louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06818825: Nudging High Emergency Department Utilizers to Consider Non-emergent Healthcare Resources
Official title: Point of ED Discharge Interactive Outreach: High ED Utilizers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergency Service, Hospital
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 2279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this campaign is to reduce unnecessary ED visits by providing patients who are high ED utilizers (with a visit of any acuity) with alternative resources to manage their health outside of the ED. In this campaign, patients will be randomized to receive one of two types of outreach following discharge aligned with the goal. Outreach may occur via (1) a phone call from a Geisinger Community Health Worker (CHW) or Community Medical Assistant (CMA); current standard practice or (2) an interactive chatbot message providing similar information and questions to those provided by the CHW/CMA. The study team will measure whether ED use differs across patients in different outreach conditions. The study team will also examine whether patients followed through on the message-specific calls to action in the messages differently across conditions.


Eligibility criteria: Inclusion Criteria:

* Geisinger Health Plan insurance or KACO membership
* Any PCP or no PCP
* Visit of any acuity
* 4 or more ED visits in the past 6 months

Exclusion Criteria:

* Institutionalized
* Cannot be contacted via the communication modality being used in the study (i.e., SMS), due to insufficient/missing contact information in the electronic health record or because the patient opted out
* Admitted to hospital
* Eloped from ED
* Left ED without being seen
* Deceased prior to messaging
* Qualifies for more intensive care management due to higher-level category of complexity

Primary outcomes:
measure: Return to ED (Y/N)
timeFrame: Within 120 calendar days following day of discharge
Secondary outcomes:
Other outcomes:
measure: Successful Patient Contact (Y/N) - 3 days
timeFrame: Within 3 business days following day of discharge
measure: Successful Patient Contact (Y/N) - 5 days
timeFrame: Within 5 business days following day of discharge
measure: Time to Contact
timeFrame: Within 30 calendar days following day of discharge
measure: Patient replied via SMS text (Y/N) to Artera chatbot
timeFrame: Within 7 calendar days following first Artera outreach
measure: ED Use (Y/N)
timeFrame: Within 30 calendar days following day of discharge
measure: ED Use After Outreach (Y/N)
timeFrame: Within 30 calendar days following day of outreach by Artera, CMA, or CHW
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Amir Goren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02381925: Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism
Official title: Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parathyroid Adenoma
Keywords: CT
Scintigraphy
Ultrasound
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of Arkansas
First posted: 2015-03-06
Enrollment: 0
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: The subjects will include all patients, aged 18 years or older, who underwent parathyroid surgery from July 2009 to July 2016.

Brief summary: The study aims are:

1. To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT), scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary hyperparathyroidism.
2. To compare 4D-CT, scintigraphy, and ultrasound for the ability to perform focused parathyroidectomy, and for rates of persistent hyperparathyroidism and complications from parathyroid surgery.

Methods The investigators will create a multicenter registry consisting of patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016. Initial participating centers include Duke University Medical Center, University California Los Angeles (UCLA) and University of Arkansas for Medical Sciences (UAMS).

There will be no intervention in the patient's treatment or imaging. The management will be determined by the surgeon or clinician supervising the patient's care.

The registry will consist of patient data regarding basic demographics, history of prior neck/chest surgery or radiation, parathyroid imaging, biochemical evaluation, intraoperative surgical findings, parathyroid pathology, and surgical outcomes within the first 6 months (persistent disease, recurrent laryngeal nerve injury, and hypoparathyroidism). Data will be entered into REDCap with no PHI. The investigators expect to include 3000 patients in the registry (1000 from Duke).


Eligibility criteria: Inclusion Criteria:

* patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016

Exclusion Criteria:

* age less than 18 years
* parathyroid carcinoma
* secondary or tertiary hyperparathyroidism

Primary outcomes:
measure: diagnostic performance of imaging
timeFrame: 6 months
Secondary outcomes:
measure: ability to perform focused parathyroidectomy
timeFrame: 6 months
measure: rates of persistent hyperparathyroidism after parathyroidectomy
timeFrame: 6 months
measure: parathyroidectomy surgical complications
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06450925: Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
Official title: A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Graft Vs Host Disease
Vitamin A Deficiency
Vitamin D Deficiency
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.

Detailed description: Hematopoietic stem cell transplantation (HSCT) is an effective treatment strategy for many malignancies, marrow failure syndromes, and immune deficiencies in children, adolescents, and adults. Vitamin A and its derivatives regulate growth and differentiation of intestinal cells, and vitamin A deficiency is associated with increased susceptibility to infection in both human and animal models. The investigators' preliminary data suggest lower vitamin A levels were associated with an increased incidence of gastrointestinal graft versus host disease (GI GVHD) in patients undergoing HSCT.

This study is a randomized double blinded comparison of vitamin A supplementation comparing a single large dose of vitamin A with a placebo.

Eligibility criteria: Inclusion Criteria:

* Be 18 years of age or older
* Be scheduled for allogeneic stem cell transplant.
* Have a vitamin A level \< upper limit of normal for age.
* Be able to tolerate enteral vitamin dose administration.
* Have a total bilirubin level \< 1.5x ULN and an AST and/or ALT\< 3xULN for age
* Receiving PBSCs as stem cell graft

Exclusion Criteria:

* Ongoing raised intracranial pressure
* Liver cirrhosis
* Patients will be excluded if they are currently pregnant.

Primary outcomes:
measure: Incidence of moderate-severe chronic graft versus host disease (GVHD)
timeFrame: 1 year after transplant
Secondary outcomes:
measure: Incidence of acute gastrointestinal graft versus host disease (GI GVHD)
timeFrame: 2 years after transplant
measure: Incidence of relapse
timeFrame: 2 years after transplant
measure: Overall survival.
timeFrame: 2 years after transplant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Pooja Khandelwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00868725: Detecting Lesions in the Oral Cavity With Thermal Imaging
Official title: Detecting Lesions in the Oral Cavity With Thermal Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Squamous Cell
Keywords: oral cavity
carcinoma
thermal imaging
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-25
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients reporting for oral cavity examination under the possibility of presenting with oral cavity lesions

Brief summary: Previous studies indicate that there are significant differences in the temperature of tumors and normal, adjacent tissues. The present study will test this hypothesis for lesions in the oral cavity. Thermal images of the oral cavities of patients, undergoing examination in the Department of Oral and Maxillofacial Surgery of Sheba hospital, will be compared to the diagnoses of the examining doctors. The results, apart from enhancing the delineation of oral cavity tumors, may help the decision to develop miniature thermal cameras to scan thermally, the GI tract.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed in the Department of Oral and Maxillofacial Surgery as suffering from malignant or possibly malignant lesions.

Exclusion Criteria:

* none

Primary outcomes:
measure: Ability of a thermal camera to detect and delineate tumors in the oral cavity
timeFrame: during and immediately after the examination
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Arie Orenstein, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stefanadis C, Chrysohoou C, Panagiotakos DB, Passalidou E, Katsi V, Polychronopoulos V, Toutouzas PK. Temperature differences are associated with malignancy on lung lesions: a clinical study. BMC Cancer. 2003 Jan 6;3:1. doi: 10.1186/1471-2407-3-1. Epub 2003 Jan 6.
Clinical trial NCT05452525: Pharmacokinetics and Safety/Tolerability Profile of CKD-379
Official title: A Randomized, Open-label, Single Dose, 3-period, 6-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type II Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-07-11
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

Detailed description: A randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Eligibility criteria: Inclusion Criteria:

* Between 19 aged and 50 aged in healthy adult
* 50.0kg ≤ Body weight ≤ 90.0kg and 18.0kg/m2 ≤ body mass index (BMI) ≤ 27.0kg/m2

Exclusion Criteria:

* Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis ect.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness
* Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis
* Have a gastrointestinal disease(Crohn's disease, ulcer ect.) history that can effect drug absorption or surgery
* Those who are pregnant or breastfeeding
* Those who are deemed inappropriate to participate in clinical trial by investigators

Primary outcomes:
measure: Cmax
timeFrame: 0~48hours
measure: AUClast
timeFrame: 0~48hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Jaeseong Oh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560625: Does Inhaled Busedonide or Fluticasone Impair Adrenal Function?
Official title: Low Dose(1mcg) ACTH Stimulation Test for Assessment of the Hypothalamus-pituitary-adrenal Axis in Patients Treated With Inhaled Busedonide or Fluticasone.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adrenal Insufficiency
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital-based respiratory diseases clinic

Brief summary: Inhaled corticosteroids are largely used in patients with asthma or chronic obstructive lung diseases. The purpose of this study is to determine if the use of inhaled corticosteroids is associated with suppression of endogenous cortisol production, as seen in patients treated with pharmacologic doses of oral or parenteral steroids.

Detailed description: The normalcy of the hypothalmic-pituitary-adrenal (HPA) axis of enrolled subjects will be assessed by low dose (1mcg) corticotropin (ACTH)stimulation test. Serum cortisol levels will be measured before , 30 minutes and 60 minutes after 1 mcg ACTH intravenous injection.

Eligibility criteria: Inclusion Criteria:

* patients receiving inhaled busedonide or fluticasone at daily dose of 200-800 mcg ' for at least 4 weeks

Exclusion Criteria:

* patients receiving any corticosteroid therapy, except inhaled busedonide or fluticasone.

Primary outcomes:
measure: stimulated serum cortisol levels
timeFrame: within 30 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Endocrine Institute, Haemek medical Center
Study officials:
affiliation: Endocrine Institute , Haemek Medical Center, Afula. 18101 Israel
name: Avraham Ishay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02046525: Autologous Fecal Therapy
Official title: Restoration of the Fecal Microbiome After Antimicrobial Exposure With Autologous Fecal Flora Restoration Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infectious Disease of Digestive Tract
Keywords: Fecal microbiota therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ten healthy volunteers will be recruited to receive either an autologous stool transplant or a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly, and safely, restore a patient's fecal microbiome after antimicrobial exposure.


Eligibility criteria: Inclusion Criteria:

Healthy Adults 18-70 years of age-

Exclusion Criteria:

history of allergic reaction to beta-lactam antimicrobials; any non-topical antimicrobial exposure or tube feeds as a primary source of nutrition in the past six months; pregnant or risk of becoming pregnant during the study period; gastroenteritis in the last 3 months; incontinent of stool; prior resection or alteration of the stomach; small bowel, or colon; unwillingness to receive an enema/FMT; known colonization with an MDRO; anticipated change in diet or medications, or elective surgery, during the study period; or a history of an intestinal disorder -

Primary outcomes:
measure: Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema
timeFrame: 90 days after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References:
citation: Bulow C, Langdon A, Hink T, Wallace M, Reske KA, Patel S, Sun X, Seiler S, Jones S, Kwon JH, Burnham CA, Dantas G, Dubberke ER. Impact of Amoxicillin-Clavulanate followed by Autologous Fecal Microbiota Transplantation on Fecal Microbiome Structure and Metabolic Potential. mSphere. 2018 Nov 21;3(6):e00588-18. doi: 10.1128/mSphereDirect.00588-18.
Clinical trial NCT05895825: A Study of EOC237 in Patients With Advanced Solid Tumor
Official title: A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This research study is studying an investigational drug called EOC237 in Patients With Advanced Solid Tumor.

Detailed description: Part 1 Dose Escalation: an open, single/multiple dose, multi-center phase I study to evaluate the safety, tolerability and pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor.

Part 2 Food influence research: to assess the effect of food on the pharmacokinetics of EOC237, by investigating the bioavailability following single dose administration under fed and fasted conditions.

Eligibility criteria: Inclusion Criteria:

* Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective.
* Expected survival≥ 3 months.
* ECOG performance status 0-1.
* Good organ and marrow function.

Exclusion Criteria:

* Patients with a history of severe drug allergic reaction.
* Pregnant or lactating female subjects.
* Uncontrolled, significant intercurrent or recent illness.
* Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms per electrocardiogram (ECG)
* Concomitant use of certain medications

Primary outcomes:
measure: Proportion of subjects with dose-limiting toxicity (DLT)
timeFrame: Up to approximately 3 years
measure: Determination of maximum tolerated dose (MTD)
timeFrame: Up to approximately 3 years
measure: the recommended phase 2 dose (RP2D)
timeFrame: Up to approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT06430125: Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus
Official title: Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .


Eligibility criteria: Inclusion Criteria:

* Patients newly diagnosed with T2DM with diet control and good glycemic index ( Hb A1C\< 7 )
* Age range between 18 and 60 years old.
* Both sexes.
* Stage 1and Stage 2 CKD according to KDIGO .
* Controlled HTN .

Exclusion Criteria:

* Pregnant and lactating females.
* Patients with hypersensitivity to nicorandil.
* Other Causes of CKD or Nephropathy eg : Uncontrolled HTN , Renal Malignancy , collagen disease as Amyloidosis and some autoimmune disease as ( SLE and Rh.fever ) .
* Uncontrolled HTN and its antihypertensive medications ( ACEI , ARB ) and other antihypertensive medications .
* Patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.

Primary outcomes:
measure: prevention of progression of kidney disease as measured by KDIGO.
timeFrame: 12 weeks
Secondary outcomes:
measure: change in the serum concentrations of Kidney injury molecule 1(Kim-1).
timeFrame: 12 weeks
measure: change in the serum concentrations of Interleukin 18 (IL-18).
timeFrame: 12 weeks
measure: change in the serum concentrations of Nitric oxide (NO).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: EL Gharbia
Study officials:
References:
Clinical trial NCT00834925: Low Dose of Diltiazem for Rate Control of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation with rapid ventricular response
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 380
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: This study is to show the efficacy and safety of low dose diltiazem for the treatment of atrial fibrillation with rapid ventricular response in emergency room. We will compare the standard dose of diltiazem(0.25mg/kg) with low dose diltiazem(0.1mg/kg)in atrial fibrillation with rapid ventricular response in ED.


Eligibility criteria: Inclusion Criteria:

* atrial fibrillation with rapid ventricular response in emergency room

Exclusion Criteria:

* age\<18
* systolic blood pressure\<90mmHg
* no consent

Primary outcomes:
measure: Success rate of rate control
timeFrame: in 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: