louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02490449: Dexlansoprazole MR in Nonerosive Reflux Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonerosive Reflux Disease
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 356
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after breakfast in patients with nonerosive reflux disease.


Eligibility criteria: Inclusion Criteria:

* NERD confirmed by gastroscopy

Exclusion Criteria:

* PPI medication within 2 weeks before enrollment

Primary outcomes:
measure: Percentage (%) of patients free of reflux symptoms
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine
state: Gyeonggi-do
Study officials:
affiliation: Soonchunhyang University Hospital
name: Su Jin Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00015249: Prepulse Inhibition of Startle in Cocaine Dependence - 7
Official title: Prepulse Inhibition of Startle in Cocaine Dependence (Human)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: New York MDRU
First posted: 2001-04-18
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the effects of chronic cocaine use on the acoustic startle response and on gating of this response in humans.

Detailed description: The objective of this study is to assess the effects of chronic cocaine use on the acoustic startle response and on gating of this response in humans.

Eligibility criteria: Inclusion Criteria:

Cocaine dependence. Male. Right handed. Negative urine for cocaine

Exclusion Criteria:

Positive urine for cocaine. History of head trauma. Significant medical disease.

Primary outcomes:
measure: Percent prepulse inhibition
measure: Cocaine assessment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York MDRU
state: New York
Study officials:
affiliation: New York MDRU
name: John Rotrosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: CPDD, 98, 99 NIDA Research Monograph Series 179, 1998 Manuscript submitted..
Clinical trial NCT02103049: The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients
Official title: The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Transplants
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In kidney transplant patients atherosclerosis process is accelerated even in asymptomatic patients. This is mainly the consequence of immunosuppressive therapy. Dyslipidemia is treated with statins in low doses only as high doses can lead to rhabdomyolysis and are therefore contraindicated. As second lipid lowering agent most commonly ezetimibe is used. The investigators hypothesise that ezetimibe as a second lipid lowering drug in kidney transplant patients lowers LDL cholesterol for additional 10 per cent.

Detailed description: In addition to observing the lipid profile the investigators intend to look for other pathophysiological effects of ezetimibe, such as its influence on oxidative stress, endothelial function and inflammatory biochemical markers.

Eligibility criteria: Inclusion Criteria:

LDL \> 2.5 mM, Already treated with statin, Stable renal function of various GFR, Men or women older than 18 years, Signed informed consent.

Exclusion Criteria:

Acute heart disease or any heart disease in the last 3 months, kidney graft failure, active systemic inflammatory disease, active malignant disease, chronic diarrhea and malabsorption, transaminases increased \> 3 fold, creatin kinase increased \> 5 fold, hypersensitivity reactions, active peptic ulcer disease.

Primary outcomes:
measure: Decrease of LDL cholesterol concentration.
timeFrame: At enrolment, at three, six and nine months thereafter.
Secondary outcomes:
measure: Change in oxidative markers
timeFrame: At enrolment, at three, six and nine months thereafter.
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
affiliation: University Medical Center Ljubljana, Slovenia
name: Gregor Mlinsek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02178449: Prolongation of Pain Free Time by the Use of Dexamethasone in Peripheral Nerve Blockade
Official title: The Effect of Dexamethasone Used Together With Low Volume Ropivacaine in a Single Shot Interscalene Block on the Pain Free Time Experienced by the Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Interscalene Block
Shoulder Arthroscopy
Dexamethasone
Low Volume Regional Anesthesia
Lead sponsor: Landesklinikum Sankt Polten
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 109
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 main aim of the study is to investigate the proven effect of dexamethsone on the duration of the interscalene block. The investigators try to define optimal dose and volume for ropivacaine, when used together with dexamethsone. The current literature uses often very high volumes of ropivacain when used together with dexamethasone. The investigators try to research the effect of using dexamethsone together with low volume, high concentration ropivacaine for interscalene blockade. The investigators' hypothesis is that dexamethasone has an positive effect on the pain free after used together with ropivacaine at the scalene block.


Eligibility criteria: Inclusion Criteria:

* atroscopy of the shoulder
* repair of the RM

Exclusion Criteria:

* patient under 18 years
* patient is fertile
* chronic opiat use more than 30mg oxycodone per day
* operations at the shoulder that involves the bone
* usage of cortisone for more than 2 weeks
* risk greater as asa III
* damage to nerves
* neuropathy at the target arm

Primary outcomes:
measure: Pain free time measured by the duration between block and the point at which the patient is asking for painkillers
timeFrame: Patients will be followed during their stay at the hospital, which will be normally around 24 to 48 hours.
Secondary outcomes:
measure: Visual Rating Scale for Pain at Movement and Rest
timeFrame: Measured 10 hours after the intervention
Other outcomes:
measure: Patient satisfaction
timeFrame: 1 day, when the patient leaves the hospital
Locations:
city: Sankt Pölten
country: Austria
facility: Landesklinikum Sankt Pölten
state: Lower Austria
city: Sankt Pölten
country: Austria
facility: Landesklinikum Sankt Pölten
state: Lower Austria
Study officials:
affiliation: Landesklinikum Sankt Polten
name: Christoph Hörmann, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06616649: Closed Loop Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy, a Pilot Study.
Official title: Closed Loop Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy, a Pilot Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Neuropathy Due to Chemotherapy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Saluda Medical Pty Ltd
First posted: 2024-09-27
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: TREATMENT

Brief summary: To explore the benefits of using closed loop spinal cord stimulation (SCS) in the treatment of patients experiencing painful chemotherapy induced peripheral neuropathy (CIPN) by assessing changes in pain, quality of life, pain medication use, sensory improvement through quantitative sensory testing, and improvement of gait through quantitative gait testing.

Detailed description: Primary Objective:

To explore the impact of using closed loop spinal cord stimulation (SCS) on pain control, quality of life, and pain medication use in patients suffering from chemotherapy induced peripheral neuropathy (CIPN).

Secondary Objective:

To assess the relationship between pain control from closed loop spinal cord stimulation and any associated changes in quantitative sensory testing (QST) and quantitative gait testing (QGT).

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Diagnosis history of CIPN of lower extremities
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of SCS
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients undergoing active chemotherapy or immunotherapy
* Patients undergoing medical litigation.
* Patients with active infection, being treated with antibiotics
* Patients that are pregnant or planning to conceive
* Patients who are receiving any investigational agents.
* Patients with brain metastases.
* Patients with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
* Patients with history of alternative forms of sensorimotor neuropathies prior to CIPN presentation

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Matthew Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02840149: SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors
Official title: Correlation Between SUV on 68Ga-DOTATATE PET/CT and Ki-67 Index in Neuro-Endocrine Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuroendocrine Tumors
Keywords: 68Ga-DOTA-TATE, PET/CT
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Positron emission tomography/computed tomography (PET/CT) is an advanced nuclear medicine scan. This technology allows precise and early cancer to be visualized and measured on whole body images. Patients with Neuro-Endocrine tumors (NETs), require specialized molecular imaging to stage, re-stage and assess eligibility and response to therapy. 68Ga-DOTATATE is a nuclear medicine imaging agent that is not yet approved by Health Canada but used extensively throughout the world. The Ki-67 index, a marker of cell proliferation in NETs, is one of the most important prognostic factors in this disease. The objective of this study is to evaluate if the maximal standard uptake value (SUVmax) on PET/CT in NETs inversely correlates with Ki-67 score on initial biopsy. If this hypothesized correlation between SUV and Ki-67 score is reproduced, then DOTATATE would serve as a non-invasive method to assess cellular proliferation and therefore prognosis of these patients.


Eligibility criteria: Inclusion Criteria:

* Known or suspected somatostatin receptor positive tumor such as: neuroendocrine tumor (carcinoid, gastro-entero-pancreatic neuroendocrine tumors, etc); pheochromocytoma; neuroblastoma; medulloblastoma; ectopic Cushing syndrome/non-pituitary ACTH elevation; tumor-induced osteomalacia. Supporting evidence may include MRI, CT, biochemical markers, and/or pathology report.
* Previous diagnosis of NET with Ki-67 index available or soon to be obtained.
* ECOG performance status 0 - 3, inclusive.
* 18 years or older and able to understand and provide written informed consent
* Patients must be able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 45 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug

Exclusion Criteria:

* Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
* Patients who exceed the safe weight limit or bore of the PET/CT bed
* Patients who are claustrophobic or pregnant

Primary outcomes:
measure: Correlation between SUV on 68Ga-DOTATATE PET/CT with Ki-67 index in NET
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre, Jewish General Hospital
name: Gad Abikhzer, MDCM
role: PRINCIPAL_INVESTIGATOR
affiliation: Jewish General Hospital
name: Stephan Probst, MDCM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02091349: Tolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber
Official title: Tolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tolerance
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to determine the tolerance and utilization of polydextrose and soluble corn fiber through analyses of fecal samples of fermentative end-products (short-chain fatty acids, ammonia, phenol, and indole) and shifts in microbial populations.

Detailed description: Soluble fibers have been shown to have many positive effects in humans, including laxation and maintaining gastrointestinal health. It is expected that feeding soluble fibers will decrease protein fermentative end=products while increasing carbohydrate fermenative end-products, and lead to a more beneficial microbial profile. Determination of the effects of nutriose and polydextrose when included as supplemental fiber in a human diet will give insights to its potential to maintain or improve gut health and highlight its use in the food industry.

The object of this study are first to determine the tolerance of soluble fibers polydextrose, inulin and nutriose when provided as supplemental fiber to an existing diet. The second objective is to determine the utilization of polydextrose and nutriose through analyses of fecal samples of fermentative end-products and shifts in microbial populations.

Eligibility criteria: Inclusion Criteria:

* have body mass index (BMI) between 18.5 and 31 kg/m2
* free of metabolic and gastrointestinal disease

Exclusion Criteria:

* BMI less than 18.5 or greater than 31 kg/m2
* presence of metabolic or gastrointestinal diseases

Primary outcomes:
measure: Fecal bacteria
timeFrame: Days 16-21 of each treatment period
measure: Fecal fermentation end products
timeFrame: Days 16-21 of each treatment period
Secondary outcomes:
measure: Gastrointestinal Tolerance
timeFrame: Daily during each 21 day treatment period
measure: Daily Stool Characteristics
timeFrame: Daily during each 21 day treatment period
Other outcomes:
measure: Daily food intake journals
timeFrame: Daily during each 21-day treatment period
Locations:
Study officials:
affiliation: UIUC
name: George Fahey, Jr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holscher HD, Caporaso JG, Hooda S, Brulc JM, Fahey GC Jr, Swanson KS. Fiber supplementation influences phylogenetic structure and functional capacity of the human intestinal microbiome: follow-up of a randomized controlled trial. Am J Clin Nutr. 2015 Jan;101(1):55-64. doi: 10.3945/ajcn.114.092064. Epub 2014 Nov 12.
Clinical trial NCT00615849: Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax
Official title: Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Spontaneous Pneumothorax
Keywords: pneumothorax, thoracoscopy, pleurodesis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 1440
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb obliteration with pleural adhesive procedure is generally accepted as a standard. But additional pleurodesis is potentially useless procedure on the parietal pleura for treating visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural physiology and cause chronic pain. According to our previous study, stapling resection of the bulla without pleurodesis gave comparable result in recurrence comparing with articles with additional pleurodesis. The purpose of this study is to evaluate surgical outcome of thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure is essential in the management of PSP.


Eligibility criteria: Inclusion Criteria:

* recurrent pneumothorax
* bilateral pneumothorax
* total collapse/tension pneumothorax
* previous history of contralateral pneumothorax
* visible bulla on simple X-ray
* special occupation/situation
* air leakage more than 2 days with drainage catheter for 1st attack patients

Exclusion Criteria:

* patient refusal and reoperation case

Primary outcomes:
measure: recurrence
timeFrame: follow up more than 1 year
Secondary outcomes:
measure: complications
timeFrame: follow up more than 1 year
Other outcomes:
Locations:
city: Seungnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University College of Medicine
name: Sanghoon Jheon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06138249: Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels
Official title: Different Kinds of Vitamin D Intake and Its Metabolites: Blood Levels and Bone Mineral Density. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypovitaminosis D
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
Collaborators: name: Silvana De Giorgi
name: Davide Bizzoca
name: Angela Notarnicola
First posted: 2023-11-18
Enrollment: 90
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: Patients with hypovitaminosis D are randomized into three arms of treatment:

Group A: Calcifediol 0,266mg each month Group B: Cholecalciferol 25000UI each 15 days Group C: Calcifediol 4 drops per day. Serum levels of vitamin D are dosed after one month of treatment

Detailed description: Patients with hypovitaminosis D are randomized into three arms of treatment:

Group A: Calcifediol 0,266mg each month Group B: Cholecalciferol 25000UI each 15 days Group C: Calcifediol 4 drops per day. Serum levels of vitamin D are dosed after one month of treatment to support the best dosage of Vitamin D intake.

Eligibility criteria: Inclusion Criteria:

* Hypovitaminosis D (\<20ng/mL)

Exclusion Criteria:

* Osteoporosis (T score \<-2.5SD)
* Renal or hepatic diseases

Primary outcomes:
measure: level of Vitamin D
timeFrame: Between recruitment and 1 month
measure: level of Vitamin D
timeFrame: Between recruitment and 6 month
Secondary outcomes:
measure: DEXA
timeFrame: Between recruitment and 18 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari
Study officials:
affiliation: University of Bari
name: Angela Notarnicola, AP
role: STUDY_CHAIR
References:
citation: Paterson C. Vitamin D deficiency: a diagnosis often missed. Br J Hosp Med (Lond). 2011 Aug;72(8):456-8, 460-2. doi: 10.12968/hmed.2011.72.8.456.
citation: Castano L, Madariaga L, Grau G, Garcia-Castano A. 25(OH)Vitamin D Deficiency and Calcifediol Treatment in Pediatrics. Nutrients. 2022 Apr 29;14(9):1854. doi: 10.3390/nu14091854.
citation: Haddow JE. Vitamin D and rickets: much has been accomplished, but there is room for improvement. J Med Screen. 2011;18(2):58-9. doi: 10.1258/jms.2011.011059. No abstract available.
Clinical trial NCT04218149: Serratus Plane Block vs Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery
Official title: Comparison of the Effects of Serratus Plane Block and Erector Spinae Plane Block on Postoperative Analgesia in Patients Undergoing Unilateral Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Postoperative Pain
Keywords: serratus plane block, erector spinae plane block, postoperative analgesia
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interfacial plan blocks are becoming more widely used for postoperative analgesia because of their easier applicability and less risk of complications. In this study, we aimed to compare the effects of serratus plane block (SPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* Age: 18 - 65 years
* unilateral breast surgery

Exclusion Criteria:

* Does not approve the study
* Pregnant
* Emergency
* ASA III-IV
* History of local anesthetic allergy
* Infection in the block area
* Coagulation disorder
* Morbid obesity (body mass index\> 40 kg / m²)
* Severe organ failure
* Previous neurological deficit
* Psychiatric disease
* History of chronic pain

Primary outcomes:
measure: Postoperative pain score
timeFrame: Postoperative 24 hours
measure: Postoperative tramadol consumption
timeFrame: Postoperative 24 hours
measure: Rescue analgesic
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Analgesia time
timeFrame: Procedure
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi
Study officials:
References: