louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01659931: Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 10 mg Tablets Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Asthma
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Montelukast Tablet under fasted conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to montelukast or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute, Ltd.
name: Alan K Copa, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01073631: Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea
Official title: Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serious Fungal Infections
Keywords: voriconazole
Korea
invasive fungal infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-23
Enrollment: 543
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are indicated for voriconazole tablet according to the drug package insert.

Brief summary: This is a non-interventional study of voriconazole tablet in Korea which is mandated by the Korean government agency.


Eligibility criteria: Inclusion Criteria:

* Patients who are indicated for voriconazole table according to the drug package insert.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable
timeFrame: Baseline (Day 1) up to 2.1 Years
Secondary outcomes:
measure: Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable
timeFrame: Baseline (Day 1) up to 2.1 Years
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00645931: Psychological Effects of Bone Marrow Transplants in Children
Official title: Proposal for a Bone Marrow Transplant Pre, Post, and Long Term Psychological Evaluation Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological
Keywords: Bone Marrow
Bone Marrow Transplant
Pediatric
Psychological Impact
Psychology
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Helen DeVos Children's Hospital
First posted: 2008-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients under the age of 18

Brief summary: This study is designed to examine the psychological effects of bone marrow transplants on children and their families. The investigators hypothesis is that families who show signs of psychological distress before transplant will continue those signs post transplant. The investigators are examining cognitive placement, emotional placement and other psychological factors in both the child undergoing transplant and his or her parent.

Detailed description: Previous research on bone marrow transplants has conflicting results concerning the effects of maladjustment. The current research is conducted in consortium with DeVos Children's Hospital. Children receiving bone marrow transplants are assessed using the Child Behavior Check List (CBCL) and Cognitive based testing. Parents are assessed using the Parenting Stress Index (PSI). Children and parents are evaluated prior to transplant and then 50 days, 6 months, and one year post transplant. Descriptive statistics are currently being used to determine results.

Eligibility criteria: Inclusion Criteria:

* bone marrow transplant eligible patients
* 18 years and under
* male and female

Exclusion Criteria:

* over the age of 18

Primary outcomes:
measure: The specific measure that will be used to determine the effect of the intervention(s). The description should included the time at which the measure will be taken. Examples: all cause mortality at one year; score on a depression rating scale at 6 weeks
timeFrame: 1 year post transplant
Secondary outcomes:
measure: Other measures that will be used to evaluate the intervention(s), and that are specified in the protocol. The description should include the time at which the measures will be taken. Ex. cardiovascular mortality at 6 mos.; functional status at 4 wks
timeFrame: 1 year post transplant
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital
state: Michigan
Study officials:
affiliation: Helen DeVos Children's Hospital
name: Heather Hammerstrom, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02982031: A Comparison of Visualization Between Shamrock Technique and Paramedian Transverse Scan in Lumbar Plexus Blockade
Official title: A Comparison of Visualization Between Shamrock Technique and Paramedian Transverse Scan in Lumbar Plexus Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Plexus Blockade
Keywords: Ultrasound-guided lumbar plexus blockade
Shamrock technique
Paramedian transverse scan
USG LPB
USGRA
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study was to compare ultrasound visibility of the lumbar plexus at the intertransverse space between paramedian transverse scan and shamrock technique. Moreover obtaining a clear image of relevant structures is imperative. Thus, the secondary objective was to assess ultrasound visibility of each relevant structure and overall visibility between these two methods.

Detailed description: Background: Ultrasound-guided lumbar plexus block (USG LPB) is regarded as a form of advanced ultrasound-guided regional anesthesia (USGRA). One of the key challenges of USG LPB is visualization of the lumbar plexus. That are currently in use for ultrasound-guided lumbar plexus blockade - paramedian transverse scan (PMTS) and shamrock technique.

Method: Twenty-three healthy adult volunteers aged ≥ 18 years were enrolled in this prospective cohort study. Ultrasound visualization results were compared between methods.

Eligibility criteria: Inclusion Criteria:

* healthy volunteer, age \>/= 18

Exclusion Criteria:

* spinal deformity and history of previous back or spine surgery

Primary outcomes:
measure: Percentage of Video (VDO) loops visualization of lumbar plexus
timeFrame: 1 month
Secondary outcomes:
measure: Ultrasound visibility score of each relevant structures
timeFrame: 1 month
measure: Overall ultrasound visibility score of 10 structures
timeFrame: 1 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: 66864001721
name: Pawinee Pawinee, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02653131: The Use of DPP-4 Inhibitors in Short Bowel Syndrome
Official title: The Use of Dipeptidyl Peptidase-4 Inhibitor Influences the Absorption of Intestine in Short Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Short Bowel Syndrome
Keywords: Short bowel syndrome
Lead sponsor: Stanley Dudrick's Memorial Hospital
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The inhibition of Dipeptidyl peptidase-4 should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.

Detailed description: The only effective (to some extend drug) in short bowel syndrome is Glucacone-like peptide 4. Its price is, however, to high to really change the treatment strategy for intestinal failure. The Dipeptidyl peptidase-4 inhibitor, which a drug which is commonly used in the treatment of diabetes mellitus type II, should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.

Eligibility criteria: Inclusion Criteria:

* patients receiving home parenteral nutrition (HPN) because of short bowel syndrome for at least 12 months
* stable metabolic status
* benign disease

Exclusion Criteria:

* HPN \< 12 months
* metabolically unstable
* cancer as the reason for intestinal failure

Primary outcomes:
measure: Improvement of intestinal absorption
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
Study officials:
References:
citation: Jeppesen PB. Pharmacologic options for intestinal rehabilitation in patients with short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):45S-52S. doi: 10.1177/0148607114526241. Epub 2014 Mar 10.
Clinical trial NCT05570331: Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women
Official title: Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women：a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV Infection
Cervical Cancer
Keywords: Cervical cancer screening, HPV test, HPV integration
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 2200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: aged 20y-70y HPV-positive women

Brief summary: The American Society for Colposcopy and Cervical Pathology (ASCCP) recommended HPV testing or co-cytology testing as the standard primary approach for cervical cancer (CC) screening, which is highly sensitive for detection of cervical intraepithelial neoplasia grade 3 or worse. However, in clinical CC screening practice, the specificity and positive predictive value of the ASCCP-recommended strategy is relatively low, which leads to excessive colposcopy and common overtreatment, especially in China with a large number of cervical cancer cases. HPV integration in the host genome is a critical step in cervical carcinogenesis and is highly specific for detection of cervical cancer. Whether HPV integration analysis can play a role in the triage of cervical cancer screening has not yet been investigated.

Detailed description: Based on the dilemma of the cervical cancer screening process, in the last five years, our team developed a novel cervical cancer triage strategy and conducted a large cohort study, which evaluated the clinical performance of HPV integration triage alone and in combination with HPV16/18 or HPV16 genotyping of HPV-positive women. We found that the specificity of HPV integration for greater than cervical intraepithelial neoplasia 3 was 94.5%, which was significantly higher than that of cytology (63.8%; P \< 0.001) in our previous retrospective study.Here, we conducted a large prospective cohort study evaluating the clinical performance of HPV integration triage of HPV-positive women.

Eligibility criteria: Inclusion Criteria:

* Consenting women aged 20y-70y with HPV-positive results

Exclusion Criteria:

* Not providing informed consent
* previously confirmed CIN, cervical cancer, or other malignancies
* previous therapeutic procedure to cervix
* pregnancy

Primary outcomes:
measure: Risk of CIN2+ disease
timeFrame: 3 years
measure: Risk of CIN3+ disease
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Ding Ma, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01272427: Glucose, Whey Protein and Time to the Next Meal on Mealtime Food Intake in Children
Official title: The Effect of Glucose, Whey Protein and Time to the Next Meal on Food Intake and Subjective Appetite in Normal Weight and Overweight/Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-01-07
Enrollment: 36
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that glucose and whey protein given 30 and 60 min before a pizza meal will exert different effects on food intake in adolescent children, and will depend on pubertal stage. Food intake will be measured at 30 and 60 min following a glucose(0.75 g of glucose/kg body weight), whey protein (0.75 g of glucose/kg body weight) or sweetened noncaloric beverage. Subjective appetite will be measured as well.


Eligibility criteria: Inclusion Criteria:

* children with no emotional, behavioral or learning problems

Exclusion Criteria:

* underweight children
* children with emotional, behavioral or learning problems
* children who dislike foods in study

Primary outcomes:
measure: Food intake (kcal)
timeFrame: 30 and 60 min after the treatment
Secondary outcomes:
measure: subjective appetite
timeFrame: 0-120 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05736627: Learning Effect of Onsite vs. Online Education in a Medical Context
Official title: Learning Effect of Onsite vs. Online Education in a Medical Context
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Online Learning
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Copenhagen Academy for Medical Education and Simulation
name: University of Copenhagen
First posted: 2023-02-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to learn about the effects of online medical education in PhD students. The main question it aims to answer is:

What is the effect of onsite compared to online research courses on theoretical knowledge of research methodology and motivation for young medical researchers? Participants will join 20 research courses which are computer randomised to be delivered online (intervention) or onsite (control group) with 10-12 PhD students of each course (200-240 participants). Participants will be followed for up to two years after their course. The outcomes are

* theoretical learning (main)
* academic achievements
* motivation
* self-efficacy

Researchers will compare online and onsite research courses to see if there is a difference in theoretical learning, academic achievements, motivation and self-efficacy.


Eligibility criteria: Inclusion Criteria:

* All PhD students on the courses if they are able to give informed consent

Exclusion Criteria:

* Declining to participate
* Withdrawal of informed consent

Primary outcomes:
measure: Theoretical learning
timeFrame: Up to 3 months
Secondary outcomes:
measure: Academic achievement
timeFrame: Up to 25 months
measure: Motivation
timeFrame: Up to 3 months
measure: Self-efficacy
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Rie Raffing
state: Frederiksberg Hospital
Study officials:
References:
Clinical trial NCT01531127: Executive Function in Learning in Children With Attention Deficit Hyperactivity Disorder (ADHD) Receiving Medical Treatment Alone Compared to Children Receiving Additional Treatment to Improve Learning Strategies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ADHD
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with ADHD treated in the Institute for Child Development at Hillel Yaffe Medical Center

Brief summary: The purpose of this study is to determine whether there is a difference in executive function in learning in children with ADHD receiving medical treatment alone to the executive function in children receiving, in addition to medical treatment in learning strategies.


Eligibility criteria: Inclusion Criteria:

* Normal development for age
* ADHD

Exclusion Criteria:

* Low compliance
* Developmental delay
* Chronic disease

Primary outcomes:
measure: Level of Executive Functioning
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05723627: Comparison of Remimazolam and Propofol Effect on Oxygenation Reservoir During Diagnostic Gastric Endoscopy
Official title: Comparison of Remimazolam and Propofol Effect on Oxygenation Reservoir During Diagnostic Gastric Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnostic Gastric Endoscopy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for diagnostic gastric endoscopy.


Eligibility criteria: Inclusion Criteria:

Patients (age 19\~80 yrs, ASA Class I\~III, ECOG 0\~1) who are scheduled for elective diagnostic gastric endoscopy

Exclusion Criteria:

Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Hypotension (SBP \<80mmHg) or hypoxemia (SpO2 \<90%) assessed prior to procedure

Primary outcomes:
measure: Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation
timeFrame: Evaluation begins after sedative administration until the end of endoscopic procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Internal Medicine, Yonsei University College of Medicine
name: Sung Kwan Shin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05102227: Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle.
Official title: Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle. The CROSS LEFT Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Bundle Branch Area Pacing
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with an indication of a new implantation of a cardiac resynchronization therapy system.

Brief summary: Evaluation of ventricular arrhythmias sensing via a left bundle branch area pacing lead.


Eligibility criteria: Inclusion Criteria:

* Ischemic or non-ischemic cardiomyopathy
* Left ventricular ejection fraction ≤35% despite optimal medical therapy
* Left bundle branch block with QRS ≥130 milliseconds

Exclusion Criteria:

* Previously implanted intra-cardiac material

Primary outcomes:
measure: Number of patients with successful defibrillation at 35 Joules.
timeFrame: 24 hours
Secondary outcomes:
measure: Time from ventricular fibrillation induction to defibrillation shock.
timeFrame: 24 hours
measure: Number of appropriate and inappropriate arrhythmic episodes.
timeFrame: 6 months
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de Tours
state: Please Select...
Study officials:
References:
citation: Clementy N, Bodin A, Ah-Fat V, Babuty D, Bisson A. Dual-chamber ICD for left bundle branch area pacing: the cardiac resynchronization and arrhythmia sensing via the left bundle (cross-left) pilot study. J Interv Card Electrophysiol. 2023 Jun;66(4):905-912. doi: 10.1007/s10840-022-01342-6. Epub 2022 Aug 16.