louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00423007: Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With Allergic Conjunctivitis
Official title: Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With a History of Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment in subjects with a history of allergic conjunctivitis


Eligibility criteria: Inclusion Criteria:

* History of clinically active allergic conjunctivitis
* Agree to return for all required visits
* Agree to avoid disallowed meds

Exclusion Criteria:

* Known hypersensitivity to bromfenac and salicylates

Primary outcomes:
measure: Treatment of ocular itching
Secondary outcomes:
measure: Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Jon Williams, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05389007: .German TTP-Registry (Thrombotic Thrombocytopenic Purpura)
Official title: German TTP- Registry- Prospective Cohort of Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP): Pathophysiology, Diagnosis, Treatment and Follow-Up
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombotic Thrombocytopenic Purpura
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 156
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: It is planned to include all patients with TTP in Germany.

Brief summary: Open, multi-center, observational, prospective cohort study, only disease-indicated treatment, in patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18 for 1.) prospective investigation of patients with TTP in an acute bout and during long-term follow and 2.) assessment of prevalence, course of disease, success of therapy, possible triggers for relapses and possibilities for better diagnosis and prognosis.

Detailed description: 1.) Identification of predictive markers for morbidity and mortality in acute TTP and in TTP relapses using a prospective long-term registry and 2.) Investigation of the pathophysiological processes in acute bouts and in remission by recording the clinical symptoms and diagnostics for a better understanding of the course of the disease, optimization of diagnostic procedures and their correlation with the clinical course, recording of therapy response of all therapeutic options in acute bouts, observation of current treatment options to evaluate outcome and prognostic markers and recording of clinical and laboratory chemical data during follow-up to assess long-term morbidity.

Eligibility criteria: Inclusion Criteria:

* Patients with clinically diagnosed acquired and congenital TTP regardless of gender, ethnicity, and comorbidities, over the age of 18.
* Patients incapable to give consent, who are accompanied by a legal representative during admission to the study, after the written informed consent of the legal representative.
* Written informed consent of the patient.

Exclusion Criteria:

* Patients who are not able to understand the German or English language.
* Patients who are permanently unable to communicate and who are not accompanied by a legal representative.

Primary outcomes:
measure: Predictive markers for morbidity and mortality
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Hospital Mainz, Hematology
Study officials:
affiliation: Universitätsmedizin Mainz
name: Charis v. Auer-Wegener
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05590507: Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women
Official title: A Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to figure out if postmenopausal women find a mindfulness audio recording acceptable for use along with physical activity, and to find out if this tool is helpful in increasing daily physical activity.


Eligibility criteria: Inclusion Criteria:

* Patients self-report as being \> 1 year postmenopausal.
* Patients are able to walk without a walking aid.
* Patients own and know how to operate a smart phone or tablet.
* Patients are willing and able to complete the activity monitoring.
* Patients are self-reportedly underactive.

Exclusion Criteria:

* Patients are \< 1 year postmenopausal.
* Patients require a walking aid for daily mobility.
* Patients do not own a smartphone or table, or are unwilling to use such a device for the purposes of the study.
* Patients' primary form of exercise is swimming (the activity monitors are not waterproof).
* Patients are unable or unwilling to complete activity monitoring.
* Patients are unable to provide informed consent independently.

Primary outcomes:
measure: Acceptability of a mindfulness-based physical activity intervention
timeFrame: 4 weeks
Secondary outcomes:
measure: Daily physical activity
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Emma Fortune-Ngufor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05238207: A Study to Evaluate BBI-001 in Hereditary Haemochromatosis (HH) Patients and Iron Deficient Volunteers
Official title: A Phase Ia/Ib Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacodynamics of BBI-001 in Iron Deficient Volunteers and HH Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hereditary Hemochromatosis
Lead sponsor: Bond Biosciences
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a first in human, double-blind, randomized, placebo-controlled, two-arm crossover study evaluating the safety, tolerability and PD of ascending dose levels of BBI-001 after:

* a single administration in iron deficient male and female participants, and male and female HH patients (Part A),
* two administrations per day in HH patients (Part B). BBI-001 administrations will be accompanied with consumption of a meal enriched with stable iron isotope Fe57, while corresponding placebo dose administrations will be with a meal enriched with stable iron isotope Fe58.


Eligibility criteria: Inclusion Criteria:

* Otherwise healthy iron deficient participants or patients with hereditary hemochromatosis

Exclusion Criteria:

* Serious or unstable medical or psychiatric conditions
* Significant medical history
* Current infections
* Receiving iron chelation therapy or treatment other than stable maintenance phlebotomy for the prior 6 months
* Organ damage from iron overload in the view of the PI would prevent successful completion of the protocol

Primary outcomes:
measure: Adverse Events (AE)
timeFrame: up to 17 days
measure: Clinical Laboratory Testing - Iron Panel
timeFrame: up to 17 days
Secondary outcomes:
measure: Evaluation of Iron Isotope Blood Levels
timeFrame: up to 17 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Networks
state: Victoria
Study officials:
affiliation: Sponsor GmbH
name: Curtis Scribner, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01297907: Bronchial Hyperreactivity in Children With Crohn Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Bronchial hyper reactivity
Fractional exhaled NO
Methacholine Challenge Test
Pediatric Crohn's Disease Activity Index
To determine the frequency of bronchial hyperreactivity in pediatric patients followed and treated for Crohn disease
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 47
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty-three children with Crohn disease in the age of 11 to 22 yr

Brief summary: Background: Latent pulmonary involvement is described in Crohn Disease(CD). Bronchial hyperreactivity measured by the Methacholine Challenge Test (MCT) has been evaluated in two studies involving mainly adults.Our aim was to determine the frequency of bronchial hyperreactivity in pediatric patients followed and treated for Crohn disease.

Methods: Twenty-three children with Crohn disease completed a questionnaire, followed by spirometry, Methacholine Challenge Test (MCT) and determination of Fractional Exhaled NO (FENO). The control group included patients evaluated for functional cough who had negative Methacholine Challenge Test (MCT).


Eligibility criteria: Inclusion Criteria:

* Children with Crohn disease
* Children that can perform lung function tests (MCT)

Exclusion Criteria:

* Upper respiratory tract infection last month
* Fever or Pneumonia last month
* Smoking
* Other chronic diseases
* Other respiratory diseases

Primary outcomes:
measure: Methacholine challenge test
timeFrame: 18 months
Secondary outcomes:
measure: Fractional Exhaled NO
timeFrame: Day 1
measure: Eosinophils count
timeFrame: Day 1
measure: Pediatric Crohn's Disease Activity Index (PCDAI)
timeFrame: Day 1
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT00915707: Pathways Linking Reduced Sleep Duration and Quality to Obesity Risk
Official title: Pathways Linking Reduced Sleep Duration and Quality to Obesity Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Keywords: obesity
diabetes, risk
obesity, diabetes risk related to sleep
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-06-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is designed to study the pathways through which short sleep duration or poor sleep quality can lead to an increased risk of developing diabetes and obesity.


Eligibility criteria: Inclusion Criteria:

* Normal weight
* Healthy
* Normal sleep times

Exclusion Criteria:

* Sleep disorders
* Overweight
* Diabetes
* Other health conditions
* Excessive caffeine and alcohol intake
* Smoking

Primary outcomes:
measure: Disposition Index reflecting Diabetes Risk as a result of decreased sleep duration and/or quality.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Esra Tasali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00521807: Hypnosis as a Treatment of Chronic Widespread Pain in General Practice. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Widespread Pain
Keywords: Hypnosis,
Chronic widespread pain,
CWP,
General Practice
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2007-08-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (CWP).

Design: A randomized control group-controlled study. Setting and subjects: 16 patients were randomized into a treatment group or a control group, each constituting eight patients. Seven patients in the treatment group completed the schedule. After the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions.

Intervention: The intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy.

Main outcome measures: A questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering.


Eligibility criteria: Inclusion Criteria:

* Chronic widespread pain for at least three months and at most five years.

Exclusion Criteria:

* Patients having primarily other organic diseases or serious psychiatric disorders were excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: 1) Institute of General Practice and Community Medicine, University of Oslo
Study officials:
affiliation: The Institute of General Practice and Community Medicine, University of Oslo, Norway.
name: Jan R Grondahl, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grondahl JR, Rosvold EO. Hypnosis as a treatment of chronic widespread pain in general practice: a randomized controlled pilot trial. BMC Musculoskelet Disord. 2008 Sep 18;9:124. doi: 10.1186/1471-2474-9-124.
Clinical trial NCT03268707: Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization
Official title: Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization And Quality of Life After Cryoballoon Pulmonary vEin Isolation in Patients With Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Paroxysmal Atrial Fibrillation
Pulmonary Vein Isolation
Telemetry Monitoring
Cryoballoon ablation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: A randomized, open, mono-centric pilot study to investigate the influence of an innovative telemetric smartphone application on re-hospitalization and quality of life after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

Detailed description: The telemetric smartphone application includes a digitized medical record, a mobile ECG device and a 24-hour on call service by a cardiologist. The hypothesis is that the use of a telemetric smartphone application can reduce re-hospitalization in patients after cryoballoon pulmonary vein isolation. Secondary endpoints are quality of life measurements, health care cost calculations and recurrences of atrial fibrillation after ablation. All patients will undergo ablation and will be randomized into two groups: 1) conventional follow up with outpatient visits 6 and 12 months after ablation compared to 2) a structured follow up with the smartphone application, a mobile ECG device (patients will be able to send in as many ECGs as wanted), up to three phone calls with a cardiologist (24-hour on call service) as well as outpatient visits 6 and 12 months after cryo-ablation.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Written informed consent
* symptomatic paroxysmal atrial fibrillation (at least two episodes within 3 months prior to ablation)
* cryoballoon pulmonary vein isolation
* possession of a compatible smartphone

Exclusion Criteria:

* Age \< 18 years
* persistent or permanent atrial fibrillation (AF)
* prior catheter or surgical ablation of AF
* pregnant females
* contraindication for oral anticoagulation
* manifest hyper-/hypothyroidism
* no intention to cooperate
* alcoholism

Primary outcomes:
measure: Rehospitalization Recurrence of AF
timeFrame: in 12 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Asklepios St Georg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitaeres Herzzentrum Hamburg GmbH
name: Christian Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03662607: Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
Official title: Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Preprocedure Anxiety
Keywords: preprocedure
anxiety
cardiac catheterization
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to test the hypothesis that use of VR combined with standard procedural education will result in less pre-procedural anxiety than standard procedural education alone among patients undergoing first-time cardiac catheterization. The VR technology being evaluated in this study will allow patients to experience a 3-D simulation of certain aspects of their upcoming procedure prior to the actual procedure date.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo a left-heart catheterization procedure at the Meijer Heart Center
* 18-75 years of age
* Signed study consent form

Exclusion Criteria:

* History of cardiac procedure(s) in a cardiac catheterization laboratory
* History of seizures, migraine headaches or severe susceptibility to motion sickness
* Currently taking psychotropic drugs or on long-term psychotropic treatment
* Unable to read and speak English
* Visually impaired
* Unable to provide written consent

Primary outcomes:
measure: Change in Anxiety Measured by the Sate-Trait Anxiety Inventory (STAI)
timeFrame: Change from baseline visit to procedure day. Baseline visits will occur up to 4 weeks prior to procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
References:
Clinical trial NCT05179707: A Research for Combination of Prostate Health Index (Phi) and mpMRI PI-RADS in the Diagnosis of Prostate Cancer
Official title: A Prospective, Multicenter Research for Combination of Prostate Health Index (Phi) and mpMRI PI-RADS in the Diagnosis of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Zibo Central Hospital
First posted: 2022-01-05
Enrollment: 936
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male patients aged 50 to 80 years with indications for prostate puncture

Brief summary: Before prostate puncture, the patient's serum was collected for PHI detection, and multi-parameter MRI was performed to obtain the PI-RADS score. The sensitivity and specificity of PHI combined with PI-RADS score in the diagnosis of clinically significant prostate cancer were explored.

Detailed description: This study is a multi-center prospective study. Patients who meet the indications for prostate puncture and whose PSA is in the gray area (4.0\~10.0 ng/mL) undergo standard prostate biopsy. The patient's serum was collected for PHI detection before puncture, and multi-parameter MRI was performed before puncture. To explore the sensitivity and specificity of PHI combined with PI-RADS score in the diagnosis of clinically meaningful prostate cancer. Assess the benefit of combining PHI and mpMRI before biopsy compared with phi or mpMRI alone. Formulate clinical recommendations for PHI and mpMRI.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected prostate cancer
* Patients can perform standardized prostate biopsy

Exclusion Criteria:

* Have a history of prostate cancer
* Use of drugs that affect PSA before blood sampling

Primary outcomes:
measure: Prostate Health Index
timeFrame: 1 year
measure: PI-RADS score
timeFrame: 1 year
measure: Prostate biospy pathology
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital
state: Shandong
Study officials:
References: