louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01915407: AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction
Official title: AggreGuide 325 mg. Aspirin Study for Aspirin Induced Platelet Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Dysfunction Due to Aspirin Ingestion
Lead sponsor: Aggredyne, Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: aspirin naïve subjects over 18

Brief summary: To test the AggreGuide A-100 AA Assay's effectiveness for detecting aspirin induced platelet dysfunction.


Eligibility criteria: Inclusion Criteria:

* over 18

Exclusion Criteria:

* on aspirin in prior week
* medical history of platelet disorders
* contraindications to aspirin

Primary outcomes:
measure: Platelet Activity Index (PAI) before and after ingestion of aspirin
timeFrame: 2 - 30 hours post aspirin ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Aggredyne, Inc.
state: Texas
Study officials:
References:
Clinical trial NCT05346107: PLD-cyclophosphamide-Nab-P Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer
Official title: PLD Plus Cyclophosphamide Followed by Nab-paclitaxel (Nab-P) as Primary Chemotherapy Continuously Combined With Dual HER2 Blockage for HER2-positive Breast Cancer: A Single-arm Phase 2 Trial(Brecan Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
HER2-positive Breast Cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: patients with HER2-positive breast cancer (cT2-3/N0-1/M0) were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles

Detailed description: Upon approval by the Medical Ethics Committee of Xijing Hospital, patients with HER2-positive breast cancer (cT2-3/N0-1/M0) receiving neoadjuvant therapy, were enrolled. The patients were treated with PldCHP (pegylated liposomal doxorubicin 35mg/m2, cyclophosphamide 600mg/m2, trastuzumab 8 mg/kg loading, then 6 mg/kg, pertuzumab 840 mg loading, then 420 mg, iv, q3w) for 4 cycles followed by Nab-PHP (Nab-Paclitaxel 260mg/m2, trastuzumab 6 mg/kg, pertuzumab 420 mg, iv, q3w) for 4 cycles, with strict monitoring of cardiotoxicity. The primary endpoint was pCR rate, and secondary endpoints were cardiac safety during neoadjuvant therapy.

Eligibility criteria: Inclusion Criteria:

1. HER2-positive breast cancer
2. cT2-3/N0-1/M0
3. aged18-80 years
4. receiving neoadjuvant therapy
5. ECOGPS score 0 or 1
6. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures
7. Adequate organ function

Exclusion Criteria:

1. cardiac, hepatic, renal, or psychiatric disease history
2. History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Primary outcomes:
measure: Rate of pathological complete response
timeFrame: At the end of Cycle 1 (each cycle is 14 days)
Secondary outcomes:
measure: adverse effects
timeFrame: during the period of neadjuvant chemotherapy, an average of 14 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital ， Fourth Military Medical University
state: Shaanxi
Study officials:
References:
Clinical trial NCT02011607: Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia
Official title: Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: SEDLine
Accoustic Respiratory Monitor RAD87
Adverse Events
Advanced Endoscopic Procedures
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patints undergoing advanced endoscopic procedures

Brief summary: We propose to collect the data of vital signs and anesthesia medications administered in a subcategory of patients coming for anesthesia for upper GI endoscopy. This data will be analyzed to see any relation between the preoperative risk factors, procedure, type of anesthesia and the airway intervention. The adverse events that will be automatically recorded and later analyzed will be number of apnea episodes (described as no respiration for at least 30 seconds) duration of each apnea, number and duration of each desaturation event (oxygen saturation as measured by the pulse oximeter). A pulse oximeter saturation of less than 93 percent and lasting 30 seconds will be considered as a desaturation event. The airway interventions that will be recorded will be anything other than considered being routine. This includes LMA insertion, endotracheal intubation and the need to withdraw gastroscope to facilitate face mask ventilation. We also propose to monitor their awareness/depth of sedation/depth of anesthesia levels. This will be done using a monitor that analyses brain waves and gives an idea of sleep (anesthesia) depth. We can then see any correlation between any unwanted events and the sleep depth.


Eligibility criteria: Inclusion Criteria:

* All the patients considered as high risk (see above) or undergoing an advanced upper GI procedure (see above) will be included. This is the prospective analysis of the data that is collected and stored in the monitors. We will be using the massimo Pulse oximeter ,masimo acoustic respiratory monitor and Masimo SED line Brain function monitors that allows electronic storage and retrieval of information.
* Postprocedure analysis of the data will not influence the patient care.

Exclusion Criteria:

* Any patient who cannot give a valid consent will be excluded
* Children
* Pregnant women
* Fetuses and/or Neonates
* Prisoners

Primary outcomes:
measure: incidence of adverse events
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Basavana G Goudra
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05980507: An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma
Official title: An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Relapsed/Refractory Multiple Myeloma
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 0
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: An open label, single-arm clinical study evaluating the safety and efficacy of ICI201 infusion in relapsed/refractory multiple myeloma


Eligibility criteria: Inclusion Criteria:

* 1. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma. 2. Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD). 3. Measurable disease as defined by the protocol 4. ECOG score is 0 or 1. 5. Expected survival time ≥12 weeks. 6. GPRC5D positive expression in bone marrow plasma cells

Exclusion Criteria:

* 1. Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs. 2. Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection. 3. Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses \< 10mg/ day). 4. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg). 5. Patients who have recieved GPRC5D-targeted therapy

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: Time Frame: 28 days post ICI201 administration
measure: Incidence and severity of all adverse events related to study drug
timeFrame: Time Frame: 2 years post ICI201 administration
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: First Affiliated Hospital, Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT06542107: Weaning From Mechanical Ventilation in Patients With Acute Brain Injury
Official title: Prediction of Weaning for Patients With Acute Brain Injury Undergoing Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ventilator Lung
Acute Brain Injury
Keywords: mechanical ventilation
acute brain injury
weaning
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to the ICU due to acute brain injury and treated with invasive mechanical ventilation

Brief summary: Acute brain injury (ABI) patients frequently necessate intubation and invasive mechanical ventilation (IMV). While some ABI patients are capable of breathing spontaneously, which is one of the main criteria of extubation and weaning. However, the rate of extubation failure was significantly higher in ABI patients compared with non-neurological critical care patients. In patients who have failed one or several trials of extubation, tracheostomy is recommend according to the latest ESICM consensus. Tracheostomy can enhance comfort, improve pulmonary hygiene and decrease sedation requirement, which could facilitate the liberation from ventilator.

Numerous studies have explored the causes of weaning failure and provide various predictive models in guiding extubation and tracheostomy. Yet, due to limitations of such as small sample size or a lack of external validation, there is paucity of practical weaning algorithm tailored for ABI patients. The liberation from IMV in ABI patients still remains challenging with poor level of evidence in current guidelines or expert consensus.

We aim to describe the weaning outcomes in ABI patients, and further investigate the potential predictors of weaning success in ABI patients.


Eligibility criteria: Inclusion Criteria:

* acute brain injury
* age \>=18 years
* invasive mechanical ventilation for at least 24 hours

Exclusion Criteria:

* tracheostomized before ICU admission
* pregnant or lactation
* with cervical spinal cord injury
* decision to receive palliative care within 24 hours of ICU admission

Primary outcomes:
measure: weaning success
timeFrame: up to 7-day period (ICU stay)
Secondary outcomes:
measure: extubation
timeFrame: up to 7-day period (ICU stay)
Other outcomes:
measure: tracheostomy
timeFrame: up to 7-day period (ICU stay)
Locations:
city: Nanjing
country: China
facility: Ling Liu
state: Jiangsu
Study officials:
References:
Clinical trial NCT06344507: Iconographic Registry of Pancreatobiliary Endoscopy Procedures
Official title: Iconographic Registry of Pancreatobiliary Endoscopy Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Neoplasm
Cancer of Pancreas
Pancreatitis
Neuroendocrine Tumors
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 12,000 patients who, between 2000 and 2027, underwent endoscopic ultrasound procedures at the Bilio-Pancreatic Endoscopy and Endoscopic Ultrasound Unit of the IRCCS San Raffaele Hospital for suspected diagnoses (based on clinical and/or diagnostic evaluations suggesting a potential diagnosis of one of the diseases listed below) and/or confirmed diseases (verified by histological and/or radiological reports when histological diagnosis was not possible).

Brief summary: The aim of the TAILOR-EUS study (Iconographic Registry of Bilio-Pancreatic Endoscopic Ultrasound Procedures) is to establish a clinical registry comprising images and videos generated during endoscopic procedures conducted for the investigation of pancreatic diseases (PD). The study will compile historical, pathological, and imaging data from approximately 12,000 patients (2,000 retrospectively and 10,000 prospectively) who underwent endoscopic ultrasound procedures for inflammatory pancreatic conditions (e.g., acute, recurrent, chronic pancreatitis), autoimmune bilio-pancreatic diseases (e.g., autoimmune pancreatitis), neoplastic bilio-pancreatic conditions, and screenings for individuals at high risk of developing such diseases at the Bilio-Pancreatic Endoscopy and Endoscopic Ultrasound Unit of the IRCCS San Raffaele Hospital between 2000 and 2027.

Participants have undergone or will undergo the standard diagnostic pathway appropriate for their conditions as part of routine clinical practice. All instrumental examinations and endoscopic ultrasound procedures are integral to the standard diagnostic and therapeutic approach for pancreatic diseases.


Eligibility criteria: Inclusion Criteria:

* Suspected or confirmed diagnosis of inflammatory pancreatic disease (e.g., acute, recurrent, or chronic pancreatitis) or autoimmune bilio-pancreatic disease (e.g., autoimmune pancreatitis) or bilio-pancreatic neoplastic disease, necessitating an endoscopic ultrasonography procedure.
* Age over 18 years.
* Ability to provide informed consent.

Exclusion Criteria:

* Pregnancy and breastfeeding status.
* Contraindications to the endoscopic ultrasonography procedure

Primary outcomes:
measure: Registry for images and videos
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References:
Clinical trial NCT02014207: The Effect of Potato Fries Processing on Food Intake, Satiety and Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Diabetes
Metabolic Syndrome
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2013-12-18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: Potato is one of the world's most popular foods and is widely accepted as a staple food. The objective of this study is to determine the effect of altering commercial blanching and cooling times during manufacture of frozen fries produced by the on blood glucose, satiety and appetite. It hypothesized that the processing regime predetermines the physiologic responses to ingested product and therefore it is possible to produce healthier product lines of potato fries.


Eligibility criteria: Inclusion Criteria:

* Healthy men with a body mass index (kg/m2) of 20-24.9

Exclusion Criteria:

* smocking, medication, breakfast skipping, restrained eating

Primary outcomes:
measure: blood glucose
timeFrame: 120 min
Secondary outcomes:
measure: food intake
timeFrame: 120 min
Other outcomes:
measure: subjective appetite
timeFrame: 120 min
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences
state: Ontario
Study officials:
References:
Clinical trial NCT02696707: An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer
Official title: An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: cardiac toxicities
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Several large adjuvant trastuzumab trials have demonstrated improved overall survival, in participants with early stage breast cancer, with a 33% decrease in risk of death. However, retrospective analyses of participant outcomes in these trials have demonstrated increased risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%).

At this time, investigators are unable to predict which participants are at increased risk of cardiac-related treatment complications. Currently all patients receive regular cardiac imaging throughout their one year of trastuzumab treatment.

At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains unknown, and several published consensus guidelines are currently in use as "standard of care.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed early stage HER2-positive breast cancer
* Planned trastuzumab therapy for early stage breast cancer
* ≥18 years of age
* Able to provide verbal consent
* Normal LVEF (\>53%) before trastuzumab therapy

Exclusion Criteria:

• Contraindication to transthoracic echocardiography or MUGA

Primary outcomes:
measure: LVEF results
timeFrame: at year one
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Olexiy Aseyey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dent S, Fergusson D, Aseyev O, Stober C, Pond G, Awan AA, McGee SF, Ng TL, Simos D, Vandermeer L, Saunders D, Hilton JF, Hutton B, Clemons M. A Randomized Trial Comparing 3- versus 4-Monthly Cardiac Monitoring in Patients Receiving Trastuzumab-Based Chemotherapy for Early Breast Cancer. Curr Oncol. 2021 Dec 3;28(6):5073-5083. doi: 10.3390/curroncol28060427.
Clinical trial NCT03461107: Evaluation of Clinical and Genetic Modifiers of Long-term Survival in Heart Failure
Official title: Evaluation of Beta-adrenergic Receptor Gene Polymorphisms in the Long-term Effects of Beta-blockade in Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2500 outpatients or hospitalized patients with chronic heart failure will be enrolled in this study.

Brief summary: The purpose of this study is to evaluate the beta-adrenergic receptor gene polymorphisms in the long-term effects of beta-blockade in patients with chronic heart failure.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older;
2. Patients are required to have chronic heart failure (NYHA II-IV) with a left ventricular ejection fraction lower than 40%;
3. Patients are voluntary and signed informed consent.

Exclusion Criteria:

1. Pregnant women or plan to;
2. Participate in any drug clinical trials within 3 months;
3. Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);
4. Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;
5. Patients refused to comply with the requirements of this study to complete the research work;
6. According to the researchers, patients can not complete the study or not to comply with the requirements of this study (because of the reasons for the management or other reasons).

Primary outcomes:
measure: Cardiovascular death
timeFrame: up to 24 months
measure: Heart transplantation
timeFrame: up to 24 months
Secondary outcomes:
measure: All cause death
timeFrame: up to 24 months
measure: Heart failure recuring
timeFrame: up to 24 months
measure: Readmission because of cardiovascular diseases
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Dao Wen Wang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu D, Xiao L, Li S, Hu S, Sun Y, Wang Y, Wang DW. Prediction of HF-Related Mortality Risk Using Genetic Risk Score Alone and in Combination With Traditional Risk Factors. Front Cardiovasc Med. 2021 Apr 26;8:634966. doi: 10.3389/fcvm.2021.634966. eCollection 2021.
citation: Hu D, Li S, Hu S, Sun Y, Xiao L, Li C, Wang J, Wang Y, Ni L, Zhao C, Wang DW. A Common Missense Variant in OMA1 Associated with the Prognosis of Heart Failure. Cardiovasc Drugs Ther. 2020 Jun;34(3):345-356. doi: 10.1007/s10557-020-06960-8.
citation: Hu D, Huang J, Hu S, Zhang Y, Li S, Sun Y, Li C, Cui G, Wang DW. A common variant of RIP3 promoter region is associated with poor prognosis in heart failure patients by influencing SOX17 binding. J Cell Mol Med. 2019 Aug;23(8):5317-5328. doi: 10.1111/jcmm.14408. Epub 2019 May 31.