louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03717649: Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit (CPB)
Official title: Negative Venous Line Pressure in a Miniaturised Cardiopulmonary Bypass Circuit - the Influence of a Fenestrated Venous Cannula and Its Effect on Pump Flow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Surgery
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A single centre, prospective, randomised, double-blind trial
Primary purpose: TREATMENT

Brief summary: Study to measure the ability of a 'fenestrated' venous line cannula to reduce the negative line pressure seen with kinetic-assist active venous drainage (KAVD) in a standard miniaturised cardiopulmonary bypass circuit and thereby increase the flow characteristics of the bypass pump.

Detailed description: To investigate whether a new venous drainage pipe (cannula) which has three sets of drainage holes (three-stage) compared with the standard two-stage cannula, or a three-stage which also has additional windows (fenestrations), can improve the drainage of blood into the circuit, reducing the negative pressure produced and increase the blood flow delivered to the patient. Patients who consent to participate will be randomly assigned to one of three types of venous cannula:

1. Standard venous cannulation with a two-stage venous cannula
2. The three-stage cannula (91437C, Medtronic)
3. The fenestrated three-stage cannula (MC2X, Medtronic)

Eligibility criteria: Inclusion Criteria:

* All patients over the age of 18 years of age scheduled to undergo isolated Coronary Artery Bypass Grafting (CABG) or isolated Aortic Valve Replacement (AVR), who are able and willing to consent.
* Consultant surgeon willing to operate using either Mini-CPB for CABG or AVR surgery.

Exclusion Criteria:

* Re-operation and emergency surgery
* Patients refusing or unable to provide informed consent

Primary outcomes:
measure: Average blood flow
timeFrame: duration of surgery
Secondary outcomes:
measure: Negative pressure readings
timeFrame: duration of surgery
measure: Number of microbubbles
timeFrame: duration of surgery
measure: Size of microbubbles
timeFrame: duration of surgery
measure: Haemolysis
timeFrame: duration of surgery
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals Plymouth NHS Trust
name: Mark Bennett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04020549: Single-Session Computerized Mental Health Intervention for Rural Indian Adolescents
Official title: Evaluating the Effectiveness of a Computerized, School-Based, Single-Session Intervention for Rural Indian Adolescents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Well-Being
Depression
Anxiety
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Sangath
First posted: 2019-07-16
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall aim of this project is to understand if single-session interventions are acceptable, culturally appropriate, and effective for Indian adolescents attending a rural, low-resource government school. The investigators will be examining the effects of a computerized intervention on the well-being and mental health of adolescents. The investigators hypothesize that the intervention will yield statistically significant improvements in wellbeing and mental health relative to a study skills control condition.


Eligibility criteria: Inclusion Criteria:

* Attending a participating secondary school
* Age 12 to 18
* Literate in English

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Change in The Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: Baseline, 4 week follow-up, 12 week follow-up
measure: Intervention Appropriateness Measure
timeFrame: Immediately post-intervention (i.e., 0 weeks)
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: Baseline, 4 week follow-up, 12 week follow-up
measure: Generalized Anxiety Disorder Screener-7
timeFrame: Baseline, 4 week follow-up, 12 week follow-up
measure: The EPOCH Measure of Adolescent Well-being
timeFrame: Baseline, 4 week follow-up, 12 week follow-up
measure: Acceptability of Intervention Measure
timeFrame: Immediately post-intervention (i.e., 0 weeks)
measure: Feasibility of Intervention Measure
timeFrame: Immediately post-intervention (i.e., 0 weeks)
measure: Perceived Stress Scale-4
timeFrame: Time Frame: Baseline, 4 week follow-up, 12 week follow-up
Other outcomes:
Locations:
city: Pune
country: India
facility: Z P school, Wablewadi
state: Maharashtra
Study officials:
affiliation: University of Pennsylvania
name: Rob DeRubeis, PhD
role: STUDY_DIRECTOR
affiliation: Sangath
name: Sachin Shinde, PhD
role: STUDY_DIRECTOR
affiliation: Modern College Pune
name: Sadhana Natu, PhD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Akash Wasil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03371849: PK and Safety Study of HCP1102, HGP0813 and HGP1408
Official title: A Randomized, Open Label, Single Dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of HCP1102 in Comparison to HGP0813 and HGP1408 Administered in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2017-12-13
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of HCP1102 in comparison to HGP0813 and HGP1408 administered in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

1. Age 19\~45 years in healthy male volunteers
2. BMI is more than 19kg/m\^2 , no more than 28.0 kg/m\^2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Primary outcomes:
measure: AUClast of Montelukast
timeFrame: 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour
measure: Cmax of Montelukast
timeFrame: 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour
measure: AUClast of Levocetirizine
timeFrame: 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour
measure: Cmax of Levocetirizine
timeFrame: 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
citation: Moon SJ, Yu KS, Jung J, Kim YI, Kim MG. Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast and levocetirizine after a single oral administration in healthy Korean male subjects . Int J Clin Pharmacol Ther. 2020 Jun;58(6):354-362. doi: 10.5414/CP203709.
Clinical trial NCT06793449: BCMA CAR-T Versus ASCT in Transplant-eligible Patients With Multiple Myeloma
Official title: A Prospective, Non-inferiority Study Comparing VRD±D Followed by BCMA CAR-T Cell Therapy Versus VRD±D Followed by Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Patients With Newly-diagnosed Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-inferiority study comparing VRD±D followed by BCMA CAR-T cell therapy versus VRD±D followed by autologous hematopoietic stem cell transplantation in the treatment of newly diagnosed multiple myeloma patients.


Eligibility criteria: Inclusion Criteria:

1. Be informed and voluntarily sign the Informed Consent Form (ICF).
2. Age between 18 and 70 years (inclusive).
3. Have measurable disease meeting at least one of the following criteria: Serum M-protein ≥1 g/dL (\>10 g/L) as detected by serum protein electrophoresis (SPEP), or quantifiable IgA or IgD levels for IgA or IgD-type myeloma; Urine M-protein ≥200 mg/24 hours; In cases where serum and urine M-protein do not meet the above thresholds, an abnormal free light chain (FLC) ratio (normal range: 0.26 to 1.65) and involved serum FLC ≥100 mg/L.
4. Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone marrow immunohistochemistry.
5. Assessed by the investigator as transplant-eligible.

Exclusion Criteria:

1. Primary plasma cell leukemia.
2. Concurrent amyloidosis.
3. Involvement of the central nervous system (CNS).
4. Previous treatment with BCMA-targeted therapy or CAR-T cell therapy.

Primary outcomes:
measure: Persistent MRD-negative rate
timeFrame: Up to 2 year
measure: Progression free survival (PFS)
timeFrame: Up to 5 year
Secondary outcomes:
measure: Complete response rate (CRR)
timeFrame: within 1 week after induction therapy, 1 month after the CAR-T cell infusion or ASCT, within 1 week after consolidation therapy
measure: Duration of Remission(DOR)
timeFrame: Up to 5 year
measure: Overall Survival (OS)
timeFrame: Up to 5 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Study officials:
References:
Clinical trial NCT04943549: Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression
Official title: Erector Spinae Plane Block Impact on Quality of Recovery After Lumbar Spinal Decompression Surgery; a Comparative Study Between Addicts and Non-addicts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Lumber surgery
Postoperative analgesia
Erector spinae pain block
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Erector spinae plane block (ESPB) as a new trunk fascia block technique was proposed in 2016. ESPB has aroused the interest of many nerve block experts. The benefits of ESPB are not yet demonstrated. The specific mechanism is still controversial. Some believe that ESPB can block the posterior root of the spinal nerve and produce part of the para-spinal block effect with the diffusion of the drug solution.

The present study will carried out to compare the performance of the erector spinae plane block combined with general anesthesia in addicts versus non addicts' patients regarding the local analgesic effect, recovery after surgery and side effects.


Eligibility criteria: Inclusion Criteria:

1. Male gender.
2. Age range of 18-60 years.
3. Scheduled for open lumbar decompression surgery.
4. A minimum of 1-year experience of drug consumption or having drug withdrawal symptoms when stopping for inclusion in the drug addicts group(according to the patient's statement and rapid opiate urine test).

Exclusion Criteria:

1. Hepatic or renal insufficiency.
2. Preoperative cognitive dysfunction or communication disorder.
3. Allergy to amide-type local anaesthetics.
4. Back puncture site infection.
5. Coagulation disorders.
6. Emergency surgery.

Primary outcomes:
measure: The quality of recovery score (QoR-15) at 24th hour
timeFrame: at 24th hour
Secondary outcomes:
measure: Postoperative pain.
timeFrame: At half an hour, 2, 4, 8, 12, 24 hours.
measure: Intraoperative fentanyl dosage.
timeFrame: From the start of operation till its end up to 3 hours.
measure: First-time morphine use.
timeFrame: In 24 hours
measure: First time to ambulation after surgery.
timeFrame: In 24 hours
measure: Length of hospital stay.
timeFrame: up to 3 days.
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha Faculity of Medicine
state: Elqalyoubea
Study officials:
References:
Clinical trial NCT02331849: Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.
Official title: Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry - Effect on Esophageal Motility of Standard Therapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic esophagitis (EoE)
GERD
esophageal motility
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Esophageal Motility in eosinophilic esophagitis will be evaluated by High Resolution Manometry before and after medical treatment - motility is suspected to change/improve after therapy.

Detailed description: After identification of eosinophilic inflammation of the esophagus -\> differentiation between GERD and eosinophilic esophagitis (via pH/MII-measurements or PPI-trial) -\> High-resolution manometry (HRM) for evaluation of esophageal motility in patients with eosinophilic esophagitis (exclusion of GERD-patients)-\> initiation of budesonide-therapy -\> after eight weeks of therapy reevaluation of esophageal motility by HRM

Eligibility criteria: Inclusion Criteria:

• patients with eosinophilic inflammation of the esophagus

Exclusion Criteria:

* refusal to participate in study
* pregnancy
* eosinophilic gastroenteritis
* Achalasia
* contraindication for gastroscopy / HRM / 24-h-pH/Impedance-monitoring
* contraindication for therapy with budesonide
* eosinophilic inflammation due to GERD

Primary outcomes:
measure: Improvement of esophageal motility (IBP) measureable in high resolution manometry (HRM)
timeFrame: Two months
Secondary outcomes:
measure: Improvement of esophageal motility (e.g. specified in the chicago classification) represented in high resolution manometry (HRM)
timeFrame: Two months
measure: Endoscopic evaluation of inflammation before/after therapy
timeFrame: Two months
measure: Symptoms before/after therapy
timeFrame: Two months
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum rechts der Isar, II. Medizinische Klinik
Study officials:
affiliation: Klinikum rechts der Isar, II. Med. Klinik
name: Simon Nennstiel, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum rechts der Isar, II. Med. Klinik
name: Christoph Schlag, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum rechts der Isar, II. Med. Klinik
name: Monther Bajbouj, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weidlich S, Nennstiel S, Jesinghaus M, Brockow K, Slotta-Huspenina J, Bajbouj M, Schmid RM, Schlag C. IgG4 is Elevated in Eosinophilic Esophagitis but Not in Gastroesophageal Reflux Disease Patients. J Clin Gastroenterol. 2020 Jan;54(1):43-49. doi: 10.1097/MCG.0000000000001154.
Clinical trial NCT05202249: Effect of Muscle and Skin Fixation of Thoracic Drainage Tube on Postoperative Pain
Official title: Effect of Muscle and Skin Fixation of Thoracic Drainage Tube on Postoperative Pain in Patients Undergoing Uniport Thoracoscopic Pulmonary Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Lung Cancer
Pulmonary Neoplasm
Postoperative Pain
Thoracoscopic Surgery
Keywords: chest tube drainage
thoracic drainage
thoracoscopic surgery
Postoperative Pain
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. The investigators aimed to determine whether a muscle layer fixation of thoracic drainage tube could release postoperative pain in patients with uniport thoracoscopic pulmonary resection compared with conventional skin fixation.


Eligibility criteria: Inclusion Criteria:

* 18\<age\<80;
* ASA≤III
* Patients with no clinically significant cardiac history, such as ischaemic heart disease, valvular heart disease, rhythm disturbances such as frequent atrial fibrillation or premature ventricular contractions (PVCs). Patients with significant cardiac history should be optimized according the relevant guidelines before surgery is considered.
* Normal cardiopulmonary function \[predicted forced expiratory volume in the first second(FEV1%) \>50% and ejection fraction (EF) \>50%of predicted value\]. Resting blood gas analysis showing arterial partial pressure of oxygen (PaO2)≥75 mmHg and arterial partial pressure of carbon dioxide (PaCO2) \<45 mmHg;

Exclusion Criteria:

* History of ipsilateral surgery and other conditions which can result in extensive pleural adhesion;
* Coagulopathy, hypoxemia (PaO2 \<60 mmHg), hypercapnia \[arterial carbon dioxide tension(PaCO2) \>50 mmHg\];
* Significant cardiac history.

Primary outcomes:
measure: Postoperative Pain
timeFrame: From date of operation until the date of chest tube removal, assessed up to 7 days
measure: Pain-associated inflammatory factor
timeFrame: the first day after surgery
measure: Dosage of analgesics
timeFrame: From date of operation until the date of chest tube removal, assessed up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT03201549: The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
Official title: The Effects of Increased Fructose Ingestion on FGF-21 Levels in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary aim of this study is to examine the effect of fructose ingestion on serum FGF-21 levels in humans.


Eligibility criteria: Inclusion Criteria:

* Ages 18-60
* BMI 19-25 kg/m2; 19-23 for Asian subjects
* Stable weight (variation \< 3 kg within 6 months of screening visit)
* Ability to give informed consent in English
* Use of medically approved form of contraception

Exclusion Criteria:

* Fasting blood glucose \>100
* Hemoglobin A1C% \> 6.5%
* Fasting triglycerides \>150
* Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
* Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
* Uncontrolled hypertension (BP \> 160/100 mmHg on or off antihypertensive medication) intravenous drug use
* Recent weight loss (\> 3 kg within 6 months of the screening visit)
* Gastroparesis
* Inflammatory or irritable bowel disease
* Malignancy treated with chemotherapy within the past 3 years
* Depression or psychosis requiring hospitalization
* Renal insufficiency (creatinine clearance \< 40 ml/min)
* Transaminases \> 2x above the normal range
* Known liver disease
* Pregnancy within 6 months of the screening visit
* Lactation
* Failure to use medically approved contraceptive methods
* History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
* Change in dose of thyroid hormone or antithyroidal medication within 3 months of screening visit
* History of alcohol abuse within the past 5 years
* Fructose intolerance

Exclusionary medications:

* Oral steroids
* Metformin
* Weight loss medications including nonprescription supplements

Primary outcomes:
measure: Change in serum FGF21 levels
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References: