louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01319747: Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial
Official title: Video-Assisted Thoracoscopic Pulmonary Vein Isolation Versus Percutaneous Catheter Ablation in Atrial Fibrillation Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial
fibrillation
pvi
vats
ablation
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) and surgically video assisted thorascopic pulmonary vein isolation (VATS-PVI) are acceptable or even superior alternatives to antiarrhythmic drug therapy in patients with symptomatically paroxysmal atrial fibrillation (AF). However, data comparing effectiveness in both interventions are limited.

The investigators want to compare the effectiveness of PVI and VATS-PVI. Secondary objectives are to compare the duration of hospitalization, quality of Life, cost and to compare the satisfaction of the patients.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age
* Documented, symptomatic, episodes of paroxysmal or persistent AF
* During the last 6 months patients must have at least 2 documented episodes of AF, despite the use of at least 1 anti arrhythmic drug.
* Able of providing informed consent

Exclusion Criteria:

* Pregnancy
* Unwillingness to use or contra-indications for vitamin K antagonists
* Severely enlarged left atrium (\>50 mm) on echocardiography
* Prior AF ablation or AF surgery
* Intracardiac thrombus
* Prior heart surgery or pulmonary disease hampering thoracoscopic surgery

Primary outcomes:
measure: Recurrence of AF
timeFrame: one year
Secondary outcomes:
measure: Treatment impact
timeFrame: one year
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: OV
Study officials:
affiliation: Medisch Spectrum Twente
name: Marcoen Scholten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426347: Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis
Official title: Vitamin Therapy in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Vitamin D Deficiency
Keywords: Rheumatoid Arthritis
Vitamin D deficiency
Disability
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-08-31
Enrollment: 139
Sex: ALL
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: The purpose of this study is to investigate the effect of vitamin D repletion on disease activity and disability in patients with rheumatoid arthritis.

The investigators hypothesize that rheumatoid arthritis (RA) patients with vitamin D deficiency have greater disease activity and disability, compared to RA patients with normal vitamin D levels. The investigators also hypothesize that vitamin D treatment in these deficient patients will result in a decrease in RA disease activity and disability.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR) criteria
* ages 18-75 years

Exclusion Criteria:

* Diagnosis of any other autoimmune disease:

such as Lupus, Scleroderma, Myositis, Sjogren's Syndrome, Vasculitis'

* Having any of the following conditions with in the last 6 months Hypercalcemia, Hyperparathyroidism, Active tuberculosis (TB), Lymphoma or any other type of cancer, Sarcoidosis, Seizure, Stroke
* Severe heart problems
* Kidney failure requiring dialysis treatment
* Liver failure or cirrhosis of the liver
* Poorly controlled hypertension
* current uncontrolled Depression, Bipolar Disorder, or other Psychiatric illness
* Pregnancy

Primary outcomes:
measure: Disease Activity Score (DAS) 28
timeFrame: Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))
Secondary outcomes:
measure: Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)
timeFrame: Baseline and 16 weeks (end of RCT)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Uzma J Haque, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00356447: Safety/Efficacy Study of Drospirenone/Estradiol to Treat Postmenopausal Chinese Women With Vasomotor Symptoms.
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Investigating the Efficacy and Tolerability of Angeliq® (Drospirenone 2mg and Estradiol 1mg) in Postmenopausal Chinese Women With Vasomotor Symptoms Over Four 28-day Treatment Cycles.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasomotor Symptoms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-07-26
Enrollment: 249
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates in Chinese post-menopausal women the combination of drospirenone 2 mg and estradiol 1 mg for the treatment of climacteric symptoms, such as hot flushes (vasomotor symptoms) and uro-genital complaints.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Chinese postmenopausal women with moderate to severe vasomotor symptoms

Exclusion Criteria:

* History of steroid hormone dependent malignant disease
* Known or suspected malignant or premalignant disease
* Current or history of severe heart, liver, renal, psychiatric disease
* Hyperlipemia

Primary outcomes:
measure: Frequency of hot flushes
timeFrame: From baseline to week 16
measure: Change in intensity of hot flushes
timeFrame: From baseline to week 16
Secondary outcomes:
measure: Change in other climacteric symptoms
timeFrame: From baseline to week 16
measure: Vaginal Bleeding pattern
timeFrame: From baseline to week 16
measure: Global clinical impression
timeFrame: From baseline to week 16
Other outcomes:
Locations:
city: Wuhan
country: China
state: Hubei
city: Nanjing
country: China
state: Jiangsu
city: Jinan
country: China
state: Shandong
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Shanghai
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04357847: Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection
Official title: Assessment of Endothelial and Haemostatic Changes During Severe SARS-CoV-2 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Endothelial Dysfunction
Thrombosis
Critically Ill
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 100
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: ICU patients with documented SARS-CoV-2 infection (PCR or CTscan)

Brief summary: The outbreak at covid-19 is caused by the SARS-CoV-2 virus. This virus can be responsible for severe respiratory failure but also for extra-respiratory organ dysfunctions associated with severe inflammatory stress. The endothelium is an important structure of the blood vessels and is implicated in the organ failure of many patients admitted in intensive care units. It could be affected by the virus and its alteration may explain the organ dysfunction of covid-19 ICU patients as well as the thrombotic processes frequently obstructed in this infection.


Eligibility criteria: Inclusion Criteria:

* all adult patients admitted in ICU for covid-19 disease within the past 24 hrs

Exclusion Criteria:

* bactrial co-infection at admission
* expected death within the next 24 hrs
* pregnancy

Primary outcomes:
measure: Association of InterCellular Adhesion Molecule-1 plasma level with 28 days mortality
timeFrame: 24 hours
Secondary outcomes:
measure: Association of Endothelin-1 plasma level with 28 days mortality
timeFrame: 24 hours
measure: Association of Vascular Endothelial Growth Factor A plasma level with 28 days mortality
timeFrame: 24 hours
measure: Association of soluble Vascular Endothelial Growth Factor Receptor type 1 with 28 days mortality
timeFrame: 24 hours
measure: Association of syndecan -1 plasma level with 28 days mortality
timeFrame: 24 hours
measure: Association of D-dimers plasma levels with thrombotic events
timeFrame: 24 hours
measure: Association of von Willebrandt Factor with thrombotic events
timeFrame: 24 hours
measure: Association of Viscoelastic testing with thrombotic events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
Clinical trial NCT06306547: Clinical Study Cohort of Idiopathic Inflammatory Myositis
Official title: Clinical Study Cohort of Idiopathic Inflammatory Myositis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Idiopathic Inflammatory Myopathies
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Aged 18-75 years and eligible for the 2017 European League Against Rheumatism/American College of Rheumatology.

Brief summary: Idiopathic inflammatory myositis (IIM), also known as myositis, are a heterogeneous group of diseases characterized by chronic inflammation of striated muscles and skin, with different clinical manifestations, treatment responses, and prognosis. This project will build a clinical follow-up cohort for idiopathic inflammatory myositis (IIM) centered on Renji Hospital, Shanghai Jiao Tong University School of Medicine, to promote the clinical and pathogenesis of this group of diseases.


Eligibility criteria: Inclusion Criteria:Subjects must meet the following criteria for inclusion in this study: meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (IIM) or the 2018 ENMC-DM classification criteria (see above), plus:

1. Age≥ 18 years old and ≤ 75 years old
2. Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (IIM), the above score ≥ 5.5 points if there is no muscle biopsy, and 6.7 points ≥ if there is muscle biopsy
3. Cooperate with follow-up, examination and treatment and voluntarily sign the informed consent form.

   -

   Exclusion Criteria:Potential subjects who meet the inclusion criteria will be excluded if they meet any of the following criteria:

   a. IIM with other connective tissue diseases; b. Negative myositis antibody test; c. Those who are in the period of acute infection, or have a history of active tuberculosis in the past; d. People with allergies or allergies to multiple drugs; e. Those who have mental illness or other reasons and cannot cooperate with examination, follow-up or treatment; f. Women who are pregnant, or are trying to become pregnant; g. Those who are participating in or have participated in clinical trials within the specified time.

   -

Primary outcomes:
measure: High Resolution Computed Tomography of Chest
timeFrame: three months
measure: Cutaneous Disease Area and Severity Index
timeFrame: three months
measure: Forced vital capacity
timeFrame: three months
measure: Manual Muscle Testing
timeFrame: three months
measure: Forced expiratory volume in one second
timeFrame: three months
Secondary outcomes:
measure: Serum creatine kinase
timeFrame: three months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03980847: Evaluation, the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in the Preservation of the Tooth Socket
Official title: Teh Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Alendronate in Teh Preservation of Teh Tooth Socket
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Resorption
Lead sponsor: Islamic Azad University, Sanandaj
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Twenty patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in teh research project, which TEMPhas more TEMPthan 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for teh periodontal problem, caries or Fractures were selected.

Detailed description: 20 healthy patients referring to periodontics department of Boroujerd Azad university of dentistry after obtaining consent to participate in the research project, which has more than 20 teeth, are over 18 years old and require socket preservation surgery to tooth extraction for the periodontal problem, caries or Fractures were selected. Furthermore, divided the socket randomly to two groups(A, B)including A: bone graft wif Alendronate and B: bone graft alone, after 3 months wif trephine will collect the samples. following the histomorphometric analysis.

Eligibility criteria: Inclusion Criteria:

1. at least 18 years old
2. tooth fracture, root caries
3. Patients are volunteered for placement of teh implant

Exclusion Criteria:

1. systemic diseases
2. Pregnancy and breastfeeding
3. malignancy, radiation therapy,
4. history of periodontal surgery during teh six months ago.
5. medicine(phosphonates, antibiotic,...)

Primary outcomes:
measure: New bone formation (bone area as percent)
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Amirhossein Farahmand
Study officials:
References:
Clinical trial NCT06431347: Prospective Observational Cohort Study of Transplant and Cell Therapy Candidates and Recipients to Assess Social Determinants of Health
Official title: Prospective Observational Cohort Study of Transplant and Cell Therapy Candidates and Recipients to Assess Social Determinants of Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transplant and Cell Therapy
Keywords: Social Determinants of Health
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 2000
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: MD Anderson Cancer Center

Brief summary: To learn more about social and financial factors that may influence outcomes of TCT treatment at MD Anderson.

Detailed description: Primary Objective:

To determine the relationship between participant social determinants of health (SDOH) and outcomes following transplantation and cellular therapy at MDACC.

Eligibility criteria: Inclusion Criteria

1. ≥ 18 years of age.
2. Received financial clearance for TCT.

Qualitative study - patients

1. Patient ≥ 18 years of age who is currently cared for at MD Anderson as a TCT candidate/ recipient,
2. The patient reports social and/or financial challenges impacting care delivery.
3. The patient is willing to participate in a semi-structured interview.

Qualitative study - caregivers

1. Caregiver(s) of a patient ≥ 18 years of age who is currently cared for at MD Anderson as a TCT candidate/ recipient.
2. The patient reports social and/or financial challenges impacting care delivery.
3. The patient has referred the caregiver(s) to participate and provided us with permission to contact their caregiver(s).
4. The caregiver(s) is (are) willing to participate in a semi-structured interview.

Exclusion Criteria Patients - Quantitative study 1) Did not receive financial clearance for TCT

Patients - Qualitative study

1) Not impacted by social or financial challenges.

Caregivers (qualitative study)

1. Did not care for a patient impacted by social or financial challenges
2. Were not referred to participate in the study by patient they cared for.

Primary outcomes:
measure: Social Determinants of Health Questionnaire
timeFrame: At 6, 12, 18, and 24 months post Transplant and Cell Therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Warren Fingrut, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00538447: Prospective Database for Chronic Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leukemia, Myeloid, Chronic
Keywords: CML
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Prospective Database for Chronic Myelogenous Leukemia


Eligibility criteria: Inclusion Criteria:

* Patients with CML

Primary outcomes:
measure: safety and efficacy
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Naeeem Chaudhri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00166647: Thiopurine Methyltransferase Polymorphisms Evaluation
Official title: Evaluation of Thiopurine Methyltransferase Polymorphisms in the Hispanic Population
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Keywords: Cancer
Chemotherapy
Hematological disorder
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2005-09-14
Enrollment: 0
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of the study is to determine the frequency of allelic variants in TPMT in the Hispanic population and to compare the frequency in the Hispanic population with the Caucasian Population.

Detailed description: Relatively few studies have been performed evaluating the variant allele frequencies in Spanish populations. To date, no studies evaluating the TPMT variant allele frequency in the Hispanic population have been reported. Hispanics are a growing part of the patient population treated in the United States. Characterization of the proportion of patients with variant genotypes in this population is important since Hispanic children represent a significant proportion of children being treated with thiopurines.

A single 3 cc heparinized blood sample will be obtained for TPMT genotyping. The sample will be obtained either simultaneously with a clinical sample, at the time of an otherwise medically indicated intravenous catheter placement or scavenged from excess blood remaining following clinical laboratory testing.

Eligibility criteria: Inclusion Criteria:

* All Hispanic children and adolescents diagnosed and treated at Texas Children's Cancer Center within the last 5 years for malignant diseases/cancer and non-malignant hematological disorders that necessitate chemotherapy
* All Hispanic children and adolescents who will be treated at Texas Children's Center for malignant diseases/cancer and non-malignant hematological disorders that will necessitate chemotherapy.

Exclusion Criteria:

* Any child or adolescent registering at Texas Children's Cancer Center and not requiring any form of therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine, Texas Children's Hospital
state: Texas
Study officials:
References:
Clinical trial NCT04097847: Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study
Official title: Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoradionecrosis of Jaw
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients treated at Brest hospital University for ENT cancer and who had cervicofacial radiotherapy, with maxillary and / or mandibular osteoradionecrosis treated with PENTOCLO alone or in combination with other therapies

Brief summary: osteoradionecrosis (ORN) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. Differents therapeutics exist but there is no consensus concerning the management of the maxillary ORN. The understanding of new pathological mechanisms opens the way to new therapeutic perspectives.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 being or having been treated by pentoclo combination for an osteoradionecrosis of the jaw

Exclusion Criteria:

* Tumoral recidivism
* Precocious stop of pentoclo

Primary outcomes:
measure: Clinical evolution of the osteoradionecrosis lesion after introducing PENTOCLO protocol
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: