louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03826875: Poststroke Depression in Hemorrhagic Stroke
Official title: Preventative Treatment of Depression in Survivors of Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stroke Hemorrhagic
Depression
Keywords: stroke
hemorrhagic stroke
subarachnoid hemorrhage
depression
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blinded placebo-controlled randomized trial
Primary purpose: PREVENTION

Brief summary: A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke.

Detailed description: Patients who suffered aneurysmal subarachnoid hemorrhage will be randomly assigned either an oral antidepressant or placebo and evaluated for the preventative treatment of depression and health-related quality-of-life.

Eligibility criteria: Inclusion Criteria:

Patients 18-85 years of age aged 18 years and older will be included.

Patients admitted for subarachnoid hemorrhage from a ruptured cerebral aneurysm will be included.

Only patients who provide informed consent will be included.

Exclusion Criteria:

Non-English speaking patients will be excluded.

Patients currently receiving therapy for depression or related mental health diagnoses before admission will be excluded.

Patients with medical contraindications to fluoxetine therapy will be excluded.

Pregnant patients or patients considering pregnancy during the trial period at the time of consent will be excluded.

Patients with active psychosis will be excluded.

Patients who are incarcerated or in police custody will be excluded.

Patients with a comorbidity or cognitive impairment (as determined by a recruiter-administered Montreal Cognitive Assessment; Patients scoring \>26 are considered of appropriate cognitive function for consent) that precludes informed consent and participation in the research interviews will be excluded.

Primary outcomes:
measure: Depression
timeFrame: 1 year
measure: Depression
timeFrame: 1 year
Secondary outcomes:
measure: Anxiety
timeFrame: 1 year
measure: Fatigue
timeFrame: 1 year
measure: Healthcare Utilization
timeFrame: 1 year
measure: Social Support
timeFrame: 1 year
measure: Sleep Disturbance
timeFrame: 1 year
measure: Function
timeFrame: 1 year
measure: Function
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Michael Levitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03009175: PRoMOTE Follow-up Observational Study
Official title: Patient Risk Triage in ICD Remote Follow-up Observational Study (PRoMOTE FU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2017-01-04
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include patients of both sexes included in the Medtronic CareLink® Network and implanted with a Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities device (CRT-D) at Hospital Araba (former Hospital Txagorritxu). There are approximately 223 ICD and CRT-D patients included in the CareLink® Network at this site, and average number of transmissions per month is \~80, so it is expected that 480 transmissions are received during the study duration.

From this population, less than 10% are implanted with a device without Optivol® feature. For these patients we will not have HFRS data.

Brief summary: The purpose of the study is:

* To evaluate the Heart Failure Risk Status (HFRS) feature performance.
* To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature as supplemental information.


Eligibility criteria: Inclusion Criteria:

Patients that meet all of following criteria could be included in the study:

* Implant of a commercially available Medtronic CRTD or ICD device with or without the Optivol Fluid Status Monitoring feature.
* Inclusion in the Medtronic Carelink Network.
* Local consent available for CL network as well as general local consent available for the use of data in observational studies signed and informative sheet delivered.

Exclusion Criteria:

* Patients under the age of 18 years.

Primary outcomes:
measure: Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04432675: Effects of Crystal Solution and Colloid Solution on Mother and Fetus
Official title: Comparison of the Effects of Crystal Solution (Lactic Acid Ringer's Solution) and Colloid Solution (Hydroxyethyl Starch) on Mother and Fetus After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Spinal Anesthesia
Parturition
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison of the effects of crystal solution (lactic acid Ringer's solution) and colloid solution (hydroxyethyl starch) on mother and fetus after cesarean section

Detailed description: The Hydroxyethl group use 10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch. The control group 10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution. During the whole operation of elective cesarean section

Eligibility criteria: Inclusion Criteria:

* Healthy singleton pregnancy scheduled for elective cesarean section under CSEA; American Society of Anesthesiologists (ASA) physical status Ⅰ/Ⅱ; Age ranging from 20 to 40 years old.

Exclusion Criteria:

* History of mental disorder or epilepsy; History of central nervous system (CNS) disease; Preexisting or pregnancy-induced hypertension; History of lumber injury; Severe hypovolemia; Allergy or hypersensitivity to norepinephrine; Body mass index (BMI) above 40 kg/m2; Infection at the puncture site; Tricyclic or imipramine antidepressants.

Primary outcomes:
measure: hypotension
timeFrame: during operation procedure
Secondary outcomes:
measure: umbilical vein blood gases
timeFrame: 24 hours
measure: umbilical artery blood gases
timeFrame: 24 hours
measure: Maternal vein blood gase
timeFrame: 24 hours
measure: The incidences of maternal complications
timeFrame: 24 hours
measure: Hemodynamic data at time point
timeFrame: 24 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital
state: Beijing
Study officials:
affiliation: China International Neuroscience Institution
name: Yanghai Cui
role: STUDY_CHAIR
References:
Clinical trial NCT00232375: Intervention to Preserve Beta-Cell Function in GAD Ab-Positive Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GAD Ab Positive Clinically Type 2 Diabetic Patients
Keywords: SPIDDM
LADA
GAD antibody
Beta cell function
Insulin
Lead sponsor: Tokyo Study Group
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We tested the hypothesis that insulin therapy rather than sulfonylurea (SU) treatment has a preferable outcome to reverse or preserve beta cell function in the patients with diabetes that is called slowly progressive insulin-dependent (type 1) diabetes (SPIDDM) or latent autoimmune diabetes in adult (LADA).

Detailed description: In a multicenter, randomized, nonblinded clinical study, 4,089 non-insulin dependent diabetic patients were screened for glutamic acid decarboxylase autoantibodies (GADAb). Sixty GADAb-positive non-insulin requiring diabetic patients with duration of diabetes =/\<5 years were assigned to either the SU group (n = 30) or the Insulin group (n = 30). Serum C-peptide response to annual oral glucose tolerance tests were followed for 57 mean months. The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values \[sigma C-peptide\] \<4 ng/ml).

Eligibility criteria: Inclusion Criteria:

* Subjects should use SU agents to obtain as a goal good glycemic control.
* Duration of diabetes within 5 years from the onset (or diagnosis).

Exclusion Criteria:

* Subjects having history of hyperglycemia requiring insulin treatment and/or history of ketosis/ketoacidosis were excluded.
* Subjects with malignant diseases, systemic inflammatory diseases, renal or liver disorders or malabsorption were also excluded.

Primary outcomes:
measure: The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values [sigma C-peptide] <4 ng/ml).
Secondary outcomes:
Other outcomes:
Locations:
city: Tamaho
country: Japan
facility: University of Yamanashi
state: Yamanashi
Study officials:
affiliation: Third Department of Internal Medicine, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi
name: Tetsuro Kobayashi, Professor
role: STUDY_DIRECTOR
References:
citation: Maruyama T, Tanaka S, Shimada A, Funae O, Kasuga A, Kanatsuka A, Takei I, Yamada S, Harii N, Shimura H, Kobayashi T. Insulin intervention in slowly progressive insulin-dependent (type 1) diabetes mellitus. J Clin Endocrinol Metab. 2008 Jun;93(6):2115-21. doi: 10.1210/jc.2007-2267. Epub 2008 Apr 8.
Clinical trial NCT05262075: Online Mindful & Resiliency Program Intimate Partner Violence
Official title: Experiences of an Online Mindfulness Program Integrating Resiliency Factors for Women Who Have Experienced Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Intimate Partner Violence
Keywords: Mindfulness
Resiliency
Online
Domestic violence
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: 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 explore the experiences and benefits of offering an online mindfulness program that integrates resiliency factors to women.

Detailed description: The purpose of this study is to explore the experiences and benefits of offering an online mindfulness program that integrates resiliency factors to women. Investigators will recruit participants via email and social media flyers to local community sites as well as approved Loma Linda University affiliated sites. Participants who consent will then complete a Demographic Questionnaire(before initial session of program), Pre and Post Stress Surveys (at the start and end of each session), Five-Facet Mindfulness Questionnaire(before and after completion of the program), and a semi-structured interview after the completion of the program. The program will be done be 20-minutes sessions for 3x/week for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Women who self-identify as having or who are currently experiencing intimate partner violence
* English or Spanish speaking
* Between 18 and 85 years old.

Exclusion Criteria:

* Males
* No experience of partner violence
* Not fluent in either English or Spanish \<18 and \>85 years of age

Primary outcomes:
measure: Level of Stress
timeFrame: Change between Baseline and Week 5 of mindfulness training
measure: Level of Self-Awareness
timeFrame: Change between Baseline and Week 5 of mindfulness training
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Dragrana Krpalek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02975375: The Impact of Perioperative Geriatric Care on Outcomes After Elective Noncardiac Surgery
Official title: The Impact of Perioperative Geriatric Care on Outcomes After Elective Noncardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SURGICAL PROCEDURES, OPERATIVE
Aged
Epidemiology
Mortality
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 266499
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals \>65 years of age on the day of the potential participant's first elective non-cardiac surgery in the study period

Brief summary: The investigators will conduct a population-based study using health administrative data to evaluate the impact of preoperative geriatric consultation on postoperative outcomes in older patients having elective, non-cardiac surgery

Detailed description: The investigators will use multilevel multivariable analyses to measure the association between preoperative geriatric assessment or consultation and outcomes after major elective non-cardiac surgery. Sensitivity analyses will be done to evaluate types and timing of geriatric care around surgery, as well as for effect modification based on patient and procedural factors.

Eligibility criteria: Inclusion Criteria:

* \>65
* Resident of Ontario
* Having elective non-cardiac surgery (inpatient admission)

Exclusion Criteria:

* Residing in a nursing home or long term care facility at baseline

Primary outcomes:
measure: Number of Participants With All-Cause Mortality at 90-days
timeFrame: date of surgery to 90 days after surgery
Secondary outcomes:
measure: Patient Safety Event
timeFrame: From surgery to hospital discharge (on average 6 to 7 days)
measure: Hospital Length of Stay
timeFrame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
measure: Non-independent Discharge Location
timeFrame: date of surgery to date of hospital discharge, or 365 days after surgery, whichever comes first
measure: 30-day Hospital Readmission
timeFrame: Date of discharge (on average 6 to 7 days) to 30 days after discharge (on average 5 weeks)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
References:
Clinical trial NCT03709875: Telerehabilitation in Severe Acquired Brain Injury
Official title: A Cost-effective Analysis of Telerehabilitation in Patients With Severe Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injuries
Stroke
Keywords: Telerehabilitation
Motor outcomes
Cognitive dysfunction
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
Collaborators: name: IRCCS San Camillo, Venezia, Italy
name: University of Messina
First posted: 2018-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multi-center, prospective, parallel design, single-blind trial
Primary purpose: TREATMENT

Brief summary: We will investigate the use of TR, based on advanced Information and Communication Technology (ICT) solutions, taking into account that the supervision of rehabilitation at home will be enriched with the counselling and vital parameters monitoring. The aim of the study is to evaluate that TR is at least non-inferior in comparison with the same amount of usual territorial rehabilitative physical treatments (UTRT), taking into account patients' functional recovery, psychological well-being, caregiver burden, and healthcare costs. The enrolled patients will be balanced for pathology and randomized in two groups, performing TR (G1) or standard rehabilitation training (G2), respectively, according to a pc-generated random assignment.TR will be delivered by means of an advanced video-conferencing system, whereas the patient will be provided with low-cost monitoring devices, able to collect data about his/her health status and QoL. In both the groups each treatment (either cognitive or motor, or both as per patient functional status) will last about one hour a day, five days/week, for 12 weeks. Two structured telephone interviews will be administered to the patients (when possible) and/or their caregivers, and to all the healthcare professionals involved in the patient management, one week after the beginning and at the end of the TR.


Eligibility criteria: Inclusion Criteria:age range 18 to 65 years; diagnosis of SABI; availability at home internet connection.

Exclusion Criteria: severe cognitive and behavioral impairments, cardio-respiratory instability or other medical illness potentially interfering with the treatment, severe limb spasticity, high-risk of spontaneous fracture, substance abuse.

Primary outcomes:
measure: WHO Disability Assessment schedule
timeFrame: 3 months
measure: Montreal Cognitive assessment
timeFrame: 3 months
Secondary outcomes:
measure: Fugl- Meyer for Upper limb
timeFrame: 3 months
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino-Pulejo"
Study officials:
affiliation: IRCCS Centro Neurolesi
name: Rocco S Calabrò, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02165475: Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents
Official title: Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents is Effective for the Treatment of Fecal Incontinence in Women - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2014-06-17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Background: Biofeedback and medical treatments have been extensively used for moderate fecal incontinence. There is limited data comparing and combining these two treatments.

Aim: To evaluate the effect of biofeedback and medical treatments, separately and in combination.

Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal incontinence were included. The patients were randomized to start with either biofeedback (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both groups continued with a combination treatments, i.e. medical treatment was added to biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age
* Patients with at least one or more episodes of FI during a period of 2 weeks as recorded by bowel function diary
* Patients from whom written consent was obtained

Exclusion Criteria:

* Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
* Presence of neurological diseases or peripheral vascular disease
* Uncontrolled diabetes mellitus
* Congenital anorectal malformations
* Recent colorectal or gastrointestinal surgery
* Presence of external full-thickness rectal prolapse
* Inflammatory bowel disease
* Chronic diarrhoea
* Use of tibial nerve or sacral nerve stimulations
* Ongoing pregnancy
* Any malignant disease

Primary outcomes:
measure: symptom diary
timeFrame: Up to eight months
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Pelvic floor unit, University hospital of Linköping
Study officials:
References:
Clinical trial NCT06004375: THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL
Official title: THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: COVID-19
Oral Nutrition Supplement
Lead sponsor: Universitas Sriwijaya
Sponsor class: OTHER
Collaborators: name: M. Djamil General Hospital
First posted: 2023-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine effect of arginine and glutamine on outcome of COVID-19 patients. The main questions it aims to answer are:

-to test the effect of oral nutritional supplements containing arginine and glutamine on covid-19 patients outcome Dr. M. Djamil General Hospital Padang

Participants will given ONS containing arginine and glutamine. Researchers will compare intervention group with control group to see if ONS affected outcome of COVID-19 patients


Eligibility criteria: Inclusion Criteria:

* Patients confirmed positive for COVID-19
* Age over 17 years
* The patient can take food orally

Exclusion Criteria:

* Patients with restricted fluid intake
* Patients who cannot take food orally
* suffering from diabetes mellitus and kidney failure

Primary outcomes:
measure: length of stay
timeFrame: 3 months
measure: Outcome
timeFrame: 3 months
measure: ICU Admission
timeFrame: 3 months
Secondary outcomes:
measure: Il-6 and CRP Levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Padang
country: Indonesia
facility: Dr. M. Djamil General Hospital
state: West Sumatera
Study officials:
References:
Clinical trial NCT02060175: Comparison of the 3-month Strut Coverage After Coronary Stenting by Optical Coherence Tomography; Cilotax and DESyne
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCI
Keywords: Optical coherence tomography, Drug-eluting stent, Strut coverage
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We will compare the stent coverage at 3 months by optical coherence tomography (OCT) between the Cilotax and DESyne drug-eluting stents (DES). The extent of the strut uncoverage has not been evaluated yet for both the Cilotax and DESyne and we first sought to decide the reference intervals using 40 samples (total 44 patients for each group considering 10% drop-out rate) as the pilot study.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 20 years old
* Patients in the treatment of subjects with all-comer who are to undergo PCI

Exclusion Criteria:

* Pregnant women or women with potential childbearing
* Life expectancy \< 1 year

Primary outcomes:
measure: Stent coverage
timeFrame: up to 3 months after stent implantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: