louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01325857: Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach
Official title: Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 97
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to investigate the analgesic effect of bilateral superficial cervical plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The investigators hypothesized that bilateral superficial cervical plexus blockade would reduce the patient's pain score by more than 10 (on a VAS scale of 0\~100) compared to a placebo group and control group.


Eligibility criteria: Inclusion Criteria:

* ASA class 1 or 2 adult patients scheduled for robot-assisted endoscopic thyroidectomy

Exclusion Criteria:

* Patient refusal
* Bleeding diathesis
* Allergies to local anesthetics
* Patient unable to read consent form (Foreigner, illiterate)
* Pregnant women

Primary outcomes:
measure: Visual analogue pain score
timeFrame: Immediate post-operation (at recovery room) (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Shin S, Chung WY, Jeong JJ, Kang SW, Oh YJ. Analgesic efficacy of bilateral superficial cervical plexus block in robot-assisted endoscopic thyroidectomy using a transaxillary approach. World J Surg. 2012 Dec;36(12):2831-7. doi: 10.1007/s00268-012-1780-0.
Clinical trial NCT05368857: DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers
Official title: A Mechanistic Study to Evaluate Impact of Subcutaneous Implants of Afamelanotide on Ultraviolet Radiation-induced DNA Damage and DNA Repair Capacity in Healthy Volunteers With Skin Types I-III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers
Lead sponsor: Clinuvel Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2022-05-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This mechanistic study's aim is to assess the DNA damage repair capabilities of afamelanotide in healthy volunteers with skin type I-III following exposure to ultraviolet radiation (UVR)-induced DNA damage.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteers (aged 18-45) with Fitzpatrick skin types I, II or III.
* Written informed consent obtained from volunteers prior to study-start.

Exclusion Criteria:

* Female who is pregnant or lactating.
* Females of child-bearing potential not using adequate contraceptive measures or a lifestyle excluding pregnancy.
* Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.
* Any significant illness during the four weeks before the study screening period.
* Taking known photosensitisers.

Primary outcomes:
measure: Change in UV photoproduct levels in UVR-exposed skin.
timeFrame: From Baseline to Day 28
measure: Change in rate of UV photoproduct repair in UVR-exposed skin.
timeFrame: From Baseline to Day 28.
Secondary outcomes:
measure: Change in UV-induced DNA damage and repair markers.
timeFrame: From Baseline to Day 28
measure: Change in Minimal Erythema Dose (MED).
timeFrame: From Baseline to Day 28
measure: Change in UVR-erythema dose-response.
timeFrame: From Baseline to Day 28
Other outcomes:
Locations:
city: Clinuvel Investigational Site
country: United Kingdom
facility: CLINUVEL Investigational Site
Study officials:
References:
Clinical trial NCT00510757: Multi Cervical Unit Measures of Cervical Isometric Strength and Range of Motion: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervicogenic Headache
Neck Pain
Whiplash
Kyphotic and Reversed Cervical Curves
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2007-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consenting males and females between the ages of 18 and 65.

Brief summary: This study is designed to collect normative data on cervical isometric strength and range of motion to supplement an existing normative data base.


Eligibility criteria: Inclusion Criteria:

* Logan students, faculty and staff

Exclusion Criteria:

* recent surgery,or unstable or fused joints of the cervical spine
* using medications, prescription or herbal muscle stimulants, relaxants, etc
* previous cervical spine injury, surgery or condition that would affect your range of motion in the cervical spine
* currently have any local infection, injury or other malignancy affecting the cervical spine
* congenital conditions affecting the cervical spine, i.e. block vertebrae
* systemic illness with an adverse effect on the cervical spine
* a history of dizziness, light headedness or passing out, or any seizure disorder
* had a neck, shoulder or back injury
* ever been in an automobile accident
* exercise regularly
* pregnant
* spinal manipulation mobilization or other therapy in the last 48 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan University, College of Chiropractic
state: Missouri
Study officials:
affiliation: Logan College
name: Rodger E Tepe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03992157: Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
Official title: Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Infarction
Keywords: stroke
ECG
telemetry
atrial fibrillation
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to show that an ambulatory ECG telemetry monitoring of some patients hospitalized for cerebral infarction increases the frequency of the diagnosis of atrial fibrillation, cause of their stroke, and reinforces the protection against recurrences.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Diagnosis of transient ischemic or cerebral accident
* Absence of etiological orientation after the initial assessment (including at least cerebral MRI, angiography of the supra aortic trunks by CT or MRI, echocardiography with search for patent foramen ovale, standard biology)
* Affiliated to a social security system.
* Having given no opposition to participation in research

Exclusion Criteria:

* AF known or diagnosed during stay in USINV

Primary outcomes:
measure: Diagnostic impact of outpatient ECG telemetry
timeFrame: 6 months
Secondary outcomes:
measure: Identification of prognostic factors to identify de novo atrial fibrillation
timeFrame: 6 months
measure: Evaluate the therapeutic impact (prescription anticoagulant) at the end of hospitalisation
timeFrame: 6 months
measure: Evaluate the benefit on the recurrence rate of cerebral infarction after the exit of the service
timeFrame: 3 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Bertrand Lapergue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00463957: The Pharmacological Basis for the Increase in Visual Time Constants Induced by Single Oral Doses of Sildenafil
Official title: The Pharmacological Basis for the Increase in Visual Time Constants Induced by Single Oral Doses of Sildenafil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Keywords: sildenafil
tadalafil
phosphodiesterase
visual persistence
reaction time
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Sildenafil and similar drugs have been used for several years to treat erectile dysfunction. It has been noticed that in some people, sildenafil causes a subtle increase in the length of time that visual images that we see are retained by the retina. It is thought that this might be due to an effect of sildenafil on inhibiting an enzyme called phosphodiesterase type 6 (PDE6) which is present in the retina. By giving single oral doses of sildenafil and a similar drug called tadalafil which has less effect on PDE6, we hypothesise that this is the mechanism of the change in vision caused by sildenafil. By performing computerised visual test, we plan to compare the effects of sildenafil, tadalafil and placebo tablets on vision in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Male
* 18-55 years

Exclusion Criteria:

* Significant medical or psychiatric illness
* Cardiac disease
* Hyper or hypotension
* Renal disease
* Liver disease
* Stroke
* Sickle cell anaemia
* Multiple myeloma
* Leukaemia
* Bleeding disorders
* Peyronie's disease
* Priapism
* Subjects receiving prescribed medications
* Subjects with known visual abnormalities other than refractive errors, including retinitis pigmentosa, optic neuropathy

Primary outcomes:
measure: visual persistence
measure: reaction time
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: University of Cambridge
Study officials:
affiliation: University of Cambridge
name: Morris J Brown
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00827957: Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients
Official title: A Phased Prospective Clinical Study Comparing Controlled Therapeutic Hypothermia Post Resuscitation After Cardiac Arrest Using External and Internal Cooling to Standard Intensive Care Unit Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Arrest
Keywords: Hypothermia
Internal cooling
External cooling
Cardiac arrest
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart Centre Singapore
First posted: 2009-01-23
Enrollment: 51
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: Controlled therapeutic hypothermia is a method of preserving neurological function post-resuscitation.It has been associated with improved functional recovery and reduced histological deficits in animal models of cardiac arrest.

Detailed description: Three randomized clinical studies have been reported showing improved neurological outcome and reduced mortality in post-resuscitation patients treated with hypothermia compared to controls. Of the various methods of inducing hypothermia, internal cooling using an endovascular catheter and external cooling using gel pads with a water based circulating system have shown the most promise. There have not been any studies looking at outcomes between the two methods of cooling.

Eligibility criteria: Inclusion Criteria:

1. Sustained return of spontaneous circulation (ROSC) after cardiac arrest, for more than 30 min
2. Patients aged between 18 to 80 years.
3. Patients who are hemodynamically stable, with a systolic BP \> 90 mmHg with or without inotropic support.
4. Patients comatose or unresponsive post-resuscitation

Exclusion Criteria:

1. Hypotension despite fluid and/or vasopressor support
2. Positive pregnancy test in women below 50 years
3. Premorbid status bedbound and uncommunicative

Primary outcomes:
measure: Survival to hospital discharge
timeFrame: 30 days post arrest
Secondary outcomes:
measure: Neurological status of post-resuscitation patients
timeFrame: 1 year post discharge
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Marcus EH Ong, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010.
Clinical trial NCT06681857: Maxillary Sinus Floor Elevation With Gelatin Sponge Versus Allogenic Demineralized Bone Matrix
Official title: Evaluation of Simultaneous Implant Placement and Maxillary Sinus Floor Elevation With Gelatin Sponge Versus Allogenic Demineralized Bone Matrix: (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maxillary Sinus Disease
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The post-extraction pneumatization of the maxillary sinus often compromises the ability of the maxillary molar to the optimal recipient of dental implants as a consequence of the quantitative reduction of the vertical bone height and the reduced bone quality of the region posterior maxillary segment.


Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes, with an age range of (25 to 55 years) with unilateral or bilateral edentulous posterior maxillary molar region with \\ vertical residual bone height of (four to six millimeters), a minimal horizontal bone width of six millimeters bone width, acceptable interarch space, and fair inter-jaw anteroposterior, horizontal and vertical relationships.
2. Proper general health and oral hygiene.

Exclusion Criteria:

1. The presence of sinusitis, local sinus pathosis, or a systemic disease that would affect the final treatment outcomes, bone remodeling process, or maxillary sinus health.
2. Those patients with a history of previous bone graft, sinus lift, or failed implant.

Primary outcomes:
measure: Bone Density
timeFrame: 6 months
measure: Stability
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university
Study officials:
References:
Clinical trial NCT00000357: Buprenorphine Maintenance for Opiate Dependence - 6
Official title: Buprenorphine Maintenance for Opiate Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: opiate dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of buprenorphine as a substitution pharmacotherapy for opiate dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: PDVAMC Treatment Research Center
name: Charles O'Brien, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00782457: Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: RECTAL CANCER
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.


Eligibility criteria: Inclusion Criteria:

* Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)
* Histology of adenocarcinoma

Exclusion Criteria:

* Locally advanced disease (T4)
* Emergency surgery
* Rectal cancer over familial colic polyposis

Primary outcomes:
measure: Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lujan J, Valero G, Hernandez Q, Sanchez A, Frutos MD, Parrilla P. Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer. Br J Surg. 2009 Sep;96(9):982-9. doi: 10.1002/bjs.6662.
Clinical trial NCT03474757: Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases
Official title: Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases - TREND Colombia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2018-03-23
Enrollment: 10528
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: Using the population from the Audifarma database, the study will be comprised of three separate cohorts of first time users of rivaroxaban, dabigatran and apixaban using the first prescription date (index date) of the respective drug (index drug). All patients aged ≥18 years with at least one year of enrollment in the databases and one year since first encounter with healthcare provider will be included in the study.

Brief summary: This population-based descriptive study will characterize first-time users of three NOACs (rivaroxaban, dabigatran and apixaban) in prevention of stroke in non-valvular atrial fibrillation (SPAF) patients and will assess the patterns of drug utilization in routine general practice in Colombia


Eligibility criteria: Inclusion Criteria:

* First prescription of NOACs (rivaroxaban, dabigatran and apixaban) in the outpatient setting.
* Non valvular Atrial Fibrillation (NVAF) Patients
* aged ≥18 years
* at least one year of enrollment in the Audifarma database
* one year since first encounter with healthcare provider will be included in the study

Exclusion Criteria:

* Patients with any record of index drug prescription prior to the enrolment period.
* Patients who qualify as members of more than one cohort study on the same day

Primary outcomes:
measure: Age
timeFrame: At Baseline
measure: Sex
timeFrame: At Baseline
measure: Co-morbidity
timeFrame: At Baseline
measure: Healthcare utilization
timeFrame: Up to 2 years
measure: Proportion of Naive to non-naive patient
timeFrame: At Baseline
measure: Dose at first prescription
timeFrame: Up to 6 years
measure: Duration of treatment
timeFrame: Up to 6 years
measure: Discontinuation
timeFrame: Up to 6 years
measure: Switch to another study drug
timeFrame: Up to 6 years
Secondary outcomes:
measure: Time trends of usage of study medications
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Multiple Locations
country: Colombia
facility: Many Locations
Study officials:
References:
Clinical trial NCT00387257: Effect Of Rilapladib (SB-659032) On Platelet Aggregation
Official title: A Double Blind, Placebo Controlled, Parallel Study to Evaluate Effects of Repeat Doses of Rilapladib on Platelet Aggregation in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Atherosclerosis
Keywords: platelet aggregation
SB-659032
rilapladib
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-12
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the effects of repeat doses of SB-659032 with placebo on platelet aggregation in subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects with QTc \< 450 msec as measured at screening.

Exclusion Criteria:

* History of asthma.
* Smokers.

Primary outcomes:
measure: Collagen EC50 values on Day 35 (or 21 days post last dose) as determine by optical aggregometry.
timeFrame: on Day 35 (or 21 days post last dose) as determine by optical aggregometry
Secondary outcomes:
measure: Collagen EC50 values on Day 1 and Day 14 as determined by optical aggregometry Plasma Lp-PLA2 activity Clinical safety data Concentrations of rilapladib and SB-664601.
timeFrame: on Day 1 and Day 14 as determined by optical aggregometry
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Shaddinger BC, Xu Y, Roger JH, Macphee CH, Handel M, Baidoo CA, Magee M, Lepore JJ, Sprecher DL. Platelet aggregation unchanged by lipoprotein-associated phospholipase A(2) inhibition: results from an in vitro study and two randomized phase I trials. PLoS One. 2014 Jan 27;9(1):e83094. doi: 10.1371/journal.pone.0083094. eCollection 2014.