louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04994431: Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin
Official title: Post-Operative Urinary Retention (POUR) in Thoracic Surgery Patients Receiving Prophylactic Tamsulosin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Thoracic Diseases
Urinary Retention
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: UMass Memorial Health
First posted: 2021-08-06
Enrollment: 109
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All subjects that sign a study consent and meet inclusion and exclusion criteria will receive the the study drug.
Primary purpose: TREATMENT

Brief summary: Post-Operative Urinary Retention (POUR) in Thoracic Surgery is a prospective interventional study aiming to test the hypothesis that the prophylactic use of tamsulosin prior to thoracic surgery in high risk patients leads to reduce the rates of POUR.

Detailed description: Post-operative urinary retention (POUR) is one of the most common post-operative complications encountered by most surgical specialties. The incidence of POUR can vary from five to 70%.

Post-operative urinary retention is a prevalent complication. Patients who undergo thoracic surgery have greater urinary retention rates compared to others. Data on effective methods to reduce the risk of POUR in this high-risk group are limited.

All subjects who meet inclusion and exclusion criteria will be invited to participate. There will be no randomization. All will receive tamsulosin in the pre operative period.

Eligibility criteria: Inclusion Criteria:

* All male patients \>=60 years old who undergo inpatient thoracic surgery for major resections.

Exclusion Criteria:

* - Prisoners
* Adults unable to consent
* End stage renal disease on hemodialysis
* Indwelling urinary catheter
* Child-Pugh class C hepatic failure
* Usage of the following medications prior to surgery: strong CYP 3A4 inhibitors, strong CYP2D6 inhibitors, other alpha-adrenergic blocking agents, PDE5 inhibitors, and cimetidine
* patients known to be CYP2D6 poor metabolizers
* History of prostatectomy or cystectomy
* Patients with contraindications to tamsulosin and those at high risk for side effects: hypersensitivity to tamsulosin HCl or any component of FLOMAX capsules, hypersensitivity to sulfonamides. History of known glaucoma, hypotension, plan to undergo cataract surgery in the next 2 weeks

Primary outcomes:
measure: Participants With Post-Operative Urinary Retention (Pour)
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Healthcare, Inc.
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Feiran Lou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03284931: A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model
Official title: A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2017-09-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.

Detailed description: Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4).

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Inclusion Criteria:

* Subject is willing and able to participate in the study, including all assessments, planned inpatient stays and all follow-up visits
* Subject is a healthy, ambulatory volunteer
* Subject meets sleep Qualification criteria

Exclusion Criteria:

* Subject has a medical history of suicidal behavior, epilepsy, eating disorders, sleep disorders, or circadian rhythm disorders
* Subject has worked a night shift or flown \>1 time zone within 30 days prior to Screening

Primary outcomes:
measure: Sleep efficiency, as determined by polysomnography (PSG)
timeFrame: 16 days
Secondary outcomes:
measure: Safety and tolerability, as assessed by adverse events
timeFrame: 36 days
measure: Safety and tolerability, as assessed by vital signs
timeFrame: 29 days
measure: Safety and tolerability, as assessed by clinical laboratory data
timeFrame: 29 days
measure: Safety and tolerability, as assessed by ECG
timeFrame: 29 days
measure: Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 29 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Sage Investigational Site
state: New York
Study officials:
References:
Clinical trial NCT04742231: Handheld Dynamometer During Awake Craniotomy Pilot
Official title: Use of Handheld Dynamometer As a Novel Tool to Assess Motor Function During Awake Craniotomy for Brain Lesions Located Within or Adjacent to the Motor Cortex: a Single-Center Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Lesion
Brain Tumor Adult
Brain Tumor
Keywords: Awake Craniotomy
Dynamometer
Motor
Brain Mapping
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The primary purpose of this study is to assess the feasibility, safety and reliability of the use of handheld dynamometry in evaluating intraoperative motor function for patients undergoing awake craniotomy for the resection of brain lesions located within or adjacent to the motor cortex.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old.
* Primary or Recurrent Brain tumors
* Single brain lesion
* Lesion within or adjacent to the motor cortex- Lesion located within the primary or supplementary motor area (Verified by preoperative fMRI and DTI).

Exclusion Criteria:

* Patients \< 18 years old.
* Major comorbidities (congestive heart failure, severe chronic obstructive pulmonary disease, morbid obesity, obstructive sleep apnea).
* Patients with cognitive, intellectual or psychiatric impairment that could affect the capacity of following instructions evaluated during preoperative neuropsychological testing.

Primary outcomes:
measure: Intraoperative maximum grip strength (KgF) baseline
timeFrame: 1 day
measure: Intraoperative maximum grip strength (KgF) variability
timeFrame: 1 day
measure: Maximum grip strength (KgF) variability from preoperative baseline
timeFrame: 1 day
measure: Operative Time (Minutes)
timeFrame: 1 day
Secondary outcomes:
measure: Correlation Coefficient (ρ) between hand-held dynamometry and manual motor testing during AC
timeFrame: 1 day
measure: Postoperative Maximum Grip Strength (KgF)
timeFrame: 1 month
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Kaisorn Chaichana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04127331: Gastric Ultrasound
Official title: Ultrasonographic Evaluation of Gastric Volume and Contents Before Surgery in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to evaluate gastric volume and contents as well as gall bladder size in patients scheduled for routine, urgent, and emergency surgery. The hypothesis is that patients with stress, pain and opioid administration will have delayed gastric emptying and therefore a larger gastric fluid volume than those scheduled for elective surgery. The patients who have an appropriate NPO time will have a larger gallbladder size than the patients with shorter NPO time.


Eligibility criteria: Inclusion Criteria:

* ASA 1-3 patients aged 2-18 years of scheduled for elective, urgent, or emergent surgery under general anesthesia.

Exclusion Criteria:

* History of upper gastro-intestinal surgery.

Primary outcomes:
measure: Aspiration Risk Grade
timeFrame: Baseline
Secondary outcomes:
measure: NPO at the Time of Injury
timeFrame: Baseline
measure: NPO at the Time of Surgery
timeFrame: Baseline
measure: Pre-operative Opioid Administration
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02642731: Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty
Official title: Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty- a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Knee
Acute Kidney Injury
Keywords: total knee arthroplasty
Kidney function
Renal markers
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients coming to elective knee arthroplasty

Brief summary: Sensitive renal markers have been studied abundantly in connection with open heart, liver and transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty acid-binding protein), and IL-18 (interleukin -18), in patients coming for elective TKA (total knee arthroplasty) as a pilot study before large study concerning acute kidney injury in orthopaedic surgery.

Detailed description: Acute renal deterioration is a serious adverse event in elective surgery. Serum creatinine based diagnostics of acute kidney injury may delay diagnosis and produce false negative results since serum creatinine is affected by diet, muscle mass, used hydration therapy. In recent times new markers have been developed and tested in order to find sensitive, fast and reliable marker of renal deterioration.

Eligibility criteria: Inclusion Criteria:

* informed consent
* allergy to NSAIDs

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: Renal function
timeFrame: time zero hours to 48 hours
Secondary outcomes:
measure: Concentraton of sensitive renal markers
timeFrame: time zero hours to 24 hours
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Kuopio University Hospital
name: Merja Kokki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03732131: The Finnish Faecal Microbiota Transplantation Study (FINFMT)
Official title: Long Term Safety and Efficacy of Faecal Microbiota Transplantation: a Nationwide Obeservational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Faecal Microbiota Transplantation
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Helsinki University Central Hospital
name: Turku University Hospital
name: Tampere University Hospital
name: Oulu University Hospital
name: Kuopio University Hospital
name: South Karelia, Social and Health Care District
name: North Karelia Central Hospital
name: Keski-Pohjanmaa Central Hospital
name: Seinajoki Central Hospital
name: Jyväskylä Central Hospital
name: Kanta-Häme Central Hospital
name: Mikkeli Central Hospital
name: Vaasa Central Hospital, Vaasa, Finland
name: Lapland Central Hospital
name: Satakunta Central Hospital
name: Kymenlaakso Social and Health Services
name: Kainuu Social and Health Care Joint Authority
First posted: 2018-11-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Finnish patients over 18 years of age. Receiving FMT for recurring Clostridium difficile infektion (rCDI) which is the only indication for FMT. If experimental FMT would be given for any other condition after a throughout work up of a collegue of experts such a patien would meet inclusion criteria as well.

Brief summary: The objective of the study is to follow up the long term effects of faecal microbiota tranplantation (FMT). All the over 18 years old patients receiving FMT and not included in other trials meet inclusion criteria to this study. Patients will be asked for a written consent. The outcome and possible side effects of the FMT will be followed by blood and feces samples for one year and with questionaires up to ten years after the FMT.


Eligibility criteria: Inclusion Criteria:

* \> 18 years age
* receiving FMT for rCDI or any other madical condition
* written consent
* Not included in other FMT trials

Exclusion Criteria:

* Unable to provide written consent
* \< 18 years age
* Included in other FMT-trial

Primary outcomes:
measure: The long term effects of FMT -questionnaire
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Joint Authority for Päijät-Häme Social and Health Care
Study officials:
affiliation: Head of Department
name: Perttu Arkkila, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02164331: Blood Pressure (BP) Visit Intensification Study
Official title: A Multimodal Quality Improvement Intervention Using the JNC Guidelines to Promote Control of Patients' BP in Federally Qualified Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Hypertension
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Aim 1: The purpose of the study is to implement the Seventh Joint National Committee on the Diagnosis, Prevention and Treatment of Hypertension (JNC VII) recommendation for monthly visits for hypertensive patients with uncontrolled blood pressure (BP) using a theoretically-informed, empirically grounded, multimodal quality improvement (QI) intervention.

Aim 2: To improve BP control and reduce disparity in BP through implementation of monthly visits.

Aim 3: To assess potential mediators and moderators of the intervention.

Detailed description: This study is a stepped wedged cluster randomized trial designed to improve management of uncontrolled blood pressure among patients in federally qualified health centers through the auspices of the the Clinical Directors Network Practice-Based Research Network (CDN PBRN).

Eligibility criteria: Inclusion Criteria:

* Federally Qualified Health Center in the Clinic Directors Network, Practice Champion, Electronic Medical Record System

Exclusion Criteria:

* Clinicians who have been at the practice less than 6 months, Practices planning to change Electronic Medical Record systems within the next 6 months

Primary outcomes:
measure: Number of office visits
timeFrame: Baseline and aniticipated at 1 year
Secondary outcomes:
measure: Reduction in Blood Pressure
timeFrame: Baseline and anticipated at year
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Kevin A Fiscella, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Directors Network
name: Jonathan Tobin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fiscella K, He H, Sanders M, Cassells A, Carroll JK, Williams SK, Cornell J, Holder T, Khalida C, Tobin JN. Blood Pressure Visit Intensification in Treatment (BP-Visit) Findings: a Pragmatic Stepped Wedge Cluster Randomized Trial. J Gen Intern Med. 2022 Jan;37(1):32-39. doi: 10.1007/s11606-021-07016-9. Epub 2021 Aug 11.
citation: Fiscella K, Ogedegbe G, He H, Carroll J, Cassells A, Sanders M, Khalida C, D'Orazio B, Tobin JN. Blood Pressure Visit Intensification Study in Treatment: Trial design. Am Heart J. 2015 Dec;170(6):1202-10. doi: 10.1016/j.ahj.2015.08.022. Epub 2015 Sep 12.
Clinical trial NCT00149331: The Effects of Two Education Strategies About Insulin on Patient Preferences and Perceptions About Insulin Therapy
Official title: A Randomized Controlled Trial Comparing the Effects of Two Education Strategies About Insulin on Preferences and Perceptions About Insulin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Diabetes, Insulin, Education
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: This study compared the impact of two educational strategies (an education program versus a pamphlet) on participants preferences for insulin and their perceptions about insulin and injections after attending an educational session with a diabetes educator about insulin.

Main research question: Among adults with type 2 diabetes who are potential candidates for insulin therapy, does an education strategy that involves a personal letter from the family physician, a presentation about insulin, and information about giving an injection, versus a pamphlet education strategy, effect: preference to accept insulin therapy; perceptions about insulin therapy; or perception about the injection?

Detailed description: Many people with type 2 diabetes who need insulin therapy are often reluctant to start using insulin to manage their diabetes. This may be because they are worried about giving an injection and do not know enough about insulin to make an informed choice. This research is important because it will help researchers and health care providers better understand the feelings and educational support that patients need when they are thinking about starting insulin. This can help health care providers to better tailor the care they give to patients.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Have a diagnosis of type 2 diabetes mellitus in their medical chart
* Have suboptimal glycosylated hemoglobin (HgA1c \> 7.5%) recorded in their chart as the most recent lab result
* Currently perform self-monitoring of blood glucose
* Able to understand written and spoken English

Exclusion Criteria:

* Are currently using, or have previously used insulin
* Have cognitive, visual, hearing or other medical impairment
* Have terminal malignancies or dementia
* Have psychiatric illness not controlled with medications

Primary outcomes:
measure: Preference for Insulin therapy
Secondary outcomes:
measure: Perceptions about insulin therapy
measure: Perceptions about injection
measure: Satisfaction with the education session
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Henderson Site
state: Ontario
Study officials:
affiliation: McMaster University
name: Lisa Dolovich, PharmD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03765931: Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment
Official title: Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment for Patients With Non-malarial Fever: a Randomized Non-inferiority Trial in Senegal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fever
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
First posted: 2018-12-05
Enrollment: 274
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.
Primary purpose: TREATMENT

Brief summary: Abstract: Background The current practice in Senegal is to use broad-spectrum antibiotics including amoxicillin and/or cotrimoxazole in case of non-malarial fevers. First-line treatment with doxycycline has cured such patients. The investgators aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.

Detailed description: Methods The investgators conducted a non-inferiority, open-label, randomized controlled trial in patients aged \> 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature \> 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (1:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investgators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature \< 37.5°C. The investgators used a non-inferiority margin of 10%. This trial was approved by the national ethic committees of the Senegalese Ministry of Health in May 2017 (0026/MSAS/DPRS/CNERS, March, 7, 2016).

Eligibility criteria: Inclusion Criteria:

* Participants over 8 years with no malaria fever

Exclusion Criteria:

Under 8 years Pregnanants women

-

Primary outcomes:
measure: Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of follow-up
timeFrame: 7 days follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Niakhar
country: Senegal
facility: Niakhar observational site
state: Fatick
Study officials:
References: