louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02623634: Effects of Different Postures and Ventilator Flow Waveforms on the Cuff Leak Test
Official title: Effects of Different Postures and Ventilator Flow Waveforms on the Cuff Leak Test: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cuff Leak Volume
Keywords: Cuff leak test, relative factors
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients in RICU of Beijing chaoyang hospital with tracheal intubation

Brief summary: the purpose of this study is to analyzes the factors influencing the results of cuff leak test, in order to improve the cuff leak test on the accuracy of the prediction on airway edema after extubation.


Eligibility criteria: Inclusion Criteria:

* Intubation less than 24 hours before amitting respiratory intensive care unit;

Exclusion Criteria:

* unstable hemodynamics;PEEP≥10cmH2O or FiO2≥0.8

Primary outcomes:
measure: post-extubation stridor
timeFrame: 48 hours
Secondary outcomes:
measure: Extubation failure due to PES
timeFrame: 48 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao Yang Hospital RICU
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Huiwen Chu, bachelor
role: STUDY_DIRECTOR
References:
citation: Prinianakis G, Alexopoulou C, Mamidakis E, Kondili E, Georgopoulos D. Determinants of the cuff-leak test: a physiological study. Crit Care. 2005 Feb;9(1):R24-31. doi: 10.1186/cc3012. Epub 2004 Nov 29.
citation: Kemper KJ, Benson MS, Bishop MJ. Predictors of postextubation stridor in pediatric trauma patients. Crit Care Med. 1991 Mar;19(3):352-5. doi: 10.1097/00003246-199103000-00012.
citation: Potgieter PD, Hammond JM. "Cuff" test for safe extubation following laryngeal edema. Crit Care Med. 1988 Aug;16(8):818. doi: 10.1097/00003246-198808000-00020. No abstract available.
citation: El-Orbany M, Salem MR. Endotracheal tube cuff leaks: causes, consequences, and management. Anesth Analg. 2013 Aug;117(2):428-34. doi: 10.1213/ANE.0b013e318292ee21. Epub 2013 Jun 6.
Clinical trial NCT03159234: Prediction of Fetal Lung Maturity
Official title: Evaluation of New Methods for Prediction of Fetal Lung Maturity in Diabetic Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Distress
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Diabetes is the most common medical complication of pregnancy in the united states four to five percent of pregnancies are complicated by diabetes.

Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87 percent . The prevalence of pregestational diabetes has been increasing due to the increasing prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical management of pregestational diabetes involves frequent monitoring of blood glucose levels with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is important because maintenance of maternal blood glucose concentration at or near normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as miscarriage , congenital anomalies , macrosomia and fetal death.


Eligibility criteria: Inclusion Criteria:

* All pregnant diabetic women
* 37 weeks gestational age .

Exclusion Criteria:

* Women before 37 and after 39 weeks gestational age
* Pregnancies with known fetal anomalies that may potentially affect the lung maturity .
* Multiple pregnancies.
* Women received steroids for lung maturation after ultrasound image acquisition and before delivery .
* Women with premature rupture of membranes (prom)
* Pregnancies complicated by medical disorders other than diabetes mellitus .
* Failure to obtain an informed consent .

Primary outcomes:
measure: APGAR score
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT01783834: Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients
Official title: Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Previous Treated Metastatic Non-small Cell Lung Cancer
Keywords: Pemetrexed
Gefitinib
iressa
alimta
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer


Eligibility criteria: Inclusion Criteria:

* Cells pathologically diagnosed as histological or radical surgery or radiation therapy is not possible stage IIIB and stage IV non-small-cell lung cancer patients
* second line
* ECOG 0～2
* Patients with normal liver function and renal function

Exclusion Criteria:

* Patients with severe acute infection requiring antibiotic therapy
* Patients who have received treatment in other areas of cancer within 5 years
* During pregnancy and lactation patients

Primary outcomes:
measure: Overall response rate
timeFrame: 5 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 5years
Other outcomes:
measure: Number of participants with adverse events
timeFrame: 5years
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon university Gil Medical Center
Study officials:
References:
Clinical trial NCT06795334: Long Term Impact of Induced Abortion
Official title: Long Term Impact of Induced Abortion: a Multicenter Prospective Cohort Study in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-medical Abortion Surgery
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 13000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who voluntarily request non-medical abortion surgery, early pregnancy (≤ 10 weeks of gestation); Age range: 20-40 years old (inclusive); Willingness to have another child; No long-term intention to go abroad during the research period; Willing to accept regular postoperative follow-up and voluntarily sign an informed consent form.

Brief summary: Through prospective observation of the queue, the risks of mid to long term complications for Chinese women caused by surgical and medical abortion, as well as their potential impacts on women's fertility, pregnancy complications/comorbidities, and maternal and infant health, are identified. This provides scientific evidence for the assessment, protection, and preservation of fertility among Chinese women of childbearing age, and decision-making basis for the development and improvement of artificial abortion and fertility policies and guidelines for the country.


Eligibility criteria: Inclusion Criteria:

* Women who voluntarily request non-medical abortion surgery, early pregnancy (≤ 10 weeks of gestation); Age range: 20-40 years old (inclusive); Willingness to have another child; No long-term intention to go abroad during the research period; Willing to accept regular postoperative follow-up and voluntarily sign an informed consent form.

Exclusion Criteria:

* Pathological miscarriage such as spontaneous abortion and missed abortion; Difficulty in reading, writing, or understanding; Other situations deemed unsuitable for inclusion by doctors.

Primary outcomes:
measure: artificial abortion
timeFrame: 2 years
Secondary outcomes:
measure: medical abortion
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00751634: Temperature Control in Central Fever in the Neuro-ICU
Official title: Temperature Control in Central Fever in the Neuro-ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fever
Brain Hemorrhage
Keywords: subarachnoid hemorrhage
intracerebral hemorrhage
fever
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Gaymar Industries, Inc.
First posted: 2008-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.


Eligibility criteria: Inclusion Criteria:

* Two or more days with core temperature ≥ 100.4F
* Approval of the patient's primary attending physician
* Need for core temperature measurement independent of the study.
* Admission to the Neuro-ICU \[intensive care unit\] for an underlying condition

Exclusion Criteria:

* Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS \[central nervous system\] infection or urinary tract infection.
* Expected death from any cause
* Known sensitivity to the device
* History of pre-admission hypothalamic dysfunction or known temperature dysregulation
* Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely
* Hemodynamic instability

Primary outcomes:
measure: Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care
timeFrame: baseline, one, two and six hours after application.
Secondary outcomes:
measure: Time From Start of Cooling Device to Core Temperature < 100.4F
timeFrame: Six hours
measure: Number of Participants With Severe Shivering
timeFrame: six hours
measure: Number of Participants With Hypotension
timeFrame: six hours
measure: Number of Participants With Arrhythmia
timeFrame: Six hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Andrew M Naidech, MD MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01233934: Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Insect Bites
Keywords: Insect bites
Dexchlorpheniramine
Gel
Cream
Lead sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.


Eligibility criteria: Inclusion Criteria:

* Presence of papules resulting from insect bites within the last 72 hours;
* Presence of symmetric lesions to compare one side to the other;
* Compliance of the subject to the treatment protocol;
* Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old.

Exclusion Criteria:

* Pregnancy or risk of pregnancy;
* Lactation;
* Use of topical or systemic anti-inflammatory, anti-histaminics or immunosuppressive drugs within the last 48 hours prior to the study;
* History of atopy or allergic diseases;
* History of allergy of any component of the formulations;
* Other conditions considered by the investigator as reasonable for non-eligibility.

Primary outcomes:
measure: Pruritus Intensity at Insect Bite Site, Evaluated With a 10 Point Visual Analogic Scale (VAS)
timeFrame: 7 days
Secondary outcomes:
measure: Composite Clinical Evaluation of Erythema, Pruritus and Papule Formation, Performed by the Investigator Using a 4-point Scale for Each One of the Parameters (Absent, Mild, Moderate, Intense). This Evaluation Constitutes the Insect Bite Score.
timeFrame: 7 days
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto da Pele Ltda.
state: São Paulo
Study officials:
References:
Clinical trial NCT06544434: Laser Acupuncture for Meniere Disease
Official title: Laser Acupuncture for Meniere Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Meniere Disease
Keywords: Meniere Disease
RCT
Laser acupuncture
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 324
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: Objective: To evaluate the effect of laser acupuncture for the patients Meniere disease.

Methods: We enrolled 324 patients at Beijing Tongren Hospital. Patients completed outcome measures at baseline, 3 months, 6 months, and 12 months. Video head impulse test (vHIT), The Caloric Test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry (PTA), and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of meniere disease.

Exclusion Criteria:

1. Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases.
2. Planning for pregnancy, those in pregnancy, or those who were lactating.

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Baseline, month 3, 6 and 12
measure: Tinnitus Handicap Inventory (THI)
timeFrame: Baseline, month 3, 6 and 12
measure: Pure tone thresholds (PTA)
timeFrame: Baseline, month 3, 6 and 12
measure: Visual analogue scale (VAS)
timeFrame: Baseline, month 3, 6 and 12
Secondary outcomes:
measure: Video head impulse test (vHIT)
timeFrame: Baseline, month 3, 6 and 12
measure: The Caloric Test
timeFrame: Baseline, month 3, 6 and 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TongRen Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT06457334: Effect of Helicobacter Pylori Eradication on Gastroesophageal RefIux Disease (GERD)
Official title: Effect of Helicobacter Pylori Eradication on Gastroesophageal RefIux Disease (GERD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GERD
Keywords: Helicobacter pylori
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed as GERD clinically and endscopically.

Brief summary: Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and symptoms improvement

Detailed description: HeIicobacter PyIori (H.pyIori) is a gram-negative spiral shaped bacterium that affects up to 50% of the population worldwide, with a higher prevalences in the developing countries,Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus, resulting in a significant economic burden in direct and indirect costs and adversely affects the quality of life.GERD is caused by multiple different mechanisms that can be intrinsic, structural, or both, leading to the disruption of the esophago-gastric junction barrier resulting in exposure of the esophagus to acidic gastric contents, Clinically, GERD typically manifests with symptoms of heartburn and regurgitation. It can also present in an atypical fashion with extra-esophageal symptoms such as chest pain, dental erosions, chronic cough, laryngitis, or asthma.The relationship between H. pylori and gastroesophageal reflux disease (GERD) is still unclear, and the effect of H. pylori eradication on GERD treatment is unknown.Several studies have shown the inverse relationship between the occurrence of GERD and H.pyIori infection, in particular an increased severity of the disease is documented in patients with pre-existing symptoms .It has been showed that a markedly resolution of dyspepsia in patients at whom the eradication therapy was successful when compared with subjects with a persistent infection

Eligibility criteria: Inclusion Criteria:

* All patients diagnosed as GERD clinically and endscopically.

Exclusion Criteria:

* NO exclusion criteria

Primary outcomes:
measure: Eradication of Helicobacter pylori after triple therapy
timeFrame: 1\2024 to 12\2024
measure: Effect of Helicobacter pylori eradication on Gastroesophageal RefIux disease (GERD) syptomes
timeFrame: 1\2024 to 12\2024
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Alrajhi Hospital
Study officials:
affiliation: Assiut University
name: Saad Z Mahmoud, Professor
role: STUDY_DIRECTOR
References:
citation: Ceylan A, Kirimi E, Tuncer O, Turkdogan K, Ariyuca S, Ceylan N. Prevalence of Helicobacter pylori in children and their family members in a district in Turkey. J Health Popul Nutr. 2007 Dec;25(4):422-7.
Clinical trial NCT05544734: Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Official title: Analysis of Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nail Diseases
Nail Abnormality
Keywords: nail diseases
nail biopsy
nail procedure
pain management
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone for nail-procedure associated pain management. The investigators hypothesize that ropivacaine with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for managing pain.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing fingernail or toenail, excision, or shave biopsy
* Must understand and voluntarily sign an informed consent form
* Must be male or female and aged 18-95 years at time of consent
* Must be able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

* Subject is unable to provide written informed consent for any reason
* Subject has peripheral vascular disease, arterial insufficiency, peripheral neuropathy
* Subject is on Aspirin, NSAIDs, or consumes a chronic medication for control of any other chronic pain
* Subject has a history of opioid or alcohol use disorder
* Subject has a history of peptic ulcer disease, gastritis, chronic renal insufficiency or a history of kidney disease, or has underlying liver disease
* Subject has a history of severe constipation
* Subject is sensitive or allergic to any of the elements included in this study
* Subject is unable to complete the required pain dairy
* Subject is pregnant, planning pregnancy, or nursing

Primary outcomes:
measure: Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale
timeFrame: Baseline, 2 days
Secondary outcomes:
measure: Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire
timeFrame: 3 days, 6 days (end of study)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Shari Lipner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01759316: Heliox in Preterm Infants With Respiratory Distress Syndrome
Official title: Nasal Intermittent Positive Pressure Ventilation and Mechanical Ventilation With Heliox in Preterm Infants With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 36
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Detailed description: Heliox can improve the oxygenation, reduce respiratory distress and lung injury caused by mechanical ventilation.

Heliox has not been widely used. More studies on the effects and safety of Heliox in addition to NIPPV and mechanical ventilation should be tried.

Eligibility criteria: Inclusion Criteria:

* Gestational age more than 28 weeks and less than 32 weeks
* Diagnosed as respiratory distress syndrome
* Need to use NIPPV ventilation
* No congenital diseases or hereditary diseases
* With an informed consent form

Exclusion Criteria:

* With congenital diseases or hereditary diseases
* Intubated in the delivery room
* Need surgery

Primary outcomes:
measure: length of ventilation and risk of mechanical ventilation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Transcutaneous blood gas analysis，ventilator parameters and lung inflammation cytokines
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: China
country: China
facility: Daping Hospital
state: Chongqing
city: Chongqing
country: China
facility: Daping Hospital and Research Institute of Surgery
Study officials:
affiliation: Dpartment of Pediatrics, Daping Hospital, Third Military Medical University
name: Yuan Shi, MD, PhD
role: STUDY_CHAIR
References: