louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00143468: The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients
Official title: The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients: Barotrauma and Volutrauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lung Injury
ARDS
Keywords: gas exchange
respiratory mechanics
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators aim to study the specific elastance in ALI/ARDS patients during invasive mechanical ventilation.

Detailed description: In sedated and paralyzed ALI/ARDS patients, we studied the specific elastance and also, we compared the specific elastance to healthy subjects during invasive mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* Stable ALI/ARDS patients during invasive mechanical ventilation

Exclusion Criteria:

* Hemodynamic failure, pneumothorax

Primary outcomes:
measure: Specific elastance
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale policlinico
Study officials:
affiliation: Policlinico Hospital
name: davide chiumello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiumello D, Carlesso E, Cadringher P, Caironi P, Valenza F, Polli F, Tallarini F, Cozzi P, Cressoni M, Colombo A, Marini JJ, Gattinoni L. Lung stress and strain during mechanical ventilation for acute respiratory distress syndrome. Am J Respir Crit Care Med. 2008 Aug 15;178(4):346-55. doi: 10.1164/rccm.200710-1589OC. Epub 2008 May 1.
Clinical trial NCT02363868: Healthcare Costs Among Patients With CML Receiving Dasatinib or Nilotinib in a Commercial and Medicare Population
Official title: Costs and Outcome Among Patients With Chronic Myelogenous Leukemia (CML) Receiving Dasatinib or Nilotinib as First or Second Line Therapy in a Commercial and Medicare Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Myeloid Leukemia (CML)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-02-16
Enrollment: 186
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: Others: Retrospecitve database analysis of patients in a health plan

Brief summary: The purpose of this study is to examine the healthcare costs among patients with CML receiving dasatinib or nilotinib as first line therapy in a commercially or Medicare insured population.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Age \>18 years
* International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9 CM) code for CML (205.1x)
* At least 2 prescriptions for dasatinib or nilotinib from July 1, 2008 to June 31, 2013
* Continuous eligibility for the 6 months pre- and post-index date (defined as the date of first fill for dasatinib or nilotinib)

Exclusion Criteria:

* History of bone marrow or stem cell transplant as identified in the 6 month pre-period

Primary outcomes:
measure: Healthcare costs
timeFrame: Intent-to-treat (ITT) at 6 months
Secondary outcomes:
measure: Healthcare costs by line of therapy
timeFrame: Intent-to-treat (ITT) at 6 months
measure: Resource utilization by line of therapy
timeFrame: Intent-to-treat (ITT) at 6 months
Other outcomes:
Locations:
city: Clinton
country: United States
facility: Franklin Pharmaceutical Consulting, Llc
state: South Carolina
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02007668: Is Kinesio Taping More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain?
Official title: Is Kinesio Taping More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
kinesio taping
Lead sponsor: Paulista University
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty patients will be randomized into three groups to receive the Kinesio taping, placebo Kinesio taping (medical adhesive tape) and control group. The group Kinesio taping receive the correct application of the method described. The placebo group will receive a medical adhesive tape. The control group will not receive any form of intervention.

Detailed description: The group Kinesio taping receive the correct application of the method described with tension paper off (10-15%). The placebo group will receive a medical adhesive tape. The control group will not receive any form of intervention.

Eligibility criteria: Inclusion Criteria:

* Patients with non-specific low back pain longer than 3 months
* Seeking care for low back pain

Exclusion Criteria:

* Contra indications to any bandage
* Serious sinal pathologies (e.g. tumors, fractures and inflammatory diseases)
* Nerve roto compromise
* Pregnancy

Primary outcomes:
measure: Pain Intensity
timeFrame: 2 days
Secondary outcomes:
measure: Disability
timeFrame: 2 days
Other outcomes:
Locations:
city: Jundiaí
country: Brazil
facility: Universidade Paulista - UNIP
state: São Paulo
Study officials:
affiliation: Paulista University
name: Mauricio Antonio da Luz Junior, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02801968: Tap Block and Cesarean Delivery: Efficacy and Consumption of Postoperative Drugs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Delivery
Lead sponsor: S. Anna Hospital
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 62
Sex: FEMALE
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 efficacy of Tap block after cesarean delivery as a component of multimodal analgesia and evaluation of postoperative drugs consumption.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* written consent
* anesthesiologist's assent on preoperative evaluation

Exclusion Criteria:

* age\< 18 years
* uncooperative patients
* written consent not obtained
* local anesthetic allergy
* BMI \> 35

Primary outcomes:
measure: Pain evaluation with Numerical Rating Scale (NRS)
timeFrame: Pain evaluation with NRS at 2,6,12,24 hours after cesarean delivery in TAP block group and in the control group.
Secondary outcomes:
measure: Evaluation of NSAIDs (nonsteroidal anti-inflammatory drugs) consumption as rescue dose during the first 24 hours after cesarean delivery
timeFrame: Doses of NSAIDs (nonsteroidal anti-inflammatory drugs) administered at 2, 6, 12 ,24 hours after cesarean delivery TAP block group and in the control group.
Other outcomes:
Locations:
city: Ravenna
country: Italy
facility: Osepdale Santa Maria delle Croci
Study officials:
References:
Clinical trial NCT01251068: Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion
Official title: Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion:A Near Infrared Spectroscopy Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion
Keywords: anemic preterms, cerebral oxygenation,somatic oxygenation, blood transfusion
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2010-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the relationship between changes in cerebral oxygenation and hemodynamics, and changes in some physiological variables during blood transfusion in anaemic preterm infants.


Eligibility criteria: Inclusion Criteria: \<32 gestational age and/or \<1500gr.,\>30th day preterm infants -

Exclusion Criteria:sepsis,shock,severe intracranial hemorrhage,NEC,abdominal and cranial surgery

-

Primary outcomes:
measure: Cerebral and peripheric oxygenation measurements in anemic preterm infants.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Maternity Teaching Hospital
state: Hamamönü
city: Ankara
country: Turkey
facility: Zekai Tahir Maternity Teaching Hospital
state: Hamamönü
Study officials:
References:
Clinical trial NCT05261568: The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in İndividuals With Epilepsy
Official title: The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in Individuals With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Sleep
Fatigue
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: It was conducted to determine the effect of web-based animation supported progressive relaxation exercise on fatigue and sleep quality in individuals with epilepsy. Material and Methods: As a randomized controlled study with a pretest- posttest model, it was conducted with individuals with epilepsy who applied to Giresun University Faculty of Medicine Neurology Outpatient Clinic between February and December 2022.The sample of the study was determined as 60 epilepsy patients, 30 of which were in the control-30 experimental group, using power analysis. The data were collected by face-to-face interview technique using Personal Information Form, Pittsburg Sleep Quality Index, Fatigue Severity Scale.


Eligibility criteria: Inclusion Criteria:

* be over the age of 18
* Having been diagnosed with epilepsy for at least 6 months
* Individuals with an average score of 4.1 or higher on the fatigue severity scale
* Individuals with a Pittsburg Sleep Quality Index total score above 5
* Being able to use mobile phone (IOS-Android)
* Being able to speak Turkish
* Up to 6 months before the study, techniques such as meditation, hypnosis, yoga not benefited,
* Having a neurological, systemic and psychiatric disease other than epilepsy not to be.

Exclusion Criteria:

* Not using a mobile phone,
* Up to 6 months before the study, techniques such as meditation, hypnosis, yoga to have benefited,
* Having a neurological, systemic and psychiatric disease other than epilepsy be.

Primary outcomes:
measure: fatigue severity scale
timeFrame: An average of 1 year
Secondary outcomes:
measure: pittsburg sleep quality scale
timeFrame: An average of 1 year
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Giresun Training and Research Hospital
Study officials:
affiliation: Ataturk University
name: Nuray DAYAPOĞLU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00584168: Using Dexamethasone After Uvulopalatopharyngoplasty
Official title: Decreasing Morbidity After Uvulopalatopharyngoplasty With the Use of Dexamethasone - A Randomized Double Blinded Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: UPPP
Dexamethasone
Uvulopalatopharyngoplasty
Pain Management
Increasing pain management in patients that have undergone UPPP surgery
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks at lessening the pain after a Uvulopalatopharyngoplasty (UPPP) surgery by using Dexamethasone (a corticosteroid).

Detailed description: The study was designed because patients have a lot of pain after they have a UPPP. Certain drugs called steroids may lessen the pain associated from this surgery. This study uses Dexamethasone (a corticosteroid), to see if it will help reduce pain, decrease the amount of time until the patient can begin to eat or return to normal activity, or increase their satisfaction with pain management. In this study the patients will be randomized (computer chosen) to receive either the study drug (dexamethasone), or a placebo. The patient will start the day before surgery with a single pill. They will then receive the dexamethasone or a placebo twice daily for the next four days and then once daily for the next two days for a total of seven days. Afterward, they will be asked to complete a questionnaire. The five questions ask patients to access the amount of pain they have, how much of their normal diet or activity they have returned to, and how much pain medication they have taken. At the next follow-up visit they will be asked to complete another questionaire (9 questions) about the patient's satisfaction with pain management.

Eligibility criteria: Inclusion Criteria:

* Candidates scheduled for UPPP surgery.
* Able to take steroids

Exclusion Criteria:

* Those patients who unable to take steroids

Primary outcomes:
measure: Quantifying patient treatment with a questionaire. Patient will rate their satisfaction with pain management.
timeFrame: Eleven days post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Veterans Affairs Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: John Houck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01262768: Efficacy of Portion Size Measurement Aids
Official title: Exploring the Accuracy and Acceptability of Portion Size Measurement Aids in Parents of Overweight Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Assessment
Obesity
Keywords: Nutrition
Obesity
Parent
Portion Size Estimation
Accuracy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Portion size measurement aids (PSMAs) are tools that facilitate the estimation of food servings. The objectives of this study are to determine (a) if food portion size estimation accuracy differs when using a two dimensional (2D) PSMA (actual-size photos called Portion Size Cards) compared to a 3D PSMA (Portion Size Kit) and (b) whether differences exist in the short-term usefulness of and satisfaction with these PSMAs in a sample of parents of overweight children and youth. We hypothesize that the group that receives the 3D PSMAs will be more accurate in food portion size estimation and will be more satisfied with the tool compared to the group that receives the 2D PSMAs.

Detailed description: Forty primary caregivers of overweight children and youth attending the Pediatric Centre for Weight and Health (Edmonton, AB) will be recruited. Participants will be randomly assigned to one of the two groups (2D PSMAs versus 3D PSMAs). After a brief explanation of the respective tool, participants will estimate the volumes of pre-measured rubber food portion models on a test plate. Participants will then be given the 2D or 3D PSMAs to take home with them to use in the real-world. After 2-4 weeks, participants will be telephoned by the research team to complete a brief survey to evaluate their usefulness of and satisfaction with the 2D or 3D PSMAs at home.

Eligibility criteria: Inclusion Criteria:

* Participants must be primary caregivers of children or youth attending a clinical appointment for weight management (clients must have a BMI greater or equal to the 85th percentile at this clinic)
* Participants must be literate and fluent in English

Exclusion Criteria:

* Any participant who does not meet the above criteria
* Participants must not have had any previous education or resources on food portion sizes at this clinic

Primary outcomes:
measure: Accuracy of food portion size estimation
timeFrame: At the time of subject interview (single time point)
Secondary outcomes:
measure: Acceptability (satisfaction and usefulness) of 2D and 3D PSMAs
timeFrame: 2-4 weeks following the accuracy assessment
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Pediatric Centre for Weight and Health- Edmonton General Continuing Care Centre
state: Alberta
Study officials:
affiliation: Department of Pediatrics, University of Alberta; Director, Pediatric Centre for Weight and Health
name: Geoff DC Ball, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342146: Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
Official title: Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Growth Hormone Deficiency
Keywords: pegylated Somatropin
PEG-GH
Growth hormone
PEG-rhGH
Growth hormone deficiency (GHD)
Phase 2 study
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Huazhong University of Science and Technology
name: First Affiliated Hospital, Sun Yat-Sen University
name: Capital Medical University
name: Children's Hospital of Fudan University
First posted: 2011-04-27
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.


Eligibility criteria: Inclusion Criteria:

* have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration \<7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (CA);
* be in preadolescence (Tanner stage 1) and have a CA \>3 years;
* have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV;
* receive no prior GH treatment.
* sign informed consent

Exclusion Criteria:

* patients with severe cardiopulmonary
* patients with hematological diseases
* a current or past history of malignant tumors
* immunodeficiency diseases
* mental diseases
* patients positive for hepatitis B e-antibody (HBeAb)
* hepatitis B surface antigen (HBsAg)
* hepatitis B e antigen (HBeAg)
* patients with other growth disorders, such as Turner syndrome
* constitutional delay of growth and puberty, and Laron syndrome

Primary outcomes:
measure: Growth velocity
timeFrame: 25 weeks
Secondary outcomes:
measure: height standard deviation score for chronological age (Ht SDSCA)
timeFrame: 25 weeks
measure: IGF-1
timeFrame: 25 weeks
measure: IGFBP3
timeFrame: 25 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Hospital
name: Xiaoping Luo, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo X, Hou L, Liang L, Dong G, Shen S, Zhao Z, Gong CX, Li Y, Du ML, Su Z, Du H, Yan C. Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies. Eur J Endocrinol. 2017 Aug;177(2):195-205. doi: 10.1530/EJE-16-0905. Epub 2017 May 31.
Clinical trial NCT00540046: Immediate vs. Delayed Insertion of Copper T 380A IUD After Termination of Pregnancy Over 12-weeks Gestation
Official title: Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception Behavior
Keywords: IUD
Second trimester termination
Contraception
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2007-10-05
Enrollment: 215
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380 IUD after termination of pregnancy after 12 weeks.

Detailed description: Patients presenting to ParkMed Women's Clinic and the Reproductive Choice clinic at Bellevue Hospital for second trimester termination will be offered participation in this study. They will be randomized to either delayed or immediate Copper T 380A IUD insertion. The subjects will be seen at a 6 month follow-up visit and Copper T 380A IUD placement will be verified by physical exam. At this 6 month follow-up visit, subjects will fill out a satisfaction questionnaire.

Eligibility criteria: Inclusion Criteria:

* women 16 years of age and older
* intrauterine pregnancy \> 14 weeks gestation
* desires termination of pregnancy
* desires IUD for contraception
* ability to give informed consent
* no contraindication for D+E

Exclusion Criteria:

* unable to give informed consent
* less than 16 years of age
* congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
* acute pelvic inflammatory disease (PID)
* known or suspected uterine or cervical neoplasia or unresolved abnormal PAP smear
* untreated acute cervicitis or vaginitis, until infection treated/controlled
* confirmed Chlamydia trachomatis or Neisseria gonorrhea infection in the previous 90 days
* acute liver disease or liver tumor (benign or malignant)
* woman or partner currently with multiple sexual partners
* history of Wilson's disease
* hypersensitivity to any component of Copper T IUD

Primary outcomes:
measure: Use of IUD
timeFrame: 6 months
Secondary outcomes:
measure: Expulsion
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: New York
country: United States
facility: Parkmed Women's Clinic
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Miriam L. Cremer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: