louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03088865: Evaluation of an Internal Hospital Practice: The Effect of Altered Test Tubes Sampling Order on Blood Culture Contamination Rates
Official title: Evaluation of an Internal Hospital Practice: The Effect of Altered Sampling Protocol on Blood Culture Contamination Rates: An Open, Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septicemia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Implementation of the initial specimen diversion technique, in which the first milliliter of the venipuncture sample is not injected into the culture bottle, led to a significant reduction in blood culture contamination rates. This technique is based on the assumption that the skin plug aspirated during venipuncture is a major source of contaminating bacteria. One such diversion method is aspirating the first blood volume into a blood collection tube. It has, however, been suggested that regular blood collection tubes carry contaminants from the tube's stopper into the blood cultures drawn afterwards, thereby increasing contamination rates. The aim of this trial is to examine the effect of aspirating the first blood volume into a regular blood collection tube on blood culture contamination rate.


Eligibility criteria: Inclusion Criteria:

* Adults evaluated in the emergency room or as inpatients for suspected sepsis or having sepsis and from whom the treating physician plans to take, in the same venous puncture, blood cultures and additional blood tests (blood count and/or blood chemistry).

Exclusion Criteria:

* None

Primary outcomes:
measure: Blood culture contamination rate
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
citation: Lalezari A, Cohen MJ, Svinik O, Tel-Zur O, Sinvani S, Al-Dayem YA, Block C, Moses AE, Oster Y, Salameh S, Strahilevitz J. A simplified blood culture sampling protocol for reducing contamination and costs: a randomized controlled trial. Clin Microbiol Infect. 2020 Apr;26(4):470-474. doi: 10.1016/j.cmi.2019.09.005. Epub 2019 Sep 17.
Clinical trial NCT03321565: Johns Hopkins Weight Management Center Patient Data
Official title: Johns Hopkins Weight Management Center Patient Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: obesity
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who enroll themselves at the Johns Hopkins Weight Management Center, with the goal of reaching or maintaining a healthy BMI.

Brief summary: Patient records from Johns Hopkins Weight Management Center historical files

Detailed description: Examination of historical patient files from the Johns Hopkins Weight Management Center, to be conducted by a study team led by the attending physician and director of the Center. Analyses will examine weight-related outcomes based on participation in the Weight Management Center program.

Eligibility criteria: Inclusion Criteria:

* enrolled as a patient at the Johns Hopkins Weight Management Center

Exclusion Criteria:

* none

Primary outcomes:
measure: Weight loss
timeFrame: 1990-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Weight Management Center
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Lawrence J Cheskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956865: Community Glaucoma Screening Follow-up
Official title: Community Glaucoma Screenings: Assessment of Interventions to Improve Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Intervention
Follow up
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Temple University
First posted: 2009-08-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine if one of three interventions improves follow-up rates for screening exam participants who are instructed to have a definitive eye exam.

Detailed description: To determine if one of three interventions: vouchers, telephone calls, and personal contacts, improves follow-up rates for screening exam participants who are instructed to have a definitive eye exam.

Eligibility criteria: Inclusion Criteria:

* All who had an eye screening exam.

Exclusion Criteria:

* None

Primary outcomes:
measure: Definitive follow-up eye exam
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Temple University
name: Jeffrey D Henderer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01483365: The Need for Luteal Support in NC-FET
Official title: The Use of Luteal Support After NC-FET
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Abnormal Menstrual Cycle
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-12-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are going to examine prospectively the need of luteal support after NC-FET.

Detailed description: The investigators are going to examine retroprospectively the need of luteal support after NC-FET in IVF cycle. One arm will receive luteal support after NC FET with vaginal tablet of Endometrin 100 mg twice a day after ET. The second arm will not. We are going to evaluate the pregnancy and implantation rate.

Eligibility criteria: Inclusion Criteria:

* Women under 39 years old, regular menstruation going through IVF NC-FET

Exclusion Criteria:

* NO

Primary outcomes:
measure: Pregnancy rate
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson medical center
Study officials:
affiliation: IVF Unit, Department of Obstetrics and Gynecology,Wolfson Medical Center . Holon, Israel
name: David Levran, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horowitz E, Mizrachi Y, Finkelstein M, Farhi J, Shalev A, Gold E, Raziel A, Weissman A. A randomized controlled trial of vaginal progesterone for luteal phase support in modified natural cycle - frozen embryo transfer. Gynecol Endocrinol. 2021 Sep;37(9):792-797. doi: 10.1080/09513590.2020.1854717. Epub 2020 Dec 14.
Clinical trial NCT02590666: Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers
Official title: Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint vs Microscissors or Graspers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Polyps
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. Several hysteroscopic systems to resect endometrial polyps are currently available. Among Others bipolar systems and microscissors or graspers, both of theme make part of routine clinical practice and are universally accepted.

The aim of the study is to compare the efficacy of bipolar resection energy polypectomy versus microscissors or graspers These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .

Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients


Eligibility criteria: Inclusion Criteria:

* The patient must be informed about the study, and sign the informed consent

Exclusion Criteria:

* Positive Pap smear test
* Pregnancy
* Uterine malignancy
* Abnormal uterine bleeding

Primary outcomes:
measure: To assess the tolerability of polypectomy using a validated visual analogue pain scale
timeFrame: we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks
Secondary outcomes:
Other outcomes:
measure: Assess the recurrence of polyps after 3 months of resection (another hysteroscopy).
timeFrame: 3 months after resection of the polyp, repeat hysteroscopy to assess recurrence
Locations:
Study officials:
References:
Clinical trial NCT05702866: Vascular Compression Assessment Using Transcutaneous Oxymetry in Patients Suspected of Having Thoracic Outlet Syndrome
Official title: Apport de l'évaluation de l'ischémie de Membre supérieur Par oxymétrie transcutanée Dans la caractérisation de la Compression Vasculaire Chez Les Patients Suspects de Syndrome du défilé Thoraco-brachial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Outlet Syndrome
Keywords: transcutaneous oximetry
thoracic outlet syndrome
arteriography
vascular compression
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-01-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient presenting to the vascular medicine department with suspected thoracic outlet syndrome.

Brief summary: Thoracic outlet syndrome (TOS) is characterized by nervous, venous or arterial symptoms resulting from a compression of the thoracic bundle in the thoracic outlet. The diagnostic approach of TOS is still controversial. The investigating team is interested in arterial TOS and have already been able to demonstrate the presence of arm ischemia during dynamic maneuvers using transcutaneous oximetry (TcpO2). The correlation between the measurement of TcpO2 during dynamic maneuvers and the vascular compression type (arterial, venous or both) will be evaluated. The evaluation the correlation between TcpO2 and degree of arterial compression observed in dynamic arteriography (considered as a gold standard examination) will be calculated too. The use of TcpO2 could be developed in the diagnosis assessment of TOS.


Eligibility criteria: Inclusion Criteria:

* patient suspected of having a thoracic outlet syndrome
* patient having carried out additional examinations as part of the diagnostic assessment : venous and arterial Doppler or dynamic arteriography and venography
* patient having carried out a dynamic TcpO2 recording

Exclusion Criteria:

* patient under 18 year old
* non french speaker
* patient who expressed his/her refusal

Primary outcomes:
measure: DROPmin according on the type of compression
timeFrame: thirty minutes
Secondary outcomes:
measure: DROPmin according on the degree of arterial stenosis
timeFrame: thirty minutes
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
References:
Clinical trial NCT01806766: Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings
Official title: Comparison of Ceramic-on-Ceramic and Ceramic-on-Highly-Cross-Linked Polyethylene Bearings in Primary Cementless Total Hip Arthroplasty in the Same Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteonecrosis
Osteoarthritis
Keywords: cementless total hip arthroplasty
ceramic on ceramic bearing
ceramic on highly cross linked polyethylene
young patient
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 100
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 prospective, randomized study was to compare the clinical and radiographic results and the prevalence of osteolysis of the cementless total hip arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked polyethylene bearings on the other side in the young and active patients.


Eligibility criteria: Inclusion Criteria:

* Primary hip osteoarthritis
* Secondary hip osteoarthritis
* Avascular necrosis of femoral head

Exclusion Criteria:

* Previous surgical history of hip

Primary outcomes:
measure: Harris hip score
timeFrame: Pre-op, last follow-up(11-13 years)
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
timeFrame: preop, last follow-up(11-13 years)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Young-Hoo Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03927066: Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans
Official title: Physiological Validation of Current Machine Learning Models for Hemodynamic Instability in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension and Shock
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will be collecting data on participants undergoing lower body negative pressure (LBNP) to simulate progressive blood loss. The goal of the study is to collect data to allow for development of an algorithm with machine learning to predict blood pressure responses to hyporvolemia by analyzing the arterial waveforms collected during LBNP.

Detailed description: Death from exsanguination continues to be a major problem in combat casualty care and the care of civilians subjected to trauma. The ability to detect significant blood loss using traditional vital signs (heart rate, blood pressure) is marginal due to a variety of compensatory mechanisms that maintain blood pressure in the face of marked reductions in circulating blood volume. Along these lines, it is critical to develop monitoring devices and algorithms to non-invasively assess central blood volume in humans for the purposes of facilitating more timely interventions. The standard way to simulate hemorrhage in humans is to use Lower Body Negative Pressure (LBNP). In this technique, the lower body of a supine volunteer is enclosed in an airtight container while suction is applied to cause venous pooling in the legs and reduce central blood volume. This technique generates many physiological adaptations that are similar to that observed during blood loss studies in animals and human volunteers. Thus, the purpose of this study is to obtain data for use in developing monitoring technology to detect hemorrhage and other surrogate markers of central blood volume in humans.

Eligibility criteria: Inclusion Criteria:

* Non-obese (BMI \< 30)
* Non-smokers
* Free of any systemic diseases including hypertension, diabetes, coronary artery disease, neurologic disease, or any other major medical co-morbidity
* Women will be either surgically sterilized or non-pregnant as determined by a urine pregnancy test

Primary outcomes:
measure: Blood Pressure
timeFrame: One day of study visit
Secondary outcomes:
measure: Heart rate
timeFrame: One day of study visit
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Timothy B Curry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03947866: Ezetimibe-Rosuvastatin Evaluation Study
Official title: An Observational Clinical Study to Evaluate the Effectiveness of Fixed-dose Combination of eZEtimibe-rosUvaStatin.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypercholesterolemia
Hyperlipidemias
Combinations of Drugs; Dependence
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hyperlcholesterolaemia

Brief summary: Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in achieving the target plasma LCL-C level.

Detailed description: Additional study objectives:

1. Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia with respect to changes in the rest of the lipid profile (HDL-C, TC, TG).
2. Evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in altering non-HDL cholesterol (non-HDL - cholesterol) levels.
3. The assessment of the achievement of the LCL-C target of patients receiving the stable ezetimibe-rosuvastatin combination according to their cardiovascular risk category.
4. Assessing patient safety throughout treatment.

Eligibility criteria: Inclusion Criteria:

* Adult patients who have voluntarily consented to participate in the study.
* Adult patients who are already on treatment with the stable combination of ezetimibe-rosuvastatin (Lipopen), at the discretion of the treating physician.
* Adult patient adequately controlled with rosuvastatin and ezetimibe according to ESC / EAS 2019 guidelines.

Exclusion Criteria:

* Patients who have not fully understood the study procedures and have not signed the consent form.
* Patients who are contraindicated for taking the drug according to the Summary of Product Characteristics (MSF) of the study drug.

Hypersensitivity to the active substances or to any of the excipients of Lipopen.

* Pregnancy and breastfeeding.
* Active liver disease involving unexplained, persistent increases in serum transaminases and any increase in serum transaminases that exceeds 3 times the normal upper limit (ULN) or unexplained persistent increases in serum transaminases.
* Patient with severe renal impairment (creatinine clearance \<30 ml / min).
* Patient with myopathy
* Patient receiving concomitant treatment with cyclosporine

Primary outcomes:
measure: LDL-C
timeFrame: 12 months
Secondary outcomes:
measure: Lipidemic profile
timeFrame: 12 months
measure: Cardiovascular risk factor
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Athens University Hospital HIPPOKRATEION
Study officials:
References:
Clinical trial NCT04248166: Thyroid Cancer and Photoacoustic Imaging
Official title: Diagnosis of Thyroid Cancer Using Photoacoustic Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Cancer
Thyroid Nodule
Keywords: Thyroid cancer
Photoacoustic imaging
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Pohang University of Science and Technology
First posted: 2020-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to evaluate the usefulness of photoacoustic imaging in thyroid nodules. In addition, we would like to confirm the relationship between the results of photoacoustic imaging and histopathologic findings when thyroid nodules were diagnosed as thyroid cancer.


Eligibility criteria: Inclusion Criteria:

* All thyroid nodule identified as benign or as thyroid cancer

Exclusion Criteria:

* Patient refuses to participate in the study or withdraws consent

Primary outcomes:
measure: Photoacoustic analysis of thyroid nodule and thyroid cancer
timeFrame: As soon as the photoacoustic test was performed
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
Study officials:
References:
Clinical trial NCT05682066: TVMR With the Innovalve System Trial - Pilot in Georgia
Official title: TVMR With the Innovalve System Trial - Pilot in Georgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2023-01-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Detailed description: The study is a multi-center, First-In-Human, prospective, single pilot study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Eligibility criteria: Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
* EF\<25%

Primary outcomes:
measure: Absence of implant or delivery related serious adverse events at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Technical success
timeFrame: Procedure
measure: Procedural success
timeFrame: 30 days
measure: NYHA functional class
timeFrame: 30 days, 6, 1 year
measure: Six-minute walk test
timeFrame: 30 days, 6, 1 year
measure: Quality of life improvement (KCCQ-12) Kansas City Cardiomyopathy Questionnaire
timeFrame: 30 days, 6, 1 year
measure: Reduction in Mitral Regurgitation grade
timeFrame: 30 days, 6, 1 year
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
Study officials:
References: