louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04026802: Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
Official title: Safety and Feasibility of a Novel In--Bed Resistance Training Device in Elderly Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Old Age; Debility
Keywords: deconditioning of elderly inpatients
loss of functionality
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 11
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to decrease deconditioning of elderly inpatients in acute care institutions and to assess the safety and feasibility of a newly developed resistance training device. Investigators believe this device will help hospitalized seniors maintain their independence by preventing the loss of functionality from deconditioning and improve value of care through decreased length of stay and utilization of care. Current therapy will be complemented with a new in--bed resistance training device to target weak elderly patients and standardize progressive resistance training in facilities.


Eligibility criteria: Inclusion Criteria:

* Patients greater than or equal to 70 years old
* Admitted to acute inpatient medicine unit at NYU Langone Health (17E and 17W) from - - - - - Emergency Department
* Receiving Physical Therapy
* Initial AMPAC 6 clicks score 11-18
* English Speaking

Exclusion Criteria:

* ICU level care
* Acute cardiac risk (including recent acute MI and stroke, unstable arrhythmias, or uncontrolled hypertension)
* Exercise-limiting physical disability (ie rotator cuff injury, neurologic impairment)
* Severe cognitive impairment (1) No significant dementia or delirium (2) Patient able to accept readiness for PT and comprehend education
* Contact Precautions

Primary outcomes:
measure: AMPAC 6 Clicks Composite PT (range 11-18)
timeFrame: 1 Year
Secondary outcomes:
measure: Grip Strength using a dynamometer
timeFrame: 30 seconds
measure: Modified 30 second sit to stand
timeFrame: 1 Year
measure: SF-12
timeFrame: 1 Year
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Alex Moroz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00111202: Schizophrenia and Genetic Counseling
Official title: Schizophrenia and Genetic Counseling: A Survey of People With Schizophrenia and Their Relatives
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: Genetic counseling
Genetic counselling
Genetics
Schizophrenia
Lead sponsor: Sarah Lawrence College
Sponsor class: OTHER
First posted: 2005-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: This research is designed to investigate the perceptions and opinions of individuals who either have schizophrenia or who have a family member with schizophrenia, in relation to genetic counseling. Data will be collected via a 15 minute online questionnaire. There is also an option for respondents to participate in a 45 minute interview if they wish.

It is expected that the study will show that adequate information about genetic counseling is not provided to these individuals. It is also hoped that this research will help to make genetic counseling sessions more specific to people with schizophrenia in their family.

Detailed description: For more information please go to the following website:

http://schizophreniageneticcounseling.blogspot.com

Eligibility criteria: Inclusion Criteria:

* anyone diagnosed with schizophrenia OR who has family member diagnosed with schizophrenia
* Over 18 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SLC
name: Study Completed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02797002: Validity of Neck Extensor Muscles Endurance Test in Non-specific Chronic Neck Pain and Asymptomatic Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Lead sponsor: University of Social Welfare and Rehabilitation Science
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with and without neck pain

Brief summary: Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's societies. Cervical muscles endurance has been commonly associated with the development of NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical therapists to evaluate muscle structure, function and activation patterns. The aim of this study is if change in muscle thickness can correlate with the results of the endurance testing.


Eligibility criteria: Inclusion Criteria:

* Subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale.
* Healthy subjects: no history of neck pain

Exclusion Criteria:

* History of cervical discopathy
* Any surgery on neck
* Traumatic neck injury
* Any congenital disorders

Primary outcomes:
measure: Flexor and Extensor cervical muscles holding time (second)
timeFrame: 6 months
measure: Anteroposterior diameter of the flexor and extensor cervical muscles (mm)
timeFrame: 6 months
measure: Mediolateral diameter of the flexor and extensor cervical muscles (mm)
timeFrame: 6 months
measure: Cross section area of the flexor and extensor cervical muscles (cm2)
timeFrame: 6 months
measure: Neck disability questionnaire score
timeFrame: 6 months
measure: Visual analogue scale score
timeFrame: 6 months
Secondary outcomes:
measure: Pearson correlation coefficient of the cervical muscles holding time with Anteroposterior and border and cross section area of the flexor and extensor cervical muscles
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: University of Social Welfare and Rehabilitation Sciences
Study officials:
References:
Clinical trial NCT03547102: Effect of Cherry Concentrate on Brain Activation and Perfusion in Healthy Older Adults
Official title: Effect of Cherry Concentrate on Brain Activation and Perfusion in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Effect of 8 weeks of cherry concentrate supplementation on cognitive function and brain perfusion in healthy older adults

Detailed description: The investigators will perform a double blind, randomised controlled study to determine whether cherry polyphenols improve peripheral vascular function and cerebral perfusion resulting in improved task related brain activation and cognitive function. 30 healthy elderly men and women 60-85y years will be recruited to complete 8-week supplementation with MC concentrate or an isoenergetic cherry placebo concentrate. Participants will be pair matched for age, sex, and cognitive function (Adenbrooke's Cognitive Examination III, ACE-III) and then randomised using a sealed envelope system to receive either placebo or cherry.

Eligibility criteria: Inclusion Criteria:

* physically inactive consuming 5 or less portions of fruit per day Addenbrookes cognitive examination III score \>88

Exclusion Criteria:

* physically active consuming more than 5 portions of fruit per day Addenbrookes cognitive examination III score \<88 Contraindications for MRI

Primary outcomes:
measure: Brain perfusion
timeFrame: Change from baseline to 8 weeks supplementation
Secondary outcomes:
measure: Cognitive function
timeFrame: Change from baseline to 8 weeks supplementation
measure: Brain activation (fMRI)
timeFrame: Change from baseline to 8 weeks supplementation
measure: Plasma nitrite concentration
timeFrame: Change from baseline to 8 weeks supplementation
Other outcomes:
Locations:
Study officials:
affiliation: University of Exeter
name: Joanna L Bowtell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05896202: Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
Official title: Addressing Disparities in Neuromodulation for Rehabilitation: A Mixed Methods Approach to Optimize Access for Underrepresented Racial Minorities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: neurostimulation
video enhanced consent
neuromodulation
transcutaneous auricular vagus nerve stimulation
transcranial direct current stimulation
transcranial magnetic stimulation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Center of Neuromodulation for Rehabilitation
First posted: 2023-06-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to:

1. Development of culturally sensitive videos for enhance informed consent with neurostimulation and determination of factors that influence minority interest in participating in neurostimulation research.
2. Examination of the influence that video enhanced informed consent has on expectations with transcutaneous auricular vagus nerve stimulation (taVNS) and on treatment intended effects.


Eligibility criteria: Inclusion Criteria:

1. between the ages of 18-80 years
2. neuropathic pain lasting longer than 3 months (i.e., complaint of sensation of burning, stabbing or pressing pain, shooting or shock like pain, or paresthesias)
3. Neuropathic Pain Symptom Inventory score ≥10.
4. self identifies as Black or Hispanic

Exclusion Criteria:

1. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
2. pregnancy
3. currently taking Buprenorphine or recently stopped taking (within 1 month)
4. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
5. implants in the head or neck, cochlear implants, or pacemaker
6. head or neck metastasis or recent ear trauma
7. history of seizures.

Primary outcomes:
measure: Change in Heart Rate Variability (HRV)
timeFrame: Baseline, up to 90 minutes
Secondary outcomes:
measure: Change in expectations for pain relief as measured by EXPECT scores
timeFrame: Baseline, and up to 90 minutes
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Marlon Wong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06139302: A Study to Test How Different Doses of BI 1015550 Are Taken up in the Body of Healthy Japanese Men
Official title: Pharmacokinetics of R-BI 1015550 After Single Oral Doses of BI 1015550 in Japanese Healthy Male Subjects (Open-label, Non-randomised, and Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objectives of this trial are to investigate pharmacokinetics (PK) of R-BI 1015550 in Japanese healthy male subjects following oral administration of two different single BI 1015550 doses.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), Respiratory rate (RR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 45 years (inclusive)
* Body mass index (BMI) of 18.5 to 25 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR, RR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 40 to 90 mmHg, or PR outside the range of 40 to 99 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: Up to 7 days
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo, Sumida-ku
country: Japan
facility: SOUSEIKAI Sumida Hospital
Study officials:
References:
Clinical trial NCT04644302: Circulatory Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis
Official title: Circulatory and Endothelial Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis - Prospective, Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Pneumonia
Sepsis
Keywords: microcirculation
endothelial glycocalyx
COVID-19
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 28
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: Adult patients admitted to the ICU with signs of circulatory instability with any method of organ support. Patients expected to have a particular method of organ support for at least 3 days.

Brief summary: This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation, endothelial glycocalyx, and clinical course

Detailed description: This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation (sublingual area video recordings and biochemical parameters of endothelial cells activation and damage) endothelial glycocalyx (sublingual area video recordings and biochemical parameter of glycocalyx degradation), and clinical course.

Eligibility criteria: Inclusion Criteria:

* adult
* ICU admission due to sepsis with organ failure
* need for organ support therapy (mechanical ventilation, CRRT, ECMO)
* clinical and/or laboratory signs of circulatory instability

Exclusion Criteria:

* family withdrawal/disagreement
* death within three days from ICU admission

Primary outcomes:
measure: change in Proportion of Perfused Vessels (PPV) parameter
timeFrame: 1st, 2nd and 3rd day
measure: change in Syndecan-1 serum concentration
timeFrame: 1st, 2nd and 3rd day
Secondary outcomes:
measure: change in albuminuria
timeFrame: 1st, 2nd and 3rd day
measure: mortality in 28 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Kralove
state: Třebeš
Study officials:
References:
Clinical trial NCT02267902: Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism, Excretion of DA-1229
Official title: A Phase I, Open-Label, 2-Part Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism and Excretion of DA-1229 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Volunteers
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The objectives of this study are to evaluate the absolute bioavailability, and absorption and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Age 18 to 55
* BMI 18.0 to 30.0 kg/㎡

Exclusion Criteria:

* History of any drug or alcohol abuse in the past 2years
* Regular alcohol consumption nin males \>21 units per week
* Current smokers and those who have smoked within the last 12months
* Radiation Exposure
* Positive drugs of abuse test result
* Positive HBsAg, HCV Ab, HIV results
* Serious adverse reaction or hypersensitivity to any drug of the formulation excipients
* Clinically significant allergy
* Donation of loss of blood within the previous 3 months
* Taking any prescribed or OTC drug or herbal remedies in the 14days before IMP administration

Primary outcomes:
measure: the absolute bioavailability of DA-1229 (F)
timeFrame: 240 hours
measure: The mass balance recovery (Ae, %Ae)
timeFrame: 240 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
state: Ruddington
Study officials:
References:
Clinical trial NCT03983902: Placental Transfusion Methods and Stem Cells
Official title: The Effect of Placental Transfusion Methods on the Potentially Transfusion Levels of Endothelial Progenitor Cell and CD34+ Hematopoietic Stem Cell
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placental Transfusion
Stem Cells
Keywords: stem cell
newborn
endothelial progenitor cell
CD34+ hematopoietic stem cell
delayed cord clamping
umbilical cord milking
immediate cord clamping
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 96
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

Brief summary: To measure the levels of endothelial progenitor cells and CD34+ hematopoietic stem cells levels, and placental residual volume by delayed cord clamping, umbilical cord milking or immediate cord clamping in newborns at different gestational weeks.

Detailed description: Umbilical cord blood is a rich source of stem cells. Placental transfusion is the transfer of the placental blood to the baby until the cord clamped during the birth. Placental transfusion can be accomplished by delayed cord clamping or umbilical cord milking.

One group will receive 2 minutes of delayed cord clamping, the second group will receive umbilical cord milking and the third group will receive immediate cord clamping. Following the cord clamping, the blood samples will be taken from the placental site of the umbilical cord to measure the stem cells from all subjects and placental residual volume will be measured.

Delivery room conditions, hospitalization (if needed), short-term outcome during hospitalization, prematurity related morbidities (if baby is preterm) will be recorded.

Eligibility criteria: Inclusion Criteria:

Born at 24 weeks to 42 weeks infants

Exclusion Criteria:

Without parental consent, known congenital anomalies

Primary outcomes:
measure: The levels of stem cells
timeFrame: 18-months
Secondary outcomes:
measure: Placental residual volume
timeFrame: 18-months
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University
name: Emel Okulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00347802: Diurnal Curves With Bimatoprost 0.03% Versus Travoprost 0.004%
Official title: Diurnal Curves With Bimatoprost 0.03% Versus Travoprost 0.004%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare the diurnal curves in patients using bimatoprost 0.03% versus travoprost 0.004% for the treatment of glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* · Male or female \> 18 years of age

  * Naive to treatment or washed off any ocular hypotensive agents
  * Untreated IOP \>19 mm Hg
  * Diagnosis of open-angle glaucoma or ocular hypertension
  * Ability to provide informed consent and likely to complete study

Exclusion Criteria:

* · Known contraindication to bimatoprost or travoprost, or any component of any study medication

  * Uncontrolled systemic disease
  * Active ocular disease other than glaucoma or ocular hypertension
  * Required use of ocular medications other than the study medications during the study
  * History of intraocular surgery within the last 3 months
  * Prior discontinuation of any of the study medications for reasons related to efficacy or safety

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Dr. Noecker
state: Pennsylvania
Study officials:
affiliation: UPMC Eye Center
name: Robert Noecker, MD
role: PRINCIPAL_INVESTIGATOR
References: