cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in healthy Japanese adult male participants in Part 2.

This is a double-blind (neither physician nor participant knows the treatment that the participant receives), randomized (the study drug is assigned by chance), placebo-controlled study (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial). The study consists of 2 Parts. In Part 1, three groups of healthy Japanese men and 3 groups of healthy Caucasian men will receive a single oral dose of JNJ-39439335 or placebo on Day 1. Each group will include 8 participants. The study duration of Part 1 for each participant is approximately 8 weeks: screening phase of up to 28 days prior to dose, treatment phase of 14 days, and a follow-up phase of 14 to16 days. In Part 2, three groups of healthy Japanese men will receive once-daily doses of either JNJ-39439335 or placebo for 21 days. Each group will include 12 participants. The study duration of Part 2 for each participant is approximately 11 weeks: screening phase of up to 28 days prior to dose, treatment phase of 21 days, and a follow-up phase of approximately 28 days. During the treatment phases, the participants will remain in the study unit. Blood samples and urine will be collected for drug concentration measurements and laboratory safety assessments.

Eligibility Criteria:
Inclusion Criteria:

* Japanese or Caucasian participants
* Nonsmoker
* Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive, and body weight not less than 50 kg
* Healthy on the basis of a physical examination, vital signs, hematology, coagulation, serum chemistry (including liver function tests) and urinalysis
* Willing to adhere to the prohibitions and restrictions specified by the study protocol

Exclusion Criteria:

* Oral temperatures \> 37.5 Celsius degrees
* Participants who have occupations or hobbies in which they are routinely exposed to situations in which they could sustain thermal burns
* Abnormal electrocardiogram (ECG) results
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
* History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
The Effect of Mandala Coloring Activity on Test Anxiety

This study aims to investigate the effect of mandala coloring activity on test anxiety of nursing students.

University life poses various challenges for students, such as being away from family, financial difficulties, and exam anxiety, which can increase stress levels. Test anxiety, a form of situation-specific anxiety, negatively impacts students' academic performance and well-being by reducing concentration and learning efficiency. The combination of theoretical and clinical demands in nursing education further amplifies stress, making it a particularly challenging field for students.

This study is a randomized controlled experimental research conducted between December 2, 2024, and January 13, 2025. The study population consists of nursing students enrolled in the Mental Health and Psychiatric Nursing course at a private university during the 2024-2025 academic year. Based on sample size calculations conducted using the G\*Power program, considering similar studies and measurement methods, it was determined that 26 students per group are required. Accounting for potential data loss, it is planned to conduct the study with a total of 62 students, 32 in each group.

Students will be informed about the research, and those who voluntarily agree to participate will complete a "Demographic Characteristics Form" and a pre-test using the "Test Anxiety Inventory." Subsequently, students will be randomly assigned to the intervention and control groups in a 1:1 ratio using a random numbers table, with 31 students in each group. Students in the intervention group will be provided with mandala templates and coloring materials. They will be asked to color for 15 minutes twice a week over a two-month period. Email reminders will be sent to the students about the coloring sessions, and they will submit their completed mandalas to the researchers every Friday. Students who fail to complete two consecutive coloring sessions will be excluded from the study. Thirty minutes before the exam, the "Test Anxiety Inventory" will be applied as a post-test, and the study will be concluded. The data obtained will be subjected to statistical analysis, and the process of writing the manuscript will follow.

Eligibility Criteria:
Inclusion Criteria:

* Being a student enrolled in the Mental Health and Psychiatric Nursing course at the selected private university.
* Proficiency in the Turkish language.
* Having no physical disability that would hinder coloring activities.
* Willingness to participate voluntarily.

Exclusion Criteria:

* Students with psychological diagnoses such as anxiety or depression.
* Students who do not fully complete the questionnaire/survey forms.
* Students who neglect mandala coloring for two consecutive sessions.
Impact of Smart Connected Insulin Pens on Quality of Life in Dependent Patients with Diabetes Using Continuous Glucose Measurement

Insulin-treated diabetes in dependent or institutionalized patients is often poorly balanced and continuous glucose measurement is underused. The purpose of this tudy is to know how smart connected insulin pens and continuous glucose measurement can improve insulin therapy practice in dependent and/or institutionalized patients?

Insulin-treated diabetes in dependent or institutionalized patients is often poorly balanced and continuous glucose measurement is underused. Current practice and my experience in diabetes show a misuse of insulin therapy by caregivers at home and in institutions. Studies on the elderly insulin-treated person living in institutions show, through continuous glucose measurement, frequent nocturnal hypoglycemia at 79%. The continuous measurement of glucose has also shown its interest in reducing hospitalizations for acute event and, permanently.

A norwegian study shows that hypoglycemic treatments are too frequently prescribed in nursing homes. Hospitalizations for severe hypoglycemia are often due to dose errors or unsupervised recommendations in people over 65 years.

Smart connected insulin pens have shown a benefit in the management of insulin therapy in patients living with type 1 diabetes, improving glycemic balance.

Study focuses on the identification of misuses of insulin therapy in dependent and/or institutionalized patients. A study of everyday life, we expect a decrease in dysfunctions in patients equipped with a continuous glucose measurement system and connected pens after advice given to their caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years patient with type 1 or 2 diabetes
* Treated with multiple insulin injections
* Equipped with a continuous glucose measurement system and smart connected insulin pens at least one month before
* Dependent on a health professional for treatment management.
* Subject informed of the study and not objecting to data collection.

Exclusion Criteria:

- Patient refusing study.
BONEBRIDGE Bone Conduction Implant in Adults

Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and effectiveness of the BONEBRIDGE implant.


Eligibility Criteria:
Inclusion Criteria:

* Adults, 18 years of age or older at the time of implantation
* Conductive or mixed hearing loss, defined as:
* Conductive hearing loss with pure-tone average (PTA) for bone conduction thresholds better than or equal to 25 dB at 500, 1000, 2000 and 3000 Hz
* Mixed hearing loss with PTA for bone conduction thresholds better than or equal to 45dB at 500, 1000, 2000, and 3000 Hz
* Air-bone gap greater than or equal to 30 dB at 500, 1000, 2000, and 3000 Hz
* Ability to benefit from amplification as defined by a monosyllabic (CNC) word score of 30% correct or better
* Bilateral BONEBRIDGE can be considered if the difference in PTA for bone conduction thresholds is 10 dB or less between the right and left ears
* Prior experience with acoustic or bone conduction hearing aids, unless candidate is unable to wear amplification for medical reasons
* Able to complete testing materials in English
* CT scan indicating the patient's anatomy is adequate to enable placement of the implant
* Ability to undergo general anesthesia
* Appropriate motivation and expectation levels
* Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria:

* Evidence that hearing loss is retrocochlear in origin
* Skin or scalp condition precluding use of external audio processor
* Suspected cognitive impairment or organic brain dysfunction
Relationship Between Vitamins Deficiency and Caries Experience Among a Group of Egyptian Children

Dental caries is a worldwide condition characterized by localized destruction of dental hard tissue by acidic by-products from bacterial fermentation of dietary carbohydrates . Dental caries is considered to be the single most common chronic childhood disease, and its prevalence is thought to have increased recently.

According to the World Health Organization "WHO", dental caries is considered a major health problem in most industrialized countries, where 60-90% of children and the vast majority of adults are affected by dental caries . Oral hygiene, salivary flow rate and unhealthy nutritional habits are considered as an etiologic factor of dental caries.

Vitamin deficiencies remain common globally. Unless severe, they are often clinically unrecognized, yet even mild deficiency may have significant adverse consequences. Vitamin deficiencies affect all ages. The groups most susceptible to vitamin deficiencies are pregnant and lactating women and young children, because of their relatively high needs for these compounds and susceptibilities to their absence. These include death from infectious diseases, anemia, death during pregnancy or childbirth, and impaired cognition and physical development. The effects of vitamin deficiencies are related to the biochemical roles they play .

Eligibility Criteria:
Inclusion Criteria:

* Children age range from 3 to 5 years.
* Parents acceptance for their children's participation in the study.

Exclusion Criteria:

* Children on long-term medication.
* Children undergoing orthodontic treatment.
Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.

This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.

Eligibility Criteria:
Inclusion:

* Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
* Adapted soft Contact Lens wearers (i.e. \>1 month), daily disposable and reusable lens wearers.
* Spectacle cylinder 0.75D in both eyes.
* Correctable to 6/9 (20/30) in both eyes
* Be between 18 and 50 years of age (inclusive)
* Able to read, comprehend and sign an informed consent
* Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
* Willing to comply with the wear and study visit schedule

Exclusion:

* Existing Biofinity or Ultra wearers
* Any active corneal infection, injury or inflammation
* Systemic or ocular allergies, which might interfere with Contact Lens wear
* Systemic disease, which might interfere with Contact Lens wear
* Ocular disease, which might interfere with Contact Lens wear
* Strabismus or amblyopia
* Subjects who have undergone corneal refractive surgery
* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
* Pregnant or lactating
* Use of systemic/topical medication contraindicating Contact Lens wear
* Diabetic
* Site employees or family members of site employees
A Study to Assess the Safety and Effectiveness of FLX-787 in Subjects With Charcot-Marie-Tooth Disease Experiencing Muscle Cramps.

The COMMIT Study will assess the safety and effectiveness of FLX-787 in men and women with Charcot-Marie-Tooth disease (CMT) experiencing muscle cramps. Participants will be asked to take two study products during the course of the study. One of these study products will be a placebo.

Approximately 120 participants in 20 study centers across the United States are expected to take part. Participants will be in the study for approximately 3 months and visit the study clinic 3 times.


Eligibility Criteria:
Inclusion Criteria:

* Presence of symptoms of CMT since at least 6 months prior to Screening, and confirmed diagnosis of CMT as defined by:

  1. Genetic confirmation of a mutation known to cause CMT, or
  2. Clinical and electrophysiological evidence of CMT and a genetic confirmation in a family member. Clinical features include length dependent sensory and motor loss, with sensorimotor axonal or demyelinating changes on a nerve conduction study.
* Weekly muscle cramping (defined as: a sustained muscle contraction that's most often painful and lasts seconds to minutes)

Exclusion Criteria:

* Presence of major gastrointestinal disorders, such as inflammatory bowel disease, diverticulitis, active peptic ulcer disease, or significant gastroesophageal reflux disease (i.e., not well-controlled on antacids or proton pump inhibitors), or oral or esophageal lesions/ulcers
* Presence of significant swallowing problems
* Unable or unwilling to discontinue medications for cramps and/or opiates
* Inability to tolerate a spicy sensation in the mouth or stomach
* Actively using illicit drugs or history of chronic substance abuse within the past year prior to screening, including abuse of alcohol
* Intention to change the current level of tobacco use or use of nicotine-containing products (i.e., new smokers or those actively trying to quit may not enrolled)
* Participated in a clinical study (except natural history studies without administration of an investigational product) within 30 days prior to screening
Smartphone Application Based Reminder Therapy in Orthodontic Patients

This randomized control trial was performed to asses the efficiency of smartphone application based reminder therapy on plaque control and oral hygiene at two points in time.

This randomized controlled trial was performed to assess the effect of the smartphone application based reminders for oral hygiene reinforcement on orthodontic patients. Methods: 60 orthodontic patients were randomly allocated to either control or experimental group (30 each). Experimental groups received reminders twice a day by a smartphone application. Plaque scoring was done by using Turesky modified Quigley-Hein plaque index (TMQHPI) at baseline(T0), after 2 weeks(T1) and after 6 weeks(T3). Results: Significant difference in plaque scores was found at T2(6 weeks), but no significant difference was found at T1(2 weeks). Conclusions: Active smartphone-based reminder therapy for oral hygiene maintenance during fixed appliance orthodontic treatment decreases the plaque scores in patients in medium to long term

Eligibility Criteria:
Inclusion Criteria:

- A total of Sixty (60) patients between 12-30 years of age undergoing fixed appliance therapy were included in the study. All the participants had to be in at least 4 weeks of active orthodontic therapy with fixed appliances in all the quadrants of the oral cavity. Further inclusion criteria were familiarity with smartphone and a personal smartphone with Android version ≥ 6.0 or iOS version ≥ 10 operating system, good general and dental health (no active caries, no advanced gingivitis, or periodontitis needing periodontal therapy), with no history of smoking or any other form of tobacco use, no antibiotic or chlorhexidine containing mouth rinses used within two weeks of screening.

Exclusion Criteria:

- Patients with prosthesis in the mouth and those taking antibiotics, anti-epileptics, anti-hypertensives and immunosuppressive medications were excluded from the study.
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance

The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.

Study participants will be followed up, under existing protocol derived from a study protocol developed by the "Union internationale contre les maladies respiratoires" and carried out already in 9 Africans countries. Participants will be hospitalised for at least four month, period which they will be given treatments, assessed for adverse events, monitored for TB-MR strains using culture techniques, at the monthly basis. If patients found with negative sputum culture at month four they will be dischrged from the hospital, and then treated four an additional five montns and then follow up, clinically and biologically for an additional six months before being declared as cured.

Eligibility Criteria:
Inclusion criteria:

* Aged 15 years and above
* Never been treated with second line anti-TB drugs for more than one month,
* Give written consent to participate
* Agree to be hospitalised for at least four months in specialised healthcare
* Willing to adhere to ambulatory directly observed treatment by a healthcare worker;

Exclusion criteria:

* Pregnant during inclusion process
* Presented with altered clinical status condition as judged by the clinician
* Knowing of history of hypersensitivity reaction to any of the drugs to be used
* Baseline ECG does not show a QT space superior to 500ms
* Refusal to participate into study.
The Effect of an Ergonomic Educational Intervention on Laparoscopic Surgeons' Ergonomic Risk Scores (ErgoEd)

This study aims to determine whether education of surgeons can reduce the physical strain of performing surgery. Laparoscopic surgery is known to be beneficial for patients but can cause both short- and long-term musculoskeletal injuries for the surgeons who perform it. The purpose of the study is to investigate whether the physical risks to surgeons can be reduced by educating them on how to best set up the operating theatre and equipment, and how to optimise their posture and position whilst operating.

This study has been designed to assess whether receiving education in ergonomic principles can lower surgeons' ergonomic risk scores when performing laparoscopic surgery. The study will recruit surgeons who regularly perform laparoscopic surgery, with no stipulations on surgeon speciality. All surgeons will be required to have completed at least 20 laparoscopic cases beforehand.

The primary outcome will be assessed intraoperatively, with additional questionnaire data collected immediately postoperatively. Assessment of ergonomics (REBA score) will be done from still photographs that focus on the operating surgeon, although other team members may be visible in the background. Photographs will be analysed postoperatively by the research team and an overall REBA score calculated for each surgeon.

Other secondary outcomes will be assessed via a questionnaire. After each operation surgeons will complete a subjective cognitive and physical strain questionnaire based on the NASA-TLX and SURG-TLX scales, which are both widely used and validated tools. Additional questions have been added in order to provide data for the development of a new subjective physical strain questionnaire based on pooled data from several surgical ergonomics trials.

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic surgeon from any surgical subspecialty
* Can commit sufficient time to ergonomic training

Exclusion Criteria:

• Training grade more junior than a registrar
Study Evaluating the Effect of IMA-026 on Allergen-Induced Late Asthma Response in Mild Asthma

The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a screening period and a treatment period which includes doses on day 1 and day 8.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women 18 to 60 yrs with mild allergic asthma
2. only asthma med is short-acting bronchodilator used not more than twice weekly
3. FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction

Exclusion Criteria:

1. Upper respiratory infection or asthma exacerbation with 4 weeks of screening
2. Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration
3. Positive radiographic findings indicative of respiratory disease other than asthma
Preoperative IV Versus Oral Acetaminophen

The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.

This study will use a randomized, double-blind, controlled design with two arms:

Arm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively

120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia

Exclusion Criteria:

* Allergy to Acetaminophen
* Lactose intolerance or lactose allergy (placebo capsules contain lactose)
* Hepatic disease
* Having taken a product containing acetaminophen within 6 hours of scheduled surgery time
* Pregnant
* Weight less than 50kg
* Opioid addiction - admits to current opioid addiction and/or substance abuse disorder, and/or currently in treatment for opioid addiction or substance abuse
* Emergent or on-call procedures
* Inpatient surgery
Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device

Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 14 years old
* Benign tracheoesophageal fistulas identified through bronchoscopy;

Exclusion Criteria:

* Malign neoplasia
* Current mechanical ventilation
* Immunosuppressed
* Current local inflammatory process at fistulas borders
* Other clinical risk factors