louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02264821: Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia
Official title: Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Caesarean Analgesia
Keywords: analgesia
caesarean
wound infiltration
intrathecal morphine.
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
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 compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery.

Detailed description: Double blind, 3 groups

* Control group: Rachi 0,1 ml saline, Infusion 300ml saline
* Group rachi-morphine: 0,1ml =100µg morphine/300ml saline
* Group KT: 0,1 ml saline/300 ml naropin 0.2%

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a Pfannenstiel incision and having signed the informed consent form.

Exclusion Criteria:

* Refusal of the patient or contra-indication to locoregional anesthesia
* Allergy to the products used
* ASA 3
* ASA 4
* Sleep apnea syndrome and/or obesity (BMI \> 35)
* Size inferior to 155cm
* existence of a language barrier

Primary outcomes:
measure: Duration of Effective Analgesia
timeFrame: 30 hours after spinal injection T0
measure: Morphine Consumption
timeFrame: 30 hours after spinal injection T0
Secondary outcomes:
measure: Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.
timeFrame: 30 hours after spinal injection
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Centre Hospitalier Universitaire Brugmann
Study officials:
affiliation: CHU Brugmann
name: Philippe Van der Linden, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03910764: Surveillance Study of Candiduria in Hospitalized Patients
Official title: Retrospective Surveillance Study of Candiduria in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candiduria
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 536
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with Candiduria

Brief summary: The purpose of the study is to explore the epidemiology, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis of patients with Candiduria.

Detailed description: The study is a retrospective study. Investigators will review medical records of patients with Candiduria from January 2015 to December 2017 to collect data about personal data, underlying diseases, indwelling catheter duration, laboratory data of urine routines and urine cultures, the symptom of fever, diagnosis, treatment and prognosis. After the data collection, investigators will run a descriptive statistics to find out the profile of the medical care of Candiduria in Taiwan.

Eligibility criteria: Inclusion Criteria:

* patients with Candiduria

Exclusion Criteria:

* patients without Candiduria

Primary outcomes:
measure: prevalence rate of Candiduria
timeFrame: January 2015 to December 2017
measure: morbidity rate of underlying diseases
timeFrame: January 2015 to December 2017
measure: indwelling catheter rate
timeFrame: January 2015 to December 2017
measure: pyuria rate
timeFrame: January 2015 to December 2017
measure: Candiduria rate
timeFrame: January 2015 to December 2017
measure: treatment rate
timeFrame: January 2015 to December 2017
measure: mortality rate
timeFrame: January 2015 to December 2017
measure: average indwelling catheter duration
timeFrame: January 2015 to December 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT06183164: Awareness Based Stress Reduction Program Applied to Breast Cancer Patients Receiving Chemotherapy
Official title: The Effect of Awareness-Based Stress Reduction Program Applied to Breast Cancer Patients Receiving Chemotherapy on Symptom Management Psychological Resilience and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Patients Receiving Chemotherapy
Keywords: life quality mindfulness psychological resilience symptom management
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is an exprimental study with pre-test, intermediate test and post-test control groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Implementation of awareness-based stress reduction program in breast cancer patients receiving chemotherapy and examining its effects on psychological resilience, symptom management and quality of life.

Detailed description: The conscious awareness-based stress reduction program is a program that lasts eight weeks, each session lasting 2-2.5 hours and including a 6-hour silence day. In order to apply the mindfulness stress reduction program to the experimental group, the 'Conscious Awareness Stress Reduction Program day and time were determined for 30 breast cancer patients receiving chemotherapy who met the inclusion criteria and were sampled. It was applied to the patients in the experimental group, once a week for 150 minutes, lasting 8 weeks, and consisting of 8 times in total. Then, an intermediate test was applied to the patients. After the interim test, patients were asked to repeat the It applications individually for 8 weeks (between weeks 8-16). In addition, after It was applied to the patients in the experimental group by the researcher, the 'Conscious Awareness Stress Reduction Program booklet prepared by the researcher was given to the patients in order to provide a guide for the patients in the experimental group. During the implementation of the research, no intervention was applied to the control group.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age
* Ability to communicate adequately
* No psychiatric problems
* Implementation of the Awareness-Based Stress Reduction Program is an obstacle
* Volunteering to participate in the research

Exclusion Criteria:

* Those who have communication problems
* Those with psychiatric problems
* Not agreeing to participate in the study.

Primary outcomes:
measure: ESTO SYMPTOM DIAGNOSIS SCALE
timeFrame: At the end of Sessions 16 ( each Session 1 days a week)
measure: EORTC QLQ-C 30 Quality of Life Scale
timeFrame: At the end of Sessions 16 ( each Session 1 days a week)
measure: Brief Psychological Resilience Scale
timeFrame: At the end of Sessions 16 ( each Session 1 days a week)
Secondary outcomes:
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Fırat university
state: Center
Study officials:
References:
Clinical trial NCT02742064: Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression
Official title: Quantified Mobile Sensing for Improving Diagnosis and Measuring Disease Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Bipolar Disorder
Lead sponsor: Cogito Health Inc
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts General Hospital
name: Partners HealthCare
First posted: 2016-04-18
Enrollment: 899
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: Participants will be selected from the MoodNetwork, an online network of individuals with mood disorders, which is hosted by MGH. A subset of participants with mood disorders enrolled in MoodNetwork will download Cogito's mobile sensing platform on their mobile phones.

Brief summary: The purpose of this study is to determine if a mobile sensing platform can passively and objectively detect the presence of clinically significant mood disorder symptomatology and symptom progression over time. Meeting this goal will allow for improved risk categorization, prediction of relapse, and measurement of disease progression in a lifetime prevalence population.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Have a smartphone and cell service plan, including voice and data, that meets the device requirements of the Mobile Sensing Platform.
* Enrolled in the MoodNetwork

Exclusion Criteria:

* Report positively on the QIDS-SR suicide item during study intake
* Total score greater than 15 on the QIDS-SR during the screening process

Primary outcomes:
measure: Severity of MDD symptoms as assessed by QIDS SR
timeFrame: 6 months
measure: Severity of Mania symptoms as assessed by ASRM
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00600964: A Phase I/II Study of GX15-070MS in Untreated CLL
Official title: A Multi-Center, Open-Label, Phase I/II Study of Single-Agent GX15-070MS Administered Every 2 to 3 Weeks to Patients With Previously-Treated Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
obatoclax
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.

Detailed description: Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed B-CLL
* Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1
* Age ≥18 years
* ECOG Performance Status ≤1
* Life expectancy of \>8 weeks

Exclusion Criteria:

* Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy
* Patients with history of seizure disorders
* Pregnant women and women who are breast feeding
* HIV-positive patients receiving combination anti-retroviral therapy

Primary outcomes:
measure: Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks
timeFrame: 14 days
Secondary outcomes:
measure: Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks.
timeFrame: 14 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of CA- San Diego
state: California
city: Washington
country: United States
facility: Lombardi Cancer Center
state: District of Columbia
city: Hershey
country: United States
facility: Milton S Hershey Medical Center Penn State Cancer Institute
state: Pennsylvania
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Gemin X, Inc.
name: Jean Viallet, MD
role: STUDY_DIRECTOR
References:
citation: O'Brien SM, Claxton DF, Crump M, Faderl S, Kipps T, Keating MJ, Viallet J, Cheson BD. Phase I study of obatoclax mesylate (GX15-070), a small molecule pan-Bcl-2 family antagonist, in patients with advanced chronic lymphocytic leukemia. Blood. 2009 Jan 8;113(2):299-305. doi: 10.1182/blood-2008-02-137943. Epub 2008 Oct 17.
Clinical trial NCT03252964: Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics
Official title: Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Savvysherpa, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-17
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. The educational program will involve calls from coaches to check subjects' progress and answer questions.


Eligibility criteria: Inclusion Criteria:

* Be diagnosed with type 2 diabetes
* Currently take a DPP4 inhibitor, SGLT2 inhibitor, GLP-1 agonist, and/or basal insulin
* Be able to read and understand English
* Have access to a telephone
* Have a Medicare health plan

Exclusion Criteria:

* Pregnant
* Blind
* Deaf
* Currently receiving chemotherapy or radiation therapy to treat cancer
* Addicted to any drugs (including alcohol, painkillers, hallucinogens, or others)
* Critically ill
* Diagnosed with or experiencing:

  * Kidney disease stages 4 and 5
  * End stage renal disease
  * Severe liver disease
  * Dementia
  * Schizophrenia
  * Bipolar disorder
  * Autism
  * An intellectual or learning disability
  * Arrhythmias other than atrial fibrillation
  * Congestive heart failure
* Has had a:

  * Myocardial infarction within the last 6 months
  * Stroke within the last 6 months
  * Stroke that resulted in significant disability (e.g., unable to write clearly or walk)

Primary outcomes:
measure: Program Enrollment Rate (%)
timeFrame: up to three months
measure: Program Completion Rate (%)
timeFrame: up to six months
Secondary outcomes:
measure: Change in A1c Measurement (%)
timeFrame: Day 0 and Day 180
measure: Weekly Average of Estimated Glucose Values (EGV) (Average)
timeFrame: up to six months
measure: Change in Medication Dosage (mg/Day; U/Day)
timeFrame: up to six months
measure: Average Age of Participants Who Start Trial (Yrs)
timeFrame: up to three months
measure: Average Age of Participants Who Complete Trial (Yrs)
timeFrame: up to six months
measure: Race of Participants Who Start the Trial (n)
timeFrame: up to three months
measure: Ethnicity of Participants Who Start the Trial (n)
timeFrame: up to three months
measure: Texting With Coaches (Daily Average of Text Messages)
timeFrame: up to six months
measure: Coaching Participation Rate
timeFrame: up to six months
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Rogelio Machuca, MD Family Medicine, PLLC
state: Nevada
Study officials:
References:
Clinical trial NCT00002964: Porfimer Sodium in Diagnosing Patients With Head and Neck Cancer
Official title: Pilot Study for the Diagnosis of Head and Neck Cancer: Photofrin and Visible Light
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: stage 0 oropharyngeal cancer
stage 0 laryngeal cancer
stage 0 hypopharyngeal cancer
stage 0 lip and oral cavity cancer
stage I lip and oral cavity cancer
stage I hypopharyngeal cancer
stage I laryngeal cancer
stage I oropharyngeal cancer
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2004-04-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Drugs that make cancer cells more visible to light may help in the diagnosis of head and neck cancer.

PURPOSE: Phase II trial to study the usefulness of porfimer sodium in diagnosing patients with head and neck cancer.

Detailed description: OBJECTIVES: I. Determine whether porfimer sodium fluorescence can be used to reveal early malignant changes in patients with lesions of the oral cavity. II. Investigate whether porfimer sodium fluorescence can define areas of field cancerization in the oral mucosa, specifically satellite foci of malignant cells within the margins of an excision. III. Determine whether uptake of fluorescence is indicative of disease stage.

OUTLINE: Patients receive porfimer sodium IV bolus and are kept in subdued light until examination with a fluorescence photometer 48 hours later. Patients must avoid sunlight and other intense lights for an additional 30 days.

PROJECTED ACCRUAL: 20 patients will be accrued per year.

Eligibility criteria: DISEASE CHARACTERISTICS: Malignant or suspected lesions of the head and neck that are scheduled for excisional biopsy Lesions no greater than 2 cm in diameter in the mouth, oropharynx, hypopharynx or larynx Suspected severe dysplasia, carcinoma in situ and/or invasive carcinoma of the head and neck

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3500/mm3 Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT no greater than 2 times upper limit of normal Alkaline phosphatase no greater than 2 times upper limit of normal Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: No known hypersensitivity to porphyrins Not pregnant Fertile patients must use effective birth control

PRIOR CONCURRENT THERAPY: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Wesley L. Hicks, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03388164: Adherence to Antidepressant Treatment in Subjects With Depression
Official title: Adherence to Antidepressant Treatment in Subjects With Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Depression
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to determine whether a combination a first-line antidepressant plus "RT2CK17" in a capsule relative to a first-line antidepressant plus placebo in a capsule results in higher rates of medication adherence in individuals with moderate to severe depression. In this double-blind randomized placebo controlled trial, 100 individuals with a Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) scale score ≥ 14 will be enrolled to participate in an 8 week treatment study. Participants will be randomized with a 1-1 ratio to receive 5 milligrams (mg) "RT2CK17" + 10 mg escitalopram or placebo + 10 mg escitalopram to be taken orally once per day. Participants will undergo a 3 hour baseline evaluation visit at week 0, two 30-minute office visits (week 2 and 4), one 60-minute office visit (week 8) and three 5-minute phone calls (weeks 1, 3, and 6) during which clinical assessments and measures will be obtained. The trial is designed with two stages: 20 participants in Stage 1 will be used to estimate the adherence effect size; Stage 2 is designed with an interim analysis to test our hypotheses.


Eligibility criteria: Inclusion Criteria:

* Baseline QIDS-SR ≥ 14 (moderate depression)
* Age 18 - 65
* Written Informed Consent
* Major Depressive Disorder, single-episode/recurrent, not in remission

Exclusion Criteria:

* RT2CK17-related exclusions
* Uncontrolled hyperthyroidism
* Glaucoma
* Motor tics
* Monoamine oxidase inhibitor treatment
* Serious coronary artery disease, cardiomyopathy, serious cardiac arrhythmias
* Uncontrolled hypertension
* Peripheral vasculopathy
* Pregnancy
* Bipolar Disorder
* Psychotic Disorder
* History of intolerability of study medications
* Currently taking psychiatric medications
* Current Substance Use Disorder (other than nicotine)
* Current Alcohol Use Disorder

Primary outcomes:
measure: Rate of Adherence
timeFrame: 8 weeks
Secondary outcomes:
measure: Adherence Consistency
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Martin P Paulus, M.D.
role: STUDY_DIRECTOR
References:
citation: Paulus MP, Kuplicki R, Victor TA, Yeh HW, Khalsa SS. Methylphenidate augmentation of escitalopram to enhance adherence to antidepressant treatment: a pilot randomized controlled trial. BMC Psychiatry. 2021 Nov 19;21(1):582. doi: 10.1186/s12888-021-03583-7.