louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03491618: Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain
Official title: Evaluación de la Analgesia a Corto y Medio Plazo de Las Diferentes Posiciones y Tipos de Las cánulas de Radiofrecuencia, en la denervación Del Ramo Medial Del Nervio Dorsal Lumbar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Facet Joint Pain
Lumbar Medial Branch Neurotomy
Keywords: lumbar facet joint pain
Lumbar Medial Branch Neurotomy
Chronic Low Back Pain
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective comparative study.
Primary purpose: TREATMENT

Brief summary: Prospective study to analyse pain reduction with two types of canulae and two types of placements for lumbar medial branch radiofrequency denervation.

Detailed description: Patients who suffer from lumbar zygapophyseal joint pain often receive radiofrequency medial branch denervation as treatment. Many types if canulae exist, and many types of placing them in relation to the Medial Branch nerves (MB). The EARL study tries to compare the analgesic effect of thin canulae (22 gauge) placed perpendicular to MB to thicker canulae (18 gauge) placed parallel to MB.

Eligibility criteria: Inclusion Criteria:

* Low back pain of \> 3 months
* 18-80 years
* VAS or NRS\>6
* Positive controlled block

Exclusion Criteria:

* Pregnancy
* Psichiatric disorders
* Not being able to fulfil questionnaires
* Body Mass Index\>35
* Labor Litigation
* Negative or non conclusive controlled block
* Failed Back Surgery Syndrome

Primary outcomes:
measure: PAIN REDUCTION ON VAS/NRS
timeFrame: 1-3-6 months
Secondary outcomes:
measure: OSWESTRY DISABILITY INDEX
timeFrame: 1-3-6 months
measure: ROLAND MORRIS
timeFrame: 1-3-6 months
measure: MEDICATION REDUCTION
timeFrame: 1-3-6 months
measure: WORKING STATUS
timeFrame: 1-3-6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References:
Clinical trial NCT00132418: Study of Enbrel in Rheumatoid Arthritis (RA) Subjects With Comorbid Disorders
Official title: Double-blind, Randomized, Placebo-controlled Study of Enbrel (Etanercept) in the Treatment of Rheumatoid Arthritis Subjects With Comorbid Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis and at least 1 qualifying comorbid condition (diabetes, chronic pulmonary disease, recent infection)
RA
rheumatoid arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
First posted: 2005-08-22
Enrollment: 564
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 objective of this study was to evaluate the safety of Enbrel (etanercept) in rheumatoid arthritis (RA) subjects with greater than or equal to 1 documented comorbid disease (diabetes mellitus; chronic pulmonary disease; pneumonia within the last year; or recurrent bronchitis, sinusitis, or urinary tract infection) that might increase infection risk.


Eligibility criteria: Inclusion Criteria: - Active RA - Documented comorbid condition (diabetes mellitus requiring insulin or oral hypoglycemic agents; chronic pulmonary disease; history of pneumonia in the last year; or recurrent bronchitis, sinusitis or urinary tract infection) - Able to self-inject study drug Exclusion Criteria: - Previous use of anti-tumor necrosis factor (TNF) monoclonal antibody - Receipt of anti-CD4 or diphtheria interleukin-2 fusion protein within the previous 6 months with subsequent abnormal absolute T cell count - Receipt of intra-articular corticosteroids within 2 weeks before screening - Receipt of cyclosporine, thalidomide or azathioprine within 4 weeks before screening - Significant concurrent medical diseases (serious infection; open cutaneous ulcers; current antibiotic treatment; myocardial infarction \[MI\] within 12 months of screening; angina pectoris; uncontrolled hypertension; cancer; or HIV positive)

Primary outcomes:
measure: Incidence of medically important infections, defined as infections that result in hospitalization or treatment with intravenous antibiotics
timeFrame: 16 weeks
Secondary outcomes:
measure: Infections associated with antimicrobial use; physical examination, vital signs, clinical laboratory assessments; symptom assessment, withdrawals, deaths, and serious adverse events
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Weisman MH, Paulus HE, Burch FX, Kivitz AJ, Fierer J, Dunn M, Kerr DR, Tsuji W, Baumgartner SW. A placebo-controlled, randomized, double-blinded study evaluating the safety of etanercept in patients with rheumatoid arthritis and concomitant comorbid diseases. Rheumatology (Oxford). 2007 Jul;46(7):1122-5. doi: 10.1093/rheumatology/kem033. Epub 2007 Apr 29.
Clinical trial NCT00704418: Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: Cataract extraction
intraocular lens implantation
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 156
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: Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery


Eligibility criteria: Inclusion Criteria:

* Scheduled for cataract surgery

Exclusion Criteria:

* Known hypersensitivity to bromfenac and salicylates

Primary outcomes:
measure: Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
timeFrame: Day 15
Secondary outcomes:
measure: Number of Participants That Are Pain Free
timeFrame: Day 1
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
References:
citation: Silverstein SM, Cable MG, Sadri E, Peace JH, Fong R, Chandler SP, Gow JA, Klier SM, McNamara TR; Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.
Clinical trial NCT04504318: Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
Official title: A Randomized Controlled Trial Comparing Apixaban Versus Enoxaparin Following Microsurgical Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Venous Thromboembolism
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level factors, thus, resulting in VTE events despite guideline-compliant prophylaxis. A population at particular risk is the growing number of patients who undergo autologous breast reconstruction. Direct oral anticoagulants (DOAC) might be a less invasive, yet, more efficacious mode of chemoprophylaxis in this patient population. Hence, the proposed work has the potential to cause a paradigm shift in chemoprophylaxis guidelines in a large population of patients undergoing plastic surgery.


Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years) women
* Scheduled to undergo unilateral or bilateral microsurgical breast reconstruction with free abdominal flaps (i.e. muscle-sparing transverse rectus abdominis musculocutaneous \[TRAM\] and/or deep inferior epigastric artery perforator \[DIEP\]) flap)
* Caprini score of 6 or greater.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Contraindication to the use of apixaban or enoxaparin
* Active bleeding
* History of bleeding disorder
* History of coagulopathy
* History of heparin-induced thrombocytopenia
* History of liver disease
* History of renal disease (creatinine clearance \<30 mL/min; serum creatinine \>1.6 mg/dL)
* Major neurosurgical intervention (brain/spine) within the past 90 days
* Ophthalmologic procedure within the past 90 days
* Uncontrolled hypertension
* History of alcohol and/or substance abuse
* Need for therapeutic anticoagulation
* Pregnant or Nursing

Primary outcomes:
measure: Apixaban vs. Enoxaparin - Bleeding event
timeFrame: 90-day events
Secondary outcomes:
measure: Apixaban vs. Enoxaparin - Venous Thromboembolism (VTE) event
timeFrame: 90-day events
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Arash Momeni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02244918: Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers
Official title: Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-09-19
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The researchers are testing if counseling alone or counseling plus over-the-counter nicotine replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily smokers quit smoking.

Detailed description: Non-daily smokers represent a growing number of racial/ethnic minority smokers. 1 out of 4 African Americans are non-daily smokers. African Americans seem to have a harder time quitting and have greater medical problems related to smoking even at lighter usage rates compared to Whites.

Current tobacco treatment guidelines target daily smokers. There are no guidelines for non-daily smokers. This study will allow the researchers to explore treatment options for African American non-daily smokers and find out if some treatments work better than others.

Participation in this study will last about 6 months. Over this course of time, participants will be asked to visit the study location 3 times and will talk with a member of the study team on the phone 4 times.

Eligibility criteria: Inclusion Criteria:

* African American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screening

Exclusion Criteria:

* Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening

Primary outcomes:
measure: Smoking Abstinence
timeFrame: Week 12
Secondary outcomes:
measure: Smoking Abstinence
timeFrame: Week 26
measure: Concentration of Urinary Cotinine
timeFrame: Weeks 0, 26
measure: Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol)
timeFrame: Weeks 0, 12
measure: Total Days Abstinent
timeFrame: Week 0-26
measure: Cigarettes Used
timeFrame: Weeks 0-26
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Swope Health Central
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Nikki Nollen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nollen NL, Cox LS, Mayo MS, Ellerbeck EF, Madhusudhana S, Ahluwalia JS. A randomized clinical trial of counseling and nicotine replacement therapy for treatment of African American non-daily smokers: Design, accrual, and baseline characteristics. Contemp Clin Trials. 2018 Jul;70:72-82. doi: 10.1016/j.cct.2018.05.011. Epub 2018 May 19.
Clinical trial NCT06116513: Secondary Obliteration of Old Radical Cavities Using S53P4 Bioactive Glass
Official title: Efficacy of Secondary Obliteration of Chronically Discharging Old Radical Cavities Using S53P4 Bioactive Glass
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mastoid Cavity
Lead sponsor: Diakonessenhuis, Utrecht
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients operated in our hospital between 2011 and 2022 for troublesome radical cavities that received secondary obliteration

Brief summary: In canal wall down surgeries, the posterior bony wall of the external auditory canal (EAC) is removed to increase exposure. The creation of a so-called radical cavity comes with several possible disadvantages, such as higher rates of postoperative otorrhea and purulence, pain, adherence to water precautions and dizziness. Secondary obliteration of the mastoid cavity and reconstruction of the posterior wall of the EAC can help alleviate these symptoms. Our goal is to study the efficacy of secondary obliteration using S53P4 bioactive glass as obliteration material. This bioactive glass has several important characteristics, such as retaining of volume over time and antibacterial effects. The main outcome will be postoperative otorrhea as indicated by the Merchant grading scale.


Eligibility criteria: Inclusion Criteria:

* Old canal wall down cavity
* Operated between 2011 and 2022

Exclusion Criteria:

* Middle ear cholesteatoma
* Previous obliteration

Primary outcomes:
measure: Number or participants with a dry ear pre- and postoperatively
timeFrame: At 1, 3 and 5-year postoperatively.
Secondary outcomes:
measure: Pre- and postoperative air conduction
timeFrame: pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively
measure: Pre- and postoperative air-bone gap
timeFrame: pre-operatively, in the first 6 months following surgery and 6-12 months postoperatively
measure: The number of patients with postoperative surgical complications
timeFrame: First year following surgery
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
affiliation: Diakonessenhuis, Utrecht
name: J.J. Quak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02251613: Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan
Official title: Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of Olopatadine Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a history of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with Japanese cedar pollen will be performed.


Eligibility criteria: Inclusion Criteria:

* Be Japanese and live in Japan;
* History of allergic conjunctivitis;
* Positive skin test reaction to Japanese cedar at Visit 1;
* Positive bilateral CAC reaction to the allergen at Visit 1 and Visit 2;
* Able and willing to avoid all disallowed medications during the specified period;
* Able to discontinue wearing contact lenses during the specified period;
* Sign Informed Consent;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History of hypersensitivity to the study drug or compounds;
* Any ocular condition that, in the opinion of the investigator, could affect the patient's safety;
* Ocular surgical intervention within 3 months or refractive surgery within 6 months prior to the start of the study;
* Presence of active ocular infection;
* Use of disallowed medications as specified in the protocol;
* Pregnant, nursing, or planning to become pregnant during the study;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Ocular Itching at 7 Minutes Post-CAC, Day 1
timeFrame: Day 1, 7 minutes post-CAC
Secondary outcomes:
measure: Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1
timeFrame: Day 1, 20 minutes post-CAC
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Japan, Ltd.
name: Tsunemitsu Senta
role: STUDY_DIRECTOR
References:
Clinical trial NCT03946813: The Efficacy of Platelets Rich Plasma for Ovarian Rejuvenation
Official title: The Efficacy of Platelets Rich Plasma (PRP) for Ovarian Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Keywords: Ovarian Rejuvenation , Infertility
Lead sponsor: Al-Kindy College of Medicine
Sponsor class: OTHER
Collaborators: name: High Institute for Infertility Diagnosis and Assisted Reproductive Technologies
First posted: 2019-05-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In recent years, an increased approach has appeared in the use of autologous blood products to assist tissue and organ healing. Application of platelet rich plasma (PRP) has emerged as a potential solution for infertile women with poor ovarian reserve in reproductive specialty.

Detailed description: Quantitative and qualitative functional improvement of ovarian function has been reported in several studies after using autologous PRP in a reproductive field. Ovarian rejuvenation, stimulating the ovaries to produce new eggs after injecting PRP, can offer hope for renewed fertility to women with poor reserve volume, advanced maternal age, or either naturally occurring or premature menopause. But, these encouraging results should be supported by several new studies.

This study aimed to estimate the efficacy of trans-vaginal ovarian injection with PRP in rejuvenates ovaries in woman with poor ovarian reserve, and to assess any association of some women variables (age, menstrual status, parity, BMI) as predicting factors in success of ovarian injection with PRP.

Eligibility criteria: Inclusion Criteria:

1. Menopause or peri-menopause under the age of 50.
2. Premature ovarian insufficiency which is ovarian failure before the age of 40.
3. Woman with primary ovarian failure of any cause.

Exclusion Criteria:

1. A previous injection with any medication, plasma, or PRP
2. Invisible or difficult access ovaries.
3. Medical disease or unfit for anesthesia patient.

Primary outcomes:
measure: Follicle-stimulating hormone (FSH) concentration
timeFrame: 4 weeks
measure: Anti-Müllerian hormone (AMH) concentration
timeFrame: 4 weeks
measure: Antral follicles numbers
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: High Institute for Infertility Diagnosis and Assisted Reproductive Technologies
Study officials:
affiliation: Arab Board for Medical Specializations
name: Thuraya H Abdulla, Professor
role: STUDY_DIRECTOR
References:
citation: A
Clinical trial NCT06687213: Effect of Smoking Cessation on Glycemic Control in Type 2 Diabetics
Official title: Effect of Smoking Cessation on Glycemic Control in Patients with Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Smoking Cessation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 178
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The goal of this observational study is to learn about the long-term effects of smoking cessation on glycemic control in type 2 diabetic patients The main question it aims to answer is:

Does smoking cessation lower HbA1c in type 2 diabetics on long term ? The participants will be counseled to cessate smoking and will be followed for 6 months and compared to control who will not cessate smoking .

Detailed description: Smoking and diabetes are both major public health issues specially in our community. They act synergistically on morbidity and mortality. Diabetic smokers have much higher rates of micro and macrovascular complications. \[Carole Clair et al., 2020\] Approximately 1.3 billion people worldwide use tobacco, most commonly in the form of tobacco smoking, and more than 7 million people die every year as a result of smoking related conditions \[Magdalena Walicka et al.,2022\] Exposure to cigarette smoke is associated with vascular damage, endothelial dysfunction, and activation of oxidative stress, inflammatory pathways, coagulation, and fibrinolysis A similar mechanism of endothelial dysfunction is described for people with diabetes. It is therefore not surprising that smoking enhances the combined harmful effects of elevated blood glucose levels, accelerating vascular damage in diabetic patients who smoke The prevalence of current smoking was 45.5% in male patients with type 2 diabetes. The levels of fasting blood glucose and HbA1c increased with number of cigarettes smoked per day compared with non-smokers Smoking and its cessation showed dose- and time-dependent relationship with glycemic control and insulin resistance in patients with type 2 diabetes mellitus. These findings may highlight the importance of smoking cessation in the clinical management of diabetes mellitus.

the effect of smoking and its cessation on glycemic control in diabetic patients has not been fully examined yet.

There is lack of evidence regarding interventions for smoking cessation among individuals with diabetes

Eligibility criteria: Inclusion Criteria:

- Moderate Somking index Having been diagnosed with a type 2 diabetes Being ≥ 35 years old HbA1c \> 7

Exclusion Criteria:

Type 1 diabetes Drug induced Diabetes mellitus Type 2 diabetes on insulin treatment

Primary outcomes:
measure: Glycemic control after smoking cessation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assuit university
Study officials:
References: