louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04883827: Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer
Official title: Monitoring Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-05-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18 year or older) with Renal Cell Carcinoma with clear cell component and receiving an IO-containing regimen or healthy volunteers (18 years or older)

Brief summary: This study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy

Detailed description: Primary Objective:

- Evaluate tumor cell free (cf)DNA as a dynamic marker of response to immuno-oncology (IO) therapy

Exploratory Objective:

- Collect data on somatic mutations in cfDNA to gain insight into the biology of IO-responders and -non-responders

Eligibility criteria: Inclusion Criteria:

* Renal Cell Carcinoma with clear cell component
* Stage IV
* Receiving IO-containing regimen
* Measurable disease per RECIST 1.1

Exclusion Criteria:

* Active cancer (exclusion criteria only for healthy patient cohort)

Primary outcomes:
measure: Evaluate tumor cfDNA as a dynamic marker of response to IO therapy
timeFrame: Up to about 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Valley Health Care System
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Vanderbilt Medical Center
name: Scott Haake, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00346827: Apomorphine Nasal Powder in the Treatment of Parkinson's Disease "Off" Periods.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Britannia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2006-06-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: 3-week, double-blind, placebo-controlled, 3 × crossover efficacy phase followed by 12 week open label phase, followed by 36 week open continuation phase
Primary purpose: TREATMENT

Brief summary: To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease.


Eligibility criteria: Inclusion Criteria:

* 1 year history of Parkinson's Disease; stable PD medications for 4 weeks; at least one documented "off" period per day

Exclusion Criteria:

* hypersensitivity to apomorphine; participation in a clinical trial in the last 12 weeks; pregnant or lactating females

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Swansea Hospital, Swansea, Wales
name: Richard Weiser, MB, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06625827: A Study of the Effect of Nemtabrutinib (MK-1026) on the Plasma Levels of Digoxin in Healthy Participants (MK-1026-012)
Official title: A Study to Evaluate the Effect of Nemtabrutinib on the Pharmacokinetics of Digoxin in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to learn what happens to levels of digoxin in a healthy person's body over time. Researchers will compare what happens to digoxin in the body when it is given with and without another medicine called nemtabrutinib. Researchers are testing if digoxin levels in the body are different when digoxin is given with or without nemtabrutinib.


Eligibility criteria: Inclusion Criteria:

* Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
* Has a body mass index (BMI) 18.0 to 32.0 kg/m\^2 (inclusive)

Exclusion Criteria:

* Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
* Has a hypersensitivity to digoxin and/or to other digitalis preparations including inactive ingredients (eg, lactose, corn starch and potato starch)

Primary outcomes:
measure: Area under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Digoxin
timeFrame: At designated timepoints (up to approximately 7 days)
Secondary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Digoxin
timeFrame: At designated timepoints (up to approximately 7 days)
measure: Maximum Plasma Concentration (Cmax) of Digoxin
timeFrame: At designated timepoints (up to approximately 7 days)
measure: Plasma Concentration 24 Hours Postdose (C24) of Digoxin
timeFrame: At designated timepoints (up to approximately 24 hours)
measure: Time to Maximum Plasma Concentration (Tmax) of Digoxin
timeFrame: Predose and at designated timepoints (up to approximately 7 days)
measure: Apparent Terminal Half-life (t1/2) of Digoxin
timeFrame: At designated timepoints (up to approximately 7 days)
measure: Apparent Clearance (CL/F) of Digoxin
timeFrame: At designated timepoints (up to approximately 7 days)
measure: Apparent Volume of Distribution (Vz/F) of Digoxin
timeFrame: At designated timepoints (up to approximately 7 days)
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 8 weeks
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 8 weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON (Site 0001)
state: Kansas
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01917227: Evaluation of Group Health Teaching With Video in Diabetic Patients
Official title: Evaluation of Group Health Teaching With Video in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective:Health videos and group education to allow patients to a correct understanding of diabetes and insulin treatment.

Method:

Standards and number of patients: The patients received subcutaneous insulin injection, estimated 30 people enrolled.

Experimental Design and Methods:

1. Screening out-patient treatment with insulin use, HbA1c\> 8% or poor postprandial glucose (PPG)
2. At the time of the visits, invite the patient to participate in the Video group education on insulin therapy By answering some questions about insulin injections, such as: do not know how to perform; afraid of the pain; fear of inconvenience, give patients time to complete the questionnaire.

Detailed description: Diabetes is a long-term chronic disease. The patients need to correct "knowledge and action" lifestyle in order to achieve effective blood glucose control. Upon the general control of diabetic patients in Taiwan, however, glycosylated hemoglobin (HbA1c) is not satisfactory. One of the important reasons is the low rate of insulin injection. For the use of insulin, the patient has many misconception. The patients in the clinic need to spend a lot of time to explain and description, but the results are not necessarily good. So we hope that in this part of the health education activities through organized groups Videos to assist doctors and patients as a bridge of communication, to enhance diabetes doctor thus contributing to glycemic control results.

Eligibility criteria: Inclusion Criteria:

1. Willing to sign the informed consent
2. Age over 20 years old
3. HbA1c\>8% or PPG) \> 200 mg/dl even under insulin therapy

Exclusion Criteria:

1. Vegetation status
2. Inability of visual or hearing contact with the video program

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: CHIA-HUNG LIN, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01303627: Safety of Remifentanil Infusion
Official title: The Effects of Maintenance a Remifentanil Infusion on the Hemodynamic Variables and Recovery Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Problem
Keywords: Remifentanil
Laryngeal mask airway removal
Hemodynamic changing
Infusion
Ureterorenoscopy
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated.

Detailed description: In all patients (control group and remifentanil group induction of anesthesia will be achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil (1-4 ng/mL) by TCI target controlled infusion, and desflurane . Throughout the surgery hemodynamic parameters are going to be recorded. As soon as the surgery has been finished, in control group remifentanil infusion and desflurane inhalation is going to be stopped.In remifentanil group,desflurane inhalation is going to be stopped and remifentanil infusion will be maintained until the removal of LMA. During the emergence period the time of eye opening, hemodynamic parameters and emergence quality (score 1-2)are going to be recorded.

Eligibility criteria: Inclusion Criteria:

* ASA I-II status
* aged 18-60 years old
* presenting for ureterorenoscopy

Exclusion Criteria:

* history of hypertension
* asthma and chronic obstructive lung disease
* recent respiratory tract infections

Primary outcomes:
measure: Smooth cLMA Removal Condition (Score 1)
timeFrame: At the end of the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ministry of Health Diskapi Yildirim Beyazit Research and Training Hospital departement of 1. Anesthesiology
Study officials:
affiliation: Ministry of Health Dıskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1.
name: Jülide Ergil, MD
role: STUDY_CHAIR
affiliation: Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1
name: Alp Alptekin, MD
role: STUDY_CHAIR
affiliation: Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital , Anesthesiology 1
name: Nihan Aktürk, MD
role: STUDY_CHAIR
affiliation: Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1
name: Haluk Gümüs, MD
role: STUDY_CHAIR
References:
citation: Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.
Clinical trial NCT06906627: Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)
Official title: Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease(CKD)
Type 2 DM
Type 2 Diabetes Mellitus (T2DM)
Keywords: CKD
T2DM
T2D
Type 2 Diabetes
Chronic kidney disease
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Bayer
name: Boehringer Ingelheim
name: Eli Lilly and Company
First posted: 2025-04-02
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: (IRIS-CKD Screening Program) is a randomized trial of delivery of a home testing kit for eGFR and/or UACR versus a standard laboratory order to increase rates of CKD screening in people who have lapsed beyond the recommended screening interval.
Primary purpose: OTHER

Brief summary: IRIS-CKD is an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

Detailed description: IRIS-CKD Screening Program: will focus on CKD screening in T2D. We will identify patients with T2D that have not received appropriate screening for CKD within the last 15 months and randomize patients to receive either a home kit to complete CKD screening ("home kit") versus a standard laboratory order ("laboratory order"). The primary objective is to evaluate whether delivery of home testing kits versus standard laboratory testing influences the degree to which patients receive guideline-recommended CKD screening. Patients will complete approximately 3 months of follow-up.

Eligibility criteria: Screening Program-

Inclusion Criteria:

* Adults with type 2 diabetes (T2D)
* Receiving primary care within the healthcare system, Primary Care Provider (PCP) visit within the past 24 months (any PCP provider, including APP).
* Lack of estimated glomerular filtration rate (eGFR) and/or urine albumin- creatinine ratio (UACR) measurement in the prior 15 months within the EHR

Exclusion Criteria:

• Chronic kidney disease (CKD) diagnosis

Primary outcomes:
measure: CKD Screening Lab Opportunity Score
timeFrame: 3 months
Secondary outcomes:
measure: CKD Screening Lab Opportunity Score by Subgroup
timeFrame: 3 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner
state: Louisiana
city: Duluth
country: United States
facility: Essentia Health
state: Minnesota
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Temple
country: United States
facility: Baylor Scott & White
state: Texas
city: Murray
country: United States
facility: Intermountain Health
state: Utah
Study officials:
affiliation: Duke University
name: Neha Pagidipati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01589627: Wrist Extension Dynasplint (WED) Distal Radius Fracture
Official title: Contracture Reduction Following Distal Radius Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
Wrist Contracture
Keywords: distal radius fracture
wrist contracture
dynasplint
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture.


Eligibility criteria: Inclusion Criteria:

* Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up

Exclusion Criteria:

* Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)
* Radial nerve entrapment
* Arthrodesis
* Traumatic dislocation of the distal ulna

Primary outcomes:
measure: Change in maximal active range of motion in wrist extension
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Advanced Centers for Orthopaedic Surgery and Sports Medicine
name: Stacy Berner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01597427: Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery
Official title: Intravenous Clonidine Does Not Reduce Pulmonary Artery Pressure in Patients Subjected to Cardiac
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia
Keywords: Clonidine
Hypertension Pulmonary
Cardiac Surgical Procedures
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-05-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the ability of clonidine to reduce the mean pulmonary artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.

Detailed description: Prospective, clinical-interventionist, randomized, and double-blind study. Patients with group 2 pulmonary hypertension will be included and subjected to cardiac surgery with extracorporeal circulation. Mean pulmonary artery pressure and the doses of dobutamine and sodium nitroprusside will be assessed four times: before (T0) administration of 2 μg/kg of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately after extracorporeal circulation (T2), and 10 minutes after the injection of protamine (T3).

Eligibility criteria: Inclusion Criteria:

* Signing an informed consent form,
* Aged 18 to 80 years
* Pulmonary hypertension due to left heart disease,
* Physical status 2 or 3 according to the classification system of the American Society of Anesthesiologists,
* Subjected to cardiac circulation with extracorporeal circulation

Primary outcomes:
measure: Reduction pulmonary artery pressure
timeFrame: During intraoperative (hours)
Secondary outcomes:
measure: Doses of Dobutamine
timeFrame: During intraoperative (hours)
measure: Doses of Sodium nitroprusside
timeFrame: During intraoperative (hours)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Luiz Fernando dos Reis Falcao
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Luiz Fernando R Falcao, Ph.D.
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Benedito B Joao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00245427: Outcomes of Patients Not Responding to Antibiotics in the Community
Official title: Outcomes of Patients Not Responding to Outpatient Macrolide or b-Lactam Therapy for the Treatment of Community Acquired Pneumonia: Expansion to Include Acute Exacerbations of Chronic Bronchitis and Acute Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Bronchitis, Chronic
Pneumonia, Bacterial
Keywords: beta-lactam
macrolide
antibiotics
Lead sponsor: CPL Associates
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-10-28
Enrollment: 200
Sex: ALL
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community

Detailed description: To document and describe the clinical, microbiological, and pharmacoeconomic outcomes of two hundred patients who failed to respond to outpatient macrolide or beta-lactam therapy. Evaluable patients must have a positive culture obtained after they failed their initial macrolide or beta-lactam. The isolated pathogen must have a known MIC to the antibiotic class they failed to respond to (i.e. macrolide or b-lactam). The isolate must be available to be sent to the central laboratory for MIC testing

Eligibility criteria: Inclusion Criteria:

Patients who have failed to respond to at least three (ABECB and CAP) or five (AMS/ABRS/AECRS) days of macrolide or b-lactam therapy meeting all of the protocol criteria for acute bacterial exacerbations on chronic bronchitis(ABECB), community acquired pneumonia(CAP) and acute maxillary sinusitis(AMS) will be eligible for enrollment. All patients, whether enrolled retrospectively or concurrently, must have a positive culture. The pathogenic bacteria must be identified by a local laboratory and have a known susceptibility to the antibiotic class the patient failed to respond to (i.e. macrolide or b-lactam). The isolate must be sent to the Study Coordinating Center for precise MIC determination.

Exclusion Criteria:

Patients presenting with any of the following will not be included in the study:

1. Life expectancy \<3 months from underlying disease
2. Underlying lung carcinoma
3. Cystic fibrosis

Primary outcomes:
measure: Clinical outcome
timeFrame: varies
Secondary outcomes:
measure: PK/PD pharmacoeconomics
timeFrame: varies
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Deaconess Medical School
state: Washington
Study officials:
affiliation: State University of NY at Buffalo
name: Jerome J Schentag, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of NY at Buffalo
name: Joseph Paladino, Pharm.D.
role: STUDY_DIRECTOR
References: