bioihbjkbjnl/mcl2 huggingface dataset:
Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the impact on glucose control by inhaled insulin alone or added to two oral
      anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral
      anti-diabetic agents.
    


Intervention name(s): Inhaled Human Insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to
      US-licensed Prolia in women with postmenopausal osteoporosis (PMO).

      Participants will be randomized at the beginning of the Double-blind Core Treatment Period
      (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every
      26 weeks for up to 52 weeks.

      At the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who
      received US-licensed Prolia will be re-randomized to either continue receiving US-licensed
      Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up
      to 78 weeks.

      Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core
      Treatment Period will continue to receive this treatment during the Double-blind Transition
      Period.

      For Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA)
      only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the
      proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO.
    


Intervention name(s): FKS518; US-licensed Prolia
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive FKS518 via subcutaneous injection, every 26 weeks.; Participants will receive US-licensed Prolia via subcutaneous injection, every 26 weeks.
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postmenopausal Osteoporosis; FKS518; Denosumab; US-licensed Prolia
Clinical and Radiographic Evaluation of the Entire Papilla Preservation (EPP) Technique Versus Modified Minimally Invasive Surgical Technique (M-MIST) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial
Condition: Intrabony Periodontal Defect
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      Periodontitis is defined as loss of periodontal attachment due to microbial associated host
      mediated inflammation. This would lead to the apical migration of the junctional epithelium
      allowing the bacterial biofilm to undergo apical widespread along the root surfaces of teeth
      causing bone resorption (Tonetti, Greenwell, & Kornman, 2018).

      The main objective of periodontal surgeries is directed at complete preservation of the
      interdental soft tissues to achieve primary closure over the intraosseous defected sites
      during the early phases of wound healing. Evidence shows that surgical techniques are highly
      predictable in the treatment of pockets associated with deep and shallow intrabony defects
      affected majorly by the selected flap design. The purpose of the flap design of minimally
      invasive periodontal surgery is to overcome the drawbacks of conventional periodontal
      surgeries decreasing the surgical trauma, improving the clot stability, reducing patient
      discomfort post operatively and minimizing the surgical chair time (Aslan, Buduneli, &
      Cortellini, 2017b) Modified Minimally Invasive Surgical Technique (M-MIST) is considered one
      of the latest minimally invasive techniques that have been used in the treatment of
      intraosseous defects, this technique however entails an incision over the defect-associated
      interdental papilla that may jeopardize the volume and complex vascular integrity of the
      interdental tissues, lacking the special flap design that would emphasis clot stability for
      better wound healing. Where a new surgical technique turned entire papilla preservation has
      been developed for protection of the wound without affecting the vascularity of the area.
      (Pierpaolo Cortellini & Tonetti, 2015) This randomized clinical trial compared the clinical
      and radiographic efficacy of entire papilla preservation surgical technique (EPP) to Modified
      minimally invasive surgical technique (M-MIST) in the treatment of periodontal intraosseous
      defects in stage III periodontitis patients.
    


Intervention name(s): Entire Papilla Preservation technique; Modified Minimally invasive Surgical Technique
Intervention type(s): Procedure; Procedure
Intervention description(s): A minimally invasive technique that allow access to the intrabony defect without affecting the interdental papilla related to it; a minimally invasive technique that allow access to the intrabony defect area from the buccal aspect through a horizontal incision below the papilla without elevating it.
Other intervention name(s): EPP; M-MIST
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Combined Ultrasound and Fluoroscopy Guided Cervical Transforaminal Injection
Condition: Chronic Cervical Radicular Pain
Study type: Interventional

Summary: 
      The combined use of Doppler ultrasound and fluoroscopy may increase efficacy and safety
      during cervical transforaminal epidural injection of steroid and local anaesthetic

      The study will detect by which technique we have to start and confirm by the other to reach
      the favourable outcome.
    

Detailed description: 
      In a previous Ultrasound study involving the C5C6 levels, a performance time of 248.8 ± 82.7
      seconds was reported. On the basis of these findings, a 30% difference in performance time
      would represent an effect size of 0.82 and would require 20 patients per group to achieve an
      alpha error of 0.05 and beta error of 0.1. For dropped cases; 5% will be added. So a total
      sample size of 64 patients (32 per group) will be required.

      Statistical Analysis: will be performed using SPSS version 22 statistical software. For
      quantitative data, normality will be first assessed with the Shapiro test and then analyzed
      with the Student t-test. Data that will not have a normal distribution, as well as ordinal
      data, will be analyzed with the Mann-Whitney U test. For binomial data, Fisher exact test
      will be used. All P values presented will be 2-sided and values of less than 0.05 will be
      considered significant.
    

Intervention name(s): Ultrasound guidance with fluoroscopic confirmation; Fluoroscopic guidance with ultrasonographic confirmation.
Intervention type(s): Procedure; Procedure
Intervention description(s): the cervical spine will be sonographically examined to determine the C7 transverse process then after lidocaine skin infiltration, a 22G spinal needle is directed towards the hypoechoic shadow of the nerve root using the in-plane technique. then 1ml of non-ionic contrast will be injected and AP and the oblique foraminal fluoroscopic view will be obtained. After confirmation of correct placement of the needle,(2ml, 8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.; After AP view, alignment or squaring of the target lower end plate, an oblique foraminal view is obtained. Following lidocaine 1% skin infiltration, a 22G spinal needle is directed towards the target foramen then, the superficial ultrasound probe will be applied to delineate the foramen. The needle will be advanced ~3mm towards the dorsal root ganglia under fluoroscopic guidance. After contrast confirmation of needle placement, 2ml,8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19
Condition: Healthy; Chronic Stable Illness
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives are:

        -  To assess the occurrence of adverse events of special interest (AESIs) in participants
           treated with repeated subcutaneous (SC) doses of REGN10933+REGN10987 compared to placebo

        -  To assess the concentrations of REGN10933 and REGN10987 in serum over time after single
           and repeated SC administration

      The secondary objectives are:

        -  To assess the safety and tolerability of repeated SC doses of REGN10933+REGN10987
           compared to placebo

        -  To assess attainment of target concentrations of REGN10933 and REGN10987 in serum after
           single and repeated SC administration

        -  To assess the immunogenicity of REGN10933 and REGN10987
    


Intervention name(s): REGN10933+REGN10987; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneous (SC) every 4 weeks (Q4W); Administered subcutaneous (SC) every 4 weeks (Q4W)
Other intervention name(s): REGN-COV2; Casirivimab; Imdevimab; REGEN-COV™; Ronapreve™
Intervention MeSH terms: Casirivimab and imdevimab drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
Pharmacokinetics of HR17031 Injection in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetics and safety of HR17031 injection, SHR20004 injection and/or
      INS068 injection in healthy subjects
    


Intervention name(s): HR17031 injection ；INS068 injection；SHR20004 injection; HR17031 injection ；INS068 injection；SHR20004 injection; HR17031 injection ；INS068 injection；SHR20004 injection; HR17031 injection ；INS068 injection；SHR20004 injection
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose; INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose; SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose; (INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate sleep onset following administration of zolpidem
      tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.
    


Intervention name(s): zolpidem tartrate sublingual tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.; Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Other intervention name(s): Intermezzo®
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insomnia
Chama Cha MamaToto: a Pilot Study of Peer Support Groups in Kenya
Condition: Pregnancy Related; Group, Peer
Study type: Interventional

Summary: 
      Preventing maternal and newborn deaths remain high on the global agenda. To address this, the
      Academic Model Providing Access to Healthcare (AMPATH), in partnership with the Government of
      Kenya, launched Chama cha MamaToto, a community-led peer-support model that groups women
      together in pregnancy and infancy. Central to the chama approach is the integration of
      health, social and financial literacy education with a savings/loans program.
    

Detailed description: 
      To evaluate the feasibility of chamas, we analysed group attendance rates, GISE
      participation, membership retention, and continuation of the groups beyond the one year. To
      evaluate the effect of chamas, the investigators compared data from a prospective cohort of
      women in chamas with a group of controls who did not belong to a chama, matched for age,
      parity, and location of prenatal care. To evaluate the acceptability of chamas, FGDs were
      carried out with chama and non-chama participants, health providers and community health
      workers.
    

Intervention name(s): Chama cha Mamtoto
Intervention type(s): Behavioral
Intervention description(s): Chama cha Mamatoto is a community-based model of peer support group in pregnancy and infancy that combines health education, relationship building and a savings and loans program, led by community health workers
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Efficacy and Safety of Tofacitinib (TF) With Iguratimod (IGU) on RA
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      RA is a common autoimmune disease that causes joint damage.It is necessary to reach the
      standard as soon as possible and give effective drugs according to the patient's disease
      activity to avoid disability. Tofacitinib(TF) is a new type of oral tyrosine kinase inhibitor
      (JAKi) for the treatment of moderate to severe active RA. However, there is alack of Chinese
      data on the joint scheme, long-term use, maintenance and stop of TF in the real world. We
      will use the new JAK combination regimen to treat RA patients, and carry out long-term
      clinical follow-up for 30 weeks.
    

Detailed description: 
      Objective: To observe the clinical efficacy and safety of TF combined with/ without IGU for
      30 weeks in patients with moderate to severe active RA with different clinical
      characteristics and subgroups by using a prospective cohort , and to find the best
      combination scheme of TF.
    

Intervention name(s): Iguratimod; Tofacitinib; Pred
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.; Tofacitinib,5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.; Pred, 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.
Other intervention name(s): IGU; T-614; TF; Prednisone
Intervention MeSH terms: Prednisone; Tofacitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tofacitinib; Iguratimod
Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone
Condition: Obstetric Labor, Premature
MeSH terms: Premature Birth; Obstetric Labor, Premature; Inflammation
Study type: Interventional

Summary: 
      The aim of this study is to investigate the In Vitro and In Vivo effect of progesterone on
      immature myeloid cells (IMC), inflammation characteristics and maturation into dendritic
      cells (DC).
    


Intervention name(s): Culture with progesterone; Culture without progesterone; Culture with growth factors
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells; Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone; Culture of placental IMC cells with growth hormones only and analysis
Intervention MeSH terms: Progesterone; Mitogens
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Neural Mechanisms of Anesthesia and Human Consciousness (Part 6)
Condition: Anesthesia; Unconsciousness
MeSH terms: Unconsciousness
Study type: Interventional
Phase: Phase 4

Summary: 
      Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and
      electroencephalography (EEG) studies will be carried out to reveal the neural correlates of
      consciousness. Consciousness of the subjects will be manipulated with anesthetic agents
      dexmedetomidine, propofol, S-ketamine and sevoflurane. One-hundred-and-sixty (160) healthy
      male subjects will be recruited to receive EC50 concentration of the anesthetic (40
      dexmedetomidine, 40 propofol, 20 S-ketamine, 40 sevoflurane) or placebo (20) while being
      imaged for cerebral metabolic rate of glucose (CMRglu). Also genetic, immunological and
      metabolomics samples will be taken and analysed to find possible genetic factors explaining
      the variability in drug response and to find chemical fingerprints of acute drug effect.
    

Detailed description: 
      The explanation of consciousness poses one of the greatest challenges to science and
      philosophy in the 21st century. It remains unclear what consciousness is and how it emerges
      from brain activity. Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and
      electroencephalography (EEG) studies will be carried out to reveal the neural correlates of
      consciousness. Consciousness of the subjects will be manipulated with anesthetic agents
      dexmedetomidine acting through α2-agonism, with propofol and sevoflurane both mainly acting
      through the enhancement of gamma-aminobutyric acid (GABA) system, and with S-ketamine acting
      through N-methyl-D-aspartate (NMDA) receptor antagonism. One-hundred-and-sixty (160) healthy
      male subjects will be recruited to receive EC50 concentration of either dexmedetomidine,
      propofol, S-ketamine or sevoflurane, or placebo while being imaged for cerebral metabolic
      rate of glucose (CMRglu). 40 subjects will receive dexmedetomidine, 40 subjects propofol, 20
      subjects S-ketamine, 40 subjects sevoflurane and 20 subjects will receive placebo. Also
      genetic, immunological and metabolomics samples will be taken and analysed to find possible
      genetic factors explaining the variability in drug response and to find possible
      immunological and chemical fingerprints of acute drug effect.
    

Intervention name(s): Dexmedetomidine; Propofol; S-ketamine; Sevoflurane; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous infusion; Intravenous infusion; Intravenous infusion; Inhalation; Intravenous infusion of saline (Ringer's Acetate)
Other intervention name(s): Dexdor; Propofol-Lipuro; Ketanest-S; Sevorane
Intervention MeSH terms: Dexmedetomidine; Ketamine; Propofol; Sevoflurane; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Natural History Study of Patients With Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Observational

Summary: 
      RATIONALE: Gathering information about patients with chronic myelogenous leukemia may help
      doctors learn more about the disease and find better methods of treatment and on-going care.

      PURPOSE: This natural history study is collecting health information and disease-related
      information over time from patients with newly diagnosed chronic myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the impact of current procedures for diagnosis, management, and follow-up on
           disease status of patients with newly diagnosed chronic myelogenous leukemia (CML).

        -  Determine the natural history of patients with CML who achieve response to imatinib
           mesylate.

        -  Determine the health perceptions, symptoms, insurance issues, and work issues of these
           patients.

        -  Determine whether medication compliance and planned dose reduction affect imatinib
           mesylate effectiveness in these patients.

        -  Determine the molecular and biologic factors associated with disease progression and
           good and poor response to imatinib mesylate in these patients.

      OUTLINE: This is a longitudinal, prospective, cohort study.

      Patients complete quality of life, functional status, medical and treatment history, and
      medication questionnaires at baseline and then every 6 months for 5 years.

      Blood samples are collected at baseline and then every 6 months for 5 years. Specimens may be
      examined in the future in gene array studies and mutation analyses.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic myelogenous leukemia of any phase
      
Keywords: accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; meningeal chronic myelogenous leukemia