louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01941602: A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery
Official title: A Comparative Study of Prophylactic Enoxaparin Routinely Administered Preoperative for Prevention of Venous Thromboembolism in Meningioma Surgery - an Acceptable Risk-benefit Ratio?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningioma
Keywords: surgery
enoxaparin
venous thromboembolism
perioperative care
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: University Hospital of North Norway
name: Karolinska University Hospital
First posted: 2013-09-13
Enrollment: 979
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having had surgical treatment for intracranial meningioma in Norway (St Olavs University Hospital, Trondheim, and University Hospital North Norway, Tromsø) and Sweden (Karolinska University Hospital, Stockholm).

Brief summary: The aim of the study is to compare different strategies for prevention of venous thromboembolism related to intracranial meningioma surgery. The investigators identified three hospitals where two have a very restrictive approach with respect to anticoagulant therapy while at the third hospital the use of anticoagulation the day before surgery was initiated as routine prophylaxis.

Based on this "natural experiment" it will be explored whether the use of anticoagulant prophylaxis is associated with reduced risk of venous thromboembolism and/or associated with increased risk of postoperative hemorrhage as compared to the 2 cohorts where this intervention were absent.


Eligibility criteria: Inclusion Criteria:

* First included patient 1.january 2007 and latest included patient 1.july 2013 (allows for 30 day follow up with respect to morbidity)
* Histological verification of a meningioma (of any grade) from the current surgery

Exclusion Criteria:

* Intracranial surgery or venous thromboembolism the last 3 months

Primary outcomes:
measure: frequencies of venous thromboembolism
timeFrame: 30 days
Secondary outcomes:
measure: frequencies of hematomas in need of reoperation or that significantly alters subsequent care
timeFrame: 30 days
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Lars Jacob Stovner, MD PhD
role: STUDY_DIRECTOR
References:
citation: Sjavik K, Bartek J Jr, Solheim O, Ingebrigtsen T, Gulati S, Sagberg LM, Forander P, Jakola AS. Venous Thromboembolism Prophylaxis in Meningioma Surgery: A Population-Based Comparative Effectiveness Study of Routine Mechanical Prophylaxis with or without Preoperative Low-Molecular-Weight Heparin. World Neurosurg. 2016 Apr;88:320-326. doi: 10.1016/j.wneu.2015.12.077. Epub 2015 Dec 31.
Clinical trial NCT00895102: Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers
Official title: An Open-Label Randomized, Crossover Study to Evaluate the Bioavailability of ABT-333 Tablets Versus Capsules, and A Double-blind, Randomized, Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending Doses of ABT-333 Tablets Versus Placebo in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Keywords: Bioavailability (BA)
Single Ascending Dose (SAD)
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-05-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to determine the bioavailability, pharmacokinetic and safety profiles of an experimental Hepatitis C virus (HCV) polymerase inhibitor in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* overall healthy subjects;
* non-childbearing potential females included

Exclusion Criteria:

* history of significant sensitivity to any drug;
* positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab;
* history of gastrointestinal issues or procedures;
* history of seizures, diabetes or cancer (except basal cell carcinoma);
* clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder;
* use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration;
* donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration;
* abnormal screening laboratory results that are considered clinically significant by the investigator;
* current enrollment in another clinical study;
* previous enrollment in this study;
* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol;
* pregnant or breastfeeding female;
* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Primary outcomes:
measure: To determine relative bioavailability of the ABT-333 tablet formulation compared to the FIH capsule formulation
timeFrame: 2 days post dosing
measure: To evaluate single dose safety and tolerability of a ABT-333 tablet formulation relative to placebo
timeFrame: 2 days post dosing
measure: To evaluate single dose pharmacokinetics of a ABT-333 tablet formulation
timeFrame: 2 days post dosing
measure: Pharmacokinetics
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 19441
state: Illinois
Study officials:
affiliation: Abbott
name: Daniel Cohen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01893502: Duration of Follow-Up Counselling on Smoking Cessation Outcomes
Official title: Smoke Free Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Smoking cessation improves mortality, even in patients with existing smoking-related morbidity. Telephone follow-up after smoking cessation counselling as been shown to be an important method to provide support to smokers and to improve quit rates, especially if three or more calls were used in addition to face-to-face counselling. While it is reasonable to assume that more counselling leads to better smoking cessation outcomes, little evidence exists over the amount of telephone follow-up counselling that is required for optimal and sustained abstinence. We aim to investigate if six-months of weekly telephone follow-up is superior to one-month of weekly telephone follow-up.


Eligibility criteria: Inclusion Criteria:

* Current smokers among outpatients, including hospital employees, who provide informed consent for enrollment in the smoking cessation program

Exclusion Criteria:

* Subjects who decline smoking cessation or who do not provide informed consent
* Subjects who are participating or will be participating in other smoking cessation programs within the next six months
* Subjects who are currently using smoking cessation medications
* Subjects who cannot be followed up for at least six months, for instance, subjects who would be resigning and going overseas within the next six months
* Subjects with language limitations that would impede completion of self-administered questionnaires
* Subjects who are difficult to communicate with over the telephone (e.g. having speech or hearing problems)
* Subjects with cognitive impairments that would impede counselling and follow-up
* Subjects with no telephone number
* Subjects who are too sick to receive smoking cessation counselling
* Subjects with limited life expectancy (e.g. metastatic cancer)

Primary outcomes:
measure: Seven-day point prevalence abstinence
timeFrame: Six months
Secondary outcomes:
measure: Average number of cigarettes smoked per day over the past seven days
timeFrame: 3, 6, 12 months
Other outcomes:
measure: Exhaled carbon monoxide levels
timeFrame: 3, 6, 12 months
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Kay C See, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01178502: PGx Study to Develop and Validate the Predictive Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy
Official title: Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy in Korean Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Diseases
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 405
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients taking warfarin

Brief summary: To develop and validate the predictive warfarin dosing algorithm.

Detailed description: This study aims to develop and validate the predictive warfarin dosing algorithm for personalized warfarin pharmacotherapy in Korean patients.

Eligibility criteria: Inclusion Criteria:

* the patients taking warfarin

Exclusion Criteria:

* noncompliance

Primary outcomes:
measure: To Develop and Validate the Predictive Warfarin Dosing Algorithm
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University
Study officials:
References:
Clinical trial NCT02330302: Single Shot Fascia Iliaca Block vs Femoral Nerve Block for Analgesia for Surgical Fixation of Hip Fractures
Official title: A Randomized Controlled Trial Comparing Single Shot Fascia Iliaca Block With Femoral Nerve Block for Analgesia Following Surgical Fixation of Hip Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hip fractures are common in our elderly population and is associated with pain before and after surgery. The current pain management for patients who have undergone surgery for hip fractures include a combination of oral painkillers, opioids (eg morphine) and regional anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves supplying the hip joint to numb the operation site. As opioids have many side effects, especially in the elderly patients, regional anaesthesia techniques can help to reduce the use of opioids and the related side effects. This may enhance their recovery and length of hospital stay


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for surgical fixation of hip fracture
* Patients with isolated inter-trochantric fracture
* American Society of Anesthesiologists (ASA) physical status 1 to 3
* Patients who are able to give their own consent

Exclusion Criteria:

* Patients unable to give consent or inability to communicate/ cooperate
* Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
* Patients with allergy to local anaesthetics or any drugs included in the study
* Patients with contraindications to spinal anaesthesia such as coagulation disorders/ thrombocytopenia and local infection at site of injection

Primary outcomes:
measure: Pain scores
timeFrame: up to 24 hours
Secondary outcomes:
measure: opioid requirement/consumption
timeFrame: for first 24 hrs (including intra operatively) following intervention
Other outcomes:
measure: complications associated with intervention
timeFrame: at 24 hrs post intervention
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Yean Chin Lim, MBBS, MMed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04110002: An Injury Prevention Program for Professional Ballet
Official title: An Injury Prevention Program for Professional Ballet: a Randomized Controlled Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidents Sports
Injury Prevention
Keywords: injury prevention program; professional ballet
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm: randomized to injury prevention protocol or control group
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the efficacy of an injury prevention program for professional ballet dancers.


Eligibility criteria: Inclusion Criteria:

* Professional Ballet Dancer
* Willing to participate and undergo informed consent process

Exclusion Criteria:

* Pregnant Women, non-English speaking subjects, or those who decline participation in the study.

Primary outcomes:
measure: Rate of Injury
timeFrame: 1 year
Secondary outcomes:
measure: Turn-out degrees
timeFrame: 1 year
measure: Beighton
timeFrame: 1 year
measure: AOFAS ankle-hindfoot
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Joshua D Harris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vera AM, Barrera BD, Peterson LE, Yetter TR, Dong D, Delgado DA, McCulloch PC, Varner KE, Harris JD. An Injury Prevention Program for Professional Ballet: A Randomized Controlled Investigation. Orthop J Sports Med. 2020 Jul 28;8(7):2325967120937643. doi: 10.1177/2325967120937643. eCollection 2020 Jul.
Clinical trial NCT03564002: Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity
Official title: Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lysosomal Acid Lipase Deficiency
Obesity
Ketogenic Dieting
Ketosis
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: obese patients referred to our Clinic in order to assess and treat obesity

Brief summary: The very low carbohydrates diet (VLCKD) induces liver steatosis amelioration. Lysosomal acid lipase (LAL) deficiency plays a role in fats accumulation in liver. To date, no studies have assessed LAL activity in morbid obesity. The aim of our study is to evaluate VLCKD impact on metabolic/vascular parameters and LAL activity in obese patients.

A VLCKD is administered for 25 days to 52 morbid obese patients (BMI 44.7±8.3 kg/m², age 49±12.5 years); at baseline and after diet we evaluated: BMI, glyco-lipidic pattern, abdominal ultrasonography (liver steatosis and visceral fat area) and flow-mediated dilation (FMD). In a subgroup of 20 patients we also tested lysosomal acid lipase (LAL)-activity. A group of healthy normal weight subjects (age 43±13, BMI 22.8±2.6 kg/m²) was also included in the study.


Eligibility criteria: Inclusion Criteria:

* BMI \> 40 Kg/m2 or \> 35 kg/m2 with comorbidities

Exclusion Criteria:

* Type-2 diabetes
* Kidney, heart or liver failure

Primary outcomes:
measure: lysosomal acid lipase activity
timeFrame: change from baseline after 25 days
measure: endothelial function
timeFrame: change from baseline after 25 days
measure: visceral fat
timeFrame: change from baseline after 25 days
measure: liver steatosis
timeFrame: change from baseline after 25 days
measure: lipid assessment
timeFrame: change from baseline after 25 days
measure: general adiposity assessment
timeFrame: change from baseline after 25 days
Secondary outcomes:
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: University of Perugia
Study officials:
References:
Clinical trial NCT01398202: Dietary Supplementation With 25-hydroxyvitamin D3 in Older Adults
Official title: Comparison of the Bioefficacy of Oral 25-hydroxyvitamin D3 and Vitamin D3 Supplements on Vitamin D Status in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Status as Reflected by Serum 25-hydroxyvitamin D
Keywords: Vitamin D status
25-hydroxyvitamin D
Vitamin D3
RCT
Bio-efficacy
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 56
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate whether a supplement of 25-hydroxyvitamin D is five-times more potent in raising vitamin D status (as reflected by serum 25(OH)D) compared to an equivalent amount of vitamin D3 in older adults. It will entail a 10 week supplementation study during winter months.

Detailed description: The UK (McCance \& Widdowson) food composition tables suggests that 25-hydroxyvitamin D (which is present in some foods, albeit at very low concentrations, but which is also commercially available) may possess up to 5-times the activity of native vitamin D3 in food. Thus, in theory, each micogram of 25-hydroxyvitamin D consumed in the diet could boost vitamin D status up to five times most effectively compared to each microgram of native vitamin D in food. It is worth noting, however, that estimates of potency range from 2 to 5, depending on approach used, and that the real potency needs to be confirmed in a human study. This study aims to examine the biological activity of 25-hydroxyvitamin D (i.e., its potency relative to vitamin D3) as well as its effect on selected functional markers in a randomised, double-blind, human intervention trial in older adults.

Eligibility criteria: Inclusion Criteria:

* Subjects will be eligible if they are 45+ years of age
* Body Mass Index (BMI) 19-30

Exclusion Criteria:

* have hypercalcaemia
* chronic illness
* renal or liver disorders
* taking medications that might interact with vitamin D or metabolite
* drank more than \> 21 standards (male)/ 14 standards (female) of alcohol per week
* planning to change smoking habits

Primary outcomes:
measure: serum 25-hydroxyvitamin D concentration
timeFrame: 10 weeks
Secondary outcomes:
measure: serum parathyroid hormone
timeFrame: 10 weeks
measure: blood pressure
timeFrame: 10 weeks
measure: biochemical markers of bone turnover
timeFrame: 10 weeks
measure: serum calcium adjusted for albumin
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: University College Cork
Study officials:
affiliation: University College Cork
name: Kevin D Cashman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cashman KD, Seamans KM, Lucey AJ, Stocklin E, Weber P, Kiely M, Hill TR. Relative effectiveness of oral 25-hydroxyvitamin D3 and vitamin D3 in raising wintertime serum 25-hydroxyvitamin D in older adults. Am J Clin Nutr. 2012 Jun;95(6):1350-6. doi: 10.3945/ajcn.111.031427. Epub 2012 May 2.
Clinical trial NCT05151302: The Italian Version of the Computer-Vision Symptom Scale Questionnaire: Translation, Validation and Reliability.
Official title: The Italian Version of the Computer-Vision Symptom Scale Questionnaire: Translation, Validation and Reliability.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Video Display Terminal Workers
Computer Vision Syndrome
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Video display terminal users frequently refer computer-related visual and ocular symptoms, that are the most frequently occurring health problems among such these subjects.

The Italian law has established an eye examination to assess ocular status (D.Lgs 81/08 ex law 626/96) in VDT workers: subjects are evaluated by clinical signs and symptoms. The availability of a validated questionnaire could be very useful to diagnose visual disturbances and to follow them during follow-up examinations in 2014, a Spanish group has developed and validated a questionnaire for the assessment of visual and ocular symptoms in VDT workers.

Aim of the present study is to make available to Italian health professionals a new instrument to assess asthenopic symptoms, taking into account the patient's perspective.


Eligibility criteria: Inclusion Criteria:

* VDT workers as defined by the Italian law (\>20 hours a week on PC); in the control group patients no VDT workers.
* VDT workers at the Foundation or VDT accessing to the general service of the Clinic for a routine visit (VDT group)
* patients, not working at VDT, accessing to the "general service" of the eye clinic to perform a routine visit will be asked to participate the study (control group)
* no ocular surgery in the preceding 6 months
* written consent to participate to study procedures and personal data utilization in an encoded form

Exclusion Criteria:

* ocular surgery in the preceding 6 months
* patients unable to respond to questionnaire

Primary outcomes:
measure: To assess reliability (Cronbach alpha) of the CVSS
timeFrame: one year
Secondary outcomes:
measure: To assess: -item internal consistency -equality of item-scale correlations -item discriminant validity -temporal stability -discriminating ability (between VDT and non-VDT workers) -external validity
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: irccs policlinico san matteo foundation
name: Gemma Caterina M Rossi
role: PRINCIPAL_INVESTIGATOR
References: