louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01278524: International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU
Official title: International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium
Analgosedation
ICU
Pain
Implementation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: European Society of Intensive Care Medicine
First posted: 2011-01-19
Enrollment: 1002
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients

Brief summary: An anonymous international multicenter - clinical survey, one-day observational study.

Detailed description: Delirium is a serious complication in postoperative and critically ill patients and is independently associated with cognitive impairment at hospital discharge and with significantly higher 6-month mortality. Furthermore, ICU delirium is associated with more days requiring mechanically ventilation, longer ICU length of stay, and longer hospital length of stay. More recently a study by Pisani and co-workers' could show an association between days of delirium and mortality; - each additional day spent in delirium is associated with a 20% increased risk of prolonged hospitalization - translating to over 10 additional days - and a 10% increased risk of death.The reported prevalence of delirium in critically ill patients ranges widely from 11% to 87%. The aim of our study is to investigate the implementation rate of routine delirium assessment in European ICUs.

Eligibility criteria: Inclusion Criteria:

* Patients staying in the ICU on the 25th of January (one-day prevalence study)

No exclusion Criteria:

Primary outcomes:
measure: Implementation rate of routine delirium assessment
timeFrame: 24 hours
Secondary outcomes:
measure: Point prevalence of ICU delirium
timeFrame: 24 hours
measure: Methodology of delirium assessment (e.g. type of score, frequency of evaluation)
timeFrame: 24 hours
measure: Non-pharmacological treatment-/prevention strategies
timeFrame: 24 hours
measure: Drugs used for delirium treatment
timeFrame: 24 hours
measure: Sedation practices (e.g. scales, daily sedation goals, SBT - spontaneous breathing trials, SAT - spontaneous awakening trials)
timeFrame: 24 hours
measure: Analgesia regimes (e.g. scales)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Study officials:
affiliation: Charité - Universitaetsmedizin Berlin
name: Claudia Spies, MD
role: STUDY_DIRECTOR
References:
citation: Luetz A, Balzer F, Radtke FM, Jones C, Citerio G, Walder B, Weiss B, Wernecke KD, Spies C. Delirium, sedation and analgesia in the intensive care unit: a multinational, two-part survey among intensivists. PLoS One. 2014 Nov 14;9(11):e110935. doi: 10.1371/journal.pone.0110935. eCollection 2014.
Clinical trial NCT01849224: Randomized Trial of Exercise on Lower Extremity Edema After Lymphadenectomy in Gynecologic Cancer
Official title: Randomized Trial of Pelvic and Lower Extremity Exercise in Patients Who Underwent Pelvic Lymphadenectomy With Lower Extremity Edema-related Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gynecologic Cancer
Keywords: Lower extremity edema
Lower leg lymphedema
Lower leg edema
Lymphedema
Pelvic lymphadenectomy
Exercise
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2013-05-08
Enrollment: 148
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 primary outcome is the change in lower extremity edema-related symptoms. Secondary outcomes include the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise.


Eligibility criteria: Inclusion Criteria:

* More than 18 years of age
* Patients who underwent pelvic lymphadenectomy
* Patients with suspicious pelvic cancer who finished active treatments such as chemotherapy, radiotherapy or surgery. The interval between the time of randomization and the end of the treatment should be more than 2 weeks.
* The patient is able to understand the study and is willing to give written informed consent to the study
* patient with edema-related symptoms such as leg heaviness, distension, tightness, pain, limited movement, or weakness etc.

Exclusion Criteria:

* Severe systemic diseases causing peripheral edema, including renal disease
* Severe or uncontrolled cardiopulmonary disease, including implantable device such as a pacemaker
* Acute superficial or deep vein thrombosis
* Previous major surgery for lower extremities, including metallic surgical implant
* Local infection in the lower extremities
* Auto-immunological disorders or vasculitis
* Use of systemic corticosteroids
* Pregnant or currently breastfeeding
* Alcohol or drug abuse
* Uncontrolled diabetes

Primary outcomes:
measure: Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise
timeFrame: 1 year after randomization
Secondary outcomes:
measure: the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise
timeFrame: 1 year after randomization
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Myong Cheol Lim
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center
name: Lim Myong Cheol, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05209724: Remote Monitoring of Home Exercise in Peripheral Arterial Disease
Official title: Remote Monitoring of Home Exercise in Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: PAD
Home walking
Remote monitoring
Claudication
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2022-01-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many patients with blockages in the arteries in their legs (peripheral arterial disease, "PAD") suffer from pain in their legs when walking. Exercise therapy is known to decrease pain levels as well as increase the distance that patients with PAD can walk. The purpose of this study is to understand whether home exercise using a digital exercise monitoring system (LIVMOR) with provider supervision/ feedback will improve walking distance compared to those undergoing home exercise using the same monitoring system but without provider supervision/ feedback.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Diagnosis of PAD (based on ABI \<0.9 in either leg or prior intervention) with mild/moderate claudication

Exclusion Criteria:

* Prior above ankle amputation
* Wheelchair bound
* Inability to walk \>200m during 6 min walk test
* Use of walking aid other than cane
* Walking impairment for reason other than PAD
* Critical limb ischemia
* Planned vascular surgery within next 3 months, recent surgery within past 3 months

Primary outcomes:
measure: Change in 6 minute walk test distance between groups
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Walking Impairment Questionnaire score
timeFrame: 12 weeks
measure: Change in VascuQOL-6 (VQ6) quality of life survey
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas North Texas Veterans Affairs Hospital
state: Texas
Study officials:
affiliation: Dallas VA Hospital
name: Subhash Banerjee, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01246024: Influence of Hypoxia on Electroretingraphy (ERG) Measurements
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ERG Under Hypoxia
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the influence of induced hypoxia on the ERG.


Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* under 18 and over 80 years, respiratory diseases, cataracta and corneal hazes, myopia more than 6 dpt, hyperopia more than 3 dpt, allergy for any topical anesthetics in ophthalmology, photic epilepsy, asthma bronchiale.

Primary outcomes:
measure: Electroretingraphy Measurements
timeFrame: 01.02.2011-01.06.2011
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Centre for Ophthalmology
Study officials:
References:
Clinical trial NCT01454024: Evaluating Safety of NovoPen® 3 and/or FlexPen® Devices in Routine Clinical Practice
Official title: A Study Evaluating the Safety of NovoPen®3 and FlexPen® in Subjects With Type 1 and Type 2 Diabetes. A 24-week, Prospective, Multi-centre, Open-labelled, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-10-18
Enrollment: 1031
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The selection of the subjects will be at the discretion of the individual physician based on clinical judgement.

Brief summary: This study is conducted in Asia. The aim of of this study is to evaluate the safety of NovoPen® 3 and/or FlexPen® devices (if available on the market) measured by the number of adverse events and technical complaints in patients with type 1 and type 2 diabetes in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Any subjects who are previously using Actrapid®, Insulatard®, and Mixtard® 30 with vial / NovoLet® or insulin human with ErgoPen®2 for type 1 and type 2 diabetes treatment, will be eligible for the study after the physician has taken the decision to use study insulin products with the study devices

Exclusion Criteria:

* Subjects treated with Actrapid® Penfill®, Insulatard® Penfill®, or Mixtard® 30 Penfill® with NovoPen®3 or Actrapid® FlexPen®, Insulatard® FlexPen®, or Mixtard® 30 FlexPen® for more than 4 weeks before inclusion into this study
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to insulin human or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months

Primary outcomes:
measure: Number of adverse events and technical complaints
timeFrame: Week 0-24
Secondary outcomes:
measure: Number of adverse drug reactions (ADR) including hypoglycaemic events
timeFrame: Week 0-12, week 24
measure: Number of serious adverse drug reactions including major hypoglycaemic events
timeFrame: Week 0-12, week 24
measure: HbA1c (haemoglobin A1c)
timeFrame: Week 0, week 12 and week 24
Other outcomes:
Locations:
city: Karachi
country: Pakistan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00124124: Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine
Official title: A Randomized, Controlled Trial of Melanoma Treatment: Comparison of Dendritic Cells Versus Montanide as Adjuvants to Stimulate Anti-tumor Immunity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: Bhardwaj, Nina, M.D.
Sponsor class: INDIV
Collaborators: name: Cancer Research Institute, New York City
First posted: 2005-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or dendritic cells as adjuvants. This randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.

Detailed description: In this study, we will examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens in melanoma patients who are clinically free of disease but at high risk for recurrence. This vaccine will be compared to direct injection of the same peptides with KLH and Montanide as adjuvant.

Eligibility criteria: Inclusion Criteria:

* Resected stage IIB, IIC, or stage III melanoma.
* Fully recovered from surgery
* Human leukocyte antigen (HLA) A\*0201 positive.
* Age \>18 years.
* Karnofsky performance status: \>80% and normal labs.

Exclusion Criteria:

* Prior chemotherapy.
* Known chronic infection with HIV, hepatitis B or C.
* Patients with known autoimmune disease \[e.g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA)\]. Patients with vitiligo are not excluded.
* Pregnant women.
* Patients with known allergy to gentamicin, tobramycin, streptomycin and amikacin (risk of cross-reaction between aminoglycosides).
* Patients who have known retinal or choroidal eye disease.
* Patients previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible.
* Allergy to shellfish.

Primary outcomes:
measure: Immunology
timeFrame: Examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens
Secondary outcomes:
measure: Safety
timeFrame: Post drug administration
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Sylvia Adams, MD
role: STUDY_DIRECTOR
affiliation: NYU Langone Health
name: Nina Bhardwaj, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05537324: Effects of a Single Dose of Brazil Nuts on Blood Lipids
Official title: Effects of a Single Dose of Brazil Nuts on Blood Lipids. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholesterol Level, High
Keywords: Blood lipids, Brazil nut, coconut
Lead sponsor: Skogli Health and Rehabilitation Center
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 52
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 was a non-blinded randomized controlled trial, where participants were requited and enrolled to the study / intervention continuously over about two years. Half of the participants (26) in the experimental group and half of the participants in the control group
Primary purpose: TREATMENT

Brief summary: Several studies have shown that regular intake of nuts may improve blood lipids. However, few studies have investigated the effects on blood lipids after a single intake of nuts. The present study was conducted in order to evaluate the acute effects of a single intake of Brazil nuts on blood lipids.

The study was a non-blinded randomized controlled study with 52 participants, 26 participants in both the Brazil nut group and in the control group. Blood tests were taken at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of either 50g Brazil nuts or an isocaloric amount of coconut flakes. We then conducted an unpaired t-test in order to compare changes in blood lipids between the two groups. P-values \< 0.05 were considered statistically significant


Eligibility criteria: Inclusion Criteria:

* Patients who participated in a rehabilitation program over three weeks at a rehabilitation center. Participants were at the rehabilitation center due to rheumatic diseases or chronic pain conditions / fibromyalgia.

Exclusion Criteria:

* Food allergy, lactose intolerance, celiac disease, mild illness for the last 3 weeks (infections or inflammatory conditions), serious illness (eg. heart attack) or undergone surgery during the previous 3 months, intake of Brazil four weeks prior study enrollment, using cholesterol-lowering or blood-thinning drugs, planning to eat more than one meal in other places than the rehabilitation center during the study.

Primary outcomes:
measure: Changes in total cholesterol, LDL cholesterol and HDL cholesterol (mmol/l)
timeFrame: Blood tests are measured at baseline, 3 hours, 6 hours, 24 hours, 7 days and 14 days after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Skogli Health and Rehabilitation Center
state: Innlandet
Study officials:
affiliation: Skogli Health and Rehabilitation Center
name: Allan Fjelmberg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05134324: The Effects of rTMS and tDCS Copuled With Robotic Therapy In Patients With Stroke
Official title: The Effects of rTMS and tDCS Copuled With Robotic Therapy on Upper Extremity Functional Recovery in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stroke
Keywords: stroke
rTMS
tDCS
robotic therapy
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of rTMS and tDCS coupled with robotic therapy on upper extremity functional recovery

Detailed description: After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rTMS, sham rTMS, active tDCS and sham tDCS.

Eligibility criteria: Inclusion Criteria:

* ischemic stroke with a disease interval of 6 months to 2 years
* aged based 18 years
* first stroke
* Mini mental test score ≥ 22
* upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS)≤2
* Shoulder, elbow and wrist muscle strength ≥ 2 according to Medical Research Council- MRC

Exclusion Criteria:

* hemorrhagic stroke
* history of epilepsy
* a cardiac pacemaker
* pregnancy
* Fugl Meyer upper extremity assessment score ≥44
* history of previous stroke or ischemic attack
* neurological diseases other than stroke
* metallic implant in brain or scalp (including cochlear implant)
* previous brain surgery
* orthopedic disease that prevents upper extremity movements
* diagnosis of malignancy
* receiving robotic /TMS/tDCS treatments in the last 6 months

Primary outcomes:
measure: Upper Extremity Fugl-Meyer Motor Function Scale
timeFrame: initial, 3th week 9th week changes
Secondary outcomes:
measure: Motor Activity Log-28
timeFrame: initial, 3th week 9th week changes
measure: Barthel Index
timeFrame: initial, 3th week 9th week changes
measure: Stroke Impact Scale version 3.0
timeFrame: initial, 3th week 9th week changes
measure: Box and Block Test
timeFrame: initial, 3th week 9th week changes
measure: Modified Ashworth Scale
timeFrame: initial, 3th week 9th week changes
measure: The amplitude of motor evoked potentials (MEPs)
timeFrame: initial, 3th week 9th week changes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Esra Celik Karbancioglu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03654924: Continuous Laryngeal Cuff Pressure Monitoring
Official title: Continuous Laryngeal Cuff Pressure Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Value of Continuous Pressure Monitoring in Laryngeal Mask
Keywords: LMA
Leak
Sore Throat
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Observational study
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the airway seal of LMA during intraoperative manipulation.

Detailed description: The laryngeal mask airway (LMA) is widely used in dental surgery as it provides an unobstructed airway and provides a reliable seal from bleeding and surgical debris. However, there have been few studies of the integrity of the LMA seal during intraoperative surgical manipulation with the use of the LMA.

In general anesthesia using LMA, airway and esophagus cannot be separated completely. Insufficient airway seal become the risk of aspiration in airway management. This study will focus on airway seal following LMA use in dental surgery.

Eligibility criteria: Inclusion Criteria:

* NUH patients who will undergo wisdom teeth extraction.

Exclusion Criteria:

* Patients with tooth braces
* Patients who are at risk of aspiration
* Patients with missing any of incisor tooth
* Pregnant woman
* Non-English speaking patients

Primary outcomes:
measure: Utility of continuous LMA cuff pressure monitoring in dental surgery
timeFrame: Intra-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Health System
Study officials:
affiliation: National University Health System
name: Lian Kah Ti, MBBS, MMed
role: PRINCIPAL_INVESTIGATOR
References: