bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Effects of Beetroot Juice and Mediterranean Diet on Liver Enzymes and Sonography in Patients With NAFLD
Condition: NAFLD, Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial study is to investigate comparing Effects of Beetroot juice
      and Mediterranean diet on Liver Enzymes and Sonographic appearance in Patients with
      Non-Alcoholic Fatty Liver Disease (NAFLD)

      The main question[s] it aims to answer are:

        1. Beetroot juice has role in reduce Liver Enzymes

        2. Mediterranean diet has role in reduce Liver Enzymes
    

Detailed description: 
      Patients with NAFLD were identified and enrolled for this research at the PAR hospital in the
      Kurdistan Region of Iraq.

      For 12 weeks, for the group members who were receiving the MeD, we recommended consuming
      Mediterranean foods like fish, poultry, sources of omega-3, vegetables and colored fruits,
      legumes and nuts, and low-fat goods while avoiding inflammatory foods like high-fat foods,
      processed meats, fast food, simple sugars, chips, and soft drinks.

      At baseline, the participants' demographic and anthropometric information, including as
      gender, age, weight, height, smoking status, location of residence, and physical activity,
      were recorded.
    

Intervention name(s): Beetroot juice; placebo; Mediterranean diet alone (MeD); Mediterranean diet with beet juice (BJ+MeD)
Intervention type(s): Other; Other; Other; Combination Product
Intervention description(s): 250 ml of concentrated beetroot juice, were given to participants in the BJ groups .This was carried out in the morning, 30 minutes before breakfast, and on an empty stomach.; 250 ml of a placebo; Mediterranean diet alone (MeD); Mediterranean diet with beet juice (BJ+MeD).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were split into four groups: control, Mediterranean diet with beet juice (BJ+MeD), Mediterranean diet alone (MeD) and beetroot juice (BJ). The Mediterranean diet included fruits, vegetables, fish, poultry, and other lean meats (without skin), sources of omega-3 fatty acids, nuts, and legumes. Beetroot juice had 250 mg of beetroot.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mediterranean diet; Beetroot juice; nonalcoholic fatty liver
Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with
      Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy
    


Intervention name(s): sitagliptin phosphate; Comparator: Placebo; Comparator: Sitagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg once daily (QD), taken orally for 4 weeks; Placebo tablet, QD, taken orally for 4 weeks; 50 mg twice daily (BID), taken orally for 4 weeks
Other intervention name(s): MK0431; MK0431
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cognitive Biases Modification Treatment for Social Anxiety
Condition: Social Phobia
MeSH terms: Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      Adults with Social Phobia will be randomly assigned to either an attention bias modification
      treatment, interpretation bias modification treatment, both, or a placebo control condition
      not designed to change cognitive bias patterns.

      Outcome measures will be social anxiety symptoms and severity as measured by gold standard
      questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from
      structured clinical interviews based on DSM-IV criteria.

      The investigators expect to find significant reduction in social anxiety symptoms in the
      Treatment groups relative to the placebo control group. The investigators want to find out
      the relative efficacy of attention and interpretation oriented treatments and the combination
      of the two.
    


Intervention name(s): Attention Bias Modification Treatment (ABMT); Interpretation Bias Modification (IBM); Control Condition; Attention and Interpretive biases modification (CBM)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.; Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias.; Attention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns.; Attention and interpretation training via computerized tasks intended to direct attention away from threat stimuli and to facilitate a more benign interpretation bias.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: attention bias modification treatment; interpretive bias modification; cognitive bias modification; attention training; social anxiety
Dosing of Levetiracetam (Keppra) in Neonates
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg
      loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with
      seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading
      dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady
      state drug levels of levetiracetam in neonates.
    


Intervention name(s): levetiracetam
Intervention type(s): Drug
Intervention description(s): 50 mg/kg single loading dose of IV levetiracetam
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: seizures; neonate; levetiracetam; Epilepsy; central nervous system diseases; anticonvulsants
A Follow-up Study to Investigate the Effects of a New Infant Formula on Growth and Body Composition
Condition: Healthy
Study type: Observational

Summary: 
      A follow-up study of a randomised, controlled, study to investigate the effects of a new
      infant formula given in the first 12 months of life on growth and body composition up to 5
      years of age
    

Detailed description: 
      A follow-up study of a randomised, controlled, study to investigate the effects of a new
      infant formula given in the first 12 months of life on growth and body composition up to 5
      years of age. Participants from Venus study will be invited to participate in this follow-up
      study.

      Hypothesis: Significant difference in body mass index (BMI) development for subjects who had
      received infant formula and follow on formula with scGOS/lcFOS/Nuturis® compared to the
      control product scGOS/lcFOS and standard formula. No significant difference in growth of
      subjects who had received infant formula and follow on formula with scGOS/lcFOS/Nuturis®
      compared to the breast-feeding reference group.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participation in the intervention period of VENUS study until 12 months of age or
        participation in the VENUS study as breast-fed reference group
      
Biospecimen description: 
      Stools, saliva and blood (optional)
Prediction Model for Multiple Pulmonary Nodules
Condition: Multiple Pulmonary Nodules
MeSH terms: Multiple Pulmonary Nodules
Study type: Observational

Summary: 
      This study compares the sensitivity, specificity and accuracy of radiologists, thoracic
      surgeons and a predictive model (PKUM model) to discriminate malignancy from benign nodules
      in patients with multiple pulmonary nodules.
    

Detailed description: 
      It is clinically difficult to diagnose and manage patients with multiple pulmonary nodules
      (MPNs). We have developed a web-based mathematic model (PKUM model) by using a multi-centric
      database from three institutions (Peking University People's Hospital, Haidian Section of
      Peking University Third Hospital, People's Hospital Affiliated to Hebei Medical University)
      to predict the probability of a nodule to be malignant in patients with MPNs. This
      prospectively observational study will recruit patients with MPNs between January 2019 and
      March 2019, allowing radiologists, surgeons, and a predictive model (PKUM model) to
      discriminate malignancy from benign nodules, and compare their sensitivity, specificity, and
      accuracy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population include patients with multiple pulmonary nodules who will be diagnosed and
        treated between January 1，2019 and March 30, 2019. Patients with at least 2 nodules
        resected will be enrolled in this study.
      
Keywords: multiple pulmonary nodules; predictive model
CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea
Condition: Obstructive Sleep Apnea; Idiopathic Pulmonary Fibrosis
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The recent literature shows an increased incidence of obstructive sleep apnea (OSA) in
      patients with idiopathic pulmonary fibrosis (IPF). On the other hand there are no published
      studies related to CPAP treatment in this patient group. The investigators aim was to assess
      the effect of CPAP on sleep and overall life quality parameters in IPF patients with OSA and
      to recognize and overcome possible difficulties in CPAP initiation and acceptance by these
      patients.
    

Detailed description: 
      Recently published studies report a high incidence of obstructive sleep apnea (OSA) in
      patients with IPF. Underlying, and usually under-diagnosed OSA in these patients may be a
      reason for impaired sleep quality and may consequently have a negative influence on their
      daily activities and overall quality of life. In addition, underlying OSA may have a negative
      influence on the already impaired IPF-related morbidity and mortality. The absence of any
      effective treatment for IPF so far indicates that the recognition and treatment of generally
      under-diagnosed OSA in IPF patients should be a primary goal. Therefore, our primary aim in
      this study was to assess the results of effective CPAP therapy in terms of sleep quality and
      overall quality of life in IPF patients with moderate to severe OSA. The investigators used
      generally accepted instruments to assess quality of sleep and overall life. In addition, the
      investigators tried to determine and overcome the reasons for poor CPAP compliance in these
      patients
    

Intervention name(s): Continuous Positive Airway Pressure (CPAP)
Intervention type(s): Procedure
Intervention description(s): Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained in the use of CPAP and will be instructed to use CPAP every night for 6 months. These subjects will then return for a post-treatment completion of questionnaires assessing sleep and quality of life 1, 3 and 6 months after the start of effective CPAP treatment.
Other intervention name(s): positive pressure ventilation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Idiopathic Pulmonary Fibrosis
A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
Condition: Non-Alcoholic Fatty Liver Disease (NAFLD)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess the effect of PF 05221304 alone, PF 06865571 alone, the co
      administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with
      NAFLD. In addition, this study will evaluate the safety and tolerability of co administration
      of PF 05221304 and PF 06865571 along with the effects on selected pharmacodynamics
      (PD)/exploratory parameters, compared to administration of PF 05221304 alone, PF 06865571
      alone, and placebo in adults with NAFLD.
    


Intervention name(s): PF-05221304 Monotherapy; PF-06865571 Monotherapy; Placebo; PF-05221304 and PF-06865571 Combination
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of Placebo for PF-06865571, each to be taken twice daily for 41 days and once on Day 42.; Participants enrolled in this Arm will receive 300 mg dose of PF-06865571 (3 tablets of 100 mg each) and 3 tablets of Placebo for PF-05221304, all to be taken twice daily for 41 days and once on Day 42.; Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42.; Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of PF-06865571 (3 tablets of 100 mg each), each to be taken twice daily for 41 days and once on Day 42.
Other intervention name(s): Arm B; Arm C; Arm A; Arm D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetics With Two New Oral Nicotine Replacement Products and Nicorette® Gum
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Single-dose pharmacokinetics with two new oral nicotine replacement products and Nicorette®
      gum.
    

Detailed description: 
      The study is a single-dose, randomized, cross-over study. The investigational products will
      be given as single doses at separate visits. The product administrations comprise 30 minutes
      of chewing. Periods without NRT, lasting for at least 36 hours, will separate treatment
      visits. Before and after the start of product administration at each treatment visit, blood
      will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of
      product administration. Used gums will be collected and analyzed to determine the amount of
      remaining nicotine. Subjects will also be monitored to capture any adverse events that may
      occur. Treatment labels will be concealed from subjects and study personnel.
    

Intervention name(s): Nicotine
Intervention type(s): Drug
Intervention description(s): 2 mg, Single Dose
Other intervention name(s): Experimental NRT UNG-GA and UNG-GB, and Nicorette® Gum
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking Cessation, Nicotine pharmacokinetics
ARMS: The Arm Rest and Support Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Primary Objectives

      1. Determine the effect of an unsupported and poorly positioned arm on initial and average
      triplicate blood pressure done according to clinical practice guidelines with an automated
      device.

      a. Hypothesis: Compared to blood pressure measurements obtained with the arm supported with
      mid-cuff positioned at heart level, blood pressures measured with an unsupported arm and/or
      with mid-cuff below heart level will be significantly higher.

      Secondary Objective

      1. To determine if the effects differ based on the following patient characteristics:

        -  Hypertensive blood pressure (SBP≥130 mmHg vs. <130 mmHg).

        -  Age (≥ 60 years vs. < 60 years) Greater vascular stiffness > lesser vascular stiffness

        -  Regular health care (Last BP measured >1 year ago vs. ≤1 year ago)

        -  Arm length:cuff width
    

Detailed description: 
      The investigators propose a cross-sectional study of adult participants recruited from the
      community. Enrolled participants will have four sets of three automated blood pressure
      measurements, with each set taken with the arm positioned and supported as follows:

        -  Arm supported on a desk, with mid-cuff at mid-heart level (4th intercostal space)

             -  Desk1

             -  Reference measurement

        -  Arm supported on the participant's lap

             -  Lap

        -  Arm hanging at the participant's side, unsupported

             -  Side

        -  The last period of triplicate BP measurements will always have the arm supported and
           mid-cuff positioned at mid-heart level

             -  Desk2

      In the prior 3 periods, the arm position and support conditions are randomly ordered. Each
      participant will undergo a total of 12 systolic and 12 diastolic BP measurements
    

Intervention name(s): Position of arm while taking blood pressure measurement
Intervention type(s): Other
Intervention description(s): Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which their arm position changes prior to each set of measurements.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Blood pressure
Circumcision With a Novel Disposable Device in Chinese Children: a Hospital-based Randomized Controlled Trail
Condition: Circumcision
Study type: Interventional
Phase: Phase 4

Summary: 
      Circumcision, a removal of the foreskin, is performed commonly at any age in male worldwide.
      Globally over 25% of men are circumcised. In the Middle East, circumcision is even performed
      routinely in every male newborn. The benefits from it vastly outweigh the risks. Gradually,
      more and more Chinese male are willing to undergo it with themselves and their sons. But
      there are also some complications with circumcision, such as pain, edema, infection, and
      hemorrhage. Considering of that, physicians continually manage to improve their surgical
      methods and analgesic techniques.

      In the study of Peng, a disposable minimally invasive circumcision anastomosis device named
      Shenghuan (China Wuhu Snnda Medical Treatment Application Technology Co. Ltd.) (ShD) was
      introduced to be applied in circumcision. And they concluded that method was quicker, safer
      and less pain than the conventional techniques of incision. In present study, we carry out a
      randomized controlled trail, using a different method as Peng introduced with this device in
      children's circumcision (Yan's), compared with the method as Peng used and the conventional
      technique in our hospital, and then observe the outcomes.
    


Intervention name(s): circumcision with Shenghuan in Yan's method; circumcision with Shenghuan in Peng's method; conventional method with incision
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The foreskin is first separated from the glans.Then the inner ring is placed between them and over the glans. After adjusting the position of inner ring to retain 0.5cm inner foreskin, the operator install the outer ring over the foreskin and combine them together. Removal of excess foreskin is then performed upon the device.; The foreskin is first separated from the glans. Then the inner ring is placed on the outer layer of foreskin. Next, the rim of the foreskin is clamped with blood vessel forceps at the 3, 6, 9 and 12 o'clock points. An urologist and an assistant each hold two clamps to widen the opening of the foreskin, and pull it over the inner ring. After the inner and outer layers of the foreskin and the frenulum are symmetrically positioned, the assistant install the outer ring over the foreskin and gently combine it together. Removal of excess foreskin is then performed below the device.; The procedure of conventional circumcision involve transection of the excess foreskin with reservation of 0.5cm inner foreskin, haemostasis by electrocautery and suture of skin edges with 4-0 absorption sutures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: circumcision, chinese children, pain