bioihbjkbjnl/mcl2 huggingface dataset:
Study of Cimzia for the Treatment of Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if Cimzia (certolizumab pegol) is an effective
      treatment for patients with Ulcerative colitis.
    

Detailed description: 
      Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often results in
      significant morbidity as well as impairment in quality of life. Cimzia (certolizumab pegol),
      an inhibitor of tumor necrosis factor-alpha, is an effective treatment for Crohn's disease, a
      similar inflammatory bowel disease. The aims of this study are to determine if Cimzia is
      effective for both the induction and maintenance of response/remission for the patients with
      moderate to severe Ulcerative colitis.
    

Intervention name(s): Cimzia
Intervention type(s): Drug
Intervention description(s): Cimzia 400mg administered via two 200mg subcutaneous injections at weeks 0, 2, and 4; followed by every 4 week dosing.
Other intervention name(s): certolizumab pegol
Intervention MeSH terms: Certolizumab Pegol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcerative colitis; UC; Inflammatory Bowel Disease
Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Lovastatin, Minocycline and the combination
      Lovastatin/Minocycline are effective in treating behavioral symptoms in Fragile X
      individuals.
    


Intervention name(s): Minocycline, then Minocycline/Lovastatin; Lovastatin, then Minocycline/Lovastatin
Intervention type(s): Drug; Drug
Intervention description(s): Participants of this group will take 1 tablet of minocycline 50mg daily for 4 weeks, minocycline 100mg for the following 4 weeks and finally a combined treatment of minocycline 100 mg and lovastatin 40mg for the following 12 weeks.; Participants of this group will take 1 tablet of lovastatin 20 mg daily for 4 weeks, lovastatin 40 mg for the following 4 weeks and finally a combined treatment of minocycline 100 mg and lovastatin 40 mg for the following 12 weeks.
Other intervention name(s): Minocin; Mevacor
Intervention MeSH terms: Minocycline; Lovastatin; L 647318; Dihydromevinolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fragile X Syndrome; Autism; FMR1; FRAXA
Sirolimus in Conjunction With Eylea vs Eylea Alone for Exudative AMD
Condition: Exudative Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine safety and efficacy of intravitreal injections of Sirolimus with adjunct EYLEA
      in subjects with exudative age related macular degeneration (AMD) with persistent
      intraretinal or subretinal edema due to neovascular AMD despite previous intravitreal
      anti-vascular endothelial growth factor (antiVEGF) treatment.
    

Detailed description: 
      This study is a single-center, masked, randomized, 36 week study, designed to evaluate the
      safety and treatment efficacy of intravitreal Sirolimus with adjunct EYLEA® (aflibercept) in
      patients with persistent edema due to neovascular AMD versus EYLEA® (aflibercept) alone.
      Twenty (20) patients will be randomized to receive study medication in a 1:1 ratio. Study
      treatment will be administered by intravitreal injections. The sham injections given in the
      EYLEA® alone group are needleless and they are given in order to help preserve the masking of
      those subjects in that treatment group.
    

Intervention name(s): Sirolimus; EYLEA
Intervention type(s): Drug; Drug
Other intervention name(s): DE-109; aflibercept
Intervention MeSH terms: Sirolimus; Aflibercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: AMD
Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity
Condition: Acute Compartment Syndrome
MeSH terms: Compartment Syndromes
Study type: Observational

Summary: 
      Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring
      tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS).
      Placement of these sensor pads on the surface of the skin must be such that light penetrates
      the intended compartment without inadvertently obtaining measurements of an adjacent
      compartment. The objective of this study is to examine whether the NIRS measurements of each
      compartment truly represent the tissue perfusion of the intended compartment, as indicated by
      the predictable decrease in muscle oxygenation of a given compartment in response to muscle
      fatigue. The investigators hypothesize that the tissue oxygenation values of the stimulated
      compartment will significantly decrease following muscle stimulation, indicating that the
      intended muscle compartment was successfully isolated. Additionally, the investigators
      hypothesize that NIRS values of unstimulated muscle compartments will not change from
      baseline.
    


Intervention name(s): Muscle contraction
Intervention type(s): Behavioral
Intervention description(s): Participants will perform a 30-60 second exercise designed to cause a temporary decrease in muscle oxygenation of a specific muscle group.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study sample will consist of healthy volunteers recruited from the principle
        investigator's private practice.
      
Keywords: near-infrared spectroscopy
Effects of GABA Modulator AZD7325 on Cutaneous Sensation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      GABA (gamma-aminobutyric acid) is the main inhibitory neurotransmitter in the human brain.
      For years, drugs that enhance its effects (e.g., benzodiazepines such as diazepam/Valium)
      have been used to treat various diseases such as epilepsy, insomnia, anxiety or movement
      disorders. However, the use of these medications is often compromised because of their side
      effects, such as sleepiness, memory problems, and addiction.

      Therefore, effort has been made to develop drugs that act more selectively in the brain to
      exert the positive therapeutic effects and are devoid of the unwanted side effects. AZD7325
      is one of these drugs. It has been tested in more than 700 people and so far proved to be
      generally well tolerated. Positron emission tomography (PET) study in humans demonstrated
      that AZD7325 binds to GABA A receptors in the brain after a single dose. Early clinical
      studies have shown that it has less sedative and cognitive adverse events as compared with a
      benzodiazepine lorazepam.

      The investigators now wish to evaluate if effects of AZD7325 can be objectively measured in
      healthy volunteers and to establish which of the drug's outcomes could be utilised for
      further studies in patients with neurological diseases.

      The investigators are especially interested in the effects of AZD7325 on manual dexterity and
      skin sensation of the hand. This can be assessed by a number of simple non-invasive tests of
      object manipulation and detection of different sensory stimuli such as touch, vibration, or
      temperature. Recent studies show that healthy individuals who performed better in similar
      tasks had more GABA in relevant areas of their brain. If performance in these tasks in
      healthy volunteers can be improved by enhancing GABA effects in the brain with AZD7325, this
      would create the grounds for the use of this medication to treat symptoms of certain
      neurological disorders in which motor control and sensation of the hand is impaired (e.g.,
      polyneuropathy).
    


Intervention name(s): 20 mg AZD7325; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single 20 mg oral dose of AZD7325; A single oral dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: GABA modulator; AZD7325; Object manipulation; Cutaneous sensation; Manual dexterity
The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy
Condition: Varicocele
MeSH terms: Varicocele; Hypertrophy
Study type: Interventional

Summary: 
      In varicocele the venous pressure in the prostatic bed is increased .This may result in
      raised hydrostatic pressure which in turn may stimulate prostatic hypertrophy.

      Restoring normal venous drainage is expected to lower hydrostatic pressure followed by
      inhibition of prostatic growth and possibly leading regression in prostatic dimensions.
    

Detailed description: 
      35 male patients, aged 45 years or older, with documented benign prostatic hypertrophy
      (BPH)and varicocele as visualized by ultrasound and/or termography examination will be
      enrolled.

      Each patient will undergo a full urologic examination to exclude possible malignancy as well
      as a thorough medical examination to establish eligibility for treatment.

      In all selected patients the varicocele will be obliterated by means of embolization of the
      spermatic veins.

      The patients will be followed every three months by abdominal ultrasound as well as by serial
      PSA for a period of 6-12 months.
    

Intervention name(s): Sclerotherapy
Intervention type(s): Procedure
Intervention description(s): Super-selective retrograde venography and sclerotherapy of internal spermatic veins and associated venous bypasses and retro-peritoneal collateral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Varicocele
A Study to Evaluate the Effect of a Dual CYP2C19 and CYP3A4 Inhibitor, Fluconazole, on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to test the effect of fluconazole (a dual CYP2C19 and CYP3A4
      inhibitor) on the Pharmacokinetics (PK) of fedratinib. Knowledge of these effects can be used
      to determine if dose adjustments should be considered when fedratinib is coadministered with
      drugs that are dual CYP2C19 and CYP3A4 inhibitors.

      Subjects will be screened for eligibility. Subjects who meet all inclusion criteria and none
      of the exclusion criteria will return to the clinical site on Day -1 for protocol-specified
      assessments, and will be domiciled at the clinical site from Day -1 to Day 27.
    


Intervention name(s): Fedratinib; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): Fedratinib; Fluconazole
Intervention MeSH terms: Fluconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy adult subjects; Fedratinib; CYP2C19; CYP3A4
Evaluation of Visual Acuity With a Reusable Toric Multifocal Contact Lens
Condition: Visual Acuity
Study type: Interventional

Summary: 
      The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the
      visual performance of the study lenses.
    

Detailed description: 
      The study is a bilateral, single-masked, single-arm, 4-visit dispensing study evaluating the
      visual performance of the study lenses.
    

Intervention name(s): Bausch + Lomb Ultra® Multifocal for Astigmatism
Intervention type(s): Device
Intervention description(s): Study Lens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia
Condition: Infectious Disease; SARS-CoV Infection; Covid19
MeSH terms: COVID-19; Communicable Diseases; Infections; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The benefit of the research is to provide information regarding the efficacy and safety of
      Favipiravir plus the Standard of Care (SoC) for mild-moderate COVID-19 patients to be a
      reference for policy recommendations regarding the use of Favipiravir as an antiviral drug
      for the treatment of Covid-19.
    

Detailed description: 
      Pre-screening is assessing patients who meet the inclusion and exclusion criteria. Screening
      was carried out to assess whether the subjects met the inclusion and exclusion criteria.
      Randomization was performed to determine the study drug allocation. The research subjects
      were inpatients at selected hospitals and at the time of recruitment, the time was called D1.
      The next day is called D2 and so on Follow-up will be carried out from the first day of
      recruitment, taking medication up to a maximum of 19 days for test drugs and 11 days for SoC
      drugs. Recording of clinical and laboratory manifestations will be carried out from
      recruitment until the patient returns from the hospital.

      All results will be recorded in a case report form, and if a case of clinical and laboratory
      manifestations is found to be severe, it will be written on the adverse case report form and
      reported immediately according to standard GCP procedures. Subjects may also drop out of the
      study due to discontinuation of follow-up or a protocol violation
    

Intervention name(s): Favipiravir; Azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Assignment of Administration Group 1:
Favipiravir 1600 mg twice a day at day 1 and 600 mg twice a day at day 7-14 + Azithromycin 500 mg once a day for 5 days.; Azithromycin 500 mg once a day for 5 days.
Other intervention name(s): Treatment Group; Group 2
Intervention MeSH terms: Azithromycin; Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: Favipiravir 1600 mg twice a day at day 1 and 600 mg twice a day at day 7-14 + Azithromycin 500 mg once a day for 5 days.
Group 2: Azithromycin 500 mg once a day for 5 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Favipiravir; Covid19; SARS-Cov2
Pravastatin Sodium 40 mg Tablets Food Challenge Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the relative bioavailability of pravastatin 40 mg
      tablets with that of Pravachol 40 mg tablets in healthy adult male subjects under non-fasting
      conditions. A second objective is to compare the difference in plasma levels after dosing the
      test formulation with and without food.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): pravastatin; Pravachol®
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg tablet; 40 mg Tablet
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Healthy Subjects
Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women
Condition: Menopause; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to determine the extent of
      bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a
      marketed estradiol/norethisterone acetate (NETA) preparation.
    


Intervention name(s): 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA); 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA); 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single oral dose of 2 tablets under fasting conditions; A single oral dose of 2 tablets under fasting conditions; A single oral dose of 1 tablet under fasting conditions
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate histological results of the treatments with the
      TempSure Firm handpiece on the flanks performed in the CYN20-FIRM-LIPO study.
    

Detailed description: 
      Up to 10 subjects will be enrolled at up to 3 study centers. Subjects will receive 2
      biopsies, 1 biopsy in the treatment area (the flanks) and 1 biopsy outside of the treatment
      area to serve as a control.
    

Intervention name(s): TempSure treatment
Intervention type(s): Device
Intervention description(s): Self-controlled, single-arm study using the TempSure device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness and Safety of Chinese Medicine to Treat Hand, Foot, and Mouth Disease
Condition: Hand, Foot, and Mouth Disease
MeSH terms: Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional

Summary: 
      The study is aimed to evaluate the effectiveness and safety of Xiyanping injection,a
      traditional Chinese medicine (TCM), in the treatment of severe type of hand, foot, and mouth
      disease (HFMD).
    

Detailed description: 
      By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to
      evaluate the effectiveness, safety and economic evaluation of a traditional Chinese medicine,
      Xiyanping injection,for treatment of HFMD, and to provide scientific evidence for the
      construction of TCM methods in treating HFMD.
    

Intervention name(s): Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge); Xiyanping injection plus western therapy
Intervention type(s): Drug; Drug
Intervention description(s): Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.; Xiyanping injection:5-10mg/kg/d (0.2-0.4ml/kg/d),qd ivgtt; Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
Intervention MeSH terms: Methylprednisolone; Mannitol; Immunoglobulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HFMD; Traditional Chinese Medicine; Xiyanping
Pelvic Floor Muscle Contraction Among Physiotherapy Students Before and After "Women Health" Course
Condition: Pelvic Floor Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      The study aim is to evaluate the ability to correctly contract pelvic floor muscle among
      physiotherapy students before and after "women health" course. Pelvic floor muscle
      contraction will be evaluated via transabdominal ultrasound.
    

Detailed description: 
      Physiotherapy students during their studying in the physiotherapy Bachelor degree program
      will be examined. Students will be divided into 2 groups according to their year of studying
      (if they already studied "women health course or not implying 4th year students compared with
      1-3 year level students). Each participant will be asked to contract the pelvic floor
      muscles.

      The assessment of pelvic floor contraction will be measured by measuring bladder displacement
      via abdominal ultrasound. A curved linear array transducer will be placed in the transverse
      plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the
      vertical. Upward movement of the bladder during contraction will be marked as correct
      contraction. An on screen caliper and measurement tool will be used to measure bladder amount
      of bladder displacement.
    

Intervention name(s): pelvic floor contraction
Intervention type(s): Other
Intervention description(s): Ultrasound examination will be performed to asses urinary bladder displacement being a marker for pelvic floor muscle function
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups according to the year of physiotherapy school.
Masking: Single (Participant)
Primary purpose: Screening
Keywords: pelvic diaphragm, Physiotherapy students, education
Lifting and Tightening of the Face and Neck Following an Increased Density Treatment
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the Ulthera® System for obtaining lift and
      tightening of the cheek tissue, reduction of jowling, and improving jawline definition and/or
      submental skin laxity when increased density treatment is applied.
    

Detailed description: 
      All enrolled study subjects will receive one full face and neck Ultherapy™ treatment. Pre-
      and post-treatment photos will be taken. Subjects will be required to return for follow-up
      visits at 60 days, 90 days, 180 days and 1 year following treatment.
    

Intervention name(s): Ulthera System Treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin.
Other intervention name(s): Ultherapy™; Ulthera, Inc.; Ultrasound treatment for skin tightening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.
Cell-free DNA: a Non-invasive Test for Assessing Embryo Quality
Condition: Culture Media; DNA
Study type: Observational

Summary: 
      In the present project we propose to deeply characterize nuclear and/or mitochondrial DNA in
      embryo culture medium, in order to investigate whether both cell-free nucleic acid types may
      provide additional, reliable, predictive parameters for embryo viability and implantation
      potential.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Culture media from human embryos collected at day 2-7 after in-vitro fertilization.
      
Biospecimen description: 
      After normally fertilized oocytes will be identified, they will be transferred into Sydney
      IVF Cleavage Medium (Cook Medical) for culture from day 1 to day 3 (up to 8 cell stage). For
      a subset of embryos we will also perform culture until blastocyst stage. For this purpose,
      embryos will be transferred into Sydney IVF Blastocist medium (Cook Medical) from day 3 to
      day 5/6. We will focus on embryo development in a single embryo culture medium. Embryos will
      be cultured at 37°C, 6.0% CO2, 5.0% O2 into Galaxy 48R incubators (New Brunswick Scientific).
      At the moment of transfer of embryos into the uterine cavity, we will collect embryo culture
      media into DNase- and RNase-free 1.5 ml tubes (Eppendorf AG). The media will be immediately
      frozen and stored at -20° until nucleic acid purification.
    
Keywords: Human embryo; Culture media; Cell-free DNA; In vitro fertilization; Infertility