louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00020631: Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer
Official title: A Pilot Study Of Pirfenidone For The Treatment Of Radiation-Induced Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Fibrosis
Keywords: radiation fibrosis
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Pirfenidone may prevent or lessen fibrosis caused by radiation therapy.

PURPOSE: Pilot trial to study the effectiveness of pirfenidone in preventing or lessening fibrosis in patients who have undergone radiation therapy for cancer.

Detailed description: OBJECTIVES:

* Determine the safety and therapeutic efficacy of pirfenidone in cancer patients with radiation-induced fibrosis.

OUTLINE: Patients receive oral pirfenidone 3 times daily. Treatment continues for up to 2 years in the absence of disease progression or unacceptable toxicity.

Principal functional abilities are assessed at baseline, every 3 months, and at termination of therapy.

PROJECTED ACCRUAL: A total of 10-25 patients will be accrued for this study within 1 year.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Regional post-radiation fibrosis of a specific body area (e.g., neck, back, or extremities)

  * At least moderate impairment in at least 1 of the following principal functional abilities:

    * Range of motion
    * Strength
    * Edema
    * Swallowing
* Prior radiation for cancer received more than 6 months ago
* No evidence of recurrent or metastatic cancer
* No history of collagen vascular disease
* No positive antinuclear antibody

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Hepatitis B and C negative

Renal:

* Not specified

Other:

* HIV negative
* No evidence of second primary cancer
* No life-threatening situation requiring rehabilitation intervention
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent anticancer immunotherapy

Chemotherapy:

* No concurrent anticancer chemotherapy

Endocrine therapy:

* No concurrent anticancer hormonal therapy

Radiotherapy:

* See Disease Characteristics
* No concurrent anticancer radiotherapy

Surgery:

* Not specified

Other:

* No other concurrent anticancer investigational agents
* Stable doses of medicine (e.g., non-steroidal anti-inflammatory drugs) currently being taken are allowed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
Study officials:
affiliation: NCI - Radiation Oncology Branch; ROB
name: Kevin Camphausen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03602820: Long-term Follow-up Study in Subjects Who Received Voretigene Neparvovec-rzyl (AAV2-hRPE65v2)
Official title: A Long-Term Follow-Up Study in Subjects Who Received an Adenovirus-Associated Viral Vector Serotype 2 Containing the Human RPE65 Gene (AAV2-hRPE65v2, Voretigene Neparvovec-rzyl) Administered Via Subretinal Injection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Inherited Retinal Dystrophy Due to RPE65 Mutations
Keywords: Leber congenital amaurosis, retinitis pigmentosa
Lead sponsor: Spark Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who received the subretinal administration of AAV2-hRPE65v2 (voretigene neparvovec-rzyl) in the Phase 1 or Phase 3 clinical trials

Brief summary: Multi-site, non-randomized, observational study, for up to 15 years after subretinal AAV2-hRPE65v2 administration for each subject. The study is a non-interventional, follow-up study of subjects who participated in previous AAV2-hRPE65v2 gene therapy clinical trials.

Detailed description: This is an observational follow-up study of subjects who participated in previous Phase 1 and Phase 3 clinical trials of AAV2-hRPE65v2 gene therapy (voretigene neparvovec-rzyl) to evaluate long term durability and safety for 15 years after subretinal administration.

Eligibility criteria: Inclusion Criteria:

1. Subjects who participated in prior subretinal AAV2-hRPE65v2 gene therapy clinical studies

Exclusion Criteria:

1. Subjects who will not consent for study.
2. Subjects who the investigators believe are not capable of performing study assessments

Primary outcomes:
measure: Mobility testing, Bilateral
timeFrame: 15 years
Secondary outcomes:
measure: Full-field light sensitivity threshold (FST) testing
timeFrame: 15 years
measure: Mobility testing, Monocular
timeFrame: 15 years
measure: Visual acuity
timeFrame: 15 years
Other outcomes:
measure: Visual field testing - Humphrey and/or Goldmann
timeFrame: 15 years
measure: Visual function questionnaire
timeFrame: 15 years
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Albert Maguire, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Stephen Russell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03037320: Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial
Official title: Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession, Generalized
Root Coverage
Lead sponsor: Indira Gandhi Institute of Dental Science
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of Coronally advanced flap with semilunar vestibular incision technique for root coverage in patients with multiple gingival recession in maxillary teeth.

Detailed description: the subjects attending the OPD department of periodontology, IGIDS and patients will be selected based on inclusion criteria, informed consent to be obtained from the patients,

Randomization process:

1. Patient to be selected for one of the two procedures by simple random sampling (Lottery method)
2. Baseline value will be recorded by a calibrated examiner other than the operator
3. The procedure is performed by the operator ( primary investigator)
4. Post op values to be recorded by the calibrated examiner.

Patient to be reviewed at 3 and 6 months Results will be dicussed

Eligibility criteria: Inclusion Criteria:

* Males and females subjects of 20-50 years.
* Patients with multiple gingival recession (2-4 teeth) of class I \& II in maxillary teeth.
* Patients with well aligned teeth

Exclusion Criteria:

* Patients with class III \&IV gingival recession in maxillary teeth
* Recession in relation to molars
* Patients with systemic diseases
* Medically compromised patients
* Patient with history of smoking
* Patients with erosion and root caries

Primary outcomes:
measure: amount of root coverage
timeFrame: 6 months
Secondary outcomes:
measure: width of keratinised gingiva
timeFrame: 6 months
Other outcomes:
Locations:
city: Puducherry
country: India
facility: Indira Gandhi Institute of dental sciences
Study officials:
References:
Clinical trial NCT06605820: Shared Decision-making and Antimicrobial Stewardship in Secondary Care
Official title: Shared Decision-making and Antimicrobial Stewardship in Secondary Care: Exploring Opportunities Along the Start Smart Then Focus Patient Pathway
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Antibiotic Prescribing is the Study Focus (no Condition)
Lead sponsor: Royal Cornwall Hospitals Trust
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2024-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will use semi-structured interviews with patients and clinicians to address the research question. Patients that have received antibiotics during a recent inpatient stay will be identified using the hospital electronic prescribing system and a letter inviting study participation will be included in their discharge medication pack. Senior prescribing decision makers will be recruited from participating hospitals.

Brief summary: To identify opportunities for antibiotic prescribing shared decision making between patients and prescribers in secondary care.

Detailed description: This is a qualitative study with patients and clinicians in secondary care.

We will use semi-structured interviews with patients and clinicians to address the research question. Patients that have received antibiotics during a recent inpatient stay will be identified using the hospital electronic prescribing system and a letter inviting study participation will be included in their discharge medication pack. Senior prescribing decision makers will be recruited from participating hospitals. In total, we hope to carry out up to 50 interviews with patients and clinicians.

Eligibility criteria: Inclusion Criteria:

For clinicians:

* Participant is willing and able to give informed consent for participation in the study.
* Senior registrar or consultant medical or surgical doctor working at participating hospitals and caring for inpatients.
* Fluent in English.

For patients:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 16 years or above (no upper age limit).
* Good standard of speaking English and able to read and understand study materials.
* Received antibiotic for treatment of suspected or confirmed bacterial infection during inpatient stay.

Exclusion Criteria:

* For clinicians:

  * Prescribers not currently caring for inpatients

For patients:

• Patient who received prophylaxis antibiotics only

Primary outcomes:
measure: Patient and prescriber views and experiences with shared decision making (SDM) around antibiotic prescribing in secondary care and to identify further opportunities for SDM.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: Truro
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
References:
Clinical trial NCT00837720: Evaluation of Atacand® (Candesartan) in Daily Medical Practice
Official title: A 12-Week Open-Label Non-Interventional Evaluation of Atacand® (Candesartan) Efficacy, Tolerability, Compliance and Treatment Satisfaction in Patients With Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: hypertension
blood pressure
Atacand®
candesartan
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-05
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients (outpatient or hospitalised) in whom Atacand is indicated according to the current Summary of product characteristics (SPC)

Brief summary: This open label, non-interventional study is to show the efficacy of antihypertensive treatment with Atacand in hypertensive patients. Efficacy is to be evaluated based on the difference in systolic and diastolic blood pressure at baseline and at both follow-up visits.


Eligibility criteria: Inclusion Criteria:

* a patient with arterial hypertension who has been prescribed Atacand according to physician's judgement, irrespective of the inclusion in the study

Exclusion Criteria:

* hypersensitivity to candesartan or any other ingredient of Atacand
* liver function impairment and/or cholestasis
* severe renal insufficiency
* woman of child-bearing potential and not using appropriate contraceptive measures, pregnancy or lactation

Primary outcomes:
measure: Systolic and diastolic blood pressure reduction
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence and reasons of treatment discontinuation
timeFrame: 12 weeks
measure: Patient treatment satisfaction (using 5-point answering scale) as the measure of the patient's overall tolerance
timeFrame: 12 weeks
measure: Physician overall evaluation of the therapy (using 5-point answering scale)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Centre Ljubljana
name: Rok Accetto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01901120: Long-Term Specified Drug Use-results Survey of Betanis Tablets
Official title: Long-Term Specified Drug Use-results Survey of Betanis Tablets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: Betanis®
mirabegron
Overactive Bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-07-17
Enrollment: 1263
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.

Brief summary: This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.


Eligibility criteria: Inclusion Criteria:

* Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: Up to 36 months after treatment
Secondary outcomes:
measure: Overactive Bladder Symptom Score (OABSS)
timeFrame: At the start of treatment and 3, 6, 12, 18, 24, 30, and 36 months after treatment
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Tohoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT00581620: Study Evaluating Prevenar Immunogenicity in High Risk Children
Official title: To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccines, Pneumococcal Conjugate Vaccine
Keywords: pneumococcus conjugated vaccine
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.

Detailed description: This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months

Eligibility criteria: Inclusion Criteria:

* Children between 2 months to 9 years old.
* Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease
* No history of seizures

Primary outcomes:
measure: To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition
timeFrame: 4 months
Secondary outcomes:
measure: To evaluate tolerability of Prevenar* in that population.
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00655720: The Effects on Growth of a Non-Routine Infant Formula
Official title: The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Keywords: infant formula
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 293
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics


Eligibility criteria: Inclusion Criteria:

* Term infant
* Solely formula fed
* 14 days of age

Exclusion Criteria:

* History of underlying disease
* Evidence of formula intolerance
* Current illness

Primary outcomes:
measure: Growth (weight)
timeFrame: 106 days
Secondary outcomes:
measure: Tolerance
timeFrame: 106 days
Other outcomes:
Locations:
Study officials:
affiliation: Mead Johnson Nutrition
name: Deolinda Scalabrin, MD
role: STUDY_DIRECTOR
References:
citation: Scalabrin DM, Johnston WH, Hoffman DR, P'Pool VL, Harris CL, Mitmesser SH. Growth and tolerance of healthy term infants receiving hydrolyzed infant formulas supplemented with Lactobacillus rhamnosus GG: randomized, double-blind, controlled trial. Clin Pediatr (Phila). 2009 Sep;48(7):734-44. doi: 10.1177/0009922809332682. Epub 2009 Mar 4.
Clinical trial NCT01820520: Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
Official title: Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Macular Hole
Epiretinal Membrane
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study designed to evaluate the safety and efficacy of double staining with brilliant blue G 0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or epiretinal membrane will be included. Safety will be evaluated by optic coherence tomography, pattern reversal electroretinogram and multifocal electroretinogram.


Eligibility criteria: Inclusion Criteria:

* Patient age 18 years of older
* Signing of informed consent
* Macular pathology requiring vitrectomy (epiretinal membrane, macular hole, vitreomacular traction syndrome)

Exclusion Criteria:

* Diagnosis of glaucoma
* Known allergy to brilliant blue G

Primary outcomes:
measure: Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography
timeFrame: 6 months
measure: Amplitude of pattern reversal electroretinogram
timeFrame: 6 months
measure: Amplitude of b-wave of multifocal electroretinogram
timeFrame: 6 months
Secondary outcomes:
measure: Visual acuity
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociación para Evitar la Ceguera en México
state: DF
Study officials:
References:
Clinical trial NCT00488020: Stem Cells for Treating Critical Ischemia
Official title: the Use of Autogenous Adult Stem Cells in the Treatment of Critical Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Critical Limb Ischemia
Ischemic Ulcers
Keywords: rest pain
ischemic ulcers
Lead sponsor: Instituto de Molestias Cardiovasculares
Sponsor class: OTHER
First posted: 2007-06-19
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots

Detailed description: About 500cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution in albumin (40cc)the mononuclear cells are injected into the calf muscles through 40 shots.This procedure is indicated for patients with lower limb ischemia on whom all the others known therapies have failed

Eligibility criteria: Inclusion Criteria:

* Fontaine's classification grade 3 and 4 patients

Exclusion Criteria:

* Record of cancer in the last 5 years
* Over 80 years
* Diabetic retinopathy

Primary outcomes:
measure: Suppress pain and heal ischemic ulcers
timeFrame: 6 months
Secondary outcomes:
measure: improve quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: São José do Rio Preto
country: Brazil
facility: Instituto de Molestias Cardiovasculares
state: Sao Paulo
Study officials:
affiliation: Instituto de Molestias Cardiovasculares
name: Jose D Araújo, MD
role: PRINCIPAL_INVESTIGATOR
References: