louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02033070: Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System
Official title: Single Center Patient Registry Using Radio Frequency Ablation of Barrett's Esophagus Using HALO System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Barrett's Esophagus
Keywords: RFA
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2014-01-10
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: Adult patients presenting with esophageal intestinal metaplasia (IM), including the pathological subclasses of non-dysplastic IM, low-grade dysplasia (LGD) and high-grade dysplasia (HGD)

Brief summary: The purpose of this study is to provide a tool for physicians to compare outcome data related to the use of the HALO Ablation Systems. This study is a single-center patient registry which will contribute to a framework for treatment and follow-up of patients with Barrett's Esophagus.


Eligibility criteria: Inclusion Criteria:

* candidate for ablation of Barrett's Esophagus with the HALO Ablation System (Prospective)
* received an ablation with the HALO Ablation System to treat Barrett's Esophagus (Retrospective)
* candidate agrees to proposed follow-up schedule of yearly surveillance following treatment
* signs consent

Exclusion Criteria:

* has not been diagnosed with Barrett's Esophagus

Primary outcomes:
measure: Endoscopic clearance rate for Barrett's Esophagus
timeFrame: Outcome measure is assessed at Month 12
Secondary outcomes:
measure: Histological clearance rate for intestinal metaplasia
timeFrame: Biopsy taken at 12 months
Other outcomes:
measure: Histological clearance rate for dysplasia
timeFrame: Biopsy taken at 12 months to determine effectiveness
Locations:
city: Kenner
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
affiliation: Oshsner Clinic Foundation and Medical Center-Kenner
name: Virendra Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05494970: Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment.
Official title: Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment: a Feasibility Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ORL Cancer
Keywords: ORL Cancer
Oral hygiene
Radiotherapy
Written information guide
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2022-08-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with ORL cancer for which radiotherapy (+/- associated chemotherapy) is indicated.

Brief summary: Feasibility, prospective, monocentric study aiming to evaluate the interest of a written information guide, given and explained by the dental assistant, on the improvement of the oral hygiene of patients with ORL cancer at 3 months post-radiotherapy.

The study will be conducted on a population of 44 patients with ORL cancer requiring radiation treatment.

Each patient will be followed during 3 months post-radiotherapy (follow-up for up to 12 months post-inclusion).


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years at study entry.
2. Patient with ORL cancer requiring radiotherapy (+/- associated chemotherapy).
3. Patient with a plaque index \> or = 30%.
4. Patient affiliated to a social security system in France.
5. Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Any psychological, familial, geographic or sociological condition that does not allow for compliance with the medical follow-up and/or procedures outlined in the study protocol.
3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Primary outcomes:
measure: Rate of patients with improved oral hygiene between the inclusion visit and 3 months post-radiotherapy.
timeFrame: 3 months per patient
Secondary outcomes:
measure: Patient satisfaction with the oral hygiene information guide and the consultations performed by the dental assistant.
timeFrame: 3 months per patient
measure: The motivation of the patients towards their oral health.
timeFrame: 3 months per patient
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
Study officials:
References:
Clinical trial NCT03908970: Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome
Official title: A Multicenter, Randomized, Double-blind, Vehicle Controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Ointment to the Vehicle in Adult Patients With Atopic Dermatitis (Phase 3 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 364
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the superiority of IMP (1% OPA-15406 ointment or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in adult patients with AD.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of AD based on the Japanese Dermatological Association's criteria
* History of AD for at least 3 years
* Atopic dermatitis affecting more than or equal to 5%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
* IGA score of 2 or 3 at the screening and baseline examinations

Exclusion Criteria:

* Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD, within 28 days prior to the baseline examination

Primary outcomes:
measure: Responder Rate of Investigator's Global Assesment(IGA) of Disease Severity
timeFrame: At Week 4
Secondary outcomes:
measure: Change From Baseline in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline, Week 4
measure: Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Kitago Hifuka Clinic
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Osamu Sato
role: STUDY_DIRECTOR
References:
Clinical trial NCT01607970: Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making
Official title: Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Keywords: Oxytocin
Startle
moral dilemma
oxytocin receptor gene
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether oxytocin affects the modulation of startle reactivity by aversive social stimuli and to investigate the oxytocin effect on moral judgements. Furthermore the investigators explore the effects of oxytocin receptor (OXTR) polymorphisms on behavioral responses to social stimuli.

Detailed description: The neuropeptide oxytocin (OXT) can enhance the impact of positive social cues but may reduce that of negative ones, although it is unclear whether the latter causes blunted emotional responses. After OXT or placebo application participants are exposed to acoustic startle probes presented alone and during viewing of 60 color pictures mostly selected from the 'International Affective Picture System'. The paradigm featured 20 negative (mostly threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. In the other part of the experiment, after intranasal OXT or placebo application participants respond to 60 moral dilemmas.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers

Primary outcomes:
measure: baseline startle magnitude and affective modulation of the startle magnitude after oxytocin and placebo administration
timeFrame: 24 Months
Secondary outcomes:
measure: moral decision making after oxytocin and placebo administration
timeFrame: 24 months
measure: oxytocin receptor (OXTR) polymorphism and correlation with social behavior
timeFrame: 24 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
Study officials:
affiliation: Department of Psychiatry, University of Bonn, Germany
name: Rene Hurlemann, MSc MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01390870: Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
Official title: Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Keywords: Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, adherence
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 400
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion criteria:

* Physician confirmed diagnosis of enlarged prostate (EP)
* Age 50 or older
* Resident of the United States with health insurance that covers prescription drugs
* EP is consistently treated with a medication that was intiated within the previous 12 months

Exclusion criteria

* age less than 50
* receiving medication on an as needed basis
* diagnosis of prostate cancer

Brief summary: Patient-based surveys will be conducted to evaluate the drivers of medication adherence in patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB) therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will be evaluated. The researchers believe that the majority of participants will report that they are compliant with therapy. The data source is a cross-sectional patient survey administered at one time point.


Eligibility criteria: Inclusion Criteria:

* Males
* Aged 50 years or older
* Residents of the United States
* Receiving a prescription for an enlarged prostate (EP) treatment within 12 months prior to survey initiation

Exclusion Criteria:

* Patients with prostate cancer
* no health/prescription insurance
* patients receiving medication(s) for EP on a PRN basis

Primary outcomes:
measure: Number of Participants Reporting Compliance With Medication
timeFrame: Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02104570: Effects of Muscle Fatigue and Kinesio Taping on Shoulder Position Sense
Official title: Effects of Muscle Fatigue and Kinesio Taping on Shoulder Joint Position Sense
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Proprioception
Keywords: Fatigue
Proprioception
Shoulder
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Sao Carlos
First posted: 2014-04-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effects of Kinesio Taping on the position sense of shoulder after muscle fatigue.


Eligibility criteria: Inclusion Criteria:

* Healthy participants

Exclusion Criteria:

* prior shoulder surgery
* shoulder injury that required rehabilitation in the last 2 years
* shoulder dislocation
* ligamentous laxity

Primary outcomes:
measure: Changes in joint repositioning angle errors
timeFrame: Baseline (in the beginning of the session, without taping), 5 minutes after taping (or equivalent time resting, in the control session) and average of 3 minutes after fatigue protocol.
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Andrew Karduna, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03920670: Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Official title: Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Residual Neuromuscular Blockade
Keywords: Neuromuscular Blockade
ToFscan
Tetragraph
AMG
EMG
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.


Eligibility criteria: Inclusion Criteria

* Age \> or = 18 years old
* Patients willing to participate and provide an informed consent
* Patients undergoing an elective surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.

Exclusion Criteria

* Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.

Primary outcomes:
measure: Mean Train-of-Four Ratios (TOFR's)
timeFrame: baseline, after 5 minutes, after + 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Debrecen
country: Hungary
facility: University of Debrecen
Study officials:
affiliation: Mayo Clinic
name: J Ross Renew, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400.
Clinical trial NCT01262170: A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers
Official title: A Randomized, Double-Blind, Active-Controlled, Crossover, Pilot Study to Evaluate the Safety and Efficacy of CigRx™ Lozenge, a Non-Nicotine Non-Tobacco Dietary Supplement, in Daily Smokers in Temporarily Reducing the Desire to Smoke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Tobacco Use Disorder
Keywords: dietary supplement
nutraceutical
Lead sponsor: Rock Creek Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 109
Sex: ALL
Minimum age (years): 23
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke

Detailed description: Subjects will orally self-administer 2 study products, each in the form of a dissolvable lozenge, and will complete questionnaires on demographics, urges to smoke, and product rating.

Eligibility criteria: Inclusion Criteria:

* Healthy adult smokers
* Smoking for at least 5 years
* Smoking at least one (1) pack of cigarettes a day

Exclusion Criteria:

* Allergy to lozenge components

Primary outcomes:
measure: Effect on subject's craving to smoke
timeFrame: 4 hours
Secondary outcomes:
measure: Collection of information on adverse events related to study products
timeFrame: 5 hours
Other outcomes:
Locations:
city: Martinsburg
country: United States
facility: Comfort Inn
state: West Virginia
Study officials:
affiliation: Star Scientific, Inc
name: Maria Varga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675570: A Study of RX-10045 in the Treatment of Dry Eye Disease
Official title: A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Keywords: RX-10045
Dry Eye Disease
Lead sponsor: C.T. Development America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 150
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 primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.


Eligibility criteria: Inclusion Criteria:

1. Have a patient reported history of dry eye in both eyes
2. Presence of dry eye symptoms
3. Presence of dry eye signs, destabilized tear film break-up time and corneal staining

Exclusion Criteria:

1. Known contraindications or sensitivities to study medication or its components
2. Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
3. Use of disallowed medication during the period indicated prior to the enrollment or during the study
4. Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control

Primary outcomes:
measure: Corneal staining
timeFrame: Baseline to day 28
measure: Worst symptom score
timeFrame: Baseline to day 28
Secondary outcomes:
measure: Ocular discomfort symptom score
timeFrame: Baseline to day 28
measure: Tear film break-up time
timeFrame: Baseline to day 28
measure: Visual-related function subscale of Ocular Surface Disease Index score
timeFrame: Baseline to day 28
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02841670: Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF
Official title: Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: SAV-IOL SA
Sponsor class: INDUSTRY
Collaborators: name: CEISO
First posted: 2016-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cataract will be recruited from the clinic by the investigator based on the inclusion and exclusion criteria

Brief summary: This is a monocentric, longitudinal, prospective, observational post-market follow-up study.

30 patients with a cataract will receive an InFo - Instant Focus © lens implant. After the cataract procedure, data collection will take place during visits planned by the physician as part of normal follow-up.

Patients with cataract will be recruited from the clinic by the investigator based on the inclusion and exclusion criteria.

The patient will be followed up after one day, one week, one month, six months, one year and three years post-op. An interim analysis will be performed with one-year clinical results.

The main objective of the study is to evaluate is to evaluate efficacy and long-term safety for the InFo - Instant Focus © lens.


Eligibility criteria: Inclusion criteria:

* Suffering from cataract
* Physician has made the decision to implant on InFo - Instant Focus © lens
* Age ≥ 18 years, of either sex
* Having given written informed consent, prior to any procedure

Non inclusion criteria:

* Presenting with an astigmatism of \>1.00D
* Presenting contraindications for the implantation of an intraocular lens
* Presenting an ophthalmic disorder liable to interfere with study endpoints
* History of previous intraocular surgery in the study eye in the previous 6 months
* Refusing or unable to comply with the follow-up schedule
* Participation in other interventional therapeutic trial at time of inclusion
* Pregnant, breastfeeding, or unable to understand the character and individual consequences of the investigation

Primary outcomes:
measure: Near best corrected visual acuity
timeFrame: Year 1
measure: Intermediate (80cm) best corrected visual acuity
timeFrame: Year 1
measure: Far best corrected visual acuity
timeFrame: Year 1
measure: Near uncorrected visual acuity
timeFrame: Year 1
measure: Intermediate (80cm) uncorrected visual acuity
timeFrame: Year 1
measure: Far uncorrected visual acuity
timeFrame: Year 1
Secondary outcomes:
measure: Contrast sensitivity
timeFrame: Year 1
measure: Tilting sensitivity
timeFrame: Year 1
measure: Decentration sensitivity
timeFrame: Year 1
measure: Patient satisfaction
timeFrame: Year 1
measure: Adverse events
timeFrame: Year 1
Other outcomes:
Locations:
Study officials:
affiliation: Clinique Montchoisi Lausanne
name: André Mermoud, Prof
role: PRINCIPAL_INVESTIGATOR
References: