louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05548543: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions
Official title: A Randomized, Open Label, Single Dose, 4-period Replicate Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2202 and Co-administration of RLD2202 and RLD2203 in Healthy Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2202 and co-administration of each component in fed condition in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Age 19\~54 years in healthy volunteers 18.5 kg/m\^2 ≤ BMI \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* 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
* Subjects who judged ineligible by the investigator

Primary outcomes:
measure: AUCt
timeFrame: 0~24 hours
measure: Cmax
timeFrame: 0~24 hours
Secondary outcomes:
measure: AUCinf
timeFrame: 0~24 hours
measure: Tmax
timeFrame: 0~24 hours
measure: t1/2
timeFrame: 0~24 hours
measure: CL/F
timeFrame: 0~24 hours
measure: Vd/F
timeFrame: 0~24 hours
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospital
name: Mingul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06936943: ONO-4538 Study in Patients With Richter's Transformation
Official title: A Multicenter, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of ONO-4538 in Patients With Richter's Transformation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Richter's Transformation
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2025-04-20
Enrollment: 14
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: Investigate the efficacy and safety of ONO-4538 in patients with Richter's transformation


Eligibility criteria: Inclusion Criteria:

* Diagnosis of diffuse large B-cell lymphoma (DLBCL)-type or Hodgkin lymphoma (HL)-type Richter's transformation
* In the case of DLBCL-type Richter's transformation, refractory, intolerant or ineligible for treatment of DLBCL
* Patients with measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Expected to survive for 90 days or more

Exclusion Criteria:

* Serious complications
* Active multiple cancers
* Active central nervous system (CNS) disease
* History of allogeneic hematopoietic stem cell transplantation

Primary outcomes:
measure: Objective response rate (ORR) (Centralized assessment)
timeFrame: up to 4 years
Secondary outcomes:
measure: Objective response rate (ORR) (site investigator assessment)
timeFrame: up to 4 years
measure: Overall survival (OS)
timeFrame: up to 4 years
measure: Progression free survival (PFS)
timeFrame: up to 4 years
measure: Disease control rate (DCR)
timeFrame: up to 4 years
measure: Duration of response (DOR)
timeFrame: up to 4 years
measure: Time to response (TTR)
timeFrame: up to 4 years
measure: Best overall response (BOR)
timeFrame: up to 4 years
measure: Change rate from baseline in the sum of diameters (SPD) of target lesions
timeFrame: up to 4 years
measure: Best change rate from baseline in the sum of diameters (SPD) of target lesions
timeFrame: up to 4 years
measure: Improvement rate of B symptom
timeFrame: up to 4 years
measure: Safety (Adverse event)
timeFrame: Up to 30 days after the last dose
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Kyusyu University Hospital
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT05074043: COVID-19 Associated Mucormycosis: A Multidisciplinary Dilemma in Assiut University Hospital
Official title: COVID-19 Associated Mucormycosis: A Multidisciplinary Dilemma in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucormycosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 433
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with mucormycosis in a confirmed diagnosis of COVID-19

Brief summary: We aimed to describe the frequency; presentations, predictors, in-hospital outcome of mucormycosis patients in the scope of COVID-19.

All patients with COVID-19 associated Mucormycosis (CAM) admitted to Assuit University Hospital between March 1, 2021, and July 30, 2021, were included in this study. The patient characteristics, the site of mucormycosis, the comorbidities, the steroids usage, and the outcome were analyzed in people with COVID-19.


Eligibility criteria: Inclusion Criteria:We recruited all cases admitted to Assuit University Hospital for the management of COVID-19 and/or associated complications between March 1, 2021, and July 30, 2021, specifically those with probable mucormycosis based on clinical condition. At various times, internists, intensivists, neurologists, and otolaryngologists were among the specialists who assessed and treated them. Clinical; radiological and histopathological confirmed cases of mucormycosis with coexisting or previous history of COVID-19 were included in this study.

-

Exclusion Criteria:Participants with fungal infections other than mucormycosis or without a confirmed diagnosis of COVID-19 (or serological evidence of preceding COVID-19) were excluded.

-

Primary outcomes:
measure: incidence of covid19 associated mucor
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Marwa Abdelrady
Study officials:
References:
Clinical trial NCT04260243: Myofascial Release in Patients with Chronic Obstructive Pulmonary Disease
Official title: Effects of Myofascial Release in Patients with Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Copd
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the effects of a myofascial release protocol in patients with chronic obstructive pulmonary disease (COPD).

Detailed description: So far, there are no previous studies that analyze the effects of a myofascial relaxation protocol applied to the diaphragm within the respiratory rehabilitation treatment in patients with chronic obstructive pulmonary disease.

Aim: The main objective of this study is to assess the effects of a 3 weeks myofascial release protocol applied to the diaphragm on respiratory parameters in patients with chronic obstructive pulmonary disease.

Design: Randomized clinical trial

Eligibility criteria: Inclusion Criteria:

* COPD;
* Forced expiratory volume in the first second (FEV1) \< 80%;
* FEV1/Forced vital capacity (FVC) \< 70%;
* Maximal inspiratory pressure (MIP) \< 70%.

Exclusion Criteria:

* Recent (6 months) spine or abdominal surgery;
* Allergic status of any kind;
* systemic diseases (rheumatic, infectious conditions, febrile state, vascular alterations, endocrine diseases including diabetes, metabolic, and neoplastic syndromes);
* neuromuscular or neurological injuries;
* previous myofascial release treatment.

Primary outcomes:
measure: Quality of life measured with the Chronic Obstructive Pulmonary Disease Assessment Test: Score
timeFrame: 3 weeks
Secondary outcomes:
measure: 6 Minutes Walking Test
timeFrame: 3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Cardenal Herrera University
name: JUAN FRANCISCO L PÁRRAGA
role: STUDY_CHAIR
References:
citation: Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
citation: Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary. Arch Bronconeumol. 2017 Mar;53(3):128-149. doi: 10.1016/j.arbres.2017.02.001. Epub 2017 Mar 6. English, Spanish.
Clinical trial NCT02529943: Changes in Motor Latency During Spinal Decompression: Relationship to Outcomes
Official title: Changes in Motor Latency During Spinal Decompression: Relationship to Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis
Keywords: Spinal Stenosis
Motor Evoked Potential
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with central spinal stenosis scheduled for surgical decompression.

Brief summary: Is there a relationship between changes in motor evoked potential latency intraoperatively and post-operative changes in walking function in patients undergoing spinal decompression.

Detailed description: Is there a relationship between changes in motor evoked potential latency intraoperatively and post-operative changes in walking function in patients undergoing spinal decompression. Tests will include the pre and post decompression MEP (motor evoked potential) latency and pre and post surgery walking speed and quality of life assessments.

Eligibility criteria: Inclusion Criteria:

* Central spinal stenosis
* Ability to ambulate prior to onset of symptoms

Exclusion Criteria:

* Arthritis affecting walking ability (hip, knee or ankle).
* Diabetes
* Implanted pacemaker or other electrostimulator.

Primary outcomes:
measure: Motor Evoked Potential Latency
timeFrame: Day 0
Secondary outcomes:
measure: 10 m Timed Walking speed
timeFrame: pre-surgery and 3 months post surgery
measure: Quality of Life measured in SF-36
timeFrame: pre-surgery and 3 months post surgery
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Jonathan Norton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02555943: DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)
Official title: Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Hepatitis C Infection
HBV Coinfection
Hepatitis B Reactivation
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
name: Nanfang Hospital, Southern Medical University
First posted: 2015-09-22
Enrollment: 23
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 study to determine the incidence, morbidity, mortality and predisposing factors for the reactivation of hepatitis B virus replication during direct anti-HCV treatment of HCV/HBV co-infection patients.

Detailed description: Patients who receive direct-acting anti-HCV treatment will be prospectively studied during 2-year period. All patients have HCV/HBV co-infection.

The inclusion/exclusion criteria and the follow up plan will be listed in following part.

Eligibility criteria: Inclusion Criteria:

* HCV RNA positive,
* HBsAg positive with detectable or undetectable HBV DNA,
* Receiving pan oral direct-acting anti-HCV regimen

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner;
* HIV infection;
* Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
* Active or recent history (≤ 1 year) of drug or alcohol abuse;
* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Primary outcomes:
measure: Proportion of participants who experience virological breakthrough
timeFrame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
measure: Proportion of participants who experience virological rebound
timeFrame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Secondary outcomes:
measure: Proportion of participant who experience biochemical rebound
timeFrame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Other outcomes:
measure: Proportion of participant who experience liver failure
timeFrame: From the commencement of DAAs treatment to 12 weeks post DAAs treatment
Locations:
city: Hong Kong
country: China
facility: Humanity and Health GI and Liver Centre
state: Hong Kong
Study officials:
affiliation: Humanity and Health GI and Liver Centre
name: George Lau, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04266743: FeetMe® Monitor: Alternative for the Evaluation of Gait Speed After Stroke
Official title: FeetMe® Monitor Connected Insoles Are a Valid and Reliable Alternative for the Evaluation of Gait Speed After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait Disorders, Neurologic
Keywords: Gait analysis
Stroke
FeetMe
GaitRite
Lead sponsor: FeetMe
Sponsor class: INDUSTRY
First posted: 2020-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite for a pathologic gait. The device evaluate gait parameters in real time thanks to an embedded algorithm based on the processing of inertial measurement unit and 19 sensors signals.

At D0 and D7, the patient is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Hemiparetic patients have two measurements 7 days apart. The patient repeats 5 trials at a comfortable speed on the GaitRite® mat while wearing the FeetMe® insoles. Each measurement is repeated by 4 different operators. A total of 20 trials are made by the patient.


Eligibility criteria: Inclusion Criteria:

* Have more than 18 years old
* Don't be pregnant or breast feeding
* Have a stroke for more than 6 months

Exclusion Criteria:

* Be part of another study
* Not be able to give consent
* Not have access to social security

Primary outcomes:
measure: Velocity measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
Secondary outcomes:
measure: Stride length measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
measure: Cadence measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
measure: Stance phase measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
measure: Swing phase measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
measure: Stride duration measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
Other outcomes:
Locations:
city: Créteil
country: France
facility: Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris
Study officials:
References:
Clinical trial NCT02363543: Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bandages
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2015-02-16
Enrollment: 0
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 purpose of this randomized, comparative study is to determine whether Hyalomatrix is as effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive concurrent treatments with both products on their first and/or second degree burns located on both hands.


Eligibility criteria: Inclusion Criteria:

* Written consent must be obtained
* First and/or second degree burns on both hands
* Subject must be enrolled within 48 hours of the injury occurrence.

Exclusion Criteria:

* Subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation.
* Subject has a prognosis that indicates unlikely survival past the study period.
* Subject's diagnosis indicates third degree burns.
* Subject suffers from burns sustained as a result of an electrical/chemical injury or by frostbite.
* Subject suffers from any inhalation-related burn trauma.
* Subject suffers from ongoing bone fractures.
* Subject has a known sensitivity to materials containing silicone, hyaluronan, bovine collagen, or chondroitin and/or derivatives of these products.
* Subject has received any treatment prior to study enrollment that may, in the opinion of the Investigator, affect the outcome of the study.
* Subject suffers from a medical condition that may impede wound healing, above any beyond that which would typically be expected.

Primary outcomes:
measure: Wound Infection Rate
timeFrame: Up to 21 days
measure: Number of days required for wound healing
timeFrame: Up to 21 days
Secondary outcomes:
measure: Range of Motion Scores
timeFrame: Up to 21 days
measure: Physician Scores on Products Ease of Use
timeFrame: Up to 21 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01384643: Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery
Official title: Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Valve Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting patient outcome following cardiovascular surgeries. Propofol, an intravenously administered anesthetic with antioxidant properties, protects organs from I/R injury. This study aimed to investigate the ability of propofol to protect kidneys against I/R injury in the patients undergoing valvular heart surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing valvular heart surgery.
* Age: 20\~75.

Exclusion Criteria:

* Emergency operation.
* Patients with vitamin E or vitamin C within 5 days before surgery.
* Patients with preoperative C-reactive protein (CRP) \> 16 mg/L.
* Patients with serum creatinine ≥ 2.0 mg/dL
* Patients under hemodialysis.
* Patients with acute myocardial infarction within 1 week before surgery

Primary outcomes:
measure: Serum creatinine
timeFrame: incidence of AKI during 48 hours after the surgery incidence of AKI
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: