louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01960738: Common Recreational Diving Practices: A Randomized Control Trial Using Pre-Dive Checklist
Official title: A Group Randomized Trial to Evaluate the Efficacy of Using Pre-dive Checklist to Prevent the Incidence of Recreational Scuba Diving Mishaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries
Keywords: Diving
Water
Recreation
Precursor
Lead sponsor: Divers Alert Network
Sponsor class: NETWORK
First posted: 2013-10-11
Enrollment: 1116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy of using a pre-dive checklist to prevent the incidence of diving mishaps in recreational divers.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Having a valid Diver Certification
* Deemed fit by the Dive operator to dive on the day of participation
* Planning to dive on the day of participation
* Have basic knowledge of English

Exclusion Criteria:

* Anyone not meeting all of the inclusion criteria
* A diver who did not answer the outcomes questionnaire was later excluded

Primary outcomes:
measure: Mishaps
timeFrame: One day
Secondary outcomes:
measure: Major mishaps
timeFrame: One day
measure: Minor Mishaps
timeFrame: One day
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Aquatic Safaris
state: North Carolina
city: George Town
country: Cayman Islands
facility: Sunset House
state: Grand Cayman
city: Cozumel
country: Mexico
facility: Aldora Divers
state: Q,roo
city: Cozumel
country: Mexico
facility: Sand Dollar Sports
state: Q,roo
Study officials:
affiliation: Research Assistant, Medical Research
name: Shabbar I Ranapurwala, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Vice President, Medical Research
name: Petar J Denoble, MD, DSc
role: STUDY_DIRECTOR
References:
citation: Ranapurwala SI, Denoble PJ, Poole C, Kucera KL, Marshall SW, Wing S. The effect of using a pre-dive checklist on the incidence of diving mishaps in recreational scuba diving: a cluster-randomized trial. Int J Epidemiol. 2016 Feb;45(1):223-31. doi: 10.1093/ije/dyv292.
Clinical trial NCT06561438: Postoperative Pain Management Following Laparoscopic Cholecystectomy
Official title: Postoperative Pain Management Following Laparoscopic Cholecystectomy- Vortioxetine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: laparoscopic
5-HT3 and 5-HT7 receptors inhibition
post-operative pain
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated Vortioxetine as an adjuvant to standard care for postoperative pain management in patients undergoing LC

Detailed description: Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Vortioxetine (VO) is a multimodal serotonergic antidepressant with a unique mechanism of action that is effective in treating neuropathic pain. The purpose of this study is evaluating the efficacy and tolerability of preoperative oral administration of Vortioxetine on postoperative pain control in patients undergoing LC

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to undergo elective LC.
* Adults (males and/or females) between the ages of 18-70 years old.

Exclusion Criteria:

* Chronic pain other than cholelithiasis.
* Patients who received analgesics or sedatives 24 h before scheduled surgery.
* Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl \<30ml/min)
* Previous allergic response to vortioxetine.
* Pregnancy and lactation
* Patients with communication problems, cognitive dysfunction, or psychological disorders
* Daily corticosteroid use

Primary outcomes:
measure: VAS score (Visual analogue scale)
timeFrame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours
Secondary outcomes:
measure: Time to analgesic request
timeFrame: 24 hours
measure: Quality of life (QoL) after laparoscopic cholecystectomy (LC)
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Hepatology and Tropical Research Institute
Study officials:
References:
Clinical trial NCT02593838: Dynamic CT Myocardial Perfusion Imaging
Official title: Diagnostic Value and Practicability of Dynamic CT Stress and Rest Myocardial Perfusion Imaging in Daily Clinical Practice - A Monocentric Prospective Diagnostic Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims at evaluating the feasibility of CT myocardial perfusion imaging in daily clinical practice and compare it to SPECT perfusion imaging in order to assess sensitivity and specifity of CT myocardial perfusion imaging compared to SPECT.

Detailed description: If after the clinically indicated CCTA a myocardial perfusion examination is indicated, first a single ultra low dose CT scan will be performed to look for late enhancement of potentially scarred myocardium. Together with the contrast agent co-injection of the clinically indicated tracer 99mTc-Tetrofosmin will be performed for later scintigraphic perfusion evaluation. After stress perfusion imaging CT rest perfusion imaging will be performed in a similar fashion. After acquisition of CT rest perfusion images scintigraphic stress and rest image acquisition will be performed as in daily clinical routine with an additional administration of 99mTc-Tetrofosmin resting dose if necessary.

CT stress and rest perfusion will be compared to the clinically indicated and well established SPECT examination.

Eligibility criteria: Inclusion Criteria:

* Referral for cardiac hybrid imaging with CCTA and SPECT
* Male and Female subjects 18 years of age or older,
* Written informed consent by the participant after information about the project

Exclusion Criteria:

* Contraindications for CCTA (including renal failure with a GFR \<60ml/min/1.73m2, allergies to ionidated constrast agents)
* Inability to follow the examination procedure due to language barriers, mental disease, dementia etc.
* Pregnancy or breast feeding
* Known allergies to iodinated contrast agent (Visipaque ®), 99mTc-Tetrofosmin (Myoview ®), betablockers (Beloc i.v. ®) or nitrates (Isoket -Spray®)
* Hypersensitivity to adenosine
* Asthma bronchiale

Primary outcomes:
measure: Validation of CT-MPI against SPECT-MPI
timeFrame: 2 years
Secondary outcomes:
measure: Parameters influencing image quality of CT-MPI - Body physique
timeFrame: 2 years
measure: Parameters influencing image quality of CT-MPI - Heart rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Nuclear Medicine, University Hospital Zurich
Study officials:
affiliation: University Hospital Zurich, Department of Nuclear Medicine
name: Ronny R Buechel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00386438: Efficacy of Honan Balloon in Intraocular Pressure Reduction Before Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2006-10-11
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: -Does Honan balloon reduce intraocular pressure preoperatively?

Detailed description: -Does Honan balloon improve surgeon's satisfaction and patients' pain score when compared to no honan group?

Eligibility criteria: Inclusion Criteria:

* cataract patient,who plan to undergo phacoemulsification
* no previous ocular surgery

Exclusion Criteria:

* one eye
* high myopia
* Use ASA or anticoagulants
* History of glaucoma or ocular hypertension
* uncooperative patients

Primary outcomes:
measure: intraocular pressure reduction
Secondary outcomes:
measure: pain score
Other outcomes:
Locations:
city: Patumwan
country: Thailand
facility: King Chulalongkorn Memorial hospital
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Thitima Lunchakonsiripan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04745338: Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients
Official title: Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study will be carried to investigate the effect of cryolipolysis on visceral adiposity index in pco women randomized controlled trial

Detailed description: This study will be carried out on sixty females with polycystic ovarian syndrome (PCOS) who were selected from the Outpatient Clinic of Gynecology at Qasr Al Aini University Hospital. Their age ranged from 17-28 years, body mass index was 25-30 Kg/m2. They experienced hyperandrogenism, hyperinsulinemia and amenorrhea not less than 6 months.

PCOS females will be randomly assigned into two equal groups: group (A) (control group) consisted of 30 women who received low caloric diet (1200 Cal/day) and group (B) (study group) consisted of 30 women who received the same diet regime and cryolipolysis

Eligibility criteria: Inclusion Criteria:

* age ranges from 20-28 years, body mass index ranges 25-30 Kg/m2. They have pco syndrome .

Exclusion Criteria:

* Diabetic patients.
* Women with BMI\>30
* Women having circulatory dysfunction.
* Women with respiratory or cardiac disease
* liver disease.
* Skin disease .
* Previous abdominal or uterine surgery
* Physical impairment

Primary outcomes:
measure: Visceral adiposity index
timeFrame: 3 months
Secondary outcomes:
measure: weight
timeFrame: up to 3 months
measure: waist circumference
timeFrame: up to 3 months
measure: high density lipoprotein
timeFrame: up to 3 months
measure: serum triglyceride level
timeFrame: up to 3months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: fahema me okiel, phd
role: STUDY_DIRECTOR
affiliation: Cairo University
name: amal mo youssef, phd
role: STUDY_CHAIR
References:
Clinical trial NCT04289038: The Efficacy of VR and AR on Pruritus
Official title: Evaluation of the Efficacy of VR and AR on Pruritus Symptoms in Patients Receiving Hemodialysis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Insufficiency
Pruritus
Itch
Keywords: itch
pruritus
nursing
virtual reality
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Baskent University
First posted: 2020-02-28
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research will be conducted randomly in order to determine the effect of VR and AR on pruritus symptom.

Detailed description: In this study, there will be three groups: intervention group 1 with autogenic relaxation (AR), intervention group 2 with virtual reality (VR) game application and control group with routine nursing care and kidney functions narration. The number of volunteers to be included in the study was determined by power analysis. Forty patients with itch symptoms will be included in each group. Preliminary application for all three groups will be performed in the patient group registered to the Dialysis Unit of the Nephrology Department of Hacettepe University and Baskent University Hospital. Socio-Demographic Form, 5-D Itch Scale, Dermatology Life Quality Index, State and Trait Anxiety Scale, Pruritus Behavior and SGO / OR Application Log.

Eligibility criteria: Inclusion Criteria:

* Receiving hemodialysis treatment for the last 6 months,
* Receiving four hour hemodialysis treatment three times a week,
* 18-65 years of age,
* experiencing pruritus for the last month.
* Not taking any pharmacological / non-pharmacological treatment for pruritus
* No cognitive and psychiatric diagnosis,
* Do not use hearing aids,
* Open to communication and cooperation,
* Using smart mobile phone,
* Without liver disease and dermatological diseases,
* Patients who agree to participate in the study will be included in the study.

Exclusion Criteria:

* Pregnant in the research process,
* Kidney transplantation,
* Experiencing discomfort due to virtual reality glasses,
* Patients who voluntarily leave the trial will be excluded from the follow-up.

Primary outcomes:
measure: 5-D Itch Scale
timeFrame: Assessing change of 5-D Itch Scale scores baseline, first, fifth and seventh weeks.
Secondary outcomes:
measure: Dermatology Life Quality Index
timeFrame: Assessing change of Dermatology Life Quality Index scores baseline, first, fifth and seventh weeks. .
measure: State-Trait Anxiety Inventory
timeFrame: Assessing change of State-Trait Anxiety Inventory scores baseline, first, fifth and seventh weeks.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Neşe Altinok Ersoy
state: Eyalet/Yerleşke
Study officials:
affiliation: Hacettepe University
name: NEŞE ALTINOK ERSOY, PHDC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06164938: Study of Cerebral Glucose Metabolism in Healthy Volunteers Using 18 F-FDG PET: Evaluation of the Effects of Aging, Comparative Evaluation of Neurodegenerative and Psychiatric Pathologies.
Official title: Study of Cerebral Glucose Metabolism in Healthy Volunteers Using 18 F-FDG PET: Evaluation of the Effects of Aging, Comparative Evaluation of Neurodegenerative and Psychiatric Pathologies.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuro-Degenerative Disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 healthy volunteers, over 40 years of age, capable of understanding and wanting, who have not had a previous clinical history of neurological or psychiatric diseases, will be enrolled. Subjects with cognitive impairment and who at the time of recruitment are taking drugs active on the central nervous system will be excluded.

Brief summary: The aim of the study is to obtain information on cerebral glucose metabolism measured with the 18F-FDG PET technique in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for voxel-based statistical analyzes for comparison with individual subjects ( patients with disease neurological or psychiatric) which will be evaluated with the same method to improve the specificity and diagnostic sensitivity of the FDG PET exam.

The objective is to obtain a functional measure of brain glucose metabolism in every normal subject because this is a functional measure of brain activity. The subjects will represent different decades of age to have a wider range of comparison with patients.


Eligibility criteria: Inclusion Criteria:

* absence of neurological and psychiatric pathologies, negative pregnancy test.

Primary outcomes:
measure: Study of glucose metabolism with 18 F FDG PET
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00879138: Efficacy and Safety of VA106483 in Elderly Males
Official title: A Double-blind, Placebo-controlled Dose Response Study to Investigate Pharmacodynamics and Pharmacokinetics of Single and Repeated Oral Doses of VA106483 in Elderly Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nocturia
Lead sponsor: Vantia Ltd
Sponsor class: INDUSTRY
Collaborators: name: Veeda Clinical Research
First posted: 2009-04-09
Enrollment: 27
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.

Detailed description: VA106483 is a selective vasopressin V2 receptor agonist which is currently under development for the treatment of nocturia in males. This study examines the pharmacological action of VA106483 on markers of clinical efficacy (urine volumes and osmolality) and safety markers (coagulation factors and haemodynamics). The study will also assess the pharmacokinetics in the study population. The study design includes both cross-over and parallel phases so that pharmacodynamic and pharmacokinetic parameters can be assessed following both single and repeat dosing. Three dose levels will be given.

Eligibility criteria: Inclusion Criteria:

* Males 65 years and above with history of nocturia

Exclusion Criteria:

* Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
* Participation in any other clinical study within 30 days
* Intake of non-prescription medication within 14 days

Primary outcomes:
measure: Pharmacodynamic profile of VA106483
Secondary outcomes:
measure: Pharmacokinetic profile of VA106483
measure: Safety and tolerability of VA106483
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Veeda Clinical Research
Study officials:
References:
Clinical trial NCT01369238: East-West Collaborative Medicine Using Bee-Venom Acupuncture on Whiplash-Associated Disorders
Official title: Clinical Research on the Efficacy of East-West Collaborative Medicine Using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders After Traffic Collisions; A Randomized, Controlled, Parallel Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Whiplash Injuries
Keywords: bee venom acupuncture
east west collaborative medicine
whiplash associated disorder
Lead sponsor: Korean Pharmacoacupuncture Institute
Sponsor class: OTHER
First posted: 2011-06-08
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Purpose of study

   1. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders using VAS scale
   2. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders using NDI, BDI, SF-36, and EQ-5D.
2. Interventions \& Groups

   1. group 1: Bee-Venom Acupuncture Therapy
   2. group 2: zaltoprofen
   3. group 3: Bee-Venom Acupuncture Therapy \& zaltoprofen


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Whiplash injuries
* Must have cervicalgia of more than VAS 5

Exclusion Criteria:

* cancer, osteoporosis, ankylosing spodylitis, cauda equina syndrome, infection
* spinal operation
* other musculoskeletal pain
* physicological or mental disorders

Primary outcomes:
measure: pain scores on Visual Analogue Scale
timeFrame: changes from baseline in VAS at 1 month
Secondary outcomes:
measure: neck disability scores on Neck Disability Index
timeFrame: changes from baseline in NDI at 1 month
measure: depression scores on Beck Depression Inventory
timeFrame: changes from baseline in BDI at 1 month
measure: quality of life scores on short form SF-36
timeFrame: changes from baseline in short form SF-36 at 1 month
measure: quality of life scores on EQ-5D
timeFrame: changes from baseline in EQ-5D at 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Kyung Hee Oriental Medical Center
name: Seok-Hee Chung
role: STUDY_CHAIR
affiliation: Kyung Hee University Hospital at Gangdong
name: Jun-Hwan Lee
role: STUDY_DIRECTOR
affiliation: Kyung Hee Oriental Medical Center
name: Koh-Woon Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03796338: Sleep Quantity and Quality in the ICU: a Prospective Observational Stud
Official title: Sleep Quantity and Quality in the ICU: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disturbance
Critical Illness
Keywords: intensive care unit
Sleep interruption
Sleep phases
Lead sponsor: Careggi Hospital
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients

Brief summary: Several evidences in the literature suggest sleep interruption in critical care patients. Nowadays, the amount and the quality of sleep phases during the length of stay in the intensive care unit are largely unknown.

In this study, the amount of time spent by the patients in N1, N2 N3 and REM phases during sleep is quantified.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years

Exclusion Criteria:

* Pregnancy
* Previous enrollment in the same study (sleep recording during previous night)
* Previous use of hypnotic drugs

Primary outcomes:
measure: Sleep N2 phase
timeFrame: The sleep architecture will be observed during the first night spent in the ICU
Secondary outcomes:
measure: Sleep N1 phase
timeFrame: The sleep architecture will be observed during the first night spent in the ICU
measure: Sleep N3 phase
timeFrame: The sleep architecture will be observed during the first night spent in the ICU
measure: Sleep REM phase
timeFrame: The sleep architecture will be observed during the first night spent in the ICU
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
Study officials:
affiliation: Azienda Careggi
name: Gianluca Villa, MD
role: STUDY_DIRECTOR
References: