louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00363558: Fixation of Skin Grafts in Patients With Burns: Comparison Between Cyanoacrylate Glue and Skin Staples
Official title: Fixation of Skin Grafts in Patients With Burns: Comparison Between Cyanoacrylate Glue and Skin Staples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Grafting, Skin
Burn
Keywords: skin graft
fixation
cyanoacrylate glue
skin staples
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 44
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: RETROSPECTIVE

Brief summary: Skin graft fixation is essential for the success of its survival. There are several common methods for skin graft fixation including sutures, skin staples and glue. The study objective is to compare between skin graft fixation with staples and glue in burn patients. The study is retrospective. It Includes 44 patients that were hospitalized in the burn unit, Rabin Medical Center, Israel with 2nd and 3rd degree burns, total body surface area 1-50% during 1/2002-5/2003.All patients were operated for debridement and skin grafting. In 29 patients the skin graft was fixated with staples and in 15 with cyanoacrylate glue (histoacryl). The parameters that will be compared are skin graft take, hospitalization length and local infection.


Eligibility criteria: Inclusion Criteria:

* hospitalized patients with 2nd and 3rd degree burns who were operated for debridement and skin grafting
* burn total body surface area 1-50%

Exclusion Criteria:

* burn total body surface area\> 50%

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center , Israel
name: Neta Adler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaplan HY. A quick stapler tie-over fixation for skin grafts. Ann Plast Surg. 1989 Feb;22(2):173-4. doi: 10.1097/00000637-198902000-00015.
citation: Zaki I, Scerri L, Millard L. Split skin grafting on severely damaged skin. A technique using absorbable tissue adhesive. J Dermatol Surg Oncol. 1994 Dec;20(12):827-9. doi: 10.1111/j.1524-4725.1994.tb03713.x.
citation: Shorr N, Cohen MS, Lessner A. Histoacryl closure of eyelid skin grafts. Ophthalmic Plast Reconstr Surg. 1991;7(3):190-3. doi: 10.1097/00002341-199109000-00007.
Clinical trial NCT00717158: Lifestyle Intervention's Impact on Health Care Costs
Official title: Evaluating Healthcare Utilization, Costs and Health-Related Outcomes of a Medical Nutrition Therapy Intervention on Obese Patients With Type 2 Diabetes - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: Health Behavior
Lifestyle
health care costs
quality of life
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-07-16
Enrollment: 147
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of life outcomes of a nutrition intervention involving lifestyle case management and medical nutrition therapy by a registered dietitian compared to usual medical care in obese persons with type 2 diabetes. The intervention is aimed at moderate weight loss (\> 5-10%), improvement in diet quality and an increase in physical activity.


Eligibility criteria: Inclusion Criteria:

* BMI \> 30 kg/m2, calculated from measured weight and height.
* Type 2 diabetics on medication for their diabetes.
* Age 20 -60 years of age.
* Have phone.
* Fluency in reading, writing and comprehension of English
* Have Qualchoice as their primary health insurer.

Exclusion Criteria:

* Depression, BDI score \> 20
* Pregnancy

Primary outcomes:
measure: Health Care utilization and costs using claims data
timeFrame: one year
Secondary outcomes:
measure: Weight change
timeFrame: one year
measure: Change in hemoglobin A1c
timeFrame: One Year
measure: Work days lost
timeFrame: One year
measure: Disability Days
timeFrame: One year
measure: Change in quality of life
timeFrame: one year
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
Study officials:
affiliation: University of Virginia School of Medicine
name: Anne M Wolf, MS, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolf AM, Conaway MR, Crowther JQ, Hazen KY, L Nadler J, Oneida B, Bovbjerg VE; Improving Control with Activity and Nutrition (ICAN) Study. Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Diabetes Care. 2004 Jul;27(7):1570-6. doi: 10.2337/diacare.27.7.1570.
citation: Wolf AM, Siadaty M, Yaeger B, Conaway MR, Crowther JQ, Nadler JL, Bovbjerg VE. Effects of lifestyle intervention on health care costs: Improving Control with Activity and Nutrition (ICAN). J Am Diet Assoc. 2007 Aug;107(8):1365-73. doi: 10.1016/j.jada.2007.05.015.
Clinical trial NCT03075358: Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial
Official title: Effects of Lidocaine Spray for Reducing Pain During Endometrial Aspiration Biopsy : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Bleeding
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 240
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endometrial aspiration biopsy has been accepted as a diagnostic procedure of choice for women with abnormal uterine bleeding to examine endometrial pathology. The procedure has high accuracy comparing to conventional fractional curettage. However, it is associated with significant pain during the procedure. In general, there is no specific recommendation regarding the proper anesthesia used during the procedure.

The aim of this study is to examine the effect of lidocaine spray for reducing pain during the endometrial aspiration procedure by comparing it with placebo and no intervention.


Eligibility criteria: Inclusion Criteria:

* Women undergoing endometrial aspiration biopsy at Maharaj Nakorn Chiang Mai hospital

Exclusion Criteria:

* Lidocaine allergy
* Pregnancy
* Previous uterine or cervical surgical procedures
* Neurological abnormalities
* Coagulopathy
* Infection of cervix, vagina, or pelvic cavity
* Taking any analgesic drugs within 4 hours before the procedure

Primary outcomes:
measure: Aspiration pain
timeFrame: Immediately following endometrial aspiration biopsy
measure: Postprocedure pain
timeFrame: 10 minute after procedure completion
Secondary outcomes:
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Faculty of Medicine, Chiang Mai University
name: Kittipat Charoenkwan, MD, MSc
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Chiang Mai University
name: Ratpaporn Piyawetchakarn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02868658: Asymptomatic Flu Project
Official title: Incidence of Symptomatic and Asymptomatic Influenza Among Healthcare Workers : A Multicenter Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza
health care workers
nosocomial
asymptomatic
France
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Although clinical presentation of influenza is often symptomatic, asymptomatic cases also occur. The knowledge of the incidence of asymptomatic influenza among healthcare workers is very important because of the risk of cross-transmission to hospitalized patients. The principal objective of the study is to estimate the incidence of symptomatic and asymptomatic influenza among healthcare workers in short-stay wards. The results of this study will lead to a better understanding of the burden of asymptomatic influenza among healthcare workers and might be used as an argument to increase influenza vaccine coverage among healthcare workers.


Eligibility criteria: Inclusion Criteria:

* Volunteer health-care workers
* Working in the following wards: short-stay, inpatient (including ICU) and emergency

Exclusion Criteria:

* Presence of influenza symptoms at enrolment
* Programmed absence (maternity leave, vacation, etc.)
* Administrative agents

Primary outcomes:
measure: Incidence of influenza cases
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Fraction of asymptomatic influenza cases
timeFrame: 6 months after inclusion
measure: Stratified incidence ratios
timeFrame: 6 months after inclusion
measure: Incidence of influenza-like illness
timeFrame: 6 months after inclusion
measure: proportion of health-care workers with Influenza vaccine coverage
timeFrame: 6 months after inclusion
measure: Number of sick-leave days per participating ward
timeFrame: 6 months after inclusion
Other outcomes:
Locations:
city: Lyon cedex 03
country: France
facility: Edouard Herriot Hospital; Department of Epidemiology, Hygiene and Public Health
Study officials:
References:
citation: Benet T, Amour S, Valette M, Saadatian-Elahi M, Aho-Glele LS, Berthelot P, Denis MA, Grando J, Landelle C, Astruc K, Paris A, Pillet S, Lina B, Vanhems P; AFP Study Group. Incidence of Asymptomatic and Symptomatic Influenza Among Healthcare Workers: A Multicenter Prospective Cohort Study. Clin Infect Dis. 2021 May 4;72(9):e311-e318. doi: 10.1093/cid/ciaa1109.
Clinical trial NCT00731458: Prospective Comparison of Cirrus Versus Stratus Ocular Coherence Tomography for Different Retinal Pathology.
Official title: Prospective Comparison of Cirrus and Stratus Optical Coherence Tomography for Quantifying Retinal Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Pathology
Keywords: OCT;
Cirrus;
Stratus;
macular thickness
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Research to Prevent Blindness
First posted: 2008-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Ocular Coherence Tomography (OCT) is a non-invasive ophthalmologic test that uses reflected, unheated, non-concentrated visible light in order to scan and provide a 2-dimensional topographic analysis of the retina and optic nerve. It has wide diagnostic utility especially in patients with clinically significant macular edema, glaucoma, and other retinal eye diseases. At the University of Chicago, we have utilized the Stratus brand OCT (Carl Zeiss Inc) for the past 5 years. Recently we have acquired a beta version of the company's new model, the Cirrus HD-OCT (Carl Zeiss Inc.) which features improved resolution, shorter scanning time and a more user-friendly interface. The purpose of this study is to compare findings between the two models in patients with different common and uncommon eye diseases, including diabetic macular edema, glaucoma and age-related macular degeneration. We hypothesis that the Cirrus OCT is able to accurately quantify eye pathology compared to Stratus OCT.


Eligibility criteria: Inclusion Criteria:

* Any eye pathology that may cause macular edema.

Exclusion Criteria:

* Vitreous media opacities including dense cataracts, vitreous hemorrhage, and corneal opacities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: Seenu Hariprasad, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forooghian F, Cukras C, Meyerle CB, Chew EY, Wong WT. Evaluation of time domain and spectral domain optical coherence tomography in the measurement of diabetic macular edema. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4290-6. doi: 10.1167/iovs.08-2113. Epub 2008 May 30.
citation: Gupta V, Gupta P, Singh R, Dogra MR, Gupta A. Spectral-domain Cirrus high-definition optical coherence tomography is better than time-domain Stratus optical coherence tomography for evaluation of macular pathologic features in uveitis. Am J Ophthalmol. 2008 Jun;145(6):1018-1022. doi: 10.1016/j.ajo.2008.01.021. Epub 2008 Mar 17.
Clinical trial NCT00455858: Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea
Official title: A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-04-04
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes (diagnosed more than 12 months ago)
* HbA1c greater than 7.0 and less than 12.0% at screening
* Currently on any OAD in more than 3 months ago
* BMI (Body Mass Index) less than 35kg/m2

Exclusion Criteria:

* Previous treatment with insulin in more than 7 days within the last 3 months
* Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)

Primary outcomes:
measure: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20
timeFrame: week 0, week 20
Secondary outcomes:
measure: Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12
timeFrame: week 0, week 12
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: week 0, week 12, week 20
measure: Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%
timeFrame: week 12, week 20
measure: Occurence of Hypoglycaemic Episodes
timeFrame: weeks 0-20
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04913558: Effect of Aerobic Exercise on Stress and Fatigue of Lactating Employed Women
Official title: Effect of Aerobic Exercise on Stress and Fatigue of Lactating Employed Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Fatigue
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women.

Detailed description: The study aims to determine the effect of aerobic exercise on stress and fatigue of employed lactating women. This study will be carried out on Sixty lactating mothers working in the medical field who have returned to work after maternity leave and suffering from stress and fatigue.

The subjects will be divided randomly into two groups equal in number, the Aerobic exercise group ( group A) and the Control group ( group B).

Group A will consist of thirty employed lactating women suffering from stress and fatigue. These women will perform aerobic exercise for 30 minutes for each session, 5 times per week, for 6 weeks in the form of treadmill training (60- 70% of HR max) and do some modifications of their routine by following lifestyle modification advice given to them during the 6 weeks of the program period.

Control group (group B):

This group will consist of thirty employed lactating women suffering from stress and fatigue. This group will receive the same lifestyle modification advice that will be given to group (A) during the six weeks of the program period.

Eligibility criteria: Inclusion Criteria:

* All participants are lactating mothers.
* Working in the medical field 4 to 6 hours per day, 4 to 5 days per week.
* Returned to work after 4 months of maternity leave.
* Suffering stress and fatigue considering the perceived stress questionnaire and the fatigue assessment scale.
* Their babies' ages will be ranged from 6 to 8 months old.
* Having at least one year of work experience before giving birth.
* Their age will be ranged from 25 to 35 years.
* They haven't exercised more than twice per week during the previous 3 months.

Exclusion Criteria:

* Any neurological, cardiovascular disorders, or metabolic disease
* Physical impairments that prevent following the program.
* Women who are planning to stop breastfeeding in the next 4 months.
* Women with regular medications.
* Mothers of formula feeding babies.
* women who are smoking will be excluded from this study.

Primary outcomes:
measure: Stress assessment
timeFrame: Baseline and 6 weeks post-intervention
measure: Fatigue assessment
timeFrame: Baseline and 6 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Sara Zahrer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00328458: EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients
Official title: A Phase I, Open-label, Dose-escalation, Safety Study of the Combination of EPO906 and Radiation Therapy for the Treatment of Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Central Nervous System Neoplasms
Head and Neck Neoplasms
Keywords: CNS and head and neck cancers
Histologically confirmed CNS malignancy head and neck
there is on standard therapy or
have failed standard therapy
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2006-05-22
Enrollment: 39
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 safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients.

Detailed description: * To determine the maximum tolerated dose (MTD) of EPO906 administered in combination with radiation therapy and establish a recommend phase II dose.
* To evaluate the safety and toxicity profile of EPO906 when administered concurrently with radiotherapy in three disease cohorts.
* To evaluate tumor response.

Eligibility criteria: Inclusion Criteria:

* Requires a minimum of 3 weeks of radiation therapy
* Solid tumors with advanced or recurrent disease for which there is no standard therapy or tumors have failed standard therapy
* World Health Organization (WHO) performance status equal to or less than 2
* Life expectancy equal to or greater than 3 months

Exclusion Criteria:

* Any peripheral neuropathy
* Unresolved diarrhea greater than grade 1
* Patients who received any other investigational compound within the past 28 days
* Severe cardiac insufficiency
* Patients on Coumadin

Primary outcomes:
measure: Maximum tolerated dose (MTD) of EPO906
timeFrame: Baseline to 7 weeks
Secondary outcomes:
measure: Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy
timeFrame: Baseline to 7 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Adam Dicker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01629758: Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors
Official title: A Phase 1 Dose Escalation Study of BMS-982470 (Recombinant Interleukin-21, rIL-21) in Combination With BMS-936558 (Anti-PD-1) in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms by Site
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.


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

Inclusion Criteria:

* All subjects will have locally advanced or metastatic solid tumors
* For Part 2 (Cohort Expansion):

  * Tumor types will be restricted to clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer (NSCLC), and melanoma
* At least 1 lesion with measurable disease
* Only subjects with tumor samples that are PD-L1 positive or negative are eligible

Exclusion Criteria:

* Uncontrolled central nervous system (CNS) or leptomeningeal metastasis
* Inadequate liver or kidney function
* History of autoimmune Disease

Primary outcomes:
measure: Safety, as measured by the rate of adverse events and serious adverse events
timeFrame: Approximately up to 4.5 years
Secondary outcomes:
measure: Efficacy as measured by tumor assessment (RECIST)
timeFrame: Week 6 of for the first 4 cycles, Week 6 of alternate cycle starting with cycle 6, End of Treatment (2 years) and approximately every 12 weeks during follow-up (approximately 1 year)
measure: Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558
timeFrame: Up to 2 years + 100 days post-treatment follow-up
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Oncology Research Associates, Pllc D/B/A
state: Arizona
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
state: Maryland
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: