louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04183881: A Phase 4 Clinical Study of Brodalumab
Official title: An Extension Study of Brodalumab in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Psoriatic Arthritis
Pustular; Psoriasis, Palmaris Et Plantaris
Psoriatic Erythroderma
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-03
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study \[4827-005 (post market)\] is designed to evaluate the safety and efficacy of long-term exposure to brodalumab in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic arthritis) who have completed Study 4827-003 (Study 003) and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004). 4827-005 study was conducted as phase 3 clinical trial until July 4th 2016 (approval date in Japan). After that date 4827-005 study was switched to phase 4 study.


Eligibility criteria: Inclusion Criteria:

* Subject has voluntarily signed the written informed consent form to participate in this study
* Subject has completed the study 4827-005 (phase 3)

Exclusion Criteria:

* Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
* Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators

Primary outcomes:
measure: Incidence and types of adverse events and adverse reactions
timeFrame: 28 weeks
measure: Anti-KHK4827 antibody
timeFrame: 28 weeks
Secondary outcomes:
measure: Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.
timeFrame: 28 weeks
measure: Percent improvement in PASI
timeFrame: 28 weeks
measure: PASI 50, 75, 90, and 100
timeFrame: 28 weeks
measure: Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
timeFrame: 28 weeks
measure: sPGA of "0 (clear)"
timeFrame: 28 weeks
measure: Change in body surface area involvement (BSA) of lesion
timeFrame: 28 weeks
measure: Clinical Global Impression (CGI)
timeFrame: 28 weeks
measure: American College of Rheumatology (ACR) 20
timeFrame: 28 weeks
measure: Pustular symptom score
timeFrame: 28 weeks
measure: Serum KHK4827 concentration
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: The Jikei University Scoole of Medicine
Study officials:
References:
Clinical trial NCT02787681: Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube
Official title: Multi-center Evaluation of the NEMO Gauge to Aid in Correct Positioning of the Endotracheal Tube After Intubation of Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to verify the safety and accuracy of an FDA-approved device called the NEMO™ Gauge to aide in the proper positioning of the endotracheal tube (ETT), inserted in the lungs of patients admitted to the intensive care unit. The hope is that the NEMO™ Gauge is able to properly determine the correct position of the endotracheal tube without the use of a chest radiograph (chest x-ray). The study investigators anticipate sixty-eight (68) subjects will participate in this study at three (3) study centers in the Inland Empire of Southern California, with subjects being enrolled at Loma Linda University Medical Center, Riverside University Medical Center and Loma Linda Veterans Affairs Hospital.


Eligibility criteria: Inclusion Criteria:

1. Adult patients ≥ 18 years of age admitted to the intensive care unit (ICU)
2. Patients who have been intubated or at high risk of being intubated, requiring confirmation of ETT position after intubation as determined by the clinical team
3. Endotracheal tube size 7.0 mm to 8.5 mm in diameter

Exclusion Criteria:

1. Patients with active hemoptysis
2. Patients with known tracheal or bronchial masses prior to endotracheal intubation
3. Patients with known tracheal or bronchial abnormalities requiring surgical repair

Primary outcomes:
measure: Number of Correct Endotracheal Tube Position
timeFrame: Immediate, post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Moreno Valley
country: United States
facility: Riverside University Medical Center
state: California
Study officials:
affiliation: Loma Linda University
name: H. Bryant Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04772781: Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain
Official title: National, Multicentre, Randomized, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of S (+) - Ibuprofen for Pain Control in Individuals With At Least Moderate Mechanical Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain, Mechanical
Low Back Pain
Acute Low Back Pain
Keywords: Pain control
Low back pain
Pain relief
Ibuprofen
Inflammation
Anti-inflammatory
Lead sponsor: Apsen Farmaceutica S.A.
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 177
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: The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals with at least moderate acute mechanical low back pain.


Eligibility criteria: Main Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Patient with acute low back pain who responds to the pain period less than or equal to 3 days;

Main Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* Previous history of alcohol or drugs abuse diagnosed by DSM-V;
* Current or previous history (less than 12 months) of smoking;
* Have clinically relevant abnormal laboratory results according to medical evaluation;
* Women who are pregnant, lactating, or positive for β - hCG urine test.

Primary outcomes:
measure: At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax)
timeFrame: Change from Baseline to 6 hours
Secondary outcomes:
measure: Adverse events rates between groups
timeFrame: During treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Apsen Farmacêutica S.A.
Study officials:
References:
Clinical trial NCT02015481: Safety Tolerability and Efficacy Study of Cabaletta to Treat Oculopharyngeal Muscular Dystrophy (OPMD) Patients
Official title: Multi-Center, Dose-Escalation Study, to Assess Safety, Tolerability and Efficacy of Intravenous Cabaletta® in OPMD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oculopharyngeal Muscular Dystrophy
Keywords: Case control, safety, tolerability, efficacy.
Lead sponsor: Bioblast Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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, Tolerability and Efficacy of Intravenous Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) Patients.


Eligibility criteria: Inclusion Criteria:

* Males and females
* 18 - 80 years (inclusive) of age
* Clinically and genetically diagnosed as OPMD
* Moderate dysphagia (abnormal drinking test at screening and on the first dosing day, before drug administration)
* Patients who provide written informed consent to participate in the study
* Body Mass Index (BMI) \<30 kg/m2

Exclusion Criteria:

* Diabetes mellitus type 1 or 2
* Other major diseases, e.g.: renal failure (creatinine clearance \<60ml/min), liver failure and chronic liver diseases (e.g. hepatitis B or C) , HIV carriers, tuberculosis, SLE, rheumatoid polyarthritis, sarcoidosis, collagenosis
* Uncontrolled heart disease , CHF,
* Other neuromuscular diseases
* Other disorders associated with esophageal dysphagia: e.g. severe gastroesophageal reflux (GERD), esophageal stricture due to mechanical or chemical trauma, infection (e.g. esophageal moniliasis), drug-induced dysphagia (e.g. bisphosphonates), esophageal rings and webs, spastic motility disorders of the esophagus.
* History of malignancy (except non-invasive skin malignancy)
* History of neck irradiation
* Pregnant or currently lactating women
* Obesity (BMI≥ 30) and associated morbidity
* Prior pharyngeal myotomy
* Weight loss of more than 10% in the last 12 months.
* Known hypersensitivity to any ingredients in the injection
* Patient receiving anticoagulant treatment (e.g. warfarin)

Primary outcomes:
measure: Safety Lab Evaluations
timeFrame: 24 weeks
Secondary outcomes:
measure: Drinking Test Score
timeFrame: 24 weeks
measure: Videofluoroscopy (VFS) Score
timeFrame: 24 Weeks
measure: SWAL-QOL, Swallowing Quality of Life Questionnaire
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Orange
country: United States
facility: Tahseen Mozaffar
state: California
city: Montreal
country: Canada
facility: Montreal Neurological Institute, McGill University
state: Quebec
city: Jerusalem
country: Israel
facility: Hadassah medical center
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Bernard Brais, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02631681: Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
Official title: Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Exercise Therapy
Androgen Deprivation Therapy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Exercise intervention for men with prostate cancer on androgen deprivation therapy.

Detailed description: The aim of the project is to investigate the effects of patient education and exercise intervention implemented in daily clinical practice for men with prostate cancer on androgen deprivation therapy

* Functional capacity
* Quality of life
* Body composition
* Blood pressure

and to assess safety of progressive resistance training for participants with bone metastases.

Eligibility criteria: Inclusion Criteria:

* Patients with a prostate cancer diagnosis on androgen deprivation therapy

Exclusion Criteria:

* Opioid demanding treatment for skeletal pain
* Eastern Cooperative Oncology Group performance status \> 2
* Inability to perform floor and machine exercises independently

Primary outcomes:
measure: Change in 30second Chair-Stand test (30s-CST)
timeFrame: Baseline, 12 and 24 weeks
measure: Change in Graded Cycling Test with Talk Test (GCT-TT)
timeFrame: Baseline, 12 and 24 weeks
Secondary outcomes:
measure: change in QoL
timeFrame: Baseline, 12 and 24 weeks
measure: change in Body composition
timeFrame: Baseline, 12 and 24 weeks
measure: change in Bloodpressure
timeFrame: Baseline, 12 and 24 weeks
measure: Safety of exercise assessed by serious adverse events according to the FDA
timeFrame: Study period baseline - 24 weeks
measure: Compliance assessed by attendance and continued exercise (yes/no)
timeFrame: Baseline, 12 and 24 weeks
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
state: Please Select An Option Below
Study officials:
affiliation: Herlev and Gentofte Hospital, Faculty of Health and Medical Sciences, Copenhagen University, Denmark
name: Peter B Østergren, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostergren P, Ragle AM, Jakobsen H, Klausen TW, Vinther A, Sonksen J. Group-based exercise in daily clinical practice to improve physical fitness in men with prostate cancer undergoing androgen deprivation therapy: study protocol. BMJ Open. 2016 Jun 29;6(6):e011460. doi: 10.1136/bmjopen-2016-011460.
Clinical trial NCT05390281: Preoperative Level of Hemoglobin A1c and Acute Kindey Injury After Coronary Artery Bypass Grafting Surgery
Official title: Association Between Preoperative Level of Hemoglobin A1c and the Incidence of Acute Kindey Injury After Coronary Artery Bypass Grafting Surgery: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study compared the AKI incidence between patients with prediabetic level of HbA1c (5.7-6.4) and patients with elevated levels of HbA1c (\> or = 6.5). Forty patients who underwent elective CABG were enrolled in this cohort study.

Brief summary: Background: The development of acute kidney injury (AKI) is an important indicator of clinical outcomes after cardiac surgery. Elevated preoperative hemoglobin A1c level may be associated with acute kidney injury in patients undergoing coronary artery bypass grafting. This study will investigate the association of preoperative HbA1c levels with AKI after isolated coronary artery bypass grafting (CABG).


Eligibility criteria: Inclusion Criteria:

* ASA physical status II-III
* scheduled to undergo isolated coronary artery bypass grafting

Exclusion Criteria:

* Patients with history of renal failure
* Patients with history of hepatic failure
* Patients with history of heart failure
* previous cardiac surgery
* cerebrovascular event in the last 30 days
* percutaneous coronary intervention in the last 30 days prior to operation
* peripheral arterial disease
* malignancy
* infectious diseases
* patients who required surgical revision
* patients who required postoperative intra-aortic balloon pump
* patients with CBP time \> 120 min or aortic cross clamp time \> 90 min

Primary outcomes:
measure: serum creatinine level
timeFrame: 3 days
Secondary outcomes:
measure: Patients in need of RRT
timeFrame: 7 days
Other outcomes:
measure: Length of ICU stay
timeFrame: 7days
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University
Study officials:
References:
Clinical trial NCT04663581: Comparison Between the Right Lateral Decubitus and the Left Lateral Decubitus as Starting Position in Colonoscopy
Official title: Comparison Between the Right Lateral Decubitus and the Left Lateral Decubitus as Starting Position in Colonoscopy. Randomized Clinical Trial (POSCOL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy
Keywords: Colonoscopy
Lead sponsor: Sanitas University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 167
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: SCREENING

Brief summary: Randomized Clinical trial between two positions to initiate colonoscopy, Right Sided vs Left Sided

Detailed description: Objective To assess whether in the colonoscopy, the initial position of the patient in the right lateral decubitus (DLD) translates into advantages such as: shorter examination time or greater range of detection of polyps, compared to the left lateral decubitus (DLI), a position traditionally used.

Methodology This is a randomized and controlled clinical trial to be carried out in the city of Bogotá, in the Gastroenterology and Digestive Endoscopy Unit of the Colombia University Clinic, a fourth-level private clinic, a unit in which 7746 colonoscopies were performed in 2017.

The study will be carried out over a period of 2 months until the sample is completed.

Patients will be randomized to start their colonoscopy in the right lateral decubitus or left lateral decubitus and it would be assessed, the time to reach transverse colon, cecum and comfort perceived by the gastroenterologist and the patient.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for diagnostic colonoscopies in the digestive endoscopy unit.

Exclusion Criteria:

* Therapeutic colonoscopies.
* Patients with a history of colonic resection.
* Patients who cannot give their informed consent.
* Under 18 years old.
* Pregnant women.
* Patients with significant cardiopulmonary, renal or psychiatric disease.

Primary outcomes:
measure: Time to Reach Transverse Colon
timeFrame: During Procedure
measure: Time to Reach Cecum
timeFrame: During Procedure
Secondary outcomes:
measure: Number of polyps
timeFrame: During Procedure
measure: Number of diverticula
timeFrame: During Procedure
measure: Cecal Intubation
timeFrame: During Procedure
measure: Endoscopist Comfort
timeFrame: During Procedure
measure: Patient Comfort
timeFrame: During Procedure
measure: Change position needed
timeFrame: During Procedure
measure: Abdominal pressure needed
timeFrame: During Procedure
measure: Major adverse event
timeFrame: During Procedure
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Clinica Universitaria Colombia
Study officials:
References:
Clinical trial NCT04426981: Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study
Official title: Behavioral Activation in Orthopaedic Trauma Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures, Bone
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury.

Detailed description: This is a prospective observational pilot study designed to evaluate feasibility and acceptability as well as preliminary efficacy of a behavioral activation intervention among orthopaedic trauma patients after discharge home following their injury. Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older
* Presenting at initial (approximately 2-week) postoperative follow-up
* Prior management of isolated fracture or multi-trauma

Exclusion Criteria:

* Incarceration
* Problems, in the judgement of study personnel, with maintaining follow-up
* Cognitive disability (either acute or chronic)

Primary outcomes:
measure: Percentage of patients who agree to enroll
timeFrame: 6 months
measure: Score on Modified Treatment Evaluation Inventory Short Form
timeFrame: 6 months
measure: Percentage of patients who complete 5 out of 8 possible Behavioral Activation sessions
timeFrame: 6 months
Secondary outcomes:
measure: Score on PROMIS general health survey (Response range is 0 to 100 where 100 indicates better function)
timeFrame: 6 months
measure: Score on VAS pain score (Response range is from 0 to 10 where 10 indicates greater pain)
timeFrame: 6 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT02365181: A Trial Between the Intra-articular Local Anesthetic Infiltration With Catheter and Interscalene Block With Catheter in Postoperative Analgesia After Shoulder Prosthesis
Official title: A Randomized Controlled Non-inferiority Trial Between the Intra-articular Local Anesthetic Infiltration With Catheter and Interscalene Block With Catheter in Postoperative Analgesia After Shoulder Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Shoulder arthroplasty
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 98
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: The control of perioperative pain is necessary to avoid worst surgical suites after shoulder arthroplasty. Interscalene block (ISB) with or without catheter is the gold standard in postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse events can occured . The intra-articular local (IAL) anesthetic infiltration with catheter is a simple procedure. Its efficacy was proved in knee and hip arthroplasty but not in shoulder arthroplasty. Our hypothesis was the IAL is as effective as ISB in early postoperative analgesia after shoulder arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Shoulder arthroplasty
* Osteoarthritis
* Consent

Exclusion Criteria:

* Previous surgery in the same shoulder

Primary outcomes:
measure: Mean postoperative pain
timeFrame: during the 48 first hours
Secondary outcomes:
measure: Complications dues to anesthesia procedure
timeFrame: At 12 hours after surgery
Other outcomes:
Locations:
city: Bezons
country: France
facility: Polyclinique du Plateau
city: Boulogne-Billancourt
country: France
facility: Hospital Ambroise Paré Paris
city: Ermont
country: France
facility: Clinique Claude Bernard
city: Nantes
country: France
facility: Clinique Jules Verne
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
References: