louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03218098: Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
Official title: Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 44
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: Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?

Postoperative pain control remains one of the most common problems after major lung resection. Pain is considered a major independent factor responsible for increased perioperative morbidity and mortality: in particular, in patients with preoperative compromised clinical conditions. In fact, acute pain may compromise the patient's mobilization and the secretion's clearance with secondary possible bronchial obstruction and parenchymal lung infection.

Today, the treatment of postoperative pain after lung resection is based on association of the pharmacological therapy, including systemic use of opioids and non-steroid drugs, epidural analgesia, intercostal nerve block and cryoanalgesia with the minimally invasive surgery, like use of mini-thoracotomy, a thoracoscopic approach or intercostal nerve protection with the use of muscle sparing. In the literature, reduced tissue damage consequent to the use of limited surgical approaches is reported to be significantly effective in decreasing early postoperative pain. Thus, the use of a minimally invasive surgery for lung resections has proved to produce more tolerable pain and allow quicker functional recovery and lower postoperative complications. The aim of this prospective randomized study was to evaluate the equivalency of a smaller incision (4 cm) when compared to a longer length (8 cm) of incision performing uniportal VATS lobectomy in terms of postoperative pain results. Primarily, to evaluate the differences of operative time between the groups.

Secondly, to investigate the differences of pain scores between the two groups and the impact of pain reduction on functional results.


Eligibility criteria: Inclusion Criteria:

* be aged ≥ 18 years (of either gender)
* have provided written informed consent prior to participation in the study
* undergoing to major lung surgery with an Uniportal VideoThoracocopic Access (UVATS).

Exclusion Criteria:

* rethoracotomy
* presence of pleural adhesions
* Neuropathy
* be a participant in another interventional clinical trial or have received another investigational device or device within the last 30 days (donation of excised tissue \[lung or parts of lymph nodes\] for biological research may occur in the same patients)

Primary outcomes:
measure: Operative time reduction
timeFrame: up to 180 min
Secondary outcomes:
measure: pain score
timeFrame: up to 48 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03682198: Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions
Official title: Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurosurgery
Elective Craniotomy
General Anaesthesia
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a prospective observational study, consisting of 3 substudies carried out during elective neurosurgery under general anaesthesia. Each participant will take part in all 3 substudies. First, the capability of Near Infra Red Spectroscopy (NIRS) to measure the brain oxygenation is examined. A NIRS-electrode is placed on forehead skin, on the skull, and on dura. Secondly, a small dose of Phenylephrine is given, and the brain oxygenation is measured by a Clark-electrode and a NIRS-electrode, to see how Phenylephrine affects these measurements. In the third substudy, the brain oxygenations' (NIRS and Licox) response to an inspired oxygen fraction of 0.30 vs. 0.80 is investigated.


Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years) patients
* Elective craniotomy

Exclusion Criteria:

* Repeat craniotomy
* Preoperative hypotension (defined as systolic blood pressure below 110 mmHg)
* Preoperative hypoxia (defined as peripheral oxygen saturation (SpO2) \< 90% without oxygen supplementation before surgery)
* No negative pregnancy test for women \<50 years.

Primary outcomes:
measure: ScO2 (NIRS-measured cerebral oxygen saturation)
timeFrame: During surgical procedure
Secondary outcomes:
measure: PBrO2 (Partial pressure of brain tissue oxygen)
timeFrame: During surgical procedure
measure: PBrO2 (Partial pressure of brain tissue oxygen)
timeFrame: 'Normoxia' is induced with FiO2 = 0.30 for 5 minutes, and then changed to 'Hyperoxia' with FiO2 = 0.80 for the subsequent 5 minutes, while registering the Licox-signal.
measure: ScO2 (NIRS-measured cerebral oxygen saturation)
timeFrame: Measurements will be performed as the surgeon exposes the skull.
measure: ScO2 (NIRS-measured cerebral oxygenation)
timeFrame: NIRS signal is obtained continuously during the Phenylephrine intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT04832698: Survey of Current Interventional and Diagnostic Imaging Residents After Participation in Endovascular Simulator Training
Official title: Survey of Current Interventional and Diagnostic Imaging Residents After Participation in Endovascular Simulator Training Regimen
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Vascular Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-04-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current interventional and diagnostic radiology residents participating in the training curriculum on the Mentice Endovascular Simulator at MD Anderson Cancer Center.

Brief summary: This study looks at the comfort of interventional and diagnostic imaging residents in performing simulated endovascular procedures after completing training on the Mentice endovascular simulator device. Implementation of a training curriculum with radiology residents interested in interventional radiology will help facilitate hands-on training in a low-risk environment and allow for safer future patient encounters.

Detailed description: PRIMARY OBJECTIVE:

I. To measure trainee comfort performing simulated endovascular procedures after completing training on the Mentice endovascular simulator device.

OUTLINE:

Participants complete a survey over 10 minutes before and after completing training and using the Mentice endovascular simulator device.

Eligibility criteria: Inclusion Criteria:

- Current interventional and diagnostic radiology residents participating in the training curriculum on the Mentice Endovascular Simulator will be eligible to participate in the survey

Primary outcomes:
measure: Trainees' feelings about using simulation to help with procedural training
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Joshua D Kuban
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00997945: 10mg ZD4054 (Zibotentan) PK Study in Male, Elderly Chinese Patients With Advanced Solid Malignancies
Official title: A Phase I, Open-label, Single-arm Study to Determine the Single and Multiple Dose Pharmacokinetics of 10mg ZD4054 (Zibotentan) Administered Once Daily in Male, Elderly Chinese Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignancies
Keywords: Phase I, advanced solid malignancies, advance solid tumour
advanced cancer
ZD4054 (Zibotentan)
china
PK
pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 15
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Histological and/or cytological confirmed advanced solid malignancies
* WHO performance status\<2

Exclusion Criteria:

* History of significant gastrointestinal impairment, as judged by the investigator, that could significantly affect the absorption of ZD4054 (Zibotentan) , including the ability to swallow the tablet whole.
* ALT or AST³2.5 ´ULRR. If liver metastases are present ALT or AST more than 5times ULRR, Serum bilirubin \> 1.5 x ULRR, Serum creatinine\>1.5 x ULRR or creatinine clearance of \<50mL/min calculated by Cockroft-Gault
* Recent (\<14 days) major surgery prior to entry into the study, or a surgical incision that is not fully healed, Radical radiotherapy within the previous 4 weeks, or unresolved acute or subacute toxicities from prior radiotherapy

Primary outcomes:
measure: To assess the pharmacokinetics of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies
timeFrame: PK samples will be taken until Day 16
Secondary outcomes:
measure: To assess the safety and tolerability of single and multiple doses of 10mg ZD4054 (Zibotentan) in male, elderly Chinese patients with advanced solid malignancies
timeFrame: Safety assessments to be taken until Day 16 (while patient remains on study treatment), then every 8 weeks until treatment discontinuation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Research Site
state: Shanghai
Study officials:
affiliation: The Cancer Hospital Affiliated Fudan University
name: Li Jin
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca China MC
name: Helen Lin
role: STUDY_DIRECTOR
References:
Clinical trial NCT03378245: Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations
Official title: Telemedicine-based, Multidisciplinary-team, Intervention to Reduce Unnecessary Hospitalizations and Healthcare Costs in Appalachia KY Skilled Nursing Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Alzheimers
Disruptive Behavior
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the use of telemedicine-based intervention at urban and rural skilled nursing facilities to recommend multidisciplinary dementia care to residents with dementia who are at risk for unnecessary hospitalization due behavioral or neuropsychiatric symptoms and/or complications as well as caregivers and facility staff. The multidisciplinary team is comprised of trained behavioral neurologists, social workers, advanced practice providers, primary medical team and nurse coordinators.


Eligibility criteria: Inclusion Criteria:

Dementia Care facility resident Problematic behavioral problems

Exclusion Criteria:

None

Primary outcomes:
measure: Change in the Neuropsychiatric Inventory (NPI) total score
timeFrame: 6 months
Secondary outcomes:
measure: Change in the Resource Utilization in Dementia - Formal Care (RUD-FOCA)
timeFrame: 6 months
measure: Change in Quality of Life in Alzheimers Dementia (QoL-AD)
timeFrame: 6 months.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References:
Clinical trial NCT00601445: Homeostatic Sleep Regulation in Older Persons
Official title: Homeostatic Sleep Regulation in Older Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Aging
Keywords: Changes in sleep with aging
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
Collaborators: name: Brigham and Women's Hospital
First posted: 2008-01-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to test the hypothesis that sleep homeostasis, also known as sleep pressure or sleep drive, is different in healthy older and younger individuals.

Detailed description: This was an inpatient study of healthy individuals to determine whether homeostatic "sleep drive" effects on sleep change with healthy aging. Sleep, performance, and mood were studied on individuals sleeping different lengths of time and during wake periods of different durations.

Eligibility criteria: Inclusion Criteria:

* Ages 18-30 and 60-85 years
* Healthy

Exclusion Criteria:

* Any medications
* Sleep Disorder

Primary outcomes:
measure: Total Sleep Time
timeFrame: During inpatient study
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Elizabeth B Klerman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03464045: Empa PASS on Urinary Tract Malignancies
Official title: Post-authorisation Safety Study to Assess the Risk of Urinary Tract Malignancies in Relation to Empagliflozin Exposure in Patients With Type 2 Diabetes: a Multi-database European Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2018-03-13
Enrollment: 344995
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is an observational, comparative, cohort safety study based on European healthcare databases and includes databases from the UK, Finland, and Sweden.

Brief summary: The aim of the study is to assess the risk of urinary tract malignancies in patients initiating empagliflozin (free or fixed dose combination) compared to patients initiating a dipeptidyl peptidase-4 (DPP-4) inhibitor.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Age over 18 years at index date
* At least 1 year of membership in the medication database prior to index date

Exclusion Criteria:

* Patients with any cancer (excluding non-melanoma skin cancer) recorded at any time prior to the index date (i.e. during the available look-back time)
* Diagnosis of type 1 diabetes or other specific non-type 2 diabetes
* Use of any SGLT-2 inhibitor or any DPP-4 inhibitor (including free and fixed-dose combinations) recorded at any time prior to index date (i.e. during the available look-back time).
* Use of fixed-dose combinations of SGLT-2 inhibitors with DPP-4 inhibitors
* Diagnosis of end stage renal disease or receipt of renal dialysis recorded at any time prior to index date (i.e. during the available look-back time)

Primary outcomes:
measure: Occurrence of Urinary Tract Cancer
timeFrame: From 181 days after index date until the occurrence of a censoring event or cancer outcome event. Up to 6 (Sweden/Finland) or 7 years (UK).
measure: Occurrence of Bladder Cancer
timeFrame: From 181 days after index date until the occurrence of a censoring event or cancer outcome event. Up to 6 (Sweden/Finland) or 7 years (UK).
measure: Occurrence of Renal Cancer
timeFrame: From 181 days after index date until the occurrence of a censoring event or cancer outcome event. Up to 6 (Sweden/Finland) or 7 years (UK).
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: The National Register Data
city: Stockholm
country: Sweden
facility: The Swedish prescribed drug register
city: London
country: United Kingdom
facility: United Kingdom Clinical Practice Research Datalink (CPRD)
Study officials:
affiliation: pasi.korhonen@epidresearch.com
name: Pasi Korhonen, 358-50-3652990
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02444845: Study of Anemia in Chronic Kidney Disease (CKD) Among High-Risk Hypertensive and Diabetic Patients in Pakistan
Official title: Prevalence of Anaemia Secondary to Early Stage Chronic Kidney Disease in High Risk Diabetic and/or Hypertensive Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Diabetes, Kidney Disease, Chronic, Hypertension
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 246
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll high-risk hypertensive and/or diabetic patients in Pakistan who meet eligibility criteria for observation.

Brief summary: The purpose of this study is to evaluate the prevalence of CKD-related anemia at an early stage through screening of high-risk patients in Pakistan at the level of physicians, cardiologists, and diabetologists. The information gathered may serve as a foundation in formulating national guidelines for better early diagnosis and management of patients with CKD.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 40 years
* Known hypertension and/or diabetes for at least 3 years
* Positive dipstick test result for proteinuria

Exclusion Criteria:

* Known CKD
* Receiving erythropoietin
* Blood transfusion within 8 weeks
* History of acute or chronic bleeding, hemolysis, or hemoglobinopathy

Primary outcomes:
measure: Number of patients with anemia secondary to CKD
timeFrame: Up to 12 months
Secondary outcomes:
measure: Use of treatment modalities for the management of anemia secondary to CKD
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
city: Karachi
country: Pakistan
city: Lahore
country: Pakistan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05781945: COVID-19 Pneumonia and Gut Inflammation
Official title: COVID-19 Pneumonia and Gut Inflammation: The Role of a Mix of Three Probiotic Strains in Reducing Inflammatory Markers and Need for Oxygen Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 80
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 primary objective of our study was to evaluate the efficacy of a mix of three probiotic strains (Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302, and Lactobacillus acidophilus LA 201; Lactibiane Iki®) in the reduction in fecal calprotectin in patients with COVID-19 pneumonia, compared to a control group. The secondary aim was to evaluate the reduction in oxygen support and length of hospital stay in patients taking the probiotic mix.


Eligibility criteria: Inclusion Criteria:

* patients admitted to our hospital for SARS-CoV-2 infection with respiratory and/or gastrointestinal symptomsandradiological imaging (chest X-ray/CT with/without contrast) of interstitial pneumonia. Patients with mild COVID-19 disease (requiring oxygen support with 2L or 4L nasal cannula or Ventimask 28-35-40% to reach a SpO2-target of 95%)

Exclusion Criteria:

* patients on antibiotic therapy or patients who had taken antibiotics in the previous month; patients with IBD,IBS,or infectious colitis of non-COVID-19 bacterial and/or viral etiology; patients with colonic neoplasia (first to last stage); patients who had undergone colon surgery; patients with severe hepatopathy, nephropathy, heart disease or terminal oncological disease; pregnant women; and patients in circulatory shock and under positive pressure support on admission to hospital.

Primary outcomes:
measure: efficacy of probiotics in reducing calprotectin and CRP
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
References: