louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04731896: Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6
Official title: Early Versus Late Amniotomy During Labor Induction in Women With Bishop's Score of ≥ 6 : a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor, Induced
Amniotomy
Keywords: labor
Amniotomy
induction
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Labor induction is the stimulation of uterine contractions during pregnancy, before labor begins on its own to achieve a vaginal birth.

A health care provider might recommend labor induction for various reasons: primarily when there's concern for a mother's health or a baby's health.

Combined with oxytocin infusion, amniotomy is commonly used in the induction of labor. However the perfect timing of amniotomy is still unknown.

The aim of this study is to determine whether the early amniotomy followed by oxytocin, or initiating induction of labor with oxytocin followed by late amniotomy, is effective to reach active phase of labor.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Full term (36 weeks and 3 days of gestation reached)
* Singletion gestation in cephalic presentation
* Bishop score of ≥ 6

Exclusion Criteria:

* Prior uterine surgery, previous cesarean section
* Ruptured membranes
* Spontaneous labor
* Multifetal pregnancy
* Dystocic presentation
* Fetal head not fixed at pelvic brim
* Macrosomia
* Hydramnios
* Severe fetal growth restriction
* Major fetal anomaly
* Women with HIV, hepatitis C, hepatitis B
* Women with medical conditions contraindication to a vaginal delivery
* Women with COVID-19 infection

Primary outcomes:
measure: Time to active phase of labor
timeFrame: At delivery
Secondary outcomes:
measure: Cesarean delivery rate
timeFrame: At delivery
measure: Time to vaginal delivery
timeFrame: At delivery
measure: Maternal outcomes
timeFrame: From inclusion to discharge, up to 2 weeks
measure: Fetal and neonatal outcome
timeFrame: From inclusion to discharge, up to 2 weeks
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: University hospital Mongi Slim la Marsa
state: La Marsa
Study officials:
References:
Clinical trial NCT00740896: Acute Effects of Smoking on Airway Dendritic Cells
Official title: Acute Effects of Smoking on Airway Dendritic Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Cigarette Smoking
Airway dendritic cells
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2008-08-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Airway dendritic cells control pulmonary immune responses to inhaled particles. It is the aim of the present study to investigate the acute effects of smoking on the number and surface molecule expression of human airway dendritic cells.


Eligibility criteria: Inclusion Criteria:

* Active smoking (at least 10 cigarettes per day)
* Age \> 18 years

Exclusion Criteria:

* Any chronic diseases
* Any regular medication
* Any signs or symptoms of an acute infection

Primary outcomes:
measure: Total number of dendritic cells in bronchoalveolar lavage fluid
timeFrame: June - September 2008
Secondary outcomes:
measure: Surface molecule expression on dendritic cells in bronchoalveolar lavage fluid
timeFrame: June - September 2008
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock
Study officials:
affiliation: University of Rostock
name: Johann C. Virchow, Professor, MD, FRCP, FCCP
role: STUDY_CHAIR
References:
citation: Bratke K, Klug M, Bier A, Julius P, Kuepper M, Virchow JC, Lommatzsch M. Function-associated surface molecules on airway dendritic cells in cigarette smokers. Am J Respir Cell Mol Biol. 2008 Jun;38(6):655-60. doi: 10.1165/rcmb.2007-0400OC. Epub 2008 Jan 18.
Clinical trial NCT01251796: A Study of ARQ 197 in Combination With Erlotinib
Official title: A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced/Recurrent Non-small-cell Lung Cancer
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.


Eligibility criteria: Inclusion Criteria:

* Voluntary written informed consent for study participation must be obtained
* A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
* History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
* ECOG PS of 0 or 1
* Life expectancy of ≥3 months
* Poor metabolizers as defined by CYP2C19 genotype

Exclusion Criteria:

* Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
* Surgery for cancer within 28 days prior to ARQ 197 dose
* Active double cancer
* Known symptomatic brain metastases
* An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
* Pregnant or lactating
* Subjects who wish to have a child and who would not agree to use contraceptive measures

Primary outcomes:
measure: Dose-Limiting Toxicity in the combination of tivantinib and erlotinib
timeFrame: DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.
Secondary outcomes:
measure: Pharmacokinetic profile of ARQ 197
timeFrame: Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
measure: Pharmacokinetic profile of Erlotinib
timeFrame: At pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
measure: Antitumor activity
timeFrame: Baseline, and then every 6 week of imaging until discontinuation criteria met
Other outcomes:
Locations:
city: Shizuoka
country: Japan
Study officials:
References:
Clinical trial NCT01007396: Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
Official title: Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Latent Tuberculosis Infection
Keywords: Interferon-gamma release assay
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 322
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The present study was to evaluate the usefulness of a whole-blood interferon-r release assays (IGRAs) as diagnostic tool of the latent tuberculosis infection for healthcare workers.


Eligibility criteria: Inclusion Criteria:

* doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.

Exclusion Criteria:

* Non-applicable

Primary outcomes:
measure: Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea
timeFrame: QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years.
Secondary outcomes:
measure: Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)
timeFrame: 3 months after LTBI treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won-Jung Koh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05466396: Lung Health of Early COPD: A Multi-center Cohort Study
Official title: Lung Health of Early Chronic Obstructive Pulmonary Disease: A Multi-center Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Keywords: early COPD
spirometry
lung health
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2022-07-20
Enrollment: 1550
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers with mild lung function abnormality will be included in this cohort study.

Brief summary: This is a multi-center, prospective, cohort study in early COPD patients. This study aims to elucidate the lung function decline and its association with smoking and other risk factors. Other biomarkers and image markers from chest CT scan are also analyzed to investigate the lung function in early COPD patients.


Eligibility criteria: Inclusion Criteria:

1. Gender: male or female
2. Age: 35-75 years old
3. post-bronchodilator spirometry: FEV1/FVC \< 0.8 and FEV1%pred ≥80%

Exclusion Criteria:

1. Other diseases may affect lung function, like lung cancer, bronchiectasis, interstitial lung disease or chest surgery.
2. BMI \> 35 kg/m2
3. Dementia or other severe neurological disease
4. Pregnancy
5. Conditions that contraindicated lung function test

Primary outcomes:
measure: Lung function decline in Pre-COPD and Mild-COPD patients
timeFrame: 2 years
Secondary outcomes:
measure: Lung function decline in smokers with Pre-COPD and Mild-COPD
timeFrame: 2 years
measure: Lung function decline in non-smokers with Pre-COPD and Mild-COPD
timeFrame: 2 years
Other outcomes:
measure: Lung function decline and biomarkers in Pre-COPD and Mild-COPD patients
timeFrame: 2 years
measure: Lung function decline and Image markers in Pre-COPD and Mild-COPD patients
timeFrame: 2 years
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
Study officials:
affiliation: China-Japan Friendship Hospital
name: Ting Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03398096: Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study
Official title: Improvement of Cardiac Function in Patients With Ischemic Cardiomyopathy by Extracorporeal Shock Wave Therapy: a Multicenter Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 200
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: TREATMENT

Brief summary: Cardiac shock wave therapy (CSWT) is a noninvasive new therapeutic option in the treatment of chronic refractory angina pectoris. Many domestic and international researches have revealed that CSWT contributes to revascularization by stimulating angiogenesis. We were aimed to evaluate the safety and efficiency of CSWT in the treatment of refractory angina.


Eligibility criteria: Inclusion Criteria:

* Patients were 18 to 80 years old;
* Coronary angiography (CA) or multi-slice CT coronary angiography (CTCA) suggestive of moderate to severe coronary artery stenosis;
* Chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft);
* Hospitalized more than 2 times within 1 year due to the aforementioned problems;
* CCS angina grading higher than grade II, and New York Heart Association (NYHA) class I-III;
* More than 1 month after acute myocardial infarction (AMI) and 1 month after percutaneous coronary intervention (PCI) surgery.

Exclusion Criteria:

* AMI、PCI or coronary artery bypass graft (CABG) within the 4 weeks prior to the study;
* History of heart transplantation;
* History of metal valve replacement surgery;
* Intra-cardiac thrombus;
* Left Ventricular Ejection Fraction (LVEF) \< 30 % and unstable hemodynamics;
* Arrhythmia with a rate \< 40 bpm or \> 120 bpm;
* Skin ulceration or infection in the treatment area;
* Severe obstructive lung disease.

Primary outcomes:
measure: Canadian Cardiovascular Society (CCS) grading of angina
timeFrame: 6 months
measure: Seattle angina questions (SAQ)
timeFrame: 6 months
measure: 6-min walk test
timeFrame: 6 months
measure: Nitrate consumption
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
citation: Weijing L, Ximin F, Jianying S, Mengyun Z, Xuehua F, Yawei X, Liqiong H. Cardiac Shock Wave Therapy Ameliorates Myocardial Ischemia in Patients With Chronic Refractory Angina Pectoris: A Randomized Trial. Front Cardiovasc Med. 2021 Jul 21;8:664433. doi: 10.3389/fcvm.2021.664433. eCollection 2021.
Clinical trial NCT02670096: A Single-center Pilot Study Evaluating the Immediate Effects of Low-dose Acetazolamide on Respiratory Control in Subjects With Treatment Emergent Sleep Disordered Breathing
Official title: A Single-center Pilot Study Evaluating the Immediate Effects of Low-dose Acetazolamide on Respiratory Control in Subjects With Treatment Emergent Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Apnea
Keywords: acetazolamide
Treatment Emergent Sleep Disordered Breathing
Sleep Apnea
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 0
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: TREATMENT

Brief summary: This is a single center pilot study evaluating the immediate effects of low-dose acetazolamide on respiratory control in subjects with treatment emergent sleep disordered breathing. The purpose of this study is to assess the immediate effect one-time low-dose acetazolamide on sleep breathing in (Treatment Emergent Sleep Disordered Breathing) TE-CSA subjects compared to subjects' baseline evaluation without acetazolamide. Investigators will also try to determine the immediate effect of one-time low-dose acetazolamide on subjects' resting ventilation and ventilatory response slope compared to subjects' baseline evaluation without acetazolamide.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 to 80 years
* TE-CSA
* Subjects are capable of giving informed consent

Exclusion Criteria:

* Hypersensitivity to acetazolamide or other sulfonamides
* Intake of carbonic anhydrase inhibitors within the last 72 hours
* Intake of medication that influences breathing, sleep, arousal or muscle physiology
* Cheyne-Stokes respiration
* Heart failure
* Renal failure
* Liver failure
* Chronic hypercapnea
* Hyponatremia
* Hypokalemia
* Pregnancy
* Breastfeeding mothers
* Active drug/alcohol dependence or abuse history

Primary outcomes:
measure: Severity of Obstructive Sleep Apnea before and after acetazolamide administration using Laboratory Nocturnal Polysomnography
timeFrame: 60 Days
measure: Total lung capacity before and after acetazolamide administration
timeFrame: 60 Days
Secondary outcomes:
measure: Gas composition with and without acetazolamide using Resting Ventilation Study (RVS)
timeFrame: 20 Minutes
measure: Measure of ventilatory response to carbon dioxide (CO2) without and with acetazolamide
timeFrame: 15 Minutes
measure: Measurement of Arterial Blood Gas (ABG)
timeFrame: 60 Days
measure: Measurement of Venous Blood (VB) Analysis
timeFrame: 60 Days
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: David Rapoport, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01626196: Evaluation of the Main Determinants of Patient Acceptability of the Bowel Cleansing Procedure, and of Success of Bowel Cleansing and Caecal Intubation
Official title: Multicentre, Observational, Prospective Study, Conducted on Italian Out-patients Undergoing Colonoscopy, for the Evaluation of the Main Determinants of the Patient's Acceptability of Bowel Cleansing Procedure, and of the Success of Bowel Cleansing and Caecal Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Routine Colonoscopy
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2012-06-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients invited for routine colonoscopy were invited to participate in hte study.

Brief summary: Several factors are important in achieving a successful colonoscopy, including patient acceptability of the bowel cleansing procedure and the overall quality of cleansing.

This observational study has been designed to explore the main determinants of acceptability of the bowel cleansing procedure to the patient in an Italian "real life" setting. In addition, the study is to examine the determinants of quality of bowel cleansing and describe aspects of the technical performance of the colonoscopy (time to reach the caecum and adenoma detection rate).


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained prior to inclusion.
* Male and female outpatients, aged ≥ 18, treated with bowel cleansing preparation the day before undergoing routine colonoscopy at selected participating centres.

Exclusion Criteria:

* Children and adolescents aged less than 18 years. Pregnant or breastfeeding women.
* Listed contra-indications to the relevant product used for the bowel cleansing procedure.
* Patients having been submitted to a previous colonoscopy over the last five years.
* Patients who have taken laxative enemas the day preceding the colonoscopy.

Primary outcomes:
measure: Patients acceptability of the procedure
timeFrame: One day
Secondary outcomes:
measure: Time to reach the caecum
timeFrame: One day
measure: Adenoma detection rate
timeFrame: One day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Instituto Clinico Humanitas
state: Rozzano
Study officials:
affiliation: Instituto Clinico Humanitas
name: Alessandro Repici, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005296: Sleep Apnea: Age Effects On Prevalence and Natural History
Official title: Sleep Apnea: Age Effects On Prevalence and Natural History
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Sleep Apnea Syndromes
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Enrollment: 741
Sex: MALE
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: stratified random sample following phone interview

Brief summary: To identify the prevalence of sleep apnea in men and its relationship to age, assess the natural history of the disorder, and predict those men at risk.

Detailed description: BACKGROUND:

Sleep apnea is potentially a life-threatening disorder commonly associated with the aging process. Often sleep apnea is accompanied by considerable morbidity for both physical and mental health; the associated excessive daytime sleepiness, cardiovascular abnormalities, and cognitive impairment impact greatly on daytime functioning. In 1990, the prevalence of sleep apnea in the general population was undetermined, and there was much speculation regarding its natural history.

DESIGN NARRATIVE:

For the prevalence study, 4,364 randomly-sampled men selected from the general population and stratified by age were evaluated for risk factors for sleep apnea. A total of 741 men found to be at risk were evaluated in the sleep laboratory to determine the degree, if any, of sleep apnea or sleep disordered breathing. Prior to recording subjects in the sleep laboratory, a thorough history was obtained from each subject and a physical examination completed. All men entering into the first four years of the prevalence portion of the study who were found to have sleep apnea or sleep disordered breathing were reevaluated yearly over a five year period in the natural history part of the study. The natural history portion also included 150 men previously studied in the sleep laboratory for apnea but who were not part of the random sample of 4,000 and who were not part of the prevalence study.

Eligibility criteria: stratified random sample based on risk severity for sleep disordered breathing based on phone interview

Primary outcomes:
measure: sleep disordered breathing
timeFrame: immediately upon time of recording
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bixler EO, Vgontzas AN, Ten Have T, Tyson K, Kales A. Effects of age on sleep apnea in men: I. Prevalence and severity. Am J Respir Crit Care Med. 1998 Jan;157(1):144-8. doi: 10.1164/ajrccm.157.1.9706079.