louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01317823: Bishop Score and Transvaginal Ultrasound for Preinduction Cervical Assessment in Multiparas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Induction of Labor
Keywords: Multiparas, Bishop score, Cervical length, Cervical ripening
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 154
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare the ultrasonographic cervical length with the Bishop score in determining the administration of prostaglandin for preinduction cervical ripening in multiparous women at term.


Eligibility criteria: Inclusion Criteria:

* multiparous patients
* singleton pregnancy
* live fetus with vertex presentation
* intact amniotic membranes
* \> 37 weeks gestation
* absence of labor
* no previous uterine surgical procedures

Exclusion Criteria:

* major congenital anomaly

Primary outcomes:
measure: Successful labor induction
timeFrame: Eleven hours of initiating oxytocin on the fist day of induction
Secondary outcomes:
measure: the need for oxytocin induction, percentage of patients treated with prostagladins
timeFrame: After removing prostaglandin, the following day when an intravenous oxytocin infusion was started
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kyo Hoon Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01596023: Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients
Official title: Evaluation of Effect of Breathe Ventilation System on Work of Breathing in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Lung Disease
Keywords: COPD
Lead sponsor: Breathe Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tufts Medical Center
First posted: 2012-05-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe chronic obstructive lung disease (COPD) to assess their work of breathing while using the NIOV system as measured by esophageal and stomach pressures.


Eligibility criteria: Inclusion Criteria:

1. Subject is \>18 years of age at time of consent.
2. Subject has diagnosis of severe COPD (GOLD stage III or IV) as demonstrated by a FEV1 \< 50% predicted and FEV1/FVC ratio \< 70% predicted.
3. Subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration

Exclusion Criteria:

1. Subject has acute exacerbation of COPD - within 1 week of acute hospitalization
2. Subject has respiratory rate at rest \> 28/min
3. Subject requires \> 5 L/min nasal O2/min to maintain O2sat \> 90%
4. Subject has severe dyspnea at rest
5. Subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement.
6. Subject has history of pneumothorax secondary to lung bullae.
7. Subject is too cognitively impaired to give subjective ratings for visual analog scale
8. Subject has sensitivity or an allergy to lidocaine
9. Subject has known history of oxygen intolerance.

Primary outcomes:
measure: Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System
timeFrame: 10 min
Secondary outcomes:
measure: Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min
timeFrame: 10 Min
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Nicholas Hill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06166823: Electronic Medical Record Alerts to Optimize Medical Therapy in Heart Failure and Reduced Ejection Fraction
Official title: Electronic Medical Record Alerts to Optimize Medical Therapy in Heart Failure and Reduced Ejection Fraction in a Low-middle Income Country
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HFrEF - Heart Failure With Reduced Ejection Fraction
Lead sponsor: Instituto Cardiovascular de Buenos Aires
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 240
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: OPTIMAL-HF is a pragmatic, cluster randomized, single-blind intervention trial that will be conducted at an outpatient clinic in Argentina. The trial will assess the effectiveness of an individualized-based alert system compared to usual care in improving GDMT optimization at 90 days in patients with HFrEF.


Eligibility criteria: Patients

Inclusion Criteria:

* Eligible patients will include those with an EF ≤ 40% on their most recent echocardiogram, age \> 18, and an outpatient cardiology encounter during the study period.
* Age 18 or over

Exclusion Criteria:

* under optimal medical treatment
* palliative care, or undergoing hemodialysis will be excluded

Cardiologist

Inclusion criteria:

Cardiologists from an outpatient clinic at a cardiovascular center in Buenos Aires will be selected for potential participation in the study.

Exclusion criteria Cardiologists belonging to the heart failure service

Primary outcomes:
measure: The primary efficacy endpoint will be the GDMT optimize score in HfrEF patients 90 days after randomization.
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02238223: Postmarketing Surveillance to Investigate the Safety and Efficacy Information of Alesion® Tablet
Official title: Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Tablet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 2001
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients without experience treating of epinastine are selected by physicians at medical institutions

Brief summary: Study to investigate the safety and efficacy information of Alesion® Tablet under the proper use in daily clinical practice after new treatment guideline for allergic rhinitis, bronchial asthma, eczema, dermatitis, urticaria, pruritus, prurigo and psoriasis vulgaris with itching


Eligibility criteria: Inclusion Criteria:

All the patients who:

* haven't treatment experience of epinastine product;
* have at least one out of following diseases. allergic rhinitis, eczema, dermatitis, pruritus, prurigo, urticaria, psoriasis with itching, bronchial asthma

Exclusion Criteria:

* Alesion® Tablet is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Tablet in package insert. However, it is unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey is drug utilization study to observe actual use in any patients. Therefore exclusion criteria is not set in the protocol

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: up to 24 months
measure: Incidence of adverse drug reactions classified by patient's background/treatment factors
timeFrame: up to 24 months
Secondary outcomes:
measure: Overall assessment of efficacy by investigator on a 3-point scale
timeFrame: after 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01870323: The Social Media and Activity Research in Teens Trial
Official title: The Social Media and Activity Research in Teens Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 21
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In an effort to address the physical inactivity crisis among adolescents, the present study will examine the efficacy of using an already established Web-based social networking platform (i.e., Facebook) to deliver a physical activity intervention to adolescents.

Detailed description: In an effort to address the physical inactivity crisis among adolescents, the present study will examine the efficacy of using an already established Web-based social networking platform (i.e., Facebook) to deliver a physical activity intervention to adolescents. The primary objectives of this trial are to 1) test the efficacy of a social media-delivered physical activity program for increasing lifestyle physical activity in adolescents, and 2) determine the effectiveness of a physical activity intervention based on social cognitive principles in comparison to a simple information-based physical activity condition. Additional objectives include an examination of how program participation may influence psychosocial health and how these changes affect physical activity patterns in youth.

Eligibility criteria: Inclusion Criteria:

* Must be between 13-15 years of age
* Must not regularly meet nor exceed 60 minutes of daily physical activity
* Must have access to computer with Internet connection at home
* Must reside in Champaign County

Exclusion Criteria:

* Physical limitations that may prevent regular participation in physical activity or may inadvertently exacerbate any per-existing medical condition

Primary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline, Week 8, 4-Week Follow-Up (i.e., Week 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Exercise Psychology Laboratory
state: Illinois
Study officials:
affiliation: Kinesiology & Community Health, UIUC
name: Edward McAuley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wojcicki TR, Grigsby-Toussaint D, Hillman CH, Huhman M, McAuley E. Promoting Physical Activity in Low-Active Adolescents via Facebook: A Pilot Randomized Controlled Trial to Test Feasibility. JMIR Res Protoc. 2014 Oct 30;3(4):e56. doi: 10.2196/resprot.3013.
Clinical trial NCT05879523: A Trial of HRS-1893 in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effects of Food on the Pharmacokinetics of HRS-1893 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-30
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HRS-1893 compared with placebo
Primary purpose: TREATMENT

Brief summary: The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy


Eligibility criteria: Inclusion Criteria:

1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF)
2. Male or female aged 18-55（adult healthy volunteers）or 18-85 (oHCM patients).
3. Body mass index (BMI) between 19 and 28 kg/m2.
4. Normal Electrocardiogram (ECG)

Exclusion Criteria:

1. History of persistent tachyarrhythmia and syncope;
2. A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy);
3. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.

Primary outcomes:
measure: incidence of adverse event (AE), serious adverse event (SAE)
timeFrame: Start of Treatment to end of study (approximately 34 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT06679023: Wound Biofilm Detection Kit Development: Validation of Grading System With Biofilm Severity
Official title: Biofilms in Chronic Wounds Pathogenesis and Diagnosis: Quantification of Biofilm and Validation of Grading System in Modified Alcian Blue Biofilm Detection Kit (WBDK-GB)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Wound
Wound Healing
Biofilm Infection
Keywords: chronic wound
wound healing
Biofilm detection
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 60
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: chronic wound

Brief summary: Chronic wound is a leading health issue in current health care system. Biofilm is a notorious risk factor of unhealed wound. Although biofilm-direct wound care has been a prevalent strategy of wound care currently, diagnosis of biofilm still remained as an unmet clinical need. Several advanced diagnostic tools of biofilm had been published in recent years, however, the evidence was still insufficient.

In this study, we will enroll patients with chronic wounds, collect the wound debris, quantify the biofilm and validate with the signals of advanced diagnostic tools for biofilm detection, hoping to transform the tools which could only tell us whether the biofilm is present or not, into the severity of biofilm infection. The two tested tools includes of MolecuLight i:X and wound blotting and Alcian blue biofilm detection kit.


Eligibility criteria: Inclusion Criteria:

* 1.Age 18 or older
* 2.Has an unhealed wound and is scheduled for debridement surgery
* 3.Patients who are receiving wound care at this hospital (Hsinchu branch) and are able to comply with follow-up wound monitoring

Exclusion Criteria:

* Does not consent to provide remaining tissue from wound treatment for in vitro analysis.
* Allergic to nylon components.
* Under 18 years of age.

Primary outcomes:
measure: 90-day wound healing
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT00449423: Metabolic Modulation as Treatment in Acute Heart Failure
Official title: Metabolic Modulation as Treatment in Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Heart Failure
Keywords: Acute heart failure
Metabolic modulation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-03-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate whether metabolic modulation improves hemodynamics and outcome in acute heart failure

Detailed description: Acute heart failure is a serious disease that despite modern therapies carries a high mortality. Inotropic drugs improve patient status but yield a higher risk of death. Previous studies have shown that myocardial contractility improves when glucose fermentation is up regulated and decreases when Free Fatty Acids are high. In a placebo-controlled design we wish to shift myocardial substrate metabolism towards increased glucose uptake and utilization and measure hemodynamics and biochemical markers of metabolism and prognosis.

Eligibility criteria: Inclusion Criteria:

* Acute heart failure
* NYHA class III - IV.
* ejection fraction \<35

Exclusion Criteria:

* Age \<18 år or \>85 år,
* allergy
* renal failure
* recently developed brady- or tachy-arrythmias
* Serious infection
* Heart failure due to restrictive or hypertrophic cardiomyopathy or stenotic valvular heart disease
* Recent Myocardial infarction (\<6 Weeks)
* Pulmonary Wedge pressure \>30 mm Hg
* diabetes mellitus treated with insulin
* peptic ulcer
* pregnancy

Primary outcomes:
measure: Cardiac index
measure: pulmonary Wedge Pressure
measure: Ejection fraction
Secondary outcomes:
measure: myocardial glucose- and Free Fatty Acid-extraction
measure: cardiac output
measure: Regional left ventricle function
measure: outcome day 6 and 30
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby Sygehus, Department of Cardiology
Study officials:
affiliation: Aarhus University Hospital, Department of Cardiology
name: Mads Halbirk, dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04034823: KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
Official title: KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HER2-positive Breast Cancer
Keywords: HER2-positive breast cancer
PD-L1 immune checkpoint
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Female subjects with age 18 to 70 (inclusive) years at the time of consent
* LVEF ≥50% at baseline
* ECOG performance status of 0-1
* Have not received 1L treatment for recurrent or metastatic breast cancer
* Adequate organ function

Exclusion Criteria:

* History of exposure to the cumulative doses of doxorubicin \> 400 mg / m2 or equivalent
* History of autoimmune diseases
* Active brain metastasis
* Concurrent diseases that compromise patient's safety

Primary outcomes:
measure: Objective response
timeFrame: 12 months
Secondary outcomes:
measure: Adverse events
timeFrame: 12 months
Other outcomes:
measure: Disease control rate
timeFrame: 12 months
Locations:
Study officials:
References:
Clinical trial NCT01338623: Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State
Official title: Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hyperplasia Prostatic
Keywords: bioequivalence
tansulosine
Lead sponsor: Biocinese
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the bioavailability (rate and extent of absorption) of two tansulosine 0,4 mg capsule formulations. An open, randomized, two-period crossover study with a seven-days washout interval was conduced in 32 healthy male volunteers. The plasma samples were obtained up to 72 hours after drug administration. A sensitive and specific LC-MS/MS method was developed and validated for the determination of tansulosine in human plasma. Bioequivalence between the products was determined by calculating 90% confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.

Detailed description: The study protocol was approved by Local Ethics Committee (UNICAMP - Campinas, Brazil). The study was performed with 32 healthy male volunteers. They were within 10% of their ideal body weight. Biochemical test and physical examination were carried out. Their medical history was also obtained. . Volunteers did not drink caffeine-containing drinks 48-hours before the study. The volunteers gave written informed consent to participate in study.

The study was designed as two-single-dose, randomized, open-label, balanced, crossover study, with two periods separated by 7-days washout. In both periods after a standard breakfast volunteers were given a single dose of their formulation (reference or test) of tansulosine with 200 mL of water. Blood samples (8 ml) were collected at 0 (pre-dose) and at 01:00; 02:00; 03:00; 04:00; 04;30; 05:00; 05:20; 05:40; 06:00; 06:20; 06:40; 07:00; 07:30; 08:00; 08:30; 09:00; 10:00; 12:00; 24:00; 48:00; 72:00h. These samples were centrifuged immediately and kept frozen at -20°C until the time of analysis. Standard meals were served at 4 and 8h after administration. During hospital confinement, volunteers were always under medical supervision.

Eligibility criteria: Inclusion Criteria:

* They were within 10% of their ideal body weight.
* Biochemical test and physical examination were carried out.
* No concomitant medications were allowed.
* Volunteers did not drink caffeine-containing drinks 48-hours before the study.
* The volunteers gave written informed consent to participate in the study.

Exclusion Criteria:

* Chronic disease
* Smokers

Primary outcomes:
measure: Bioequivalence interval
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Brazil
facility: Biocinese
state: Paraná
Study officials:
affiliation: Biocinese
name: Josélia Manfio, Dr
role: PRINCIPAL_INVESTIGATOR
References: