louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00178984: Biomagnetic Characterization of Gastric Dysrhythmias:Study 2
Official title: Biomagnetic Characterization of Gastric Dysrhythmias:Study 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia
Keywords: Blood supply
Mesentery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-09-15
Enrollment: 78
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care clinic

Brief summary: The purpose of this study is to use the Squid magnetometer (Superconducting QUantum Interference Device) to help diagnose electrical and mechanical abnormalities of the stomach and intestines.

Detailed description: The Squid magnetometer is a non-invasive investigational device that measures the electrical activity in the smooth muscle of the intestines. Volunteers with normal bowel activity, those with gastric problems, and diabetics with gastric problems will be studied under the SQuid to determine normal and abnormal activity. Diabetics with an abnormal gastric emptying study will be asked to participate.

Eligibility criteria: Inclusion Criteria:

* Normal volunteers, those with stomach problems, and Diabetics with abnormal gastric emptying study

Exclusion Criteria:

* Diabetics with a normal gastric emptying study
* Participants with claustrophobia

Primary outcomes:
measure: to observe a difference in the magnetic activity between the normal and diseased smooth muscle of the stomach and intestines.
timeFrame: 2010
Secondary outcomes:
measure: to specifically study the electrical activity of diabetics with an abnormal gastric emptying.
timeFrame: 2010
measure: Measurement of mesenteric ischemia
timeFrame: 2010
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Department of Physics and Surgery
name: Leonard A. Bradshaw, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02438384: Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial
Official title: Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American Federation for Aging Research
name: The John A. Hartford Foundation
First posted: 2015-05-08
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a three arm pilot randomized trial. Patients will be assigned to:

1. Usual care
2. Video education in the Emergency Department (ED)
3. Video education in the ED plus phone follow-up at three days with geriatric pain management specialist for all patients with pain \>=4/10

Detailed description: This is a three arm pilot randomized trial. Patients will be assigned to:

1. Usual care
2. Video education in the ED (10 minute interactive video)
3. Video education in the ED plus phone follow-up at three days with geriatric pain management specialist for all patients with pain \>=4/10

Eligibility criteria: Inclusion Criteria:

* Age 50 and older; ED visit for acute musculoskeletal pain

Exclusion Criteria:

* Cognitively impaired; chronic pain (daily opioid use prior to onset of pain or pain symptoms more than one month); prison; injury or pain condition requiring hospital admission.

Primary outcomes:
measure: Change in Pain Score
timeFrame: ED visit and 30 days post-ED visit
Secondary outcomes:
measure: Number of Participants Experiencing Medication Side Effects
timeFrame: 30 days after ED visit
measure: Average Overall Pain at One Month
timeFrame: 30 days after ED visit
measure: Mean Physical Function Scores
timeFrame: 30 days after ED visit
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals Emergency Department
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Tim Platts-Mills, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Platts-Mills TF, Hollowell AG, Burke GF, Zimmerman S, Dayaa JA, Quigley BR, Bush M, Weinberger M, Weaver MA. Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients. Trials. 2018 Jan 5;19(1):10. doi: 10.1186/s13063-017-2403-8.
Clinical trial NCT00576784: Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin
Official title: Multi Center, Open Label Study to Evaluate the Influence of Pioglitazone Treatment Over 6 Months on Metabolic Control in Type II Diabetic Patients Previously Treated With Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Insulin Resistance
Keywords: type 2 diabetes
insulin treatment
ß-cell function
Lead sponsor: IKFE Institute for Clinical Research and Development
Sponsor class: OTHER
First posted: 2007-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the study is to demonstrate whether a switch from insulin therapy to an oral therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control (increase in HbA1c by more than 0.5 %) within a 6 month observation period.

Detailed description: To demonstrate that reconverting type 2 diabetic patients from insulin treatment to oral treatment using pioglitazone in combination with or without glimepiride is possible without deterioration of blood glucose control.

Primary aim is to maintain glycaemic control (HbA1c) defined as an increase in HbA1c of not more than 0.5 % after 6 months of treatment (visit 7) compared to baseline HbA1c value (screening visit V1).

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* insulin therapy \> 1 year
* residual ß-cell function (C-peptide increase in iv glucagon test)
* written informed consent

Exclusion Criteria:

* type 1 diabetes
* oral therapy
* life-threatening disease
* heart failure (NYHA I-IV)

Primary outcomes:
measure: The proportion of patients with an increase in HbA1c by 0.5 % after 6 months of treatment compared to baseline HbA1c value
timeFrame: 6 months
Secondary outcomes:
measure: Absolute change of HbA1c Insulin resistance according to minimal model and HOMA-S analysis change of insulin resistance according to minimal model and HOMA-S analysis to baseline first phase insulin response
timeFrame: 6 months
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: IKFE
Study officials:
References:
Clinical trial NCT05152784: The TRAMPOLINE VT Study
Official title: Trial of Rapid Activation MaPping Using a nOveL Catheter and Integrated Non-invasivE Imaging in Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: Octaray
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2021-12-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Propensity-matched cohort study
Primary purpose: TREATMENT

Brief summary: This non-randomised, prospective trial will examine the feasibility and efficacy of VT ablation guided by activation mapping using the Octaray and Optrell catheters. Annotation algorithms within the CARTO3 electro-anatomical mapping system will be integrated with 3D scar segmentation data from cardiac MRI (ADAS-VT), and extrastimulus voltage mapping will identify sites of interest for focussed activation mapping. The investigators hypothesise that the examination of these data will identify critical target sites for ablation. Intra-procedural diagnostic performance of the Octaray and Optrell catheters will be assessed as the primary outcome, and will be compared with the standard of care. Secondary, clinical outcomes - primarily the need for ICD therapies at 12 months post ablation - will be compared with propensity-matched controls undergoing substrate-based ablation alone. Follow-up MRI scans will review the impact of ablation on the elimination of conduction channels.


Eligibility criteria: Inclusion Criteria:

* ICD in situ
* Clinical indication for VT ablation; incessant VT or receiving appropriate ICD therapies for VT despite anti-arrhythmic drugs
* Ischaemic or non-ischaemic heart disease

Exclusion Criteria:

* Valvular heart disease precluding LV access
* Cardiotomy within previous 3 months
* Acute coronary syndrome within 6 weeks
* Dialysis patients
* Coagulopathy/Thrombocytopaenia
* Pregnancy/breastfeeding women
* CMR contraindicated
* Prognosis \<12 months
* Unable to provide informed consent

Primary outcomes:
measure: Correct identification of VT exit site
timeFrame: Intra-procedural
measure: Completeness of diastolic pathway recording
timeFrame: Intra-procedural
Secondary outcomes:
measure: Requirement for ICD therapies at 1 year
timeFrame: 12 months following VT ablation
measure: VT burden
timeFrame: 12 months following VT ablation
measure: Symptoms related to arrhythmia
timeFrame: 12 months following VT ablation
measure: Morphological changes on serial cardiac MRIs
timeFrame: 3 months following VT ablation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
Study officials:
References:
Clinical trial NCT03093584: Auricular Stimulation vs. Expressive Writing for Exam Anxiety
Official title: Auricular Acupuncture (AA) vs. Expressive Writing in Treatment of Pre-exam Anxiety - Randomised Crossover Study in Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Title of the study: Auricular acupuncture (AA) vs. expressive writing for pre-exam anxiety - a randomised crossover study

Study period: 04 / 2014 - 07 / 2014

Principal Investigator: Prof. Dr. T. Usichenko Department of Anaesthesiology and Intensive Care Medicine University Medicine of Greifswald

Aim of the study: To investigate the anxiolytic effect of AA vs. expressive writing and vs. no intervention in students, passing the oral exams in anatomy at the University of Greifswald

Design: Prospective randomised crossover trial

Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Expressive writing

Number of volunteers: N = 40

Healthy medical students at the University of Greifswald Participants of the anatomy exams in spring/summer 2014 Without previous anxiolytic, sedative and analgesic medication No pregnancy or lactating Informed consent

Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase


Eligibility criteria: Inclusion Criteria:

1. Medical students at the University of Greifswald
2. Going to take part in oral exams of human anatomy
3. Participants without previous anxiolytic medication
4. Ability to express the thoughts and emotions ("expressive writing")
5. Written informed consent

Exclusion Criteria:

1. Recidivist alcoholics
2. Local auricular skin infection
3. Pregnant or lactating women
4. Participants with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA)
5. Participants who are unable to understand the consent form
6. History of psychiatric disease

Primary outcomes:
measure: Intensity of anxiety
timeFrame: 2 days
Secondary outcomes:
measure: salivary alpha-amylase
timeFrame: 1 day
measure: heart rate
timeFrame: 1 day
measure: blood pressure
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University Medicine of Greifswald
name: Taras Usichenko, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06064084: Incretin Effect in Patients With Psoriasis and Controls
Official title: Incretin Effect in Patients With Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases with psoriasis vulgaris (PASI\>8) Controls with no existing skin disease. Matched for Age, BMI and Sex

Brief summary: To investigate the incretin effect and postprandial incretin responses in plasma in patients with psoriasis


Eligibility criteria: Inclusion Criteria:

no diabetes BMI \< 27 kg/m\^2 normal Glucose tolerance test at screening normal fasting plasma glucose no islet auto antibodies no hormonel contraception informed consent psoriasis vulgaris (PASI\>8) (case not controls)

Exclusion Criteria:

other chronic inflammtory skin disease other chronic inflammatory disease pregnancy psychiatric illness

Primary outcomes:
measure: Incretin effect measured with Beta-cell secretory response
timeFrame: 0-180 minutes
Secondary outcomes:
measure: Insulin sensitivity measures
timeFrame: 0-180 minutes
measure: Concentration of Glucose-independent insulinotropic polypeptide
timeFrame: 0-180 minutes
measure: Concentration of Glucagon-like peptide 1
timeFrame: 0-180 minuntes
measure: Concentration of Glucagon
timeFrame: 0-180 minutes
measure: Concentration of Insulin
timeFrame: 0-180 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01759784: Intraventricular Transplantation of Mesenchymal Stem Cell in Patients With ALS
Official title: Safety of Intraventricular Injection of Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Keywords: mesenchymal stem cell intraventricular injection ALS
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2013-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ALS is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment that has been found to improve survival but only to a modest extent. It lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. It also extends the time before a person needs ventilation support.Stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.

Detailed description: In this study our purpose is to evaluate the safety of intraventricular injection of bone marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell intraventricular injection by stereotaxis.after injection he will be under observed in ICU to monitor the adverse events(allergic and neurological side effects).patients are followed 1th,3th ,6th and 12 months after injection and each time these parameters are checked:ALS-FRS,EMG-NCV,FVC,side effect check list.

Eligibility criteria: Inclusion Criteria:

* Age:18-65
* both gender
* duration of disease\<2 years
* FVC\>40% ALS-FRS\>26

Exclusion Criteria:

* neurological and psychiatric concomitant disease
* concomitant systemic disease
* treatment with corticosteroid,Ig,immunosuppressive during 12 months.

Primary outcomes:
measure: fever
timeFrame: 48hours
measure: unconsciousness
timeFrame: 6months
measure: brain hematoma
timeFrame: 48hours
measure: vomiting
timeFrame: 48hours
Secondary outcomes:
measure: ALS-FRS
timeFrame: 6months
measure: EMG-NCV
timeFrame: 6months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of Royan department of degenerative medicine,Head of Royan celltherapy center
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Head of Neurosurgery research center of Shahid Beheshti University
name: Ali Reza Zali, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00151684: Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men
Official title: Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Hyperinsulinism
Keywords: Obesity
Hyperinsulinism
Diazoxide
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2005-09-09
Enrollment: 25
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.

Obesity is associated with markedly elevated plasma insulin levels throughout the day. The concept is that obese subjects predominantly develop lean tissue resistance against the glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion, might be useful to treat obesity because it will help to reverse the process of lipid storage.

Detailed description: The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia.

Study design:

This study is an open-labelled, non-randomized, phase IIa study.

Treatment:

During a 6 month period, the dosage of Diazoxide will be raised gradually until a maximum of 900 mg/day, under control of bloodpressure and glucose levels.

Endpoints, monthly determined:

* body weight
* abdominal circumference
* body composition measured by Dual Energy X-ray Absorptiometry
* glucose tolerance

Eligibility criteria: Inclusion Criteria:

* fasting glucose \< 7.0 mmol/L
* fasting C-peptide plasma level \> 1.0 nmol/L
* HbA1c of 6.0% or lower
* Absence of comorbidity
* Absence of medication use

Exclusion Criteria:

* Plasma Creatinine \> 120 micromol/L
* Liverenzymes \> 2 times the upper normal limit
* Gout
* Alcohol use \> 2 units/day
* Illicit drug use
* Quit smoking less than 6 months ago

Primary outcomes:
measure: body weight
measure: abdominal circumference
measure: body composition measured by Dual Energy X-ray Absorptiometry
measure: glucose tolerance
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
affiliation: Rijnstate Hospital, Arnhem, The Netherlands
name: Hans de Boer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schreuder T, Karreman M, Rennings A, Ruinemans-Koerts J, Jansen M, de Boer H. Diazoxide-mediated insulin suppression in obese men: a dose-response study. Diabetes Obes Metab. 2005 May;7(3):239-45. doi: 10.1111/j.1463-1326.2004.00449.x.
Clinical trial NCT03035084: Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?
Official title: Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
25-Hydroxyvitamin D Concentration
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in 25(OH)D2 level.

The investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve


Eligibility criteria: Inclusion criteria:

* non-pregnant adults (age ≥18 years)
* healthy
* total 25(OH)D level between 20 to 65 nmol/L.
* living in Riyadh area

Exclusion criteria:

* consumption of more than one serving of milk daily
* taking vitamin D supplements
* habitual weekly sun exposure of 10 hours or more
* history of granulomatous, liver, or kidney disease
* taking anticonvulsants, barbiturates, or steroids

Primary outcomes:
measure: ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
timeFrame: day 28
measure: ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
timeFrame: day 28
Secondary outcomes:
measure: ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
timeFrame: day 56
measure: ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
timeFrame: day 56
measure: Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level
timeFrame: day 28
measure: Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level
timeFrame: day 28
measure: Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group
timeFrame: day 28
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
state: Central
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center (Riydah)
name: Muhammad M Hammami, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hammami MM, Abuhdeeb K, Hammami S, Yusuf A. Vitamin-D2 treatment-associated decrease in 25(OH)D3 level is a reciprocal phenomenon: a randomized controlled trial. BMC Endocr Disord. 2019 Jan 18;19(1):8. doi: 10.1186/s12902-019-0337-8.