louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01314703: Topical Antimicrobial Effectiveness Testing
Official title: Test for Preoperative Skin Preparations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antimicrobial Effectiveness
Lead sponsor: CareFusion
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.


Eligibility criteria: Inclusion Criteria:

* in good general health
* have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.

Exclusion Criteria:

* topical or systemic antimicrobial exposure within 14 days prior to Screening Day

Primary outcomes:
measure: Antimicrobial Efficacy Will be Measured by the Change (+/-) in Bacterial Count on the Skin 10 Minutes After a Single Application of Test Material Relative to the Baseline Bacterial Count.
timeFrame: 10 minutes after single application of test material
Secondary outcomes:
Other outcomes:
Locations:
city: Sterling
country: United States
facility: Microbiotest
state: Virginia
Study officials:
affiliation: Microbiotest
name: Muhammad H Bashir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02015403: To Compare The Efficacy Of N -Acetylcysteine and Standard Therapy Versus Standard Therapy In The Prevention Of Ischemic Hepatitis And Survival Post Upper GI Bleed
Official title: TO COMPARE THE EFFICACY OF N -ACETYLCYSTEINE AND STANDARD THERAPY VERSUS STANDARD THERAPY IN THE PREVENTION OF ISCHEMIC HEPATITIS AND SURVIVAL POST UPPER GI BLEED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Hepatitis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences) emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care Unit) in view of upper GI bleed randomized to two groups

GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours

GROUP B : 110 Patients will receive standard care only

NAC will be given at following rate :

Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then continuous infusion of 6.25 mg/kg for the remaining 67 hrs


Eligibility criteria: Inclusion Criteria:

* Age \> 18 and \< 75
* Cirrhotics with UGIE (Upper Gastrointestinal Endoscopy ) within last 24 hours.

Exclusion Criteria:

* Non cirrhotic
* Hepatocellular carcinoma
* Advanced cardiopulmonary disease
* Pregnancy
* Extrahepatic malignancy
* Patient on anticoagulation therapy

Primary outcomes:
measure: To study the efficacy of NAC (N -ACETYLCYSTEINE) in preventing ischemic hepatitis in cirrhotics with upper Gastrointestinal bleed.
timeFrame: Day 5
Secondary outcomes:
measure: To study effect of NAC (N -ACETYLCYSTEINE) infusion on 5 day survival post bleed.
timeFrame: 6 weeks
measure: To study incidence of complication like AKI (Acute Kidney Injury), HE(Hepatic Encepahlopathy) and SBP(Spontaneous Bacterial Peritonitis).
timeFrame: day 5
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
citation: Maiwall R, Kumar A, Bhadoria AS, Jindal A, Kumar G, Bhardwaj A, Maras JS, Sharma MK, Sharma BC, Sarin SK. Utility of N-acetylcysteine in ischemic hepatitis in cirrhotics with acute variceal bleed: a randomized controlled trial. Hepatol Int. 2020 Jul;14(4):577-586. doi: 10.1007/s12072-020-10013-5. Epub 2020 Feb 11.
Clinical trial NCT05607303: Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
Official title: Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Headache
Gender Identity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 140
Sex: ALL
Minimum age (years): 9
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population is limited to transgender females (male sex, female gender identity) for the case population and cisgender males (male sex, male gender identity) for the purposes of the study analysis as outlined in the protocol.

Brief summary: With a rising population of transgender adults and youth, there is a need for more research to meet the needs of this community. Transfemale (MTF) youth (male sex, female gender identity) who begin clinical Gender Affirming Hormone Therapy (GAHT) with estrogen may be at a higher risk for headache since estrogen has been linked to headache in cisgender females (female sex, female gender identity). This research hopes to learn more about headache in MTF youth.

Detailed description: MTF youth who will begin estrogen clinically will be enrolled in the study and will be seen twice, once before starting estrogen and then one year after beginning estrogen. Cisgender males (male sex, male gender identity) will also be enrolled as a control group and will be seen once at the beginning of the study and then once a year later. The researchers will track how often youth have headaches during this time to see if it is different between groups. In a subset of the youth enrolled, an MRI will be completed to also look at brain structure and function.

Eligibility criteria: Inclusion Criteria:

For MTF youth (cases):

* Identify as MTF
* Age 11-20 years at the time of enrollment
* Plan to start estrogen clinically in \&lt; 6 months

For cisgender male youth (controls):

* Identify as cisgender male
* Age 9-20 years at the time of enrollment
* No diagnosis of Klinefelter Syndrome (XXY)

Exclusion Criteria:

* Cognitive, or psychiatric impairment resulting in inability to tolerate the study procedures not including depression or anxiety
* Known history of stroke, multiple sclerosis, or other serious neurologic condition

  * MRI-specific exclusion criteria (Weight \&gt; 500 lbs, claustrophobia, metal in body)

Primary outcomes:
measure: Change in frequency of headache.
timeFrame: 1 year
Secondary outcomes:
measure: Change in amygdala structure.
timeFrame: 1 year
measure: Change in resting state functional connectivity pattern.
timeFrame: 1 year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Jennifer Hranilovich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04274803: Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
Official title: Dose Intralipid Infusion Reduces Pregnancy Complications Caused by Antiphospholipid Antibody Syndrome?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Antiphospholipid Syndrome in Pregnancy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will address the value of adding intralipid infusion in reducing pregnancy complications related to antiphospholipid syndrome

Detailed description: This study will be conducted in the Department of Obstetrics and Gynecology, Tanta University on patients attending the antenatal care clinic and also on patients attending the researchers private clinics for antenatal care. The number of patients enrolled in the study will be 105 patients after application of inclusion and exclusion criteria.

All women wil be thoroughly informed about the study aims and through discussion about the procedure, associated benefits and risks and will sign a written consent.

Eligibility criteria: Inclusion Criteria:

* Pregnant women at booking date who were already diagnosed to have antiphospholipid syndrome (APS) .

Exclusion Criteria:

* Patients with gestational age ≥ 9 weeks
* patients with diagnosed other auto-immune disorder
* patients with chronic hypertension, diabetes mellitus, thyroid disorders,
* patient with renal diseases
* patients who requested to withdraw from the study at any point .

Primary outcomes:
measure: Fetal loss
timeFrame: within 9 months
measure: Premature delivery
timeFrame: Before 37 weeks
measure: Preeclampsia
timeFrame: > 20 weeks
measure: fetal growth restriction
timeFrame: within 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Adel Elgergawy
Study officials:
References:
Clinical trial NCT03727503: Casptesia Versus PICCO in Cardiac Surgical Patients in the ICU
Official title: Ability of a New PPV Smartphone Application to Predict Fluid Responsiveness in Cardiac Surgical Patients in the ICU
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Agreement and precision between two methods to measure pulse pressure variation (PPV)
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to assess the ability of a new smartphone PPV app to predict fluid responsiveness in cardiac surgical patients in the Intensive care unit (in the postoperative period)

Detailed description: Pulse pressure variation (PPV) remains a good predictor of fluid responsiveness in the ICU in ventilated and sedated patients. However, PPV can be time-consuming to calculate (manual determination), is not always displayed on monitoring screens nor reliable through visual assessment and needs additional often costly devices to be displayed. A new Android application (Captesia) automatically calculates the PPV utilizing a digital photograph of the arterial waveform from the monitor. The application determines the PPV by selecting peaks and troughs of the arterial curve.

Eligibility criteria: Inclusion Criteria:

* adults patients ( \>18 years)
* Patients scheduled for cardiac surgery
* equipped with a femoral arterial catheter and the PICCO device

Exclusion Criteria:

* Atrial fibrillation
* severe cardiac dysfunction

Primary outcomes:
measure: PPV measure
timeFrame: baseline
measure: PPV measure
timeFrame: 1 minute after the end of volume expansion
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: ERASME
name: Alexandre Joosten, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00721903: Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies
Official title: 3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancers
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2008-07-25
Enrollment: 88
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.

Detailed description: To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed breast cancer prior to receiving breast cancer therapy.
* Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.

Exclusion Criteria:

* Poorly controlled diabetes.
* Contralateral mastectomy prior to neoadjuvant chemotherapy.
* Not a surgical candidate.
* No previous axillary lymph node dissection.

Primary outcomes:
measure: Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
timeFrame: 2002-2014
Secondary outcomes:
measure: Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.
timeFrame: 2002-2014
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Paul L. Carson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Paul Carson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05972603: Role of Topical Vancomycin in Reducing Infections in Hip and Knee Arthroplasty
Official title: Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Primary Hip and Knee Arthroplasty? Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Rheumatoid Arthritis
Avascular Necrosis of Hip
Lead sponsor: Independent Public Healthcare Center in Rypin
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 1000
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 study is designed to assess the efficacy of vancomycin powder and dilute povidone-iodine lavage (VIP protocol) in reducing the PJI after primary Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA). We hypothesized that VIP protocol provides superior reduction of periprosthetic joint infection (PJI) rates after primary THA and TKA compared with diluted povidone-iodine (PI) protocol.

Detailed description: Patients who undergo primary hip or knee arthroplasty, before closure 0,35% povidone-iodine (17,5mL in 500 mL saline) solution lavage left for 3 minutes following final implantation.

Patients drawn by random numbers calculator will be administered with 1.0 g Vancomycin powder into the wound around the prosthesis and no suction will be used.

Eligibility criteria: Inclusion Criteria:

* undergoing THA or TKA as a result of osteoarthritis or rheumatoid arthritis, can understand and comply with the study protocol, have signed the informed consent document at screening

Exclusion Criteria:

* Patients referred to the hospital in order to undergo THA or TKA due to different reason than osteoarthritis, rheumatoid arthritis or avascular necrosis of the femoral head, such as: failed femoral neck fractures, displaced acetabular fractures or revision acetabular fractures, revision knee or hip arthroplasty

Primary outcomes:
measure: periprosthetic joint infection
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rypin
country: Poland
facility: IPHC Rypin
state: Kujawsko-pomorksie
Study officials:
References:
Clinical trial NCT06340503: Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors
Official title: Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors in Clinical Practice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Colon Cancer
Keywords: Physical activity
Exercise coaching
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-04-01
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer.

Detailed description: To assess the feasibility (participation rate, adherence, and retention) of the Physical Activity Index (PAI) intervention in breast and colon cancer survivors supported by exercise coaching and self-monitoring tools.

Eligibility criteria: Inclusion Criteria:

* Survivors of breast or colon cancer (stages 0-III) diagnosed within the last three years prior to enrollment.
* Completed primary treatment (surgery, chemotherapy, and/or radiation) at least 3 months prior to enrollment.
* At least 50 years of age or older.
* Access to internet or cellular plan for video calls.
* Being willing and able to comply with the approved protocol and able to sign an IRB-approved informed consent document directly, remotely or via electronic consent.
* Able to read and speak English

Exclusion Criteria:

* Participants with metastatic disease.
* Participants with recurrence or diagnosis of a different cancer.
* Participants receiving treatment other than maintenance therapy for their primary cancer (breast or colon).
* Participants has prior conditions that contraindicate exercise as determined by treating physician.
* Participants has gross cognitive impairment as determined by treating physician.

Primary outcomes:
measure: Number of Eligible Participants - Participation Rate
timeFrame: 17 months
measure: Percentage of Participants to Complete Exercise Sessions - Adherence
timeFrame: 17 months
measure: Number of Participants Who Complete Study Questionnaires - Retention
timeFrame: At baseline and up to 17 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Shirley Bluethmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02842203: Use of CtDNA for Monitoring of Stage III Colorectal Cancer
Official title: Use of CtDNA for Monitoring of Stage III Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stage III Colorectal Cancer
Keywords: colorectal cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-07-22
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present in a UPMC Cancer Center and meet the criteria for this study will be approached by their treating physician about participation.

Brief summary: This observational study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of disease recurrence in stage III colorectal cancer (CRC).

Detailed description: Circulating tumor DNA (ctDNA) are small fragments of nucleic acid that originate from apoptotic or necrotic tumor cell turnover. Characteristic of the malignant process, ctDNA can be assessed in plasma and offers the potential of a sensitive and specific biomarker for prognostic information on disease-free or overall survival, and predictive information on chemotherapy resistance and probability of lack of response to treatment. This study will evaluate ctDNA as a prognostic marker and as a monitor of disease recurrence in stage III colorectal cancer (CRC). We will recruit newly diagnosed stage III CRC patients, determine their tumor mutational profile, and systematically collect high volume (\>10 ml), serial plasma specimens every 3 months for up to 3 years and every 6 months in years 4-5 for ctDNA and concurrent carcinoembryonic antigen (CEA) measurement. Clinical outcome and survival will be tracked. The resulting data will permit assessment of ctDNA as a prognostic marker for disease-free and overall survival and as a monitor of disease recurrence in comparison with CEA.

Eligibility criteria: Inclusion Criteria:

* Men and women with CRC Stage III A, B, or C
* Age ≥18 years
* Willingness to provide blood samples for research purposes
* Ability to understand written informed consent document, and written informed consent provided

Exclusion Criteria:

* Blood sampling would compromise patients overall health such as presence of severe anemia
* Unable to give informed consent

Primary outcomes:
measure: ctDNA assessment and relation to clinical outcome
timeFrame: up to 5 years
Secondary outcomes:
measure: ctDNA versus CEA
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Robert Schoen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02106403: A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
Official title: A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this randomised, examiner and subject blinded study is to evaluate and compare cooling performance and overall consumer liking of the prototype formulation with the currently marketed wound spray and negative control in subjects with experimental wounds. For each subject, three superficial wounds will be induced on two volar forearms, by sequential tape strippings until a glistening layer is visualized. After wounding, a randomised test product will be sprayed twice on test site, and the subject will be asked to complete a questionnaire evaluating product cooling performance and overall liking.


Eligibility criteria: Inclusion Criteria:

* Participants in good health with healthy and intact skin on the test area
* Age 18-60 years

Exclusion Criteria:

* Pregnancy or breast-feeding
* Allergy/Intolerance
* Participants currently taking any topical or systemic treatments that may interfere with or mask the test results
* Participants who have taken any topical anti-inflammation treatment in the application area in past 2 months
* Participants who are vulnerable to any intervention
* Damaged skin close to test site, active skin disorders, any visible skin disorder

Primary outcomes:
measure: Participant-perceived Cooling Sensation Immediately Post Product Application
timeFrame: Immediately after product application
measure: Participant-perceived Cooling Sensation at 3 Min
timeFrame: At 3 min after product application
measure: Participant-perceived Cooling Sensation at 5 Min
timeFrame: At 5 min after product application
measure: Participant-perceived Cooling Sensation at 15 Min
timeFrame: At 15 min after product application
Secondary outcomes:
measure: Overall Sensory Liking of Study Products
timeFrame: Immediatey, 3 min, 5 min and 15 min after product application
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Landproof Testing Technology Co., LTD
state: Guangdong
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: