cyrilzakka/clinical-trials huggingface dataset:
Fasting Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg

The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose administered under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide, in a SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) tablet formulation with three different dosing conditions in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject aged 18-75 years (both inclusive) at the time of signing informed consent
* Body mass index of 18.5-29.9 kg/m\^2 (both inclusive)
* A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose of oral semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
* History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
* Not able or not willing to refrain from smoking or use of nicotine substitute products when staying at the clinical unit
* Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
* Previous gastrointestinal surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder, pancreas or intestinal resections. Exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic- and gastric endoscopy
Viscoat Versus Visthesia. A Comparative Study of Post-cataract Endothelial Cell Loss

Objective of this study is the comparative assessment of the beneficial impact of the Viscoat viscoelastic (OVD) and Visthesia OVD on endothelial cells and corneal edema following torsional-ip cataract extraction surgery.

Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA) in a consecutive-if-eligible basis. Eligibility criteria include diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale. By means of a custom computer randomization program all participants will randomly populate two study groups according to the OVD used (ie. viscoat or visthesia).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of senile cataract with stage 3 nuclear opalescence according to the - Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion Criteria:

* Endothelial cell count less than 1900,
* glaucoma,
* IOP-lowering medications,
* former incisional surgery,
* former diagnosis of corneal disease,
* diabetes or autoimmune diseases
Antibiotic Susceptibility of Conjunctival Bacterial Isolates From Refractive Surgery Patients

The purpose of this study is to determine the in vitro antibiotic susceptibility patterns of conjunctival bacterial flora isolated preoperatively from patients undergoing refractive surgery.

Laser in situ keratomileusis (LASIK) is the most commonly performed refractive surgical procedure for the correction of ametropia worldwide. Infectious keratitis, although rare, is a potentially devastating complication of LASIK, and it can lead to horrifying outcomes. Previous studies on antibiotic susceptibility of preoperative ocular bacterial flora focused primarily on intraocular surgeries with particular interests in endophthalmitis. This study was aimed at refractive surgeries with special interest in infectious keratitis after LASIK. Intraocular surgeries for cataract, glaucoma or retinal disease are performed mostly on aged patients at a large hospital on an inpatient or outpatient basis; however, most refractive surgeries are performed on young, healthy people in private clinics on an outpatient basis. The patient populations are therefore quite different between these two types of surgery. The aim of this study is to determine the in vitro antibiotic susceptibility patterns of conjunctival bacterial flora isolated preoperatively from patients undergoing refractive surgery at an outpatient laser surgery clinic. Preoperative conjunctival swab samples are directly inoculated in culture media at the bedside before topical anesthetic or antibiotic application. Blood agar, chocolate agar, thioglycolate broth, Sabouraud dextrose agar, and Ogawa media are used for bacterial, fungal and mycobacterial cultures. Minimum inhibitory concentrations (MICs) of ofloxacin (OFX), levofloxacin (LEV), gatifloxacin (GAT), moxifloxacin (MOX), gemifloxacin (GEM) and other commonly used antibiotics are determined using an E-test.

Eligibility Criteria:
Inclusion Criteria:

* Myopia patients scheduled for refractive surgery

Exclusion Criteria:

* Active keratitis
* Current treatment of antibiotics (systemic or topical)
Effectiveness of a Group Intervention to Promote Health Through a Clinical Trial

Objectives

Main objective: Assessing the effectiveness of the health workshops, in terms of quality of life.

Secondary: To determine the effectiveness of the health workshops in relation to: Increase knowledge of healthy habits (physical activity, diet), incorporate and maintain a balanced diet. Incorporate and maintain regular physical activity; Keep variables related to risk factors (BP, Weight, Cholesterol) within normal limits, reduce cardiovascular risk (RCV). To estimate costs.

Methodology

Design: randomized controlled trial comparing a group of patients who performed the health workshops with a control group with similar characteristics.

Scope of the Study: The study was conducted in 54 health centers of Barcelona city.

Subjects of study: general population between 18 and 65 years who consent to. 188 people with speech (have conducted workshops for health) and 188 people without (not made health workshops. Data Analysis: T- test to compare the differences between quantitative variables or equivalent non-parametric if the distribution of the variable does not meet criteria of normality (Kolmogorov-Smirnov).

This is the evaluation of an educational activity to promote health in the general population in order to establish healthy habits and changes in quality of life.

We have designed a proposal for a workshop aimed at general public health which includes biological, psychological, social, cultural and spiritual health related and welfare. It is structured in 12 sessions that will provide tools that facilitate the involvement of people in maintaining their health.

Content of the sessions: Breathing and Snuff. Food. Disposal. Physical activity. Sleep and rest. Appropriate clothing. Hygiene. Avoid danger. Communicate feelings and emotions. Feel useful. Recreational activities. Each participant is given a folder and at the end of each session a summary sheet of the same with the aim that at the end of the course have a reference material.

To validate this material is piloted with the participation of 13 persons. Participants completed the SF36 questionnaire at the beginning and end of the workshop.

Eligibility Criteria:
Inclusion Criteria:

* General population between 18 and 65 years who consent to participate.

Exclusion Criteria:

* Difficulty to maintain their participation for 12 months.
* Difficult to understand and speak Catalan or Spanish language.
* Severe mental health problems.
* Other health problems that their participation was not appropriate or fail to follow up planned (terminally ill, serious organic disease).
Efficacy of a Pragmatic Intervention to Improve Adaptation to Context and Interlocutor

Patients with Developmental Language Disorder (DLD) or Autism Spectrum Disorder (ASD) have communicational difficulties to adapt their language to context and to interlocutors. These difficulties have long term impacts on education and social life of these patients. Speech language therapists (SLT) helps child and teenagers with pragmatic and communicational disorders. Nevertheless, few research evaluated the efficacy of such interventions.

In the present research, the students will do a literature review to identify efficacy intervention's strategies of pragmatic disorders. Then, 2 to 5 patients, aged from 8 to 14 years old, with ASD or DLD and pragmatic disorders, and who haven't intellectual disorder will be recruited. They will come to the faculty of psychology of UCLouvain before the beginning of the intervention. In this pretest session, parents will answer questionnaires et children will have tests in order to evaluate their pragmatic abilities (during 30 minutes), like conversations, role plays, communication referential tasks, etc. This evaluation will be video recorded to code pragmatic abilities. Then, a group intervention of ten sessions will be proposed (1 session per week, 10 weeks). Activities will include role plays, conversations, etc. At the end of the intervention period, a post test session, like the pretest session, will be proposed to evaluate intervention efficacy.

The design is multiple study cases. This is the best design to control efficacy of these kind of interventions considering the inter-individual variability of DLD and ASD patients. This study is original since few research evaluated the efficiency of pragmatic intervention. Some studies demonstrated the efficacy of pragmatic intervention in DLD and ASD patients but theses researches were conducted in English-speaking countries. Furthermore, the present research will propose a group intervention, which weren't proposed in the literature to our knowledge (individual intervention). If the group intervention is efficacy, the cost-benefice ratio would be interested.


Eligibility Criteria:
Inclusion Criteria:

* diagnostic of ASD or DLD
* pragmatic difficulties

Exclusion Criteria:

* intellectual deficiency
A Study of LY3537031 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3537031 in healthy participants. The blood tests will be performed to check how much LY3537031 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3537031. Each participant will receive a single dose of LY3537031 or placebo. The study will last up to approximately 71 days for each participant, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female not of childbearing potential
* Have a body mass index (BMI) between 19 and 35 kilograms per square meter (kg/m²) and a body weight ≥ 54 kilograms (kg)
* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for blood sampling

Exclusion Criteria:

* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have a diagnosis or history of cancer or malignant disease within 5 years
* Have been treated with prescription and over-the-counter medications that promote weight loss within 3 months prior to screening
* Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive
* Have undergone any form of bariatric surgery
* Have previously completed or withdrawn from this study
* Are currently participating in or completed a clinical trial within the last 3 months
* Regularly use known drugs of abuse or with positive drug results
* Smoke \>10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during CRU admission
3D vs 2D HD Laparoscopy in Cholecystectomy

The 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Even though the 3D-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical point of view and no prospective randomized trials have been published. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system for cholecystectomy (LCC).


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

* Some other surgical operation planned during LCC
* Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis, previous cholecystitis)
* Operating surgeon experience less than 5 3D laparoscopy operations
The Efficacy of Using Far Infrared Radiation to Manage Muscular Dystrophies

The muscular dystrophies (MD) are a group of more than 30 neuromuscular disorders that are characterized by progressive skeletal muscle weakness, defects in muscle proteins and the death of muscle cells and tissue. This study will investigate the use of far infrared radiation for managing muscular dystrophies.

Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly cure these neuromuscular disorders.

Eligibility Criteria:
Inclusion Criteria:

* Persons with muscular dystrophies

Exclusion Criteria:

* None
Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?

Despite increasing interest in emergency manuals (EMs), relatively little is known about their effectiveness and limitations in the perioperative setting. Prior studies have been limited in that they evaluated EMs using crises that were tailor-made to match one of their chapters, and there has been minimal participation by attending surgeons and other experienced personnel. The Investigators' preliminary experience suggests less-than-expected EM use and suboptimal usage, which may be due to the simulation scenario falling "halfway between" two different chapters of the EM, raising the question of whether limitations were due to the EM content, team dynamics, or inadequate training in the EM use. In this randomized, prospective, two-center simulation-based study, the investigators utilize clinical scenarios specifically designed to observe the patterns of use and to test the limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen, clinical performance in situations that do not exactly match a specific chapter of that EM, and that EM usage patterns will identify both strengths and limitations of the tools and its implementation. The participating healthcare providers consisting of experienced surgeons, anesthesiologists, and nurses will be randomized into four experimental groups, each exposed to either a "specific" or "non-specific" simulation scenario, along with or without the availability of the EM. The major experimental endpoint will be how many "critical actions" each team performs, scored as the percentage of actions taken from a pre-determined list. The goal of this study is to improve EM content and use by understanding its limitations during interprofessional team-training simulations and to study whether EMs enhance or detract from clinical performance. This is especially a concern in situations that do not exactly match a specific chapter of the EM, such as cases that are vague and represent multi-factorial diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is to strengthen patient safety by providing guidance for improving EM content, use, and training protocols.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare providers (anesthesiologists, surgeons, nurses) participating in the crisis management curriculum at each participating simulation site

Exclusion Criteria:

* Those unwilling to be recorded during the simulation scenario
Testing a Digital Intervention for Adolescents

Teen participants (ages 13-17) will be randomly assigned to either an experimental (the Happify Teens digital platform), or a waitlist control group. The study includes an 8-week intervention period and a 1-month follow up period.

Teen participants (ages 13-17) will be randomly assigned to either the experimental group in which participants receive access to Happify Teens, a digital platform rooted in several therapeutic traditions that aims to improve wellbeing, or a waitlist control group. Both group conditions last 8 weeks. Participants assigned to the Happify Teens platform will have full access to the intervention, with featured tracks that focus on dealing with stress, worries and building skills for greater happiness. Participants assigned to the waitlist (control) condition will not have access to the Happify Teens platform for the full study period (12 weeks total). Participants in the waitlist control will receive access to Happify Teens after the full study period is complete (12 weeks). Perceived stress, rumination, and optimism will be assessed via self-report at baseline, end of the 8-week intervention, and at 1 month post intervention.

Eligibility Criteria:
Inclusion Criteria:

* 13-17 years of age
* US resident
* Perceived Stress Scale Score ≥ 10
* Ruminative Responses Scale Score ≥ 14
* Ability and willingness to complete study activities
* Willingness and access to using a digital intervention via mobile application or web browser

Exclusion Criteria:

* Current or past user of any Happify platform
* Non-US Resident
* Perceived Stress Scale Score \< 10
* Ruminative Responses Scale Score \< 14
NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures

This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.

This is an observational, prospective, nonrandomized open label, post-market clinical study, designed to evaluate the use a flexible intramedullary fixation device used in the treatment of fractures of the humerus. This is a multicentre trial.

Eligibility Criteria:
Inclusion Criteria:

* Humeral Fracture
* Surgical intervention can be performed within 14 days of injury (injury being Day 0 for this particular criteria)
* Fully functioning contralateral limb (e.g., hand, arm, shoulder)
* Age 18 years or older and skeletally mature

Exclusion Criteria:

* Intraarticular fractures or those involving shoulder or elbow of the index arm
* Pathologic fracture (e.g., tumor involvement, osteomalacia, etc.; osteoporosis is not an exclusion)
* Evidence of neurologic injury in the index arm, including compartment syndrome or radial nerve palsy
* Additional upper body injuries (e.g., upper extremity, abdominal, thoracic, neck or head injury) that may affect or inhibit the evaluation of the index or contralateral arm, shoulder, elbow, etc or would not allow the patient to follow or comply with appropriate post-operative regimens
* Any previous bodily injury or surgery that may interfere with function or evaluation of index or contralateral arm, shoulder, elbow, etc.
CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study

CHILDNEPH is a pan-Canadian project to observe clinical care for children with nephrotic syndrome. Previous studies have indicated that there is wide practice variation in how health care providers treat this remitting and relapsing disease of childhood. The disease mechanism is not yet understood, and long-term use of steroids can affect children's health. This study involves assessment of routine clinical care and establishing a long-term patient registry for children with nephrotic syndrome.

CHILDNEPH is an ongoing prospective longitudinal study of children with incident and prevalent nephrotic syndrome. Children are recruited from 12 centres across Canada and followed for at least 30 months. The project starting in August of 2013 with the goal of following 400 patients. Data is collected at enrollment, beginning and end of each relapse, semi-annual visits and end of study. Detailed prescription data is collected regarding glucocorticoids and all second line agents. All relapses are recorded with time to urinary remission of proteinuria.

The investigators are moving towards registry based trials to determine optimal treatment protocols for nephrotic syndrome with an overall goal to minimize glucocorticoid exposure, a patient priority.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with Nephrotic Sydrome at initial presentation, first or second relapse

Exclusion Criteria:

* unable to participate in English or French
* Nephrotic Syndrome is secondary to other disease
* Younger than one year old or older than 17 years
Study of MDX-010 in Stage IV Breast Cancer

This Phase II study is designed to treat patients who have been diagnosed with Stage IV Breast Cancer, which has progressed despite treatment with primary therapies, including hormonal therapy, chemotherapy, and antibody therapy. Thirty-three patients will be treated with the monoclonal antibody MDX-010. The initial antitumor activity profile of MDX-010 will be determined, as well as identification of the induction of any antitumor immunity following the MDX-010 treatment.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* diagnosed with Stage IV adenocarcinoma that has progressed despite previous therapy
* at least 18 years of age
* measurable disease defined by RECIST
* must discontinue any alternative therapy used to treat breast cancer at least 4 weeks prior to enrollment and agree to not use such therapies during the duration of the study (patients may continue to receive tamoxifen, bisphosphate therapy and trastuzumab)
* prior radiation must be completed at least 4 weeks prior to enrollment
* ECOG performance status of 0-2
* Negative pregnancy test
* Screening lab values must be met

Exclusion Criteria:

* must be disease free from other cancers for at least 5 years
* symptomatic or untreated brain metastases
* active or history of autoimmune disease
* active HIV, HTLV, HBV or HCV infection
* concurrent medical condition requiring the use of systemic corticosteroids, must be discontinued at least 4 weeks prior to enrollment
* prior therapy with anti-CTLA-4 antibody
* significant organ compromise, uncontrolled heart, liver, lung, or renal disease or other serious illness
* pregnancy or nursing