louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00789386: The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers
Official title: The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hyperalgesia
Keywords: Capsaicin
Remifentanil
Hyperalgesia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.

Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.

Intradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.


Eligibility criteria: Inclusion Criteria:

* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination
* Drug free for 1 week prior to the study day

Exclusion Criteria:

* Regular use of medication especially analgesics
* Abuse of alcoholic beverages, drug abuse
* History of asthma
* Participation in a clinical trial in the 2 weeks preceding the study
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Resting systolic blood pressure \> 135 mmHg or diastolic blood pressure \> 85 mmHg
* Acute skin diseases like sunburn on the relevant areas or skin lesions
* Pregnancy or breast feeding

Primary outcomes:
measure: Area of pin prick hyperalgesia
timeFrame: 0-6 hours
Secondary outcomes:
measure: Stimulus-response (SR)function to a set of modified rigid von Frey filaments (8-512 mN)
timeFrame: 0-6 hours
measure: Pain immediately after injection
timeFrame: 0-15 minutes
measure: Heat pain threshold within the area of mechanical hyperalgesia
timeFrame: 0-6 hours
measure: Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush
timeFrame: 0-6 hours
measure: Adverse effects
timeFrame: 10 and 30 min after infusion of study medication
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Anaesthesia, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Burkhard Gustorff, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05933486: Efficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome
Official title: A Multicenter, Randomized, Double-blind Study on the Efficacy and Safety of Tongluo-Kaibi Tablet in the Treatment of Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fibromyalgia Syndrome
Keywords: Tongluo-Kaibi Tablet
Traditional Chinese Medicine
Fibromyalgia Syndrome
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate efficacy and safety of Tongluo-Kaibi tablets in patients with Fibromyalgia Syndrome.


Eligibility criteria: Inclusion Criteria:

* Those who meet the classification criteria for Fibromyalgia formulated by the American Rheumatology Association in 2016.
* Pain VAS score ≥ 4 points.
* The variety and dosage of the medication used to treat the disease should be stable for at least 2 weeks.

Exclusion Criteria:

* Severe cardiovascular and cerebrovascular diseases.
* Malignant tumors, hematological diseases, inflammatory arthritis, or other serious or progressive systemic diseases.
* ALT and AST are more than 2 times the upper limit of normal.
* Cr is more than 1.2 times the upper limit of normal.
* Allergic constitution or allergic to experimental drugs Tongluo-Kaibi tablet, pregabalin capsules, excipients or similar ingredients.
* Pregnant, lactating or recently planned pregnancy.

Primary outcomes:
measure: VAS
timeFrame: 8 weeks
Secondary outcomes:
measure: MFI-20
timeFrame: 8 weeks
measure: BDI
timeFrame: 8 weeks
measure: PSQI
timeFrame: 8 weeks
measure: WPI
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02160886: Effects of a Task Oriented Intervention With Two Goal-setting Approaches
Official title: Effects of a Task Oriented Intervention for Children With Disabilities, Based on Children's or Parent's Goals, a Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Movement Disorder
Learning Disability
Autism Spectrum Disorder
Children
Lead sponsor: Region Gävleborg
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 34
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized trial investigating if effects of a goal-directed task oriented intervention is influenced by who takes the decision and establishes the goal (the child or the parent) and whether establishing a goal per se influence performance and goal-achievement. The main hypothesis are that children's participation in the goal-setting process would positively influence goal achievement, children's self-identified goals would be achievable and that both groups would achieve goals that were the target of a goal-directed intervention.


Eligibility criteria: Inclusion Criteria:

* enrollment in pediatric rehabilitation, age between 5-12 years and any type of disability but functioning at or above a 5 year old level in receptive language.

Exclusion Criteria:

* involvement in another block of intensive intervention during the 5-month study period

Primary outcomes:
measure: Goal Attainment Scaling (GAS)
timeFrame: Three times, at baseline, post-intervention (8-weeks) and follow-up (5-months)
Secondary outcomes:
measure: Performance scale of the Canadian Occupational Performance Measure
timeFrame: Assesed once a week up to 11 weeks which include three baseline assesments and eight assesments during the egiht weeks intervention period
measure: Beck Youth scales, subscale self-concept
timeFrame: Three times, at baseline, post-intervention (eigth weeks) and at follow-up (5-months)
Other outcomes:
measure: Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: One time, at baseline
measure: Parental questionnaire
timeFrame: Assesed once a week up to egiht weeks during the eight weeks intervention period
Locations:
city: Gävle
country: Sweden
facility: Gävleborg County Council
Study officials:
affiliation: Department of Women's and Children's Health Karolinska Institutet
name: Kristina Vroland-Nordstrand, Phd-student
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of women's and Children's Helath Karolinska Institutet
name: Lena Krumlinde-Sundholm, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of women's and children's Health, Karolinska Institutet
name: Ann-Christin Eliasson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00188786: Cone Beam CT for Daily Image Guidance - Prostate Cancer
Official title: A Phase II Feasibility Study of Cone Beam Computed Tomography for Daily Image Guidance in Patients Receiving Dose Escalated Conformal Radiation Therapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-16
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Conformal dose escalated radiation therapy (CRT) is standard treatment for patients with low and intermediate risk prostate cancer. CRT requires accurate daily localization of the prostate prior to treatment to correct for prostate motion and set-up errors. Cone beam computed tomography (CT) can accurately localize fiducial markers within the prostate. Cone Beam CT also provides important information on daily position of organs within the pelvis. This study aims to assess the feasibility of cone beam CT for daily localization of the prostate as well as document changes in size and location of pelvic organs during an entire course of CRT.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of adenocarcinoma of the prostate
* Patient undergoing dose escalated conformal external beam radiation therapy
* Low or intermediate risk prognostic factors (PSA 20 or less, Gleason score \<8, Clinical T category \<T3, Clinical N category 0 or X, M category 0 or X
* Age 18 years or older
* ECOG performance status 0 or 1
* Informed consent

Exclusion Criteria:

* Inflammatory bowel disease or collagen vascular disease

Primary outcomes:
measure: To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving conformal radiation therapy for prostate cancer.
Secondary outcomes:
measure: To measure the amount of interfraction movement of the prostate and seminal vesicles with current bowel regimen of daily milk of magnesia.
measure: To measure the amount of interfraction movement and deformity of the rectum and bladder with current bowel regimen of daily milk of magnesia.
measure: To develop a technique for delivery of radiation therapy that reduces normal tissue toxicity, based on rectal and bladder avoidance models.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Charles Catton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01204086: Pharmacogenomics Studies of Antidepressants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Antidepressive Agents
Pharmacogenetics
Venlafaxine
Fluoxetine
Keywords: Major Depressive Disorder
Antidepressants
Pharmacogenetics
venlafaxine
fluoxetine
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2010-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
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 establish the clinical effectiveness of antidepressants by pharmacogenomic approach, and to determine the levels of inflammatory factors between the baseline and the end point of the study in Taiwanese major depressive disorder (MDD) patients.


Eligibility criteria: Inclusion Criteria:

* Age: 16-65 years old
* Signed informed consent by patient or legal representative
* Hamilton Rating Scale for Depression (HDRS) scores ≥ 16
* A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry

Exclusion Criteria:

* monoamine oxidase inhibitor or antidepressant treatment within two weeks prior to entering the study
* A DSM-IV diagnosis of substance abuse within the past three months
* An organic mental disease, mental retardation or dementia
* A serious surgical condition or physical illness
* Patients who were pregnant or breastfeeding

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: baseline
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: 2 weeks
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: 4 weeks
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: 6 weeks
Secondary outcomes:
measure: C-reactive Protein and IL-6
timeFrame: baseline
measure: fasting blood glucose, lipid profiles
timeFrame: baseline
measure: C-reactive Protein and IL-6
timeFrame: 6 weeks
measure: fasting blood glucose, lipid profiles
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Po See Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04633486: Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation
Official title: Endoscopically One-year Follow-up in Patients After Small-bowel Transplantation, Role of SASAKI Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Graft Dysfunction
Keywords: endoscopic monitoring, intestinal transplantation
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intestinal transplant reciepients since 2005

Brief summary: Intestinal transplantation is associated with high numbers of ejection events. A close endoscopic controll of the intestinal graft is possible. Sasaki et al. presented 2002 an endoscopic score using zoom-endoscopes for early detection of rejection events.

Detailed description: Small bowel transplantation is a potentially life-saving procedure for patients with irreversible gut failure, especially for those with total parenteral nutrition complications, inability to adapt to quality-of-life limitations posed by intestinal failure, and high risk of death if the native gut is not removed. Endoscopy provides the quickest method for assessing the overall health of graft mucosa and is essential in obtaining specimens from large areas for histologic evaluation, which continues to remain the gold standard for a diagnosis of rejection. Recently, the use of zoom videoendoscopy has been reported as a better evaluation of intestinal mucosa than the use of a standard endoscope. Acute cellular rejection in short-term follow-up, appears with acute and dramatic clinical symptoms (fever, vomiting, nausea, increased stomal output/diarrhea, abdominal pain, and distension), so that it is rarely predictable with surveillance.

Comparison of endoscopic and histo-pathologic findings should be performed.

Eligibility criteria: Inclusion Criteria:

* intestinal transplant recipients

Exclusion Criteria:

* younger age (\< 16)

Primary outcomes:
measure: Rate of congruent findings of zoom-endoscopy and pathological examinations
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital of Tuebingen
Study officials:
References:
Clinical trial NCT05206786: A Gluteus Maximus Strength Exercise Effectiveness for Improving Dynamic Postural Control in Female Basketball Players
Official title: Effectiveness of a Specific Strength Program of the Gluteus Maximus Muscle to Improve Dynamic Postural Control in Female Basketball Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basketball
Keywords: Dynamic Postural Control
Gluteus Maximus
Lower limb
Injury prevention
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 92
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. A total of 92 female basketball players aged between 12 and 25 will be selected and randomized in two different groups.

The control group will carry out a conventional preventive work out and the experimental group will carry out a specific strengthening program for the gluteus maximus in addition to the conventional preventive exercises.

The treatment will take place during the basketball club season and will last 4 months, from January to April 2022.

The objective is to evaluate the effectiveness of the inclusion of a specific gluteus maximus strength program in the conventional preventive work to improve the dynamic stability and to reduce the injury rate and pain in female basketball players.


Eligibility criteria: Inclusion Criteria:

* Female basketball players belonging to a sports club.
* Female basketball players between 12 and 25 years old.

Exclusion Criteria:

* Acute lower limb injuries at the start of the study.
* Surgery on the lower limb in the previous year.
* Injuries or diseases that prevent the correct performance of the evaluation tests.

Primary outcomes:
measure: Dynamic stability change assessed by a modified version of the Star Excursion Balance Test (SEBT). For this, Octobo-Balance device will be used.
timeFrame: Baseline and 4 months later
Secondary outcomes:
measure: Change in the rate of lower limb injuries measured with a Daily Injury Report
timeFrame: Daily from baseline until the end of the research study 4 months later
measure: Pain change measured with the Visual Analogue Scale
timeFrame: Baseline and 4 months later
measure: Vertical Jump Height using the app MyJump2
timeFrame: Baseline and 4 months later
measure: Dynamic knee valgus measured with the programme Kinovea
timeFrame: Baseline and 4 months later
measure: Treatment adherence through an exercise tracking diary
timeFrame: Weekly from baseline until the end of the research study 4 months later
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Sandra Sánchez
state: Madrid
Study officials:
affiliation: University of Alcalá, Madrid, Spain
name: Sandra Sánchez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04932486: Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea
Official title: Randomised Controlled Trial of Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Sunrise
Sponsor class: INDUSTRY
First posted: 2021-06-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the upper airway muscles in patients with obstructive sleep apnea.


Eligibility criteria: Inclusion criteria:

* Obstructive apnea-hypopnea index \> 15 events/hour
* Patients who do not tolerate or do not accept positive airway pressure therapy

Main exclusion criteria:

* Body mass index \< 18.5 or \> 32 kg/m2
* Unable or incapable of providing informed written consent
* Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
* Significant co-morbidities making the patient unable or inappropriate to participate in the trial

Primary outcomes:
measure: Apnea-hypopnea index (AHI)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Respisom
Study officials:
affiliation: Respisom
name: Jean-Benoit Martinot
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01253486: Expressive Writing for Heart Healing
Official title: Use of Expressive Writing in the Cardiac Rehabilitation of Obese In-patients With Ischemic Heart Disease (IHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Obesity
Keywords: expressive writing
cardiac rehabilitation
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 100
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether the psychological and physical benefits of expressive writing extend to obese in-patients with Ischemic Heart Disease (IHD)referred to cardiac rehabilitation

Detailed description: Expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve both physical and psychological health based on health outcome measures such as number of doctor's visits and hospital days, blood pressure control, lung and immune function, pain, anxiety and depression. Given its simplicity and obvious advantages in terms of cost-effectiveness, expressive writing has great potential as a therapeutic tool or as a means of self-help, either alone or as an adjunct to traditional therapies. This modality has not been studied in obese patients with Ischemic Heart Disease.

Eligibility criteria: Inclusion Criteria:

* obesity
* Ischemic Heart disease
* Signed informed consent

Exclusion Criteria:

* Visual or manual limitations that preclude reading and writing
* Unwilling to participate

Primary outcomes:
measure: SF12
timeFrame: 1 year
measure: BDI-II
timeFrame: 1 year
measure: BDI
timeFrame: 1 year
measure: Brief-PTGI
timeFrame: 1 year
Secondary outcomes:
measure: BMI
timeFrame: 1 year
measure: Multiple Coronary Risk Factors
timeFrame: 1 year
measure: METs
timeFrame: 1 year
Other outcomes:
Locations:
city: Verbania
country: Italy
facility: San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS
Study officials:
affiliation: Istituto Auxologico Italiano
name: Gianluca Castelnuovo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. doi: 10.1037/0033-2909.132.6.823.
citation: Manzoni GM, Castelnuovo G, Molinari E. The WRITTEN-HEART study (expressive writing for heart healing): rationale and design of a randomized controlled clinical trial of expressive writing in coronary patients referred to residential cardiac rehabilitation. Health Qual Life Outcomes. 2011 Jul 8;9:51. doi: 10.1186/1477-7525-9-51.