louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02358954: Vestibular Pain Interactions
Official title: Modulation of Pain Responses by Vestibular Stimulation. A Contact Heat Evoked Potential Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: quantitative sensory testing
contact heat evoked potentials
vection stimulation
3D-turntable
Volunteers
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal is to establish the practical usefulness of vestibular stimulation for modulating pain perception and to describe the possible mechanisms that could underlie neural vestibular-somatosensory interactions.


Eligibility criteria: Inclusion Criteria:

* Weight: 50 - 100 kg
* Height: 155 - 185 cm
* Male subjects 18 years to 60 years of age
* Sufficient command of German language
* Written informed consent by the participant after information about the project
* Without any known history of neurological disease (especially motor, somatosensory disorders, peripheral neuropathies).
* Right-handedness

Exclusion Criteria:

1. Intellectually or mental impaired subjects
2. Drug abuse
3. Chronic alcohol consumption
4. No use of marihuana 24h before measurements.
5. No history of vestibular or auditory disorders.
6. Diabetes mellitus
7. Participants of other studies during study period and 30 days prior to study begin
8. Any regular concomitant medication
9. Abnormal QST parameters at the baseline measurement.
10. Absent CHEPs-Potentials at the baseline measurement.

Primary outcomes:
measure: Pain thresholds
timeFrame: After study inclusion, Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University hospital Zurich
Study officials:
References:
Clinical trial NCT02741154: Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI
Official title: Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI(Intracytoplasmic Sperm Injection) a Case Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility Indicated for ICSI
Keywords: aromataze inhibitor, poor responder ,induction
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: study the effect of aromataze inhibitor induction together with short stimulation protocol by gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before ICSI

Detailed description: This is a prospective randomized case control study will be conducted in Maternity hospital IVF unite Minia University after being approved by local ethical committee of obstetrics and gynecology department faculty of medicine, all study details will be explained to patients and informed consent will be obtained before inclusion in the study . enrolled patients will be randomized into two groups using simple randomization by sealed opaque envelops contain serial computer generated numbers Control group will receive HMG 300 IU daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) when at least three follicles reach 14mm diameter GnRh antagonist given 0.1 ml continue follow up when at least three follicles reach 17mm in diameter ovum pickup will done under TVUS guide if less than three follicles cycle will be cancelled .

Study group will receive same management plus letrozole 2.5mg daily start at the first day of menses for 5 days and continue with same protocol

Eligibility criteria: Inclusion Criteria:

* infertlity indicated for ICSI
* Ovarian factor
* Tubal factor
* Unexplained infertility
* poor responders

Exclusion Criteria:

* Expected high responder
* Endometriosis
* Male and uterine factors
* Ovarian mass or cyst

Primary outcomes:
measure: Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova)
timeFrame: day of HCG injection
measure: quality of ova
timeFrame: day of ovum pick up
Secondary outcomes:
measure: pregnancy rate
timeFrame: 14 days after ovum pick up
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: Minia University
Study officials:
References:
citation: Mitwally MF, Casper RF. Aromatase inhibition improves ovarian response to follicle-stimulating hormone in poor responders. Fertil Steril. 2002 Apr;77(4):776-80. doi: 10.1016/s0015-0282(01)03280-0.
Clinical trial NCT05088954: Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Chronic Lumbar Radiculopathy
Official title: Effect of Metabolic Syndrome on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Patients With Chronic Lumbar Radiculopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Herniated Disk Lumbar
Metabolic Syndrome
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: transforaminal epidural steroid injection
Primary purpose: TREATMENT

Brief summary: Transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation. The aim of our study is to evaluate the effect of metabolic syndrome on the treatment results of transforaminal epidural steroid injection in patients with chronic radicular low back pain due to lumbar disc herniation.


Eligibility criteria: Inclusion Criteria:

* lumbar radiculopathy due to lumbar disc herniation, unresponsive to conservative treatments, duration of pain is less than 3 months, Patients aged 18 to 65 years

Exclusion Criteria:

* the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...), to have a history of lumbar spinal surgery, inflammatory diseases (rheumatoid arthritis, spondyloarthropathy), spinal infection or malignancy, systemic infection, Spondylolisthesis or spinal stenoz at the involved or adjacent segments, allergies to local anesthetics, contrast dyes or steroids, Refusal of a patient, History of prior lumbar spine surgery, presence of hip pathology (avascular necrosis, congenital hip dislocation etc...

Primary outcomes:
measure: Rate of Successful Response
timeFrame: 6 months
Secondary outcomes:
measure: Numerical Rating Scale
timeFrame: 6 months
measure: Istanbul Low Back Pain Disability Index (ILBPDI)
timeFrame: 6 months
measure: Short Form 12 (SF-12)
timeFrame: 6 months
measure: Beck Depression Inventory (BPI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT03804554: A Study of Participants in Australia Who Have Non-small Cell Lung Cancer Being Treated With Nivolumab
Official title: Nivolumab in the Treatment of Patients With Non-small Cell Lung Cancer: The Australian Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-01-15
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Previously-treated advanced NSCLC patients commencing treatment with nivolumab between May 2015 and August 2017 under the Australian Patient Access Program

Brief summary: This study is to capture and describe the patient and disease characteristics and the outcomes of adult patients with previously-treated advanced NSCLC who have been treated with Nivolumab


Eligibility criteria: Inclusion Criteria

* Adult male or female (≥18 years of age) patients with NSCLC
* Treated with nivolumab on the Australian PAP
* Initiated Nivolumab between May 2015 and August 2017
* Attending clinician agreeable to provide patient data
* Local institutional ethics requirements satisfied

Exclusion Criteria:

* Insufficient data available

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Time to treatment failure (TTF)
timeFrame: Approximately 27 months
Secondary outcomes:
measure: Best overall response (BOR)
timeFrame: Approximately 27 months
measure: Progression free survival rate (PFSR)
timeFrame: Approximately 27 months
measure: Overall survival rate (OSR)
timeFrame: Approximately 27 months
measure: Incidence of AE's
timeFrame: Approximately 27 months
measure: Incidence of SAE's
timeFrame: Approximately 27 months
measure: Reasons for ceasing treatment
timeFrame: Approximately 27 months
measure: Incidence of patients with brain metastases
timeFrame: Approximately 27 months
measure: Incidence of re-treatment
timeFrame: Approximately 27 months
Other outcomes:
Locations:
city: Heidelburg
country: Australia
facility: Local Institution
state: Victoria
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06607354: Consuming Grass Finished Lamb Improves Blood Plasma ω-3 Fatty Acid Response Among Healthy Consumers.
Official title: The Effect of Consuming Grass Finished Lamb Meat on Omega-3 Blood Response Among Healthy Consumers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Lamb
Omega-3
Fatty acids
Plasma
Plasma phospholipids
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Agri-Food and Biosciences Institute
First posted: 2024-09-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Describe parallel arms
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate the impact of consuming grass-finished lamb meat on blood omega-3 PUFAs and cardiovascular risk factors compared to concentrate-finished lamb meat. Healthy volunteers will consume three portions of lamb meat/week from a grass-finished meat treatment or a concentrate-finished meat treatment for four weeks. Blood samples will be taken at weeks zero and four. The primary outcome is to assess difference in change in omega-3 PUFA concentration in plasma and platelets between treatment groups. The secondary outcome is to assess between groups differences in change in cardiovascular disease risk factors including blood pressure, BMI and lipids among healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers aged between 18-64 years old.

Exclusion Criteria:

* Participants with a BMI of \<18.5 km/m² and greater than \>35 km/m².
* Participants who take prescribed medication, including statins to reduce LDL cholesterol, and any form of dietary supplements (excluding vitamin D).
* People who smoke.
* Participants who consume more than two portions of fish per month.

Primary outcomes:
measure: Fatty acid (%) change in blood plasma between treatments
timeFrame: Week 0 and week 4
measure: Fatty acid change (%) in blood plasma phospholipids between treatments
timeFrame: Week 0 and week 4
Secondary outcomes:
measure: Change in weight (kg) in participants between treatments
timeFrame: Week 0 and week 4
measure: Change in Body Mass Index (BMI) in participants between treatments - calculated by dividing weight (kg) by height in meters squared
timeFrame: Week 0 and week 4
measure: Cholesterol
timeFrame: Week 0 and week 4
measure: Blood pressure (diastolic and systolic)
timeFrame: Week 0 and week 4
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: School of Biological Sciences, Queen's University Belfast
Study officials:
affiliation: Queen's University, Belfast
name: Nigel D Scollan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University, Belfast
name: Jayne V Woodside, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02838654: Cervical Epidural Waveform Analysis Using Pressure Monitoring Kit
Official title: Reliability of Epidural Waveform Analysis for Cervical Epidural Blocks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analysis, Event History
Keywords: cervical epidural space
wave form analysis
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who complain chronic neck pain due to cervical spinal disease or acute herpes zoster

Brief summary: The purpose of this study is to analyze the reliability of epidural wave form during cerivical epidural injection.

Detailed description: The epidural space can be confirmed by loss of resistance (LOR) technique. However, LOR has very low specificity, although its sensitivity is high. Especially, cysts between ligaments, clefts in ligamentum flavum, paraspinal muscle and nonspecific spaces between muscles make false LOR.

Epidural wave form analysis (EWA) is very simple and reliable method which can substitue the LOR technique. If the epidural needle is located correctly in the epidural space, the investigators can observe a pulsatile wave and this pulsatile wave corresponds to arterial wave. Generally, sensitivity of EWA through needle is known to be superior to the sensitivity of EWA through catheter and most studies were focused on catheter EWA.

Cervical epidural space shows high false LOR rate and Lee et al demonstrated that false LOR at cervical epidural space was 68.7%. Therefore, nonspecificity of LOR technique require substitution method which can confirm epidural space.

Eligibility criteria: Inclusion Criteria:

* Cerivical Herniated nucleusus
* Cerivical spinal stenosis
* acute herpes zoster

Exclusion Criteria:

* Coagulopathy
* Infectious cervical disease
* Pregnancy

Primary outcomes:
measure: epidural wave form reliability (sensitivity, specificity) analysis
timeFrame: 1 minute after the completion of the epidural injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Keimyung University
name: JiHEE Hong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03614754: Sacral Neuromodulation and Pudendal Somatic Afferents
Official title: The Involvement of Pudendal Somatic Afferents in Sacral Neuromodulation Assessed by Somatosensory Evoked Potentials of the Pudendal Nerve
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overactive Bladder, Non Obstructive Urinary Retention
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urological patients with overactive bladder or non-obstructive urinary retention.

Brief summary: Sacral neuromodulation is a well-excepted minimally invasive procedure for the treatment of overactive bladder and non-obstructive urinary retention.A tined lead with 4 stimulation electrodes is placed through the third or fourth sacral foramen and stimulates sacral roots in its vicinity. Since the sacral roots are mixed nerves, it is currently still unknown which nerve fibers are stimulated (autonomic vs somatic, afferent vs efferent) and what the mechanism of action is.

This study examines the involvement of pudendal somatic afferents by measuring somatosensory evoked potentials elicited by stimulation of the pudendal nerve.


Eligibility criteria: Inclusion Criteria:

* Overactive bladder
* Non-obstructive urinary retention

Exclusion Criteria:

* Neurogenic disorders (e.g. cerebrovascular accident, spinal cord injury,...)

Primary outcomes:
measure: Latency change
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
Clinical trial NCT06002854: Comparison Of Outcome Of Microneedling With Autologous PRP Vs Microneedling With Topical Insulin In Treatment Of Post Acne Atrophic Scars.
Official title: Comparison Of The Outcome Of Treatment of Microneedling With Autologous Platelet- Rich -Plasma Versus Microneedling With Topical Insulin In The Treatment Of Post Acne Atrophic Scars.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ATROPHIC ACNE SCARS
Lead sponsor: Jinnah Postgraduate Medical Centre
Sponsor class: OTHER_GOV
First posted: 2023-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Microneedling with topical INSULIN is a simple, effective tool for building body's new collagen layers and thus an alternative to all erosive techniques such as lasers, peels. The skin responds to fine punctures with the release of growth factors. 8 It is a safe procedure that can be performed in the office without complications, with a good cost-benefit because it is economically viable without any effect on patient's daily activities. 9


Eligibility criteria: Inclusion Criteria:

* postacne atrophic scars ≥ 2 on Goodman and Baron's acne scar-grading system
* Either gender.
* Age 20-50 years.

Exclusion Criteria:

* lactation and pregnancy
* skin cancers and infection
* photosensitivity like SLE ,XP
* use of RETINOIDS in last 6 months.

Primary outcomes:
measure: Efficacy of Topical Insulin R with microneedling versus Platelets rich plasma in atrophic acne scars
timeFrame: Efficacy will be assesed upto 4 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: JPMC
state: Sindh
Study officials:
affiliation: JPMC
name: KHADIJA ASADULLAH, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: JPMC
name: FAIZA INAM, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: JPMC
name: PARISA SANAWAR, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04215354: Association Between Fatigue and Balance in Patients With Multiple Sclerosis
Official title: Association Between Fatigue and Balance in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: MULTIPLE SCLEROSIS
FATIGUE
BALANCE
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
Collaborators: name: King AbdulAziz City for Science and Technology
First posted: 2020-01-02
Enrollment: 95
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The relationship between fatigue and balance was established. Fatigue was correlated with 8 parameters of balance scales. Moreover, there was a strong correlation between the level of fatigue from one side and depression, quality of life and disease severity from the other side.Fatigue seems to be the main problem in patients with MS which may influence other signs and symptoms such as balance.

Detailed description: Electromagnetic field significantly reduced fatigue level in patients with MS.This effect reflected significantly on other symptoms such as balance, depression, disease severity and the quality of life in those patients.

Virtual reality program significantly improving balance and balance perception .Virtual reality program also improved quality of life by improving general health, physical function and decreasing physical limitation significantly. However, Virtual reality programs did not improve fatigue.

Eligibility criteria: Inclusion Criteria:

* Relapsing remitting type of MS.
* Age between 20-50 years.
* Ambulatory with or without an device.
* Complaining of fatigue, Have a score of 4/10 or more on the fatigue visual analogue scale in last four weeks

Exclusion Criteria:

* An acute episode of MS within the last 30 days.
* Pregnancy at any stage.
* Severely blurred vision.
* A pacemaker.
* Epilepsy of any type.
* Recent organ transplant.
* Cardiac arrhythmia.
* Large aneurysm.
* Heavy psychosis.
* Otitis media in last 2 weeks.

Primary outcomes:
measure: Modified Fatigue Impact Scale
timeFrame: 12 weeks.
measure: Balance
timeFrame: 12 weeks.
measure: balance confidence
timeFrame: 12 weeks.
measure: Depression (Beck depression inventory ii (BDI-II))
timeFrame: 12 weeks.
measure: Static balance using posturography,
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life measurement (Short Form 36 (SF-36)
timeFrame: 12 weeks.
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Imam Abdulrahman Bin Faisal University
state: Eastern
Study officials:
References:
Clinical trial NCT00314054: Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults
Official title: An Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of HCV-796 in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Hepatic Insufficiency
Keywords: Hepatitis C
Hepatic Impairment
Healthy Volunteer
Phase 1
Hepacivirus
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: ViroPharma
First posted: 2006-04-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the pharmacokinetics (PK) of HCV-796 in subjects with chronic hepatic impairment and in matched healthy adults.


Eligibility criteria: Inclusion Criteria:

* Men and women of non-childbearing potential.
* Hepatic impairment subjects: Child-Pugh class A, B, or C according to the C-P classification based on history, physical examination, and laboratory test results.
* Healthy volunteers: healthy as determined by the investigator.

Exclusion Criteria:

* History of alcoholism within 1 year.
* Hepatic impairment subjects: evidence of unstable clinically significant disease other than impaired hepatic function.
* Healthy volunteers: positive serologic findings for hepatitis B surface antigen (HBsAg) and/or hepatitis C virus (HCV) antibodies.

Primary outcomes:
measure: To assess PK in subjects with chronic hepatic impairment and in matched healthy adults
timeFrame: 7 days
Secondary outcomes:
measure: To assess the safety and tolerability in subjects with chronic hepatic impairment and in matched healthy adults
timeFrame: 15 days
Other outcomes:
Locations:
city: Gainesville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: St. Paul
country: United States
state: Minnesota
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: