louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05691907: Directional Preference Exercises in Comparison to Motor Control Exercises in Mechanical Low Back Pain
Official title: Effects Of Directional Preference Exercises in Comparison to Motor Control Exercises in Patients With Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain, Mechanical
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects Of Directional Preference Exercises in Comparison to Motor Control Exercises in Patients With Mechanical Low Back Pain


Eligibility criteria: Inclusion Criteria:

* Both male \& Female patients
* Age group 20-60 Years
* Diagnosed with mechanical low back pain having pain aggravation in flexion bias

Exclusion Criteria:

* Lumbar stenosis
* Cauda Equina
* Spondylolisthesis
* Ankylosing Spondylitis
* Scoliosis
* Leg Length Discrepancy
* Muscular Dystrophy
* Low back pain from non-musculoskeletal causes
* Fracture or traumatic low back pain
* Any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded

Primary outcomes:
measure: Back Pain
timeFrame: 2 week
measure: Disability
timeFrame: 2 week
measure: Range of Motion
timeFrame: 2 week
measure: Sleep Quality
timeFrame: 2 week
measure: Postural Stability Index
timeFrame: 2 week
measure: Real time Physical Activity
timeFrame: 2 week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University
city: Islamabad
country: Pakistan
facility: Kulsum International Hospital
Study officials:
affiliation: FUI
name: Muhammad Osama, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00129207: Ketoconazole Administration: How it is Affected by the Body and Broken Down and How it Acts on the Body When Used With Velcade
Official title: Effect of Ketoconazole Administration on the Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: pharmacokinetic
pharmacodynamics
VELCADE
Ketoconazole
CYP 3A4
Solid Tumor
Advanced Solid Tumors
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2005-08-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate how ketoconazole (Nizoral) affects the pharmacokinetics (how the study drug is affected by the body and broken down) and pharmacodynamics (how the study drug acts on the body) of the active ingredient in the study drug Velcade (bortezomib).


Eligibility criteria: Inclusion Criteria:

* Male and female patients 18 years of age or older, with a diagnosis of advanced solid tumor for which no curative or other treatment of higher priority is available
* Karnofsky Performance Status (KPS) equal to or greater than 70%
* Normal liver function tests (aspartate transaminase \[AST\] or alanine transaminase \[ALT\] equal to or less than 2 x upper limit of normal \[ULN\])
* Total bilirubin equal to or less than 1.5 x ULN
* Calculated creatinine clearance equal to or greater than 50 mL/min
* Normal serum calcium

Exclusion Criteria:

* Patients with significant cardiac disease
* Equal to or greater than Grade 2 neuropathy
* Active hepatitis
* HIV infection
* Secondary malignancy
* Transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment
* Patients taking concomitant medications having inhibitory or inducing activity for CYP 3A4

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Medical Center, UPMC Cancer Pavilion
state: Pennsylvania
Study officials:
References:
citation: Venkatakrishnan K, Rader M, Ramanathan RK, Ramalingam S, Chen E, Riordan W, Trepicchio W, Cooper M, Karol M, von Moltke L, Neuwirth R, Egorin M, Chatta G. Effect of the CYP3A inhibitor ketoconazole on the pharmacokinetics and pharmacodynamics of bortezomib in patients with advanced solid tumors: a prospective, multicenter, open-label, randomized, two-way crossover drug-drug interaction study. Clin Ther. 2009;31 Pt 2:2444-58. doi: 10.1016/j.clinthera.2009.11.012.
Clinical trial NCT05662007: Scapular Kinematics of Young Swimmers
Official title: Scapular Kinematics of Asymptomatic Young Swimmers During Dynamic Shoulder Elevation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scapula Injuries
Keywords: swimmers
scapula
kinematic
motion asymmetries
three dimensional
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cross-sectional study included volunteer young swimmers with at least 3 years of experience in a professional swimming club and healthy non-athletes participants. The swimmer training program includes swimming training 6 days a week (10 hours in total), and 3 land training (3 hours in total) including a general strengthening program (strength of the posterior shoulder musculature, core, squats, pull-ups, etc.) and stretching the anterior shoulder musculature.

Brief summary: The aim of this study was to (a) compare the scapular kinematics of asymptomatic swimmers and healthy non-athletes and to (b) compare the scapular kinematics of the dominant and non-dominant shoulders in asymptomatic young swimmers.

Detailed description: This cross-sectional study included 27 volunteered asymptomatic young swimmers (mean age: 12.7 yrs) with at least 3 years of experience in a professional swimming club and 22 healthy non-athletes (mean age: 11.5 yrs). 3D scapular kinematics were evaluated at 0°, 30º, 60º, 90º, and 120º with the electromagnetic tracking system during bilateral arm elevation and lowering on the scapular plane. The differences in the scapular kinematics of the dominant and the non-dominant side in both groups were analyzed with 2 by 8 Mixed Model ANOVA.

Eligibility criteria: Inclusion Criteria:

* Absence of shoulder pain in the last 6 months,
* No discomfort in the shoulder joint during swimming,
* Use of symmetrical breathing patterns in training competitions

Exclusion Criteria:

* Participants with a history of upper extremity injury (dislocation, fracture, muscle strain, etc.),
* Pain in clinical tests (Hawkins and Neer),
* Those who did not attend training regularly.

Primary outcomes:
measure: Scapular Kinematic
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT00757107: Taperloc Versus Taplerloc Microplasty
Official title: Clinical Evaluation of Taperloc Total Hip System With Two Different Stem Lengths
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Short femoral stem
Stress shielding
Stem migration
Implant Survival
DEXA
Radiostereometric analysis
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Biomet U.K. Ltd.
First posted: 2008-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis

Detailed description: Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study.

Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.

Eligibility criteria: Inclusion criteria:

* Patients with primary osteoarthritis of the hip scheduled for THA.
* Suitable anatomy for both stems
* Willingness and ability to follow study-protocol

Exclusion Criteria

* Malignancy or metastatic bone disease.
* Any other disease severely affecting bone and mineral metabolism
* Ongoing or previous treatment (within 5 years prior to inclusion) with steroids
* Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives.
* Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs.
* Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy.
* Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.

Primary outcomes:
measure: Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame:
timeFrame: bone mineral density (BMD) measured postoperatively at 2 years
Secondary outcomes:
measure: Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis
timeFrame: 2 years
Other outcomes:
measure: Clinical outcome measures with Harris Hip Score comparing patients receiving different stems.
timeFrame: 3, 6, 12 and 24 months
measure: Clinical outcome measures with Womac Score comparing patients receiving different stems.
timeFrame: 3, 6, 12 and 24 months
Locations:
city: Linkoping
country: Sweden
facility: University hospital of Linkoping
Study officials:
affiliation: University hospital of Linkoping
name: Ingemar IVARSSON, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03887507: Vojta Therapy in Multiple Sclerosis.
Official title: The Implementation of a Reflex Locomotion Program According to Vojta Produces Short-term Automatic Postural Control Changes in Patients With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Physical Therapy
Keywords: Vojta therapy
core stability
postural balance
Lead sponsor: NUMEN Foundation
Sponsor class: OTHER
Collaborators: name: Multiple Sclerosis Foundation of Madrid
name: Fisiovillalba Clinical center
First posted: 2019-03-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Study evaluates the effectiveness of a Vojta locomotion reflex program as short-term automatic postural control in patients with Multiple sclerosis

Detailed description: In two consecutive weeks two interventions will be conducted: Vojta group(A) and standard therapy group(B). The last one is based on balance exercises targeting core stability, Bobath concept and sensory strategies. In the Vojta group 5 sessions will be conducted for a duration of 2 weeks and the same will be realised on the standard group. In addition, during the study, a daily activity shall be prescribed in both groups: Vojta exercise during 20 minutes for group A and walking for 20 minutes in group B.

Eligibility criteria: Inclusion Criteria:

* Final diagnosis of MS according to McDonald criteria.
* Walkability with or without assistance (4.0 to 6.5 in EDSS) and dysfunctions defined by the inability to hold the tandem position for 30 seconds with the arms close to body.
* Older than 18 years-old.
* Escorted sessions, a family member or close person.

Exclusion Criteria:

* Phase outbreak or outbreak in the 3 months before the study.
* Medication that prevents or limits the performance of the Locomotion reflex.
* Participation in other studies during the conduct of this study.
* Score inferior to 6 in the Abbreviated Mental Test that prevents understanding of the study consent or that limits the understanding of the test during its realisation.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 2 weeks
measure: 10 metres walk
timeFrame: 2 weeks
Secondary outcomes:
measure: Tandem 6 metres test
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: NUMEN Foundation
state: España
Study officials:
affiliation: Rehabilitation Clinic Fisiovillalba
name: Natalia Valdez Palmero, Degree
role: STUDY_CHAIR
affiliation: Multiple Sclerosis Foundation of Madrid
name: Laura Garcia Ruano, coordinator
role: STUDY_CHAIR
References:
citation: Lopez LP, Palmero NV, Ruano LG, San Leon Pascual C, Orile PW, Down AV, Gor Garcia-Fogeda MD, Tore S. The implementation of a reflex locomotion program according to Vojta produces short-term automatic postural control changes in patients with multiple sclerosis. J Bodyw Mov Ther. 2021 Apr;26:401-405. doi: 10.1016/j.jbmt.2021.01.001. Epub 2021 Jan 9.
Clinical trial NCT05477888: Psychometric Properties of the Chinese Version of Penn State [Electronic] Cigarette Dependence Index
Official title: Psychometric Properties of the Chinese Version of Penn State [Electronic] Cigarette Dependence Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: E-Cig Use
Keywords: Adolescent
Electronic Nicotine Delivery Systems / psychology
Psychometrics
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total number of 275 adults who used nicotine-containing e-cigarettes at least once a week for the past month and have smoked daily for the last 3 months

Brief summary: The purpose of this study is to realize the first evaluation of the psychometric characteristics of the Chinese version of the the Penn State University Electronic Cigarette Dependence Index Scale.

Detailed description: This study will use forward translation, reverse translation, and comprehensive methods to Chinese-translate the Penn State University Electronic Cigarette Dependence Index Scale to form a Chinese version of the Penn State University Electronic Cigarette Dependence Index Scale that is more in line with the Chinese language and cultural environment. This study will also verify its reliability and validity in a large sample population to form a formal version of the scale. The scale will provide an effective tool for evaluating the degree of e-cigarette dependence among young people and adolescents in my country.

Eligibility criteria: Inclusion Criteria:

* (1)≥18 years old;
* (2)Those who used e-cigarettes at least once a week for the past month;
* (3)Be able to read and communicate in Chinese.

Exclusion Criteria:

* Those who are unable to communicate due to serious mental or physical illnesses such as deafness, confusion caused by mental illness, etc.

Primary outcomes:
measure: E-cigarette dependence
timeFrame: Baseline
Secondary outcomes:
measure: Self-reported addiction
timeFrame: Baseline
measure: Time to first vape
timeFrame: Baseline
measure: Vapes/day and vaping days/week
timeFrame: Baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: XIAW
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Wei Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04778488: Vienna Near-Infrared Spectroscopy in Cardiac Arrest Study (VINIRSCA)
Official title: Messung Der Cerebralen Sauerstoffsättigung Mitttels Near-Infrared Spectooxymetrie in Der Reanimation Und Postreanimationsbehandlung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: NIRS
cardiac arrest
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Emergency Medical Service of Vienna
First posted: 2021-03-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Observational cohort study.
Primary purpose: DIAGNOSTIC

Brief summary: Measurement of Near-Infrared Spectroscopy (NIRS) during and after out-of-hospital cardiac arrest (OHCA) in the city of Vienna and the tertiary university hospital of the Medical University of Vienna, Austria.

NIRS will be evaluated as a tool for resuscitation quality assessment as well as a prognosticator for cardiac arrest outcomes. Already-existing literature will be taken into account, and already-existing cutoffs and prognosticating values will be assessed and - if eligible - validated in a real-life setting.

Detailed description: Patients suffering from out-of-hospital cardiac arrest (OHCA) and receiving cardiopulmonary resuscitation (CPR) in terms of advanced life support (ALS) in the city of Vienna, Austria, will be included. A special study team will be dispatched to the event sites by the ambulance service. Trained study fellows will include patients by placing NIRS optodes on the patients' forehead as soon as possible during and/or after CPR. Measurements will continue until 72h post return of spontaneous circulation (ROSC) or the patient's death.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* out-of-hospital cardiac arrest

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: near-infrared-spectroscopy
timeFrame: minute 0
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
citation: Schnaubelt S, Sulzgruber P, Menger J, Skhirtladze-Dworschak K, Sterz F, Dworschak M. Regional cerebral oxygen saturation during cardiopulmonary resuscitation as a predictor of return of spontaneous circulation and favourable neurological outcome - A review of the current literature. Resuscitation. 2018 Apr;125:39-47. doi: 10.1016/j.resuscitation.2018.01.028. Epub 2018 Feb 2.
citation: Schnaubelt S, Uray T. The need for comprehensive NIRS-measurement from on-scene treatment to post-ROSC phase. Resuscitation. 2019 Nov;144:191-192. doi: 10.1016/j.resuscitation.2019.07.038. Epub 2019 Sep 9. No abstract available.
Clinical trial NCT00425009: Therapeutic Effects of Berberine in Patients With Type 2 Diabetes
Official title: Effects of Berberine on Improvement of Glucose and Lipid Metabolism in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Keywords: Berberine
Type 2 diabetes
Treatment
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-01-22
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
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 determine whether berberine is effective in the treatment of type 2 diabetes.

Detailed description: Type 2 diabetes is health threats worldwide. However, treatment of this disease is limited by availability of effective medicines. All of the existing oral hypoglycemic agents have secondary failure after long term administration. Thus, new oral medicines are needed for long term control of blood glucose in patients with type 2 diabetes. In diabetes care, dietary approaches have drawn more and more attention in the prevention and treatment of hyperglycemia. Generally regarded as safe (GRAS) plants have been widely used for their benefits in antioxidation, anti-inflammation, anticancer, anti-obesity and anti-diabetes. Numerous botanical products such as pigments that include anthocyanins and flavonoids have been consumed or studied for anti-obesity and anti-diabetes. However, most of these botanical products are mixtures of multiple compounds. It is difficult to control their quality in the study or production. Up to now, as a single purified compound, berberine is demonstrated to have hypoglycemic effect in vitro and in vivo. Berberine is the main active component of Coptis chinensis French, which was used for thousands of years in China in the treatment of human diseases including diabetes.

Comparison(s): Effects of berberine compared with metformin in newly diagnosed type 2 diabetic patients.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes
* HbA1c \> 7.0% or FBG \> 7.0 mmol/L
* Stable or worsening glycemic control for at least 3 months

Exclusion Criteria:

* Liver damage
* Kidney damage

Primary outcomes:
measure: HbA1c at 13 weeks
Secondary outcomes:
measure: Blood glucose at 13 weeks
measure: Blood lipids at 13 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Department of Endocrinology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
name: Jun Yin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: