louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03966898: A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
Official title: A Phase III Study to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole Versus Placebo in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Advanced Breast Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-29
Enrollment: 426
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole
Primary purpose: TREATMENT

Brief summary: This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for this study.


Eligibility criteria: Inclusion Criteria:

1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
2. Age: 18 - 75 years old
3. No prior systemic anti-cancer therapy for advanced HR+ disease.
4. Eastern Cooperative Oncology Group \[ECOG\] 0-1

Exclusion Criteria:

1. Patients who received prior treatment with any CDK4/6 inhibitor.
2. Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.

Primary outcomes:
measure: Investigator-assessed PFS
timeFrame: Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, Up to approximately 24 months.
Secondary outcomes:
measure: Progression-free Survival (PFS) per RECIST 1.1
timeFrame: Up to approximately 24 months
measure: OS
timeFrame: up to 2 years
measure: ORR
timeFrame: Up to approximately 24 months
measure: DoR
timeFrame: Up to approximately 24 months
measure: CBR
timeFrame: Up to approximately 24 months
measure: Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0
timeFrame: Up to approximately 24 months
Other outcomes:
measure: Ctrough
timeFrame: Up to 4 weeks
Locations:
city: Shanghai
country: China
facility: Nayima Bayaxi
Study officials:
References:
Clinical trial NCT00137098: Coronary Care Caffeine: Influence of Coffee on Heart Rate Post Myocardial Infarction
Official title: Influence of Coffee on Heart Rate Variability Post Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
First posted: 2005-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of either gender, over 18 and under 80 years of age, admitted to the Coronary Care Unit following myocardial infarction.

Brief summary: Sudden cardiac death due to a heart rhythm disturbance after a heart attack (myocardial infarction) is a common cause of death. It is well documented that sudden cardiac death after a myocardial infarct (MI) is associated with low or poor heart rate variability (HRV). HRV is a measure of beat-to-beat changes in heart rate, with a greater variation associated with a "healthier" heart. The effect of caffeine on HRV in patients at high risk for sudden cardiac death is unknown. We, the investigators at the Royal Bournemouth Hospital, aim to study the effect of coffee or tea on HRV after MI.

Detailed description: 120 post MI patients on CCU will be studied during the first week of admission. Patients will be categorised using the following criteria: Infarct size and site; PMH; Co-morbidities; Drugs; Regular caffeine ingestion.

Patients will be randomised to receive either caffeinated or de-caffeinated coffee or tea during admission. HRV will be assessed by non-invasive Holter-monitoring on the fifth day. Salivary caffeine concentration will be assessed concurrently to assess compliance.

Eligibility criteria: Inclusion Criteria:

* ST-segment elevation (trans-mural) MI; sinus rhythm.
* Age \< 80 years.

Exclusion Criteria:

* Cardiogenic shock
* Nothing by Mouth (NBM)
* Caffeine intolerance
* Atrial fibrillation, temporary or permanent pacing
* Complete heart block, bundle branch block, severe left ventricular impairment, non-ST segment MI/acute coronary syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
Study officials:
affiliation: Royal Bournemouth Hospital
name: Tristan Richardson, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01305798: The Effect of Time-Slot Scheduling and Active Choice on Biometric Screening Participation
Official title: The Effect of Time-Slot Scheduling and Active Choice on Biometric Screening Participation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventative Health
Keywords: Biometric Screenings
Active Choice
Behavioral Economics
Default
Lead sponsor: National Bureau of Economic Research, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-03-01
Enrollment: 11000
Sex: ALL
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: The goal of this project is to see if behavioral nudges will increase an individual's likelihood of participating in a biometric screening. The behavioral nudges under consideration are assigning preselected time-slots, encouraging subjects to make an active choice, and sending reminders.

Detailed description: The employees in our sample will schedule their time slot for a biometric screening via e-mail and a health service provider website. Much as is the case in the current system, the control group will be informed via e-mail of the window of dates during which they can take part in the on-site screening and given instructions for scheduling an appointment. The first treatment group, the active choice and default option arm, will be informed via e-mail of a preselected time and date for their screening, which we will have generated randomly. This group will be asked to accept the default time, schedule a different time, defer the scheduling decision, or decline to receive a screening by clicking the appropriate option in the email. The second treatment group, the active choice only arm, will be given the same information as the control group, but they will also be asked to make an appointment immediately, defer the scheduling decision, or decline to receive a screening. The two treatment groups will also receive email reminders one week before their appointment and again one day before their appointment.

Eligibility criteria: Inclusion Criteria:

* Employee of Express Scripts
* Employee at a targeted Express Scripts location

Exclusion Criteria:

* Non-employees of Express Scripts

Primary outcomes:
measure: Number of employees enrolled in the intervention who complete a biometric screening through their work on-site clinic.
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Express Scripts
state: Missouri
Study officials:
affiliation: National Bureau of Economic Research
name: David I Laibson, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02925598: AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy
Official title: AuraGainTM and I-Gel® Laryngeal Masks in General Anesthesia for Laparoscopic Cholecystectomy - Performance Characteristics and Effects on Hemodynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Aspiration of Gastric Content
Keywords: Laringeal masks
Cholecystectomy, Laparascopic
Intubation, intratracheal
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries. The aim of this study was to evaluate and compare the performances of new types of SADs with EI regarding their insertion times, durations, perioperative complications and effects on hemodynamic parameters and peak airway pressures (Paw) in LC as well.

Detailed description: The standard procedure used for airway control in general anesthesia for LC (laparoscopic cholecystectomy) is endotracheal intubation (EI). AuraGain and I-Gel are supraglottic airway devices (SADs) used for airway control for certain types of surgeries.Previous studies have investigated and/or compared the performance of ProSeal™ LMA (Intavent Orthofix, Maidenhead, UK) during LC. But the performances of I-Gel and AuraGain have not been studied well yet. The main aim of this study was to evaluate and compare the performances of new types of SADs (i.e. AuraGain and I-Gel) with endotracheal intubation regarding their insertion times, ease of insertion and perioperative complications. The secondary aim was to observe their effects on hemodynamic parameters and peak airway pressures.

Eligibility criteria: Inclusion Criteria:

* (ASA) 1-2 physical status scheduled for elective LC

Exclusion Criteria:

* under the age of 18, history of hiatus hernia, gastroesophageal reflux, body mass index (BMI) \> 30 kg m-2, ASA physical status 3 or over and patients who met the difficult intubation criteria

Primary outcomes:
measure: Insertion time
timeFrame: Perioperative
measure: Attempts to insertion
timeFrame: Perioperative
measure: Airway related complications
timeFrame: Perioperative
Secondary outcomes:
measure: Heart Rate bpm
timeFrame: Perioperative
measure: Systolic blood pressure mmHg
timeFrame: Perioperative
measure: Diastolic blood pressure mmHg
timeFrame: Perioperative
measure: Peak airway pressure
timeFrame: Perioperative
Other outcomes:
Locations:
Study officials:
affiliation: Adiyaman university Research and Educational Hospital
name: Ulku Sabuncu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00870298: Computer Stop Order Alert to Prevent Concurrent Prescribing of Trimethoprim/Sulfamethoxazole and Warfarin
Official title: Randomized Controlled Study of a Computer Stop Order Versus Routine Practice When Trimethoprim/Sulfamethoxazole is Ordered Concurrently With Warfarin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prescribers' Drug Orders
Keywords: drug orders
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 1971
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To determine if a computerized stop order will reduce the number of concurrent trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic ordering system while a patient is hospitalized.


Eligibility criteria: Inclusion Criteria:

All resident physicians and nurse practitioners involved in inpatient care.

Exclusion Criteria:

None-

Primary outcomes:
measure: Reduce concomitant orders for warfarin and tmp/smx
timeFrame: 7 months
Secondary outcomes:
measure: Determine if computerized stop order will increase risk for inadvertent cessation of warfarin
timeFrame: 7 months
measure: Determine if computerized stop order will increase risk of delay of treatment with tmp/sulfa when determined to be necessary for treatment
timeFrame: 7 months
Other outcomes:
Locations:
Study officials:
References:
citation: Strom BL, Schinnar R, Aberra F, Bilker W, Hennessy S, Leonard CE, Pifer E. Unintended effects of a computerized physician order entry nearly hard-stop alert to prevent a drug interaction: a randomized controlled trial. Arch Intern Med. 2010 Sep 27;170(17):1578-83. doi: 10.1001/archinternmed.2010.324.
Clinical trial NCT01743898: A Prospective Pharmacodynamic Study of Rivaroxaban
Official title: A Prospective Pharmacodynamic Study of Rivaroxaban Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Rivaroxaban
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Clot
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients taking FDA-approved doses of rivaroxaban and control subjects not taking an anticoagulant or antiplatelet were eligible for inclusion

Brief summary: The ability to explain bleeding or clotting complications in patients treated with rivaroxaban remains challenging. In addition, there is limited data on how coagulation tests perform in patients treated with therapeutic doses of rivaroxaban. Predicted responses of coagulation tests to therapeutic doses of rivaroxaban may be helpful in better understanding abnormal responses to rivaroxaban. The purpose of the study is to define a therapeutic reference range for peak and trough coagulation tests in patients taking FDA approved doses of rivaroxaban and to determine which tests may be most clinically useful for monitoring rivaroxaban.


Eligibility criteria: Inclusion Criteria:

Person taking therapeutic dose of Rivaroxaban

Exclusion Criteria:

* CrCl \< 15 mL/min
* Non-FDA approved dose based on calculated CrCl with most recent SCr
* Age \< 18 years
* Inability to communicate in the English language
* Decisionally-impaired individuals
* Incarcerated
* Pregnant/Lactating (Pregnancy category: C, unevaluated effects in lactation)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Carolina Point II
state: North Carolina
Study officials:
affiliation: Department of Family Medicine
name: Emily Hawes, PharmD, BCPS, CPP
role: STUDY_DIRECTOR
References:
Clinical trial NCT03175198: Japanese Pradaxa PMS, Long Term
Official title: Post-Marketing Surveillance on the Use of Prazaxa® Capsules in Japanese Patients With Nonvalvular Atrial Fibrillation After the Availability of Idarucizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 5660
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for nonvalvular atrial fibrillation must be according to regular medical practice and at discretion of physician (i.e., no randomised assignment of patient to treatment \[Prazaxa® Capsules or other treatment\] is performed).

Brief summary: The study objective is to confirm appropriate use and safety profile of Prazaxa® Capsules in real-world setting after the availability of idarucizumab

Detailed description: The study is Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Japanese patients with nonvalvular atrial fibrillation after the availability of idarucizumab. Even after the availability of idarucizumab in real clinical practice, appropriate use of Prazaxa® Capsules will continue. The patient population who receive Prazaxa® Capsules and the safety profile of Prazaxa® Capsules is not expected to change. This study investigates appropriate use with prospective investigation in the routine medical practice

Eligibility criteria: Inclusion Criteria:

* Male and female patients with nonvalvular atrial fibrillation who have never received Prazaxa® Capsules / dabigatran etexilate for preventing the occurrence of ischemic stroke and systemic embolism before enrolment in Japan

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
timeFrame: From baseline till the last administration + 6 days. Up to 364 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd
Study officials:
affiliation: zzCDMJP_PV_PMS@boehringer-ingelheim.com
name: Rie Ikeda, 81364172200
role: STUDY_CHAIR
References:
Clinical trial NCT03816098: The Accuracy of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly
Official title: The Accuracy of Chinese Version of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deglutition Disorders
Keywords: elderly
screening
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 elderly inpatients age over 65 are included in this study.

Brief summary: The aim of this research was to examine the accuracy of translated Chinese version of Swallowing Dysphagia Questionnaire and to evaluate the prevalence of dysphagia and its clinical manifestation in patients over 65 years old.


Eligibility criteria: Inclusion Criteria:

* (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious mental or cognitive conditions; no aphasia

Exclusion Criteria:

* (1) age under 65; (2) use enteral tube feeding; (3) subjects with serious mental or cognitive conditions or aphasia (4) Allergy to barium sulfate suspension

Primary outcomes:
measure: Swallowing Disturbance Questionnaire
timeFrame: At the baseline
measure: Videofluroscopy Swallowing Study (VFSS)
timeFrame: At the baseline
Secondary outcomes:
measure: Clinical water test
timeFrame: At the baseline
measure: Mini-Mental State Examination (MMSE)
timeFrame: At the baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04615598: Assessment of the Effects of Mental Practice on Tongue Strength in Brain-damaged Patients
Official title: Evaluation of the Effects of Action Observation Training on Tongue Strength in Brain-damaged Patients: a Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Movement, Involuntary
Keywords: Action observation
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2020-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to evaluate the effects of action-observation training on tongue strength in brain-damaged patients.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70
* Date of injury : 6 months onwards
* Medical diagnosis: brain damage or head trauma
* Clinical diagnosis of dysphagia by videofluoroscopy or V-CAM and expert opinion.

Exclusion Criteria:

* Not understanding verbal or auditory/visual commands through the Boston Test
* Present behavioural alterations
* Presence of seizures
* Presence of tracheotomy
* Impulsivity
* Attention Problems

Primary outcomes:
measure: Lingual strength
timeFrame: Change in immediately at the end of the intervention and also, changes between the end and three months
Secondary outcomes:
measure: Cervical Range of motion
timeFrame: Change in immediately at the end of the intervention and also, changes between the end and three months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT02308098: To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product
Official title: Study Comparing Bronchodilator Efficacy of Two Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler; a Randomised, Double-blind, Double-dummy, Multicentre, Single Dose, Crossover Study in Asthmatic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.


Eligibility criteria: Main inclusion criteria:

* Written informed consent
* Asthma diagnosis for at least 6 months
* Prebronchodilator FEV1 45-90% of the predicted value
* Demonstration of reversible airway obstruction
* Stable asthma on the same regular treatment for at least 4 weeks before the study
* Non-smoker for at least 6 months before the study

Main exclusion criteria

* Respiratory infection within 4 weeks before the study
* Smoking history of more than 10 pack-years
* Other severe chronic respiratory disease than asthma
* Concurrent illness that would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study
* Corrected QT interval \> 450 ms in males or \> 470 ms in females
* Abnormal serum potassium value or other clinically significant laboratory finding
* Systolic blood pressure over 180 mmHg and/or diastolic blood pressure over 100 mmHg
* Treatment with a long-acting β2-agonist, a xanthine-derivative, a β-blocker or with a corticosteroid (other than inhaled) within 4 weeks before the study
* Use of drugs that prolong QT-interval
* Women who are pregnant, breast-feeding or without reliable contraception
* Participation in another clinical drug study

Primary outcomes:
measure: Average FEV1
timeFrame: 12 h
Secondary outcomes:
measure: Maximum FEV1
timeFrame: 12 h
measure: FEV1 at 12 h
timeFrame: 12 h
Other outcomes:
Locations:
city: Ruse
country: Bulgaria
facility: Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
Study officials:
affiliation: Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
name: Hristo Metev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lahelma S, Vahteristo M, Metev H, Taseva M, Stamatova N, Bartha A, Schlezak J, Sairanen U. Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma. Respir Med. 2016 Nov;120:31-35. doi: 10.1016/j.rmed.2016.09.016. Epub 2016 Sep 25.