cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of CKD-348

A Clinical Trial to evaluate the Pharmacokinetics and Tolerability of CKD-348

An open label, randomized, single dose, 2-sequence, 4-period, cross-over clinical trial to evaluate the pharmacokinetics and tolerability of CKD-348 with coadministration of CKD-828, D097 and D337 in healthy adult volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
3. Those who meet the blood pressure criteria during screening tests:

   * Systolic Blood Pressure: 90 to 139 mmHg
   * Diastolic Blood Pressure: 60 to 89 mmHg
4. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
6. Those who agree to contraception during the participation of clinical trial.
7. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
2. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
3. Those who donated whole blood or apheresis within 2 months or 1 month respectfully, or received blood transfusion within a month.
4. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
5. Those who exceed an alcohol and cigarette consumption than below criteria

   * Alcohol: Man_21 glasses/week, Woman_14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
   * Smoking: 20 cigarettes/day
6. Those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism.
7. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.
Evaluation of the Expression and Prognostic Role of Tumor Stem Cell Marker SOX2 in Odontogenic Cysts and Tumors

The pathogenesis of odontogenic lesions remains unclear; however, a probable explanation may involve the existence of tumor stem cells (TSCs), which are thought to generate both benign and malignant tumors. The preservation of stem cells during early dental development is governed by many transcription factors, including sex-determining region Y (SRY)-box 2 (SOX-2). Numerous studies observed the increased expression of SOX2 in various benign and malignant tumors, as its impact on tumorigenesis varies according to tumor type. The purpose of this study is to assess the immunoexpression of the stem cell marker SOX2 in diverse types of odontogenic cysts and tumors in order to identify its prognostic significance and to show if it correlates to clinicopathologic parameters of those odontogenic lesions.

Forty-five surgical specimens were included in this study: 15 ameloblastomas (Ab), 15 odontogenic keratocysts (OKC), and 15 dentigerous cysts (DC). An immunohistochemical (IHC) study using the SOX2 Rabbit Polyclonal Antibody was done, and SOX2 expression was evaluated by two methods: computer-assisted digital image analysis to measure staining surface area percentage and a semi-quantitative method for subjectively scoring percentage and intensity of SOX2 staining. Positive specimens were considered when the nucleus had brown staining.

Eligibility Criteria:
Inclusion criteria:

1. Patients with benign odontogenic cysts and tumors which presented either in Maxilla or Mandible ( as indicated by incisional biopsies )

Exclusion criteria:

1. Patients with systemic diseases that absolutely contraindicate surgical procedures.
2. Malignant odontogenic tumors.
BlueWind RENOVA iStim™ System for the Treatment of OAB

The OASIS study is prospective, interventional, multi-center study to evaluate the safety and efficacy of the BlueWind RENOVA iStim™ implantable tibial neuromodulation System for the treatment of patients diagnosed with overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18 or greater (21 in the US)
* More than or equal to 6 months history of UUI diagnosis
* Patient who is mentally competent with the ability to understand and comply with the requirements of the study

Exclusion Criteria:

* Any significant medical condition that is likely to interfere with study procedures
* Patients who are breastfeeding
* Predominant stress incontinence
* Have a life expectancy of less than 1 year
* Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
Do Handgrip Strength and Dexterity Predict of Respiratory Function ?

Dysfunction due to weakness in respiratory muscles is one of the biggest problem that causes mortality and morbidity in neuromuscular diseases.Since the NMD have a crucial life-threading natural progression, many clinicians and researchers are trying to working out to increase life span and/or quality of life with medical and rehabilitative approaches.The relationship between upper extremity functions and respiratory functions in pediatric neuromuscular patients is still not clear. The clinician working with children with neuromuscular disease should be aware of the effects of muscle weakness and cognitive dysfunction on the respiratory system. Symptoms can be insidious and cause progressive loss of function, respiratory failure, and even death

Background:Neuromuscular diseases are acquired or hereditary diseases that affect the function of the muscles in our body caused by the nerves not sending information to your muscles and/or problems with the muscles not working properly.

Objective:The aim of our study is to discover more cost-effective and practical tools to predict respiratory function losses that may be a significant problem in children with neuromuscular disease.

Methods: Hand grip strength and dexterity of children with neuromuscular disease were measured using the dynamometer and the nine-hole-peg-test respectively. The Vignos and Brooke Upper Extremity Functional Scales were used to evaluate functional status for patient recruitment.Respiratory function parameters:forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and peak expiratory flow(PEF) were evaluated with spirometry.

Eligibility Criteria:
Inclusion Criteria:

* to be diagnosed with NMD
* to be in Stage 5 or below according to the Vignos scale (walking without assistance)
* to be between Stage 1-4 according to the Brooke scale.

Exclusion Criteria:

* Patients with severe systemic disease, ambulatory problem, cognitive problem, and upper extremity deformity were excluded
Small Fiber Assessment by Cutaneous Silent Period

Our primary objective in this study is to investigate the cutaneous silent period (CSP) in normal subjects in the Egyptian population, as it was not carried out before in Egypt. The aim was to carry out the test in our unit to study the appropriate method, technique, and parameters of this new test so that we can apply it in future research. In addition, to obtain preliminary normative data of the test; onset latency, end latency, duration, and latency difference (LD) of CSP, as well as assess the effect of age, height, upper limb length, and gender on CSP values.

Nerve conduction studies performed routinely in electromyoneurography laboratories deal mainly with large myelinated fast conducting nerve fibers. A reliable method allowing the study of small peripheral nerve fibers (Aδ \& C) would be of interest (Jovita et al., 2006). As they are initially affected and maybe the earliest exhibited sign of neuropathy.

In recent years, the cutaneous silent period (CSP) has received increased attention in health and disease. The CSP is an inhibitory spinal reflex that appears following strong electrical stimulation of the cutaneous nerve and causes suppression of voluntary muscular contraction for a certain period of time (Kofler et al., 2019). This action presents a reciprocal action to the nociceptive flexor withdrawal response (FWR) which serves as an 'excitatory reflex' increasing activity in primary flexor muscles. When taken into context, the interplay between the CSP and FWR can clearly be seen.

The evaluation of the CSP represents a useful electrophysiological method for investigating the function of small fibers by using standard electromyography equipment (Eckert et al., 2018).

Eligibility Criteria:
Inclusion criteria:

* Healthy participants able to cooperate and to follow instructions.
* Participants having a normal value for electrophysiological parameters (Nerve conduction studies)
* Participants must be free from any musculoskeletal impairment of the limbs

Exclusion criteria:

* Participants with neurological disorders
* Participants with cognitive impairment
* Participants receiving medications that may affect the NCS
* Participants with small fiber neuropathy (burning sensation, pricking sensation, allodynia, and hyperalgesia)
* Participants with an abnormal value for Nerve conduction studies
* Participants with musculoskeletal impairment of the limbs
Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity

The objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial.

H1: The clinic + home intervention will result in a significantly greater decrease in BMIz compared to the in clinic only intervention or pediatric standard of care at 6 months post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* 2 years 0 months to 5 years 11 months of age
* at or above the 95th percentile BMI for age and sex
* have at least one parent with a BMI at or greater than 25
* medical clearance from pediatrician

Exclusion Criteria:

* non-English speaking
* living greater than 50 miles from medical center
* a disability or illness that would preclude engagement in moderate activity
* medical condition/medication associated with weight
* enrolled in another weight management program
Single Dose Escalation Study of CM383 in Healthy Volunteers

This study is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects.

Alzheimer's disease (AD) is the most common type of dementia, which is a degenerative disease of the central nervous system with insidious onset and progressive development. Its clinical features mainly include memory impairment, cognitive impairment, psychobehavioral abnormalities, and social decline.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males, voluntarily participate;
* 18 and 80 years old (including boundary values);
* able to communicate well with the researchers and follow up the protocol requirements.

Exclusion Criteria:

* The average daily smoking volume within three months before screening is greater than 5 cigarettes;
* Excessive alcohol consumption within three months before screening, or positive alcohol breath test;
* Urine drug abuse screening is positive;
* Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.
Effect of Using Shade Blocker Versus Chameleon Effect of Two Single Shade of Resin Composite in Class IV Restorations

Aim of this study will be conducted to compare the shade matching and clinical performance of shade blocker versus chameleon effect of two single-shade of universal resin composite in class IV restorations over 1 year evaluation period

The color matching of both groups will be evaluated visually using modified USPH criteria

Eligibility Criteria:
Inclusion Criteria:

moderate class IV defect with no lingual wall presence of favorable occlusion and teeth are in normal contact with the adjacent teeth good oral hygiene cooperative patients

-

Exclusion Criteria:

* tooth hypersensitivity severe periodontal affection non vital teeth heavy smoking
Study of Sulfasalazine in Treating Painful Neuropathy

The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this study, the investigators will evaluate whether sulfasalazine improves pain due to painful peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Painful neuropathy
* Michigan Neuropathy Screening Instrument score of 3 or greater
* no obvious alternative explanation for neuropathy
* average baseline pain \> 4/10

Exclusion Criteria:

* other severe pain
* anticipated difficulty weaning off medications
* past or current psychiatric disorder as determined by Mini International Neuropsychiatric Interview
* medical contraindication to sulfasalazine
* not proficient in English (due to heavy use of questionaires)
* pregnant or breast feeding women
Covid-19 Fear and Compliance With Protective Measures of Students

This study was carried out to determine the fear of Covid-19 and the compliance with protective measures of students who continue their education face-to-face during the covid-19 pandemic process.

The study was carried out descriptively. The study population of a province pandemic period junior ongoing training to face in Turkey. Sample constituted reached 188 students with snowball sampling method. The data of the study were collected using the "Questionnaire Form" prepared by the researchers and the "Covid-19 Fear Scale". Data collection tools were applied to the participants electronically via Google Forms.

Eligibility Criteria:
Inclusion Criteria:

Students who volunteered to participate in the study, had their parents' consent, had a web-based smart device, and continued face-to-face education were included.

Exclusion Criteria:

-
A Comparison of Hip Extension and Nordic Hamstring Exercise Programmes on Isokinetic Hamstring Strength

This study aimed to compare the effect of two hamstring strengthening programmes on hamstring muscle strength in Gaelic footballers. 26 Gaelic footballers were recruited and randomly assigned to one of two 4-week hamstring strengthening programmes, namely the hip extension exercise programme and the Nordic hamstring exercise protocol. Isokinetic hamstring and quadriceps strength were measured before and after the intervention.

Recruitment:

Participants were recruited from the local university sports clubs. Club chairpersons were asked to send an email to club players. Players interested in participating in the study expressed an interest by replying to the email. Potential participants were asked to attend a meeting where they had the study explained to them. Those who were interested were then assessed for inclusion and exclusion criteria.

Group allocation:

A four block randomisation method was used to allocate participants to the Nordic hamstring exercise protocol or the hip extension exercise protocol.

Interventions:

The Nordic hamstring exercise protocol or the hip extension exercise protocol

Testing procedure:

The isokinetic strength of the participants' hamstrings and quadriceps were recorded before and after the exercise intervention.

A 10 point visual analogue scale was used to record the level of muscle soreness experienced after each training session.

Eligibility Criteria:
Inclusion Criteria:

* male
* free from hamstring injury in the 6 months prior to the study
* currently playing Gaelic football at a varsity level on at least three occasions per week

Exclusion Criteria:

* history of a hip or knee injury in the 3 months prior to the study
* a history of anterior cruciate ligament rupture
* a history of involvement in a hamstring strengthening, injury prevention programme in the 3 months prior to the study.
Comparative Effects of Getting it Right Addressing Shoulder Pain and Rotator Cuff Strengthening Exercise Military Sports

This research will use a randomized clinical trial (RCT) method to get military athletes with rotator cuff tendinopathy. People will be chosen at random to either get the GRASP method or normal exercises for making the shoulder muscles stronger. The main things the investigator will look at are how bad the pain is how well the shoulder works and if they can go back to work or sports. Tests will be done at the start, right after a treatment, and later times to measure the short-term and long-term advantages of the treatments. This study's careful way of doing things aims to provide strong information for military sports medicine. It helps doctors in treating shoulder problems like rotator cuff tendinopathy.

The rationale for conducting this study lies in the critical need to address rotator cuff tendinopathy, a prevalent and debilitating issue among military athletes. The unique demands placed on military personnel, involving repetitive overhead tasks and rigorous training, contribute significantly to the higher incidence of rotator cuff problems. The impact of this condition on performance, readiness, and overall well-being in the military cannot be overstated.

In the end, the plan for this study wants to fix a gap in what we know right now about dealing with muscle problems in military sports players' shoulders. This study looks at the GRASP trial methods and compares them with standard rotator cuff exercises. It aims to improve treatments and help military staff be healthier and work better.

Eligibility Criteria:
Inclusion Criteria:

* People in the military who are between 18 and 50 years old.
* Active participation in sports activities for the military.
* Diagnosing rotator cuff tendon pain in medical practice.
* Basic shoulder movement within a certain range of motion.

Exclusion Criteria:

* History of shoulder surgery.
* Systemic inflammatory diseases.
* Disorders of the brain or mind that affect physical actions.
* Not being able to stick to the plan for later.
Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour

The purpose of this study is to investigate the effectiveness and safety of vaginally administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in induction of labour in nulliparous women.


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous
* Singleton at term pregnancy (\>36+6 weeks)
* Unfavourable cervix (Bishop score \< 6)
* Fetal cephalic position

Exclusion Criteria:

* Pre-term pregnancy (\<37 weeks)
* Multiple pregnancy
* Rupture of membranes
* Other than fetal cephalic position
* Intra-uterine growth retardation
* Severe pre-eclampsia
* Severe hypertension
* Previous cesarean section
Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD

This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI.

This is an open-label, multicenter, TMAI study with Levalbuterol HFA MDI in adult and pediatric subjects with asthma or COPD. Period I: One week, open-label, run-in period during which subjects must have asthma or COPD symptoms requiring use of, as needed, Levalbuterol HFA MDI(without TMAI) on at least half of the days \[4-12 actuations on a single day\]. Period II: Nine week, open-label period during which subjects will use the Levalbuterol HFA MDI with TMAI PRN. The total study duration for a subject will not exceed 10 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have a documented diagnosis of asthma or COPD for a minimum of 6 months.
* Subject must have stable baseline asthma or COPD and have been using a beta-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months.
* Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.

Exclusion Criteria:

* Female subject who is pregnant or lactating.
* Subject who has a history of hospitalization for asthma or COPD within 45 days.
* Subject with currently diagnosed life-threatening asthma or COPD, defined as a history of asthma or COPD episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior.
* Subject with supplemental oxygen use
* Subject with a history of cancer
* Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders that currently are not well controlled by medication.
* Subject with asthma with a greater than 10-pack per year history of cigarette smoking or use of any tobacco products within 6 months.