louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01786421: Diurnal Triglyceridemia in Relation to Alcohol Intake
Official title: Observational Study of Diurnal Triglyceridemia in Relation to Alcohol Intake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Hyperlipidemias
Type 2 Diabetes Mellitus
Cardiovascular Diseases
Keywords: Ethanol
Lipemia
Postprandial
Triglyceride
Lead sponsor: Sint Franciscus Gasthuis
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects were healthy volunteers or patients with hyperlipidemia or a known medical history of cardiovascular diseases, type 2 diabetes mellitus participating in several clinical studies with the same protocol, aimed to investigate factors influencing postprandial lipemia

Brief summary: The purpose of this study is to determine the impact of alcohol consumption in diurnal triglyceridemia in a free living situation.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Patients with:

* Hyperlipidemia
* Type 2 Diabetes Mellitus
* Cardiovascular diseases

Exclusion Criteria:

* Renal disease
* Liver disease
* Thyroid disease

Primary outcomes:
measure: Determination of diurnal triglyceridemia depend on alcohol intake
timeFrame: For 3 days.
Secondary outcomes:
measure: Gender differences in diurnal triglyceridemia by alcohol consumption
timeFrame: For 3 days
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
city: Utrecht
country: Netherlands
facility: Utrecht University Medical Center
Study officials:
References:
Clinical trial NCT00933621: Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
Official title: Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Ischemic Symptomatic Heart Failure
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-07-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization.

Detailed description: Several studies have demonstrated the short term safety, feasibility and efficacy of cell transplantation in patients with advanced heart failure. There are no data about the long term outcome.

Eligibility criteria: Inclusion Criteria:

* Patients with evidence of hibernation and/or ischemia in at least 2 different myocardial segments underwent coronary angiography

Exclusion Criteria:

* Idiopathic or non-ischemic cardiomyopathy
* Other etiology for heart failure, history of past or current disease involving the bone marrow
* Patients on dialysis
* Positive serologic test for HIV, hepatitis B or C or any neoplastic or terminal disease

Primary outcomes:
measure: Procedure success
timeFrame: 9 months
Secondary outcomes:
measure: Functional class improvement
timeFrame: 9 months
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh
Study officials:
affiliation: Assaf Harofeh MC
name: Alex Blatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murry CE, Reinecke H, Pabon LM. Regeneration gaps: observations on stem cells and cardiac repair. J Am Coll Cardiol. 2006 May 2;47(9):1777-85. doi: 10.1016/j.jacc.2006.02.002. Epub 2006 Apr 17.
Clinical trial NCT06675721: A Survey of Acceptance and Factors Associated With Hesitancy Vaccination in Northeast Brazil
Official title: A Survey of Acceptance and Factors Associated With Hesitancy Vaccination in a Socioeconomically Disadvantaged Population and Professionals Working in a City Located in Northeast Brazil
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vaccine Hesitancy
Vaccine Refusal
Lead sponsor: Centro De Estudos E Pesquisas Em Molestias Infecciosas
Sponsor class: OTHER
Collaborators: name: MSD Pharmaceuticals LLC
First posted: 2024-11-05
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vulnerable populations residing in neighborhoods characterized by socioeconomic vulnerability and high infectious disease incidence. Four neighborhoods in Natal will be the focus, each with their respective population: Lagoa Azul (61,289), Pajuçara (58,021), Felipe Camarão (50,997), and Planalto (31,206).

In this project, the inclusion of health professionals as a unified group is essential because of their critical role as trusted source of health information. In Natal, these professionals consist of 5,238 physicians and an estimated 7,066 nurses (derived from a 61.6% prevalence applied to the 11,471 registered nurses in Rio Grande do Norte).

Brief summary: The objective of this study is to investigate vaccination acceptance and identify the reasons why people are not vaccinated.

People over 18 years of age who live in neighborhoods with socioeconomic vulnerability and with many cases of infectious diseases, as well as health professionals, will respond to a research questionnaire.


Eligibility criteria: Inclusion Criteria:

* Individuals who are over 18 years old and are residents of the PAJUÇARA, FELIPE CAMARÃO, LAGOA AZUL, or PLANALTO neighborhoods, willing to answer the study questionnaire.
* Healthcare professionals who work in Natal, willing to answer the study questionnaire.

Primary outcomes:
measure: Resistance to adherence to vaccination
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro De Estudos E Pesquisas Em Molestias Infecciosas
name: Kleber G Luz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00564421: Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis (P08648)
Official title: A Phase 3 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple Dose Safety and Efficacy Study of Epinastine Nasal Spray vs. Placebo in Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-11-28
Enrollment: 798
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis


Eligibility criteria: Inclusion Criteria:

* A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen

Exclusion Criteria:

* Significant medical condition
* Significant nasal abnormality
* Significant cardiac condition
* Recent infection
* Use of other allergy medication during the study
* Use of asthma medication other than as-needed albuterol

Primary outcomes:
measure: Change in nasal symptom scores
timeFrame: 14 days
Secondary outcomes:
measure: Change in ocular symptom scores and quality of life scores
timeFrame: 14 days
measure: Standard safety assessments
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Donald Kellerman, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04963621: RCT of CESIP for Children With Emotional and Stress Problems
Official title: Child-Adolescent Emotion and Stress Intervention Program for Children With Emotional and Stress Problems- a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Stress
Keywords: emotional stress
intervention
RCT
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 72
Maximum age (years): 155
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the effect of Child-Adolescent Emotion and Stress Intervention Program for children with emotional and stress problems, providing early social psychological intervention for aiming the core impairments of emotional and stress problems.

Detailed description: 80 children with emotional and stress problems will be randomly divided into the intervention group and the waiting group. The waiting group received regular clinical intervention, while the intervention group received 12-week training. The intervention program includes emotional regulation and stress intervention training for children by two therapists, which were carried out in one meeting rooms in Xinhua Hospital. Therapists are psychotherapists with a background in child psychotherapy training. After 12 weeks, the improvement of emotional symptoms was compared.

Eligibility criteria: Inclusion Criteria:

* The results were positive on the SCARED scale; Age 6 years 0 to 12 years 11 months; Total IQ is above 80 assessed by WPPSI.

Exclusion Criteria:

* Attention deficit disorders resulting from organic neurological diseases, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders; parent or guardian with a serious mental illness, such as schizophrenia, mood disorder (onset), etc., and Educational level is lower than junior middle school; Participants who failed to attend more than 80% of the intervention sessions (at least 9 sessions).

Primary outcomes:
measure: Strengths and Difficulties Questionnaire (SDQ) total score
timeFrame: 12 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
Study officials:
References:
Clinical trial NCT05361421: Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial
Official title: Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cardiovascular Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although there have been studies regarding intensive lowering of low-density lipoprotein (LDL)-cholesterol with high intensity statins in patients with cardiovascular disease, elderly patients were either excluded or accounted only a small portion of study subjects. Therefore, this study sought to compare the clinical outcomes according to the LDL-cholesterol therapy targeting (intensive targeting \[LDL-cholesterol \<55mg/dL\] vs. conventional therapy \[moderate intensity statin therapy\]) in elderly patients with ≥75 years and documented cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

1. Age ≥75 years
2. Documented cardiovascular disease (at least 1 of the following) A. Previous acute coronary syndrome (MI or unstable angina) B. Or stable angina with imaging studies of coronary artery disease or functional studies of myocardial ischemia C. Or coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft) D. Or peripheral artery disease.

Exclusion Criteria:

1. MI or stroke within 1 year
2. LDL-cholesterol level less than 55 mg/dL without statin therapy
3. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
4. Allergy or hypersensitivity to any statin
5. Life expectancy less than 1 years
6. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

Primary outcomes:
measure: Clinical efficacy of intensive lipid-lowering therapy
timeFrame: 3 years
Secondary outcomes:
measure: Efficacy endpoint
timeFrame: 3 years
measure: Safety endpoint
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT05434221: Communication Skill Training Program for Occupational Therapy Interns
Official title: Development and Evaluation of a Communication Skill Training Program for Occupational Therapy Interns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Education, Medical
Keywords: Communication skill
occupational therapy
intern
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 216
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Effective communication is one of important skills in occupational therapy (OT) practice, affecting the effectiveness and quality of therapy. Although there are only a few courses on communication skills related to OT, there is a lack of a complete, suitable, and evidence-based OT communication skills teaching programs that can effectively improve the interns' communication skills. The purpose of the study is to develop a communication skills training program for occupational therapy interns in physical dysfunction practice (COPE), and examine the effectiveness of COPE.


Eligibility criteria: Inclusion Criteria:

\[interns\]

* age ≥ 20 years
* an intern of occupational therapy

\[patients\]

* age ≥ 20 years
* enable to communicate with the others

Exclusion Criteria:

\[interns\]

* unwilling to be recorded

\[patients\]

* have communication barriers
* unwilling to be recorded

Primary outcomes:
measure: Experts assessed interns' communication skills：Gap-Kalamazoo Communication Skills Assessment Forms (GKCSAF)-Faculty version
timeFrame: during procedure
Secondary outcomes:
measure: Patients or caregivers assessed interns' communication skills：Gap-Kalamazoo Communication Skills Assessment Forms (GKCSAF)-patient/caregiver version
timeFrame: during procedure
measure: Interns self-reported communication skills：Gap-Kalamazoo Communication Skills Assessment Forms (GKCSAF)-self-assessment version
timeFrame: during procedure
measure: Patients' engagements in occupational therapy：Occupational Therapy Engagement Scale (OTES)
timeFrame: during procedure
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
citation: Calhoun AW, Rider EA, Peterson E, Meyer EC. Multi-rater feedback with gap analysis: an innovative means to assess communication skill and self-insight. Patient Educ Couns. 2010 Sep;80(3):321-6. doi: 10.1016/j.pec.2010.06.027. Epub 2010 Jul 17.
citation: Peterson EB, Calhoun AW, Rider EA. The reliability of a modified Kalamazoo Consensus Statement Checklist for assessing the communication skills of multidisciplinary clinicians in the simulated environment. Patient Educ Couns. 2014 Sep;96(3):411-8. doi: 10.1016/j.pec.2014.07.013. Epub 2014 Jul 19.
citation: Wu TY, Lien BY, Lequerica AH, Lu WS, Hsieh CL. Development and Validation of the Occupational Therapy Engagement Scale for Patients with Stroke. Occup Ther Int. 2019 Mar 6;2019:3164254. doi: 10.1155/2019/3164254. eCollection 2019.
Clinical trial NCT06658821: The Effect of LDL557 on Improving Degenerative Arthritis in the Elderly
Official title: The Effect of LDL557 on Improving Degenerative Arthritis in the Elderly
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthritis
Joint Pain
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: SYNBIO TECH INC. Kaohsiung Taiwan
First posted: 2024-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project is to conduct a clinical trial of SYNBIO TECH INC.'s LDL557 capsule for joint protection. To understand the improvement of joint discomfort and inflammation after supplementation, we hope to provide an updated choice for modern people's joint protection.


Eligibility criteria: Inclusion Criteria:

* BMI 18-40 kg/m2;
* Those with early stage degenerative arthritis symptoms judged by X-ray to be Kellgren-Lawrence Grading Scale level 1 or 2, and the physician determines that long-term treatment is not needed or WOMAC score\>2.0 or WOMAC total scale score\>12 or VAS score ≦3.

Exclusion Criteria:

* Smoking
* alcoholism
* diabetes
* breastfeeding women and pregnant women.
* Those consuming dietary supplements were excluded.
* Those who use non-steroidal anti-inflammatory analgesics and those who have had joint surgery.
* Rheumatoid arthritis.
* Those who have had joint injections within 6 months.
* Those with cardiovascular and cerebrovascular, rheumatoid or mental diseases.
* Patients undergoing cancer treatment.

Primary outcomes:
measure: WOMAC
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
References:
Clinical trial NCT04892121: Prevention in Volleyball Players
Official title: The Efficiency of a Warm-up Prevention Program in Volleyball Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention
Keywords: prevention, shoulder, exercises, volleyball
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 93
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to assess the interest and the efficiency of a warm-up prevention program on the prevalence of shoulder injuries in amateur volleyball players.

Around ten teams will be included in the study. They will be divided into two groups (blind): an intervention group and a control group.

A warm-up prevention program will implemented in the teams of intervention group. This program will have to be followed twice a week, at the beginning of the training session.

In both groups, shoulder injuries will be registered each month by an online questionnaire.

Detailed description: Around ten teams will be recruted among the clubs in the Province of Liege. They will be divided into two groups (blind): an intervention group and a control group.

Each month, both groups will be asked to fill in a form with the potential injuries they experienced during the past month.

* Intervention group :

All the teams included in the intervention group will be asked to follow a warm-up prevention program (about 15 minutes) at least twice a week, at the beginning of the training session.

At the beginning of the season, one experimenter will go to the different clubs in order to present the program, to explain the exercises and to correct the players while doint the exercises.

During the season, the same experimenter will go to the clubs at regular intervals to make sure that the players are well doing the program and to assess the compliance.

- Control group :

The objective of the control group is to estimate the prevalence of shoulder injuries in a group without any prevention implementation. The players of this group will jus have to answer the monthly questionnaire about the potential injuries they experienced during the previous month.

Eligibility criteria: Inclusion Criteria:

* volleyball players in Provincial level (P1-P2)
* practicing volleyball at least 4 hours in a week
* no "prevention routines"

Exclusion Criteria:

* having a prevention program

Primary outcomes:
measure: Prevalence of shoulder injuries
timeFrame: through study completion, an average of 1 year
measure: Compliance with the program
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Fédération de Volleyball Wallonie-Bruxelles
Study officials:
References:
Clinical trial NCT03130621: Screening of Hereditary Upper Gastrointestinal Cancer in China
Official title: Screening of Hereditary Upper Gastrointestinal Cancer in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Improve the Screening Criteria of Chinese Hereditary Upper Gastrointestinal Tumors
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Upper Gastrointestinal Cancer

Brief summary: Through exploring the specific genetic mutations in the upper gastrointestinal tract tumors with a family history and specific clinical pathological types，we establish a complete family and follow-up system，in order to improve the screening criteria of Chinese hereditary upper gastrointestinal tumors and carry on primary prevention of disease.


Eligibility criteria: Inclusion Criteria:

Patients with gastric cancer, esophageal adenocarcinoma, or duodenal adenocarcinoma meet one of the following criteria:

1. age≤30;
2. age≤35，gastric cancer with special pathological types;
3. age≤50，≥one first-degree relative of a malignant tumor;
4. ≥ two first-degree／second-degree relatives of a malignant tumor，and ≥one first-degree relative;
5. have ≥two types of malignancies，and age ≤50 at the first time of diagnosis;
6. MSI or dMMR of tissue specimen;

Patients with esophageal squamous cell carcinomas meet one of the following criteria:

1. ≥ two first-degree／second-degree relatives of a malignant tumor，and ≥one first-degree relative;
2. have ≥two types of malignancies，and age ≤50 at the first time of diagnosis;
3. MSI or dMMR of tissue specimen;

Exclusion Criteria:

* Patients do not meet one of the inclusion criteria;

Primary outcomes:
measure: Pedigree analysis
timeFrame: In the first phase of the project, we plan to detect 40-50 families in one year. And in the second phase，we will increase the number of predigree to 200. We hope to finish the phase before 2022.3
Secondary outcomes:
measure: somatic mutation landscape of hereditary upper gastrointestinal cancer
timeFrame: We plan to accomplish sample collection, sequencing and data analysis before 2022.3
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: