louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06040294: Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills
Official title: Evaluation of a Dementia and Disability Simulation Program for Senior Activity Facilitation Skills Among College Nursing Students
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dementia
Keywords: dementia
disability
simulation
nursing student
Lead sponsor: Tzu Chi University of Science and Technology
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-group randomised controlled trial
Primary purpose: OTHER

Brief summary: This study aims to evaluate the effectiveness of a dementia and disability simulation (DDS) program on dementia knowledge, attitude, empathy, and activity design skills for seniors among college nursing students.

Detailed description: This two-group randomised controlled trial aims to evaluate the effectiveness of a dementia and disability simulation program on dementia knowledge, attitude, empathy, and activity design skills for seniors among college nursing students.

The interventional group will receive a 6-week dementia and disability simulation program of activity design for seniors.

The control group will receive 6 weeks of regular dementia course and group discussion of activity design for seniors with no dementia and disability simulation.

Both groups will be assessed for their dementia knowledge, attitude, empathy and activity design skills for seniors at baseline, week 12, and week 18.

Eligibility criteria: Inclusion Criteria:

* college nursing students with age ranged from 19 to 40 years,
* Taiwanese nationality,
* Sophomore and above
* provide informed consent to participate in the study.

Exclusion Criteria:

-college nursing students who do not meet the inclusion criteria

Primary outcomes:
measure: Dementia Knowledge Assessment Scale (DKAS)
timeFrame: Baseline, week 12, week 18
measure: Approaches to Dementia Questionnaire (ADQ)
timeFrame: Baseline, week 12, week 18
measure: Jefferson Scale of Empathy (JSE)
timeFrame: Baseline, week 12, week 18
measure: Rubrics of activity design skills for seniors
timeFrame: Baseline, week 12, week 18
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Tzu Chi University of Science and Technology
Study officials:
affiliation: Tzu Chi University of Science and Technology
name: Huei-Chuan Sung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00615394: Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
Official title: Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dilated Cardiomyopathy
Keywords: cardiomyopathy, stem cell, cardiac failure
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2008-02-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.


Eligibility criteria: Inclusion Criteria:

* diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
* left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram
* age below 60 years
* absence of neoplasm
* absence of hematologic disease or systemic disease
* no previous cardiac intervention

Exclusion Criteria:

* episodes of tachycardia or ventricular fibrillation
* severe or moderated mitral insufficiency
* any other valvulopathies

Primary outcomes:
measure: safety: morbidity/mortality
timeFrame: eighteen months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: RS
Study officials:
References:
citation: Kalil RA, Ott D, Sant'Anna R, Dias E, Marques-Pereira JP, Delgado-Canedo A, Nardi NB, Sant'Anna JR, Prates PR, Nesralla I. Autologous transplantation of bone marrow mononuclear stem cells by mini-thoracotomy in dilated cardiomyopathy: technique and early results. Sao Paulo Med J. 2008 Mar 6;126(2):75-81. doi: 10.1590/s1516-31802008000200003.
Clinical trial NCT05010694: GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH35 Tablets in Patients Harboring With G12C Mutation in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors Harboring With G12C Mutation
Keywords: Advanced Solid Tumors, KRAS
Lead sponsor: Suzhou Genhouse Bio Co., Ltd.
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and tolerability of GH35 in patients with KRAS mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects greater than or equal to 18 years old.
2. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified.
3. Expected survival time ≥12 weeks.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
6. Have documented disease progression or intolerance after first-line treatment.

Exclusion Criteria:

1. Gastrointestinal (GI) tract disease causing the inability to take oral medication.
2. Previous accept with KRAS G12C inhibitor.
3. Uncontrollable general infection.
4. Serious cardiovascular disease.
5. Left ventricular ejection fraction (LVEF) \<50 %.
6. Known history of hypersensitivity to any of the excipients of GH35 tablets
7. Pregnant or nursing (lactating) women.

Primary outcomes:
measure: Dose-limiting toxicities (DLT)
timeFrame: 24 Days
Secondary outcomes:
measure: Characterize the safety of GH35 in subjects
timeFrame: 30 Months
measure: Pharmacokinetics of GH35
timeFrame: 1 Month
measure: Objective response rate (ORR) as defined by RECIST 1.1 criteria
timeFrame: 30 Months
measure: Duration of response (DOR) as defined by RECIST 1.1 criteria
timeFrame: 30 Months
measure: Progression-free survival (PFS) as defined by RECIST 1.1 criteria
timeFrame: 30 Months
measure: Disease control rate (DCR) as defined by RECIST 1.1 criteria
timeFrame: 30 Months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Baohui Han, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05755594: A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy
Official title: A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Common Bile Duct Diseases
Periampullary Carcinoma
Keywords: Robot-assisted pancreaticoduodenectomy
Safety and Efficacy
randomized controlled trial
Lead sponsor: The First Affiliated Hospital of University of South China
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Further studies are needed to investigate the prognosis and perioperative safety of patients undergoing robotic-assisted pancreaticoduodenectomy. In this study, clinical data and prognostic data of patients undergoing this procedure were prospectively collected and analyzed to explore its safety and efficacy.

Detailed description: Perioperative clinical data and prognostic data of patients undergoing robotic-assisted pancreaticoduodenectomy were collected and analyzed to explore the safety and efficacy of this surgical approach.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Preoperative imaging suggested the presence of space occupying in the head of the pancreas, ampullary abdomen, and distal common bile duct tumor lesions to be treated with Pancreaticoduodenectomy
* No distant transfer
* No significant vascular invasion was received

Exclusion Criteria:

* With tumors of other organs
* Patients unable to tolerate anesthesia and operation due to serious abnormalities in functions of heart, lung and other important organs
* Patients found intraoperative peripheral organ metastasis combined with excision of other organs or found intraoperative radical excision could not be performed and underwent palliative drainage surgery or end the surgery
* Preoperative adjuvant therapy was given

Primary outcomes:
measure: Rate of long-term Survival
timeFrame: 3 years
Secondary outcomes:
measure: Unplanned re-admission rate after discharge within 30 days
timeFrame: 3 months
measure: Incidence of postoperative complications
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of University of South China
name: Guodong Chen, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04750694: High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players
Official title: High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophy
Keywords: The focus is blood flow restricted exercise
Lead sponsor: Department of Public Health, Denmark
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Purpose of the study is: to investigate the effects of 8 weeks intervention of high intensity resistance training(HIRT) combined with Blood Flow Restricted Exercise (BFRE) compared to high intensity resistance training alone.

Detailed Description: 30 elite handball players will be randomized into 2 groups of 15 participants each. Participants will be evaluated in the week before and the week after an 8-weeks training intervention with 2 weekly sessions. Based on their baseline muscle strength the participants will be randomized into two groups: HIRT-BFRE or HIRT-HIRT. Participants in both groups will perform a full-body training programme of HIRT. After the Full-body programme, Back squat exercise with low intensity and Blood flow restriction will be performed to the HIRT-BFRE group and back squat exercise with high intensity without blood flow restriction will be performed by HIRT-HIRT. Evaluation protocol includes: muscle strength measurement with 1 repetition maximum of Back squat and knee extension, muscle mass with Dual-Energy X-ray absorptiometry, muscle thickness of the thigh with ultra sound measurement, vertical jump height with linear Encoder, sprint performance with 30m sprint time.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Ds
* Minimum of 2 years of resistance training experience
* \>\< Two resistance training sessions each week
* \>\< three handball sessions each week
* No injuries that prevent participants to perform test of maximal muscle strength
* No injuries, that affects the muscle strength or the ability to train

Exclusion Criteria:

* Elevated blood pressure (\>140/90)
* Anabolic steroids or prescription-only medical products with know or potential effect on muscle hypertrophy

Primary outcomes:
measure: Change in Maximal Muscle Strength
timeFrame: Baseline measurements at week 1, after four weeks of exercise at week 5 and post intervention at week 10.
Secondary outcomes:
measure: Change in Lean body mass
timeFrame: Baseline measurements at week 1 and post intervention at week 10.
Other outcomes:
measure: Jump Performance
timeFrame: Baseline measurements at week 1 and post intervention at week 10.
measure: Sprint performance
timeFrame: Baseline measurements at week 1 and post intervention at week 10.
Locations:
city: Aarhus
country: Denmark
facility: Dept. of Public Health
Study officials:
References:
Clinical trial NCT05162560: Incidence and Outcome of Acute Diverticulitis in Finland
Official title: Incidence of Acute Diverticulitis in Finland: Nationwide Register Study of Epidemiology and Outcome of Treatment Between 2009-19
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Diverticulitis
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
name: Mikkeli Central Hospital
First posted: 2021-12-17
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute diverticulitis is whole Finland and in two study hospitals during years 2009-2019

Brief summary: The incidence of acute diverticulitis (AD), conservative vs. surgical treatment and outcome of patients are studied using national registries and patient charts from two hospitals between years 2009-19.

Detailed description: Acute diverticulitis (AD) of colon is increasing in Finland. Incidence, prevalence and mortality of AD of colon are investigated during 10-year period (2009-2019) in whole country. Epidemiological data is compared to data of acute appendicitis. Nationwide data of patients with AD are asked from Finnish Institute for Health and Welfare (THL). To compare registry-based nationwide data, patient charts from electronic database of two hospitals (Mikkeli Central Hospital and Tampere University Hospital) are reviewed from same study period. Patient characteristics, medication, treatment (conservative vs surgery), recurrence of AD and long-term outcome are recorded.

Eligibility criteria: Inclusion Criteria:

* all patients with acute diverticulitis (K57) in Finland and in two hospitals

Exclusion Criteria:

* other reasons for acute or chronic abdominal pain

Primary outcomes:
measure: Rate of annual incidence and prevalence of acute diverticulitis
timeFrame: January 2009-December 2019
Secondary outcomes:
measure: Number of patients with surgical or conservative treatment
timeFrame: January 2009-December 2019
measure: Number of treatment complications and survival of patients with acute diverticulitis
timeFrame: January 2009-December 2019
Other outcomes:
Locations:
city: Mikkeli
country: Finland
facility: Mikkeli Central Hospital
Study officials:
affiliation: Eastern Univerisity of Finland
name: Hannu EK Paajanen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02990260: Effect of Saccharomyces Cerevisiae in LDL Cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Lead sponsor: Lesaffre International
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.


Eligibility criteria: Inclusion Criteria:

* Moderate hypercholesterolemia (LDL cholesterol between 1.3 and 1.9 g/L) with maximum 1 associated cardiovascular risk factor.

Exclusion Criteria:

* Total cholesterol \> 3.5 g/L (on an empty stomach)
* Triglycerides \> 3 g/L (on an empty stomach)
* Familial hypercholesterolemia (IIa type)
* Diabete mellitus treated or not
* Subjects having consumed drugs known for their impact on lipid metabolism (statines, ezetimibes, colestyramin, fibrate...) in the month before beginning if the study and/or susceptible to consume such drugs during the study
* Subjects having consumed food supplements or functional foods known for their impact on cholesterolemia (phytosterols, phytostanols, policosanols, beta-glucans...) in the month before the study and/or susceptible to consume such products during the study
* Subjects having consumed probiotics food supplements in the month before the study and/or susceptible to consume such products during the study
* Subjects following a low diet regimen (intakes \< 1500 kcal/day) in the month before the study and/or susceptible to start such a regimen during the study
* Food behaviour disorders diagnosed
* Subjects with rare serious diseases (rare digestive diseases, renal failure, cardiovascular diseases, tumor...) or having endure a serious surgery
* Subjects having endure bariatric surgery or having a gastric bypass in place
* Pregnant or lactating women
* Women willing a pregnancy Excessive alcohol consumption
* Susceptible to modify their tobacco consumption before the end of the study

Primary outcomes:
measure: Plasma LDL cholesterol
timeFrame: 8 weeks
Secondary outcomes:
measure: LDL cholesterol
timeFrame: 4 weeks
measure: Total cholesterol
timeFrame: 4 weeks, 8 weeks
measure: Triglycerides
timeFrame: 4 weeks, 8 weeks
measure: HDL cholesterol
timeFrame: 4 weeks, 8 weeks
measure: Apo B
timeFrame: 4 weeks, 8 weeks
measure: Apo A1
timeFrame: 4 weeks, 8 weeks
measure: gamma GT
timeFrame: 4 weeks, 8 weeks
measure: ASAT
timeFrame: 4 weeks, 8 weeks
measure: ALAT
timeFrame: 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: Institut Pasteur de Lille
Study officials:
References:
Clinical trial NCT06901960: Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients with Chronic Kidney Disease Stages 3-5
Official title: Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients with Chronic Kidney Disease Stages 3-5 to Reduce Rate of Hyperkalemia - a Practical Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Stages 3-5
Keywords: Chronic kidney disease
hyperkalemia
ECG
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The clinical trial will be conducted in a real-world outpatients setting with the goal of learning if monitoring serum potassium frequently among patients with moderate-to-advanced stages of chronic kidney disease leading to optimal management of hyperkalemia (the reduced occurrence of serum potassium ≥ 5.5 mmol/L during 1-year follow-up). It will also learn about the adherence of using a mobile monitoring device.

Participants will:

* Measure their serum potassium using an AI-enhanced point-of-care ECG device at least once per week
* Receive health education prompts to reduce intake of potassium rich foods if their eletrocardiogram device measured serum potassium is abnormal
* Receive alerts to visit nephrology clinic if their eletrocardiogram device measured serum potassium is continuously abnormal


Eligibility criteria: Inclusion Criteria:

* Patients with chronic kidney disease stages 3-5 (eGFR: 10 - \<60 ml/min/1.73m²)
* Patients with regular visits in the study sites to manage their chronic kidney disease (≥ 1 visit per 3 months during the past year before enrollment)
* Willingness to participate in the study with signed informed consent

Exclusion Criteria:

* Patients already under kidney replacement therapy or will receive kidney replacement therapy in 6 months
* Unwillingness or without the ability to monitor hyperkalemia using the study device
* Patients with heart pacemaker implantated

Primary outcomes:
measure: First occurrence of hyperkelamia (plasma potassium ≥ 5.5 mmol/L) within 1 year after recruition
timeFrame: From enrollment to the end of 1 year
Secondary outcomes:
measure: First occurrence of hyperkelamia (plasma potassium ≥ 5.5 mmol/L) within 6 month after recruition
timeFrame: From enrollment to the end of 6 months
measure: Adherence to the monitoring of hyperkalemia
timeFrame: From enrollment to the end of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Wuhan
country: China
facility: Hubei Provincial Hospital of TCM
state: Hubei
Study officials:
References:
Clinical trial NCT05612360: Message Encouraging Vaccination in Preparation for the Holidays
Official title: Message Encouraging Vaccination in Preparation for the Holidays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
behavioral science interventions
vaccination promotion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 520000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the different arms.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This experiment is part of a megastudy with a total of ten experimental conditions and a holdout control condition to which patients will be randomly assigned. Ther focal comparison in this experiment is between a message encouraging vaccination by reminding participants that the holiday season is just a few weeks away and getting vaccinated will allow them to more safely gather with loved ones and a control message telling patients that an updated COVID booster vaccine is waiting for them. The intervention testing if text messages encouraging vaccination by reminding participants that the holiday season is just a few weeks away and getting vaccinated will allow them to more safely gather with loved ones will produce more vaccinations than otherwise identical messages.


Eligibility criteria: Exclusion Criteria:

1. The patient unsubscribed from texts before the send date and time of the patient's SMS/MMS message
2. The patient received a bivalent COVID booster before the send date and time of the patient's SMS/MMS message.

Primary outcomes:
measure: COVID bivalent booster receipt
timeFrame: During the 30 days after receiving the SMS/MMS intervention
Secondary outcomes:
measure: COVID bivalent booster receipt
timeFrame: 60 days after receiving the SMS/MMS intervention
measure: COVID bivalent booster receipt
timeFrame: 90 days after receiving the SMS/MMS intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: