bioihbjkbjnl/mcl2 huggingface dataset:
Single Ascending Dose Study of TD-0714 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TD-0714 in healthy subjects.
    


Intervention name(s): TD-0714; Placebo Comparator
Intervention type(s): Drug; Drug
Intervention description(s): One time dosing in capsule formulation; One time dosing in capsule formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Single ascending dose; volunteers; Phase 1; first-in-human; TD-0714
Effect of Fasting on Ghrelin and Growth Hormone in Healthy Young and Older Adults
Condition: Aging
Study type: Observational

Summary: 
      The overall objective of this study is to determine the extent to which circulating ghrelin
      levels (total and bioactive ghrelin) are regulated by nutritional state and age.
    

Detailed description: 
      Normal volunteers: young and older men and women studied under fed and fasting (total 62.5h)
      conditions, frequent blood sampling for ghrelin and other related hormones
    

Intervention name(s): Fasting
Intervention type(s): Other
Intervention description(s): normal volunteers fast from food on one occasion for 62.5 h; on another occasion fed 3 meals
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        normal volunteers
      
Keywords: ghrelin; growth hormone; aging; normal volunteers
Brain-oscillation Synchronised Stimulation of the Prefrontal Cortex
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Combining TMS and EEG, this study investigates a personalized therapeutic non-invasive brain
      stimulation protocol in patients with major depression, whereby the timing of the TMS pulses
      is synchronized with the instantaneous phase of ongoing brain oscillations in order to
      modulate the inter-hemispheric left and right dorso-lateral prefrontal cortical brain
      network.
    

Detailed description: 
      Major depressive disorder is a severe psychiatric illness with a lifetime prevalence of about
      8-16%. Many patients fail to achieve complete remission of symptoms under antidepressant
      medication, with about 10% of patients being chronically resistant to several
      psychopharmacological treatments. Development of alternative non-pharmacological treatments
      is therefore essential to improve patient care.

      Repetitive transcranial magnetic stimulation (rTMS) offers therapeutic potential in this
      context. Current protocols apply high-frequency rTMS over left dorsolateral prefrontal cortex
      (DLPFC) to reverse the increased alpha-band oscillatory activity and cortical
      hypo-excitability in patients with depression. However, translation of rTMS therapy into
      routine clinical practice has been limited due to low efficacy and high inter-individual
      variability.

      This study aims to optimize rTMS stimulation protocols for MDD by deterministically coupling
      the timing of TMS to the ongoing oscillatory neural activity in the underlying cortex as
      measured in real-time with high-density surface EEG. It is hypothesized that alpha
      phase-locked rTMS of the left DLPFC reverses increased alpha-band oscillatory activity and
      cortical hypo-excitability more efficiently than current open-loop rTMS protocols used in the
      treatment of MDD.
    

Intervention name(s): Intermittent theta-burst stimulation; Negative-peak-triggered-TMS; Open-loop replay TMS
Intervention type(s): Device; Device; Device
Intervention description(s): see associated arm/group description; see associated arm/group description; see associated arm/group description
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Assessing the Efficacy, Safety, and Tolerability of Met DR in Subjects With T2DM Over 12 Weeks
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compared the effect of delayed-release metformin (Met DR) to placebo and extended
      release metformin (Met XR) on glycemic control (fasting plasma glucose and HbA1c) and body
      weight, and assessed the safety and tolerability of a range of doses of Met DR when
      administered in subjects with type 2 diabetes mellitus (T2DM).
    


Intervention name(s): Met DR; Met XR; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): metformin delayed-release tablets; metformin extended-release tablets; placebo delayed-release tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Management of Glycemia Following a Pizza Meal
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Glycemia following pizza consumption is typically managed with a dual wave insulin bolus.
      This study evaluated the effect of a simple bolus on glycemia following consumption of
      traditionally prepared pizzas with long (22 hours) or short (8 hours) dough fermentation
      periods.
    

Detailed description: 
      All participants received pizza prepared in one of two ways, as described below, on two
      separate days. On the first day, they were given a pizza prepared with dough fermented for 8
      hours (pizza A), and on the second study day they received a pizza prepared with dough
      fermented for 24 hours (pizza B). Participants and their parents were blinded to the type of
      pizza served on each day. Both meals were served at 7.00 pm at the pizzeria where the pizza
      had been prepared, and consumed within 30 minutes.

      Children and adolescents aged between 4 and 18 years with type 1 diabetes were eligible for
      inclusion in the study if they had received SIP therapy (MiniMed™ 640G, Medtronic,
      Tolochenaz, Switzerland) for at least 3 months One pizza of each type was prepared for
      chemical analysis
    

Intervention name(s): the patients ate a pizza that fermented for 8 hours; the patients ate a pizza that fermented for 24 hours
Intervention type(s): Other; Other
Intervention description(s): Patients eat pizza prepared with controlled ingredients but fermented 8 hours; Patients eat pizza prepared with controlled ingredients but fermented 24 hours
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Continuous Subcutaneous Insulin Infusion; diet; postprandial glucose; postprandial hypoglycemia; postprandial hyperglycemia
A Biomarker Study in Patients With HER2-negative Metastatic Breast Cancer Treated With Bevacizumab and Paclitaxel
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore molecular biomarkers and/or gene expression signatures that predict response to
      bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative
      metastatic breast cancer (MBC).
    

Detailed description: 
      This is a prospective, randomized, 2-arm, open-label, single-center, phase II trial. A total
      of 30 patients will be included during a period of 2 years.

      The study will be initiated with a non-randomized, feasibility stage including ten patients
      who will be treated with bevacizumab and paclitaxel, in order to determine the safety of
      metastatic tumor biopsies during therapy with bevacizumab.

      In the second phase, patients will be randomized (1:1) between two treatment arms: A.
      Bevacizumab + paclitaxel and B. Paclitaxel
    

Intervention name(s): Bevacizumab; Paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): 15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly; 80mg/m2 iv weekly
Other intervention name(s): Avastin; Paxene; Taxol
Intervention MeSH terms: Paclitaxel; Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic breast cancer
Radiation Therapy to Prevent Brain Metastases in Patients With Previously Treated Extensive-Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy
      to the brain may be effective in preventing brain metastases. It is not yet known if
      radiation therapy is effective following chemotherapy in preventing brain metastases.

      PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in
      preventing brain metastases in patients who have received chemotherapy for extensive-stage
      small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the incidence of, and time to, symptomatic brain metastases in patients with
           previously treated extensive stage small cell lung cancer treated with prophylactic
           cranial irradiation vs no further therapy.

        -  Compare the quality of life and survival of these patients.

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the health economics associated with this study.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      participating center and performance status. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Within 5 weeks after completion of prior chemotherapy, patients undergo
           prophylactic cranial irradiation once daily for 5-12 days.

        -  Arm II: Patients receive no further therapy after completion of prior chemotherapy.

      Quality of life is assessed at baseline, 6 weeks, every 3 months for 1 year, and then every 6
      months thereafter.

      Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months
      thereafter.

      PROJECTED ACCRUAL: A total of 287 patients will be accrued for this study within 3 years.
    

Intervention name(s): radiation therapy
Intervention type(s): Radiation
Allocation: Randomized
Primary purpose: Treatment
Keywords: extensive stage small cell lung cancer
A Comparative Study of the SoftTouch Non-Invasive Finger-Mounted Device
Condition: Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters
Study type: Interventional

Summary: 
      1. Aim:

           SoftTouch is a non-invasive device intending for use in the temporarily quantitative
           measurement of peripheral blood biomarkers. The aim of the clinical trial is to study
           the accuracy of the SoftTouch device compared with registered (FDA-approved) invasive
           and non-invasive devices.

        2. Hypothesis:

      Human physiological biomarkers may be measured from the color distribution of the internal or
      external (skin) tissue. The technology of the SoftTouch finger-mounted device is based on the
      color distribution of the peripheral blood tissue, which enables the measurement of certain
      biomarkers and vital signs under consideration.
    

Detailed description: 
      Description of the Method:

        1. The method of measuring non-invasive peripheral physiological parameters such as Pulse,
           Blood Pressure, Blood pH, SpO2, CO2, Hemoglobin, Blood Glucose, Hematocrit and
           additional physiological parameters is based on the color distribution of a human
           tissue. SoftTouch is a finger-mounted device incorporated a dedicated light source and a
           color image sensor similar to a digital camera. The light transverses and is reflected
           from the tissue under consideration. Analyzing the tissue color distribution of the
           sampled real-time video in the frequency color space time domain may provide certain
           information about the biomarkers and vital-signs under consideration. The current
           study's goal is to find out if the results accuracy are satisfactory compared with
           regulatory cleared devices by the FDA and other notified bodies.

        2. The Patient signals shall be recorded as is for algorithm improvement, future research
           of additional bio parameters and calibration.

        3. the device is declared calibrated if executed successfully on the entire recorded data.

        4. for non invasive blood glucose the device shall be provided to selected diabetic
           patients for the own use at home.
    

Intervention name(s): Non Invasive peripheral blood screening (Cnoga Medical Ltd.,SofTouch,OnlyTouch, CM-CL-R-007, CMC 07015922,HT 4502, HTA 4502)
Intervention type(s): Device
Intervention description(s): Non Invasive screening of various independent peripheral blood parameters: Glucose, hemoglobin, Hematocrit, blood pressure, pulse, SpO2, CO2, pH.
Other intervention name(s): Cnoga Medical Ltd.; SoftTouch; SofTouch; Soft-Touch; OnlyTouch; CM-CL-R-007; CMC 07015922; HT 4502; HTA 4502
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Invasive; Non-Invasive; Peripheral blood parameters; Finger mounted device; Blood tissue; Tissue color distribution; Accuracy; Tissue pigmentation; pH; Hemoglobin; Hematocrit; SpO2; Blood pressure; Pulse; CO2
Distal Radius Buckle Fracture RCT
Condition: Distal Radius Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      This study evaluates the influence of cost information on decision-making for immobilization
      for treatment of distal radial buckle fractures. Half of the participants will receive cost
      information from an orthopaedic surgeon prior to making their decision for treatment, while
      the other half will receive cost information from another member of the study team after they
      had made their decision treatment.
    

Detailed description: 
      Research has shown equipoise in treatment outcomes after casting and splinting for pediatric
      buckle fractures. Despite the similarly favorable treatment outcomes associated with both
      casting and splinting these fractures, there is wide disparities in cost between the two
      types of immobilization. However, cost information is not routinely presented to families
      during the discussion of immobilization types.

      The primary objective of this study is to determine if cost information influences family
      decision-making about immobilization type after pediatric buckle fractures. A secondary
      objective is to determine if the timing of and person disseminating the cost information
      changes the influence it has on families' decision-making.
    

Intervention name(s): Monetary Cost of Immobilization Treatments; Physician; Study Team; Before Initial Treatment Decision; After Initial Treatment Decision
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Information regarding the monetary cost of casting and splinting patient's buckle fracture to be presented to adult subject/payer.; The monetary cost information is relayed by the patient's physician; The monetary cost information is relayed by a member of the study team; Monetary cost information is relayed during the initial consult, before the treatment decision is made.; Monetary cost information is relayed after the initial consult with the treating physician, after the treatment decision is made.
Other intervention name(s): Cost Information; Initial Consult; Post-Consult
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Distal Radius Fracture; Cost; Buckle Fracture
A Two-Arm Study Evaluation H.P. Acthar Injection Gel in Treatment of Chronic Migraines
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This small study is to investigate the efficacy of Acthar in the treatment of chronic
      migraine in patients who have failed multiple treatments, including Botox (which is defined
      as having <30% reduction from baseline in the number of headache days per month). Despite the
      widespread use of anti-seizure medications, there remain a significant number of patient
      whose migraines are refractory to these agents. The pathophysiology of migraine is such that
      the neural substances calcitonin G related protein (CGRP), substance P, and neurokinin A are
      released at the trigeminal nerve endings innervating the large cranial and dura mater blood
      vessels and this neurotrasmission generates migraine associated pain. Because of this,
      treatment for migraine can be directed towards down regulating those receptor sites
      accordingly. Acthar may provide pain relief through this mechanist, as ACTH has been shown to
      inhibit the release of CGRP and may also provide relief through a negative feedback loop as
      exogenous ACTH inhibits CRH release and mast cell degranulation.
    


Intervention name(s): H.P. Acthar Gel
Intervention type(s): Drug
Intervention description(s): Acthar (40IU or 80IU) given subcutaneously for 5 days in the 1st week, followed by every other day (3 times per week for the next 3 weeks)
Other intervention name(s): Acthar; Repository Corticotropin Injection; ACTH Gel
Intervention MeSH terms: Adrenocorticotropic Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Migraine; Headache; Refractory Chronic Migraine
Randomized Study of Z-100 Plus Radiation Therapy to Treat Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase III, multicenter, double-blind, placebo-controlled, parallel group
      comparative study to evaluate the efficacy and safety of Z-100 with primary uterine cervical
      cancer on radiotherapy. The study will use a central randomization with a dynamic allocation
      using biased coin minimization.
    


Intervention name(s): Z-100; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43
Condition: Pseudomonas Aeruginosa Infection
MeSH terms: Pseudomonas Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase
      II/III study. The study population consists of male or female intensive care unit (ICU)
      patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and
      80 years.
    

Detailed description: 
      This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase
      II/III study. The study population consists of male or female intensive care unit (ICU)
      patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and
      80 years.

      Eight-hundred patients will be enrolled at approximately 50 study centers. Informed consent
      (i.e., from the patient or from the patient's legally authorized representative) or waiver
      will be obtained according to regional requirements prior to any study related procedures.
      Patients will be randomized to receive either IC43 100 mcg or placebo and will receive the
      first vaccination on Day 0. The second vaccination will be applied on Day 7. In case ICU
      discharge occurs before Day 7, immunization will be done at the hospital ward.
    

Intervention name(s): IC43; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 100 mcg; phosphate buffered saline (PBS) solution containing 0,9 % NaCl
Other intervention name(s): Pseudomonas Aeruginosa; phosphate buffered saline (PBS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: IC43; Pseudomonas Aeruginosa; mechanically ventilated ICU patients; ICU patients
Heat Therapy for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to see if heat therapy intervention via hot water immersion
      (i.e., a hot tub) is an effective treatment for patients with Fibromyalgia.
    

Detailed description: 
      Fibromyalgia (FM) is a complex and difficult-to-treat painful medical condition and is marked
      by chronic widespread musculoskeletal pain, decreased pain threshold, and comorbid
      symptomatology (e.g. fatigue, trouble thinking). Several factors appear to play a role in the
      pathophysiology of FM: abnormal pain processing, abnormal autonomic nervous and
      neuroendocrine system function, genetics, and environmental triggers. The prognosis for
      recovery in traditional medicine is generally poor and current pharmacological treatments for
      FM are often insufficient to control persistent symptoms. As such, complementary medicine and
      alternative lifestyle approaches are needed. Heat therapy, such as saunas and hot tubs, has
      been used historically for its presumed therapeutic benefits, and emerging research
      highlights the benefits of heat therapy on metabolic and cardiovascular disease risks.
      Finnish saunas, which result in total-body heating, have shown beneficial clinical effects
      for rheumatic patients and new studies are needed to determine if heat therapy could improve
      pain symptoms in patients with FM.

      The short-term goal of the investigators is to determine, in a pilot clinical study, that
      heat therapy intervention via hot water immersion is a safe and efficacious treatment for
      pain in patients with FM. The overall hypothesis is that heat therapy intervention will
      improve clinical pain severity and associated dysfunction in a cohort of FM patients and that
      the anti-inflammatory actions of heat shock proteins may mediate this improvement. The
      proposed interdisciplinary study will provide data regarding treatment efficacy and will
      explore potential molecular and physiologic processes that may underlie improvement in pain
      symptoms after heat therapy intervention for FM. Furthermore, these key pilot studies will
      provide important preliminary data for future studies.
    

Intervention name(s): Heat therapy via hot water immersion
Intervention type(s): Other
Intervention description(s): Participants will be asked to participate in a 4-week heat therapy intervention, which consists of ~12-15 visits (45 min each) of immersion in to a hot tub.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Pain