louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02358252: Heart Rate Variability and Orthostatic Hypotension in Stroke Patients Evaluated by Intelligent Biosensor System
Official title: Heart Rate Variability and Orthostatic Hypotension in Stroke Patients Evaluated by Intelligent Biosensor System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cerebrovascular Accident
Keywords: Heart Rate Variability
orthostatic hypotension
stroke
integrated intelligent biosensor system
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: stroke patients

Brief summary: This research investigated the heart rate variability (HRV) and stroke patients' orthostatic hypotension in hospitalized stroke patients accompanied with dizziness at varied tilting angle controlled by tilting table with intelligent biosensor.

Detailed description: Stroke patients readily accompany with the occurrence of orthostatic hypotension. To earlier predict patients occurring dizziness during the tilt table test, this study utilized a self-developed integrated intelligent biosensor system to assist clinical staff efficiently and immediately assessing stroke patients with orthostatic hypotension. Further purposes were to survey the relationship between the orthostatic hypotension and heart rate variability (HRV) and find the predicted models of orthostatic hypotension.

Eligibility criteria: Inclusion Criteria:

* Patients who are first time to get stroke.

Exclusion Criteria:

* unstable physiological conditions, serious joint spasticity, use cortisol or calming drugs, other neurological diseases

Primary outcomes:
measure: Change of Heart Rate Variability (HRV)
timeFrame: Baseline: before Tilt table test, resting position, measure HRV with 3 minutes interval, totally 7 HRVs were measured
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
affiliation: Changhua Christian Hospital
name: TaSen Wei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914952: Alternate Dosing Strategies for Beta-hydroxy-beta-methylbutyrate (HMB) Supplementation: Effect on Plasma HMB Responses
Official title: Alternate Dosing Strategies for Beta-hydroxy-beta-methylbutyrate (HMB) Supplementation: Effect on Plasma HMB Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of the Study is to Examine Plasma HMB Levels After Oral HMB Supplementation
Keywords: CaHMB
HMB free acid
HMB
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the rise in plasma Beta-hydroxy-beta-methylbutyrate (HMB) after the dietary supplement has been administered in different forms. Prior studies have indicated that form of administration affects bioavailability of the HMB supplement. Therefore the current study will examine the bioavailability of a single dose of HMB given as:

* 1.0g CaHMB in gelatin capsule
* 0.8 g HMB free acid in a gelcap
* 0.8 g HMB free acid in water
* 1.0 g CaHMB in water
* 0.8 g HMB free acid

The randomized study will be a crossover design and each study subject will undergo the experimental protocol for each of the supplementation forms. Because of the different administration forms, the study will be an open label study. Briefly, the fasted participants will report to the laboratory in the morning. After an initial blood sample is taken, the dose of HMB will be administered. Blood will then be samples at 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min post administration. A 24 h complete urine collection will also be performed. Participants will be given a light sack lunch 4 h after administration of the dosage and will remain at the laboratory through the 360 min sampling. Participants will then be allowed to leave the laboratory and return for the 720 min sampling after which the participants can eat an normal evening meal. Participants will return to the laboratory fasted the next morning for the final sample. A minimum 48 h washout period will be required before the next dosage form is administered and the process repeated.


Eligibility criteria: Inclusion Criteria:

* Must not be taking amino acid, protein, or HMB supplements; Must not be pregnant; Must not be breastfeeding

Exclusion Criteria:

* Currently taking amino acid, protein, or HMB supplements; Currently pregnant; Currently breastfeeding

Primary outcomes:
measure: Plasma HMB Level
timeFrame: Plasma samples collected at 0, 2, 5, 10, 15, 25, 35, 45, 60, 90, 120, 180, 360, 720, and 1440 min after treatment administration
Secondary outcomes:
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
References:
Clinical trial NCT04746352: Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of MFPP
Official title: Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of Myofascial Pelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pelvic Pain
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 82
Sex: FEMALE
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: Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor of female chronic pelvic pain. However, the effect of the patient's self-myofascial release (SMFR) is not clear. Current study is to investigate the effect of SMFR combined with biofeedback and electrical stimulation (BES) therapy compared with BES alone in patients with MFPP.

Detailed description: 68 patients was enrolled and randomly allocated into two groups: BES-SMFR group (n=34) and BES group (n=34). Every patient received 4 weeks treatment, and was evaluated at baseline (T0), 4-week post-intervention (T4) and 12-week follow-up (T12). The primary outcome was pain intensity. The secondary outcomes were degree in activation of MTrPs, surface electromyography (sEMG) levels, and Patient Global Impression of Improvement (PGI-I).

Eligibility criteria: Inclusion Criteria:

1. age between 18 and 70 years;
2. presence of persistent chronic pelvic pain ≥ 4 points on a 10 points numeric rating scale for at least 3 months;
3. at least one active MTrP in one of muscle group including obturator internus, levator ani, piriformis, coccygeus on pelvic examination.

Exclusion Criteria:

1. diseases of the urinary, genital, colorectal systems;
2. prolapse of the pelvic organ;
3. a history of pelvic rehabilitation within the 3 months prior to study;
4. psychiatric disorders;
5. pregnancy;
6. breastfeeding.

Primary outcomes:
measure: The change of pain intensity
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: The degree in activation of MTrPs
timeFrame: Up to 12 weeks
measure: Surface electromyography (sEMG) levels of the PFMs
timeFrame: Up to 12 weeks
measure: The score of Patient Global Impression of Improvement (PGI-I)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Yang Shen, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03182452: Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (Europe)
Official title: Outcomes and User Acceptance of the IntelliVue Alarm Advisor Software (Europe)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Alarms
Keywords: Alarms
Alarm Fatigue
Alarm Nuisance
Alarm Reduction
Patient Monitoring
Intensive Care
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2017-06-09
Enrollment: 1487
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Monitored intensive care unit patients

Brief summary: This Clinical Study will be conducted as a comparative study focusing on usability and efficiency by comparing alarm burden pre- and post-implementation of an "Alarm Advisor software".

Detailed description: In a first phase of data collection (pre-implementation) all alarms of an intensive care unit population are recorded.

In an interim period an Alarm Advisor software will be introduced to the unit.

In a second phase (post-implementation) the same set of alarm data will be recorded.

The "Alarm Advisor" Software can identify alarms based on criteria set by the medical staff and provide hints to reduce alarms and alarm nuisance (e.g. by proposing adjustments of alarm limits).

The effect of reduction of recurring nuisance alarms through the implementation of the Alarm Advisor shall be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the intensive care unit during the study period

Exclusion Criteria:

* none

Primary outcomes:
measure: Clinical Alarms
timeFrame: six to eight months
Secondary outcomes:
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: Klinikum Konstanz
state: Baden-Württemberg
Study officials:
affiliation: Klinikum Konstanz, Germany
name: Michael Trick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03456232: High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease
Official title: High-flux Hemodialysis Versus Hemodiafiltration for End-Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Failure
Keywords: hemodialysis
hemodiafiltration
end-stage renal disease
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on small and moderate molecule substances clearance. Meanwhile, this study evaluates the effect of high-flux hemodialysis compared to hemodiafiltration on cardiac function. In this self matching study, participants will receive high-flux hemodialysis compared to hemodiafiltration.

Detailed description: Hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water, is one of the most commonly replacement therapy.

Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.

Eligibility criteria: Inclusion Criteria:

1. Subject has end-stage renal disease.
2. Subject has been on regular dialysis treatment for at least 6 months.
3. Subject has autologous vascular access.
4. Subject is offered thrice weekly hemodialysis.
5. Subject is offered 4 hours duration hemodialysis.

Exclusion Criteria:

1. Infectious disease
2. Poor echocardiographic window that was unsuitable for interpretation

Primary outcomes:
measure: Clearance of moderate molecule substance
timeFrame: 4 hours after dialysis
Secondary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 4 hours after dialysis
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Wei Shi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03738332: Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
Official title: Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lymphedema
Fibrosis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-and post design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot clinical trial is to evaluate the feasibility of the use of low-level laser for head and neck cancer survivors with lymphedema.

Detailed description: Primary aim:

To determine the feasibility of the use of LLLT for HNC survivors with lymphedema, specifically to 1) obtain recruitment estimates and determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety; and 4) evaluate patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Completion of either postoperative radiation or chemoradiation therapy
* No evidence of cancer
* Having head and neck external lymphedema
* Either completion of lymphedema therapy or not in active lymphedema therapy
* Ability to speak and read English
* Able to provide informed consent

Exclusion Criteria:

Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of LLLT: pregnancy; photosensitivity; chronic inflammatory diseases; venous thrombosis; history of severe trauma; medication that affects body fluid and electrolyte balance; use of high doses of non-steroidal anti-inflammatory drugs; or pre-existing skin rash, ulceration, open wound in the treatment area; and allergic and other systemic skin diseases.

Primary outcomes:
measure: Number of Participants Consented and Enrolled in Study
timeFrame: Approximately 5-month recruitment window
measure: Number of Participants Completed the Study Visits
timeFrame: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
measure: Number of Participants With Adverse Events
timeFrame: Approximately 10 weeks, from baseline visit to 4-week post-intervention visit
measure: Number of Participants Who Were Satisfied With Study Intervention.
timeFrame: at 4-week post-intervention visit
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
Study officials:
References:
citation: Deng J, Lukens JN, Swisher-McClure S, Cohn JC, Spinelli BA, Quinn RJ, Chittams J, McMenamin E, Lin A. Photobiomodulation Therapy in Head and Neck Cancer-Related Lymphedema: A Pilot Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211037938. doi: 10.1177/15347354211037938.
Clinical trial NCT05904132: Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease
Official title: Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The project is a placebo-controlled study that aims to use closed-loop transcranial alternating current stimulation (tACS) to study patients with symptoms of mild cognitive impairment which is likely due to Alzheimer's disease or another form of dementia (AD-MCI). Patients will undergo an EEG and complete some questionnaires and computer tasks during each study visit. The project has the following aims and hypotheses: 1.) To determine the impact of closed-loop 40 Hz tACS on the entrainment of natural gamma rhythms in patients with AD-MCI, 2.) To determine the impact of closed-loop 40 Hz tACS on cognitive performance in patients with AD-MCI, and 3.) To assess the relationship between baseline neurodegenerative burden and impact of tACS. \[exploratory\]


Eligibility criteria: Inclusion Criteria:

* Overall cognitive functional status consistent with amnesic MCI (CDR 0.5) likely due to AD (AD biomarker supported)
* 50-80 years of age
* English native speakers

Exclusion Criteria:

* Known presence of a structural brain lesion (e.g., tumor, cortical infarct)
* Acute or decompensated active medical conditions, including cancer, cardiovascular disease, stroke, congestive heart failure
* Active hematological, renal, pulmonary, endocrine or hepatic disorders
* Longstanding premorbid history (i.e., longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
* tACS contraindications (lesions in the scalp, history of seizures)

Primary outcomes:
measure: Changes in the power of entrainment of natural gamma rhythms in patients with AD-MCI.
timeFrame: After a single stimulation session (30 minutes).
measure: Changes in cognitive performance in patients with AD-MCI.
timeFrame: After a single stimulation session (30 minutes).
measure: Changes in gamma power on cognition in patients with AD-MCI including the effect of baseline neurodegenerative burden/biomarkers. [exploratory]
timeFrame: After a single stimulation session (30 minutes).
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH, Division of Neuropsychiatry and Neuromodulation
name: Joan Camprodon, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01627132: Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
Official title: Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Shimousa Hematology Study Group
Sponsor class: OTHER
Collaborators: name: Epidemiological and Clinical Research Information Network
First posted: 2012-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.


Eligibility criteria: Inclusion Criteria:

* Chronic Myeloid Leukemia in the Chronic Phase.
* Patients with BCR-ABL-negative checks.
* 15 years old over.
* ECOG performance status (PS) score 0-2.
* Adequate organ function (hepatic, renal and lung).
* Signed written informed consent.

Exclusion Criteria:

* A case with the double cancer of the activity.
* Women who are pregnant or breastfeeding.
* Patients with complications or a history of severe.
* Patients with mutation of T315I、F317L、V299L.
* Patients with additional chromosome abnormalities.
* The case of Pleural effusion with poor control.
* Patients with a history of hematopoietic stem cell transplantation.

Primary outcomes:
measure: The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.
timeFrame: at 12 months
Secondary outcomes:
measure: Rate of complete molecular remission that will be sustained after dasatinib rechallenge.
timeFrame: at 12 months
Other outcomes:
Locations:
city: Sendagi 1-1-5
country: Japan
facility: Nippon Medical School
state: Bunkyo-ku,Tokyo
Study officials:
affiliation: Nippon Medical School
name: Koiti Inokuchi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumagai T, Nakaseko C, Nishiwaki K, Yoshida C, Ohashi K, Takezako N, Takano H, Kouzai Y, Murase T, Matsue K, Morita S, Sakamoto J, Wakita H, Sakamaki H, Inokuchi K; Kanto CML, Shimousa Hematology Study Groups. Silent NK/T cell reactions to dasatinib during sustained deep molecular response before cessation are associated with longer treatment-free remission. Cancer Sci. 2020 Aug;111(8):2923-2934. doi: 10.1111/cas.14518. Epub 2020 Jun 26.
Clinical trial NCT02180932: Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 25
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
Primary purpose: BASIC_SCIENCE

Brief summary: The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used in combination with chemotherapy. Patients treated with radiotherapy have multiple oral diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over 70% of patients with head and neck cancers treated with radiotherapy have a lower level of dental clinical attachment and 92% have loose teeth or missing. The management of these oral complications is a priority in OLR oncology. The aim is to improve the oral health of patients to achieve a comfortable life acceptable and necessary for healing.

This project proposes to deepen the investigation with two main objectives:

1. To study in vivo the effect of radiation treatment on the evolution of the viral flora of the periodontium in a cohort of patients and matched controls.
2. To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated with EBV that existence were recently discovered.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years
* Patients treated with curative radiotherapy on tumor site or surgery for cancer of the oral cavity and / or oropharynx
* Patients naive treatments for head and neck cancers
* Patients affiliated or beneficiary of a social security scheme
* Patients who gave informed consent in writing

Exclusion Criteria:

* Patients treated with neoadjuvant chemotherapy, adjuvant or concomitant
* Patients taking immunosuppressants after organ transplantation
* Taking anticoagulants incompatible with dental samples (possible bleeding)
* Patients edentulous and / or whose dental condition is incompatible with the dental samples

Primary outcomes:
measure: Measure of level of EBV nucleic acids
timeFrame: day 1
measure: Measure of level of EBV nucleic acids
timeFrame: day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital saint Roch
Study officials:
References: