louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02379637: Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and Cough
Official title: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple-Dose, Proof-of-Concept Study to Evaluate the Efficacy of N-acetylcysteine Capsules in the Treatment of the Common Cold (Viral URTI) Associated With Cough in an Adult Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Common Cold Associated With Cough
Keywords: N-acetylcysteine
adults
cough and cold
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-03-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.


Eligibility criteria: Inclusion Criteria:

* Cold/URTI symptoms occurring no more than 4 days
* cough due to a cold or acute viral (URTI) with an onset of no more than 3 days
* cough frequency with specified cut-off

Exclusion Criteria:

* A subchronic, or chronic cough (cough duration \> 2 months) due to any condition other than a cold/URTI
* Diagnosed as suffering from any pulmonary conditions associated with cough, e.g., chronic obstructive pulmonary disease (COPD), acute or chronic bronchitis, asthma, cystic fibrosis
* Taking any medications known to induce cough
* Fever of greater than 39°C (102°F) orally
* Complication of the common cold like otitis media, severe sinusitis, or pneumonia
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
timeFrame: 72 hours
Secondary outcomes:
measure: Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
timeFrame: 7 Days
Other outcomes:
Locations:
city: Chicoutimi
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sherbrook
country: Canada
state: Quebec
city: Victoriaville
country: Canada
state: Quebec
city: Quebec
country: Canada
Study officials:
References:
Clinical trial NCT05395637: Reliability of Longshi Scale With Remote Assessment
Official title: Reliability of Longshi Scale With Remote Assessment of Smartphone Video Calls for Stroke Patients'Activities of Daily Living
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Telemedicine
Keywords: Stroke
Tele-rehabilitation
Activities of Daily Living
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke survivors from the Department of Rehabilitation Medicine at Shenzhen Second People's Hospital are invited to participate in this study according to the inclusion and exclusion criteria

Brief summary: To explore the reliability of remote Longshi Scale assessment with smartphone video calls by comparing the consistency of remote assessment and bedside assessment, as well as the test-retest reliability of the remote assessment. The evaluation duration of these two methods was recorded and the level of satisfaction of patients and evaluators was investigated.


Eligibility criteria: Inclusion Criteria:

* a.Stroke survivors

  1. aged 18 and above;
  2. diagnosed with cerebral infraction or intracerebral hemorrhage;
  3. stroke onset2 weeks;
  4. stable vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation and temperature);
  5. voluntary or guardian consent to participate in the study.

     b.Evaluators

  <!-- -->

  1. registered rehabilitation practitioner;
  2. experience in rehabilitation scientific research or education related work for more than two years

Exclusion Criteria:

* a.Stroke survivors

  1. brain tumor, Parkinson's disease or active epilepsy within past three months;
  2. a history of mental illness such as mania or delirium;
  3. participation in any other clinical study. b.Evaluators

  <!-- -->

  1. unable to finish the training of Longshi Scale or use smartphones proficiently.

Primary outcomes:
measure: Consistency of the disability degree evaluated using the remote assessment and the bedside assessment of Longshi Scale.
timeFrame: Within 24 hours
Secondary outcomes:
measure: The test-retest reliability of the remote video assessment
timeFrame: Within 24 hours after first evaluation
measure: Satisfaction survey of remote assessment
timeFrame: Within 24 hours after the remote assessment
measure: Assessment duration
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT05910437: Optimizing Treatments for Heart Failure During Hospitalization
Official title: Optimizing Treatments for Heart Failure During Hospitalization
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Decompensated Heart Failure
Keywords: Decompensated heart failure
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized (≥24h) patient for decompensated heart failure in cardiology between november 2021 and october 2022

Brief summary: Heart failure reaches 1.5 million people in France and is responsible for 200,000 hospitalizations per year.

Over the past ten years, new therapies have emerged (treatment of martial deficiency, Entresto, iSGLT2).

Hospitalization in a context of acute heart failure is a moment of choice in the history of the disease to introduce recommended treatments under closer supervision (clinical, biological) than in ambulatory, and allows a decrease in hospitalizations, morbidity and mortality.

The purpose of this study is to describe the introduction of heart failure drugs (including iSGLT2) in real-life settings in patients hospitalized for decompensated heart failure.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years
* Hospitalized (≥24h) for decompensated heart failure in cardiology.

Exclusion Criteria:

* Patient opposition participation in research and use of data.

Primary outcomes:
measure: Prescription score
timeFrame: During hospitalisation for decompensated heart failure (up to 10 days)
Secondary outcomes:
measure: serum concentration of creatinine
timeFrame: During hospitalisation for decompensated heart failure (up to10 days)
measure: serum concentration of potassium
timeFrame: During hospitalisation for decompensated heart failure (up to 10 days)
measure: Concentration of hemoglobin
timeFrame: During hospitalisation for decompensated heart failure (up to 10 days)
measure: All cause Death
timeFrame: 6 months
measure: Rate of hospitalization for heart failure
timeFrame: 6 months
Other outcomes:
Locations:
city: Ars-Laquenexy
country: France
facility: Chr Metz Thionville
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de NANCY
Study officials:
affiliation: CHRU de NANCY
name: Nicolas GIRERD, MD-PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06106737: A Modified Calculation Formula for Meibomian Gland Grading
Official title: A Modified Calculation Formula for Meibomian Gland Grading
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient population

Brief summary: The meibomian gland (MG) is a modified sebaceous gland located in the upper and lower eyelids. The grades of MG loss (i.e. meiboscore) is calculated as the ratio between the area of the MGs and the eyelids, and this calculation is based on the two-dimensional digital infrared images.In the current formula, the area of the eyelid is the denominator. However, because the eyelids need to be flipped over for the examination and evaluation, and there may be interobserver variability in the measurement of the area of the eyelids. Aging and involutional eyelid disorders, such as ptosis, ectropion, and entropion, may lead to laxity or deformation of eyelids, and impact the shape and area of eyelid area consequently.These factors could cause inaccuracy in current evaluation method, and impact the grading and evaluation of treatment efficacy of MGD, especially in self-controlled studies, such as in clinical trials.

In this study, the investigators propose to use a modified calculation formula for the grading of MGs. The investigators could measure the white to white (WTW) distance of cornea, and then calculate the area of cornea (i.e. corneal base area) accordingly.Unlike the eyelid, the WTW distance does not change significantly during aging or between sexes.Thus, the investigators hypothesize that using the corneal base area as the new denominator in the formula for the grading of MG loss is a better way comparing with the conventional method.


Eligibility criteria: Inclusion Criteria:

* people aged 18 to 80

Exclusion Criteria:

* Exclusion criteria included contact lens wearer, history of eye surgeries, systemic health conditions affecting ocular health and those who were unable to cooperate with examinations.

Primary outcomes:
measure: the area of the MGs and the whole eyelids
timeFrame: Baseline (Once a subject has enrolled in research)
measure: the WTW distance of the cornea
timeFrame: Baseline (Once a subject has enrolled in research)
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT00351637: Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients
Official title: Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients: a Phase II Multicenter, Open Label, Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Pain
Keywords: Sublingual methadone
iatrogenic
treatment related incident breakthrough pain
feasibility study
Phase II/open-label
inpatients
Safety/efficacy
Cancer related breakthrough pain
previously receiving opioids
speak English
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2006-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the impatient population, in the clinical setting of preventing or managing breakthrough pain, before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an effective dose of sublingual methadone.


Eligibility criteria: Inclusion Criteria:

* Pain due to cancer or its treatment; Controlled baseline pain; episodes of predictable, treatment related pain every day that are 4"/10" in severity or greater, last 10 minutes or longer, or episodes of breakthrough pain not related to cancer treatment, and are responsive to short acting oral opioids such as morphine or hydromorphone; are able to hold a volume of 1.0cc of water under tongue for a 2-minute period; are able to provide written informed consent; are able to fill out the study forms, and are inpatients

Exclusion Criteria:

* Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses od opioid; prior sensitivity to methadone; currently are being administered methadone; are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely; and if they do not understand English sufficiently to provide written informed consent.

Primary outcomes:
measure: to demonstrate the feasibility of a novel model to assess sublingual methadone to relieve iatrogenic,
measure: treatment related incident breakthrough pain.
Secondary outcomes:
measure: to develop a research tool
measure: the Breakthrough Pain Assessment Tool (BPAT)
measure: and to demonstrated proof of concept
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Neil Hagen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04020237: Impact of Particulate Matter in Chronic Obstructive Pulmonary Disease Patients
Official title: Evaluation of Quality of Life in Patients With Chronic Pulmonary Obstructive Disease According to Particular Matter Exposure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Centers for Disease Control & Prevention
First posted: 2019-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A prospective study will be conducted in patients with COPD. The investigators will suggest about intervention for preventing in recurrence and aggravation of adult chronic respiratory disease due to exposure to particulate matter.

Detailed description: Study trends and intervention plans related to particulate matter exposure and adult chronic respiratory disease in literature Measurement of particulate matter exposure by individual activities and collection of clinical information Linkage between individual particulate matter exposure and clinical information Investigation about effectiveness of intervention to avoid particulate matter

Eligibility criteria: Inclusion Criteria:

* COPD over 40 years of age
* Patients with pulmonary function tests with Forced expiratory volume at 1 second / forced vital capacity \<0.7 and Forced expiratory volume at 1 second1 \<80%

Exclusion Criteria:

* Patients under the age of 18
* Elderly people over 80 years old
* People with respiratory symptoms with modified Medical Research Council dyspnea scale 0
* Persons who do not understand the brief description of the particulate matter exposure device
* A person who does not agree to the study

Primary outcomes:
measure: Chage from life quality scale at 1 year
timeFrame: Up to 1 year
Secondary outcomes:
measure: Change from pulmonary function test at 1 year
timeFrame: Up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center
name: Sei Won Lee
role: STUDY_DIRECTOR
References:
citation: Park S, Ra SW, Kang SY, Kim HC, Lee SW. Effect of particulate matter exposure on patients with COPD and risk reduction through behavioural interventions: the protocol of a prospective panel study. BMJ Open. 2020 Nov 9;10(11):e039394. doi: 10.1136/bmjopen-2020-039394.
Clinical trial NCT01684137: Monitoring of Allergic and Asthmatic Symptoms in Patients Taking Dietary Supplements Joalis Bambi Bronchi and Joalis Bambi Analerg
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children
Keywords: Food supplements
Asthma bronchiale
Lead sponsor: DSC Services, s.r.o.
Sponsor class: INDUSTRY
First posted: 2012-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Reduction of the total IgE antibody, improved vital capacity and lung volume measured by spirometry.

Improving quality of life observed in the visual analogue scale (VAS).


Eligibility criteria: Inclusion Criteria:

* subjects with confirmed Asthma bronchiale I-III. degrees in possible combination with other allergic symptoms treating with classic pharmacological treatment
* 9-18 years
* signed Infromed Conset

Exclusion Criteria:

* subjects who have previously used a food suplemts Joalis
* subjects with known intolerance or hypersensitivity to the components of food supplements
* subjects with alcohol abuse or drugs at the time of recruitment into the study
* subjects enrolled in another clinical trial in the last 1 month before enrollment in this study
* subjects in a situation which in the opinion of a doctor may interfere with optimal participation in the study or can pose a risk to the subjects
* pregnant girls, lactating girls and girls of childbearing age without adequate contraception

Primary outcomes:
measure: Reduction of the total IgE (IU/ml) antibody.
timeFrame: 1 year
measure: Improving of vital capacity measured by spirometry (litre).
timeFrame: 1 year
measure: Improving of lung volume measured by spirometry (litre).
timeFrame: 1 year
Secondary outcomes:
measure: Improving of quality of life observed in the visual analogue scale (VAS).
timeFrame: 1 year
Other outcomes:
measure: Asthma bronchiale, age 9-18 year
timeFrame: 1 year
Locations:
city: Zlín
country: Czech Republic
facility: Alergologická ambulance
Study officials:
affiliation: DSC Services, s.r.o.
name: Karel Chroust, RNDr., Ing., PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01124552: A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Official title: A Phase 2, Double-Blind, Randomized, 4-Arm, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of RT001 Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Crow's Feet
Facial Wrinkles
Keywords: Lateral Canthal Lines
Crow's Feet Wrinkles
Facial Wrinkles
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.

Detailed description: RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.

Eligibility criteria: Inclusion Criteria:

* Written informed consent including authorization to release health information
* Female or male, 18 to 65 years of age and in good general health
* Willing and able to follow study instructions and likely to complete all study requirements
* Moderate to severe lateral canthal lines (crow's feet wrinkles)

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active disease or irritation at the treatment areas including the eye and the skin
* Pregnant, nursing, or planning a pregnancy during the study; or is a women of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
* Previous participation in a RT001 clinical study

Primary outcomes:
measure: Subject improvement based in investigator assessment
timeFrame: Week 4
Secondary outcomes:
measure: Subject Improvement Based on investigator and patient assessments
timeFrame: Week 4
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Dermatology Research Institute, LLC
state: Florida
Study officials:
References:
Clinical trial NCT01504152: International Travel Patterns and Health Preparations of Hematopoietic Stem Cell Transplant Recipients at Memorial Sloan-Kettering Cancer Center
Official title: Survey to Assess International Travel Patterns and Health Preparations of Hematopoietic Stem Cell Transplant Recipients at Memorial Sloan-Kettering Cancer Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplant
Keywords: International travel
cancer patients
HSCT
Quality of Life
questionnaire
11-176
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2012-01-05
Enrollment: 519
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received HSCT at MSKCC between 2005-2010 and were alive after the first year after HSCT.

Brief summary: The purpose of this study is to survey patients who underwent hematopoietic stem cell transplant (HSCT) to assess if they have traveled or not internationally after transplant. This information will help to improve the understanding of the needs for travel health strategies and interventions to provide healthy and safe travel to HSCT patients. The findings of this survey will also be used to develop travel health related interventions for patients living with cancer as well.


Eligibility criteria: Inclusion Criteria:

* Hematopoietic Stem Cell Transplant (HSCT) recipients at MSKCC from 1/1/2005 to 12/31/2010.
* Age at HSCT ≥ 18 years
* Permanent mailing address in the United States of America

Exclusion Criteria:

* Subject unable to fill the questionnaire due to language barriers.

Primary outcomes:
measure: prevalence of international travel
timeFrame: 2 years
Secondary outcomes:
measure: international travel was during a high-risk specific period
timeFrame: 2 years
measure: patients that sought pre-travel health advice
timeFrame: 2 years
measure: travelers that becomes ill and required medical attention
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Monika Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: