louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01384929: Study of Intensive Care Units in India
Official title: Indian Intensive Care Case Mix and Practice Patterns Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: Indian Society of Critical Care Medicine
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 4236
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients present in the ICU July 14, 2010, October 13, 2010, January 12, 2011 and April 13, 2011

Brief summary: There is scant data on the casemix and practices in Indian intensive care units (ICUs). Most of the available data comes from single centre studies. There is a dire need to have data from Indian ICUs to reflect the vast spectrum of critical care illness, services and practices. INDICAPS planned to collect data of all patients in the ICU on one particular day, and four such days spread throughout a one-year period were selected: the second Wednesday of July and October this year, i.e. July 14 and October 13, 2010 and the second Wednesday of January and April next year, i.e. January 12 and April 13, 2011. As many ICUs all over the country as possible were asked to participate. The investigators aimed to gather information about ICUs, patients in ICUs, the types and severity of illness, monitoring and therapeutic modalities used, types of infections,mortality rates, etc.

Detailed description: The following information will be analysed:

Case-mix, severity of illness, prevalence of infection, hemodynamic monitoring and therapy, mechanical ventilation practices, nutrition and outcome

* Seasonal and regional variations in the above
* Epidemiology and variations in antibiotic use
* Patterns of microorganisms and outcome
* Prevalence and outcome of specific tropical febrile illnesses, including malaria, dengue fever, leptospirosis, scrub typhus
* Prevalence and outcome of toxins and poisonings
* Relation of ICU and hospital organizational issues to prevalence of infection and outcome
* Organisation of intensive care services
* End of life - Ethical decisions

Eligibility criteria: Inclusion Criteria:

* All patients present in the ICU July 14, 2010, October 13, 2010, January 12, 2011 and April 13, 2011

Primary outcomes:
measure: All cause mortality
timeFrame: 30-days
Secondary outcomes:
measure: ICU Length of stay
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Hospital survival
timeFrame: 30 days
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
Study officials:
affiliation: Indian Society of Critical Care Medicine
name: Jigeeshu Divatia, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01553929: Physical Training and Cognitive Activity on the Mild Cognitive Impairment (MCI) Patient
Official title: Physical Trainig and Cognitive Activity on the MCI Patient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Keywords: MCI
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Regular physical activity is now recognized as a key element of good physical and mental health and this all ages.

MAIN GOAL : Evaluate the effectiveness of physical training associated with a cognitive training in improving the cognitive function of patients diagnosed with Mild Cognitive Impairment (MCI).

DESIGN : Controlled randomized monocentric and prospective study with clinical benefit for the patient with three groups : one physical training and cognitive exercise group, one physical training without cognitive exercise group and one control group.

In agreement with the literature on the effects of physiological stress on cognitive performance, the investigators expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD, depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire. Furthermore the investigators hypothesize that this positive effect is greater in the physical training and cognitive exercise group compared with the physical training group only.


Eligibility criteria: Inclusion Criteria:

* Diagnosed patient MCI (Mild Cognitive Impairment)
* Elderly from 40 to 75 years old
* MMSE upper to 22
* Affiliated or beneficiary of a national insurance scheme
* Medical capacity to the physical proposed activity (filling of the conditions of the Medical certificate of not contraindication in the sport)

Exclusion Criteria:

* The placed persons under guardianship, under protection of justice,
* The private persons of freedom (administrative or judicial)
* Nobody already participating in a clinical trial

Primary outcomes:
measure: effectiveness of physical training
timeFrame: up to 3 months
Secondary outcomes:
measure: Cognitive improvement
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Franck LE DUFF, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03943329: Trial of a Distal Targeting System for Cephalomedullary Nails as Part of Surgical Repair of Hip and Femoral Shaft Fractures
Official title: Trial of a Distal Targeting System for Cephalomedullary Nails as Part of Surgical Repair of Hip and Femoral Shaft Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Femoral Shaft Fractures
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will be a prospective, case - control trial looking at the use of a previously FDA approved device made by Stryker, a distal targeting system that eases the distal targeting of screws in cephalomedullary nails in hip and femoral shaft fractures. Patients who consent to participate in the study will either be in the control or device arm of the study depending on their surgeon.

Detailed description: Surgeries conducted by Dr. Konda or Dr. Leucht will be done using the device technique, surgeries completed by Dr. Egol or Dr. Tejwani will be done without the device, "free hand" technique. Each arm of the study will contain 29 patients. Patients who consent to participation will be enrolled in the study and placed in the correct arm based on who their surgeon is. Demographic and injury data will be collected. Intra-operatively, control patients will receive the SOC procedure. Device arm patients will have the distal targeting device used in their procedure, but the implant, will not be different than SOC.

Eligibility criteria: Inclusion Criteria:

* The patient must be greater than or equal to 18 years of age.
* The patient must have sustained a hip or femur fracture that is indicated for cephalomedullary nailing as the primary and definitive treatment measure.
* The patient must be medically cleared for operative fixation of their fracture.

Exclusion Criteria:

* The patient does not meet all of the inclusion criteria.

Primary outcomes:
measure: Change in mean intra-operative radiation exposure to patients during their cephalomedullary nailing procedure.
timeFrame: Baseline, 1 Day
Secondary outcomes:
measure: Change in mean length of time to distal screw placement
timeFrame: Baseline, 1 Day
measure: Change in total operative time
timeFrame: Baseline, 1 Day
measure: Change in total operative cost ($)
timeFrame: Baseline, 1 Day
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Sanjit Konda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01942629: Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas
Official title: Prognostic Value of Quantitative p63 Immunostaining in Adenocarcinoma of Lung, Breast, and Pancreas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Adenocarcinoma
Breast Adenocarcinoma
Pancreatic Ductal Adenocarcinoma
Keywords: prognostic markers,Pancreatic ductal adenocarcinoma
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 patients, 100 for each group.

Brief summary: The p63 gene is a recently discovered member of the p53 family located at chromosome 3q27Many studies have reported that overexpression of p63 can mimic p53 activities by binding DNA, activating transcription, and inducing apoptosis.

Various studies proved p63 as a marker of basal cells in normal salivary glands, breast, prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies. Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast carcinoma, and no study has described the correlation of p63 with pancreatic ductal adenocarcinoma.

In the current study, we aim to evaluate the prognostic value of the expression of p63 in the lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We will achieve this aim by collecting clinical data retrospectively from the patients' medical records as well as assessing the histological sections and performing immunohistochemical staining for p63.


Eligibility criteria: Inclusion Criteria:

* Patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma.
* Available histopathological diagnosis of the malignancy.

Exclusion Criteria:

* Patients with inoperable tumors.
* Patients with second primary tumor.
* Patients with pathological blocks not enough for future slicing.

Primary outcomes:
measure: 5 year overall survival
timeFrame: 5 years
Secondary outcomes:
measure: recurrence free survival
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05359029: Duodenostomy to Treat Duodenal Perforation
Official title: Duodenostomy on Foley and Gastroenteroanastomosis: Treatment of Second Duodenal Part Perforation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Focus of Study is to Elucidate Which Are the Factors Requiring the Duodenostomy and Which Postoperative Course is for These Patients
Keywords: Duodenostomy
duodenal perforation
emergency surgery
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 5
Sex: ALL
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In 2 cases a tube duodenostomy was executed, due to excessive size of perforation and extreme presence of intra-abdominal infections.

In addition, other cases of duodenal injury due to other causes were treated, 3 of these requiring a tube duodenostomy approach.

Brief summary: In this study the investigators focused on duodenal perforations, requiring a tube duodenostomy and have analyzed the main features, that have influenced the surgical choices. Five patients were enrolled. Most of duodenal perforations can successfully be managed by simple repair, while complicated procedures are needed for complex injuries. Tube duodenostomy is a damage control procedure, for large duodenal perforations when further repair techniques are not recommended due to the duodenal damage, hemodynamic instability of the patient or the absence of surgical expertise for complex reconstruction.


Eligibility criteria: Inclusion Criteria:

* excessive size of perforation
* extreme presence of intra-abdominal infections.

Exclusion Criteria:

* patients treated by medical therapy, endoscopic techniques, o surgical approaches

Primary outcomes:
measure: Death of patient
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Policlinico Di Foggia
Study officials:
References:
Clinical trial NCT03125629: Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals
Official title: Comparison of PET/CT vs. PET/MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer Diagnosis
Diagnostic Techniques and Procedures
Diagnostic Imaging
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants receive both scans.
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies how well positron emission tomography (PET)/computed tomography (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of cancer and other types of cancers.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate if PET/CT and PET/MRI scanners provide equivalent results for evaluation of cancer patients.

OUTLINE:

Patients receive standard of care 18F-fludeoxyglucose (FDG) or Ga68-DOTA-TATE intravenously (IV). Within 45-60 minutes, patients then undergo PET/CT imaging immediately followed by PET/MRI. Each participant is to receive 18-FDG or 68Ga-DOTA-TATE only, no participant was to receive both radiotracers.

Eligibility criteria: INCLUSION CRITERIA

* Cancer diagnosis
* Capable of complying with study procedures
* Able to remain still for duration of imaging procedure (approximately 90 minutes total)
* Written informed consent

EXCLUSION CRITERIA

* Pregnant or nursing
* Metallic implants
* Impaired renal function

Primary outcomes:
measure: Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
timeFrame: 4 hours
Secondary outcomes:
measure: PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer
timeFrame: estimated average of 2 hours
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Andrei Iagaru
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03591029: Evaluation of PCO2 and PO2 Values in the Pulmonary Artery and Superior Vena Cava
Official title: Evaluation of PCO2 and PO2 Values in the Pulmonary Artery and in the Superior Vena Cava: Relationship With Cardiac Output, Hematocrit and Post Operative Organ Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Will be enrolled adult patients only , eligible for cardiac surgery (CABG, valvular replacement, aortic surgery) with extra corporeal circulation.

Brief summary: The study is about comparing blood samples obtained from the superior vena cava and the pulmonary artery. The investigators will compare the values of PCO2 and PO2 from these two sites, in order to see if exists a PCO2 gap and a PO2 gap, different from zero. Moreover the investigators want to find out if these gaps are related with changes in the cardiac output, the hematocrit or if they can predict post operative dysfunctions.

Blood samples will be taken at six different times as scheduled by the protocol. Along with the two venous blood samples, an arterial blood sample will be taken too, from a radial of femoral artery catheter.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* patient undergoing cardiac surgery with extracorporeal circulation
* hemodynamic monitoring with a central venous catheter and a Swan Ganz catheter placed in the internal left giugulare vein

Exclusion Criteria:

* severe tricuspid insufficiency
* EF \< 50%
* SOFA score \>1 in at least one of all the criteria

Primary outcomes:
measure: PCO2 gap changes
timeFrame: two days
measure: PO2 gap changes
timeFrame: two days
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: catholic University of the sacred Heart
city: Rome
country: Italy
facility: Francesca Bevilacqua
Study officials:
References:
Clinical trial NCT05197829: Glycemic Optimization On Discharge From the Emergency Room
Official title: Glycemic Optimization On Discharge From the Emergency Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Continuous glucose monitors can help people with diabetes avoid blood sugar levels that are either dangerously high or low. This study evaluates whether continuous glucose monitoring after discharge from the emergency room can help people with type 1 or type 2 diabetes avoid repeat emergency room visits, achieve improved blood sugar control, and feel less distressed about managing their diabetes.


Eligibility criteria: Inclusion Criteria:

* Seen in the Emergency Department for hypo- or hyperglycemia
* Either an existing diabetes center patient or a new referral
* Type 1 or type 2 diabetes
* Able to provide informed consent
* Fluent in English or Spanish

Exclusion Criteria:

* Current CGM use
* Need for hospital admission
* Upcoming CT or MRI within 2 weeks
* Pregnancy
* Altered mental status
* Not appropriate for diabetes center follow up
* Prisoners

Primary outcomes:
measure: Change in Diabetes Distress
timeFrame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
measure: Outpatient Clinic Attendance Rate
timeFrame: Follow-up visits will generally occur within 2 or 3 weeks
measure: Change in the Problem Areas in Diabetes Score
timeFrame: Change from emergency room visit to first outpatient follow-up visit (2 or 3 weeks)
Secondary outcomes:
measure: Number of Patients With Repeat Emergency Utilization
timeFrame: 6 months
measure: Change in Hemoglobin A1c
timeFrame: 6 Months
measure: Outpatient Visits for Which the CGM Data Changed Management
timeFrame: 2-3 Weeks
measure: Time In Range
timeFrame: Up to 14 days after the initial emergency visit
measure: Percentage Time CGM Active
timeFrame: Up to 14 days after the initial emergency visit
measure: Number of Sensor Checks Per Day
timeFrame: Up to 14 days after the initial emergency visit
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Mark J O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03123029: Expanded Access to Venetoclax
Official title: Expanded Access to Venetoclax
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Chronic Lymphocytic Leukemia (CLL)
Multiple Myeloma
Acute Myeloid Leukemia (AML)
Non-Hodgkin's Lymphoma
Acute Lymphoblastic Leukemia (ALL)
Amyloidosis
Plasma Cell Leukemia
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-04-21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Venetoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

* The participant must not be eligible for a venetoclax clinical trial.
* Pediatric participants may be evaluated on a case by case basis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05398029: A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease
Official title: Open-label, Phase 1b, Single-ascending Dose and Optional re Dosing Study to Evaluate the Safety of VERVE-101 Administered to Patients With Heterozygous Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, and Uncontrolled Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heterozygous Familial Hypercholesterolemia
Atherosclerotic Cardiovascular Disease
Hypercholesterolemia
Keywords: VERVE-101
Familial Hypercholesterolemia
Cardiovascular Disease
Dose Escalation
Gene Editing
Base Editing
Lead sponsor: Verve Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single ascending dose escalation/adaptive design followed by single dose expansion.
Primary purpose: TREATMENT

Brief summary: VT-1001 is an open-label, phase 1b, single-ascending dose study that will evaluate the safety of VERVE-101 administered to patients with heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease (ASCVD), and uncontrolled hypercholesterolemia. VERVE-101 uses base-editing technology designed to disrupt the expression of the PCSK9 gene in the liver and lower circulating PCSK9 and LDL-C in patients with established ASCVD due to HeFH. This study is designed to determine the safety and pharmacodynamic profile of VERVE-101 in this patient population.


Eligibility criteria: Inclusion Criteria:

* Male and/or female participants 18 up to 75 years at time of signing of informed consent
* Female participants not of child-bearing potential
* Diagnosis of HeFH
* Established ASCVD

Exclusion Criteria:

* Active or history of chronic liver disease
* Current treatment with PCSK9 monoclonal antibody therapy
* Current or past treatment with inclisiran
* Clinically significant or abnormal laboratory values as defined by the protocol

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
timeFrame: up to Day 365
Secondary outcomes:
measure: Evaluation of maximum observed concentration (Cmax)
timeFrame: up to Day 365
measure: Evaluation of time to maximum observed concentration (tmax)
timeFrame: up to Day 365
measure: Evaluation of terminal elimination half-life (t1/2)
timeFrame: up to Day 365
Other outcomes:
measure: Percent and absolute change from baseline in plasma PCSK9 concentration.
timeFrame: up to Day 365
measure: Percent and absolute change from baseline in LDL-C.
timeFrame: up to Day 365
Locations:
city: Auckland
country: New Zealand
facility: Clinical Study Center
city: Christchurch
country: New Zealand
facility: Clinical Study Center
city: London
country: United Kingdom
facility: Clinical Study Center
Study officials:
References: