louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06595355: Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin
Official title: Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin in Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diabetic Macular Edema
Macular Edema
Retinal Neovascularization
Keywords: macular edema
diabetic macular edema
central macular edema
bevacizumab
Diabetic Retinopathy
Retinal Neovascularization
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 40
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 evaluate the effectiveness of adding curcumin oral treatment to bevacizumab intravitreal injection in patients with central macular edema.

A blind study and a randomized and controlled clinical trial are conducted on diabetic patients with macular edema. The patients are divided into two intervention groups (bevacizumab + curcumin) and control (bevacizumab + placebo).

The evaluation of the central thickness of the macula and the evaluation of the central volume of the macula are the primary goals and the evaluation of the best visual acuity of the patient is the secondary goal.


Eligibility criteria: Inclusion Criteria:

Patients with center-involving macular edema with macular center thickness more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the last 6 months.

3- The amount of BCVA should not be \<20/400. 4-Consent to participate in the study

Exclusion Criteria:

1. Other retinal diseases except for DME and macular edema due to other causes including uveitis, epiretinal membrane, central retinal vein occlusion, and...
2. Existence of proliferative diabetic retinopathy and patients with a history of vitrectomy
3. Patients with glaucoma, vitreous hemorrhage, age-related macular degeneration (ARMD)
4. Media opacities that limit the interpretation of diagnostic tests
5. Surgery or procedure 3 months before starting treatment
6. Pregnancy or breastfeeding
7. History of allergy to curcumin
8. Use of warfarin
9. Changing the patient's clinical diagnosis or the need for surgical interventions in the course of the disease
10. Change in the patient's general health condition
11. Absence of patient referrals
12. Lack of consent to continue treatment and follow-up

Primary outcomes:
measure: central macular thickness (CMT)
timeFrame: 3 months
measure: central macular volume (CMV)
timeFrame: 3 months
Secondary outcomes:
measure: best visual acuity (BCVA)
timeFrame: 3 months
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Mohsen Pourazizi
state: Isfahan University of Medical Sciences
Study officials:
References:
Clinical trial NCT01082055: Antiarrythmic Drugs - Long-term Follow-up in the Modern Era
Official title: Retrospective Record Linkage Study to Investigate the Incidence of Complications and Follow-up Associated With Anti-arrythmic Drug Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Dysrhythmia
Keywords: Cardiac
Dysrhythmia
Safety
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: NHS Tayside
First posted: 2010-03-05
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in Tayside receiving a prescription for an anti-arrythmic drug since 1994

Brief summary: Antiarrhythmic drugs are associated with significant side effect profiles. Amiodarone has primarily class III action and whilst it has unrivalled efficacy in management of certain arrhythmias, it has a formidable side effect profile. Complications of continued therapy include, thyroiditis, hepatitis, cholestasis, increased skin sensitivity and pulmonary fibrosis. Current prescribing guidelines recommend frequent blood tests to monitor kidney, liver and thyroid function, in addition to frequent pulmonary function tests. Sotalol is a betablocker which possesses class III action in high doses and may predispose to QT prolongation Other class I agents such as flecainide and propafenone can be associated with sudden cardiac death in certain populations, and may predispose to other arrhythmias.

This study will examine the incidence of discontinuation of AAD therapy and adverse events.


Eligibility criteria: Inclusion Criteria:

* At least one prescription for antiarrythmic drug

Primary outcomes:
measure: Adverse Event
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Univeristy of Dundee
Study officials:
References:
Clinical trial NCT03779555: Lenalidomide Adherence in Older Adults
Official title: Lenalidomide Adherence in Older Adults: A Pilot Prospective Cohort Study of Oral Therapy for Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Alliance for Clinical Trials in Oncology
First posted: 2018-12-19
Enrollment: 17
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from Siteman Cancer Center and its satellite sites with multiple myeloma who are taking lenalidomide.

Brief summary: To describe patterns of adherence and pilot baseline measures to investigate factors associated with lower adherence to lenalidomide in older adults with myeloma.


Eligibility criteria: Inclusion Criteria:

* Age ≥65
* Receiving lenalidomide for treatment of multiple myeloma.
* Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
* Able to read and understand English.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Estimated life expectancy \<6 months.
* Anticipated duration of lenalidomide therapy \<3 months.
* Residing in a nursing facility where their medications are administered to them OR patient reports they do not self-administer their own medications.

Primary outcomes:
measure: Adherence rate as measured by the number of days in which the lenalidomide pill bottle was open
timeFrame: Through completion of study (estimated to be 3 months)
Secondary outcomes:
measure: Adherence rate as measured by a modified Brief Adherence Rating Scale
timeFrame: Through completion of study (estimated to be 3 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Mark A Fiala, MSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05863455: Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Residents
Official title: Effect of Mild Sedation and Analgesia on Radial Artery Cannulation in Novice Residents: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation and Analgesia
Keywords: Radial Artery Cannulation
Novice Operators
Lead sponsor: Affiliated Hospital of Jiaxing University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to conduct a prospective, single-center randomized controlled study to investigate the effect of mild midazolam combined with sufentanil on radial artery cannulation in novice operators.

Detailed description: outcome: patients discomfort，visual analogue scale，First-attempt success rate，the success rate of radial artery cannulation within 10 minutes, Complication rate

Eligibility criteria: Inclusion Criteria:

* Patients who required arterial cannulation for continuous blood pressure monitoring
* Aged \>20years
* ASA physical status of 1-3
* BMI 18-28kg/m2
* All patients agreed to participate in this study at the time of recruitment and signed an informed consent form.

Exclusion Criteria:

* a positive Allen's test
* infection at the puncture site
* coagulation disorders; arterial diseases (such as Raynaud's disease or thromboangiitis obliterans)
* use of vasoactive drugs within 30 minutes before measurement during the study
* patients with arterial abnormalities and bends; hemorrhagic shock
* arterial atherosclerosis; radial artery puncture within the past 30 days
* chronic use of opioid or benzodiazepine drugs
* and known allergies or adverse reactions to benzodiazepines or opioids.

Primary outcomes:
measure: Overall success rate
timeFrame: During radial artery cannulation (up to 1 hour)
Secondary outcomes:
measure: patients discomfort
timeFrame: During radial artery cannulation (up to 1 hour)
measure: visual analogue scale
timeFrame: During radial artery cannulation (up to 1 hour)
measure: First-attempt success rate
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Complication rate
timeFrame: postoperative 1 day and 3 day
Other outcomes:
Locations:
city: Jiaxing
country: China
facility: Affiliated Hospital of Jiaxing University
state: Zhejiang
Study officials:
affiliation: Affiliated Hospital of Jiaxing University
name: Qinghe Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01102855: Endomicroscopy and Crohn´s Disease
Official title: Confocal Laser Endomicroscopy in Patients With Crohn´s Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn´s Disease
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Crohn´s disease.

Brief summary: Purpose:

The main objective of this study is to determine endomicroscopic features of Crohn´s disease.

Background:

Crohn´s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract from anus to mouth, causing a wide variety of symptoms. Diagnosis is based on several histologic features including transmural pattern of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.

Scope:

In patients with Crohn´s disease.

Detailed description: Methods:

Patients underwent colonoscopy for the evaluation of Crohn´s disease. During the endoscopic procedure CLE will be performed.

Procedure:

The patient underwent colonoscopy. During the procedure the patient will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing colonoscopy

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Impaired renal function (Creatinine \> 1.2 mg/dl)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Known allergy to fluorescein, acriflavin or cresyl violet
* Residing in institutions (e.g. prison)

Primary outcomes:
measure: To determine endomicroscopic features of Crohn´s disease.
timeFrame: October 2009 until May 2010
Secondary outcomes:
measure: Comparison of CLE findings with conventional histology.
timeFrame: October 2009 until May 2010
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine I, University of Erlangen-Nuremberg
Study officials:
affiliation: University of Erlangen-Nürnberg
name: Markus F. Neurath
role: STUDY_DIRECTOR
References:
citation: Neumann H, Vieth M, Atreya R, Grauer M, Siebler J, Bernatik T, Neurath MF, Mudter J. Assessment of Crohn's disease activity by confocal laser endomicroscopy. Inflamm Bowel Dis. 2012 Dec;18(12):2261-9. doi: 10.1002/ibd.22907. Epub 2012 Feb 16.
Clinical trial NCT01453855: Travoprost 3-Month Safety and Efficacy Study
Official title: A Multicenter, Double-Masked Study of the Safety and Efficacy of Travoprost Ophthalmic Solution, 0.003% Compared to TRAVATAN in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-10-18
Enrollment: 1099
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 was to demonstrate that the intraocular pressure-lowering efficacy of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or ocular hypertension.

Detailed description: This study consisted of six visits conducted during two sequential phases. The Screening/Eligibility phase included one screening visit and two eligibility visits. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1) at the second eligibility visit. The Treatment phase consisted of three on-therapy visits (Week 2, Week 6, and Month 3).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension.
* Qualifying intraocular pressure at both eligibility visits.
* Understand and sign an informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential if pregnant, breast-feeding, or not on adequate birth control.
* Severe central visual field loss in either eye.
* Chronic, recurrent or severe inflammatory eye disease.
* Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen).
* Any abnormality preventing reliable applanation tonometry.
* Hypersensitivity to prostaglandin analogs or to any component of the study medications.
* Therapy with another investigational agent within 30 days prior to the Screening Visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)
timeFrame: Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Theresa A Landry, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01548755: The Western Galilee Hospital in Nahariya Home Monitoring Registry
Official title: Workload Assessment of a Home Monitoring Based Follow up for Biotronik ICD and CRTD Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tachycardia
Keywords: Home monitoring
cardiomessenger
ICD
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2012-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICD or CRTD implanted patient

Brief summary: The purpose of this study is to study workload assessment of home monitoring based follow up for ICD or CRTD implanted patient.

Detailed description: EP unit device clinic is a very busy clinic. Every 6 month the patients arrive for device follow up where the device parameters, patient condition and arrhythmic events are being reviewed, and reprogramming of the device (if needed) is done. Average net time of patient's stay in the clinic is between 30-45 minutes.

Patients implanted with the Lumax device family allows for a better automated follow up procedure via remote management (Home Monitoring).

The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.

Eligibility criteria: Inclusion Criteria:

* Approved indication for ICD or CRTD.
* Implanted with or replaced with a Biotronik Lumax device.
* Patient is willing and able to sign consent form.
* Willing and able to attend clinic visits and follow up schedule.
* Transmission of more than 80% at 3-month FU.
* Patient older than 18 years.

Exclusion Criteria:

* No indication for ICD or CRTD implant.
* Life expectancy shorter than 12 months.
* Pregnancy.
* Participation in other clinical studies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: The Western Galilee Hospital in Nahariya
Study officials:
affiliation: The Western Galilee Hospital in Nahariya
name: Ron Sela, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02305355: Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia
Official title: Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Hypertriglycemia
Lead sponsor: Kuhnil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia


Eligibility criteria: Inclusion Criteria:

* LDL-C \< 100mg/dL, TG \> 150mg/dL, patients on statin treatment for at least 6 weeks prior to randomization.
* Type 2 Diabetes
* HbA1c ≤ 10.0

Exclusion Criteria:

* Type 1 Diabetes
* Patients with PPAR gamma agonist therapy
* Patients with acute MI, Unstable angina within 6 months
* History of malignant tumor within 2 years
* Women with pregnant, breast-feeding

Primary outcomes:
measure: The mean percent change of Triglyceride(TG)
timeFrame: from baseline at week 16
Secondary outcomes:
measure: The mean percent change of Total Cholesterol(TC)
timeFrame: from baseline at week 16
measure: The mean percent change of LDL-C
timeFrame: from baseline at week 16
measure: The mean percent change of HDL-C
timeFrame: from baseline at week 16
measure: The mean percent change of HBA1c
timeFrame: from baseline at week 16
measure: The mean percent change of FPG
timeFrame: from baseline at week 16
measure: The mean percent change of hs-CRP
timeFrame: from baseline at week 16
measure: The mean percent change of PAI-1
timeFrame: from baseline at week 16
measure: The mean percent change of Apolipoprotein A1
timeFrame: from baseline at week 16
measure: The mean percent change of apolipoprotein B
timeFrame: from baseline at week 16
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital
Study officials:
References:
citation: Son JW, Kim CH, Nam MS, Park IB, Yoo SJ. Efficacy and Safety of Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy in Korean Patients with Type 2 Diabetes and Hypertriglyceridemia: a Randomized Controlled Trial. J Lipid Atheroscler. 2019 Sep;8(2):221-231. doi: 10.12997/jla.2019.8.2.221. Epub 2019 Jul 4.
Clinical trial NCT00173355: Clinical Outcome of Pediatric Dermatofibrosarcoma Protuberans
Official title: Retrospective Clinical Outcome Study of Pediatric Dermatofibrosarcoma Protuberans: Single Institutional Experience of Twelve Cases From 1977-2002
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Soft Tissue Neoplasms
Keywords: pediatric Dermatofibrosarcoma Protuberans
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 12
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Retrospective review of clinical outcome of pediatric Dermatofibrosarcoma Protuberans (PDFSP) after active invitation

Detailed description: Soft tissue sarcoma was rarely seen in pediatric patients, and pediatric Dermatofibrosarcoma Protuberans (PDFSP) was even rare. To our knowledge, the largest report constituted of 19 cases (five of them had no follow-up (FU) status) (1). So we proposed this retrospective study based on the cancer registry of our hospital. Twelve cases who were diagnosed as DFSP before age of 18 were identified. But all of them had been lost of FU for at least two years. So we will try to contact these patients and asked them to be back to our clinic for routine surveillance (history taking and physical exam and optional local image/chest xray) and quality of life (QoL) evaluation after pathological review if this clinical study was approved (2)

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as DFSP before age of 18 after pathological review according to the cancer registry of our hospital

Exclusion Criteria:

* age \> 18 at diagnosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Rong-Sen Yang, M.D., Ph.D.
role: STUDY_CHAIR
References: