louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02805244: Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis
Official title: A Phase 1, Open-label, Single Dose, Mass Balance Study to Evaluate the Pharmacokinetics, Biotransformation and Excretion of 14C-JTZ-951 in Male Subjects With End-stage Renal Disease Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia of Chronic Kidney Disease
Keywords: JTZ-951
Pharmacokinetics
14C-JTZ-951
Mass balance
Time course
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-17
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters of JTZ-951 and its metabolite(s).


Eligibility criteria: Inclusion Criteria:

* Subjects with end stage renal disease on hemodialysis
* Post-dialysis body weight \>45.0 kg
* BMI between 18.0 and 40.0 kg/m2 (inclusive)

Exclusion Criteria:

* Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.0 × upper limit of normal (ULN), or total bilirubin \>1.5 × ULN at the Screening Visit
* Subjects who have hepatobiliary disease or condition (such as biliary cirrhosis)
* Subjects with positive test results for HBsAg (hepatitis B surface antigen), HCV antibody or HIV antibody
* Subjects with known history of liver failure or liver surgery
* Subjects with a history or current clinically significant chronic or acute blood loss

Primary outcomes:
measure: Radioactivity concentration in urine, feces and dialysate
timeFrame: maximum 20 days
measure: Radioactivity concentration in whole blood and plasma
timeFrame: maximum 20 days
measure: Plasma concentrations of JTZ-951 and its metabolite
timeFrame: maximum 20 days
measure: Cmax (maximum concentration)
timeFrame: maximum 20 days
measure: tmax (time to reach maximum concentration)
timeFrame: maximum 20 days
measure: AUC (area under the concentration-time curve)
timeFrame: maximum 20 days
measure: t1/2 (elimination half-life)
timeFrame: maximum 20 days
measure: Number of adverse events
timeFrame: maximum 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
state: Minnesota
Study officials:
References:
Clinical trial NCT00367744: Rosiglitazone Effect on Mitochondria and Lipoatrophy
Official title: Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: mitochondria
HIV
lipoatrophy
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: GlaxoSmithKline
First posted: 2006-08-23
Enrollment: 71
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 study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT).

Detailed description: This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT. The study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid IMT, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.

Eligibility criteria: Inclusion Criteria:

* Lipoatrophy
* Thymidine sparing ARV for at least 24 weeks
* Prior thymidine NRTIs for at least 12 months

Exclusion Criteria:

* Diabetes
* Heart failure
* Liver disease
* Hormonal therapies

Primary outcomes:
measure: Change in Limb Fat at 48 Weeks
timeFrame: 48 weeks
Secondary outcomes:
measure: the Change in the Carotid IMT of the Common Carotid Artery
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinc Foundation
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland/Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Grace McComsey
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tungsiripat M, El-Bejjani D, Rizk N, Dogra V, O'Riordan MA, Ross AC, Hileman C, Storer N, Harrill D, McComsey GA. Carotid intima media thickness, inflammatory markers, and endothelial activation markers in HIV Patients with lipoatrophy increased at 48 weeks regardless of use of rosiglitazone or placebo. AIDS Res Hum Retroviruses. 2011 Mar;27(3):295-302. doi: 10.1089/aid.2010.0187. Epub 2010 Oct 23.
citation: Tungsiripat M, Bejjani DE, Rizk N, O'riordan MA, Ross AC, Hileman C, Storer N, Harrill D, McComsey GA. Rosiglitazone improves lipoatrophy in patients receiving thymidine-sparing regimens. AIDS. 2010 Jun 1;24(9):1291-8. doi: 10.1097/QAD.0b013e328339e274.
Clinical trial NCT00528944: Single-Breath Measurement Underestimates Ventilatory Volume According to Emphysema Severity
Official title: Single-Breath Measurement Underestimates Ventilatory Volume According to Emphysema Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emphysema
Keywords: alveolar volume
pulmonary function testing
emphysema
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective trial in all outpatients with emphysema referred for full pulmonary function testing to the pulmonary diagnostic unit.

Brief summary: Although single breath helium (He) dilution measurement (VASB) is currently used in pulmonary function laboratories to assess functional alveolar volume and diffusing capacity for carbon monoxide, the extent to which VASB reflects ventilatory and thoracic volume has not been prospectively determined in emphysema. We hypothesized that VASB underestimates rebreathe helium dilution volume (VARB), and plethysmographic volume (VApleth) as clinical and physiologic severity of emphysema increases.

Detailed description: VASB, VARB, and VApleth were measured in 52 consecutive stable outpatients with clinical and radiographic emphysema. Thirteen patients with an obstructive ventilatory defect without emphysema (OVD) and 18 normal controls were similarly studied. All subjects underwent spirometry followed by whole body plethysmography and He dilution volume measurements; VASB and VARB order was randomized.

Eligibility criteria: Inclusion Criteria:

* All outpatients between the ages of 18 and 81 years referred to the Columbia University Medical Center Pulmonary Diagnostic Unit between 1/18/06 and 7/30/07 for full pulmonary function evaluation, and with an obstructive ventilatory defect on spirometry, were considered eligible.

Exclusion Criteria:

* Patients who did not want to undergo the re-breathe diffusing capacity testing
* Patients who could not give informed consent;and
* Patients who were too physically compromised to undergo full testing including the re-breathe maneuver as deemed by our technicians.

Primary outcomes:
measure: Difference between DLCO SB alveolar volume and the total lung volume measurement from plethysmography
timeFrame: 10 seconds
measure: Difference between DLCO RB alveolar volume and the total lung volume measurement from plethysmography
timeFrame: 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: NY
country: United States
facility: Columbia University Cardiopulmonary, Sleep and Ventilatory Disorders Center
state: New York
Study officials:
affiliation: Columbia University
name: Robert C Basner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02061644: Spinal Anesthesia - Intraocular Pressure
Official title: Intraocular Pressure Changes After Spinal Anesthesia: Acute and Subacute Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: We aim to investigate the effect of spinal anesthesia on intraocular pressure.

Detailed description: Spinal anesthesia provides adequate anesthetic conditions for many operations. These operations include orthopedic, urological, gynecological and many general surgery operations. Although few, side effects of the procedure and its effects on body are well known. However, there is inadequate knowledge about the effects of spinal anesthesia on pressure changes in the eyes. These pressure changes in eyes can result in some detriments. Elevated pressures in the eyes can result in disease known as glaucoma, that makes hazard to eyes. Decreased eye pressures can also result in some eye detriments.

We aimed to investigate the effects of spinal anesthesia procedure on eye (intraocular) pressure changes.

Eligibility criteria: Inclusion Criteria:

* patients having general surgery operations under umbilicus
* patients of American Society of Anesthesiologists (ASA) status I-II

Exclusion Criteria:

* patients denying spinal anesthesia
* contraindications for spinal anesthesia
* eye diseases
* hypertension
* ASA status III or more

Primary outcomes:
measure: Number of the patients with changed intraocular pressure
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Adiyaman University Research Hospital
Study officials:
affiliation: Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation, Adiyaman City, Turkey.
name: Ruslan Abdullayev, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02920944: Diagnostic Yield of 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions
Official title: Technical Feasibility and Diagnostic Yield of New 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions; Comparison With 22-gauge Procore Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasms
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Seoul St. Mary's Hospital
First posted: 2016-09-30
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study.


Eligibility criteria: Inclusion Criteria:

* Patients older than 20 years referred to our medical center for EUS-FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies.

Exclusion Criteria:

* cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio \[INR\] \> 1.5 or platelet count \< 50,000 cells/cubic millimeter \[cmm3\]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.

Primary outcomes:
measure: single diagnostic yield of the histologic core
timeFrame: up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
Secondary outcomes:
measure: total diagnostic yield of the histologic core
timeFrame: up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea
state: No State
Study officials:
affiliation: The Catholic University of Korea
name: In Seok Lee, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06797544: Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis
Official title: The Clinical Effect of Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis: Single Arm Open-label Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cutaneous Leishmaniasis
Lead sponsor: Al-Mustafa University College
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 40
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: Aim of the study to evaluate the effectiveness of intralesional levofloxacin 0.5% solution as a local injection in treating cutaneous leishmaniasis.

In an open-label single-arm clinical trial, all patients were given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion was considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured.

Intralesional levofloxacin (5 mg/ml, 100 ml, Tavanic®, Sanofi, France) will be injected into each lesion based on its size (5 mg/cm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment. A fine insulin needle will be used to infiltrate the lesion.

Detailed description: Local therapies have been recommended by the World Health Organization (WHO), the Pan American Health Organization, and other experts as an alternative to systemic drugs in patients with at least four lesions smaller than 4 cm in diameter, especially when the face or joints are not affected. Usually, they are easy to use and have a lower risk, toxicity, and cost compared to traditional therapies. Local treatment includes thermotherapy, cryotherapy, and topical and intralesional drugs. The last approach is effective and safe in localized forms

Eligibility criteria: Inclusion Criteria:

* Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis and patients ranging in age from 20 to 75 years old.

Exclusion Criteria:

* Patients who received anti-leishmaniasis treatment locally or systemically for the last month before this study and patients on prolonged corticosteroid therapy.

Primary outcomes:
measure: Cure rate
timeFrame: From enrollment to the end of treatment up to 90 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Mustansiriyah University
Study officials:
References:
Clinical trial NCT06339944: Effects of Sensory Motor Training and Kinesthetic Exercises in Knee Osteoarthritis.
Official title: Effects of Sensory Motor Training Versus Kinesthetic Exercises on Pain, Range of Motion, Proprioception and Quality of Life in Knee Osteoarthritis .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis
pain
SMT
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study i will see the effects of kinesthetic exercises and sensory motor training on pain and range of motion in patients with knee OA.

Detailed description: In 2022 a A Pilot Randomized Trial of Different Weekly Applications of Kinesthesia, Balance and Agility Exercise Program for Individuals with Knee Osteoarthritis was conducted.In 2023 A critically appraised research was conducted on Sensorimotor or Balance Training to Increase Knee-Extensor and Knee-Flexor Maximal Strength in Patients With Knee Osteoarthritis.

In past there is no study that compares the effects of SMT and kinesthetic exercises in knee OA.

Eligibility criteria: Inclusion Criteria:

* patients having osteophytes and definite joint space reduction confirmed by radiographs
* Patients having age 40-60 years or both gender are included

Exclusion Criteria:

Rheumatoid arthritis. Hip or ankle instability Hip or knee replacement Unresolved balance disorder Patients with active synovitis

Primary outcomes:
measure: VAS
timeFrame: 6th week
Secondary outcomes:
measure: goniometer
timeFrame: 6th week
measure: WOMAC questionaire
timeFrame: 6th week
measure: joint position sense test
timeFrame: 6th week
Other outcomes:
Locations:
city: Sheikhupura
country: Pakistan
facility: Tariq Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Sanaullah, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: UzunkulaoGlu A, KerIm D, Ay S, ErgIn S. Effects of Single-Task Versus Dual-Task Training on Balance Performance in Elderly Patients With Knee Osteoarthritis. Arch Rheumatol. 2019 Apr 26;35(1):35-40. doi: 10.5606/ArchRheumatol.2020.7174. eCollection 2020 Mar.
citation: Kus G, Tarakci E, Razak Ozdincler A, Ercin E. Sensory-motor training versus resistance training in the treatment of knee osteoarthritis: A randomized controlled trial. Clin Rehabil. 2023 May;37(5):636-650. doi: 10.1177/02692155221137642. Epub 2022 Nov 12.
citation: Gomiero AB, Kayo A, Abraao M, Peccin MS, Grande AJ, Trevisani VF. Sensory-motor training versus resistance training among patients with knee osteoarthritis: randomized single-blind controlled trial. Sao Paulo Med J. 2018 Jan-Feb;136(1):44-50. doi: 10.1590/1516-3180.2017.0174100917. Epub 2017 Dec 7.
Clinical trial NCT02813044: Effects of Total Intravenous Anesthesia With Propofol-remifentanil Versus Inhalational Anesthesia With Sevoflurane on Quality of Recovery in Patients Undergoing Transsphenoidal Surgery for Pituitary Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pituitary Tumor
Keywords: anesthesia
intravenous
neurosurgery
pituitary neoplasm
postoperative period
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 82
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A number of studies have compared the effects of total intravenous anesthesia(TIVA) versus inhalational anesthesia on perioperative period during transsphenoidal surgery. However, they have limitations especially for the phase of recovery after anesthesia: a fragmentary assessment. Quality of Recovery 40 (QoR-40) questionnaire was multi-dimensionally designed to assess the degree of recovery, specially after anesthesia and surgery. In this study, the investigators aim to compare the quality of recovery after inhalational anesthesia and after TIVA through QoR-40 questionnaire in patients undergoing transsphenoidal surgery for pituitary tumor under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients over age 19
* Scheduled to undergo transsphenoidal surgery for pituitary tumor
* ASA class I and II

Exclusion Criteria:

* Left ventricular ejection fraction \< 55%
* Third-degree atrioventricular block
* Second-degree atrioventricular block (P:QRS ratio of 3:1 or higher)
* Fever
* History of myocardial infarction, stroke or cardiac surgery within the previous 1 year
* Severe neurological disease
* Use of sedative, opioid or sleep-inducing drugs
* Allergic history of any study drug
* Pregnancy

Primary outcomes:
measure: QoR-40 score
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Associate Professor Department of Anesthesiology and Pain Medicine,
Study officials:
References:
citation: Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.
Clinical trial NCT00011544: Physical Performance Measures for Manual Wheelchair Users
Official title: Physical Performance Measures for Manual Wheelchair Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: wheelchair, biomechanics, aging, functional outcome, disability
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-02-26
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The project is intended to modify the Functional Independence Measure (FIM) for manual wheelchair users. It will determine if the new measure is a better measure of community independence for manual wheelchair users than the FIM. During the Phase 1 of the study it will then use this new measure to determine whether a home exercise program increases functional independence in wheelchair users. In Phases II and III of the study 120 manual wheelchair users will participate to test and validate the new measure and to test the effectiveness of therapeutic exercise. Subjects will range in age from 20 to 79 yrs. and have a variety of disabilities.


Eligibility criteria: Wheelchair users

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VAMC, Baltimore
state: Maryland
Study officials:
affiliation: Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: John Fryer, Ph.D., Asst. Director
affiliation: Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: Nancy Rocheleau, Program Analyst
References: