louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06020872: My Meal Plate - Promoting the Health Literacy of Patients
Official title: My Meal Plate - Promoting the Health Literacy of Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Keywords: health literacy
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Taiwan Adventist Hospital
First posted: 2023-09-01
Enrollment: 133
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study was to investigate the results on health literacy through the program of my meal plate.

Detailed description: Subjects were randomized to the intervention group and control group. The primary outcome was the Health Literacy on my Plate.

Eligibility criteria: Inclusion Criteria:

* patients who have ordered the general diet of the hospital and took more than three meals in a row.

Exclusion Criteria:

* pregnant woman
* unconscious
* people who cannot read

Primary outcomes:
measure: Health Eating Literacy questionnaire
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taiwan Adventist Hospital
state: Songshan District
Study officials:
affiliation: Taiwan Adventist Hospital
name: Shu-Chi Lin, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04704895: Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy
Official title: A Prospective RCT Study of Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enteral Nutrition
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To prove that early enteral nutrition after pancreaticoduodenal operation is of great significance to improve the immune response, reduce the incidence of postoperative infection and other related complications, and shorten the length of hospital stay

Detailed description: Arm A: Total parenteral nutrition. TPN also started from POD 1 and was delivered through a central venous catheter. Target energy of 1.5 amino acids/kg/day reached 30 kcal/kg/day.

Arm B: NJEEN was defined as providing at least 50% of the nutritional requirements through the nasojejunal tube prior to the 5th day after surgery (POD) and having no parenteral nutrition for 72 h or more.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years old, gender is not limited;
* All patients underwent pancreaticoduodenectomy;
* ECOG 0 \~ 2 for physical condition score;
* Imaging examination found pancreatic head, periampullary space, no distant metastasis and ascites;
* No bone marrow dysfunction;
* Those without obvious surgical contraindications;
* Expected postoperative survival ≥3 months;
* The study visit plan and other programme requirements are now available;
* Voluntary participation and signing of informed consent.

Exclusion Criteria:

* Patients with stage II and IV periampullary carcinoma of head of pancreas and periampullary carcinoma;
* Active infected persons;
* Distant metastasis or ascites were found in imaging examination;
* Patients with serious impairment of heart, liver and kidney function (grade 3 to 4, ALT and/or AST more than 3 times the normal upper limit, Cr more than the normal upper limit);
* patients with other malignant tumors or blood diseases;
* Pregnancy, planned pregnancy and lactation female patients (urine HCG \>02500 iu /L, diagnosed as early pregnancy);

Primary outcomes:
measure: The percentage of patients with one or more postoperative complications (time range: 90 days) was observed, and data were recorded during the hospital stay (expected average of 3 weeks) and during control visits 3 months postoperatively.
timeFrame: 3month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
state: Sahnghai
Study officials:
References:
Clinical trial NCT05447195: Phase 2 Study of CAN008 in Subjects With GBM
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CAN008 Plus TMZ During and After Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Newly-diagnosed Glioblastoma
Keywords: Glioblastoma
CAN008
APG101
Lead sponsor: CANbridge Life Sciences Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-07
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-blind, placebo-controlled Phase 2 study whose objectives are to evaluate the clinical efficacy and safety of CAN008 plus TMZ during and after radiation therapy in newly-diagnosed subjects with glioblastoma who have undergone surgical excision.

Detailed description: This study plans to enroll approximately 117 subjects. Subjects determined as having met inclusion criteria through screening will be randomized into treatment groups (CAN008 + RT + TMZ, 78 subjects) and the control group (placebo + RT + TMZ, 39 subjects) in a ratio of 2:1.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 70.
* Newly diagnosed glioblastoma.
* Tumor excision rate ≥80%.
* Karnofsky performance score ≥70.

Exclusion Criteria:

* Medical history of brain radiation therapy or electric field treatment of tumor.
* Primary infratentorial glioblastoma, multifocal glioma (≥ 2), or leptomeningeal metastasis.
* Any malignant tumor (excluding WHO grade I-II low-grade astrocytomas, basal cell carcinoma, and carcinoma in situ).
* Receiving high-dose hormone therapy.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Wenbin Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05536895: C-arm Cone Beam CTP Guided Cerebrovascular Interventions
Official title: C-arm Cone Beam CTP Guided Cerebrovascular Interventions: Evaluating Predictability and Accuracy for the Treatment of Acute Cerebral Ischemia in the Angiography Suite
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2022-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, randomized controlled trial
Primary purpose: DIAGNOSTIC

Brief summary: The study objective for the Phase 2 of this research is to demonstrate and confirm the substantial time savings that can be obtained using cone beam computed tomography (CB-CT) for both complete image acquisition and rapid image reconstruction in a Direct to Angio paradigm (One Stop Shop) for selected acute ischemic stroke (AIS) patients.

Detailed description: Phase 2 of this research is aimed at validating the feasibility and time savings of bringing selected acute ischemic stroke patients with suspected large vessel occlusion directly on hospital arrival to the angiography suite, avoiding the emergency room and conventional MD-CT imaging. In order to make this phase of the study more robust and to reduce bias on image assessment we will prospectively randomize the patients in a 2:1 fashion to either direct to angio for CB-CT imaging or MD-CT imaging in the emergency room. A total of 60 CB-CT subjects and 30 MD-CT subjects will comprise this cohort. Entrance criteria will be identical to those in Phase 1, except the NIHSS must be greater than 8 which is clinically correlative with a likely large vessel occlusion and, since this is standard of care imaging for acute ischemic stroke, GFR will be removed as an exclusionary criteria.

The Phase 1 of this research was registered to NCT03232151.

Eligibility criteria: Inclusion Criteria:

1. Patients with acute ischemic stroke presenting within 24 hours of onset
2. Patients that present with a large artery occlusion
3. Adults 18 years of age or older.
4. Patients of childbearing potential must not be pregnant.
5. National Institutes of Health Stroke Scale (NIHSS) of \<8
6. No severe co-morbidities

Exclusion Criteria:

1. Patients that are pregnant
2. History of severe renal disease (e.g. stage 4-5)
3. History of renal transplant

Primary outcomes:
measure: Feasibility measured as the amount of time from hospital arrival to the angiography suite
timeFrame: 1 visit (up to 120 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Beverly Aagaard-Kienitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03420495: Decision-making Impairments in OCD: An Integrated Behavioral Economics Model
Official title: Decision-making Impairments in OCD: An Integrated Behavioral Economics Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Intolerance of Uncertainty
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Obsessive Compulsive Foundation
First posted: 2018-02-05
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The current study has two diagnostic arms (the OCD group and the Non-Psychiatric Control group) all receiving a single interventional protocol.
Primary purpose: DIAGNOSTIC

Brief summary: The investigators are examining whether conditions of ambiguity during decision-making may prime intolerance of uncertainty beliefs (i.e., difficulties coping with ambiguity, unpredictability, and the future) and lead to impaired performance when individuals with obsessive-compulsive disorder (OCD) are making uncertain decisions compared to non-psychiatric controls.

Detailed description: The primary aims of this study are to examine the extent to which individuals with OCD avoid decisions that involve ambiguity through the use of self-report and behavioral measures. Specifically, the investigators will examine how individuals with OCD minimize risk at the expense of monetary profit under conditions of ambiguity (relative to risky but unambiguous options) compared to non-psychiatric controls utilizing a series of judgment and decision-making (JDM) tasks.

Eligibility criteria: Inclusion Criteria:

* Adults (age 18+)
* Meet DSM-5 criteria for principal OCD (OCD group) or no current DSM-5 diagnosis (NPC group).
* Sufficient fluency of English to understand study procedures and questionnaires
* Ability to provide informed consent.
* Comfortable and capable of using a computer to complete computer-based decision-making tasks.

Exclusion Criteria:

* Color-blindness (which prevents completion of certain tasks)
* Acute psychosis, bipolar disorder, substance use disorder, or suicidality. All other diagnostic comorbidities will be permitted to foster the accrual of a clinically relevant sample.
* Serious neurological disorder or impairment (e.g., brain damage, blindness), attention deficit hyperactivity disorder (ADHD), intellectual disability, or autism.

Primary outcomes:
measure: Ambiguity aversion score on the Risk and Ambiguity Task
timeFrame: Day 1
measure: Average adjusted pump scores on the Balloon Analogue Risk Task (BART)
timeFrame: Day 1
Secondary outcomes:
measure: Money spent on draws to decision (DTD) in the Beads Task
timeFrame: Day 1
measure: Intolerance of Uncertainty Scale (IUS-12)
timeFrame: Day 1
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ryan J Jacoby, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04668495: Impact of Timing of PD Assessments on Measures of Platelet Reactivity in Patients Undergoing PCI Treated With Cangrelor
Official title: Impact of Timing of Pharmacodynamic Assessments on Measures of Platelet Reactivity in Patients Undergoing Percutaneous Coronary Intervention Treated With Cangrelor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2020-12-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are undergoing percutaneous coronary intervention (PCI) and have been treated with cangrelor per standard of care.

Brief summary: This study is assessing the impact of timing of PD assessments on measures of platelet reactivity in patients undergoing PCI treated with cangrelor.

Detailed description: Cangrelor is characterized by reversible binding to the P2Y12 receptor and is promptly inactivated through dephosphorylation by ectonucleotidase leading to its very short plasma half-life. Consequently the timing at which PD assessments are performed after blood sample collection may impact measures of platelet reactivity in patients treated with cangrelor. We therefore hypothesize that measures of platelet inhibitory effects observed in cangrelor treated patients will reduce with time following blood sampling.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* CAD patients (stable CAD, NSTE-ACS, or STEMI) undergoing PCI and treated with cangrelor per standard of care.
* Treated with aspirin prior to the PCI procedure per standard of care

Exclusion Criteria:

* Treatment with an oral P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) within past 10 days
* Treatment with oral anticoagulation (vitamin K antagonist, dabigatran, apixaban, rivaroxiban) within past 3 days
* Treatment with a glycoprotein IIb/IIIa inhibitor during PCI
* Fibrinolytics within 48 hours
* Known hemoglobin\<10 gm/dL
* Known platelet count \<80x106/mL
* Active bleeding or hemodynamic instability
* Known end stage renal disease on hemodialysis
* Known severe hepatic dysfunction

Primary outcomes:
measure: Change in platelet reactivity
timeFrame: wiithin 30 min, 1 hour, 2 hours, and 4 hours of blood sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: Professor of Medicine
name: Dominick Angiolillo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franchi F, Rollini F, Galli M, Been L, Ghanem G, Shalhoub A, Rivas A, Zhou X, Pineda AM, Suryadevara S, Soffer D, Zenni MM, Bass TA, Angiolillo DJ. Impact of Timing of Pharmacodynamic Assessment on Platelet Reactivity in Patients Treated With Cangrelor. JACC Cardiovasc Interv. 2021 Nov 8;14(21):2410-2412. doi: 10.1016/j.jcin.2021.07.051. No abstract available.
Clinical trial NCT00124995: Trial of Terbutaline for the Treatment of Status Asthmaticus in Children
Official title: Double-blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Status Asthmaticus
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2005-07-29
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although widely used for the treatment of pediatric status asthmaticus, intravenous terbutaline has potentially significant side effects; may not improve outcomes; and may increase Intensive Care Unit (ICU) length of stay. This study is designed to test the efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or placebo will be titrated according to severity of illness as quantified by a validated clinical asthma score. Differences in outcomes between the study groups, such as length of stay, hospital costs, and lung function will be compared.


Eligibility criteria: Inclusion Criteria:

* Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care Unit (PICU) with a primary admission diagnosis of status asthmaticus
* Modified Pulmonary Index Score (MPIS) of greater than or equal to 12
* Age between birth and 18 years old

Exclusion Criteria:

* Pre-existing cardiac or pulmonary disease
* Existing respiratory failure (requiring invasive or non-invasive mechanical ventilation)
* Hemodynamic or cardiovascular instability requiring inotropic support
* The patient meets one of the criteria for withdrawal from the study due to patient safety concerns

Primary outcomes:
measure: ICU length of stay
Secondary outcomes:
measure: To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
measure: To prospectively analyze the side effects of terbutaline
Other outcomes:
Locations:
city: Hartford
country: United States
facility: CT Children's Medical Center
state: Connecticut
Study officials:
affiliation: CT Children's Medical Center
name: Christopher Carroll, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02324595: Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
Official title: Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage IV Ovarian Carcinoma
Effects of Chemotherapy
Peritoneal Cavity Cancer
Keywords: Ovarian Cancer
Laparoscopy
Neoadjuvant Chemotherapy
Robotic
Interval Debulking Surgery
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Fagotti, Anna, M.D.
name: Fanfani, Francesco, M.D.
name: Salvatore Gueli Alletti
First posted: 2014-12-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II multicentric study

Detailed description: The aim of this prospective Phase II multicentric study is to assess feasibility and early complications rate of "total laparoscopic/robotic" interval debulking surgery in patients with a clinical complete/partial response to neoadjuvant chemotherapy for advanced ovarian cancer.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years,
* Advanced ovarian cancer submitted to neoadjuvant chemotherapy,
* Clinical or serological complete/partial response (RECIST; GCIG),
* PS ≤ 2 (ECOG),
* Informed consent

Exclusion Criteria:

* Borderline and non-epithelial ovarian tumors,
* Stable/progressive disease,
* ASA 3-4,
* Severe cardiopulmonary disease,
* BMI \> 40

Primary outcomes:
measure: Operative complication rate
timeFrame: 30 days
Secondary outcomes:
measure: Progression Free survival
timeFrame: one year
measure: Overall Survival
timeFrame: One year
Other outcomes:
Locations:
city: Rome,
country: Italy
facility: Catholic University of Sacred Heart Rome,
state: Rome
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Giovanni Scambia, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gueli Alletti S, Bottoni C, Fanfani F, Gallotta V, Chiantera V, Costantini B, Cosentino F, Ercoli A, Scambia G, Fagotti A. Minimally invasive interval debulking surgery in ovarian neoplasm (MISSION trial-NCT02324595): a feasibility study. Am J Obstet Gynecol. 2016 Apr;214(4):503.e1-503.e6. doi: 10.1016/j.ajog.2015.10.922. Epub 2015 Oct 31.
Clinical trial NCT02588495: Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
Official title: Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aspiration
Keywords: Ultrasound
Gastric area
Accuracy
Aspirate
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: During surgery, there is a risk that food or liquid in the stomach might be forced back up the throat where it could enter the lungs (aspirate) and result in serious complications or even death. This is why people going for surgery are required not to eat before their surgery. However, in emergency situations it is often not possible to know whether a patient has recently eaten or not. Anesthesiologists have recently developed an ultrasound test to determine if there is content in a patient's stomach and how much. This test involves an ultrasound examination of the abdomen and taking some measurements on the ultrasound screen.

The purpose of this study is to determine how accurate these measurements are. In other words, how good are we at detecting an empty stomach from one that has liquids, or solids in it. You are being asked to participate in this study because we require non-pregnant volunteers in order to answer the aforementioned study question.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged 18 to 85 years
* Male or female
* American Society of Anesthesia physical status classification I and II
* Height greater than 145 cm
* Ability to understand the study protocol and provide informed consent

Exclusion Criteria:

* Subjects predisposed to have an increased residual gastric volume at baseline (eg. Diabetes or any known dysmotility)
* History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)

Primary outcomes:
measure: Ultrasound's sensitivity to identify a "full stomach"
timeFrame: 5 minutes
Secondary outcomes:
measure: Ultrasound's accuracy in detecting a "full stomach"
timeFrame: 5 minutes
measure: Inter/Intra-rater reliability of observer in detecting a "full stomach"
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: Staff Anesthesiologist
name: Anahi Perlas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.