louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02913794: Fimasartan and Rosuvastatin for Hypertension and Dyslipidemia Control
Official title: A Single-center Cross-sectional Study to Evaluate the Effectiveness of Antihypertensive Treatment Including Fimasartan and the Dyslipidemia Treatment Including Rosuvastatin and to Assess the Association Between the Two Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Hyperlipidemias
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 541
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 1,056 patients

Brief summary: Fimasartan and Rosuvastatin for hypertension and dyslipidemia control


Eligibility criteria: Inclusion Criteria:

* Hypertension patients who are taking an anti-hypertensive agent, including Fimasartan at least 12 weeks or more.
* Dyslipidemia patients who are taking dyslipidemia drug, including Rosuvastatin at least 12 weeks or more
* Patients who has blood pressure and lipid levels (Total cholesterol, LDL-C, HDL-C, non-HDL-C, \* TG) checks 2 weeks before registration

Exclusion Criteria:

* Patients being hospitalized
* Patients who stop taking Fimasartan or Rosuvastatin within 12 weeks 14 or more consecutive days
* Patients who have more than 400mg/dl triglyceride(TG) at the registration time

Primary outcomes:
measure: Co-relation between blood pressure and dyslipidemia
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Boryung Pharmaceutical Co., Ltd
name: Hyung-Jin Jung
role: STUDY_DIRECTOR
References:
Clinical trial NCT01449994: Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction in Juvenile Athletes
Official title: Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction.A Randomized Placebo-controlled Clinical Study on Juvenile Athletes With Leg Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain in Leg, Unspecified
Knee Sprain
Keywords: knee
hip
ankle
foot
pain
lower limb
activator
instrumental
chiropractic
Painful functional conditions of the lower extremity
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 26
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to prove efficacy of instrumental chiropractic treatment for leg pain in juvenile athletes.

A randomized placebo controlled clinical trial including juvenile athletes with functional impairment and pain in thigh, leg or foot is performed.

Hypothesis: Instrumental chiropractic treatment with the "activator instrument "following the "activator methods" diagnostic evaluation should lead to significant improvement of complaints and functional impairment compared to the control group treated by a deactivated instrument following a sham evaluation protocol.

Detailed description: Pain and functional impairment may force young athletes to interrupt training plans and/or even stay away from competition. Usually elite athletes run through an abundance of tests and diagnostic features-too often these high cost diagnostics don´t provide useful information for treatment. Treating the symptoms in the first place (after ruling out severe pathology) will reduce the need for extensive diagnostic routines and bring athletes back to competition earlier.

In our outpatient department of young elite sportsmen chiropractic instrumental treatment is performed routinely- mostly a pain reduction of 3-4 levels in VAS is achieved within the first session of treatment.

The following study is thought to prove the efficacy of the Chiropractic Instrumental Treatment performed at our sports-medicine outpatient department.

Eligibility criteria: Inclusion Criteria:

* functional problems in the lower extremities

Exclusion Criteria:

* severe pathology that requires different treatment

Primary outcomes:
measure: Reduction of Pain
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: MedUni Graz Pediatric Surgery and Ped. Orthopedics
state: Styria
Study officials:
affiliation: Meical University Graz Department of pediatric orthopedics
name: Frank J Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406094: Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
Official title: The Evaluation of Singulair for the Treatment of Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rhinitis
Keywords: NARES
eosinophils
nasal symptoms
Lead sponsor: Bernstein, Jonathan A., M.D.
Sponsor class: INDIV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-12-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine if patients with NARES treated with montelukast (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.

Detailed description: Patients will receive either montelukast or placebo in the treatment of NARES. 4 visits will be conducted over 12 weeks. A history and physical will be performed at the beginning of the trial and at the end. Skin testing will be done at Visit 1. Nasal smears and lavages will be performed at every visit. Patients will be compensated for time and travel.

Eligibility criteria: Inclusion Criteria:

* Aged 18 - 65 years
* Diagnosed with NARES

Exclusion Criteria:

* Smokers, exposed to passive smoke
* Diagnosis of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), or vasomotor rhinitis (VMR)

Primary outcomes:
measure: Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES
timeFrame: December 2008
measure: Determine whether montelukast is more effective than placebo at reducing nasal symptom scores
timeFrame: December 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Bernstein Allergy Group
state: Ohio
Study officials:
affiliation: Bernstein Allergy Group
name: Jonathan A Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00850694: Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity
Official title: Assessment of Prevalence of Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Obesity
Insulin Resistance
Keywords: Vitamin D deficiency
Obesity
Insulin resistance
Glucose tolerance
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 114
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese female adolescents

Brief summary: Sub-clinical vitamin D deficiency is a commonly unrecognized disorder in obese adolescents. The investigators hypothesize vitamin D deficiency will be highly prevalent in obese adolescents and those who are vitamin D deficient will be more insulin resistant.

Detailed description: This is a cross-sectional study of obese female adolescents matched for age, sex and pubertal staging. Serum 25-OH vitamin D, intact PTH , lipid profile, serum CRP measurements and oral glucose tolerance tests (with glucose and insulin level measurements) will be done to assess the prevalence of vitamin D deficiency and to assess the insulin sensitivity- resistance indices.

Eligibility criteria: Inclusion Criteria:

* Female adolescents
* Obese: BMI \> 95th percentile
* Menarchal
* Tanner stage ≥ 4

Exclusion Criteria:

* Children with diabetes, other endocrine or acute or chronic medical illnesses, children on oral contraceptive pills, diuretics and anticonvulsant medications

Primary outcomes:
measure: To determine the prevalence of subclinical vitamin D deficiency in obese female adolescents.
timeFrame: At study entry
Secondary outcomes:
measure: To assess the relationship of serum 25 (OH) D statuses to insulin and glucose concentrations during an OGTT and to serum transaminases and CRP.
timeFrame: At study entry
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital, Universiy of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ambika Ashraf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02014194: Attentional Bias Modification Treatment in OCD
Official title: Attentional Bias and Attentional Bias Modification Treatment in Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-compulsive Disorder
Keywords: Attentional Bias
Attentional Bias modification treatment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obsessive-compulsive disorder is a chronic condition. Even with proper treatment, no significant improvement is reached in about 30% to 40% of patients. Thus, the development of new treatment strategies is necessary. The attentional bias - ability to aversive stimuli in capturing the attention of an individual compared to a neutral stimulus - has been extensively studied. Already training attentional bias modification has been shown effective in reducing anxiety present in other anxiety disorders.This project aims to: 1 - generate knowledge on attentional bias in individuals with OCD through the use of a standardized protocol developed for OCD; 2 - available to the scientific community the first specific paradigm for the study of attentional bias in OCD patients, 3 - test the effectiveness of a training protocol for reversing attentional bias in individuals with OCD.


Eligibility criteria: Inclusion Criteria: - 30 patients with obsessive-compulsive diagnosis according to DSM-V (with cleaning and or symmetry dimensions)

* 30 health controls

Exclusion Criteria: - doing any kind of behavioral therapy in the moment

Primary outcomes:
measure: Percentage of reduction of attentional bias
timeFrame: Patients will be followed an expected average of 7 weeks (baseline, 2 sessions per week - totalizing 5 weeks, 10 sessions and a session after end of treatment). Measures of attentional bias will be assessed in baseline, session 5 and after session 10.
Secondary outcomes:
measure: Reduction of anxiety symptoms
timeFrame: Baseline, session 5 and end of treatment (after session 10) (expected average of 7 weeks)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo Medical School
Study officials:
References:
Clinical trial NCT02844894: Hemodynamic Response to Intubation
Official title: The Effects of Preintubation Esmolol and and Dexmedotimidine on Ischmeia Modified Albumin Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intubation
Keywords: intubation, ischemia modified albumine, dexmedetomidine, esmolol
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the effects of dexmedetomidine and esmolol given intravenously before intubation on sympathetic response caused by intubation itself. Half the patients will recevice dexmedetomidine and the other half will receive dexmedetomidine. Ischemia modified albumine levels will be measured


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective surgery under general anesthesia

Exclusion Criteria:

* Patient refusal
* Morbid obesity (BMI\>30)
* Advanced systemic disease
* Hypoalbumiemia
* beta-blocker usage
* Anticipated difficult ventilation and/or intubation

Primary outcomes:
measure: ischemia modified albumine
timeFrame: 10 minutes after endotracheal intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University Hospital
Study officials:
References:
citation: Yallapragada SV, Vidadala KS, Vemuri NN, Shaik MS. Comparison of the efficacy of dexmedetomidine with that of esmolol in attenuating laryngoscopic and intubation response after rapid sequence induction. Anesth Essays Res. 2014 Sep-Dec;8(3):383-7. doi: 10.4103/0259-1162.143154.
Clinical trial NCT01734694: Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
Official title: Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Health Care Associated Pneumonia
Osteomyelitis/Septic Arthritis
Endocarditis
Bacteremia
Acute Bacterial Skin and Skin Structure Infections
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Receiving intravenous vancomycin for the treatment of healthcare associated pneumonia, osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and skin structure infections
* Expected to receive vancomycin for at least 72 hours and are within the first 72 hours of therapy
* Have at least two or more of the following risk factors for drug-induced nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e. aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous contrast dye) d) pre-existing renal dysfunction (i.e. SCr greater than or equal to 1.5 mg/dL).

Exclusion Criteria:

* Pregnancy
* End-stage renal disease
* Receipt of more than 4 grams of vancomycin prior to enrollment on current admission
* Absolute neutrophil count \< 1000/mm3

Primary outcomes:
measure: Proportion of Individuals With Nephrotoxicity
timeFrame: Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.
Secondary outcomes:
measure: Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity
timeFrame: Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.
measure: Proportion of Individuals With Clinical Success
timeFrame: Daily assessment of signs and symptoms of infection, and a median of 7 days.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Jose Vazquez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04693494: Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones
Official title: Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Term
Healthy
Motor Delay
Development, Infant
Keywords: motor milestones
term
newborn
motor development
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and control group.
Primary purpose: PREVENTION

Brief summary: this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. The purpose of this study is to know if motor development can be improved by the environment.

Detailed description: Infants in both groups are recruited by the principal investigator at the hospital within two to three days after birth. An initial assessment was carried out at 2 months of age.

Intervention group:

1. Four training sessions (before the baby is 1 month old, at 3 months, at 6, and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given bits of advice.
2. Three evaluations of motor milestones at 9, 12, and 15 months old.

Control group:

1. Three evaluations of motor milestones at 9, 12, and 15 months old.

Eligibility criteria: Inclusion Criteria:

* Healthy-term infants
* Male and female
* Apgar score of at least 7 in the first minute and at five minutes.
* Natural or cesarean birth
* Absence of congenital malformations or orthopedic injury
* Absence of known congenital or genetic pathology
* Normal neurological medical examination of the newborn at hospital discharge.

Exclusion Criteria:

* Newborns who have required hospitalization before being enrolled.
* Multiple births

Primary outcomes:
measure: Score of the Alberta Infant Motor Scale (AIMS) at month 9
timeFrame: 9 months old
measure: Score of the Alberta Infant Motor Scale (AIMS) at month 12
timeFrame: 12 months old
measure: Score of the Alberta Infant Motor Scale (AIMS) at month 15
timeFrame: 15 months old
Secondary outcomes:
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad San Jorge
state: Aragón
Study officials:
affiliation: Universidad San Jorge
name: Luis Fernández Sola, Physical Th
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad San Pablo CEU
name: Beatriz Cano Díez, Physical Th
role: STUDY_DIRECTOR
References:
Clinical trial NCT06880094: Study of Congenital Orofacial Clefts by Implementing Optical Genome Mapping
Official title: Study of Congenital Orofacial Clefts by Implementing Optical Genome Mapping
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Orofacial Clefts
Next Generation Sequencing (NGS)
Optical Genome Mapping
Keywords: orofacial clefts
Next Generation Sequencing
Optical Genome Mapping
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Orofacial clefts, the most common congenital craniofacial malformations, have a complex etiology involving an interaction between genetic and environmental factors.

Chromosomal abnormalities, including structural variations, represent a major cause of human pathology. Recently, technological developments and the introduction of next-generation sequencing (NGS) technologies have revolutionized the field of medical genetics.

Optical genome mapping (OGM) is an innovative, high-resolution "long read" technique that enables the identification of all classes of chromosomal variation, consisting in the direct visualization of long, labeled DNA molecules throughout the genome. This technology is gradually becoming an essential tool for studying onco-hematology and constitutional genetic pathologies The purpose of this study is to search for structural chromosomal variants (SV) or copy number variants (CNV) not identifiable either by cytogenetic methods nor by "short read" NGS "short read, in individuals with oral-facial clefts with no genetic diagnosis.


Eligibility criteria: Inclusion Criteria:

* Individuals with syndromic, complex or familial oral-facial clefts
* With no established genetic diagnosis
* Followed up at the Amiens-Picardie University Hospital

Exclusion Criteria:

* genetic diagnosis of oral-facial cleft
* No health insurance affiliation
* Patient under guardianship or curatorship, under safeguard of justice or deprived under public law
* Pregnant, parturient or breast-feeding woman

Primary outcomes:
measure: Identification of a structural chromosomal variant
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References: