louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03819244: Comparison of Er,Cr:YSGG and Diode Lasers In Second Stage Implant Surgery
Official title: Clinical Comparison of The Use of Er,Cr:YSGG and Diode Lasers In Second Stage Implant Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Soft Tissue Bleeding
Wound Heal
Keywords: Diode Laser
Erbium Laser
Second-stage Implant Surgery
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluates postoperative pain, intraoperative bleeding and wound healing after second stage implant surgery. Submerged implants were exposed with diode laser in Group 1 (n=20) and by using Er,Cr:YSGG laser in Group 2 (n=20).


Eligibility criteria: Inclusion Criteria:

* subject has osseointegrated implants embedded under oral mucosa.
* subject undergoes second-stage implant surgery.

Exclusion Criteria:

* inadequate keratinized gingiva in the implant site.
* localization of the implant site is not possible due to excessive thickness of the oral mucosa

Primary outcomes:
measure: Postoperative pain on 1st day
timeFrame: 1st Day
measure: Postoperative pain on 2nd day
timeFrame: 2nd Day
measure: Postoperative pain on 3rd day
timeFrame: 3rd Day
Secondary outcomes:
measure: Number of analgesics used daily
timeFrame: 3 days
measure: Intraoperative bleeding
timeFrame: During operation
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University Faculty of Dentistry
Study officials:
affiliation: Yuzuncu Yıl University
name: Erkan Feslihan, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Kholey KE. Efficacy and safety of a diode laser in second-stage implant surgery: a comparative study. Int J Oral Maxillofac Surg. 2014 May;43(5):633-8. doi: 10.1016/j.ijom.2013.10.003. Epub 2013 Nov 7.
citation: Arnabat-Dominguez J, Espana-Tost AJ, Berini-Aytes L, Gay-Escoda C. Erbium:YAG laser application in the second phase of implant surgery: a pilot study in 20 patients. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):104-12.
Clinical trial NCT00814944: A Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model
Official title: A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: dry eye
sirolimus
rapamycin
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
Collaborators: name: MacuSight, Inc.
First posted: 2008-12-25
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE Model.


Eligibility criteria: Inclusion Criteria include, but are not limited to:

* Have a reported history of dry eye in both eyes;
* Have a history of use of or desire to use an eye drop for dry eye symptoms within the past 6 months.

Exclusion Criteria include, but are not limited to:

* Have contraindications to the use of the study medications;
* Have known allergy or sensitivity to the use of the study medications or diagnostic dyes;

Primary outcomes:
measure: Mean corneal fluorescein staining (inferior region) after CAE exposure.
timeFrame: Day 28
measure: Mean ocular discomfort during CAE exposure.
timeFrame: Day 28
Secondary outcomes:
measure: Safety across treatment groups.
timeFrame: Through 28 days
measure: Additional evaluations of dry eye including fluorescein staining, lissamine green staining, conjunctival redness, tear film break-up time, blink rate, ocular protection index, Schirmer's Test, and corneal sensitivity.
timeFrame: Day 28
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ophthalmic Research Associates
state: Massachusetts
Study officials:
affiliation: MacuSight, Inc.
name: Joel Naor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01975844: The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability
Official title: The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
End Stage Renal Disease
Keywords: Anemia
End Stage Renal Disease
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
Collaborators: name: Western New England Renal & Transplant Associates, PC
First posted: 2013-11-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron) protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain in target

Objectives:

1. Decreased variability of Hgb
2. Increase the % of patients in target range c Increase in time that Hgb remains target range

Detailed description: Study Design One dialysis unit shift comprising up to 200 patients. Study participation will last for 12 months broken into 3 phases as described below.

Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.

Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP.

The individual AMP will be utilized weekly during the 9 months of Phase 2.

The 3 objectives will be evaluated and updated weekly, Baseline to Year 1.

All Epo dosing recommendations must be reviewed by the treating physician who can either accept or modify doses at his/her discretion based on clinical event that are not includes in the transmitted data such as bleeding, infection, and hospitalization.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* Receiving hemodialysis in an out-patient dialysis unit

Exclusion Criteria:

* Not receiving EPOGEN as part of their standard medical care
* Patient refusal

Primary outcomes:
measure: Intraindividual Hemoglobin (Hgb) variability
timeFrame: Evaluated and updated weekly for 52 weeks
Secondary outcomes:
measure: Average hemoglobin levels
timeFrame: Evaluated and updated weekly for 52 weeks
Other outcomes:
Locations:
city: Chicopee
country: United States
facility: Chicopee Dialysis Center
state: Massachusetts
Study officials:
affiliation: Baystate Medical Center
name: Michael J Germain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05433844: To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers
Official title: A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Trial to Compare the Safety, Pharmacokinetics and Pharmacodynamics of JW0301 to C2105 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A randomized, open, single-dose, 2x2 crossover-design clinical trial
Primary purpose: OTHER

Brief summary: 1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions
2. To evaluate the safety and drug tolerance after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions

Detailed description: 1. It is analyzed for subjects who receive scheduled clinical trial drugs according to the clinical trial plan, have no significant violations in comparative analysis, and have completed all scheduled blood collection for pharmacokinetic evaluation.

   To analyze subjects who receive clinical trial medications scheduled according to the clinical trial plan, have no significant violations in comparative analysis, and have assessable intragastric pH information by completing a 24-h pH monitoring measurement.
2. All subjects who received more than one dose of clinical trial drugs are evaluated.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria

Primary outcomes:
measure: AUCτ, SS(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
timeFrame: 0 ~ 24h
measure: Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
timeFrame: Baseline versus Multiple dose during 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Seoul National University Hospital
Study officials:
affiliation: Clinical Trial Center, Seoul National University Hospital
name: SeungHwan Lee, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01535144: Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Lead sponsor: Syntellix AG
Sponsor class: INDUSTRY
First posted: 2012-02-17
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to show the equivalence of a new degradable metallic device to a non-degradable metallic device in patients with Hallux Valgus.


Eligibility criteria: Inclusion Criteria:

* Female and male patients with an age of 40 to 79 years at the day of surgery
* Symptomatic Hallux Valgus
* Radiological criterium area of proximal joint angle
* Normal motorically functions
* Female patients of childbearing age must be using two reliable contraception methods

Exclusion Criteria:

* Previous bone and/or soft tissue surgeries of the the first metatarsal of the respective foot
* BMI \> 32
* Cysts of the first metatarsal of the respective foot
* Neurological disorders with modified motorically functions
* Clinical evidence of osteoporosis
* Chronic renal impairment
* Known hypersensitivity to components of the implants
* Regular administration of medications containing the metallic elements of the degradable implant
* Pregnant or lactating women
* Current participation in another clinical trial or within 30 days before surgery

Primary outcomes:
measure: difference of metatarsal angles in degree post surgery and 6 months after surgery
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Clinic for Orthopaedic Surgery (in the Annastift Hospital)
state: Lower Saxony
Study officials:
affiliation: Clinic for Orthopaedic Surgery (in the Annastift Hospital)
name: Henning Windhagen, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03443544: Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients
Official title: Fournier's Gangrene and the Origin of the Infection as a Prognostic of Morbidity and Mortality, an Analysis of 121 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fournier Gangrene
Fournier's Gangrene of Penis
Fournier's Gangrene of Scrotum
Keywords: fournier's
gangrene
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 121
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from a single hospital (Hospital Universitario "Dr Jose E. Gonzalez") from 2007 to 2016 were included.

Brief summary: Background:

Fournier's gangrene it's a necrotizing infection of the genital area, with high morbidity and mortality. The site of infection its the origin of the necrotizing fasciitis. There are 4 well known origins of Fournier's gangrene: Testicular, Intestinal, Urinary and cutaneous, and its prognostic value has not been established yet, that's because the lack of case series with adequate number of patients. This is a retrospective study in which we evaluate the prognostic factors of every patient and its mortality compared with its origin area and multiple scores with their survival rates and hospital stay.

Detailed description: Objective:

To evaluate origins of Fournier's gangrene as a prognostic value in the morbidity and mortality.

Patients and methods:

This is a retrospective study where patients from a single hospital from 2007 to 2016 were included. They were categorized in 4 groups matching the origin of infection. In every group categorizing with the origin of infection and determined severity factors, days of hospital stay, Fournier's gangrene severity index and mortality. A statistic analysis will be done using lineal multivariable analysis.

Eligibility criteria: Inclusion Criteria

* Male Patient
* Fournier's Gangrene
* All patients treated with two antibiotics
* All patients undergone with aggressive debridement

Exclusion Criteria

* Female
* Not having Fournier's Gangrene

Primary outcomes:
measure: Fournier's Gangrene Severity Index
timeFrame: 0-24 hours
measure: Hospital stay ( in days)
timeFrame: 0 to 2 months
measure: Couture
timeFrame: 24 hours
Secondary outcomes:
measure: Diabetes mellitus
timeFrame: 0 - 100 years
measure: Hypertension
timeFrame: 0 - 100 years
measure: Alcohol drinking
timeFrame: 0 - 100 years
measure: Tobacco smoking
timeFrame: 0 - 100 years
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr Jose Eleuterio Gonzalez"
Study officials:
References:
Clinical trial NCT05769244: Near Infrared Spectroscopy and Testicular Torsion in Children
Official title: Near Infrared Spectroscopy and Testicular Torsion in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnostic Test
NIRS
Testicular Torsion
Diagnosis
Child
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 55
Sex: MALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: NIRS estimates tissue saturation of oxygenation in tissue beds. Animals studies suggested that transscrotal NIRS measurements can quantify testicular hypoxia and differentiate between torsed and non torsed testicles. The results of human studies are not conclusive. The hypothesis is that the difference in NIRS values between torsed and healthy testicles would not be zero and that this difference would be zero in control group and that NIRS could help to detect rapidly a TT Testicular torsion (TT) is a functional emergency. The diagnosis is sometimes difficult to make. No paraclinical examination can eliminate it with certainty. The investigators aimed to evaluate the interest of transscrotal near-infrared spectroscopy (NIRS) for the diagnosis of TT of child


Eligibility criteria: Inclusion Criteria:

* Step 1: healthy boys between 0 and 16 years old
* Step 2Testicular pain group (Group 1 and 2): boy under 18 years, testicular pain

Exclusion Criteria:

* cutaneous scrotal lesion,
* fever (for the control group),
* hypertension

Primary outcomes:
measure: mean tissue oxygenation percentage (NIRS measurements) of the testicles for healthy boys
timeFrame: one day
measure: mean tissue oxygenation percentage (NIRS measurements) of the both testicles for boys with scrotal pain
timeFrame: one day
measure: mean tissue oxygenation percentage (NIRS measurements) between both testicles for boys with scrotal pain
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT04231344: Laryngeal Disorders and GERD in Assiut University
Official title: Prevalence of Laryngeal Disorders in Patients With GERD in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngeal Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who diagnosed GERD by gastroenterology department before start of treatment of GERD Will examine by laryngoscopy for laryngeal lesions then they Will take treatment to GERD by gastroenterology department without any treatment to laryngeal disorders and study effect of GERD treatment on these laryngeal disorders

Brief summary: Study laryngeal disorders by laryngoscopic examination by two physicians on GERD patients diagnosed by gastroenterology department by endoscopy and effect of GERD treatment for 3 months on these laryngeal disorders without any treatment to laryngeal disorders


Eligibility criteria: Inclusion Criteria:

Patients diagnosed GERD by gastroenterology department before start of treatment and have laryngeal symptoms

Exclusion Criteria:

* voice abusers as singers ,teachers and readers.

Primary outcomes:
measure: Prevalence of laryngeal disorders in GERD patients
timeFrame: One year from February 2020 to February 2021
Secondary outcomes:
measure: Effect of treatment of GERD on these laryngeal disorders
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
citation: Cohen JT, Bach KK, Postma GN, Koufman JA. Clinical manifestations of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):19-23.
citation: Belafsky PC, Postma GN, Amin MR, Koufman JA. Symptoms and findings of laryngopharyngeal reflux. Ear Nose Throat J. 2002 Sep;81(9 Suppl 2):10-3.
Clinical trial NCT02075944: Effects of Aerobic Exercise on Cognitive Function and Brain-derived Neurotrophic Factor in Young Adults
Official title: Effects of Aerobic Exercise on Cognitive Function and Brain-derived Neurotrophic Factor in Young Adults Aged 15-21 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Conditioning, Human
Cognition
Keywords: Aerobic exercise
Cognitive function
Executive function
Brain-derived neurotrophic factor
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 130
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study will investigate the effects of aerobic exercise on cognition and growth factors including brain-derived neurotrophic factor (BDNF) in young adults aged 15-21 years. The included subjects will be randomized to three different groups including one control group and two exercise groups. Subjects randomized to the exercise groups will complete 30 minutes of aerobic exercise 3 times a week for 9 weeks incorporating low (group I) or high (group II) intensity aerobic exercise. The exercise will be conducted as running or indoor cycling (supervised). At baseline and 9-weeks follow-up all subjects will complete two cognitive tests (measures of concentration and sustained attention), a maximal cycling test (direct measures of VO2max), an intelligence quotient test, anthropometric measures, fasting blood samples and blood samples immediately following the cycling test. The blood samples will be analyzed for growth factors including BDNF and metabolic factors.


Eligibility criteria: Inclusion Criteria:

* age 15-21

Exclusion Criteria:

* injury preventing one from being physically active

Primary outcomes:
measure: The Flanker Task
timeFrame: 9 weeks
measure: The AX-Continuous Performance test
timeFrame: 9 weeks
measure: Brain-derived neurotrophic factor
timeFrame: 9 weeks
Secondary outcomes:
measure: Intelligence quotient
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Anne K Thorsen, Cand. Scient
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01357044: Effects of Plant Extracts on Semen Quality
Official title: An Extract of Pomegranate Fruit and Galangal Rhizome Increases the Numbers of Motile Sperm: A Prospective, Randomised, Controlled, Double-Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Semen Quality
Keywords: Semen quality
Plant extracts
Lead sponsor: Horsens Hospital
Sponsor class: OTHER
Collaborators: name: Videns- og Forskningscenter for Alternativ Behandling
First posted: 2011-05-20
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this is a prospective randomized placebo-controlled double-blinded trial investigating the effect of plant extracts from Alpinia galanga and Punica granatum on human semen quality. The investigators hypothesize that these plant extracts will improve semen quality.


Eligibility criteria: Inclusion Criteria:

* Reduced semen quality

Exclusion Criteria:

* Total count of motile sperm less than 1 million sperm/ejaculate or more than 200 million sperm/ejaculate

Primary outcomes:
measure: Count of motile sperm per ejaculate
timeFrame: Each participant is given plant extract for three months with flanking semen analyses.
Secondary outcomes:
measure: Morphology: percentage of morphologically abnormal sperm in the ejaculate
timeFrame: Each participant is given plant extract for three months with flanking semen analyses.
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Laboratory of Reproductive Biology
Study officials:
References:
citation: Fedder MD, Jakobsen HB, Giversen I, Christensen LP, Parner ET, Fedder J. An extract of pomegranate fruit and galangal rhizome increases the numbers of motile sperm: a prospective, randomised, controlled, double-blinded trial. PLoS One. 2014 Oct 2;9(9):e108532. doi: 10.1371/journal.pone.0108532. eCollection 2014.