louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04334811: Stereotactic Ablative Radiotherapy (SAbR) for Treatment of Ventricular Tachycardia (VT) Refractory Standard Invasive Ablation Techniques
Official title: Stereotactic Ablative Radiotherapy (SAbR) for Treatment of Ventricular Tachycardia (VT) Refractory Standard Invasive Ablation Techniques
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tachycardia, Ventricular
Keywords: heart
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy and safety of stereotactic ablative radiotherapy (SAbR), also known as stereotactic body radiation therapy (SBRT), for treatment of ventricular tachycardia (VT) requiring implantable cardioverter defibrillator (ICD) treatments in patients with VT refractory to standard invasive ablation techniques. We hypothesized that SAbR is effective in suppressing sustained VT and reducing ICD treatments in this group of patients and is associated with acceptably low risk of serious complications.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Have an ICD implanted \> 6 months and all VT episodes in the past 6 months are available in device memory.
* Within the past 3 months, the patient has at least one episode of symptomatic monomorphic VT that requires ICD treatment (anti-tachycardia pacing and/or ICD shock) or was sustained/incessant but falls under ICD treatment zone. These VT episodes must occur after at least one standard invasive VT ablation or occur in a patient that is clinically deemed not eligible to the standard VT ablation procedure.
* Two independent cardiac electrophysiologists reviewed the case and agreed that the patient would benefit from suppression of these VT episodes but there is no optimal invasive VT ablation or antiarrhythmic drug options.

Exclusion Criteria:

* Has contraindication to receive SAbR or VT clinically deemed not suitable for SAbR.
* Is pregnant
* Has severe co-morbid medical condition or terminal illness and is unlikely to survive more than 6 months regardless of VT status based on clinical judgement by treating or enrolling physicians.
* On potent immunosuppressive therapy (e.g., post organ transplant)
* Has severe collagen vascular disorder with organ involvement
* Not willing or not able to consent to participate in the study

Primary outcomes:
measure: Primary efficacy outcome of ICD (implantable cardioverter-defibrillator) Treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center - Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: James Daniel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06730711: Association Between Blood Pressure and Risk of PSCI
Official title: Association Between Blood Pressure and the Risk of Post-stroke Cognitive Impairment: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Cognitive Decline
Blood Pressure
Keywords: stroke
cognitive impairment
blood pressure
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients admitted to the First Branch of the First Affiliated Hospital of Chongqing Medical University between 2022 and 2024 were retrospectively reviewed.

Brief summary: This retrospective cohort study was designed to explore the relationship between blood pressure and cognitive impairment after stroke

Detailed description: Patients who have been followed up for more than 3 months after stroke will be included in the study. Basic data of patients and factors that may be related to cognitive impairment will be collected, and the relationship between blood pressure and cognitive impairment after stroke will be explored by univariate regression analysis and multivariate regression analysis. Univariate logistic regression model and multivariate logistic regression model were used to explore the relationship between blood pressure level and the risk of cognitive impairment after stroke, and the effect of blood pressure level and cognitive impairment sub-line in different patients was evaluated by subgroup analysis.

Eligibility criteria: Inclusion criteria:

1. Patient diagnosed with stroke by CT or MRI,
2. Patients completed the MMSE scale at least once during hospitalization
3. The follow-up time was more than three months after the stroke occurred;

Exclusion criteria:

1. Patients with incomplete data, follow-up time less than three months after the stroke occurred less than 3 months,
2. Patients with pre-existing cognitive impairment before stroke according to their medical records,
3. patients failed to complete MMSE assessment because of aphasia or any other reasons,
4. Patients combined with malignant tumors, patients combined with psychiatric disorders.

Primary outcomes:
measure: Mental State Examination Scale (MMSE)
timeFrame: Mini-Mental State Examination (MMSE) assessment will be completeed at 3 monthes after stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT01899911: Clinical Study of Peripheral Capillary Oxygen Saturation (SpO2): Vital Signs Patch (VSP)
Official title: Pulse Oximeter Response TO Multiple Levels Of Stable Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Desaturation of Blood
Lead sponsor: LifeWatch Services, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-16
Enrollment: 12
Sex: ALL
Minimum age (years): 23
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A clinical study designed to determine the accuracy of the peripheral capillary oxygen saturation (SpO2) function of the Vital Signs Patch (VSP) device for measuring blood saturation level.

Detailed description: The clinical study protocol was designed for determining the accuracy of the SpO2 function of the Vital Signs Patch device for measuring blood oxygen saturation level, according to the guidelines for "evaluating and documenting SpO2 accuracy in human subjects" as set out in Annex EE of ISO 80601-2-61. Section 4.

Eligibility criteria: Inclusion Criteria:

* Ages 23 to 33.
* Skin tone varied from light to dark.

Exclusion Criteria:

* Smokers
* Anemic

Primary outcomes:
measure: Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level
timeFrame: within 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, Room M454, Moffitt Hospital, Box 0542, UCSF,
state: California
Study officials:
affiliation: University of California, San Francisco
name: Philip E., Bickler, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06052111: Dexmedetomidine vs Fentanyl on Time to Extubation in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Official title: Dexmedetomidine Versus Fentanyl on Time to Extubation in Patients With Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy: A Randamized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dexmedetomidine
Fentanyl
Time to Extubation
Morbid Obesity
Laparoscopic Sleeve Gastrectomy
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy of dexmedetomidine versus fentanyl during general anesthesia for patients with morbid obesity undergoing laparoscopic sleeve gastrectomy.

Detailed description: The use of opioids in surgeries for patients with morbid obesity is controversial since they are known for having ventilatory depressing effects. Therefore, alternative analgesics are needed to improve anesthetic management for patients with obesity.

Eligibility criteria: Inclusion Criteria:

* Age from 20 to 50 years old.
* Both sexes.
* American Standards Association (ASA) physical status II - III.
* Body Mass Index (BMI) ≥ 35 kg/m2.

Exclusion Criteria:

* Allergy to α2 -adrenergic agonist.
* History of cardiac disease (uncontrolled hypertensive patient with blood pressure above 140/90, implanted pacemaker, poor cardiac function (ejection fraction\< 50%), history of myocardial infarction, cerebral stroke, transient ischemic attack, or coronary artery disease with or without stents.
* Neuromuscular disease, liver disease (coagulopathy INR\>1.5 or platelet count \<100.000/μl), renal impairment (serum creatinine \>1.2mg/dl, serum K \>5.5mmol/l).
* Opioid medication within 24 hours before the operation.
* Respiratory diseases as COPD, uncontrolled asthmatic patients.

Primary outcomes:
measure: The time for extubation
timeFrame: 30 minutes till end of surgery.
Secondary outcomes:
measure: Mean arterial blood pressure (MAP)
timeFrame: Intraoperatively.
measure: Heart rate (HR)
timeFrame: Intraoperatively
measure: Incidence of hypotension
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Helwan
country: Egypt
facility: Helwan University
state: Cairo
Study officials:
References:
Clinical trial NCT02197611: Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia.
Official title: Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia. The Haemo-Adhaesione Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Haemophilia
Keywords: Haemophilia
Adherence of Treatment
Knowledge of Illness
Medical-patient Relationship
Illness Behavior
Treatment Difficulties.
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with haemophilia

Brief summary: Research project for the development, construction and validation of a questionnaire of adherence to treatment in adult patients with hemophilia. It aims to build a scale according to five relevant dimensions of adherence to treatment: 1) physician-patient relationship, 2) knowledge of the disease, 3) previous bleeding problems, 4) knowledge of future consequences and difficulties, and 5) benefits of treatment.

Detailed description: * Descriptive study for the construction of a multidimensional scale of adherence to treatment in adult patients with hemophilia.
* Validation of a scale specific measure for patients with hemophilia that includes 5 dimensions that may affect adherence to treatment: a) the doctor-patient, b) regarding knowledge of the disease, c) the previous hemorrhages, d) knowledge future sequels, e) difficulties with treatment.
* Statistical and psychometric analysis of the adherence questionnaire for adult patients with hemophilia.
* Description of the theoretical framework that justifies the completion of the questionnaire, and the choice of the dimensions and items that make up the measurement scale.
* The questionnaire obtained in this project will identify the actual degree of patient adherence to multidisciplinary treatment, taking as gold standard, compliance with pharmacological treatment (the difference between the treatment prescribed and consumed).

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hemophilia A or B.
* Patients over 18 years of age.

Exclusion Criteria:

* Patients with neurological or cognitive impairments that hinder oral and written comprehension.
* Patients who have not signed the informed consent document

Primary outcomes:
measure: Phase substantive for the creation of a scale
timeFrame: Screening visit
measure: Structural phase for the creation of a scale
timeFrame: Screening visit
measure: Empirical phase for the creation of a scale
timeFrame: Screening visit
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad de Murcia
Study officials:
affiliation: Universidad Católica San Antonio
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01638793: Capnographic Monitoring of Propofol-sedation During Colonoscopy
Official title: Capnographic Monitoring of Propofol-sedation During Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.


Eligibility criteria: Inclusion Criteria:

* Indication for colonoscopy
* Patient wishing sedation during colonoscopy
* ≥ 18 years of age
* Signed informed consent form

Exclusion Criteria:

* Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
* Non-contractually capable persons
* Pregnancy
* Lactation

Primary outcomes:
measure: Hypoxia (SO2 <90%)
Secondary outcomes:
measure: Severe Hypoxia (SO2 <85%)
measure: Time to hypoxia
measure: Hypoxia in relation to sedation
measure: Vegetative Symptoms
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum der J. W. Goethe-Universität
city: Frankfurt am Main
country: Germany
facility: Praxisklinik am Staedel
Study officials:
affiliation: Klinikum der J. W. Goethe-Universität Frankfurt am Main
name: Mireen Friedrich-Rust, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06604793: Creatine Supplementation in Young Healthy Adults
Official title: Effects of Equal-volume Creatine Supplementation With Different Dosing Strategies on Body Composition and Muscle Performance in Young Healthy Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Improve Muscle Performance in Young Adults
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Iovate Health Sciences International Inc
First posted: 2024-09-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to compare the effects of bolus ingestion (5 grams) vs. intermittent ingestion (2 x 2.5 grams) of creatine supplementation vs. placebo for 21 days on measures of body composition (lean tissue mass-indicator of muscle mass, total body water) and muscle performance (i.e., power, strength, endurance).

Detailed description: Creatine is a naturally occurring compound produced in the liver and brain. Creatine can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products (i.e. creatine supplementation).

Evidence-based research shows that creatine supplementation improves measures of body composition and muscle performance. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.

Eligibility criteria: Inclusion Criteria:

* if you are 18-39 years of age
* if you have not been performing resistance training for at least 4 weeks prior to the start of the study.

Exclusion Criteria:

* if you are pregnant or nursing
* have taken creatine monohydrate within 30 days prior to the start of the study
* if you have pre-existing allergies to the placebo (corn-starch maltodextrin)

Primary outcomes:
measure: Whole-body lean mass (kg)
timeFrame: baseline, day 21
measure: Strength
timeFrame: baseline, day 21
measure: Endurance
timeFrame: baseline, day 21
measure: Hydration
timeFrame: baseline, day 21
measure: Power
timeFrame: baseline, day 21
measure: Power
timeFrame: baseline, day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Darren Candow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05255393: Survey on Lymphedema After Sentinel Lymph Node Biopsy in People With Cervical or Vulvar Cancer
Official title: RELEVANT Prevalence of Patient-Reported Lymphedema Following Surgical Management of Cervical or Vulvar Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Vulvar Cancer
Keywords: Questionnaire
Sentinel Lymph Node Biopsy
Lymphedema
22-002
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 1026
Sex: FEMALE
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: All patients in the GYN DMT's cervical cancer and vulvar cancer databases

Brief summary: The purpose of this study is to collect information that may identify people who are at risk of developing lower extremity lymphedema (LEL) after sentinel lymph node biopsy (SLN) during surgery for early-stage vulvar or cervical cancer, and to improve the quality and accuracy of the information that is given to people who have this procedure.

Please note that, during this study, the researchers will collect information from a questionnaire completed by people who had SLN and LND+/- SLN during surgery for early-stage cervical or vulvar cancer. No form of treatment will be provided as part of the study, and no investigational tests or procedures will be performed.


Eligibility criteria: Inclusion Criteria:

* Presented to MSK with newly diagnosed early-stage cervical cancer of any histologic profile or early stage vulvar cancer of any histologic profile.

  °Early stage: Stage 1-2
* Underwent primary surgery at our institution between January 2006 and January 2022.
* Alive at the time of study activation
* English comprehension
* Capable of providing informed consent

Exclusion Criteria:

* Had documented macroscopic evidence of metastatic disease at the time of initial diagnosis

Primary outcomes:
measure: prevalence of patient-reported lower extremity lymphedema
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mario Leitao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06858293: Mental Imagery to Improve Quadriceps Strength Post Anterior Cruciate Ligament Reconstruction: a Feasibility Study
Official title: Mental Imagery of Open and Closed Chain Exercises to Improve Quadriceps Strength Post Anterior Cruciate Ligament Reconstruction: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Mental Imagery
knee
strength
physical therapy
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 20
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: The goal of this clinical trial is to understand if people recovering from anterior cruciate ligament reconstruction (ACLR) surgery will complete mental imagery training and if this will improve their injured leg's strength. The main questions are:

* Will people complete a five-day mental imagery exercise schedule while in physical therapy for ACLR?
* Does mental imagery exercise help raise leg strength during ACLR recovery? Researchers will also compare if different mental imagery exercises involving leg extension or squats will change leg strength.

Participants will be asked to:

* Participate in two testing sessions to make measurements of leg function
* Complete about 10 minutes of mental imagery exercises once per day for five days at home and write down whether they complete the exercises.


Eligibility criteria: Inclusion Criteria:

* post anterior cruciate ligament reconstruction (ACLR) surgery
* cleared to participate in physical therapy
* currently in physical therapy related to ACLR

Exclusion Criteria:

* greater than 9 months post ACLR surgery
* history of lower back of hip pain that would limit lower limb motor testing
* current neurological condition that limits muscle strength
* history of substance abuse in the last 5 years
* any uncontrolled medical condition
* inability to follow 2-step commands

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: Once per day for 5 days
Secondary outcomes:
measure: Knee Extension Strength
timeFrame: Pre and post 5 days of mental imagery intervention
Other outcomes:
measure: Walking speed
timeFrame: Pre and post 5 days of mental imagery intervention
measure: Knee range of motion
timeFrame: Pre and post 5 days of mental imagery intervention
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
References: