louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05705453: Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
Official title: Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SCI - Spinal Cord Injury
Keywords: spinal cord stimulation
epidural stimulation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.

Detailed description: Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.

Eligibility criteria: Inclusion Criteria:

* 22 years of age or older
* Able to undergo the informed consent process
* Stable spinal cord injury
* International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5
* No ventilator dependency within the last year
* American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation
* Medically stable in the judgment of the Principal investigator
* Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery
* Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation
* Spinal imaging of the stimulator system

Exclusion Criteria:

* Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator
* Use of botulinum toxin (Botox) injections in the previous six months
* Clinically significant mental illness in the judgment of the principal investigator
* Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator
* Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI
* Current Pregnancy
* Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.

Primary outcomes:
measure: Change in Volitional electromyography (EMG) power
timeFrame: 10 years
Secondary outcomes:
measure: Prediction of power preferences
timeFrame: 10 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David Darrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02009553: Pre-procedural Information Sheet Reduces Anxiety of Patients Before Urodynamic Studies
Official title: Pre-procedural Information Sheet Reduces Anxiety of Patients Before Urodynamic Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Keywords: Anxiety
Urodynamics
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-12
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will be designated to have multichannel Uridynamic study in our center.

Brief summary: Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is that pre-procedural explanation note about the test may reduce the anxiety level of the patients.

Detailed description: Urodynamic study is one of the most common procedures in urological outpatient practice. Patients who wait for the tests may experience significant anxiety.

in this study, patients who are designated to have multichannel Urodynamic study will be randomized to two groups: group 1 - patients who received an explanation note about the test; group 2 - patients who did not receive the note. The explanation notes will be sent to the patients in group 1 by mail one month before the test.

Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress immediately before the test. Comparison opf the anxiety level between the two groups will be performed.

Eligibility criteria: Inclusion Criteria:

All patients who will be referred for Urodynamic studies in order to evaluate lower urinary tract symptoms.

Exclusion Criteria:

1. inability to complete the questionnaire due to mental disorders
2. patients who had undergone Urodynamic study previously

Primary outcomes:
measure: State Anxiety Inventory
timeFrame: 10 minutes before the test
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaakov
country: Israel
facility: Assaf Harofe Medical Center
state: Zeriffin
Study officials:
affiliation: Assaf Harofe Medical Center
name: Kobi Stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05643053: Comparison of Endotracheal Tube Fixation Methods in Prone Position
Official title: Impact of Endotracheal Tube Fixation Methods on Tube Displacement During Pron Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fixation Device; Complications
Keywords: endotracheal tube fixation
fiberoptic bronchoscopy
prone position
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-12-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In particular, prone position surgeries risk potentially life-threatening ET tube dislocation. Failure to place the plaster used for ET tube fixation correctly and adequately in this position may contaminate the patch with body fluids and loosen the weight of the breathing circuit, causing the ET tube to slip and dislodge. Adhesive tape (plaster), bandage (non-adhesive), suturing, or a commercially available tube holding device are recommended for ET tube fixation in patients operated in the prone position. In addition, the adhesive plasters used can be taped on the patient's face to the maxilla, mandible, or both. Because of the urgent and critical settings, a fast, reliable, and easy-to-use method of ET tube fixation is invaluable as it will provide clinicians with greater confidence in the stability of alternative airways and reduce complications from airway maintenance. In our clinic, different fixation methods are used according to the experience and preference of the anesthesiologist. Our study aims to compare other fixation methods using FOB to fix the position of the ET tube with an appropriate method in prone position procedures and ensure that patients have safe airway management throughout the surgery.


Eligibility criteria: Inclusion Criteria:

* ASA Physical Status I-II
* Mallampati score I-II

Exclusion Criteria:

* Patients who did not want to participate in the study
* Restricted mouth opening
* BMI ≥ 35 kg/m2
* Risk of airway malformation and aspiration (gastroesophageal reflux, hiatal -hernia, history of previous gastric surgery, GIS motility disorder)

Primary outcomes:
measure: Correct placement and subsequent fixation of the endotracheal tube in the prone patient
timeFrame: periopeative
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Medical Science, Yıldırım Beyazıt Training and Research Hospital
Study officials:
References:
citation: Singh G, Manikandan S, Neema PK. Endotracheal tube fixation in neurosurgical procedures operated in prone position. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):574-5. doi: 10.4103/0970-9185.86621. No abstract available.
Clinical trial NCT06053853: Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
Official title: Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Safety Issues
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 68
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin

Detailed description: To assess the occurrence of serum sickness after Diphtheria Antitoxin administration.

To assess local and systemic reactions within 24 hours to 10 days. To assess the occurrence of positive reactions after the sensitivity test (skin test). To assess the presence of SAE after Diphtheria Antitoxin administration.

Eligibility criteria: Inclusion Criteria:

* Subjects with a probable diagnosis or laboratory confirmation of Diphtheria.
* Subjects who received therapy with the intended DAT

Exclusion Criteria:

* Receiving a different brand of Diphtheria Antitoxin (DAT)

Primary outcomes:
measure: The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)
timeFrame: Within 10 days after injection
Secondary outcomes:
measure: The occurrence of local and systemic reactions after administration of Diphtheria Antitoxin (DAT)
timeFrame: Within 24 hours to 10 days after injection
measure: The occurrence of positive reaction after a sensitivity test (skin test) of Diphtheria Antitoxin (DAT)
timeFrame: Before injection of Diphtheria Antitoxin
measure: The occurrence of serious adverse event (SAE) after administration of Diphtheria Antitoxin (DAT)
timeFrame: Within 10 days after injection
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: RSUD Dr. Soetomo
state: East Java
Study officials:
affiliation: Dr. Soetomo Hospital, Surabaya, Indonesia
name: Dominicus Husada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06798753: Occlusion Balloon vs. 5FR Ureteral Catheter
Official title: The Presence of Ureteral Calculi Upon Supine PCNL Completion: Occlusion Balloon Catheter Versus 5FR Ureteral Catheter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Stones
Keywords: percutaneous nephrolithotomy
PCNL
Occlusion Balloon Catheter
kidney stone
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Occlusion Balloon catheter provides the ability to occlude the exit of the kidney pelvis during percutaneous nephrolithotomy (PCNL) and potentially prevents the migration of stone fragments into the ureter. The necessity for it might be questioned during supine PCNL due to the upward oblique position of the kidney. The objective of the study is to compare the presence of ureteral stone fragments upon completion of supine PCNL with and without using an occlusion balloon catheter (OBC).


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and older.
* Diagnosed with kidney stones and scheduled for PCNL.
* Able and willing to provide informed consent.

Exclusion Criteria:

* Pregnant women
* Urinary tract anomalies such as urinary diversion, previous ureteral reconstruction surgeries, horseshoe kidney, solitary kidney, duplicated system, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum.
* Prone procedure

Primary outcomes:
measure: Number of ureteral stone fragments identified endoscopically
timeFrame: During procedure
Secondary outcomes:
measure: Length of procedure
timeFrame: During procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mantu Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06121453: Adherence Intervention in Patients With Metastatic Breast Cancer
Official title: P50 Supplement: Improving Medications Adherence Equitably Among Patients With Metastatic Breast Cancer and Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-11-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the preliminary efficacy of a multicomponent adherence intervention focused on enhancing digital equity and pharmaco-equity among nonadherent patients with metastatic breast cancer (MBC) and cardiovascular disease (CVD) risk factors on endocrine therapy (ET), CDK4/6 inhibitor (CDK 4/6i), and CVD medications. To assess the acceptability and appropriateness of this intervention in patients with MBC and CVD risk factors through validated measures of implementation outcomes. To gain a deeper understanding of the impact of social determinants of health (SDOH) on medication nonadherence through semi-structured interviews with a subset of study participants.


Eligibility criteria: Inclusion Criteria:

* Women or men age \>18 years
* Diagnosed with stage IV/metastatic breast cancer prescribed endocrine therapy and a CDK4/6i
* Prescribed at least 1 antihypertensive or statin medication for CVD prevention or treatment
* Self-report of at least some nonadherence ET/CDK4/6i or CVD medication on nonadherence screener or verbally to a treating clinician, or nonadherent to ET, CDK4/6i, and/or CVD medication on pharmacy fill data in the EHR (proportion of days covered over prior 180 days \<80%).

Exclusion Criteria:

* Non-English or Non-Spanish speaking
* Not cognitively able to complete study requirements
* Inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use)
* Unavailable for 28 weeks of follow-up

Primary outcomes:
measure: Number of Participants on multicomponent adherence intervention
timeFrame: at 28 weeks
Secondary outcomes:
measure: Changes in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at 28 weeks
timeFrame: at 28 weeks
measure: Digital Health Literacy Scale
timeFrame: at 28 weeks
measure: Number in using the Voils DOSE Nonadherence measure
timeFrame: at 28 weeks
measure: Changes in Medical Adherence Self-Efficacy Scale (MASES) at 28 Weeks
timeFrame: at 28 weeks
measure: total number of medications and number of doses per day
timeFrame: at 28 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02552953: A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
Official title: A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Cyclacel Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single arm, dose escalation study in patients with advanced cancers.

Detailed description: This is an open-label, single arm, dose escalation study in patients with advanced cancers. Treatment will be administered on an outpatient basis.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed solid tumors or lymphomas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* 18 years or older
* ECOG performance status 0-1
* Life expectancy ≥ 3 months
* Evaluable disease
* Adequate organ functions
* 4 weeks from prior chemotherapy ( 6 weeks for mitomycin C and nitrosourea) , immunotherapy, investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
* At least 4 weeks from major surgery
* Agree to practice effective contraception
* Agree to follow protocol required evaluations
* Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

* Previously untreated CNS metastasis or progressive CNS metastasis
* Currently receiving radiotherapy, biological therapy, or any other investigational agents
* Uncontrolled intercurrent illness
* Pregnant or lactating women
* Known to be HIV-positive
* Known active hepatitis B and/or hepatitis C infection

Primary outcomes:
measure: Number of patients who experience dose-limiting toxicities
timeFrame: cycle 1(each cycle is 21 -28 days)
Secondary outcomes:
measure: Plasma concentrations
timeFrame: cycle 1(each cycle is 21 -28 days)
measure: Half-life of CYC065
timeFrame: cycle 1(each cycle is 21 -28 days)
measure: changes in certain protein levels in peripheral white blood cells by western blots
timeFrame: cycle 1(each cycle is 21 -28 days)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Geoffrey Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01355653: Heat Wrap Device Safety With Age and Body Fat
Official title: An Open Label Study To Compare The Effects Of Age And Body Fat On The Safety Of Two Heat Wrap Devices In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: heat
device
safety
performance
heatwrap
elderly
overweight
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-18
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

Detailed description: Safety measurements

Eligibility criteria: Inclusion Criteria:

* Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2
* or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or \< 30 kg/m2
* Females who are not pregnant or breastfeeding
* Subject is medically cleared for study participation

Exclusion Criteria:

* No sensitivity or allergy to device components in contact with skin
* Diabetes
* Any active skin disease or tattoos at the test site that would affect participation

Primary outcomes:
measure: Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema ≥ 2.0 [moderate], or pain upon touch plus non-zero erythema)
timeFrame: morning after product wear through 15 days after last product application
Secondary outcomes:
measure: Percentage of subjects with any adverse event
timeFrame: during and after wear for 28 days after last wear
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02955953: A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants
Official title: Bioequivalence Study Comparing the Pharmacokinetics and Glucodynamics of LY2963016 U-200 Formulation With LY2963016 U-100 Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-11-04
Enrollment: 127
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will aim to evaluate the following:

* Whether there are any differences in the way the body handles LY2963016 U-200 and LY2963016 U-100.
* How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.
* How LY2963016 U-200 affects the level of blood sugar in the body compared with LY2963016 U-100.

The study will last up to 17 weeks for each participant, including initial screening and follow up.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m²)
* Have a fasting plasma glucose less than (\<) 6.0 millimoles per liter (mmol/L) (108 milligram per deciliter \[mg/dL\])
* Have venous access sufficient to allow for blood sampling and clamp procedures per protocol

Exclusion Criteria:

* Have known allergies to the study drug, or any components of the formulation
* Have donated or had a blood loss of 450 milliliter (mL) within 3 months prior to study enrollment

Primary outcomes:
measure: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation
timeFrame: One hour before dosing up to 48 hours following administration of study drug
measure: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation
timeFrame: One hour before dosing up to 48 hours following administration of study drug
Secondary outcomes:
measure: Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of LY2963016 U-200 and LY2963016 U-100
timeFrame: One hour before dosing up to about 30 hours post clamp procedure
measure: Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of LY2963016 U-200 and LY2963016 U-100
timeFrame: One hour before dosing up to about 30 hours post clamp procedure
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: