louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00219076: A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients
Official title: A Six-week, Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren 150 mg and Amlodipine 5 mg Compared to Amlodipine 5 mg and 10 mg in Hypertensive Patients Not Adequately Responsive to Amlodipine 5 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, blood pressure, amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.


Eligibility criteria: Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study Exclusion Criteria
* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in mean sitting diastolic blood pressure after 6 weeks
Secondary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure after 6 weeks
measure: Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 6 weeks
measure: Achieve mean sitting blood pressure target of < 140/90 mmHg after 6 weeks
measure: Change from baseline in standing diastolic blood pressure after 6 weeks
measure: Change from baseline in standing systolic blood pressure after 6 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01812876: A Registry Study on Shenqifuzheng（a Chinese Medicine Injection）Used in Hospitals in China
Official title: A Registry Study on Shenqifuzheng（a Chinese Medicine Injection）Used in Hospitals in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Carcinoma
Carcinoma of the Lungs
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 30000
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: An anticipated sample size was caculated in this study, about 30000 Patients using Shenqifuzheng injection from 2013 to 2014 in more than 30 hospitals.

Brief summary: This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

The purpose of this study is to make a cohort event monitoring to see whether and how Shenqifuzheng injection in hospital results in adverse events or adverse drug reactions.

Detailed description: It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.

A registry study for Shenqifuzheng injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2014.

Eligibility criteria Patients who will use Shenqifuzheng injection in selected hospitals

Eligibility criteria: Inclusion Criteria:

- Patients using Shenqifuzheng injection from 2013 to 2014

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of participants with adverse events; incidence of Shenqifuzheng'ADRs and identify factors that contributed to the occurrence of the adverse reaction
timeFrame: to assess Shenqifuzheng's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Shenqifuzheng will be registered every day. The registry procedure will last 3 years only for patients using Shenqifuzheng
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Xie M Yan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00204776: XELOX for Metastatic Breast Cancer
Official title: A Phase II Trial of Capecitabine and Oxaliplatin in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-09-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Both capecitabine and oxaliplatin have single agent activity in breast cancer. The combination has improved activity in other solid tumors. This study seeks to assess the activity of the combination in breast cancer.


Eligibility criteria: Inclusion Criteria:

* preserved organ function
* good performance status
* no more than one prior therapy
* no active brain metastasis

Exclusion Criteria:

* No prior capecitabine or oxaliplatin
* no con-current therapy

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Toxicity
measure: Time to progression
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Sherry Morgan-Meadows
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03925376: Prognostic Factors of Patients Undergoing Redo Cardiac Surgery
Official title: Prognostic Factors of Patients Undergoing Redo Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Redo Cardiac Surgery
Keywords: Redo cardiac surgery
Outcome
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Redo cardiac surgery is associated with an increased risk of postoperative morbidity and mortality. Patients undergoing redo cardiac surgery are becoming increasingly complex due to multiple comorbidities, adherence of mediastinal structures to the undersurface of the sternum as well as the spatial location of patent bypass grafts relative to the route of entry.

Brief summary: This study aims to investigate the prognostic significance of baseline characteristics for patients undergoing redo cardiac surgery.

Detailed description: Redo cardiac surgery is associated with an increased risk of postoperative morbidity and mortality. Patients undergoing redo cardiac surgery are becoming increasingly complex due to multiple comorbidities, adherence of mediastinal structures to the undersurface of the sternum as well as the spatial location of patent bypass grafts relative to the route of entry. Association estimates between baseline characteristics and outcomes in those cohort are imprecise. The aim of this study is to identify prognostic factors associated with redo cardiac surgery which may help physicians predict clinical outcomes and guide their treatment decision.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing redo cardiac surgery

Exclusion Criteria:

* Age \<18 years;
* Patients with a DNR order or "do not escalate care" order.

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Secondary outcomes:
measure: 60- and 90-day mortality
timeFrame: 60 days and 90 days
Other outcomes:
measure: Length of stay in the ICU
timeFrame: up to 90 days
measure: Length of stay in the hospital
timeFrame: up to 90 days
measure: Percentage of participants with adverse events
timeFrame: up to 90 days
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
Study officials:
References:
Clinical trial NCT04648176: Application of MOSES Technology in BPH
Official title: Evaluation of Surgical and Functional Results of the Application of MOSES Technology in the Holmium Laser Prostate Enucleation as a Treatment for Tract Symptoms Lower Urinary Secondary to Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Lower Urinary Tract Symptoms
Keywords: laser
Holmium
HoLEP
Moses
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation.

Detailed description: In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation using MOSES technology.

Eligibility criteria: Inclusion Criteria:

* Prostatic volume between 70-200cc
* Acceptance to participate in the study.

Exclusion Criteria:

* Previous urethra stricture
* Previous prostate surgery
* Neurogenic bladder
* Bladder tumor
* Neurological disease with repercussion in the lower urinary tract.
* Severe psychiatric illness
* Inability of the patient to consent

Primary outcomes:
measure: Hemoglobin
timeFrame: 24 hours after the surgery
Secondary outcomes:
measure: Enucleation time
timeFrame: during the surgery
measure: Hemostasis time
timeFrame: during the surgery
measure: Morcellating time
timeFrame: during the surgery
measure: Surgery time
timeFrame: during the surgery
measure: Irrigated volume of serum
timeFrame: during the surgery
measure: complication rate
timeFrame: one month after the surgery
measure: urinary tract infection
timeFrame: one month after the surgery
measure: lower urinary tract symptoms
timeFrame: through study completion, an average of 3 years
measure: sexual function
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
Study officials:
affiliation: Vall d'Hebrón University Hospital
name: José Placer Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00971776: Voyager I: Patient Discharge Using the AB5000 Portable Driver System
Official title: Voyager I: Patient Discharge Using the AB5000 Portable Driver System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Cardiac Dysfunction
Keywords: Patient receiving AB5000 ventricle potentially recoverable
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The AB Portable Driver System will allow patients supported with the Circulatory Support System to be discharged home when their medical condition improves to an ambulating status and will continue to receive the assistance of the AB 5000 ventricle for their heart recovery.


Eligibility criteria: Inclusion Criteria:

* The subject is an AB5000 Circulatory Support System patient (in accordance FDA-approved indications for use) who is suffering acute cardiac dysfunction and is potentially recoverable;
* The subject is male or female, age 18 years or older;
* The subject is able to ambulate unassisted;
* The subject is on stable oral anticoagulation over 7 days (INR 2-4) with no active bleeding;
* The subject is willing and able to read, understand and sign the study specific informed consent form;
* The subject agrees to comply with study protocol requirements, including all follow-up visits and completion of Qol and NIH stroke scale assessments.

Exclusion Criteria:

* The subject, pre-device implant, is qualified as a transplant candidate.
* There is an absence of a trained companion.
* There is an absence of a psycho-social support.
* The subject has an inadequate home environment, such as poor access which may hinder movements.
* The subject has experienced hypotension in last 24 hours based on two consecutive readings spaced by 8 hours with systolic blood pressures \< 90 mmHg.
* The subject requires respiratory assistance.
* The subject has an active infection (positive blood culture and/or body T ≥ 38 degrees C, and/or WBC ≥ 12K/µL).
* The subject requires tube feeding.
* The subject has any other medical condition requiring hospitalization.

Primary outcomes:
measure: Adverse events, Quality of life assessment, NIH Stroke Scale Assessments, and patient outcome after readmission
timeFrame: Pre-discharge, 30 days post-discharge, 90 days or re-admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04262076: Remineralization of Caries Affected Dentin
Official title: Effect of Pulpine and Combination of Pulpine With Polyamidoamine Dendrimer on Remineralization of Carious Affected Human Dentin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Caries
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: split mouth design
Primary purpose: TREATMENT

Brief summary: Remineralization of carious affected dentin

Detailed description: Remineralization of Carious affected dentin by using Pulpine alone and combination of Pulpine with Polyamidoamine Dendrimer.

Eligibility criteria: Inclusion Criteria:

* Presence of at least one class one carious posterior teeth in both left and right side.
* Absence of spontaneous pain, Mobility and tenderness on percussion.
* Radiographically, the preoperative inclusion criteria are, no internal or external resorption and no widening of the periodontal membrane space.

Exclusion Criteria:

* Patients with poor oral Hygiene.
* Evidence of Rampant Caries.
* Teeth with periodontal involvement.
* Poor general health condition.

Primary outcomes:
measure: Remineralization & increase dentin density that is measured by using Vista Scan Radiography.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University, Faculty of Dentistry for Girls
Study officials:
References:
Clinical trial NCT06265376: Do Patient Educational Videos Improve Pain and Recovery After Laparoscopic Hysterectomy?
Official title: A Single-site Randomized Controlled Trial of an Patient Educational Video to Improve Postoperative Pain and Overall Recovery Satisfaction After Laparoscopic Hysterectomy Benign Indication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of multi-model patient education has been used in a variety of medical specialties to educate patients on expectations for various medical procedures and improve patients' understanding of their own health care. However, it is unknown what type of audio and/or visual materials work best in a given clinical setting. By surveying overall pain/post-operative recovery satisfaction we can measure how well our video intervention educates and reinforces post-operative management at home when compared to the current method of education that patients receive at the pre-operative visit prior to laparoscopic hysterectomy at this institution.


Eligibility criteria: Inclusion Criteria:

* 18y/o or older
* planned for a laparoscopic hysterectomy for benign indications

Exclusion Criteria:

* inability to consent
* language other than English
* conversion to laparotomy, vNOTES (a type of laparoscopic assisted vaginal hysteroectomy)
* vaginal hysterectomy
* chronic opioid use prior to surgery

Primary outcomes:
measure: Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy
timeFrame: Within 10 days post surgery
Secondary outcomes:
measure: Pain score at the time of survey completion (0=no pain 10=worst pain
timeFrame: Within 10 days post surgery
measure: Average pain score for the first 7 days as perceived by the patients (likert scale)
timeFrame: Within 10 days post surgery
measure: Number of post-op phone calls received
timeFrame: Within 10 days post surgery
measure: Number of post-op emergency room visits
timeFrame: Within 10 days post surgery
measure: Number of readmissions
timeFrame: Within 10 days post surgery
measure: Number of patients with steri-strips still in place
timeFrame: Within 10 days post surgery
measure: Number opioids taken since surgery
timeFrame: Within 10 days post surgery
measure: Overall satisfaction with pre-operative education regarding surgery (5 point Likert scale)
timeFrame: Within 10 days post surgery
measure: ding surgery (5 point likert scale) Overall satisfaction with educations regarding what to expect post-operatively (5 point Likert scale)
timeFrame: Within 10 days post surgery
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Megan Loring, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02514876: Foresight Intracardiac Echocardiography (ICE) System
Official title: Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Atrial Fibrillation
Lead sponsor: Conavi
Sponsor class: INDUSTRY
First posted: 2015-08-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation procedures.

Detailed description: This study is part of a multiphase study. Phase 1 involves 10 patients at a single centre. Phase 2 will be done a multi centre study.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years old.
* Patient is undergoing an atrial fibrillation ablation procedure.
* Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
* Patient provides informed, written consent for participation in the study.

Exclusion Criteria:

* Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician performing the procedure).
* Patients in whom transseptal puncture is relatively contraindicated.
* Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk.
* Women of child bearing potential, in whom pregnancy cannot be excluded.
* Patients unable to grant informed, written consent for participation in the study.

Primary outcomes:
measure: Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device
timeFrame: During ablation procedure (2-4 h)
Secondary outcomes:
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
Study officials:
affiliation: Southlake Regional Health Centre
name: Atul Verma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00279227: Role of Epicardial Adipose Tissue in Coronary Artery Disease
Official title: Role of Epicardial Adipose Tissue in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Obesity
Keywords: coronary artery disease
epicardial adipose tissue
epicardial fat
obesity
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2006-01-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: We sight to evaluate whether patients with coronary artery disease (CAD) have more epicardial fat than patients without CAD, which would suggest that epicardial fat may be more than an "innocent bystander" and be actively involved in the disease process. Its role as a modulator of vascular response and myocardial function could potentially lead to new areas of cardiac research. We also sight to evaluate whether epicardial fat from patients with CAD releases more adipokines than subcutaneous fat from these patients which could prompt studies into the differential regulation of adipokine secretion in this tissue. Thus for e.g., the use of thiazolidinediones (glitazones), statins, ARBs or other compounds that can specifically modulate adipokine secretion could be explored to determine their benefit in ameliorating the effects attributable to increased epicardial fat.


Eligibility criteria: Inclusion Criteria:

* All patients elegible for elective cardiac surgery are elegible
* Ability to provide written informed consent in accordance with GCP guidelines and local legislations.
* \> 18 years of age

Exclusion Criteria:

* Control patients will not have clinical signs of CAD and will show normal coronary arteries on angiography.
* Any medical, social or geographic condition, which, in the opinion of the investigator would not allow safe or reliable completion of the protocol.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Cardiovascular Obesity Research and Management Center
state: Ontario
Study officials:
affiliation: McMaster University
name: Arya M Sharma, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: