cyrilzakka/clinical-trials huggingface dataset:
Effect of Laser-aided Csf on the Rate of Leveling and Alignment of Mandibular Anterior Crowding

To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment


Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for orthodontic treatment 18-25 years
* full permanent dentition (not necessarily third molars)
* mandibular anterior crowding
* no visible anomaly of enamel
* good oral hygiene

Exclusion Criteria:

* patients with mandibular anterior teeth with advanced caries, prosthetic restorations or dental anomalies
* patients with dentofacial deformities or medical problems
* patients indicated for extractions as a part of orthodontic treatment
* patients with severe mandibular gingival inflammation/periodontitis
* pregnant female patients
* patients with previous orthodontic treatment
* patients with previous mandibular extractions except third molars
* patients taking medications that could alter orthodontic treatment
* patients with clefts,syndromes, systemic diseases
Acetic Acid 2% Solution for Skin Ulcers

The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).

Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Continued care (hospital or outpatient) in one of the Consorci Sanitari Alt Penedes i Garraf (CSAPG) units.
* Presence of a cutaneous ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region).
* Plan to undergo treatment and follow-up of the lesion (at least 8 weeks) at the study center.
* Ability to cooperate in necessary evaluations.
* Informed consent for inclusion in the study, either from the participant themselves or from their legal representative.

Exclusion Criteria:

* Participants diagnosed with any of the following conditions:

  1. Ulcers with exposed bone tissue.
  2. Neoplastic-origin ulcers.
  3. Ulcers lasting more than 18 months.
* Participation in another clinical trial involving an experimental intervention during the period of the current trial and/or establishing a visit frequency incompatible with the current trial.
A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants

The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females
* Have body mass index between 18.5 and 29.9 kilograms per meter square (kg/m\^2)
* Are nonsmokers and have not smoked for at least 2 months prior to entering the study
* Have normal blood pressure and pulse rates at screening
* Have electrocardiograms (ECGs) at screening considered as within normal limits
* Have clinical laboratory test results within normal reference ranges

Exclusion Criteria:

* Are currently enrolled in or discontinued within the last 30 days from a clinical study involving an investigational drug or device or are concurrently enrolled in any other type of medical research
* Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases
* Show evidence of current use of known drugs of abuse or a history of use within the past year
* Have a history of first-degree relatives known to have diabetes mellitus
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
* Have positive hepatitis B surface antigen at screening
* Intend to use over-the-counter or prescription medication within 7 or 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement medication, or birth control methods)
* Have donated or had a blood loss of 450 milliliters (mL) within 3 months prior to study enrollment
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption from 24 hours prior to each dosing until discharged from the clinical research unit (CRU)
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum.

Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of tinea capitis confirmed by positive KOH determined by the central mycology laboratory.
* Male or female patients who are at least 4 years old and no more than 12 years old.

Exclusion Criteria:

* Patients having a medical condition that alters the absorption and/or metabolism of terbinafine (e.g. liver, renal disease etc.)
* Patients receiving medication that may interfere with the evaluation of the drug's effect
* Patients who have kerions requiring immediate treatment or treatment with systemic corticosteroids and/or systemic antibiotics
* Patients with a history of liver disease or current/active liver disease or with elevation of livery enzymes outside of the normal range corresponding to their age
* Patients who have received recent systemic or topical treatment for tinea capitis within the specified time periods (e.g. systemic antifungals within 2 months of screening visit, topical treatments \[e.g. antifungals, corticosteroid preparations, zinc pyrithione or selenium sulfide or tar containing products\] within 1 week of screening).
* Patients with a history of systemic lupus erythematosus
The MARY-JANE Cannabis and Heart Rhythm Trial

Despite recreational cannabis now being legal in 23 states, where more than 100 million Americans reside, studies on the actual health effects are limited. This study is a randomized trial, where each participant will be instructed to consume or avoid cannabis on randomly assigned days during a 14-day monitoring period. The goal of this study is to answer the question:

"Does cannabis use increase the frequency of 'early' and abnormal heart beats?"

During the 14-day period, participants will wear an external heart monitor, a glucose monitor, and a fitness tracker to track heart rhythm, glucose levels, step counts, and sleep health. Participants will use a mobile app or a text messaging service for daily instructions/reminders on cannabis use, and short surveys. The investigators ask that participants smoke or vape cannabis at least once on days they are instructed to consume cannabis. Compelling evidence of heart and other health effects would be important to the clinical care of our patients.

This study is designed as a case-crossover randomized trial, where each participant will be instructed to consume or avoid inhaled cannabis on randomly assigned days during a 14-day monitoring period. Participants will be asked to smoke or vape cannabis at least once on days they are instructed to consume cannabis. Participants will also wear an external electrocardiographic (ECG) monitor, a continuous glucose monitor, and a fitness tracker for up to two weeks while utilizing a mobile application or text messaging service to receive daily instructions/reminders on cannabis use, and short surveys. The investigators will compare participant self-report of cannabis consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the relationship between acute cannabis consumption and heart rhythm changes. A total of 100 participants will be enrolled at the UCSF study site.

Eligibility Criteria:
Inclusion Criteria:

1. Are age 21 or older
2. Have a smartphone
3. Are able to use the Eureka mobile application and Mosio text messaging software
4. Have inhaled cannabis in the past month and on at least four different days in the same week in the past year
5. Are willing to consume and abstain from inhaled cannabis for no more than two consecutive days as instructed over the 14-day trial period

Exclusion Criteria:

1. Currently pregnant or trying to get pregnant
2. Have a medical reason to avoid cannabis
3. Are unwilling to avoid all forms of cannabis consumption on days instructed to abstain from cannabis
4. Are currently taking anti-arrhythmic medications
5. Have a history of atrial fibrillation or heart failure
6. Have congenital heart disease
7. Have an implantable cardioverter-defibrillator or pacemaker
8. Have had a previous cardiac ablation procedure
Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials

To allow continuation of axitinib (AG 013736) treatment to patients experiencing clinical benefit in a closing axitinib trial

This is a roll over study aimed to provide continued access to axitinib (monotherapy or combination, according to treatment received in prior axitinib study) to patients who have documented stable, or responding disease, or received clinical benefit (as defined by protocol) at the time of the prior study closure.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were assigned to an axitinib (AG-013736) containing treatment arm in a previous clinical trial
* Patients who were receiving axitinib (AG-013736) tablets at the time their previous trial ended
* Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response criteria from the previous axitinib (AG-013736) protocol should be used to determine stable or responding disease).
* Patients who have progressive disease (PD) but have experienced "clinical benefit" as defined in the study protocol

Exclusion Criteria:

* Patients may not participate in this trial if the conditions for continuing treatment in the previous axitinib (AG-013736) protocol are not met
Optimization of Guidance in a Digital Tool for Problematic Alcohol Use

The purpose of the study is to evaluate the effects on alcohol consumption, and the consumption of time spent by a qualified clinician, by adding different forms of guidance to a digital intervention based on an alcohol diary and techniques from cognitive behavioral therapy and relapse prevention. The participants will be adults with problematic alcohol use. The trial will be a 2\*2 factorial experiment where written guidance and/or an extra mid-treatment telephone interview will be added to the basic digital intervention, by randomization. The randomized factorial experiment will create four equally large groups (1:1:1:1) who will receive different combinations of added guidance. Main outcome will be effects on alcohol consumption. Effects on alcohol consumption will also be combined with clinician time spent on guidance to assess the resource-effectiveness of added forms of guidance.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Access to internet
3. ≥8 points for men and ≥6 points for women on Alcohol Use Disorders Identification Test (AUDIT)

Exclusion Criteria:

1. Insufficient knowledge of the Swedish language
2. Difficulties reading or writing related to a digital intervention.
3. Other ongoing psychological treatment with a content similar to that in the current study (problematic alcohol use).
4. High suicide risk based on telephone assessment.
5. Other urgent need for more intensive psychiatric care, or addiction care services, based on telephone assessment.
Randomised Controlled Trial (RCT) of 6 Versus 3 Steps for Hand Hygiene

The aim is to compare the effectiveness of the 6 step hand rub technique versus 3 step hand rub technique in hand coverage and in reducing bacterial contamination on the hands of healthcare workers in practice.

Research questions

1. What is the effectiveness of the 6 step technique in hand coverage compared to the 3 step technique?

   1. What are the most frequently missed sites in hand surface coverage using 6 steps compared to 3 steps?
   2. What is the reduction in bacterial contamination of the hand with the 6 step compared to the 3 step technique?
2. Does site missed or coverage relate to bacterial load?
3. What is the time taken for 6 step technique versus 3 step technique?

The 6 step for decontamination of healthcare workers hand is recommended by the World Health Organization but the 3 step technique is easy to perform and has been shown by some studies to be effective. Compliance with the 6 step technique is not optimum. If the 3 step was more as or more effective than the 6 step compliance with it could be compared with that for the 6 step. No randomised controlled trial comparing the effectiveness of these two techniques using alcohol based hand rub has been conducted.

Eligibility Criteria:
Inclusion Criteria:

* Medical and nursing staff performing a clinical procedure

Exclusion Criteria:

* A procedure requiring use of gloves
* A self declared active skin condition
Quantitative Evaluation of the Progression of Liver Disease, Using ShearWaveTM

Liver biopsy for the assessment of fibrosis has multiple limitations. Liver ShearWaveTM Elastography may provide a non-invasive, fast, and reproducible alternative for the quantitative assessment of liver fibrosis.

To obtain a quantitative evaluation of the progression of liver disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine.

To compare the glomerular filtration rate and the quantitative evaluation of the progression of renal disease, using ShearWaveTM Elastography measurements obtained with the Supersonic Imagine Aixplorer ultrasound machine in post-liver transplantation patients.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females over the age of 18
* Patients of Liver Consultant's of Texas Dallas office, with chronic liver disease or liver transplant patient seen in Liver Transplant Clinic
* Patients diagnosed with heart failure

Exclusion Criteria:

- Any person unable to provide an informed consent
Fed Study of Finasteride Tablets 5 mg and Proscar® Tablets 5 mg

The objective of this study was to investigate the bioequivalence of Mylan's finasteride 5 mg tablets and Merck's Proscar® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years and older
2. Sex: Male During the course of the study, from study screen until study exit, male volunteers must use a spermicide-containing barrier method of contraception to prevent the pregnancy of their sexual partner. This advice should be documented in the informed consent form.
3. Weight: At least 60 kg (132 lbs) and all subjects within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B, Hepatitis C and HIV tests, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Exclusion Criteria:

1. Institutionalized subjects will not be used.
2. Social Habits:

   1. Use of any tobacco products within one year prior to dosing.
   2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
   3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
   4. Any recent, significant change in dietary or exercise habits.
3. Medications:

   1. Use of any medication within the last 14 days prior to the initial dose of study medication, including over-the-counter medications.
   2. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
4. Diseases:

   1. History of any significant chronic disease and/or hepatitis.
   2. History of drug and/or alcohol abuse.
   3. Acute illness at the time of either the pre-study medical evaluation or dosing.
   4. A positive HIV, Hepatitis B, or Hepatitis C test result.
5. Abnormal and clinically significant laboratory test results:

   1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
   2. Abnormal and clinically relevant ECG tracing.
6. Donation or loss of a significant volume of blood or plasma (\> 450 mL) within 28 days prior to the initial dose of study medication.
7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
8. Allergy or hypersensitivity to finasteride or other related products.
9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
The Effect of ShotBlocker on Pain and Satisfaction During Measles-Rubella-Mumps Vaccination

Objective The aim of this study was to evaluate the effects of ShotBlocker administration during measles-mumps-rubella (MMR) vaccination on infants' pain level and mothers' satisfaction.

Method. The study was conducted in a Family Health Center affiliated to the Public Health Directorate of a province in eastern Turkey between August and October 2024 using a randomized controlled experimental design. The study sample consisted of 60 infants who received MMR vaccination (ShotBlocker group: n = 30, control group: n = 30). Infants in the ShotBlocker group received ShotBlocker before vaccine injection, while infants in the control group received only routine vaccine injection. Infant information form, FLACC pain scale and Newcastle Satisfaction with Nursing Care Scale were used for data collection. Ethical principles were followed throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* He's 12 months old,
* MMR vaccine will be administered,
* growth-development is normal,
* no analgesic medication was given during the day,
* at least high school graduate
* mothers who volunteered to participate in the study

Exclusion Criteria:

* Neurological disease,
* a chronic disease,
* allergy (egg allergy)
* infants with symptoms of hyperthermia
The Effect of Mandala Coloring on Depression, Anxiety and Quality of Life of Inpatients in a Psychiatric Clinic

The aim of this study is to examine the effects of mandala coloring activity applied to individuals hospitalized in a psychiatric clinic with a diagnosis of anxiety and depression disorder on quality of life, psychological resilience and depression, anxiety and stress levels.

Introduction: It is stated that healthcare professional-patient interaction and patient activity improve clinical outcomes for patients with mental illness. When compared to psychosocial interventions, the most commonly used method in 49% of clinics was found to be artistic practices. It is stated that mandala painting has a calming and healing effect on the individual, facilitating psychological integration and personal meaning in life.

Objective: The aim of this study is to examine the effects of mandala coloring activity applied to individuals hospitalized in a psychiatric clinic with a diagnosis of anxiety and depression disorder on quality of life, psychological resilience and depression, anxiety and stress levels.

Method: The research will be conducted using a randomized controlled experimental research design. The research sample will consist of 50 patients in a university hospital psychiatry clinic. Research data will be collected using the Introductory Information Form, Depression-Anxiety-Stress Scale Short Form, Quality of Life Scale (SF-12), and Brief Resilience Scale. Patients diagnosed with anxiety and depression will undergo 8 sessions of mandala application. Data will be collected in two time periods before starting the mandala application and at the end of the 8-session application.

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the study
* Being 18 years of age or older
* Diagnosed with anxiety and depression disorder

Exclusion Criteria:

* Those who gave incomplete answers to the scales used in the study
* Those with serious psychiatric symptoms (e.g. harming themselves or others, sedation)
* Those who did not participate in the mandala coloring session
* Those who did not agree to participate in the study
Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)

Observational study of patients at Boston Childrens Hospital with type 1 diabetes (T1D) who elected to treat their diabetes with the Medtronic 670 G hybrid closed loop insulin pump.

Outcome study of 90-100 patients with type 1 diabetes who elected to use the Medtronic 670G.

Major outcome measure was to assess the percent of patients who were able to successfully continue to use the 670G technology over time.

Additional outcome variables included hemoglobin A1c pre and post treatment with the 670G, time in desired glucose range 70-180.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of T1D
* patient of Boston Childrens Hospital diabetes program
* deemed to be adequate candidates for hybrid closed loop technology by their diabetes health care team
* patient received Medtronic 670G training at Boston Childrens Hospital
* patient received follow up diabetes care at Boston Childrens Hospital for at least 3 months after starting on the 670G

Exclusion Criteria:

* patients not trained at Boston Childrens Hospital or self started
Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)

This is a single center collection of discarded biological samples and electronic medical review (EMR) data on patients who are hospitalized with clostridium difficile infections and treated with Fidaxomicin

This single site study will be a clinical research data base of patients hospitalized and diagnosed with Clostridium difficile infection (CDI), treated with Fidaxomicin and willing to allow us to collect discard biological samples for testing and analysis in the investigators lab. An additional blood sample will be obtained if a clinically indicated bronchoscopy is performed as to measure the amount of medication in the BAL. We will also complete a medical record review will also occur.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age
2. Currently an inpatient at UPMC Presbyterian
3. Diagnosed with an CDI
4. Being treated with Fidaxomicin

Exclusion Criteria:

not meeting entry criteria