louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00569322: Admission Glucose ICU Study
Official title: Evaluation of Admission Blood Glucose Levels in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperglycemia
Keywords: ICU
Admission
BG
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2007-12-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Determine if routine BG testing at the time of ICU admission is being done on all patients, irrespective of a prior diagnosis of diabetes mellitus, and whether it provides clinically important information.

Detailed description: This prospective, observational study was performed in the medical-surgical ICU of a single hospital within a large multi-specialty healthcare system.

It was determined that it was not standard care to do glucose testing on all patients admitted to medical/surgical ICU's who did not have diagnosed diabetes and varied widely with the admitting service.

The primary objective of the study was to assess the availability and clinical value of blood glucose testing at the time of ICU admission after testing was implemented as routine care in the ICU.

Eligibility criteria: Inclusion Criteria:

* ICU Admission

Exclusion Criteria:

* \< 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Methodist Hospital - Park Nicollet Health Services
state: Minnesota
Study officials:
affiliation: International Diabetes Center - Park Nicollet Health Services
name: Lisa H Fish, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03394222: Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt During OLV
Official title: Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt in Patients Received One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Cancer
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to conduct a randomized controlled trial to evaluate the effect of preoperative budesonide inhalation on arterial blood oxygenation and intrapulmonary shunt in patients received one-lung ventilation

Detailed description: Population:

The target population comprises all adult aged 45-65 years who was diagnosed lung cancer and to receive video-assist thoracoscopic lobectomy under general anethesia.The study sample will include 50 subjects of both gender and any race or ethnicity.

Procedures:

Eligible and consented patients will be enrolled into the study if all eligibility criteria are met and will be randomly allocated to one of the two study arms:Budesonide inhalation group vs Normal saline inhalation group

Study Duration:

Overall duration of the study is 10 months.

Eligibility criteria: Inclusion Criteria:

* Aged 45 yr to 65 yr ,height 155-176cm,weight 45-75kg,body mass index(BMI)18-27kg/m2,ASA Physical Status Classifications I to II,left-lateral position during OLV ,normal cardiac and pulmonary function ,and no cardiac,hepatic,renal and endocrine diseases.Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia.

Exclusion Criteria:

* FEV1/FVC\<70%,asthma,chronic obstructive pulmonary disease,acute lung infection,past history of thoracic surgery. preoperative glucocorticoid medication,preoperative chemotherapy,SpO2 kept below 90% for more than 15 minutes during operation,blood transfusion during operation,OLV less than an hour,occurrence of severe complications like allergic shock.

Primary outcomes:
measure: Arterial blood oxygenation
timeFrame: Arterial blood oxygenation was assessed through blood gas analysis before intervention,before OLV ,10 min after OLV,30 min after OLV,60 min after OLV and 10min after two-lung ventilation.
Secondary outcomes:
measure: Intrapulmonary shunt
timeFrame: Intrapulmonary shunt was assessed through blood gas analysis before intervention,before OLV ,10 min after OLV,30 min after OLV,60 min after OLV and 10min after two-lung ventilation
Other outcomes:
Locations:
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Wenhua chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02876822: High Dose Vitamin D Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation
Official title: Safety and Efficacy of Single, High Dose Vitamin D Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 10
Sex: ALL
Standard ages: CHILD
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 test the efficacy and safety of high dose vitamin D therapy among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin D sufficiency.

Detailed description: Vitamin D deficiency is common in childhood and has been associated with increased incidence of graft versus host disease (GVHD) and decreased survival in patients undergoing hematopoietic stem cell transplantation (HSCT). Recently, quality improvement efforts to correct serum vitamin D levels among inpatients at CCHMC who have already received HSCT and who were vitamin D deficient suggest that current recommended doses of vitamin D are inadequate to treat vitamin D deficiency. Possible hindrances to vitamin D treatment in the HSCT population include malabsorption related to gut GVHD, mucositis, increased requirement for calcium and/or vitamin D, kidney disease, liver disease, and infection. Single, high dose vitamin D treatment (stoss-therapy) has been utilized effectively to treat rickets and other chronic illnesses such as cystic fibrosis in children. The investigators hypothesize that stoss-therapy provided orally prior to transplantation will result in rapid and sustained correction of vitamin D deficiency in children who require HSCT. The investigators propose to test the efficacy and safety of high dose vitamin D therapy among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin D sufficiency.

Eligibility criteria: Inclusion Criteria:

* Step 1: Patients who are preparing for HSCT, 25OHD level (\<50 ng/mL), and no prior history of HSCT.
* Step 2: Patients who are preparing for HSCT 25OHD level (\<50 ng/mL).

Exclusion Criteria (both Step 1 and Step 2):

* Patients with history of pathologic fractures,
* uncorrected hypocalcemia or hypophosphatemia,
* known history of nephrocalcinosis or nephrolithiasis,
* current granulomatous disease,
* those currently in ICU.

Primary outcomes:
measure: Serum 25OHD level
timeFrame: Weekly for 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's Hosptial Medical Center
name: Jonathan Howell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03806322: A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis
Official title: A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis: A Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 89
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we compared the effects of intermittent pneumatic compression along with conventional treatment and cold-pack treatment along with conventional treatment on clinical outcomes in patients with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with knee OA according to the criteria of the American College of Rheumatology (ACR), and were considered as stage 2 and 3 according to Kellgren-Lawrence criteria.

Exclusion Criteria:

Exclusion criteria were previous knee surgery, malignancy, circulation disorder, and conditions preventing exercise or causing muscle weakness, pregnancy, diagnosis of mental disorder, scar tissue, or metal implants.

Primary outcomes:
measure: Knee Swelling
timeFrame: 3 minutes
measure: Pain Intensity
timeFrame: 3 minutes
Secondary outcomes:
measure: Range of Motion
timeFrame: 3 minutes
measure: Muscle Strength
timeFrame: 10 minutes
measure: Functional Status
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Sari Z, Aydogdu O, Demirbuken I, Yurdalan SU, Polat MG. A Better Way to Decrease Knee Swelling in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2019 May 2;2019:8514808. doi: 10.1155/2019/8514808. eCollection 2019.
Clinical trial NCT03237130: Prediction of Lymphatic Metastasis in Esophageal Cancer by CT Radiomics
Official title: Prediction of Lymphatic Metastasis in Esophageal Cancer by CT Radiomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagus Cancer
Keywords: esophagus cancer; radiomics; computed tomograpy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 133
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pathologically proven esophageal cancer patients who receive preoperative CT and surgical resection in our hospital.

Brief summary: This study proposes to establish a CT radiomics-based prediction model for identifying metastasis lymph nodes in esophageal cancer.

Detailed description: This study proposes to establish an image feature extraction and selection method for identifying lymph node metastasis of esophageal cancer.The study will consider the relationship between the main lesion and the suspected lymph node, extract association characteristics in order to improve the sensitivity and specificity of the CT radiomics-based prediction model for identifying metastasis lymph nodes. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.

Eligibility criteria: Inclusion Criteria:

* pathologically proven esophageal cancer
* scheduled to preoperative enhanced chest CT and undergo surgery
* sign the patient informed consent

Exclusion Criteria:

* failed to receive preoperative enhanced chest CT or undergo surgery
* inavailable pathological results for local lymph node status
* inquality of CT images for feature extraction
* patient quit

Primary outcomes:
measure: pathological local lymph node status
timeFrame: Pathologic evaluation will be performed for each patient within 1 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Dept.Radiology,Peking University Cancer Hospital
name: Ying-Shi Sun, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03386630: Effects of Analgesics in Cesarean Section Elective
Official title: The Effects of Sufentanil or Morphine Added to Hyperbaric Bupivacaine in Spinal Anaesthesia for Elective Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia; Functional
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial, without masking techniques, is proposed in pregnant women who are to undergo elective caesarean section by subarachnoid anesthesia with hyperbaric bupivacaine associated with sufentanil or morphine
Primary purpose: TREATMENT

Brief summary: Two approved treatments for spinal anesthesia will be compared in women undergoing cesarean section.

It is usual to perform cesarean sections using spinal anesthesia with a local anesthetic (bupivacaine) plus some opioid, such as sufentanil or morphine. Both have been shown to decrease postoperative pain, but we try to check if one brings more benefit than the other.


Eligibility criteria: Inclusion Criteria:

* Patients of at least 18 years.
* Patients at least 36 weeks gestation.
* Patients scheduled for non-urgent cesarean section.
* Patients classified in the physical state of the American Society of Anesthesiologists (ASA) as grade I-II, and without important fetal pathological conditions.
* Signature of informed consent that allows them to be part of the study.

Exclusion Criteria:

* Pregnant women who reject the spinal technique.
* Patients with contraindication to spinal anesthesia.
* Patients with ASA\> II classification.
* Patients with multiple pregnancy.
* Patients with three or more previous cesareans,
* Patients with BMI greater than or equal to 40 kg / m2.
* Language barrier.
* Patients with pre-eclampsia.
* Patients with a history of chronic pain.
* Patients with a history of psychiatric or drug abuse.
* Patients with allergy to any of the drugs used in the study.

Primary outcomes:
measure: To evaluate the time it takes the patients administer a first analgesic bolus of morphine intravenous personally after subarachnoid anesthesia in elective cesarean section.
timeFrame: 3 days
Secondary outcomes:
measure: Lower intravenous morphine consumption
timeFrame: 24 hours after surgery
measure: Levels of minor pain verbal scales
timeFrame: At 3, 6, 12 and 24 hours after surgery
measure: Beginning of sitting and standing
timeFrame: At 48 hours after surgery
measure: Mother´s side effects with respect to hemodynamic alteration, nausea, vomits, pruritus, tremor, urinary retention, sedation, respiratory depression, headaches, motor deficits, permanent sensory or autonomic deficits.
timeFrame: At intraoperative
Other outcomes:
measure: Values in the Apgar test
timeFrame: At 1 and 5 minutes after birth
Locations:
city: Cadiz
country: Spain
facility: Hospital La Línea
Study officials:
References:
Clinical trial NCT04613830: Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients
Official title: Continuous Erector Spinae Plane Local Anesthetic Infusion for Postoperative Analgesia in Pediatric Patients Undergoing Nephrectomy: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediatric Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to evaluate the analgesic efficacy of erector spinae plane block in pediatric cancer patients undergoing open nephrectomy

Detailed description: * Sixty patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 30) and the tramal group (group T, n =30).
* All patients will receive standard general anesthesia. Ultrasound-guided ESPB will be performed to group erector spinae plane block

Eligibility criteria: Inclusion Criteria:

* Physical status ASA II.
* Patients (age 2-7yrs) scheduled for open nephrectomy for malignant kidney tumors

Exclusion Criteria:

* History of psychological disorders.

  * Known sensitivity or contraindication to local anesthetics.
  * Localized infection at the site of block.
  * patients with coagulopathy or an (INR ≥ 2)

Primary outcomes:
measure: total amount of opioid consumption in milligram
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer instIitute
Study officials:
affiliation: Assiut University
name: fatma el sherif, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06151730: Evaluation of Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors, the HALT Study
Official title: Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-Cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors (HALT) - A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Hematopoietic and Lymphoid System Neoplasm
Mantle Cell Lymphoma
Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with B-cell malignancies on BTKi treatment at Mayo Clinic.

Brief summary: This study evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To prospectively define the incidence of new and/or worsening HTN in patients with B-cell malignancies on BTKi.

II. To identify the hemodynamic changes associated with new and/or worsening HTN in patients with B-cell malignancies on BTKi by impedance cardiography (ICG) and thereby to define the optimal anti-hypertensive strategies.

III. To compare 1-year MACE rates between patients with B cell malignancies on BTKi with new or worsening HTN on optimal anti-HTN strategies with patients who do not develop HTN on BTKis.

OUTLINE: This is an observational study.

Patients attend hypertension clinic visits, undergo optional blood pressure monitoring, electrocardiograms, impedance cardiography testing and blood and urine sample collection and have medical records reviewed throughout study.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom macroglobulinemia (WM), and marginal zone lymphoma (MZL), planned to begin Bruton tyrosine kinase inhibitors (BTKi) treatment or who will start a new BTKi agent after a 5-day wash out period (either as a single agent or on combination with other chemotherapies), who are willing to return to Mayo Clinic for ongoing follow-up

Exclusion Criteria:

* Patients with known central nervous system (CNS) involvement of their B-cell malignancy

Primary outcomes:
measure: Incidence of major adverse cardiovascular events (MACE)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Incidence of new and/or worsening hypertension (HTN)
timeFrame: Up to 12 months
measure: Hemodynamic changes associated with new and/or worsening HTN
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Joerg Herrmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06272630: Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients with Chronic Liver Disease
Official title: A Multicenter, Randomized, Placebo Controlled, Double-blinded, Phase 4 Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients with Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Liver Disease
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-02-22
Enrollment: 263
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded.


Eligibility criteria: Inclusion Criteria:

* Patients with Chronic liver disease(presented with abnormal serum ALT levels \>6 months and twice continuously or abnormal area of liver through medical imaging test within 6 months
* Abnormal serum ALT levels at screening and baseline

Exclusion Criteria:

* Subjects who have diseases that liver cirrhosis, liver cancer, renal dysfunction etc.
* Subjects who are taking medications or supplements related to chronic liver disease, fatigue.

Primary outcomes:
measure: At 8 weeks, the change of ALT level compared to baseline
timeFrame: 8 weeks after randomization
Secondary outcomes:
measure: At 4 weeks, the change of ALT level compared to baseline
timeFrame: 4 weeks after randomization
measure: At 4, 8 weeks, the change of AST level compared to baseline
timeFrame: 4, 8 weeks after randomization
measure: At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline
timeFrame: 4, 8 weeks after randomization
measure: At 8 weeks, the change of liver function comparator Fibrotest compared to baseline
timeFrame: 4, 8 weeks after randomization
measure: At 8 weeks, the change of liver function comparator Fibroscan compared to baseline
timeFrame: 4, 8 weeks after randomization
measure: At 4, 8 weeks, the change of K-CFQ(Korean version of Chalder Fatigue Scale) scores, compared to the baseline
timeFrame: 4, 8 weeks after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Seoul Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Jae Young Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: