bioihbjkbjnl/mcl2 huggingface dataset:
10cmH2O Peep Application and Cerebral Oxygenation in Laparoscopic Surgery: a Comparative Study With Invos and Foresight Devices
Condition: Laparoscopic Cholecystectomy
Study type: Observational [Patient Registry]

Summary: 
      In this study the investigators investigated changes in hemodynamic parameters and cerebral
      oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the
      respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at
      the 30°head-up left side position, is compared with using two individual devices
      (INVOS-FORESIGHT).

      Methods: Afterwards the ethics committee approval of the hospital and receiving the written
      patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were
      randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the
      right side forehead region. Totally 11 evaluation periods were formed, respectively:
      Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd
      period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of
      insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th
      period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10
      cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data,
      hemodynamic values and rSO2 values were recorded for both groups at all 11 periods.
    


Intervention name(s): FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor; FORESIGHT and INVOS monitor
Intervention type(s): Device; Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing laparoscopic cholecystectomy
      
Keywords: laparoscopic cholecystectomy, near infrared spectroscopy, positive end expiratory pressure
Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, first-in-human, multi-center, open-label, single dose cohort study to
      evaluate the safety and tolerability, pharmacokinetics (PK), exploratory pharmacodynamics
      (PD), and biomarkers of target engagement of CSL889 following single intravenous (IV) doses
      in subjects with sickle cell disease (SCD). The study involves sequential dose escalation of
      cohorts with between-group assessments of key safety and PK variables.
    


Intervention name(s): CSL889
Intervention type(s): Biological
Intervention description(s): Administered as an IV infusion
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as
      first-line treatment for metastatic pancreatic cancer in China.
    

Detailed description: 
      Although FOLFIRINOX regimen was recently presented to be effective for metastatic pancreatic
      cancer in selected patients who have good physical condition, there is still insufficient
      evidence on this regimen in treating patients with metastatic pancreatic cancer in China.
      Since for many tumors, different races may show different responses to the same regimen, we
      design this open, multicenter phase Ⅱ study to evaluate the the efficacy and safety of
      mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.
    

Intervention name(s): mFOLFIRINOX
Intervention type(s): Drug
Intervention description(s): Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
Other intervention name(s): Oxaliplatin; Irinotecan; Leucovorin; 5-Fluorouracial
Intervention MeSH terms: Leucovorin; Oxaliplatin; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Blood Flow in the Lower Limb
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional

Summary: 
      Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among
      hospitalized patients, with death occurring in approximately 6% of cases. It involves the
      formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the
      legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),
      hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to
      blood vessel wall), collectively known as Virchow's triad.

      Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have
      been shown to improve lower limb blood flow. However, few studies have directly compared the
      two methods and those that have, have used dated NMES techniques.

      The objective of this study is to compare the two methods in terms of blood flow, in both a
      young and an older population.
    

Detailed description: 
      Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among
      hospitalized patients, with death occurring in approximately 6% of cases. It involves the
      formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the
      legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood),
      hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to
      blood vessel wall), collectively known as Virchow's triad.

      Intermittent Pneumatic Compression (IPC) involves the use of an inflatable cuff placed around
      the limb. This cuff inflates and deflates intermittently in order to squeeze blood from the
      underlying veins. Neuromuscular Electrical Stimulation (NMES) leads to a contraction of
      muscles by delivering a series of controlled electrical pulses via skin surface electrodes
      placed over the motor points of the targeted muscle.
    

Intervention name(s): Neuromuscular electrical stimulator; AV Impulse System Model 6000
Intervention type(s): Device; Device
Other intervention name(s): Intermittent Pneumatic Compression Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Deep Vein Thrombosis; Neuromuscular Electrical Stimulation; Intermittent Pneumatic Compression; Doppler Ultrasound
Evaluation of the Effect of Using WeChat Applet to Intervene in the Home Functional Exercise of Patients After Anterior Cruciate Ligament Reconstruction Based on the Health Belief Model
Condition: Anterior Cruciate Ligament Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      Based on the home rehabilitation exercise of patients undergoing ACL reconstruction, the
      existing WeChat applet of sports medicine of the Third Hospital of Beijing Medical University
      is optimized to be used as a health education tool to guide patients undergoing home
      rehabilitation exercise after ACL reconstruction.
    

Detailed description: 
      With the development of national fitness and sports, the incidence of ACL injury is
      increasing year by year. ACL reconstruction is the best way to treat ACL injuries, and the
      success rate of the operation is high, but patients still need to recover after surgery,
      otherwise, it will be difficult to fully restore knee joint function. However, my country's
      rehabilitation medical resources are obviously insufficient. After discharge from the
      hospital, ACL reconstruction patients usually go home and exercise at home according to the
      rehabilitation plan formulated by the surgeon or rehabilitation physician. However,
      compliance is still poor, and rehabilitation is relatively difficult to achieve the expected
      results, which affects the lives of patients quality. The WeChat official account and its
      affiliated mini-programs have been widely used in different health fields as a means of
      health communication. The health belief model is a guiding theory commonly used in the field
      of health education to guide patients to make behavior changes. This study intends to use the
      functional advantages of the WeChat applet to explore the optimization of the existing Peking
      University Third Hospital Sports Medicine WeChat applet based on the health belief model and
      to use the postoperative rehabilitation of patients undergoing ACL injury reconstruction as a
      pilot to evaluate the optimized The WeChat Mini Program can improve the intervention effect
      of patients' home functional exercise compliance after ACL injury reconstruction, to provide
      effective health education for more extensive sports medicine-related home functional
      exercises, improve their rehabilitation effects and quality of life, and better To ensure the
      efficacy of surgery.
    

Intervention name(s): WeChat Mini Program
Intervention type(s): Behavioral
Intervention description(s): Through the WeChat applet, it provides services such as visit content configuration, self-image configuration, self-image measurement configuration, and visit reminders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU
      compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to
      anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.
    


Intervention name(s): epoetin beta; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks; Subcutaneous administration of placebo once-weekly for 12 weeks
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cancer; patients; with; chemotherapy; induced; anemia
Evaluation of Metacognitive Training for Depression in Later Life (MCT-Silver)
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The study will evaluate the efficacy of metacognitive training for depression in later life
      (MCT-Silver) vs. cognitive remediation (mybraintraining©) in reducing depressive symptoms
      among older adults.
    

Detailed description: 
      The study examines the efficacy of Metacognitive Training for depression in later life
      (MCT-Silver). The study intends to investigate the extent to which MCT-Silver leads to a
      significant reduction in depressive symptoms compared to an active control group
      (mybraintraining©) (primary outcome: change in clinician-assessed depressive symptoms from t0
      to t1 and t2). Secondary outcomes include change in self-reported depressive symptoms and
      dysfunctional (meta) cognitive beliefs, as well as quality of life, rumination, self-reported
      anxiety, attitudes toward aging and neuropsychological functioning from t0 to t1 and t2. The
      study design is a randomized-controlled trial with one intervention group and one active
      control group.
    

Intervention name(s): MCT-Silver; Cognitive Remediation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Metacognitive training for depression in later life (MCT-Silver) is a cognitive-behaviorally based group therapy, which focuses on helping participants gain (metacognitive) distance from their thought patterns that contribute to depression. Over 8 modules, MCT-Silver addresses issues specific to depression in later life, such as coping with physical changes and loss, as well as adapting to new (social) roles. The program also includes modules on identifying and re-defining values in later life and how one may move toward acceptance of situations that cannot be prevented or changed. MCT-Silver addresses cognitive and metacognitive biases that contribute to the onset and maintenance of depression through fun and engaging exercises, as well as using examples from daily life.; mybraintraining© is a computer-based cognitive remediation program, which covers a wide range of neuropsychological exercises involving memory, reasoning, selective attention and psychomotor speed. The program is administered individually on personal computers and each session lasts approximately 45-60 min. To match the MCT-Silver group, participants will complete up to eight sessions of cognitive remediation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid; Weight Loss
Study type: Interventional

Summary: 
      Morbid obesity is an increasing medical problem in the western countries. It's related to
      comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia.
      The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese
      patients. A part of these patients will have disappointing results, and have weight regain on
      the long term. Some studies show more weight reduction by increasing the biliopancreatic limb
      in patients with morbid obesity.

      The objective of this study is to investigate the effect of variations in the length of
      biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery.
      We hypothesize that longer biliopancreatic limb results in more weight reduction.

      The study design is a prospective, randomized control trial. The patients will be randomized
      in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.
    


Intervention name(s): Roux-en-Y Gastric Bypass
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bariatric surgery; Roux-en-Y Gastric Bypass
Water for Reducing Pain in Negative Pressure Wound Therapy
Condition: Treatment
Study type: Interventional
Phase: Phase 2

Summary: 
      Negative pressure wound therapy (NPWT) is a technique using vacuum dressing to promote wound
      healing in complicated wound. However for many patients, the application and removal of the
      NPWT is source of procedural pain. Some techniques had been reported to reduce these pain
      such as administering topical lidocain or normal saline solution before the dressing change.
      The authors hypothesized that administering cold water into the NPWT sponge would decrease
      pain during dressing changes.
    


Intervention name(s): NPWT with cold water; NPWT with normal saline room temp; NPWT without other intervention
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Each of dressing change would be treated with NPWT and injection of cold sterile water kept in 4°C temperature into sponge 10 minutes before dressing change; Each of dressing change would be treated with NPWT and injection of room temperature sterile water kept in room temperature into sponge 10 minutes before dressing change; Each of dressing change would be treated with NPWT without injection of any liquids into sponge before dressing change
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cold water; Negative pressure wound therapy; pain
Efficacy and Toxicity of Increasing Doses of Idarubicin, Cytarabine and G-CSF in Acute Myeloid Leukemia
Condition: Di Novo Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      While several studies have been reported with increasing doses of daunorubicin in the first
      line treatment of Acute Myeloid Leukemia (AML), there is no similar experience with
      idarubicin as initial treatment of AML.

      As idarubicin is the most common treatment used for AML, it is needed to find the optimal
      dose for the combination of idarubicin, cytarabine and G_CSF, to explore if this combination
      improves the outcomes of current treatments for AML.

      The aim of this dose-finding study is to find the optimal dose for the combination of
      idarubicin, cytarabine and G-CSF that could improve the response rate, reduce relapse and
      improve survival of patients with primary acute myeloid leukemia. This could be a significant
      advance in a field where treatment outcomes have stabilized in the last 15 years. This study
      will be the basis for further prospective, randomized, multicenter trial comparing idarubicin
      maximum tolerated dose, compared to standard treatment with idarubicin and cytarabine,
      including raising both arms in G-CSF. The dose of 12 mg/m2 will be administered as control
      arm in this future randomized study, which will investigate the benefit of enhanced dose
      identified as optimal in this phase II pilot study.
    


Intervention name(s): Idarubicin
Intervention type(s): Drug
Intervention MeSH terms: Idarubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute; myeloid; leukemia; CETLAM; Idarubicin
A Study Assessing the Mass Balance of a Single Oral Dose of [14C] DS-8500a in Healthy Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, single-center, non-randomized study to assess the mass balance
      of a single oral dose of DS-8500a in healthy male subjects, 18 years (y) to 60 y of age,
      inclusive. The radiolabeled investigational medicinal product will be administered to 12
      healthy male subjects in 2 cohorts of 6 subjects each.
    


Intervention name(s): DS-8500a
Intervention type(s): Drug
Intervention MeSH terms: Firuglipel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Mitopure (Urolithin A) on Skeletal Muscle Function, Iron Metabolism and Endurance Performance
Condition: Healthy
Study type: Interventional

Summary: 
      This is a randomized, double-blind, placebo-controlled study enrolling 36 (16 Elite and 20
      Sub-Elite trained endurance runners (18 placebo and 18 Mitopure intervention) who are 18-40
      years of age. Mitopure or Placebo supplement, will be given as a daily oral dose for 4-weeks.
    


Intervention name(s): Mitopure; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Softgel containing 250 mg of Urolithin A (Mitopure) with excipients. 4 soft-gels to be taken daily; Softgel containing only excipients. 4 soft-gels to be taken daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy of Digital Breast Tomosynthesis + Standard 2- Dimensional Mammography in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide
      additional information to evaluate the extent of disease and additional findings that would
      aid in staging a new breast cancer patient. This would impact surgical planning and improve
      patient outcomes.
    

Detailed description: 
      Primary Objective:

      The primary objective of the study is to measure the frequency with which DBT alters the
      surgical plan to mastectomy versus lumpectomy. Only positive findings, like an additional
      site of cancer or DCIS, will be taken into account when estimating the frequency of changes
      to surgical management.

      Secondary objectives:

        1. To measure the frequency and nature of additional findings like atypical pathology
           (Atypical ductal/ lobular hyperplasia, papilloma, Lobular carcinoma in situ (LCIS) ,
           requiring surgical intervention).

        2. To identify variables on 2D (e.g. dense breasts, architectural distortions, non
           calcified masses) that might predict which patients would benefit from DBT.

        3. To measure the proportion of patients undergoing additional work-up following the DBT,
           and the subset of these patients with benign findings (i.e. False Positives).
    

Intervention name(s): 2-dimensional mammogram; digital breast tomosynthesis (DBT)
Intervention type(s): Device; Device
Intervention description(s): This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.; The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.
Other intervention name(s): 3-dimensional mammogram
Intervention model: Single Group Assignment
Intervention model description: The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: mastectomy; lumpectomy; 3-Dimensional Mammogram; digital breast tomosynthesis