louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03042533: Union Rate of Transverse Tibia Fracture
Official title: Union Rates of Transverse Tibia Fractures Managed With Internal Fracture Compression Through an Intramedullary Rod Compared to Standard Backslapping or Backslapping With Dynamic Locking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Closed Transverse Fracture of Shaft of Tibia
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 9
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.


Eligibility criteria: Inclusion Criteria:

* Closed Tibia Shaft Fracture Treated with an IMN

Exclusion Criteria:

* Unable to consent due to language
* Unlikely to follow-up for one year

Primary outcomes:
measure: Healing of Tibia Fracture by Radiographic Exam
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Claude Sagi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02223533: Multimodal Analgesia With Interfascial Continuous Wound Infiltration: A Randomized Clinical Trial
Official title: Multimodal Analgesia With Interfascial Continuous Wound Infiltration of a Local Anaesthetic vs Intravenous Opioids After Laparoscopic Colon Surgery: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: analgesia
post-operative
wound catheter infusion
laparoscopic colon surgery
Lead sponsor: Hospital Galdakao-Usansolo
Sponsor class: OTHER_GOV
First posted: 2014-08-22
Enrollment: 110
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: Objectives: For major laparoscopic surgery, as with open surgery a multimodal analgesia plan can help control postoperative pain. Placing a wound catheter intraoperatively following colon surgery could optimize the control of acute pain with less consumption of opioids and few adverse effects.

Methods: We conducted a prospective, randomized, study of 103 patients scheduled to undergo laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital.

Patients were recruited and randomly allocated to wound catheter placement plus standard postoperative analgesia or standard postoperative analgesia alone. A physician from the acute pain management unit monitored all patients for at multiple points over the first 48 hours after surgery. The primary outcome variables were verbal numeric pain scale (NRS) scores and amount of intravenous morphine used via patient controlled infusion.


Eligibility criteria: Inclusion Criteria:

* Patients were eligible for the study if they were aged 18 years or older, with an American Society of Anesthesiologists (ASA) 14 grade of I to IV (anaesthetic risk), were scheduled to undergo laparoscopic colon surgery, and voluntarily agreed to participate by signing an informed consent form.

Exclusion Criteria:

* Patients were excluded if they were allergic to amides or pyrazolones, were likely to require conversion to open surgery with laparotomy, were long-term users of opioids, required emergency surgery, were unable to participate due to cognitive deterioration, or declined to participate in the study.

Primary outcomes:
measure: Assessment of Numerical Rating Pain Scale (NRS) after laparoscopic colon surgery using interfascial continuous wound infiltration
timeFrame: Over the 48 hours after laparoscopic colon surgery
measure: Assessment of intravenous morphine consumption after laparoscopic colon surgery
timeFrame: Over the 48 hours after laparoscopic colon surgery
Secondary outcomes:
measure: Complications related to intravenous morphine consumption
timeFrame: Over the 48 hours after laparoscopic colon surgery
Other outcomes:
Locations:
city: Usansolo
country: Spain
facility: Hospital de GAldakao-Usansolo
state: Biscay
Study officials:
affiliation: Hospital Galdakao-Usansolo
name: Sorkunde Telletxea, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01892254: Incretin Effect in PCOS Women
Official title: Inkretineffekten Hos Patienter Med Polycystisk Ovariesyndrom før og Efter Behandling af Insulinresistens (Incretin Effect in Patients With Polycystic Ovary Syndrome Before and After Treatment of Insulin Resistance)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: incretin effect
PCOS
insulin resistance
OGTT
IIGI
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the incretin effect in women with polycystic ovary syndrome (PCOS) before and after removal of their insulin resistance by metformin.

The investigators' hypothesis is that insulin resistant women with PCOS have a reduced incretin effect and elevated glucagon responses as measured by a 75-g oral glucose tolerance test and isoglycemic i.v. glucose infusion. The investigators hypothesise that both can be improved when their insulin resistance is removed.


Eligibility criteria: Inclusion Criteria PCOS-women:

* Diagnosed with PCOS according to the Rotterdam criteria
* more than 18 years old
* BMI less than 30 kg/m2
* Normal glucose tolerance and fasting plasma glucose (assessed by 75-g OGTT)
* Negative GAD65 and islet cell autoantibodies
* Insulin resistant according to HOMA-IR
* informed consent

Inclusion Criteria healthy women:

* more than 18 years old
* BMI less than 30 kg/m2
* Normal glucose tolerance and fasting plasma glucose (assessed by 75-g OGTT)
* Negative GAD65 and islet cell autoantibodies
* informed consent
* regular menstrual cycle (28-35 days)
* Plasma androgen levels within reference levels

Exclusion Criteria PCOS and healthy women:

* First or second degree relatives with diabetes
* pregnancy or breast feeding
* treatment with medication which influences the glucose metabolism (incl hormonal contraception)
* Congenital diseases which cause hyperandrogenism and irregular bleeding
* Known adrenal hyperplasia
* Known hyperprolaktinemia
* Alcohol consumption of more than 20 grams a day
* Hemoglobin less than 7.8 %

Primary outcomes:
measure: The change in incretin effect from baseline and until after removal of insulin resistance
timeFrame: baseline and 12 weeks' treatment
Secondary outcomes:
measure: Glucagon response
timeFrame: 0, 12 and 30 weeks
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Copenhagen University Hospital Gentofte
state: Select A State
Study officials:
affiliation: Copenhagen University Hospital, Gentofte
name: Louise Vedtofte, MSc., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005733: Develop and Implement Asthma Controlling Strategies (2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To develop and implement asthma controlling strategies for inner city and high risk populations.

Detailed description: BACKGROUND:

Asthma is a serious chronic disease affecting about 12 million Americans; about 3 million are children. The study was part of an initiative, "Developing and Implementing at the State and Local Level Educational Strategies and Interventions for Controlling Asthma in Inner City and High Risk Populations", released in February 1993 by the National Asthma Education Program of the Office of Prevention, Education and Control.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wilson SR, Scamagas P, Grado J, Norgaard L, Starr NJ, Eaton S, Pomaville K. The Fresno Asthma Project: a model intervention to control asthma in multiethnic, low-income, inner-city communities. Health Educ Behav. 1998 Feb;25(1):79-98. doi: 10.1177/109019819802500107.
Clinical trial NCT03402633: Leucotrichia in Vitiligo
Official title: Leucotrichia in Vitiligo Patients : A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leucotrichia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vitiligo patients with/ without leukotrichia within the vitiliginous areas presenting to dermatology outpatient clinic at Kasr Alainy Teaching Hospital

Brief summary: The incidence of leucotrichia has been reported to range from 9 to 48.4% of all vitiligo patients.Leucotrichia is more often observed in segmental vitiligo with a very high percentage. However, further studies considering the prevalence of leucotrichia in different types of vitiligo need to be conducted.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Vitiligo patients with/ without leukotrichia within the vitiliginous areas

Exclusion criteria:

* Age \< 18
* Premature hair graying in the trunk before the age of 30

Primary outcomes:
measure: Detection of prevalence of leukotrichia within vitilignous areas in vitiligo patients
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02964533: Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial
Official title: Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Fatigue Syndrome
Lead sponsor: Guangzhou University of Chinese Medicine
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 70
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: Chronic fatigue syndrome is a group of syndrome and is prevalent in adult. Thunder-fire moxibustion is a commentary therapy belonged to acupuncture therapy. To evaluate the effect and safety of thunder-fire moxibustion therapy for chronic fatigue syndrome, we apply a randomized controlled trial by recruiting chronic fatigue syndrome patient as subject, applying thunder-fire moxibustion on shenque acupoint contrasted to common moxa-stick moxibustion, taking fatigue rating scale score, the content of CD3+、CD4+、CD8+、CD4+/CD8+ as evaluation indexes. The treatment time is 20-30 minutes per session, 3-4 times a week, there are totally 15 sessions.


Eligibility criteria: Inclusion Criteria:

* 1.Clinical diagnosis of chronic fatigue syndrome, 2.Age between 18 to 65 years old. 3.Must be able to accept moxibustion treatment 4.Never receive any treatment or has suspended treatment over 2 weeks 5.Patients with good adherence, signed informed consent by themselves

Exclusion Criteria:

* 1.Other primary disease caused by chronic fatigue 2.Pregnancy or breast-feeding women. 3.Merge in other serious diseases, such as severe damage in heart, liver, kidney ,lung or mental illness 4.Has took durg for insomnia treatment 5.Has received acupuncture,massage for chronic fatigue syndrome treatment 6.Suffered from infectious disease

Primary outcomes:
measure: fatigue rating scale score
timeFrame: 5 minutes
Secondary outcomes:
measure: content of peripheral t-lymphocyte subsets
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Clinical Medical College of Guangzhou University of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Haili Luo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tian L, Wang J, Luo C, Sun R, Zhang X, Yuan B, Du XZ. [Moxibustion at Gaohuang (BL 43) for chronic fatigue syndrome: a randomized controlled trial]. Zhongguo Zhen Jiu. 2015 Nov;35(11):1127-30. Chinese.
Clinical trial NCT01205633: Multi-center Registry for CCSVI Testing and Treatment
Official title: Multi-center Registry for CCSVI Testing and Treatment
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: CCSVI
Chronic Cerebrospinal Venous Insufficiency
Venous Malformations of CNS Draining Veins
Keywords: neurodegenerative disease
neurovascular disease
fatigue
Hubbard Foundation
angioplasty
Lead sponsor: Hubbard Foundation
Sponsor class: OTHER
First posted: 2010-09-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspected of obstructions in the veins draining the central nervous system which may adversely affect CNS function

Brief summary: Patients suspected of CCSVI (chronic cerebrospinal venous insufficiency) may be tested and if appropriate treated with catheter venoplasty by an interventional radiologist in their local community who has been credentialled either by the local hospital's IRB or a national IRB if the procedure is done in an outpatient facility. Catheter angioplasty is a long-established and accepted medical procedure, patients' insurance should but may not cover the testing or treatment.

Detailed description: more to follow

Eligibility criteria: Inclusion Criteria:

Referral by patients primary treating physician for suspected CCSVI

Exclusion Criteria:

Abnormal kidney function Allergy to either or both of the imaging contrast agents Pacemaker or other implantable device Ferrous metal in or on the body Claustrophobia Pregnancy

-

Primary outcomes:
measure: Short-Form 36 (SF36) Quality of Life Instrument
timeFrame: Baseline and at 1, 6 and 12 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Downey
country: United States
facility: Vascular Access Center of Downey
state: California
city: Oceanside
country: United States
facility: North County Radiology
state: California
city: Atlanta
country: United States
facility: Vascular Access Care of Atlanta
state: Georgia
city: New York
country: United States
facility: Columbia endovascular Associates
state: New York
city: Poughkeepsie
country: United States
facility: Valley Endovascular Associates
state: New York
city: Dayton
country: United States
facility: Dayton Interventional Radiology
state: Ohio
city: Provo
country: United States
facility: Utah Valley Interventional Associates
state: Utah
city: Salt Lake City
country: United States
facility: Utah Vascular Clinic
state: Utah
city: Seattle
country: United States
facility: Vascular Access Center of Seattle
state: Washington
Study officials:
affiliation: Hubbard Foundation
name: David R Hubbard, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02860533: iPhone App Compared to Standard Riva-Rocci (RR)-Measurement During Stress Testing
Official title: iPhone App Compared to Standard RR-measurement During Stress Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Blood pressure
smartphone App
Hypertension
Stress testing
Prevention
Cardiovascular risk factors
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The iPARR DELTA BP Study is designed to evaluate whether a new smartphone app using the photoplethysmography signal of the inbuilt camera can measure blood pressure (BP) fluctuations with sufficient correlation compared to the goldstandard oscillometric BP measurements. Investigators will recruit patients who are scheduled for a routine treadmill stress test and assess their blood pressure before and right after the test with the smartphone app and the standard BP measurements on the opposite upper extremity. Pronounced BP fluctuations are encountered during vigorous activities. The primary endpoint of the iPARR DELTA BP Study is the correlation of the absolute difference of subsequent measurements between both techniques. If the relative chances of BP fluctuations are sufficiently assessed with this new device, BP fluctuations could be monitored continuously after calibration.


Eligibility criteria: Inclusion Criteria:

- able to give informed consent

Exclusion Criteria:

* atrial fibrillation
* medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)

Primary outcomes:
measure: Absolute difference between conventional blood pressure measurements and the corresponding iPhone blood pressure estimations
timeFrame: 1 day
Secondary outcomes:
measure: Number of measurement failures
timeFrame: 1 day
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Jens Eckstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01227733: Comparative Genomic and Genetic Analysis of Paired Primary Breast - Metastatic Tumor Specimens Using High-throughput Platforms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2010-10-25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 10 archival breast tumor blocks will be obtained from the Department of Pathology, NUH - half of these blocks will be from patients who were diagnosed before year 2000, and the other half of the blocks will be from patients diagnosed between year 2000-2005 (control specimens). Basic tumor and patient information will be collected without patient identifiers - grade, stage, ER/PR/HER2 status, treatment received, outcome data. 8-10 ten-micron sections will be cut from each tumor block. RNA will be extracted from the tumor sections using the Roche High Pure FFPE RNA Micro Kit. RNA will be profiled using the Illumina Veracode assay and the Affymetrix Quantigene assay. RNA extraction and gene expression profiling will be performed by collabroators at the Genome Institute of Singapore.

Brief summary: Adequate quality and quantity of RNA may be extracted from paraffin-embedded tumor blocks for gene expression analysis. This has clinical relevance as gene expression signatures may then be profiled using archival tumor blocks, which are more readily available than frozen tissues.


Eligibility criteria: Inclusion Criteria:

No participants are involved.

Exclusion Criteria:

No participants are involved.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
citation: Barrios CH, Liu MC, Lee SC, Vanlemmens L, Ferrero JM, Tabei T, Pivot X, Iwata H, Aogi K, Lugo-Quintana R, Harbeck N, Brickman MJ, Zhang K, Kern KA, Martin M. Phase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer. Breast Cancer Res Treat. 2010 May;121(1):121-31. doi: 10.1007/s10549-010-0788-0. Epub 2010 Mar 26.
citation: Lim YW, Goh BC, Wang LZ, Tan SH, Chuah BYS, Lim SE, Iau P, Buhari SA, Chan CW, Sukri NB, Cordero MT, Soo R, Lee SC. Pharmacokinetics and pharmacodynamics of docetaxel with or without ketoconazole modulation in chemonaive breast cancer patients. Ann Oncol. 2010 Nov;21(11):2175-2182. doi: 10.1093/annonc/mdq230. Epub 2010 Apr 29.
Clinical trial NCT01548833: Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses
Official title: Randomized Cross-Over Evaluation of Silicone Hydrogel Daily Disposable Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Myopia
Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Aston University
First posted: 2012-03-08
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.


Eligibility criteria: Inclusion Criteria:

* Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
* Require vision correction in both eyes.
* Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
* Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
* Willing and able to wear study contact lenses 16 hours per day.
* Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
* Require monovision correction.
* Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
* Ocular surgery/trauma within the last 6 months.
* Topical or systemic antibiotic use within 7 days of enrollment.
* Topical ocular or systemic corticosteroid use within 14 days of enrollment.
* Pregnant and nursing women.
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)
timeFrame: Day 7, 16 hours after lens insertion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jami Kern, PhD
role: STUDY_DIRECTOR
References: