louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04531761: Evaluating the Efficacy of the Parent Support Program
Official title: Evaluating the Efficacy of the Parent Support Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prejudice
Gender Identity
Knowledge, Attitudes, Practice
Keywords: transgender
trans youth
parental acceptance
parental support
LGBTQ
Lead sponsor: Palo Alto University
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
First posted: 2020-08-28
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of the study is to evaluate the efficacy of an online intervention (the Parents Support Program) aimed at increasing supportive behaviors among parents of transgender youth. The intervention consists of three modules that include a variety engaging activities such as social perspective taking exercises, writing prompts, videos of parents, youth, and experts, and psycho-educational materials. The study uses an experimental design with a waitlist control. Both the experimental and control groups will complete a pre-test, one month follow up, and two month follow up survey. Targeted outcomes include knowledge about gender diversity, attitudes about trans youth, and supportive parenting behaviors.


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older.
* Must live in the United States.
* Must be comfortable communicating in English.
* Must be a parent of a trans child between the ages of 10 - 24.

Exclusion Criteria:

* Participants who participated in pilot study or focus groups related to this project.

Primary outcomes:
measure: Trans-supportive behaviors scale
timeFrame: One month
Secondary outcomes:
measure: Attitudes Toward Trans Youth Scale (ATTYS - Birnkrant, 2018)
timeFrame: One month
measure: Objective knowledge about gender diversity
timeFrame: One month
measure: Subjective knowledge about gender diversity
timeFrame: One month
measure: Self-compassion
timeFrame: One month
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto University
state: California
Study officials:
affiliation: Palo Alto University
name: Em Matsuno, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05688111: Tranexamic Acid as an Intervention in Placenta Previa
Official title: Tranexamic Acid in Pregnant Women With Placentae Previa: A Double-blind, Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interventional Drug in Placenta Previa
Keywords: Placenta previa
Tranexamic acid
intervention
Double blind
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization for both groups to the 2 groups will be done using Randomization Allocation Software program and whom will add the numbers on each syringe will be a pharmacist not involve in the study and will have the cods belong to the type of the intervention with him until the end of the research .

Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
Primary purpose: TREATMENT

Brief summary: Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women

Detailed description: Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.

Eligibility criteria: Inclusion Criteria:

* Pregnant at 28 weeks gestation and more
* Vaginal bleeding due to placenta previa
* Stable hemodynamically
* Accept to participate in the trial

Exclusion Criteria:

* Hypersensitivity to tranexamic acid
* Acquired defective color vision
* History of venous thromboembolism
* Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease)
* Smokers
* Refused to participate in the trial

Primary outcomes:
measure: To stope or decrease vaginal bleeding
timeFrame: Up to time of delivery
measure: Prolong pregnancy to 36 weeks
timeFrame: Up to delivery of the fetus
measure: Favorable perinatal outcome
timeFrame: 7 days post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Ariana kh. Jawad
state: Kurdistan Region
city: Erbil
country: Iraq
facility: Kurdistan Board for Medical speciality
state: Kurdistan Region
Study officials:
affiliation: Hawler Medical University
name: SHAHLA K ALALAF, prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kurdistan Higher Counsel of Medical Specialties
name: Ariana Jawad, professor
role: STUDY_DIRECTOR
affiliation: karkuk Medical college
name: khalida Amin, Ass. Prof
role: STUDY_CHAIR
References:
Clinical trial NCT00176111: Effects of Local Anesthetic or Saline Solution on Peripheral Nerve Stimulation - a Randomised Study
Official title: Effects of Local Anesthetic or Saline Solution on Peripheral Nerve Stimulation - a Randomised, Double-Blind, Multicenter Study About the Stimulability of Anesthetized Nerves
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Percutaneous Electric Nerve Stimulation
Keywords: peripheral nerve stimulation
saline
local anesthestics
regional anesthestia
nerve damage
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Rechbergklinik Bretten
First posted: 2005-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study we want to examine the effect of a small amount of local anesthetic or saline solution on nerve conduction using a peripheral nerve stimulator.

Detailed description: Using electrical nerve stimulation in performing peripheral nerve helps to control the needle position in relation to the nerve and therefore may increase the likelihood of a successful nerve block. Defining the minimal stimulating current accepted also may help to avoid direct contact between nerve and needle or accidental endoneural injection and subsequent nerve lesion.

In recent years there have been many reports where several nerves, parts thereof or plexuses have been anesthetised using a multiple injection approach. That is, nerves in close proximity of each other have been subsequently blocked after using a nerve stimulator to locate them.

It is not clear though, whether a nerve may already be partially anesthetised in this situation and whether that would impair the correct use of a peripheral nerve stimulator.

The aim of this study is to examine the excitability of a peripheral nerve after injecting a small amount of local anesthetic agent or saline solution into the proximity of the nerve.

Eligibility criteria: Inclusion Criteria:

ASA 1-2

Exclusion Criteria:

peripheral neuropathy, ASA \>2

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bretten
country: Germany
facility: Rechbergklinik
state: Baden Wuerttemberg
Study officials:
affiliation: Rechbergklinik Bretten
name: Heinz Kaiser, MD
role: STUDY_CHAIR
References:
citation: Neuburger M, Gultlinger O, Ass B, Buttner J, Kaiser H. [Influence of blockades with local anesthetics on the stimulation ability of a nerve by peripheral nerve stimulation. Results of a randomized study]. Anaesthesist. 2005 Jun;54(6):575-7. doi: 10.1007/s00101-005-0824-3. German.
Clinical trial NCT03010111: Latent Tuberculosis Infection in Korean Health Care Workers
Official title: Latent Tuberculosis Infection in Korean Health Care Workers Using Interferon Gamma Releasing Assay
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Latent Tuberculosis
Keywords: Latent Tuberculosis
Interferons
Tuberculosis
Healthcare
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean health care workers.

Detailed description: Further study details as provided by Hanyang University Hospital

Eligibility criteria: Inclusion Criteria:

* Health care workers in University affiliated hospital
* Adult aged 20-65

Exclusion Criteria:

* Active tuberculosis
* Subjects diagnosed with HIV infection, malignancy
* Subjects having immunosuppressive drug therapy

Primary outcomes:
measure: Percentage of latent tuberculosis infection developed in Korean health care workers
timeFrame: Three months
Secondary outcomes:
measure: Annual incidence of latent tuberculosis infection in Korean health care workers
timeFrame: 1 year after first QFT-IT test (12-15 months)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
Study officials:
affiliation: Hanyang University Hospital, Seoul, Korea
name: Jang Won Shon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06553911: Exploring the Application Efficacy of Artificial Intelligence (AI) Diagnostic Tools in Medical Imaging (MI) of Respiratory(R) Infectious (I) Disease (D)
Official title: Exploring the Application Efficacy of Artificial Intelligence (AI) Diagnostic Tools in Medical Imaging (MI) of Respiratory(R) Infectious (I) Disease (D)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Infectious Diseases
Artificial Intelligence
Medical Imaging
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The early identification and severe warning of acute respiratory infectious diseases are of paramount importance. Utilizing effective means to make correct diagnoses of the source of infection at an early stage is the premise of all effective measures. AI-MID is a research initiative that uses artificial intelligence tools to assist in the clinical medical imaging diagnosis of respiratory diseases, aiming to reduce the time doctors spend reviewing images, increase work efficiency, and enhance the sensitivity and specificity of pneumonia detection, thereby improving the detection rate of pneumonia at the grassroots level. This approach facilitates precise prevention, accurate diagnosis, and precise treatment.


Eligibility criteria: Inclusion Criteria:

1. 1-90 years old, gender not specified.
2. Exhibits symptoms of respiratory tract infection
3. Must have etiological examination results
4. Must have imaging data;

Exclusion Criteria:

1. Severe artifacts in medical images
2. Clinical diagnosis indicates concurrent pulmonary edema
3. Dual review results in unclear diagnosis or potential misdiagnosis
4. Other situations that may cause difficulties in reading the films, or as determined by the researcher, the study participant is deemed unsuitable for enrollment.

Primary outcomes:
measure: Evaluating the Diagnostic Efficacy of Artificial Intelligence Diagnostic Tools in Medical Imaging of Respiratory Infectious Diseases
timeFrame: 2 years
Secondary outcomes:
measure: Utilizing artificial intelligence tools for early identification and severe warning of respiratory infectious diseases
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
References:
Clinical trial NCT01811511: Efficacy and Safety of Chungkookjang on Improvement of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators performed a 12-week, randomized, double-blind, placebo-controlled crossover human trial to evaluate the efficacy and safety of chungkookjang on improvement of metabolic syndrome. The investigators measured decrement of body fat parameters, including Body Fat Mass, Percent Body Fat, Fat Free Mass, Weight and BMI(body mass index), and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 18-29 years old
* BMI(body mass index) ≥ 23 kg/m2 or WC(Waist Circumference) ≥ 90(men), WC(Waist Circumference) ≥ 85(women)
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* The diagnosis of type 1 and type 2 diabetes or fasting glucose ≥ 126mg/dL
* Systolic pressure ≥ 160mmHg, diastolic pressure ≥ 100mmHg
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study

Primary outcomes:
measure: Change in Body Fat Mass
timeFrame: 12 weeks
measure: Changes in Percent Body Fat
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Glucose
timeFrame: 12 weeks
measure: Changes in Cholesterol
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Obesity Research Center of Chonbuk National University
state: Jeollabuk-do
Study officials:
References:
citation: Byun MS, Yu OK, Cha YS, Park TS. Korean traditional Chungkookjang improves body composition, lipid profiles and atherogenic indices in overweight/obese subjects: a double-blind, randomized, crossover, placebo-controlled clinical trial. Eur J Clin Nutr. 2016 Oct;70(10):1116-1122. doi: 10.1038/ejcn.2016.77. Epub 2016 Jun 15.
citation: Back HI, Ha KC, Kim HM, Kim MG, Yu OK, Byun MS, Jeong DY, Jeong SY, Cha YS, Park TS. The influence of the Korean traditional Chungkookjang on variables of metabolic syndrome in overweight/obese subjects: study protocol. BMC Complement Altern Med. 2013 Oct 31;13:297. doi: 10.1186/1472-6882-13-297.
Clinical trial NCT03718611: To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects
Official title: A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Generic
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics and safety of oral administration of BR9001 compared with BR900A in healthy subjects

Detailed description: This is an open-label, randomized, crossover study to evaluate the pharmacokinetics and safety. Within each period, randomized subjects will be take 2 dosing regimens that BR9001 or BR900A.

Eligibility criteria: Inclusion Criteria:

* Adults 19-50 years of age
* Body mass index (BMI) ≥ 18.5 and ≤ 27.0 kg/m\^2 at screening
* Medically healthy with no clinically significant medical history
* No clinically significant result with laboratory test including chemistry, serum, urine test within 3 weeks in prior to administration of investigational product
* Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease.
* Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
* Creatinint clearance \< 80 mL/min (using Cockcroft-Gault) at screening.
* Whole blood donation within a 2 months prior to the first dose of study drug.
* Participation in another clinical trial or bioequivalence study within 12 weeks prior to the first dose of study drug(s).

Primary outcomes:
measure: Cmax
timeFrame: 0-24 hours after administration
measure: AUClast
timeFrame: 0-24 hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Young-Ran Yoon, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06864611: Evaluating Huddles As a Novel Approach to Improving Concussion Safety
Official title: Evaluating Huddles As a Novel Approach to Improving Concussion Safety
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: concussion
brain injury
prevention
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of Pre-Game Safety Huddles (Huddles) in youth soccer.

Detailed description: The clinical trial portion of this study will enroll 16 youth soccer leagues within four US states. Within each participating league we will enroll two "brackets" (closed units of teams at the same level that compete against each other during the regular season of play) of U12 boys' and girls' U12 teams. Based on typical league and bracket size we anticipate will be 384 teams. Randomization will happen at the league-level. Leagues in the Huddle intervention condition will be supported by US Soccer in implementing Pre-Game Safety Huddles before each regular season game. Leagues in the control condition will continue US Soccer's standard concussion education prevention activities.

Our primary effectiveness and implementation outcomes will be measured at the end of the regular season of play (anticipated to be 10 weeks). Maintenance outcomes will be measured at the end of the regular season of play one year later.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 9 and 13 on eligible teams in participating leagues.
* Soccer coaches of children between the ages of 9 and 13 on eligible teams in participating leagues.
* Read and write English

Exclusion Criteria:

* Cannot read and write English

Primary outcomes:
measure: Expected concussion reporting behavior (Concussion Reporting- Expectations scale)
timeFrame: Baseline, 10 weeks (end of regular competitive season)
measure: Identification of suspected concussions
timeFrame: Baseline, 10 weeks (end of regular competitive season)
Secondary outcomes:
measure: Perceived concussion reporting norms - Athlete (CR-N)
timeFrame: Baseline, 10 weeks (end of regular competitive season)
measure: Perceived concussion reporting norms - Coach (CR-N)
timeFrame: Baseline, 10 weeks (end of regular competitive season)
measure: Huddle implementation
timeFrame: 10 weeks (end of regular competitive season), 1 year and 10 weeks (end of following year's regular competitive season)
Other outcomes:
Locations:
Study officials:
affiliation: Seattle Children's Hospital
name: Emily Kroshus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454011: The Effect of Testosterone Replacement on the High Density Lipoprotein Cholesterol Subgroups
Official title: Phase 4 Study That Compares the High Density Lipoprotein Cholesterol (HDL) Cholesterol Subgroups of the Patients With Congenital Hypogonadotrophic Hypogonadism With That of the Healthy Control Subjects, and Investigates the Effect of Testosterone Treatment on HDL Subgroups.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hypogonadism
Keywords: hypogonadism
testosterone
HDL cholesterol subgroups
hsCRP
HOMA-IR
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 140
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to answer the following questions:

1. Is there any difference between the compositions of the HDL cholesterol subpopulations of patients with hypogonadism and the healthy controls.
2. What is the effect of testosterone replacement therapy on the distributions of HDL subgroups.
3. Is there any difference between the effects of the two different testosteron replacement regiments

Detailed description: This study has two designs:

1. The case control design to search for the difference between the HDL subgroups and the other metabolic parameters between the healthy subjects and the patients with hypogonadism
2. The follow-up study to search for the effects of two different testosterone replacement regiments.

Eligibility criteria: Inclusion Criteria:

* Congenital hypogonadotrophic hypogonadism,
* Male sex

Exclusion Criteria:

* Previous history of androgen replacement,
* any chronic disorder

Primary outcomes:
measure: Changes in the HDL cholesterol levels and the HDL subgroups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine
Study officials:
References: