louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06844357: A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.
Official title: A Multi-center, Randomized, Controlled, Open-label Phase II/III Clinical Trial to Investigate Whether Transarterial Tirapazamine Injection Followed by Transarterial Embolization (TATE) is Superior to Traditional Transarterial Chemoembolization (TACE) in Patients With Intermediate-Stage Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: HCC
Lead sponsor: Zhejiang Raygene Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 300
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 phase I/II clinical trial aims to determine the efficacy and safety of TATE compared to TACE in patients with intermediate-stage HCC. The results will provide valuable insights into the potential benefits of TATE as a novel treatment option for HCC.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with primary hepatocellular carcinoma according to AASLD criteria.
* No evidence of extrahepatic metastasis, regional lymph node involvement, or vascular tumor thrombus.
* Patients must be eligible for TAE or TACE treatment.
* ECOG ≤ 1.
* Child-Pugh score ≤ 7.
* Adequate bone marrow, liver, and kidney function is required.

Exclusion Criteria:

* History of liver transplantation.
* Previous radioemblization or radiotherapy for liver tumors.
* severe cardiovascular or renal diseases, active systemic infections.
* Clinically significant hypoxia (oxygen saturation \< 92% without oxygen supplementation)

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 36 months
Secondary outcomes:
measure: Complete Response (CR) rate
timeFrame: 36 months
measure: objective response rate (ORR)
timeFrame: 36 months
measure: duration of complete response (DOCR)
timeFrame: 36 months
measure: overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Affiliated to Southeast University
state: Jiangsu
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
Study officials:
affiliation: Zhongda Hospital
name: Gaojun Teng, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of Lishui City
name: Jiansong Ji, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05058157: Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
Official title: Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Men and Women
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each testing cycle design will be either a complete or partial cross-over.
Primary purpose: TREATMENT

Brief summary: This research project aims at evaluating the effect of various ketone precursors and their formulations on blood ketone level after oral intake. Evaluation of the GI tolerability of the various formula will be also evaluated.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women, based on the screening visit and medical history,
* BMI in the normal and overweight range 18.5 ≤ BMI ≤ 27;
* Able to understand and sign informed consent form.

Exclusion Criteria:

* Any medication possibly impacting the postprandial glucose and insulin response (based on anamnesis),
* Any medication impacting dietary fat absorption and metabolism,
* Pregnancy (on anamnesis) and/or lactation,
* Known food allergy and food intolerance,
* Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional,
* Individuals under ketogenic diets, or taking regular ketones products,
* Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of bier,
* Having given blood within the last month, or willing to make a blood donation until one month following the end of the study,
* Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland,
* Volunteer who cannot be expected to comply with the protocol,
* Smokers unable to stop for the day of the visit.

Primary outcomes:
measure: Ketone Plasma Kinetics After Oral Intake of Different Ketogenic Formulae
timeFrame: 0 (baseline) to 4 hours after products consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestlé Clinical Innovation Lab
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Pamela Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229957: Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness
Official title: Rehabilitation in Primary Care: A Project to Maximize the Health Status of Adults With Chronic Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Hypertension
Back Pain
Obesity
Arthritis
Keywords: Occupational therapy
Physical therapy techniques
Primary health care
Chronic disease
Rehabilitation
Disease management
Self care
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2005-09-30
Enrollment: 303
Sex: ALL
Minimum age (years): 44
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether occupational therapy and physiotherapy delivered in a primary care setting to adults with chronic illness is effective in improving health.

Detailed description: Primary health care is changing so that people receive the care that they need at the front line. Rehabilitation has been identified as one service that should be offered in primary care, to address the needs of adults who have or are at risk of poor health from chronic conditions such as arthritis, heart disease and depression.

Two full time therapists (one physiotherapist and one occupational therapist) will offer rehabilitation to a sample of 170 adults with chronic illness over an 18 month period (170 people will also be enrolled in a control group) at the Stonechurch Family Health Centre. Key outcomes include health, hospital admissions and emergency room visits.

Eligibility criteria: Inclusion Criteria:

* At least 1 chronic condition
* 3 visits to family physician in the past year

Exclusion Criteria:

* None

Primary outcomes:
measure: SF-36 Physical Component
timeFrame: 15 months
Secondary outcomes:
measure: Use of Hospital Services
timeFrame: baseline, 15 months
measure: Independence in Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)
timeFrame: baseline, 15 months
measure: Functional Limitations
timeFrame: baseline, 15 months
measure: Falls and Injuries
timeFrame: baseline, 15 months
measure: HOME Falls and Accident Screening Tool (FAST)
timeFrame: baseline, 15 months
measure: Self-management and Self-efficacy
timeFrame: baseline, 15 months
measure: Physical Abilities (Strength, Balance)
timeFrame: baseline, 15 months
measure: Patient Satisfaction Questionnaire - 18 (Modified)
timeFrame: 15 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Stonechurch Family Health Centre, 549 Stonechurch Rd. E.
state: Ontario
Study officials:
affiliation: McMaster University
name: Lori Letts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Julie Richardson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05487157: Social Workers of Elderly Care in Hungary
Official title: Social Workers of Elderly Care in Hungary- Investigation of Workplace Conditions- Workplace Stress, Burnout and Turnover Intention After the Covid-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
COVID-19
Burnout, Professional
Keywords: social workers
stress
turnover
covid-19
burnout
hungarian social sector
validation of TIS
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hungarian actively employed Social workers

Brief summary: In our Research the goal is to examine the level of stress and burnout among social care workers and their causes and effects after COVID-19 pandemic. We would like to examine the migration from work trend and its socio-demographic causes in the light of COVID-19 pandemic among social care workers in Hungary. We would like to analyze the extent of stress and burnout at work after COVID-19 pandemic, as well as the resulting turnover intentions in Hungary among social care workers. Our goal is to validate on hungarian population the Turnover Intention Scale (TIS-6), to measure fluctuation and migration.

Detailed description: A number of stress factors have been identified that affect nurses' burnout and job change, but there is little domestic research on the topic among social workers in connection with the COVID-19 epidemic.

As a result of our research, we expect that higher fear of COVID-19 is associated with lower job satisfaction, increased workplace anxiety, burnout, and increased turnover intentions.

Eligibility criteria: Inclusion Criteria:

* Social workers in Hungary, who are actively employed,
* 18 years of age or older
* working in the field of elderly care.

Exclusion Criteria:

* people, who do not have an active employment
* currently have no job
* working online
* non-professional staff working in social care (eg. cleaning, maintenance)

Primary outcomes:
measure: Social workers's stress, burnout and turnover intention
timeFrame: Day 1
measure: Social workers's stress, burnout and turnover intention
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Overall Hungary
state: Baranya
Study officials:
References:
Clinical trial NCT05808257: Thulium vs. Hol:YAG Laser
Official title: Superpulsed Thulium Fiber Laser VS. Pulse Modulated High Power Holmium:YAG Laser For Retrograde Intrarenal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrolithiasis
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 82
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 is a randomized prospective study to compare stone free rates and operative efficiency of two laser systems used during retrograde intrarenal surgery for kidney stone disease:

1. A superpulsed thulium fiber laser (thulium)
2. A pulse modulated high power holmium laser (Holmium)

Detailed description: This is a randomized prospective study. The purpose is to compare the stone free rate and operative efficiency of two leading contemporary laser systems used during retrograde intrarenal surgery for kidney stone disease. The researchers will compare the following two systems:

1. A superpulsed thulium fiber laser (thulium)
2. A pulse modulated high power holmium laser (Holmium)

The researchers will recruit 82 subjects undergoing single stage unilateral ureteroscopy for renal stones with a volume between \>5mm to \< 20 mm. Subjects will be randomized to undergo lithotripsy with either Ho:YAG or Thulium lasers.

All subjects will undergo surgical interventions that abide by broadly accepted guidelines and standards of care.

The primary outcome is stone free rate evaluated by postoperative CT scans done 6-12 weeks after surgery.

Eligibility criteria: Inclusion criteria:

* Undergoing single stage unilateral RIRS for total stone burden volume \>5mm to \< 20 mm
* Preoperative CT scan for baseline measurements

Exclusion criteria:

* Anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture
* Ureteral stent
* Uric acid component \>50% on stone analysis
* Prior ureteroscopy within 6 weeks of current surgery
* Irreversible coagulopathy
* Urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope.

Primary outcomes:
measure: Number of Participants With Stone Free Status
timeFrame: 6-12 weeks postoperative
Secondary outcomes:
measure: Fragmentation Speed
timeFrame: Intraoperatively (Day 1)
measure: Lasing Activity
timeFrame: Intraoperatively (Day 1)
measure: Energy Utilization
timeFrame: Intraoperatively (Day 1)
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mantu Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01173757: To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
Official title: A Phase I, Healthy Volunteer Determination Of 5HT4 Receptor Occupancy Of PF-04995274, Using PET With Ligand [11C]PF-05127401.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-04995274 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
* Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire

Primary outcomes:
measure: Exposure response of overall 5HT4 receptor occupancy of PF-04995274
timeFrame: up to 3 days
measure: 5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain
timeFrame: up to 3 days
Secondary outcomes:
measure: Adverse events
timeFrame: up to 3 days
measure: change from baseline in vital signs
timeFrame: up to 3 days
measure: Singlet ECG post-dose
timeFrame: up to 3 days
measure: Clinical safety laboratory endpoints
timeFrame: up to 3 days
measure: Clinical examinations
timeFrame: up to 3 days
measure: Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma
timeFrame: up to 3 days
measure: Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma
timeFrame: up to 3 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05251857: Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients
Official title: Animation Education Program Applied to Laparoscopic Sleeve Gastrectomy Patients Effect on Patient Care Results: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Educational Problems
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objectives This study investigated the effect of animation education developed for respiratory rehabilitation among sleeve gastrectomy patients on patient care results.

Design This is a randomized controlled study. Method A total of 66 patients who were going to have sleeve gastrectomy were randomly divided into two groups each including 33 participants. The intervention group was provided with animation education. The control group received routine face-to-face education. Postoperative risk of respiratory complications, presence of dyspnea, nausea, and vomiting, frequency of postoperative respiratory exercises, and satisfaction with postoperative respiratory education were examined. Patients' pain and sleep quality were examined one day before the surgery and on the postoperative first and fifth days.


Eligibility criteria: Inclusion Criteria:

The patients,

who are in clinical treatment for sleeve gastrectomy; who are 18 years of age or older, mentally healthy; who can speak and understand Turkish; who owns and can use smartphones; who do not have chronic diseases related to the respiratory system (lung diseases, etc.); who are volunteers, will be included in the study.

Exclusion Criteria:

The Patients

who are a lung infection in the last month who are neurological disease who are major psychiatric diagnosis who are vision and hearing problems who are intolerable dyspnea who do not agree to participate in the study, will be excluded

Primary outcomes:
measure: Visual Analog Scale
timeFrame: until the treatment is completed,an average of 5 days
measure: Richard Campbell Sleep Questionnaire (RCSQ)
timeFrame: until the treatment is completed,an average of 5 days
Secondary outcomes:
measure: Respiratory complications question form
timeFrame: until the treatment is completed,an average of 5 days
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT01593657: Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery
Official title: Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Malignancy
Abdominal Surgery by Laparotomy
Pain
Psychological Distress
Lung Function
Surgical Complications
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this clinical trial is to understand if women undergoing surgery for a suspected gynecologic malignancy are interested in participating in a Mindful Movement and Breathing program and what the effects of this program are on women and the surgery-related symptoms they experience. Mindful Movement and Breathing programs may be effective for easing distress, post-surgical pain, and other symptoms of surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Signed protocol specific informed consent
* 18 years of age or older
* Scheduled for a major abdominal gynecological surgery to remove a mass that is suspected to be malignant

Exclusion Criteria:

* Unable to read or understand English
* Cognitively impaired and/or cannot complete interviews as judged by the referring physician, nurse, or study staff

Primary outcomes:
measure: Feasibility of implementing and evaluating a Mindful Movement and Breathing Program among women undergoing gynecologic surgery for a suspected malignancy (recruitment, retention, adherence, and program evaluation and acceptability rates)
timeFrame: 4-5 days
Secondary outcomes:
measure: Immediate effects of the Mindful Movement and Breathing program on reducing postsurgical pain, psychological distress and lung function
timeFrame: 4-5 days
measure: Collect data on measures that will be used to evaluate the efficacy of the Mindful Movement and Breathing program in a future larger randomized controlled trial
timeFrame: 4-5 days
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne Danhauer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01132157: Comparison of the Protective Effect of Desflurane and Propofol in Patients With Renal Transplantation
Official title: The Comparison of Preconditioning Effect of Desflurane and Antiapoptotic Effect of Propofol in Patients With Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
End Stage Renal Disease
Keywords: Healthy Kidney Donors and Their Recipients with End Stage Renal Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 99
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ischemia/reperfusion (IR) injury is the major cause of early renal dysfunction and acute renal failure of the transplanted kidney after renal transplantation. In 1986, Murry et al. described the phenomenon "ischemic preconditioning". Also, it was reported that a few non-ischemic stimuli could provide cellular tolerance against major ischemia through a mechanism similar to ischemic preconditioning. In an animal study, 1 minimal alveolar concentration of volatile anesthetics - a clinically relevant concentration - was reported to have a protective effect against ischemia/reperfusion injury, the effect being variable between types of anesthetics. Also, there were somm reports that intravenous anesthetics such as propofol could reduce IR injury by decreasing oxidative stress and apoptosis.

By reducing the ischemia/reperfusion injury of the grafted kidney, the morbidity and mortality related to renal transplantation can be reduced as well. The objective of this study is to find out whether, according to the type of anesthetics (Desflurane vs. Propofol), there is a difference in the protective effect against ischemia/reperfusion injury of the grafted kidney in patients receiving renal transplantation.


Eligibility criteria: Inclusion Criteria:

* healthy kidney donors and their recipients of renal transplantation.

Exclusion Criteria:

* a donor that has any medical or surgical history,
* a recipient that is scheduled to have any other surgery with renal transplantation surgery.

Primary outcomes:
measure: BUN(Blood Urea Nitrogen)
timeFrame: 1 hour after surgery
measure: Cr density
timeFrame: 1 hour after surgery
measure: estimated GFR(Glomerular Filtration Ratio)
timeFrame: 1 hour after surgery
measure: urine output to check the the degree of protection for renal function
timeFrame: 1 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital, Yonsei University College of Medicine
name: Bon Nyeo Koo, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: