louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03554005: Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)
Official title: Open-Label Extended Administration of SCH 54031 (PEG Interferon Alfa-2b/PEG Intron) in Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-06-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an extension study to base study protocol C/I97-188 (MK-4031-006). Its primary purpose is to assess the safety and tolerability of extended administration of polyethylene glycol (PEG) interferon alfa-2b in participants with solid tumors.


Eligibility criteria: Inclusion Criteria:

* Had a response of stable disease or better in PEG interferon alfa-2b base study C/I97-188 (MK-4031-006).
* Has a Performance Status of 0 (normal activity), 1 (symptoms, but fully ambulatory), or 2 (symptomatic, but in bed \<50% of the day).
* Is enrolled within two weeks of completing their last dose of PEG Interferon alfa-2b on the previous study and has not have received any other therapy during this period.

Exclusion Criteria:

* Discontinued prior to completing PEG interferon alfa-2b base study C/I97-188 (MK-4031-006).
* Is pregnant or nursing.

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event
timeFrame: Up to 42 Weeks
measure: Number of Participants Who Discontinued Treatment Due to an Adverse Event
timeFrame: Up to 40 Weeks
Secondary outcomes:
measure: Best Objective Response
timeFrame: Up to 40 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06349005: Laryngoscopy and Coronary Artery Bypass Graft Surgery
Official title: Hemodynamic Response to Various Laryngoscopes During Tracheal Intubation in CABG Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Videolaryngoscopy
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this prospective, randomized, controlled trial, the purpose is to compare Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope in terms of hemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).

Detailed description: During endotracheal intubation, laryngoscopy can significantly affect hemodynamic responses, including tachycardia and elevated blood pressure, which may be particularly detrimental to individuals with cardiovascular conditions. Various studies have explored the hemodynamic reactions associated with laryngeal stimulation through different intubation devices. Researchers hypothesize that endotracheal intubation using video laryngoscopy will elicit a reduced hemodynamic response compared to traditional (Macintosh) laryngoscopy. In this prospective and randomized clinical study, the purpose is to compare the Macintosh laryngoscope, EzVision® video laryngoscope, McGrath® video laryngoscope and Storz® video laryngoscope concerning haemodynamic response associated with intubation in adult patients undergoing Coronary Artery Bypass Surgery (CABG).

Eligibility criteria: Inclusion Criteria:

* Age range between 18 and 75 years.
* Scheduled for elective coronary artery bypass surgery.
* Classified under American Society of Anesthesiologists (ASA) physical status II-III.
* Patients with no history of difficult intubation or associated risk factors.

Exclusion Criteria:

* Emergency case
* Predicted difficult airways
* Body mass index \> 35 kilograms per meter squared
* Baseline hemodynamic instability

Primary outcomes:
measure: Hemodynamic response
timeFrame: Change from baseline Systolic or Diastolic or mean Blood Pressure at 10 minutes
measure: Hemodynamic response
timeFrame: Change from baseline heart rate at 10 minutes
Secondary outcomes:
measure: Intubation time
timeFrame: 180 seconds
measure: Visualization of the glottis
timeFrame: 180 seconds
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
References:
Clinical trial NCT00817505: To Evaluate the Bioavailability of a Tablet of AZD1656
Official title: A Randomized, Open, Single-Dose, Single-Centre, Cross-over, Phase I Study in Type 1 Diabetes Mellitus Patients to Estimate the Extent and Rate of Absorption of AZD1656 After Administration of a Tablet Formulation in the Fasting State and Just Before Food in Comparison With an Oral Suspension of AZD1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Keywords: Type I diabetes
bioavailability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the bioavailability of a tablet of AZD1656.


Eligibility criteria: Inclusion Criteria:

* Male or female, type I diabetes patients, female with non child-bearing potential.
* Treated with insulin for more than 3 years. Well controlled HbA1c.
* Have a body mass index (BMI) ≥19 and ≤35

Exclusion Criteria:

* Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
* Daily use of nicotine containing substances.

Primary outcomes:
measure: Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)
timeFrame: Blood samples taken up to 72 hours
Secondary outcomes:
measure: Pharmacodynamic variables (Plasma glucose)
timeFrame: Taken repeatedly during treatment periods
measure: Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)
timeFrame: Taken during treatment periods
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Research site
state: Texas
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Klas Malmberg, MD, PhD, Prof
role: STUDY_DIRECTOR
affiliation: Healthcare Discoveries LLC Icon Development Solutions
name: Emanuel P DeNoia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00181805: Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Official title: The Natural History of Children With Persistent Gastroesophageal Reflux Disease (Ages 12 to 17 Years)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Keywords: GER
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-16
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects will be selected from a database of patients seen at Children's Hospital, Boston or Massachusetts General Hospital between 1977 and 1990 who had biopsies or pH probe for symptoms of GERD.

Brief summary: The goal of this project is to determine the long-term health outcome of children diagnosed with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have compiled a database of more than 300 subjects that completed diagnostic testing for GER in the 1970's, 1980's, and 1990's. Subjects are being contacted initially by mail using a previously approved recruitment letter. Subjects that fail to respond to this recruitment letter are called by phone. In each case, contact information has been abstracted from the Children's Hospital database. Subjects are then given the opportunity to complete a questionnaire either by phone or in hard copy. Subjects receive no compensation for their participation in this study. Subjects will be compared to controls. Controls will complete the same questionnaire as the subjects. Inclusion of potential controls will be determined by a lack of medical history of gastroenterological diseases before the age of 21 and whether the potential control was born within a year of a subject in the study. Controls will receive $25 to participate in the study.


Eligibility criteria: Inclusion Criteria for Subjects:

* Patients who were evaluated for GERD at the age of 12-17 years, inclusive at Children's Hospital, Boston or Massachusetts General Hospital
* Positive for GERD per biopsies or pH probe results

Exclusion Criteria for Subjects:

None

Inclusion Criteria for Controls:

* No GI diseases prior to age 21 including, but not limited to reflux, inflammatory bowel disease,Hirschsprung's disease
* Date of birth is within 1 year of a subject's date of birth

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Harland S. Winter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06577805: The Outcomes of Living Donor Robotic Assisted Kidney Transplantation
Official title: A Retrospective Cohort Study of Prospectively Collect the Outcomes of Recipients After Robot-assisted Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant; Complications
Renal Failure Chronic
Keywords: robotic surgery
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage 5 chronic kidney disease undergoing living robot-assisted kidney transplantation

Brief summary: The technology for robot-assisted kidney transplantation (RAKT) has become increasingly advanced, with numerous studies demonstrating comparable outcomes between RAKT surgery and open surgery. This advancement is particularly noteworthy as it extends its suitability to transplant patients with obesity. It will be important to explore the results of robot-assisted kidney transplantation as compared with open surgery or within cohorts.


Eligibility criteria: Inclusion Criteria:

1. living-donor kidney transplant recipients
2. receiving standard triad immunosuppressive regimen

Exclusion Criteria:

1. active infection
2. multi-organ transplantation
3. malignancy history in the donor and recipient
4. human immunodeficiency virus infection

Primary outcomes:
measure: The graft function of recipients
timeFrame: in the follow-up period，about six months to one year
Secondary outcomes:
measure: total operative time
timeFrame: about 150 minutes to 300 minutes
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT06219005: Ultrasound-guided Nerve Block Training Model and Evaluation Method
Official title: Standardized Assessment of Emergency Physician Ultrasound-guided Nerve Block Training Using a Low-fidelity Simulation Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nerve Blocks
Medical Education, Simulation, Crisis Resource Management
Medical Education in Emergency Ultrasound
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective observational cohort study
Primary purpose: OTHER

Brief summary: The aim of this study is to assess emergency medicine physician knowledge and technical skill in performance of ultrasound-guided serratus anterior nerve block in a low-fidelity simulation model workshop and to determine the feasibility, acceptability, and usability of the training program. By performing this study, the investigators hope to create a standardized training model which could potentially facilitate POCUS and critical procedural performance and thereby improve patient care.


Eligibility criteria: Inclusion Criteria:

* Emergency medicine attending and resident physicians

Exclusion Criteria:

* ED nursing, ED technicians, and advanced practice physicians (APPs)

Primary outcomes:
measure: Physician knowledge assessment
timeFrame: 4 months
measure: Physician technical skills assessment
timeFrame: 4 months
Secondary outcomes:
measure: acceptability of our implementation strategy
timeFrame: 4 months
measure: appropriateness of our implementation strategy
timeFrame: 4 months
measure: feasibility of our implementation strategy
timeFrame: 4 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
Study officials:
References:
citation: Petrosoniak A, Herold J, Woolfrey K. Emergency medicine procedural skills: what are residents missing? CJEM. 2013 Jul;15(4):241-8. doi: 10.2310/8000.2013.130897.
citation: Sherbino J, Bandiera G, Frank JR. Assessing competence in emergency medicine trainees: an overview of effective methodologies. CJEM. 2008 Jul;10(4):365-71. doi: 10.1017/s1481803500010381.
Clinical trial NCT05323305: Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients
Official title: Ultrasound Guided Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients: A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Post Operative
Keywords: Ultrasound, pectointercostal, Cardiac surgery
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will be designed to compare the analgesic effect of ultrasound-guided pectointercostal fascial plane block versus tansversus thoracic plane block in adult cardiac surgery.

Detailed description: A prospective study will be carried out in Alexandria Main University Hospitals on 60 adult patients planned for elective cardiac surgery, after approval of the Ethical Committee of Faculty of Medicine, Alexandria, and having an informed written consent taken from patients included in the study. Patients will be categorized into two equal groups; group P (n=30)) will receive ultrasound-guided pectointercostal fascial plane block and group T (n=30) will receive ultrasound-guided transversus thoracic plane block.

All patients will receive the ultrasound-guided block after induction of anesthesia and an equal booster dose of the same block before extubation in the ICU. Patients in both groups will also receive an ultrasound-guided bilateral serratus anterior plane block before extubation.

Eligibility criteria: Inclusion Criteria:

1. Adult patient.
2. Elective cardiac surgery.

Exclusion Criteria:

1. Refusal to participate.
2. Redo or urgent cardiac surgery.
3. Local infection of the skin at the site of needle puncture.
4. Allergy to bupivacaine.
5. Coagulation disorders.
6. Clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension.
7. when extubation is intentionally planned to be delayed

Primary outcomes:
measure: the analgesic effectiveness of the two blocks on midline sternotomy pain,
timeFrame: from end of surgery till discharge from ICU (96 hours)
Secondary outcomes:
measure: pulmonary complications
timeFrame: from end of surgery till discharge from ICU (96 hours)
measure: length of stay in ICU
timeFrame: average 4 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Hospitals
Study officials:
affiliation: Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university
name: islam Omar, MD
role: STUDY_CHAIR
affiliation: Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university
name: Ibrahim Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university
name: Moustafa Halwag, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06921005: Can Lower-body Occlusion Influence Sports Recovery?
Official title: Can Lower-body Occlusion During Low-intersity Cycling Influence Recovery of Youth Elite Soccer Players?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Recovery of Function
Sports
Keywords: sports
recovery
blood flow restriction
Lead sponsor: University of Maia
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 15
Sex: MALE
Minimum age (years): 17
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study ai ms to compare the recovery kinetics of different interventions: i) active recovery; ii) continuous vascular occlusion during active recovery; iii) intermittent vascular occlusion during active recovery; iv) control group.


Eligibility criteria: Inclusion Criteria:

* soccer players
* elite athletes
* present in the pitch training sessions

Exclusion Criteria:

* injured athletes
* female athletes

Primary outcomes:
measure: countermovement jump height
timeFrame: Baseline, post 30 minutes, post 24 hours
measure: squat jump height
timeFrame: Baseline, post 30 minutes, post 24 hours
measure: Bar velocity during squat
timeFrame: Baseline, post 30 minutes, post 24 hours
measure: hip thrust bar velocity
timeFrame: Baseline, post 30 minutes, post 24 hours
measure: Perceived fatigue
timeFrame: Baseline, post 30 minutes, and post 24 hours.
measure: Muscle soreness Visual Analogue Scale
timeFrame: Baseline, 30 minutes post, 24 hours post.
measure: Perceived recovery
timeFrame: Baseline, 30 minutes post, 24 hours post.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01835405: LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds
Official title: A Prospective, Single-centre Study to Compare the Use of LiquiBand® Flex, Dermabond Advanced™ or Conventional Sutures for the Topical Closure of Surgical Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Incisions
Lead sponsor: Advanced Medical Solutions Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-19
Enrollment: 66
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: To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.


Eligibility criteria: Inclusion Criteria:

* Male or Female aged 18 or older on day of enrollment
* Scheduled for surgical procedure by a delegated study surgeon
* Fresh surgical wound with evenly distributed tension over length of incision
* Willing and able to sign informed consent
* Agree to return for 2 week (+/- 7 days) and 3 month (90 days +/- 7 days) post-procedure follow-up visit

Exclusion Criteria:

* Known sensitivity to cyanoacrylates, formaldehyde or acetone products
* Wounds in which incision edges are under high tension or not easily apposed (after deep layer suture), or over joints (unless immobilized)
* Wounds less than 15mm in length
* Wounds in which haemostasis is not able to be achieved, eg, drain is placed or Warfarin level \>2.5 prior to surgery
* Wounds in which deep closure could not be achieved
* Surgical procedures involving mucus membranes or eyes
* Mental incapacity, dementia, or inability to give informed consent
* Pregnant or nursing
* Disease related or pharmacologically immuno-compromised

Primary outcomes:
measure: To compare cosmetic outcomes at follow up
timeFrame: 3 months post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly
country: United States
facility: Oncology Care Center, Beverly Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01480505: Primary Vitrectomy for the Treatment of Retinal Detachment in Highly Myopic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure,
Postoperative Complications
Keywords: Retinal detachment
high myopia
macular hole
axial length
Scleral buckling
Vitrectomy
Visual acuity
fundus examination results
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: On the basis of axial length greater than 30 mm, 67 eyes of 67 patients with at least six-month follow-up in our department were selected.

Brief summary: Purpose:

To assess the functional and anatomical outcome of primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length over 30 mm.

Methods Design: Retrospective single center series. Setting: University Hospital. Patients: High myopic patients treated with primary vitrectomy without scleral buckling for a rhegmatogenous retinal detachment.

Outcome measures: Anatomical success rate with complete reattachment of the retina without silicone oil tamponade and postoperative best-corrected visual acuity (BCVA).


Eligibility criteria: Inclusion Criteria:

* retinal detachment secondary to peripheral breaks (retinal tears, atrophic retinal hole)
* secondary to posterior breaks (MH, PVT).

Exclusion Criteria: retinal detachment secondary to

* severe eye injury,
* diabetic retinopathy,
* retinopathy of prematurity,
* uveitis.

Primary outcomes:
measure: Assessing the functional and anatomical outcome of primary vitrectomy in Rhegmatogenous retinal detachment in highly myopic eyes
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Ophthalmology Department
state: Burgundy
Study officials:
References: