louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06439446: Functionality and Family Characteristics in Children With Cerebral Palsy
Official title: The Effect of Family Characteristics on the Functional Level of Children With Cerebral Palsy of the Spastic Type With Walking Ability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Family Characteristics
Keywords: Functional Level
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 68
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was carried out at Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center. Patients who applied to the Physical Medicine and Rehabilitation Polyclinic with the diagnosis of CP were examined by a physical therapist. Parents of children who met the inclusion criteria were interviewed and informed about the study.

Brief summary: The aim of this study was to investigate the effect of family characteristics on functional level in children with Spastic Type Cerebral Palsy who are able to walk.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with hemiparetic and diparetic type CP
* Between the ages of 5-15
* GMFCS level I, II and III
* Volunteer individuals were included.

Exclusion Criteria:

* Having undergone a surgical operation within the last year,
* Having contracture in the lower extremity,
* Having had a fracture in the lower extremity in the last 6 months,
* Botulinum Toxin A (BTX-A) administered in the last 6 months
* Patients with cognitive, visual or hearing impairments that would prevent communication with their peers and siblings were excluded from the study.

Primary outcomes:
measure: Gross Motor Function Level
timeFrame: 36 week
measure: Parents' Quality of Life
timeFrame: 36 week
Secondary outcomes:
measure: Gross Motor Function Classification
timeFrame: 36 week
measure: Sociodemographic Form
timeFrame: 36 week
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center
Study officials:
References:
Clinical trial NCT06601946: Supporting Tools and Cognitive Aids for BLS
Official title: Supporting Tools and Cognitive Aids for Lay Resuscitation - a Simulation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Basic Life Support (Simulation)
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: OTHER

Brief summary: Various studies have shown that rapid and correctly performed cardiopulmonary resuscitation (CPR) significantly increases the survival rate after cardiac arrest. Such a situation can affect anyone, anywhere and at any time, making it all the more important to master the basic skills and abilities of Basic Life Support (BLS). Thanks to constant technical progress, there are now numerous digital tools in the field of lay resuscitation. There are also feedback devices for CPR for laypersons, the use of which is currently the subject of scientific debate. In order to evaluate the influence of various tools on the quality of lay resuscitation, we are planning a prospective, randomized study in a parallel group design. This study is aimed at medical laypersons between the ages of 18 and 70 who have completed a BLS course (e.g. first aid course for driver\&#39;s license) within the last 10 years. All participants are asked to take part in a mannequin-based simulation scenario in a public place. As part of this simulation scenario, the BLS algorithm is to be performed (recognizing respiratory-circulatory arrest, calling for help, performing chest compressions, organizing a defibrillator). After performing the 1-minute cardiac massage, the scenario is ended. We plan to randomize into 3 groups. Group 1 will receive paper-based information material on how to perform BLS correctly. Group 2 will receive a first aid app. Group 3 will receive a small medical device (CorPatch®), which gives direct feedback on the quality of chest compressions (e.g. frequency, depth), including an accompanying app for support. The time to blood flow (defined as the succession of 5 sufficient chest compressions in this study) will be evaluated as the primary outcome. Secondarily, resuscitation management will be evaluated using a validated BLS checklist, the time to critical actions (such as time to alert the emergency services), the quality of CPR, the cognitive load of the participants and the user-friendliness of the assigned aid.


Eligibility criteria: Inclusion Criteria:

* 18-70 years
* First Aid Training within the last 10 years

Exclusion Criteria:

- medical student, physician, nurse, paramedic

Primary outcomes:
measure: Time to blood flow
timeFrame: within 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT02349646: A Post Market Cohort With the Spinal Modulation Neurostimulator System in Peripheral Neuropathy
Official title: A Post Market Cohort With the Commercially Available Spinal Modulation Neurostimulator System for the Management of Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Neuropathy
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-01-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peripheral Neuropathy Patients

Brief summary: 10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Peripheral neuropathy for at least 6 months
4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
5. Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
7. Subject is able to provide written informed consent

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
4. Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months
5. Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Subjects currently has an active infection
8. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
9. Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator

Primary outcomes:
measure: Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
timeFrame: Baseline, 3, 6 and 12-Month Visits
measure: Percentage of Subjects With at Least 50% Pain Reduction
timeFrame: 3, 6 and 12-Month Visits
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Heinrich Heine Universität Düsseldorf
Study officials:
References:
Clinical trial NCT00189046: Effects of Pain on Driving Performance and Cognition.
Official title: Effects of Pain on Driving Performance, Attentional Capacity and Psychomotor Performances: a Comparative Study Between Healthy Controls and Chronic Pain Patients.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Pain
Keywords: driving, chronic pain, attention
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Utrecht University
First posted: 2005-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: It has been suggested that cognitive functioning is impaired in chronic pain patients. Since most of these pain patients engage in daily activities including driving, it was hypothezised that they may have an increased risk of becoming involved in traffic accidents.

Detailed description: Most chronic pain patients engage in daily activities including driving. Driving a car is a complex task requiring mental alertness and a variety of cognitive functions such as perception, attention, learning, memory and decision making.Several studies have demonstrated cognitive impairments on laboratory tasks in patients with chronic pain, particularly on measures assessing attentional capacity, processing speed and psychomotor speed. These findings suggest that car driving performance might be impaired, and that chronic pain patients may therefore have an increased traffic accident risk. Unfortunately, no studies have investigated the impact of chronic pain on actual driving ability. The present study was designed to investigate the effects of chronic pain on actual driving performance during normal traffic. In addition to the on-the-road driving test, psychomotor, and memory tests measuring driving-related skills were conducted in the laboratory. Moreover, effects of pain on an attentional capacity test were tested using event-related potentials.

Eligibility criteria: Inclusion Criteria:

age driving licence driving experience normal vision right-handed fluently Dutch speaking

Exclusion Criteria:

psychological or physical disorder drug or alcohol abuse psychotropic medication use excessive smoking, drinking

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Department of Psychopharmacology
Study officials:
affiliation: University of Utrecht, Department of Psychopharmacology
name: Edmund Volkerts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01668446: Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles
Official title: Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometrial Preparation
Frozen Embryo Transfer
Keywords: Sildenafil
Endometrial thickness
Frozen embryo transfer
ultrasonographic endometrial thickness
endometrial pattern
Implantation rate
chemical pregnancy rate
Lead sponsor: Shahid Sadoughi University of Medical Sciences and Health Services
Sponsor class: OTHER
Collaborators: name: Razieh dehghani firouzabadi
name: Robab davar
First posted: 2012-08-20
Enrollment: 2
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The target of this study was an estimate the result of sildenafil on ultrasonographic endometrial thickness, endometrial pattern investigation estrogen level on the day of progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .


Eligibility criteria: Inclusion Criteria:

* women \> 40 years old,
* history of endocrine disease
* Hysteroscopic surgery
* cardiovascular, renal and liver disease
* hypotension( blood pressure \< 90/50)
* history of stroke or myocardial infarction
* use of alcohol or substance

Exclusion Criteria:

A total of 80 patients with antecedent of poor endometrial response and had frozen embryo included in this study all women must to be \< 40 years old,

* no history of endocrine disease,
* no Hysteroscopic surgery, had a high quality embryos no cardiovascular,
* renal and liver disease and
* no hypotension (blood pressure \< 90/50) or
* history of stroke or myocardial infarction and
* don't use of alcohol or substance Patients with these conditions enter this study and based on randomized tables are divided in two groups.

Primary outcomes:
measure: estimate the result of sildenafil on ultrasonographic endometrial thickness
timeFrame: between 2009-2011 (up to 2 years)
Secondary outcomes:
measure: estimate the result of sildenafil on Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .
timeFrame: between 2009-2011 (up to 2 years)
Other outcomes:
Locations:
city: Yazd
country: Iran, Islamic Republic of
facility: Farzaneh Hojjat
Study officials:
affiliation: Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science, Bouali Ave. Safaieh, Yazd,Iran.
name: farzaneh hojjat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04822246: Root Caries Excavation with Air Water/powder Prophylaxis Device for ART Restorations
Official title: Excavation of Root Caries with Air-water Powder Stream Vs Manual Excavation for Atraumatic Restorative Treatment in Older Patients: a Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Caries Extending Into Dentin
Root Caries
Keywords: Root caries
Elders
Atraumatic restorative treatment
Glass-ionomer cement
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, RCT
Primary purpose: TREATMENT

Brief summary: The main objective of this RCT is to compare the efficacy of a powder/water jet prophylaxis device and conventional hand excavation in excavating root surface caries, with regard to restoration survival/success in older adults.

The secondary outcome of this RCT is to assess the participants' treatment preferences for the received treatment with regard to the procedures involved and in the invasiveness of the procedures carried out during the ART restoration.


Eligibility criteria: Inclusion criteria

* Adults ≥65 years
* Dentinal root caries lesions with no painful symptomology
* Can follow instructions for oral hygiene
* Not dependent for care for their ADLs.

Exclusion criteria:

* Symptomatic carious teeth
* Non-carious attrition, erosion or abrasion cavities
* Periodontally compromised teeth with Grade 3 mobility, and active signs of infections.
* Not willing or able to sign informed consent

Post-hoc exclusion:

* Participant withdraws consent
* Medical reasons.

Primary outcomes:
measure: Restoration Success rate
timeFrame: 1 year, year 1
measure: Restoration survival rate
timeFrame: 1 year, year 1
Secondary outcomes:
measure: Participants' Treatment preference
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinic of General, Special care, and Geriatric Dentistry, Center for Dental Medicine, University of Zurich
Study officials:
References:
Clinical trial NCT06609746: Effectiveness of Thyme in the Management of Clinical Symptoms in Patients with Irritable Bowel Syndrome
Official title: The Effect of Low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides and Polyols) Diet with Thyme on Clinical Symptoms and Quality of Life in Patients with Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome (IBS)
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 52
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: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if thyme supplement enhances the effects of a low FODAMP diet on reducing clinical symptoms and improving the quality of life of patients with irritable bowel syndrome or not.

The main questions it aims to answer are:

1. Does consumption of thyme reduce the severity score of clinical symptoms in patients with irritable bowel syndrome?
2. Does consumption of thyme increase the quality of life score in patients with irritable bowel syndrome? Researchers will compare thyme supplementation with placebo to see if thyme supplement enhances the effects of a low FODAMP diet on clinical symptoms and quality of life in patients with irritable bowel syndrome.

Participants will:

1. Receive thyme supplement plus a low FODMAP diet or placebo with low FODMAP diet for 8 weeks.
2. Recorde 3 days (1weekend and 2 workday) dietary recalls at week 4 and week 8 to assess adherence to the low FODMP diet.
3. Visit the clinic at the beginning of the study and the end of the study for a check-up and score record


Eligibility criteria: Inclusion Criteria:

* Ages 18-65;
* Patients with irritable bowel syndrome;
* Body Mass Index in the range of 18-25 kg/m2

Exclusion Criteria:

* Any organic intestinal disease;
* Medical history of chronic gastrointestinal and colorectal disease;
* Any major bowel surgery;
* Medical history of liver and kidney disorders;
* Regular use of laxative, anti-diarrhea and anti inflammatory medications.

Primary outcomes:
measure: Irritable Bowel Syndrome symptom severity score
timeFrame: baseline and 8 weeks following therapy
Secondary outcomes:
measure: Defecation frequency
timeFrame: baseline and 8 weeks following therapy
measure: Stool consistency
timeFrame: baseline and 8 weeks following therapy
measure: Quality of life score
timeFrame: baseline and 8 weeks following therapy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04219969: FDG PET-MRI for the Diagnosis of Spinal Cord Lesions
Official title: Ideal Imaging Time Point Assessment for Spinal Cord Lesions of Unknown Etiology With FDG PET-MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-01-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To compare the results and understand the possible benefits from FDG-PET/MRI during different scanning time points after FDG, a type of contrast drug, is given.

Detailed description: Primary Objectives:

--To identify the optimal imaging time point using F18-FDG positron emission tomography (PET) that gives the best lesion conspicuity as defined by the best lesion to background (L/B) ratio when evaluating spinal cord lesions of unknown etiology.

Exploratory Objectives:

* To identify malignancy specific factors in F18-FDG metabolism derived from metrics such as maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), total lesion glycolysis (TLG), metabolic tumor volume (MTV) and L/B ratio.
* To identify patterns of metabolism derived from metrics such as SUVmax, SUVmean, TLG, MTV, L/B ratio and magnetic resonance imaging metrics such as regional perfusion abnormalities, apparent diffusion coefficient values and mean diffusivity measures.

OUTLINE:

Patients receive fludeoxyglucose F-18 intravenously (IV) over 1 minutes and then undergo PET-magnetic resonance imaging (MRI) over 15-60 minutes at 60, 300, and 480 minutes after fludeoxyglucose F-18 injection in the absence of unacceptable toxicity.

Eligibility criteria: Inclusion Criteria:

* Patients with untreated intramedullary cord lesion(s)
* Ability to undergo FDG PET MR examination

Exclusion Criteria:

* No prior surgery or biopsy of the spinal cord
* No metal implanted in area of interest
* Spine radiation therapy
* Known allergy to FDG or gadolinium based contrast agents
* Blood glucose (\> 200 mg/dl)
* Pregnant women are excluded
* Children of less than 18 years of age
* Need for conscious sedation or anesthesia in order to tolerate study

Primary outcomes:
measure: Standard uptake value (SUV) max
timeFrame: Up to 8 hours
measure: Lesion to background (L/B) ratio
timeFrame: Up to 8 hours
measure: Optimal imaging time point
timeFrame: Up to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Maria K Gule-Monroe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00483769: One Year Glargine Treatment in CFRD Children and Adolescents
Official title: One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Glucose Metabolism Disorders
Keywords: Cystis Fibrosis
Glucose intolerance
Glargine
FEV1%
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2007-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by glucose derangements

Detailed description: To evaluate the effect of glargine treatment on BMI, lung function, acute pulmonary infections and HbA1c in cystic fibrosis (CF) patients with different glucose derangements, eighty-seven patients were screened for glucose derangements with fasting hyperglycaemia or abnormalities at the oral glucose tolerance test. They were classified on the basis of a "gluco-score" ranging 0-5. Patients with gluco-score \> 1 were treated with glargine. We report on the results of the first 20 patients who completed 12 months of treatment. BMI z-score, forced expiratory volume in the first second (FEV1), number of acute lung infections in the previous year and HbA1c were the study outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients affected by Cystic Fibrosis who had shown glucose derangements.

Exclusion Criteria:

* Patients with/without Cystic Fibrosis without glucose derangements.

Primary outcomes:
measure: Reduction of decline in pulmonary function measured as FEV1
timeFrame: One year
Secondary outcomes:
measure: Improvement of: Body Mass Index, Number of Lung Infections, HbA1c
timeFrame: One Year
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Deptm of Pediatrics Regional Cystic Fibrosis Center- University of Naples - Federico II
Study officials:
affiliation: Federico II University
name: Adriana Franzese, Dr
role: STUDY_DIRECTOR
affiliation: University of Naples Dept of Pediatrics Regional Cystic Fibrosis Center
name: Adriana Franzese, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Federico II University
name: Adriana Franzese, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franzese A, Spagnuolo MI, Sepe A, Valerio G, Mozzillo E, Raia V. Can glargine reduce the number of lung infections in patients with cystic fibrosis-related diabetes? Diabetes Care. 2005 Sep;28(9):2333. doi: 10.2337/diacare.28.9.2333. No abstract available.