louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02153242: The Effects of Selective Site Right Ventricular Pacing
Official title: Does a Surrogate Marker Exist That Can be Used as A Predictor For Left Ventricular Dysfunction In Patients Undergoing Right Ventricular Pacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Keywords: Pacing
Haemodynamics
Pilot
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing SVT studies

Brief summary: This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population with structurally normal hearts. The investigators aim to measure heart function directly when pacing.

When normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical impulse to stimulate a beat. The usual site for pacing is the tip of the RV. This has been shown to be less efficient than the normal conduction system of the heart and in some cases leads to markedly reduced function. What the investigators do not know is why this is the case.

Much effort has been directed at looking at features within the left ventricle (LV) for markers of disease progression but little has been investigated regarding the RV.

There may be some benefit to pacing the heart preferentially from different parts of the RV and the investigators aim to measure if any differences are detectable from stimulating the heart at various sites within the RV.

Detailed description: Inclusion Criteria;

* Patients undergoing elective Electrophysiological Studies +/Ablation
* Age 18-80
* Normal Heart on Pre-procedural Echocardiogram

Exclusion criteria;

* Atrial Fibrillation
* Evidence of anterograde conducting accessory pathway
* Permanent Pacemaker insitu
* Pregnant
* Breast Feeding

Outcome Measures; Change in load-independent indices of LV and RV contractility before and after pacing intervention. LV and RV function measured by transthoracic echocardiography and tissue Doppler imaging.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective Electrophysiological Studies +/Ablation
* Age 18-80
* Normal Heart on Pre-procedural Echocardiogram

Exclusion criteria:

* Atrial Fibrillation
* Evidence of anterograde conducting accessory pathway
* Permanent Pacemaker insitu
* Pregnant
* Breast Feeding

Primary outcomes:
measure: Ventricular Function
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: The Essex Cardiothoracic Centre
state: Essex
Study officials:
affiliation: Basildon & Thurrock University Hospital NHS Trust
name: Stuart Tan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00812942: Participation to Colorectal Cancer Screening With Fecal Occult Blood Test and Colonoscopy
Official title: Participation to Colorectal Cancer Screening With Faecal Occult Blood Test and Colonoscopy: an Italian, Multicenter, Randomized Population Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: average-risk subjects for
Lead sponsor: Istituto Superiore di Sanità
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 9889
Sex: ALL
Minimum age (years): 55
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adherence rate to screening colonoscopy (TC) in the average-risk general population is still unclear. Aim of this study was to compare the uptake of TC screening with that of fecal occult blood (FOBT) in the general population of different Italian areas.

Detailed description: A nationwide, population-based, multicenter, randomized trial comparing attendance to TC with that to FOBT was performed. Sixty-four general practitioners (GPs), overall including in their lists 9,889 average-risk subjects aged 55-64 years, were randomized between TC and FOBT screening programs. Eligible subjects were mailed a personal invitation letter co-signed by their GP and the coordinator of the area-reference GI centre. Attendance rate and detection rate for advanced neoplasia (colorectal cancer, adenoma \>10 mm or with villous histology or high-grade dysplasia) for each arm of the study were assessed.

Eligibility criteria: Inclusion Criteria:

* asymptomatic 55-64 years subjects

Exclusion Criteria:

* already studied for colorectal cancer, severe comorbidities

Primary outcomes:
measure: Participation to colorectal cancer screening
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IIstituto Nazionale Tumori Regina Elena
Study officials:
References:
Clinical trial NCT03259542: Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor
Official title: A Phase 1, Open-Label, Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inhibitor (Itraconazole) of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interaction Potentiation
Healthy
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-08-23
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations are given after a meal.


Eligibility criteria: Inclusion Criteria:

* Be healthy
* Have a BMI of 18 to 32 kg/m2, inclusive and body weight more than 50 kg (110 pounds)
* Be judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings
* Have suitable veins for multiple venipuncture/cannulation

Exclusion Criteria:

* Have multiple drug allergies, or be allergic to any of the components of mifepristone or itraconazole
* Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
* In the 1 year before study drug administration, have a history of drug or alcohol abuse
* In the 6 calendar months before study drug administration, on average

  * Have smoked more than 5 cigarettes/day
  * Have consumed more than 21 units of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)
* In 2 months prior to study drug administration, have donated/lost blood or plasma in excess of 400 mL
* In the 30 days before study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine

Primary outcomes:
measure: Cmax of mifepristone at Day 42 compared to Day 28
timeFrame: Day 42 compared to Day 28
measure: AUC0-24 of mifepristone at Day 42 compared to Day 28
timeFrame: Day 42 compared to Day 28
Secondary outcomes:
measure: Cmax of mifepristone at Day 42 compared to Day 14
timeFrame: Day 42 compared to Day 14
measure: AUC0-24 of mifepristone compared to Day 14
timeFrame: Day 42 compared to Day 14
measure: T1/2 of mifepristone
timeFrame: Days 14 and 28
measure: Ctrough of mifepristone
timeFrame: Days 1 through 28
Other outcomes:
Locations:
city: Miami
country: United States
facility: SeaView Research
state: Florida
Study officials:
affiliation: Corcept Therapeutics
name: Ada Lee, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04705142: Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy(HIE)
Official title: Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy(HIE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIE
Keywords: HIE, MgSO4
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2021-01-12
Enrollment: 200
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case control study
Primary purpose: TREATMENT

Brief summary: Neonatal mortality rate is the highest in Pakistan. And Birth Asphyxia is one of the main reversible causes. Outcomes related to birth asphyxia can be improved, if intervention done in time with proper measures. MgSO4 is cheaper and easily available drug.

Detailed description: Some studies showed positive results if given within 6 hours of birth asphyxia, whereas some are not supportive. But still less know about this drug, especially in low income countries. Objective of this study is to see beneficial effects of MgSO4 in neonates presenting with birth asphyxia.

Eligibility criteria: Inclusion Criteria:

* After informed consent, any child who is term, inborn or out born fulfilling the definition of hypoxic ischemic encephalopathy according to history, apgar or scoring system and reaching within 6 hours of delivery in nursery department of pediatric medicine unit-II, Services Hospital, Lahore

Exclusion Criteria:

* Preterm Syndromic/dysmorphic child Term child with HIE and arriving after 6 hours of life. Term child with unrelated co morbidities eg congenital heart defects, Renal failure etc

Primary outcomes:
measure: Reduction in Immediate complications of disease
timeFrame: 2 weeks
measure: Reduction in mortality
timeFrame: 2 weeks
measure: Reduction in hospital stay
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Institute of Medical Sciences, Lahore
state: Punjab
Study officials:
affiliation: Associate Prof, Surgery
name: Dr Uzair Ahmed, MBBS, FCPS
role: STUDY_DIRECTOR
References:
citation: Gathwala G, Khera A, Singh J, Balhara B. Magnesium for neuroprotection in birth asphyxia. J Pediatr Neurosci. 2010 Jul;5(2):102-4. doi: 10.4103/1817-1745.76094.
Clinical trial NCT00659542: Glubran Mesh Fixation in Lichtenstein Hernioplasty
Official title: Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inguinal Hernia
Keywords: inguinal hernia
inguinal hernioplasty
mesh fixation
Lichtenstein hernioplasty
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: North Karelia Central Hospital
name: Paijat-Hame Hospital District
First posted: 2008-04-16
Enrollment: 300
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 purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty.

Detailed description: Repair of inguinal hernia in one of the most frequently performed surgical operation in western world. The technique of choice is currently to support inguinal tissues by using polypropylene mesh. Chronic postoperative pain and discomfort occur in 25-30% of patients after inguinal hernioplasty. Pain might be related to mesh fixation by sutures. This randomized study investigates whether mesh fixation by tissue glue (cyanoacrylate) is better than sutures. The patients are followed 1 year postoperatively. Pain, quality of life, operative parameters (time, cost) and recurrences are reported.

Eligibility criteria: Inclusion Criteria:

* inguinal hernia
* adult patient

Exclusion Criteria:

* patient not willing
* multiple recurrences
* inguinal pain without evidence of hernia
* femoral hernia
* large scrotal hernia

Primary outcomes:
measure: postoperative pain
timeFrame: 1 year
Secondary outcomes:
measure: hernia recurrence, quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Hannu Paajanen
Study officials:
affiliation: University hospital of Kuopio, Finland
name: Pekka Miettinen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ong CC, Jacobsen AS, Joseph VT. Comparing wound closure using tissue glue versus subcuticular suture for pediatric surgical incisions: a prospective, randomised trial. Pediatr Surg Int. 2002 Sep;18(5-6):553-5. doi: 10.1007/s00383-002-0728-0. Epub 2002 Jun 14.
citation: Matikainen M, Kossi J, Silvasti S, Hulmi T, Paajanen H. Randomized Clinical Trial Comparing Cyanoacrylate Glue Versus Suture Fixation in Lichtenstein Hernia Repair: 7-Year Outcome Analysis. World J Surg. 2017 Jan;41(1):108-113. doi: 10.1007/s00268-016-3801-x.
citation: Paajanen H, Kossi J, Silvasti S, Hulmi T, Hakala T. Randomized clinical trial of tissue glue versus absorbable sutures for mesh fixation in local anaesthetic Lichtenstein hernia repair. Br J Surg. 2011 Sep;98(9):1245-51. doi: 10.1002/bjs.7598. Epub 2011 Jun 28.
Clinical trial NCT00010842: Natural Antioxidants in the Treatment of Multiple Sclerosis
Official title: Natural Antioxidants in the Treatment of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of three antioxidant regimens in treating the symptoms of multiple sclerosis (MS).

Detailed description: Multiple sclerosis (MS) is an immune mediated disease of the central nervous system that affects over 350,000 Americans. T lymphocytes, macrophages and soluble mediators of inflammation cause demyelination and axonal injury in MS. Activated macrophages release nitric oxide and oxygen free radicals that cause demyelination and axonal injury in MS and experimental autoimmune encephalomyelitis (EAE). Natural antioxidants may favorably influence the course of MS by decreasing oxidative injury. Chronic relapsing EAE in mouse models is clinically and pathologically useful for testing potential therapies for MS.

This study will assess three natural antioxidant regimens for their potential as treatments for MS: Ginkgo biloba, alpha-lipoic acid/essential fatty acids, and vitamin E/selenium. The effects of each regimen will be compared to determine which regimen appears most effective at suppressing EAE and decreasing markers of oxidative injury in patients with MS. As part of this study, two smaller trials will be conducted. A Phase I/II trial in patients with MS will determine if the selected antioxidant regimen can decrease disease activity as detected with gadolinium-enhanced magnetic resonance imaging. The results of this study will serve as the basis for a Phase III trial to assess the long term effectiveness of natural antioxidant therapy in MS.

Eligibility criteria: Exclusion Criteria:

* Pregnant
* Other significant health problems

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
affiliation: VA Medical Center-Brooklyn
name: Dr. Dennis Bourdette
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919542: Ciclosporin in the Management of New Erythema Nodosum Leprosum
Official title: A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leprosy
Keywords: Leprosy
ENL
Erythema Nodosum Leprosum
Prednisolone
Ciclosporin
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Homes and Hospitals of St Giles
name: Alert Hospital, Ethiopia
name: Armauer Hansen Research Institute, Ethiopia
First posted: 2009-06-12
Enrollment: 12
Sex: FEMALE
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: Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum

Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).

Detailed description: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).

Eligibility criteria: Inclusion Criteria:

* Individuals with clinical evidence of new ENL
* Aged 18-65
* Weigh more than 30Kg

Exclusion Criteria:

* Unwillingness to give informed consent
* Patients with severe active infections such as tuberculosis
* Pregnant or breastfeeding women (see Appendix II)
* Those with renal failure, abnormal renal function, hypertensive
* Patients taking thalidomide currently or within the last 3 months
* Patients not willing to return for follow-up
* Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
* HIV positive patients

Primary outcomes:
measure: Number of ENL recurrence episodes per patient
timeFrame: up to 32 weeks
Secondary outcomes:
measure: Mean time to ENL recurrence after initial control
timeFrame: up to 32 weeks
measure: Amount of additional prednisolone required by patients
timeFrame: up to 32 weeks
measure: Frequency of adverse events for patients in each treatment arm
timeFrame: up to 32 weeks
measure: Difference in score in Quality of Life assessment between start and end for patients in each treatment arm
timeFrame: up to 32 weeks
Other outcomes:
Locations:
city: Addis Abeba
country: Ethiopia
facility: Alert Hospital
Study officials:
affiliation: London SHTM
name: Diana NJ Lockwood, MBchB
role: STUDY_DIRECTOR
References:
Clinical trial NCT05481242: An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients
Official title: An Observational Study About Adverse Outcomes in Acute Pulmonary Embolism Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Embolism and Thrombosis
Deterioration, Clinical
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese

Brief summary: This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.

Detailed description: This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.

Eligible patients were collected to develop and evaluate a simple predictive model for predicting the adverse outcomes. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.

Eligibility criteria: Inclusion Criteria:

* age of ≥ 18 years and a pulmonary embolism diagnosis based on CT pulmonary angiography

Exclusion Criteria:

* pregnancy
* reception of reperfusion treatment before admission
* missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.

Primary outcomes:
measure: Adverse outcomes
timeFrame: 30 days
Secondary outcomes:
measure: Adverse outcomes
timeFrame: 2 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shenjing Hospital of CHINA MEDICAL UNIVERSITY
state: Liaoning
Study officials:
affiliation: Shenjing Hospital of CHINA MEDICAL UNIVERSITY
name: DONG JIA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02517970: Observing Infant Feeding Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Classical Music
Television Show
Keywords: infant feeding
breast-feeding
bottle-feeding
feeding interactions
maternal feeding practices
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 27
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of environmental distractions on a mothers' ability to recognize and feed in response to infants' feeding cues. Investigators hypothesize that mothers will spend significantly more time looking at their technology compared to looking at their infant, which will be negatively associated with the mothers' responsiveness to her infant. This will have a positive association with infant intake during the feeding. Investigators also hypothesize that mothers will show less sensitivity when distracted when compared to when they are not distracted.


Eligibility criteria: Inclusion Criteria:

* Mothers must be 18 years or older
* Infants must be between 0-6 months of age

Exclusion Criteria:

* Preterm birth
* Medical conditions that interfere with feeding

Primary outcomes:
measure: Infant intake within a feeding (mL)
timeFrame: 2-hour period
measure: Maternal responsiveness
timeFrame: 2-hour period
Secondary outcomes:
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
Study officials:
affiliation: Assistant Professor
name: Alison K Ventura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Golen RB, Ventura AK. Mindless feeding: Is maternal distraction during bottle-feeding associated with overfeeding? Appetite. 2015 Aug;91:385-92. doi: 10.1016/j.appet.2015.04.078. Epub 2015 May 4.