louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00702104: Frequency of Prostate-Specific Antigen Screening in African American Men in the San Francisco Area
Official title: PSA Screening of African-American Men in The San Francisco Area
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-06-20
Sex: MALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to treat.

PURPOSE: This research study is looking at whether patients who are being screened for prostate cancer have been previously screened.

Detailed description: OBJECTIVES:

Primary

* To determine the degree to which patients who are being screened for prostate cancer have been previously screened.

OUTLINE: Participants complete questions on a survey about prior prostate-specific antigen blood tests done for the purpose of screening for prostate cancer and are asked about their pastor, church, and how they heard about the SELECT study to determine the degree to which African-American men in a church-going population have been previously screened.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets all of the following criteria:

  * African-American male
  * Age 35 years or older
  * Attends church on a regular basis
  * Resides in the San Francisco area

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Degree to which patients who are being screened for prostate cancer have been previously screened
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mack Roach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914004: To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets
Official title: A Two-Way Crossover Bioequivalency Study Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Antidepressant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioequivalency of comparing single 100 mg doses Of Cord's 50 mg Desipramine Hcl tablets to Merrell Dow's 50 mg Norpramin tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biodecision Laboratories
name: Jules Kann, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04112004: Effect Of Delta Sodium on the Postoperative Outcomes in Liver Transplant Recipients
Official title: Effect of Perioperative Delta Sodium on Outcomes in Liver Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
Perioperative/Postoperative Complications
Electrolyte Disturbance
Keywords: liver transplantation
perioperative sodium
sodium
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver transplant recipients more than 18 years in ILBS during study period

Brief summary: We analyzed the association of delta sodium levels with their effect on post liver transplant outcomes in consecutive patients undergoing liver transplantation. Records were analyzed for electrolytes and outcome measures, and data was analyzed.

Detailed description: Preoperative hyponatremia was identified in patients. The mean change in sodium in hyponatremic patients was compared with inpatients with normal sodium levels. The impact of the delta sodium levels with short-term outcomes, such as duration of intubation, intensive care unit length of stay were analyzed with univariate and multivariate logistic regression analyses.

Eligibility criteria: Inclusion Criteria:

* All liver transplant recipients between Jan 2011 to Jan 2017
* Records available

Exclusion Criteria:

* Acute fulminant liver failure
* All patients less than 18 years
* Re operated cases
* Pregnant patients

Primary outcomes:
measure: change in serum sodium in liver transplant recipients
timeFrame: 1 day
measure: post transplant mortality
timeFrame: 1 month
Secondary outcomes:
measure: post operative neurological complications
timeFrame: 1 month
measure: duration of mechanical ventilation
timeFrame: 1 month
measure: Duration of hospital stay
timeFrame: 1 month
measure: Duration of ICU stay
timeFrame: 1 month
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Karthik T Ponnappan, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04938804: Non-risk Based Lang Cancer Screening With a One-off LDCT
Official title: Non-risk Based Lung Cancer Screening With One-time Low-dose Computed Tomography: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Screening
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 11000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021.The primary outcome was LC detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases, and to investigate the various factors associated with the development of LC.

Detailed description: Guangzhou Lung-Care Project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of LC, recruiting residents aged 40-74 years from four communities in Guangzhou between 2015 and 2021. Follow-up for post-screening management and survival was recorded. The primary outcome was LC detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage I LC cases, and to investigate the various factors associated with the development of LC. Additionally, we compared the detection rates of LC and the proportion of stage I LC cases between "high-risk" and "non-high-risk" groups according to the National Comprehensive Cancer Network (NCCN) guidelines and Chinese guideline.

Eligibility criteria: Inclusion Criteria:

* Minimum age of 40 years among the residents in Guangzhou

Exclusion Criteria:

* Persons who had a diagnosis or treatment related to LC within the past 5 years, had undergone chest CT within the past year, or had significant cancer-related symptoms (e.g., hemoptysis, dyspnea, inability to climb two flights of stairs).

Primary outcomes:
measure: The detection rate of lung cancer
timeFrame: 11 years
measure: To investigate the various factors associated with the development of lung cancer
timeFrame: 11 years
Secondary outcomes:
measure: Detection rates of lung cancer and the proportion of stage I lung cancer cases between "high-risk" and "non-high-risk" groups
timeFrame: 11 years
measure: Cost-effectiveness ratio (costs of examinations, diagnoses, and treatments)
timeFrame: 11 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Wenhua Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03793504: Cardio-Respiratory Response of a Training Session Versus an Adapted Physical Activity Session
Official title: Cardio-Respiratory Response of an Exercise Training Session With Ergocycle or Treadmill Compared to an Adapted Physical Activity Session on a Wii, in Patients With Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease
Keywords: pulmonary rehabilitation
exercise
physical activity
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with pulmonary disease admitted in pulmonary rehabilitation unit of CHU Brest

Brief summary: the aim of this study is to show that training session with nintendo WII requires the same cardiorespiratory demand than training session on ergocycle or treadmill, traditionally used in pulmonary rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* patients with pulmonary disease

Exclusion Criteria:

* exacerbation of the pulmonary disease
* Weight \>150Kg
* Refusal to participate
* People in pre and post surgical rehabilitation

Primary outcomes:
measure: compare heart rate between a training session on cycle or treadmill and a training session on Nintendo WII
timeFrame: one day
Secondary outcomes:
measure: compare dyspnea between a training session on cycle or treadmill and a training session on nintendo WII
timeFrame: one day
measure: compare lower limb muscle fatigue between a training session on cycle or treadmill and a training session on nintendo WII
timeFrame: one day
measure: compare pulse oxymetry (SpO2) between a training session on cycle or treadmill and a training session on nintendo WII
timeFrame: one day
measure: Compare the felt pleasure between a training session on cycle or treadmill and a training session on nintendo WII
timeFrame: one day
Other outcomes:
Locations:
city: Morlaix
country: France
facility: CH Morlaix
Study officials:
affiliation: CHRU de Brest
name: Marc BEAUMONT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00409604: PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)
Official title: Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2006-12-11
Enrollment: 60
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: To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

Detailed description: To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute myocardial infarction, requiring PCI within 2 to 6 hours following symptoms
* Total occlusion of a coronary artery with reference vessel diameter \>or= 3mm

Exclusion Criteria:

* Thrombolitics
* Severe bradycardia requiring cardiac pacing
* Previous PCI or CABG
* Recent stroke or CV surgery
* Recent major surgery or trauma
* Clinical and hemodynamic unstability
* Implanted CRM device
* Evidence of previous MI
* Diabetes using rosiglitazone or other fibrates
* Permanent AF
* Mechanical tricuspid valve
* Pregnancy
* Exclusion for MRI
* Incapability of participating in exercise test

Primary outcomes:
measure: Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months
timeFrame: 4 & 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital of Maastricht (azM)
Study officials:
affiliation: University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands
name: JOhannes Waltenberger, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waltenberger J, Gelissen M, Bekkers SC, Vainer J, van Ommen V, Eerens F, Ruiters A, Holthuijsen A, Cuesta P, Strauven R, Mokelke E, Gorgels A, Prinzen FW. Clinical pacing post-conditioning during revascularization after AMI. JACC Cardiovasc Imaging. 2014 Jun;7(6):620-6. doi: 10.1016/j.jcmg.2014.01.017.
Clinical trial NCT06935604: Healing Hearts of Hospitalized Patients
Official title: Healing Hearts of Hospitalized Patients: A Randomized, Non-inferiority Study of Therapeutic Virtual Reality Facilitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Anxiety
Stress
Loneliness
Keywords: Virtual Reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to investigate therapeutic virtual reality (VR) facilitation with adult inpatients using VR as an analgesic and anxiolytic during their hospitalization. Specifically, this study will evaluate the outcomes of patients who experience therapeutic VR with and without a trained facilitator as a form of escapism.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and above
* Able to provide informed consent
* Able to follow commands
* Adequate motor skills for upper extremities to operate VR equipment
* Clinically stable
* Experiencing anxiety related to their medical condition as evidenced by a VAS-A score \>4 at time of enrollment.
* English speaking
* Willing to engage in Therapeutic VR

Exclusion Criteria:

* Severe cognitive impairment
* Facial trauma prohibiting headset use
* Physical limitations in facial, neck, upper extremities that hinder use of VR equipment
* Aggression or violence
* Harm to self or others
* Isolation room
* History of seizures or other neurological conditions
* Severe motion sickness
* Active nausea
* Severe visual impairment
* Severe cognitive impairment

Primary outcomes:
measure: Change in anxiety levels
timeFrame: baseline, immediately after the intervention
Secondary outcomes:
measure: Change in pain levels
timeFrame: baseline, immediately after the intervention
measure: The Perceived Stress Scale
timeFrame: Baseline
measure: State-Trait Anxiety Inventory
timeFrame: baseline, immediately after the intervention
measure: Change of Visual Analog Scale for Stress (VAS-Stress)
timeFrame: baseline, immediately after the intervention
measure: Change in Loneliness as Measured by the UCLA 3-Item Loneliness Scale
timeFrame: baseline, immediately after the intervention
measure: Participant Satisfaction as Measured by a Self-Developed Satisfaction Survey
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Health Care (SHC)
state: California
Study officials:
References:
Clinical trial NCT03563404: Portal Blood Flushes in the Peri-Reperfusion Stage of Liver Transplantation
Official title: Are Portal Blood Flushes Useful in Maintaining Hemodynamic Stability in the Peri-Reperfusion Stage of Orthotopic Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Disease
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 20
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: Liver Transplant

Brief summary: By showing that increased levels of acidotic metabolites and electrolytes in the systemic blood of patients who do not receive portal blood flush prior to reperfusion compared to patients who do receive portal blood flush, and that these increased levels correlate with cardiac depression as seen on TEE, the investigators hope to find a superior technique for liver reperfusion.


Eligibility criteria: Inclusion Criteria:

* Liver Transplantation
* 18 years old or older

Exclusion Criteria:

* None

Primary outcomes:
measure: Hemodynamic Stability
timeFrame: 5 days
Secondary outcomes:
measure: correlation between the cardiac dysfunction and the degree of hyperkalemia seen after reperfusion.
timeFrame: 5 days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Grayce Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01233804: Opting In vs Opting Out
Official title: Opting In vs Opting Out: Impact on Influenza Vaccination in Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Vaccination
Keywords: influenza vaccination rates
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Gilstrap, Larry C, M.D.
First posted: 2010-11-03
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare methods for consenting (opting in vs opting out) on influenza vaccine uptake rate in pregnant women. This study is designed to learn about the impact of influenza vaccination in pregnant women. This study will help gather knowledge about influenza vaccine side effects (if given) and whether the vaccine reduces the number of respiratory infection in mothers and their infants.

Detailed description: Pregnant women who present for routine prenatal care when influenza vaccine is available would be eligible. Enrolled women would be randomized to either the Opting in (obtaining written consent to administer the vaccine) or Opting out (signing only to refuse the vaccine) study group (Part 1). Vaccine uptake rate and reason for refusal will be captured for enrollees. At the end of this clinic visit, enrollees will be asked if they are interested in participating in Part 2 and 3 of the study. If yes, consent will be obtained. Part 2 of the study, a random sample of 50 women will be called 2 days after enrollment to determine 1) vaccine side effects 2) recall of information provided in consent and 3) to confirm next followup visit with Obstetrician. During Part 3, at 6 weeks post EDD (estimated due date), data about episodes of respiratory illness in the mothers and their infants occuring between the time when influenza vaccine was offered (Part 1) and 6 weeks post-EDD will be abstracted using a standard form. Data will be collected retrospectively by research nurses.

Eligibility criteria: Inclusion Criteria:

* pregnant female age \>17 years
* presenting for routine PNC at UT Houston or UT Galveston
* pregnant during influenza season
* pregnant when influenza vaccine available

Exclusion Criteria:

* influenza vaccine contraindication

Primary outcomes:
measure: Vaccination rates
timeFrame: time 0 of part one study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch, Women's Clinics
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston, Professional Building
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Susan H Wootton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06934304: The Impact of a Redesigned Handout for Robotic Sacrocolpopexy on Patient Preoperative Preparedness and Satisfaction
Official title: Randomized Controlled Study on Patient Preoperative Preparedness and Satisfaction Using a Redesigned Handout for Robotic Sacrocolpopexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Patient Satisfaction
Keywords: Robotic sacrocolpopexy handout study
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of Texas, Southwestern Medical Center at Dallas
First posted: 2025-04-18
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn if a new preoperative handout for patients undergoing robotic sacrocolpopexy will improve patient sense of preparedness and satisfaction in comparison to the previously used handout. The main questions it aims to answer are:

* Does the new preoperative handout for patients undergoing robotic sacrocolpopexy improve patient preparedness and satisfaction?
* Will the new preoperative handout for patients undergoing robotic sacrocolpopexy impact postoperative queries in the form of phone calls and messages to the clinic?

Participants will:

* Receive routine counseling regarding robotic sacrocolpopexy from their surgeon
* Be randomized to the new or old preoperative handout
* Undergo robotic sacrocolpopexy
* Complete a questionnaire at their 4 week postoperative follow up visit regarding their sense of preparedness for surgery and overall satisfaction


Eligibility criteria: Inclusion Criteria:

* women who were to undergo robotic sacrocolpopexy with or without supracervical hysterectomy, rectopexy, salpingectomy, urinary incontinence procedures, or other minor procedures.

Exclusion Criteria:

* patients unable to provide informed consent, those undergoing other concomitant major abdominal surgeries, patients less than 18 years old, pregnant patients, non-English speaking patients, and patients planning postoperative follow up at an outside facility.

Primary outcomes:
measure: Patient preparedness
timeFrame: Assessed at the postoperative visit 4 to 6 weeks after srugery
Secondary outcomes:
measure: patient satisfaction
timeFrame: 4 week postoperatively
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: