bioihbjkbjnl/mcl2 huggingface dataset:
Gastric Emptying During Labor at Term: Non-inferiority Clinical Trial
Condition: Gastric Emptying; Pregnancy Vomits
Study type: Interventional

Summary: 
      This study evaluates the gastric emptying of pregnant woman at term who received one of the
      three solutions: maltodextrin, orange juice or coffee with milk.
    

Detailed description: 
      Allocation in maltodextrin, orange juice or coffee with milk will be random using sealed
      envelopes. Gastric ultrasound will be used for estimating gastric volume by measuring antral
      area in right lateral decubiti. All solutions will have the same volume and total of
      calories.
    

Intervention name(s): Maltodextrin; Orange Juice; Coffee with milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Maltodextrin 50g in water 500ml; Orange juice 480ml + 20ml of water; Coffee with milk (330 ml of milk + 220 of water)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Gastric Emptying; labor; maltodextrin; orange juice; coffee; ultrasound
Conditioning Regimen Before Infusion of Allogeneic Hematopoietic Stem Cells
Condition: HEMATOLOGIC MALIGNANCIES
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Observational

Summary: 
      Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning
      for Younger Patients with Hematologic Malignancies.
    

Detailed description: 
      Primary end points are treatment-related mortality and engraftment. Secondary end points are
      regimen-related toxicities, graft-versus-host-disease, relapse, and overall survival.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        acute leukemia chronic myelogenous leukemia myelodysplastic syndrome
      
Keywords: patients without comorbidity
Study of VIR-2482 in Healthy Volunteers
Condition: Influenza A
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study in which healthy volunteers will receive VIR-2482 or placebo and will
      be assessed for safety, pharmacokinetics, and immunogenicity of VIR-2482 in preventing
      Influenza A illness.
    


Intervention name(s): VIR-2482; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VIR-2482 given by intramuscular injection; Sterile normal saline (0.9% NaCl) given by intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza A
The Feasibility Study for Real-time Remote CT Reading for Suspected Acute Appendicitis Using iPhone
Condition: Telemedicine
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      1. Purpose

           - The investigators aim to evaluate the feasibility of iPhone based remote control
           system as a real-time remote CT reading tool for suspected appendicitis under 3G network
           and the suboptimal illumination.

        2. Methods

             -  A total of 120 abdominal CT examinations; sixty had no findings of appendicitis,
                while the other sixty showed signs of acute appendicitis, were selected. The 16
                raters reviewed these images using an LCD monitor of the PACS workstation and also
                an iPhone which was connected to the PACS workstation via remote control system,
                grading the probability of presence of acute appendicitis on each examination by a
                five Likert scale.

             -  The investigators will compare the diagnostic performance between two devices.
    

Detailed description: 
      The 16 raters were randomly divided into two groups

        -  The raters in group one reviewed the CT examinations numbered from one to 60 using LCD
           monitor and reviewed the remaining CT examinations numbered from 61 to 120 using iPhone
           with TeamViewer at their first visit

        -  The other group firstly reviewed the CT scans numbered from one to 60 using iPhone with
           TeamViewer and 61 to 120 with the LCD monitor.

        -  They visited twice with an interval of four weeks and reviewed the CT scans using
           revered devices at each session.

        -  The raters were instructed to rate the likelihood of the presence or absence of
           appendicitis in each case using a five-Likert scale (1 = obvious no appendicitis, 2 =
           unlikely appendicitis, 3 = unsure, 4 = likely appendicitis, 5 = obvious appendicitis).
    

Intervention name(s): Remote CT reading using the iPhone; CT reading using LCD monitor
Intervention type(s): Device; Device
Other intervention name(s): Smartphone (A1530, iPhone 5S, USA); LCD monitor (MX210, EIZO, Japan)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Telemedicine; appendicitis; remote consultation
Molecular Epidemiology of Benzene-exposed Workers.
Condition: Hematologic Diseases
MeSH terms: Hematologic Diseases
Study type: Observational

Summary: 
      The purpose of this study is to investigate the health effects of benzene exposure in workers
      in Shanghai, China.
    

Detailed description: 
      The purpose of this study is to investigate the dose-response relationship between benzene
      exposure and blood diseases in Shanghai workers and to characterize genetic polymorphisms
      that are associated with increased risk of developing benzene hematotoxicity.
    

Intervention name(s): Shanghai workers
Intervention type(s): Other
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Shanghai Workers
      
Keywords: Hematologic Diseases; Benzene; Genetic Polymorphisms
A Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Participants
Condition: Healthy Male Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to evaluate the absorption, metabolism, and excretion of a
      single oral dose of [14C]-E6007 in healthy male participants.
    


Intervention name(s): [14C]-E6007
Intervention type(s): Drug
Intervention description(s): Oral administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: E6007; Pharmacokinetics; Radioactivity
PRoGReSS-PS: Patient Response to GRraded Sensory Stimulation: A Pilot Study
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The Patient Response to Graded Sensory Stimulation-Pilot Study (PRoGReSS-PS) will measure
      back pain perceptions in participants who receive either chiropractic treatment or foot
      massage. The study will also measure back pain and function with research questionnaires and
      other measures.
    

Detailed description: 
      The Patient Response to Graded Sensory Stimulation Pilot Study (PRoGReSS-PS) will measure
      back pain perceptions in participants who receive either chiropractic treatment or foot
      massage. In this study, the researchers will:

        1. Measure the participant's back pain and function using research forms.

        2. Test the participant's ability to discern different touch sensations in the low back.

        3. Assess the participant's perceptions of the study procedures on research forms during
           the study and in a short interview at the end of the study.
    

Intervention name(s): Spinal treatment; Massage
Intervention type(s): Procedure; Procedure
Intervention description(s): This treatment will be applied to the low back region only. During a HVLA treatment, the study doctor will ask the participant to lie on their side on a treatment table. After carefully helping the participant into the proper position, the doctor will make a quick and controlled push with their hand to slightly move joints in the low back. During this procedure, the participant may feel and/or hear a popping sound. After treatment, the doctor may ask the participant to rest on the table for a few moments. During palpation procedure, the doctor will touch several areas in the low back while asking questions about pain, tenderness and other sensations felt during this procedure. The participant will watch the doctor perform the palpation procedure in real time with a tablet computer.; The study doctor will perform a massage of each foot while the participant lies face up in a relaxed position on a treatment table. The procedure will last approximately 10-20 minutes including massage to the toes, heel, sole, and top of each foot.
Other intervention name(s): High Velocity Low Amplitude Spinal Manipulation (HVLA); Chiropractic Adjustment; Focus Palpatory Procedure; Visual Input; Foot Massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain; Chiropractic; Spinal Manipulation; Massage
Ibuprofen Gel or Capsaicin Cream for my Painful Knee Osteoarthritis?
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Despite evidence that topical non-steroidal anti-inflammatory drugs (NSAIDs) and capsaicin
      are effective in osteoarthritis (OA), it is still unclear why they work for some people but
      not others. The investigators are undertaking an individual patient data (IPD) meta-analysis
      to identify responders according to patient characteristics, however, no studies report the
      presence of synovial hypertrophy or neuropathic-like pain. These two traits are of interest
      as they may be used to optimise the treatment effects of the two drugs which work via
      different mechanisms to reduce pain in OA. The investigators are therefore conducting this
      pilot n-of-1 trial series.

      This pilot n-of-1 trial series will investigate whether a person with OA, who has a different
      balance between inflammatory and neuropathic pain, shows a preference between these
      mechanistically different treatments. The trial will also be used to offer recommendations on
      the use of n-of-1 trial series for individualised (precision) medicine in OA.
    


Intervention name(s): Topical NSAID; Topical Capsaicin
Intervention type(s): Drug; Drug
Intervention description(s): Applied four times daily; Applied four times daily
Other intervention name(s): Ibuprofen 5% gel; Zacin 0.025% cream
Intervention MeSH terms: Ibuprofen; Capsaicin
Intervention model: Single Group Assignment
Intervention model description: N-of-1 trial series: several within-individual, randomised, multiple cross-over trials aggregated into a series.
Masking: None (Open Label)
Primary purpose: Other
Keywords: osteoarthritis; n-of-1; ibuprofen; capsaicin; NSAID; topical
Assessment of the Efficacy of Vitamin D-fortified Oil in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of daily intake of fortified sunflower oil
      with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy
      subjects compared to plain oil.
    

Detailed description: 
      Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D,
      calcium or omega-3 supplements within the last three months will be excluded. Subjects will
      be assigned randomly to one of the two intervention groups: 1.fortified sunflower oil, 2.
      plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g
      of oil every day for 2 months.

      At the first and last visits, dietary and laboratory assessments will be performed for all
      subjects. Primary outcomes are the improvement in vitamin D status and secondary outcome is
      the improvement of glycemic and lipidemic markers and prevention of problems related to
      hypovitaminosis D.
    

Intervention name(s): fortified oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 35 g fortified sunflower oil; plain oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vitamin D; fortified oil
Safety and Tolerability of PRO-185
Condition: Hyperemia Eye
MeSH terms: Hyperemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose)
      ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular
      pressure, hyperemia and mydriasis and adverse events.
    

Detailed description: 
      A total of 22 healthy volunteers will apply PRO-185 ocular solution on both eyes QID (four
      times per day) for 8 days. The safety variables will include intraocular pressure, heart
      rate, systolic and diastolic blood pressure. Tolerability variables will include: hyperemia,
      mydriasis, and expected and unexpected adverse events. The presence of any of these in ≤ 20%
      will deem PRO-185 as safe and tolerable.
    

Intervention name(s): Naphazoline / Hypromellose Ophthalmic
Intervention type(s): Drug
Intervention description(s): Naphazoline 0.03% / Hypromellose 0.2%
Intervention MeSH terms: Naphazoline
Intervention model: Single Group Assignment
Intervention model description: Phase I, controlled, non-comparative, single-center, open study.
Masking: None (Open Label)
Primary purpose: Treatment
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of
      several blood thinner drugs on laboratory tests. The study also is evaluating the blood
      levels of PRT064445 given at different doses.
    

Detailed description: 
      A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability,
      pharmacokinetics (PK), and pharmacodynamics (PD) of intravenously administered PRT064445
      after dosing to steady state with one of four direct/indirect factor Xa (fXa) inhibitors in
      healthy volunteers.
    

Intervention name(s): PRT064445/Rivaroxaban; Placebo/Rivaroxaban; Placebo
Intervention type(s): Combination Product; Combination Product; Drug
Other intervention name(s): Andexanet
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.
Module 1, NCT01758432 (54 subjects with 7 cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective, randomized, placebo-controlled, double-blind part of the phase III trial to
      assess the safety and efficacy of 4 weeks oxytocin (OT) administration on oral and social
      skills in neonates/infants with Prader-Willi Syndrome (PWS) aged less than 3 months at
      inclusion. Phase III clinical trial.
    


Intervention name(s): OT; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): One group will receive OT for 4 weeks, then placebo or OT for 8 weeks; One group will receive Placebo for 4 weeks, then Placebo or OT for 8 weeks.
Other intervention name(s): oxytocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Women Veterans' Substance Abuse Treatment
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy of a gender-focused addiction treatment
      model (A Woman's Path to Recovery) versus a non-gender focused addiction treatment model
      (12-Step Facilitation) in a sample of women Veterans with substance use disorder.
    

Detailed description: 
      Substance use disorder (SUD) is problem among women military Veterans, especially younger
      ones. The goal of this study was to examine the efficacy a gender-focused model of SUD
      treatment (A Woman's Path to Recovery, WPR) compared to an evidence-based active comparator
      that is not gender-specific (12-Step Facilitation, 12SF), in a sample of for women Veterans.
      The investigators randomized 66 women Veterans, ages 18-65, who were diagnosed with current
      SUD and used substances in the last 90 days. The treatment phase was 12 weekly individual
      therapy sessions and all participants could also obtain treatment-as-usual (any other
      treatments they chose to attend). Assessments were conducted at baseline, end of treatment
      and 3-month follow up. Sample size was based on power analysis (an effect of .80 at a .05
      level of significance). The primary outcome variable was substance use, with various
      secondary outcomes also studied (e.g., psychosocial functioning, psychiatric symptoms, coping
      skills, 12-step attendance). Urinalysis / breathalyzer (biological measures) were also
      included to validate substance use self-report. The investigators hypothesized that
      participants in the experimental condition (WPR) would have more positive outcomes on both
      primary and secondary variables compared to those in the comparison condition (12SF). The
      investigators also hypothesized that WPR patients would increase coping skills more and 12SF
      would increase 12-step attendance more, relative to the other condition.
    

Intervention name(s): A Woman's Path to Recovery; 12-Step Facilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): WPR is a gender-specific therapy model for women with substance use disorder. It uses A Woman's Addiction Workbook to provide education and coping skills. In this trial it was conducted in 12 weekly individual sessions.; 12SF is an evidence-based therapy designed to facilitate early recovery from substance addiction. It is an individual model consisting of 12 sessions that use the principles of 12-step groups such as Alcoholics Anonymous, and strongly emphasizes participation in those. In this trial the model was conducted weekly.
Other intervention name(s): A Woman's Addiction Workbook
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Women; Substance Use Disorders; Treatment Efficacy; Women's Health; Outcome Assessment (Health Care)
Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hypertrophy With Outflow Obstruction; Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Hypertrophy
Study type: Interventional

Summary: 
      Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action
      on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume,
      improving the patient's quality of life and eventually limiting the number of patients who
      require surgery or endoscopy after medical treatment.
    

Detailed description: 
      The aim of this phase II open clinical trial was to determine if Odyliresin, given its unique
      chemical structure, has a therapeutic effect on BPH-related LUTS, so as to reduce symptoms,
      prostate volume, improve the patient's quality of life and eventually to limit number of
      patients who require surgery or endoscopy after medical treatment. To this aim, patients who
      seek specialist advice for LUTS with no previous surgical treatment for BPH have been
      selected for treatment with Odyliresin in addition to an alpha-antagonist, in order determine
      whether at 12 months a clinical result is obtained, if after 6 and 12 months BPH symptoms are
      significantly improved, and a reduction of prostatic volume can be observed, thus changing
      the usual course of the disease. All patients with BPH-related LUTS received both alphalitic
      and Odyliresin treatment, clinical parameters and uroflowmetry parameters significantly
      improved, adenoma volume and post-void residual volume were significantly reduced at 12
      month. This is the first clinical experience with Iresine Celosia in BPH.
    

Intervention name(s): Odyliresin; Alfuzosin
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg); 10Mg Oral Tablet, Extended Release
Other intervention name(s): Iresine Celosia; alphalytic
Intervention MeSH terms: Alfuzosin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LUTS; Iresine celosia; Odyliresin; medical therapy
Immune Regulation in Multiple Sclerosis: MicroRNA and Antigen-Presenting Cells
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in
      many human diseases. The purpose of this pilot study is to determine if microRNA expression
      is changed in untreated and interferon-beta-treated patients with multiple sclerosis.
    

Detailed description: 
      MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in
      many human diseases. The purpose of this pilot study is to determine if microRNA expression
      is changed in untreated and interferon-beta-treated patients with multiple sclerosis. The
      expression of microRNA will be analysed in cell subsets separated from peripheral blood
      mononuclear cells.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        human subjects will be enrolled in New Brunswick, NJ
      
Biospecimen description: 
      peripheral blood