louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00946426: Insulin Resistance in Type I Diabetes in Pediatric Care
Official title: Insulin Resistance in Type I Diabetes in Pediatric Care
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type 1 Diabetes
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endocrinology clinic patients

Brief summary: 24 children (12 African-American, Hispanic, or American Indian, 12 Caucasian) previously diagnosed with type 1 diabetes mellitus will participate in this pilot study to evaluate the presence of hepatic and peripheral insulin resistance. The investigators will use this pilot information to test the hypothesis that insulin resistance occurs in some children with type 1 DM, is secondary to underlying risk factors, and is responsible for increased insulin needs. Methods will include a "step-up" hyperinsulinemic euglycemic clamp and infusion of the stable isotope 6,6-\[2H2\]-glucose. Patient and parent interviews will be conducted to gather information about nutritional intake, ethnicity, family history, and socioeconomic status. The investigators will also measure inflammatory cytokines and free fatty acids to determine whether they are associated with differences in insulin resistance among type 1 diabetes mellitus patients.


Eligibility criteria: Inclusion Criteria:

* Previously diagnosed with type 1 diabetes
* ages 9 -11 tanner 1 or 16-23 tanner 4-5

Exclusion Criteria:

* None

Primary outcomes:
measure: Insulin sensitivity
timeFrame: Baseline
Secondary outcomes:
measure: Hepatic glucose output
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: The Research Institute at Nationwide Children's Hospital, The Ohio State University
name: Dana S Hardin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01674426: Pathogenesis of Functional Hypothalamic Amenorrhea
Official title: Pathogenesis of Functional Hypothalamic Amenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Endocrine Ovary
Hypersecretion; Cortisol
Metabolic Disturbance
Stress, Psychological
Keywords: functional hypothalamic amenorrhea
stress induced anovulation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2012-08-28
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized pilot study of the use of cognitive behavior therapy versus observation to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.

Detailed description: The study enrollment was completed in 2003. The study results are being analyzed.

Eligibility criteria: Inclusion Criteria:

* women with functional hypothalamic amenorrhea
* day awake / night asleep schedule

Exclusion Criteria:

* eating disorders, depression, excessive exercise or any other cause of amenorrhea and anovulation other than functional hypothalamic amenorrhea
* weight loss greater than 10 pounds when amenorrhea developed
* running more than 10 miles per week or exercising more than 10 hours per week

Primary outcomes:
measure: ovarian function
timeFrame: Change before and after 20 weeks of CBT or observation
Secondary outcomes:
measure: metabolism
timeFrame: Change before and after 20 weeks of CBT or observation
Other outcomes:
measure: psychological inventories
timeFrame: Change before and after 20 weeks of CBT or observation
Locations:
city: Pittsburgh
country: United States
facility: UPittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sarah L Berga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berga SL, Marcus MD, Loucks TL, Hlastala S, Ringham R, Krohn MA. Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy. Fertil Steril. 2003 Oct;80(4):976-81. doi: 10.1016/s0015-0282(03)01124-5.
citation: Kawwass JF, Sanders KM, Loucks TL, Rohan LC, Berga SL. Increased cerebrospinal fluid levels of GABA, testosterone and estradiol in women with polycystic ovary syndrome. Hum Reprod. 2017 Jul 1;32(7):1450-1456. doi: 10.1093/humrep/dex086.
citation: Michopoulos V, Mancini F, Loucks TL, Berga SL. Neuroendocrine recovery initiated by cognitive behavioral therapy in women with functional hypothalamic amenorrhea: a randomized, controlled trial. Fertil Steril. 2013 Jun;99(7):2084-91.e1. doi: 10.1016/j.fertnstert.2013.02.036. Epub 2013 Mar 16.
Clinical trial NCT00464126: The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
Official title: The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Diseases
Keywords: crystalloid
colloid
pediatric
cardiac
resuscitation
Postoperative
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to help determine if either crystalloid solution or colloid solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac patients.

Detailed description: The study is designed to help detect if there is an advantage in giving one type of resuscitative fluid versus another in the setting of post-operative pediatric cardiac patients. The two types of fluid being compared are crystalloid solution (normal saline) and colloid solution (5% albumin). The primary outcome measurement will be how much volume of each type of fluid will be required in order to maintain hemodynamic stability as determined by mean arterial blood pressure within predetermined parameters. Other secondary outcomes will include determinations of lactate clearance, inotropic support requirements, urine output, peripheral and pulmonary edema that occurs post-operatively, and the over all costs for each fluid based on number of required boluses and number of hours on mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* Congenital heart defect with two ventricle anatomy and physiology
* Ages: 0 - 36 months of age

Exclusion Criteria:

* History of bleeding disorder
* History of renal disorder

Primary outcomes:
measure: maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
timeFrame: Throughout the post operative period
Secondary outcomes:
measure: lactate clearance
timeFrame: Throughout the post operative period
measure: inotropic requirements
timeFrame: throughout the post operative period
measure: establishment of adequate urine output
timeFrame: Throughout the post operative period
measure: post-operative occurrence of edema (peripheral and pulmonary)
timeFrame: Througout the post operative period
measure: monitoring of cost difference as determined by total number of boluses, number of ventilator hours, and length of ICU stay
timeFrame: Throughout the ICU stay
Other outcomes:
Locations:
city: Nashville
country: United States
facility: The Monroe Carell, Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center Department of Pediatrics Division of Critical Care
name: Mary B Taylor, M.D., MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02554526: Basic Study of Combination Therapy Based on APCC-induced FVllI Activation in Hemophilia A Patients With Inhibitors
Official title: Basic Study on Novel Therapeutic Strategy With Bypassing Agent Therapy in Hemophilia A Patients With Inhibitors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemophilia A With Inhibitor
Keywords: hemophilia A
inhibitor
bypassing therapy
factor VIII
Lead sponsor: Nara Medical University
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2015-09-18
Enrollment: 10
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We guess that there are approximately 200-300 hemophilia A patients with inhibitors in our country. We have approximately 20 out-patients in our hospital. Based on this information, we set up the patients subjects (n=10).

Brief summary: Using whole blood samples and plasma samples obtained from some hemophilia A patients with inhibitors, the investigators will perform the coagulation assessment in the co-presence of aPCC and factor VIII by comprehensive coagulation assays and flow chamber analysis under blood flow conditions.

Detailed description: Comprehensive coagulation assays using recently popular rotational thromboelastometry (ROTEM), factor Xa/thrombin/plasmin generation test, and coagulation wave analysis and recently developed flow chamber system under blood flow conditions (T-TAS®) will be used. A bypassing agent, aPCC (Feiba®) and recombinant factor VIII (Advate®) will be added ex vivo to whole blood and plasma samples from patients with hemophilia A with inhibitors to compare with the coagulation effects of aPCC in the presence of factor VIII and those of aPCC in its absence under the conditions close to the physiological condition. Furthermore, the difference in the coagulation effects by the difference in inhibitor epitopes will be examined.

Eligibility criteria: Inclusion Criteria:

* Patients with hemophilia A with inhibitors (Inhibitor titer; \>0.5 Bethesda U/ml)
* Patients with agreement consents with the patients signatures

Exclusion Criteria:

* Patients that do not fill the conditions described above

Primary outcomes:
measure: Evaluation of coagulation effects using patients' plasmas by FXa/thrombin/plasmin generation tests and clot waveform analysis
timeFrame: up to 10 months
measure: Evaluation of coagulation effects using patients' whole bloods by ROTEM and T-TAS
timeFrame: up to 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kashihara
country: Japan
facility: Department of Pediatrics
state: Nara
Study officials:
affiliation: Nara Medical University
name: Midori Shima, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04921826: Potential Causes of Retained Items During Surgery
Official title: Potential Causes of Retained Items During Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Foreign Bodies
Surgical Sponge, Retained
Lead sponsor: Imam Mohammad ibn Saud Islamic University
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: an online survey will be send through cluster administration to operating room staff ,to answer voluntarily without compensation. informed consent was obtained. This study was exempt from review board approval at authors' institutions.

Brief summary: to understand and analyze the potential causes of retained items (sponge and instruments) during surgery, which include room preparations, initial count, adding sponges, removing sponges, first closing count, final closing count.


Eligibility criteria: Inclusion Criteria:

• operating room staff of hail hospital cluster

Exclusion Criteria:

• none

Primary outcomes:
measure: study potential causes of retained item during surgery
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: Hail Health Cluster
state: Other
Study officials:
affiliation: imam mohamamd ibn saud islamic university
name: mohammad alharbi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03363126: Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma
Official title: Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Tumor
Optic Chiasm Disorder
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-12-06
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in the Rothschild Foundation (Paris) between 2009 and 2013 by transsphenoidal endonasal surgery for pituitary tumor causing optic chiasm compression and visual disorders

Brief summary: Endoscopic endonasal transsphenoidal surgery is a procedure for the treatment of pituitary macroadenomas that cause visual impairment through optic chiasm compression. The aim of this retrospective study is to describe visual outcome after this procedure.


Eligibility criteria: Inclusion Criteria:

* Pituitary tumor causing optic chiasm compression (documented on MRI or CT-scan)
* Visual impairment caused by chiasm compression
* Treatment by transsphenoidal endonasal surgery
* Treatment in the Rothschild Foundation (Paris) between 2009 and 2013

Exclusion Criteria:

* Ophtalmologic condition other than optic chiasm compression

Primary outcomes:
measure: Post-operative gain in visual acuity
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06594757: Plaque Removal by Triple-Headed Manual Toothbrush
Official title: Evaluation of Plaque Removal by Triple-Headed Manual Toothbrush: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque, Dental
Keywords: oral hygiene
Rustogi Modifiye Navy Plaque Index
Modified Bass Technique
toothbrush
dental plaque
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial aimed to determine the effectiveness of a plaque removal by triple-headed manual toothbrush by comparing changes in Rustogi Modifiye Navy Plaque Index.

Participants will be divided into two groups and will be made to brush with different designed toothbrushes.

The researchers will compare the plaque removal efficiency of the brushes by comparing the changes in the plaque index of the intervention and control groups before and after brushing.


Eligibility criteria: Inclusion Criteria:

* age ranging from 18-60 years;
* a minimum of 12 teeth;
* participants were wanted to be right-handers when toothbrushing to standardization.

Exclusion Criteria:

* Patients with systemic illnesses or conditions,
* smokers and individuals taking any medication that may affect periodontal health were not included in the study.
* Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.

Primary outcomes:
measure: Rustogi Modifiye Navy Plaque Index
timeFrame: 1 minute before brushing
measure: Rustogi Modifiye Navy Plaque Index
timeFrame: 1 minute after brushing
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
Study officials:
affiliation: Ataturk University
name: Didem Özkal Eminoğlu
role: STUDY_DIRECTOR
References:
Clinical trial NCT01705457: Impact of Vitamin A on RAR Gene Expression in Multiple Sclerosis
Official title: Impact of Vitamin A Supplementation on RAR Gene Expression in PBMC Cells in Multiple Sclerotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: multiple sclerosis
Vitamin A
retinoic acid receptor
retinoic x receptor
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the comparison between the effects of supplementation with 25000 IU preformed vitamin A (retinyl palmitate)on retinoic acid receptor and retinoic x receptor expression.

Detailed description: Multiple Sclerosis (MS) is a chronic inflammatory disease where Th1 like responses from myelin-specific CD4+ T cells, as secretion of pro-inflammatory IFNγ, are believed to play a major role in the pathogenesis. The myelin-specific T cells that mediate tissue destruction in MS are believed to become activated outside the central nervous system (CNS) in lymphoid tissue and when they cross the blood brain barrier they will re-encounter their antigen. Immune deviation is the redirection of the immune response from most often Th1 like responses to Th2 like responses, even though the opposite can also occur. Vitamin A or Vitamin A-like analogs known as retinoids, are potent hormonal modifiers of type 1 or type 2 responses but a definitive description of their mechanism(s) of action is lacking. High level dietary vitamin A enhances Th2 cytokine production and IgA responses, and is likely to decrease Th1 cytokine production. Retinoic acid(RA) inhibits IL12 production in activated macrophages, and RA pretreatment of macrophages reduces IFNγ production and increases IL4 production in antigen primed CD4 T cells. Supplemental treatment with vitamin A or RA decreases IFNγ and increases IL5, IL10, and IL4 production by increase of retinoic acid receptor and retinoic x receptor .

Record Verification Date: August 2011

Eligibility criteria: Inclusion Criteria:

* Patients who have used interferon beta in last 3 months.
* Patients with 0-5 EDSS

Exclusion Criteria:

* Patients who have diseases which affect on Th1/Th2 balance such as asthma, active viral infections, and autoimmune diseases, OR
* Patients who have allergy to vitamin A compounds, OR
* Patients who have used vitamin supplements in last 3 months.

Primary outcomes:
measure: Gene expression of RAR(Relative quantification)
timeFrame: Change from baseline at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences,
Study officials:
affiliation: Tehran University of Medical Sciences
name: Ali Akbar saboor Yaraghi, PhD
role: STUDY_CHAIR
affiliation: Tehran University of Medical Siences
name: Sama Bitarafan, MD, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05858957: Magnesium Sulphate and Extubation Quality
Official title: The Effect of Magnesium Sulfate on Extubation Quality Score and Recovery in Larynx Laser Microsurgery, Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perioperative Complication
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators aimed to search effect of magnesium Sulfate on extubation quality scores, recovery and pain in larynx micro surgery. The patients allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Anesthesia induction performed with propofol 2 mg/kg, rocuronium 0.6 mg/kg, remifentanil 0.5 µg/kg and general anesthesia maintained with total intravenous anesthesia (propofol 3-7 mg/kg, remifentanil 0.05-0.1 µg/kg/min and O2/air 30/70 mixture) to the all patients. Extubation quality scores, Extubation time, NRS scores were assessed.

Detailed description: The investigators aimed to search effect of magnesium sulfate on extubation quality, recovery feature and complications.98 adult patients scheduled for larynx laser microsurgery were included and randomly allocated to two groups to receive magnesium sulfate 30 mg/kg in 100 ml saline infusion (maximum 2g) (Group m) or saline 100 ml (Group S) before induction of anesthesia. Anesthesia induction performed with propofol 2 mg/kg, rocuronium 0.6 mg/kg, remifentanil 0.5 µg/kg and general anesthesia maintained with total intravenous anesthesia (propofol 3-7 mg/kg, remifentanil 0.05-0.1 µg/kg/min and O2/air 30/70 mixture) to the all patients. Paracetamol 15 mg/kg applied to all patients.Extubation quality score, extubation time, stay in postanesthesia unit (PACU) time, numeric rating scale (NRS) and complications were recorded.

Eligibility criteria: Inclusion Criteria:

* 18 age over
* American society of Anesthesiology (ASA) clinical status I-III
* the patients who experience larynx micro surgery

Exclusion Criteria:

* under 18 years old
* ASA IV and over
* severe airway obstruction
* neuromuscular disease
* presence of tracheostomy

Primary outcomes:
measure: extubation quality scores
timeFrame: at the time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).
Secondary outcomes:
measure: extubation time
timeFrame: time between stop the total intravenous anesthesia and extubation of patient (last 20 min of anesthesia).
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: çukurova university faculty of medicine
name: ebru biricik
role: PRINCIPAL_INVESTIGATOR
References: