louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00650715: Effects of Whole-Body Vibration Exercise on Serum IGF-1 in Fibromyalgia
Official title: Effect of Acute and Chronic Whole-Body Vibration Exercise on Serum Insulin-Like Growth Factor-1 Levels in Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Hormonal Responses to Exercise in Patients With Fibromyalgia.
Keywords: Fibromyalgia
Whole-Body vibration
Exercise
IGF-1
Lead sponsor: Institut Nacional d'Educacio Fisica de Catalunya
Sponsor class: OTHER
First posted: 2008-04-02
Enrollment: 24
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the acute and chronic effect of whole-body vibration exercise on serum insulin-like growth factor-1 levels in women with fibromyalgia (FM). It was hypothesized that women with FM would exhibit an increase in IGF-1 following both acute and chronic WBV. Twenty-four women with FM were randomized into two groups: Vibration Group (VG) and Control Group (CG). The VG underwent a protocol with WBV exercise twice a week for a total of six weeks, whereas the CG performed the same protocol without vibratory stimulus. Both groups continued with their usual pharmacological treatment. Serum IGF-1 levels were determined using Enzyme-Linked Immunosorbent Assay (ELISA). To test the effect of chronic WBV, serum IGF-1 measurements were taken at baseline and at weeks 1,3, and 6 of intervention. To test the effect of acute WBV, within week 1, serum IGF-1 measurements were taken before and immediately following a session of WBV.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed of fibromyalgia according to the American College of Rheumatology criteria for at least three years.

Exclusion Criteria:

* Orthopedic limitation, or cardiovascular, pulmonary, or metabolic disease that would preclude exercise.
* Participation in any other study.

Primary outcomes:
measure: Serum IGF-1 levels
timeFrame: Baseline, Week 1, Week 3, Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut Nacional d'Educación Física de Catalunya
Study officials:
affiliation: INEFC
name: Eduard Alentorn-Geli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01458015: Tapentadol Versus Oxycodone - a Mechanism-based Treatment Approach in Neuropathic Pain
Official title: Phase 4 Study of Tapentadol vs Oxycodone in Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Peripheral Neuropathy
Keywords: QST (quantitative sensory testing)
neuropathic pain
tapentadol pr
oxycodone
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to elucidate whether the additional mechanism of analgesia, i.e. reuptake inhibition of norepinephrine, of tapentadol leads to a change in different pain signs and symptoms in comparison to oxycodone.


Eligibility criteria: Inclusion Criteria:

* thermal or mechanical hyperalgesia
* chronic neuropathic pain (NRS =\> 6)

Exclusion Criteria:

* non-specific

Primary outcomes:
measure: Mechanical Pain Threshold (MPT)
timeFrame: day 0 (baseline) and day 78 (V6; 10 weeks)
measure: Heat Pain Threshold (HPT)
timeFrame: day 0 (baseline) and day 78 (10 weeks)
measure: Wind-Up Ratio (WUR)
timeFrame: day 0 (baseline) and day 78 (10 weeks)
measure: Cold Pain Threshold (CPT)
timeFrame: day 0 (baseline) and day 78 (10 weeks)
measure: Pressure Pain Threshold (PPT)
timeFrame: day 0 (baseline) and day 78 (V6; 10 weeks)
measure: Mechanical Pain Sensitivity (MPS)
timeFrame: day 0 (baseline) and day 78 (V6; 10 weeks)
measure: Dynamic Mechanical Allodynia (DMA)
timeFrame: day 0 (baseline) and day 78 (V6; 10 weeks)
measure: Pain Upon Numeric Rating Scale
timeFrame: day 0 (baseline) and day 78 (V6; 10 weeks)
Secondary outcomes:
measure: Cold Detection Threshold (CDT)
timeFrame: day 0 (baseline) and day 78 (10 weeks)
measure: Warmth Detection Threshold (WDT)
timeFrame: day 0 (baseline) and day 78 (V6; 10 weeks)
measure: Thermal Sensory Limen (TSL)
timeFrame: day 0 (baseline) and day 78 (V6; 10 weeks)
measure: Mechanical Detection Threshold (MDT)
timeFrame: day 0 (baseline) and day 78 (V6; 10 weeks)
measure: Vibration Detection Threshold (VDT)
timeFrame: day 0 (baseline) and day 78 (V6; 10 weeks)
measure: Paradoxical Heat Sensations (PHS)
timeFrame: day 0 (baseline) and day 78 (V6; 10 weeks)
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Division for Neurological Pain Research and Therapy
state: Schleswig Holstein
Study officials:
affiliation: Head of Unit of Neuropathic Pain Research and Therapy, Department of Neurology, University Clinic Kiel
name: Ralf Baron, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05855915: Effectiveness of KT VS ST Along With Routine Physical Therapy Among Patients of Chronic Low Back Pain RCT
Official title: Effectiveness of Kinesio Taping Versus Sham Taping Along With Routine Physical Therapy Among Patients of Chronic Low Back Pain A Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 74
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: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the effectiveness of Kineso taping (KT) Versus Sham taping along with routine physical therapy among Chronic Low Back pain (CLBP) patients.


Eligibility criteria: Inclusion Criteria:

Pain in the area between 12 ribs and hip crease with or without leg pain. Age ranges from 18 to 65 years. Low back pain for 6 weeks. Moderate pain intensity with pain score.

Exclusion Criteria:

Known or suspected Spinal lesions. Spinal surgery within first 6 months. Physical Therapy for low back pain for past 6 months. Severe Complications.

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References:
Clinical trial NCT06249815: Sequential Use of Foley's Catheter and Misoprostol Versus Misoprostol Alone for Induction of Labour: a Multicentre Randomised Controlled Trial
Official title: Sequential Use of Foley's Catheter and Low Dose Oral Misoprostol Versus Misoprostol Alone for Induction of Labour : a Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Induction of Labor
Keywords: Induction of labor
low dose misoprostol
Foley Catheter
Lead sponsor: Kazakhstan's Medical University "KSPH"
Sponsor class: OTHER
Collaborators: name: Asfendiyarov Kazakh National Medical University
First posted: 2024-02-08
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of efficacy of inducing labour using a Foley's catheter and low dose oral misoprostol sequentially, in comparison with low dose oral misoprostol alone.

Detailed description: a multicentre, open-label randomised controlled trial in 2 hospitals in the Almaty,Kazakhstan. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section will be randomly allocated to 2 groups: 1 group -cervical ripening with Foley's catheter for 16 hour and sequentially 25 μg oral misoprostol once every 2 hour, 2 nd group- 25 μg oral misoprostol once every 2 hour. The primary outcome will be vaginal delivery within 24 hours(to evaluate effectiveness) and secondary outcoms 1-5-min Apgar score and hospitalization in ICU, rate of hyperstimulation ,hemorrage,chorioamnionitis (for evaluating safety)

Eligibility criteria: Inclusion Criteria:

* women with an unfavourable cervix who will scheduled for induction of labour

Exclusion Criteria:

* Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )

Primary outcomes:
measure: Efficiency of induction
timeFrame: 24 hours.
Secondary outcomes:
measure: Safety for baby
timeFrame: 5 minutes
measure: Safety for mother
timeFrame: 24 hour
measure: rete of hemorrage
timeFrame: 24 hour
measure: rate of chorioamnionitis chorioamnionitis
timeFrame: 24 hour
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: City Perinatology Centre 3
city: Almaty
country: Kazakhstan
facility: Center for Perinatology and Pediatric Cardiac Surgery
Study officials:
affiliation: Asfendiyarov Kazakh National Univercity
name: Saule Issenova
role: STUDY_CHAIR
affiliation: Kazakhstans Medical Uivercity
name: DILFUZA SULTANMURATOVA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03335085: Oxytocin Administration and Emotion Recognition Abilities in Adults Reporting Adverse Childhood Experiences
Official title: Long-term Consequences of Childhood Adversity: Exploring Stress Responsive Molecular Pathways and Psychobiological Intervention Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2017-11-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates whether intranasal administration of a single dose of oxytocin improves the ability to recognize emotional states. In a cross-over design, half of the participants first received oxytocin, the other half first received placebo.

Detailed description: Adverse childhood experience such as neglect or abuse can lead to long-term deficits in emotion processing abilities, and these effects might be mediated via alterations in oxytocin production or sensitivity. The goal of this study was to test whether emotion recognition abilities and empathy might be improved by intranasal oxytocin administration in adults with a history of childhood maltreatment.

In a double-blind, placebo-controlled experiment with a crossover design, we assessed the performance of 40 healthy participants with a history of childhood adversity on the Reading the Mind in the Eyes Test (RMET) and an emotion recognition task under 24 IU oxytocin vs. placebo and compared them to a control group of 40 matched individuals without traumatic childhood experiences.

Eligibility criteria: Inclusion Criteria:

• presence of moderate to severe experiences of childhood adversity (early adversity group)

Exclusion Criteria:

* Acute psychiatric disorders and personality disorders or psychiatric disorders within the last 12 months
* Pregnancy

Primary outcomes:
measure: Reading the Mind in the Eyes Test
timeFrame: 45 minutes post-dose
measure: Gradual Emotion Recognition Test
timeFrame: 50 minutes post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Schwaiger M, Heinrichs M, Kumsta R. Oxytocin administration and emotion recognition abilities in adults with a history of childhood adversity. Psychoneuroendocrinology. 2019 Jan;99:66-71. doi: 10.1016/j.psyneuen.2018.08.025. Epub 2018 Aug 27.
Clinical trial NCT03574285: A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions
Official title: A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2018-06-29
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions

Detailed description: To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy Thai volunteers under feeding condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 19 years of age or older
* BMI ≥ 18.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of childbearing or non-childbearing potential

Exclusion Criteria:

* Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Primary outcomes:
measure: Maximum Plasma Concentration
timeFrame: 0-24hr
measure: Area under the plasma concentration versus time curve
timeFrame: 0-24hr
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Deawoong pharmaceutical
state: Gangnam-gu
Study officials:
References:
Clinical trial NCT05352685: Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma
Official title: Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Propofol
Glioma
Auditory Event-related Potential (AERP)
Electroencephalogram (EEG)
Brain Network Connectivity
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The growth of gliomas often infiltrates important brain tissues and impairs subcortical fiber transmission, resulting in changes in global brain network connectivity. Most of the current anesthesia depth monitoring methods are based on healthy brain function population，which is difficult to reflect the sedation depth of glioma patients accurately. Therefore, this study aims to explore the characteristics of brain network connectivity in glioma patients under different sedation depths by electroencephalogram (EEG) and auditory event-related potential (AERP) methods, which may provide a research basis for sedative titration and anesthesia depth identification in glioma patients.


Eligibility criteria: Inclusion Criteria:

1. Age 18 - 60 years old;
2. American Society of Anesthesiologists (ASA) physical status rating I-II;
3. Supratentorial glioma (frontal, temporal, parietal, insular ；WHO grade I-III);
4. Native Chinese speaker;
5. Signed informed consent.

Exclusion Criteria:

1. Mallampati airway class≥III;
2. BMI\>30kg/m2;
3. Combined OSAS or Stop-BANG score≥3;
4. Hearing impairment
5. Combined epilepsy symptoms
6. Recurrent or multiple intracranial tumors
7. Concomitant other psychiatric or neurological disorders
8. Pregnancy and lactation

Primary outcomes:
measure: The amplitude of auditory event-related potential
timeFrame: During the trial(up to 3 hours for each subject)
measure: The latency of auditory event-related potential
timeFrame: During the trial(up to 3 hours for each subject)
Secondary outcomes:
measure: Brain network functional connectivity
timeFrame: During the trial(up to 3 hours for each subject)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT03383185: Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives
Official title: Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives, 5-year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraceptive Usage
Metabolic Syndrome
Body Weight Changes
Keywords: contraception
Body mass index
Metabolic Syndrome
obesity
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 489
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women in menacme, users of the same contraceptive hormonal (combined oral contraceptives, progestin-only pills and depot-medroxyprodestereone acetate) and non-hormonal contraceptive methods (IUD) during five years

Brief summary: Evaluation of metabolic profile of users of hormonal and non-hormonal contraceptives during five years follow-up

Detailed description: Were eligible for the study 489 Women, followed in Federal University of São Paulo Family Planning Service, who used the same contraceptive method during five year of follow-up, According to the service protocol, the patients, after had participated of a orientation group about contraceptives methods, elected one of them. After that, if the choice had been according to the eligibility criteria of World Health Organization, it was approved by a gynecologist.

The contraceptive methods available were the intrauterine device (IUD) oral contraceptives, including combined pills and progestin-only formulations, and depot medroxyprogestereone acetate.

The study consisted in the evaluation of their medical records of weight, BMI, Blood pressure, glycemia, seric levels of cholesterol and triglycerides, during the five years, and in the comparison of the differences of these data between the contraceptive methods.

Eligibility criteria: Inclusion Criteria:

* women in reproductive age followed in Federal university of Sao Paulo Family Planning Service
* use of the same contraceptive method during five years

Exclusion Criteria:

* incomplete data

Primary outcomes:
measure: Body Mass Index
timeFrame: five years follow-up
Secondary outcomes:
measure: glycemia
timeFrame: five years follow-up
measure: cholesterol level
timeFrame: five years follow-up
measure: triglycerides level
timeFrame: five years follow-up
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo - Unifesp
state: SP
Study officials:
References:
Clinical trial NCT00675285: Effects of Montelukast in Children With Asthma
Official title: Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: airway inflammation
childhood asthma
fractional exhaled nitric oxide
leukotriene receptor antagonists
lung function
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-05-09
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Leukotriene receptor antagonists (LTRAs) reduce fractional exhaled nitric oxide (FENO) concentrations in children with asthma, but the effect of LTRA withdrawal on FENO and lung function is unknown. We will aim to study the effect of treatment and withdrawal of montelukast, a LTRA, on airway inflammation as reflected by FENO and lung function in children with asthma.

A double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18 atopic children with mild persistent asthma who will be treated with oral montelukast (5 mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive matching placebo.

A follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.


Eligibility criteria: Inclusion Criteria:

* Children 6 to 14 yrs old, step 1 and step 2 GINA (Global INitiative for Asthma) guidelines
* exhaled nitric oxide (NO) \>20 PPB at visit 2
* symptoms more often than twice a day, FEV1 equal or higher than 80% of predicted value and reversibility equal or higher than 12% to salbutamol, or a positive provocation test with methacholine, or exercise
* no regular medication, inhaled short-acting beta-2 agonists for symptom relief

Exclusion Criteria:

* Patient is hospitalized
* Patient has FEV1 \< 80% predicted on visit 1
* Patient has 2 or more nighttime awakenings for asthma per week or pef variability 30% or more
* upper respiratory infection in the previous 3 weeks
* treatment with glucocorticoids or LTRAs in the previous 4 weeks
* treatment with inhaled glucocorticoids for more than 4 weeks in the previous year

Primary outcomes:
measure: post-treatment fractional exhaled nitric oxide
Secondary outcomes:
measure: fractional exhaled nitric oxide 2 weeks after montelukast withdrawal
measure: post-treatment FEV1
measure: post-treatment FVC
measure: post-treatment FEV1/FVC
measure: post-treatment FEF25%-75%
measure: FEV1 2 weeks after montelukast withdrawal
measure: FVC 2 weeks after montelukast withdrawal
measure: FEV1/FVC 2 weeks after montelukast withdrawal
measure: FEF25%-75% 2 weeks after montelukast withdrawal
measure: asthma exacerbation rate
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Paolo Montuschi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: