louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00626652: Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study of the Effects of K201 Injection, 2 mg/mL on the Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: Sequel Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 153
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: To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.


Eligibility criteria: Inclusion Criteria:

* Symptomatic atrial fibrillation
* Atrial fibrillation documented by ECG
* Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.

Exclusion Criteria:

* Systolic blood pressure \<100 mmHg
* Heart rate \<50 bpm
* Temperature \>38°C
* QT or QTcB \>440 ms
* QRS \>140 ms
* Paced atrial or ventricular rhythm on ECG
* Serum potassium \<3.5 meq/L
* History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
* History of amiodarone in last 6 months.
* Clinical evidence of acute coronary syndrome
* Acute pulmonary edema or embolism
* Hyperthyroidism
* Acute pericarditis
* History of failed electrical cardioversion at any time
* History of torsades des pointes
* History of familial long QT interval syndrome
* History of ventricular tachycardia requiring drug or device therapy
* History of NYHA Heart Failure Class 3 or 4.

Primary outcomes:
measure: Restoration of sinus rhythm
timeFrame: 24hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Nazareth
country: Israel
city: Safed
country: Israel
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
Study officials:
affiliation: Russian Cardiologic Scientific and Manufacturing Complex of Roszdrav, Institute of Cardiology n.a. A.L.Myasnikov, Department of clinical electrophysiology
name: Sergey Pavlovich Golitsyn, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Barzilai Medical Center
name: Amos Katz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06315452: FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g
Official title: FREQUENCY OF VITAMIN D DEFICIENCY IN PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vitamin D Deficiency
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PREMATURE NEWBORN BORN BEFORE 32 WEEKS AND/OR WITH A BIRTH WEIGHT UNDER 1500g

Brief summary: Vitamin D plays an important role in phosphocalcic metabolism and bone homeostasis in newborns. Premature newborns are at risk of vitamin D deficiency and may require supplementation. In this context, the French Society of Pediatrics (Société Française de Pédiatrie) recommends systematic vitamin D testing at 1 month.

The aim of this study was to determine the frequency of vitamin D deficiency in premature newborns.


Eligibility criteria: Inclusion Criteria:

* Premature newborns born at a gestational age less than 32 weeks and/or birth weight less than 1500g
* Having received at least one dosage of 25 OH vitamin D.-

Exclusion Criteria:

* - Newborn whose parents or legal guardian refuse the use of their data for this research

Primary outcomes:
measure: Vitamine D deficiency frequency
timeFrame: 6 months
Secondary outcomes:
measure: vitamine D deficiency and maternal or feotal caracteristics
timeFrame: 6months
measure: vitamine D deficiency and premature newborn comorbidities
timeFrame: 6 months
measure: effect of supplementation
timeFrame: 6months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint Joseph
Study officials:
References:
Clinical trial NCT02710552: Low-dose Combination of Three Antihypertensive Drugs
Official title: Randomized Comparison of Fixed Low-dose Combination of THREE Antihypertensive Drugs Versus Fixed High-dose Combination of Two Antihypertensive Drugs in Arterial Hypertension (the 3D Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arterial Hypertension
Keywords: arterial hypertension
antihypertensive drugs
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the efficacy and safety of low-dose combination of three antihypertensive drugs versus fixed high-dose combination of two antihypertensive drugs in arterial hypertension

Detailed description: The aim of the study is to compare the efficacy and safety of commercially available low-dose combination of three antihypertensive drugs versus commercially available fixed high-dose combination of two antihypertensive drugs in arterial hypertension

Eligibility criteria: Inclusion Criteria:

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria:

None

Primary outcomes:
measure: Number of patients who reach target blood pressure
timeFrame: From baseline to the end of the 3-month study period
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University
Study officials:
affiliation: Sapienza University
name: Carlo Gaudio, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01784952: Consumption of Whole Grains and Legumes Modulates the Genetic Effect of the APOA5 -1131C Variant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects With Mild Hypertriglyceridemia in Type 2 DM
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We examined whether a substitution of whole grains and legumes for refined rice in a high carbohydrate diet (about 65% of energy derived from carbohydrate) may modify the effect of this variant on changes in apolipoprotein A-V (apoA-V) and triglyceride concentrations.

Detailed description: We genotyped the APOA5 -1131T\>C in individuals with impaired fasting glucose (IFG) or newly diagnosed type 2 diabetes, who were randomly assigned to either a group ingesting whole grain and legume meals daily or a control group for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose \<126 mg/dL) and newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL) were referred to the Department of Family Medicine or Internal Medicine. They were rechecked for their health and lipid profiles, and then those who satisfied the study criteria were recommended to participate in the dietary intervention program

Exclusion Criteria:

* Current and/or past history of cardiovascular disease including angina
* Liver or kidney dysfunction
* Thyroid or pituitary disease
* Unstable weight loss/gain (≥2 kg) over the previous 6months
* Pregnancy or lactation. Subjects who were taking medication were also excluded

Primary outcomes:
measure: Triglyceride
timeFrame: change from baseline in TG at 12 weeks
Secondary outcomes:
measure: Apolipoprotein A5
timeFrame: Change from baseline in ApoA5 at 12 weeks
Other outcomes:
measure: Apolipoprotein A5 gene
timeFrame: ApoA5 -1131T>C polymorphism
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang R, Kim M, Chae JS, Lee SH, Lee JH. Consumption of whole grains and legumes modulates the genetic effect of the APOA5 -1131C variant on changes in triglyceride and apolipoprotein A-V concentrations in patients with impaired fasting glucose or newly diagnosed type 2 diabetes. Trials. 2014 Apr 1;15:100. doi: 10.1186/1745-6215-15-100.
Clinical trial NCT06100952: Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age with Keratoconus
Official title: A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age with Keratoconus (APRICITY-B)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Keratoconus
Lead sponsor: Epion Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 400
Sex: ALL
Minimum age (years): 8
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus


Eligibility criteria: Inclusion Criteria:

* Diagnosis of keratoconus

Exclusion Criteria:

* Minimal corneal thickness \< 350 microns
* Non-keratoconic ectatic disease
* Contraindications or hypersensitivities to any required study medications
* Pregnancy or breastfeeding
* Certain concomitant ocular conditions

Primary outcomes:
measure: Best Spectacle-Corrected Distance Visual Acuity (BSCDVA)
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Vision-related Quality of Life as Assessed by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25)
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Tucson
country: United States
facility: Catalina Eye Center
state: Arizona
city: Murrieta
country: United States
facility: Inland Eye Specialists
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Highland Park
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: North Dartmouth
country: United States
facility: Claris Vision LLC Eye Health Vision Centers - Dartmouth
state: Massachusetts
city: Omaha
country: United States
facility: Truhlsen Eye Institute
state: Nebraska
city: Charlotte
country: United States
facility: Providence Eye and Laser Specialists
state: North Carolina
city: Memphis
country: United States
facility: VRF Eye Specialty Group
state: Tennessee
city: Austin
country: United States
facility: Dell Laser Consultants
state: Texas
city: Draper
country: United States
facility: Hoopes Vision
state: Utah
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Epion Therapeutics
name: Michael Belin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05115552: Comparison Between Urocortin 2 and Brain Type Natriuretic Peptide
Official title: Comparison Between Urocortin 2 and Brain Type Natriuretic Peptide as a Biomarker in Patients With Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urocortin 2
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: both gender above 18 years old with acute decompensated heart failure without ACS or stroke in the past 3 months or severe valvular disease or severe CKD .

Brief summary: 1. Evaluation of the role of serum urocortin 2 levels in acute decompensated HF patients and their association with clinical and echocardiographic findings.
2. Assessment of the clinical utility of urocortin 2 in monitoring AHF patients.
3. Comparison between urocortin 2 and BNP as a biomarker in AHF patients

Detailed description: Heart failure (HF) is a clinical syndrome with symptoms and/or signs caused by a structural and/ or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion. (1) .The pathophysiology of HF is a complex interplay of genetic and multiple molecular mechanisms (from inﬂammation to hormonal pathways) performing in the composite network of the cardiovascular system environment. (2).

Monitoring of biomarkers in HF can be used to make an initial diagnosis, to aid in prognostic stratification, and to identify a patient's response to therapeutic intervention. (3).

Natriuretic peptide (NP) concentrations are quantitative plasma biomarkers for the presence and severity of haemo-dynamic cardiac stress and heart failure. (4). That facilitate renal filtration and sodium excretion whilst suppressing the vasoconstrictor sodium, retaining Renin angiotensin aldosterone system and exerting a tonic anti-trophic effect. (5). But the natriuretic peptide levels are significantly affected by weight, the NT- proBNP in obese subjects is much lower than normal weight subjects. (6). Other factors that affect BNP levels including gender, age and renal disease

Eligibility criteria: Inclusion Criteria:

* Adult patients with acute decompensated heart failure.

Exclusion Criteria:

* Acute coronary syndrome or stroke in the past 3 months.
* Severe chronic kidney disease.
* Severe valve disease.

Primary outcomes:
measure: Evaluation of the role of serum urocortin 2 levels
timeFrame: baseline
measure: Assessment of the clinical utility of urocortin 2 in monitoring AHF patients
timeFrame: baseline
Secondary outcomes:
measure: Comparison between urocortin 2 and BNP
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01380652: Vibration Training in Chronic Obstructive Pulmonary Disease (COPD)-Patients During a Three-week Rehabilitation
Official title: Effects of Whole Body Vibration Training on Physical Activity in Chronic Obstructive Pulmonary Disease (COPD) III/IV-Patients During a Three-week Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD III/IV
Activity Monitoring
SenseWear
Vibration training
Galileo
Pulmonary rehabilitation
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 72
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 aim of this study is to investigate the change of physical activity in COPD-patients performing a whole body vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a standard rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Chronic obstructive pulmonary disease III/IV

Exclusion Criteria:

* Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
* Severe disease other than COPD, that could influence the results of the study
* Abuse of alcohol or drugs
* Simultaneously participation in another study
* Tachypnea (\>30/min)
* Severe exacerbation during rehabilitation
* Cardiac insufficiency (NYHA IV)
* Myocardial infarction during the last 6 weeks
* Mental-health problem
* Pregnancy
* Known HIV-infection
* Slipped disk
* Acute discopathy
* Acute thrombosis
* Implants in trained regions of the body (lower extremities)
* Acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis
* Acute tendinopathy in trained regions of the body
* Acute hernia
* Fresh fractures, wounds or scars in trained regions of the body
* Gallstones or stones in the urinary tract collection system

Primary outcomes:
measure: Activity
timeFrame: day 2 and 17
Secondary outcomes:
measure: Diffusion Capacity
timeFrame: day 1
measure: BODE-Score
timeFrame: day 1 and 19
measure: lung function
timeFrame: day 1
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Klinikum Berchtesgadener Land, Schön Kliniken
Study officials:
References:
Clinical trial NCT02325752: A Prospective Randomised Control Trial to Study the Effectiveness of a Health Service Innovation Using a Modified Virtual Ward Model to Prevent Unscheduled Readmission of High Risk Patients
Official title: A Prospective Randomised Control Trial to Study the Effectiveness of a Health Service Innovation Using a Modified Virtual Ward Model to Prevent Unscheduled Readmission of High Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diseases
Keywords: readmission
chronic diseases
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Integrated Care, Singapore
name: Duke-NUS Graduate Medical School
First posted: 2014-12-25
Enrollment: 840
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators conducted an open randomized control study of patients who received the transitional care program versus patients who received usual care at the Singapore General Hospital from Aug 2011 to Sept 2012.

Detailed description: The investigators conducted an open randomized control study of patients who received the transitional care program versus patients who received usual care at the Singapore General Hospital from Aug 2011 to Sept 2012.

Eligibility criteria: Inclusion Criteria:

* Patients with 2 or more unscheduled admission in the last 90 days to selected medical departments
* LACE score of ≥10.

Exclusion Criteria:

* Non-residents
* No telephone contact or a resident address
* Residing in long term care facilities.

Primary outcomes:
measure: Rate of readmission
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Singhealth Foundation
name: Kheng Hock Lee, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee KH, Low LL, Allen J, Barbier S, Ng LB, Ng MJ, Tay WY, Tan SY. Transitional care for the highest risk patients: findings of a randomised control study. Int J Integr Care. 2015 Oct 22;15:e039. doi: 10.5334/ijic.2003. eCollection 2015 Oct-Dec.
Clinical trial NCT06524752: Risk Factors for PONV in Patients Undergoing Hysteroscopic Surgery
Official title: Risk Factors for Postoperative Nausea and Vomiting in Patients Undergoing Day-case Hysteroscopic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Nursing
Postoperative Complications
Keywords: PONV
Risk factor
Nursing
Lead sponsor: Weifang Medical University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 1583
Sex: FEMALE
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: Female patients undergoing gynaecological hysteroscopic day-case surgery.

Brief summary: The purpose of this study was to construct and validate a risk prediction model for PONV in patients undergoing hysteroscopic day-case surgery.

Detailed description: This study predicted the risk of postoperative nausea and vomiting in patients undergoing day-case hysteroscopic surgery by constructing and validating a web-based dynamic nomogram.

Eligibility criteria: Inclusion Criteria:

* Female patients undergoing hysteroscopic day-case surgery and aged 18 years.

Exclusion Criteria:

* Patients with intraoperative change of surgical method and unstable postoperative vital signs.

Primary outcomes:
measure: PONV
timeFrame: Within 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
Study officials:
affiliation: Weifang People's Hospital
name: Shirong Fang, Researcher
role: STUDY_DIRECTOR
References:
Clinical trial NCT05811052: The Effect of Suboccipital Release Technique in Individuals With Anxiety
Official title: The Effect of Suboccipital Release Technique on Trapezius Muscle Activation and Pain in Individuals With Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Trapezius Muscle Strain
Pain
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 36
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: The purpose of this study is to determine the immediate effect of the suboccipital release technique on trapezius muscle pain threshold, muscle activation, and anxiety level in individuals with anxiety.Thirty-six people with anxiety symptoms were included in the study. These people were divided into two groups, 18 control group and 18 treatment group. Upper trapezius muscle pain threshold, muscle activation and anxiety levels were evaluated. The experimental group received a single session of suboccipital release technique. The control group received a single session of sham suboccipital release. The evaluations were performed before and immediately after the treatment.The suboccipital release technique can increase the trapezius muscle upper part pain threshold and concentric muscle activation immediately after the application in individuals with anxiety.


Eligibility criteria: Inclusion Criteria:

* Being over the age of 18
* Agree to participate the study

Exclusion Criteria:

* Use psychiatric, analgesic and antispasmodic drugs

Primary outcomes:
measure: The State- Trait Anxiety Inventory
timeFrame: Change from Baseline Anxiety Level at immediately after treatment
measure: Pain Assessment
timeFrame: Change from Baseline anxiety level at Immediately After treatment
measure: Surface Electromyography Measurements
timeFrame: Change from Baseline anxiety level at Immediately After treatment
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
Secondary outcomes:
measure: Cranial Rhythm
timeFrame: Change from Baseline anxiety level at Immediately After treatment
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: sezen Tezcan
state: Merkez
Study officials:
References: