louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01769066: Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC
Official title: Random Open Exploratory Clinical Research of Sequential Gefitinib With Pemetrexed/Platinum Compare With Pemetrexed/Platinum Treatment for Advanced Non-small Cell Lung Cancer Exploratory Clinical Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: NSCLC
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-01-16
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.

Detailed description: Patients will be randomized to 2 groups

Eligibility criteria: Inclusion Criteria:

1. 18\~70 years
2. Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
3. Presence of at least one index lesion measurable by CT scan or MRI
4. Ecog0-1
5. Expected life time longer than 12 weeks
6. Normal laboratory values:

   * leucocyte ≥ 4×109/L
   * neutrophil ≥ 1.5×109/L
   * platelet ≥ 100×109/L
   * Hemoglobin ≥ 10g/L
   * ALT and
   * AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis)
7. Signed written informed consent

Exclusion Criteria:

* Patients have used drugs according to protocol
* Patients were allergic to pemetrexed or cisplatin
* Patients received radiotherapy or other biological treatment 4 weeks before the trial
* Uncontrolled hydrothorax or hydropericardium
* neuropathy toxicity ≥ CTC 3
* Severe symptomatic heart disease
* Active upper gastrointestinal ulcer or digestive disfunction
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception

Primary outcomes:
measure: 12 weeks of non-progression rate
timeFrame: from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes:
measure: PFS
timeFrame: from the first cycle of treatment (day one) to two month after the last cycle
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
affiliation: Cancer hospital Fudan University
name: Chang jian hua, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03699566: Assessment of Trunk Muscle Endurance, Respiratory Functions and Respiratory Muscle Strength in Healthy Individuals
Official title: The Relationship Between Trunk Muscle Endurance, Respiratory Functions and Respiratory Muscle Strength in Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Muscles and Core Stabilization
Keywords: Trunk muscle endurance
respiratory muscle strength
respiratory functions
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: T.C. Dumlupınar Üniversitesi
First posted: 2018-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The diaphragm forms the upper segment of the core structure. At the same time, the diaphragm muscle acts as the first muscle in the inspiratory function. The aim of this study was to investigate the relationship between respiratory functions and trunk muscle endurance. In this context, respiratory muscle strengths, respiratory functions and body muscle endurance of the cases were measured.

Detailed description: The study was conducted on 60 healthy volunteers ranging in age from 20 to 36 years. 27 woman and 33 men participated in the study. Respiratory muscle strength, trunk muscle endurance, pulmonary function test values and physical activity levels were evaluated for the subjects participating in the study.Respiratory muscle strength and respiratory function tests were performed with a Cosmed Pony Fx portable spirometer. Trunk muscle endurance of the individuals were evaluated by prone bridge, side bridge, flexor endurance and sorensen test.

Eligibility criteria: Inclusion Criteria:

* Not having any chronic disease
* Not being pregnant

Exclusion Criteria:

* History of cardiopulmonary disease.
* Morbid obesity
* Major surgical history

Primary outcomes:
measure: Maximal voluntary inspiratory (PImax)
timeFrame: Baseline assessment no follow- up
measure: Prone Bridge Test
timeFrame: Baseline assessment no follow- up
Secondary outcomes:
measure: Maximal voluntary expiratory (PEmax)
timeFrame: Baseline assessment no follow- up
measure: Side Bride Test
timeFrame: Baseline assessment no follow- up
measure: Forced Vital Capacity ( FVC)
timeFrame: Baseline assessment no follow- up
measure: Forced Expiratuar Volume 1. Second ( Fev1)
timeFrame: Baseline assessment no follow- up
measure: Abdominal Flexor Endurance Test
timeFrame: Baseline assessment no follow- up
measure: Sorensen Test
timeFrame: Baseline assessment no follow- up
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Nevin Güzel, prof. dr.
role: STUDY_CHAIR
References:
Clinical trial NCT02243566: Post-marketing Surveillance Study With MicardisPlus® in Treatment of Morning Hypertension (Self-monitored by Patient)
Official title: Morning Hypertension and Patient Self-monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-18
Enrollment: 2707
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: Outpatients with essential hypertension

Brief summary: The purpose of the study was to examine the effect of six- to eight-week treatment with MicardisPlus® on blood pressure and the effect of patient self-monitoring on blood pressure control. In addition, the post-marketing surveillance study offered the possibility to obtain information about the influence on different laboratory parameters during treatment with MicardisPlus® from an unselected patient group under office conditions


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Hypertension

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Changes in morning blood pressure (systolic and diastolic)
timeFrame: Pre-dose, up to 8 weeks after start of treatment
measure: Changes from baseline in laboratory values
timeFrame: Pre-dose, up to 8 weeks after start of treatment
measure: Investigator assessment of efficacy on a 5-point scale
timeFrame: Up to 8 weeks after start of treatment
measure: Investigator assessment of influence on metabolism on a 3-point scale
timeFrame: Up to 8 weeks after start of treatment
measure: Investigator assessment of tolerability on a 5-point scale
timeFrame: Up to 8 weeks after start of treatment
measure: Number of patients with adverse events
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05771766: Postural Drainage With and Without Aerobic Training on Chronic Suppurative Lung Disease
Official title: Effects of Postural Drainage With and Without Aerobic Training on Respiratory Rate, Oxygen Saturation and Endurance in Chronic Suppurative Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Disease Chronic
Keywords: CSLD, Respiratory Rate, Endurance, Oxygen Saturation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a randomized controlled trial Patients will be divided into two groups randomly. Both groups will receive postural drainage as baseline treatment thrice a week for two weeks. The intervention group will undergo additional Aerobic Training thrice a week for two weeks as well along with postural drainage. Aerobic training will include a 5-step stair-climbing and a 10-step walk during each session. Data will be collected before and at the end of two weeks. Respiratory Rate, Pulse Oximeter, 10-meter Endurance walk test, and Pediatric Cough Questionnaire will be used to collect data pre and post-treatment. Data will be analyzed by use of SPSS Version 2010. Data will be presented in the form of mean and standard deviation.

Detailed description: Chronic suppurative lung disease (csld) is a clinical syndrome in children with respiratory symptoms and signs. Children who have bronchiectasis symptoms but non-diagnostic scans are described as having chronic suppurative lung disease (csld). Postural drainage improves secretion clearance techniques, it is equally as effective as other airway clearance techniques. This study will focus on the implementation of postural drainage and aerobic training in this disease to find their effect on respiratory rate, oxygen saturation, and endurance.

Eligibility criteria: Inclusion Criteria:

* Age of 5-13 years
* Medically stable,
* Patients must have 2 episodes of productive cough, each episode lasting for 4 weeks per year.

Exclusion Criteria:

* Non-Chronic Suppurative Lung Disease related chronic disease
* Chronic Suppurative Lung Disease-related conditions posing an increased risk to the patient when exercising.

children with any MSK-disorder or gait abnormalities

Primary outcomes:
measure: Respiratory Rate
timeFrame: 2 weeks
measure: Oxygen Saturation
timeFrame: 2 Weeks
measure: 10 Meter Walk Test
timeFrame: 2 Weeks
Secondary outcomes:
measure: 5-item Pediatric Cough Questionnair
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Gulab Devi Teaching Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Arnab Altaf, Mphill
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00734266: Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease
Official title: Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Dysfunction
Inflammatory Response During Cardiac Surgery
Keywords: COPD
CPB
Leukotrienes
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients schedules to undergo cardiac surgery with use of CPB.

Brief summary: The hypotheses of this study are that:

* Production and release of inflammatory substances called leukotrienes are increased during heart surgery with use of a heart-lung machine in humans;
* The increase in these leukotrienes levels after heart surgery is higher in patients with bronchitis and/or emphysema than in patients without previous history of lung disease;
* Levels of leukotrienes are directly correlated with worsening of lung function during and after heart surgery.

Detailed description: In this project, we will test the hypothesis that cys-leukotrienes are released and correlated with the impairment of the lung function after cardiac surgery in patients with COPD. If such hypothesis is substantiated in the study, it would allow us to propose the use of leukotriene inhibitors in the peri-operative period to improve pulmonary function and to decrease complications after cardiac surgery in COPD patients.

Eligibility criteria: Inclusion Criteria:

* Adult patients schedules to undergo cardiac surgery with use of CPB.

Exclusion Criteria:

* inability to provide consent;
* previous diagnosis of asthma;
* acute pre-operative respiratory failure;
* emergency surgery.

Primary outcomes:
measure: urine cysteinyl leukotriene
timeFrame: intra-operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Marcos F Vidal Melo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04388566: Development of the Danish Prospective Sarcoidosis Registry and Baseline Characteristics of a Danish Sarcoidosis Cohort
Official title: Development of the Danish Prospective Sarcoidosis Registry and Baseline Characteristics of a Danish Sarcoidosis Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 150
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 sarcoidosis seen in the Department of Respiratory Diseases, Aarhus Denmark

Brief summary: Development of a Danish Sarcoidosis Registry. Characterization of a cohort of sarcoidosis patients with respect to the baseline epidemiological characteristics, comorbidities, radiology, histopathology, diagnostic investigations and treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of sarcoidosis
* Signed informed consent

Exclusion Criteria:

* Inability or unwillingness to adhere to the study
* Inability to give informed consent

Primary outcomes:
measure: Characterization of Danish sarcoid patients
timeFrame: 2 years
measure: Feasibility and completion of a Sarcoidosis Registry.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT04447066: The Prevalence of Semicircular Canal Dysfunction Among Rehabilitation Patients
Official title: Semicircular Canals Dysfunction Among Patients Hospitalized at the Rehabilitation Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vertigo
Dizziness
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at the rehabilitation department

Brief summary: Patients hospitalized at the rehabilitation department at the hospital will fill a questionnaire regarding dizziness and ear diseases, and the Dizziness Handicap Inventory, and then will be examined by an ENT physician, followed by a video Head Impulse Test (vHIT) study.


Eligibility criteria: Inclusion Criteria:

* Over 65 years old
* Hospitalized at the rehabilitation department

Exclusion Criteria:

* Blindness or loss of vision which is not corrected using glasses
* Past CVA with neurological remnants
* Movement disorder
* Lower body part weakness
* Limitation in neck movement
* Vestibular pathology diagnosed in the past 6 months

Primary outcomes:
measure: Video Head Impulse Test (vHIT) results
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02940366: Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome
Official title: the Long-term Effects of High-doSe pitavaStatin on Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM) Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Metabolic Syndrome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: JW Pharmaceutical
First posted: 2016-10-20
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as metabolic syndrome according to National cholesterol Education Program criteria
* Patients with hypercholesterolemia who required to start statin therapy

Exclusion Criteria:

* overt diabetes
* acute coronary syndrome within 2 months
* acute cerebrovascular event within 2 months
* recent treatment of statin within 1month
* recent diagnosed neoplasm
* recent diagnosed liver disease
* chronic kidney disease
* patients with myopathy
* pregnant women, nursing mothers, women with possibility of pregnant
* patients being adminstered cyclosporine
* patients with genetic disease such as galactose intolerance, lactose intolerance, glucose-galactose malabsorption
* patients with treatment cyclosporin

Primary outcomes:
measure: Absolute change in HbA1c level
timeFrame: baselina and after 24months treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Park JB, Jung JH, Yoon YE, Kim HL, Lee SP, Kim HK, Kim YJ, Cho GY, Sohn DW. Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial. Trials. 2017 Oct 27;18(1):501. doi: 10.1186/s13063-017-2229-4.
Clinical trial NCT01056666: Conveen Optima Urisheaths With Collecting Bags Versus Absorbents
Official title: Evaluation de l'Impact Sur la qualité de Vie de l'Utilisation d'un système Collecteur Conveen( étuis pénien Conveen Optima Avec Poches de Recueil Conveen) Chez Des Hommes Souffrant d'Une Incontinence Urinaire modérée ou sévère, Comparativement à Leur Protection Absorbante Habituelle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 61
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of Conveen Optima urisheath in comparison with their usual absorbent protection.


Eligibility criteria: Inclusion Criteria:

* Patient over 18
* Out clinic patient
* Patient using absorbent protection for his urinary incontinence
* Moderate to severe urinary incontinence (1 hour pad test \> 10g)
* All kind of stable urinary incontinence
* Patient able to apply himself the device
* Patient able to understand the questions
* Patient having given his informed consent
* Patient whose overall treatment for his urinary incontinence is not modified during the study

Exclusion Criteria:

* Patient having a retracted penis
* Patient having skin problem on the penis
* Patient using urisheaths
* Bedridden patient
* Institutionalized patient
* Patient with indwelling catheter or under intermittent catheterisation
* Patient with fecal incontinence leading to the use of absorbent protection
* Patient suffering of urinary tract infection

Primary outcomes:
measure: Impact on quality of life
timeFrame: Days 0, 15, 30
Secondary outcomes:
measure: Efficacy (leakages)
timeFrame: days 13, 14, 15 and days 28, 29, 30
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Caremeau Nimes. France
name: Pierre Costa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054066: Managing Chronic Kidney Disease in Eastern North Carolina
Official title: Management of Chronic Kidney Disease in Eastern North Carolina (MARKER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Cardiovascular Disease
Hypertension
Anemia
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: The Kate B. Reynolds Charitable Trust
First posted: 2010-01-22
Enrollment: 1257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this program is to educate primary care physicians in four underserved clinics in eastern North Carolina about chronic kidney disease.

Detailed description: The Division of Nephrology within the Brody School of Medicine recently form a center to focus attention on the needs of patients with kidney disease in eastern North Carolina. It is estimated that more than 40 million Americans have or at risk for CKD. The estimate for CKD in eastern North Carolina is exacerbated by poor access to health care. The mission of the East Carolina University Center for the Study and Treatment of Kidney Disease (ECCKD) is to increase education and awareness, improve treatment and outcomes through research, and better serve patients with CKD in eastern North Carolina.

Eligibility criteria: Inclusion Criteria:

* Primary care clinics in eastern North Carolina with a high penetration of chronic kidney disease, risk factors for chronic kidney disease and poverty.

Primary outcomes:
measure: To determine the effect of CKD education on the behavior of the primary care physician in underserved areas in Eastern North Carolina.
timeFrame: every 6 months
Secondary outcomes:
measure: To assess the rate of reduction of CKD in patients in Eastern North Carolina.
timeFrame: every 6 months
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Paul Bolin, MD
role: PRINCIPAL_INVESTIGATOR
References: