louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03488017: Ocular Coil Drug Delivery Comfort Trial
Official title: Evaluation of the Safety and Tolerability of an Ocular Coil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2018-04-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The Ocular Coil is intended to provide drug delivery to the ocular surface. This study will evaluate the safety and tolerability of the placebo Ocular Coil in healthy subjects.

Detailed description: This study is designed to evaluate the safety and comfort of a placebo Ocular Coil for 28 days in 40 healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75 years old
* Informed and having given informed consent
* Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

* Subjects with a history of eye disease that can make them vulnerable for irritation by the coil.
* Subjects wearing contact lenses (unless they are willing to replace them for glasses for the duration of the study).
* Subjects using eye drops (during the study).
* Subjects with an Oriental/Asian lid crease, because of their narrow fornix.
* Subjects who do not speak and/or write Dutch properly.
* Subjects with a history of serious adverse reaction or hypersensitivity to components of the ocular coil. or to ophthalmic anaesthetics
* Women who are pregnant or nursing their child, or have the intention to become pregnant during the course of the study.

Primary outcomes:
measure: Change from baseline in terms of ocular irritation
timeFrame: 28 days
Secondary outcomes:
measure: Total time of Ocular Coil retention
timeFrame: 28 days
measure: Percentage of Participants in Each Response Category of Subject Comfort
timeFrame: 28 days
measure: Incidence of ocular adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
Study officials:
References:
Clinical trial NCT01071317: Trial of Comprehensive Migraine Intervention
Official title: A Random Controlled Trial a Comprehensive Migraine Intervention at the Time of Discharge From the Emergency Department After Treatment for Acute Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite the fact that more than 10% of Americans suffer from migraine, this headache disorder is often not diagnosed and not appropriately treated. The goal of this proposal is to determine whether a migraine protocol designed for use in an emergency room can be used to deliver the headache care that many migraine patients never receive. This is a randomized trial. Consecutive inadequately treated migraine patients will be randomized to TYPICAL care or to COMPREHENSIVE care. Those patients in the comprehensive care arm will receive the following intervention: 1) reinforcement of diagnosis, 2) an adaptable online educational intervention, reading material, and headache diaries, 3) two migraine specific medications and 4) expedited referral to a headache specialist, if needed. Patients in the typical care arm will receive whatever intervention the emergency physician feels is most appropriate. Headache surveys will be used toll if the protocol improves migraine-related pain and functional disability one month after the ER visit.


Eligibility criteria: Inclusion Criteria:

* Migraine,
* Baseline migraine related disability of mild or worse,
* No current or past triptan use,
* Not satisfied with current headache care.

Exclusion Criteria:

* Allergy or contraindication to study medications,
* Daily or near daily analgesic medication use.

Primary outcomes:
measure: Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale
timeFrame: 1 month after study enrollment
Secondary outcomes:
measure: Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale
timeFrame: 1 month after study enrollment
measure: Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale
timeFrame: 1 month after study enrollment
measure: Number of Participants Who Returned to the Emergency Department for Management of Headache
timeFrame: 1 month after study enrollment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01053117: Reducing Hemodialysis Catheter Use in Prevalent Hemodialysis Patients
Official title: Reducing Hemodialysis Catheter Use in in a Prevalent Hemodialysis Population; A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hemodialysis
Keywords: central venous catheter
arteriovenous fistula
hemodialysis
vascular access
dialysis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre Foundation, Manitoba
First posted: 2010-01-21
Enrollment: 3
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: To determine if a protocolized approach to converting hemodialysis central venous catheters (CVC) to arteriovenous fistulae will improve rates of functioning AVF and decrease CVC use.

Detailed description: In order to receive dialysis, patients require repeated access to their bloodstream. This access can be either via a central venous catheter (CVC) or a surgically created arteriovenous fistula (AVF) or graft (AVG). This is a pilot randomized control trial of prevalent hemodialysis patients with a central venous catheter (CVC), to determine if a systematic approach using an algorithm protocol to convert the CVC to an AVF (arteriovenous fistula) will improve rates of functioning AVF and decrease CVC use. The algorithm (intervention group) will be compared to current practice (control group), a non-standardized approach at the discretion of the caring nephrologist and/or surgeon.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* Dialyzing with a CVC
* Receiving hemodialysis three times weekly for \> 3 months

Exclusion Criteria:

* Awaiting peritoneal dialysis catheter insertion
* Scheduled living donor transplant
* Transient patients from out of province
* Expected transfer to satellite dialysis unit within 6 months
* Surgical plan for AVF (i.e. scheduled date)
* Documented lack of suitable vasculature for AVF
* Refusing AVF

Primary outcomes:
measure: The proportion of patients using a CVC in a prevalent hemodialysis population after the implementation of an algorithm protocol to convert the CVC to an AVF compared with patients who received current standard care.
timeFrame: 9 months
Secondary outcomes:
measure: The proportion of patients with a functioning AVF after the implementation of an algorithm protocol to convert the CVC to an AVF compared with patients who received current standard care.
timeFrame: 9 months
measure: Proportion of patients with a maturing AVF
timeFrame: 9 months
measure: Primary fistula failure rate
timeFrame: 9 months
measure: Incidence of AVF salvage procedures, including balloon angioplasty and accessory vein ligation, within 9 months of AVF creation
timeFrame: 9 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Lisa M Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03202017: Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS
Official title: A Pilot Study of Lung Volume Recruitment Combined With Expiratory Muscle Strength Training in ALS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 23
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 purpose of this study is to investigate the effects of two treatment techniques called Expiratory Muscle Strength Training (EMST) and Lung Volume Recruitment (LVR) on breathing, swallowing, speech, and cough function in persons with mild to moderate ALS. Half of the participants will do EMST alone, and the other half of the participants will do EMST and LVR.


Eligibility criteria: Inclusion Criteria:

* ALS defined as possible, laboratory-supported probable, probable, or definite by El Escorial criteria
* Reduced Maximal Expiratory Pressure (MEP) compared to norms for age and sex
* Forced Vital Capacity (FVC) \> 65% predicted

Exclusion Criteria:

* Inability to provide informed consent
* Relative contraindications to LVR, including known pneumothorax, active internal bleeding, unstable hypertension, unstable angina, emphysema, recent barotrauma, or FEV1 (Forced Expiratory Volume, trial 1)/FVC ratio \< 0.7.
* Use of EMST or breath stacking \> 3 days/week within 12 weeks of screening
* Amyotrophic Lateral Sclerosis-Cognitive Behavioral Scale (ALS-CBS) score predictive of dementia (≤ 10)
* Participation in another clinical trial of an intervention in ALS within 30 days of study enrollment or during study enrollment

Primary outcomes:
measure: Peak Cough Flow
timeFrame: Baseline (Week 0), Week 6, and Week 12
Secondary outcomes:
measure: Maximal Expiratory Pressure
timeFrame: Week 0, Week 6, Week 8, Week 10, and Week 12
measure: Forced Vital Capacity
timeFrame: Baseline (Week 0), Week 6, and Week 12
measure: Eating Assessment Tool - 10 (EAT-10)
timeFrame: Baseline (Week 0), Week 6, and Week 12
measure: Swallowing Related Quality of Life (SWAL-QOL)
timeFrame: Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
measure: Speech Intelligibility Test (SIT)
timeFrame: Baseline (Week 0), Randomization (Week 6), and End of Study (Week 12)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David Walk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00520117: Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions
Official title: Assessing the Psychosocial Burden in Women With an Abnormal Pap Results After Screening Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papanicolaou Smear
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2007-08-23
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having pap-smear at Ratchawithi Hospital

Brief summary: The primary purpose of this study is to assess the psychosocial burden in women who have experienced an abnormal pap results after screening interventions.

Detailed description: This study will be a Thailand, clinic-based, cross-sectional, questionnaire study. Approximately 151 female participants will be enrolled. Study staff will interview the subject to collect basis demographic data and self reported medical history. And the subjects will be given the questionnaire packet for self-administration. After subjects complete the packet, study staff will review the questionnaires for completeness prior to the study subject leaving the clinic.

Eligibility criteria: Inclusion Criteria:

* female, between 18 and 45 years of age and must have recently experienced an abnormal pap results within the past 3 months.

Exclusion Criteria:

* has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
* has other concurrent/active STD's
* has a history of known prior vaccination with an HPV vaccine
* has a history of recent (within 1 year from date of enrollment) or ongoing alcohol abuse or other drug abuse.

Primary outcomes:
measure: psychological burden of women with abnormal pap-smear
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Clinical Infectious Diseases Research Unit
Study officials:
affiliation: Department of Clinical ITropical Medicine, Faculty of Tropical Medicine, Mahidol University
name: Punnee Pitisuttithum, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01066117: Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence
Official title: Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence Over Existing Solutions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinent
Lead sponsor: Tisteron Ltd.
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the proposed study is to test the effect of the new gel pad on the quality of life of urinary incontinent men and women and to assess to what extent the gel pad improves the quality of life of incontinence persons.

Detailed description: The devices available today on the market serve two polar incontinence conditions: those who have severe urinary incontinence and need to use diapers several times per day, or those who have mild urinary incontinence and can use pads.

Such circumstances call for a search of new solution that may provide the benefit of freeing those with moderate incontinence from changing pads several times a day or staying constantly very near a bathroom, as well as freeing those with severe incontinence from using cumbersome diapers.

A larger gel containing pad was developed, suitable to absorb up to half a litter liquid, it eliminates odors and enables the users to wear ordinary clothes . It was presented for clinical trial.

The objectives of the clinical trial, proposed hereafter is to assess to what extent the new gel pad presents an advantage over the existing means of coping with urinary incontinence in cases when medicinal treatment or surgery is not appropriate.

Eligibility criteria: Inclusion Criteria:

1. Urinary incontinent women and men who loose urine at a quantity higher than drops (50CC or more).
2. Three segments of such persons will be included in the study:

   * pregnant women who are temporary urinary incontinent
   * women of the age 40+ who are urinary incontinent
   * men who are urinary incontinent (post prostatectomy)

Exclusion Criteria:

1. Urinary incontinent disabled patients who need nursing
2. Patients who presently have cancer of any kind,

Primary outcomes:
measure: Significant improvement in quality of life for men and women who use the new gel pad in comparison to usage of existing solutions; this means a difference of at least 5 scores on the 1-100 I-QoL score scale
timeFrame: two weeks
Secondary outcomes:
measure: Pad weight and number of pads used per day
timeFrame: daily
measure: Observation for any development of rash due to patients' sensitivity to the pad
timeFrame: two weeks
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References:
Clinical trial NCT04604717: Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
Official title: Effect of Exercise Training on Salivary Immunoglobulin A in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD,
Pulmonary rehabilitation,
Airway immunity
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Austin Health
name: Newcastle University
First posted: 2020-10-27
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether whole body exercise training alters the immunity in the lungs of people with COPD and reduces the incidence of chest infections over the longer term.

Detailed description: Patients will undertake an 8 weeks pulmonary rehabilitation program of exercise and education. Those who decline to take part in pulmonary rehabilitation will have the same outcome measures collected at the same timepoints.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD (FEV1/FVC \< 70), smoking Hx of minimum of 10 pack years

Exclusion Criteria:

* Diagnosis of asthma, bronchiectasis, attendance at pulmonary rehabilitation within last 12 months, exacerbation of COPD within last 4 weeks

Primary outcomes:
measure: Change in Salivary Immunoglobulin A levels
timeFrame: Change over 8 weeks
Secondary outcomes:
measure: Change in circulatory inflammatory markers
timeFrame: Change over 8 weeks
measure: Change in physical activity levels
timeFrame: Change over 8 weeks
measure: Health status
timeFrame: Change over 8 weeks
measure: Exercise capacity (6MWT)
timeFrame: Change over 8 weeks
measure: Number of acute exacerbations
timeFrame: 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: Alfred Health, La Trobe University
name: Anne Holland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01786317: Anal Motor Function in Fecal Incontinence
Official title: Measure of Ano-rectal Motility in Fecal Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Keywords: Fecal incontinence, ano-rectal manometry
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heathy controls Patient with Fecal Incontience

Brief summary: Traditionnal measurment of anorectal function is perfomed with manometric device using 2 to 3 pressure sensors. The investigators aim to evaluate the usefulness of high resolution manometry to measure anorectal motility

Detailed description: Measurment of anorectal function is traditionnaly made using manometric device composed of perfused or ballon catheters. This allows the recording of anorectal pressure on 2-3 sites. Recently, high resolution manometryu devices using \> 36 pressure channels have been developped. The investigators therefore aim to evaluate the usefullness of the high resolution manometry in patient with fecal incontinence in terms of feasability and diagnosis accuracy

Eligibility criteria: Inclusion Criteria:

* patient with fecal incontinence (group "fecal incontinence"
* subject without significant medical or surgical hisotry (group healthy controls)

Exclusion Criteria:

* pregnacy
* unable to speack/understand French language
* not affilitated to the French healthcare system
* history of anorectal disease (for the group of healthy controls) including fecal incontinence, or protocologic surgery
* constipation
* diarrhea

Primary outcomes:
measure: Anal squeezing pressure
timeFrame: Day 1
Secondary outcomes:
measure: anal tone pressure
timeFrame: day 1
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
state: Normandy
Study officials:
affiliation: University Hospital, Rouen
name: guillaume Gourcerol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00829517: Computer-Assisted Provision of Reproductive Health Care
Official title: Computer-Assisted Provision of Reproductive Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Sexually Transmitted Diseases
Keywords: Contraception
sexually transmitted diseases
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-01-27
Enrollment: 814
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project seeks to demonstrate that computer kiosks in a clinic waiting room can improve access to hormonal contraception and screening for sexually transmitted infections. The study will be a randomized controlled trial which will evaluate the use of a computer kiosk module to compare the proportion of women of reproductive age who receive a prescription for hormonal contraception when computer-assisted provision of hormonal contraception is offered (intervention) to encounters when the study clinic provides standard contraceptive care (control). Subjects will be contacted approximately 3 months (range 2-4 months) after the clinic visit to complete a follow-up phone interview. The study population will include English and Spanish-speaking women ages 18-45 who seek care at this clinic. Our hypothesis is that computer-assisted provision of hormonal contraception (intervention)will increase the proportion of women of reproductive age who receive a prescription for hormonal contraception versus standard contraceptive care(control).

Detailed description: Data collection has been completed

Eligibility criteria: Inclusion Criteria:

* women who speak English or Spanish who visit a study clinic

Exclusion Criteria:

* women who do not speak English or Spanish

Primary outcomes:
measure: self-reported use of hormonal or more effective contraception
timeFrame: 3 months
measure: receipt of screening for sexually transmitted infection
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Eleanor B Schwarz, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: