bioihbjkbjnl/mcl2 huggingface dataset:
A Study of N-Acetyl Cysteine in Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC)
      in children with Autism. NAC is a compound that increases the levels of Glutathione, the
      body's main antioxidant. Glutathione is a compound in the blood that is part of a natural
      defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by
      internal toxins called "free radicals." It is possible that children with Autism tend to have
      lower levels of glutathione, an important compound in our bodies that helps combat the
      effects of toxic free radicals.

      We hope that by studying the antioxidant system in more detail, we will increase our
      understanding of the reasons why people develop Autism so that we can design better ways to
      treat individuals with this condition. This study is meant to test the safety tolerability of
      NAC and its effectiveness in the treatment of behavioral difficulties in children with
      autism. It will also examine the possible benefit of this agent in improving the core
      deficits in autism such as social deficits.
    


Intervention name(s): N-Acetyl Cysteine; Placebo - sugar pill
Intervention type(s): Drug; Other
Intervention description(s): Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous).; Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous).
Other intervention name(s): NAC; Placebo
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Influence of Cognitive Rest on Minor Traumatic Brain Injury
Condition: Minor Head Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Wounds and Injuries
Study type: Interventional

Summary: 
      Background: Head injury is a common presentation to family medicine clinics and emergency
      departments (EDs), and the majority will not result in intracranial injury requiring
      neurosurgical consultation, but will have symptoms of mild traumatic brain injury (MTBI). It
      is estimated between 15-50% of patients with MTBI develop post-concussive syndrome (PCS).
      Research in the management of MTBI and prevention of PCS has been scarce to date. Although
      expert consensus recommends cognitive rest and graduated return to usual activities, these
      and other interventions are not based on prospective clinical evidence.

      Objective: The purpose of this study is to determine if providing graduated return to usual
      activities discharge instructions to MTBI patients in the ED decreases MTBI symptoms
      post-injury as compared to providing usual ED MTBI discharge instructions.

      Study Design: This will be a pragmatic, single-centered, 2-arm parallel-group, superiority
      randomized trial.

      Patient Population: Male and female patients presenting to the ED ages greater than 17 and
      less than 65 with the Canadian Emergency Department Information System (CEDIS) presenting
      complaint of "head injury".

      Outcomes: The primary outcome of this study is to determine if patients whom receive
      graduated return to usual activity discharge instructions have more clinically significant
      decreases in their Post-Concussion Symptom Score (PCSS) 2 weeks after MTBI versus patients
      who received usual care MTBI discharge instructions. Secondary outcomes include the
      intervention group's compliance with the intervention, comparison of PCSS between groups 4
      weeks after initial ED visit, comparison of groups' number of return visit(s) to either an ED
      or physician's office, and the mean number of days of school or work missed for each group.

      Hypothesis: Given cognitive rest and graduated return to usual activities are concepts
      recommended by expert consensus, it is expected patients who follow the graduated return to
      usual activities and cognitive rest guidelines will have less MTBI symptoms at two weeks
      after ED discharge.
    


Intervention name(s): Cognitive rest; Usual care
Intervention type(s): Other; Other
Intervention description(s): The intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.; These are usual care emergency department discharge instructions provided at emergency department discharge for minor traumatic brain injury.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Head injury; Concussion; Cognitive rest; Emergency department
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This two-arm study will assess the efficacy and safety of a long-term calcineurin
      inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an
      orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g
      twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The
      anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500
      individuals.
    


Intervention name(s): mycophenolate mofetil [CellCept]; Tacrolimus; Cyclosporine; Sirolimus
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1-1.5 g orally or intravenously twice daily; As prescribed, for 12 months; As prescribed, for 12 months; 2-4 mg orally once daily for 9-11 months
Intervention MeSH terms: Cyclosporine; Sirolimus; Mycophenolic Acid; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to investigate the safety and efficacy of SB-742457 when added to
      stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.
    


Intervention name(s): SB-742457 15mg; SB-742457 35mg; Placebo; donepezil 5-10mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): SB-742457 - 15mg added to existing donepezil treatment; SB-742457 - 35mg added to existing donepezil; Placebo added to existing donepezil; existing donepezil treatment
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's disease cognition SB-742457
Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to determine whether interferon-beta impairs the ability of
      plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple
      sclerosis.
    


Intervention name(s): Interferon-beta 1b (Betaseron)
Intervention type(s): Drug
Intervention description(s): Treatment of patients with FDA-approved Rx
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple Sclerosis Clinic patient
      
Keywords: Multiple sclerosis; Interferon beta; plasmacytoid dendritic cells
Temozolomide Plus PEG-Interferon Alfa-2B in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. PEG-interferon alfa-2B may interfere with the growth of cancer
      cells. Combining temozolomide with PEG-interferon alfa-2B may be an effective treatment for
      advanced solid tumors.

      PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and
      PEG-interferon alfa-2B in treating patients who have advanced solid tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the safety and tolerability of temozolomide and PEG-interferon alfa-2b in
           patients with advanced refractory solid tumors or chemotherapy-naive advanced cancer.

        -  Determine the maximum tolerated dose (MTD) and dose-limiting toxicity of this regimen in
           this patient population.

        -  Determine the pharmacokinetics of PEG-interferon alfa-2b at the MTD when administered
           with temozolomide in this patient population.

        -  Determine the anti-tumor activity of this regimen in these patients.

      OUTLINE: This is a dose-escalation study.

      Patients receive oral temozolomide on days 1-7 and 15-21 and PEG-interferon alfa-2b
      subcutaneously on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of
      disease progression or unacceptable toxicity.

      Cohorts of 1-9 patients receive escalating doses of temozolomide and PEG-interferon alfa-2b
      until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
      preceding that at which at least 2 of 3 or 6 patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.
    

Intervention name(s): PEG-interferon alfa-2b; temozolomide
Intervention type(s): Biological; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Temozolomide
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients
Condition: Chemotherapy-induced Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of the efficacy and safety of recombinant human serum albumin /
      granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced
      neutropenia
    

Detailed description: 
      -  Brief Protocol: Treat the patients taking Taxotere+Epirubicin +Cyclophosphamide (TEC)
           treatment or Taxotere+Epirubicin (TE)treatment chemotherapy with the study medicine or
           positive control during the period between two chemotherapy treatments.

        -  Targeted patients: breast cancer

        -  Subjects were randomly divided into two groups. The test group received recombinant
           human serum albumin / granulocyte thorns for injection Stimulant fusion protein 2.4mg
           treatment. Positive control group received recombinant human granulocyte colony stimuli
           Factor injection therapy

        -  Number of patients: 80
    

Intervention name(s): rHSA-GCSF 2.4mg; GCSF
Intervention type(s): Drug; Drug
Intervention description(s): Human Serum Albumin GCSF 2.4mg at day 3 and day 7; GCSF 5 mcg/kg/day
Other intervention name(s): Human Serum Albumin GCSF; jisaixin
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chemotherapy; Neutropenia; breast cancer
Protocol To Evaluate Patient Measurements After Ultrasonic Treatment
Condition: Patients Treated With VaserShape MC1
Study type: Observational

Summary: 
      Patients enrolled in this study will come from the Investigator's patient population and be
      ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no
      different if they participate than if they do not. The study is only to observe the patients
      before, during and after their usual treatment.
    


Intervention name(s): VASERShape MC1
Intervention type(s): Device
Intervention description(s): Use of the VASERShape MC1 device as part of routine practice
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All subjects presenting to the investigator for treatment using the MC1 are potential study
        candidates and will be screened for eligibility. Every effort will be made to establish
        eligibility of the participants before enrollment. Subjects who do not meet all
        inclusion/exclusion criteria will not be enrolled. Enrollment in the study occurs at the
        time the patient is randomized to the assigned treatment.
      
Keywords: VASER; VASERShape; MC1; ultrasound
Effect of Liver MSCs in Blood of Patients With Liver Disease.
Condition: Decompensated Cirrhosis
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Liver MSCs or Adult Derived Human Liver Stem/progenitor Cells (ADHLSCs) infusions are
      currently being developed as a therapeutic medicinal product for the treatment of different
      liver defects. Nevertheless, a main concern for clinicians and health authorities is the risk
      of therapy-induced thrombosis, which has been reported in several patients after intravenous
      infusion. Previous studies showed in fact that most MSCs express a procoagulant activity.
      ADHLSCs could be used to treat acute de-compensated cirrhotic patients due to their
      immunomodulatory and anti-fibrotic effects. However in these patients, disturbances of
      coagulation and haemostasis are common and result in profound haemostatic alterations that
      can lead to thrombosis as well as to bleeding complications. The aim of this study is to
      evaluate the effect of ADHLSCs in cirrhotic blood compared to control blood.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        hospitalised cirrhotic patients in hepatology or intensive care unit
      
Biospecimen description: 
      blood plasma
A Pilot Study of SPG Block for PTSD
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Some patients with Post Traumatic Stress Disorder (PTSD) respond only partially to
      medication. This study is a pilot study investigating whether blocking the SPG helps reduce
      the symptoms of PTSD. This study does not involve treatment with medications. It is a proof
      of principal study.
    

Detailed description: 
      The sphenopalatine ganglion (SPG) is a collection of neurons involved in autonomic regulation
      (which refers to bodily processes that are automatic like heart rate and blood pressure).
      Blocking the SPG is used to treat disorders, such as migraines or cluster headaches (short,
      severe headaches that occur together). The procedure will be performed by a doctor who
      specializes in ear, nose throat surgery. The block consists of the injection of a numbing
      agent (similar to the type used by dentists) to the SPG. After the SPG block, we will follow
      patients for 8 weeks to see how they feel.
    

Intervention name(s): Sphenopalatine ganglion block
Intervention type(s): Other
Intervention description(s): The block is performed with a nasoscope and the administration of a local anesthetic.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese Subjects
Condition: Healthy Subjects; Plasma Concentration of Mirabegron
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and absorption, distribution and elimination
      of mirabegron after oral administration to Chinese subjects.
    

Detailed description: 
      This study is an open-label study. The subjects will receive single administration of
      mirabegron in a fasted condition. After the non-dosing period, subjects will receive
      mirabegron for 8 days.
    

Intervention name(s): YM178 (mirabegron)
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): mirabegron
Intervention MeSH terms: Mirabegron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Mirabegron; Phase 1; YM178
Effect of Focused Ultrasound on Abdominal and Intrahepatic Fat in Patients With Non-alcoholic Fatty Liver Disease
Condition: Fatty Liver
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      In recent years, a number of modalities have become available for the noninvasive reduction
      of adipose tissue. One of those is high intensity focused ultra sound (HIFU). The study aimed
      to discover the effect of Focused Ultrasound on localized abdominal fat size in fatty liver
      patients.

      Methods: In total, 40 participants with a body mass index (BMI) 30-40 kg/m2, whose age ranged
      between 30 and 45 years, mild to moderate fatty liver (Liver to Spleen ratio < 1), and with
      waist-hip ratio (WHR) greater than 0.8 for females and greater than 0.95 for males were
      included. The participants were randomly assigned to two groups, one group received focused
      ultrasound, diet, and exercises (the study group) and the other group received exercises, and
      diet only (the control group), respectively. Measures were abdominal subcutaneous fat volume,
      abdominal visceral fat volume, and liver to spleen ratio (L/S ratio) were measured at the
      beginning of the study and 3 months later.
    


Intervention name(s): focused ultrasound, diet and exercise; diet and exercise
Intervention type(s): Procedure; Procedure
Intervention description(s): Focused Ultra Sound using a device of Mabel6 DUO Ultra Cavitation Technology produced by DAEYANG MEDICAL CO., KOREA applied on the abdominal region which extending bilaterally from the line extending from mid-axilla to iliac crest, and above from center of diaphragm to the line extending between two iliac crests below.
an aerobic exercise 3 to5 times/week for 12 weeks in the form of walking on treadmill for 30 minutes with moderate intensity a weight maintenance diet, which ranged from 1700 kcal to 2200 kcal/day, which was calculated in an individual basis for each subject according to his BMR, throughout the study period (12 weeks) to ensure that the reduction in the circumference was due to the treatment intervention rather than due to their weight reduction; weight maintenance diet, which ranged from 1700 kcal to 2200 kcal/day, which was calculated in an individual basis for each subject according to his BMR, throughout the study period (12 weeks) to ensure that the reduction in the circumference was due to the treatment intervention rather than due to their weight reduction. All subjects in both groups (A & B) followed an aerobic exercise 3 to5 times/week for 12 weeks in the form of walking on treadmill for 30 minutes with moderate intensity (moderate intensity = 12-14 according to Borg Scale). The beginning period will be 15 mints and increased gradually until reaching 30 mints per time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
Condition: Respiratory Tract Infections; Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      In the proposed study, the investigators plan to evaluate the efficacy and safety of
      Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory
      and urinary tract acute bacterial infection.
    

Detailed description: 
      Piperacillin sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the
      former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive
      inhibition of β-lactamase.The antimicrobial effect of Piperacillin can be enhanced by the two
      combined. The compound specifically aims to the mechanism of bacterial resistance, extending
      the life of Piperacillin in the treatment-resistant pathogen infections.
    

Intervention name(s): Piperacillin Sodium and Sulbactam Sodium
Intervention type(s): Drug
Intervention description(s): 1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days
Other intervention name(s): xin te mie; te mie jun; xin ke jun
Intervention MeSH terms: Piperacillin; Sulbactam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Respiratory and urinary tract infections; Piperacillin Sodium and Sulbactam Sodium for Injection (2:1); Phase IV
Deep Learning for Classification of Scheimpflug Corneal Tomography Images
Condition: Eye Diseases
MeSH terms: Eye Diseases
Study type: Observational

Summary: 
      Keratoconus is a common disorder. An early diagnosis influences the disease prognosis in the
      affected patients and prevents postoperative complications in patients with keratoconus
      considering refractive surgery. Machine learning approaches have been widely used for image
      classification. Here, we will assess the ability of deep learning to enable high-performance
      image classification of the color-coded corneal maps obtained by Scheimpflug camera in
      patients with keratoconus, subclinical keratoconus, and normal individuals.
    


Intervention name(s): Scheimpflug Camera Corneal Tomography
Intervention type(s): Other
Intervention description(s): Pentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterir and posterior surfaces of the cornea to obtain corneal tomographic maps.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with keratoconus, subclinical keratoconus & normal individuals from refractive
        surgery candidates.
      
Keywords: Keratoconus; Deep learning; Scheimpflug camera; Corneal tomography