louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03950180: Assessing The Impact Of Incorporating Charlson Comorbidity Scores On Patient Anxiety And Satisfaction
Official title: Assessing The Impact Of Incorporating Charlson Comorbidity Scores On Patient Anxiety And Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Virginia Mason Hospital/Medical Center
name: Axio Research Corporation
First posted: 2019-05-15
Enrollment: 277
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study was to determine whether providing patients with life expectancy (LE) information in the form of their Prostate Cancer Comorbidity Index (PCCI) scores impacted their decisional conflict or anxiety about prostate cancer or death.

Detailed description: Patients with newly diagnosed prostate cancer were consented and randomized to receive standard of care counseling (SOC) versus the same counseling plus provision of their specific LE (PCCI). Patients were blinded to the specific content of their counseling session. After counseling, patients completed the Decisional Conflict Scale (DCS), Death Anxiety Scale (DAS), Memorial Anxiety Scale for Prostate Cancer (MAX-PC), and Patient Satisfaction Questionnaire (PSQ-18). Treatment preferences were assessed.

Eligibility criteria: Inclusion Criteria:

* Men 18 years and older
* Newly diagnosed prostate cancer

Exclusion Criteria:

* Non-English speaking
* Prior history of prostate cancer

Primary outcomes:
measure: Traditional Decisional Conflict Scale (DCS)
timeFrame: within 120 days of receiving counseling
Secondary outcomes:
measure: The Modified 18-item Memorial Anxiety Scale for Prostate Cancer
timeFrame: within 120 days of receiving counseling
Other outcomes:
Locations:
Study officials:
affiliation: Benaroya Research Institute at Virginia Mason
name: John M Corman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01127880: Role of Antibiotics to Reduce Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax
Official title: The Role of Antibiotics in the Reduction of Infectious Complications in Tube Thoracotomy Management of Traumatic Hemopneumothorax: A Prospective, Double-Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hemopneumothorax
Pneumothorax
Keywords: Traumatic Hemopneumothorax
Thoracotomy
Antibiotics
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.

Detailed description: In this study, the medication (an antibiotic which is used to treat or prevent infections) will be compared with a placebo. A placebo is something that looks like a "real" medication, but it doesn't contain any active medication. As a participant in this study, you may receive the active medication (Cefazolin Sodium Injection or Clindamycin) or you may receive a placebo.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 16 years of age.
2. Admission to Trauma, General Surgery, and/or Surgical Critical Care services.
3. Traumatic pneumothorax, hemothorax or hemopneumothorax

Exclusion Criteria:

1. Pregnancy
2. Open fracture
3. Immunocompromised
4. Require antibiotics for treatment of other injuries
5. Chest tube placement greater than 72hrs after admission

Primary outcomes:
measure: efficacy of prophylactic antibiotics in reduction of empyema
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of Pneumonia and/or development of resistant microorganisms
timeFrame: 30 days
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's Hospital and Health Network
state: Pennsylvania
Study officials:
affiliation: St. Luke's Hospital and Health Network
name: Nathaniel McQuay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00087880: Maintaining Abstinence in Chronic Cigarette Smokers - 1
Official title: Maintaining Abstinence in Chronic Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: smoking cessation
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-07-19
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.

Detailed description: The work adapts interventions that have been successful in the general populations, and tailors them to chronic smokers, who may have numerous previous smoking treatment failures. If successful it will: (1) make available a treatment intervention that produces hight long term abstinence rates; (2) provide information on variables that predicts success and failure in this population of smokers; (3) examine the cost-effectiveness of more intensive, longer term treatments.

Eligibility criteria: Subjects (N=400) will be men and women (50%) over the age of 18 who smoke at least 10 cigarettes per day and answers yes to the question "Do you smoke within 30 minutes of arising?"

Inclusion Criteria:

-Subjects are age 18 and over, currently smoking 10 or more cigarettes per day, and report a smoking history of at least 5 years in response to the question "How long have you been a regular smoker?"

Exclusion Criteria:

* History of seizure or head injury resulting in unconsciousness
* Any condition that might predispose to seizures (brain tumor or stroke)
* A current or history of anorexia nervosa or bulimia
* Any disease acutely life-threatening or so severe that the patient is judged unable to comply with the protocol
* Use of a protease inhibitor of MAO inhibitor within the last two week
* Current use of psychiatric drugs that would interfere with interpretation of study results, including antidepressants
* Treatment for alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol
* Patients who know they are leaving the Bay Area within the study period and non-English speakers will be excluded
* Suicidal or homicidal ideation
* Current major depression
* History of bipolar disorder
* Recent (within twelve months) myocardial infarction
* Any other medical condition that would contraindicate use of NRT or bupropion
* Physical limitation so severe that participation in a program of moderate exercise is not possible
* Pregnancy or lactation

Primary outcomes:
measure: Smoking Behavior
timeFrame: 2
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sharon M Hall, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00961480: A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
Official title: A 3-Part, Open-Label, Randomized, 2-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of the FMI Sitagliptin/Metformin 50/500 mg, 50/850 mg and 50/1000 mg FDC Tablet and Co-administration of Corresponding Doses of Sitagliptin and Metformin as Individual Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).


Eligibility criteria: Inclusion Criteria:

* Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception
* Subject is in good health and is a non-smoker

Exclusion Criteria:

* Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder
* Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Subject is a nursing mother
* Subject consumes excessive amounts of alcohol or caffeine
* Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks

Primary outcomes:
measure: The area under the plasma concentration-time curve (AUC) after administration of sitagliptin/metformin (50/500; 50/850; 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.
timeFrame: Up to 72 hours postdose
Secondary outcomes:
measure: Peak plasma concentration (Cmax) for metformin after administration of sitagliptin/metformin (50/500; 50/850, 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets.
timeFrame: Up to 72 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05511480: Reshaping the Motor Engram - An Online Crowdsourcing Study.
Official title: Reshaping the Motor Engram - An Online Crowdsourcing Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A critical point in learning and memory research is whether memories, once consolidated, remain unchanged or whether they continue to undergo plastic changes and remodeling. While previous research has focused on experimental destabilization during early stages of the memory life cycle, i.e., during encoding or early consolidation, experimental data that provides information about the effect of destabilization interventions on well-consolidated memories is still missing. This is particularly true for the procedural memory domain, such as learning a sensorimotor skill. This project is designed to characterize the effect of a single behavioral interference intervention on a previously consolidated sensorimotor skill in a large sample of healthy volunteers recruited through an online crowdsourcing platform. In a longitudinal design, participants will perform an implicit sequence learning task over five consecutive sessions, followed by an interference intervention in session six and a follow-up evaluation of the stability of the learned skill in session seven. The experimental design includes two levels of sequential information (spatial and temporal), which allows the testing of the specificity of the interference intervention. Behavioral performance throughout the experimental sessions is acquired via the manual input on the participants' computer keyboards and used to extract the learning rate and the interference effect (primary outcome).


Eligibility criteria: Inclusion Criteria:

* registered Amazon Mechanical Turk users (called 'workers')
* with \>95% approval rate on all previous Amazon Mechanical Turk assignments
* location in North America or Europe
* ≥18 years of age
* not having participated in this experiment before

Exclusion Criteria:

• prior participation in this experiment

Primary outcomes:
measure: Immediate interference rate (change in performance precision)
timeFrame: six days
measure: Delayed interference rate (change in performance precision)
timeFrame: seven days
Secondary outcomes:
measure: Learning rate (change in performance precision)
timeFrame: five days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kirstin-Friederike Heise, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01343680: Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients
Official title: A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Childhood Cancer
Aplastic Anemia
Metabolic Disorders
Lead sponsor: Alberta Children's Hospital
Sponsor class: OTHER
Collaborators: name: Stollery Children's Hospital
First posted: 2011-04-28
Enrollment: 2
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether flushing Central Venous Catheters (CVCs) with Normal saline once per week is not inferior to flushing with 10U/ml heparin 3 times per week, in preventing CVC occlusions.

Detailed description: Tunneled central venous catheters (CVCs) are now used routinely in pediatric hematology and oncology patients. Flushing with heparin solution is routinely recommended to prevent occlusion of long term CVCs, although the concentration of heparin used, and frequency of its use varies between centres. Once weekly Normal saline is also used successfully in some pediatric enters. There is little evidence to support one method over the other.

The investigators have designed a randomised crossover trial to directly compare once weekly Normal saline flushing with 3 times per week 10U/ml heparin flushing, to determine whether Normal saline is not inferior to heparin.

Eligibility criteria: Inclusion Criteria

* Diagnosis of any malignant or nonmalignant disease that requires a single lumen Broviac or double lumen Hickman-type CVC for the purpose of chemotherapy, blood product support or hematopoietic stem cell transplantation.
* CVC is planned to remain in situ for 6 months from study entry

Exclusion Criteria:

* Thrombophilia (e.g. Factor V Leiden mutation, antiphospholipid syndrome) or previous thrombosis requiring anticoagulation (e.g. enoxaparin, unfractionated heparin)
* Bleeding disorder (e.g. von Willebrand's disease, hemophilia)
* Previous CVC that was removed due to any complication

Primary outcomes:
measure: Occlusion rate
timeFrame: 6 months
Secondary outcomes:
measure: Complication rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: Alberta Children's Hospital
name: Martin A Campbell, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05844280: The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries
Official title: The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fracture of Foot
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the role of blood flow restriction (BFR) + neuromuscular electrical stimulation (NMES) in improving post-operative physical therapy and recovery after ankle fracture surgery. We expect to see improved muscle strength, less muscle wasting, and improved functional recovery after surgery when making these additions to routine post-operative (postop) physical therapy protocols.

Detailed description: Few studies have examined BFR in patients sustaining operative foot and ankle injuries. Due to the weight bearing limitations and prolonged immobilization following these injuries, patients often experience increased time away from work and delays with return to sport. These factors are responsible for the rapid muscle atrophy that occurs in the immediate post injury period because of immobility and disuse. Recently, blood flow restriction (BFR) therapy has been shown to be effective in improving muscle strength and preventing atrophy when combined with low load resistance training physical therapy programs.7,8 Neuromuscular electrical stimulation (NMES) is an adjunctive agent that has been show to augment the effects of BFR alone.4 The null hypothesis is that a 2 week BFR + NMES + low load resistance training program in patients age \>= 18 recovering from foot and ankle surgery will have no effect on short term (2 weeks postop) lower extremity muscle hypertrophy or atrophy, patient pain and satisfaction, or functional recovery after foot and ankle surgery.

Eligibility criteria: Inclusion Criteria:

* isolated, closed low-energy rotational ankle fracture without prior surgery or implants to injured area

Exclusion Criteria:

* history of Deep Vein Thrombosis in affected extremity
* history of significant cardiac disease defined as a recent stent placement in past
* history of peripheral arterial disease
* history of sickle cell disease
* history of coagulopathy
* presenting to surgery \>14 days after injury

Primary outcomes:
measure: Assess for calf muscle atrophy as measured by calf circumference
timeFrame: 2 weeks postop
measure: Assess for calf muscle atrophy as measured by hand held dynamometry
timeFrame: 2 weeks postop
Secondary outcomes:
measure: Patient tolerance of the BFR treatment using the Visual Analogue Pain Scale.
timeFrame: 2 weeks postop
measure: Patient tolerance of the BFR treatment using the the Borg Rating of Perceived Exertion f
timeFrame: 2 weeks postop
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02205580: Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children
Official title: Comparison of Three Different Rates of Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Coblation Tonsillectomy or Adeno-tonsillectomy in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sleep Breathing Disorders
Tonsillitis
Adenoid Hypertrophy
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in children. There are few reports about its use for postoperative analgesia by continuous intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or vomiting.

The investigators design this protocol to test efficacy of analgesia of three different rates of continuous intravenous sufentanil infusion for postoperative pain management following coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare incidence rate of complications for three groups.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists grade I or II children aged 5-8 years undergoing coblation tonsillectomy or adeno-tonsillectomy as in-patient

Exclusion Criteria:

* Children with a history of adverse reaction to opioids, long-term use of opioid medications, and history of chronic pain.
* Psychiatric illness, kidney failure, hypotension, atrioventricular block, myasthenia gravis etc.

Primary outcomes:
measure: objective pain score
timeFrame: up to 48 hours after operation
Secondary outcomes:
measure: incidence rate of hypoxia
timeFrame: 4h,8h,24h,48h after operation
Other outcomes:
measure: incidence rate of pruritus
timeFrame: 4h,8h,24h,48h after operation
measure: incidence rate of nausea and/or vomiting
timeFrame: 4h,8h,24h,48h after operation
measure: incidence rate of sedation
timeFrame: 4h,8h,24h,48h after operation
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
affiliation: Guangzhou Women and Children's Medical Center
name: Jin Ni, M.D.
role: PRINCIPAL_INVESTIGATOR
References: