therapeutic effect and mechanism of transcranial magnetic stimulation (rTMS) in the treatment of the tardive dyskinesia.

The study was a parallel control design trial for 2 weeks. Patients with schizophrenia were treated with 10-Hz rTMS on left motor cortex (added to the ongoing treatment). Clinical symptoms and MEP were assessment before and after rTMS treatment.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of schizophrenia according to DSM-IV；
* At least two item of Abnormal Involuntary Movement Scale（AIMS） must be 2 points or higher
* these symptoms are not from Parkinson，tourette's syndrome,huntington disease
* Signed an informed consent

Exclusion Criteria:

* rTMS contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure
* patients to be diagnosed according to DSM-IV for substance abused, development delayed
* current treatment with anticonvulsant acting drugs such as anticonvulsants, benzodiazepines
* Acute risk of suicide and impulse
* history of epileptic seizures or the presence of epileptic activity documented on the basis of EEG
* pregnant and lactant women
Bioavailability of Berberine and Dihydroberberine and Their Impact on Glycemia

The purpose of this study is to determine the bioavailability of berberine and dihydroberberine and their impact on changes in plasma concentrations of glucose and insulin.

Once determined eligible and provided consent, participants will be assigned in a randomized, double-blind, placebo-controlled, crossover fashion. Eligible study participants will complete one of four testing conditions. For each testing condition, study participants will arrive in the lab after observing an overnight fast. Upon arrival, participants will donate the first of six venous blood samples. Follow-up blood samples will be collected at 20, 40, 60, 90, and 120 minutes. All collected samples will be collected into two, 4mL EDTA tubes and have aliquots of 600 ul of plasma isolated and frozen at -80 degrees celsius. Collected plasma will be analyzed for changes in berberine, glucose, and insulin. Participants will observe a minimum of 72 hours washout between conditions

Eligibility Criteria:
Inclusion Criteria:

* All participants will be between the ages of 18-45 years.
* Participants will be healthy and free of disease as determined by evaluation of a medical history
* Body mass index (BMI) between 18.5 - 30 kg/m\^2

Exclusion Criteria:

* Those individuals less than 18 and greater than 45 years of age will be excluded.
* Participants younger than 18 are excluded due to necessity of parental consent.
* Participants greater than 45 years old lie outside of the target demographic for the current study.
* As indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with any cardiac, respiratory, endocrine, psychiatric, musculoskeletal, renal, hepatic, neuromuscular or metabolic disease or disorder.
* Additional exclusion criteria include: participants with a fasting capillary blood glucose level \> 100 mg/dL.
* Current smokers (including vaping) or have quit within the past six months.
* Any over-the-counter or prescription drugs and/or dietary supplements that are known or are purported to impact glycemia and insulinemia.
* Currently or have been following with the past 30 days a ketogenic or very-low carbohydrate diet.
* Participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more.
Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma

The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the end of radiation.
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation.
* Agreement to adhere to Lifestyle Considerations (as outlined in protocol) throughout study duration.
* Pathologically (histologically or cytologically) proven diagnosis of high-grade (grade 2 or 3) Soft Tissue Sarcoma (STS) of the deep trunk and/or extremity. Clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for T stage)
* Primary site deemed resectable prior to the start of trial
* American Joint Committee on Cancer (AJCC) 8th edition staging T1-4 N0 M0, no evidence of distant metastases
* Patients must have clinically or radiographically evident measurable disease at the primary site.
* Pre-Radiation Therapy (RT) MRI within 4 weeks of the start of RT.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 3.
* Deemed a surgical candidate
* Participant agrees to blood and plasma preservation for future analysis.

Exclusion Criteria:

* Contraindications to an MRI
* Positive urine pregnancy test
* Gross total excision of primary STS, including an unplanned excision
* Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue
* Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
* Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.
Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)

The objective of this registry is to confirm the safety and the performance of the ECE50 in medical routine by collecting data.

The Endoscopic Cap Electrode (ECE50) has been designed for the delivery of electrostimulation to selected laryngeal muscles. The primary objective of this registry is to retrieve real-life data on the safety and performance of the Endoscopic Cap in medical routine. Subject's participation will last a maximum of 2 hours. Upon successful conclusion of the screening session starts the testing session of the ECE50. The ECE50 has been designed to be placed on the top of a videoendoscope for the delivery of electrostimulation to the laryngeal region. The stimulation and reaction of the muscles can provide information about the presence and type of dysfunctions and thus influence the treatment procedure. Being a registry a collection of records generated within routine medical procedures with a medical device approved for the EU market, it does not pose additional risks for the patients participating in it.

Eligibility Criteria:
Inclusion Criteria:

* Legal adults (i.e., as a general rule patients ≥ 18 years old)
* Legal adults requiring a diagnosis for a disorder that could be traced back to uni- or bilateral dysfunction of one or more laryngeal muscle(s) of the posterior cricoid region
* Signed and dated informed consent before the start of any registry-specific procedure for all the recruited subjects

Exclusion Criteria:

* Lack of compliance with any inclusion criteria
* Use of an active medical implant
* Known allergies or intolerance to the material used for this registry
* Parallel participation in a device/drug registry in the period of data collection, which could confound the results of the registry
* Anything that, in the opinion of the Registry Responsible, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this registry
Effect of Cranberry Juice on Endothelial Function

A pilot study of 15 subjects will be completed to determine whether acute consumption of cranberry juice has an effect on endothelial function. We will then complete a randomized, double blind, placebo controlled crossover study designed to investigate the effects of cranberry juice consumption on endothelial function. Participants (n=40) will drink 480 ml of double strength cranberry juice or a similar appearing and tasting placebo per day for four weeks. After a two week rest period, they will cross over to the other beverage. We will examine endothelial function before and after each of the two treatment periods. The study will provide information about the chronic vascular effects of cranberry juice.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease

Exclusion Criteria:

* Pregnant and lactating women
* Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate
* Treatment with an investigational new drug within the last 30 days
* History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
* Treatment with Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 2 weeks of enrollment (subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the RDA will not be excluded).