bioihbjkbjnl/mcl2 huggingface dataset:
Maestro LIFT-OFF: Surgical Assistance Device in Abdominal Laparoscopic Surgery
Condition: Surgery
Study type: Interventional

Summary: 
      The objective of the study is to provide evidence for the safety and effectiveness of the
      Maestro Platform for surgical assistance in abdominal laparoscopic surgery.
    


Intervention name(s): Laparoscopic surgery using the Maestro Platform
Intervention type(s): Device
Intervention description(s): Laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic bariatric surgery (gastric sleeve or gastric bypass), or laparoscopic colectomy performed using the Maestro Platform.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: abdominal laparoscopic surgery; laparoscopic cholecystectomy; laparoscopic hernia repair; laparoscopic appendectomy; laparoscopic bariatric surgery; laparoscopic colectomy
Use of Virtual Reality Games for the Treatment of Balance and Reducing the Occurrence of Falls in Patients After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The aim of this study was to investigate the therapeutic effect of virtual reality associated
      with conventional physiotherapy on balance during gait and the occurrence of falls in
      patients after stroke.
    

Detailed description: 
      Randomized clinical trial conducted with patients of both sexes with hemiparesis after stroke
      of 18 to 65 years. They excluded those who had less than six months of injury, with sensory
      or perceptual deficit. Patients included were randomized into two groups, a treatment group,
      which conducted rehabilitation with virtual reality associated with conventional physical
      therapy and the control group that performed only conventional physiotherapy. Randomization
      was done by a computer program in blocks, by a third person, respecting the allocation
      concealment. After selection and randomization, patients were evaluated at baseline, when
      they were collected demographic and clinical data, investigated the occurrence of falls in
      the three months prior to evaluation and rated the balance in motion using the Dynamic Gait
      Index (DGI). Patients were followed for 20 physiotherapy sessions, visits twice a week for an
      hour each. The assessment of the balance and the investigation of the occurrence of falls
      were repeated at the end of treatment, which occurred on average three months after the start
      of the intervention, by the same examiner, who remained blind to the group that the patient
      belonged.
    

Intervention name(s): Virtual Reality; Conventional
Intervention type(s): Other; Other
Intervention description(s): Rehabilitation with virtual reality, using Football games, Boxe, Bambolê and Tennis.; Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Stroke; Virtual reality; Balance; Falls
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
Condition: Partial Epilepsy
MeSH terms: Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with
      an 8-week prospective baseline and an 18 week double-blind treatment period (including a
      6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study
      drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for
      subjects who will participate in the open-label extension).

      The primary objective of this study is to determine the effective dose range of YKP3089 as
      adjunctive therapy for the treatment of partial seizures.

      The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy
      population.
    


Intervention name(s): YKP3089; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cenobamate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Predictive Value of DNA Mismatch Repair System in Colorectal Cancers
Condition: MSI-H Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      -  Microsatellite instable (MSI) tumors represent almost the 15% of all sporadic colorectal
           cancers (CRCs).

        -  Literature data show that this unique tumor population appears to be poorly responsive
           to conventional chemotherapy and conversely reveals excellent results to immunotherapy.

        -  Our data, as demonstrated by propensity score-matched and win ratio analysis, show that
           there are no substantial differences between MSI and MSS tumors in early CRC stages
           treated with surgery alone.

        -  On the contrary, stable tumors (MSS) did much better than MSI tumors in advanced CRC
           stages undergoing conventional adjuvant treatment.

        -  Determination of status of DNA mismatch repair system is crucial in high-risk CRCs to
           optimize treatment.
    

Detailed description: 
      Colorectal cancers (CRCs) with deficient DNA mismatch repair (MMR) system (so called dMMR or
      MSI tumors) represent a no-negligible part of sporadic CRCs. Prognostic value of this unique
      cell population remains controversial, but undoubtedly these tumors are characterized by poor
      response to conventional chemotherapy, an high tumor mutational burden resulting in a brisk
      immuno response, and, as recently observed, excellent results to the immunotherapy. The aim
      of this study was to evaluate, by using sophisticated statistical analyses, the predictive
      value of MSI status and its optimal treatment.

      A series of 403 consecutive CRC patients treated by the same oncological team from 2014 to
      2021 entered the study. No patients underwent immunotherapy. Immunohistochemistry, integrated
      by polymerase chain reaction if appropriate, was used to categorize specimens in
      microsatellite stable (MSS) and instable (MSI) tumors. The win ratio (WR) approach was
      utilized to compare composite outcomes of MSS and MSI tumors while controlling for radical
      versus no radical resection, propensity score-matched analysis, and reversing primary
      endpoint.
    

Intervention name(s): colorectal resection
Intervention type(s): Procedure
Intervention description(s): potential resective surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        CRC patients undergoing surgery
      
Biospecimen description: 
      specimens from surgical resection
    
Keywords: Colorectal cancers;; DNA mismatch repair;; Win ratio
PACE CALL: Weight Loss Study for Childhood Leukemia Survivors
Condition: Acute Lymphoblastic Leukemia; Cancer; Obesity
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      UC San Diego researchers conducted a study to develop and evaluate an internet and text
      message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors.
      We hypothesized that those study participants randomized to the intervention will demonstrate
      greater reduction in BMI-z score as compared to the control group.
    

Detailed description: 
      The PACE CALL or Fit4Life study, sponsored by the American Cancer Society , was a 4-year
      research project aimed at developing and testing the efficacy of a web & cell phone based
      weight loss program. The purpose of the intervention was to promote weight loss and
      management and improve physical activity, diet and sedentary behaviors among preadolescent
      and adolescent youth (7-18) who are survivors of childhood ALL (defined as being off therapy
      for at least 2 years without disease relapse). Fit4Life was based on and adapted from notable
      prior successful adolescent weight control interventions, and physical activity and diet
      behavioral promotion interventions in the preadolescent and adolescent age group. Particular
      sensitivity to issues experienced by cancer survivors and their families were incorporated
      into this newly developed intervention based on systematic cancer survivor input and feedback
      as well as mentor/collaborator input regarding cancer survivor research.
    

Intervention name(s): PACE CALL/Fit4Life
Intervention type(s): Behavioral
Intervention description(s): The Fit4Life E intervention will be designed to promote weight loss and subsequent weight loss maintenance through the adoption and maintenance of improved eating, physical activity and sedentary behaviors in at risk for overweight and overweight adolescent survivors of ALL and their parent/guardian. the Fit4Life intervention will incorporate elements of the Chronic Care Model, including frequent phone and mail interactions, an initial in-person encounter to provide encouragement and initial patient-tailored counseling for obesity management, family-centered skill development to achieve healthy behavioral modification via goal setting, self-monitoring, and problem solving.
The Fit4Life intervention includes:
Web-based weight loss program Text and Picture messages Counseling Calls Health Coach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: obesity; text messages; internet; cancer; overweight
EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)
Condition: Lipid Disorder
MeSH terms: Lipid Metabolism Disorders; Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      The EMERALD intervention involves 1) ordering an Emergency Department (ED) lipid panel, 2)
      calculating 10-year Atherosclerotic cardiovascular disease (ASCVD) risk using the Pooled
      Cohort Equations, 3) prescribing a moderate- or high-intensity statin if applicable, and 4)
      referring patients to outpatient care (primary care, preventive cardiology, or general
      cardiology, depending on risk level).
    

Detailed description: 
      EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) is a pilot
      study seeking to determine the feasibility of initiating medical therapy for hyperlipidemia
      (HLD) in the Emergency Department (ED) and will collect data essential to inform a future
      randomized controlled trial comparing ED HLD treatment to usual care. HLD is a key
      cardiovascular disease (CVD) risk factor that is causally associated with atherosclerotic
      cardiovascular disease (ASCVD), the leading cause of US mortality and morbidity.
    

Intervention name(s): moderate- or high-intensity statin/ rosuvastatin
Intervention type(s): Drug
Intervention description(s): moderate- or high-intensity statin (either rosuvastatin 10mg daily or rosuvastatin 40 mg daily)
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Intervention model description: 20 patients designed to assess the feasibility of Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) and to explore changes in low-density lipoprotein-cholesterol (LDL-C) by initiating medical therapy in the ED
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hyperlipidemia; cardiovascular disease; atherosclerotic cardiovascular disease
Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
Condition: Laboring Women Requesting Neuraxial Labor Analgesia
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to compare the onset and duration of the initial dose
      of medications given through three different epidural (conventional epidural, combined spinal
      epidural and dural puncture epidural) techniques for labor pain relief.

      The secondary objective of this study is to compare the fetal effects of these three epidural
      labor analgesia techniques.
    


Intervention name(s): Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique
Intervention type(s): Procedure
Intervention description(s): Three different techniques, using the same medications (bupivacaine and fentanyl)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuraxial Technique; Epidural Technique; Dural Puncture Epidural Technique; Combined Spinal Epidural Technique; Labor Analgesia; Obstetric
OxIGen: Oxford Imagery Generation: Investigating the Effects of an Internet Based Computer Program in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is designed to investigate the effects of an online computer program,
      called OxIGen (Oxford Imagery Generation), on thinking style and mood in depression. The
      OxIGen program will be delivered online over four weeks and with follow-up at one, three and
      six months. This will inform potential future development of this computerized task into an
      online intervention to modify negative thinking styles in depression.
    


Intervention name(s): OxIGen; OxIGen: control version
Intervention type(s): Other; Other
Intervention description(s): Internet-based intervention with 12 sessions over 4 weeks; A control version of the OxIGen internet-based intervention (i.e. identical but with putative active components removed)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Depression; Cognitive Bias; Internet
Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis
Condition: Spontaneous Bacterial Peritonitis
MeSH terms: Peritonitis
Study type: Observational

Summary: 
      Current reports have demonstrated that copeptin predicts disease progression and prognosis in
      cirrhotic patients, independent of liver-specific scoring systems. To the best of our
      knowledge, few studies have addressed the association between copeptin and sepsis in
      cirrhotic patients, however, they were performed on different types of infections. Therefore,
      we will conduct this study with a focus on it is possible role in patients with SBP.
    


Intervention name(s): Serum copeptin
Intervention type(s): Diagnostic Test
Intervention description(s): Blood test
Intervention MeSH terms: Arginine Vasopressin
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with liver cirrhosis and ascites
Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients
Condition: Stroke; Spasticity
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke
      patients. They cause disabled condition of patients in activities of daily life and
      functional performance, and also accidental falls and subsequent fractures.

      This study is to evaluate and compare the effects of different phase injection of Botulinum
      Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone,
      functional performance, gait pattern and energy consumption in stroke patients.
    


Intervention name(s): Botox_A; Botox_B
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prolonged Exposure Versus Treatment as Usual in Chronic Posttraumatic Stress Disorder Combat and Terror Related Patients
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Assessing the efficacy of Posttraumatic Stress Disorder (PE) treatment for chronic
      Posttraumatic Stress Disorder (PTSD)
    


Intervention name(s): Prolonged Exposure (PE) therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Auditory Brainstem Implantation in Young Children
Condition: Developmental Cochlear Nerve Deficiency; Acquired Cochlear Nerve Deficiency; Cochlear Aplasia; Post-meningitis Cochlear Ossification; Cochlear Malformation
MeSH terms: Meningitis; Congenital Abnormalities
Study type: Interventional

Summary: 
      To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus
      24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children
      without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed
      cochlear implantation (CI) or have been unable to receive a CI secondary to cochlear or
      cochlear nerve disorders. These conditions can include: developmental or acquired cochlear
      nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic cochlear ossification or
      cochlear malformation.

      This study proposes to implant up to 10 young children (<5 yrs. of age) with the Nucleus 24
      Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical procedure,
      tolerance of device stimulation, and the potential for auditory benefit beyond that
      experienced with their CI. This study will provide the preliminary experience for a larger
      scale clinical trial.

      Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development
      of sound awareness and improved speech understanding among children implanted with the ABI
      when compared to their baseline skills. Aim 3: Demonstrate the development of oral language
      skills following the use of the ABI that were not evident prior to its use.
    


Intervention name(s): Auditory Brainstem Implantation in Children
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; profound hearing loss; auditory brainstem implant; cochlear implant; developmental or acquired cochlear nerve deficiency (CND); cochlear aplasia (Michel); post-meningitis cochlear ossification; cochlear malformation; CND
PET Scan as a Screening Tool for Liver Transplant in Patients With Hepatocellular Carcinoma (HCC)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      This study aims at testing the utility of PET Scan as a screening tool for liver
      transplantation in patients with Hepatocellular Carcinoma. Patients being worked up for liver
      transplant for hepatocellular carcinoma will undergo a PET Scan and will be followed until 2
      years after transplantation. At that time survival data will be analysed according to PET
      Scan results to determine if it can be used to predict outcome.
    


Intervention name(s): PET Scan
Intervention type(s): Other
Intervention description(s): All patients will have a PET scan as part of their pre-transplant assessment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Transplant
Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit
Condition: ARDS
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the role of lung sonography during different PEEP
      settings in ICU patients with ARDS.
    

Detailed description: 
      Acute respiratory distress syndrome (ARDS) is a clinical syndrome that often occurs in
      critically ill patients.

      Patients with ARDS invariably require mechanical ventilation to improve oxygen transport. An
      improvement in oxygenation can be obtained by an increase in positive end-expiratory pressure
      (PEEP).

      In critically ill patients with ARDS, lung imaging is been held by the use of chest
      radiography and the "gold standard" technique, Computed Tomography (CT).

      We designed an observational study in which we included patients under mechanical ventilation
      admitted in our ICU. In all patients PEEP changes were applied and lung sonography was
      performed.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ICU population
      
Keywords: Sonography; ICU; PEEP
Metabolic and QOL Effects of GH Treatment in Patients With TBI and AGHD
Condition: Adult-Onset Growth Hormone Deficiency
Study type: Observational

Summary: 
      This PILOT, NON-INTERVENTIONAL STUDY will follow patients about to start rhGH for a period of
      six months and collect valuable pilot data to evaluate feasibility of a larger study and
      treatment tolerability and compliance. The effect of rhGH on cognitive function, depression,
      fatigue, sleep quality, and QOL will also be collected. This exploratory study will also
      provide important information about recruitment and AGHD screening procedures in military
      settings.
    

Detailed description: 
      Growth hormone replacement has consistently shown improvements in body composition, exercise
      capacity, endothelial function, inflammatory biomarkers, bone mineral density, lipoprotein
      metabolism, and self-reported quality of Life (QOL) in patients suffering from adult growth
      hormone deficiency (AGHD). One of the causes for AGHD is traumatic brain injury (TBI), a
      condition that affects approximately 20% of Veterans from Operation Enduring Freedom (OEF),
      Operation Iraqi Freedom (OIF), and Operation New Dawn (OND). Because OIF/OEF/OND Veterans are
      a new population, there is a paucity of data regarding the effects of rhGH in these patients.
      The investigators propose to perform a pilot observational study of Veterans with confirmed
      adult growth hormone deficiency (AGHD) due to TBI who have been prescribed recombinant human
      growth hormone (rhGH) replacement in order to determine changes in metabolic parameters and
      QOL induced by rhGH.

      Our hypothesis is that GH replacement will improve QOL and metabolic parameters (glucose,
      insulin resistance, lipids, inflammatory markers, and body composition) in patients with
      confirmed AGHD due to TBI.The primary aim for this proposal is to determine the effects of
      rhGH treatment given daily for 6 months to Veterans with TBI and AGHD on QoL measured by the
      Quality of Life Assessment for GHD in Adults questionnaire (QoL-AGHDA, primary outcome).
      Secondary specific aims for this proposal are to gather high quality pilot data of the
      effects of 6 months of rhGH replacement in Veterans with TBI and AGHD.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Veterans being prescribed rhGH replacement for Adult Onset Growth Hormone Deficiency due to
        Traumatic Brain Injury
      
Keywords: fatigue; quality of life; depression; cognitive function; growth hormone; traumatic brain injury