louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00539734: Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration
Official title: Electrophysiologic Changes After Intravitreal Ranibizumab (Lucentis) for Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Keywords: age-related macular degeneration (AMD)
choroidal neovascularization membrane(CNVM)
ranibizumab
anti-vascular endothelial growth factor
electrophysiology
electroretinography
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2007-10-04
Enrollment: 25
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the changes in retinal function after an injection of ranibizumab.

Detailed description: The functional changes of the retina can be recorded by an electroretinography (ERG).

Eligibility criteria: Inclusion Criteria:

* Age 45 years and above
* Clinical diagnosis of wet AMD
* First injection of ranibizumab protocol
* Best corrected visual acuity 20/32 - 20/320
* Consent form obtained

Exclusion Criteria:

* Previously treated wet AMD patients
* Patients with other ocular diseases which can cause abnormal ERG such as glaucoma, uveitis or retinitis pigmentosa, etc.
* Pregnancy
* History of seizure

Primary outcomes:
measure: Height (Amplitude) of Multifocal ERG Signal
timeFrame: baseline, 3 months
measure: Time to Response (Implicit Time) of Multifocal ERG Signal
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Postoperative Complication
timeFrame: 1 month
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Department of Ophthalmology, Faculty of Medicine, Prince of Songkla University
name: Patama Bhurayanontachai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.
citation: Kaiser PK, Brown DM, Zhang K, Hudson HL, Holz FG, Shapiro H, Schneider S, Acharya NR. Ranibizumab for predominantly classic neovascular age-related macular degeneration: subgroup analysis of first-year ANCHOR results. Am J Ophthalmol. 2007 Dec;144(6):850-857. doi: 10.1016/j.ajo.2007.08.012. Epub 2007 Oct 22.
Clinical trial NCT03306134: The Effect of Beta-blockers in Substance P Levels and the Swallowing Function
Official title: The Effect of Beta-blockers in Substance P Levels and the Swallowing Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Beta Blockers
Swallowing Disorder
Substance P
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All population.

Brief summary: A non-randomised, prospective study to assess the effects of beta-blockers on substance P levels and the swallowing function. The study is going to be carry out in the Gastrointestinal Physiology Laboratory of the Hospital de Mataró (Spain). All participants will be actively recruited from a Linked hospital and primary care database. We include two groups: the first group (group 1) are participants taking beta-blockers and the second group (group 2) are participants not-taking beta-blockers.


Eligibility criteria: Inclusion Criteria:

- Patients taking and not taking beta-blockers

Exclusion Criteria:

* Participants with heat and neck or esophageal cancer
* Participants with stroke or neurological disease
* Participants with central nervous system disease
* Participants with concomitant treatment with Angiotensin converting enzyme inhibitors (ACEI), Angiotensin II receptor antagonists (ARA-II), Antipsychotics, Dopamine agonists, Capsaicine.
* Participants with severe clinical signs of aspiration, including oxygen desaturation ≥3%.

Primary outcomes:
measure: Substance P levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Mataró Hospital
state: Barcelona
Study officials:
affiliation: Mataró Hospital
name: Marta Miarons
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02345434: The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances
Official title: The Effect of Informative Letters on the Prescription and Receipt of Schedule II Controlled Substances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Economics
Fraud
Delivery of Health Care
Health Expenditures
Centers for Medicare and Medicaid Services (U.S.)
Lead sponsor: Abdul Latif Jameel Poverty Action Lab
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
name: General Services Administration (GSA)
First posted: 2015-01-26
Enrollment: 1525
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Fraud and waste is estimated to cost the American health care system nearly $200 billion each year, and the public Medicare and Medicaid programs about $60 billion each year. This study will evaluate a new method for fighting fraud: mailing informative letters to outlier providers to notify them of their aberrant behavior. These letters are targeted at high prescribers of schedule II controlled substances in Medicare Part D. The investigators will look at the effects of these letters on the behavior of providers and their patients. These effects are of substantial policy interest as they suggest how to best design anti-fraud policies. They are also of academic interest, shedding light on the behavior of physicians and their patients.


Eligibility criteria: Inclusion Criteria:

* Outlier with respect to the count of schedule II prescription drug events relative to peer group of prescribers in two of the three years 2011, 2012, and 2013
* Outlier with respect to the 30-day equivalent prescriptions of schedule II substances relative to peer group of prescribers in two of the three years 2011, 2012, and 2013

Exclusion Criteria:

- Deceased

Primary outcomes:
measure: 30-day Equivalent Prescribing of Schedule II Controlled Substances
timeFrame: 3 months
Secondary outcomes:
measure: 30-day Equivalent Prescribing of Schedule II Controlled Substances
timeFrame: 1 month
measure: 30-day Equivalent Prescribing of Schedule II Controlled Substances
timeFrame: 6 months
measure: 30-day Equivalent Prescribing of Schedule II Controlled Substances
timeFrame: 9 months
measure: 30-day Equivalent Prescribing of Schedule II Controlled Substances
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts Institute of Technology
name: Amy Finkelstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01805934: Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection
Official title: Quadruple Therapy With Furazolidone Versus Dual Therapy With High Doses of Amoxicillin as Rescue Regimens for Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rescue Therapy for Helicobacter Pylori
Keywords: Helicobacter pylori, rescue, quadruple therapy，dual therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not satisfactory. The study aims to compare the efficacy and safety between quadruple therapy with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.


Eligibility criteria: Inclusion Criteria:

* Patients aged from 18 to 80 years, who presented with upper gastrointestinal symptoms and endoscopically proven H. pylori-positive non-ulcer dyspepsia, were recruited into the study.

Exclusion Criteria:

* patients with peptic ulcer,
* previous H. pylori eradication treatment,
* previous gastric surgery,
* pregnancy,
* lactation,
* major systemic diseases,
* receipt of anti-secretory therapy,
* antibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.

Primary outcomes:
measure: 13C-urea breath test
timeFrame: 4 weeks after treatment
Secondary outcomes:
measure: scale analysis of drug safety
timeFrame: 4 weeks after treatment
Other outcomes:
measure: 13C-urea breath test
timeFrame: baseline
Locations:
city: Shanghai
country: China
facility: Shanghai Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: xiaobo Li, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05239234: Ultrasonographic Predictors of Hypotension After Induction
Official title: Pre-operative Ultrasonographic Evaluation of Inferior Vena Cava Collapsibility Index and Caval Aorta Index to Predict Hypotension After Induction of General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthesia
Hypotension on Induction
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who scheduled for elective non-cardiac surgery under general anesthesia

Brief summary: The purpose of the study is to evaluate the predictive value of the inferior vena cava collapsibility index and caval aorta index for detecting hypotension after induction of general anesthesia.

Detailed description: Since cardiovascular depressant and vasodilatory effects of anesthetic agents, patients may be at risk of hypotension after induction of general anesthesia. Previous studies reported that, for evaluating volume status, some ultrasonographic measurements such as inferior vena cava collapsibility index (IVCCI) could be used. Also some studies stated that measurement of aorta diameter index (IVC : Ao index) is reliable to predict hypotension after induction of spinal anesthesia. At the study, the investigators aimed to investigate the predictive values of the inferior vena cava collapsibility index and caval aorta index under ultrasound guidance in predicting post-induction hypotension in patients under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* patients more than 18 years of age
* American Society of Anesthesiologists' (ASA) physical status 1 or 2

Exclusion Criteria:

* BMI more than 30 kg/m²
* Use of angiotensin converting enzyme inhibitors
* pregnancy,
* emergency operations
* baseline arterial systolic blood pressure less than 90 mmHg
* mean arterial blood pressure less than 70 mmHg

Primary outcomes:
measure: Diagnostic value of IVCCI to detect post-induction hypotension assessed by Receiver operating characteristic (ROC) curve analysis.
timeFrame: 20 minutes
measure: Diagnostic value of IVC : Ao index to detect post-induction hypotension assessed by ROC curve analysis.
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Researching Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Enes Eskin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02088034: Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
Official title: Promotora-led Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 92
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overarching goal of this project is to develop and test a behavioral intervention delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.

Detailed description: The goal of the proposed research is to compare two evidence-based strategies for preventing type 2 diabetes - promotora-led lifestyle intervention and metformin - vs. usual care (UC) among Latinas in a "real world" setting. The aims of this study are to 1) develop a protocol-based, promotora-led lifestyle intervention (PLI) to promote weight loss in at-risk Latinas, and assess its feasibility; 2) compare changes in weight and cardiometabolic markers-hemoglobin A1C, fasting lipids, blood pressure-from baseline to 1 year between at-risk Latinas randomly assigned to the PLI group versus metformin and usual care (UC) groups; and 3) understand the social and cultural context surrounding weight-related behaviors among Latinas at-risk for diabetes. The investigators hypothesize that Latinas assigned to PLI and metformin will have greater weight loss (primary outcome) and greater improvements in cardiometabolic markers from baseline to 1 year than those randomized to UC

Eligibility criteria: Inclusion Criteria:

* Female gender
* Latino ethnicity
* Spanish fluency
* Age ≥20 years
* BMI ≥25 kg/m2
* And "increased risk of diabetes" (ADA Diabetes Risk Score ≥4 as determine by 7-item questionnaire and hemoglobin A1C ≥ 5.6%)

Exclusion Criteria:

* Hemoglobin A1C ≥ 6.5%
* Current or planned pregnancy during the study period
* Chronic conditions that could affect potential participants' ability to participate (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily bronchodilator use, and severe psychiatric disease)
* Medical comorbidities that could influence weight loss or weight gain (thyroid disease, cancer, and HIV)
* Medications that could affect weight or glucose metabolism (thiazide diuretics, β-blockers, and systemic glucocorticoids).

Primary outcomes:
measure: Body Weight
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University - Center for Obesity Research and Education
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Matthew J O'Brien, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01050634: Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)
Official title: Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST) a Non-interventional Trial With Aromasin®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Menopausal Women With Early Breast Cancer
Keywords: Aromatase inhibitor
Switch after Tamoxifen
Quality of Life
Safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-15
Enrollment: 980
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early Breast Cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy

Brief summary: Quality of life under therapy with Aromasin® (exemestane) according to IBCSG (International Breast Cancer Study Group) questionnaire.

Change of the endometrium after switching from tamoxifen to Aromasin® (exemestane).

Deeper knowledge of Adverse Events during routine administration.


Eligibility criteria: Inclusion Criteria:

* Early Breast Cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy.

Exclusion Criteria:

* Not applicable.

Primary outcomes:
measure: Change From Baseline in International Breast Cancer Study Group (IBCSG) Linear Analogues Self-Assessment (LASA) Quality of Life (QoL) Core Questionnaire Scores
timeFrame: Baseline, Month 12
measure: Change From Baseline in Thickness of Endometrium
timeFrame: Baseline, Month 12
measure: Change From Baseline in IBCSG LASA Items Scores - QoL Module 24-26
timeFrame: Baseline, Month 12
measure: Change From Baseline in 12-Item Short Form Health Survey (SF-12) Summary Subscales (Physical Summary Scale Derived From Items 1-5, 8 and Mental Summary Scale Derived From Items 6, 7, 9-11) Scores
timeFrame: Baseline, Month 12
measure: Change From Baseline in IBCSG Vaginal Symptoms - QoL Module 24-26
timeFrame: Baseline, Month 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01818817: Ultrasound Paravertebral Block in Breast Surgery.
Official title: Single Injection, Ultrasound Guided Paravertebral Block for Anesthesia in Breast Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Ultrasound-guided paravertebral block
regional anesthesia
breast surgery
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient candidate for minor breast surgery.

Brief summary: The purpouse of the study is to determine wether Ultrasound Guided,Ens-assisted paravertebral block with single shot is a safe and reliable anesthetic technique in breast surgery.

Detailed description: General anaesthesia is currently the conventional technique used for breast surgery. Thoracic Paravertebral block (PVB) has been used with multiple injection.

We compared a single injection thoracic PVB with general anaesthesia (GA) in 20 consenting patients, scheduled for unilateral breast surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists classification I-III
* Written informed consent
* Age older than 18 years old

Exclusion Criteria:

* allergy to local anesthetics
* local sepsis

Primary outcomes:
measure: Post-operative pain
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Consumption of analgesic drugs
timeFrame: up to 24 hours
measure: Efficacy of Paravertebral block
timeFrame: pre-operative
Other outcomes:
measure: Post-operative nausea and vomit
timeFrame: up to 24 hours
measure: Appreciation of patients
timeFrame: At 24 hours
Locations:
city: Rome
country: Italy
facility: Campus Bio Medico
state: RM
Study officials:
affiliation: Campus Bio Medico
name: Massimiliano Carassiti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03108417: Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial
Official title: Home Study of Subjects With Obstructive Sleep Apnea Who Have Previously Completed an In-Lab Continuous Negative External Pressure (cNEP) Titration and Were Considered to be "Responders"
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Sommetrics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.


Eligibility criteria: Inclusion Criteria:

* must have completed study SOM-012 and been categorized as a "responder"
* the subject agrees to participation by signing an informed consent statement

Exclusion Criteria:

* medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk

Primary outcomes:
measure: Reduction in baseline apnea hypopnea index from baseline
timeFrame: End of Week 2 of home use
Secondary outcomes:
measure: Collection of adverse events
timeFrame: two week study period
measure: Apnea hypopnea index, as measured by home sleep testing
timeFrame: two weeks
Other outcomes:
measure: Clinical global impression of cNEP experience
timeFrame: end of week two of home use
measure: Bed partner's views of cNEP via a clinical global impression scale
timeFrame: end of two weeks of home use
Locations:
city: Alameda
country: United States
facility: California Center for Sleep Disorders
state: California
Study officials:
affiliation: California Center for Sleep Disorders
name: Jerrold Kram, MD
role: PRINCIPAL_INVESTIGATOR
References: