bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is
      safe and how it goes in and out of the body in healthy people. PF-07817883 is for the
      potential treatment of COVID-19. Participants will take PF-07817883 by mouth up to 2 times a
      day. This study may also evaluate how much PF-07817883 gets into the body when taken as pill.
      We may study if people's diets can affect this study medicine. We may also examine how
      PF-07817883 is processed and removed by the human body. Finally, we may look into if
      PF-07817883 has potential to interact with midazolam.
    

Detailed description: 
      Combined 6-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3:
      Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5: Drug-drug
      interaction with midazolam Part-6: Supratherapeutic exposure Part-1,2 and 6 are double blind,
      sponsor open and Part-3,4 and 5 are open label study.
    

Intervention name(s): PF-07817883; Placebo; Midazolam; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral suspension or solid oral formulation(s); Placebo suspension; midazolam oral solution; Moxifloxacin 400 mg tablet
Intervention MeSH terms: Moxifloxacin; Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: PART-1 and -2 are a randomized, double-blind, sponsor-open, placebo-controlled trial to evaluate safety, tolerability and PK of single and multiple escalating oral doses of PF 07817883 in healthy adult participants, respectively. PART-1 is crossover while PART-2 is parallel cohort study design. PART-2 of the study may also evaluate the safety, tolerability and PK in Japanese and Chinese participants. PART-3 is a randomized, open-label, cross-over, study to evaluate relative bioavailability and food effect of up to 2 new PF 07817883 oral formulations. PART-4 is an open label, non-randomized, single period cohort to evaluate the metabolism and excretion of PF 07817883. PART-5 is an open-label, randomized, cross-over cohort to evaluate the effect of steady state PF-07817883 on PK of midazolam in healthy participants. PART-6 is a sponsor-open, randomized, 3-treatment, 3-period, cross over study to evaluate safety, tolerability, and PK of PF 07817883 at supratherapeutic exposure.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Oral Antiviral; COVID-19; Protease Inhibitor; Mpro; PF-07817883
Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation
      treatment for tinnitus.
    

Detailed description: 
      Participants with chronic tinnitus will be provided with a CE marked neuromodulation device.
      Devices will be programmed with one of 3 stimulation parameter settings. After 12 weeks of
      use, differences in tinnitus severity scores will be compared between the 3 arms and within
      the arms for patient subtype analysis.
    

Intervention name(s): PS1; PS2; PS3
Intervention type(s): Device; Device; Device
Intervention description(s): Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are synchronous with the tones.; Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones.; Participants in this arm shall be given an audio stimulus which comprises of a sequence of single-frequency tones mixed with a broadband noise with the frequency characteristics of both chosen outside the region of any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bi-modal neuromodulation
Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?
Condition: Pre Diabetes; Insulin Resistant
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The possibility that obesity-associated inflammatory changes may play a role in the
      pathogenesis of type 2 diabetes (2DM) has led to increased interest in the possibility that
      salicylates might represent a useful treatment to improve glucose tolerance. Several studies,
      performed in patients with 2DM, as well as in nondiabetic, obese individuals, have
      demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but
      have not led to a coherent view as to the mechanism(s) involved.

      In this research proposal we will use specific methods to quantify insulin mediated glucose
      uptake (IMGU), glucose-stimulated insulin secretion rate (GS-ISR), and insulin clearance
      (I-Cl) in overweight/obese, nondiabetic, insulin resistant individuals. We will use the
      insulin suppression test (IST) to quantify IMGU in nondiabetic, overweight/obese volunteers
      to identify those individuals who are sufficiently insulin resistant to be enrolled in this
      study. We will then use the graded glucose infusion technique in these insulin resistant
      subjects to generate specific measures of both GS-IS and I-Cl. Following these baseline
      measurements, salsalate or placebo will be administered for one month to the participants,
      after which time the IST and the graded glucose infusion will be repeated to quantify and
      compare the changes in IMGU, GS-ISR, and I-Cl that have resulted from salsalate versus
      placebo. These results will provide for the first time quantitative data of the effect of
      salicylates on IMGU, GS-ISR, and I-Cl in overweight/obese, insulin resistant, nondiabetic
      individuals.
    


Intervention name(s): salsalate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner; Participants will take 3 tablets with breakfast and 4 tablets with dinner
Intervention MeSH terms: Salicylsalicylic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: insulin resistant
Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance; Hypersensitivity; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult
      population suffers the disease.

      Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is
      a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have
      benefits on blood pressure, triglycerides levels and help to raise the levels of high density
      lipoproteins cholesterol (c-HDL).

      The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome,
      insulin sensitivity and insulin secretion.

      The investigators hypothesis is that the administration of dapagliflozin modifies the
      metabolic syndrome, insulin sensitivity and insulin secretion.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial its going to carry out in 24
      patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes
      Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and
      acid uric are going to be load after a 75 g of dextrose load.

      12 patients will receive Forxiga (dapagliflozin), 10 mg, one per day before breakfast during
      3 months.

      The remaining 12 patients will receive placebo at the same dose.

      There will be calculated Area Under the Curve of glucose and insulin, total insulin secretion
      (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin
      sensitivity (Matsuda index).

      This protocol it's already approved by the local ethics committee and written informed
      consent it's going to be obtained from all volunteers.

      Results will be presented as mean and standard deviation. Intra and inter group differences
      are going to be tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively;
      p≤0.05 it's going to be considered significant.
    

Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.; Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Other intervention name(s): Forxiga; Calcined magnesium
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: metabolic syndrome; forxiga; dapagliflozin; insulin secretion; insulin sensitivity
The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to demonstrate, that there is no difference in metabolic control
      in patients with type 2 diabetes mellitus and therapy with human insulin with or without
      injection-meal-interval.
    


Intervention name(s): injection-meal-interval
Intervention type(s): Procedure
Intervention description(s): The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences:
Group A: with injection-meal-interval: 50 patients educated to inject the insulin with an injection-meal-interval of 15 minutes
Group B: without injection-meal-interval: 50 patients educated to inject the insulin without injection-meal-interval
Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: injection to meal time; human insulin
Cord Blood Infusion for Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; ASD; Autism; PDD
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single site, prospective, randomized, double-blind study of a single intravenous
      autologous or allogeneic, unrelated cord blood (CB) infusion in children ages 2-7 years with
      Autism Spectrum Disorder (ASD). Participants will be randomly assigned to Sequence A,
      consisting of a single infusion of CB cells at baseline followed 6 months later by a single
      infusion of placebo, or Sequence B, consisting of an infusion of placebo at baseline followed
      6 months later by an infusion of CB cells. All participants will ultimately be treated with
      CB cells at some point during the study. Participants with an available qualified autologous
      CB unit will receive autologous cells, and those without a suitable autologous CB unit
      available will receive cells from a ≥4/6 HLA-matched, ABO-matched allogeneic, unrelated donor
      CB unit from the Carolinas Cord Blood Bank. All infusions will be double-blinded. The primary
      outcomes will be assessed 6 months after the initial infusion in the sequence. Additional
      testing for secondary exploratory analyses will be performed at 12 months. Duration of study
      participation will be 12 months from the time of baseline infusion.
    


Intervention name(s): Cord Blood Infusion; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Role of Dietary Protein on Satiety, Food Intake and Thermic Effect of Food
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Objectives: To determine the effect of protein content of familiar breakfast meals on
      subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in
      normal weight (NW) and overweight (OW)/obese (OB) children.

      Specific Objectives:

      1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying
      in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food
      intake at a test meal 4 h later in NW and. OW/OB children.

      1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in
      protein (optimal protein from Objective 1a) or low in protein on TEF and substrate
      utilization over 5 h in NW and OW/OB children.
    

Detailed description: 
      Hypothesis: The investigators hypothesize that increasing the high-quality protein content of
      a breakfast meal will dose dependently increase subjective satiety, lower FI and glycemic
      response, and increase the TEF in both NW and OW/OB children.
    

Intervention name(s): Control Meal; Low Protein Meal; Moderate Protein Meal; High Protein Meal
Intervention type(s): Other; Other; Other; Other
Intervention description(s): High carbohydrate meal; Omelet with 15 g of protein; Omelet with 30 g of protein; Omelet with 45 g of protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Dietary Protein; Satiety; Food Intake; Thermic Effect of Food; Diet Induced Thermogenesis
Prasugrel With Lower Dose - Loading Dose
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent
      platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested
      especially in East Asian ethnicities. The investigators compared the effect of lower loading
      dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.
    

Detailed description: 
      Although clopidogrel together aspirin has been a backbone of anti-platelet therapy in
      coronary artery disease patients, clopidogrel has several limitations. It has delayed onset
      of peak concentration and pharmacodynamic inter-patient response variability resulting in
      high on-treatment platelet reactivity (HPR). Those demerits are known to be associated with
      adverse cardiovascular outcomes.

      Prasugrel has a more effective metabolism pathway than clopidogrel and exhibits more rapid
      and potent platelet inhibition. Recent guidelines recommend prasugrel as a first line
      antiplatelet agent or put precedence over clopidogrel for the patients with acute coronary
      syndrome. However, there have been concerns of different pharmacodynamic and pharmacokinetic
      response to prasugrel in East Asian ethnicities.

      In addition, lower loading dose of prasugrel exhibited more potent pharmacodynamic effect
      than clopidogrel 600 mg with comparable efficacy compared to conventional loading dose of
      prasugrel in healthy Korean subjects.

      The investigators compare the antiplatelet effect of lower loading dose of prasugrel 30 mg
      with conventional loading dose of clopidogrel 600 mg and prasugrel 60 mg in Korean coronary
      artery disease patients undergoing elective coronary angiography.
    

Intervention name(s): Clopidogrel 600 mg; Prasugrel 30 mg; Prasugrel 60 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel; Patients administer 30 mg of prasugrel as lower loading dose of prasugrel.; Patients take 60 mg of prasugrel as conventional loading dose of prasugrel.
Other intervention name(s): Plavix 600 mg; Effient 30 mg; Effient 60 mg
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary artery disease; prasugrel; platelet function tests
Phase I/II Study of PRO044 in Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to see whether PRO044 is safe and effective to use as medication
      for DMD patients with a mutation around location 44 in the DNA for the dystrophin protein.
    

Detailed description: 
      To assess the effect of PRO044 at different dose levels in subjects with Duchenne muscular
      dystrophy To assess the safety and tolerability of PRO044 at different dose levels in
      subjects with Duchenne muscular dystrophy To determine the pharmacokinetics of PRO044 at
      different dose levels after subcutaneous and intravenous administration in subjects with
      Duchenne muscular dystrophy.
    

Intervention name(s): PRO044 SC; PRO044 IV
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection, once a week, for five weeks; Intravenous injection, once a week, for five weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study aims to evaluate the asthma control status, asthma symptoms (severity, frequency,
      and limitations on activities, etc.), QOL, and use of drugs for asthma attack in adult asthma
      patients.
    

Detailed description: 
      Rationale for this Non-Interventional Study According to the Japanese Asthma Prevention and
      Management Guideline 2015 (Japan guideline (JGL) 2015), the goal in the management and
      treatment of asthma is "to be able to lead a life like a healthy individual." In order to
      achieve this therapeutic goal, the achievement of "well-controlled" state based on the asthma
      control status is considered to be a clinical goal. However, there are few studies in which
      the asthma control status is accurately surveyed in a real life setting in adult asthma
      patients receiving continued treatment from physician in Japan and the actual situation is
      unknown. By understanding the status of asthma control in asthma patients in a real life
      setting, the clinical issues could be clarified. Therefore, such information would contribute
      to appropriate treatment of asthma.

      Thus, we planned this study to evaluate the asthma control status, asthma symptoms (severity,
      frequency, and limitations on activities, etc.), Quality of line (QOL), and use of drugs for
      asthma attack in the study population in a real life setting by recruiting patients through
      medical institutions providing continued care for asthma patients.

      Objectives of this Non-Interventional Study

        1. Primary objective

           To assess the proportion of adult asthma patients receiving continued treatment from
           physician in Japan in each asthma control status defined by JGL 2015
           ("poorly-controlled," "insufficiently-controlled," and "well-controlled").

        2. Secondary objectives

      To evaluate asthma symptoms (intensity, frequency, and limitations on activities, etc.), QOL,
      use of drugs for asthma attack, and emotional feelings in the study population; and to
      investigate the effects of demographic characteristics and pathologic properties of each
      patient on the status of asthma control, asthma symptoms, QOL, use of drugs for asthma
      attack, and emotional feelings.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult asthma patients receiving continued treatment by physician in Japan
Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Condition: Rectal Neoplasms
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary:

        -  To assess complete pathological response rate of both strategies.

      Secondary:

        -  Safety profile

        -  To assess downstaging rate of both strategies.

        -  To compare relative dose intensity of oxaliplatin and capecitabine of both strategies

        -  To compare time to progression and overall survival of both strategies.
    


Intervention name(s): Oxaliplatin, capecitabine; Oxaliplatin, capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery; XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.
Other intervention name(s): Radiotherapy; Radiotherapy
Intervention MeSH terms: Capecitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment