louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01592916: Acute Effects of Exercise in Women With Fibromyalgia (FM)
Official title: Acute Effects of Exercise in Women With FM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Pain
Women
Exercise
IGF1
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: The Swedish Research Council
First posted: 2012-05-07
Enrollment: 55
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants are recruited from previous studies.

Brief summary: The investigators previous studies of aerobic exercise in women with fibromyalgia (FM) have shown that exercise improves body functions and/or symptom severity in most patients, but not in all. About a third of patients with FM have been shown to have low levels of IGF-1. The purpose of this project is to study individual and biological factors that interact with outcomes of short-term (acute) exercise in FM.

Method. A controlled prospective exercise study. Thirty women with FM and 30 healthy age-matched women, aged 20-50 years, will be recruited to the study. Two 15-minute ergometer bicycle exercise tests will be conducted in feasting patients, separated by one month. The first exercise test is at a low and the second at a high intensity. Measurements comprise blood test, pain rating and pain threshold, conducted before and after the test. The levels of IGF-1, IL-6 and IL-8 will be measured, and the changes in them will be related to health status and pain.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of fibromyalgia
* age 20-50 years

Exclusion Criteria:

* heart disease
* neurological disease
* severe osteoarthritis

Primary outcomes:
measure: IGF1 level
timeFrame: 15 min
Secondary outcomes:
measure: Pain rating
timeFrame: 15 minutes
measure: Pain threshold
timeFrame: 15 minutes
measure: Interleukin 6 and 8
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital, Dept of Physical Therapy
Study officials:
affiliation: Göteborg University
name: Kaisa Mannerkorpi, Assoc prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mannerkorpi K, Landin-Wilhelmsen K, Larsson A, Cider A, Arodell O, Bjersing JL. Acute effects of physical exercise on the serum insulin-like growth factor system in women with fibromyalgia. BMC Musculoskelet Disord. 2017 Jan 25;18(1):37. doi: 10.1186/s12891-017-1402-y.
Clinical trial NCT06553716: Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis
Official title: Ultrasound-Guided Hydrodilatation With Triamcinolone Acetonide for Adhesive Capsulitis:The Effect of the Rotator Cuff Interval With Posterior Glenohumeral Recess Approaches on the Improvement of Joint Motion and Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperation Pain
Keywords: Adhesive capsulitis
hydrodilatation
corticosteroid
rotator cuff interval
Posterior Glenohumeral Recess
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the efficacy of ultrasus-guided hydrodilation of Rotator Cuff Interval combined with Posterior Glenohumeral recess approach and hydrodilation of the Rotator cuff Interval alone in Adhesive Capsulitis.

Detailed description: For patients with perihumeral arthritis, shoulder capsule hydrodilation is usually performed using ultrasound-guided water dilation through the posterior glenohumeral recess. Recently, a new transrotator cuff space approach has been described, and this study was designed to compare the efficacy of triamcinolone olonide transrotator cuff space combined with posterior glenohumeral recess and rotator cuff space dilation in the treatment of adhesive joint capsitis.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, clinical diagnosis of periarthritis of shoulder;
2. symptom duration \> 1 month, shoulder ROM limitation in at least two directions, defined as abduction \< 80°, flexion \< 130°, and rotation \< 30°;
3. Before enrollment, the patients received plain radiographs, ultrasound images, and magnetic resonance imaging to rule out the cause of secondary shoulder capsitis.

Exclusion Criteria:

1. Secondary frozen shoulder, such as rotator cuff tear, calcifying tendinitis, osteoarthritis, infection, tuberculosis infection, rheumatic disease, shoulder impingement syndrome;
2. Previous history of shoulder joint surgery;
3. Involved cervical nervous system symptoms or abnormal nervous system;
4. corticosteroid injection in the affected shoulder within 3 months;
5. Mental illness;
6. Patients with contraindications to cortisol-hormone use.

Primary outcomes:
measure: Shoulder Pain and Disability Index
timeFrame: At baseline, one week, three weeks, six weeks, 12 weeks after treatment.
Secondary outcomes:
measure: visual analogue scale
timeFrame: At baseline, one week, three weeks, six weeks, 12 weeks after treatment.
measure: Active shoulder range of motion
timeFrame: Baseline data, six weeks,12 weeks after treatment
measure: adverse reaction
timeFrame: one week after treatment
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General hospital of Ningxia medical university
state: Ningxia
Study officials:
References:
Clinical trial NCT03819816: Development and Evaluation of the DEA App
Official title: Development and Evaluation of an Application for Supporting Informal Caregivers of People With Dementia in Their Daily Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: informal caregivers
person with dementia
e-health solution
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: FH Campus Wien, University of Applied Sciences
First posted: 2019-01-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background, current situation, and motivation

According to current estimates, 100,000 people in Austria suffer from various types of dementia. According to forecasts, this number of people will rise to approximately 230,000 by 2050 due to the demographic development and the increase of the prevalence rate. Data from the service statistics show that 85% of dementia patients still live in the community in their homes and informal caregivers, such as relatives, support them. In total, more than 300,000 people care for their relatives in Austria in addition to professional support. However, not only the person affected from dementia suffers from the disease, but also, and often at a higher rate, the informal caregivers. Vice versa, the quality of life of those suffering from dementia is significantly influenced by the caregivers' competences and their strategies for resilience.

Study aim and hypothesis

The aim of this study is to evaluate the usability, acceptance, and effect of an app consisting of three modules that provide multidimensional support for informal caregivers of a person with dementia.


Eligibility criteria: Inclusion Criteria:

* informal caregivers of a person with dementia
* 18 years or older
* enough language skills to participate
* give written and oral informed consent
* have an Android smartphone or tablet (required to use the app).

Exclusion Criteria:

* none

Primary outcomes:
measure: Burden Scale for Family Caregivers
timeFrame: 3 month after baseline
Secondary outcomes:
measure: 12-item Short-Form Health Survey
timeFrame: 3 month after baseline
measure: Adult carers quality of life questionnaire
timeFrame: 3 month after baseline
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: University of Applied Sciences FH Campus Wien
Study officials:
affiliation: Medical University of Vienna
name: Tanja A Stamm, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01442116: Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension
Official title: Evaluation of Regional Myocardial Dynamics at Physical Stress in Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Left Ventricular Hypertrophy
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study hypothesis is stress-related regional tissue dynamics is related to left ventricular outflow tract blood flow.


Eligibility criteria: Inclusion Criteria:

* Essential hypertension

Exclusion Criteria:

* History of Myocardial Infarction
* Diabetes Mellitus
* Renal Failure
* Orthopedic problems

Primary outcomes:
measure: measurement of LVOT velocity before and after exercise by echocardiography
timeFrame: 1 day (before and after exercise stress)
measure: measurement of TDI S wave before and after exercise by echocardiography
timeFrame: 1 day (before and after exercise)
Secondary outcomes:
measure: myocardial regional functions measured by tissue Doppler imagination
timeFrame: 1 day
Other outcomes:
Locations:
city: Antioch
country: Turkey
facility: Mustafa Kemal University School of Medicine, Department of Cardiology
Study officials:
affiliation: Mustafa Kemal University: Turkey
name: Fatih Yalcin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03457116: Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty
Official title: Narcotics vs Non-steroidal Ant Inflammatory Drugs Post-operative Analgesia in Outpatient Rhinoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinoplasty
Non-steroidal Ant Inflammatory Drugs
Opioid Use
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 70
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: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of oral opiate pain medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative rhinoplasty pain. This study will also evaluate potential contributing factors affecting the efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used for post-operative pain. The study will then compare which is more effective in controlling post operative pain.


Eligibility criteria: Inclusion Criteria:

* Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

Exclusion Criteria:

* Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.
* Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.
* Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.
* Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.

Primary outcomes:
measure: Average Pain Score
timeFrame: Day 0
measure: Average Pain Score
timeFrame: Day 1
measure: Average Pain Score
timeFrame: Day 7
measure: Average Post-Operative Day (POD) of Medication Cessation
timeFrame: Day 7
Secondary outcomes:
measure: Number of Participants in NSAIDs Group Who Were Upgraded to Opiates Due to High Levels of Pain
timeFrame: Day 7
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone
name: Judy Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00473616: Phase I Single Ascending Dose/Multiple Ascending Dose in Patients Treated With AZD7762 and Irinotecan
Official title: A Phase I Open-label, Multi-center, Dose-escalation and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Cancer
Advanced Solid Malignancies
Keywords: Phase I
solid tumors
solid malignancies
cancer Eligibility
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-05-15
Enrollment: 60
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 is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with irinotecan. The study is sponsored by AstraZeneca.


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
* Must be suitable for treatment with irinotecan
* Relatively good overall health other than your cancer

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells)
* Serious heart conditions
* Poor liver or kidney function
* Any prior anthracycline treatment

Primary outcomes:
measure: The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan
timeFrame: assessed after each course of treatment
Secondary outcomes:
measure: To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762.
timeFrame: assessed after each course of treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: New York
country: United States
facility: Research Site
state: New York
city: Nashville
country: United States
facility: Research site
state: Tennessee
Study officials:
affiliation: AstraZeneca
name: Peter Langmuir, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01968616: Ranibizumab Treatment for Retinal Vein Occlusion
Official title: Predictive Factors of 2-year Visual Outcome in Retinal Vein Occlusion Following Intravitreal Ranibizumab Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Edema Due to BRVO/CRVO
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2013-10-24
Enrollment: 100
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: In retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment have not been evaluated comprehensively. Therefore, we have planned to analyze predictors for visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological features by SD-OCT.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Male or female of aged 18 years or older
* Macula edema secondary to BRVO/CRVO
* Decrease of VA due to macular edema

Exclusion Criteria:

* Prior episode of RVO
* Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
* Ocular disorders in the study eye that may confound interpretation of study results
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
* The pregnant or lactating woman

Primary outcomes:
measure: Mean foveal thickness measured by SD-OCT
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Department of Ophthalmology, Kyoto University Hospital
Study officials:
References:
Clinical trial NCT00952016: Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency
Official title: A Non-randomised Phase II Trial of Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Colorectal Cancer
Keywords: colorectal cancer
MSH2
metastatic
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 2
Sex: ALL
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: To assess the efficacy of methotrexate in a genetically selected population of patients with advanced colorectal cancer, who have loss of a particular gene, MSH2. The efficacy of methotrexate will be evaluated by the proportion of cases that have a significant response to treatment (objective response rate).

Detailed description: The study will involve treating 29 subjects with methotrexate given intravenously. All subjects will receive treatment; there is no control arm or randomisation. The subjects will be known to have deficiency of MSH2, or a mutation (genetic change) in MSH2 that stops it functioning normally. This can either be demonstrated by testing for loss of MSH2 protein in the tumour itself, or by the demonstration of a mutation in the MSH2 gene in the subject's blood.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of metastatic or locally recurrent colorectal carcinoma
* Aged 18 years or older
* Paraffin embedded histological material available for analysis
* Either confirmed loss of expression of MSH2 on immunohistochemistry IHC or confirmed mutation in MSH2 on gene sequencing
* Life expectancy of \> 3 months

Exclusion Criteria:

* Previous treatment with methotrexate, either for malignant or non-malignant disease, except when methotrexate was given at low dose with other drugs to modify their effects
* Concomitant uncontrolled medical conditions
* Concomitant metastatic malignancy apart from non-melanotic skin cancers and carcinoma in situ of the uterine cervix in the last 10 years
* Any contraindication to treatment with methotrexate (as this will affect safety)

Primary outcomes:
measure: Objective response rate, to include complete response and partial response, as defined radiologically using RECIST (Response, Evaluation Criteria in Solid Tumours) on imaging CT scans performed during treatment.
Secondary outcomes:
measure: Disease stabilisation rate; progression free survival; 1 year survival and median overall survival; Quality of Life assessment; toxicity assessment.
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
References:
Clinical trial NCT00875316: Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients
Official title: A Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One Month
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Phase I
Lead sponsor: Phytopharm
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in both healthy volunteers and Parkinson's disease patients and to determine if there is a difference in the way that the body deals with Cogane (pharmacokinetics) between these two groups.

It is expected that the study will prove that Cogane™ is safe and well tolerated and will provide us with a pharmacokinetic profile for both subject groups.


Eligibility criteria: Key Inclusion Criteria (Healthy Volunteers):

* Male \& Female healthy volunteers aged between 40 and 80 years at the time of informed consent
* Females of non-childbearing potential
* General Good Health

Key Exclusion Criteria (Healthy Volunteers):

* No clinically significant and relevant medical history
* Smoked within the 3 months prior to screening
* Use of prescription or non-prescription systemic or topical medication (including herbal remedies) within 14 days of the first dose administration

Key Inclusion Criteria (Parkinson's disease patients):

* Male \& Female Parkinson's disease patients aged between 40 and 80 years at the time of informed consent
* Must have a diagnosis of idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria
* Subjects who are taking Parkinson's disease treatments should be on a stable regimen for at least 4 weeks prior to screening

Key Exclusion Criteria (Parkinson's disease patients):

* Diagnosis of dementia
* Parkinson's disease of a known genetic cause
* History of surgical intervention for Parkinson's disease

Primary outcomes:
measure: To investigate the safety and tolerability of Cogane™ oral solution
timeFrame: Throughout 28 day dosing period
Secondary outcomes:
measure: To investigate the pharmacokinetic profile of Cogane™ and its metabolites
timeFrame: Throughout 28 day dosing period
Other outcomes:
Locations:
city: Bourn
country: United Kingdom
facility: LCG Bioscience
state: Cambridgeshire
Study officials:
affiliation: Cambridge, UK
name: Investigator
role: PRINCIPAL_INVESTIGATOR
References: