louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02082470: Survivorship Care Planning in Improving Quality of Life in Survivors of Ovarian Cancer
Official title: Feasibility and Preliminary Outcomes of Survivorship Care Planning in Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Stage IA Ovarian Epithelial Cancer
Stage IB Ovarian Epithelial Cancer
Stage IC Ovarian Epithelial Cancer
Stage IIA Ovarian Epithelial Cancer
Stage IIB Ovarian Epithelial Cancer
Stage IIC Ovarian Epithelial Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIC Ovarian Epithelial Cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-10
Enrollment: 14
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies survivorship care planning in supporting quality of life in ovarian cancer survivors following primary treatment. Survivorship care plans have the potential to empower patients and provide them with a plan of care following treatments. Survivorship care planning may support patient's overall well-being and quality of life after treatment of ovarian cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the feasibility and acceptability of survivorship care planning (SCP) in ovarian cancer.

SECONDARY OBJECTIVES:

I. To develop the infrastructure and strategy for a larger comparative intervention study (National Cancer Institute \[NCI\] R01).

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants receive standard post-treatment care consisting of regular cancer surveillance visits with treating oncologists.

ARM II: Participants complete survivorship care planning in close collaboration with treating oncologists.

After completion of study treatment, participants are followed up at 2 months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage I, II, or III ovarian cancer
* Ability to read or understand English
* All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Primary outcomes:
measure: Percentage of attrition
timeFrame: 2 months
measure: Total retention
timeFrame: 2 months
measure: Recruitment rates
timeFrame: 2 months
measure: Patient satisfaction assessed using the Survivor Satisfaction Tool and Debriefing Form
timeFrame: 2 months
Secondary outcomes:
measure: Infrastructure for a larger comparative intervention study
timeFrame: 2 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Virginia Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05620875: The Association Between Delivered Oxygen and Cerebral Impact During the Use of Cardiopulmonary Bypass.
Official title: The Association Between Delivered Oxygen and Cerebral Impact During the Use of Cardiopulmonary Bypass.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac; Arteriosclerosis
Aortic Valve Disease
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2022-11-17
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 research subjects scheduled for coronary arterial bypass grafting surgery and/or aortic valve replacement in Uppsala University Hospital.

Brief summary: Investigating the connection between delivered oxygen index and cerebral impact with COx (cerebral oximetry index) och cerebral injury markers during the routine use of cardiopulmonary bypass.

Detailed description: The research subjects are to be treated with CPB with according to local standards (perfusion index 2.4 x body surface area). While measuring impact on cerebral autoregulation with the aid of Near InfraRed Spectroscopy (NIRS) and brain injury markers in blood, research subjects depending on initial hemoglobin value, will divide into two subgroups: one with DO2I of \>280 ml/min/m2, and one with DO2I of \<280 ml/min/m2.

DO2I will during CPB be calculated using the patient data monitoring system Metavision.

With a correlation analysis between NIRS and MAP (mean arterial pressure) a COx (Cerebral Oxymetry Index) r-value can indicate impact on cerebral autoregulation with values \>0.3 - 0.5 during use of CPB 4.

Brain injury markers (Tau, Glial Fibrillary Acidic Protein (GFAP), Neurospecific Enolase (NSE)) are collected during 5 occasions during the first 24 hours and then once per day for 4 days, as well as markers for AKI (S-Creatinine) in some extent.

Registrations during the intensive care regarding delirium, stroke or other neurological impact will also be included in the study.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for CABG and/or AVR

Exclusion Criteria:

* Former diagnosed neurological insults, carotid stenosis

Primary outcomes:
measure: COx
timeFrame: 24 hours
measure: Brain injury markers; tau, GFAP, NSE
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University
name: Karl-Henrik Grinnemo, Adj. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04142775: Predictors of Intracranial Hemorrhage in ARDS Patients on ECMO
Official title: Predictors of Intracranial Hemorrhage in Critically Ill Patients With Acute Lung Failure (ARDS) on Extracorporeal Membrane Oxygenation (ECMO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS, Human
Extracorporeal Membrane Oxygenation Complication
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically ill patients on the ICU with acute lung failure (ARDS) in a German regional ARDS referral center

Brief summary: Intracranial hemorrhage is is a rare, but critical incident in patients with acute lung failure undergoing ECMO therapy. Predictors of intracranial hemorrhage are yet to be defined to identify patients at (high) risk. This retrospective analysis investigates the predictive value and validity of parameters and specific risk factors of critically ill ARDS patients treated with ECMO.


Eligibility criteria: Inclusion Criteria:

* ARDS following Berlin definition (mild, moderate, severe)
* ECMO therapy (veno-venous cannulation)

Exclusion Criteria:

* ECMO, other than VV
* ICH at initiation of ECMO
* no cerebral CT scan at any time

Primary outcomes:
measure: mortality
timeFrame: up to 28 days
Secondary outcomes:
measure: ICU stay
timeFrame: up to 28 days
measure: ventilator/ECMO-free days
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite university medicine Berlin
Study officials:
References:
Clinical trial NCT03757975: Impact of Hysterectomy on Quality of Life and Urethral Length
Official title: Impact of Hysterectomy and Supracervical Hysterectomy on Quality of Life, Urinary Incontinence and Urethral Length
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibroid Uterus
Urethral Diseases
Sex Disorder
Keywords: quality of life
urethral length
sexual function
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who have been qualified to hysterectomy due to fibroids or other benign cndition and who had not undergone any vaginal operation in the past

Brief summary: To establish the impact of hysterectomy on sexual function, urethral length and quality of life

Detailed description: The investigators evaluate impact of total hysterectomy (abdominal, by laparoscopy and vaginal) and supracervical hysterectomy (abdominal and by laparoscopy) on quality of life, sexual function, urethral length and urinary incontinence. The patients fulfill questionnaires (UDI 6, IIQ7, FSFI and ICIQ) before operation and 6 months after. Additionally the investigators measure urethral length before procedure and 6 months after.

Eligibility criteria: Inclusion Criteria:

* patients qualified to hysterectomy due to benign condition

Exclusion Criteria:

* serious health condition
* previous vaginal operations

Primary outcomes:
measure: Change from Baseline urethral length at 6 months after hysterectomy
timeFrame: 6 months
Secondary outcomes:
measure: Change from Baseline in sexual functions at 6 months after hysterectomy
timeFrame: 6 months
measure: Change from Baseline in appearance of urinary incontinence at 6 months after hysterectomy
timeFrame: 6 months
measure: Change from Baseline in impact of urinary incontinence at 6 months after hysterectomy
timeFrame: 6 months
measure: Change from Baseline in urinary tract symptoms at 6 months after hysterectomy
timeFrame: 6 months
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: 2nd Gynecology Department
Study officials:
affiliation: Medical University of Lublin
name: Tomasz Rechberger, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03461575: Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
Official title: A Multicenter, Randomized, Double Blind, Restasis®-Controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndrome
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-12
Enrollment: 209
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome


Eligibility criteria: Inclusion Criteria:

* age over 19
* Corneal staining score(Oxford grading) ≥ 2 or Schirmer test ≤ 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test ≥ 3mm/5min)
* Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause or who has negative result of pregnancy test or use effective contraception

Exclusion Criteria:

* The patients with systemic or ocular disorders affected the test result
* Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
* Being treated with systemic steroid
* Wearing contact lenses within 72 hr of screening visit
* Pregnancy or Breastfeeding

Primary outcomes:
measure: change from Baseline in Corneal staining(Oxford grading) score
timeFrame: Week 12
Secondary outcomes:
measure: change from Baseline in Corneal staining(Oxford grading) score
timeFrame: Week 4,8
measure: change from Baseline of Conjunctival staining(Oxford grading) score
timeFrame: Week 4,8,12
measure: change from Baseline of Strip meniscometry assessment
timeFrame: Week 4,8,12
measure: change from Baseline of Tear film break-up time
timeFrame: Week 4,8,12
measure: change from Baseline of Standard patient evaluation of eye dryness questionnaire
timeFrame: Week 4,8,12
measure: arrival time of 100% clearence in Corneal staining test
timeFrame: Week 0-12
measure: The number of total rescue drug usage
timeFrame: Week 0-12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul ST.Mary's Hospital
Study officials:
affiliation: Huons Co., Ltd.
name: Namsick Kim
role: STUDY_DIRECTOR
affiliation: Seoul St. Mary's Hospital
name: Choun-Ki Joo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03341975: Enhanced SexHealth Intervention to Improve Adolescent Outcomes
Official title: Enhanced SexHealth Intervention to Improve Adolescent Outcomes: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Diseases
Reproductive Behavior
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 91
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is an adaptive trial with an initial Formative Revision Process followed by a Randomized Controlled Trial (RCT). Up to 500 adolescents will be consented into this study to achieve 6 completed subjects for the formative process and 86 completed subjects for the RCT.

Detailed description: In a randomized controlled trial at a pediatric emergency department, sexually active adolescents will receive the control (i.e., printed materials) or intervention (i.e., motivationally-guided facilitation) arm delivered by a health educator. The tablet-based, interactive intervention includes motivational techniques to promote risk reduction, condom skills training, and tailored service recommendations. The primary outcome is uptake of ≥1 service at the index visit (i.e., counseling, condoms, emergency contraception for immediate or future use, pregnancy/sexually transmitted infection (STI)/HIV testing, STI treatment, and clinic referral). We assess feasibility (i.e., intervention completion, recommendations discussed, and satisfaction). Participants report sexual risk and care-seeking behaviors at 2, 4, and 6 months. We compare uptake between arms using Fisher exact tests.

Eligibility criteria: Inclusion Criteria:

* Aged 14-19 years old
* Reside within 30 minutes travel time
* Report previous sexual activity

Exclusion Criteria:

* Subjects who are unable to provide consent (i.e., determined to be too ill by the ED team, have cognitive impairment due to chronic condition or acute medical concern)
* Subjects in police custody
* Subjects seeking care due to sexual assault or psychiatric emergency
* Subjects who do not speak English
* Subjects who are patients under the clinical care of a study investigator working in the ED

Primary outcomes:
measure: Number of Participants With Uptake of 1 or More Health Services
timeFrame: Index visit
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Melissa Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller MK, Catley D, Adams A, Staggs VS, Dowd MD, Stancil SL, Miller E, Satterwhite CL, Bauermeister J, Goggin K. Brief Motivational Intervention to Improve Adolescent Sexual Health Service Uptake: A Pilot Randomized Controlled Trial in the Emergency Department. J Pediatr. 2021 Oct;237:250-257.e2. doi: 10.1016/j.jpeds.2021.06.007. Epub 2021 Jun 16.
Clinical trial NCT01319175: Hip-Flexion Strength Training: Can Elastic Bands Induce a Relevant Effect?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Flexion Strength
Keywords: hip flexion strength training
elastic bands
external resistance
Lead sponsor: Amager Hospital
Sponsor class: OTHER
First posted: 2011-03-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: Strength training of the hip flexors using elastic bands can induce an effect on isometric hip strength of at least 15 %.


Eligibility criteria: Inclusion Criteria:

* Physically active (more than 2.5 h/week) individuals

Exclusion Criteria:

* Injury in the lower back or legs within the last 6 months.
* Systematic strength training of the hip flexors more than once a week within the last 6 months before the study was initiated.

Primary outcomes:
measure: Isometric hip flexion strength
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Metropol, Campus Raadmandsmarken
Study officials:
References:
Clinical trial NCT03802175: The Application Of Lung Ultrasound In Postoperative Hypoxemia Patients
Official title: The Application Of Lung Ultrasound About Pulmonary Complications In Postoperative Hypoxemia Patients After General Anesthesia：A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoxemia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Xuzhou Medical University
First posted: 2019-01-14
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parients in postoperative care unit(PACU) of 18 years at least and suffering from hypoxemia after general anesthesia and noncardiac surgeries were included in our study.

Brief summary: Postoperative hypoxemia was persistent and common after surgery.Rapid diagnosis and subsequent therapeutic measures must be adopted by anesthesiologists.Lung ultrasound has been confirmed to be more sensitive and accurate for diagnosis of pulmonary ailment than chest radiography.The primary objective of the present study was to evaluate lung complications by bedside lung ultrasonography on patients suffered from hypoxemia after general anesthesia in the postoperative period.


Eligibility criteria: Inclusion Criteria:

- at least 18 years of age, hypoxemia after general anesthesia ( definded as a SPO2 \<92%,greater than 30s)

Exclusion Criteria:

* Covered with surgical dressings from opening thoracic and breast surgery, noncooperate from schizophrenia or delirium, a BMI higher than 40 kg/m2, unstable hemodynamics, dyspnea from residual opioids or muscle relaxants, hemoglobin of 8g/L or less, risk of bleeding, body temperature was more than 38℃ or less than 36℃

Primary outcomes:
measure: Pulmonary Complications of Lung Ultrasound
timeFrame: 20 minutes after tracheal extubation
Secondary outcomes:
measure: Comparison of Lung Ultrasound and Computed Tomography(CT)
timeFrame: Within 1 hour after examnation of Lung Ultrasound
Other outcomes:
measure: Correlative Factors of Lung Ultrasound Score
timeFrame: Through study completion, up to 8 months
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Min Yan, Doctor
role: STUDY_CHAIR
References:
citation: Xie C, Sun K, You Y, Ming Y, Yu X, Yu L, Huang J, Yan M. Feasibility and efficacy of lung ultrasound to investigate pulmonary complications in patients who developed postoperative Hypoxaemia-a prospective study. BMC Anesthesiol. 2020 Sep 1;20(1):220. doi: 10.1186/s12871-020-01123-6.
Clinical trial NCT03052075: Percent Change in Baseline Bone Mineral Density (BMD) After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Official title: Percent Change in Baseline Bone Mineral Density (BMD) After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Hyperparathyroidism
Keywords: Primary Hyperparathyroidism
Parathyroidectomy
Bone mineral density
BMD
Data Review
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient cohort for this study consists of all patients with primary hyperparathyroidism who underwent parathyroidectomy and also had pre- and post-operative DEXA studies performed at MD Anderson Cancer Center.

Brief summary: The primary objective of this study is to estimate the percent change in baseline bone mineral density (BMD) starting at one year after parathyroidectomy and all the following available dates in patients presenting with primary hyperparathyroidism. The secondary objective is to identify patient factors associated with change in BMD.

Detailed description: The research plan is for a retrospective review to be performed of a prospectively maintained parathyroid database within the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center. The patient cohort for this study consists of all patients with primary hyperparathyroidism who underwent parathyroidectomy and also had pre- and post-operative DEXA studies performed. The database will be reviewed to obtain patient and disease characteristics, laboratory values, DEXA imaging results, and surgical outcomes.

Eligibility criteria: Inclusion Criteria:

1. The patient cohort for this study consists of all patients within the prospectively maintained parathyroid database within the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center.
2. Patients with a diagnosis of primary hyperparathyroidism who underwent parathyroidectomy during the period of September 27, 1990 to December 31, 2013 were considered.
3. All patients who had a preoperative and one year post-operative DEXA study over the time period will be included.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Percent Change in Bone Mineral Density
timeFrame: Baseline to at least one year after parathyroidectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Nancy D. Perrier, MD
role: PRINCIPAL_INVESTIGATOR
References: