louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04971811: Effects of Energy Density on Self-served Snacks in Preschool Children
Official title: Self-served Snack Study for Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 55
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine whether the energy density of snack foods affects the amounts that preschool children serve themselves and then consume. We will serve snacks that vary in energy density to preschool children in their childcare centers and measure the amount they serve themselves and consume. The results will have implications for guidance about the provision of snacks for preschool children and may help in identifying strategies for the prevention of obesity in children.


Eligibility criteria: Inclusion Criteria:

* Children who are enrolled in a scheduled classroom of the participating childcare centers
* Children who are between the ages of 4 and 6 years old at the time of enrollment

Exclusion Criteria:

* Children who have tested positive or are showing symptoms of COVID-19, or have recently had potential exposure with a person with COVID-19
* Children who are allergic to any of the foods served
* Children whose diets exclude any of the foods served
* Children who are absent from the childcare center on the acclimation day or both study days
* Children who are not able to serve themselves the two foods that are provided during the acclimation day

Primary outcomes:
measure: Difference between interventions in the weight of self-served snack food
timeFrame: Study weeks 1 and 2
measure: Difference between interventions in the weight of snack food consumed
timeFrame: Study weeks 1 and 2
Secondary outcomes:
measure: Difference between interventions in the volume of self-served snack food
timeFrame: Study weeks 1 and 2
measure: Difference between interventions in the volume of snack food consumed
timeFrame: Study weeks 1 and 2
measure: Difference between interventions in the energy of self-served snack food
timeFrame: Study weeks 1 and 2
measure: Difference between interventions in the energy of snack food consumed
timeFrame: Study weeks 1 and 2
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01161511: Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
Official title: A Phase 1 Study of XmAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Keywords: CLL
SLL
CD19
Lead sponsor: Xencor, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-13
Enrollment: 27
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 an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK, PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL.


Eligibility criteria: Inclusion Criteria:

* relapsed or refractory CLL/SLL
* at least 18 years of age
* able to receive outpatient treatment and follow-up at the treating institution
* completed all CLL therapies \> 4 weeks prior to first study dose

Exclusion Criteria:

* previously treated with an anti-CD19 antibody therapy
* undergone prior allogeneic stem cell transplantation within 6 months or having active graft versus host disease
* active Richter's syndrome
* designated Class III or IV by the New York Heart Association (NYHA) criteria
* history of myocardial infarction or stroke within the last 6 months
* active viral, bacterial, or systemic fungal infection requiring treatment
* HIV or Hepatitis C positive
* Hepatitis B infection

Primary outcomes:
measure: To determine the dose limiting toxicities
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: Ohio State University, Columbus, Ohio
name: John C Byrd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia Health Sciences University, Augusta, Georgia
name: Farrukh Awan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sarah Cannon Research Institute, Nashville, Tennessee
name: Ian W Flinn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woyach JA, Awan F, Flinn IW, Berdeja JG, Wiley E, Mansoor S, Huang Y, Lozanski G, Foster PA, Byrd JC. A phase 1 trial of the Fc-engineered CD19 antibody XmAb5574 (MOR00208) demonstrates safety and preliminary efficacy in relapsed CLL. Blood. 2014 Dec 4;124(24):3553-60. doi: 10.1182/blood-2014-08-593269. Epub 2014 Oct 9.
Clinical trial NCT01936311: Study of Screening Self-management Goals on Short Term Behavior Change
Official title: Study of Screening for Patients Self-selected Health Goal and Treatment Modality Prior to Primary Care Visit and the Effect on Short-term Behavior Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Health Behaviors
Keywords: Health Behavior
Behavior change
self-management goal
health goal
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: Advancing Care Together
name: Colorado Health Foundation
First posted: 2013-09-06
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test whether having patients identify a self-management goal (health goal), prior to a visit with their primary care provider, leads to health behavior improvement over six weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years of age)
* Attending primary care visit at Lowry Family Health Center or Level One Physicians
* English- or Spanish-Speaking

Exclusion Criteria:

* Exhibit signs of cognitive impairment or significant hearing impairment
* Provider recommendation against enrolling in study

Primary outcomes:
measure: Self-rated health
timeFrame: 6 weeks
Secondary outcomes:
measure: Health behavior improvement
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Level One Physicians
state: Colorado
city: Denver
country: United States
facility: Lowry Family Health Center
state: Colorado
Study officials:
References:
Clinical trial NCT03076411: Pepsin in Patients With Functional Dyspepsia
Official title: A Non-interventional, Observational Study With a Fixed Combination of Pepsin and Amino Acid Hydrochloride in Patients With Functional Dyspepsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Gastrointestinal Disorders
Abdominal Pain
Dyspepsia
Nausea
Vomiting
Flatulence
Keywords: Dyspepsia
Observational trial
Enzyme therapy
Pepsin
Lead sponsor: Nordmark Arzneimittel GmbH & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: ClinSupport GmbH
name: MWI Medizinisches Wirtschaftsinstitut GmbH
name: das forschungsdock
First posted: 2017-03-10
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presented with acute and chronic gastrointestinal symptoms, it was decided on the basis of their history, previous findings (diagnostic endoscopy and imaging, if available) and findings on physical examination whether they could participate in the postmarketing surveillance.

Brief summary: This non-interventional, observational study investigates the course of symptoms in patients with functional dyspepsia under treatment with a fixed combination of pepsin and amino acid hydrochloride over a period of approximately 6 weeks. The change of the Gastrointestinal Symptom Score (GIS©) was the primary parameter for the assessment of efficacy and was performed at baseline, after 3 and 6 weeks of treatment respectively. Safety measures included recording of AEs and physical examination as well as measurement of vital signs. The aim was to observe 100 patients during the course of this non-interventional study.


Eligibility criteria: Inclusion Criteria:

* Patients with dyspepsia
* Women and men aged between 18 and 75

Exclusion Criteria:

- Unwilling to consent

Primary outcomes:
measure: Gastrointestinal Symptom Score (GIS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Tolerability assessed by Adverse Events
timeFrame: 6 weeks
measure: Subjective assessment of efficacy (4 point Likert scale)
timeFrame: 6 weeks
measure: Subjective assessment of feasibility of use (4 point Likert scale)
timeFrame: 6 weeks
measure: Symptomatology
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Immanuel Krankenhaus
Study officials:
affiliation: Nordmark Arzneimittel GmbH & Co. KG
name: Kristin Forssmann, MD
role: STUDY_DIRECTOR
References:
citation: Forssmann K, Meier L, Uehleke B, Breuer C, Stange R. A non-interventional, observational study of a fixed combination of pepsin and amino acid hydrochloride in patients with functional dyspepsia. BMC Gastroenterol. 2017 Nov 25;17(1):123. doi: 10.1186/s12876-017-0675-9.
Clinical trial NCT01443611: The Relevance of Performing Lumbar Puncture in Infants Aged 3 to 12 Months With First Episode of Febrile Convulsion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Convulsions
Keywords: Infants
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 122
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants aged 3 to 12 months who presents with First Episode of Febrile Convulsions

Brief summary: The actual recommendations for infants aged 3 to 12 months presented with first episode of Febrile Convulsions highly recommend performing lumbar puncture in order to rule out Bacterial Meningitis. On the other hand, recent studies in the era of anti Pneumococcal vaccination arise the question if in the presence of a normal physical examination those recommendations are still relevant. The purpose of this study is to summarized retrospectively the clinical records of all the infants admitted to the pediatric wards in the ten years period since 2000 to 2010 in order to record the incidence of Bacterial Meningitis among infants admitted with the First episode of Febrile Convulsions.

Detailed description: Demographic data, including ethnic origin, age an gender will be recorded. The type of Convulsions (Simple or Complex), duration, and time since the fever was noticed will be also recorded. Another data that will be summarized included: previous antibiotic treatment, physical examination with special emphasis on neurological examination and meningeal signs, routine laboratory analysis including blood count and cerebrospinal fluid (CSF) results and the final diagnosis including the cause of fever.

Eligibility criteria: Inclusion Criteria:

* Infants aged 3 to 12 months who presents with First Episode of Febrile Convulsions during the period 1/1/2000 until 31/12/2010

Exclusion Criteria:

* infants with previous neurological diseases, or
* recent neurological disease that are not included in the characteristics of Febrile Convulsion

Primary outcomes:
measure: Number of patients with abnormal lumbar puncture
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Dpt B - Ha'Emek Medical Center
Study officials:
References:
Clinical trial NCT06143111: A Comparison of Thoracic Electrical Bioimpedance and FloTrac/Vigileo
Official title: A Comparison of Stroke Volume Variation for Prediction of Fluid Responsiveness Measured by Thoracic Electrical Bioimpedance and FloTrac/Vigileo
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke Volume Variation
SVV-FloTrac
Thoracic Electrical Bioimpedance
Fluid Responsiveness
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Stroke volume variation (SVV) is an indicator used to assess the patient's volume status. The FloTrac system (Edwards Lifesciences, Irvine, CA) continuously monitors cardiac output (CO) and SVV (SVV-FloTrac) by analyzing the systemic arterial pressure wave. Numerous studies have demonstrated that SVV-FloTrac serves as a reliable indicator of fluid responsiveness. However, its peripheral invasiveness raises concerns about susceptibility to reflecting waves, damping, and vascular tone influences.In contrast, Transthoracic electrical bioimpedance (BioZ.com™) offers a non-invasive approach for continuously monitoring various hemodynamic variables. In this study, the primary aim was to assess the agreement between simultaneously measured SVV-FloTrac and SVV-BioZ.


Eligibility criteria: Inclusion Criteria:

* Age 18≤ Age ≤65.
* patients undergoinglaparoscopic elective surgery for gastrointestinal tumors under general anesthesia
* 18 kg/m2≤BMI≤30 kg/m2
* ASA classification I-III
* Patients signed informed consent form

Exclusion Criteria:

* Arrhythmias
* The patient is diagnosed with severe cardiovascular disease（pulmonary arterial hypertension、left ventricular ejection fraction\< 50%、aortic aneurysm、extensive peripheral arterial occlusive disease,、significant valvulopathy）
* Severe heart failure (METS\<4)
* The patient is diagnosed with severe hepatic dysfunction (ChildePugh class C)
* The patient is diagnosed with severe renal dysfunction (undergoing dialysis before surgery)
* There is an infectious lesion on the skin or subcutaneous tissue where the non-invasive electrode piece is placed
* History of allergy to anesthetic drugs
* Weight\<40kg
* Allergies to 6% hydroxyethyl starch, Fresenius Kabi, Deutschland

Primary outcomes:
measure: The agreement between simultaneously measured SVV-FloTrac and SVV-BioZ
timeFrame: From anesthesia induction to the nonresponsive VLS about one hour.
Secondary outcomes:
measure: The capacity to predict fluid responsiveness.
timeFrame: From anesthesia induction to the nonresponsive VLS about one hour.
Other outcomes:
Locations:
city: Pudong
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT02884011: Evaluating the Effect of Chronic Antihypertensive Therapy on Vasopressor Dosing in Septic Shock
Official title: Evaluating the Effect of Chronic Antihypertensive Therapy on Vasopressor Dosing in Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Keywords: Chronic antihypertensives
Septic shock
Vasopressor
Vasopressor dosing
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, non-pregnant medical intensive care unite (MICU) patients with septic shock requiring vasopressor support

Brief summary: Retrospective study to examine the effects of chronic antihypertensive medications on vasopressor dosing in septic shock

Detailed description: This will be a retrospective four-cohort study. The four cohorts will be septic shock patients that were: 1) not on either a chronic β-blocker or chronic angiotensin-converting-enzyme inhibitor (ACE-Inhibitor), 2) on chronic β-blocker, 3) on ACE-Inhibitor, and 4) on both chronic β-blocker and ACE-inhibitor

Eligibility criteria: Inclusion Criteria:

* Adult patients 18 years of age or older
* Diagnosis of septic shock requiring vasopressor therapy (norepinephrine, epinephrine, phenylephrine, dopamine, or vasopressin)
* Admitted to an intensive care unit (ICU) at Rush University Medical Center (RUMC)
* Time frame: 01/01/2012 to 07/1/2016

Exclusion Criteria:

* Pregnant patients
* Transfer from outside hospital on vasopressors
* Admitted in cardiopulmonary arrest
* Prior arrest within 24 hours of admission to RUMC

Primary outcomes:
measure: Total Vasopressor Dose
timeFrame: 48 hours
Secondary outcomes:
measure: 30 mL/kg Fluid Within 6h
timeFrame: 48 hours
measure: Inotrope Use
timeFrame: 6, 12, 24, 48 hours
measure: Hydrocortisone Use
timeFrame: 6, 12, 24, 48 hours
measure: Cumulative Vasopressor Dose for Patients Receiving Other Antihypertensives
timeFrame: 6, 12, 24, 48 hours
measure: 6-hour Vasopressor Dose
timeFrame: 6 hours
measure: 12-hour Vasopressor Dose
timeFrame: 12 hours
measure: 24-hour Vasopressor Dose
timeFrame: 24 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush Univeristy Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Joshua DeMott, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Ishaq Lat, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Gourang Patel, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03914911: In Vivo Smart Biopsy Device Protocol In Radiology
Official title: In Vivo Smart Biopsy Device Protocol In Radiology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Image Guided Biopsy
Lead sponsor: Dune Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.

Detailed description: This is a single arm, multicenter study. It will be conducted in 3 medical centers, in the breast-imaging unit during ultrasonic guided core needle biopsy procedures performed in women with abnormality in the breast.

The study duration is only during the biopsy procedure, and the follow up period is 2 -3 weeks.

Eligibility criteria: Inclusion Criteria:

* Women over 18 years of age
* Undergoing ultrasonic guided core needle biopsy procedure due to abnormality in the breast
* Signed Informed Consent Form

Exclusion Criteria:

* Concurrent infectious disease
* Pregnancy or breastfeeding
* Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
* Implanted devices / Implants in the operated breast

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) Adverse events (AEs)
timeFrame: The subjects will be followed for a period of 2 -3 weeks following the biopsy procedure
measure: Correlation between pathology results and device readings
timeFrame: 2-3 weeks following biopsy procedure
measure: Ergonomic Assessment of the Smart Biopsy Device
timeFrame: At the day of the biopsy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Campus Beilinson
Study officials:
affiliation: Meir Medical Center
name: Noemi Weisenberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02458911: Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions and Restenosis From Prior Endovascular Procedures in This Sector.
Official title: Luminor Registry: Registry of the Results of Angioplasty With Drug-eluting Balloon (Paclitaxel) in the Treatment of Infrainguinal Occlusive Lesions (Superficial Femoral Artery (SFA), Popliteal Artery (PA) and Tibial Arteries (ATs)) and Restenosis From Prior Endovascular Procedures in This Sector.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Disease
Lead sponsor: iVascular S.L.U.
Sponsor class: INDUSTRY
First posted: 2015-06-01
Enrollment: 214
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: Patients with peripheral artery disease due to occlusive lesions, stenosis of ingraguinal arteries and restenosis after previous angioplasty with/without stent in that sector

Brief summary: The purpose of the study is to obtain data regarding safety and efficacy of drug-eluting balloon luminor 14 \& luminor 35 in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery (PA) and tibial arteries (ATs)) and restenosis from prior endovascular procedures in this sector.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes aged at least 18
* Primary injuries and restenosis of the infrainguinal sector of AFS, AP and ATs, and intrastent restenosis or post-ATP prior in that sector.

  * Stenosis \>50% and occlusions. (image test)
  * Length: 20 to 200 mm
  * Artery diameter: 2-7 mm.
* Symptomatic patients (grades 2-5 Rutherford-Baker both included; Fontaine II-IV), affected in their quality of life and that accept treatment (moderate / severe claudication patients, critical ischemia without gangrene or injuries severe enough to foresee limb amputation).

Exclusion Criteria:

* Patients with acute or subacute ischemia will be excluded.
* Existence of flow-limiting lesions in arteries of the "in flow" or the "out flow" of the sector or artery under treatment (\> 50 % of the arterial diameter).
* Aneurysmal dilatation in the ipsilateral arterial axis.
* Intolerance / allergy to heparin, thienopyridine derivatives (clopidogrel , ticlopidine) and aspirin.
* Hemorrhagic diathesis during the 3 months prior to inclusion.
* Patients with a life expectancy of less than 12 months.
* Serious allergy to contrasts or PTX.
* Inability to cross the lesion with the guide (these cases will be recorded for the analysis as "intention to treat).
* Those participating simultaneously in another clinical trial.
* Pregnancy or lactation (pregnancy tests on fertiles).

Primary outcomes:
measure: Primary patency
timeFrame: 1 year
measure: Freedom of adverse events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario Getafe
state: Madrid
Study officials:
References: