bioihbjkbjnl/mcl2 huggingface dataset:
Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers
Condition: Anesthesia
Study type: Observational

Summary: 
      The aim of the study is to assess the accuracy of shear wave elastography in volunteers.
      Shear wave elastography is a non-invasive, non-painful measure of tissue stiffness obtained
      using an ultrasound machine. It may be easier to think of shear wave elastography as a
      special type of ultrasound imaging which gives doctors a colour picture of body structures
      based on their stiffness.
    

Detailed description: 
      Shear wave elastography is a quantitative ultrasound modality increasingly used to
      differentiate between "hard" breast cancer masses and "soft" normal tissue. Unlike strain
      elastography, shear wave elastography applies a non-compressive longitudinal acoustic
      radiation force to underlying tissues, inducing transverse shear waves. Studies in Thiel
      embalmed human cadavers have shown significant differences in Young's modulus between
      intraneural and extraneural tissue, and ready colour differentiation between tissues.

      Therefore, before clinical application, we wish to measure the repeatability and
      reproducibility of Young's modulus of intraneural and extraneural tissue in volunteers. For
      measurement, a region of interest (ROI) will be selected over the appropriate nerve and
      adjacent tissue. The ROI results will be regarded as paired data. Paired data will be
      measured over and adjacent to the interscalene C5 nerve root, infraclavicular lateral cord,
      musculocutaneous, median, femoral, saphenous and sciatic nerves.
    

Intervention name(s): shear wave elastography
Intervention type(s): Device
Intervention description(s): ultrasound
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study of 8 subjects - volunteer medical students. Recruitment: Male medical students at
        Ninewells Hospital & Medical School, Dundee.

        Male medical students will be e-mailed by the chief investigator.
      
Keywords: Shear wave; Elastography; Repeatability and Reproducibility
The Use of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Condition: Fissure in Ano
MeSH terms: Fissure in Ano
Study type: Interventional
Phase: Phase 3

Summary: 
      use of platelet rich plasma had good effect in treating chronic wounds. healing of perianal
      fissure could be prolonged and associated with pain. injection of platelet rich plasma under
      fissure base and edges had the advantage of improved fissure healing and reduction of the
      pain, with minimal side effects.
    

Detailed description: 
      Thirty milliliters of venous blood were withdrawn into eight syringes with preloaded 0.4
      milliliters of anticoagulant (dextrose solution A) in each syringe to achieve concentration
      of 9:1.

      The mixture centrifuged for 3000 round per minute for three minutes. After centrifugation
      separation of supernatant from the red blood cells, using three way-stopcock connector to
      collect the supernatant of all syringes into four new syringes that preloaded with 1
      microgram of Prostaglandin E1 that diluted in normal saline (0.05 milliliters).

      The four syringes centrifuge at 4000 round per minute for 15 minutes. The supernatant
      discarded using a three way-stopcock connector. The sediment mixed with vortex mixer (Vortex
      V-1 plus, BIOSAN).
    

Intervention name(s): Platelet rich plasma injection; Nitroglycerin ointment
Intervention type(s): Procedure; Drug
Intervention description(s): venous blood drown from the patient, centrifugation and separation of platelet rich plasma, injection under fissure and edges base.; application of the ointment twice daily
Other intervention name(s): Rectocare - Ointment
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fissure in Ano; Platelet-Rich Plasma; Lateral Internal Sphincterotomy
A New Portable Monitor for Measuring Odorous Compounds in Oral, Exhaled and Nasal Air
Condition: Halitosis
MeSH terms: Halitosis
Study type: Observational

Summary: 
      The B/B Checker, a new portable device for detecting odorous compounds in oral, exhaled, and
      nasal air, is now available. As a single unit, this device is capable of assessing several
      kinds of gases mixed with volatile sulfur compounds (VSCs) in addition to other odorous
      gasses. The purpose of the present study was to evaluate the effectiveness of the B/B Checker
      for detecting the malodor level of oral, exhaled, and nasal air.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects were recruited at the Clinic of Preventive Dentistry, Okayama University Hospital.
      
Keywords: Halitosis
Secondary Analysis of Gut Hormones and Inflammatory Cytokines in Fasting Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The original study executed between 2002-2004 was an interventional trial in which 20,
      healthy, normal-weight female subjects were randomized to a four-day fast plus daily
      subcutaneous injections of leptin or a four day fast plus daily subcutaneous injections of a
      placebo. The primary endpoints were gonadotropin pulsatility, TSH secretion and thyroid
      function, and cortisol secretion. The current study is a secondary analysis focussed on the
      placebo group which underwent a four-day fast. The study is looking at the effects of fasting
      on gut-derived hormones and inflammatory markers in healthy, normal-weight women. The
      hypothesis for this secondary analysis was that four days of fasting would augment levels of
      orexigenic gut-derived hormones and suppress levels of anorexigenic gut-derived horomones,
      while suppressing secretion of inflammatory cytokines.
    


Intervention name(s): Leptin administration; Fasting
Intervention type(s): Drug; Behavioral
Intervention description(s): Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days.; Complete fasting, save for water and multivitamin, for four days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Fasting; Gut hormones; Inflammatory Cytokines
Treatment of Forehead/Glabellar Rhytide Complex With Combination Botulinum Toxin A and Hyaluronic Acid Versus Botulinum Toxin A Injection Alone
Condition: Forehead/Glabellar Rhytid Complexes
Study type: Interventional

Summary: 
      The objective of this study is to determine whether the use of botulinum toxin (Dysport ®) in
      conjunction with a hyaluronic acid filler (Restylane®) will improve the appearance of
      wrinkles on the forehead and glabella (area between the eyebrows) better than botulinum toxin
      alone. These two products have been FDA approved to improve the appearance of facial
      wrinkles.
    


Intervention name(s): Combination Botulinum Toxin A and Hyaluronic Acid; Botulinum Toxin A
Intervention type(s): Procedure; Procedure
Intervention description(s): One side of subject's face will randomly be assigned combination treatment.; Other side of subjects face with receive Botulinum Toxin A treatment alone.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Low Molecular Weight Heparin in Recurrent Implantation Failure
Condition: Infertility; Fertilization in Vitro; Recurrent Implantation Failure
MeSH terms: Infertility; Recurrence
Study type: Interventional

Summary: 
      Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts
      with in vitro fertilization treatment. The reason is usually obscure. Many empirical
      treatments have been offered without substantial evaluation. Heparin is thought to play a
      role in the embryo implantation process beyond its anticoagulation effects. The proposed
      study aims to assess the effectiveness and safety of empirical administration of low
      molecular weight heparin in patients undergoing a new IVF treatment cycle after multiple
      failed attempts.
    


Intervention name(s): low molecular weight heparin (enoxaparine sodium); crinone 8% gel
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg/kg/day subcutaneously in the luteal phase after IVF treatment; routine luteal phase support with progesterone gel
Intervention MeSH terms: Heparin; Enoxaparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Enoxaparin sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: fertilization in vitro; assisted reproduction; recurrent implantation failure; low molecular weight heparin; heparin; luteal phase
Neurocognitive Follow-Up (FU) Study
Condition: Cognitive Developmental Delay
Study type: Observational

Summary: 
      This is a follow-up study of a recently completed trial (17.14.INF) evaluating the growth of
      pre-term infants. Enrolled children will undergo neurocognitive assessments at 18- and
      24-months of corrected age (CA).
    

Detailed description: 
      This is a follow-up study of a recently completed multi-center, prospective, single-arm,
      open-label interventional trial (17.14.INF - Alprem RTF: NCT03728764) evaluating the growth
      of pre-term infants receiving a two-stage PTF feeding system while in the neonatal care unit
      and continuing until 30 days post-discharge.

      Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected
      age (CA). The timing of the cognitive assessments aligns with routine check-up visits and
      reflect the period at which developmental delays may first become evident.
    

Intervention name(s): Neurocognitive Follow-up
Intervention type(s): Other
Intervention description(s): Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants who have previously participated in the 17.14.INF Alprem RTF study are eligible to
        participate, wherein preterm infants of gestational age ≥ 27 weeks and ≤ 32 weeks with body
        weight <1500g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile
        and ≤90 percentile on the Fenton growth chart had been enrolled.
Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease
Condition: Gastrointestinal Disorders in Parkinson's Disease
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to evaluate the efficacy of STW5 Iberogast, over a 28-day
      period, for the treatment of constipation in parkinsonian patients suffering from
      gastrointestinal disorders.
    

Detailed description: 
      Gastrointestinal disorders are the most common non-motor symptoms of Parkinson's disease
      (PD). They affect the entire intestinal tract and include excess saliva stasis (70% of
      patients), dysphagia (52%), gastroparesis (34-45%), and constipation. Gastroparesis
      participates in dyspepsia and abdominal pain. Constipation, as defined by the international
      standards criteria of Rome III, is present in 59% of PD patients and leads to functional
      impairment in 70% of patients. The mechanism underlying constipation is multifactorial and
      may include slow transit and defecation disorders secondary to anorectal dysfunction. Bowel
      disorders are present in the early stage of the disease and usually precede the onset of
      motor symptoms. They may result from lesions of the enteric nervous system, of the autonomic
      nervous system, and from probable alterations in gastrointestinal motility controlled by the
      central nervous system. The STW5 (Iberogast, Steigerwald, Germany) is a herbal agent composed
      of nine plant extracts, with prokinetic, antispasmodic, prosecretory, anti-inflammatory and
      anti-oxidant properties. These properties have been demonstrated in animals and in human
      pathology, in the treatment of dyspepsia and irritable bowel syndrome. It is the only
      phytotherapeutic agent which efficacy was demonstrated by randomized double-blind trials in
      these indications. In PD, the STW5 could improve constipation due to its prokinetic effects
      of the prosecretory enteric neurons. It could also improve dyspepsia and abdominal pain by
      its antispasmodic properties. We propose to study the efficacy and the safety of STW5 on
      bowel dysfunction in parkinsonian patients, especially on constipation.
    

Intervention name(s): IBEROGAST
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor
Condition: Itch
Study type: Interventional

Summary: 
      In this experiment the investigators would like to assess if papain induces an itch sensation
      comparable to the itch sensation induced by cowhage and to confirm that the mechanism of
      action of papain follows the non-histaminergic pathway.
    


Intervention name(s): Doxepin Topical; Papain; Histamine; Cowhage
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Four of the areas will be treated with doxepin for 1 hour and 30 minutes (with a patch to deposit 1.2 grams of cream). Each patch will be covered with Tegaderm I.V., an occlusive, adhesive dressing (3M), for at least 1½ hours; Papain will be applied by 1 SPT prick thought the skin; Histamine will be applied by 1 SPT prick thought the skin; Cowhage spicules are 1-2 mm in length and have diameter of 1-3 µm at their tip. 30-35 spicules are gently rubbed into a 1 cm diameter skin area.
Intervention MeSH terms: Doxepin; Histamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Study Comparing Pegylated rhG-CSF and rhG-CSF as Support to Breast Cancer Patients Receiving Chemotherapy
Condition: Breast Cancer; Neutropenia; Febrile Neutropenia
MeSH terms: Breast Neoplasms; Neutropenia; Febrile Neutropenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor
      to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was
      independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2
      trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma
      half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to
      determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia
      following chemotherapy in patients with breast cancer.
    


Intervention name(s): Drug: Pegylated rhG-CSF: 100µg/kg; Pegylated rhG-CSF: 6mg; rhG-CSF 5ug/kg/day
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).; Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).; Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer; neutropenia; febrile neutropenia
Combination of Radiation Therapy and Anti-PD-1 Antibody SHR-1210 in Treating Patients With Esophageal Cancer
Condition: Esophageal Neoplasms; Esophageal Diseases; Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma, Squamous Cell; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Esophageal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy and safety of radiation therapy
      combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer
    


Intervention name(s): Radiation; SHR-1210
Intervention type(s): Drug; Drug
Intervention description(s): RT to 60 Gy, 5 x per week，for 6 weeks. Radiation begun the day after the first dose of SHR-1210; SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal Squamous Cell Carcinoma; Radiation; Anti-PD-1 Antibody
A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve
      IBS pain or discomfort and associated symptoms in IBS patients.
    


Intervention name(s): GW427353; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): GW427353
Intervention MeSH terms: Solabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: GW427353; b3-Adrenergic Receptor Agonist; Irritable Bowel Syndrome (IBS); efficacy; tolerability; pharmacokinetics
Study of Efficacy of PEAR-004 in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study was to determine in patients currently being administered
      antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia
      as measured by the Positive and Negative Syndrome Scale (PANSS).

      The overall rationale for the study was to assess the first prescription digital therapeutic
      (PDT) in schizophrenia using a form of proven psychosocial intervention, cognitive behavioral
      therapy (CBT), to supplement standard of care with antipsychotic medications.
    

Detailed description: 
      This was a randomized, sham-controlled, rater-blinded, parallel group trial. Overall, 112
      subjects were randomized 1:1 in to the following groups:

        -  Group A: Clinician-directed pharmacotherapy + PEAR-004

        -  Group B: Clinician-directed pharmacotherapy + sham app An up to 28-day screening period
           included standard screening assessments as defined in the assessment schedule. Eligible
           subjects were randomized on Day 1 into one of the treatment groups.

      Subjects in both groups continued to receive their clinician-directed standard-of-care
      treatment for schizophrenia, including pharmacotherapy. Subjects in Group A used PEAR 004 and
      subjects in Group B used a sham for a period of 12 weeks. Subjects returned to the clinic for
      outpatient visits at Week 4 (day 29), Week 8 (day 57), and Week 12 (day 85). At each visit,
      standard assessments were performed according to the assessment schedule, including PANSS,
      ISST-Plus, CGI, BMQ, MAP-SR, WHOQOL-BREF, BDI-II, ISI, and adverse events (AEs). A final
      follow-up visit was performed at Week 16 (day 115),
    

Intervention name(s): PEAR-004; Sham
Intervention type(s): Device; Device
Intervention description(s): PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable.; PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Digital Therapeutic; CBT; smartphone app; mental disorder; psychosis; acute psychotic reaction; chronic psychosis; failure to recognize what is real; false beliefs; unclear thinking,; confused thinking; auditory hallucinations; paranoia; reduced social engagement; reduced emotional expression
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCGRRx
      in combination with metformin versus placebo + metformin
    


Intervention name(s): ISIS-GCGRRx - Dose Level 1; ISIS-GCGRRx - Dose Level 2; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 doses on alternate days during the first week and then once weekly for 12 weeks; 3 doses on alternate days during the first week and then once weekly for 12 weeks; 3 doses on alternate days during the first week and then once weekly for 12 weeks
Other intervention name(s): Isis 449884; Isis 449884
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; T2DM