louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06149143: Cardiac Performance System Data Collection Study - Minnesota
Official title: Cardiac Performance System Data Collection Study - Minnesota
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Disease
Lead sponsor: Sensydia Corporation
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for cardiac catheterization procedure

Brief summary: Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Detailed description: Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* 22 years of age or older
* Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.

Exclusion Criteria:

* Previous Heart Transplant
* Presence of Left Ventricular Assist Device
* Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
* Surgical scars/wounds/bandages/ports at the site of sensor placement

Primary outcomes:
measure: Cardiac Performance System electronic data for Cardiac Output
timeFrame: 10 minutes before cardiac catheterization procedure
measure: Cardiac Performance System electronic data for Pulmonary Artery Pressure
timeFrame: 10 minutes before cardiac catheterization procedure
measure: Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure
timeFrame: 10 minutes before cardiac catheterization procedure
measure: Pulmonary Artery Catheter electronic data for Cardiac Output
timeFrame: 60 minutes during cardiac catheterization procedure
measure: Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure
timeFrame: 60 minutes during cardiac catheterization procedure
measure: Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure
timeFrame: 60 minutes during cardiac catheterization procedure
measure: Echocardiography electronic data for Ejection Fraction
timeFrame: 15 minutes at a time prior to or after Pulmonary Artery Catheter procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT03931343: Comparison of Thoracolumbar Interfascial and Erector Spinae Plane Block on Analgesic Efficiency of After Spinal Surgery
Official title: Randomized, Double Blind Trial of Thoracolumbar Interfascial Plane Block and Erector Spinae Plane Block for Adult Spinal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Postoperative Nausea and Vomiting
Opioid Use
Keywords: Thoracolumbar interfascial block, Erector spinae plane block
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: Spinal surgery is typically associated with severe postoperative pain. Although the number of spinal surgeries has increased day by day, postoperative pain management have been limited. The recently described thoracolumbar interfacial plane block (TLIPB) has been reported to provide effective postoperative analgesia in spinal surgery. In addition, the recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the spina muscles and the transverse process of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small number of publications showing the analgesic efficacy of ESP in spinal surgery have been reported in the literature. In this study, the investigators aimed to compare the analgesic efficacy of TLIPB and ESPB in spinal surgeries.


Eligibility criteria: Inclusion Criteria:

1. 20-75 years
2. ASA 1-2-3
3. Patients scheduled for elective surgery

Exclusion Criteria:

1. Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)
2. Allergy to drugs
3. Major cardiac disease
4. Renal failure
5. Psychiatric disease
6. Patients who refuse to participate in the study
7. Chronic back and lower back pain

Primary outcomes:
measure: Total morphine consumption
timeFrame: 48 hour
Secondary outcomes:
measure: Pain intensity score at rest
timeFrame: 48 hour
measure: Pain intensity score at movement
timeFrame: 48 hour
measure: Time to first rescue analgesia
timeFrame: 48 hour
measure: Postoperative nausea and vomiting
timeFrame: 48 hour
measure: Patient satisfaction score
timeFrame: 48 hour
Other outcomes:
Locations:
Study officials:
affiliation: Bezmialem Vakif University
name: Serdar Yeşiltaş
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05939843: Brief Mindfulness for Foot and Ankle Pain
Official title: Brief Mindfulness for Foot and Ankle Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a single-site, four-arm, parallel-group randomized clinical trial (RCT). The clinical effects of three different formats of a very brief (i.e., 3 minute), audio-recorded mindfulness intervention for foot and ankle patients will be investigated relative to a 3-minute audio-recoding about pain psychoeducation.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Seeking foot or ankle treatment at the University Orthopaedic Center

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures.
* Current cancer diagnosis,
* Other unstable illness judged by medical staff to interfere with study involvement.

Primary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: Immediately before to after 3-minute audio recording
Secondary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: Immediately before to after 3-minute audio recording
measure: Change in Pain Medication Desire Numeric Rating Scale
timeFrame: Immediately before to after 3-minute audio recording
Other outcomes:
measure: Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
timeFrame: From before the patient's intervention visit to their subsequent re-evaluation. This time span is typically around 6 weeks.
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT01115543: Efficacy and Safety of Alfacalcidol Compared to Calcitriol for Treatment of Secondary Hyperparathyroidism
Official title: A Randomized Trial Comparing Pulse Calcitriol and Alfacalcidol for the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
End Stage Renal Disease
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was performed to determine whether calcitriol provides a therapeutic advantage to alfacalcidol for treatment of secondary hyperparathyroidism in ESRD patients.

Detailed description: Secondary hyperparathyroidism has a significant impact on morbidity and mortality in advanced chronic kidney disease (CKD).Both nonselective and selective vitamin D receptor activators (VDRAs) are demonstrated in many studies for their efficacy on suppression of PTH. Most of them are quite expensive and unavailable in many countries. Calcitriol and alfacalcidol are less expensive and worldwidely distributed. There is only one short-term study which directly compares these two drugs. This study demonstrates that calcitriol is superior to alfacalcidol. However, alfacalcidol is a prohormone of calcitriol. It has to be converted by 25-hydroxylase at the liver to generate 1,25-dihydroxyvitamin D3 to act on target cells. Many pharmacokinetics studies demonstrate that alfacalcidol has lower AUC compared to calcitriol if they are administered in the same dose. Therefore, the authors hypothesize that alfacalcidol may be equivalently efficacious as calcitriol if its dose is adjusted according to the pharmacokinetics studies.

Eligibility criteria: Inclusion Criteria:

* Chronic hemodialysis patients who underwent scheduled hemodialysis for at least 3 months with secondary hyperparathyroidism (intact PTH levels \> 300 pg/mL)

Exclusion Criteria:

* (1) age \< 18 years (2) hypersensitivity to calcitriol or alfacalcidol (3) inadequate dialysis \[defined as single-pooled Kt/V (sp-Kt/V) \<1.2 and \<2.0 for thrice a week and twice a week hemodialysis\] (4) corrected serum calcium \>10.2 mg/dL or serum phosphate \>6 mg/dL after adjusting dialysate calcium and phosphate binders (5) diameter of parathyroid gland \>10 mm (6) pregnancy or lactation (7) liver cirrhosis (8) active kidney transplantation (9) previous parathyroidectomy (10) malignancy or chronic infection/inflammation.

Primary outcomes:
measure: Reduction of intact parathyroid hormone levels
timeFrame: 48 weeks
Secondary outcomes:
measure: hypercalcemia and hyperphosphatemia
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Bangkok-noi
country: Thailand
facility: Siriraj Medical School
state: Bangkok
Study officials:
References:
Clinical trial NCT01475643: Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
Official title: Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: Pediatric cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-11-21
Enrollment: 107
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.

Detailed description: The objective of this study is to compare the efficacy and safety of topical Loteprednol Etabonate (LE), 0.5%, to Prednisolone Acetate 1%, for the treatment of postoperative inflammation following ocular surgery for childhood cataract.

Eligibility criteria: Inclusion Criteria:

* Subject is a candidate for routine, uncomplicated surgery for childhood cataract

Exclusion Criteria:

* Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
* Subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure (IOP) lowering therapy in either eye or systemically.
* Subjects with a history of steroid-induced IOP elevation in either eye.
* Subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.

Primary outcomes:
measure: Anterior Chamber Inflammation
timeFrame: Postoperative Day 29
Secondary outcomes:
measure: Anterior Chamber Cells & Flare
timeFrame: Over all visits 42 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Inc
state: New York
Study officials:
affiliation: Valeant/Bausch & Lomb
name: Johnson Varughese
role: STUDY_DIRECTOR
References:
Clinical trial NCT06231043: Diclofenac IM Versus Tramadol IV in Acute Renal Colic, RCT
Official title: Comparative Efficacy of Intramuscular Diclofenac Injection Versus Intravascular Tramadol Injection in Acute Renal Colic, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Renal Colic
Keywords: Diclofenac IM versus Tramadol IV in acute renal colic, RCT
Lead sponsor: Lampang Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients presented with acute pain from renal colic, the standard of care are prescribed NSAIDs, most common drug used is intramuscular (IM) Diclofenac injected at the gluteal muscle. Due to adverse effects in some patients, the nursing council has banned the injection by nurses. Since then, there has been a change in treatment by using intravascular (IV) Tramadol. According to various research, Diclofenac has a higher efficacy in controlling pain compared to other medications. In clinical practice, Tramadol has less efficacy of decreasing pain and a longer onset of action. At presence, there has been no research performed comparing the efficacy between these two drugs especially from the viewpoint of time dimension.

Detailed description: To compare the efficacy Diclofenac 75 mg IM versus Tramadol 50 mg IV in patients with acute pain from renal colic.

Eligibility criteria: Inclusion Criteria:

1. Age over 18 years
2. Acute pain in renal/ureteric colic
3. Pain score more than 4
4. Confirmation diagnosis by ultrasound bedside

Exclusion Criteria:

1. Refused to participate in the research
2. Pregnancy
3. Contraindicated of Diclofenac or Tramadol
4. Urinary tract infection
5. Skin infection at Buttock area
6. Acute kidney injury
7. CKD stage III, IV, V
8. Bilateral severe hydronephrosis
9. Physician refusal

Primary outcomes:
measure: Diclofenac 75 mg IM or Tramadol 50 mg IV
timeFrame: 30,60,90,120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lampang
country: Thailand
facility: Lampang hospital
Study officials:
affiliation: Lampang Hospital
name: Jarupa Yaowalaorng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01421043: A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects
Official title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Triazolam Liquid Oral Drops at a Dose of 0.25 Mg Versus Triazolam 0.25 Mg Tablet in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: bioequivalence study
triazolam
liquid oral drops
tablet
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-08-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will determine whether an oral drops formulation of triazolam at a dose of 0.25 mg is bioequivalent to a tablet formulation at a dose of 0.25 mg in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.

Primary outcomes:
measure: Area Under the Curve (AUC) to last time point (t)
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
measure: Maximum concentration of drug (Cmax)
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Secondary outcomes:
measure: Area Under the Curve (AUC) to time infinity (inf) (if data permit)
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
measure: Area Under the Curve (AUC) percent extrapolated (%exp)
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
measure: Half-life (if data permit)
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
measure: Time at maximum concentration (Tmax)
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16 and 24 hours postdose
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04706143: Immunologic Responses to Single and Double Doses of COVID-19 Vaccines in Egyptians
Official title: T Cell, Antibody and Cytokine Responses to Single and Double Doses of COVID-19 Vaccines in Egyptians
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Vaccines
Keywords: COVID-19
Safety
Efficacy
T cell responses
Cytokine responses
Antibody responses
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults aged from 25-65 years old non immune-compromised or immune suppressed receiving COVID-19 vaccines

Brief summary: The recent Coronavirus Disease 2019 (COVID-19), has caused a global pandemic, and development of safe, effective vaccines is mandatory to return back to pre pandemic life. Many vaccines have been developed and requested by the authorities after the emergency license issued. The main mechanism of protection is through humoral and cell-mediated immune responses that might reduce the potential for disease development or severity. Cytotoxic T cells clear virus-infected host cells and contribute to control of infection. Preliminary data are now available indicating safty and effecacy of different vaccines . The vaccines were tolerated, with induction of neutralizing antibodies and antigen-specific T cells against the SARS-CoV-2 spike protein. The aim of this work is to evaluate the immune responses in adults, aged 25-65 years, up to 8 weeks after vaccination with a single and double doses live inactivated (Sinopharm), mRNA (Pfizer/ Biontech) and viral vector (Oxford/AZ- ChAdOx1 nCoV-19) vaccines. The Th1- response ( interferon-γ and tumor necrosis factor-α cytokine secretion by CD4+ T cells) and antibody production predominantly of IgG1 and IgG3 subclasses as well as CD8+ T cells mono, polyfunctional and cytotoxic phenotypes, will be also measured.


Eligibility criteria: Inclusion Criteria:

* healthy adults receiving COVID-19 vaccines

Exclusion Criteria:

* any contraindication of each COVID-19 vaccine as listed by WHO

Primary outcomes:
measure: measure immune cell activation induced by the vaccine
timeFrame: 8 weeks
measure: measure antibody response to vaccines
timeFrame: 8 weeks
measure: measure the cytokine response to different vaccines
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01712243: Light to Maximize Vision, Minimize Insomnia
Official title: Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Balance
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: Stanford University
First posted: 2012-10-23
Enrollment: 29
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether specific wavelengths of light at night can be used to improve mobile balance while simultaneously not increasing alertness.


Eligibility criteria: Inclusion Criteria:

* Aged 55-85
* At least 20/200 corrected visual acuity
* Greater than 20° visual field with no lower visual field loss
* Stable health
* Male or female
* Normal color vision
* Normal hearing

Exclusion Criteria:

* Extreme chronotype
* Sleep disorders
* Dementia
* Smoker
* Depression
* Alcohol abuse
* Use of illegal drugs
* Use of sleep/wake altering drugs on an acute or as needed basis (including nutraceuticals, antihistamines)
* Use of light sensitizing drugs
* Self-reported history of nocturia (\>3 times per night)

Primary outcomes:
measure: Mobile balance
timeFrame: 15 minutes
measure: Alertness
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References:
Clinical trial NCT01740843: The Effect of tDCS on Motor Performance and Cortical Excitability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cortical Excitability
Motor Performance
tDCS
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study the effect of tDCS intensity on motor performance and corticospinal (CS) excitability is evaluated. The investigators expect that a positive relationship between current intensity and motor performance/CS excitability.


Eligibility criteria: Inclusion Criteria:

- Healthy subjects

Exclusion Criteria:

* Contraindications for tDCS/TMS
* TMS measurements have to be possible

Primary outcomes:
measure: Change in motor performance
timeFrame: Baseline and POST (30 min after baseline) intervention
measure: Change in cortical excitability
timeFrame: Baseline and POST (30 min after baseline) intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: