cyrilzakka/clinical-trials huggingface dataset:
Effects of Muscle Strengthening and Fatigue on Activities in Cortex and Muscle

We will explored the effect of cross education training on different cortex functional connectivity, cortex and muscle functional connectivity, and maximal voluntary contraction.

Healthy participants receive cross education training of the elbow flexor (12 rep./set, 3sets, 60%MVC, 180°/s, eccentric).Maximal voluntary contraction, electroencephalogram and electromyogram will record during cross education tasks to determine the effects of cross education training on cortical network and muscle functional connectivity

Cross education (CE) training was observed in 1894, when unilateral strength training of single limb was found to increase in strength of untrained muscle group. CE has potential clinical relevance in rehabilitation for patient who have acute injuries of the limb, post-surgical limb immobilization and certain neurological disorders with unilateral muscle weakness. Although CE has several potential clinical application, the precise physiological mechanisms underlying CE remains unknown. Previous studies reported that CE may involve bilateral cortical activity in both contralateral primary motor cortex (cM1), and ipsilateral primary motor cortex (iM1).In addition, neuroimaging studies have demonstrated that bilateral supplementary motor area, but CE immediate change of functional connectivity in cortical network remains unknown.

The purposes of this study are to investigate the immediate effect of CE training of biceps brachii (1) Immediate change of functional connectivity in cortical network; (2) Immediate change of functional connectivity in cortex and target muscle; (3) Explore immediate change of corticomuscular functional connectivity on maximal voluntary contraction. We hypothesize that (1) Bilateral cortical motor network that exhibit changes in functional connectivity during cross education; (2) Cross education would immediately enhance functional connectivity between cortex and target muscle; (3) Cross education would immediately change corticomuscular functional connectivity on maximal isometric voluntary contraction.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults who are 20-40 years old

Exclusion Criteria:

1. Upper extremity (UE) pain or discomfort
2. Medical condition that substantially influenced their UE strength
3. Experience of UE surgery
4. Paresthesia in UE
5. Open wound on UE
OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study

To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.

This is a prospective, open, non-randomized, study involving two (2) centers in the United States. A minimum of twelve (12) and a maximum of fifteen (15) subjects will be consented, treated and have blood samples drawn to evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.

Eligibility Criteria:
Inclusion Criteria:

* Subject is an eligible candidate for PCI
* Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
* Subject is an acceptable candidate for CABG
* Subject has ≤ 3 de novo target lesions in ≤ 2 native coronary artery vessels, with ≤ 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria
* Target lesion(s) must be located in a native coronary artery with RVD ≥ 2.25mm and ≤ 4.00mm

Exclusion Criteria:

* Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina
* Subject's target lesion(s) is located in the left main coronary artery
* Subject's target lesion(s) is located within 3mm of the origin of the LAD or LCX coronary artery
* Subject's target lesion(s) is located within a SVG or an arterial graft
* Subject's target lesion(s) will be accessed via SVG or arterial graft
Efficacy and Safety of XG-102 in Reduction of Post-cataract Surgery Intraocular Inflammation and Pain

The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg) compared to vehicle in the treatment of subjects with inflammation and pain following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Have provided written informed consent, approved by the appropriate institutional review board;
* Be greater than or equal to 18 years of age of either sex or any race;
* Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye;
* Have a pin-hole visual acuity (VA) \< 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1;
* (For females of childbearing potential) agree to have urine pregnancy testing performed at Visit 1 (must be negative) and at exit visit; must not be lactating; and must agree to use a medically acceptable form of birth control1 throughout the study duration. Women of childbearing potential include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).

Exclusion Criteria:

* Have a known sensitivity or allergy to the class of medication of the active ingredient in the study medication or any of the study medication's components;
* Have any intraocular inflammation (e.g., white blood cells or flare) present in the study eye at the Visit 1slit lamp examination;
* Have a score greater than "0" on the Ocular Pain Assessment at Visit 1 or 2 in the study eye;
* Have an immunosuppressive or an autoimmune disease that in the opinion of the Investigator could affect intraocular inflammation or the normal healing process of the eye;
* Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing;
* Currently have suspected or known malignancy or be currently receiving antineoplastic therapy;
* Be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the study duration, or have a positive urine pregnancy test at Visit 1;
* Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics and other pain medications) or immunomodulating agents, systemically, or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through the duration of the study
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male, who is considered to be generally healthy, based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator
* Age 18-64 years (both inclusive) at the time of signing informed consent
* BMI (body mass index) 20.0-29.9 kg/m\^2 (both inclusive)

Exclusion Criteria:

* History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
* Subject with previous GI surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
Evaluation of Effaclar Duo+M on Acne Lesions in Subjects With Mild to Moderate Acne on Face and Trunk

This single-center, open, non-randomized study aims the efficacy evaluation of Effaclar Duo+M and Effaclar+M Purifying foaming gel on total acne lesion count, pigmented lesions and scars for 6 months in subjects with mild to moderate facial and truncal acne.

The study will be conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil3, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice.

Statistical methodology:

Quantitative variables, or those that can reasonably be treated as such, are summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (SD). Qualitative variables are summarized in the form of counts and percentages.

Significance level:

The null hypothesis will generally be rejected if a p-value less than 0.05 (5% significance level) is produced by the statistical procedure.

Eligibility Criteria:
Inclusion Criteria:

* phototype I to VI
* mild to moderate acne on the face and trunk

Exclusion Criteria:

* cutaneous pathology on the studied zone other than acne
* topical or systemic treatment during the previous weeks liable to interfere with the assessment of the acceptability and efficacy of the studied products
Bioceramics Pain Control

Postoperative pain in endodontic retreatment cases presents a challenge to any endodontist. Tricalcium silicate materials as mineral trioxide aggregate (MTA) and bioceramics have shown favorable periapical tissue reactions and healing when used as part of the root canal filling material. This study was conducted to compare the difference in the postoperative pain when resin cements are used versus bioceramic cements in the obturation of root canals.

The Faculty of Dentistry Ain Shams University's Research Ethics Committee reviewed the current proposal for ethical approval. One hundred patients with permanent molar teeth requiring endodontic non-surgical retreatment were treated in this study. Teeth with fractured instruments were excluded. Patient ages ranged from twenty to fifty years, both men and women were treated in the current study. Infants, children, people unable to take decisions, university students, orphans, mentally or physically disabled patients were excluded from the current study.

Preoperative assessment of the degree of the patient's pain was done using the visual analog scale. Fifty teeth were obturated with gutta percha using the epoxy resin-based sealer (AH Plus) as the control group, and in the other fifty bioceramic based cement (Endosequence) was used. All teeth were prepared by the protaper next rotary files (Dentsply Sirona) under copious irrigation with 30ml of 2.6 % sodium hypochlorite throughout the procedure. Ethylamine diamine tetracetic acid (EDTA) 17% was used to remove the smear layer before the obturation commenced. Obturation was done using the cold lateral compaction technique in the resin group and single cone technique in the bioceramic group. Postoperative pain assessment was done for each patient after six hours, twenty-four hours, four days and one week.

Eligibility Criteria:
Inclusion Criteria:

* • Mandibular molars with fully formed roots that need retreatment.

  * Age range 20 - 50 years.
  * Teeth having a baseline periapical lesion (PAI score ≥2) in the affected root.

Exclusion Criteria:

* • Patients with separated files that need to be retrieved or bypassed.

  * Pregnant females.
  * Patients suffering from a systemic disease.
  * Teeth with lesions connected to adjacent teeth.
  * Teeth with root fractures or perforations.
  * Teeth with lesions communicating with the alveolar crest.
  * Patients with generalized chronic periodontitis or teeth that need periodontal surgery prior to coronal restorations due to marginal deficiency
  * Teeth with damaged or resorbed peri- apex
  * Teeth that were treated with a fiber post and teeth with canal curvature more than 30 degrees.
Screening and Brief Intervention Via IVR for Problematic Use of Alcohol: A Randomized Controlled Trial

Objectives: The study evaluates the efficacy of two automated telephony, also known as, Interactive Voice Recognition (IVR) interventions, Short IVR and Therapeutic IVR. The Short IVR works as an interactive alcohol diary where the user is contacted once a week for four weeks to register their alcohol consumption during the preceding week. The user is given feedback on changes in alcohol consumption compared to last week. The Therapeutic IVR contacts the user once a week for four weeks and is also available for user-initiated calls 24/7 during this four-week period. The Therapeutic IVR allows the user to traverse a menu where the user chooses among listening to vignettes and doing exercises with the purpose of looking at alcohol consumption and exploring ways of coping with it.

Method: The design is a three-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use at follow up six months after study initiation and baseline data gathering. Participants with problematic alcohol use (AUDIT \>7 for men and \>5 for women) are randomized into one of three groups: 1. Short IVR, 2. Therapeutic IVR and 3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction with the intervention are assessed after 6 months.

The primary hypothesis for this study is that having access to one of the two IVR interventions will lead to a greater reduction of problematic alcohol use compared to controls who undergo only screening and follow-up assessment. The secondary hypothesis is that having access to either Short IVR or Therapeutic IVR leads to comparable reductions in risky drinking.


Eligibility Criteria:
Inclusion Criteria:

* AUDIT \>7 for men or AUDIT \>5 for women.

Exclusion Criteria:

* AUDIT \<8 (men) or \<6 (women)
Small Intestinal Absorption in Patients With Chronic Obstructive Pulmonary Disease and Cor Pulmonale

Aim: To investigate whether patients with pulmonary hypertension have reduced absorption capacity compared to COPD patients without cor pulmonale potentially due to venous obstruction in the portal vein system.

The presence of cor pulmonale was determined by echocardiography. The concentration of D-xylose and zinc were measured in peripheral blood one, two and three hours after ingestion and used as markers of absorption. Furthermore, urine was collected for five hours to determine the amount of excreted D-xylose.

Background: Cor pulmonale is a common complication to Chronic Obstructive Pulmonary Disease (COPD), and may result in increased pressure in the inferior caval vein and stasis of the liver. The chronic pulmonary hypertension may lead to stasis in the veins from the small intestine and thereby compromise absorption of nutrients.

Aim: To investigate whether patients with pulmonary hypertension have reduced absorption capacity compared to COPD patients without cor pulmonale.

Methods: Absorption of D-xylose (25 g) and zinc (132 mg), administered as a single dose, was tested in 14 COPD patients, seven with and seven without cor pulmonale. The presence of cor pulmonale was determined by echocardiography. The concentration of D-xylose and zinc were measured in peripheral blood one, two and three hours after ingestion and used as markers of absorption. Furthermore, urine was collected for five hours to determine the amount of excreted D-xylose.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of COPD
* Clinically stable = Unchanged medication for COPD for at least 6 months

Exclusion Criteria:

* Unable to understand Danish
* Other clinically important heart-disease than chronic right heart changes presumably due to lung disease
* Clinically significant gastro-intestinal or kidney disease
* Diabetes
* Treatment with corticosteroids for at least 6 months.
Endoscopic Repair of Frontal Sinus CSF Leak

This retrospective study was conducted on patients with frontal sinus leaks came to ENT departments of Al-Azhar University Hospital, New Damietta, Egypt, for a period of five years.

All patients in this study were evaluated during the follow-up period. Patients' age, sex, occupation, residence, and telephone number were recorded for each participant for demographic purposes. General and local examinations were also performed preoperatively as usual.

Medical history, surgical approach, leakage site, complications, reconstruction technique, and follow-up were recorded.

All cases were treated by endonasal endoscopy

* Complete sphenoethmoidectomy.
* Draf type IIa, IIb, and III according to defect location.
* Defect less than 3 mm closed by a plug of fat and facia lata or middle turbinate mucosa.
* Defect more than 3 mm closed by underlying facia lata, underlying cartilage, and overlay facia lata.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent endoscopic frontal sinus repair. Traumatic or spontaneous patients with a CSF leak at a minimum of six months not responding to conservative measures were included.

Exclusion Criteria:

* Known malignancy or patients with frontal leak due to extensive tumor resection or intracranial injury
Clinical Value of Homeopathic Prophylaxis of Recurrent Urinary Tract Infections in Persons With Spinal Cord Injury

recurrent symptomatic urinary tracts infections (UTI) in persons with spinal cord injury are a frequent problem, leading to significant morbidity and to a decreased quality of life.

* until today, there is no effective prophylaxis for UTI for patients with spinal cord injury.
* homeopathy has been shown to be an effective treatment option in several chronic diseases
* study hypothesis: the addition of homeopathic assessment and treatment to a standard prevention strategy for recurrent UTI will significantly reduce the number of symptomatic UTI per year in this group of patients compared to standard prevention alone


Eligibility Criteria:
Inclusion Criteria:

* neurogenic bladder dysfunction treated by intermittent catheterization
* recurrent (\>3/year) symptomatic urinary tract infections

Exclusion Criteria:

* inability to speak German
* already under homeopathic treatment
Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Lung Fluid of Adults With and Without HIV Infection

Lung immune responses are regulated independently of systemic responses. Injected vaccines may induce optimal responses in blood but not at mucosal surfaces. We compared the responses in serum and lung fluid to injected pneumococcal conjugate vaccine.

We tested the hypothesis that conjugate vaccine offered less protection against pneumonia due to a reduced mucosal response compared to serum. We further hypothesized that this response would be further compromised with HIV co-infection\[32\] due to lack of local CD4 lymphocyte support and an altered alveolar milieu. We measured pneumococcal capsular specific immunoglobulin responses to 7-valent conjugate vaccine in both lung fluid and serum from healthy HIV infected and uninfected volunteers, together with flow cytometric assessment of the relative numbers and phenotypes of BAL T lymphocyte, B lymphocyte and macrophages.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer adults

Exclusion Criteria:

* pregnant, recent illness, previous vaccination, asthma
Safety and Efficacy of Albumin Interferon Administered Every 4 Weeks in Genotype 2/3 Hepatitis C Patients

This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Clinical diagnosis of chronic hepatitis C
* Infection with HCV genotype 2 or 3
* No previous IFNα-based therapy

Exclusion Criteria:

* Women of child-bearing potential if not using double barrier method of contraception, pregnant or nursing
* Fertile males, unless condom with spermicide is used and female partner agrees to use one or more of the acceptable methods until 7 months after last dose of RBV
* History or current evidence of decompensated liver disease; other forms of liver disease
* Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* History of moderate, severe or uncontrolled psychiatric disease
* History of seizure disorder
* History or clinical evidence of chronic cardiac disease, preexisting interstitial lung disease or severe lung disease
* Clinically significant findings on eye/retinal examination
* History of immunologically mediated disease
* Organ transplantation other than cornea or hair transplant
* History of clinically significant hemoglobinopathy
* Diagnosis of malignancy of any organ system with the exception of localized basal cell carcinoma of the skin
* History of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
* Drug or alcohol addiction within the last 6 months and/or positive drug screening tests
* Received systemic corticosteroids (prednisone equivalent of \> 10 mg/day) within 14 days prior to Baseline visit
* Received concomitant systemic antibiotics, antifungals or antivirals for the treatment of active infection within 14 days prior to Baseline visit.
* Received herbal therapies (including milk thistle or glycyrrhizin) or an investigational drug within 35 days prior to Baseline visit
* Have a clinically significant laboratory abnormality

Other protocol-defined inclusion/exclusion criteria may apply.