louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04081155: Effect of PEEP on Lung Regional Ventilation and Perfusion
Official title: Effect of Positive End-expiratory Pressure(PEEP) on Regional Ventilation and Perfusion Estimated by Indicator-based Electrical Impedance Tomography(EIT) Method in Critically Ill Patients With Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Respiratory Failure
Hypoxia
Keywords: EIT
pulmonary perfusion
ventilation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients within 7 days, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters and mechanically ventilation were eligible for the study

Brief summary: Investigate effects of PEEP on pulmonary regional ventilation and perfusion assessed by EIT

Detailed description: 1. When the research team was available, adult patients within 7days who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters and mechanically ventilation were eligible for the study.
2. Written informed consent was obtained from all patients or next of kin before data were included in the study.
3. Information collected at enrollment included demographic characteristics, such as age, sex.
4. The blood pressure（BP）,heart rate（HR）, pulse O2（SpO2）,tidal volume and lung regional ventilation and perfusion were collected at PEEP 0 centimeter H2O column and PEEP 12-15 centimeter H2O column.
5. Indicator-based EIT method: rapidly inject 10ml 10% Sodium chloride（NaCL） through central venous catheter during a 8s respiratory hold, and the curve of impedence change was collected by EIT machine

Eligibility criteria: Inclusion Criteria:

1. have been placed central venous catheter based on patient's condition
2. Under mechanically ventilation
3. Under sedation and control ventilation mode
4. Year\>18

Exclusion Criteria:

1. Pneumothorax
2. pregnancy
3. Severe chest wall wound
4. Severe hypernatremia

Primary outcomes:
measure: lung regional ventilation distribution
timeFrame: Hour 1
measure: lung regional perfusion distribution
timeFrame: Hour 1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Science
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yun Long
role: STUDY_CHAIR
References:
citation: He H, Chi Y, Long Y, Yuan S, Frerichs I, Moller K, Fu F, Zhao Z. Influence of overdistension/recruitment induced by high positive end-expiratory pressure on ventilation-perfusion matching assessed by electrical impedance tomography with saline bolus. Crit Care. 2020 Sep 29;24(1):586. doi: 10.1186/s13054-020-03301-x.
Clinical trial NCT00686855: Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
Official title: An Open Label Phase II Randomized Trial of Topical Dexamethasone and Tacrolimus for the Treatment of Oral Chronic Graft-Versus-Host Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Chronic Graft-versus-host Disease
Keywords: tacrolimus
dexamethasone
oral rinse
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Boston Children's Hospital
name: Beth Israel Deaconess Medical Center
name: Massachusetts General Hospital
First posted: 2008-05-30
Enrollment: 46
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine the effectiveness of topical steroid therapy (with a drug called dexamethasone) and topical tacrolimus therapy for the treatment of oral chronic Graft-Versus-Host Disease (cGVHD)

Detailed description: * Because no one knows which study option is best, participants will be "randomized" into one of two study groups: topical dexamethasone or topical tacrolimus.
* Participants will take the medication by mouth rinse four times a day for 5 minutes at a time. After rinsing they will spit out the medication and will not be able to eat or drink for 15 minutes.
* Participants will also take anti-fungal medication (fluconazole) orally once a week.
* After two weeks on study treatment, participants will have a blood drawn to monitor tacrolimus levels.
* After the final treatment (4 weeks), participants will have the following tests and procedures: clinical examination; questionnaire; blood tests; oral culture; optional tissue biopsy.

Eligibility criteria: Inclusion Criteria:

* Patients with oral chronic graft-versus-host disease
* Patients 4 years of age or older
* Stable cGVHD medication regimen for the four weeks prior to study enrollment

Exclusion Criteria:

* Patients already on topical steroid or tacrolimus therapies

Primary outcomes:
measure: The Clinical Efficacy of Topical Steroid and Topical Tacrolimus Therapies for the Treatment of Oral cGHVD.
timeFrame: Participants were assessed at Baseline and 4 weeks after start of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth-Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Nathaniel Treister, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01163955: A Postural Study Comparing Sitting on the Floor Versus Sitting in a Chair While Playing Video Games.
Official title: A Postural Analysis of Children Playing Video Games Sitting on the Floor vs. Sitting in a Chair: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Keywords: Posture analysis
Video gaming
Forward Head Position
Rounded Shoulder Position
Spine Posture
Lead sponsor: Glinn and Giordano Physical Therapy
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 56
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To determine if sitting in a chair or sitting on the floor lends itself to better posture while playing video games.

Detailed description: Upon completion of the parental consent form, each test subject will be instructed to flip a two-sided coin to determine the sitting position of the test subject. If the flip reveals a "heads", the child will be instructed to sit in a chair; chairs will be appropriately sized to allow the child to rest his/her feet on the ground. If the flip reveals a "tails", the child will be instructed to sit on a small carpet piece that measures 2-feet by 2-feet. Each test subject will be taken to their gaming station which will sit approximately 8 feet away from a 55-inch flat screen television that will be on a 30-inch table and handed a wireless controller. Two gaming stations will be available with one featuring the game Lego Batman and the other featuring Lego Indiana Jones with both gaming stations testing simultaneously. The test subjects will be told they can play for 5 minutes with a Physical Therapist at each station to monitor and record the test subjects' positioning.

Eligibility criteria: Inclusion Criteria:

* English and Spanish Speaking

Exclusion Criteria:

* Non-english or non-spanish speaking

Primary outcomes:
measure: Posture Control of Head Position, Shoulder Position and Back Position
timeFrame: 5 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Best Buy Electronics
state: California
Study officials:
affiliation: Glinn and Giordano Physical Therapy
name: William B Monroe, DPT, OCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Glinn and Giordano Physical Therapy
name: Erin P Pandol, MPT, OCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01730755: Ruxolitinib for Chuvash Polycythemia
Official title: Ruxolitinib for Chuvash Polycythemia
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Erythrocytosis, Familial, 2
Keywords: Polycythemia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Incyte Corporation
First posted: 2012-11-21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Chuvash polycythemia (CP) is a rare form of congenital polycythemia caused by mutations in the VHL gene. Currently, there are no therapies that have proven effective for CP. Recent studies have demonstrated that VHL (von Hippel-Lindau tumor suppressor) regulates the activity of JAK2 (Janus kinase 2). In mouse models, inhibition of JAK2 reverses the CP phenotype. Therefore, the investigators hypothesize that JAK2 inhibition may have significant clinical benefits for CP patients.

Detailed description: Study involvement will last for 48 weeks. There will be approximately 11 visits through week 48. Visits may take up to 2-3 hours to complete and occur every 4 weeks for the first 24 weeks, then every 12 weeks until week 48.

During each study visit, any or all of the following procedures may occur:

* List current medications and participant general health
* Obtain blood pressure, body weight, body temperature, respiratory rate and heart rate
* Measure Spleen by examination
* Obtain an abdominal MRI to evaluate spleen and any pre-existing or new blood clots
* Obtain blood samples for safety tests and to monitor kidney/liver function.
* Questionnaires for participant to complete regarding symptoms related to disease.
* Ruxolitinib dosing may be increased after 4 weeks if needed. The dose of the ruxolitinib may be reduced related to side effects.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Chuvash polycythemia

Exclusion Criteria:

* Unable to comprehend or unwilling to sign an informed consent form.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT01408355: A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.
Official title: An Exploratory, Open Label, Fixed Sequence Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-06273588 In Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-08-03
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 21 drinks/week for males.

Primary outcomes:
measure: The number of participants with Adverse Events as a measure of Safety and tolerability.
timeFrame: 3 days
measure: Pharmacokinetics : peak plasma concentration
timeFrame: 3 days
measure: Pharmacokinetics : time of peak plasma concentration
timeFrame: 3 days
measure: Pharmacokinetics : area under plasma concentration-time curve
timeFrame: 3 days
measure: Pharmacokinetics : Terminal plasma half life
timeFrame: 3 days
measure: Pharmacokinetics : Plasma Clearance
timeFrame: 3 days
measure: Pharmacokinetics : plasma volume of distribution
timeFrame: 3 days
measure: Pharmacokinetics : oral bioavailability
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ruddington Fields
country: United Kingdom
facility: Pfizer Investigational Site
state: Nottingham
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03831555: Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic
Official title: Use of a Psychosocial Readiness Tool to Improve Hepatitis C Treatment Adherence and Outcomes at the Grady Liver Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment tool
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn more about what psychological and social factors affect people in how they take their hepatitis C medications.

Detailed description: The goal of this study is to determine if a qualitative survey that assesses a patient's readiness for treatment of Hepatitis C (HCV) and associated interventions based on identified barriers can improve treatment adherence and outcomes. HCV remains a leading cause of liver cancer and end stage liver disease despite greater than 90% cure rates with new, all-oral antiviral medications. While these new medications are easier to tolerate and access than previous treatment regimens, medication adherence still remains a great barrier to cure. In this study, we will administer the Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool, a free, online survey developed at the Mount Sinai School of Medicine to determine psychosocial readiness for treatment.

Eligibility criteria: Inclusion Criteria:

* seen in the Grady Liver Clinic during the study time period
* have a confirmed chronic hepatitis C infection (hepatitis C antibody positive and detectable hepatitis C viral load)

Exclusion Criteria:

* no chronic hepatitis C infection
* co-infection with HIV or hepatitis B
* non-English speaking
* unable to consent to participate
* already started HCV therapy

Primary outcomes:
measure: Number of participants keeping follow-up appointments
timeFrame: At 4 months
measure: Number of participants keeping follow-up appointments
timeFrame: At 8 months
measure: Number of participants refilling medications
timeFrame: At 4 months
measure: Number of participants refilling medications
timeFrame: At 8 months
measure: Number of participants who keep lab visits
timeFrame: At 4 months
measure: Number of participants who keep lab visits
timeFrame: At 8 months
measure: Rapid virologic response (RVR)
timeFrame: At 4 weeks
measure: Sustained virologic response (SVR)
timeFrame: At 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Liver Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Lesley Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05778955: Study on Dynamic CtDNA Analysis in Pediatric Soft Tissue Sarcoma
Official title: The Significance of Dynamic Monitoring of ctDNA in Pediatric Soft Tissue Sarcoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Soft Tissue Sarcoma
Keywords: Pediatric Soft Tissue Sarcoma
ctDNA
NGS
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Nanjing Geneseeq Technology Inc.
First posted: 2023-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asian population predominates

Brief summary: Pediatric soft tissue sarcoma is made up of different subtypes, some of which have distinct genetic alterations. Fusion variants were found in about 43% of bone and soft tissue sarcoma samples. Ewing sarcoma is characterized by recurrent chromosome translocation, with up to 95% of cases showing EWS-ETS translocation. The genetic features of the tumor can change as it spreads or shrinks, and can also be influenced by treatment.

To better understand treatment response and predict relapse early, our study collects liquid samples such as blood, bone marrow, or cerebrospinal fluid at various points during treatment. We then use next-generation sequencing to dynamically monitor the unique genetic profile of the tumor. Additionally, our research may identify new genetic targets and suggest potential treatment options.


Eligibility criteria: Inclusion Criteria:

* (1) pediatric patients with soft tissue sarcoma confirmed by pathology(including but not limited to rhabdomyosarcoma, Ewing sarcoma, BCOR rearrangement undifferentiated sarcoma, CIC rearrangement undifferentiated sarcoma, Epithelioid sarcoma and synovial sarcoma.
* (2)younger than 18 years old.
* (3)ECOG status: PS score0-2.
* (4)measurable lesions on CT/MRI according to RECIST 1.1 criteria : long diameter≥10mm; the longest diameter on ≥ one lymphnode ≥1.5 cm.
* (5)sufficient clinical and pathological information.
* (6)candidates can receive evaluation on time and provide samples during the trials.
* (7)candidates should be informed and provide informed consents.

Exclusion Criteria:

* Sufficient samples at baseline point can not be obtained including pre-operation plasma, tissues, bone marrow aspirate and cerebrospinal fluid.
* Plasma samples can not be obtained during monitoring.
* Ineligible candidates at the discretion of researchers.

Primary outcomes:
measure: The rate to detected tumor progression by ctDNA before radiographic tumor progression
timeFrame: Oct,2022-Dec 2023,recruting patients; Jan 2024-Mar 2024,analyzing the genetic features in samples;Jan 2023-May 2024,follow up patients
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yizhuo Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03463655: Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care
Official title: Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Cancer in a Palliative Situation With Ascites
Keywords: palliative
solid tumor
ascites
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All HDJ, UAI, and the 3 medical oncology departments patients who have ascites puncture may be included.

Brief summary: Current recommendations do not recommend the concomitant administration of albumin after ascites puncture in patients with ascites neoplasia unlike cirrhotic ascites. The etiology of ascites in cancer patients is multifactorial, particularly by hepatic invasion that can lead to ascites loaded with albumin. Ascites punctures therefore lead to undernutrition, recurrent early ascites by decreasing the oncotic pressure by hypo albuminemia and a state of anasarca affecting the quality of life.

Detailed description: According to the recommendations, each ascites fluid must be sent for biochemical and bacteriological analysis.

Demonstrate the high gradient proportion (percent only, no threshold of significance required). The literature has already validated the importance of supplementing albumen with cirrhotic ascites. Demonstrating that some cancer patients have high gradients, this will be enough to make the practitioner think to supplement.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age followed for a solid cancer in a palliative metastatic situation who had a puncture of ascites.

Exclusion Criteria:

* Minor patient
* Known cirrhosis

Primary outcomes:
measure: Serum-Ascites Albumin Gradient Prevalence
timeFrame: 3 months
Secondary outcomes:
measure: Metastatic sites
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Aurélien PROUX
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrier P, Jacques J, Debette-Gratien M, Legros R, Sarabi M, Vidal E, Sautereau D, Bezanahary H, Ly KH, Loustaud-Ratti V. [Non-cirrhotic ascites: pathophysiology, diagnosis and etiology]. Rev Med Interne. 2014 Jun;35(6):365-71. doi: 10.1016/j.revmed.2013.12.001. Epub 2014 Jan 6. French.
citation: Guide pratique des soins palliatifs Edition A.P.E.S. (2008)
citation: Ayantunde AA, Parsons SL. Pattern and prognostic factors in patients with malignant ascites: a retrospective study. Ann Oncol. 2007 May;18(5):945-9. doi: 10.1093/annonc/mdl499. Epub 2007 Feb 13.