louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01805141: Phase I Pilot Study to Evaluate the Prognostic Value of Perfusion CT for Primary Cervical Cancer
Official title: Phase I Pilot Study to Evaluate the Prognostic Value of Perfusion CT for Primary Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Cervix Uteri
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 12-15 cervical cancer patients are referred for radiation each year.

Brief summary: The investigators hope to learn whether perfusion CT is a useful way to assess primary cervical tumor microenvironment and whether there is a relationship between pretreatment perfusion CT measurements and primary cervical tumor size, lymph node involvement (as assessed by standard of care pretreatment fludeoxyglucose Positron emission tomography/CT (FDG-PET/CT)), and treatment response (as assessed by standard of care 3-month post-therapy FDG-PET/CT).


Eligibility criteria: Inclusion criteria:

* \>18 years old
* with biopsy-proven squamous, adenocarcinoma or adenosquamous cervical cancer
* no history of prior pelvic radiation and should be able to receive chemoradiation
* non-pregnant women who have not previously undergone a hysterectomy, as that would have removed the cervix.
* able to give informed consent

Exclusion criteria:

* Subjects whose tumors are not FDG avid on the pre-therapy PET.
* Allergy or inability to receive iodinated CT contrast

Primary outcomes:
measure: Measure perfusion in primary cervical tumors using perfusion CT.
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Elizabeth Kidd, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capaldi DPI, Hristov DH, Kidd EA. Parametric Response Mapping of Coregistered Positron Emission Tomography and Dynamic Contrast Enhanced Computed Tomography to Identify Radioresistant Subvolumes in Locally Advanced Cervical Cancer. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):756-765. doi: 10.1016/j.ijrobp.2020.03.023. Epub 2020 Apr 3.
Clinical trial NCT02943941: Pressure Variability Study
Official title: Aquarius Pressure Variability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2016-10-25
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to understand how the pressure in the pulmonary artery changes under different conditions of posture, respiration and exertion.

Detailed description: This is a prospective, multi-center, observational study with enrollment up to 30 subjects at 2 U.S. sites. All study data can be collected on a single day as a one-time visit (lasting approximately 90-120 minutes).

This study is a Non-Significant Risk (NSR) Investigational Device Exemption (IDE) study as LINQ™ HF investigational RAMware is required to activate additional sensors in the Reveal LINQ ICM.

The patient will come to the clinic for a single in-office visit. PA pressure will be measured while the patient is in a variety of positions and during different respiratory exercises and after brief exertion. Data will be collected on eCRFs.

The effects of the different postures, respiration and exertion will be quantified using descriptive statistics (mean, standard deviation).

Eligibility criteria: Inclusion Criteria:

* Investigator believes the patient's condition is sufficiently stable to safely participate in the study procedures
* Subject is currently implanted with a commercially available pulmonary artery pressure sensor and device communication has been reliable (recent history of successful communications with patient communication system)

Exclusion Criteria:

* Subject has a history of primary PAH

Primary outcomes:
measure: Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture
timeFrame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)
Secondary outcomes:
measure: Change in PAP During Change in Respiration
timeFrame: Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)
measure: Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.
timeFrame: Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
Study officials:
affiliation: Medtronic
name: Verla Laager
role: STUDY_DIRECTOR
References:
Clinical trial NCT00931541: AZD6088 Single Ascending Dose Study
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD6088 After Single Ascending Doses in Healthy Male and Non-Fertile Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Safety
Tolerability
Healthy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females.


Eligibility criteria: Inclusion Criteria:

* Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture.
* Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator.
* Normal and suitable EEG, as judged by a neurologist

Exclusion Criteria:

* History of any clinically significant disease or disorder which for instance includes CNS disorder or CV disorder.
* Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
* Any clinically important abnormalities in the ECG.

Primary outcomes:
measure: Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)
timeFrame: Sampling occasions during all visits.
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Intense PK-sampling during 3 pre-defined study days for PK profiling.
measure: Pharmacodynamics
timeFrame: Sampling occasions during 3 pre-defined study days.
Other outcomes:
Locations:
city: London Bridge
country: United Kingdom
facility: Research Site
state: Greater London
Study officials:
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Biljana Lilja
role: STUDY_DIRECTOR
affiliation: Quintiles GDRU, London, UK
name: Marianne Kasti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01432041: Brief Child Safety Interventions in Emergency Departments (Safety in Seconds)
Official title: Brief Child Safety Interventions in Emergency Departments (Safety in Seconds)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury Prevention
Keywords: Injury prevention
smoke alarms
car seats
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2011-09-12
Enrollment: 901
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: Safety in seconds is a randomized controlled trial of a computer tailored Injury Prevention program which was conducted in the waiting area of a level 1 pediatric trauma center. A computer kiosk was used to randomly assign participants to study groups, collect baseline data and generate tailored reports based on responses to assessment items. An intervention group received a personalized and stage-tailored safety report and a control group received a personalized, but otherwise generic report on other child health topics. Telephone follow-up interviews were conducted 2-4 weeks and again 4-6 months after enrollment. Home visits were completed for a subset (n=100) of parents who completed the 4-6 month follow-up interview. The study aimed to increase knowledge, self reported and observed safety behaviors.


Eligibility criteria: Inclusion Criteria:

* Eligible parents or guardians had to be English-speaking;
* have a child between 4-66 months of age seeking treatment for an injury or medical complaint, or have an age-appropriate sibling of a child being seen for these reasons;
* live in Baltimore City;
* and live with the child at least some of the time.

Exclusion Criteria:

-parents which did not meet inclusion criteria

Primary outcomes:
measure: Knowledge outcome
measure: Reported and Observed Home Safety behaviors
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Andrea C Gielen, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gielen AC, McKenzie LB, McDonald EM, Shields WC, Wang MC, Cheng YJ, Weaver NL, Walker AR. Using a computer kiosk to promote child safety: results of a randomized, controlled trial in an urban pediatric emergency department. Pediatrics. 2007 Aug;120(2):330-9. doi: 10.1542/peds.2006-2703.
Clinical trial NCT04853641: Impact of Age and BMI on Liver Transplant Outcomes
Official title: The Impact of Advanced Age and High BMI on Short-term Outcomes in Live-donor Liver Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
Perioperative/Postoperative Complications
Keywords: Age Related Outcomes
BMI related outcomes
Liver Transplantation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end-stage liver disease, cirrhosis, or cancer requiring a liver transplant.

Brief summary: Prospectively enrolled retrospective chart review and Liver Transplant database review to determine the modifiable and nonmodifiable risk factors specifically relating to Living Donor Liver Transplants. To observe the impact of age and BMI on graft outcomes and whether they impact the intraoperative management, post-operative length of stay, and complications.

Detailed description: There has been a great deal of research into the characteristics of the donor for organ transplant, with older donors and those with more comorbidities having worse function once the organ is implanted. There has not been a great deal of research in the United States about the recipient's characteristic including age and BMI and the effects on donor organ function. With increasingly expanded criteria for organ recipients especially in the field of living donor organs the investigators plan to show the impact of older age and increased BMI on newly transplanted organs.

Eligibility criteria: Inclusion Criteria:

* All patients who received a liver transplant at UPMC- Montefiore Hospital Age\> 18

Exclusion Criteria:

* Excludes Children (\<18 years old) as they do not receive their operation under the same protocols Lost to follow-up prior to 1 year Participation in alternate research protocol that significantly altered the care they received in the perioperative period that may make their inclusion skew results.

Primary outcomes:
measure: Graft Function 30 day
timeFrame: 30 day
measure: Mortality
timeFrame: 1 year
measure: Graft Survival 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Perioperative Complications
timeFrame: 30 day
measure: Length of Stay- Total and ICU
timeFrame: Up to 6 months
measure: Duration of Intubation/Ventilation
timeFrame: Up to 6 months
measure: Postoperative Complications
timeFrame: Up to 6 months
measure: Blood Transfusion
timeFrame: Up to 2 days
measure: Vasoactive Medication
timeFrame: Up to 2 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Montefiore
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01638741: The Need for Rehabilitation and the Connection With Attachment Styles Among Patients With Gynaecological Cancer
Official title: Rehabilitation and the Association With Attachment Styles Among Patients With Gynaecological Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Needs for Rehabilitation
Adult Attachment Style
Quality of Life.
Depression
PTSD
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Odense University Hospital
First posted: 2012-07-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population Description \* Patients referred to Odense University Hospital outpatient clinic with suspition for gynaecological cancer. The patients are from to Regions in Danmark, Region Zealand and Region South Denmark.

Brief summary: The purpose of this study is to provide new knowledge about:

* Integration of rehabilitation in a highly specialized gynaecological department.
* Development and testing of an individually adapted rehabilitation process.
* Needs for rehabilitation among women with gynaecological cancer.
* Connection between adult attachment style for women with gynaecological cancer and their quality of life, rehabilitation needs and symptoms of depression /PTSD.


Eligibility criteria: Inclusion Criteria:

* suspicion of gynaecological cancer
* surgery for gynaecological cancer

Exclusion Criteria:

* do not speak Danish

Primary outcomes:
measure: Change from baseline in Quality of life at 5 months after surgery.
timeFrame: at baseline and 5 months after surgery
Secondary outcomes:
measure: Change from baseline in Revised Adult Attachment at 5 months after surgery.
timeFrame: At baseline and 5 months after sugery
measure: Change from baseline in Depression at 5 months after surgery.
timeFrame: At baseline and 5 months after surgery.
measure: Change from baseline in Posttraumatic stress disorder at 5 months after surgery
timeFrame: At baseline and 5 months after surgery.
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Fyn
Study officials:
References:
Clinical trial NCT02889341: Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility
Official title: Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Keywords: Docosahexanoic Acid,
DNA fragmentation
male fertility
Sperm parameters improvements
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one months and after 2 months taken Docosahexanoic Acid or placebo.

Detailed description: Prospective, randomized, double blind, placebo-controlled intervention study within individuals. Assisted reproduction unit and academic research laboratory. One hundred an eighty human semen samples from 60 infertile patients of IVI Sevilla clinic were finally included. Assessment of oxidative stress, apoptosis, lipid peroxidation, mitochondrial membrane potential, DNA fragmentation and standard sperm parameters before and after supplementation with different DHA doses (0.5, 1 and 2 g) or placebo for 1 and 3 months.

Eligibility criteria: Inclusion criteria:

* 1 year of infertility
* \> 10 mill/ml of sperms
* Motility \< 60% progressive
* Morphology \< 2% (WHO 2010)

Exclusion criteria:

No meeting the inclusion criteria.

Primary outcomes:
measure: Sperm cell concentration
timeFrame: Three months
measure: Sperm cell motility
timeFrame: Three months
measure: Sperm cell morphology
timeFrame: Three
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04910841: Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine
Official title: Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperglycemia
Hypotension
Shock, Septic
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Glycemic imbalances are very common in shock patients admitted to intensive care units. A blood glucose control every 2 hours is routinely performed in patients requiring insulin therapy. In practice, we use a protocol and management software called "CPG" (Personalized Control of Blood Glucose). This involves taking capillary samples from the fingertips. In addition to the pain generated, local haematomas and sensitivity disorders have been described. Night-time sampling also leads to repeated awakenings. The "CGM GUARDIAN 2" system has been validated for the measurement of glucose in interstitial fluid in insulin-dependent diabetic patients. An electrode is placed on the patient's abdomen or arm for up to 6 days. This electrode consists of a needle that is inserted subcutaneously only during the placement. The sugar level is read using a sensor placed on the electrode and an insulin pump (which will not deliver therapy (for our study) and which will be used only as an information reader to know the glucose level and trends). Interstitial fluid is automatically drawn from the electrode every minute and averaged every 5 minutes.

This device has not yet been validated in resuscitation patients.


Eligibility criteria: Inclusion Criteria:

* Patient in septic shock
* Arterial hypotension requiring noradrenaline
* Hyperglycaemia requiring insulin therapy

Exclusion Criteria:

* Patients under guardianship, curatorship or deprived of liberty
* Pregnant or breastfeeding women

Primary outcomes:
measure: Glucose level
timeFrame: Day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Florent BILGER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06149741: Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer
Official title: Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Sunderby Hospital
name: Östersund Hospital
name: Sundsvall Hospital
First posted: 2023-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is prospective, multi centre study evaluating a novel type of defunctioning loop stoma after low anterior resection for rectal cancer. Patients will be operated with a complete splenic flexure mobilisation and total mesorectal excision. An anastomosis will be fashioned at the pelvic floor. This will leave a redundant colon which will be brought up and matured in the left iliac fossa. Patient bowel function and quality of life will be monitored at baseline and at one year postoperatively, when the stoma will typically have been reversed. Dehydration and kidney injury are expected to become infrequent in comparison with the main alternative loop ileostomy. About 20 patients will be included in this pilot study.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Capacity for informed consent
* Planned defunctioning stoma
* Planned mesorectal excision with anastomosis for rectal cancer

Exclusion Criteria:

* Manifest atherosclerotic disease (peripheral vascular disease, previous myocardial infarction, angina, etc)
* Previous oncological colonic resection
* Defunctioning stoma in situ
* Intraoperative event leading to bowel resection and subsequent inability to bring out left-sided colostomy without tension on the anastomosis
* Intraoperative circumstances as judged by the operating surgeon leading to unacceptable risks due to loop colostomy placement (abdominal wall size, short mesentery, other preconditions)

Primary outcomes:
measure: Low anterior resection syndrome (LARS)
timeFrame: 1 year
Secondary outcomes:
measure: Bowel ischaemia
timeFrame: 30 days
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
References:
Clinical trial NCT03551041: The Neural Representation of Self in Depression Patients
Official title: The Different Neural Representation of Self in Depression Patients and Healthy Individuals.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression Disorder
Healthy
Keywords: depression, self-referential, neural representation
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
Collaborators: name: Peking University
name: Southwest Medical University
First posted: 2018-06-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals diagnosed with depression and healthy control

Brief summary: To be aware of oneself as a unique entity in the world occurs early in human development and is the prerequisite of normal social functioning. The disturbance of self representation characterizes a variety of mental disorders such as autism and schizophrenia. Negative self-bias was found to serve as the core cognitive mechanism of depression disorder. However, there was no evidence to show the reason lead to negative bias. In the current study, investigators hypothesized that the blurring self representation was the neural correlates in depression disorder.

Detailed description: To test investigators' hypothesis, investigators adopted the self-referential task and fMRI to investigate the neural representation of self in depression patients, and compared with healthy control.

Eligibility criteria: Inclusion Criteria:

* Patients should be clinical diagnosis of major depression disorder.
* Healthy control participants should be age-matched with depression group, and should have no history of neurological or psychiatric diagnoses

Exclusion Criteria:

* Patients who also have bipolar disorder, schizophrenia, anxiety disorder
* Healthy controls who have history of mental disorders

Primary outcomes:
measure: Neural representation of self
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: