louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03862183: Hospital-level Variation in the Management of Blood Pressure and Low-density Lipoprotein in the Outpatient Hypertensives in China-a Cross Sectional Study
Official title: Survey on BP, Lipids and Cardiovascular Risks in the Outpatient Hypertensives and Continuing Medical Education Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 21000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients with hypertension in different levels of hospitals in China

Brief summary: To investigate the proportion, medication use and control rate of metabolic abnormalities such as dyslipidemia in outpatients with hypertension in different levels of hospitals in China. To investigate the gap between guidelines and clinical practices, and analyze the cause. we also set up a continuing medical education program to narrow the gap and the effect of the program will be estimated.


Eligibility criteria: Inclusion Criteria:

1. Outpatients from departments of Cardiology, Endocrinology, Nephrology, Neurology, Geriatrics or General Internal Medicine.
2. Diagnosed as hypertension. Diagnostic criteria: 1)The office BP measured at the day of visit and at least one time before that day were above the cut-off values ( ≥140 mmHg SBP and/or ≥90 mmHg DBP); 2)for patients with normal BP at the day of visit, they should have already been given pre-treatment with antihypertensive drugs ≥ 2 weeks.
3. Voluntary participation.

Exclusion Criteria:

1. Patients aged\< 18 years old.
2. Patients without a definite diagnosis of hypertension（for instance, if the patient has been taking antihypertensive drugs irregularly, it is difficult to confirm the diagnosis of hypertension）.
3. Patients with a definite diagnosis of secondary hypertension.
4. Patients are diagnosed dyslipidemia with clear cause, such as nephrotic syndrome, severe hypothyroidism, terminal stage of malignancy, etc.
5. Patients are diagnosed end-stage renal disease, hemodialysis, and peritoneal dialysis patients.
6. Patients diagnosed with mental abnormalities who are unable to complete the questionnaire.
7. Patients have once participated in this research during this study cycle（to avoid repeated participation）.

Primary outcomes:
measure: rate of blood pressure goal achievement
timeFrame: 2017-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cardiology Department in Huashan Hospital
state: Shanghai
Study officials:
References:
citation: Xie K, Gao X, Bao L, Shan Y, Shi H, Li Y. The different risk factors for isolated diastolic hypertension and isolated systolic hypertension: a national survey. BMC Public Health. 2021 Sep 14;21(1):1672. doi: 10.1186/s12889-021-11686-9.
Clinical trial NCT02449083: Magnet Resonance Imaging to Evaluate of Dynamic T2 Preparation Puls by Patients With Shunt or Chronic Obstructive Pulmonary Disease
Official title: Cardiac Magnet Resonance Imaging to Evaluate of Dynamic T2 Preparation Puls by Patient With Shunt or Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dynamic T2 Preparation
Keywords: MRI
Shunt
COPD
Dynamic T2 Preparation Puls
new sequences
magnet resonance imaging
ventricular septal defect
Atrial septal defect
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with atrial septal defect (ASD) or ventricular septal defect (VSD) and COPD, who is planned for MRI and angiography

Brief summary: There is preliminary evidence that a dynamic T2 Preparations Puls sequence by cardiac magnet resonance imaging can differentiate between oxygenated and deoxygenated blood.

In adult patients with inborn heart defects this has not yet been researched. Therefore,patients with ventriculoperitoneal shunt, septal and atrio-septal shunt should be examined. Also, patients with chronic obstructive pulmonary disease should be examined.

The aim of this study is the validation of a novel magnet resonance sequence in terms of a distinction of oxygenated blood to deoxygenated blood in comparison to invasive method of measuring cardiac catheterization.


Eligibility criteria: Inclusion Criteria:

* patients with atrial septal defect (ASD) or ventricular septal defect (VSD) and COPD
* written informed consent

Exclusion Criteria:

* patients with ST-elevation
* contraindication for MRI
* heavy kidney disease
* pregnant or breast feeding women

Primary outcomes:
measure: ventricular volumetry
timeFrame: baseline
Secondary outcomes:
measure: oxygen partial pressure
timeFrame: baseline
measure: carbon dioxide partial pressure
timeFrame: baseline
measure: pH-value
timeFrame: baseline
measure: Blood gas analysis
timeFrame: baseline
measure: Blood gas analysis
timeFrame: baseline
measure: Major adverse cardiac events
timeFrame: 12 month after procedure
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: University Hospital Duesseldorf
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Britta Butzbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03184883: Comparative Study Between Acrylic and Flexible Dentures
Official title: Comparative Study of Conventional Versus Flexible Mandibular Single Complete Denture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue and patient's satisfaction

Detailed description: comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue by keratinization index through PAP stain and patient's satisfaction through a questionnaire

Eligibility criteria: Inclusion Criteria:

1. Mandibular flat ridge
2. Patient with opposing natural teeth or satisfactory fixed prostheses
3. Angle class I Maxillimandibular relationship
4. No intraoral soft and hard tissue pathosis
5. Non smokers
6. Patients with no previous denture experience
7. Patients having last extraction at least 6 month before denture construction

Exclusion Criteria:

-

Primary outcomes:
measure: Cytological changes manifested as keratinization index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: supervisor
name: Essam Aziz, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00491283: QuickVue Influenza A+B Clinical Field Trial
Official title: Comparison of Swab Types for Specimen Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Lead sponsor: Quidel Corporation
Sponsor class: INDUSTRY
First posted: 2007-06-26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A comparative study of different swab types used for collection of specimens for rapid inluenza testing


Eligibility criteria: Inclusion Criteria:

Subjects must have:

* Fever (\>38°C) (at time of visit or within the previous 48 hrs by history) and at least two of the following symptoms:

  * Chills/sweats
  * Cough
  * Dyspnea (labored, difficult breathing)
  * Fatigue
  * Headache
  * Myalgia (deep muscle aches)
  * Nasal congestion
  * Runny nose
  * Sore throat

Exclusion Criteria:

* Patients who are undergoing treatment with antivirals, now or within the last 7 days cannot be included in this study.

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: five months
Secondary outcomes:
measure: Sensitivity and Specificity
timeFrame: Positive and Negative Predictive Values
Other outcomes:
Locations:
city: Mascot
country: Australia
facility: Sydney Airport Medical Centre
state: New South Wales
Study officials:
affiliation: Sydney Airport medical Centre
name: Andrew Keller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01778283: Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration
Official title: Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End-stage Renal Disease
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to detemine whether effect of Acetate-free solution on cardiac index and cardiac output measured by saline dilution techniques compares with Acetate-based solution in online-hemodiafiltration


Eligibility criteria: Inclusion Criteria:

* End-stage renal disease patients with age over 20 years and stable clinical status
* Dialytic age \> 6 months
* Maintenance hemodialysis with online-hemodiafiltration mode at King Chulalongkorn Memorial Hospital
* Use arteriovenous fistula or arteriovenous graft as vascular access for hemodialysis
* No vascular access recirculation
* No liver impairment
* No severe, intractable metabolic acidosis or alkalosis (HCO3 \<15, \>30)
* No pre-existing severe, intractable hypocalcemia (Ca \< 7.5) or clinical of hypocalcemia

Exclusion Criteria:

* On hemodialysis via tunnel catheter
* Vascular access recirculation
* Liver dysfunction
* Severe, intractable metabolic acidosis or alkalosis (HCO3 \<15, \>30)
* Pre-existing severe, intractable hypocalcemia (Ca \< 7.5) or clinical of hypocalcemia
* Acute or recent myocardial ischemia or congestive heart failure (within 1 months)
* Threatening arrhythmia (VT, VF, sustained SVT, AF with rapid ventricular response)
* Patients affected by acute or chronic infections, malignant tumor

Primary outcomes:
measure: cardiac index
timeFrame: 6 months
measure: Cardiac output
timeFrame: 6 months
Secondary outcomes:
measure: blood pressure
timeFrame: 6 months
measure: peripheral vascular resistance
timeFrame: 6 moths
measure: Patients' symptoms
timeFrame: 6 months
Other outcomes:
measure: cardiac marker, serum electrolyte, inflammatory marker
timeFrame: January 2013
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
References:
Clinical trial NCT01055483: A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia
Official title: A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia
AML
relapsed acute myeloid leukemia
refractory acute myeloid leukemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).


Eligibility criteria: Inclusion Criteria:

* Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia.
* First relapsed AML
* Primary refractory AML defined as failure to respond to initial induction chemotherapy (no CR) or recurrence within 6 months of initial CR.
* Age more than 18 years
* ECOG performance status \< 2

Exclusion Criteria:

* Prior treatment with deacetylase inhibitor
* Concurrent therapy with any other investigational agent
* Patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
* Clinical symptoms suggesting CNS leukemia
* LVEF below 45% Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Incidence of dose limiting toxicity (DLT)
timeFrame: 1 cycle (1 cycle = 28 days)
Secondary outcomes:
measure: Frequency, severity and duration of Adverse Events (AE) using CTCAE version 3.0
timeFrame: During maximal three LBH589/chemotherapy cycles and subsequent optional single-agent LBH589 treatment
Other outcomes:
Locations:
city: Paris Cedex 4
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03758183: Cost Effectiveness of Prolotherapy Injections Prior to Total Knee Arthroplasty
Official title: Cost Effectiveness of Two-stage Algorithm (Prolotherapy Injections Prior to Total Knee Arthroplasty) in the Management of Advanced Stage Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Arthroplasty
Prolotherapy
Osteoarthritis
Lead sponsor: Tokat State Hospital
Sponsor class: OTHER_GOV
First posted: 2018-11-29
Enrollment: 197
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age of the patients varied between 50 and 90

Brief summary: This study compared the cost effectiveness of two-stage algorithm (prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)) and one-stage algorithm (TKA) in the management of advanced stage knee osteoarthritis.

Detailed description: The aim of the present study was to compare the cost effectiveness of two-stage algorithm (prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)) and one-stage algorithm (TKA) in the management of advanced stage knee osteoarthritis.

A total of 197 patients who had chronic knee osteoarthritis were included in the present study. The patients were divided into two groups as two-stage algorithm (PrT combined with RP prior to TKA), (Group A, n=98) and one-stage (TKA),(Group B, n=99). Clinical effectiveness was evaluated via Visual Analog Scale (VAS), The Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline and 3-, 6-, 12-, and 18-month follow-ups. Utility scores of the groups were obtained by extracting and converting WOMAC scores to health utilities index mark 3 scores. Cost-utility per quality-adjusted life years (QALY) and Incremental cost-effectiveness ratios (ICERs) of each group were calculated.

Eligibility criteria: Inclusion Criteria:

* III and IV levels of knee osteoarthritis according to Kellgren-Lawrence
* Had at least six months of symptoms resistant to at least three months of conservative methods (lifestyle modification, weight reduction, regular exercise, physiotherapy, non-steroidal anti-inflammatory drugs, intraarticular injection methods) -

Exclusion Criteria:

* With rheumatic diseases, immune diseases or other systemic inflammatory diseases
* With active infection, osteomyelitis or history of chronic infection around knee joint
* Had undergone previous operation on knee
* Had bleeding tendency (hereditary or acquired)
* Pregnant patients

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 18 months
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Serkan Akpancar
Study officials:
affiliation: Tokat State Hospital
name: Serkan Akpancar, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01188083: Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
Official title: Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty-liver Disease
Keywords: NASH
non-alcoholic fatty-liver disease
Hispanic
overweight
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 53
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Primary Objectives:

1. To determine whether a 4 week reduction in dietary fructose intake improves hepatic steatosis in overweight children who have a baseline high fructose consumption and hepatic steatosis.
2. To determine if a 4 week reduction of dietary fructose improves fasting plasma triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as well as post-prandial levels in response to a high fructose meal.
3. To determine if a 4 week reduction of dietary fructose improves markers of oxidative stress.

Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose beverages administered over 4 weeks.

Detailed description: Planned Sample Size: Phase 1) 96 subjects Phase 2) 40 subjects

Patient Population: Overweight Hispanic children with non-alcoholic fatty-liver disease age 11 to 18 years who are stable and not taking any chronic medication with no recent acute illnesses.

Definitions:

* BMI \>95th %tile for age and gender
* Self-identified as Hispanic/Latino
* Baseline hepatic fat fraction \> 10% (Have nonalcoholic fatty liver disease)
* Sweetened beverage intake of at least 24 ounces/day

Eligibility criteria: Inclusion Criteria:

* BMI \> 85th %tile
* Self identified as Hispanic
* Age 11-18 years
* Baseline hepatic fat fraction \>8%
* Self reported sugar beverage intake of at least 24 oz (equivalent to 3 sugar sweetened drinks per day).

Exclusion Criteria:

* Currently attempting weight gain or weight loss
* Cirrhosis visible on baseline MRI
* Renal insufficiency found on screening labs (creatinine \> 2)
* Recent acute illness within past 4 weeks (defined by fever \> 100.4ºF)
* Pregnancy
* Chronic illness requiring medication including diabetes
* Fasting glucose \>120 on screening labs

Primary outcomes:
measure: Hepatic Fat
timeFrame: 2 & 4 Weeks
Secondary outcomes:
measure: Plasma Triglycerides
timeFrame: 2 & 4 Weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
Study officials:
affiliation: Emory University
name: Miriam Vos, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holzberg JR, Jin R, Le NA, Ziegler TR, Brunt EM, McClain CJ, Konomi JV, Arteel GE, Vos MB. Plasminogen Activator Inhibitor-1 Predicts Quantity of Hepatic Steatosis Independent of Insulin Resistance and Body Weight. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):819-23. doi: 10.1097/MPG.0000000000001096.
Clinical trial NCT01359683: Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias
Official title: Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiac Arrhythmia
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate non-linear heart rate variability indexes as predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery, including coronary artery bypass graft (CABG) and valvular surgery.


Eligibility criteria: Inclusion Criteria:

* All patients who will have cardiac surgery
* The patient must be mentally able and willing to participate in the study
* Male or female patients over the age of 18

Exclusion Criteria:

* Patients with major renal, hepatic, respiratory, or cerebral dysfunction
* Patients with atrial fibrillation or other forms of sinus node dysfunction
* Patients requiring continuous artificial pacing
* Patients with significant congenital heart disease with or without arrhythmias
* Patients on Intra-Aortic Balloon Pump
* Patients experiencing cardiac emergencies or undergoing cardiac salvage operations

Primary outcomes:
measure: Investigate non-linear heart rate variability (HRV) indexes as predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery, including coronary artery bypass graft (CABG) and valvular surgery.
timeFrame: Sept 07 - Sept 08
Secondary outcomes:
measure: Registration of HRV changes during cardiac surgery, and comparison HRV pre-operatively, post anesthesia induction, on emergence from anesthesia and postoperatively.
timeFrame: Sept 07 - Sept 08
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
Study officials:
References: