bioihbjkbjnl/mcl2 huggingface dataset:
A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the safety,
      tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as
      tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.

      The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or
      insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2
      diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and
      placebo.
    


Intervention name(s): NN1952; insulin aspart; placebo; NN1952; insulin aspart; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.; As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.; Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.; Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.; As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.; Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders
Condition: Ovarian Diseases
MeSH terms: Ovarian Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to compare the effectiveness of testosterone,estradiol and a
      combined treatment with estrogens/progestagens prior to IVF-ICSI in previously diagnosed low
      responder patients.
    

Detailed description: 
      During controlled ovarian hyperstimulation (COH), most of the early antral follicles are
      required to grow coordinately. Marked follicular size discrepancies during COH imply that an
      important number of follicles undergo unsatisfactory maturation. It has been proved that
      follicular priming with estradiol during the luteal phase of the cycle prior to COH or
      testosterone treatment during the early follicular phase of the COH cycle may increase the
      amount of oocytes and embryos retrieved. Nevertheless there are no prospective studies
      comparing such approaches. The present study consist of two phases:

      The present study consists of two different phases:

        -  Phase I: (Non randomized) Identification of confirmed low responder patients. Potential
           low responder patients will be subjected to an standardized ovarian hyperstimulation
           protocol

        -  Phase II: (Randomized) those patients, once confirmed as low responders, will be offered
           the opportunity to enter the interventional part of the study, being randomized to three
           different treatment groups: estradiol, testosterone or combined progestagens and
           estrogens prior to the IVF-ICSI cycle. The previous cycle (phase I) will be used as a
           self-control for each patient.
    

Intervention name(s): Testosterone; Estradiol; CombEq
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Transdermal testosterone (20µg/kg/day)from day 24 of the previous cycle to day 2 of the ICSI cycle; Transdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle; (150µg Desogestrel + 30µg Ethinylestradiol)/day during the luteal phase of the two cycles prior to the ICSI.
Valerate estradiol 4mg/day during 10 days, starting the second day of the cycle prios to the ICSI cycle.
Other intervention name(s): Testopatch, Pierre Fabre Ibérica S.A.; Alcis 100, Chiesi España; Microdiol, MERCK SHARP & DOHME; Meriestra 2mg, Novartis Farmacéutica, S.A.
Intervention MeSH terms: Estradiol; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: estradiol; testosterone; combined oral contraceptive; low responders; ICSI
Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study
Condition: Myelodysplasia
MeSH terms: Preleukemia; Myelodysplastic Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to compare outcome of high risk myelodysplasia patients aged
      from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk
      myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever
      thrombocytopenia. Patients are registered when they acquire risk factors.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients from 50 to 70 years with high risk myelodysplasia and eligible for transplantation
      
Keywords: myelodysplasia; allogeneic hematopoietic stem cell transplantation; Survival; Transplantation
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
Condition: Healthy Subjects; Pharmacokinetics of ASP2408
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK)
      of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female
      subjects and to evaluate the pharmacodynamics of ASP2408.
    

Detailed description: 
      This is single-dose escalation study composed of 8 sequential cohorts of healthy subjects
      receiving increasing doses of intravenously administered ASP2408 or matching placebo.
      Subjects will be confined in the clinic for 8 days.
    

Intervention name(s): ASP2408; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intravenous; intravenous
Intervention MeSH terms: ASP2408
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy subjects; ASP2408; pharmacokinetics
Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Although liver transplantation provide a option to cure patients suffering with decompensated
      liver cirrhosis this condition, lack of donors, postoperative complications, especially
      rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells
      (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued
      experimental liver failure and contributed to liver regeneration, which suggest the novel and
      promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord
      mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver
      cirrhosis will be evaluated.
    

Detailed description: 
      To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells
      transplantation in patients of decompensated liver cirrhosis.
    

Intervention name(s): conventional therapy plus low dose hUC-MSCs treatment; conventional therapy plus medium dose hUC-MSCs treatment; conventional therapy plus high dose hUC-MSCs treatment
Intervention type(s): Biological; Biological; Biological
Intervention description(s): patients will receive the conventional therapy plus low dose hUC-MSCs treatment; patients will receive conventional therapy plus medium dose hUC-MSCs treatment; patients will receive conventional therapy plus high dose hUC-MSCs treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Decompensated Liver Cirrhosis; Umbilical Cord Mesenchymal Stem Cells
This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding
      study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria
      (CSU) patients inadequately controlled by H1-antihistamines
    

Detailed description: 
      This was a global Phase 2b multicenter, randomized, double-blind, parallel-group,
      placebo-controlled study investigating the efficacy, safety and tolerability of six dosing
      groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with
      (second generation) H1-antihistamine. The study comprised of the 7 treatment arms: LOU064 10
      mg q.d., LOU064 35 mg q.d., LOU064 100 mg q.d., LOU064 10 mg b.i.d, LOU064 25 mg b.i.d.,
      LOU064 100 mg b.i.d. and placebo.
    

Intervention name(s): LOU064 Arm 1; LOU064 Arm 2; LOU064 Arm 3; LOU064 Arm 4; LOU064 Arm 5; LOU064 Arm 6; Placebo arm
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 mg LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85; 35 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85; 100 mg of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85; 10mg bid of LOU064 orally, twice daily from Day 1 to 85; 25 mg bid of LOU064 orally, twice daily from Day 1 to 85; 100 mg bid of LOU064 orally, twice daily from Day 1 to 85; Matching placebo, orally, twice daily from Day 1 to 85
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a global Phase 2b multicenter, randomized, double-blind, parallel-group, placebocontrolled study investigating the efficacy, safety and tolerability of 6 dosing groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with (second generation) H1-antihistamine. Study duration was 18 weeks (2 weeks of screening period; 12 weeks of treatment period and a 4 weeks follow-up period).
Study had 7 arms: 10 mg LOU064 q.d.; 35 mg LOU064 q.d.; 100 mg LOU064 q.d.; 10 mg LOU064 b.i.d.; 25 mg LOU064 b.i.d.; 100 mg LOU064 b.i.d.; and Placebo
Throughout study, subjects were treated with a 2nd generation H1-antihistamine at a locally approved licensed posology ("background medication"). Subjects could take an additional second generation H1-antihistamine that was eliminated primarily via renal excretion (e.g. cetirizine, levocetirizine or bilastine) as rescue medication. Eligible subjects could roll over to extension at Wk 12 or Wk 16
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BTK inhibitor; Urticaria Activity Score; Angioedema Activity Score; CSU
Prevention and Treatment of Voice Problems in Teachers
Condition: Voice Disorder
MeSH terms: Voice Disorders
Study type: Interventional

Summary: 
      The proposed series addresses the prevention and treatment of voice problems in teachers.
      Data in the literature clearly identify voice disorders as teachers' primary occupational
      risk not only in the U.S. but also internationally. Moreover, voice problems constitute a
      global women's health concern. Until recently, few reports have been available around the
      treatment of these problems in teachers, and even fewer have addressed the equally important
      question of prevention. The present studies are conducted within the context of a long-range
      goal to identify effective intervention methodologies for both the prevention and treatment
      of voice problems in teachers taking into consideration multicultural and linguistic factors.
      The present studies will report pragmatic data around the effectiveness of two
      theoretically-driven approaches to the prevention and treatment of voice problems in
      teachers, (a) voice hygiene education (VH) and (b) voice hygiene education + voice production
      training in "resonant voice" (VH+VP, essentially the Lessac-Madsen Resonant Voice Therapy
      program). Participants will be student teachers in Pittsburgh and Hong Kong, who will be
      followed from student teaching across their second full year of employment as a professional
      teacher. The central aims are: [1] to evaluate the effectiveness of VH and VH+VP for the
      prevention of future voice problems in student teachers who are vocally healthy at the outset
      of the protocol, versus the treatment of voice problems in student teachers who already have
      them at some level; [2] to evaluate the generality of the findings across teachers in the
      U.S. and China, using appropriate linguistic and cultural adaptations of the interventions;
      and [3] to evaluate the feasibility of an internet-based voice exercise and reporting program
      as a supplement to face-to-face interventions. Ergonomic and personal factors will also be
      evaluated for their differential ability to predict the risk for future voice problems in
      teachers. The results should be useful at a practical level, and should also lay the
      groundwork for future studies assessing similar issues around the prevention of voice
      problems in teachers, in particular as influenced by multicultural factors within the U.S.
      The results should also be useful for future studies investigating causal pathways in
      interventions around these problems.
    


Intervention name(s): voice hygiene; VH + VP
Intervention type(s): Behavioral; Behavioral
Intervention description(s): subjects will receive voice hygiene training; subjects will be trained in voice hygiene and voice production training
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Student teachers with normal or mildly disordered voices
Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk
      in type 1 diabetes (T1D). Non-esterified fatty acid elevation is a significant contributor to
      IR in T1D and may be a target of intervention. The hypothesis of the study is that isolated
      fatty acid lowering with acipimox will improve insulin action and blood vessel function and
      have the benefit of reducing mitochondrial oxidant generation and improving mitochondrial
      function in T1D. Targeting IR through fatty acid lowering is a novel approach to T1D
      treatment that may significantly improve current management of TID and of cardiovascular
      disease (CVD) risk in this high risk population.
    


Intervention name(s): Acipimox; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.; Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day
Other intervention name(s): Olbetam
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; insulin; blood vessel; type 1
Insulin Resistance and Metformin Use on Volume of Benign Thyroid Nodules
Condition: Thyroid Nodule; Insulin Resistance
MeSH terms: Thyroid Nodule; Insulin Resistance; Thyroid Diseases
Study type: Interventional

Summary: 
      It has been shown that insulin might be involved in the pathogenesis of thyroid growth.

      Objective To evaluate the impact of IR and metformin use on the volume of benign thyroid
      nodules (TNs).

      Methods A randomized clinical trial to placebo (P) or MTF use. Previous fine needle
      aspiration confirming the diagnosis is necessary to inclusion. Patients will receive similar
      tablets of MTF and placebo and instruct to take 3 tablets/day of MTF (500mg/tablet). Thyroid
      volume, as TN volume, will be assess by ultrasound, both in the beginning, six months and one
      year after randomization, by the same researcher blinded regarding location group. Blood
      samples to measure: TSH, FT4, TPO-Ab, lipid profile, glucose and insulin were done after 8h
      fasting.
    

Detailed description: 
      It has been shown that insulin might be involved in the pathogenesis of thyroid growth.
      Previous studies suggest that metformin (MTF) therapy decreased thyroid volume and nodule
      size in subjects with insulin resistance (IR).

      Objectives To evaluate the impact of IR and metformin use on the volume of benign thyroid
      nodules (TNs).

      Methods A randomized clinical trial to placebo (P) or MTF use. Previous fine needle
      aspiration confirming the diagnosis is necessary to inclusion. Exclusion criteria were:
      nodules with a predominantly cystic pattern, pregnancy, diabetes, acromegaly, previous use of
      MTF, levothyroxine, corticoid or any weight loss medication in the past six months, hepatic
      or cardiac insufficiency, creatinine levels > 1.4 mg/dL and MTF intolerance doses >1.0
      gram/day. Patients will receive similar tablets of MTF and placebo and will be instructed to
      take 3 tablets/day of MTF (500mg/tablet). Thyroid volume, as TN volume, will be accessed by
      ultrasound, both in the beginning, six months and one year after randomization, by the same
      researcher blinded regarding location group. Blood samples to measure: TSH, FT4, TPO-Ab,
      lipid profile, glucose and insulin were done after 8h fasting.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg metformin three times daily; 500 mg placebo three times daily
Other intervention name(s): MTF; PLC
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized clinical trial with two groups: to use placebo or Metformine
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: thyroid; insulin; thyroid nodule; insulin resistance; thyroid volume; metformin
A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants
Condition: Health Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of BMS-986209 in
      healthy participants. The first-in-human study is designed in 3 parts that vary based on
      duration and food effect.
    


Intervention name(s): BMS-986209; BMS-986209 Placebo; Itraconazole; Diltiazem
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Itraconazole; Diltiazem
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Participants
MRI Study of High Definition Transcranial Electrical Stimulation in Chronic Tinnitus (MRI HDtES-T)
Condition: Tinnitus, Subjective
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      The purpose of this research is to understand how a neurostimulation technique, transcranial
      electrical stimulation (tES), affects brain function in adults with chronic subjective
      tinnitus measured with functional magnetic resonance imaging (fMRI). This study targets a
      specific kind of tES called transcranial direct current stimulation (tDCS), where a mild,
      constant current is passed between electrodes placed on the scalp.
    

Detailed description: 
      This is an investigator-initiated MRI study of High Definition (HD) transcranial electrical
      stimulation (tES) in adults with chronic subjective tinnitus. HDtES is a mild, noninvasive
      form of brain stimulation using small electrodes to target a small part of the brain/cortex.
      Primary outcomes are changes in brain function and connectivity measured with MRI before and
      after a single 20-minute session of HDtES. Secondary outcomes are changes in tinnitus
      symptoms after 20-minutes of HDtES on 5 consecutive days.
    

Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effect of Insoles in Patients With Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic; Foot Orthoses; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      Demonstrate that custom-made insoles improve painful symptomatology, health and foot function
      in subjects with SLE and podiatric involvement.
    


Intervention name(s): Custom-Made Foot Orthoses; Placebo
Intervention type(s): Device; Device
Intervention description(s): The foot orthoses were custom made using phenolic foam molds of the feet. They consisted of a polypropylene layer of 2 mm from heel to just proximal to the metatarsal heads, an upper sheet of 30 Shore A polyethylene foam.; The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Lupus Erythematosus, Systemic; Foot Orthoses; Foot; Pain