louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01749865: CIK Treatment for HCC Patient Underwent Radical Resection
Official title: A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who underwent radical resection will be included. The patients will be randomized to group A (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer treatment after resection of HCC, and the randomize ratio will be 1:1.


Eligibility criteria: Inclusion Criteria:

* Male or female patients over 18 years of age.
* Without any prior anti-cancer therapy.
* Patients who have a life expectancy of at least 12 weeks.
* Patients already had radical resection of HCC.

Definition of radical resection in this study:

* All tumors were moved out, with a clean resection margin.
* Number of tumors less than 3.
* Without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein.
* No hepatic hilum lymphnode metastasis.
* No distance metastasis.
* Hepatocellular carcinoma with histological diagnose.
* No major post-operative complication.
* Patients who have an performance status of 0, or 1.
* Cirrhotic status of Child-Pugh class A only.
* The following laboratory parameters:
* Patients who give written informed consent.

Exclusion Criteria:

* Previous or concurrent cancer that is distinct in primary site or histology from HCC.
* History of cardiac disease.
* Active clinically serious infections ( over grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events version 3.0)
* Known history of human immunodeficiency virus (HIV) infection
* Known Central Nervous System tumors including metastatic brain disease.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* History of organ allograft.
* Known or suspected allergy to the investigational agent or any agent given in association with this trial.
* Pregnant or breast-feeding patients.
* Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
* Excluded therapies and medications, previous and concomitant:

Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy. Antiviral treatment is allowed.

Primary outcomes:
measure: Time to recurrence
timeFrame: 5-year
Secondary outcomes:
measure: Disease Free Survival
timeFrame: 5 year
Other outcomes:
measure: Adverse Events
timeFrame: 5 years
Locations:
city: Guangzhou
country: China
facility: Immunotherapy
state: Guangdong
Study officials:
References:
Clinical trial NCT03455465: Using Rapid Cycle Trials to Increase Patient Engagement in the Community Health Worker Program in the Emergency Department
Official title: Using Rapid Cycle Trials to Increase Patient Engagement in the Community Health Worker Program in the Emergency Department at NYU Langone Health Hospital-Brooklyn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Engagement; Community Health Workers
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 2314
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who present for a visit at the Emergency Department at NYU Langone Brooklyn Hospital and who qualify for the Community Health Worker program assessment and enrollment.

Brief summary: This study is evaluating the effectiveness of the post-discharge program facilitated by the Community Health Worker program in the Emergency Department at NYU Langone Health Hospital - Brooklyn and testing different strategies to increase patient engagement in the program.


Eligibility criteria: Inclusion Criteria:

* Patients who present for a visit at the Emergency Department at NYU Langone Brooklyn Hospital and who qualify for the Community Health Worker program assessment and enrollment.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Service utilization
timeFrame: 1 year
measure: Post-discharge program enrollment rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Leora Horwitz, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05452265: Minimal Invasive Surgery for Gastric Subepithelial Tumor
Official title: Different Approach of Minimal Invasive Surgery for Gastric Subepithelial Tumor From A Single-Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Subepithelial Tumor
Keywords: gastric subepithelial tumors
endoscopic resection
laparoscopic resection
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with gastric SETs who underwent ER or LR at the operative theater in our institution

Brief summary: The investigators conducted a retrospective study of those patients with gastric SETs receiving ER or LR at the operative theater in the single institution from January 2013 to December 2021. Medical records were retrospectively reviewed to define patient/tumor characteristics and operative outcomes.


Eligibility criteria: Inclusion Criteria:

* patients with gastric subepithelial tumors
* patients received minimal invasive surgery (endoscopy or laparoscopy) for tumor resection

Exclusion Criteria:

* patients had gastric anatomic changes due to previous surgery
* patients converted open surgery

Primary outcomes:
measure: Procedure duration
timeFrame: during the procedure/surgery
measure: Length of hospital stay
timeFrame: upto one month after surgery
measure: Rate of postoperative major complications
timeFrame: upto one month after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06559865: Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion
Official title: Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion: a Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussion, Mild
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the sub-acute period after concussion, and to document the autonomic function, and symptom severity (post-concussion symptoms, anxiety, sleep) before and after administration of the intervention.

Participants will:

will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from a concussion follow-up program.

A weekly phone meeting will be performed with the participants, to review exercise, providing, specific instructions, and making any necessary adjustments.

All participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.


Eligibility criteria: Inclusion Criteria:

* aged 9-18 years
* seven days-3 months post-concussion,
* at least one post-concussion symptom in the Post-concussion Symptom Inventory (PSCI) that is relevant to ANS dysfunction (e.g. dizziness, nausea, fatigue, confusion, anxiety or sleep disturbances).

Exclusion Criteria:

* known heart disease,
* previous neurological problems other than concussion

Primary outcomes:
measure: Feasibility-days of practice
timeFrame: 4 weeks
measure: Feasibility-daily duration of practice
timeFrame: 4 weeks
Secondary outcomes:
measure: Autonomic nervous system function-Heart rate
timeFrame: initial and 4 week evaluation
measure: Autonomic nervous system function-Heart rate variability
timeFrame: initial and 4 week evaluation
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
References:
Clinical trial NCT06589765: A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin
Official title: A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (OUTSTAND-2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HRS-7535 tablet compared with dapagliflozin tablet
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with dapagliflozin in subjects with type 2 diabetes mellitus with inadequate glycemic control using metformin.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18-75 age years, both inclusive;
2. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
3. HbA1c 7.5-11.0% (both inclusive) at screening;
4. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening.

Exclusion Criteria:

1. Known or suspected allergy to the investigational drug or its components or excipients.
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
5. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

Primary outcomes:
measure: Change from baseline in HbA1c at 32 weeks of treatment
timeFrame: at 32 weeks
Secondary outcomes:
measure: Percentage of Participants Who Achieved HbA1c <7.0% at Week 32
timeFrame: at 32 weeks
measure: Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32
timeFrame: at 32 weeks
measure: Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32
timeFrame: at 32 weeks
measure: Percentage Change from Baseline in Body Weight, from Baseline to Week 32
timeFrame: at 32 weeks
measure: Change from Baseline in Body Weight, from Baseline to Week 32
timeFrame: at 32 weeks
measure: Change from Baseline in Waist Circumference, from Baseline to Week 32
timeFrame: at 32 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03123965: Expanded Access to Glecaprevir/ Pibrentasvir
Official title: Expanded Access to Glecaprevir/ Pibrentasvir
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Hepatitis C Virus Infection
Keywords: Special Access Scheme
Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-04-21
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to glecaprevir/ pibrentasvir prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Univ Medical Ctr Ljubljana /ID# 161419
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06294665: Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block
Official title: Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block as Post-operative Analgesia in Hip Surgeries.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hip Fractures
Post Operative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries


Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years.
2. Sex: Both sexes.
3. American Society of Anaesthesiologists (ASA) Physical Status Class I and II.
4. Scheduled for hip surgeries under spinal anaesthesia.

Exclusion Criteria:

1. Declining to give written informed consent.
2. History of allergy to the medications used in the study.
3. Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
4. Psychiatric disorder.
5. American Society of Anesthesiologists (ASA) Physical Status Class III and IV.

Primary outcomes:
measure: The time to the first request of analgesia
timeFrame: 9 months
Secondary outcomes:
measure: Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively
timeFrame: 9 months
measure: Occurrence of side effects of drugs.
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT02871765: The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment
Official title: The Educational Effectiveness for Atrial Fibrillation Patients Under Warfarin Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Patient education
Knowledge
Life distress
Quality of life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective of this study is to evaluate an educational program for Atrial Fibrillation patients under Warfarin treatment regarding to patients' knowledge of Warfarin, related life distresses and quality of life.

Detailed description: This is a parallel-group randomized controlled study. Four measurements were (a) knowledge of Warfarin; (b) life distresses caused by Warfarin treatment; and (c) quality of life as primary and secondary endpoint. All participants participated in a face-to-face interview during the pretest and at the 6-month follow-up in the outpatient department (OPD). Each subject in the experimental group was taught face-to-face individually according to investigator's brochure in the OPD by researchers trained in a standardized protocol. The control group received a brochure only.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Atrial Fibrillation by a physician and taking Warfarin as treatment
* 20 years old or older
* clear consciousness for communication
* willingness to participate in research

Exclusion Criteria:

* can not communicate clearly
* without willingness to participate in research

Primary outcomes:
measure: knowledge of Warfarin
timeFrame: 6-month follow-up
Secondary outcomes:
measure: life distress
timeFrame: 6-month follow-up
measure: quality of life
timeFrame: 6-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung University
name: YU-HSIA TSAI, MS,RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pernod G, Labarere J, Yver J, Satger B, Allenet B, Berremili T, Fontaine M, Franco G, Bosson JL. EDUC'AVK: reduction of oral anticoagulant-related adverse events after patient education: a prospective multicenter open randomized study. J Gen Intern Med. 2008 Sep;23(9):1441-6. doi: 10.1007/s11606-008-0690-1. Epub 2008 Jun 20.
citation: Wofford JL, Wells MD, Singh S. Best strategies for patient education about anticoagulation with warfarin: a systematic review. BMC Health Serv Res. 2008 Feb 14;8:40. doi: 10.1186/1472-6963-8-40.
citation: Casais P, Meschengieser SS, Sanchez-Luceros A, Lazzari MA. Patients' perceptions regarding oral anticoagulation therapy and its effect on quality of life. Curr Med Res Opin. 2005 Jul;21(7):1085-90. doi: 10.1185/030079905X50624.
Clinical trial NCT06968065: Comparison of Ultrasound-Guided Serratus Combination Plane Blocks and Local Wound Infiltration for Postoperative Analgesia Management in Minimally Invasive Cardiac Surgery (MICS)
Official title: Comparison of Ultrasound-Guided Serratus Combination Plane Blocks and Local Wound Infiltration for Postoperative Analgesia Management in Minimally Invasive Cardiac Surgery (MICS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Heart Surgery
Analgesia
Keywords: Pain, Postoperative
Heart Surgery, Minimally Invasive
Analgesia
Bupivacaine
Opioid-Related Disorders
Lead sponsor: İstanbul Yeni Yüzyıl Üniversitesi
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized, prospective, single-blinded study aims to compare the efficacy of ultrasound-guided serratus anterior plane (SAP) block combined with serratus-intercostal interfascial plane (SIP) block versus local wound infiltration (LWI) for postoperative analgesia in patients undergoing minimally invasive cardiac surgery (MICS). The primary outcome is total perioperative and postoperative opioid consumption. Secondary outcomes include postoperative pain scores (NRS), opioid-related side effects, block-related complications, and ICU stay duration.

Detailed description: Minimally invasive cardiac surgery (MICS) has gained popularity due to reduced surgical trauma and faster recovery. However, postoperative pain management remains a challenge. This study evaluates the analgesic effectiveness of combining two interfascial plane blocks-SAP and SIP-under ultrasound guidance, compared to traditional local wound infiltration. A total of 60 patients scheduled for MICS with cardiopulmonary bypass will be randomized into two groups (SAP+SIP vs LWI). Pain scores, opioid usage, and complications will be recorded at predetermined intervals up to 72 hours postoperatively.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Undergoing MICS with left-sided 4th-5th intercostal incision
* ASA I-III
* Informed consent provided

Exclusion Criteria:

* Coagulopathy or on anticoagulants

  * Allergy to local anesthetics or opioids
  * Local infection at block site
  * Pregnancy or lactation
  * Bilateral thoracic incisions
  * Refusal to participate

Primary outcomes:
measure: o Total opioid consumption (mcg of fentanyl and mg of tramadol) in the first 48 hours postoperatively.
timeFrame: 48 hours
Secondary outcomes:
measure: NRS pain scores (static and dynamic) at 0, 2, 4, 8, 16, 24, 48, and 72 hours postoperatively.
timeFrame: 0 to 72 hours postoperatively.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kolan International Hospital
Study officials:
References:
Clinical trial NCT00952965: Wrist-used Blood Pressure Monitor Clinical Test (Cuff Range: 14cm-25cm)
Official title: Clinical Testing Report for Wrist-used Electronic Blood Pressure Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: BP
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 86
Sex: ALL
Minimum age (years): 23
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: resident of a community.

Brief summary: The purpose of this study is to monitor the blood pressure level of the patient using a wrist cuff ranged 14 cm-25 cm.


Eligibility criteria: Inclusion Criteria:

* wrist circumference: 14 cm-25 cm

Exclusion Criteria:

* none

Primary outcomes:
measure: level of blood pressure
timeFrame: 10 s
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Beichen hospital
state: Tianjin
Study officials:
affiliation: Andon Health Co., Ltd
name: Qi Sun
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong SN, Tz Sung RY, Leung LC. Validation of three oscillometric blood pressure devices against auscultatory mercury sphygmomanometer in children. Blood Press Monit. 2006 Oct;11(5):281-91. doi: 10.1097/01.mbp.0000209082.09623.b4.