louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06568952: Right Ventricular Function in Patients Taking Carfilzomib
Official title: Right Ventricular Function of Patients With Multiple Myeloma Treated With Carfilzomib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with multiple myeloma treated with carfilzomib

Brief summary: Patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment.

Detailed description: Patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. This is well documented in the literature. However, there are no studies looking at right ventricular function in these patients, both before and during treatment.

Patients had a cardiac ultrasound scan prior to the introduction of carfilzomib and an ultrasound scan following the introduction of carfilzomib. We will look at the evolution of right ventricular function parameters in these patients.

Eligibility criteria: Inclusion Criteria:

* Patients treated for multiple myeloma with carfilzomib
* Patients with echocardiogram before and under treatment.

Exclusion Criteria:

* /

Primary outcomes:
measure: tricuspid annular plane systolic excursion
timeFrame: 6 months after carfilzomib treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Simon VALENTIN
Study officials:
affiliation: Université de Lorraine, Département de Pneumologie, CHRU NANCY
name: Simon Valentin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01285752: A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Asahi Kasei Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2011-01-28
Enrollment: 240
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: To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of RA (class I to III)
* Stable dose of methotrexate (at least 12 weeks)

Exclusion Criteria:

* Pregnant or breastfeeding
* Abnormal screening laboratory test values considered to be clinically significant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hlucin
country: Czech Republic
city: Hostivice
country: Czech Republic
city: Praha
country: Czech Republic
city: Uherske Hradiste
country: Czech Republic
city: Zlin
country: Czech Republic
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Balatonfüred
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Bialystok
country: Poland
city: Elblag
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Bratislava
country: Slovakia
city: Martin
country: Slovakia
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Ternopil
country: Ukraine
city: Vinnytsa
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Cambridge
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
References:
Clinical trial NCT05484752: Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis.
Official title: Efficacy of Peripheral Magnetic Stimulation to Reduce Pain in Knee Osteoarthritis: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Knee
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate effects of repetitive peripheral magnetic stimulation (PMS) on pain reduction in knee osteoarthritis


Eligibility criteria: Inclusion Criteria:

* Primary knee osteoarthritis patients who have had knee pain for at least 6 months and age more than 50 years, had morning stiffness not more than 30 minutes or crepitation.
* Kellgren and Lawrence classification 2-4
* Visual analog scale of pain 4 or higher.

Exclusion Criteria:

* Patients with other musculoskeletal problems associated with knee joint
* Patient with history of physical therapy in past 1 month
* Patient with pacemaker, cochlear implant or cerebral shunt
* Patient with history of knee surgery
* Patient with neurological or other severe disease
* Patient with previous seizure.

Primary outcomes:
measure: Change of Visual analog scale
timeFrame: Change from baseline Visual analog scale at immediately after intervention and Change from Baseline visual analog scale at 1 week.
Secondary outcomes:
measure: Modified Western Ontario and McMaster University Osteoarthritis Index
timeFrame: Change from Baseline Modified Western Ontario and McMaster University Osteoarthritis Index at 1 week.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Physical medicine and rehabilitation
Study officials:
affiliation: Mahidol University, Ramathibodi Hospital
name: Apiphan Iamchaimongkol, M.D.
role: STUDY_DIRECTOR
References:
citation: Pujol J, Pascual-Leone A, Dolz C, Delgado E, Dolz JL, Aldoma J. The effect of repetitive magnetic stimulation on localized musculoskeletal pain. Neuroreport. 1998 Jun 1;9(8):1745-8. doi: 10.1097/00001756-199806010-00014.
Clinical trial NCT01378052: DNA Methylation and Urothelial Carcinoma
Official title: Level of DNA Methylation in People With Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urothelial Carcinoma
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a hospital-based case-control study. Patients with urothelial carcinoma are recruited by pathological verification of UC was done by routine urological practice including endoscopic biopsy or surgical resection of urinary tract tumors followed by histopathological examination by board-certified pathologists. Healthy controls without evidence of UC or any other malignancy were recruited including those receiving adult health examinations at China Medical University Hospital.

Brief summary: Many studies previously showed the significant association between urinary arsenic profiles and urothelial carcinoma (UC) risk and observed the increased UC risk in people with lower plasma folate and higher homocysteine than those with higher plasma folate and lower homocysteine. The investigators would expect to explore the interactions among global DNA methylation, one-carbon metabolic pathway factors, urinary arsenic profiles and UC.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of urothelial carcinoma
* The voluntary of participating the study

Exclusion Criteria:

* Age smaller than 20 years
* Pregnant women
* Not willing to participate the study because of their personal reasons

Primary outcomes:
measure: urothelial carcinoma
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Department of Urology, China Medical University Hospital
state: 404
Study officials:
affiliation: Department of Health risk Management, China Medical University
name: Chi-Jung Chung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01747252: Pharmacokinetics of Resveratrol Comprising Products
Official title: Randomized Three-way Cross-over Comparative Pharmacokinetic Study of Resveratrol Comprising Products in Fasting Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Fruitura Bioscience Ltd.
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study was designed to assess the pharmacokinetics of 2 doses of Red Grape Cells (RGC) containing resveratrol compared with a reference. RGC will be administered as single oral dose to fasting healthy volunteers. Plasma concentration of free resveratrol and total conjugates will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Ages 18-55 years;
* BMI \>/= 19 and \</= 30
* non smoking
* without history or evidence of significant cardiovascular, hepatic, renal, respiratory, gastrointestinal disease
* normal physical and laboratory examinations

Exclusion Criteria:

* History or evidence of alcohol or drug abuse
* subjects receiving chronic medication
* unusual dietary habits or a recent change in body weight
* acute medical situation 48 hours prior to initiation of the study
* poor venous access
* Subjects participated in a trial or donated blood within 4 weeks before initiation of the study

Primary outcomes:
measure: Individual plasma concentrations of free and conjugated resveratrol
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: BioStudies Center
Study officials:
References:
citation: Azachi M, Yatuv R, Katz A, Hagay Y, Danon A. A novel red grape cells complex: health effects and bioavailability of natural resveratrol. Int J Food Sci Nutr. 2014 Nov;65(7):848-55. doi: 10.3109/09637486.2014.917152. Epub 2014 May 15.
Clinical trial NCT06355752: Biomarkers of Pain and Stress Perception and Dry Needling Technique Application
Official title: Changes in Biomarkers of Pain and Stress Perception After the Application of a Dry Needling Technique in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Dry needling
Biochemical Markers
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 36
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: OTHER

Brief summary: The use of the dry needling technique has become widespread in recent years for the treatment of musculoskeletal pain. Although dry needling has been shown to be effective in the treatment of shoulder pain, elbow pain, headache, etc., we do not yet have a clear understanding of the mechanisms of action that justify its beneficial effects.

In this study, we propose to analyse the biochemical markers of pain generated by the application of a dry needling technique on the lumbar musculature in patients with mechanical lumbar pain of non-specific origin.

The aim of this study will be to evaluate the effects of dry needling technique on the plasmatic concentration of biochemical markers.Furthermore, the test subjects will be randomly distributed into two groups.

An experimental group where the subjects will receive a real dry needling technique.

Another group will be treated with a sham technique.


Eligibility criteria: Inclusion Criteria:

* Mechanical lumbar pain of more than three months of evolution.

Exclusion Criteria:

* Medical diagnosis of lumbar disc herniation or protrusion.
* Low back and leg pain.
* Pregnancy.
* Fibromyalgia.
* Fear of needles.
* Medication with anticoagulants

Primary outcomes:
measure: Extracting Blood Samples and Obtaining Serum/Plasma
timeFrame: Change from Baseline concentration at 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Centro Investigación Fisioterapia y Dolor
state: Madrid
Study officials:
affiliation: Centro de Investigación Fisioterapia y Dolor
name: Tomas Gallego-Izquierdo, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06494852: Association of Renal-tubular Acidosis in Children With Cow Milk Protein Allergy
Official title: Association of Renal-tubular Acidosis in Children With Cow Milk Protein Allergy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cow's Milk Protein Allergy
Rta
Keywords: CMPA / RTA
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years

Brief summary: Our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction.

Detailed description: This is a cross-sectional study that will be conducted over 6 months at the pediatric department, Sohag University Hospital, Sohag, Egypt.

Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years attending outpatient clinic at Sohag University Hospital will be included in the study.

The study participants will be subjected to full history taking and thorough clinical examination at the pediatric outpatient clinic and their medical files will be reviewed.

Eligibility criteria: Inclusion Criteria:

* Children proved to be with cow milk protein allergy by oral challenge test after stabilization and prevention of cow protein with Age group from 3 months up to 3 years attending outpatient clinic at Sohag University Hospital will be included in the study

Exclusion Criteria:

-

Primary outcomes:
measure: investigate association of Renal tubular acidosis in cow milk protein allergy patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag
Study officials:
References:
Clinical trial NCT03426852: INVESTIGATING THE EFFECTS SACROILIAC JOINT DYSFUNCTION ON GAIT IN INDIVIDUALS WITH BACK PAIN
Official title: INVESTIGATING THE EFFECTS SACROILIAC JOINT DYSFUNCTION ON GAIT VARIABILITY IN INDIVIDUALS WİTH LUMBAR HERNIATION NUCLEUS PULPOSUS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biomechanical; Lesion
Keywords: Biomechanical Phenomenon
Gait
Lumbar Disc Degeneration
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with lumbar disc herniation with or without sacroiliac dysfunction, age between 18-50 years.

Brief summary: Sacroiliac joint dysfunction (SJD) is a common problem in individuals with lumbar herniation nucleus pulposus (LHNP) plus back pain. It is important to determine the effects of SJD on the gait characteristics in individuals with LHNP.Twelve individuals with LHNP (control group) and six individuals with LHNP plus SJD (study group) will be the participants of the study. Gait characteristics of participants will be evaluate with treadmill. Participants will walk at their self-selected speed for six minutes and data from 2nd minutes to 4th minutes were selected for statistical analyses. Gait speed, cadance, step lengths, time on each foot and step length variabilities will be recorded.

Detailed description: Sacroiliac joint dysfunction (SJD) is a common problem in individuals with lumbar herniation nucleus pulposus (LHNP) plus back pain. It is important to determine the effects of SJD on the gait characteristics in individuals with LHNP.Twelve individuals with LHNP (control group) and six individuals with LHNP plus SJD (study group) will be the participants of the study. Gait characteristics of participants will be evaluate with treadmill. Participants will walk at their self-selected speed for six minutes and data from 2nd minutes to 4th minutes were selected for statistical analyses. Gait speed, cadance, step lengths, time on each foot and step length variabilities will be record

Eligibility criteria: Inclusion Criteria:

Have current back pain Have Lumbar Disc Herniation diagnosis Have sacroiliac dysfunction

Exclusion Criteria:

Do not want to participate Have another systemic, neurologic or orthopedic problem

Primary outcomes:
measure: Step Length Variability
timeFrame: First minute
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT01298752: Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery
Official title: The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Inflammation
Pain
Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 177
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 objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects who are candidates for routine, uncomplicated cataract surgery.
* Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria:

* Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
* Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.

Primary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
timeFrame: 8 days
measure: Percentage of Participants With Grade 0 Pain
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Rabia Ozden, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04932252: A Study of A4368 in Healthy Subjects
Official title: A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximal Tolerable Dose and to Evaluate the Safety, Tolerability and Pharmacokinetics After Single and Multiple Oral Doses of A4368 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Health Subjects
Lead sponsor: Autophagy Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-21
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A4368 is the autophagy activator that is being developed for the treatment of nonalcoholic steatohepatitis.

The goal of the study is to assess the safety, tolerability, and pharmacokinetics in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female subjects
2. Subject with a body weight of ≥ 55.0 kg and within an ideal body weight ± 20%
3. Consent to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study drug
4. Willing and able to sign the informed consent form

Exclusion Criteria:

1. History of or current clinically significant medical illness
2. History of or current gastrointestinal disease or surgery that can influence in pharmacokinetics of study drug
3. Clinically significant history of hypersensitivity to study drug or any of the excipients of study drug
4. Pregnant or lactating woman
5. Clinically significant abnormal laboratory values for hematology, clinical chemistry, or urinalysis
6. Clinically significant abnormal physical examination, vital signs, or 12-lead ECG
7. Heavy alcohol or caffeine intake or heavy smoker
8. Use of study drug in concurrent interventional study within 180 days prior to the first dose of study drug
9. Use of any drug that may affect drug metabolic enzymes within 30 days prior to the first dose of study drug
10. Donation of whole blood within 60 days or apheresis within 30 days prior to the first dose of study drug
11. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days prior to the first dose of study drug

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: Up to 21 days
Secondary outcomes:
measure: Serum concentration of A4368
timeFrame: From pre-dose to 48 hours post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: AutophagySciences
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Seunghoon Han
role: PRINCIPAL_INVESTIGATOR
References: