louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03812926: Compuflo® vs Conventional Training With an Epidural Simulator
Official title: Compuflo® Assisted Training vs Conventional Training for the Identification of the Ligamentum Flavum With an Epidural Simulator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidural Simulator
Lead sponsor: European e-Learning School in Obstetric Anesthesia
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 26
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First year trainees in anesthesia who never have performed an epidural block

Brief summary: Epidural block is one of the most difficult skills that can be mastered by trainees probably due to the difficulty of recognizing the ligamentum flavum (LF) during the loss of resistance technique (LORT).The CompuFlo® Instrument can measure the pressure of human tissues in real-time at the orifice of a needle and it has been successfully used in clinical practice to identify the epidural space.The aim of this study was to evaluate whether Compuflo® may help trainees to identify the ligamentum flavum using a realistic Epidural Simulator

Detailed description: The investigators enrolled 60 trainees who have never performed an epidural block. After having had a standardized learning module on epidural anatomy and technique, each trainee practiced the epidural and the Compuflo®-assisted LORT on the simulator for a maximum of 5 attemps. Trainees were asked to stop the needle entrance whenever they felt a sensation of an increase of resistance due to the penetration of the needle in the LF. The correct position of the needle was verified by an expert instructor. The number of attempts was noted. The power analysis required a sample size of 60 observations to set 80% test power and a 95% significance. Unpaired T-test was used to evaluate the differences in the number of epidural attempts. A logistic regression model was used to correlate the "success at the first attempt ratio" and the technique used.

Eligibility criteria: Inclusion Criteria:

First year trainees in anesthesia who never have performed an epidural block

Exclusion Criteria:

-

Primary outcomes:
measure: epidural attempts
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: EESOA Maternal Neonatal Simulation Centre
Study officials:
affiliation: European e-Learning School in Obstetric Anesthesia
name: Giorgio Capogna
role: STUDY_DIRECTOR
References:
citation: Capogna E, Coccoluto A, Gibiino G, Del Vecchio A. Compuflo(R)-Assisted Training vs Conventional Training for the Identification of the Ligamentum Flavum with an Epidural Simulator: A Brief Report. Anesthesiol Res Pract. 2019 Sep 12;2019:3804743. doi: 10.1155/2019/3804743. eCollection 2019.
Clinical trial NCT00305526: REBEAT Resynchronisation and Beta-Blocker European Trial
Official title: Resynchronisation and Beta-Blocker European Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2006-03-22
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This protocol will evaluate the effect of cardiac resynchronization therapy (CRT) combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up titrated to optimal doses before CRT. Cardiac resynchronization therapy will be combined with automatic implantable cardioverter defibrillator (AICD, CRT-D) as it has been shown to be associated with an improvement in prognosis in the patients with left ventricular systolic dysfunction and heart failure.

Detailed description: The purpose of this investigation is to evaluate the effect of CRT combined with beta-blocker therapy in patients with symptomatic heart failure in whom beta-blocker therapy was either not tolerated or could not be up-titrated to optimal doses before CRT.

Eligibility criteria: Inclusion Criteria:

* Symptomatic heart failure and indication for cardiac resynchronization therapy (CRT), Hemodynamic stability with documented intolerance to beta-blocker therapy or treatment with beta-blocking agents at sub-optimal dosages (\<25% of optimal dosage).

Exclusion Criteria:

* chronic atrial fibrillation; indications for permanent antibradycardia pacing; mechanical tricuspid valve; Severe aortic stenosis or other primary valve disease causing cardiomyopathy

Primary outcomes:
measure: LVEF changes between baseline and 6 months measured by Echocardiography
Secondary outcomes:
measure: increase % of patients with successful uptitration for Betablockers, reduce all cause hospitalizations and all cause mortality, reduce all cause mortality and heart failure hospitalizations, reduce all cause mortality and cardiovascular hospitalizations
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Milano
country: Italy
facility: Istituto clinico Humanitas
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
Study officials:
affiliation: Spedali Civili di Brescia, Brescia, Italy
name: Antonio Curnis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06581926: A Comparative Analysis of Healthy Young Adults Stratified by Gender.
Official title: A Comparative Analysis of Nutritional Knowledge, Reward-related Eating Behaviours and Body Awareness by Gender in a Cohort of Healthy Young Adults.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Young Adults
Keywords: Healthy
People
Gender
Nutrition
Body awareness
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-09-03
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young individuals

Brief summary: This project was planned to examine whether there is a difference between nutrition knowledge level, reward-related eating behaviour and body awareness in healthy young adults according to gender.

Detailed description: Nutritional knowledge is among the factors that affect individuals\&#39; eating habits and diet quality. Food consumption is rewarding in itself as it increases energy and eliminates hunger (an unpleasant sensation); however, daily experiences show that people often eat without hunger. Individuals with high body awareness are expected to be aware of the changes occurring in their body and to change these changes. In the project, nutrition knowledge level, reward-related eating behaviour and body awareness will be compared according to gender in healthy young adults, and all these values will be evaluated through scales. The study data will be collected with a single interview by face-to-face interview method. Each participant will be informed about the study and their written and verbal consent will be obtained. The application time of the questionnaires is expected to take approximately 10 minutes for each participant. In case of a difference between genders for the values investigated, it is aimed to develop individuals\&#39; awareness of these situations. In addition, the relationship between these situations will also be evaluated. It is aimed to create awareness for the situations that are found to be related.

Eligibility criteria: Inclusion Criteria:

* 18-30 years old

Exclusion Criteria:

* Under 18 years old
* not volunteering

Primary outcomes:
measure: nutrition knowledge
timeFrame: Baseline
measure: reward-related eating
timeFrame: Baseline
measure: body awareness
timeFrame: Baseline
measure: descriptive assessment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nigde
country: Turkey
facility: Nigde Omer Halisdemir University
state: Bor
Study officials:
affiliation: Nigde Omer Halisdemir University
name: Elif Gökçe İnbaşı, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002026: Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)
Official title: Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukoplakia, Hairy
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Leukoplakia, Oral
Herpesvirus 4, Human
Acyclovir
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of oral acyclovir for the treatment and suppression of Epstein-Barr virus (EBV) related hairy leukoplakia (HL). To determine the long-term safety of acyclovir in the AIDS-related complex (ARC) patient with HL. To monitor the progression of HIV disease in the HL patient and compare to existing historical control data.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Topical antifungal therapy.

Patient must have:

* Newly diagnosed clinical and histological hairy leukoplakia.
* Positive HIV antibody by licensed ELISA or Western blot.

Exclusion Criteria

Co-existing Condition:

Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded.

Concurrent Medication:

Excluded within 2 weeks of study entry:

* Systemic antifungal treatment.
* Excluded within 6 weeks of study entry:
* Immunomodulators.
* Systemic antiviral treatment.

Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded.

Prior Medication:

Excluded within 2 weeks of study entry:

* Systemic antifungal.
* Excluded within 6 weeks of study entry:
* Immunomodulators.
* Systemic antiviral treatment.
* Excluded within 8 weeks of study entry:
* Zidovudine (AZT) or other antiretroviral therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Univ of Southern California / LA County USC Med Ctr
state: California
Study officials:
References:
citation: Herbst JS, Morgan J, Raab-Traub N, Resnick L. Comparison of the efficacy of surgery and acyclovir therapy in oral hairy leukoplakia. J Am Acad Dermatol. 1989 Oct;21(4 Pt 1):753-6. doi: 10.1016/s0190-9622(89)70250-4.
Clinical trial NCT00772226: The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit
Official title: The Use of Music as Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy in a Day Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Ponv
Fatigue
Keywords: laparoscopic cholecystectomy
pain
PONV
music
therapy
fatigue after elective laparoscopic cholecystectomy
Lead sponsor: Randers Regional Hospital
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is undertaken to investigate whether relaxing music therapy before, during and after laparoscopic cholecystectomy has any effect on pain, PONV or fatigue and level of stress as measured by Cortisol and C reactive protein.

Patients will be scored according to those endpoints 1 and 3 hours after surgery and on day 1 and 7 post-OP.


Eligibility criteria: Inclusion Criteria:

* All patients going for laparoscopic cholecystectomy

Exclusion Criteria:

* Age below 18,
* Use of NSAID, morphine, steroids
* Disability
* Previous surgery in the past month
* Pregnancy

Primary outcomes:
measure: Significant reduction in post operative VAS score
timeFrame: 1 week
Secondary outcomes:
measure: Significant reduction in Stress hormone level (Cortisol and C reactive protein)
timeFrame: 1 day
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: DaySurgical unit Regionshospital Randers
city: Randers
country: Denmark
facility: Regions Hospital Randers
Study officials:
References:
Clinical trial NCT04889326: Collection of the Thrombo-VaxCov Cohort
Official title: A Clinico-biological Database on Atypical Venous Thrombosis in the Context of anticovid19 Vaccination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
SARS-CoV Infection
Venous Thrombosis
Thrombocytopenia
Vaccination; Complications
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient hospitalized with atypical thrombosis occurring within 4 weeks of anticovid vaccination

Brief summary: In the context of anti-Covid19 vaccination, atypical thrombosis have occured and potential link with vaccination is under investigation.

This study collect clinical and biological data of all atypical thrombosis occurring within 4 weeks after antiCovid vaccination.

Detailed description: In the context of anti-Covid19 vaccination, atypical thrombosis have occurred and potential links with vaccination is under investigation. In France, the study collect clinical and biological data of all atypical thrombosis occurring within 4 weeks after anti-Covid vaccination.

Eligibility criteria: Inclusion Criteria:

atypical thrombosis symptoms onset within 4 weeks of vaccination

Exclusion Criteria:

children

Primary outcomes:
measure: Functional outcome (modified rankin scale)
timeFrame: through study completion, an average of 1 years
Secondary outcomes:
measure: Recurrent vascular events
timeFrame: through study completion, an average of 1 years
measure: Mortality
timeFrame: through study completion, an average of 1 years
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU lille
Study officials:
affiliation: University Hospital, Lille
name: Charlotte Cordonnier, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05193565: Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients
Official title: Multi-center, Open-label, Randomized Controlled Phase 4 Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients Undergoing Maintenance Therapy With CNI Plus MPA.[CORAL Study]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Kidney Transplantation
Sirolimus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-01-18
Enrollment: 206
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and Safety after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.

Detailed description: This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.

Eligibility criteria: Inclusion Criteria:

1. Patients who at least 1 year and less than 10 years after kidney transplantation
2. Over 20 years old
3. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation

Exclusion Criteria:

1. Patients who have transplanted organs other than kidney
2. At the time of Screening

   * Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
   * WBC\< 2,500/mm\^3, or platelet \< 75,000/mm\^3, or ANC \< 1,300/ mm\^3
   * Protein/Creatinine ratio≥1.0(mg/mg)
3. Patents who had a record of taking mTOR inhibitor before 3 months
4. In investigator's judgement

Primary outcomes:
measure: Incidence of composite efficacy failure
timeFrame: Until 24 weeks
Secondary outcomes:
measure: Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
timeFrame: Until 24 weeks
measure: Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy
timeFrame: Until 24 weeks
measure: Survival rate of transplanted organ
timeFrame: Until 24 weeks
measure: Survival rate of Patients
timeFrame: Until 24 weeks
measure: Serum-Cr, eGFR
timeFrame: Until 24 weeks
measure: Incidence of BKV, CMV infection
timeFrame: Until 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul, St.Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Chul Woo Yang, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01377766: The Relationship Between Psychological Factors and Bell's Palsy
Official title: Study of Psychological Factors on the Occurence of Bell's Palsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bell's Palsy
Keywords: Bell's palsy
psychological stress
personality factors
psychological factors
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Hubei Hospital of Traditional Chinese Medicine
name: Wuhan No.1 Hospital
name: Xiangyang No.1 People's Hospital
name: Renmin Hospital of Wuhan University
name: Fudan University
name: Second Affiliated Hospital of Zhengzhou University
name: Yichang Hospital of Traditional Chinese Medicine
name: The First Hospital of Hebei Medical University
name: Wuhan General Hospital of Guangzhou Military Command
First posted: 2011-06-21
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 695 subjects were assigned to Cases Group (n=355) and Control Group (n=340).

Brief summary: The aim of this study was to explore the risk factors for Bell's palsy (BP) and to examine whether psychological factors are the potential risk factors for the occurrence of BP.

Detailed description: We conducted a case-control, multi-center clinical investigation. A total of 695 subjects were assigned to the case group (n=355) and the control group (n=340). All the BP patients were enrolled from 11 State Hospitals in China, and all the controls were selected from the same district to match for the patients. The study was coordinated by a tertiary referral centre, Tongji Hospital. The House-Brackmann grading system and Facial Disability Index (FDI) was adopted to assess the BP patients. Kessler 10-Item Psychological Distress Scale（K10）was usde to explore the psychological distress, and the Cattell 16 Personality Factor (16PF) scale was employed to evaluate the personality profiles of all subjects.

Eligibility criteria: Inclusion criteria:

1. Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;
2. aged 18 to 65 years.

Exclusion criteria：

1. illiterate;
2. the facial paralysis is caused by herpes zoster;
3. recurrent facial paralysis;
4. noticeable asymmetry of the face before the illness which may affect the evaluation;
5. history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.

Primary outcomes:
measure: House-Brackmann scale (HBS)
timeFrame: within 168 hours after onset of symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Institute of Integrated Traditional Chinese and Western Medicine
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wei Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03726866: A Study to Investigate Drug-Drug Interaction Between D326, D337 and CKD-828 in Healthy Subjects
Official title: A Randomized, Open Label, Repeated-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interactions and Safety Among D326, D337 and CKD-828 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dyslipidemias
Hypertension
Keywords: dyslipidemias
hypertension
Drug-Drug interaction
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate pharmacokinetic properties and drug interactions between D326 and D337 co-administered groups, the CKD-828 alone and the total co-administered groups.


Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers aged between ≥ 19 and ≤ 40 years old
2. Calculated body mass index(BMI) of ≥ 19 and ≤ 28kg/m²
3. Subject who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods from the date of first administration of Investigational product until completion of the clinical trial
4. Subject who agree not to provide sperm
5. Subject who voluntarily agree to participate in this study

Exclusion Criteria:

1. Any medical history that may affect drug absorption, distribution, metabolism and excretion
2. Subject who has a clinically significant disease or history such as endocrine, gastrointestinal, cardiovascular, muscular disease.
3. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
4. Subject who have received other clinical trial drugs within 90 days prior to the screening visit
5. Any clinically significant active chronic disease

Primary outcomes:
measure: Cmax(Maximum plasma concentration of the drug at steady state)
timeFrame: at Day 9
measure: AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
timeFrame: at Day 9
Secondary outcomes:
measure: Tmax(Time to maximum plasma concentration at steady state)
timeFrame: at Day 9
measure: t1/2(Terminal elimination half-life)
timeFrame: at Day 9
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics / Asan Medical Center, University of Ulsan
name: Hyeong-Seok Lim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: