louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00704236: Improvement of Insulin Resistance With Traditional Chinese Treatment in Patients With Type 2 Diabetes
Official title: Phase 4 Study on the Effect of Insulin Resistance With Traditional Chinese Treatment in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Traditional Chinese Treatment
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2008-06-24
Enrollment: 43
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 evaluate the efficacy of Traditional Chinese Treatment(TCT) on insulin sensitivity and other related factors in type 2 diabetes by using an double-blind, randomized, parallel control and prospective study This traditional compound Chinese herb preparation is referred to this study, with three kinds of plants: 50 mg of Coptis Chinensis, 30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica, all of which are selected by The Chinese Academy of Medical Sciences among those traditionally considered effective and safe in the treatment of diabetes.

Patients enrolled were randomized into TCT group and placebo group administrated with TCT and placebo respectively. Glucose disposal rate (GDR), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1C and other metabolic components were assessed at baseline and end point


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed type 2 diabetes poorly controlled by diet only for one month
2. Obese with a BMI of 23-35 kg/m2

Exclusion Criteria:

1. Those patients used any drugs for treatment of diabetes
2. Patients with evidence of cardiac, hepatic, renal, other chronic diseases or acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma
3. Women who were pregnant or planned pregnant.

Primary outcomes:
measure: Glucose Disposal Rate
Secondary outcomes:
measure: Fasting Plasma Glucose,Postprandial Plasma Glucose,HbA1c,triglyceride,cholesterol,HDL-c and LDL-c,lipid levels ,body weight, blood pressure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Guang Ning, MD. PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03596736: Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures
Official title: Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures. A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Humerus Fracture
Keywords: Distal Humerus Fracture
Arthroplasty, Replacement, Elbow
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2018-07-24
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Distal humeral fractures can be difficult to treat, in particular when the joint surface is affected (intra-articular fractures). If rigid internal fixation with plates and screws can be obtained it is considered to be the treatment of choice. In elderly patients, poor bone quality (osteopenia) and fragmentation of the articular surface can make rigid internal fixation non-reliable or even impossible. Total elbow arthroplasty has been shown to be of value in this type of situation. Elbow hemiarthroplasty has been proposed as an alternative to total elbow arthroplasty. The theoretical advantages as opposed to total elbow arthroplasty are: no restriction in the weight allowed to be lifted, complications related to polyethylene wear debris are avoided as there is no polyethylene liner and there is no ulna component that can loosen. Wear of the native ulna and instability are potential complications of elbow hemiarthroplasty.

The aim of this multicenter study is to test the hypothesis that elbow hemiarthroplasty gives better elbow function than total elbow arthroplasty for irreparable distal humeral fractures.


Eligibility criteria: Inclusion criteria

* Intra-articular distal humeral fracture with two or more displaced joint surface fragments devoid of soft tissue attachment
* Osteopenia
* Fracture deemed unsuitable for internal fixation
* Low-energy trauma
* Closed fracture
* Independent living

Exclusion criteria

* Comorbidity that affects elbow rehabilitation considerably
* Severe pre-existing elbow disease
* Concurrent injury that affects elbow rehabilitation considerably
* Pathologic fracture
* Vascular injury
* Inability to participate in follow-up

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Varberg
country: Sweden
facility: Varberg Hospital
Study officials:
affiliation: Linkoeping University
name: Lars Adolfsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01324336: Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
Official title: Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Keywords: ALL
acute lymphoblastic leukemia
6-Mercaptopurine
Pediatric
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Midwest Cancer Alliance
First posted: 2011-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included

Brief summary: The purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).


Eligibility criteria: Inclusion Criteria:

* Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included.

Exclusion Criteria:

* Inability to have blood drawn for the screening lab tests
* Received methotrexate or folate supplement within the last 24 hours
* Pregnant or lactating females
* Inability to swallow a pill
* Hemoglobin less or equal to 8 gm/dl
* Presence of significant co-morbid illness that makes child ineligible as deemed by the investigator
* Weight \< or = 16 kg

Primary outcomes:
measure: Pharmacokinetics of 6-MP
timeFrame: 8 hours post administration
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: The Children's Mercy Hospitals and Clinics
name: Kathleen A Neville, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05688436: A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
Official title: Pregnancy Outcomes in Women Exposed to Diroximel Fumarate
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Pregnancy
Relapsing forms of Multiple Sclerosis (MS)
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2023-01-18
Enrollment: 1178
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants included in this study will be drawn from the population of adult women with MS who become pregnant between 29 October 2019 and 31 July 2030.

Brief summary: The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.


Eligibility criteria: Key Inclusion Criteria:

* Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.
* Continuous medical and pharmacy coverage for a minimum of 6 months prior to and including the estimated LMP.
* Presence of MS.

Key Exclusion Criteria:

- Pregnancies will be excluded from this study if they are exposed to any known teratogens from the beginning of baseline through the end of the relevant exposure window.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Major Congenital Malformations (MCMs)
timeFrame: Up to 52 weeks postdelivery
Secondary outcomes:
measure: Number of Spontaneous Abortions
timeFrame: Before 20 weeks of gestation
measure: Number of Preterm Births
timeFrame: At or before the 37 weeks of gestation
measure: Number of Stillbirths
timeFrame: At or after the 20 weeks of gestation
measure: Number of Small for Gestational Age (SGA)
timeFrame: Up to 52 weeks postdelivery
Other outcomes:
Locations:
city: Eden Prairie
country: United States
facility: OptumInsight
state: Minnesota
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02805036: Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit
Official title: Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit: a Randomized Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Positive-Pressure Respiration
Keywords: alveolar recruitment
stroke volume/physiology
cardiac output/physiology
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: sedated, intubated, mechanically ventilated adult patients

Brief summary: Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for decreasing morbidity associated with mechanical ventilation.

In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from one centre to another and from one study to another.

The investigators intend to compare two currently used AR techniques with regard to their ventilatory efficacy and hemodynamic safety:

* An end-tidal plateau at 30 cmH20 for 30 seconds.
* An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds, without exceeding 30 cmH20.


Eligibility criteria: Inclusion Criteria:

* All sedated, intubated, mechanically ventilated adult patients (over-18) admitted to the surgical intensive care unit and equipped with a central venous catheter and an arterial catheter.
* Good echogenicity
* Social security coverage

Exclusion Criteria:

* Pregnancy
* Cardiac arrhythmia
* Poor echogenicity
* Legal guardianship or incarceration
* Systolic blood pressure ≤90 mmHg
* Respiratory distress
* Patients admitted on an emergency basis (first 24 hours), i.e. not for elective surgery

Primary outcomes:
measure: Variations in cardiac output induced by each type of AR manoeuvre
timeFrame: Day 0
Secondary outcomes:
measure: Variations in PaO2 variations induced by each type of AR manoeuvre
timeFrame: Day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Emmanuel LORNE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05436236: Effect of Cannabis (Marijuana) on Stomach Emptying Before Surgery
Official title: Cannabis Consumption Effect on Gastric Volumes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastric Emptying
Cannabis
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years and older with a planned surgery at one of two hospitals within the healthcare system, who are willing to state if they use or do not use cannabis

Brief summary: The purpose of this research is to study the effect of cannabis (marijuana) on gastric (stomach) emptying before surgery. The study will include people who use cannabis (study group) and people who do not use cannabis (control group).

Detailed description: About 108 people will take part in this study (54 in the study group and 54 in the control group). Subjects will have an ultrasound of the abdomen before their scheduled surgery. The ultrasound will determine how much fluid remains in the abdomen.

Researchers will also review subjects' medical records and will include: age, body mass index, history of cannabis use including how often and how consumed, reason for surgery, and length of time without eating before surgery.

Eligibility criteria: Inclusion Criteria:

* Subjects 18 years and older
* Planned surgery at one of two hospitals within the healthcare system
* Willing to state if they use or do not use cannabis
* Able to read and consent on their own behalf

Exclusion Criteria:

* Cognitively impaired
* Unable to read
* Children under the age of 18
* Pregnant women - Pregnancy status will be obtained from the routine pregnancy test performed prior to surgery
* History of gastroparesis
* Gastric surgeries
* Advanced liver or renal dysfunction
* Critically ill
* Emergent/urgent cases

Primary outcomes:
measure: Gastric content volume
timeFrame: pre-operative
Secondary outcomes:
measure: Frequency of cannabis use
timeFrame: 3 months prior to surgery
measure: Cannabis use (chronic yes or no)
timeFrame: 1 year prior to surgery
measure: Route of cannabis consumption
timeFrame: 3 months prior to surgery
measure: Time since last food; Nil per os (NPO) time
timeFrame: 24 hours prior to surgery
Other outcomes:
Locations:
Study officials:
affiliation: The Guthrie Clinic
name: Neel Kapoor, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454336: Transplantation of Autologous Mesenchymal Stem Cell in Decompensate Cirrhotic Patients With Pioglitazone
Official title: Phase 1 Trial of Combined Pioglitazone Plus Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Patients With Compensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Fibrosis
Keywords: MSCs
Pioglitazon
fibrosis
liver
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2011-10-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Liver cirrhosis (LC) is the final destiny in chronic liver disease. Liver transplantation is the only effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial considerations are it's essential problems. The immuomodulatory impact of MSCs in fibrosis was confirmed, and several clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research the investigators will study the affect of MSCs and Pioglitazone in the process of fibrosis.

Detailed description: BM Aspiration will be done twice (6 months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. MNCs will be cultured in T150 flasks. Cells will be expanded in several subcultures.MSCs will be injected (6 months interval) via portal vein under sonography monitoring.Each patient will receive 30mg Pioglitazone daily for 24 months. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months.

Eligibility criteria: Inclusion Criteria:

* 18-65 Years cirrhotic patient
* Approved cirrhosis by elastografy ,biopsy, sonography

Exclusion Criteria:

1 - Portal vein thrombosis 2-Hepatic encephalopathy, score 3\&4 3-ALT \& AST 3times more than normal 4-Serum Cr more than 1/5mg/dL 5-(Anti-HIV +) (Anti-HCV+) (HBS-Ag+) 6-Hepatocel carcinoma 7- Primary sclerosing cholangitis (PSC) 8- Esophageal varices grade 4 9-Addiction 10-Child Score B,C

Primary outcomes:
measure: ALT
timeFrame: 12 months
measure: AST
timeFrame: 12 months
measure: Serum Albumin
timeFrame: 12 months
measure: Liver Fibrosis
timeFrame: 12 months
Secondary outcomes:
measure: Progression of fibrosis
timeFrame: 12 months
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: Director of DDRC
name: Reza malekzadeh, MD
role: STUDY_DIRECTOR
affiliation: Royan regenerative medicine
name: Massoud vosough, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04496336: Non-invasive Substrate Evaluation in Atrial Fibrillation
Official title: Non-invasive Substrate Evaluation in Atrial Fibrillation Using Cardiac Magnetic Resonance and Electrocardiographic Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: C14.280.067.198
Keywords: Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Gregorio Marañón Hospital
First posted: 2020-08-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with persistent or paroxysmal atrial fibrillation, without cardiomyopathy (LVEF\> 40%) or significant valvulopathy who will undergo first AF ablation.

Brief summary: The study aims to assess the right and left atrial electrophysiological substrate in atrial fibrillation patients using the invasive electroanatomic map (basal and with extraestimulus) as well as its correlation with cardiac magnetic resonance and electrocardiographic imaging. The results will also be compared when the patient is in sinus rhythm and atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Atrial fibrillation paroxysmal or persistent with criteria for percutaneous ablation

Exclusion Criteria:

* Cardiomiopathy (FEVI\<40%) or significant valvulopathy.
* MRI not possible or contraindicated.
* Previous atrial fibrillation ablation.

Primary outcomes:
measure: Correlation between conduction velocity and MRI fibrosis.
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between voltage and MRI fibrosis.
timeFrame: Baseline
measure: Correlation between electrocardiographic image (ECGi) and MRI-LGE.
timeFrame: Baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References:
Clinical trial NCT00652236: Cost of Long Term Disability in Patients With Chronic Non-Specific Low Back Pain
Official title: Cost of Long Term Disability in Patients With Chronic Non-Specific Low Back Pain. Three-Year Follow up of a Randomized Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Low Back Pain
Keywords: Low back pain
Economics
Cost-effectiveness
Lead sponsor: Klinik Valens
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences of Western Switzerland
name: Zurich University of Applied Sciences
First posted: 2008-04-03
Enrollment: 174
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary rehabilitaton centre

Brief summary: The purpose of the study was to determine the cost-effectiveness of a function-centred treatment (FCT) compared with a pain-centred treatment (PCT) in patients with chronic low back pain (LBP) in an in-patient setting. Follow-up lasted three years. Direct and indirect costs were recorded by questionnaires sent to health insurances, employers and Swiss Disability Insurance Company.


Eligibility criteria: Inclusion Criteria:

* Chronic low back pain, sick leave of 6 weeks during the last 6 months

Exclusion Criteria:

* not able to perform a training program

Primary outcomes:
measure: cost- effectiveness
timeFrame: 3 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Valens
country: Switzerland
facility: Rehabilitationszentrum Klinik Valens
state: SG
Study officials:
affiliation: Rehabilitationszentrum Klinik Valens
name: Stefan Bachmann, MD
role: PRINCIPAL_INVESTIGATOR
References: