bioihbjkbjnl/mcl2 huggingface dataset:
Measuring Hand Edema in Burn Patients
Condition: Edema
MeSH terms: Edema
Study type: Interventional

Summary: 
      The purpose of this study is to determine the reliability and concurrent validity of the
      figure-of-eight method of measuring hand edema in the burn patient population. Establishing
      the reliability and validity would enable a more time efficient assessment than the currently
      accepted methods.
    

Detailed description: 
      A prospective study involving 33 burn patients admitted to the US Army Burn Center. Two
      raters will perform three separate blinded measurements for hand edema using the
      figure-of-eight measurement technique. A third rater will then perform two blinded
      measurements using water volumetry. All measurements will be read and recorded by an
      independent recorder. The three measurements of rater 1 and 2 will be analyzed to determine
      intratester reliability. The average of the three figure-of-eight measurements will be
      compared to measure intertester reliability. The two volumetry measurements will be compared
      to determine intratester reliability. The average of the 2 volumetry measurements and the
      average fo the three figure-of-eight measurements will be used to determine concurrent
      validity.
    

Intervention name(s): figure-of-eight hand measurements; water volumetry hand measurements
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hand Edema; Figure of eight method; Measuring edema in burn patients
Objective Measure of Recovery After Outpatient Surgery
Condition: Hernia, Inguinal; Convalescence
MeSH terms: Hernia; Hernia, Inguinal; Convalescence
Study type: Observational

Summary: 
      This is a study using wearable monitoring devices, patient activity and sleep patterns to
      monitor pre and post operative following outpatient inguinal hernia surgery to determine when
      these parameters return to baseline.
    


Intervention name(s): GENEactiv
Intervention type(s): Device
Intervention description(s): To wear a monitoring device for a period of time prior to surgery and post surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with inguinal hernia who are to have hernia repair
      
Keywords: recovery of function
Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania
Condition: Impulse Control Disorders
MeSH terms: Trichotillomania; Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the extent of symptom remission in patients with
      trichotillomania following treatment with sertraline and/or behavior therapy.
    

Detailed description: 
      The purpose of this study is to assess the extent of symptom remission in patients with
      trichotillomania following treatment with sertraline and/or behavior therapy.

      Following entry into the study, subjects will undergo a washout period if they are currently
      taking a psychotropic medication (two weeks for psychotropic medications except for
      fluoxetine, which requires a four-week washout). Subjects will then be given a single-blind
      placebo for two weeks and assessed for symptom consistency.

      Subjects will take sertraline or placebo in a double-blind design. Subjects will be assessed
      with the Hamilton Rating Scale for Depression (HAM-D-17), Beck Depression Inventory (BDI),
      Beck Anxiety Inventory (BAI), Clinical Global Impressions Scale (CGI), Hair Pulling Scale
      (HPS), Trichotillomania (TTM) Impact Scale, Psychiatric Institute Trichotillomania Scale
      (PITS), National Institute of Mental Health (NIMH) Scale, and Quality of Life Enjoyment and
      Satisfaction Questionnaire (Q-LES-Q) at the start of the washout period and at the end of
      week two in order to be randomized into the study. Subject randomization to a treatment arm
      will be based on the random table and in equal proportions.

      Subject change scores will be assessed for the above scales, and change scores for the four
      different treatment groups will be assessed.
    

Intervention name(s): Sertraline; Habit Reversal Training
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Trichotillomania; Habit Reversal Training; Sertraline; Zoloft
Type 2 Diabetes Mellitus and Chronic Kidney Disease
Condition: Renal Disorder Associated With Type II Diabetes Mellitus
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational [Patient Registry]

Summary: 
      To investigate the effect of co existance of diabetes mellitus and chronic kidney disease on
      basic coagulation profile in comparison with diabetic patients with normal kidney function
      and non diabetic patients with chronic kidney disease
    

Detailed description: 
      We will study impact of type 2 diabetes mellitus on basic coagulation profile and platelet
      indices among patients with chronic kidney disease
    

Intervention name(s): Hematologic tests for patients with diabetes mellitus and chronic kidney disease
Intervention type(s): Diagnostic Test
Intervention description(s): Study basic coagulation profile and platelet indices among diabetic patients with chronic kidney disease
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will classify study population into 3 groups First group those population with only type
        2 diabetes mellitus Second group is those population with chronic kidney disease only Third
        group is those population with combined type 2 diabetes mellitus and chronic kidney disease
      
Biospecimen description: 
      Blood samples for coagulation profile and platelet indices
Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange
Condition: Antibody-mediated Rejection; Autoimmune Reaction Mediated by Immune Complex
Study type: Observational

Summary: 
      Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal
      of pathophysiological relevant mediators in various diseases. Adipokines have recently been
      found to play an important role in a variety of immunologic diseases. However, in many of
      these disease states cardiac and inflammatory involvement is common and biomarkers are
      routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on
      biomarkers used in the clinical routine has not been investigated. The aim of this study is
      to determine adipokine and cardiac biomarker removal during TPE therapy.
    

Detailed description: 
      We performed a observational prospective single-centered study. Every patient received two
      consecutive therapeutic plasma exchange (TPE) sessions during the study. Plasma exchange
      therapy was performed using either the Spectra Optia® or the Octo Nova® apheresis system.
      Anticoagulation was applied either by heparin or citrate. The prescribed dose of exchange
      volume of every TPE treatment was 1.1-times the individual calculated total plasma volume,
      using the Nadler-Allen equation. A substitute fluid with 5% albumin concentration was used in
      every treatment. Blood samples for measurement of different adipokines (resistin, leptin,
      soluble ICAM-1, soluble CD40 ligand, monocyte chemoattractant protein-1 (MCP-1), soluble
      tumor necrosis factor receptor (sTNF-R) as well as cardiac and inflammatory biomarkers and
      routine chemistry were drawn before (pre-TPE) and at the end (post-TPE) of the first and
      second TPE session.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Tertiary hospital patients after kidney transplantation with humoral rejection and patients
        with other antibody mediated diseases.
      
Biospecimen description: 
      -  blood samples

        -  plasma samples from TPE waste bag
Characterizing ASD Adult Population Asking for a Diagnosis
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The investigators aim at offering to about 80 patients a diagnostic assessment for Autism
      Spectrum Disorder (ASD), and at testing the feasibility of this protocol to detect and
      diagnose ASD in adults without intellectual disability.
    

Detailed description: 
      About 80 adults asked for an ASD diagnosis a Donald-T unit, now closed.The investigators will
      offer to these patients a diagnostic assessment, with questionnaires, ADOS-II, Vineland
      Adaptative Behavior Scale and psychiatric examination. Patients who will show negative scores
      at the detecting questionnaires will not be further assessed, except for 10 out of them, who
      will be drawn by lot. Then the investigators will be able to discuss the feasibility of such
      a procedure with these tools, as well as to describe the clinical profile of adult people
      asking for ans ASD diagnosis.
    

Intervention name(s): screening and diagnostic assessment DONALD T unit list
Intervention type(s): Other
Intervention description(s): Screening and diagnostic assessment of the group of people awaiting assessment, and thus test the feasibility of a screening and diagnosis procedure for autism in adults without intellectual disabilities
Intervention model: Single Group Assignment
Intervention model description: adult patients without intellectual disability (IQ> 70 or college-level equivalent) and being on the waiting list for a diagnosis of ASD at the former Donald-T unit.
Masking: None (Open Label)
Primary purpose: Diagnostic
Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women
Condition: Papillomavirus Type 16/18 Infection; Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will be extended for subjects who received all three doses of vaccine in Finland,
      Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18
      vaccine. Human Papilloma virus (HPV) are viruses that cause a common infection of the skin
      and genitals in men and women. Several types of HPV infection are transmitted by sexual
      activity and, in women, can infect the cervix (part of the uterus or womb). This infection
      often goes away by itself, but if it does not go away (this is called persistent infection),
      it can lead in women over a long period of time to cancer of the cervix. If a woman is not
      infected by HPV, it is very unlikely that she will get cervical cancer. This study will
      evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified
      manufacturing processes of GlaxoSmithKline Biologicals HPV-16/18 vaccine and the vaccine
      safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.
    

Detailed description: 
      Approximately 750 study subjects received different lots of the HPV vaccine administered
      intramuscularly according to a 0-1-6 month schedule.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Cervarix™
Intervention type(s): Biological
Intervention description(s): Three doses of vaccine according to a 0, 1, 6 month schedule (during the primary study)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Non-inferiority; Immunogenicity; HPV Vaccine Consistency
Brain Networks Implicated in Lifelong Premature Ejaculation Patients
Condition: Premature Ejaculation; Sexual Dysfunction
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Using Brain Mapping and Cognitive ERPs, the investigatos have searched for a Brain Networks
      involved during Inhibitory Control in Lifelong Premature Ejaculation (LPE) participants. The
      investigators have designed a clinical trial comparing placebo with tDCS and blacebo group
      against Dapoxetine, studying the effects on LPE, as well as side effects and their medium and
      long-term duration.
    

Detailed description: 
      Lifelong premature ejaculation (LPE) is a very common male sexual dysfunction like erectile
      dysfunction. It produces great distress to sexual harmony and even fertility. Previous
      neurophysiology studies revealed an ejaculation-related control mechanism in the brain: left
      inferior frontal gyrus (IFG) activation during successful inhibition. If we use the left IFG
      as a seed, participants showed weaker resting-state functional connectivity (FC) activity,
      between the seed and two areas (left dentate nucleus (DN) and right frontal pole) compared
      with controls.

      The main goal is to compare whether the brain biomarker only exists in participants with LPD
      and how it responds to treatment with Dapoxetine and with tDCS against the IFG networks and
      lDN, measuring the connectivity changes in these brain networks and FC.
    

Intervention name(s): Transcranial Radom Noise Stimulation; Take Dapoxetine; Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants; Compare LPE EEG endophenotype between participants and healthy controls
Intervention type(s): Device; Drug; Combination Product; Diagnostic Test
Intervention description(s): tRNS against Dapoxetine in LPE patients; Dapoxetine against tRNS in LPE patients; Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups.; Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype
Other intervention name(s): tRNS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Brain Mapping; EEG; ERP; tDCS; tRNS; Dapoxetine; Lifelong premature ejaculation; central inhibitory network function; inferior frontal gyrus; dentate nucleus; right frontal pole; Resting State Networks; Funtional connectivity
Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy
Condition: Epilepsy, Rolandic
MeSH terms: Epilepsy; Epilepsy, Rolandic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy and safety of Topiramate in comparison
      to Carbamazepine in Benign rolandic epilepsy.
    

Detailed description: 
      Benign rolandic epilepsy (BRE) is a common seizure disorder confined solely to children. The
      disorder is marked clinically by nocturnal generalized tonic-clonic seizures and diurnal
      seizures consisting of simple partial seizures consisting of brief unilateral facial clonic
      activity, dysphasia, and drooling. The EEG abnormalities are unique, consisting of generally
      high amplitude, centrotemporal spikes that are activated by sleep. The seizures typically
      begin in the first decade and almost always stop by age 16 years. The seizures are usually
      infrequent although clusters of seizures do occur. When the physician elects to treat, the
      seizures are usually easily controlled. This is a randomized, open label, active controlled,
      multi-center based clinical trial to determine the efficacy and safety of Topiramate
      comparing with Carbamazepine in Benign rolandic epilepsy. The study hypothesis is that
      topiramate will be more effective in treatment of Benign rolandic epilepsy than
      Carbamazepine, as evaluated by seizure-free rate at 24 weeks and Intellectual Functioning :
      KEDI-WISC (Korean Educational Development Institute Wechsler Intelligence Scale for
      Children-Revised) and is generally well-tolerated.

      Topiramate (target dose) 4mg/kg/day, B.I.D, oral, for 24 weeks, carbamazepine(target dose)
      30mg/kg/day, B.I.D, oral, for 24 weeks.
    

Intervention name(s): topamax
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Benign rolandic epilepsy; Topiramate
Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus
Condition: Parkinson's Disease; Deep Brain Stimulation Surgery
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to find out whether dexmedetomidine changes brain cell
      activity in the subthalamic nucleus (STN).
    

Detailed description: 
      In order to find whether dexmedetomidine is optimal for sedation during Deep brain
      stimulation surgery, we will measure the electrical activity in the STN during Deep brain
      stimulation surgery, and measure how this activity is changed during administration of
      Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and
      pattern in the STN.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SubThalamic Nucleus; Microelectrode recording; Deep Brain Stimulation Electrode implantation
Pharmacokinetics, Safety and Tolerability of BI 671800 HEA Given Over 7 Days. A Randomised, Double Blind, Placebo Controlled Within Dose Groups Phase I Study in Healthy Male and Female Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of the multiple dose study are to investigate the safety, tolerability
      pharmacokinetics of BI 671800 HEA in healthy male and female volunteers following multiple
      oral administration of BI 671800
    


Intervention name(s): Placebo; BI 671800; BI 671800
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matching to HEA 200 mg tablet, oral administration; High dose oral administration; Medium dose oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study With Vortioxetine on Emotional Functioning in Patients With Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day on emotional
      functioning in patients with MDD with an inadequate response to SSRIs/SNRIs.
    


Intervention name(s): Vortioxetine
Intervention type(s): Drug
Intervention description(s): Flexible doses (10-20 mg) of vortioxetine; 10 mg during the first week which may be increased up to 20 mg week 2-8
Other intervention name(s): Brintellix ®
Intervention MeSH terms: Vortioxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Rheumatoid Hand With Magnetotherapy
Condition: Rheumatoid Arthritis; Hand Rheumatism
MeSH terms: Arthritis; Arthritis, Rheumatoid; Rheumatic Diseases
Study type: Interventional

Summary: 
      Brief Summary:

      Participants with rheumatoid arthritis with recommendation to physiotherapy.

      Created 2 study groups:

        1. Kinesiotherapy with static magnetic field

        2. Kinesiotherapy with low-frequency pulsed magnetic field

      Pulsed magnetic field give better effects then static magnetic field.
    

Detailed description: 
      Participants with rheumatoid arthritis with recommendation to physiotherapy. All participants
      have dysfunction and pain of hand. Before entering the study, all patients were examined by a
      rheumatologist, who determined the degree of radiological and functional changes and measured
      blood pressure. Patients with II° and III° of radiological and functional changes were
      qualified for the study. All the patients gave their informed consent to participate in the
      study. The examination included an overall assessment of functional status. Patients were
      examined immediately before and after the intervention.
    

Intervention name(s): Kinesiotherapy with magnetotherapy
Intervention type(s): Other
Intervention description(s): Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 10-20 Hz, type of impulse: bipolar, rectangular pulse
Other intervention name(s): Kinesiotherapy with static magnetic field; Kinesiotherapy with low-frequency pulsed magnetic field
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Magnetotherapy; Rheumatoid arthritis; Hand function
Study of the PAS-Port® Proximal Anastomosis System in Coronary Bypass Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The study has been designed to comparatively evaluate the safety and effectiveness of the
      PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the
      connection between graft veins and the aorta in patients undergoing coronary artery bypass
      graft surgery for treatment of coronary artery disease. Patients in the study will have a
      coronary angiogram approximately 9 months following surgery to determine the patency of vein
      grafts created using either the automated PAS-Port or hand sewn methods. Safety will be
      evaluated by documenting the occurence of adverse clinical events and evealuating possible
      association with either method.
    


Intervention name(s): PAS-Port Automated Proximal Anastomosis System
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Mass Balance Study of AT-527 in Healthy Adult Male Subjects (R07496998)
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Mass balance study of AT-527 in Healthy Male Subjects.
    

Detailed description: 
      This is an open-label, single-dose study assessing the absorption, metabolism, excretion, and
      mass balance of [14C]-AT-527 in healthy adult male subjects.
    

Intervention name(s): AT-527 (R07496998)
Intervention type(s): Drug
Intervention description(s): Study participants will receive a single radiolabeled dose of 550 mg AT-527.
Intervention model: Single Group Assignment
Intervention model description: Open-Label, Single-Dose pharmacokinetic (PK) study.
Masking: None (Open Label)
Primary purpose: Treatment