louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03908710: The Accumbo Home Blood Pressure Trial
Official title: A Prospective Trial of Home Blood Pressure Levels in Hypertensive Participants Using the ACCUMBO Telemedicine Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension,Essential
Keywords: Home blood pressure monitor
Telemedicine
mHealth
eHealth
Lead sponsor: Accumbo AB
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
First posted: 2019-04-09
Enrollment: 172
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system,a smartphone patient app and a home blood pressure monitor.

Detailed description: Despite the extensive knowledge of the importance of treating and thus preventing complications of hypertension, the incidence of high blood pressure is increasing, and it is still the main cause of cardiovascular disease and premature death, partly due to deficiencies in preventive care and control of the disease in an aging world. Blood pressure values obtained by self-measurement at home (HBPM) have been shown to predict the cardiovascular prognosis equally well as or better than blood pressure values obtained in the clinic (CBPM) in several observational studies. Aim of the present study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system and a electronic health record, a patient app and a home blood pressure monitor. " The patient app and the doctor's record reflect each other and basically contain the same information. Doctors can treat their patients remotely and the patients are able to manage some health issues by themselves by using the applications. Some patients need the physical examination. We therefore included patients after a so-called triage step with medical questions.

Eligibility criteria: Inclusion Criteria:

* Primary hypertension
* Smartphone at home

Exclusion Criteria:

* Secondary hypertension,
* previous stroke,
* myocardial infarction,
* known heart failure,
* known cardiac arrhytmia,
* known servere renal failure,
* known dementia

Primary outcomes:
measure: Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor
timeFrame: 3 months
measure: Patient experience
timeFrame: 3 months
Secondary outcomes:
measure: Hypotension
timeFrame: 3 months
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Martin Carlsson,
Study officials:
affiliation: Accumbo AB
name: Martin Carlsson, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01337310: Study of Tesetaxel in Japanese Patients With Solid Tumors
Official title: A Phase I Study of Tesetaxel Administered Once Every 21 Days to Japanese Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced solid tumors
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of tesetaxel in Japanese patients has been limited. This study is being conducted to determine the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to Japanese patients.


Eligibility criteria: Primary inclusion criteria:

* At least 20 years of age
* Morphologic or cytologic confirmation of an advanced or metastatic solid tumor malignancy, not to include lymphoma, for which no standard therapy exists or for which resistance or intolerance to standard therapy has developed
* ECOG performance status not more than 1
* Adequate bone marrow, hepatic, and renal function
* Willing to remain hospitalized for at least 10 days following tesetaxel administration in Cycle 1
* At least 4 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent, with resolution of any toxicity to not more than Grade 1

Primary exclusion criteria:

* Brain metastasis or leptomeningeal disease
* Significant medical disease other than cancer
* Neuropathy greater than Grade 1

Primary outcomes:
measure: Maximum tolerated dose in mg/m2 based on the dose-limiting adverse events that occur
timeFrame: First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)
Secondary outcomes:
measure: Dose-limiting toxicities (adverse events that result in a reduction in the dose of tesetaxel in the dose-escalation scheme)
timeFrame: First cycle (expected to be 21 days, including the day of first dose of tesetaxel followed by a rest period)
measure: Percentage of patients with adverse events
timeFrame: Through 30 days after the last dose of tesetaxel
measure: Tumor response rate
timeFrame: After Cycle 2 (expected to be after Day 42 counting from the date of first dose of tesetaxel)
Other outcomes:
Locations:
city: Osaka-fu
country: Japan
facility: Kinki University School of Medicine
Study officials:
References:
Clinical trial NCT05857410: Scheme of Limb Warming Blanket Combined With Dexmedetomidine
Official title: Clinical Effect Observation of Lower Limb Warming Blanket Combined With Dexmedetomidine in Preventing Postoperative Delirium and Chills in Elderly Patients Undergoing Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Surgery
Postoperative Delirium and Chills
Keywords: Elderly spinal surgery
Delirium and chills
Lead sponsor: Jincheng General Hospital
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Objective: To observe the clinical effect of lower limb warming blanket combined with dexmedetomidine (DEX) in preventing postoperative delirium (POD) and chills in elderly patients undergoing spinal surgery. Methods: A total of 160 elderly patients undergoing posterior spinal surgery under general anesthesia were selected and divided into control group (group N), heating group (group T), DEX group (group D) and heating combined with DEX group (group TD) according to the random number table method, 40 cases in each group. T group and TD group routine insulation and lower limb heating blanket. DEX was injected in group D and group TD. The dosage of anesthetics, the changes of body temperature and heart rate at different time points during operation, and the occurrence of postoperative chills and POD were compared among the groups.


Eligibility criteria: Inclusion Criteria:

* Age: between 65-80 years old;
* American Society of Anesthesiologists (ASA) grade II-III;
* Normal body temperature before operation;
* the operation time was 2-4 hours

Exclusion Criteria:

* Preoperative fever or hypothermia (body temperature≥37.5 ℃ or≤35.5℃ on the day of operation);
* Body mass index (BMI) \>30 kg/m2;
* The existence of heart, brain, lung, kidney and other important organs and circulatory system, respiratory system, immune system, central nervous system diseases;
* Patients who had taken antipsychotic drugs or β-blockers before surgery would have a greater impact on intraoperative body temperature and other patients who could not effectively cooperate with this study;
* Patients with operation time more than 5 hours

Primary outcomes:
measure: Intraoperative vital signs monitoring
timeFrame: 1 hour
measure: Intraoperative vital signs monitoring
timeFrame: 2 hour
measure: Intraoperative vital signs monitoring
timeFrame: 3 hour
measure: The incidence of postoperative chills
timeFrame: 1 hour
measure: The incidence of POD after operation
timeFrame: 1 day
measure: Postoperative extubation time
timeFrame: 1 hour
measure: Postoperative incision infection rate
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jincheng
country: China
facility: Jincheng General Hospital
state: Shanxi
Study officials:
References:
Clinical trial NCT02186210: Effect of Prewarming on Microcirculatory Response
Official title: Effect of Prewarming on Microcirculatory Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft Triple Vessel
Keywords: microcirculation
off-pump coronary artery bypass surgery
tissue oxygen saturation
vascular occlusion test
recovery slope
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is important for clinical outcome. The investigators hypothesized that prewarming during induction of general anesthesia would reduce drop of body temperature and change of peripheral microcirculation.

Detailed description: Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare the recovery slope during vascular occlusion test between prewarming treatment group and control group.

Eligibility criteria: Inclusion Criteria:

* off-pump coronary artery bypass surgery

Exclusion Criteria:

* refuse to enroll
* cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula
* preoperative left ventricular ejection fraction \< 35%
* preoperative continuous infusion of vasopressor or inotropes
* pregnancy

Primary outcomes:
measure: Recovery Slope
timeFrame: 3 hours after induction of anesthesia
Secondary outcomes:
measure: Tissue Oxygen Saturation
timeFrame: During the surgery, an average of 4 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yunseok Jeon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho YJ, Lee SY, Kim TK, Hong DM, Jeon Y. Effect of Prewarming during Induction of Anesthesia on Microvascular Reactivity in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery: A Randomized Clinical Trial. PLoS One. 2016 Jul 21;11(7):e0159772. doi: 10.1371/journal.pone.0159772. eCollection 2016.
Clinical trial NCT01635010: Obstructive Sleep Apnea in the Absence of Metabolic Syndrome
Official title: Obstructive Sleep Apnea in the Absence of Metabolic Syndrome: Pulse Wave Velocity, Inflammatory and Oxidative Stress Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
inflammation
oxidative stress
arterial stiffness
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2012-07-06
Enrollment: 34
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled clinical studies investigating the independent effects of OSA in the development of cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders such as inflammatory response, oxidative stress and vascular changes. The investigators hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular consequences in OSA patients would be less important.

The purpose of this study is to analyze the effects of OSA in the absence of MS, on inflammatory, oxidative stress and vascular markers; to verify the influence of excessive daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of nasal continuous positive airway pressure (nCPAP)in theses parameters.


Eligibility criteria: Inclusion Criteria:

* male subjects
* apnea-hypopnea index \> 15/h (OSA group)
* apnea-hypopnea index \< 5/h (control group)

Exclusion Criteria:

* body mass index (BMI) \> 30 kg/m2
* age \> 60 years
* chronic obstructive pulmonary disease
* cardiac diseases
* diabetes mellitus
* metabolic syndrome according to modified National Cholesterol Education Program Adult Treatment Panel III criteria
* previous OSA treatment

Primary outcomes:
measure: Inflammatory marker (high sensitive C-reactive protein)
timeFrame: 3 months
measure: Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)
timeFrame: 3 months
measure: Arterial stiffness (pulse wave velocity)
timeFrame: 3 months
measure: Angiotensin converting enzyme activity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Associação Fundo de Incentivo à Pesquisa
Study officials:
affiliation: Associação Fundo de Incentivo à Pesquisa
name: Daniela K. Andaku, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associação Fundo de Incentivo à Pesquisa
name: Sônia M. Togeiro, PhD
role: STUDY_CHAIR
affiliation: Associação Fundo de Incentivo à Pesquisa
name: Vânia D'Almeida, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03743610: Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
Official title: Investigation of Physiological Adaptations to Simulated Intermittent Altitude on Human Health and Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Altitude Hypoxia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators expect to find that different intensity and altitude exposure levels will show what kind of intermittent exposure protocol is more beneficial to athletes and healthy individuals that experience acute exposure to altitude during exercise. This may furthermore be related to acute altitude exposure for recreational exercise use as well.


Eligibility criteria: Inclusion criteria:

* 18-70 years of age,
* history of good health,
* generally active to competitive athletes.

Exclusion criteria:

* History of cardiac or pulmonary disease,
* not currently active,
* unable to exercise or meet study requirements (e.g., number of sessions),
* live at altitude (\>2,100m or 7,000ft).

Primary outcomes:
measure: Change in hemoglobin
timeFrame: Baseline, 2-week, 4-week, 6-week, and 8-week
measure: Change in hematocrit
timeFrame: Baseline, 2-week, 4-week, 6-week, and 8-week
measure: Change in erythropoietin
timeFrame: Baseline, 2-week, 4-week, 6-week, and 8-week
Secondary outcomes:
measure: Change in peak VO2
timeFrame: Baseline and 6- and 8-week
measure: Change in cycling performance at altitude
timeFrame: Baseline and 6- and 8-week
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Courtney M Wheatley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01118910: Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
Official title: Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Intertrigo
Keywords: Intertrigo
Vusion
Lead sponsor: Image Dermatology P.C.
Sponsor class: OTHER
First posted: 2010-05-07
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if people with moist, red, patches on their skin in body folds would benefit treatment of those areas with an FDA-approved drug called Vusion.

Detailed description: Intertrigo is an inflammatory condition of skin folds, induced or aggravated by heat, moisture, maceration, friction, or lack of air circulation. It is typically chronic with insidious onset of itching, burning, and stinging within the affected skin folds. Intertrigo frequently worsened or colonized by infection, which most commonly is candidal but also may be bacterial, fungal, or viral. The etiology of diaper dermatitis shows significant overlap with that of intertrigo. Vusion ointment, a highly effective treatment for diaper dermatitis, has been used by physicians for the treatment of intertrigo; however, there is a paucity of data in the literature regarding the use of Vusion ointment in this indication.

This study is the first to formally investigate the efficacy and safety of Vusion ointment for the treatment of intertrigo.

Eligibility criteria: Inclusion Criteria:

* Evidence of intertrigo

Exclusion Criteria:

* Pregnancy
* Use of systemic or topical antifungal or corticosteroid treatment in the previous 14 days or during the 3-month treatment period
* allergy of sensitivity to Vusion
* undergoing warfarin anticoagulation
* alcohol or drug abuse
* Investigator determines they cannot particpate
* history of non-compliance or poor cooperation
* participation in an investigaitonal drug study within 30 days of Baseline Visit

Primary outcomes:
measure: The number of patients for whom Vusion effectively treated intertrigo
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montclair
country: United States
facility: Image Dermatology P.C.
state: New Jersey
Study officials:
affiliation: Image Dermatology P.C.
name: Jeanine B. Downie, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02273310: Families Taking Control (FTC): Family-based Problem-solving Intervention for Children With Sickle Cell Disease
Official title: Families Taking Control (FTC): Family-based Problem-solving Intervention for School-age Children With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Drexel University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-10-23
Enrollment: 83
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to develop an effective, brief, family-based intervention targeting quality of life and school functioning for youth with sickle cell disease. Utilizing a randomized, delayed control group intervention methodology, the present study will systematically document the effectiveness of a family-based, one-day intervention plus booster phone calls to improve quality of life and increase school functioning for children with sickle cell disease transitioning to school and their families.

Detailed description: Families Taking Control-School-age Intervention (FTC) will provide education and problem solving training for disease management and school functioning. In 4 sessions offered over the course of one day, families (patient, caregivers, and school-age siblings) will work together and individually to learn and apply the problem solving skills training model to relevant examples and family-specific problems, culminating in an outline of family goals to target after the intervention. The three booster phone calls will provide support to families in implementing the problem-solving model by addressing and refining goals and trouble-shooting barriers to implementation. Children and caregivers completed measures at baseline (prior to intervention participation) and 6 months later.

Eligibility criteria: Inclusion Criteria: English speaking, treated at one of two participating Sickle Cell Centers -

Exclusion Criteria: severe developmental delay or children/caregivers with severe psychopathology that would adversely affect their ability to participate

-

Primary outcomes:
measure: Child-Reported Health Related Quality of Life-School Functioning Subscale
timeFrame: 6 months
Secondary outcomes:
measure: School Functioning-Absences
timeFrame: 6 months
measure: Number of Accommodations Provided to Families by Schools
timeFrame: 6 months
measure: Acceptability of Intervention
timeFrame: post intervention
Other outcomes:
Locations:
Study officials:
affiliation: The Children's Hospital of Philadelphia/University of Pennsylvania
name: Lamia Barakat, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03384810: Inhospital Resuscitation: Incidence, Causes and Outcome
Official title: Causes and Outcome of Cardiac Arrest In-a University Hospital
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: In-hospital Cardiac Arrest
Keywords: CPR
cardiac arrest
inhospital
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include all patients who develop cardiac arrest in the hospital(Dokuz Eylul University Hospital).

Brief summary: Define the frequency and survival pattern of cardiac arrests in relation to the hospital day of event and etiology of arrest.

Detailed description: Define the frequency and survival pattern of cardiac arrests in relation to the hospital day of event and etiology of arrest.

The study aims to evaluate the outcome of in-hospital cardiac arrests, focusing on the relationship between etiology and outcome and, in particular, in relation to the length of hospitalization prior to the cardiac arrest. The aimed to sought to test the hypothesis that cardiac arrests occurring after longer hospitalizations were associated with lower survival rates and worse neurological outcomes compared to shorter hospitalizations.

Eligibility criteria: Inclusion Criteria:

* Cases where the emergency help team is called

Exclusion Criteria:

* Absence of informed consent
* Lack of data records of patients

Primary outcomes:
measure: incidence of in hospital cardiac arrest
timeFrame: baseline
measure: neurologic outcome of patients according to Cerebral performance category scale
timeFrame: until six months after return of spontaneous circulation
Secondary outcomes:
measure: causes of intraoperative cardiac arrest among participants/patients
timeFrame: baseline
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care
Study officials:
affiliation: Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Intensive Care
name: Sule Ozbilgin
role: PRINCIPAL_INVESTIGATOR
References: