louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02134509: Smartphone Application for Smoking Cessation
Official title: Smartphone Application for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Cigarette smoking
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: National Institute on Drug Abuse (NIDA)
First posted: 2014-05-09
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.

Detailed description: In this randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains behavioral strategies for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.

Eligibility criteria: Inclusion Criteria:

* Smoke 5+ cigarettes/day
* \< 3 months abstinence in the past year
* Have a smartphone
* Score greater than or equal to 8 of 10 on the Contemplation Ladder (Biener \& Abrams, 1991)

Exclusion Criteria:

* None

Primary outcomes:
measure: Point prevalence abstinence at 6 months
timeFrame: 6 months after beginning treatment
Secondary outcomes:
measure: Point prevalence abstinence at 3 months
timeFrame: 3 months after beginning treatment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen A Garrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
citation: Sala M, Roos CR, Brewer JA, Garrison KA. Awareness, affect, and craving during smoking cessation: An experience sampling study. Health Psychol. 2021 Sep;40(9):578-586. doi: 10.1037/hea0001105. Epub 2021 Sep 27.
citation: Garrison KA, Pal P, O'Malley SS, Pittman BP, Gueorguieva R, Rojiani R, Scheinost D, Dallery J, Brewer JA. Craving to Quit: A Randomized Controlled Trial of Smartphone App-Based Mindfulness Training for Smoking Cessation. Nicotine Tob Res. 2020 Mar 16;22(3):324-331. doi: 10.1093/ntr/nty126.
citation: Garrison KA, Pal P, Rojiani R, Dallery J, O'Malley SS, Brewer JA. A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol. BMC Psychiatry. 2015 Apr 14;15:83. doi: 10.1186/s12888-015-0468-z.
Clinical trial NCT06030609: The Comparison Between Ringer Lactate Solution and Normal Saline with Dextrose Water in Post-Operative Period of Kidney Transplantation
Official title: The Comparison Between Ringer Lactate Solution and Normal Saline with Dextrose Water in the First Week Post-Operative Period of Deceased Donor and Living Donor Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Electrolyte Imbalance
Kidney Transplant; Complications
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 60
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 is a randomized controlled pragmatic clinical trial. We aim to evaluate the effect of Ringer lactate solution (RLS) and normal saline solution (NSS) with dextrose water (D5W) on the electrolyte abnormality of kidney transplant recipients (KTR) during the first post-operative week. The problem with using NSS with or without D5W as a standard replacement fluid is the hyperchloremic metabolic acidosis which might compromise the kidney allograft function. A total 60 KTR will be enrolled and randomized to receive either RLS or NSS with D5W. The primary outcome is serum bicarbonate level at day 5 after transplantation. Secondary outcomes include the serum potassium, serum sodium, serum chloride, cytokine panel, and the incidence of delayed graft function.


Eligibility criteria: Inclusion Criteria:

* A kidney transplant recipient who receives transplant at King Chulalongkorn Memorial Hospital.
* Age \>=18 years
* Both deceased donor and living donor kidney transplantation will be included

Exclusion Criteria:

* multiorgan transplantation
* Known allergy to RLS or NSS

Primary outcomes:
measure: Serum bicarbonate level
timeFrame: Day 5 after transplantation
Secondary outcomes:
measure: Serum potassium level
timeFrame: Day 5 after transplantation
measure: Serum chloride level
timeFrame: Day 5 after transplantation
measure: Immune function marker
timeFrame: Day 5 after transplantation
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Nephrology, Faculty of Medicine, King Chulalongkorn Memorial Hospital
Study officials:
References:
Clinical trial NCT06596109: Lifestyle Changes in Fatty Liver; Additive Effect of Honey Intake
Official title: Lifestyle Changes in Fatty Liver; Additive Effect of Honey Intake
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fatty Liver, Nonalcoholic
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: honey is a natural functional food used in control cardiovascular risk factors but its effect on fatty liver is not investigated

Detailed description: Forty fatty liver (non-alcoholic from) patients with obesity are included to be divided into group 1 who will contain 20 patients who will receive honey intake (orally, as a daily total dose of 2 g/kg, this dose will be divided to three equal subdoses, every dose will be administered before meal), low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks. Group 2 who will contain 20 patients who will receive low calorie diet, and treadmill walking (40 minutes per session, three times per week) for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* fatty liver (non alcoholic form)
* both sexes included
* obese subjects (class I)

Exclusion Criteria:

* cardiac insult
* respiratory insult
* renal insult
* lower limb insult

Primary outcomes:
measure: High density lipoprotein
timeFrame: it will be assessed after 12 weeks
Secondary outcomes:
measure: triglycerides
timeFrame: it will be assessed after 12 weeks
measure: cholesterol
timeFrame: it will be assessed after 12 weeks
measure: low density lipoprotein
timeFrame: it will be assessed after 12 weeks
measure: alanine transamianse
timeFrame: it will be assessed after 12 weeks
measure: aspartate transamianse
timeFrame: it will be assessed after 12 weeks
measure: fasting blood glucose
timeFrame: it will be measured after 12 weeks
measure: body mass index
timeFrame: it will be measured after 12 weeks
measure: waist circumference
timeFrame: it will be measured after 12 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: faculty of physical therapy Cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: Ali MA Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02692209: A Multi-Reader Multi-Case Pivotal Trial
Official title: A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm FFDM Plus DBT Versus FFDM Alone in the Detection of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Mammography
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-25
Enrollment: 298
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This research is a retrospective study with an enriched sample of breast screening or diagnostic cases that were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A.

Brief summary: The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.

Detailed description: The safety and effectiveness of FFDM + DBT are both linked to the ability of radiologists interpreting FFDM + DBT images to accurately diagnose breast cancer. Each study endpoint therefore addresses both safety and effectiveness.

Eligibility criteria: Inclusion Criteria:

* Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites.
* Meet none of the exclusion criteria under protocol FMSU2013-004A.

Exclusion Criteria:

* Subjects who are in violation of protocol FMSU2013-004A.
* Subjects who meet exclusion criteria under protocol FMSU2013-004A.
* Subjects with unknown clinical status.
* Any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal MRMC reader study.

Primary outcomes:
measure: Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging, Ltd
state: Arizona
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Rochester
country: United States
facility: Elizabeth Wende Breast Care, LLC (EWBC)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - at Chapel Hill
state: North Carolina
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Fujifilm Medical Systems USA, Inc.
name: Robert M Uzenoff
role: STUDY_DIRECTOR
References:
Clinical trial NCT02967809: Usefulness of an Ultraportative Ultrasound Device in the Management of Intra Hospital Emergencies
Official title: Usefulness of an Ultraportative Ultrasound Device in the Management of Intra Hospital Emergencies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Failure; Cardiac
Lead sponsor: Hospital Nord
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient suffering of respiratory or cardiac distress

Brief summary: Estimate if the use of a portable cardiac echograph for intra-hospital Emergencie improves the performances diagnose in the bed of patient in department of conventional medicine.

The concordance between the initial medical diagnosis (previous the utilsation of portable echograph) and the final diagnosis (after portable echograph utisation) will be evaluated. These evaluation will be performed after retrospective review of the medical files


Eligibility criteria: Inclusion Criteria:

* respiratory or cardiac distress

Exclusion Criteria:

* pulmonary or cardiac patient transplant morphologic abnormalities Patient in rescucitation care unit

Primary outcomes:
measure: Concordance between initial medecial diagnosis and final diagnosis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Departement anesthesie reanimation hopital nord
Study officials:
affiliation: DAR Nord
name: Marc Leone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zieleskiewicz L, Lopez A, Hraiech S, Baumstarck K, Pastene B, Di Bisceglie M, Coiffard B, Duclos G, Boussuges A, Bobbia X, Einav S, Papazian L, Leone M. Bedside POCUS during ward emergencies is associated with improved diagnosis and outcome: an observational, prospective, controlled study. Crit Care. 2021 Jan 22;25(1):34. doi: 10.1186/s13054-021-03466-z.
Clinical trial NCT01367509: Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function
Official title: A Phase 1, Open-Label Study to Evaluate Single Dose Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.


Eligibility criteria: Inclusion Criteria:

1. Body weight \>100 lbs. (\> 45 kg), and body mass index (BMI) between 18-38 kg/m2, inclusive (BMI 18-30 for the matched reference group)
2. For patients/subjects requiring pharmacotherapy, a stable drug regimen, defined as not having started a new drug or changed dosage within three (3) days or five (5) half-lives (whichever was longer) prior to administration of MNTX concomitant medication must either have conformed to the list of approved drugs and dosage or have been approved by the sponsor.
3. Patients with normal renal function, demographically comparable to the patients with impaired renal function weights and ages were within the range of chronic kidney disease (CKD) group and the average for the matched reference group was within 10 years and 10 kg of the average for the CKD
4. Patients with impaired renal function, good general health except for those illnesses associated with CKD.

Exclusion Criteria:

1. Subjects/patients with any conditions possibly affecting drug absorption (eg. Gastrectomy or clinically significant diabetic gastroenteropathy)
2. Methadone use
3. Consumption of grapefruit or grapefruit juice within seven (7) days prior to administration of study medication.
4. Patients requiring hemodialysis.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of MNTX in patients with impaired renal function compared to healthy subjects
timeFrame: 6 days
Secondary outcomes:
measure: Peak time of maximum concentration (Tmax) of MNTX in patients with impaired renal function compared to healthy subjects
timeFrame: 6 days
measure: Area under the plasma concentration (AUC) of MNTX in patients with impaired renal function compared to healthy subjects
timeFrame: 6 days
measure: Percent of dose excreted in urine of MNTX in patients with impaired renal function compared to healthy subjects
timeFrame: 6 days
measure: Urinary clearance of MNTX in patients with impaired renal function compared to healthy subjects
timeFrame: 6 days
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01805609: Training Model to Advance Support of the Family as a Caregiving System in the Inpatient Oncology Setting
Official title: Training Model to Advance Support of the Family as a Caregiving System in the Inpatient Oncology Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Support of the Family as a Caregiving System
Keywords: practice nurse
clinical Nurse
inpatient staff
inpatient social worker
didactic training sessions
13-030
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Ackerman Institute for Family
First posted: 2013-03-06
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to provide a communication training program to inpatient nurses and social workers at Memorial Sloan Kettering Cancer Center in order to help them assist caregiving families. The importance of this training program is that it aims to teach nurses and social workers how and when to respond more effectively and compassionately to challenges faced by caregiving families. One of the goals of this program is to address family support needs during a patient's hospitalization.


Eligibility criteria: Inclusion Criteria:

* Participating Providers:
* Provider is an MSKCC acute care advanced practice nurse and/or inpatient social worker as per self-report.
* Plans to attend at least 4/6 the didactic training sessions, and 3/6 consolidation sessions as per self-report.

A patient will be approached if:

* Patient has been admitted to an inpatient service at MSKCC.
* Patient is able to designate at least one close person who is involved in the patient's care and is willing to participate. In the case that the patient is a minor (age 7-17 yrs), s/he will need to designate at least one close, adult person who is involved in the patient's care and is willing to participate.

Family members will be approached if:

* They were identified as a close other (including a family friend) involved in the care of an admitted patient on a participating provider's floor

Exclusion Criteria:

* Evidence of cognitive impairment severe enough to preclude completing survey instruments as per clinical or research staff judgment or EMR.
* Determined to not be appropriate for this study as per clinical judgment. Anyone, patient or family member, who is younger than 12 years old.
* Anyone, patient or family member, who does not speak English.

Primary outcomes:
measure: Provider outcomes
timeFrame: 2 years
Secondary outcomes:
measure: patient and/or family members'outcomes
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Talia Zaider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02970409: Heparin Versus Saline in Peripheral Venous Catheter
Official title: A Randomized Study to Test Peripheral Venous Catheter Lock Therapy With Either Heparin or Saline in Patients Admitted to the Internal Medicine Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter-Related Infections
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
First posted: 2016-11-22
Enrollment: 354
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: A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter. Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.

Detailed description: The need of use of peripheral venous catheters and the importance of a proper management to avoid catheter colonization or phlebitis requires two possible preventive approaches: lock therapy with heparin or saline.

Heparin demonstrated its efficacy in central venous catheters, but there are still controversies of whether it is useful in peripheral venous catheters.

Objectives To compare the efficacy of heparin in peripheral venous catheters lock versus saline for the prevention of colonization and phlebitis in patients admitted to an Internal Medicine Department.

Methods: A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter.

Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.

Eligibility criteria: Inclusion Criteria:

* patients with inserted PV Catheter within 24h from admission in internal medicine

Exclusion Criteria:

* hypersensibility to heparin
* active hemorrhage
* coagulation alterations

Primary outcomes:
measure: complications
timeFrame: Daily from catheter insertion until catheter withdraw(estimated 10 days)
Secondary outcomes:
measure: catheter related infection rate
timeFrame: Through study completion( estimated 2 year after Last patient in)
measure: adverse events(number of catheter obstructions and coagulation alterations)
timeFrame: Through study completion (2 year afterLast patient in)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Internal Medicine Department HGU Gregorio Marañón
Study officials:
References:
Clinical trial NCT03058809: Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood
Official title: Evaluation of the Saftey and Efficacy of the Viatar™ Oncopheresis System in Removing Circulating Tumor Cells From Whole Blood
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Metastatic Cancer
Lead sponsor: Viatar LLC
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will be their own controls
Primary purpose: TREATMENT

Brief summary: This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the change in circulating tumor cells as determined before and after treatment.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of breast, colon or prostate cancer
* No prior cancer therapy or failed first line therapy
* \>= 25 CTC per 7.5 mL of blood within 1 week prior to oncopheresis treatment
* \> 1 month life expectancy
* Adequate baseline hematological function as assessed by the following laboratory values:

  * Hemoglobin \> 9 g/dl
  * Platelets \> 100,000/mm3
  * WBC \> 3,000/mm3
  * Absolute Neutrophil Count \> 1,500/mm3

Exclusion Criteria:

* Coagulation disorders and/or a history of thromboembolic complications, including known hypersensitivity to citrate: e.g., abnormal platelet count, prothrombin time and partial activated thromboplastin time and with a history of deep vein thrombus or pulmonary embolism
* Patients with known immunodeficiency virus (HIV)

Primary outcomes:
measure: Change in Circulating Tumor Cells
timeFrame: % change will be determined on the day of treatment
Secondary outcomes:
measure: Immune system activation
timeFrame: Immune system activation biomarkers will be followed for 7 days post treatment
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Carabineros
name: Nigel Murray, MD
role: PRINCIPAL_INVESTIGATOR
References: