louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01098942: Bariatric Surgery and Skeletal Health
Official title: Effects of Bariatric Surgery on Skeletal Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: bariatric surgery
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-04-05
Enrollment: 50
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: Obese adults

Brief summary: Bone loss may occur after bariatric (weight loss) surgery, but standard methods of measuring bone density in obese patients are potentially inaccurate. This study uses quantitative computed tomography to examine changes in bone mineral density after bariatric surgery. We are also studying mechanisms which may explain bone loss after bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Either scheduled for Roux-en-Y Gastric Bypass surgery or enrolled in a lifestyle weight management program

Exclusion Criteria:

* Weight ≥ than 450 lbs
* Postmenopausal women
* Significant heart, kidney, liver, or malignant disease
* Current disorders known to affect bone
* Use of medications known to affect bone for more than 7 days in the past 12 months

Primary outcomes:
measure: Changes in bone mineral density by dual-energy x-ray absorptiometry (DXA) and quantitative computed tomography (QCT)
timeFrame: 1 year
Secondary outcomes:
measure: Changes in serum and/or urine indices of bone formation and bone resorption, such as aminoterminal propeptide of type I collagen [PINP], osteocalcin, C-telopeptide cross-links [CTX])
timeFrame: 1 year
measure: Changes in bone microarchitecture by high-resolution peripheral quantitative computed tomography (HR-pQCT)
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joel S. Finkelstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu EW, Bouxsein ML, Putman MS, Monis EL, Roy AE, Pratt JS, Butsch WS, Finkelstein JS. Two-year changes in bone density after Roux-en-Y gastric bypass surgery. J Clin Endocrinol Metab. 2015 Apr;100(4):1452-9. doi: 10.1210/jc.2014-4341. Epub 2015 Feb 3.
citation: Yu EW, Bouxsein ML, Roy AE, Baldwin C, Cange A, Neer RM, Kaplan LM, Finkelstein JS. Bone loss after bariatric surgery: discordant results between DXA and QCT bone density. J Bone Miner Res. 2014 Mar;29(3):542-50. doi: 10.1002/jbmr.2063.
Clinical trial NCT00939042: Alster Stem Cells - Intramyocardial Stem Therapy
Official title: Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myocardial Infarction
Early Left Ventricular Dysfunction
Lead sponsor: Asklepios proresearch
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.


Eligibility criteria: Inclusion Criteria:

* LVDF \< 45% after timely (max. 6 hours after the onset of symptomps) successful PCI
* conventional therapy according to the ESC guidelines for heart failure
* BMI \> 20 and \< 35

Exclusion Criteria:

* PCI elder then 21 days
* relevant valvular disease
* history of stroke/multivessel disease/thromboembolic event etc.
* DM Type I
* pregancy

Primary outcomes:
measure: Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.
timeFrame: 12 months
measure: Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.
timeFrame: 12 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
Study officials:
affiliation: Asklepios Klinik St. Georg, Department of Cardiology
name: Karl-Heinz Kuck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02816242: Effect of Concept Mapping Teaching Method on Critical Thinking Skills of Medical Students
Official title: Effect of Concept Mapping Teaching Method on Critical Thinking Skills of Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Keywords: Concept Map
critical thinking
medical student teaching
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ahvaz University of medical sciences
First posted: 2016-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: effect of concept map in teaching critical thinking was done with randomized study

Detailed description: This quasi-experimental study with two groups design and pre-posttest method was conducted at Ahvaz University of Medical Sciences in 2014. About 100 Medical Students of in their third semester were recruited for the study based on census. Participants were divided into two intervention and control groups by using random sampling and Random Number Table List. Students in the control group were lectured in Anatomy using traditional lecture method. Whereas, students in the experimental group were taught Anatomy using concept map teaching method. Student's critical thinking was evaluated by examining" Standard California Critical Thinking Skills Questionnaire"

Eligibility criteria: Inclusion Criteria:

* any student at 1st semester of medicine who accept participation in study

Exclusion Criteria:

* do not accepting to participate

Primary outcomes:
measure: Standard California Critical Thinking Skills Questionnaire score
timeFrame: 4 months
Secondary outcomes:
measure: student satisfaction
timeFrame: 4 months
measure: anatomy score
timeFrame: 4 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Education Developmen Center
state: Fars
Study officials:
References:
Clinical trial NCT05125042: Catgut Embedding in Acupoints on Treating Persistent Atrial Fibrillation After Catheter Ablation
Official title: A Randomized Control Study of Catgut Embedding in Acupoint on Treating Persistent Atrial Fibrillation After Catheter Ablation: a Chinese Registry Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: persistent atrial fibrillation after catheter ablation
catgut embedding in acupoints
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, 2-arm, assessor and statistician blinded, pilot randomized controlled trial, to evaluate the effect of catgut embedding in acupoints of Neiguan and Zusanli in reducing early recurrence and improving long-term prognosis in patients with persistent AF after CA..

Detailed description: This multi-center, 2-arm, assessor and statistician blinded, pilot randomized controlled trial will be conducted at two centers in China: Shanghai Chest Hospital; The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine. Patients with persistent atrial fibrillation after catheter ablation are 1:1 randomized into group A (amiodarone hydrochloride tablet + acupoint catgut embedding), group B (amiodarone hydrochloride tablet). ECG, inflammatory cytokines,AFEQT scale and other indicators are analyzed the effect of catgut embedding in acupoints of Neiguan and Zusanli in reducing early recurrence and improving long-term prognosis in patients with persistent AF after CA.

Eligibility criteria: Inclusion Criteria:

* 1. Age between 18 and 80 years old; 2. Persistent AF（lasting no more than 3 years）after catheter ablation; 3. No acupuncture treatment within the previous 6 months.

Exclusion Criteria:

* 1. A history of allergy to acupuncture or amiodarone; 2. Severe heart failure (New York Heart Association（NYHA）class III or IV); 3. Echocardiographic parameters: left ventricular ejection fraction \< 40%, left atrium diameter \> 5.0cm; 4. Severe lung, liver, kidney disease or other serious primary diseases; 5. Skin allergy to ECG monitoring electrode patch. 6. The estimated life expectancy of \< 1 year.

Primary outcomes:
measure: Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
timeFrame: 12 months after ablation
Secondary outcomes:
measure: Postoperative AF recurrence rate
timeFrame: up to 12 months after ablation
measure: TCM symptom score scale
timeFrame: up to 12 months after ablation
measure: Inflammatory index
timeFrame: up to 12 months after ablation
measure: AF-specific Atrial Fibrillation Effect on QualiTy-of-life Scale
timeFrame: up to 12 months after ablation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00159042: Genetic Factors Affecting the Severity of Beta Thalassemia
Official title: Identification of Novel Genetic Modifiers in Beta-thalassemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Beta Thalassemia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients analyzed for beta thalassemia in our laboratory in Hadassah.

Brief summary: Patients with genetic diseases can have widely differing severities. We are looking for genetic factors which influence the severity of beta thalassemia.

Detailed description: The understanding of the phenotypic variability of genetically homogeneous disorders represents a major challenge. In beta thalassemia, the beta globin gene is affected by a variety of mutations. The group of patients to be analyzed here is homozygous for a splice site mutation that is common in the Middle East. In contrast to this genetic homogeneity, the spectrum of the clinical phenotype ranges from mild anemia to most severe, transfusion dependent anemia. We will use a genetic linkage approach to identify modifying factors and by analyzing the efficiency of an mRNA surveillance mechanism that is referred to as nonsense-mediated decay and represents a candidate genetic modifier of beta thalassemia and other genetic disorders.

Eligibility criteria: Inclusion Criteria:

* Identification of homozygous IVS1 nt 6 beta thalassemia mutation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Ariella Oppenheim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rund D, Oron-Karni V, Filon D, Goldfarb A, Rachmilewitz E, Oppenheim A. Genetic analysis of beta-thalassemia intermedia in Israel: diversity of mechanisms and unpredictability of phenotype. Am J Hematol. 1997 Jan;54(1):16-22. doi: 10.1002/(sici)1096-8652(199701)54:13.0.co;2-7.
Clinical trial NCT00692042: Study to Investigate Safety, Tolerability and Pharmacokinetics of a Single Ascending Dose of AZD1704
Official title: A Phase I, First Time in Man, Single-Centre, Randomised, Double-Blind (Within Panels), Placebo-Controller Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1704 After Administration of Oral Single Ascending Doses in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Safety
tolerability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary aim for this study is to investigate the safety and tolerability of the AZD1704, first time in man.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, man or woman of non child-bearing potential
* Provision of signed informed consent.

Exclusion Criteria:

* History of somatic disease/condition that may interfere with the objectives ot the study, as judged by the Investigator. History of seizures, with the exception of single occasions fever induced seizures in childhood.
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the DSM of Mental Disorder, 4th edition
* History of use of antipsychotic, antidepressant or anxiolytic drugs for the treatment of psychiatric disease or symptoms, prescribed as well as non-prescribed use.

Primary outcomes:
measure: To investigate the safety and tolerability of AZD1704 following single ascending doses in healthy volunteers.
timeFrame: At screening, during residential period (daily) and at follow-up
Secondary outcomes:
measure: To investigate the subjective CNS effects of specific adjectives (stimulated, anxious, sedated, down and high) rated on visual analogue mood scale (VAMS).
timeFrame: During residential period (daily)
Other outcomes:
Locations:
city: Macclesfield
country: United Kingdom
facility: Reserach Site
state: Cheshire
Study officials:
affiliation: AstraZeneca R&D CPU Nottingham, UK
name: Billy Fahy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Södertälje, Sweden
name: Lars Ståhle, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00601042: Serbian Smoking Reduction/Cessation Trial (2SRT)
Official title: Randomized, Placebo-controlled, Double-blind, Phase IV Trial to Assess the Efficacy of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Reduce or Replace Cigarette Smoking Among Adult Smokers in Serbia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cigarette Smoking
Keywords: smoking reduction
smoking cessation
randomized trial
Swedish snus
smokeless tobacco
Lead sponsor: Swedish Match AB
Sponsor class: INDUSTRY
First posted: 2008-01-25
Enrollment: 319
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus) can help adult smokers to reduce and eventually completely quit smoking.


Eligibility criteria: Inclusion Criteria:

* Male and female smokers in good general health aged 20-65 years regularly smoking \>10 cigarettes per day for more than 1 year who are motivated to reduce or quit smoking

Exclusion Criteria:

* Subjects with uncontrolled hypertension, history of coronary heart disease or other significant heart condition
* History of other significant medical condition that might interfere with study procedures
* Pregnant or nursing mother
* Current drug abuse.

Primary outcomes:
measure: Smoking reduction defined as a reduction in self-reported number of smoked cigarettes per day >50% compared to base-line, verified by a reduction in CO in exhaled air of >1 ppm compared to base-line
timeFrame: 6 months
Secondary outcomes:
measure: Smoking cessation defined as self-reported total abstention from cigarettes verified by CO in exhaled air <10 ppm
timeFrame: 3, 6, 9 and 12 months
measure: Clinical tests and biomarkers relevant for exposure to tobacco
timeFrame: 3, 6, 9, and 12 months
measure: Smoking reduction
timeFrame: 12, 24, 36 and 48 months
measure: Smoking reduction
timeFrame: 12, 24, 36 and 48 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Institute of Nuclear Sciences "Vinca"
city: Novi Beograd
country: Serbia
facility: Ambulanta Medicine Rada, Nis-Jugopetrol
Study officials:
affiliation: Institute for Nuclear Research "Vinca", Belgrade, Serbia
name: Gordana Joksic, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Stockholm University, Stockholm, Sweden
name: Robert Nilsson, Ph D, Prof
role: STUDY_CHAIR
References:
citation: Joksic G, Spasojevic-Tisma V, Antic R, Nilsson R, Rutqvist LE. Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation. Harm Reduct J. 2011 Sep 13;8:25. doi: 10.1186/1477-7517-8-25.
Clinical trial NCT02007642: Evaluation of High Throughput Sequencing for Screening of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.
Official title: Performance Assessment of High Throughput Sequencing for the Detection of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunodeficiency and Suspected Infection
Lead sponsor: Pathoquest
Sponsor class: INDUSTRY
Collaborators: name: Imagine Institute
First posted: 2013-12-11
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Immunocompromised patients hospitalized for a suspected infectious disease

Brief summary: The study patients are patients suffering from primary or secondary immunodeficiencies investigated in the Hospital Necker for a suspected infectious disease.

The study purpose is to assess the performance of a High Throughput Sequencing method, the PATHOQUEST method (from sample preparation to bio informatic analysis), versus the classic diagnostic approach.

The study will evaluate the capacity of the PATHOQUEST method to detect pathogens responsible for an infectious disease episode and will also evaluate the delay of obtention of results compared to the classic diagnostic approach.


Eligibility criteria: Summary of inclusion criteria:

1. Primary or secondary immunodeficiencies defined by

   * Solid organ transplantation and immunosuppressive drug
   * Recent chemotherapy
   * Hematopoïetic Stem Cells transplantation
   * Primary immune deficiency
   * Auto-immune disease
   * HIV infection
2. Infection suspicion
3. Microbiological investigation
4. Adult or child above 1 year
5. Hospitalization at Necker-Enfants malades hospital
6. Registration to Healthcare organism
7. ICF signature

Summary of exclusion criteria:

1. Obvious diagnosis following clinical examination
2. Participation in a clinical trial for a new drug
3. People under legal guardianship
4. People unable to fulfil the required medical follow-up

Primary outcomes:
measure: Identification of pathogens responsible for the infection
timeFrame: 1 year
Secondary outcomes:
measure: Delay of obtention of diagnostic
timeFrame: 1 year
measure: Economic impact of the PATHOQUEST method
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker - Enfants malades
state: Ile de France
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
affiliation: marc.lecuit@nck.aphp.fr
name: Marc Lecuit, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00581542: Moxifloxacin vs. Polytrim for Conjunctivitis
Official title: A Single Blinded Clinical Trial Comparing Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution for Treatment of Conjunctivitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Conjunctivitis
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 124
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study will investigate if both of the medications are equally good.


Eligibility criteria: Inclusion Criteria:

* 1 - 18 years of age with presumed bacterial conjunctivitis.

Exclusion Criteria:

* Previous antibiotics or to receive systemic antibiotic.

Primary outcomes:
measure: Number of Participants With Normal Physical Examination of the Eye
timeFrame: 10 days
Secondary outcomes:
measure: Number of Participants With a Negative Bacterial Culture
timeFrame: 10 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Francis Gigliotti, MD
role: PRINCIPAL_INVESTIGATOR
References: