louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01552005: Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France
Official title: Description of Drug Utilization and Assessment of Impact of Saxagliptin on Health Status of Patients With Type 2 Diabetes in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus (T2D)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be proposed by GPs and diabetologists in France to ambulatory patients

Brief summary: The purpose of this study is to respond to The French Health Authority which has requested BMS France and Astra Zeneca (AZ) France to set-up a long-term cohort study in a representative sample of French Type 2 Diabetes mellitus (T2D) patients treated with Saxagliptin to generate real world data on drug utilization, joint population, non comparative effectiveness and safety

Detailed description: Time Perspective: Ambispective cohort follow by a 18 to 24 month follow up period, Retrospective follow by Prospective.

Eligibility criteria: Inclusion Criteria:

* Registry

  * Patient ≥ 18 years old
  * Patient with T2D
* Ambispective Cohort

  * Patient ≥ 18 years old
  * Patient with T2D
  * Patient initiated with Saxagliptin in the last 6 months before the inclusion or day of inclusion visit (whatever his/her ongoing hypoglycaemic treatment)
  * Patient agreeing to participate, and not yet enrolled by another physician

Exclusion Criteria:

* Patient participating in a clinical trial

Primary outcomes:
measure: Evolution of Glycated hemoglobin (HbA1c) level, weight and the onset of hypoglycemic over time (2 years) for patients treated with Saxagliptin
timeFrame: 24 months
measure: Joint population of Saxagliptin based on socio-demographic data, medical history, disease history, comorbidities including renal, hepatic and cardiac functions, HbA1c level at treatment initiation)
timeFrame: One year (average)
measure: Utilization of Saxagliptin by General practitioners (GPs) and diabetologists in France (based on indication, initial dosage and adjustments, co-prescriptions, glycemic monitoring)
timeFrame: During the treatment (Up to 2 years)
measure: Retention rate of Saxagliptin and to describe discontinuation rate and reasons
timeFrame: At 2 years
Secondary outcomes:
measure: Distribution of different hypoglycaemic therapeutic strategies used in France and characteristics of T2D patients depending on therapeutic strategies
timeFrame: 2 month
measure: Saxagliptin utilization according to patient's profile and disease characteristics
timeFrame: 24 month
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00508105: Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty
Official title: Comparison of Two Methods of Fixation of Subscapularis During Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subscapularis Peel
Morselized Osteotomy
Keywords: Osteoarthritis
Shoulder
subscapularis peel
osteotomy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2007-07-27
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.

Detailed description: The study investigates the difference in disease specific quality of life between patients who undergo a subscapularis peel versus morselized osteotomy of the lesser tuberosity, as measured by the Western Ontario Osteoarthritis of the Shoulder (WOOS) at one year post-operatively in patients who undergo shoulder arthroplasty ?

Eligibility criteria: Inclusion Criteria:

* Patients who have failed standard non-surgical management of their shoulder arthritis who would benefit from a shoulder arthroplasty.

Exclusion Criteria:

* Active joint or systemic infection
* Significant muscle paralysis
* Rotator cuff tear arthroplasty
* Major medical illness
* Unable to speak or read English/French
* Psychiatric illness that precludes informed consent
* Unwilling to be followed for 1 year

Primary outcomes:
measure: Subscapularis Strength
timeFrame: 2 years
Secondary outcomes:
measure: Western Ontario Osteoarthritis of the Shoulder Index
timeFrame: 2 Years
measure: American Shoulder and Elbow Score
timeFrame: 2 Years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hosptial
state: Ontario
Study officials:
affiliation: OHRI
name: Peter Lapner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lapner PL, Sabri E, Rakhra K, Bell K, Athwal GS. Healing rates and subscapularis fatty infiltration after lesser tuberosity osteotomy versus subscapularis peel for exposure during shoulder arthroplasty. J Shoulder Elbow Surg. 2013 Mar;22(3):396-402. doi: 10.1016/j.jse.2012.05.031. Epub 2012 Sep 1.
citation: Lapner PL, Sabri E, Rakhra K, Bell K, Athwal GS. Comparison of lesser tuberosity osteotomy to subscapularis peel in shoulder arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Dec 19;94(24):2239-46. doi: 10.2106/JBJS.K.01365.
Clinical trial NCT05168605: Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions
Official title: Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Type 2 Diabetes
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study includes prospective intervention arm and historical control arm (data will be collected via retrospective chart review).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of study is to evaluate whether home visit programs are an effective method for HTN and T2DM management as compared to standard of care clinic visits.

Detailed description: The purpose of this study is to compare the health outcomes utilizing home medical visits to manage hypertension and type 2 diabetes as compared to standard of care clinic visits.

This project has 3 overall objectives:

1. To test the efficacy of home medical visits by Family Medicine physicians specifically designed for patients with hypertension (HTN) and Type 2 Diabetes Mellitus (T2DM)
2. To compare primary outcome of the patients randomly selected for home visits to similar patients receiving usual care in the clinical setting
3. To understand the efficacy and impact of the home visit from the patient perspective

Study participant will receive usual care from a resident doctor in home. There will be (2) home visits conducted over the course of this study that will include a comprehensive assessment of hypertension, type 2 diabetes, and social factors that may be impacting their health. Study participants will also be asked to complete several questionnaires related to their knowledge of chronic diseases, personal health management, and experience of the study home visits.

Eligibility criteria: Inclusion Criteria:

* Adult patients ages 18-60
* Spanish or English speaking
* Diagnosis of HTN or BP \>140/90 in last 3 months (based on medical record)
* Hemoglobin A1C\>8 in last 6 months (based on medical record)
* Not pregnant

Exclusion Criteria:

* Current oral steroid use
* History of solid organ transplant
* Language other than English or Spanish

Primary outcomes:
measure: Change in Blood pressure
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Nora Gimpel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02952105: Identification of Ventricular Fibrillation and Optimization of Defibrillation During CPR
Official title: Identification of Ventricular Fibrillation and Optimization of Defibrillation During Chest Compression of CPR: A Multiple Study of Cardiac Arrest Patients in China.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Identify of Electrocadiac Rhythm
Keywords: cardiac arrest
identify of electrocardiac rhythm
ventricuar fibrillation
defibrillation
Lead sponsor: The First Affiliated Hospital of Henan University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Jinhua Central Hospital
First posted: 2016-11-02
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cardiac arrest patients aged more than 14 years

Brief summary: It's so important to recognize ventricular fibrillation in cardiac arrest and defibrillation early. At the same time Research findings have identified high-quality CPR with minimum interruption is critical to the success of defibrillation therapy. Both the guidelines by American Heart Association and the guidelines by European Resuscitation Council emphasize the importance of minimizing interruptions in chest compressions, specifically, duration of the pre-shock and post-shock pauses. So AHA indicate that there will be a new algorithm of VF during chest compression, which has high sensitivity and specificity. And the investigators can identify VF and defibrillate earlier.

The aim of this study is to verify that if Sherlock algorithm of Philips MRx monitor/defibrillator can identify shockable rhythms during chest compression accurately.


Eligibility criteria: Inclusion Criteria:

1. Cardiac arrest patients
2. The length from cardia arrest to be rescued is less than 10 minutes
3. age≥14
4. Complied with ethical requirements
5. signing the informed consent form.

Exclusion Criteria:

1. DNR
2. Pregnant women

Primary outcomes:
measure: Sensitivity and specificity of Sherlock algorithm of Philips MRx monitor/defibrillator in identify ventricular fibrillation.
timeFrame: 04/10/2016-10/01/2017
measure: How long it is advanced that the first time Sherlock algorithm identified VF than the true time VF was recognized.
timeFrame: 04/10/2016-10/01/2017
measure: Comparasion of no-flue time between true scene and assumed scene that useing Sherlock algorithm.
timeFrame: 04/10/2016-10/01/2017
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xuezhong Yu, Doctor
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Henan University of Science and Technology
name: Guoxiu Zhang, Bachelor
role: STUDY_DIRECTOR
affiliation: Jinhua Central Hospital
name: Mingwei Huang, Bachelor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02930005: Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders
Official title: A Pilot Open-label Trial of Pentosan Polysulfate Sodium and Meclofenamic Acid As Adjunctive Treatments in Patients With Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psychotic Disorders
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Keywords: Psychotic
Schizophrenia
Schizoaffective
Bipolar
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the feasibility of administering meclofenamic acid or pentosan polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic disorder. Half of participants will receive meclofenamic acid, while the other half will receive polysulfate sodium.

Detailed description: Chronic, low-grade brain inflammation is involved in the development of schizophrenia and other psychotic disorders. Medications with anti-inflammatory properties, like meclofenamic acid and pentosan polysulfate may help to reduce brain inflammation and serve as a treatment of psychotic disorders.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorders, unspecified schizophrenia spectrum and other psychotic disorders
* Negative pregnancy test in females of childbearing age

Exclusion Criteria:

* Urine drug screen positive for psychostimulants such as cocaine, amphetamines and ecstasy
* Any infection, neoplasm, autoimmune disease or other primary inflammatory condition (3) Previous diagnosis of intellectual disability or dementia
* Current treatment with heparin
* Use of or allergy to non-steroidal anti-inflammatory agent or pentosan polysulfate sodium
* Current or anticipated corticosteroid use
* History of peptic ulcer disease, gastro esophageal reflux disease, or gastrointestinal bleeding
* Those on warfarin or any anticoagulant
* Current treatment with lithium or asthma medication
* Individuals with pre-existing liver, cardiac, or kidney disease

Primary outcomes:
measure: Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
References:
Clinical trial NCT05624905: Prospective Pecutaneous Coronary Intervention Registry
Official title: Prospective Registry for Identifying Long-term Prognosis in Patients Who Underwent Coronary Angiography and Percutaneous Coronary Intervention for Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 15000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients who underwent coronary angiography adn percutaneous coronary intervention

Brief summary: Coronary artery disease is the most important cause of death worldwide. Treatment option for coronary artery disease is medical treatment, percutaneous coronary intervention, or coronary artery bypass surgery. Among them, the field of percutaneous coronary intervention is rapidly developing with regard to the improvement of devices, techniques, or medical treatment, leading to reduce mortality or morbidity. Until now, numerous previous studies related to the risk factors of coronary artery disease and the prognosis of patients have been conducted. However, the field of percutaneous coronary intervention is rapidly evolving, and treatment strategies are constantly being updated. Therefore, the current study sought to identify the long-term prognosis and related risk factors of patients with coronary artery disease who underwent percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

* patients who have undergone or are scheduled to undergo coronary angiography and percutaneous coronary intervention.

Exclusion Criteria:

* patients who did not consent to the research

Primary outcomes:
measure: Rates of Cardiac death or Target-vessel myocardial infarction
timeFrame: up to 10 years
measure: Rates of Major adverse cardiac and cerebrovascular event
timeFrame: up to 10 years
Secondary outcomes:
measure: Rates of all-cause death
timeFrame: up to 10 years
measure: Rates of cardiac death
timeFrame: up to 10 years
measure: Rates of myocardial infarction
timeFrame: up to 10 years
measure: Rates of target-vessel myocardial infarction
timeFrame: up to 10 years
measure: Rates of target lesion revascularization
timeFrame: up to 10 years
measure: Rates of target vessel revascularization
timeFrame: up to 10 years
measure: Rates of cerebrovascular accident
timeFrame: up to 10 years
measure: Rates of stent thrombosis
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT04634305: Clinical and Functional Results After Total Elbow Arthroplasty
Official title: Evaluation of the Clinical and Functional Results Obtained After a Total Elbow Arthroplasty, All Indications Combined
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elbow Fracture
Elbow Arthropathy
Elbow Osteoarthritis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient that underwent a total elbow arthroplasty between january 2004 and august 2020 by a single operator in our orthopedic center

Brief summary: Analysis of clinical and functional outcomes after a total elbow arthrosplasty, all indications combined, with a minimum follow up of 24 months The hypothesis is that there a significant improvement after an elbow replacement, no matter what the surgery indication is


Eligibility criteria: Inclusion Criteria:

* Total elbow arthroplasty, all indication combined

Exclusion Criteria:

* Less than 24 months of follow up
* Revision of total elbow arthroplasty

Primary outcomes:
measure: Mayo Elbow Performance Score
timeFrame: through study completion, an average of 5 years
measure: QuickDASH
timeFrame: through study completion, an average of 5 years
measure: Range of motion
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: Implant loosening
timeFrame: through study completion, an average of 5 years
measure: Triceps deficiency
timeFrame: through study completion, an average of 5 years
measure: Bushing wear
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
state: Lorraine
Study officials:
References:
Clinical trial NCT00445705: Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fibromyalgia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-03-09
Enrollment: 211
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia syndrome
* Moderate or severe pain associated with fibromyalgia

Exclusion Criteria:

* Any other uncontrolled disease
* Pregnant or nursing females

Primary outcomes:
measure: Change From Baseline in Mean Daily-Average-Pain Score at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4
timeFrame: Baseline, Week 4
measure: Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4
timeFrame: Week 4
Other outcomes:
Locations:
city: Canton
country: United States
state: Ohio
city: Geneva
country: Switzerland
city: Stanmore
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00978705: Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
Official title: Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Burn Wound
Keywords: Keratinocyte Cell
severe burn wound
Lead sponsor: Biosolution Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-09-17
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.


Eligibility criteria: Inclusion Criteria:

* Age : 1\~70 years
* More than 30% TBSA of second degree burn or more than 10% TBSA of third degree burn
* Must provide signed informed consent prior to participation in any study-related procedures

Exclusion Criteria:

* Have a pyogenic infection
* Part of the facial cosmetic surgery cost
* Hypersensitivity reactions in patients with bovine proteins
* Hypersensitivity reactions in patients with Gentamycin
* Pregnancy or lactation

Primary outcomes:
measure: engraftment assessment
timeFrame: 4week
Secondary outcomes:
measure: the vancouver burn scar scale
timeFrame: 8, 12, 24 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
Study officials:
affiliation: Hangang Sacred Heart Hospital
name: Wook Chun, MD
role: PRINCIPAL_INVESTIGATOR
References: