bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized, Placebo-controlled Clinical Trial of Teneligliptin as Quadruple Oral Combination Therapy for Type 2 DM After Failure of an Oral Triple Anti-diabetic Regimen
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, placebo-controlled clinical trial of Teneligliptin as quadruple oral
      combination therapy for type 2 diabetes after failure of an oral triple anti-diabetic
      regimen. Patients with uncontrolled type 2 diabetes (7.1% ≤ HbA1c ≤ 9%) prescribed with
      triple combination of oral antidiabetic drugs more than 12 weeks with sufficient doses
      (metformin >= 1000mg/d, Glimepiride >=4 mg/day, Gliclazide >= 60 mg/day, SGLT-2 inhibitor
      with approved dose by Korea FDA) will be included. Using randomization, patients would take
      either teneligliptin (20mg) or placebo for 12 weeks. After 12 weeks of trial, all patients
      would receive teneligliptin for another 12 weeks. As outcomes, changes in HbA1c and fasting
      plasma glucose at 12th and 24th weeks compared with at baseline, and proportions of patients
      who achieved a glycemic goal (HbA1c <=7%) at 12th and 24th weeks will be evaluated.
    


Intervention name(s): teneligliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): teneligliptin 20mg PO qd for 24weeks; teneligliptin 20mg PO qd for 12weeks after placebo 1T PO qd for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to examine the safety, tolerability and pharmacokinetics of transdermal
      delivery of human Growth Hormone (hGH or somatropin) using the ViaDerm device in adult
      patients with Growth Hormone Deficiency Syndrome.
    


Intervention name(s): hGH-ViaDerm™ System (hGH or somatropin); hGH-ViaDerm™ System
Intervention type(s): Drug; Device
Intervention description(s): transdermal patch; Group 1: 0.2 mg/day SC hGH during Period I, and 0.5 mg per transdermal patch during Period III (expected equivalent dose to SC 0.2 mg/day) Group 2: 0.4 mg/day SC hGH during Period I, and 2.0 mg per transdermal patch during Period III (expected equivalent dose to SC 0.4 mg/day) Group 3: 1.0 mg/day SC hGH during Period I, and 5.0 mg per transdermal patch during Period III (expected equivalent dose to 1.0 mg/day); The hGH-ViaDerm™ System is a transdermal delivery system for somatropin (hGH, rDNA origin).
The ViaDerm System™ consists of a medical device component and a printed dry hGH patch component. The device component is comprised of two primary elements: a reusable, computer mouse-like electronic controller and a disposable sterile array, which is inserted onto the base of the controller, delivers RF-current to ablate cells and creates microscopic throughways, termed RF-MicroChannels™, across the stratum corneum into the upper epidermis. The drug component consists of a unique circular transdermal dry hGH patch formulated specifically for use with the ViaDerm™ device. hGH is delivered by passive diffusion through the RF-MicroChannels™ into the systemic circulation system.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential in IVF
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Andrositol® test allows to obtain additional information besides the WHO parameters and to
      evaluate the semen energetic status. The diagnosis is performed by analyzing the semen at two
      different time points: before the treatment and 30' after the addiction of myo-inositol
      directly to the semen. The purpose of this study is to evaluate if the responsiveness to the
      Andrositol® test of a sperm sample can be predictive of its fertilization rate in an ICSI
      (Intracytoplasmic Sperm Injection) cycle (primary outcome). Secondary outcomes as embryo
      development, embryo euploidy status and embryo implantation rate will be evaluated.
    


Intervention name(s): Andrositol® Test
Intervention type(s): Diagnostic Test
Intervention description(s): The intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: myo-inositol; fertilization rate; infertility; Intracytoplasmic Sperm Injection; sperm
Body Image Satisfaction In Relation To Body Mass Index And Self- Esteem Among Chinese Female Students
Condition: Healthy
Study type: Observational

Summary: 
      Body image satisfaction and self- esteem level are important to be known among students in
      order to intervene in a correct time. Body dissatisfaction is one of the factors leading to
      negative self-perception, low mood, depression, and eating disorders. This may be detrimental
      to students in their academic performance. However, the correlations of body image
      satisfaction towards body mass index and self- esteem among university female students are
      still unclear in Malaysia. Thus, the purpose of this study is to determine its relationships
      among Chinese female students. university female participants will be included with
      convenience sampling method. Participants will completed Ronsenberg Self- Esteem Scale and 8
      items version of Body Shape Questionnaire. These 2 scales used to measure level of self-
      esteem and body image satisfaction. Body mass index will be calculated from self- reported
      height and weight. The data will be analysed by using descriptive and correlation methods.
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Chinese female university students in UTAR, Sungai Long campus, Malaysia
      
Keywords: Self esteem; Body mass index
Eszopiclone Treatment & Cortisol Responsivity
Condition: Insomnia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was designed to use a sensitive neuroendocrine probe, the
      Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults
      with insomnia. The primary aim was to assess cortisol reactivity before and after long-term
      (6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone
      would result in a significant reduction in plasma cortisol response to the DEX/CRH test
      following treatment of insomnia with standard dose of eszopiclone.
    

Detailed description: 
      see above
    

Intervention name(s): eszopiclone
Intervention type(s): Drug
Intervention description(s): 6 weeks standard oral therapy
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial will study three doses of reslizumab versus placebo in children with eosinophilic
      esophagitis (EE). The objectives of the trial will be to study the effectiveness of
      reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils
      as well as assessing the safety profile compared to placebo.
    


Intervention name(s): Reslizumab; Saline
Intervention type(s): Biological; Other
Other intervention name(s): CTx55700; Cinquil™; CEP-38072
Intervention MeSH terms: Reslizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eosinophilic Esophagitis; GERD; EE; Reslizumab; IL-5; Interleukin-5; Cinquil
Dapagliflozin Effects on Hypoglycemia
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study will be to test and evaluate if dapagliflozin has an
      effect on the amount of glucagon (a hormone produced by the pancreas and stomach that
      stimulates liver glucose production) produced by the body and if that change will improve
      recovery time from hypoglycemia (low blood sugar) in participants with Type 1 Diabetes.
    

Detailed description: 
      The purpose of this research study will be to test and evaluate if dapagliflozin has an
      effect on the amount of glucagon (a hormone produced by the pancreas and stomach that
      stimulates liver glucose production) produced by the body and if that change will improve
      recovery time from hypoglycemia (low blood sugar) in participants with Type 1 Diabetes. The
      study is a blinded, placebo-controlled, crossover design, where participants will receive
      dapagliflozin during one treatment period and placebo during a separate treatment period with
      neither the study team nor participants knowing what they are receiving at any given time.
      Participants will have 9 clinic visits over the course of 14-16 weeks, with 3 of those visits
      being overnight stays. The overnight stays are intended to control blood sugars in a normal
      state throughout the night and then participants will complete a hypoglycemic challenge the
      following morning. The body's response to the hypoglycemic challenge will provide the
      information needed to determine if dapagliflozin had an effect on recovery time from
      hypoglycemia.
    

Intervention name(s): Dapagliflozin 5mg; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin treatment taken daily for 4-weeks.; Placebo treatment taken daily for 4-weeks.
Other intervention name(s): Farxiga
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Longitudinal Follow-up Study for Food Allergies
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the clinical usefulness of assessing specific human
      allergy antibodies and other immunologic parameters associated with the diagnosis, evolution,
      and management of allergic disease.
    

Detailed description: 
      The purpose of this study is to strengthen our ability to understand the long-term effects of
      food immunotherapy on the immune system and how it may induce tolerance to foods that
      participants were once allergic to. Investigators hope to determine tools and immunologic
      parameters that can help predict sustained desensitization and tolerance to food allergens
      following food immunotherapy. By evaluating the in-depth characteristics of allergy antibody
      populations and other immunologic parameters and comparing them to clinical disease, the
      investigators may uncover a more sound way to diagnose, follow and treat food allergic
      disease over time. Investigators will follow up with participants who underwent immunotherapy
      to food allergens as volunteers in clinical trials at the Sean N. Parker Center and assess
      whether they experience sustained desensitization to these foods in the long-term.
      Investigators will investigate the properties of the participants' immune cells and how they
      are affected over time by the ingestion of these food allergens. Investigators will follow
      the significance of different dosing regimens in terms of achieving tolerance. Differences in
      immune cell characteristics and other biological parameters may help predict the nature of a
      participant's tolerance to the food allergens and may help in the development of tools to
      determine permanent tolerance.
    

Intervention name(s): Immunotherapy
Intervention type(s): Other
Intervention MeSH terms: Immunomodulating Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants who underwent immunotherapy in clinical trial at the Sean N. Parker Center
      
Biospecimen description: 
      Blood Sputum Buccal swab Saliva Urine Stool
    
Keywords: IgE; Allergy; Tolerance; Immunotherapy; Desensitization
Robot-assisted Rehabilitation of the Upper Limb in Acute and Subacute Post-stroke Patients
Condition: Stroke; Cerebrovascular Accident; Upper Extremity Paresis
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      The goal of this study is to determine if robot aided rehabilitation therapy can be
      equivalent to or more effective than conventional rehabilitation therapy at promoting
      functional recovery of the paretic upper limb in acute and subacute stroke patients.
    

Detailed description: 
      The study aims to test a robotic rehabilitation protocol which involves the use of a robotic
      device (NeReBot) as an alternative to the conventional rehabilitation treatment. NeReBot is a
      3-degree-of-freedom robotic device, which can be programmed by the therapist to perform
      repetitive assistive movements (flexion and extension, adduction and abduction, pronation and
      supination, circular) of the upper limb (shoulder and elbow), combined with a visual and
      acoustic display. Acute and subacute stroke patients (≤20 days post-stroke) will be
      randomized into two groups with a procedure by a computer program: the experimental group
      (EG) and the control group (CG). Both groups will receive a total daily treatment time of 120
      minutes for five days a week and for five weeks. The EG will perform the conventional
      functional rehabilitation (proprioceptive exercises, verticalization, gait training, paretic
      hand and wrist mobilization, without mobilizing the proximal paretic arm) and occupational
      therapy for 80 minutes a day, while the proximal paretic arm will be treated by NeReBot for
      40 minutes a day. For the CG, NeReBot therapy is substituted by 40 minutes of conventional
      mobilization of the proximal paretic arm by the therapist.
    

Intervention name(s): Robot therapy (NeReBot); Conventional therapy
Intervention type(s): Device; Other
Intervention description(s): Rehabilitation therapy of the affected arm with NeRebot for five weeks, five times weekly for 40 minutes, plus 80 minutes of conventional therapy; Conventional rehabilitation therapy of the affected arm for five weeks, five times weekly for 120 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebrovascular accident; hemiparesis; recovery of function; rehabilitation; robotics; subacute therapy; training
Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Verify if the quantitative parameters of the eosinophils activation and phagocyte system
      function show a predictive value for clinical response and prognostic in patients with
      persistent asthma treated with montelukast
    


Intervention name(s): montelukast sodium; Comparator: placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): Asthmatic children and teenagers took montelukast daily for 12 weeks.
Children aged 2-5 years took 4mg tablet of montelukast
Children aged 6-15 years took 5mg tablet of montelukast
Children >15 years took 10mg tablet of montelukast; Asthmatic children and teenagers took Placebo tablet daily for 12 weeks.
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Open-label Study to Assess Increasing Levels of NAD+(Nicotinamide Adenine Dinucleotide)
Condition: Increase in Blood Levels of Nicotinamide Adenine Dinucleotide (NAD+)
Study type: Interventional

Summary: 
      The purpose of this study is to assess an effective single oral supplement or combination of
      oral supplements for increasing whole blood NAD+ levels.
    

Detailed description: 
      This is a open-label dose finding study to detect an effective single oral supplement or
      combination of oral supplements for enhancing whole blood levels of NAD+. Each subject will
      receive a specific dose of the formulation once daily for 3 days followed by a washout
      period. Upon completion of the treatment phase, there is a post-treatment period of
      assessments.

      Participants receive assessments of blood tests, vital signs, body weight with completion of
      questionnaires.

      The primary objective of the study is to identify the ideal dosage of an oral supplement to
      increase whole blood NAD+ levels in adults.

      The secondary objective of the study is to monitor for safety from a change in fasting blood
      chemistry panel parameters after three day's dosing compared to cycle baseline.
    

Intervention name(s): Oral supplement A; Oral supplement B; Oral supplement C; Oral supplement D; Oral Supplement D in combination with oral supplement C
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1, 2 or 4 capsules daily of oral supplement A for 3 days; 4 capsules daily of oral supplement B for 3 days; 1,2 or 4 capsules daily of oral supplement C for 3 days; 1 or 2 tablets daily of oral supplement D for 3 days; 1 or 2 tablets of oral supplement D in combination with 2 or 4 capsules of oral supplement C for 3 days
Other intervention name(s): Vitamin B3 derivative; Vitamin B3 derivative; Vitamin B3 derivative; Vitamin B3 derivative
Intervention MeSH terms: Vitamins; Niacinamide; Niacin; Nicotinic Acids; Vitamin B Complex
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
High Dose of Erythropoietin Analogue After Cardiac Arrest
Condition: Comatose Survivors of Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesised that the neuroprotective effects of erythropoietin and its
      analogues could lead to an improve outcome after cardiac arrest. To test this hypotheses, the
      investigators designed a randomized, multicentre, simple blind trial in which all
      participating patients will be receive usual treatments and 50% of them will also receive a
      high dose of epoetin alpha (an analogue of erythropoietin) in an "add on" fashion. The main
      end point will be the proportion of patients in each arm who will reach at day 60 the best
      level of recovery, using a 5 level score.
    

Detailed description: 
      Rationale:

      A recent pilot study showed encouraging results regarding the potentially beneficial effects
      of high dose epoetin alpha (an analogue of erythropoietin) when administered early after
      cardiac arrest. In this open label and non randomized trial, a high proportion of patients
      survived without significant cerebral disability and without experiencing severe adverse
      events (CARIOU et al. Resuscitation 2008). Efficiency of this treatment should now be
      evaluated in a randomized trial.

      Hypotheses:

      An early administration of a high dose of epoetin alpha (Epo) after cardiac arrest
      resuscitation could improve the neurological outcome of these patients by comparison with
      standard treatment. The proportion of patients reaching the level 1 of the Pittsburgh CPC
      scale (i.e., no or minor cerebral disability) at day 60 could attain 45% in the
      interventional group versus 30% as expected in the control group.

      Design:

      Multicentre, randomised, controlled, simple blind trial ("add on study").

      Main goal:

      To test the efficiency of a high dose of Epo administered at the early stage of the
      post-cardiac arrest period regarding its ability to improve the neurological outcome of these
      patients, when compared with standard care (including hypothermia when indicated).
    

Intervention name(s): EPOETINE ALPHA; Control arm
Intervention type(s): Drug; Other
Intervention description(s): 5 injections of 40000 UI of EPO; Usual take care of cardiac arrest
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac arrest; erythropoietin; post-anoxic encephalopathy; neuroprotective drugs
A Study to Assess the Effects of Epetraborole on the QT Interval in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, 4-way crossover study to evaluate the effect of single therapeutic and
      supratherapeutic oral doses of epetraborole on the heart rate (HR) corrected QT interval
      (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.
    

Detailed description: 
      On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose
      of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B),
      a single dose of epetraborole-matching placebo (Treatment C), or a single dose of
      moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole,
      metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours
      postdose in each period.

      There will be a washout of at least 10 days between doses.
    

Intervention name(s): Epetraborole and matching placebo; Epetraborole; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A (Therapeutic): 500 mg epetraborole (2 x 250 mg tablets) and epetraborole matching-placebo (6 tablets); Treatment B (Supratherapeutic): 2000 mg epetraborole (8 x 250 mg tablets); Treatment C (Placebo control): Epetraborole matching-placebo (8 tablets); Treatment D (Positive control): 400 mg moxifloxacin (1 x 400 mg tablet)
Other intervention name(s): Therapeutic; Supratherapeutic; Placebo Control; Positive Control
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Screening of subjects will occur within 28 days prior to the first dosing. Subjects will be housed on Day -1, at the time indicated by the CRU, until completion of study procedures on Day 2 of each period. On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B), a single dose of epetraborole matching-placebo (Treatment C), or a single dose of moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole, metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours postdose in each period. There will be a washout of at least 10 days between doses. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations, including a follow-up visit approximately 14 days after the last dose.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: QTc; Epetraborole