louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00715923: Modified Consent Form Utility
Official title: CTSA Utility of Modified Consent Forms in Clinical Research: Fraga Tea Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: informed consent document
ethics
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2008-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Subjects enrolling into a nutrition study of the effects of tea on fat absorption will be randomized to receive either a standard informed consent document or a modified document that is shorter and more easily understood than the standard document. The hypothesis is that using a shorter form that is more easily understood and more visually simple will lead to greater subject satisfaction in the consent process and will not compromise subject comprehension of key study aspects. Consent for study inclusion has been waived by the IRB because informing subjects of the nature and process of the study would likely affect the findings, and both the standard and modified consent forms were approved for use in the nutrition study.


Eligibility criteria: Inclusion Criteria:

* participation in parent study, English speaking

Exclusion Criteria:

* none

Primary outcomes:
measure: Subject satisfaction
timeFrame: close of parent study
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Alexander A Kon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00116623: Magnesium Sulfate Versus Indomethacin for Preterm Labor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Labor, Premature
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2005-06-30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the efficacy of Indomethacin compared to Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind randomized clinical trial. The specific aim of the project is to test the hypothesis that Indomethacin, compared to MgSO4, will decrease the proportion of neonates diagnosed with major complications or death.


Eligibility criteria: Inclusion Criteria:

* Initial episode of preterm labor for enrollment
* The diagnosis of preterm labor
* Gestational age between 24 and 32 weeks
* Singleton or twin gestation
* The ability to understand the requirements of the study

Exclusion Criteria:

* Cervical dilation \>5 cms
* Suspected chorioamnionitis
* Fetal distress
* Vaginal bleeding
* Severe pre-eclampsia
* History of gastrointestinal bleeding
* Abnormal renal function
* Suspicion of fetal malformation by ultrasound
* Known allergy to, or intolerance of, Magnesium sulfate and/or Indomethacin
* Documented rupture of amniotic membranes
* Multiple gestations of triplets or more.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: George A Macones, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Clinical trial NCT02890823: Effect of Three Different Doses of Oral Cholecalciferol on 25-Hydroxyvitamin D Changes Among Epilepsy Patients With Hypovitaminosis D
Official title: EFFECT OF THREE DIFFERENT DOSES OF ORAL CHOLECALCIFEROL (1000 IU, 3000 IU AND 6000 IU DAILY) ON SERUM 25-HYDROXYVITAMIN D CHANGES AMONG EPILEPSY PATIENTS WITH HYPOVITAMINOSIS D: A RANDOMIZED PROSPECTIVE STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Antiepileptic Drugs
Vitamin D Deficiency
Asian
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 210
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To characterize the effect of three different doses of vitamin D3 supplementation on serum 25-hydroxyvitamin D (25(OH)D) changes in epilepsy patients receiving enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs), and to determine the prevalence of and risk factors for hypovitaminosis D among Thai patients with epilepsy.

Detailed description: A single-blinded prospective, randomized study undertaken at epilepsy clinic of King Chulalongkorn Memorial Hospital. The patients with hypovitaminosis D were included and divided into two groups according to the type of AEDs use. Patients receiving each AEDs type were randomly assigned to receive vitamin D3 1000, 3000 or 6000 IU once daily. The mean increment in serum 25(OH)D levels were measured at 8 and 16 weeks.

Eligibility criteria: Inclusion Criteria:

* Epilepsy patients, age ≥ 15 years, BMI18 - 30 kg/m2
* Being treated with either enzyme inducing antiepileptic drugs (EIAEDs: phenytoin, phenobarbital, carbamazepine and topiramate) or non-enzyme inducing antiepileptic drugs (Non-EIAEDs: sodium valproate, levetiracetam, and lamotrigine) at a stable dosage regimen for at least a year.
* Serum 25(OH)D \<30ng/ml

Exclusion Criteria:

* Patients with a history of hypercalcemia, nephrolithiasis, fractures, hepatic disease, kidney disease, granulomatous disease or currently supplemented with vitamin D.

Primary outcomes:
measure: serum 25-hydroxyvitamin D changes in patients who received enzyme-inducing antiepileptic drugs (EIAEDs) versus patients receiving non enzyme-inducing antiepileptic drugs (non-EIAEDs) at the same dosage of cholecalciferal
timeFrame: 8 and 16 months
Secondary outcomes:
measure: Number (percentage) of the patients who have serum 25-hydroxyvitamin D levels more than 30ng/ml
timeFrame: 16 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06439823: Controlled Study of Upper and Lower Limb Movements in Patients Patients with Pathologies That Have an Impact on Ambulation or Motor Function
Official title: Controlled Study of Upper and Lower Limb Movements in Patients Patients with Pathologies That Have an Impact on Ambulation or Motor Function to Validate Signal Analysis Algorithms for Wearable Devices Using Magneto-inertial Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromuscular Diseases
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
Collaborators: name: SYSNAV
First posted: 2024-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the study is to validate the algorithms developed to analyze the signals from the various sensors contained in the magneto-inertial control units and reconstruct upper and lower limb movements under different normal and pathological conditions.


Eligibility criteria: Inclusion Criteria:

* Subjects over 2 years old
* Male or female
* Control subjects with no pathologies that have an impact on ambulation or motor function.
* Signed informed consent and, in the case of minors, informed consent signed by the person with parental authority/guardian

Exclusion Criteria:

* Any other previous or present pathology having an impact on current motor or balance function
* Recent surgery or trauma to upper or lower limbs, or major surgery or trauma within 6 months of inclusion.
* For control subjects, athlete of at least national level.
* Pregnant or breast-feeding women

Primary outcomes:
measure: step length and distance
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHR citadelle
state: Liege
Study officials:
References:
Clinical trial NCT05135923: Glutenfree, Gut Microbiota and Metabolic Regulation
Official title: The Effect of Gluten-free Diet on Gut Microbiota and Metabolic Regulation in People With Coeliac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Det Glutenfrie Verksted
First posted: 2021-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: High intake of dietary fiber provides health benefits and reduces the risk of developing cardio-metabolic diseases, such as type 2 diabetes (T2D) and cardiovascular disease (CVD). The intake of fiber is below the recommendations worldwide. In Norway, bread and cereals represent a major source of fiber. A low fiber intake is evident for people with celiac disease due to the removal of wheat, rye and barley from the diet. We therefore need to increase our knowledge in relation to fiber-rich food that will be tolerated also by people with celiac disease. The aim of the study is to investigate the effect of fiber rich gluten free products on blood glucose levels compared to benchmark gluten free products.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals with celiac disease
* BMI 18.5-27
* 18-65 years

Exclusion Criteria:

* chronic metabolic diseases, such as diabetes (type 1 and 2), cardiovascular diseases, cancer the last six months
* gut diseases, including chron's disease, ulcerative colite
* food allergies or intolerance, except for coliac disease
* pregnant and/or lactating
* smokers
* BMI \<18.5 and \>27
* planned weight reduction and/or 5% weight change the last three months
* blood donor the last two months and during the study period
* not willing to stop using dietary supplements, including probiotic products, cod liver oil etc, four weeks before and throughout the study
* use of antibiotics \< three months before study start and throughout the study period
* alcohol consume \> 40 g/day
* hormone treatment (except for contraceptives)

Primary outcomes:
measure: Concentration of blood glucose
timeFrame: 3 weeks
Secondary outcomes:
measure: Concentration of blood cholesterol, triglycerides, fatty acids, C-peptide
timeFrame: 3 weeks
measure: Concentration of blood inflammatory markers
timeFrame: 3 weeks
measure: Feces microbiota analyses performed with Bio-Me's Precision Microbiome Profiling platform (PMP)
timeFrame: 3 weeks
measure: Gastrointestinal Symptoms Rating Scale-Irritable bowl syndrome (GSRS-IBS)
timeFrame: 3 weeks
measure: Concentration of satiety hormones in blood
timeFrame: 3 weeks
measure: Bristol Stool Chart (BSC)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Metropolitan University
Study officials:
References:
Clinical trial NCT00553423: Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
Official title: Randomized Double Blind Placebo Controlled Trial of Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocerebral Encephalopathy
Portal-Systemic Encephalopathy
Encephalopathy, Hepatic
Encephalopathy, Hepatocerebral
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2007-11-04
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the role of lactulose in prevention of clinically overt hepatic encephalopathy (HE) in the setting of acute upper gastrointestinal bleeding in cirrhotic patients

Detailed description: Variceal hemorrhage occurs in 25 to 35 % of patients with cirrhosis and accounts for 80 to 90% of bleeding episodes in these patients. Around 25-30 percent of patients develop hepatic encephalopathy. Development of hepatic encephalopathy in patients with gastrointestinal bleed can cause increase morbidity with higher hospital costs in these patients. To date no randomized trial has been done in terms of prevention of encephalopathy in gastrointestinal hemorrhage. One trial has compared lactulose in combination with antibiotic against mannite, showed equal efficacy in both groups. No study has been done evaluate the efficacy of lactulose in prevention of encephalopathy in these patients.

We hypothesize that prophylactic use of Lactulose decreases the risk of development of hepatic encephalopathy with upper GI bleed in cirrhotics.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* All acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy at the time of admission in ER

Exclusion Criteria:

* Increased α-fetoprotein level/ Documented hepatoma
* Portal or hepatic vein thrombosis
* Large-volume or tense ascites requiring repeated therapeutic paracentesis
* Serious recurrent or ongoing co morbid illness (e.g., severe renal, cardiac, or respiratory failure; sepsis)
* Pregnancy
* Not willing to give consent to participate in the study
* Patients who are unable to read and write
* ER arrival time \> 12 hrs from index bleed

Primary outcomes:
measure: Development of Clinically Overt Hepatic Encephalopathy
timeFrame: 48hours
Secondary outcomes:
measure: Death, hospital stay
timeFrame: 48hrs
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan university
state: Sind
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sind
Study officials:
affiliation: Aga Khan University
name: Shahid Majid, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Mohammad Salih, FCPS
role: STUDY_DIRECTOR
affiliation: Aga Khan University
name: Shahid Ahmed, FCPS
role: STUDY_DIRECTOR
affiliation: Aga Khan University
name: Wasim Jafri, FCPS
role: STUDY_CHAIR
References:
Clinical trial NCT06385223: A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression
Official title: A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression: a Double Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: neuronavigated
iTBS
Accelerated
RCT
Lead sponsor: Institute of Mental Health, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2024-04-25
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 21 years.
2. DSM-5 diagnosis of current Major Depressive Episode.
3. Montgomery-Asberg Depression Rating Scale score of 20 or more.
4. Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
5. Able to give informed consent.

Exclusion Criteria:

1. DSM-5 psychotic disorder
2. Drug or alcohol abuse or dependence (preceding 3 months).
3. Rapid clinical response required, e.g., high suicide risk.
4. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
5. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
6. Pregnancy.
7. Unsuitable for MRI.

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale
timeFrame: Baseline, immediately post treatment, 1 month and 3 months post intervention
Secondary outcomes:
measure: Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)
timeFrame: Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, immediately post treatment, 1 month and 3 months post intervention
measure: EQ-5D (EuroQol)
timeFrame: Baseline, immediately post treatment, 1 month and 3 months post intervention
measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)
timeFrame: Baseline, immediately post treatment, 1 month and 3 months post intervention
Other outcomes:
measure: TMS induced changes in resting-fMRI functional connectivity
timeFrame: Baseline, immediately post treatment
Locations:
city: Singapore
country: Singapore
facility: Institute of Mental Health
Study officials:
References:
Clinical trial NCT03120923: Combined Corticosteroid With Low Volume Compared to High Volume in Impingement Syndrome
Official title: A Short Term Outcomes of Subacromial Injection of Combined Corticosteroid With Low Volume Compared to High Volume of Local Anesthetic for Rotator Cuff Impingement Syndrome: A Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impingement Shoulder
Keywords: subacromial injection
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: Khon Kaen University
First posted: 2017-04-19
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess and compare the effectiveness of two different volumes of local anesthetic combined with 40mg of triamcinolone for subacromial injections in treating patients with rotator cuff impingement syndrome

Detailed description: Patients with rotator cuff impingement syndrome were randomized to undergo subacromial injection with 10mL total volume of 1% lidocaine plus 40mg triamcinolone acetonide (n = 22), or a 4mL total volume of 1% lidocaine plus 40-mg triamcinolone acetonide (n = 23). Evaluations using a visual analog scale (VAS) for pain during motion, and the Western Ontario Rotator Cuff Index (WORC) were completed before treatment and 30 minutes, 2 weeks, and 8 weeks after injection.

Eligibility criteria: Inclusion Criteria:

1. participants with clinically diagnosed the rotator cuff impingement
2. participants aged 20 years and older
3. at least 1 month's duration
4. pain of moderate to severe intensity, defined as a score of 5 or more points on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain)

Exclusion Criteria:

1. patients with adhesive capsulitis of the shoulder (normal radiograph of affected shoulder, and restriction of passive motion \>30° in ≥2 planes of movement)
2. previous trauma history at currently affected shoulder
3. previous corticosteroid injection history at the affected shoulder
4. abnormal calcification and/or primary osteoarthritis of the shoulder joint on plain radiographs
5. use of medication such as antiplatelet agent or anticoagulation.

Primary outcomes:
measure: VAS
timeFrame: 8 weeks
Secondary outcomes:
measure: WORC
timeFrame: 8 weeks
measure: Adverse reaction
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Boonard M, Sumanont S, Arirachakaran A, Apiwatanakul P, Boonrod A, Kanchanatawan W, Kongtharvonskul J. Short-term outcomes of subacromial injection of combined corticosteroid with low-volume compared to high-volume local anesthetic for rotator cuff impingement syndrome: a randomized controlled non-inferiority trial. Eur J Orthop Surg Traumatol. 2018 Aug;28(6):1079-1087. doi: 10.1007/s00590-018-2149-3. Epub 2018 Feb 8.
Clinical trial NCT02260323: Compliance of Traditional Chinese Medicine in Young Patients With Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Rheumatic Diseases
Lead sponsor: Chengdu PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the compliance of traditional Chinese medicine (TCM) in young people with Chronic rheumatic disease


Eligibility criteria: Inclusion Criteria:

* were between 18 and 35 years of age
* without use of TCM in the previous 3 months
* and had a Steinbrocker functional status of class I, II, or III

Exclusion Criteria:

* previous general health conditions disallowed their use of TCM
* were pregnant
* lack of motivation, remote from home, time-consuming,intervention, or other personal difficulties

Primary outcomes:
measure: Changes from baseline in HBCS(Hill-Bone Compliance Scale) score at 48 weeks
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
measure: Changes from baseline in MARS(Medication Adherence Rating Scale) score at 48 weeks
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: General Hospital of Chengdu Military Area Command PLA
state: Sichuan
Study officials:
References: