bioihbjkbjnl/mcl2 huggingface dataset:
PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
Condition: Patients Undergoing High Risk PCI.
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this feasibility study is to demonstrate that the device is safe and
      potentially efficacious for use in patients undergoing high risk Percutaneous Coronary
      Interventions(PCI).Patients will be enrolled if they meet inclusion & exclusion criteria.
    


Intervention name(s): High Risk PCI
Intervention type(s): Device
Intervention description(s): High Risk Percutaneous Coronary Intervention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of Transcriptional Regulators of Ghrelin Hormone Which Causes Genetic Obesity
Condition: Prader Willi Syndrome; Obesity
MeSH terms: Prader-Willi Syndrome; Obesity; Syndrome
Study type: Observational

Summary: 
      The problem point of the Prader-Willi Syndrome (PWS) patient is the obesity which is intense
      and the plasma ghrelin level which increases unusual from the recently PWS patients was
      discovered. The Ghrelin is endogeneous ligand of growth hormone secretagogue receptor with
      peptide hormone and the location is 3p26-p25. Becomes the secretion even from nervous system
      but from dignity X/A cell it is secreted mainly and growth is important even in the vagal
      control against food and intake and a dignity function even on the action outside which
      promotes the secretion which drives it operates. It increases food intake specially and in
      order to accomplish the action which diminishes fat utilization the obesity with the week
      cause which it does the mortar it is thought. Active the ghrelin of the form is essential in
      hormonal activity of the ghrelin and appetite and growth hormone it participates to the
      secretion promotion which drives. Action of the Ghrelin measuring the quantitative change in
      middle acylated of the PWS patient ghrelin in order to happen after the acylation initially
      by one interest ghrelin which is attempted the appetite of the PWS patient is is controlled
      the method it will be able to prove the thing directly, it used the RIA kit and the ELISA it
      will be able to measure kit it will be able to measure the whole ghrelin to pick the PWS
      patient and the blood of the normal army and active ghrelin it measured a change.
    

Detailed description: 
      It will reach to respect, in 5 ' -flanking region of the ghrelin 2000 bp focus it let and it
      got luciferase assay it led and and it searched for the binding it sorted it put out and and
      to sleep the transcription factor which and and is the possibility of doing the essential
      region in the transcription and and it did an order deletion clone and and. is important in
      result and ghrelin activity the region role, -300~-200 region Basic helix-loop-helix (bHLH)
      are containing -USF (-236 to -231) binding site specially to be compressed in -500~-400 and
      -300~-200 two portions.
    

Observational model: Case-Control
Sampling method: Probability Sample
Study population: 
        Sixteen PWS patients [age, 8.1 +- 2.6 yr; 12 males, 4 females; body mass index (BMI),
        25+-1.5 kg/m2], 19 healthy normal lean subjects (age, 8.9 +- 1.4 yr; 14 males, 5 females;
        BMI, 16.5 +- 0.42 kg/m2), 13 GHD patients (age, 9.1 +- 1.8 yr; 9 males, 4 females; BMI, 27
        +- 1.8 kg/m2), and 10 healthy normal obese subjects (age, 8.7 +- 2.3 yr; 7 males, 3
        females; BMI, 26 +- 1.7 kg/m2) were enrolled in the study. The subjects had no history of
        GH treatment and were not being treated with GH at study commencement.
Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa
Condition: Eating Disorders
MeSH terms: Bulimia; Feeding and Eating Disorders; Bulimia Nervosa
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the effectiveness of two types of cognitive behavioral therapy in
      treating adult women with the dysregulated subtype of bulimia nervosa.
    

Detailed description: 
      Bulimia nervosa (BN) is a common eating disorder that is characterized by periods of bingeing
      and purging. People with the dysregulated subtype of BN experience behavioral impulsivity;
      disruption of cognitive, affective, behavioral, and neurophysiological processes
      (dysregulation); interpersonal dysfunction; and poor treatment response. To date, no
      therapies have been tested for this specific population, and it is unknown whether therapy
      that directly focuses on treating BN symptoms or one that addresses both eating and
      personality disorder symptoms is more effective. Cognitive behavioral therapy (CBT), which
      concentrates on modifying patients' behaviors and ways of thinking, has been effective in
      treating BN. This study will compare the effectiveness of two types of CBT, focused and
      broad, in treating adult women with the dysregulated subtype of BN.

      Participants in this single-blind study will be randomly assigned to receive 20 sessions of
      either broad (enhanced) or focused CBT. Participants will meet with a therapist once or twice
      weekly until 20 sessions have occurred. Broad CBT will address symptoms of BN, as well as
      those of the personality disorder. Focused CBT will concentrate only on BN symptoms. Before
      treatment begins, participants will complete a set of questionnaires pertaining to their
      experiences with BN, depression, anxiety, and interpersonal relationships. The questionnaires
      will be used throughout the study to assess participants' progress. Participants will also
      attend a clinical interview lasting approximately 3.5 hours. Questions will concern BN, other
      eating disorder symptoms, depression, anxiety, and interpersonal relationships. Blood samples
      and vital signs will also be taken at the time of the clinical interview and as needed later
      in the treatment process.
    

Intervention name(s): Cognitive behavioral therapy - focused (CBT-EF); Cognitive behavioral therapy - broad (EB)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.; Broad CBT addresses symptoms of BN, as well as those of the personality disorder. CBT-EB incorporates ED interventions from CBT-EF but also has modules focused on addressing mood intolerance and interpersonal difficulties. There will be 20 sessions over 5 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bulimia nervosa; Cognitive Behavioral Therapy; Personality Disorders
Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
Condition: Distal Radius Fracture; Osteoarthritis
MeSH terms: Osteoarthritis; Radius Fractures; Wrist Fractures
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary aim of the study is to see if a single wrist injection (intra-articular) of
      dexamethasone at the time of treatment will reduce the incidence of early-onset of post
      traumatic osteoarthritis.
    

Detailed description: 
      Our hypothesis is that the intra-articular administration of dexamethasone soon after joint
      injury will prevent the subsequent development of PTOA, and restore normal joint homeostasis.
      We plan to generate the data needed to test this hypothesis in a Phase 0 (pilot) clinical
      trial using patients who have suffered distal radius fractures.
    

Intervention name(s): Dexamethasone; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Data demonstrates that low doses of dexamethasone preserves chondrocyte viability, protects collagen, and maintains proteoglycan synthesis in cartilage subjected to injurious compression.
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: DRF; PTOA; dexamethasone
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Condition: Chronic Hepatitis C; Hepatitis C Virus (HCV) Infection
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid
      virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in
      combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone
      (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected
      participants.
    

Detailed description: 
      The study was a randomized, double blind, placebo controlled study consisting of 2
      substudies. In substudy 1, participants received 1 of 3 doses of ABT-267 or placebo +
      pegIFN/RBV for 12 weeks. In substudy 2, participants received pegIFN/RBV for 36 weeks.
      Participants were followed for 48 weeks post ABT-267 treatment for evaluation of efficacy and
      safety.
    

Intervention name(s): ABT-267; Pegylated interferon (pegIFN); Ribavirin (RBV); Placebo for ABT-267
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 5 mg or 25 mg tablets; Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly; 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day; Participants received matching placebo tablet at each dose level for ABT-267.
Other intervention name(s): Ombitasvir
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Cutaneous Acceptability and Perceived Effectiveness of a Nasal Spray (Health Care Products)
Condition: Acceptance, Social; Sensitivity, Contact
MeSH terms: Dermatitis, Contact
Study type: Interventional

Summary: 
      This is a clinical study for health care product safety assessment. The research is going to
      conducted with 45 subjects, aged 18 to 70 years, women users of the product category,
      regardless of color/race, ethnicity, sexual orientation, classes and social groups and who
      must present all the other characteristics of the inclusion criteria and no exclusion
      characteristics. The product is applied under real conditions of use, in a panel of survey
      participants corresponding to the target consumers. Medical evaluation will be available
      throughout the study to assess possible adverse events. The main of the study is to observe
      the effects of the application of the product on the skin and prove the absence of
      irritability and/or allergy and perceived acceptability.
    


Intervention name(s): Hyaluronic Nasal Spray
Intervention type(s): Other
Intervention description(s): Health care product - nasal application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
To Explore Cognitive Neural Mechanism of Autoimmune Encephalitis by Using Neuropsychological Tests and Multi-modal MRI
Condition: Cognitive Impairment; Autoimmune Encephalitis
MeSH terms: Encephalitis; Autoimmune Diseases of the Nervous System; Hashimoto Disease
Study type: Observational

Summary: 
      Most of patients with autoimmune encephalitis are left with permanent cognitive deficits of
      varying severity. The patients' life and career would be affected definitely by cognitive
      deficits. Recently, more and more clinical physician have begun to focus on cognitive
      impairment of patients with autoimmune encephalitis. Generally, the outcome was measured by
      the modified Rankin Scale (mRS). However, the mRS are commonly used to evaluate the degree of
      disability or dependence in the daily activities of the patients suffering from a stroke and
      cognition function were minimally evaluated in this scale. It is crucial to adopt detailed
      cognition tools to study the long-term cognitive outcomes and as an indicator of overall
      curative effect judgment in autoimmune encephalitis.

      Currently, only early immunotherapy is uniformly and consistently considered to produce
      favorable cognitive outcomes. However, studies concerning the association of second-line
      immunotherapy with cognitive outcomes have been scarce and have shown conflicting results
      regarding autoimmune encephalitis.

      Hence, the goal of this study was to explore cognitive neural mechanism of autoimmune
      encephalitis by using neuropsychological tests and multi-mode MRIs.
    

Detailed description: 
      The goal of this study was to explore cognitive neural mechanism of different types of
      autoimmune encephalitis by using neuropsychological tests and multi-mode MRIs.
      Neuropsychological tests involves the assessments of different cognitive domains. And
      multi-mode MRIs contains resting-fMRI, DTI and task-related fMRI.
    

Intervention name(s): rituximab; cyclophosphamide; Steroids; Intravenous immunoglobulin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 375 mg/m2 weekly for 4 weeks; 750 mg/m2 monthly for 4-6 cycles depending on the response; 500-1000 mg of methylprednisolone daily for 3 days, then tapered doses; intravenous immunoglobulin (IVIG) with or without plasmapheresis
Other intervention name(s): rituximab injection; cyclophosphamide injection; methylprednisolone; IVIG
Intervention MeSH terms: Methylprednisolone; Cyclophosphamide; Rituximab; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with autoimmune encephalitis and healthy control
      
Keywords: episodic memory; executive control; fMRI
Feasibility and Effectiveness of Computerized Cognitive Training in Adolescents With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The investigators will conduct a randomized placebo-controlled trial of a computerized
      intervention targeting cognition in 30 teens with autism spectrum disorder.
    

Detailed description: 
      Given the limited options for treatments to improve the core symptoms of autism spectrum
      disorder (ASD), strategies that could target secondary features of the condition and improve
      quality of life for affected individuals are critical. Neuroplasticity-based cognitive
      training has been found to improve cognition in youth with attention deficit hyperactivity
      disorder (ADHD) and in adults with schizophrenia. In this trial, the investigators are
      seeking to extend the relevance of computerized cognitive training to youth with ASD. Given
      the literature, the investigators hypothesize that computerized cognitive training will
      produce gains in untrained cognitive tasks and behavioral ratings of executive functions in
      youth with ASD. The investigators will assess aspects of attention and executive functions in
      30 affected youth and randomize them 1:1 to either neuroplasticity based cognitive tests or
      enjoyable age-appropriate computer games not intended to improve cognition. Cognition will be
      assessed again after 15 hours of training over 6 weeks and then again at a three month follow
      up.
    

Intervention name(s): Targeted Cognitive Training (TCT); Youth Appropriate Online Games
Intervention type(s): Behavioral; Other
Intervention description(s): The investigators have selected a set of computer exercises designed to specifically target aspects of cognition relevant to autism spectrum disorder (including attention and executive functions). The tasks were designed to benefit subjects through principles of learning dependent plasticity.; Engaging games not designed to improve cognition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Neuroplasticity-based Cognitive Training
Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia
Condition: Obesity, Adolescent; Oxidative Stress
MeSH terms: Pediatric Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half
      of the patient will receive vitamin E and the other half received placebo
    

Detailed description: 
      One of obesity treatments that play important role is antioxidant diet. The effects of
      vitamin E supplementation as an antioxidant treatment in obese adolescent have not been
      concluded yet in Indonesia. The primary aim of this study is to observe oxidative stress
      biomarker (isoprostane) in obese teenagers who consume vitamin E for 2 months. The secondary
      aim is to observe their body mass index and lipid profile after supplementation

      The study is randomized, double blind, placebo controlled trial in design and employed a
      consecutive sampling technique to sample subjects of 70 obese adolescent age 14 - 18 in
      senior high schools Jakarta.

      Blood tests of lipid profile (total cholesterol, HDL, LDL, Triglyceride), fasting blood
      glucose, liver function (AST,ALT) and oxidative stress biomarker (isoprostane) were taken for
      every subject after done fasting for 12 hours.

      This study is a randomized allocation and double blind technique. subjects divided into two
      groups, which one group receiving treatment of vitamin E and other group receiving placebo.

      The dose and duration of vitamin E treatment is 400 IU per day for 2 months. At the end of
      treatment, all subjects had to run the same medical interview, physical examination and blood
      test.
    

Intervention name(s): Vitamin E 400 UNT; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin-E capsule (alpha tocopherol) 400 IU (once per day); sugar capsule manufactured to mimic vitamin E capsule once per day
Other intervention name(s): Vitamin E; Placebo
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of The Effectiveness of Intraligamentary and Mandibular Anesthesia on Mandibular Molar Teeth
Condition: Anesthesia, Local
Study type: Interventional

Summary: 
      This study aimed to compare the effects of mandibular and intraligamentary anesthesia
      techniques on pain scores during restorative treatment of permanent mandibular molars in
      pediatric patients. Additionally, comparing the anesthesia techniques in terms of injection
      pain, the success of anesthesia, postoperative complications, and the subjects' preference
      was planned.

      This randomized, controlled, cross-over, single-blind, split-mouth study was conducted on 78
      subjects aged 6 to 12 years. Subjects with enamel-dentin caries on the bilateral permanent
      mandibular molar were included.
    

Detailed description: 
      First, the subjects who met the inclusion criteria in the study were included in 2 study
      groups according to age, gender, dental experience, DMFT / dmft values, and ICDAS II and
      radiographic evaluation criteria. Two different anesthesia techniques were applied to the
      right / left permanent first molar teeth of the patients included in the study, with an
      interval of one week. The subjects have been divided into two groups as 39 subjects were
      Group 1 received intraligamentary anesthesia in the first visit, and 39 subjects were Group 2
      received mandibular anesthesia in the first session. The pain perception rates of the
      patients during the injection and treatment phases were recorded subjectively using a visual
      analog scale and Wong-Baker FACES pain rating scale. Heart rate and arterial oxygen
      saturation were determined as the physiological parameters. The quality of anesthesia and
      success were evaluated by the operation at the end of each visit. Complications (pain, raised
      teeth, hematoma, trauma due to lip/tongue bites, swelling, infection, and bleeding) were
      explained to the patients after anesthesia. They were asked to take note of the complications
      they encountered. Postoperative complications were recorded by calling the cases 1 day after
      the 1st and 2nd visits. At the end of the second visit, anesthesia preference of the patient
      was asked and recorded.
    

Intervention name(s): Intraligamentary anaesthesia; Mandibular anaesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): one tooth anaesthesia by 2 or 4 points intraligamentary injection; Inferior alveolar nerve block by direct standart method
Other intervention name(s): 2 or 4 points intraligamentary injection; Inferior alveolar nerve block
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized controlled, single-blind, split-mouth clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: intraligamentary anesthesia; inferior alveolar nerve block; paediatric dentistry