louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04929366: Is Hemodialysis Associated With Cardiac Markers Change?
Official title: Effects of Hemodialysis With Cooled Dialysate on High Sensitive Cardiac Troponin I (TnI) and Brain Natriuretic Peptide (NT proBNP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Keywords: End-Stage Kidney Disease
Hypothermic hemodialysis
Cardiovascular events
Troponin T
Brain natriuretic peptide
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2021-06-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hemodialysis (HD) triggers recurrent and cumulative ischemic insults to the brain and the heart. Cooled dialysate may have a protective effect on major organs and improve hemodynamic tolerability of dialysis. The aim of the study was to compare HD with cooled dialysate with routine dialysis in terms of hemodynamic stability and levels of high sensitivity Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis


Eligibility criteria: Inclusion Criteria:

* Patients with renal insufficiency treated with dialysis for a period of at least three months.

Exclusion Criteria:

* Patients who experienced myocardial infarction during the three months prior to the start of the study
* Patients who underwent vascular surgery during the last month
* Patients who experienced chest pain at rest during the last week before the start of the trial - Patients who had to discontinue dialysis prematurely due to hemodynamic instability.

Primary outcomes:
measure: Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability
timeFrame: one year
measure: Assessments of the levels of high sensitivite Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Nephrology Department, Ziv Medical Center
Study officials:
affiliation: Ziv Medical Centre, Safed, Israel / Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel
name: Younes Bathish, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00664066: DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)
Official title: A Non-Interventional, Post-Authorisation Study to Assess Adverse Events and Drug Utilisation Among Chronic Kidney Disease Patients Treated With DYNEPO
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anemia
Kidney Diseases
Renal Failure, Chronic
Kidney Failure, Chronic
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with established Chronic Kidney Disease

Brief summary: This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect \& describe less common adverse drug reactions, and to summarise DYNEPO drug utilisation.


Eligibility criteria: Inclusion Criteria:

* Adult patients must have established Chronic Kidney Disease (CKD) and be willing and able to provide written informed consent.
* Patients must already be receiving DYNEPO treatment at time of study entry.
* Patients who are likely to receive DYNEPO for at least 1 year.

Exclusion Criteria:

* Known intolerance to EPO of any of its excipients
* Known of suspected Pure Red Cell Aplasia (PRCA)

Primary outcomes:
measure: Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Villingen - Schwenningen
country: Germany
facility: Nephrologische Zentrum Villingen-Schwenningen
state: Baden-Württemberg
city: Stralsund
country: Germany
facility: Hanse-Klinikum Stralsund
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00320866: Evaluation of Symptoms, Complications and Side Effects of Adding Medications Continuously To Subcutaneous Infusion (Hypodermoclysis) In Home Care Hospice Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Home Infusion Therapy
Infusion Pumps
Keywords: Hypodermoclysis
Evaluation of Symptoms
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2006-05-03
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background: Terminal patients are often unable to swallow and need medications to control symptoms. In these cases medications are administered continuously and subcutaneously by a syringe driver. A syringe driver is an expensive and sophisticated equipment to operate. Hypodermoclysis is a useful and easy alternative used in the homecare setting for hydration.

Objectives:

1. To assess the level of symptoms control by the administration of morphine, metoclopramide and midazolam by hypodermoclysis versus by a syringe driver.
2. To assess the complications and side effects of infusing these medications continuously by hypodermoclysis versus by a syringe driver.

Methods: Patients in the homecare setting who meet the criteria for parentral infusion and suffer: pain, vomit/nausea and/or agitation will be recruited for the study.

A double blind crossover methodology will be used. Each patient will serve as both intervention and control, and both patient and medical staff will be blinded to the medication route administration. A research nurse will administer the medications. Crossover will take place 48 hours thereafter. A research assistant will conduct evaluation of symptoms and side effects for a period of 4 days. A sample size of 27 patients will be included in the study (calculated for a significance level of 95% and power of 80%).


Eligibility criteria: Inclusion Criteria:

* Patients in the home care unit that need medication/s continuously subcutaneously with symptoms level of 6 or higher on a visual analogue scale (VAS) for that symptom.

Exclusion Criteria:

1. Patients and caregivers that refuse to participate.
2. Every occasion when the infusion period will be less than 48 hours.
3. Every occasion when the patient and/or main care giver are not able to provide reliable information by the judgment of the medical staff person or research worker.
4. Patients that will need other medications subcutaneously that are not included in the study during their study treatment period.

Primary outcomes:
measure: level of symptoms control
Secondary outcomes:
measure: complications and side effects
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Ben-Gurion University of the Negev Sial Research Center for Family Medicine and Primary Care
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Sasson Menachem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01381666: Evaluation of the Diagnostic Utility of INS316 in Patients With Interstitial Lung Diseases (01-701)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Interstitial Lung Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of the present work is to explore and compare the diagnostic quality of sputum specimens obtained by BAL, induction with hypertonic saline (3%), and induction with INS316 in patients diagnosed with interstitial lung diseases.


Eligibility criteria: Inclusion Criteria:

* between 18 years or older
* undergone diagnostic bronchoalveolar lavage within the previous 21 days
* diagnosed with sarcoidosis or other ILD

Exclusion Criteria:

* having resting hypoxemia
* receiving corticosteroid treatment

Primary outcomes:
measure: diagnosis of sarcoidosis using sputum induction (sputum weight)
timeFrame: 60 minutes
Secondary outcomes:
measure: adverse events
timeFrame: 60 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02935166: Innovations in Respiratory Muscles Training in Patients With Chronic Obstructive Pulmonary Disease. (INNOTORIO)
Official title: INNOTORIO: Innovations in the Training of the Inspiratory Muscles on Patients With Chronic Obstructive Pulmonary Disease: Design of a Digital Dual Valve and Evaluation of a New High-intensity Training Scheme of Short Duration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Respiratory Muscles
Training
Lead sponsor: Fundación Cardiovascular de Colombia
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
First posted: 2016-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Respiratory muscle weakness and fatigue are related to clinical deterioration in patients with Chronic Obstructive Pulmonary Disease (COPD). Respiratory muscle training (RMT) is a key therapeutic strategy in these patients. It is necessary therefore to increase its dissemination on a large scale, improve patient´s adherence and optimize the control of the implementation of training. The aim of this project was to design a RMT device including light and sound incentives, digital registration application and analysis of the training sessions, and studying the effectiveness of a new shortened RMT scheme of high intensity that could provide added value to enhance the implementation of training in patients with COPD. From an operational point of view, researches were organized into three packages of complementary work focused on the design of a new portable dual valve with electronic lighting and auditory incentives components. The conceptualization and design of a software to analyze the performance and individual continuous use of the valve, and the evaluation of the feasibility, safety and efficacy of a shortened schedule of respiratory muscle training in adult patients with COPD were realized.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis from moderate to severe COPD muscle weakness inspiratory Must be able to do exercises

Exclusion Criteria:

* Positive bronchodilator response Cardiovascular, neuromuscular, or metabolic disease Hospital admission for any pathology in the last two months have completed a rehabilitation program in the last year

Primary outcomes:
measure: Change in Respiratory muscle strength assessed by Maximun Respiratory Pressure
timeFrame: From baseline to 3 weeks
measure: Change in Exercise Capacity assessed by cardiopulmonary exercise testing
timeFrame: From baseline to 3 weeks
measure: Change in Quality of life assessed by Quality of life Short Form 36 questionnaire
timeFrame: From baseline to 3 weeks
Secondary outcomes:
measure: Change in Exercise Capacity assessed by Six minutes walking Test
timeFrame: From baseline to 3 weeks
measure: Change in Respiratory function assessed by spirometry
timeFrame: From baseline to 3 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01256866: Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
Official title: Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mechanically Ventilated Patients
Sedation
Dexmedetomidine
Midazolam
Keywords: Dexmedetomidine
Midazolam
Sedation
Mechanical ventilation
Critically ill patients
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized study is to compare the safety and efficacy of two strategies for sedation of critically ill patients submitted to mechanical ventilation: continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The two groups will be compared as to the incidence of of delirium, evaluated with the Confusion Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or older intubated and mechanically ventilated for less than 48 hours prior to start of study drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146 patients (73 patients in each group)


Eligibility criteria: Inclusion Criteria:

* Adult mechanically ventilated, critically ill patients

Exclusion Criteria:

* pregnancy or lactation, severe liver disease, hearth rate less than 50, hypotension despite volemic repletion and vasoactive drug

Primary outcomes:
measure: Incidence of delirium
Secondary outcomes:
measure: PERCENTAGE OF TIME WITHIN THE TARGET SEDATION
Other outcomes:
Locations:
city: Sao Luis
country: Brazil
facility: Hospital Sao Domingos
state: Maranhao
Study officials:
References:
Clinical trial NCT00461266: ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
Official title: A Randomized, Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-infected Fuzeon-naïve Patients With Sustained HIV Viral Suppression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: HIV Infections
Keywords: Treatment Experienced
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-04-17
Enrollment: 0
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 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count \<250 cells/mm3 and an HIV RNA viral load \<400 copies/mL. Eligible patients will be randomized to receive Fuzeon 90mg bid sc in addition to their current antiretroviral therapy, or to continue their current antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* documented chronic HIV infection;
* currently receiving a stable antiretroviral regimen;
* CD4 cell count \<250 cells/mm3;
* HIV RNA viral load \<400 copies/mL for \>12 months.

Exclusion Criteria:

* prior exposure to Fuzeon;
* prior non-adherence to antiretroviral treatment regimens;
* active opportunistic infection;
* currently taking, or anticipated to take during the study, any immunomodulator.

Primary outcomes:
measure: Mean change in CD4 cell count from baseline
timeFrame: Week 24
Secondary outcomes:
measure: Change in HIV RNA from baseline
timeFrame: Week 24
measure: Change in HIV RNA and CD4 cell count
timeFrame: Weeks 24-48
measure: Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.
timeFrame: Throughout study
Other outcomes:
Locations:
city: Carlton
country: Australia
city: Darlinghurst
country: Australia
city: Melbourne
country: Australia
city: Miami
country: Australia
city: Perth
country: Australia
city: South Yarra
country: Australia
city: Sydney
country: Australia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03231566: Pain Neuroscience Education in Total Knee Arthroplasty
Official title: A Randomized Clinical Trial of Preoperative Pain Neuroscience Education for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 120
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: To determine if education about pain given prior to Knee Arthroplasty will result in better outcomes following surgery

Detailed description: To determine if a preoperative pain neuroscience education (PNE) program would result in superior outcomes compared to usual preoperative education for total knee arthroplasty (TKA). Patients will receive traditional hospital preoperative TKA program (usual care group) or receive the same program plus an additional 30-minute PNE program (experimental group). Pre and post measurements at 1, 3 and 6 months for pain, function, fear of movement and pain catastrophization. We will also compare opioid usage, healthcare expenses and patient satisfaction between groups.

Eligibility criteria: Inclusion Criteria:

* be scheduled to have a TKA and their standard preoperative TKA education program, indicate their willingness to participate in the study, ability to read and understand English, as the study included the use of an educational booklet, and be able and willing to complete outcome data for 6 months after TKA

Exclusion Criteria:

* Because all potential participants for this study had been screened and cleared for their orthopedic surgery, the only exclusion criterion was an unwillingness to participate in the study and having had a previous TKA or scheduled for a bilateral TKA.

Primary outcomes:
measure: Pain
timeFrame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
measure: Function
timeFrame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
measure: Pain Catastrophization
timeFrame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
measure: Fear of movement
timeFrame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
Secondary outcomes:
measure: Opioid Use
timeFrame: Change at 1 month
measure: Healthcare Expenses
timeFrame: Change from Baseline to 1 month, 3 months and 6 months post-surgery
measure: Patient Satisfaction
timeFrame: Change at 1 month, 3 months and 6 months post-surgery
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas - Department of Physical Therapy
state: Nevada
Study officials:
References:
Clinical trial NCT03444766: Study of Nivolumab for Advanced Cancers in India
Official title: Safety Study of Nivolumab for Selected Advanced Malignancies in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Non-Small-Cell Lung Carcinoma
Nonsmall Cell Lung Cancer
Kidney Cancer
Kidney Neoplasms
Renal Cancer
Renal Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization

Exclusion Criteria:

* Participants with untreated, symptomatic central nervous system (CNS) metastases
* Participants with carcinomatous meningitis
* Participants with active, known or suspected autoimmune disease
* Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
* Other active malignancy requiring concurrent intervention

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events
timeFrame: 26 Weeks
Secondary outcomes:
measure: Number of Participants With Treatment-related Select Adverse Events
timeFrame: 26 Weeks
measure: Number of Participants With Treatment-related Serious Adverse Events
timeFrame: 26 Weeks
measure: Number of Participants With Adverse Events Leading to Discontinuation
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
city: Bengaluru
country: India
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
city: Jaipur
country: India
facility: Local Institution
city: Kolkata
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: New Delhi
country: India
facility: Local Institution
city: Vellore
country: India
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06762366: Substitution Heuristic on Proportional Tasks
Official title: Substitution in Adult Proportional Reasoning
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Proportional Reasoning
Substitution Heuristic
Keywords: proportion
hueristic
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Rutgers, The State University of New Jersey
First posted: 2025-01-07
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to test whether or not adults use a substitution heuristic when reasoning about proportions. The main question it aims to answer is:

Do adults use a substitution heuristic when judging non-symbolic proportions, leading them to answer an easier, yet incorrect question?

Researchers will compare performance at baseline with one of two conditions in order to see if forced behavioral changes can change performance on the task.

Participants will be asked to compare two images and judge which has the higher proportion of the target color. Each participant will also be assigned to one of two condition where they either receive a further incentive for correct selections or are required to use more time when making their calculations.


Eligibility criteria: Inclusion Criteria:

* Typically developing people within the target age range

Exclusion Criteria:

* Individuals with known developmental or cognitive disorders
* Participants must speak/read sufficient English to read and complete the informed consent document

Primary outcomes:
measure: Proportion Correct
timeFrame: up to 20 minutes
measure: Reaction Time
timeFrame: up to 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers Center for Cognitive Science
state: New Jersey
Study officials:
References: