louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01117610: A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery
Official title: A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: pain
preemptive
postoperative
epidural injection
laminectomy
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy.

Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.

Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.

Detailed description: Patients in group I will receive 0.1% ropivacaine 10 ml before skin incision under guide of C-arm.

Eligibility criteria: Inclusion Criteria:

* laminectomy

Exclusion Criteria:

* r/o infection
* reoperation
* mental change
* allergy to local anesthetics

Primary outcomes:
measure: Visual analogue scale 4hour
timeFrame: post op 4hour
Secondary outcomes:
measure: visual analogue scale 24hour
timeFrame: Post Op 24 hour
measure: visual analogue scale 12 hour
timeFrame: Post op 12 hour
measure: Visual analogue scale 48hour
timeFrame: Post Op 48hour
measure: Opioid consumption 4hour
timeFrame: Post Op 4hour
measure: Opioid consumption 24hour
timeFrame: Post op 24 hour
measure: Opioid consumption 12 hour
timeFrame: Post Op 12 hour
measure: Opioid consumption 48hour
timeFrame: Post Op 48 hour
measure: FPB 4 hour
timeFrame: Post Op 4 hour
measure: FPB 12 hour
timeFrame: post op 12 hour
measure: FPB 24 hour
timeFrame: Post Op 24 hour
measure: FPB 48 hour
timeFrame: Post Op 48 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ChungAng University
Study officials:
affiliation: ChungAng University
name: Kwang-Sup Song, M.D. & Ph.D.
role: STUDY_DIRECTOR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hyun Kang, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang H, Jung HJ, Lee JS, Yang JJ, Shin HY, Song KS. Early postoperative analgesic effects of a single epidural injection of ropivacaine administered preoperatively in posterior lumbar interbody spinal arthrodesis: a pilot randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):393-9. doi: 10.2106/JBJS.K.01729.
Clinical trial NCT06273410: Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive
Official title: Clinical Performance of An Alkasite Based Restorative Material With And Without Adhesive (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restoration Failure
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite significant advances in composite materials, they are still perceived as technique-sensitive and exhibit failure related to excessive wear and polymerization shrinkage. Cention N is a recently introduced alkasite restorative that contains special reactive fillers. Its application in restorative dentistry may be significant, promoting remineralization of carious lesions \& reduction of polymerization shrinkage. The study will aim to compare the clinical performance of Cention N (with and without adhesive) and composite resin (Filtek Bulk Fill) in class I restorations using FDI criteria. Thirty-six class I cavities will be selected and equally allocated into 3 groups: Group I (n=12): (Cention N with adhesive), Group II (n=12): (Cention N without adhesive) \& Group III (n=12): composite resin (Filtek Bulk Fill) in class I cavities. Patients will be followed up at 1 week 3, 6, and 12 months and evaluated using the FDI criteria. Postoperative sensitivity, staining, and recurrent caries will be evaluated in this clinical trial.


Eligibility criteria: Inclusion Criteria:

* Permanent molars with occlusal pit and fissure caries.
* Good oral hygiene.
* Occlusal contact with antagonist teeth.

Exclusion Criteria:

* Permanent molars with occlusal pit and fissure caries.
* Good oral hygiene.
* Age between 18- 45 years.
* Occlusal contact with antagonist teeth.

Primary outcomes:
measure: Change in pain sensitivity
timeFrame: 1 week, after 3, 6 and 12 months
measure: Change in occurrence of recurrent caries
timeFrame: 1 week, after 3, 6 and 12 months
measure: Change in occurrence of marginal stains
timeFrame: 1 week, after 3, 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT03531710: An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
Official title: An Extension Study of a Phase IIa Study in Patients With Mild Alzheimer's Disease to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: United Neuroscience Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-22
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study (NCT02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a 12-week follow-up period.


Eligibility criteria: Inclusion Criteria:

* Patients who participated in V203-AD trial without major safety concerns;
* Stable doses of permitted medications for 3 months before screening;
* With a caregiver;
* Other inclusion criteria apply

Exclusion Criteria:

* Clinically significant neurological disease other than Alzheimer's disease
* Major psychiatric disorder
* Severe systemic disease
* Serious adverse reactions to any vaccine
* Other exclusion criteria apply

Primary outcomes:
measure: The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).
timeFrame: Overall Study Duration/Early Termination, over an average study duration of 326 days
measure: Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
timeFrame: Overall Study Duration/Early Termination, over an average study duration of 326 days
Secondary outcomes:
Other outcomes:
measure: Change From Baseline and Through to the End of the Study in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog);
timeFrame: Overall Study Duration/Early Termination, over an average study duration of 326 days
measure: Change From Baseline and Through to the End of the Study in Mini-Mental State Exam (MMSE)
timeFrame: Overall Study Duration/Early Termination, over an average study duration of 326 days
measure: Change From Baseline and Through to the End of the Study in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
timeFrame: Overall Study Duration/Early Termination, over an average study duration of 326 days
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital (TVGH)
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital (LK-CGMH)
Study officials:
References:
Clinical trial NCT01100710: Age Gender Left Ventricular Mass and Cardiac Troponin T
Official title: Relative Contribution of Age, Gender and Left Ventricular Mass as Quantified by Cardiac Magnetic Resonance Tomography to Detectable Levels of Cardiac Troponin T in a Healthy Reference Population Aged Below 70 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Age Gender left ventricular mass high sensitive Troponin T
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 116
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents of Heidelberg and urban hinterland

Brief summary: The purpose of this study is to determine the influence of functional or anatomic cardiac parameters, age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals.

Detailed description: We sought to investigate the relative contribution of functional or anatomic parameters as assessed by cardiac magnetic resonance tomography (cMRI, 1.5 Tesla), and clinical variables including increasing age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals. Therefore we measured TnThs in serum samples of 120 healthy volunteers aged between 20 and 70 years. All individuals underwent cMRI including stress testing using dobutamine or adenosine.TnThs concentrations were related to cMRI and clinical findings. Partial correlation, as well as linear and hierarchical regression analyses were used to identify independent predictors and their relative contribution for prediction of TnThs values.

Eligibility criteria: Inclusion Criteria:

* agreement, age \> 18 years, men and women

Exclusion Criteria:

* measurable heart disease, any chronic or acute disease, intake of meds, hypertension, Diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg
state: Baden-Würtemberg
Study officials:
name: Evangelos Giannitsis, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Apple FS, Smith SW, Pearce LA, Ler R, Murakami MM, Benoit MO, Levy C, Dumas C, Paul JL. Use of the bioMerieux VIDAS troponin I ultra assay for the diagnosis of myocardial infarction and detection of adverse events in patients presenting with symptoms suggestive of acute coronary syndrome. Clin Chim Acta. 2008 Apr;390(1-2):72-5. doi: 10.1016/j.cca.2007.12.016. Epub 2008 Jan 11.
Clinical trial NCT01559610: Preoperatively Orientation in Cardiac Surgery: Nurses Intervention on Patients Recovery
Official title: Preoperatively Orientation in Cardiac Surgery: Nurses Intervention on Patients Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft Triple Vessel
Heart Valve Diseases
Keywords: cardiac surgery
orientation
nursing
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether the guidelines preoperative performed by a nurse contribute to the recovery of the patient submitted to cardiac surgery compared with the guidelines for routine.

Detailed description: This is a randomized clinical trial, which included patients submitted to cardiac surgery on both sexes. They are divided in two groups: control group and intervention group.

Eligibility criteria: Inclusion Criteria:

* Primary Elective Cardiac Surgical Procedures
* Age above 18 years old
* At least 24 hours of hospitalization before the procedure

Exclusion Criteria:

* Patients who do not accept and do not signed a consenting term

Primary outcomes:
measure: knowledge
timeFrame: seven days
Secondary outcomes:
measure: satisfaction
timeFrame: seven days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Institute of Cardiology
state: Rio Grande do Sul
Study officials:
affiliation: Brasil:Instituto de Cardiologia do Rio Grande do Sul/Fundacao Universitaria de Cardiologia
name: Juliane A Rodrigues, nursing
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07015710: Gamma Knife Radiosurgery on Tectal Plate Gliomas
Official title: Impact of Gamma Knife Radiosurgery on Tectal Plate Gliomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gamma Knife Radiosurgery
Tectal Plate Gliomas
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study will be conducted in the Department of Neurosurgery, Al-Azhar University Hospital.

Brief summary: This study aimed to assess the impact of gamma knife radiosurgery on tectal plate gliomas (TPGs).

Detailed description: Tectal plate gliomas (TPGs) represent a subset of brainstem gliomas that are predominantly slow-growing, low-grade tumors and rarely produce neurological deficits.

Viable options include biopsy and monitoring with serial neuroimaging, surgical resection, radiotherapy (either early following surgery or late on evidence of disease progression), chemotherapy, and stereotactic radiosurgery (SRS).

SRS using Gamma Knife radiosurgery (GKRS) has been identified in small case series as a safe and promising approach for managing TPGs that necessitate intervention beyond mere observation.

Eligibility criteria: Inclusion Criteria:

* Age from 5 to 55 years.
* Both sexes.
* Patients underwent gamma knife radiosurgery (GKRS) for tectal plate gliomas (TPGs).

Exclusion Criteria:

* High-grade glioma.
* Tumor extension beyond the tectal region.

Primary outcomes:
measure: Incidence of response
timeFrame: One year post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Al-Azhar University (Damietta)
Study officials:
References:
Clinical trial NCT00355810: Probiotics for Irritable Bowel Syndrome
Official title: Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Irritable Bowel Syndrome
Keywords: Probiotics
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Norwegian Food Research
name: Gilde
name: Norwegian Foundation for Health and Rehabilitation
name: Sykehuset Innlandet HF
First posted: 2006-07-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF 1298 with placebo in patients with irritable bowel syndrome. The results are related to dietary habits, food intolerance and food allergy.


Eligibility criteria: Inclusion Criteria:

* Irritable bowel syndrome according to the Rome II criteria
* regular symptoms

Exclusion Criteria:

* Use of probiotics last three weeks
* pregnancy
* lactation
* co-existing other gastrointestinal disorders
* use of laxatives and antibiotics within last 5 weeks.

Primary outcomes:
measure: Satisfactory relief of abdominal symptoms
timeFrame: 11 weeks
Secondary outcomes:
measure: Graded measurement of abdominal symptoms
timeFrame: 11 weeks
measure: Fecal bacterial count
timeFrame: 11 weeks
measure: Abdominal gas
timeFrame: 11 weeks
measure: Immunological parameters
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Gjovik
country: Norway
facility: Innlandet Hospital HF
state: Oppland
Study officials:
affiliation: Norwegian University of Science and Technology
name: Per G Farup, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ligaarden SC, Axelsson L, Naterstad K, Lydersen S, Farup PG. A candidate probiotic with unfavourable effects in subjects with irritable bowel syndrome: a randomised controlled trial. BMC Gastroenterol. 2010 Feb 10;10:16. doi: 10.1186/1471-230X-10-16.
citation: Farup PG, Jacobsen M, Ligaarden SC, Rudi K. Probiotics, symptoms, and gut microbiota: what are the relations? A randomized controlled trial in subjects with irritable bowel syndrome. Gastroenterol Res Pract. 2012;2012:214102. doi: 10.1155/2012/214102. Epub 2012 Jul 31.
Clinical trial NCT00162110: A Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
Official title: A Phase II Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucinous Gastrointestinal Adenocarcinoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II open-label trial evaluating the efficacy, and safety of Erbitux in patients with mucinous gastrointestinal adenocarcinoma involving the peritoneal surface.


Eligibility criteria: Inclusion Criteria:

* Able to take care of self. Out of bed less than 50% of the day
* Absolute neutrophil count \>=1,500
* Platelet count \>=100,000
* Total bilirubin count \<=1.5 times the upper limit of normal

Exclusion Criteria:

* Prior epidermal growth factor receptor antibody
* Prior treatment with Erbitux
* Other cancers

Primary outcomes:
measure: Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.
Secondary outcomes:
measure: To evaulate surgically resected tumor specimens of the EGF receptor, mucins 1-6, and anglogenic indices such as vessel counts, VEGF expression, and Ki-67 expression. To evaluate the safety of Erbitux monotherapy in this patient population.
Other outcomes:
Locations:
city: New York
country: United States
facility: Local Institution
state: New York
city: Cincinnati
country: United States
facility: Local Institution
state: Ohio
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04500210: Comparative Study of Turmeric Extract in Patients With Arthrosis.
Official title: A Double-blind, Randomized, Parallel Group, Phase III Comparative Study of Turmeric Extract and Placebo to Patients With Mild to Moderate Arthrosis of the Knee and or Hip.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthralgia
Stiffness of Unspecified Joint, Not Elsewhere Classified
Disturbance of Activity and Attention
Quality of Life
Keywords: Arthralgia, stiffness of joints, quality of life
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test if an extract of Turmeric can alleviate symptoms of osteoarthritis in volunteers with osteoarthritis of the hip and or knee.

Detailed description: The included volunteers, who are devided into two groups either placebo or turmeric extract, will be tested using WOMAC questionnaires focussing on pain, stiffness and daily activity. In addition different aspects of quality of life will be evaluated and the consumption of rescue medication will be recorded in patients personal diary.

The treatment period is 3 month with the posibility to continue for an additional 3 month.

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* 40 years of age or more
* Osteoarthritis of the hip and or the knee
* Suffering from pain in the hip and or knee -

Exclusion Criteria:

* If volunteers are on a waiting list for hip or knee surgery
* If the volunteers are involved in an other clinical trial
* If the volunteers are taking other herbal remedies, which canhav influende on # Osteoarthritis.
* Abusers of alcohol and drugs
* Volunteers not easy to cope with

Primary outcomes:
measure: Pain
timeFrame: 3 month
measure: Pain
timeFrame: 6 month
measure: ADL (Activity of daily living)
timeFrame: 3 month
measure: ADL (Activity of daily living)
timeFrame: 6 month
measure: Rescue medication
timeFrame: 3 month
measure: Rescue medication
timeFrame: 6 month
Secondary outcomes:
measure: Stiffness of joints
timeFrame: 3 month
measure: Stiffness of joints
timeFrame: 6 month
measure: The volunteer evaluation of Global Disease Severity (PGAD)
timeFrame: 3 month
measure: The volunteer evaluation of Global Disease Severity (PGAD)
timeFrame: 6 month
Other outcomes:
measure: SF-12 (Quality of life)
timeFrame: 3 month
measure: SF-12 (quality of life)
timeFrame: 6 month
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
Study officials:
affiliation: University of Copenhagen
name: Kaj W Hansen, Prof, DMSCi
role: PRINCIPAL_INVESTIGATOR
References: