bioihbjkbjnl/mcl2 huggingface dataset:
Translation of Parkinson's Disease Questionnaire -8 in Urdu Language
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Cross cultural analytical study to translate Parkinson's disease questionnaire-8 in Urdu
      language. Along with the translated version by evaluating its validity and reliability among
      the patients of Parkinson's disease. No such study has been previously conducted in Pakistan
      which translate this questionnaire in

      Urdu and follows the proper cross- culture adaptation. Condition or disease:

      Parkinson's disease. Convenient sampling technique would be used
    

Detailed description: 
      Parkinson's Disease Questionnaire-8 (PDQ-8) is the brief version of PDQ-39 formulated to
      reduce the respondent burden and for convenient use in clinical settings in patients of
      Parkinson's disease. (PDQ-8) is the patient reported outcome measure constructed by taking
      one question from each of the eight domains of PDQ-39 (mobility, activities of daily living,
      emotional well-being, stigma, social support, cognition, communication, and bodily
      discomfort. PDQ-8 will be translated into Urdu language by Beaton et al guidelines for cross
      cultural adaptation of tool. The validity and reliability of Urdu version of PDQ-8 will be
      evaluated by calculating Cronbach's alpha, intra-class correlation coefficient and
      Pearson/spearman rank correlation co-efficient.

      Continuous variables will be shown by mean and standard deviation and the categories will be
      demonstrated in frequency and percentage. Factor structure of the PDQ-8 will be extracted
      using exploratory factor analysis (EFA), utilizing principal component analysis with varimax
      rotation.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Parkinson disease
      
Keywords: PDQ-8, Parkinson's disease, validate .
Evaluating the Number of Passes Required for Diagnostic Cell Block During EUS-FNA of Solid Pancreatic Mass Lesions
Condition: Pancreatic Cancer
Study type: Interventional

Summary: 
      This study will test the amount of tissue, called "cell block", obtained from your pancreas.
      Patients who are asked to participate in this study have a growth (mass) in the pancreas that
      needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes (number
      of times the doctor biopsies the mass), at this time we do not know the ideal number of
      passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of this
      study is to compare the amount of tissue obtained with 2 passes versus 4 passes.
    

Detailed description: 
      Primary Aim:

      To compare the number of passes required for obtaining adequate cell block material during
      EUS-guided FNA of solid pancreatic mass lesions.

      Primary Research Hypothesis:

      More specimen is required to obtain definitive diagnosis on cell block. This translates to
      less need for repeat procedures (due to nondiagnostic index procedure due to inadequate FNA
      passes), prompt treatment to patients and better use of health care resources. Therefore, we
      will be comparing 2 versus 4 FNA passes to determine which number of FNA pases will yield an
      adequate diagnostic cell block.

      Secondary Aims:

      To compare the rate of complications when performing 2 versus 4 EUS-FNA passes of solid
      pancreatic mass lesions.

      Secondary Research Hypothesis:

      EUS-guided FNA is a safe procedure with a complication rate of < 1%. By performing more
      (four) NA passes one is likely to yield a better quality cell block while at the same time
      without compromising patient safety.
    

Intervention name(s): EUS FNA with 2 passes; EUS FNA with 4 passes
Intervention type(s): Procedure; Procedure
Intervention description(s): biopsy with 2 passes; biopsy with 4 passes
Other intervention name(s): Biopsy; FNA; biopsy; FNA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: cell block, number of passes
Self Administration of Subcutaneous Depot Medroxyprogesterone Acetate
Condition: Fertility
Study type: Observational

Summary: 
      The purpose of this study is to assess continuation rates and patient satisfaction with self
      administration subcutaneous depot medroxyprogesterone acetate.
    

Detailed description: 
      This observational study will include new or current Depo Provera users who express interest
      in attempting subcutaneous self administration of depot medroxyprogesterone acetate.
      Candidates will be taught self administration by a clinic assistant at Planned Parenthood of
      Southwest and Central Florida. Patients who are able to correctly self administer the
      medication and wish to attempt to continue home self administration, will be provided the
      supplies and educational materials to do so. Continuation rates and satisfaction with this
      method will be assessed using preaddressed surveys that patients will return with the above
      information.
    

Intervention name(s): Self administration
Intervention type(s): Procedure
Intervention description(s): Subjects will self administer injections of 104 mg of the subcutaneous formulation of depot medroxyprogesterone acetate (depo-subQ provera 104).
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will enroll 50 English-speaking/literate women at least 18 years of age of any
        race who have sought contraception with DMPA at the Planned Parenthood of Southwest and
        Central Florida in Tampa and Fort Myers. Patients who choose to begin DMPA or who have
        already been using DMPA will be approached regarding voluntary participation in the study.
        Because DMPA is contraindicated in pregnancy, women with a positive urine pregnancy will
        not be eligible. Should a woman become pregnant during the study, she will receive no
        further DMPA injections
      
Keywords: Undesired fertility
JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is being done to see how well the JetTouch Needle-Free Endoscopic
      Injection System is able to deliver a solution safely into the bladder wall. The JetTouch
      Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected
      into the bladder without using a needle. It is hoped that this method will provide a reliable
      and consistent method to deliver drugs into the bladder wall.
    


Intervention name(s): JetTouch Needle-free injection system
Intervention type(s): Device
Intervention description(s): Needle-free injection system believed to provide consistent and reliable delivery of material to the bladder wall.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Incidence and Risk Factors of Radiotherapy Induced Hypothyroidism in Head and Neck Cancer With Long Term Follow up
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Hypothyroidism
Study type: Interventional

Summary: 
      This is a retrospective study with long term follow up to evaluate the incidence, timing and
      risk factors of radiotherapy induced hypothyroidism in non-thyroid head and neck cancer
      patients who were treated with RT alone or in combination with surgery and/or chemotherapy.
    

Detailed description: 
      For any patient, fixation was done by a thermoplastic mask. CT scan was done at 3mm thickness
      for the head and neck region. CT images were transferred to the planning system.
      Three-dimensional conformal RT, intensity-modulated radiotherapy (IMRT) or Volumetric
      modulated arc therapy (VMAT) was created. All patients were irradiated with once-daily
      fractionation at 1.8-2.0 Gy/d with 6-MV photon beams for five days a week. The gross target
      volume (GTV) was treated with a dose of 70Gy and the lymphatic site (CTV) and areas of high
      risk microscopic disease (CTV) including lymph nose levels received a radiation dose ranging
      from 54-66 Gy according to its risk. PTV is a circumferential margin of 5mm around CTV.

      Thyroid function parameters:

      The patient's serum T4, T3 and TSH levels, were measured during follow up. Clinical
      hypothyroidism is defined as the increase in TSH above 5.0mIu/ml with a decrease in free
      thyroxine levels (free T4) in the serum while elevated TSH with normal free T4 levels was
      labeled as subclinical hypothyroidism .As per institutional values, the normal values
      intervals of T4 level (7- 25 PMOL/L), T3( 1.5-7 PMOL/L),TSH (0.2-5 mIu/L).

      The median time to onset of hypothyroidism was defined as the time interval between
      completion of radiotherapy and first abnormal recorded T3/T4/TSH value.

      For all treated patients, thyroid gland was delineated and by reviewing the DVH, the V45,
      V50, V55, V60, V65 and V70 which means the volume of the thyroid gland receiving 45 Gy, 50
      Gy, 55Gy, 60 Gy and 70 Gy respectively.
    

Intervention name(s): TSH, T3, T4 and thyroid gland DVH
Intervention type(s): Diagnostic Test
Intervention description(s): measuring thyroid functions and DVH parameters of thyroid gland
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: hypothyroidism; radiotherapy; head and neck cancer
Bioequivalence and Food Effect Study in Healthy Volunteers
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to select the formulation with the optimal pharmacokinetic
      profile for an hypnotic drug to further develop in the market.
    

Detailed description: 
      A single-centre, open-label, randomized, single-dose, 6-way crossover study to investigate
      the pharmacokinetics, safety and tolerability of 6 different formulations of SB-649868 30 mg
      (Part A) and the effect of food on the selected formulation of SB-649868 pharmacokinetic
      (Part B) in healthy male volunteers
    

Intervention name(s): Formulation A; Formulation B; Formulation C; Formulation D; Formulation E; Formulation F; Formulation G
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Formulation A represents the original formulation. SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing micronized drug substance. Formulation A will be administered in Part A.; Formulation B will represent SB-649868 10 mg film coated tablet containing micronized drug substance (3 tablets to reach 30 mg), but contains additional surfactant. Formulation B will be administered in Part A.; Formulation C will represent SB-649868 10 mg lipophilic capsule (3 capsules to reach 30 mg). Formulation C will be administered in Part A.; Formulation D will represent SB-649868 10 mg film coated tablet (3 tablets to reach 30 mg), containing nanomilled and spray dried powder. Formulation D will be administered in Part A.; Formulation E will represent SB-649868 10 mg capsule (3 capsules to reach 30 mg), containing nanomilled and spray dried powder. Formulation E will be administered in Part A.; Formulation F will represent SB-649868 15 mg liquid filled capsule (2 capsules to reach 30 mg). Formulation F will be administered in Part A.; Formulation G will be the selected formulation of SB-649868 30 mg to be assessed in Part B. The formulation will be administered after a standard FDA High-Fat breakfast
Other intervention name(s): SB-649868
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalent; pharmacodynamic; Reference formulation; 5 new formulation; Food effect; Pharmacokinetics
Transcranial Magnetic Stimulation for Facial Pain
Condition: Trigeminal Nerve Injuries; Post-herpetic Neuralgia; Facial Pain; Nervus Intermedius Neuralgia
MeSH terms: Herpes Zoster Oticus; Trigeminal Nerve Injuries; Neuralgia; Neuralgia, Postherpetic; Facies; Facial Pain
Study type: Interventional

Summary: 
      Complex oro-facial pain is a poorly diagnosed and poorly treated cause of significant
      suffering and disability. This study will explore the ability of fMRI to identify patients
      with complex oro-facial pain who respond to transcranial magnetic stimulation therapy.

      Specific Aims:

        1. To establish baseline patterns of MRI in patients with chronic oro-facial pain without a
           definitive etiologic diagnosis.

        2. To estimate the rate of treatment success of transcranial stimulation of the primary
           motor cortex (M1) in these patients.

        3. To identify post-treatment MRI patterns that are associated with treatment success.
    

Detailed description: 
      Methods: Patients diagnosed with complex oral or facial pain at the UMPhysicians Complex
      Facial Pain Clinic who meet inclusion and exclusion criteria will be offered participation in
      the study. They will undergo baseline evaluation for depression with the HAM-D and MADRAS
      scales and for quality of life with the WHOQOL-BREF scale. Pain will be assessed using a 10
      point visual analogue scale. Resting and pcasl MRI will be done within 24 hours before the
      first treatment. Treatment will consist of five daily sessions of motor cortex stimulation
      contralateral to the pain. Visual analogue pain scores will be obtained just before each
      treatment. Rating scales, resting and pcasl MRI will be repeated within 24 hours and at 2
      weeks after the last treatment. Analysis: FMRI activation patterns will be examined by the
      investigators and correlated with treatment outcomes with the goal of identifying fMRI
      characteristics that can select patients suitable for further study.
    

Intervention name(s): transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
Intervention model: Single Group Assignment
Intervention model description: This is a device study and therefore does not have a drug, biological/vaccine or combination product involved.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: trigeminal region pain
Study to Develop a Prediction Model to Understand the Effect of Low-dose Aspirin on Cancer That Develops in the Colon and/or the Rectum, Diseases That Affects the Heart or Blood Vessels and Safety Outcomes in European Countries. The Study is Also Called PEACOS Model EU
Condition: Colorectal Cancer; Cardiovascular Disease; Bleeding
MeSH terms: Colorectal Neoplasms; Cardiovascular Diseases
Study type: Observational

Summary: 
      In this study researchers want to learn more about the effect of low-dose Aspirin on cancer
      that develops in the colon (the longest part of the large intestine) and/or the rectum (the
      last several inches of the large intestine before the anus), diseases that affects the heart
      or blood vessels and safety outcomes. Study will focus on two groups of adults aged 50-59 and
      60-69 years having an increased risk of heart and/or blood vessel disease who are taking
      either low-dose aspirin or no low-dose aspirin for heart and/or blood vessel disease
      prevention. The model will be based on information publicly available either on government
      organization websites or in scientific journals. Based on these data researchers will focus
      in a first step to build a model of 2 million adults (1 million for each age group) for the
      UK population and in a second step, the model will be modified for use with other European
      countries, to reflect the epidemiology and guidelines for aspirin use in these countries.
    

Detailed description: 
      Observational Study Model is selected as "Other" - Reason: Individual-level state transition
      model simulating the number of events of CRC, CVD, safety events and deaths in hypothetical
      cohorts of 1 million adults aged 50-59 years and 1 million adults aged 60-69 years followed
      for 20 years or till death, whichever comes first. The hypothetical cohorts are reflective of
      a population eligible for taking aspirin for primary or secondary CVD prevention.

      Time Perspective is also selected as "Other"

      - Reason: Individual-level state transition model built mimicking the UK population using
      data published in scientific international peer-reviewed journals or published data from
      government agencies. In a second phase, the model results will be extrapolated to other EU
      countries, modifying the model parameters to reflect the other EU countries epidemiology.
    

Intervention name(s): Acetylsalicylic Acid (Aspirin, BAYE4465)
Intervention type(s): Drug
Intervention description(s): Low-dose acetylsalicylic acid, Aspirin (75-150 mg)
Intervention MeSH terms: Aspirin
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Disease prediction model using hypothetical populations of adults aged 50-59 and 60-69
        years at increased CVD (cardiovascular disease) risk, taking aspirin for CVD (primary or
        secondary) prevention.
Reproductive Life Plan-based Counseling With Men
Condition: Sexual Behavior; Lifestyle; Fertility; Pregnancy; Gender Role
Study type: Interventional

Summary: 
      Many women and men in fertile age are at risk for sexual transmitted infections and unwanted
      pregnancies, and have insufficient knowledge of health promoting lifestyle prior to
      conception. There is a need to increase awareness among people in fertile age about how
      sexual risk-taking and unhealthy lifestyle can negatively affect fertility and pregnancy
      outcomes. Previous studies on preconception health and care have mainly focused on women. The
      aim of our study was to investigate if Reproductive Life Plan-based counseling with a midwife
      could increase men's reproductive knowledge. The second aim was to evaluate men's experiences
      of the intervention.
    


Intervention name(s): Reproductive Life Plan (RLP)
Intervention type(s): Behavioral
Intervention description(s): A structured discussion based on the RLP, including information about reproduction and a brochure with the same information.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Interval Training and Performance in Mountain Bikers
Condition: Physical Activity
Study type: Interventional

Summary: 
      The aerobic fitness is important for mountain bikers, but riders should also be able to
      generate maximal and supramaximal efforts in some crucial phases of the competition. Although
      there is an increase interest in high-intensity aerobic training, to investigators knowledge,
      there are no studies examining the effects of interval (INTV) or intermittent training (INTM)
      in mountain bikers. The aim of this study was to compare the effects of INTV and INTM on
      aerobic fitness variables (peak power output, Wmax, lactate threshold, and onset of blood
      lactate accumulation) but more importantly on performance as measured using a controlled
      mountain bike race, i.e. simulation. The investigators hypothesized that INTV and INTM
      training were equally effective in improving Wmax, Lactate threshold and onset of blood
      lactate accumulation, but INTV was superior in enhancing performance in mountai bike race
      simulation.This hypothesis is due to studies that have shown higher gains in performance with
      long duration of aerobic high intensity interval training in comparison to the shorter
      training at a higher intensity.
    

Detailed description: 
      The study is a controlled and randomized trial.
    

Intervention name(s): Interval Training; Intermittent Training
Intervention type(s): Other; Other
Intervention description(s): The interval training group consisted of 7 to 10 repetitions of 4-6 min at the highest intensity sustainable, the active recovery was 4-6 min in intensity from 10 to 15 of scale of perceived exertion CR100.; The riders of intermittent training group completed 8 to 12 repetitions of 30 s all-out with 4 min of active recovery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Aerobic Interval Training; Supramaximal Training
Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
Condition: Terlipressin; Blood Loss
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study aims to look at the effect of terlipressin infusion on blood loss and blood
      transfusion needs during Whipple procedure
    


Intervention name(s): Terlipressin; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Terlipressin is a synthetic vasopressin analogue with relative specificity for the splanchnic circulation(Terlipressin was started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.); Patients received 50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours.
Other intervention name(s): glypressin; 0.9 Nacl
Intervention MeSH terms: Terlipressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      International clinical trial to compare ponesimod and teriflunomide in relapsing multiple
      sclerosis
    


Intervention name(s): ponesimod; teriflunomide
Intervention type(s): Drug; Drug
Intervention description(s): film-coated tablet with 20 mg ponesimod, administered orally once daily in the morning; film-coated tablet with 14 mg teriflunomide, administered orally once daily in the morning
Other intervention name(s): ACT-128800
Intervention MeSH terms: Teriflunomide; Ponesimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: relapsing multiple sclerosis