bioihbjkbjnl/mcl2 huggingface dataset:
Exploring a Potential Blood Test to Diagnose Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The purpose of this study is to develop a blood test for major depression and measure the
      effects of ziprasidone monotherapy on these markers.

      Specific Aim: Using a multiplex biomarker assay we will measure levels of 16 biomarkers in
      patients with MDD enrolled in this ancillary study (adjunct to study NCT00555997) and compare
      these results to those of healthy controls" (defined as research subjects who have not met
      criteria for any lifetime Axis-I disorder (DSM-IV)) from an existing dataset at PHB.
    

Detailed description: 
      This proposed study will be an ancillary study to clinical trial NCT00555997
      (www.clinicaltrials.gov) entitled: "A 12-Week, Randomized, Double-Blind, Placebo-Controlled,
      Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder"
      (MDD)." Precision Human Biolaboratory ("PHB") is attempting to develop a proprietary blood
      test intended to potentially serve as a biological marker ("bio-marker") for MDD.
      Specifically, PHB's research team will employ a unique approach towards developing a
      diagnostic test for MDD: measures from multiple blood-based biological markers will be
      obtained from patients with MDD and then analyzed with the use of several interrelated
      algorithms in order to derive a single biological measure ("bio-marker") with a high
      predictive value for MDD. PHBs' test panel of blood-based biological markers will consist of
      a number of cytokines, stress related hormones, and binding proteins that have each been
      linked to MDD. This innovative test panel is expected to provide general practice physicians
      with a tool to more accurately identify and classify patients with MDD which, in turn, could
      potentially , allow for the more effective monitoring of pharmacotherapy (antidepressant drug
      therapy). Thus, the development of a highly reliable biomarker for MDD could improve the
      standard of care for depression.

      For this ancillary study, 120 antidepressant-free outpatients with MDD who have been deemed
      eligible to participate in trial NCT00555997 will be recruited from participating centers.
      Participating subjects will undergo a blood draw during the baseline visit for NCT00555997.
      Values obtained will be compared with those of "healthy controls" (defined as research
      subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV)) from an
      existing dataset at PHB.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with Major Depressive Disorder (DSM-IV)
      
Biospecimen description: 
      serum, plasma
    
Keywords: Major Depressive Disorder; Blood Test
A Study in Healthy People to Measure the Amount of BI 655130 in the Blood After Injecting Different Doses Into Different Parts of the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the relative bioavailability of BI
      655130 administered as two subcutaneous injections in the left and right periumbilical region
      compared to a single subcutaneous periumbilical injection of BI 655130.

      The secondary objective is to investigate the relative bioavailability of a single
      subcutaneous injection of BI 655130 into the thigh compared to a single subcutaneous
      periumbilical injection of BI 655130.
    


Intervention name(s): Spesolimab
Intervention type(s): Drug
Intervention description(s): single-dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Therapeutic Exercise to Treat Neuropathic Pain
Condition: Gaucher Disease; Fabry Disease
MeSH terms: Neuralgia; Fabry Disease; Gaucher Disease
Study type: Interventional

Summary: 
      A quasi-experimental, prospective clinical trial with pre and post intervention measurements,
      whose porpuose is assess the efficacy of a therapeutic exercise protocol to treat neuropathic
      pain in Fabry Disease.
    

Detailed description: 
      There take part in this study women or men aged between 18 and 65 years, with a diagnosys by
      a physician specializing in Fabry disease with FabryScan. Patients must present a stable
      evolution, with a scoring system of disease severity (DS3) that must be less than 8 points
      per year in the last 2-3 years and they have to presence of neuropathic pain with a score
      greater than or equal to 4 in the questionnaire "Douleur neuropathique (DN4)".
    

Intervention name(s): Therapeutic Exercise
Intervention type(s): Other
Intervention description(s): Patients who meet the inclusion criteria and who want to carry out the workshops, fill out an informed consent explaining the procedure to be followed and accepting the cessation of data to carry out the study.
Patients will be divided into 2 working groups (approximately 10 patients in total, in a Gaucher disease group and in another Fabry disease). The workshops will be held at the foundation twice a month in sessions of 45 minutes of work for 3 months (May, June, July 2019). In these sessions the physiotherapists will show the new exercises to the patients. The exercises that are taught in that session should be done at home 3 times a week. In addition, a document will be delivered with the exercises to be carried out and the frequency and intensity of execution. The workshops will be guided at all times by a physiotherapist specialized in therapeutic exercise and EDL.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gaucher Disease; Exercise; Terapheutic
The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in
      Subject with Moderate to Severe Glabellar Lines
    


Intervention name(s): HU-014 Inj; Botox Inj
Intervention type(s): Biological; Biological
Intervention description(s): Clostridium botulinum type A; Clostridium botulinum type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transcutaneous Vagus Nerve Stimulation in Private Healthcare Center
Condition: Generalized Anxiety Disorder; Chronic Pain; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Chronic Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      This non-randomized, open-label study has the objective to study the effects and feasibility
      of Transauricular Vagus Nerve Stimulation (TaVNS) for patients suffering from Generalized
      Anxiety Disorder (GAD), Chronic Pain (CP) and Irritable Bowel Syndrome (IBS) in a private
      healthcare centre.
    

Detailed description: 
      The effects of TaVNS on GAD, CP and IBS. Participants were investigated during a 4-week
      period and a 2-month follow-up. Groups (GAD, CP, IBS) were assessed using questionnaires:
      Anxiety (Generalized Anxiety Disorder GAD-7); CP (Brief Pain Inventory Short Form
      Questionnaire) and IBS (Irritable Bowel Syndrome Severity Scoring System). TaVNS was
      performed using a standard transcutaneous electrical nerve stimulation (TENS) device and ear
      clip electrodes plugged into the concha area of the left ear. All participants received a
      bi-weekly 30 minutes stimulation (8 sessions). We defined three different TaVNS parameters
      for each group in hertz (Hz) and microsecond (µs), (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS:
      3Hz-250µs).
    

Intervention name(s): Transcutaneous Vagus Nerve Stimulation
Intervention type(s): Device
Intervention description(s): TaVNS will be applied by the TENS 7000 device. The stimulation was set according the group of treatment: (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS: 3Hz-250µs).
The current intensity was individually established under the pain threshold .The stimulus generates an continous asymmetric biphasic waveform. Ear clip electrodes were plugged in the concha area of the left ear. The stimulation will last 30 min per session (total=8)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transcutaneous Vagus nerve Stimulation; Generalized Anxiety Disorder; Chronic Pain; Irritable Bowel Syndrome; Private Practice
Effects of Shoulder Edema on Intubated Tube in Patients Undergoing Shoulder Arthroscopy
Condition: Arthroscopy
Study type: Observational

Summary: 
      Intubation is needed in general anesthesia and appropriate cuff pressure is important to
      avoid trauma or postoperative sore throat and aspiration. Shoulder arthroscope uses some
      amount of irrigation fluid and it can influence to cuff pressure. Therefore, we will measure
      cuff pressure during shoulder arthroscope.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patints who undergoing shoulder arthroscopy American Society of Anesthesiologists (ASA) 1,2
Evaluation of ACUVUE OASYS® 1-Day for Astigmatism Lenses Produced on a New Manufacturing Line
Condition: Visual Acuity
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      This is a bilateral, dispensing, randomized, controlled, double-masked, 2×2 cross-over study
      to evaluate the clinical performance of ACUVUE OASYS® 1-Day for Astigmatism contact lenses
      produced on a recently qualified manufacturing line.
    


Intervention name(s): ACUVUE OASYS® 1-Day for Astigmatism - TAM 24; ACUVUE OASYS® 1-Day for Astigmatism
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Condition: Hypoxemia; Hypobaric Hypoxemia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse
      altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.
    

Detailed description: 
      Subjects will be monitored non-invasively with pulse oximetry, end-tidal carbon dioxide,
      tissue oxygenation and ECG. The mean seal level oxygen saturation will be recorded.Subjects
      exposed to an altitude of 14,000 feet will experience moderate hypobaric hypoxia. The mean
      oxygen saturation at this altitude is 83%. Subjects will receive oxygen from both an oxygen
      concentrator or a cylinder of oxygen following exposure to hypobarism. Oxygen from each
      source will be increased in 1 liter per minute increments until the oxygen saturation returns
      to the baseline sea level oxygen saturation.

      The oxygen requirement to return oxygen saturation to baseline values will be recorded. The
      flow from the concentrator and the cylinder will be compared.
    

Intervention name(s): Pulse-dose oxygen; Cylinder oxygen delivery
Intervention type(s): Device; Device
Intervention description(s): Pulsed-dose oxygen delivery from an oxygen concentrator; Oxygen delivery from an oxygen cylinder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypobaric hypoxemia; Altitude; Oxygen; oxygen concentrator
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain
Condition: Diabetic Neuropathy
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      AV411 after single and multiple doses in patients with chronic neuropathic pain due to
      diabetes.
    


Intervention name(s): AV411
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Iron Sucrose in Stage 3/4 Kidney Disease
Condition: Kidney Failure; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      One of the complications of late stage kidney disease is the development of a low red blood
      cell count (anaemia/low haemoglobin concentration). The Australian Commonwealth government
      limits funding of medications (called erythropoietic stimulating agents) to those patients
      who have already developed anaemia.

      There is evidence supporting the beneficial effects of maintaining a higher haemoglobin in
      these patients. Higher haemoglobin can delay the onset of dialysis and reduce the development
      of heart enlargement. However, the administration of erythropoietic stimulating agents is not
      without risk, including a high financial burden, worsening of high blood pressure and a rare
      complication called pure red cell aplasia.

      Previous studies have shown that patients with chronic kidney disease require additional iron
      to maintain the production of red blood cells. Thus it would be timely to determine if the
      administration of iron sucrose to these patients can maintain a near normal haemoglobin
      concentration, without the need to start an erythropoietic stimulating agent and possibly
      delaying dialysis.

      Study Hypothesis: That administration of iron sucrose is superior to standard care in the
      prevention of anaemia in patients with stage 3 /4 kidney disease.
    

Detailed description: 
      Eligible patients will be approached. Those who agree to partake in the study will, after
      enrolment (including informed consent), be randomized to one of 2 groups.

      Group A: To receive intravenous iron sucrose to maintain supra-physiological measures of iron
      status ) Group A will be targeted to have ferritin levels between 300 and 500µg/L and/or a
      transferrin saturation of between 25 and 50%. Between 100 and 200mg of intravenous iron
      sucrose will be administered by slow bolus injection one- to two-monthly to achieve these
      levels.

      Oral iron will not be used routinely in this group.

      Group B: Will have oral iron therapy if required to maintain ferritin levels between 100 and
      150µg/L and/or transferrin saturations >20% but <25%. Patients in Group B who are unable to
      tolerate oral iron will be administered iron sucrose if necessary to maintain acceptable iron
      levels.

      Patients in Group B will therefore differ from those in Group A (a) through the routine use
      of iron sucrose and (b) through the maintenance of different ferritin and transferrin
      saturation levels.
    

Intervention name(s): Iron sucrose
Intervention type(s): Drug
Intervention MeSH terms: Ferric Oxide, Saccharated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Creatinine Clearance; Hemoglobin; Iron sucrose; Oral iron therapy; Ferritin; Transferrin saturation; Iron
Estradiol Patch as add-on to Antipsychotics in Patients With Schizophrenia, Schizoaffective or Schizophreniform Disorder
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effects of Estradiol patches vs placebo patches as add-on to antipsychotics
      on psychometric performance in patients with schizophrenia, schizoaffective or
      schizophreniform disorder
    

Detailed description: 
      Estradiol has been shown to be an effective adjunctive treatment for schizophrenia. The
      estradiol hypothesis was tested in a randomized-controlled trial in which estradiol was given
      to women with schizophrenia, schizoaffective or schizophreniform disorder aged 18 to 45 -
      Kulkarni 2014. In that 3 arms trial, Kulkarni administered transdermal 100 µg estradiol/200
      µg estradiol/ placebo to patients receiving anti-psychotics and reported reductions in PANSS
      positive, general and total symptoms in both estradiol patients' groups compared with the
      placebo group. Patients receiving 200 µg experienced greater improvement, specifically in the
      PANSS positive subscale, the effect size was 0.44.

      The objective of this study is to attempt to confirm Kulkarni's trial in a large-scale trial.
      This proposed study is a 2-arm study, in which patients will be randomized to either 200 µg
      estradiol or placebo in order to test the effectiveness of estradiol on women of childbearing
      age with schizophrenia, schizoaffective or schizophreniform disorder for a limited period of
      56 days.
    

Intervention name(s): Estradiol; Placebo
Intervention type(s): Drug; Device
Intervention description(s): 2 trans dermal patches to be changed twice a week for the duration of 8 weeks.; 2 trans dermal patches to be changed twice a week for the duration of 8 weeks.
Other intervention name(s): trans dermal patches; trans dermal patches
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, add-on to anti-psychotics, double blind, placebo-controlled, parallel group clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare combination treatment of aripiprazole plus valproate versus valproate alone in the
      prevention of relapse in bipolar I disorder patients with symptomatic remission after 5-6
      weeks open-label acute treatment with aripiprazole plus valproate for manic or mixed episode,
      with or without psychotic features.
    

Detailed description: 
      Further study details as provided by Korea OIAA
    

Intervention name(s): aripiprazole; valproate; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15-30 mg/day aripiprazole, 22 weeks; sufficient dose as determined by investigator to maintain the therapeutic level.; placebo to aripiprazole, 22 weeks
Other intervention name(s): Abilify
Intervention MeSH terms: Valproic Acid; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria
Condition: Solar Urticaria
MeSH terms: Urticaria; Urticaria, Solar
Study type: Interventional
Phase: Phase 2

Summary: 
      Solar urticaria is a rare but debilitating disease that can severely impact the quality of
      life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic
      drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or
      immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic
      urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7
      patients, to dramatically improve 71% of patients. In an open-label prospective multicenter
      study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10
      patients affected with severe and refractory solar urticaria.
    


Intervention name(s): Intravenous immunoglobulins
Intervention type(s): Drug
Intervention description(s): Single administration of 2 g/kg intravenous immunoglobulins over 2 days
Other intervention name(s): CLAIRYG
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intravenous immunoglobulins; Solar urticaria; Minimal urticaria dose; Quality of life; Safety
Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to assess the bioequivalence between two new oral nicotine
      replacement therapy products and Nicorette® microtab.
    

Detailed description: 
      The trial has a single-dose, randomized, crossover design and includes 84 subjects. The
      investigational products will be given as single doses at separate treatment visits. Periods
      without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate
      treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled
      immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2,
      3, 4, 6, 8, and 10 hours after start of product administration. The time until complete
      tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse
      events that may occur. Treatment labels will be concealed from subjects and study personnel.
    

Intervention name(s): Code STD; Code STE; Nicorette Microtab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 mg Single-dose of experimental nicotine product coded "STD"; 2 mg Single-dose of experimental nicotine product coded "STE"; A comparative 2 mg Single-dose of marketed tablet
Other intervention name(s): Not marketed; Not marketed; Nicorette® Microtab
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Smoking Cessation; Nicotine