louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00870324: OptiSense™ Performance in Detecting Atrial Episodes
Official title: OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachyarrhythmias
Atrial Fibrillation
Keywords: ICD
Tachyarrhythmias
Atrial Fibrillation
Patients who meets current ICD or CRT-D implant indications
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-03-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with approved pacemaker indications.

Brief summary: The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW). The performance of the lead will be measured as a difference in device-determined time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to the control group which will be randomized to receive SJM's Tendril™ RA leads.


Eligibility criteria: Inclusion Criteria:

* Patients who meets current ICD or CRT-D implant indications and receive a St. Jude Medical ICD/CRT-D
* Patients who will receive a new St. Jude Medical OptiSense or Tendril RA lead as part of their device implant

Exclusion Criteria:

* Patients with a history of Permanent or Persistent AF
* Patient's life expectancy is less than 12 months.
* Patient is pregnant.
* Patient's age at enrollment is less than 18 years.

Primary outcomes:
measure: The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration).
timeFrame: 3 months post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Northeast Ohio Cardiovascular Specialists
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT03675334: Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions
Official title: Clinical Comparison Between the Use of a Connective Tissue Graft or a Porcine Collagen Matrix (Mucoderm) for Treatment of Gingival Recessions Type 1: a Randomized Controlled Clinical Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Keywords: clinical trial
root coverage
biomaterials
collagen matrix
coronally advanced flap
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Split-mouth clinical trial
Primary purpose: TREATMENT

Brief summary: Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft.

The aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).


Eligibility criteria: Inclusion Criteria:

* CEJ without significant damage;
* localized bilateral RT1 gingival recession ≥3 mm in the same arch

Exclusion Criteria:

* previous periodontal surgical treatment on the involved sites;
* smokers
* pregnants or lactating
* compromised systemic health and contraindications for periodontal surgery

Primary outcomes:
measure: Root coverage after 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Keratinized tissue gain after 6 months
timeFrame: 6months
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: School of Dentistry of Ribeirao Preto - University of Sao Paulo
state: Sao Paulo
Study officials:
References:
citation: Suzuki KT, de Jesus Hernandez Martinez C, Suemi MI, Palioto DB, Messora MR, de Souza SLS, Novaes AB Jr, Chaves Furlaneto FA, Taba M Jr. Root coverage using coronally advanced flap with porcine-derived acellular dermal matrix or subepithelial connective tissue graft: a randomized controlled clinical trial. Clin Oral Investig. 2020 Nov;24(11):4077-4087. doi: 10.1007/s00784-020-03280-x. Epub 2020 May 7.
Clinical trial NCT04460534: Detection of COVID-19 (SARS-CoV-2) in the Semen of COVID+ Patients (Positive RT-PCR on a Nasopharyngeal Swab)
Official title: Detection of SARS-CoV-2 in the Semen of COVID+ Patients (Positive RT-PCR on a Nasopharyngeal Swab)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective monocentric, open-label, prospective study of male patients with CoV-2-SARS.
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to look for the presence of SARS-CoV-2 in the semen of patients diagnosed with COVID+ based on RT-PCR analysis of nasopharyngeal swabs.

Detailed description: This is a prospective monocentric, open-label, prospective study of male patients with CoV-2-SARS.

Eligibility criteria: Inclusion Criteria:

* Male patient between the ages of 18 and 65 who has read and signed the consent form for participation in the study.
* Outpatient or inpatient without signs of respiratory severity, likely to be mobile
* Patient whose medical condition warrants screening for COVID-19 by nasopharyngeal swab

Exclusion Criteria:

* Patient under protective custody, guardianship or trusteeship
* Patient not affiliated to the French social security system
* Inability to provide the subject with informed information and/or written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient

Primary outcomes:
measure: Testing for the presence of COVID-19 (SARS-CoV-2 virus) in the semen
timeFrame: 48 hours
measure: Kinetics of SARS-CoV-2 virus presence in the semen
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Hôpital Privé de Parly II
Study officials:
affiliation: Hôpital privé de Parly II
name: Lucie DELAROCHE, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05861934: The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality
Official title: The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rheumatoid Arthritis (RA) is a chronic, multisystemic, progressive autoimmune disease characterized by joint destruction in synovial tissue, causing joint swelling, pain and morning stiffness. It is estimated to affect 0.1%-2% of the world's adult population and more women than men. RA limits individuals' work, social, and home lives and functional capacities. Patients commonly experience pain and accompanying sleep problems. Interventions for these problems and symptom management are important. In this regard, this study was planned to examine the effect of distant reiki application on pain, functional status and sleep quality in rheumatoid arthritis patients.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years old,
* Not having a communication problem,
* Receiving outpatient treatment from the clinic where the research was conducted,
* To have the physical and cognitive competence to answer the data collection forms,
* Not having received body-mind therapy (yoga, reiki, meditation, etc.) in the last six months,

Exclusion Criteria:

* individuals who have done reiki therapy before
* Being under 18 years old,
* Hearing and speaking problems that prevent communication,
* Participating in yoga, reiki, meditation practices in the last 6 months,
* Individuals with cognitive and severe psychiatric problems who cannot answer the survey questions

Primary outcomes:
measure: Distant Reiki application changes the level of pain in rheumatoid arthritis patients.
timeFrame: 6 weeks
measure: Distant Reiki application changes the functional status in rheumatoid arthritis patients. Health Assessment Survey will be used to evaluate the functional status of patients in rheumatic diseases.
timeFrame: 6 weeks
measure: Distant Reiki application changes sleep quality in rheumatoid arthritis patients. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Cemile KÜTMEÇ YILMAZ
state: Aksaray
city: Aksaray
country: Turkey
facility: Aksaray University Health Science Faculty
Study officials:
References:
Clinical trial NCT02578134: US-guided Percutaneous Electrolysis (EPE®) in Plantar Fasciosis
Official title: Effectiveness of US-guided Percutaneous Electrolysis (EPE®) Versus Placebo in Individuals With Plantar Fasciosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Plantar Heel Pain, Plantar Fasciosis
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 0
Sex: ALL
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: Scientific evidence of conservative management of individuals with plantar fasciosis is sometimes conflicting. There is evidence that regular exercise programs are effective for this pain condition. The inclusion of other therapeutic modalities is still controversial. Some authors have suggested that the use of US-guided percutaneous electrolysis (EPE®) maybe useful for the management of chronic tendinopathies; however, no study has investigated the potential placebo effect of this intervention. The objective of this randomized clinical trial is to determine the effectiveness of US-guided percutaneous electrolysis (EPE®) versus sham US-guided percutaneous electrolysis for the management of patients with plantar fasciosis for pain, function, and disability.


Eligibility criteria: Inclusion Criteria:

* insidious onset of sharp pain under the plantar heel surface upon weight bearing after a period of non-weight bearing;
* plantar heel pain which increases in the morning with the first steps after waking up;
* symptoms decreasing with slight levels of activity, such as walking.

Exclusion Criteria:

* prior surgery in the lower extremity;
* diagnosis of fibromyalgia syndrome;
* previous physical therapy interventions for the foot region in the previous 6 months
* lidocaine or other injections in the plantar fascia for the management of pain in the previous 6 months

Primary outcomes:
measure: Changes in disability before and after the intervention
timeFrame: Baseline, one week after the last session, and 3 months after the last session
Secondary outcomes:
measure: Changes in pain intensity before and after the intervention
timeFrame: Baseline, one week after the last session, and 3 months after the last session
measure: Changes in thickness of the plantar fascia
timeFrame: Baseline, one week after the last session, and 3 months after the last session
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Cesar Fernandez-de-Las-Peñas
state: Madrid
Study officials:
References:
Clinical trial NCT03685734: Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty
Official title: Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty for Corneal Endothelial Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Endothelial Disorder
Keywords: DSAEK
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with corneal endothelial dysfunction underwent DSAEK

Brief summary: To assess objective and subjective visual outcomes achieved by patients with corneal endothelial dysfunction who have undergone surgical treatment with Descemet stripping automated endothelial keratoplasty (DSAEK).

Detailed description: Since 2006, the technique by removing the Descemet membrane from the recipient cornea was renamed Descemet stripping automated endothelial keratoplasty (DSAEK). In recent years, DSAEK techniques have evolved, favoring increasingly thinner and finer grafts, known as ultrathin DSAEK (UT DSAEK), with the aim of obtaining better visual results.

Endothelial keratoplasty is now the most common surgical procedure used to treat endothelial dysfunction. The current study focused on assessing both objective and subjective visual quality outcomes following DSAEK.

Eligibility criteria: Inclusion Criteria:

* Clinical eligibility for DSAEK
* Informed written consent
* Successful completion of DSAEK procedure
* Postoperative follow-up at least 1 year
* Ability to respond to the questionnaire

Exclusion Criteria:

* Patients with clinical edematous cornea
* With significant stromal opacity
* With major disturbances of ocular surface
* Previous corneal surgery

Primary outcomes:
measure: Visual acuity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00765934: Influence of Rapydan on Clinical Chemistry and Hematology Measurements
Official title: Does Rapydan Influence Routine Clinical Chemistry and Hematology Measurements?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy
Lead sponsor: LabNoord
Sponsor class: OTHER
First posted: 2008-10-03
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: There is an increasing awareness of the importance of treating procedure-related pain. Patients undergoing vascular access procedures are often afraid of needles and the discomfort associated with injections. This type of pain and/or fear can be stressful to patients. \[1\] For prevention of the pain associated with these procedures, the hospital is using Rapydan plasters. Rapydan consists out of two local anesthetics: lidocaine and tetracaïne. Rapydan produces topical anesthesia after an application time of 30 minutes and is used in the Martini Hospital for pain relieve by venipuncture and IV cannulation. The venous blood draining the anaesthetized skin contains a higher blood concentration of the local anesthetics than does venous blood in other parts of the body \[2\] Although the concentrations of the local anesthetics are low in patients with normal skin, the question is whether the presence of the local anesthetics which Rapydan contains might influence routine measurements in clinical chemistry and hematology.


Eligibility criteria: Inclusion Criteria:

Volunteers 20-60 years who are decision making competent

Exclusion Criteria:

Patients with local anesthetic allergy Patients using antiarrhythmic drugs Patients using other local anesthetics

Primary outcomes:
measure: Routine Clinical Chemistry measurements differences
timeFrame: 1
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: LabNoord
Study officials:
affiliation: LabNoord
name: Rob Oude Elferink, MSc
role: STUDY_DIRECTOR
References:
citation: Curry SE, Finkel JC. Use of the Synera patch for local anesthesia before vascular access procedures: a randomized, double-blind, placebo-controlled study. Pain Med. 2007 Sep;8(6):497-502. doi: 10.1111/j.1526-4637.2006.00204.x.
citation: Amdisen A, Glud V. No influence from topical application of EMLA cream before blood sampling on routine clinical chemistry and haematology measurements. Eur J Clin Pharmacol. 1991;41(6):619-20. doi: 10.1007/BF00314997.
Clinical trial NCT01566734: Effect of Cefazolin and Normal Saline Irrigation on Surgical Site Infections (SSIs)
Official title: Comparison of the Effect of Cefazolin and Normal Saline Irrigation With no Irrigation on the Incidence of Surgical Site Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infections
Keywords: Surgical Wound Infection
cefazolin
Cesarean Section
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study conducted to assess the effects of normal saline or cefazolin irrigation on the incidence of SSIs.

Hypothesis:

Normal saline or cefazolin irrigation decreases the incidence of SSIs.

Detailed description: All pregnant women who underwent cesarean after 6 hours passed their rupture of membrane and attended to Shariati Hospital of Bandarabbass were eligible for our study.

Eligibility criteria: Inclusion Criteria:

* pregnant women
* 6 hours passed their rupture of membrane
* needed to undergo cesarean

Exclusion Criteria:

* allergy to penicillin
* allergy to cefazolin
* history of immunosuppressive drug use
* gestational diabetes mellitus
* preeclampsia

Primary outcomes:
measure: SSI
timeFrame: one week after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Bandar 'Abbas
country: Iran, Islamic Republic of
facility: Shariati Hospital
state: Hormozgan
Study officials:
affiliation: Hormozgan University of Medical Sciences
name: Maryam Rahmani, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00622934: Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients
Official title: Relationship Between Clinical Recovery and Oxidative Stress and Inflammation Following Usage of Erythropoietin in Admitted Traumatic Patient In Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Trauma
Keywords: multiple trauma
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Erythropoietin decrease stress responses and inflammation in trauma patient.

Detailed description: Transfusion of blood products has many disadvantages. Erythropoietin is used to increase red blood cells production and decrease such disadvantages.In some studies anti inflammatory effects is shown for Erythropoietin.

One of the most problems in the intensive care unit is stress response. we are going to evaluate effects of erythropoietin on oxidative stress and inflammation in trauma patient in intensive care unit.

Eligibility criteria: Inclusion Criteria:

* All multiple trauma patients\>16 years with informed consent

Exclusion Criteria:

* Hypertension
* Allergy
* Erythroid leukemia
* Pregnancy and breast feeding
* Pre operative patient
* Severe cardiovascular and cerebrovascular diseases
* Thromboembolic disorders

Primary outcomes:
measure: apachi 2 saps 30 days mortality
timeFrame: untill discharge
Secondary outcomes:
measure: 30 days mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Sina Hospital
Study officials:
affiliation: TUMS
name: MOJTABA MOJTAHEDZADE
role: STUDY_CHAIR
affiliation: TUMS
name: MOSTAFA MOHAMMADY
role: PRINCIPAL_INVESTIGATOR
affiliation: TUMS
name: MOJTABA MOJTAHED
role: STUDY_DIRECTOR
References:
Clinical trial NCT01786434: Routine or On-demand Fentanyl in Colonoscopy
Official title: Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: colonoscopy
pain
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2013-02-08
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colonoscopy may be an unpleasant procedure. Sedation and/or analgesics is therefore routinely administered in most countries. In Norway, however, routine sedation is rare, and medication is normally given on demand, that is, if necessary during the procedure. The investigators want to evaluate whether the effect of fentanyl, a synthetic opioid with fast onset of action, is better given before the procedure than during the procedure.


Eligibility criteria: Inclusion Criteria:

* Age 18-75
* Referred for out-patient colonoscopy

Exclusion Criteria:

* ASA-score 3 or higher
* Same day upper endoscopy
* Pregnancy
* Pacemaker
* Patient require medication before colonoscopy
* Previous resection of colon or rectum
* Significant psychiatric morbidity
* Oxygen saturation \< 95% without supplementary oxygen
* Contra indications to fentanyl
* Inability to sign inform consent
* Inability to understand information about the trial

Primary outcomes:
measure: Pain during colonoscopy
timeFrame: Immediately after the procedure and after 24 hours
Secondary outcomes:
measure: Additional medication
timeFrame: During the colonoscopy
Other outcomes:
measure: Patient satisfaction
timeFrame: The day after the procedure
measure: Complications
timeFrame: During the procedure
measure: Caecum intubation time
timeFrame: During the procedure
measure: Caecum intubation rate
timeFrame: During the procedure
measure: Willingness to repeat
timeFrame: Within one hour after the procedure
measure: Recovery time
timeFrame: Immediately after the procedure Within one hour after the procedure
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital Kristiansand
Study officials:
affiliation: Sorlandet Hospital HF
name: Oyvind Holme, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holme O, de Lange T, Stallemo A, Wiig H, Hasund A, Dvergsnes K, Garborg K, Ystrom CM, Loberg M, Hoff G, Bretthauer M, Kalager M. Routine vs. on-demand analgesia in colonoscopy: a randomized clinical trial. Endoscopy. 2016 Sep;48(9):823-8. doi: 10.1055/s-0042-108433. Epub 2016 Jun 15.