louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03182608: Ultrasound Assessment of the Anatomic Landmarks for Spinal Anesthesia in Patients With Hip Fracture
Official title: Ultrasound Assessment of the Anatomic Landmarks for Spinal Anesthesia in Patients With Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover
Primary purpose: DIAGNOSTIC

Brief summary: Investigators assess the anatomic landmarks for spinal anesthesia in patients with hip fracture using ultrasonography.

Detailed description: Investigators evaluate the anatomic landmarks using Tuffier's line and the tenth rib line for spinal anesthesia in patients with hip fracture, and then assess the consistency of the landmarks-guided interspinous levels with the actual interspinous level using ultrasonography.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for hip fracture surgery under spinal anesthesia

Exclusion Criteria:

* Anatomic abnormalities or masses in the spine
* History of spinal surgery of compression fracture

Primary outcomes:
measure: Accuracy of each anatomic landmark (Tuffier's line and tenth rib line).
timeFrame: Baseline
Secondary outcomes:
measure: The estimation ratio related to the intervertebral levels
timeFrame: Baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jin-Young Hwang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04162808: Bleeding Risk Assessment System for Antithrombotic Therapy of ACS
Official title: Development and Validation of a Full Course Bleeding Risk Assessment System for Antithrombotic Therapy of Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: bleeding
antithrombosis
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Beijing Hospital
name: Beijing Luhe Hospital
name: Beijing Chao Yang Hospital
First posted: 2019-11-14
Enrollment: 6379
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ACS patients

Brief summary: Antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (ACS), which result in lower risk of mortality and ischemic events. But, accompanied side effect of bleeding always causing worsens outcomes. Tools to evaluate risk/benefit ratio is useful in daily practice. The in-used scores, such as CRUSADE, are derived from retrospective studies, without all types of ACS and without long-term prediction. This project aims to establish a database of anti-thrombosis treatment and bleeding in five large centers in Beijing through the observational registry of ACS. With the database, establish a bleeding risk assessment system that can be used for all ACS patients and can predict the full course of antithrombotic treatment.


Eligibility criteria: Inclusion Criteria:

1. Age18-85 years old
2. Diagnosed ACS
3. Signed informed consent form

Exclusion Criteria:

1. Any active bleeding
2. Not tolerate to anti-thrombotic drugs
3. A planned elective surgical procedure that would necessitate an interruption in treatment with antiplatelet therapy in the next 6 months after enrollment
4. Patients who died of non-bleeding causes within 24 hours after admission
5. Noncardiac coexisting conditions that could limit life expectancy to less than 1 year
6. Pregnancy or lactation

Primary outcomes:
measure: The number of event of bleeding
timeFrame: 30 days
measure: The number of event of bleeding
timeFrame: 1 year
Secondary outcomes:
measure: The number of event of bleeding
timeFrame: 30 days and 1 year
measure: number of event of major adverse cardiovascular or cerebrovascular events
timeFrame: 30 days and 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
Study officials:
References:
Clinical trial NCT04954508: The Hug-up Test: A New, Sensitive Diagnostic Test for Supraspinatus Tears
Official title: The Hug-up Test: A New, Sensitive Diagnostic Test for Supraspinatus Tears
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tears
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 200
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: 200 consecutive patients scheduled to undergo an arthroscopic procedure for a diagnosis related to shoulder pain and/or weakness or dislocation by one of the senior authors.

Brief summary: We developed a new test, the "hug-up test," wherein elevation is resisted as the palm is held on the opposite shoulder with the elbow held in maximal anterior translation. The purpose of this study was to describe the hug-up test and compare it with other conventional tests used for diagnosing supraspinatus tears.

Detailed description: The supraspinatus tendon is the most commonly affected tendon in rotator cuff tears. Early detection of a supraspinatus tear using an accurate physical examination is, therefore, important. However, the currently used physical tests for detecting supraspinatus tears are poor diagnostic indicators and involve a wide range of sensitivity and specificity values. Therefore, the aim of this study was to establish a new physical test for the diagnosis of supraspinatus tears and evaluate its accuracy in comparison with conventional tests.

Between November 2012 and January 2014, 200 consecutive patients undergoing shoulder arthroscopy were prospectively evaluated preoperatively. The hug-up test, empty can (EC) test, full can (FC) test, Neer impingement sign, and Hawkins-Kennedy impingement sign were used and compared statistically for their accuracy in terms of supraspinatus tears, with arthroscopic findings as the gold standard. Muscle strength was precisely quantified using an electronic digital tensiometer.

Eligibility criteria: Inclusion Criteria:

* patients scheduled to undergo an arthroscopic procedure for a diagnosis related to shoulder pain and/or weakness or dislocation by one of the senior authors from November 2012 to January 2014

Exclusion Criteria:

* Patients with a history of shoulder surgery, upper extremity fractures, and bilateral shoulder diseases.

Primary outcomes:
measure: patients' self-reported pain
timeFrame: immediately after the test
measure: diagnostic arthroscopy
timeFrame: during the arthrosocpic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yulei Liu
role: STUDY_CHAIR
References:
Clinical trial NCT01046708: Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate
Official title: Ovulation Induction With Clomiphene Citrate: to Support or Not to Support the Luteal Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: IUI
clomiphene citrate
utrogestan
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate.


Eligibility criteria: Inclusion Criteria:

* Age ≤ 36 years
* Body mass index between 18 and 29
* Presence of both ovaries
* Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three FSH level of \<12IU/L
* Patients can enter the study only once.
* Only the first IUI attempt will be included ( at the 2nd and 3 rd attempt progesterone could be administrated if it is necessary but these attempts will be excluded from the study)
* Normal HSG (maximum 3 months prior starting the stimulation).
* Donor sperm can be included

Exclusion Criteria:

* Polycystic ovarian syndrome (Rotterdam criteria)
* Endometriosis(≥AFS III)

Primary outcomes:
measure: ongoing pregnancy rate
timeFrame: 1 year
Secondary outcomes:
measure: implantation rate,clinical pregnancy rate
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Kyrou D, Fatemi HM, Tournaye H, Devroey P. Luteal phase support in normo-ovulatory women stimulated with clomiphene citrate for intrauterine insemination: need or habit? Hum Reprod. 2010 Oct;25(10):2501-6. doi: 10.1093/humrep/deq223. Epub 2010 Aug 18.
Clinical trial NCT06625008: Preoperative 3D Models and Shared Decision-making
Official title: Impact of 3D-Printed Model on Shared Decision-Making and Anxiety in Patients Undergoing Surgery: the SEAD Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Shared Decision Making
Anxiety
Informed Consent
Keywords: Colorectal cancer
3D Model
Shared Decision Making
Preoperative anxiety
Patient knowledge
Informed Consent
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objectives of this study will be to quantify, using validated scales, the effects of 3D-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.

Detailed description: In this single-center pilot cluster randomized controlled trial, the investigators will prospectively measure patient-reported outcomes on shared decision-making and change in anxiety and knowledge. This study will consist of two arms with at least 20 patients each. Six surgeons will be randomly assigned using the opaque sealed envelope method to counsel patients using a modular 3D-printed model or providing standard care during pre-operative clinic visits. The eligibility criteria for the control and investigational arms will be standardized. The biostatistician will use Student t-tests to compare mean scores and ANCOVA to compare the change in mean scores after the pre-operative clinic visit.

Eligibility criteria: Inclusion Criteria:

* Participants must be \>18 years
* Patients scheduled for surgical intervention that would involve partial or complete resection of the colon and/or rectum

Exclusion Criteria:

* Patients requiring complex surgical reconstruction of organs other than the colon and/or rectum

Primary outcomes:
measure: Shared decision making
timeFrame: Within 30 minutes after the preoperative counselling session.
Secondary outcomes:
measure: Change in patient anxiety
timeFrame: Within 30 minutes before and 30 minutes after the preoperative counselling session.
measure: Change in patient knowledge using a self-developed questionnaire
timeFrame: Within 30 minutes before and 30 minutes after the preoperative counselling session.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT03424408: Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin
Official title: Serum Thromboxane B2 Assay as a Measure of Platelet Production in Healthy Volunteers Taking Aspirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aspirin
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Some aspirin-treated patients have a blunted pharmacological response predisposing to clinical failure. The investigators hypothesize that the blunted response often results from increased rate of platelet production and some failures will be prevented by administering aspirin twice daily. The overall objective is to develop a valid method to quantify platelet production (without the use of radioactive isotopes) in order to examine the hypothesis that enhanced platelet production is a common cause of poor aspirin responsiveness in patients with atherothrombosis.

Detailed description: The specific objective of this study is to validate the Cayman Chemical serum thromboxane immunoassay as a measure of platelet production in healthy subjects who are treated with aspirin by demonstrating that the recovery of their serum thromboxane B2 levels occurs at a rate of about 10% per day after aspirin cessation.

Eligibility criteria: Inclusion Criteria:

* Healthy non-smoking volunteers;
* Age ≥ 18 years;

Exclusion Criteria:

* Allergy or intolerance to aspirin;
* Current pregnancy;
* Use of aspirin or drugs interfering with platelet function (NSAIDs, anticoagulants) within one week of study enrolment.

Primary outcomes:
measure: Serum thromboxane B2
timeFrame: daily for 5 days after aspirin cessation
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Thrombosis and Atherosclerosis Research Institute. Hamilton General Site
state: Ontario
Study officials:
affiliation: Hamilton Health Science
name: Noel Chan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05166408: Fistiulation Rate Following Primary Cleft Repair≤
Official title: A Novel Technique Predicting Velopharyngeal Insufficiency Risk in Newborns Following Primary Cleft Repair. A Randomised Clinical Trial Comparing Buccinator Flap and Bardach; Two-flap Palatoplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Palate
Keywords: Cleft palate
Primary repair
Buccinator flap
Palatal fistula
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 46
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate.

Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length.

Detailed description: Aim : The aim of present study was to evaluate the buccinator flap utilization in primary cleft palatoplasty on fistulation rate. The goal was to predict the risk of velopharyngeal insufficiency and to decrease the fistiulation rate.

Methodology: forty six patients suffering from complete wide cleft palate were randomly divided into two equal groups: study group: the cleft palate defect was repaired by buccinator myomucosal flap whereas the control group patients' clefts were repaired by Bardach (two flap) palatoplasty during primary repair. All patients evaluated at 1 week,3,6 months interval to detect fistulation and measure palatal length by taking impressions and pouring casts to measure palatal length from anterior reference point(incisive foramen) to posterior reference point(uvula) and calculation of change in palatal length.

Eligibility criteria: Inclusion Criteria:

1. patients suffering from complete wide cleft palate more than 10 mm
2. Patients age from 9 to 18 months
3. Patients free from any systemic disease that might affect normal healing or the predictable outcome
4. Patients who will agree to the consent and stick to the follow up period

Exclusion Criteria:

1. Patients with systemic disease
2. Patients who might not stick to the follow up period
3. Patients with Pierre Robin syndrome
4. Patients with previous palatal repair

Primary outcomes:
measure: Fistiulation rate
timeFrame: 6 months
Secondary outcomes:
measure: Palatal length & risk of VPI
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Research organizer
name: Wael Abdelsamee
role: STUDY_CHAIR
References:
Clinical trial NCT00005408: Reanalysis of CVD Risk Factors Via Likelihood Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To reanalyze data on risk factors for cardiovascular disease (CVD) including total cholesterol and high density lipoprotein (HDL) cholesterol for the subjects in the first, second, and third exams of the NHLBI Twin Study.

Detailed description: BACKGROUND:

The results of these longitudinal analyses yielded new insights on genetic effects affecting CVD risk factors during the aging process.

DESIGN NARRATIVE:

The analyses utilized maximum likelihood estimators of genetic variance which were asymptotically more efficient than the method-of-moments estimators used in previous analyses. The models used incorporated terms to partition the variance in a trait from twin data into either i) additive genetic variance and unshared environmental variance (the AE model), ii) additive genetic variance, dominance genetic variance, and unshared environmental variance (the ADE model), or iii) additive genetic variance, shared environmental variance, and unshared environmental variance (the ACE model). The AE, ADE, and ACE models were fitted separately to data from each of the three exams to obtain a cross-sectional analysis. The investigators also extended these models for use with longitudinal data by incorporating terms to represent the covariance of variance components from different exams.

Two important additional objectives of this study were i) to introduce resistant estimation techniques in twin modeling, which trimmed the effect of outlier data points smoothly, and ii) to carefully study the performance of maximum likelihood and method-of-moments estimators when assumptions of the twin model were violated. The results of these parts of the study should yield a more complete understanding of the relative merits and limitations of twin modeling procedures.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Williams CJ, Wijesiri UW. Lipid data from NHLBI veteran twins: interpreting genetic analyses when model assumptions fail. Genet Epidemiol. 1993;10(6):551-6. doi: 10.1002/gepi.1370100637.
citation: Williams CJ. On the covariance between parameter estimates in models of twin data. Biometrics. 1993 Jun;49(2):557-68.
citation: Wijesiri UW, Williams CJ. Approximate solutions for the maximum-likelihood estimates in models of univariate human twin data. Behav Genet. 1995 May;25(3):211-6. doi: 10.1007/BF02197179.
Clinical trial NCT01909908: ECM and Blood Components for Wound Healing
Official title: Treatment of Chronic Wounds Using Extracellular Matrix-Based Devices and the Patient's Own Blood Components
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ulcer
Venous Ulcer
Foot Ulcer, Diabetic
Keywords: Wounds and injuries
Ulcer
Diabetic angiopathies
Diabetic foot
Venous insufficiency
Extracellular matrix
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2013-07-29
Enrollment: 2
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 Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM) and autologous blood products in wound healing.


Eligibility criteria: Inclusion Criteria:

* Type 1 or Type 2 diabetes, and/or venous insufficiency to the affected leg
* Ulcer has been present between 12 and 52 weeks
* Ulcer is less than 40 cm2 in area

Exclusion Criteria:

* Less than 18 years of age
* Pregnant or planning to become pregnant during the study period
* Simultaneously participating in another investigational drug or device study
* Unable or unwilling to comply with the weekly study follow-up schedule or off-loading regimen
* Patient or legal representative refuses to sign the EC-approved informed consent form
* Known allergy to pig or porcine products
* Additional criteria may apply

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: John Embil, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: