louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03273036: Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy
Official title: Comparison of Perioperative Outcome Between Corticosteroids and Placebo in Transforaminal Endoscopic Lumbar Discectomy. A Single-center Randomized Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lumbar Disc Herniation
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The endoscopic discectomy has rapidly developed and increased need by patients. This procedure is widely performed by interventional pain physicians as well as by spine surgeons because it requires no general anesthesia or admission to a hospital. Many studies were reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy is lacking.

Detailed description: To examine whether corticosteroid administered epidural space in patients undergoing endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain relief, improves functional disability comparing to placebo

Eligibility criteria: Inclusion Criteria:

* Lumbar disc herniation patient age 20-45 year-old who have symptom duration was at least 6 weeks and conservative treatment failed

Exclusion Criteria:

* Refuse to participate and inform consent, Previous spinal surgery, History of allergic to steroid

Primary outcomes:
measure: Post-operative morphine consumption
timeFrame: Post operative 24 hour of morphine consumption in mg
Secondary outcomes:
measure: Visual analog score (back and leg) 0-10
timeFrame: 1 day, 2, 6 ,12, 24 weeks
measure: Oswestry disability index (ODI
timeFrame: 2, 6 ,12, 24 weeks
measure: MacNab scores
timeFrame: 2, 6 ,12, 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00208936: Phase II Study of Pre-Operative Chemotherapy in Patients With Resectable Local-Regional Carcinoma of Esophagus
Official title: Phase II Study of Pre-Operative Chemotherapy With Taxol, Cisplatin, and 5-Fluorouracil Followed by G-CSF in Patients With Resectable Local-Regional Carcinoma of Esophagus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Esophageal Diseases
Keywords: Esophageal Diseases
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed pre-operative for patients with resectable, local-regional carcinoma of the esophagus.

Detailed description: This study is designed for patients with resectable, local-regional carcinoma of the esophagus. In a pre-operative setting, chemotherapy with Taxol, Cisplatin, and 5-Fluorouracil will be administered followed by G-CSF.

Eligibility criteria: Inclusion Criteria:

* Measurable disease with resectable local-regional carcinoma of the esophagus. 18 years of age or older.

Exclusion Criteria:

* Pregnant or lactating. Non-resectable local-regional carcinoma of the esophagus.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: Michael Fanucchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01051336: Safety and Tolerability Study of the Taris Placebo System
Official title: Phase I Safety and Tolerability Study of the Taris Placebo System (A Novel Bladder Drug Delivery Platform)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: TARIS Placebo
Bladder
Interstitial Cystitis
Normal Healthy Volunteers
Lead sponsor: TARIS Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the development program and to provide key safety and tolerability data for the Taris platform.


Eligibility criteria: Inclusion Criteria:

* Healthy female volunteers, 18 to 55 years of age
* Body weight \>100 lbs and BMI (body mass index) within the range 18-30 kg/m2
* A score of less than 11 on the pelvic pain/urgency-frequency scale (PUF)

Exclusion Criteria:

* Presence of any bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of the TARIS placebo system
* History of significant urogenital surgery (any type of bladder suspension, prolapse repair, incontinence procedure, or vaginal hysterectomy)
* History of kidney stone formation
* Chronic or recurring bacterial or viral infections of the urogenital system

Primary outcomes:
measure: Safety, tolerability and retention of the TARIS placebo system upon insertion, 14-day exposure and removal
timeFrame: 14 days
Secondary outcomes:
measure: Subject reported symptoms
timeFrame: 14 days
measure: Routine and microscopic urinalysis
timeFrame: 14 days
measure: Urine culture
timeFrame: 14 days
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
affiliation: Dedicated Phase I (Arizona Urology)
name: Pankaj M Jain, M.D., M.B.A.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01267318: Evaluation of Gastric Juice Samples During Standard Gastroscopy Procedure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gastrointestinal Bleeding
Keywords: Gastric juice
Stomach
GI
Gastric juice samples with presence of blood.
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-12-28
Enrollment: 5
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: All gastric juice samples should contain blood. This will be determined by the treating physician based on visual assessment in a region alongside the fresh biopsy site just performed, and prior to any saline washing.

Brief summary: Development of a new diagnostic detection tool for gastrointestinal bleeding.

Detailed description: Literature does not support enough data/knowledge regarding stomach bleeding Hb levels in pathological situations and/or stomach bleeding levels following biopsy. It is important to understand the approximate concentration level of stomach bleeding before proceeding with technology development to insure this technology is capable of detecting such blood levels.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects ≥ 18 years old.
* Subject is scheduled for EGD endoscopy which includes biopsy, or,
* Subject is scheduled for EGD endoscopy following a bleeding event.

Exclusion Criteria:

* Subject is either not competent or not willing to provide written informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Rami Eliakim, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01360918: Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery
Official title: Concomitant Epicardial Pulmonary Vein Isolation in Patients With Atrial Fibrillation Undergoing Elective Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
Collaborators: name: Foundation of Cardiovascular Research and Education Enschede
First posted: 2011-05-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recent studies demonstrated that radiofrequency isolation of the pulmonary veins (PVI) is a superior alternative to antiarrhythmic drug therapy in patients with symptomatical paroxysmal atrial fibrillation (AF). A substantial proportion of patients undergoing elective cardiac surgery also suffer from atrial fibrillation. No evidence exists if epicardial PVI is beneficial in patients with a history of AF undergoing coronary bypass surgery (CABG) for the concomitant treatment of AF. The investigators aim to establish the effectiveness of incorporating epicardial pulmonary vein isolation into elective cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age
* EHRA class ≤ 2
* Documented history of paroxysmal, persistent, longstanding persistent or newly-diagnosed AF prior to admittance for cardiac surgery
* Patients will have elective coronary surgery planned Able of providing informed consent

Exclusion Criteria:

* Patients ≥70 years of age
* Pregnancy Patients with contraindications for oral anticoagulant agents
* Patients undergoing emergency operation
* Patients undergoing concomitant valve replacement
* Severely enlarged LA (\>50 mm) on echocardiography
* Prior AF ablation or AF surgery

Primary outcomes:
measure: Recurrence of atrial fibrillation
timeFrame: one year
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: One year
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
Study officials:
affiliation: Medisch Spectrum Twente
name: Marcoen Scholten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02777918: Changing Habits and Lifestyles in Older Individuals
Official title: Changing Habits and Lifestyles in Older Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behaviour
Keywords: food intake
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: British Egg Industry Council
First posted: 2016-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an intervention study, aiming to increase protein intake, by increasing egg consumption in community dwelling older adults aged 55 years and over, by providing recipes to increase flavour and variety in egg dishes.

Detailed description: Individuals will be randomized to either receive the intervention or to a control group, where the intervention group will receive 6 recipes every two weeks for a 12 week period, and at the start, after 12 weeks and after 6 months egg intake, protein intake, body protein status, and various functional measures of muscle function will be assessed in both intervention and control group.

Eligibility criteria: Inclusion Criteria:

Individuals can be considered for inclusion if they meet the following inclusion criteria:

* being over 55 years old
* living in the community
* being able to give consent
* not being allergic to eggs
* not suffering from known renal insufficiency, or having a pacemaker or defibrillator.
* not suffering from known hypercholesterolaemia, or known familial hypercholesterolaemia.
* not having undergone chemotherapy or radiotherapy in the last 6 months
* not suffering from any condition, or receiving medication or treatment that the participants feel affects their eating or sense of flavour.
* being able to perform the physical performance tests (e.g. walk, sit on a chair)
* being able to read and understand English

Primary outcomes:
measure: Egg Intake
timeFrame: Change from baseline to 12 weeks
measure: Adverse Events
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Change in Dietary Protein Intake
timeFrame: Change from baseline to 12 weeks
measure: Muscle Function
timeFrame: Change from baseline to 12 weeks
measure: Lean Body Mass
timeFrame: Change from baseline to 12 weeks
measure: Egg Intake
timeFrame: 6 months
measure: Number of Adverse Events Reported
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Bournemouth University
name: Katherine M Appleton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01696318: Program for Cardiovascular Prevention and Randomized Clinical Trial
Official title: Management Models for Cardiovascular Risk Reduction in Primary for Brazil: Developing a Program for Cardiovascular Prevention and Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital Moinhos de Vento
First posted: 2012-10-01
Enrollment: 256
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Develop and evaluate a model of organization and management in the management of patients with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control and treatment effectiveness.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of hypertension (\> 140/90 mmHg)
* Age \> 40 years
* Sitting: USF da Restinga e Extremo Sul - USF Chapéu do Sol and USF Paulo Viaro

Exclusion Criteria:

* Institutionalized individuals
* Patients with mental illness or disabling chronic illnesses
* Users of health services belonging to the supplementary health
* Individuals with life expectancy less than 1 year

Primary outcomes:
measure: Blood Pressure
timeFrame: Change from baseline in Systolic Blood Pressure at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RS
Study officials:
affiliation: UFRGS/HMV
name: Carisi Polanczyc, PhD
role: STUDY_DIRECTOR
References:
citation: Kuhmmer R, Lazzaretti RK, Guterres CM, Raimundo FV, Leite LE, Delabary TS, Caon S, Bastos GA, Polanczyk CA. Effectiveness of multidisciplinary intervention on blood pressure control in primary health care: a randomized clinical trial. BMC Health Serv Res. 2016 Aug 31;16(1):456. doi: 10.1186/s12913-016-1703-0.
Clinical trial NCT03885518: Painted Playgrounds: Aim 2: Assessments
Official title: Painted Playgrounds: A Scalable Approach to Increasing Physical Activity and Motor Skills in Louisiana Preschool Aged Children. Aim 2: Assessments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield
First posted: 2019-03-21
Enrollment: 51
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Painted Playgrounds Aim 2 (Assessment) project will examine the effects of a stenciling intervention aimed at increasing physical activity and improving fundamental motor skill functioning of preschool aged children. 72 children from local licensed childcare centers will participate in individual assessments at baseline and follow-up 6-8 weeks later. Assessments include height/weight, surveys and wearing a physical activity monitor (accelerometer) for 7 days. A parent/legal guardian will provide consent for their child to participate and will also complete a brief survey about their child's lifestyle and habits.


Eligibility criteria: Inclusion Criteria:

* A child who attends a childcare center enrolled to Aim 1.
* A child who is ≥ 3 years and ≤ 6 years old
* Your child will continue to attend this same childcare center for the duration of the study.

Exclusion Criteria:

• Parent/legal guardian is unwilling to provide written informed consent

Primary outcomes:
measure: Change in Moderate to Vigorous Activity (MVPA) During Recess
timeFrame: Baseline and follow-up (6 to 8 weeks after playground stenciling)
measure: Change in Fundamental Motor Skill Development
timeFrame: Baseline and follow-up (6 to 8 weeks after playground stenciling)
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Maura Kepper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Webster EK, Kepper MM, Saha S, Beyl RA, Kracht CL, Romain JS, Staiano AE. Painted playgrounds for preschoolers' physical activity and fundamental motor skill improvement: a randomized controlled pilot trial of effectiveness. BMC Pediatr. 2023 Sep 9;23(1):455. doi: 10.1186/s12887-023-04260-2.
Clinical trial NCT02394418: Effect of Sevoflurane, Propofol and Dexmedetomidine on Delirium & Neuroinflammation in Mechanically Ventilated Patients
Official title: Comparison of Sedative Effects of Sevoflurane, Propofol and Dexmedetomidine on the Clinical Course of Delirium and Neuroinflammation in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Delirium
Lead sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor class: OTHER_GOV
First posted: 2015-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of sedative effects of sevoflurane, dexmedetomidine and propofol on the clinical course of delirium, SIRS and neuroinflammation in mechanically ventilated patients using CAM-ICU scale, GSK-3beta and protein S100b in serum.


Eligibility criteria: Inclusion Criteria:

* presence of delirium

Exclusion Criteria:

* presence of Alzheimer's disease
* any mental disorder
* presence of cancer

Primary outcomes:
measure: Duration of Delirium
timeFrame: up to 5 days
Secondary outcomes:
measure: Change of protein S100b in serum
timeFrame: from delirium onset up to 5 days
measure: Change of GSK-3beta in serum
timeFrame: from delirium onset up to 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Moscow Regional Research Clinical Institute
name: Valery Likhvantsev, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00778518: Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
Official title: Phase IIb Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Growth Hormone Deficiency
Keywords: growth hormone
growth hormone deficiency
GHD
PEG
pegylated
IGF-1
Lead sponsor: Ambrx, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono International SA
First posted: 2008-10-23
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).

Detailed description: The primary objective of this study is to evaluate the safety, tolerability and pharmacodynamic response of three different ARX201 doses (PEG-ahGH) when administered repeatedly to young adult patients with childhood onset growth hormone deficiency (GHD).

Eligibility criteria: Inclusion Criteria:

* 18-30 years old
* GHD of childhood onset
* completed growth
* IGF-1 \<=2SDS
* rhGH treatment naive
* hGH levels below cut-off

Exclusion Criteria:

* History of malignancy or intracranial tumors
* ECG abnormality
* ICH
* hepatic dysfunction
* renal impairment
* major medical conditions
* inadequate T4
* positive for HBV, HCV, or HIV
* alcohol or drug abuse

Primary outcomes:
measure: Temporal profiling of circulating IGF-1 levels.
timeFrame: 3 period
Secondary outcomes:
measure: Body composition measurements at start of study and end of study
timeFrame: 6 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Accelsiors CRO and Consultancy Services
Study officials:
affiliation: Accelsiors CRO & Consultancy Services
name: Mihaly Juhasz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03023618: Fluid Oriented Therapy During Major Abdominal Surgery
Official title: Effect Of Stroke Volume Optimization On Complication Rate Of Patients Undergoing Pancreatic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Goal Directed Therapy
Keywords: [G09.330.380]
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this "before and after" study we will investigate the potential benefit on postoperative outcomes of a guided fluid therapy with a stroke volume optimization . The NICE protocol has been applied by means of EV1000 monitor and arterial waveform analysis ( Flotrac - Edwards). In the postoperative period overall complications, as well as exitus , will be analyzed and compared with those of a control group underwent the same surgical interventions, with a standard hemodynamic monitoring.


Eligibility criteria: Inclusion Criteria:

* ASA 1-2 patients

Exclusion Criteria:

* Severe Caridiac Disease
* Renal Failure

Primary outcomes:
measure: complication rate
timeFrame: up to 30 days postoperatively
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: an average of 30 days
Other outcomes:
measure: amount of intraoperative fluids
timeFrame: an average of 12 hours
Locations:
Study officials:
affiliation: Department of Anesthesiology
name: Valter MD Perilli, PhD
role: PRINCIPAL_INVESTIGATOR
References: