louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02890043: Clinical Trial for the Application of Tirobot System
Official title: Clinical Trial for the Application of Tirobot System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fusion of Spine (Disease)
Robotic Surgical Procedures
Keywords: spine
robot-assisted surgery
pedicle screw
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tinavi Medical Technology Co Ltd
name: Chinese PLA General Hospital
name: Tianjin Hospital
First posted: 2016-09-07
Enrollment: 88
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: The object of this study was to evaluate the accuracy and safety of the Tirobot system.

Detailed description: Tirobot system is a new-type medical robot-assisted surgery system that designed for spine and traumatic orthopaedic surgeries. This system has been certified by CE. The accuracy and safety of pedicle screw placement using this system will be evaluated.

Eligibility criteria: Inclusion Criteria:

* traumatic or degenerative thoracolumbar disease required for pedicle screw fixation surgery

Exclusion Criteria:

* severe osteoporosis
* old thoracolumbar fracture
* deformity of pedicle
* combined with coagulation disorders
* combined with other systematic disease

Primary outcomes:
measure: perforation rate of pedicle screws
timeFrame: up to postoperative 3 days
Secondary outcomes:
measure: operation time
timeFrame: through the operation complete, an average of 2 hours
measure: complications
timeFrame: up to postoperative 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
Study officials:
affiliation: Beijing Jishuitan Hospital
name: Wei Tian, MD
role: STUDY_CHAIR
References:
citation: Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab.
citation: Karapinar L, Erel N, Ozturk H, Altay T, Kaya A. Pedicle screw placement with a free hand technique in thoracolumbar spine: is it safe? J Spinal Disord Tech. 2008 Feb;21(1):63-7. doi: 10.1097/BSD.0b013e3181453dc6.
citation: Weinstein JN, Rydevik BL, Rauschning W. Anatomic and technical considerations of pedicle screw fixation. Clin Orthop Relat Res. 1992 Nov;(284):34-46.
citation: Han X, Tian W, Liu Y, Liu B, He D, Sun Y, Han X, Fan M, Zhao J, Xu Y, Zhang Q. Safety and accuracy of robot-assisted versus fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery: a prospective randomized controlled trial. J Neurosurg Spine. 2019 Feb 8;30(5):615-622. doi: 10.3171/2018.10.SPINE18487. Print 2019 May 1.
Clinical trial NCT05146843: The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients
Official title: The Impact of Chronic Mitochondrial Antioxidant (MitoQ) Supplementation on Cardiovascular Toxicity Induced by Doxorubicin-Based Adjuvant Chemotherapy in Breast Cancer Patients: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Keywords: Breast Cancer
Doxorrubicin
Mitoquinone
Cardiotoxicity
Peripheral vascular function
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
name: Instituto do Cancer do Estado de São Paulo
First posted: 2021-12-07
Enrollment: 44
Sex: ALL
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: Clinical, randomized, double-blind, placebo-controlled trial.
Primary purpose: TREATMENT

Brief summary: Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.

Detailed description: Test the hypothesis that chronic MitoQ supplementation in breast cancer patients treated with doxorubicin prevents:

1. increased mitochondrial oxidative stress;
2. the increase in cardiac markers (B-type natriuretic peptide and troponin I);
3. changes in left ventricular deformity (speckle tracking, strain) and reduction in LVEF;
4. endothelium-dependent dysfunction of peripheral vascular beds;
5. the increase in endothelial microvesicles;
6. the increase in material stiffness;
7. the elevation of central blood pressure.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years old, diagnosed with breast cancer (ductal, lobular and mixed carcinoma), in stage 1-3, with indication for the adjuvant AC-T therapeutic scheme, doxorubicin (60 mg/m2) plus cyclophosphamide, will be considered eligible for the study (600 mg/m2) in the regimen of 1 cycle every 21 days, followed by weekly taxane for 12 cycles.

Exclusion Criteria:

* Patients with metastasis, severe lymphedema, renal failure, acute myocardial infarction, heart failure, stroke and chronic liver disease.

Primary outcomes:
measure: Changes of the left ventricular deformity and reduction in left ventricular ejection fraction
timeFrame: 3 Months
Secondary outcomes:
measure: Systemic markers of oxidative stress
timeFrame: 3 Months
measure: Endothelium-dependent dysfunction of peripheral vascular beds
timeFrame: 3 Months
measure: Arterial stiffness
timeFrame: 3 Months
measure: Central blood pressure
timeFrame: 3 Months
measure: Physical capacity
timeFrame: 3 Months
Other outcomes:
Locations:
Study officials:
affiliation: D'Or Institute of Research and Education
name: Allan Kluser Sales, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00442143: Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells
Official title: Treatment of Severe Limb Ischemia With Autologous Bonemarrow Derived Mononuclear Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Ischemia
Keywords: CLI
PAOD
Severe lower limb ischemia
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2007-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate whether implantation of autologous bone marrow derived stem cells in ishemics limbs will improve vascularization

Detailed description: 10 patients with severe lower limb ischemia will be included in this pilote trial.

Bonemarrow aspiration will be performed and and the monocuclear cells isolated an injected into the gastrocnemius.

The patiens are followed for 4 months. Were trancutaneous oxygenpressure, ankel and toe blood pressure is measured.

Eligibility criteria: Inclusion Criteria:

* Ankle blood pressure \< 70 mmgHG
* Either pain at rest and/or ischemic wound
* No possible surgical treatment

Exclusion Criteria:

* Infection
* Malignant disease

Primary outcomes:
measure: Transcutaneous oxygen pressure
measure: 1st toe blood pressure (strain gauge)
measure: Ankle blood pressure
measure: Wound healing
measure: Pain
Secondary outcomes:
measure: amputation
measure: Infection
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of endocrinology M, Odense University Hospital
Study officials:
affiliation: Department of endocrinology M, Odense University Hospital
name: Moustapha Kassem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04032743: Risk Factors and Treatment Outcome of Oncology Children Hospitalized in the Intensive Care Unit Due to Sepsis
Official title: Retrospective Study: Risk Factors and Treatment Outcome of Oncology Children Hospitalized in the Intensive Care Unit Due to Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncologic Complications and Emergencies
ICU
Sepsis
Childhood Cancer
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 300
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and youth treated at Schneider Children's Hospital with chemotherapy due to oncology and hospitalized at Schneider Children's Hospital from 2008 until the end of 2018 due to sepsis.

Brief summary: Children treated with intensive chemotherapy are at increased risk for life-threatening infections (sepsis). As the survival of oncology patients increased with the use of aggressive treatment protocols, there was also an increase in the need for hospitalization in intensive care units (ICU) due to sepsis.Several prognostic factors are known to affect the survival of these patients, including the number and type of damaged systems, the type of oncology disease and the duration of neutropenia. With the development of the treatment of ICU, the survival of the oncology patients hospitalized for sepsis has also increased.

We will collect demographic details, details of their oncology and infections, laboratory tests and imaging. The goal is to identify prognostic factors in oncologic children hospitalized in ICU due to sepsis, as well as clinical and laboratory parameters that characterize this group of patients.


Eligibility criteria: Inclusion Criteria:

* Treatment in the hemato-oncology for cancer
* Admission to the ICU in SCMCI between 2008-2018 because of sepsis during chemotherapy

Exclusion Criteria:

* Admission to the ICU more than 3 month after last chemotherapy or 1 year after SCT

Primary outcomes:
measure: survival
timeFrame: 30 day
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center in Israel
name: Shlomit Barzilai Birenboim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919438: Non Invasive External Monitoring in Dialysis Patients
Official title: Fluid Removal During Adherent Renal Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure
Lead sponsor: Corventis, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care and kidney failure clinics

Brief summary: This is a single center, non randomized study to gather data to correlate physiological signals with the patient's fluid status during fluid removal in hemodialysis.

Detailed description: Patients undergoing hemodialysis will be monitored with the study device . The collected information will be correlated with fluid loss.

Eligibility criteria: Inclusion Criteria:

* Is female or male, 18 years of age or older
* Undergoing hemodialysis for fluid removal

Exclusion Criteria:

* Is participating in another clinical study that may confound the results of this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: VAMC, MN
name: Inder Anand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corventis, Inc.
name: Imad Libbus, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03148743: FMT in Gut aGVHD Treated
Official title: Department of Hematology of First Affiliated Hospital of Soochow University
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute-graft-versus-host Disease
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: After stem cell transplantating , some patients suffered the gut GVHD were recuited

Brief summary: With the stem cell transplanting increasing, patients which effected with gut GVHD were also increased. To evaluation the safety and efficacy of FMT for gut GVHD,patients with gut GVHD were recruited.


Eligibility criteria: Inclusion Criteria:

* gut GVHD

Exclusion Criteria:

* Age\>60; or Age\<10

Primary outcomes:
measure: times of stool
timeFrame: 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week
Secondary outcomes:
measure: volume in milliliter of stool
timeFrame: 24hours,48hours,72hours, 96hours,fifth day,sixth day, a week
Other outcomes:
Locations:
city: Suzhou
country: China
facility: 中国
state: Jiangsu
Study officials:
affiliation: first affiliated of Soochow university
name: depei wu
role: STUDY_CHAIR
References:
citation: Liu Y, Zhao Y, Qi J, Ma X, Qi X, Wu D, Xu Y. Fecal microbiota transplantation combined with ruxolitinib as a salvage treatment for intestinal steroid-refractory acute GVHD. Exp Hematol Oncol. 2022 Nov 9;11(1):96. doi: 10.1186/s40164-022-00350-6.
citation: Zhao Y, Li X, Zhou Y, Gao J, Jiao Y, Zhu B, Wu D, Qi X. Safety and Efficacy of Fecal Microbiota Transplantation for Grade IV Steroid Refractory GI-GvHD Patients: Interim Results From FMT2017002 Trial. Front Immunol. 2021 Jun 17;12:678476. doi: 10.3389/fimmu.2021.678476. eCollection 2021.
citation: Qi X, Li X, Zhao Y, Wu X, Chen F, Ma X, Zhang F, Wu D. Treating Steroid Refractory Intestinal Acute Graft-vs.-Host Disease With Fecal Microbiota Transplantation: A Pilot Study. Front Immunol. 2018 Sep 25;9:2195. doi: 10.3389/fimmu.2018.02195. eCollection 2018.
Clinical trial NCT01379638: Best Cardiac Output During Cardiopulmonary Bypass
Official title: Best Cardiac Output During Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bypass Complications
Keywords: cardiopulmonary bypass
cardiac output
flow rate
lactate
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients to be admitted to Aalborg Hospital, department of cardiac surgery for scheduled cardiac surgery

Brief summary: The purpose of this study is to determine whether the patients cardiac output measured before cardiopulmonary bypass (CPB), is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

Detailed description: For more than 50 years, CPB has been used to mechanically support the functions of the heart and lungs. In early studies, systemic oxygen uptake, calculated using Ficks global principle, was used to assess the efficiency of CPB. Using this measure of efficiency, a pump flow rate in liters per minute, based on the product of the body surface area (BSA) and a constant of 2.4 was found adequate to perfuse the body during normothermia. Ficks global principle is still used together with other methods to secure adequated perfusion under CPB.

The purpose of this study is to determine whether the patients cardiac output measured before CPB, is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

The hypothesis is that the patients cardiac output is a better marker for the optimal cardiac output than the estimated cardiac output.

Eligibility criteria: Inclusion Criteria:

* patients admitted for scheduled cardiac surgery during cardiopulmonary bypass
* Aged 18-90 years
* LVEF \> 50 %
* written consent from the patients

Exclusion Criteria:

* Former cerebral emboli
* Former head trauma
* known stenosis of the arteria carotis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Alborg Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Bodil Steen Rasmussen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01154738: Lidocaine and Closed-Loop Anesthesia System
Official title: Influence of Lidocaine on a Closed-Loop Anesthesia System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 82
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: The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.


Eligibility criteria: Inclusion Criteria:

* patients ASA 1, 2 or 3 scheduled for a general anesthesia surgical procedure (abdominal surgery, urology, ENT major procedure) lasting between 1 and 3 hours

Exclusion Criteria:

* age under 18 years
* simultaneous general and loco-regional anesthesia
* allergy to NSAID
* treatment with verapamil, ketamine or gabapentin
* patients receiving an opioid preoperatively
* severe hepatic insufficiency
* contra-indication to lidocaine
* contra-indication to propofol or to remifentanil
* history of central nervous system disease
* patients receiving a psychotropic treatment
* patients with a pace-maker

Primary outcomes:
measure: administered dose of propofol during maintenance of anesthesia
timeFrame: day 1
Secondary outcomes:
measure: administered dose of propofol during induction of anesthesia
timeFrame: day 1
measure: administered doses of remifentanil during induction and maintenance of anesthesia
timeFrame: day 1
measure: delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia
timeFrame: day 1
measure: hemodynamic abnormalities requiring treatment
timeFrame: day 1
measure: % of time with a BIS index between 40 and 60
timeFrame: day 1
measure: postoperative morphine requirement
timeFrame: day 1
measure: incidence of postoperative nausea and vomiting
timeFrame: day 1
measure: % of patients with an explicit memorisation of the intraoperative period
timeFrame: second postoperative day
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Tenon
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04705038: Effect of Education on Treatment Decision Making for Patients With Prostate Cancer on Chronic Hormone Treatments
Official title: A Feasibility Study of Orchiectomy in Patients With Prostate Cancer on Chronic LHRH Agonist or Antagonist Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn how an educational intervention about orchiectomy as an alternative to medical castration for those who are already on medical castration will impact the number of patients willing to undergo an orchiectomy (surgery to remove the testicles).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of metastatic prostatic adenocarcinoma
* Receiving luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist therapy continuously for at least 1 year with anticipated lifelong therapy
* Able to complete written surveys in English

Exclusion Criteria:

* More than 2 prior systemic treatment regimens utilized in addition to castration.

Primary outcomes:
measure: Number of patients that undergo orchiectomy after receiving study education intervention
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients that agree to participate in an educational session on surgical orchiectomy
timeFrame: 1 year
measure: Correlation of orchiectomy acceptance with race, socioeconomic status, level of education, and marital status.
timeFrame: 1 year
measure: Change in body image perception using the Hopwood BIS questionnaire in patients undergoing versus not undergoing orchiectomy.
timeFrame: 1 year
measure: Change in sexuality measured using the PROMIS v2.0 questionnaire in patients undergoing versus not undergoing orchiectomy.
timeFrame: 1 year
measure: Patient satisfaction with decision to under undergo orchiectomy as reported using the Regret Decision Scale.
timeFrame: 1 year
measure: Comparison of costs of medical versus surgical castration
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Walter Stadler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01170338: Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
Official title: Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Smoking
Acute Coronary Syndrome
Keywords: smoking
tobacco abuse
Lead sponsor: Newark Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 100
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: Assess the role of a nicotine antagonist in helping patients presenting to hospital with acute coronary syndrome to stop smoking.


Eligibility criteria: Inclusion Criteria:

* active smokers presenting to hospital with an acute coronary syndrome

Exclusion Criteria:

* patients with an acute coronary syndrome who are not active smokers

Primary outcomes:
measure: nicotine levels
timeFrame: 1 month
Secondary outcomes:
measure: recurrent myocardial ischemia
timeFrame: 1 month
Other outcomes:
Locations:
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
Study officials:
References: