louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02988388: Lung Tissue Research Consortium
Official title: Lung Tissue Research Consortium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2016-12-09
Enrollment: 247
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.

Brief summary: The LTRC will facilitate histopathological research of pulmonary diseases by collecting lung tissues from donors and preparing and distributing collections of tissue specimens to researchers within and outside the LTRC. Collections of specimens will be linked to individual clinical data appropriate to the particular disease. The primary goal of the LTRC is to identify participants with suspected lung cancer or metastatic disease who are willing to provide informed consent for research use of their specimens and data. Secondarily, the LTRC investigators intend to collect clinical data, limited exposure data, physiologic studies, and radiographic studies from these participants.


Eligibility criteria: Inclusion Criteria:

* Adults ages 21 or older who are undergoing lung surgery for suspected malignancy or metastases.

Exclusion Criteria:

* Diagnosis of cystic fibrosis or pulmonary hypertension.
* Any other condition that, in the judgment of the investigator, precludes participation.
* Failure to obtain written consent.

Primary outcomes:
measure: Clinical diagnosis
timeFrame: Two months following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Tom Croxton
role: STUDY_DIRECTOR
References:
citation: Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.
Clinical trial NCT05691088: Clinical Efficacy of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia
Official title: To Evaluate the Clinical Efficacy of Standardized Use of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acetaminophen,Mechanical Ventilation,Critically Ill Children
Lead sponsor: The Second Clinical Medical College of Jinan University
Sponsor class: OTHER
Collaborators: name: Kunming Children's Hospital
name: Shenzhen Windo Medical Technology Limited Company
First posted: 2023-01-19
Enrollment: 128
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical efficacy of acetaminophen in mechanical ventilation in children with new coronary pneumonia
Primary purpose: TREATMENT

Brief summary: Patients were randomized to receive either paracetamol during mechanical ventilation. When patients were randomized to receive paracetamol (40 mg/kg per day in 4 doses), a placebo infusion of normal saline was administered continuously at the same rate as an equivalent infusion. Placebos could not be distinguished from the active study drug in color, odor, or viscosity.

In both study groups, IMV was maintained with sufentanil (0-0.2 mcg/kg/h), propofol (0-4 mg/kg/h), and dexmedetomidine (0-1 mcg/kg/h). Assessment of sedation levels by the bedside nurse using the FLACC pain scale to determine if the child is adequately comfortable or in need of more or less medication to maintain adequate ventilation. Assessment of sedation levels by the bedside nurse using the FLACC pain scale (every 6 hours as a minimum time interval).


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were body weight greater than 1500 g; and mechanically ventilated patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Exclusion Criteria:

* Exclusion criteria were admitted with a tracheostomy in situ; extracorporeal membrane oxygenation treatment; neurologic dysfunction, hepatic dysfunction, or renal insufficiency; known allergy to or intolerance for paracetamol; and administration of paracetamol in the 24 hours prior to mechanical ventilation.

Primary outcomes:
measure: Mechanical ventilation time
timeFrame: an average of 5 days
Secondary outcomes:
measure: Length of ICU stay time
timeFrame: an average of 1 week
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Windo Medical
state: Guangdong
Study officials:
References:
Clinical trial NCT03917888: Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP
Official title: Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of Ventilator Associated Pneumonia: a Diagnostic Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Keywords: ventilator associated pneumonia
lung ultrasound
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study evaluates whether lung ultrasound monitoring could lead to earlier detection of ventilator associated pneumonia and influence outcome. Half of the participants will be diagnosed with VAP using a combination of lung ultrasound and clinical features and half will be diagnosed using the Johanson criteria, which is a combination of clinical features and chest x-ray.

Detailed description: The current guidelines recommend the use of chest x-ray or computed tomography of the chest to aid in the diagnosis of VAP. However many studies have shown that chest x-ray is neither very sensitive nor specific for pneumonia, and computed tomography, though has the highest diagnostic accuracy, is not routinely performed due to logistics, safety concerns, economics and radiation exposure.

Emerging studies including meta-analyses have shown high sensitivity and specificity of lung ultrasound in diagnosing pneumonia. When combined with clinical and microbiological features it has shown to be helpful in early diagnosis of VAP, but a study to show whether such early detection improves outcome is lacking.

Eligibility criteria: Inclusion Criteria:

* Mechanical ventilation for more than 48 hours
* Absence of pneumonia as the reason for mechanical ventilation (includes clinical, radiological or sonographic diagnosis)

Exclusion Criteria:

* Recent trauma or surgery to the thorax (including chest tube insertion)
* Presence of dressings or skin conditions restricting access to the thorax
* Confirmed pregnancy
* If already enrolled in the study
* Denial of consent

Primary outcomes:
measure: ventilator free days
timeFrame: day 28 from diagnosis of VAP
Secondary outcomes:
measure: icu mortality
timeFrame: through study completion, an average of 3 months
measure: icu length of stay
timeFrame: through study completion, an average of 3 months
measure: delta sofa
timeFrame: day 4 from VAP diagnosis
measure: ventilator days
timeFrame: day 28 from intubation
measure: antibiotic duration
timeFrame: day 14 from initiation of antibiotic
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhuvan university teaching hospital
state: Bagmati
Study officials:
affiliation: Institute of Medicine, TUTH
name: Saurabh Pradhan, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277588: Evaluation of the Physicians and Patients Experience of Fetal Scalp Sampling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Questionnaire
Fetal Scalp Sampling
Keywords: fetal scalp sampling
experience questionnaire
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2011-01-17
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are subjected to fetal scalp sampling during labor Physicians performning fetal scalp sampling

Brief summary: During labor, fetal scalp sampling is performed if the CTG registration is abnormal. The test is performed with the woman in the supine position and is generally described as a difficult and cumbersome procedure.

Detailed description: Women who were subjected to fetal scalp sampling are asked to fill in a questionnaire within 24 hours after delivery. The questionnaire deals with how the woman experienced the testing procedure.

Physicans who performed the test are asked to fill in a questionnaire within 24 hours after delivery. The questionnaire deals with how the physician experienced the testing procedure.

Eligibility criteria: Inclusion Criteria:

* fetal scalp sampling during labor

Exclusion Criteria:

* non-proficiency in the Swedish language

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of obstetrics and gynecology
Study officials:
References:
Clinical trial NCT04682288: Levofloxacin Ocular Implant for Ocular Surgery
Official title: An Interventional, Open Label, Non-randomized, Phase Ia Safety and Tolerability Study of Levofloxacin Ocular Implant in Subjects Undergoing Routine Cataract Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cataract
Lead sponsor: PolyActiva Pty Ltd
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi center, open label, interventional study in one eye of 5 subjects scheduled for uncomplicated cataract surgery with administration of a single Levofloxacin Ocular Implant in the posterior sulcus of the surgical eye at the end of cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cataract in the intent to treat eye
* Endothelial cell density in the study eye of at least 2000 cells per mm2

Exclusion Criteria:

* history of ocular inflammation including, macular degeneration, uveitis, macular edema or corneal edema
* recent surgery in the study eye
* subjects receiving a glaucoma device in conjunction with cataract surgery
* subjects with a compromised posterior capsule during surgery
* corneal disease that prevents effective imaging of endothelium including Fuch's Dystrophy.
* sensitivity to fluoroquinolones

Primary outcomes:
measure: Ocular Inflammation
timeFrame: 90 days
measure: Endothelial Cell Density
timeFrame: 90 days
measure: Intraocular Pressure (IOP)
timeFrame: 90 days
Secondary outcomes:
measure: Administration procedure
timeFrame: 1 week
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Ophthalmology Consultants Ltd
state: Missouri
city: Ladson
country: United States
facility: Carolina Cataract and Laser Centre
state: South Carolina
city: Fitzroy
country: Australia
facility: Melbourne Eye Specialists
state: Victoria
Study officials:
affiliation: Opthalmology Consultants Ltd
name: Joseph Gira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02534688: Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
Official title: Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometriosis
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: randomized controlled trial

Eligiblility criteria Provisional diagnosis Clinical presentation Progressive dysmenorrhea Chronic pelvic pain Deep dyspareunia Evidences of endometriosis Endometriotic nodule Cul-de-sac nodularity Endometrioma detected by ultrasonography size \< 4 cm

Inclusion criteria Female age 18-45 yr Moderate to severe pelvic pain categorized by VAS \>50 Previous sexual intercourse

Exclusion criteria Co-existing other genital tract disease associated pain Previous hormonal use within 3 months History of DMPA treatment failure WHO eligibility criteria 2009 for DMPA and LNG-IUS Category 3,4 Fertility desire in upcoming 1 year

Primary objective To compare efficacy of pain control in endometriosis associated pelvic pain between LNG-IUS and DMPA

Secondary objective To compare side effect, continuation rate, satisfaction and quality of life between LNG-IUS and DMPA in treatment of endometriosis associated pelvic pain

Primary outcome Severity of pelvic pain Measured by VAS score 0 mean no pain 100 mean most pain

Secondary outcomes Vaginal bleeding pattern Side effects of systemic progestogen Lipid profiles Weight gain Quality of life Measured by quesionaire SF36 Satisfaction Measrured by linket scale 0-4 0 mean very dissatisfied 1 dissatisfied 2 not satisfied and dissatiffied 3 satisfied 4 very satisfied Continuation rate Endometrioma size reduction


Eligibility criteria: Inclusion Criteria:

* Female age 18-45 yr
* Moderate to severe pelvic pain categorized by VAS \>50
* Previous sexual intercourse

Exclusion Criteria:

* Co-existing other genital tract disease associated pain
* Previous hormonal use within 3 months
* History of DMPA treatment failure
* WHO eligibility criteria 2009 for DMPA and LNG-IUS Category 3,4
* Fertility desire in upcoming 1 year

Primary outcomes:
measure: Severity of pelvic pain : measured by visual analog scale
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life measured by Quesionaire SF 36 Thai version
timeFrame: 6 months
measure: Lipid profile : total cholesterol, triglyceride, LDL, HDL
timeFrame: 6months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memmorial hospital
Study officials:
References:
Clinical trial NCT03822988: ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS
Official title: ACCEPTABILITY AND WRITING FREQUENCY OF ADVANCED DIRECTIVES IN ONCO-DERMATOLOGY PATIENTS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advance Directives
Oncology
Skin Cancer
Melanoma
Skin Lymphoma
Skin Squamous Cell Carcinoma
Metastatic Basal Cell Carcinoma
Keywords: advance directives
Advance care planning
Patient's informed
treatment preferences
skin cancer
dermatology
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cf beyond

Brief summary: The law about advance directives is evolving but, in France, few people write it.

Te main endpoint of this research is to estimate the proportion of patients who have written their advance directives or considering doing so in onco-dermatologic population. If this rate remains low, some insights on the reasons will be able to be advanced looking at the point of view and opinion of patients about this topic.

Seconds endpoints are :

For patients against or not planning to write it, understand their reasons

Estimate the proportion of patients requesting information and understand how they would like to receive it.

Investigate a possible association between the stage of the oncological disease and the positioning of the patient concerning advance directives.


Eligibility criteria: Inclusion Criteria:

\> 18 ya

With one of the diagnoses below:

* Melanoma
* Skin lymphoma
* Meckel Carcinoma
* localy advanced or metastatic Basal cell carcinoma or squamous cell carcinoma

Exclusion Criteria:

Patients not in possession of all of its cognitive abilities Patients who can't read patients who don't speak french

Primary outcomes:
measure: Writing by the patient of its advance directives
timeFrame: when the patient complete the survey
Secondary outcomes:
measure: reason for not writing advance directives
timeFrame: when the patient complete the survey
measure: Patient wishing to be more informed about the adavance directives during its management and, if so, by what means.
timeFrame: when the patient complete the survey
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy-Brabois hospital
Study officials:
affiliation: CHRU Nancy
name: anne-claire bursztejn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01664988: Effect of Muscular Relaxation and Breathing Technique on Blood Pressure in Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Blood Pressure in Pregnancy
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gestational hypertension is the main cause of maternal and fetal mortality, however, it has no definite effective treatment. nowadays, the stress management approaches are use for essential hypertension. So, this study aimed is study the effect of progressive muscular relaxation and breathing control technique on blood pressure during pregnancy.

this 3-groups clinical trial has been done in Mashhad Health Centers and Governmental hospitals. 60 pregnant women with systolic blood pressure less than 135 mm Hg or diastolic blood pressure more than 85 mm Hg who met inclusion criteria were assigned into three groups of progressive muscular relaxation, breathing control and control. In tow experiment groups, exercises were controlled by one day personally and the rest by CD, BP before and after interventions was controlled for 4 weeks. In control group blood pressure was measured before and after 15 minutes with no intervention.


Eligibility criteria: Inclusion Criteria:

* systolic blood pressure ≥ 135mmHg or
* diastolic blood pressure ≥ 85mmHg
* absence of severe preeclampsia condition
* eclampsia
* absence chronic hypertension
* gestational age 20-36w
* single pregnancy
* have not contraction or bleeding
* absence of underlying disease and mental disorders
* absence of polihydramnios
* hydatiform mole and placenta previa
* not addicted to drugs, alcohol, mood-altering medicine and cigarette
* not to use similar relaxation methods and breathing techniques during pregnancy
* reading and writing literacy
* have contact number

Exclusion Criteria:

* using antihypertensive drugs(for experimental groups)
* CBR
* bleeding
* contraction or watering during study
* deteriorating of preeclampsia to severe form
* hospitalization
* start medical treatment for experiment groups
* changing mind for continuing with study
* to be absent in one session of personal instruction for experiment groups do not exercises more than 3 sessions of relaxation and breathing control at home
* delivery during 4- week interventions and presence of symptoms such as confusion, fatigue, feeling of suffocation, pain, blurred vision during doing exercises

Primary outcomes:
measure: effect of muscular relaxation
timeFrame: up to1 month
measure: decrease blood pressure
timeFrame: up to 1 month
Secondary outcomes:
measure: time of decreasing blood pressure
timeFrame: up to 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01333488: Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
Official title: A Phase 2, Randomized, Controlled 2x3 Trial Comparing Clinical Outcomes in Patients With Severe Traumatic Brain Injury Using Mild Hypothermia and Concurrent and Supplemental Infusion of Magnesium Sulfate.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Traumatic Brain Injury
Keywords: Traumatic
Brain
Injury
Lead sponsor: United States Department of Defense
Sponsor class: FED
First posted: 2011-04-12
Enrollment: 6
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: The investigators hypothesize that hypothermia (body cooling) and additional magnesium sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients.

This is a study to compare the outcomes of patients with severe traumatic brain injury who have been allocated to one of the following three groups:

Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have their core body temperature lowered to 34C Group 3 - Subjects will have their core body temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium sulfate.


Eligibility criteria: Inclusion Criteria:

1. Adult males or females ≥ 18 years of age
2. Subjects with Traumatic Brain Injury and a post-resuscitation Glasgow Coma Score (GCS) ≤ 8
3. In-hospital and screened within 7 hours of injury.
4. Able to obtain legally effective written consent from authorized representative
5. Patients who are intubated and on mechanical ventilation
6. Admitted to ICU

Exclusion Criteria:

1. Bladder or rectal core temperature below 32C (89.6F) upon admission
2. Clinical brain death
3. Patients with open abdomens.
4. Multiple orthopedic injuries (\> 2 long bone fractures)
5. Persistent hypotension (systolic blood pressure \< 90mmHg)
6. Persistent hypoxia (O2 Saturation \< 94%)
7. Persistent metabolic acidosis (Lactic acid \> 5 mmol/L, arterial pH \< 7.25)
8. Positive serum pregnancy test
9. Cardiac arrhythmia with deleterious hemodynamic effects; heart block or myocardial damage (as shown on ECG)
10. History of abnormal renal function
11. Significant Co-morbidity (i.e. CAD;COPD; severe coagulopathy)
12. Pediatric patients (\< 18 years old)

Primary outcomes:
measure: GOS (Glasgow Outcome Score)
timeFrame: Discharge from Hospital - Within 2 months from Injury
Secondary outcomes:
measure: GOS
timeFrame: 12 months after injury
measure: Vasospasm
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
Study officials:
affiliation: Memorial Healthcare System
name: Greg Zorman, MD
role: PRINCIPAL_INVESTIGATOR
References: