louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02396186: An Assessment of the Glider Balloon in Complex Lesions
Official title: An Assessment of the Glider Balloon in Complex Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: TriReme Medical, LLC
Sponsor class: INDUSTRY
First posted: 2015-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases of coronary interventions involving the Glider™ PTCA Balloon Catheter at participating centers will be reviewed for patient eligibility. Patients from all eligible cases should be invited to sign an IRB-approved Informed Consent.

Brief summary: The purpose of this study is to collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions.

Detailed description: Observational Study collecting data on commercial cases in which the Glider PTCA Balloon Catheter is used in accordance with the instructions for use. This study includes up 500 patients at up to 50 study sites.

Eligibility criteria: Inclusion Criteria:

1. Lesion must be successfully crossed with a guidewire without complication (including Chronic Total Occlusions (CTOs))
2. The Glider balloon may only be used at one lesion during the procedure
3. The lesion in which the Glider balloon is used must be completed first
4. The primary lesion treated during the procedure must be treated with the Glider balloon
5. Intended treatment of a protocol-defined complex lesion that has at least one of the following factors:

   * Significant vessel tortuosity
   * Failed balloon crossing with another balloon
   * Tight stenosis
   * Heavy calcification
   * Side branch present

Exclusion Criteria:

1. Patient \< 18 years of age
2. Lesion longer than 40mm
3. Device use not consistent with Instructions for Use
4. Patient has not given consent for their data to be submitted to this registry

Primary outcomes:
measure: Technical Success Rate
timeFrame: 1 hour
Secondary outcomes:
measure: Freedom from Balloon Slippage
timeFrame: 1 hour
measure: Lesion Success Rate
timeFrame: 48 hours
Other outcomes:
Locations:
city: Elk Grove Village
country: United States
facility: Alexian Brothers Heart and Vascualr Institute
state: Illinois
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Cardiovascular Specialists of Texas
state: Texas
Study officials:
affiliation: Scottsdale Healthcare
name: David Rizik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: William Lombardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130686: A Clinical Evaluation of Omron Digital Blood Pressure Monitor
Official title: A Clinical Evaluation of OMRON Digital Blood Pressure Monitor, HEM-9210T, Blood Pressure Measurement Accuracy Based on Auscultation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: Omron Healthcare Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Biwako Chuo Hospital Japan
name: Shared Care Research and Education Consulting,. Inc. US
First posted: 2017-04-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Resident of a community

Brief summary: The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.


Eligibility criteria: Inclusion Criteria:

* Upper arm circumference: 17-50cm

Exclusion Criteria:

* Patients who has arrhythmia.
* When body motion is observed during measurement.
* Korotkoff sound is poor quality.
* Patient's arm circumference is outside cuff range.
* Patient's auscultatory systolic blood pressure readings differ by more than 12mmHg. and patient's diastolic blood pressure readings differ by more than 8mmHg.
* Patients stated they did not wish to continue with the study and it is stopped before completion.

Primary outcomes:
measure: Verify the accuracy of measure functions of device
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Muko
country: Japan
facility: OMRON HEALTHCARE CO., Ltd.
Study officials:
References:
Clinical trial NCT00673686: Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D
Official title: Single Center, Double-blind, Randomized Study to Compare the Effect of SH T 00186 D on Follicular Development in a 24-day Regimen Versus a 21-day Regimen in Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraceptives, Oral
Keywords: Oral contraceptive
Ovulation
Missing pills
Intake compliance
Cycle control
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on "contraceptive robustness" of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.


Eligibility criteria: Inclusion Criteria:

* Healthy women aged 18 to 35 years inclusive (smokers aged up to 30 years inclusive)
* No contraindications for combined oral contraceptive (COC) use
* Follicular diameter of greater-equal than 15 mm on visit 6 (admission to treatment), or an observed ovulation during pretreatment cycle Exclusion Criteria:
* Pregnancy or lactation- Substantial overweight, i.e., body mass index (BMI) \> 30,
* Known hypersensitivity to any of the study drug ingredients
* Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study, or the interpretation of the results

Primary outcomes:
measure: Hoogland scores in cycles 2 and 3
timeFrame: Treatment cycles 2 and 3 (treatment weeks 5-12)
Secondary outcomes:
measure: Follicle size
timeFrame: Treatment cycles 2 and 3 (treatment weeks 5-12
measure: Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone
timeFrame: Treatment cycles 2 and 3 (treatment weeks 5-12
measure: Endometrial thickness
timeFrame: Treatment cycles 2 and 3 (treatment weeks 5-12
measure: Cervical mucus
timeFrame: Treatment cycles 2 and 3 (treatment weeks 5-12
Other outcomes:
Locations:
city: Groningen
country: Netherlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 mug compared with a 21/7 regimen of desogestrel 150 mug/ethinylestradiol 20 mug: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.
Clinical trial NCT03208686: The Men Are Now United Program
Official title: Self-Management of Diabetes in Black Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: Gender
Men
Black/African American
Self-management
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Claremont Graduate University
First posted: 2017-07-05
Enrollment: 41
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this application is to create and implement a targeted, culturally grounded, diabetes self-management intervention for Black men that uses social support, mobile health, and remote sensing technology to improve diabetes-related outcomes.

Detailed description: The investigators propose a single-subject, repeated measures intervention where each participant will serve their own control. Participants will serve as their own controls for a period of three months prior to the start of the four-month intervention. The study will conclude with an assessment 7-months from baseline. Single-subject designs are most often used in applied research. The design allows the participant to serve as the control, rather than using another individual/group. The design is sensitive to individual differences whereas group designs are sensitive to averages of groups. Year 1 is dedicated to the development of the text messages and the content for the 10 group meeting sessions. Year 2 focuses on the Time-1 control period assessment (pre-baseline at 3 months before the intervention), the Time-2 assessment (baseline), implementation of the 10-week intervention, a post-intervention assessment (Time-3), and 3-month follow up at Time-4, and analysis. Specifically, in Year 2, the primary outcome of A1c will be assessed at Time-1, 3 months later at the start of the intervention, at the end of the intervention, and at 7-months. The investigators will also include secondary assessments of glucose readings, waist circumference, and blood pressure.

Eligibility criteria: Inclusion Criteria:

* Black/African American
* Male
* Tyep 2 Diabetes
* 21 years old or older
* Owns cell or smart (mobile) phone or willing to use one if provided

Exclusion Criteria:

* Non-ambulatory
* Serious physical illness
* Psychiatric diagnosis of serious mental illness
* Serious diabetes complications impeding meaningful participation

Primary outcomes:
measure: Blood glucose levels
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Flint
country: United States
facility: Michigan State University
state: Michigan
Study officials:
References:
Clinical trial NCT04054986: Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer
Official title: Phase 1 Study Using First-in-Human Acidosis Imaging With [18F]AlF-cysVar3 pHLIP® (18F-Var3) in Patients With Breast Cancer for Determination of Safety, Biodistribution and Radiation Dosimetry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Breast Cancer
18F-Var3
First in human
Acidosis imaging
Memorial Sloan Kettering Cancer Center
19-147
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to measure the safety of the investigational imaging agent, 18F-Var3 and to determine if it is helpful in providing information about how tumor tissues behave.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or greater
* Biopsy-proven breast malignancy
* \>/= 1 viable lesion, \>/= 1 cm, confirmed on CT, MR, or FDG PET/CT within 4 weeks of protocol enrollment
* Newly diagnosed or recurrent disease, on or off therapy
* ECOG performance of 0-2 \*Note: Lesions are considered viable if they are stable or increasing soft tissue lesions, or if they are FDG-avid bone lesions

Exclusion Criteria:

* Life expectancy \< 3 months
* Pregnancy or lactation
* Biopsy or other surgical procedures within 48 hours prior to receiving study intervention
* Patients who cannot undergo PT/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 400 pounds

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
timeFrame: 30 days after completion of study treatment and assessments
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christopher Riedle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235286: Cutaneous Remote Ischemic Preconditioning in Plastic Surgery
Official title: Effects of Remote Ischemic Preconditioning in Cutaneous Microcirculation of Anterolateral Thigh Flaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Preconditioning
Keywords: remote ischemic preconditioning, free flap, microcirculation
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Background: In plastic and reconstructive surgery, free flaps are routinely used for treatment of soft tissue defects. Treatment strategies aim at reducing or preventing flap necrosis by conditioning tissue tolerance against ischemia. Although previous studies indicate that remote ischemic preconditioning (RIPC) is a systemic phenomenon, only a few studies have focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on a potential free flap location in a human in-vivo setting for the first time.

Conclusion: Remote ischemic preconditioning improves cutaneous tissue oxygen saturation, arterial capillary blood flow and postcapillary venous flow in a remote free flap donor location. To what extent remote preconditioning might ameliorate the reperfusion injury of free flap transplantation, further clinical trials have to evaluate both in the means of microcirculatory assessment and partial or total flap loss as end points of these studies.


Eligibility criteria: Inclusion Criteria:

* healthy male and female subjects aged 18 to 35 years

Exclusion Criteria:

* soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis, chronic kidney or liver disease, cardiac dysfunction, arterial hypotension and any type of vasoactive medication, i.e. ß-blockers, calcium channel blockers, nitroglycerin

Primary outcomes:
measure: Change in microcirculation
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover
Study officials:
affiliation: Medical School Hannover, Plastic, Hand and Reconstructive Surgery
name: Robert Kraemer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraemer R, Lorenzen J, Kabbani M, Herold C, Busche M, Vogt PM, Knobloch K. Acute effects of remote ischemic preconditioning on cutaneous microcirculation--a controlled prospective cohort study. BMC Surg. 2011 Nov 23;11:32. doi: 10.1186/1471-2482-11-32.
Clinical trial NCT01753986: Alcohol Use and Relationships - III
Official title: Impact of Brief Substance Use Intervention on Substance Use and Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intimate Partner Violence
Substance Use
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 500
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 investigators hypothesize that individuals receiving the brief substance use intervention will have better substance use and intimate partner violence outcomes than individuals receiving the general health improvement intervention. All participants receive standard batterer intervention.


Eligibility criteria: Inclusion Criteria:

* Participation in Batterer Intervention Program in RI
* Hazardous Drinking

Exclusion Criteria:

* drinks too much

Primary outcomes:
measure: lower levels of intimate partner violence
timeFrame: one year
Secondary outcomes:
measure: lower levels of substance use (alcohol and drug)
timeFrame: one year
Other outcomes:
measure: fewer arrests for violence recidivism
timeFrame: one year
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT01543386: Effects of Curcumin on Vascular Reactivity
Official title: Effects of Curcumin Loading Dose on Vascular Reactivity of Healthy Middle-aged Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers (Middle-aged Smokers)
Keywords: Polyphenol
Curcumin
Endothelium, vascular
Endothelium-dependant relaxing factor
Smoking
Transcriptome
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Association Régionale de Cardiologie d'Auvergne
name: ARDEC Association de Recherche de Développement et d'Enseignement de la Cardiologie
First posted: 2012-03-05
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

Detailed description: The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

Eligibility criteria: Inclusion Criteria:

* 50 to 70 year-old volunteers
* smokers

Exclusion Criteria:

* treated hypertension
* treated hypercholesterolemia
* chronic disease
* vegetarian or other unusual diets
* chronic alcoholism

Primary outcomes:
measure: Changes in brachial Flow Mediated Dilatation
timeFrame: at Visit 1 (Day 0) and visit 2 (Day3/day5)
Secondary outcomes:
measure: Changes in fingertip arterial tonometry
timeFrame: at visit 1 (day 0) and visit 2 (day3/day5)
measure: Modifications of leukocytes transcriptome
timeFrame: at visit 1 (day 0) and visit 2 (day3/day 5)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-René LUSSON
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barber-Chamoux N, Milenkovic D, Verny MA, Habauzit V, Pereira B, Lambert C, Richard D, Boby C, Mazur A, Lusson JR, Dubray C, Morand C. Substantial Variability Across Individuals in the Vascular and Nutrigenomic Response to an Acute Intake of Curcumin: A Randomized Controlled Trial. Mol Nutr Food Res. 2018 Mar;62(5). doi: 10.1002/mnfr.201700418. Epub 2018 Feb 12.
Clinical trial NCT04174586: Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
Official title: Cord Blood Microtransplantation for Treatment of Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Safety Issues
Efficiency
Keywords: Cord blood microtransplatation
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia

Detailed description: The investigators conducted a prospective, single center clinical trial to dissuss the outcomes and toxicities of HLA-mismatched cord blood infusion after chemotherapy (microtransplantation) in older patients with acute myeloid leukemia (AML)

Eligibility criteria: Inclusion Criteria:

1. de novo acute myeloid leukemia
2. age 60-80

Exclusion Criteria:

1. have no suitable donor or donor refused
2. patient refused to accept donor cells

Primary outcomes:
measure: complete remission rate
timeFrame: 1 month
measure: time of hematopoietic recovery
timeFrame: 1 month
Secondary outcomes:
measure: time to progression
timeFrame: 2 year
Other outcomes:
measure: diease free survival
timeFrame: 2 year
measure: overall survival
timeFrame: 2 year
measure: rate of early mortality
timeFrame: 1 month
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
Study officials:
affiliation: The First Affiliated Hospital of USTC
name: Zimin Sun
role: STUDY_CHAIR
References:
Clinical trial NCT06241586: A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis
Official title: A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We conducted a retrospective, before-after, single-center study from January 2019 to September 2022 at the Department of Surgery, Tianjin Nankai Hospital. Consecutive patients older than 18 years with necrotizing pancreatitis were included.

Brief summary: The goal of this observational study is to compare patient outcomes between the groups of patients admitted before and after the full implementation of the novel surgical strategy in patients with necrotizing pancreatitis. The main question it aims to answer are:

• the efficacy and safety of the novel surgical strategy To assess the efficacy and safety of the novel surgical strategy, all included patients were divided into two groups according to the timing of receiving treatment: 1) the early period group: patients admitted before January 2021 received the hybrid strategy of traditional and novel surgical strategies; and 2) the late period group: patients admitted during and after January 2021 received the complete novel surgical strategy.


Eligibility criteria: Inclusion Criteria:

Consecutive patients older than 18 years with necrotizing pancreatitis were included.

Exclusion Criteria:

Patients who met one or more of the following criteria were excluded: (1) had a past medical history of acute pancreatitis; (2) had drainage or surgery for pancreatic necrosis in other hospitals before admission to our institute; and (3) did not complete the treatment strategy owing to nonmedical reasons.

Primary outcomes:
measure: major complications
timeFrame: 90-day follow up
Secondary outcomes:
measure: mortality
timeFrame: 90-day follow up
measure: Admission of ICU
timeFrame: up to 90-days
measure: Length of hospital stay
timeFrame: up to 90-days
measure: individual major complications
timeFrame: 90-day follow up
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin NanKai Hospital
state: None Selected
Study officials:
References: