louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03993314: Optimizing Anesthesia for Post Partum Tubal Ligations
Official title: Comparing 1% Spinal Chloroprocaine to Low-dose Bupivacaine Using the Epidural Volume Extension Technique for Post-Partum Tubal Ligation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pregnancy Related
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible for enrollment in this study. Outcomes measured will include: ability to achieve an adequate level required for surgery (T6), rate of epidural activation, and duration of the block. The investigators hope to determine the usefulness of each drug using the EVE technique in the setting of PPBTL.


Eligibility criteria: Inclusion Criteria:

* Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center will be eligible for the study

Exclusion Criteria:

* age less than 18 years old
* allergy to either local anesthetic class (amide or ester)
* contraindication to spinal anesthesia

Primary outcomes:
measure: Number of Patients Who Achieve a Level of Numbness of T6 or Higher
timeFrame: 10 minutes after spinal injection
measure: Level of Numbness
timeFrame: 10 minutes after spinal injection
Secondary outcomes:
measure: Epidural Activation
timeFrame: Day of surgery
measure: Supplemental Intravenous Sedation or General Anesthesia
timeFrame: Day of surgery
measure: Modified Bromage Score at 10 Minutes Post-injection
timeFrame: 10 minutes after spinal injection
measure: Modified Bromage Score 60 Minutes After Intrathecal Injection
timeFrame: 60 minutes after spinal injection
measure: Time to PACU Discharge
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Mark F Powell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01518114: Exercise Training in Patients With Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophic Cardiomyopathy
Keywords: Hypertrophic Cardiomyopathy
Exercise Training
Cardiac Rehabilitation
Heart Failure
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exercise training (ET) is highly beneficial in heart failure patients and has been suggested to confer significant symptomatic and functional improvements in patients with diastolic dysfunction. Accordingly, the aim of this study was to examine the safety, feasibility of a structured ET program in symptomatic HCM patients.


Eligibility criteria: Inclusion Criteria:

* Hypertrophic Cardiomyopathy
* NYHA 3
* Maximal left ventricular wall thickness \> 20 mm
* Age \>18

Exclusion Criteria:

* Severe non-cardiac limitations of functional capacity such as neurological illness, lung disease, peripheral vascular or orthopedic problem, etc.
* Patients state post resuscitation for malignant ventricular arrhythmia.
* History of effort induced syncope, complex ventricular arrhythmia or atrial fibrillation.
* An exercise-induced decrease in blood pressure
* Severe left ventricular outflow obstruction defined as resting outflow gradient \> 50 mmHg on maximal therapy
* Atrial fibrillation with a poorly controlled ventricular response
* Advanced hypokinetic stage of HCM defined as LVEF \< 40%
* Congestive heart failure of angina FC IV according to NYHA or CCS respectively.

Primary outcomes:
measure: Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation
timeFrame: 6 months
measure: Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Endpoints:
timeFrame: 12 months
Other outcomes:
Locations:
city: Tel Hashomer , Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT04365114: Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening
Official title: Patient Outcomes from Second Film-readers and Test Threshold Relaxation in Breast Screening: an Observational Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Ductal Carcinoma in Situ
Lead sponsor: University of Warwick
Sponsor class: OTHER
Collaborators: name: Public Health England
First posted: 2020-04-28
Enrollment: 13094122
Sex: FEMALE
Minimum age (years): 47
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who attended the English NHS Breast screening programme between 1988 and 2016 aged between 47 and 73.

Brief summary: Analysis of women's medical records to understand the impact of previous changes to breast cancer screening (increase from one to two clinicians examining each woman's mammograms, and what proportion of women they recall for further tests)

Detailed description: Retrospective observational study examining the records and outcomes of women who attended breast cancer screening between 1988 and 2016. Linkage of records from the breast screening service, the cancer registry, and mortality. Analysis of whether changing the threshold for whether to recall women for further tests or the number of clinicians examining the mammograms for signs of cancer affects outcomes.

Eligibility criteria: Inclusion Criteria:

* Women who attended the English National Health Service (NHS) breast cancer screening service at least once between 1988 and 2016, aged between 47 and 73
* All eligible episodes of screening for each woman (we expect women to be screened around 7 times each)

Exclusion Criteria:

* Women who did not attend routine English NHS Breast screening service within the specified date and age range, even if they attended symptomatic breast cancer services, high risk (family history) breast screening services, or if they were referred for mammograms by their general practitioner

Primary outcomes:
measure: Number of women overdiagnosed (the cancer would not have become symptomatic within the woman's lifetime) using compensatory drop method
timeFrame: 13 years, and up to 30 years
measure: Cancers detected at screening
timeFrame: 1 day screening episode
measure: False positive recalls
timeFrame: 1 day screening episode
measure: Breast cancer mortality
timeFrame: 13 years, and up to 30 years
measure: All cause mortality
timeFrame: 13 years, and up to 30 years
measure: Characteristics of cancer detected
timeFrame: 1 day screening episode, 3year, 13 year and up to 30 year follow up
Secondary outcomes:
measure: Breast cancer morbidity
timeFrame: Up to 30 years
measure: Breast cancer free survival
timeFrame: Up to 30 years follow-up
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: Univesity of Warwick
state: Warwickshire
Study officials:
affiliation: University of Warwick
name: Sian Taylor-Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04827914: Evaluation of an "Opt-Out" Inpatient Smoking Cessation Service on Smoking Behavior Study #1
Official title: Dissemination of an Inpatient Smoking Cessation Program to South Carolina Hospitals Study #1
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 1122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The modest goal of this study is to replicate the behavioral outcomes of the opt out MUSC-Tobacco Treatment Program in the following three patient groups: 1) psychiatric inpatients housed in the Institute of Psychiatry (IOP) in Charleston; 2) non-IOP patients seen in Charleston; and 3) patients seen in the other four MUSC affiliated hospitals combined (i.e., Chester, Florence, Lancaster, and Marion). The aims and the design/methods utilized for evaluation will be the same for each of the three patient groups.


Eligibility criteria: Inclusion Criteria:

* 18+ years and older
* hospitalized cigarette smokers eligible for either enhanced or basic care
* discharged from the hospital back to their home

Exclusion Criteria:

* patients without a phone number
* those unable to communicate in the English language

Primary outcomes:
measure: Self-reported smoking prevalence 6-weeks after hospitalization.
timeFrame: Assessed 6-weeks post-discharge
measure: Self-reported use of FDA Approved Smoking Cessation Medication
timeFrame: Assessed 6-weeks post-discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Institute of Psychiatry
state: South Carolina
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Chester
country: United States
facility: MUSC
state: South Carolina
city: Florence
country: United States
facility: MUSC
state: South Carolina
city: Lancaster
country: United States
facility: MUSC
state: South Carolina
city: Marion
country: United States
facility: MUSC
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kenneth M Cummings, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03973814: Hypothermia Risk With Continuous Renal Replacement Therapy
Official title: Hypothermia Risk With Continuous Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Hypothermia
Keywords: continuous renal replacement therapy
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Skane University Hospital
First posted: 2019-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The investigators will assess body temperature before-, during- and after Thermax blood warming treatment. Patients are essentially their own controls.

Moreover, we will use historic data on the previous blood warmer for the Prismaflex device to assess temperature changes.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during continuous renal replacement therapy as compared to the Prismaflo IIS blood warmer used for the PrismaFlex system.

Detailed description: Blood warming devices during continuous renal replacement therapy (CRRT) have not been adequately tested.

The novel TherMax blood warmer for the newly introduced PrisMax System heats blood and replacement solutions via a dry heat plate system. In contrast, the PRISMAFLO IIS Blood Warmer for PRISMAFLEX System uses an electric heating sleeve on a standard CRRT filter set.

Data on adverse events (AE) during continuous renal replacement therapy (CRRT) has been studied and one of the most common AE was hypothermia, reported in 44% of all cases.

The present study aims at testing if the TherMax blood warmer is more accurate and reliable in reaching and maintaining chosen target temperature during CRRT as compared to the blood warmer used for the PrismaFlex system.

Eligibility criteria: Inclusion Criteria:

* Adult (18-100 years) critically ill patients treated with CRRT.

Exclusion Criteria:

* Patients under 18 years of age. Non-RRT patients.

Primary outcomes:
measure: Temperature, accuracy
timeFrame: 24 hours
Secondary outcomes:
measure: Temperature, differences
timeFrame: 12-18 hours (six hour warming period)
measure: Historic comparator
timeFrame: 24 hours
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Max Bell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skane University Hospital
name: Marcus Broman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04762914: Observing the Perioperative Effects of Prehabilitation in Colorectal Cancer Patients
Official title: Observing the Perioperative Effects of Prehabilitation in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: Prehabilitation
Lead sponsor: Medway Primary Care Trust
Sponsor class: OTHER_GOV
First posted: 2021-02-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients over the age of 18 needing surgery were identified from clinics, endoscopy or weekly multidisciplinary meetings (MDT). Patients who were clinically judged to be frail or had multiple comorbidities were referred for prehabilitation prior to resection. Those that underwent prehabilitation were matched using operation type, age, sex and ASA with patients who did not have prehabilitation prior to resection. Surgery for all patients was carried out within the context of an enhanced recovery programme.

Brief summary: Quality Improvement Project to evaluate how prehabilitation can be incorporated into our colorectal cancer pathway and assess its clinical benefits.

Detailed description: The aim was to evaluate how prehabilitation (PH) can be incorporated into our colorectal cancer pathway and assess its clinical benefits.

Patients underwent PH (exercise, nutrition and psychological support) before resection of colorectal carcinoma in a DGH over fourteen months. Patients were matched by operation, age, sex and ASA to non-prehabilitation (NPH) patients using a prospectively maintained database. Length of stay (LoS) and complication rate and 90-day readmission rates were compared using Wilcoxon and McNemar's methods.

Prehabilitation significantly improved peak VO2 and AT. This corresponds to a reduction in predicted 30-day mortality. Despite a higher Charlson index LoS was unchanged suggesting prehabilitation may permit safe resection in comorbid patients.

Eligibility criteria: Inclusion Criteria:

* Adults over the age of 18 who had prehabilitation for colorectal cancer

Exclusion Criteria:

* Children
* Patients who had prehabilitation but not for colorectal cancer

Primary outcomes:
measure: Length of stay
timeFrame: From date of operation to date of discharge in number of days over a 90 day follow up period
measure: Complication rate
timeFrame: Follow up over a period of 90 days following operation
Secondary outcomes:
measure: Anaerobic threshold
timeFrame: CPET performed before prehabilitation and after prehabilitation (median of 36 days)
Other outcomes:
Locations:
city: Gillingham
country: United Kingdom
facility: Medway Hospitals NHS Trust
state: Kent
Study officials:
affiliation: Medway PCT
name: Richard A Dickson-Lowe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01646814: Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
Official title: A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroduodenal Ulceration
Keywords: Healthy volunteer
comparison of incidence of
treatment groups.
Lead sponsor: PLx Pharma
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 247
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.

Detailed description: Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, ≥50 and ≤75 years of age.
* No endoscopically observed baseline gastrointestinal lesions.

Exclusion Criteria:

* Baseline gastrointestinal lesions or abnormal screening/baseline laboratory parameters deemed clinically significant by the Investigator.
* Significant history of substance abuse or uncontrolled acute or chronic medical illness.
* Active H. pylori infection.
* Current use of low-dose aspirin for cardioprevention, or other ulcerogenic medications, gastroprotective, or anti-platelet agents.
* Hypersensitivity to aspirin or other NSAIDs.

Primary outcomes:
measure: Incidence of Gastroduodenal Ulcers
timeFrame: 42 Days
Secondary outcomes:
measure: Number of Subjects With Erosion and Ulcers
timeFrame: 42 days
Other outcomes:
Locations:
city: Jupiter
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Towson
country: United States
state: Maryland
city: New York
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT06426914: Clinical Pilates (CP) Exercises and Kinesiophobia in CABG
Official title: Effect of Clinical Pilates (CP) Exercises on Kinesiophobia and Post-operative Cardiopulmonary Parameters in CABG Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-cardiac Surgery
Keywords: CABG
Clinical Pilates
Kinesiophobia
Post-operative cardiopulmonary parameters
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine Effect of Clinical Pilates (CP) exercises on kinesiophobia and post-operative cardiopulmonary parameters in CABG patients. Kinesiophobia may lead to patients\&#39; psychological fear of rehabilitation exercise, thereby refusing rehabilitation exercise, affecting the rehabilitation process of patients, resulting in disuse syndrome, depression, disability and other adverse consequences. Thus, this study is to be conducted to find out the effects Pilates exercises with cardiac rehabilitation for management of Kinesiophobia in post CABG patients.

Detailed description: Clinical Pilates are also evident to be safe and effective in post-surgical patients with different surgical interventions.

A study was conducted in 2021 to evaluate the effects of the Pilates method on pulmonary function and range of motion after coronary artery bypass grafting and concluded that the Pilates method is a safe, viable, and playful option for the patient profile after CABG but they did not evaluate kinesiophobia of patients

Eligibility criteria: Inclusion Criteria:

* Hemodynamically stable patient Who underwent elective CABG.
* Patients diagnosed with Kinesiophobia via Tampa scale for Kinesiophobia Heart (TSK-SV Heart)

Exclusion Criteria:

* Neuromuscular conditions which lead to kinesiophobia
* Diseases that seriously affected the functional capacity or mobility such as liver cirrhosis, chronic renal failure and disabled patients.
* Prolong intubation
* Vital instability
* Patients needing maximum assistance
* Decline consent

Primary outcomes:
measure: Kinesiophobia
timeFrame: 2 weeks, 4 weeks
measure: Abnormal heart rhythms
timeFrame: 2 Weeks, 6 Weeks
Secondary outcomes:
measure: Functional mobility
timeFrame: 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital
state: KPK
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT-CPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01280214: Local Triamcinolone Injection in Active Thyroid Orbitopathy
Official title: Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Disease
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-01-20
Enrollment: 30
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: Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy.

Detailed description: Local Steroid treatment may help in active thyroid orbitopathy. till today, systemic Steroids are the treatment for active thyroid orbitopathy which is associated with systemic adverse effects.

In this study the investigators want to compare the effectiveness of local Triamcinolone therapy for active thyroid orbitopathy.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years.
* Active thyroid orbitopathy according to clinical activity score\>=3.

Exclusion Criteria:

* Intraorbital or active infections.
* Tuberculosis.
* Other orbital disease.
* Pregnancy.
* Compressive optic neuropathy.
* Systemic steroid therapy within 6 months of study start.

Primary outcomes:
measure: Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy .
timeFrame: 6 months
Secondary outcomes:
measure: To check if the level of TSH Receptor antibodies are affected by the local injection.
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: haemek medical center
name: Daniel Briscoe, MD
role: STUDY_CHAIR
References: