louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04451473: Lung Surgery With Enhanced Recovery VS. Lung Surgery Without Enhanced Recovery
Official title: The Short Term and Long Term Comparison of Lung Surgery With or Without Enhanced Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Surgery
ERAS
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The adoption of Enhanced Recovery Surgery programs in lung resection is relatively recent with limited outcome data. This study aimed to determine the impact of an Enhanced Recovery Surgery pathway on short- term and long- term results in patients undergoing lung resection for primary lung cancer.

Methods: A Randomized Controlled Trial was designed to collect the perioperative data on consecutive patients undergoing lung resection for primary lung cancer. Patients will be randomizely assigned to the ERAS- Group and Control- Group. Short-term and long- term effect will be compared between the two groups.


Eligibility criteria: Inclusion Criteria: patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need VATS surgery.

-

Exclusion Criteria: cardio-pulmonary function couldn't tolerate surgery

-

Primary outcomes:
measure: intensive care unit utilization
timeFrame: within 4 days after surgery
measure: the degree of pain
timeFrame: within 4 days after surgery
measure: the time of ambulation
timeFrame: within 48 hours after surgery
measure: the time for oral feed
timeFrame: within 48 hours after surgery
measure: the time of hospitalization
timeFrame: within 5 days after surgery
measure: complications
timeFrame: within 7 days after surgery
Secondary outcomes:
measure: disease- free survival
timeFrame: within 5 years after surgery
measure: overall survival
timeFrame: within 10 years after surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Yunpeng Zhao
state: Shandong
Study officials:
affiliation: The Second Hospital of Shandong University
name: Xiaogang Zhao, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02559531: Reliability of the Swiss Emergency Triage Scale (SETS®) Used by Emergency Medical Service (EMS) Providers
Official title: Reliability of the Swiss Emergency Triage Scale (SETS®) Used by Emergency Medical Service (EMS) Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Medical Services
Triage
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Swiss Emergency Triage Scale (SETS) in used for triage in emergency departments in Switzerland, France and Belgium. No validated triage scale is actually used by Emergency Medical Service (EMS) providers. The objective of this project is to evaluate the reliability and performance of triage by EMS providers with the SETS.

Detailed description: The Swiss Emergency Triage Scale (SETS) in used for triage in emergency departments in Switzerland, France and Belgium. No validated triage scale is actually used by EMS providers. The objective of this project is to evaluate the reliability and performance of triage by EMS providers with the SETS.

In order to perform this evaluation a cohort of 22 EMS providers will evaluate 28 standardized clinical scenarios using a computer simulator.

Eligibility criteria: Inclusion Criteria:

* All EMS providers employed by a private ambulance company in the State of Geneva, Switzerland

Exclusion Criteria:

* Not giving informed consent

Primary outcomes:
measure: Emergency level (1 to 4) accordingly to the SETS
timeFrame: 1 day: all computeriez vignettes will be evaluated during a one-day session in November 2015.
Secondary outcomes:
measure: Correct emergency triage level identification
timeFrame: 1 day: all computeriez vignettes will be evaluated during a one-day session in November 2015.
measure: Proper orientation
timeFrame: 1 day: all computeriez vignettes will be evaluated during a one-day session in November 2015.
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: ED of Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Olivier T Rutschmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06869031: Adaptive Intervention Model for Hypertension Self-Management in Rural Areas: a Doctor-Patient Interaction Approach
Official title: Construction and Verification of Adaptive Intervention Model for Self-Management Behavior of Hypertensive Patients in Rural Areas：A Perspective of Doctor-Patient Interactions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension Self-management
Hypertension
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The aim of this project is to develop and validate an adaptive intervention model to improve self-management behavior in rural hypertensive patients. The primary question it seeks to answer is: Can a tailored, interaction-based intervention model, guided by key doctor-patient interaction elements, effectively enhance self-management behavior among rural hypertensive patients and improve long-term blood pressure control? Researchers will evaluate the impact of different intervention strategies on self-management behavior and identify the most effective combination to establish a sustainable intervention model for rural hypertension management.


Eligibility criteria: Inclusion Criteria:

* Diagnosed hypertension patients who are permanent residents in rural areas.
* No plans for long-term relocation within the next year.
* Willing to participate in this study.
* No cognitive impairment.
* No other diseases that significantly affect self-management behavior, such as malignant tumors.

Exclusion Criteria:

* Age over 80 years.
* Having conditions such as stroke, paralysis, or mental disorders that prevent the completion of self-management behaviors.
* Severe hearing impairment or speech disorders that prevent participation in interviews.
* Likely to relocate or be away from the local area for an extended period within one year.

Primary outcomes:
measure: Hypertension self-management behavior
timeFrame: From the start of the intervention to the 6-month and the end of the trial at 12 months.
measure: Blood pressure
timeFrame: From the start of the intervention to the 6-month and the end of the trial at 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Fourth Hospital and West China School of Public Health. Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT00601731: Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months
Official title: A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months Who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Keywords: Prevention of Meningococcal disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2008-01-28
Enrollment: 382
Sex: ALL
Minimum age (years): 40
Maximum age (years): 63
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.


Eligibility criteria: Inclusion Criteria:

* Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health
* Control subjects: healthy 60 months old who had received a complete MenC immunization course

Exclusion Criteria:

* Subjects with any serious, acute or chronic progressive disease

Primary outcomes:
measure: Percentage of Subjects With hSBA ≥1:8
timeFrame: At 40 and 60 months of age
Secondary outcomes:
measure: Percentage of Subjects With hSBA ≥1:4
timeFrame: At 40 and 60 months of age
measure: GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
timeFrame: At 40 and 60 months of age
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Clinical Trials Research Center
city: Vancouver
country: Canada
facility: Vaccine Evaluation Center
city: Oxford
country: United Kingdom
facility: Oxford Vaccine Group
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Khatami A, Snape MD, Davis E, Layton H, John T, Yu LM, Dull PM, Gill CJ, Odrjlin T, Dobson S, Halperin SA, Langley JM, McNeil SA, Pollard AJ. Persistence of the immune response at 5 years of age following infant immunisation with investigational quadrivalent MenACWY conjugate vaccine formulations. Vaccine. 2012 Apr 16;30(18):2831-8. doi: 10.1016/j.vaccine.2012.02.046. Epub 2012 Mar 3.
Clinical trial NCT05948631: MISC-IPV: a Community-Based Intervention for Children Traumatized by Intimate Partner Violence
Official title: MISC-IPV: a Community-Based Intervention for Children Traumatized by Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: MISC Intervention
Treatment As Usual
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: Texas Women's University
First posted: 2023-07-17
Enrollment: 132
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study adapts and evaluates preliminary outcomes of the Mediational Intervention for Sensitizing Caregivers (MISC) for women and children of color who have survived domestic violence.

Detailed description: The investigators propose that the adverse effects of Intimate Partner Violence (IPV) trauma on children can be interrupted through an intervention that enhances maternal caregiving capacity delivered by paraprofessional caseworkers. The objective of this application is to adapt an established caregiver intervention program, Mediational Intervention for Sensitizing Caregivers (MISC), for the IPV context (thereafter named MISC-IPV). Guided by an evidence-based framework for adapting caregiver-child training programs, the investigators take a three-phase approach (Adapt, Process Evaluation, Outcome/Mediator Evaluation) with the central hypothesis that acceptability and feasibility of MISC-IPV will be demonstrated and that MISC-IPV will show positive preliminary outcomes through the mechanism of enhanced maternal caregiving. In acknowledgement of significant health disparities faced by IPV-affected African American women, the investigators will conduct our research with African American women and their children. Successful completion of the project will result in a scalable community-based approach to IPV exposure that may provide a model for future integration of child-focused work into existing woman-focused IPV programs.

Eligibility criteria: Mother inclusion criteria:

1. Enrolled in Harris County Domestic Violence rehousing program
2. Fluency in English

Mother exclusion criteria:

1. Active suicidality
2. Intellectual disability
3. Active psychotic disorder

Child inclusion criteria:

1. Exposure to domestic violence
2. 7-11 years old in a family

Child exclusion criteria:

1. Intelligence quotient below 75,
2. Active psychosis
3. Severe autism
4. Below age 7 or above age 11

Primary outcomes:
measure: Mental health problems
timeFrame: Baseline, six, 12, and 18 months.
measure: Sensitive caregiving
timeFrame: Baseline, six, 12, and 18 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: csharp2@uh.edu
name: Carla Sharp
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06180031: Effect of Adding Magnesium Sulphate in Pericapsular Nerve Group Block
Official title: Effect of Adding Magnesium Sulphate to Bupivacaine in Ultrasound Guided Pericapsular Nerve Group Block for Post Operative Analgesia in Hip Joints Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hip Fractures
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim will be to compare the analgesic efficacy and safety of magnesium sulphate as an adjuvant to bupivacaine in pericapsular nerve group block in Hip joint surgeries.

* Our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative.
* Our secondary outcome of the study: mean arterial blood pressure, heart rate, respiratory rate, adverse effects, block related complication, sedation score (by Ramsay sedation scale) and pain score (by Visual Analog Scale)


Eligibility criteria: Inclusion Criteria:

* • Patients aged 18 years or more.

  * Patients with American society of anesthesiologists (ASA) classification class I or II
  * Patients weight range from 50 to 90 Kgs

Exclusion Criteria:

* • Patient refusal of peripheral nerve block

  * Patient with infection at the site of injection
  * Patient with coagulopathy
  * Patients with known allergy to used medications.

Primary outcomes:
measure: Postoperative pain management
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Visual analog scale
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Alaa M Attia, Professor
role: STUDY_CHAIR
affiliation: South Egypt's cancer institute, Assiut University
name: Fatma A Abd Diab, Associate Professor
role: STUDY_DIRECTOR
affiliation: South Egypt's cancer institute, Assiut University
name: Moaz Tohamy, Lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT04534231: Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates
Official title: Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates: Test of an Idea to Promote Large Increases in Tobacco Cessation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Use Cessation
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary residents of the target municipality

Brief summary: One municipality with high smoking rates will be selected. A coupon for free-of-charge nicotine patches will be sent to each household. Reductions in the number of people smoking in the chosen municipality from before to after the NRT distribution will be estimated

Detailed description: A coupon offering five weeks of free nicotine patches will be mailed to every household in a small municipality with elevated smoking rates. Up to 800 participants (one per household) will be able to redeem their coupon online or by phone, and receive nicotine patches via postal mail. Participants will be asked to complete a baseline survey containing items relevant to predicting smoking cessation. Participants will be asked to complete a six-month follow-up survey to assess changes in smoking status.

Research Question: Will the concentrated distribution of nicotine patches in a region of high smoking rates lead to large reductions in smoking rates?

Eligibility criteria: Inclusion Criteria:

* speak and understand English
* 18 years or older
* smoke 10 or more cigarettes per day for at least 3 months

Exclusion Criteria:

* health contraindications for using nicotine patches without supervision of a doctor (e.g. allergy to tape, pregnant or intending to become pregnant, currently breastfeeding, serious heart or circulation problems not including high blood pressure)

Primary outcomes:
measure: 30-day pint prevalence abstinence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: John A Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunningham JA, Leatherdale ST, Chaiton M, Tyndale RF, Schell C, Godinho A. Offering nicotine patches to all households in a community with high smoking rates: Pilot test of a population-based approach to promote tobacco cessation. Int J Popul Data Sci. 2021 Feb 11;6(1):1400. doi: 10.23889/ijpds.v6i1.1400.
Clinical trial NCT04746131: Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
Official title: Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: B-cell Non-Hodgkin's Lymphoma
Keywords: IMM0306
Lead sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Sponsor class: OTHER
Collaborators: name: Worldwide Clinical Trials
First posted: 2021-02-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL).


Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* Diagnosed with B-NHL
* Relapsed after or be refractory to at least 2 line of standard therapy

Exclusion Criteria:

* Active central nervous system (CNS) metastases
* Positive Direct Antiglobulin Test (DAT)
* Active autoimmune disorder
* Skin disorders that do not requires hormone replacement therapy

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity)
timeFrame: End of Study (52 Weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
Study officials:
affiliation: VP，Clinical Development
name: Cheng Huang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00730431: Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)
Official title: A Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IDX184 After Oral Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Hepatitis C, healthy volunteers
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study.


Eligibility criteria: Inclusion Criteria:

* Participants are in general good health.
* All participants of childbearing potential must have agreed to use a consistent form of an acceptable double-barrier method of birth control

Exclusion Criteria:

* Participant is pregnant or breastfeeding.

Primary outcomes:
measure: Percentage of participants experiencing serious adverse events (SAEs)
timeFrame: Up to Day 6
measure: Percentage of participants experiencing AEs
timeFrame: Up to Day 6
measure: Percentage of participants experiencing dose-limiting toxicity (DLTs)
timeFrame: Up to Day 6
measure: Percentage of participants experiencing grade 1-4 laboratory abnormalities
timeFrame: Up to Day 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Zhou XJ, Pietropaolo K, Chen J, Khan S, Sullivan-Bolyai J, Mayers D. Safety and pharmacokinetics of IDX184, a liver-targeted nucleotide polymerase inhibitor of hepatitis C virus, in healthy subjects. Antimicrob Agents Chemother. 2011 Jan;55(1):76-81. doi: 10.1128/AAC.01101-10. Epub 2010 Nov 8.
Clinical trial NCT01789931: Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing
Official title: Examination of a New Non Invasive Sensor "Lifebeam" During HTT (Heat Tolerance Test) in Protective Clothing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heat Illness
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-02-12
Enrollment: 10
Sex: MALE
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: CB (Chemical Biological)protective clothing provides a thermal resistance between the human body and its environment. CB protective clothing will be essential for combat soldiers in case of non conventional attacks. "Lifebeam" developed a new non invasive sensor for body core temperature detection. The research purpose is to evaluate the "Lifebeam" sensor during heat tolerance test while wearing CB protective clothing.


Eligibility criteria: Inclusion Criteria:

* age 21-30
* healthy
* after medical checkup
* after signing concent form

Exclusion Criteria:

* heart disease
* respiratory disease
* baseline bp above 140/90 mmHg
* sleep disorders
* diabetes
* anhydrosis
* skin disease
* acute illness in last 3 days prior to the examination

Primary outcomes:
measure: Heat tolerance test
timeFrame: 1 year
measure: VO2 test
timeFrame: 1 year
Secondary outcomes:
measure: Skin temperature
timeFrame: 1 year
measure: Rectal temperature
timeFrame: 1 year
measure: Heart rate
timeFrame: 1 year
measure: blood circulation parameters
timeFrame: 1 year
Other outcomes:
Locations:
city: Tel-Hashomer, Ramat- Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Heller institute, Sheba medical center
name: Barliz Adato, MD
role: PRINCIPAL_INVESTIGATOR
References: