louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00573352: Far Infrared Radiation Treatment for Osteoarthritis
Official title: Phase 1 Study to Determine the Efficacy of Using Energy Specific Far Infrared (FIR) Radiation for the Treatment of Arthritis and Other Related Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: Arthritis, Degenerative
Osteoarthrosis
Osteoarthrosis Deformans
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to evaluate the possibility of using far infrared radiation to manage pain due to osteoarthritis.

Detailed description: Arthritis consists of more than 100 different conditions. These conditions range from relatively mild forms such as tendonitis and bursitis to crippling forms as rheumatoid arthritis. Pain syndromes include fibromyalgia and arthritis-related disorders as lupus erythematosus that involve every part of the body. There are forms of the disease, such as gout that almost nobody connects with arthritis. Osteoarthritis is the most common form of arthritis.

The objective for the study is to access the possibility of using far infrared radiation for pain management.

Eligibility criteria: Inclusion Criteria:

* 1 year old and above

Exclusion Criteria:

* None

Primary outcomes:
measure: The primary end point is to determine the therapeutic effects of far infrared radiation on osteoarthritis
timeFrame: 2 years and 9 months
Secondary outcomes:
measure: The therapeutic effects of far infrared radiation on all forms of arthritis
timeFrame: 2 years and 9 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: STUDY_DIRECTOR
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00808652: Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery
Official title: Prevalence and Outcome of Brachial Artery Endothelial Function in Morbidly Obese Patients Undergoing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity, Morbid
Ischemic Heart Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-12-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbisly obese patients scheduled to undergo bariatric surgery

Brief summary: The relation between obesity and ischemic heart disease (IHD) is under considerable debate. The reduction in all-cause mortality and, more specifically, the reduction in cardiac-related mortality seen after weight-loss surgery, may be due to regression or slowing developement of subclinical IHD. Function of cells lining the arteries (endothelium) is closely related to the state of IHD and its measurement can serve as a surrogate marker for the existence and severity of IHD. The investigators hypothesize that the prevalence of undiagnosed IHD in the morbidly obese population is high and that following surgery for weight reduction there is a halt in the progression, or even a regression in its severity.

The study includes measurement of endothelial function before and after weight-reducing surgery.


Eligibility criteria: Inclusion Criteria:

* Morbidly obese patients who fulfill the NIH criteria for surgical intervention.

Exclusion Criteria:

* Patients deemed unfit for surgery
* Pregnant women, or who are attempting conception.
* Subjects with any history of myocardial infarction, coronary artery bypass grafting surgery, coronary angiography with angioplasty and/or stenting, or any lesion \> 50% of the coronary artery luminal diameter, cerebrovascular accident, or peripheral vascular disease with abnormal electrocardiograms and/or echocardiography.
* History of drug or alcohol abuse.
* Chronic liver disease.

Primary outcomes:
measure: Flow-mediated (endothelial-dependent) vasodilatation (FMD) difference (before vs after surgery)
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT06323252: A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia
Official title: A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertriglyceridemia
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Its composition is high in bioactive ingredients (such as terpenic acids and polyphenols) which have proven anti-inflammatory, antioxidant, cardioprotective, chemoprotective and antimicrobial properties. The aim of this study is to determine the effect of Mastiha oil in adults with Hypetriglyceridemia. 100 participants will be allocated to two groups, (50 in intervention group and 50 in control group). Mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. Both groups will receive standard nutritional counselling. The intervention will last 3 months.

The effects of the intervention will be evaluated via clinical and laboratory markers.


Eligibility criteria: Inclusion Criteria:

* 30 years \< Age \< 75 years Hypetriglyceridemia A stable weight for ≥ 3 months pre-intervention An unchanged treatment regimen for ≥ 6 months pre-intervention

Exclusion Criteria:

Hepatotoxic Medication Untreated Diabetes Mellitus Dysthyroidism, hypopituitarism, Cushing syndrome / disease Pregnancy, lactation Psychiatric or mental disorder Any use of antioxidant-phytochemical rich supplement, vitamin D supplement, anti-, pre- or pro-biotics within 3 months pre-intervention

Primary outcomes:
measure: Change in blood triglycerides
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03493152: Expanded Access to Everolimus, for an Individual Patient With GIST (Gastrointestinal Stromal Tumors)(CTMS#18-0019)
Official title: Expanded Access to Everolimus, for an Individual Patient With GIST (Gastrointestinal Stromal Tumors)(CTMS#18-0019)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Gastrointestinal Stromal Tumor
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2018-04-10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Single patient treatment with everolimus.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01293552: Clinical Trial To Evaluate ANT-1207 In Subjects With Acne
Official title: Clinical Trial To Evaluate Botulinum Neurotoxin Type A (ANT-1207) In Subjects With Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Anterios Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 72
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: The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.


Eligibility criteria: Inclusion Criteria:

* diagnosis of moderate to severe facial acne
* 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones
* no presence of nodules
* female subjects must be not pregnant and non-lactating

Exclusion Criteria:

* presence of 1 or more nodules
* use of topical steroids on the face 4 weeks prior and during the study
* use of systemic corticosteroids 6 weeks prior and during the study
* topical or systemic acne treatment in the 4 weeks prior to Baseline

Primary outcomes:
measure: Efficacy will be assessed by lesion count.
timeFrame: Week 4
Secondary outcomes:
measure: Change from Baseline in Investigator Global Assessment Score
timeFrame: Week 1, 2, 4, 8, and 12
measure: Change from Baseline in Lesion Count
timeFrame: Week 1, 2, 4, 8, 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center
state: Alabama
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Esthetic Dermatology and Laser Center
state: Florida
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center Inc.
state: Georgia
city: Louisville
country: United States
facility: Dermatology Specialists Research, LLC
state: Kentucky
city: Metairie
country: United States
facility: William Coleman III, MD, APMC
state: Louisiana
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Verona
country: United States
facility: The Dermatology Group, P.C.
state: New Jersey
city: New York
country: United States
facility: Gramercy Park Dermatology
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Hershey
country: United States
facility: Penn State Hershey Medical Center Department of Dermatology
state: Pennsylvania
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
Study officials:
References:
Clinical trial NCT03611452: Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears
Official title: Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears : A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Episiotomy Wound
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 138
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing.

The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure


Eligibility criteria: Inclusion Criteria:

* Normal vaginal delivery.
* At term (37 40 weeks ).
* Live baby.
* Vertex presentation

Exclusion Criteria:

* Third and fourth degree perineal tear.
* Instrumental vaginal delivery.
* Previous perineal surgery.
* Anaemia with hemoglobin level \< 9 g/dl.
* Diabetes mellitus.
* Coagulation abnormalities.
* Postpartum hemorrhage.
* Delivery conducted outside Woman HealthHospital.
* Breech delivery.
* Body mass index \>35 kg/m2.
* Local infectious lesions.
* Anal fissures or hemorrhoid.

Primary outcomes:
measure: the mean score of Perineal pain during vaginal suturing
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03997552: NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration
Official title: Non-Incised Papillae Surgical Approach (NIPSA) Versus Marginal Approach by Palatal Incision and Minimally Invasive Surgical Technique (MIST) in Periodontal Regeneration: a Ramdomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Periodontal Diseases
Periodontal Pocket
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 60
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: Three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with periodontitis.
* plaque index and bleeding index of \< 30%.
* periodontal lesions with pocket probing depth \> 5 mm.
* intrabony defect \> 3 mm.
* intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

Exclusion Criteria:

* patients with systemic diseases that contraindicated treatment.
* third molars.
* teeth with incorrect endodontic or restorative treatment.

Primary outcomes:
measure: Probing pocket depth (PD)
timeFrame: 12 months
measure: Clinical attachment level (CAL)
timeFrame: 12 months
measure: Recession (REC)
timeFrame: 12 months
measure: Location of the tip of the papillae (TP)
timeFrame: 12 months
measure: Keratinized tissue width (KT)
timeFrame: 12 months
measure: Bleeding on probing
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Centro Odontologico Del Sureste Slp
Study officials:
References:
citation: Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Periodontal reconstructive surgery of deep intraosseous defects using an apical approach. Non-incised papillae surgical approach (NIPSA): A retrospective cohort study. J Periodontol. 2019 May;90(5):454-464. doi: 10.1002/JPER.18-0405. Epub 2018 Nov 28.
citation: Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
Clinical trial NCT05678452: Comparative Study Between Safety and Effectiveness of High Versus Low Power HOLEP
Official title: Comparative Study Between Safety and Efficacy of High Versus Low Power HOLEP in Enucleation of the Prostate; Prospective Randomized Double Blind Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: HOLEP, Enucleation, Prostate
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 200
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.
Primary purpose: TREATMENT

Brief summary: Holmium laser enucleation (HOLEP) has became a standard of treatment of large prostates that indicates surgery. HOLEP is widely used nowadays. Many settings are used but no optimal setting was world wide adopted. The aim of this trial is to assess the Low-power Holmium laser enucleation of the prostate (LP-HoLEP)and compare to high-power (HP-HoLEP) for enucleation efficiency pertaining to the advantages of lower cost and minimal postoperative dysuria, storage symptoms, and negative sexual impact.


Eligibility criteria: Inclusion Criteria:

* large prostate indicated for surgical intervention.

Exclusion Criteria:

* prostate cancer
* recurrent adenomas
* associated neurologic factors that may affect outcomes (e.g., neurogenic bladder)

Primary outcomes:
measure: Enucleation Efficiency
timeFrame: 3 hours
Secondary outcomes:
measure: Dysuria will be assessed by dysuria visual analog scale
timeFrame: 2 weeks
measure: The complications of both techniques
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urology department - AlAzhar university
Study officials:
References:
Clinical trial NCT00889252: Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
Official title: A Single-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 250
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.


Eligibility criteria: Inclusion Criteria:

* healthy normal, soft contact lens wearing volunteers
* normal ocular health
* contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye

Exclusion Criteria:

* active ocular infection
* history of ocular surgery
* use of topical ophthalmic preparations (including rewetting drops)
* pregnancy or lactation

Primary outcomes:
measure: Lid and Lid Margin Erythema, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Lid and Lid Margin Swelling, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Conjunctival Redness, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Conjunctival Chemosis, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Edema, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Erosion, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Endothelial, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Lens Pathology, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Flare in Anterior Chamber, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Cells in Anterior Chamber, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Staining - Nasal, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Staining - Temporal, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Staining - Inferior, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Staining - Superior, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Corneal Staining - Central, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Intraocular Pressure - Change From Baseline
timeFrame: baseline and 12 weeks
measure: Dilated Ophthalmoscopy - Fundus, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Dilated Ophthalmoscopy - Vitreous, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Visual Acuity Assessment
timeFrame: at the 12 week visit
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
state: Tennessee
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Brian Pall, OD, MS, FAAO
role: STUDY_DIRECTOR
References:
Clinical trial NCT04602052: Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia
Official title: Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia: A Quasi-experimental Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Termination of Pregnancy
Keywords: Dilation and evacuation
Second Trimester
Medical abortion
Ethiopia
Lead sponsor: St. Paul's Hospital Millennium Medical College, Ethiopia
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 279
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the safety and effectiveness of dilation and evacuation for surgical abortion as compared to medical abortion

Detailed description: All patients with a gestational age between 13-20 weeks are fully counseled on the risks and benefits and given the option of medical or surgical abortion. Those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration. Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.

Eligibility criteria: Inclusion Criteria:

* Gestational age between 13 - 20 weeks confirmed with ultrasound,
* Age at or more than18 years,
* Having a working phone and willingness to be contacted for a follow-up questionnaire 2 weeks after the procedure.

Exclusion criteria

* Inability to give consent
* complicated abortion (missed abortion, septic abortion)

Primary outcomes:
measure: Composite complication rate
timeFrame: During the abortion procedure and within 2 weeks post procedure
Secondary outcomes:
measure: Other serious maternal complications
timeFrame: During the abortion procedure and within 2 weeks post procedure
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Saint Paul's Hospital Millennium Medical College
Study officials:
References: