bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)
Condition: ALS
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of RNS60 in patients
      with Amyotrophic lateral sclerosis (ALS). Investigators will also measure the impact of RNS60
      on several markers of neuro-inflammation, measured by blood biomarkers and positron emission
      tomography (PET) imaging.
    

Detailed description: 
      Amyotrophic lateral sclerosis (ALS) is a fatal, neurodegenerative disease for which there is
      no cure. A substantial body of evidence implicates the neuroimmune system in ALS
      pathophysiology. Of relevance to this study, microglia activation in the brain has been found
      to correlate positively with faster rate of disease progression. In addition, studies of
      blood cells in people with ALS have shown an increased activation of two of the major
      inflammatory cell types in the body, monocytes and T cells. Among T cells, regulatory T cells
      (Tregs) have been recently proposed to play a role in ALS progression.

      RNS60 is an electrokinetically altered aqueous fluid. Chemically, RNS60 is composed of saline
      and oxygen. The electrokinetic processing of RNS60 in Revalesio's patented Revalesio Pump
      (RP) produces charge-stabilized nanostructures (CSNs) that exhibit electrical fields. RNS60
      is available for intravenous administration and inhalation. RNS60 has been extensively tested
      in preclinical toxicological studies and has shown very little to no side effects. In
      addition, RNS60 was well tolerated in three phase I human safety studies, one after
      intravenous administration and two after inhalation.

      Preclinical in vitro and in vivo studies in multiple disease models have demonstrated that
      RNS60 has broad anti-inflammatory effects. These effects include reduction of microglia
      activation, increase of the Tregs subpopulation of lymphocytes, and neuroprotection in
      several disease models.
    

Intervention name(s): RNS60
Intervention type(s): Drug
Intervention description(s): RNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 23 weeks.
In addition, subjects will be given the option to continue to receive drug for approximately an additional 24 weeks, for a total of approximately 48 weeks on study drug. Study drug will be given by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) during the extension phase.
Other intervention name(s): Electrokinetically Processed Fluid; saline and oxygen
Intervention MeSH terms: RNS60
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Depression and Health Outcomes in Refractory Epilepsy
Condition: Depression; Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      To define the benefits of antidepressant treatment or cognitive behavior therapy on mood,
      function, and quality of life in persons with depression and refractory epilepsy.
    

Detailed description: 
      This randomized clinical trial will be conducted to compare the drug sertraline to cognitive
      behavioral therapy on symptoms of depression, antiepileptic medication compliance, seizure
      frequency, and quality of life outcomes in persons with depression and a seizure disorder or
      epilepsy. Approximately 140 persons will be enrolled in this study over a period of five
      years. Individual participation will last approximately 16 weeks. Study participants will be
      chosen randomly to receive either the study medication (sertraline) or cognitive behavior
      therapy for 16 weeks. Sertraline is approved by the Food and Drug Administration (FDA).
      Subjects who receive cognitive behavior therapy will be provided with a one-hour individual
      session with a licensed clinical psychologist each week for 15 weeks. All study participants
      will attend scheduled clinic visits every 4 weeks for 16 weeks.
    

Intervention name(s): sertraline; cognitive behavior therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): Sertraline: 25-200mg PO (orally); Subjects begin at 25mg for week 1 and increase to 50mg at the beginning of week 2. Sertraline is increased in 50mg increments when subjects score in the depressed range on the CES-D, a questionnaire that is administered every 2 weeks over the 16 week intervention period. Subjects may reduce dosage if toxicity occurs.; CBT (Cognitive Behavior Therapy) - CBT is a psychotherapy based on modifying cognitions, assumptions, beliefs and behaviors, with the aim of influencing disturbed emotions. Subjects will meet with a trained CBT therapist for 1 hour each week over the 16 week intervention period and will be given assignments to work on each week.
Other intervention name(s): CBT
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; epilepsy; seizures
The Effect of Medical Clowns and Topical Anesthetic Cream on Pain and Anxiety in Children Undergoing Allergy Skin Tests
Condition: Anxiety Disorder; Allergic Skin Reaction
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Allergy skin tests are occasionally associated with pain and anxiety in patients undergoing
      this procedure. The investigators intend to examine if medical clowns compared with local
      anesthetic cream can decrease these feelings in children.
    


Intervention name(s): Cream of Macrogol cetostearyl ethers; Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %; Care and treatment from a medical clown; Care and treatment from a medical clown
Intervention type(s): Biological; Drug; Behavioral; Behavioral
Intervention description(s): The cream will be applied on the volar aspect of both arms for 1 hour; 1-2 gr. of the cream will be applied on the volar aspect of the second arm; for 1 hour; Medical clown will entertain the children before, during and after performing the skin test. Placebo cream will be applied on both arms.; Medical clown will entertain the children, placebo cream will be applied on one arm and anesthetic cream on the second arm
Other intervention name(s): Cetomacrogol; EMLA 5%
Intervention MeSH terms: Lidocaine; Prilocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety Disorder due to Allergy Skin Testing
Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect of inhibiting xanthine oxidase with
      allopurinol in patients with chronic kidney disease in asymptomatic hyperuricemia endothelial
      injury and vascular repair mechanisms.
    

Detailed description: 
      The purpose of this study is to determine the effect of inhibiting xanthine oxidase with
      allopurinol in patients with chronic kidney disease in asymptomatic hyperuricemia endothelial
      injury and vascular repair mechanisms, evaluating the plasma concentration of angiogenic
      factors, microparticles of endothelial cells and the cell number circulating endothelial
      progenitor.
    

Intervention name(s): Allopurinol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Allopurinol; Placebo
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic kidney disease; allopurinol; CKD
Safety and Tolerability of Liraglutide in Healthy Male Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to assess the safety and
      tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170
      (liraglutide).
    


Intervention name(s): liraglutide; liraglutide; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order; Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg; Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered; Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
Other intervention name(s): NNC 90-1170; NNC 90-1170
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in
      combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in
      patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.
    


Intervention name(s): Placebo of CDP870; CDP870 200mg; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Given every 2 weeks until Week22 (SC); 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC); Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit.
The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly.
Other intervention name(s): CIMZIA
Intervention MeSH terms: Certolizumab Pegol; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CDP870; Korea; CIMZIA
Renal Integrase Study
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to observe the safety of Truvada® (TDF/FTC) in relation to its
      impact on kidney function combined with different Integrase Inhibitors (Dolutegravir, or
      Elvitegravir/Cobicistat or Raltegravir), when given to patients who are commencing treatment
      for HIV infection for the first time.

      All three combinations (Raltegravir + Truvada®, Dolutegravir + Truvada® and Stribild®, a
      single pill which contains Elvitegravir/Cobicistat/Truvada®) are currently recommended by the
      national guide-lines and used in standard clinical practice.
    

Detailed description: 
      The study will monitor kidney function, and compare the safety and effectiveness of Truvada®
      when taken with Dolutegravir, or Elvitegravir/Cobicistat or Raltegravir, over the first 48
      weeks of treatment in HIV-1 antiretrovirals naïve patients.

      The safety and how well these drug combinations are tolerated will be determined based on
      physical examinations, laboratory tests, and questions about any problems the participant
      might experience during the study. As part of this trial, levels of HIV-1 in the blood and
      urinary markers of kidney function and inflammatory markers will be measured at various times
      during the study.

      The total duration of participant involvement in the trial will be up to 48 weeks, with up to
      45 days between the screening and baseline visits. Participants will need to visit the clinic
      6 times within the 48 weeks.

      Once participants have been confirmed to be eligible to participate in the study,
      participants will attend for a baseline visit (day 1) where they will be randomly assigned to
      receive one of the three treatments listed below:

        -  Treatment Arm 1: Stribild® (EVG/COBI/FTC/TDF) 1 tablet once a day

        -  Treatment Arm 2: Isentress® (Raltegravir 400 mg) 1 tablet twice a day + Truvada® 1
           tablet once a day

        -  Treatment Arm 3: Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® 1 tablet
           once a day
    

Intervention name(s): Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat); Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet; Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Tenofovir; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Dolutegravir; Cobicistat; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
Condition: Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in
      overweight and obese adults.
    


Intervention name(s): SHP626; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Volixibat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Covid 19 Anxiety in Endometriosis Patients
Condition: Endometriosis; Covid19
MeSH terms: COVID-19; Endometriosis
Study type: Observational [Patient Registry]

Summary: 
      It is aimed to measure the general anxiety and lifestyle information of endometriosis
      patients about covid 19 pandemic, to evaluate anxiety levels in this period.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Evaluation of endometriosis patients anxiety and lifestyle during the covid 19 pandemic
Chamomile for Chronic Primary Insomnia
Condition: Primary Insomnia; Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if an herb called chamomile can help to treat
      insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of
      time that you sleep and/or improving the quality of your sleep. The study will also be
      looking at the effect of chamomile on day time fatigue and functioning.
    

Detailed description: 
      Insomnia, defined as the inability to initiate or maintain sleep or lack of restorative
      sleep, is the most prevalent sleep complaint in primary care. Insomnia is associated with
      decreased quality of life, work limitations and increased healthcare utilization. Currently
      there is no treatment for chronic insomnia that is readily available, affordable, without
      significant side-effects and demonstrated to be safe for long term use. Consequently,
      treatments that would fill this gap are needed.

      Chamomile (Matricaria recutita) has been used as a gentle sleep agent by herbalists for
      several hundred years. It has been studied in animals for its sedative potential and shows
      promise for treating insomnia. Currently, chamomile's sedative mechanisms of action are
      unknown, but are thought to be through the major inhibitory neurotransmitter in the central
      nervous system, γ - aminobutyric acid (GABA). However, no study has examined chamomile's
      efficacy and safety for treating insomnia.

      The investigators propose a double-blind, placebo-controlled, randomized trial of chamomile
      in primary care patients with chronic insomnia. Thirty-four patients will be randomized to
      either Chamomile High Grade Extract, three 5 mg tablets standardized to 0.4% (-)-α-bisabolol
      twice daily or placebo and will be followed for 28 days for changes in a sleep diary (sleep
      efficiency, total sleep time, sleep-onset latency and sleep quality), insomnia severity and
      sleep disturbances. Secondary endpoints include assessing changes in day time functioning
      (measures of global quality of life, depression and anxiety) and monitoring for any signs of
      toxicity. The investigators will also determine the feasibility of conducting a larger trial
      with this agent.
    

Intervention name(s): Chamomile High Grade Extract; Placebo Tablet
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Matricaria; Chamomile; Herb; Insomnia
Metabolic Responses After 12-week Hypocaloric Diet Supplemented With a Cereal-based Plant Protein Biscuit
Condition: Appetite
Study type: Interventional

Summary: 
      Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and
      potential carriers of ingredients with appetite regulating properties. In the present study,
      the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds
      on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric
      dietary intervention will be examined.
    

Detailed description: 
      Women with overweight/obesity will follow a 12-week dietary intervention supplemented with a
      cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a
      daily snack.

      At the beginning and at the end of the dietary intervention postprandial metabolic responses,
      body weight reduction and subjective appetite ratings will be examined.
    

Intervention name(s): wheat biscuit enriched with plant proteins; common wheat biscuit
Intervention type(s): Other; Other
Intervention description(s): Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a biscuit enriched with plant proteins; Postprandial glucose and appetite-regulating hormone responses of subjects with overweight/obesity after a 12-week dietary intervention with a common wheat biscuit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cereal-based biscuit enriched with plant proteins; appetite regulation; glycemic control; hormone responses
Impact of Extra Virgin Olive Oil Oleocanthal Content on Platelet Reactivity
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Data from limited dietary intervention trials suggest that the cardiovascular health benefit
      of extra virgin olive oil (EVOO) may increase with phenolic content. However, while EVOOs
      contain an array of bioactive compounds, little information exists regarding the
      physiological effects of specific chemical species. Among the EVOO-derived phenolics with
      demonstrated anti-inflammatory effects in animal and in vitro models is oleocanthal, an
      inhibitor of cyclooxygenase (COX). The current study compared the impact of acute intake (40
      mL) of EVOO on platelet reactivity in healthy adult males (n=9). The volunteers were randomly
      assigned to consume three EVOOs in a double-blind controlled trial. The EVOO were
      characterized and chosen for equivalency in their total phenolic content and fatty acid
      profiles, but differing in their oleocanthal to oleacein ratio.
    

Detailed description: 
      Ten healthy adult males (20-50 years of age) will be enrolled into a randomized triple-blind,
      controlled crossover study that will test the acute effects of oleocanthal-rich extra virgin
      olive oil intake on platelet aggregation. Each participant will be asked to participate in
      four study days, separated by at least 1-week, in which they will be randomized to consume on
      each study day 40 mL (~3 tablespoons) of either oleocanthal-rich extra virgin olive oil (OO),
      or an extra virgin OO that is matched in total phenolics but oleocanthal-poor, or a refined
      OO that is low in all phenolics In addition to the oils, on a fourth study day visit, after
      completion of the study visits involving oil intake the subjects will be asked to take 400mg
      of ibuprofen.

      Collection procedures will be performed at the same time of the day to avoid circadian
      effects. A blood sample (50 mL ~ 3.5 tbsp) will be collected for the measurement of platelet
      aggregometry and COX metabolites. Following this initial blood draw, the subjects will
      consume their assigned test product for the day. Two-hours following the intake of the
      assigned olive oil, a second blood sample will be drawn (50 mL ~ 3.5 tbsp). After the second
      blood draw, the study day will be complete.
    

Intervention name(s): D2i2; D2i0.5; D2i0; Ibuprofen
Intervention type(s): Other; Other; Other; Drug
Intervention description(s): Oleocanthal provided in a 2:1 ratio compared to oleacein; Oleocanthal provided in a 1:2 ratio compared to oleacein; No oleocanthal and no oleacein; 400 mg of Ibuprofen
Other intervention name(s): Oleocanthal-rich; Oleocanthal-low; Control EVOO
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: platelet reactivity; phenolic; extra virgin olive oil; cyclooxygenase; oleocanthal; oxylipin
Learning Enhancement Through Neurostimulation in Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      This study will examine whether brain stimulation paired with social skills learning can help
      teenage boys with autism learn how to make and keep friends. Brain stimulation can enhance
      learning in some people. This study involves enrolling in a 14-week training program where
      teenage boys with autism interact in small groups and learn social skills. During the 14-week
      program participants will receive active brain stimulation, or non-active stimulation
      (placebo). Before and after this training, MRI scans will be taken to see whether the
      training with active brain stimulation made a different in brain activation.
    


Intervention name(s): Active Transcranial Direct Current Stimulation; Sham Transcranial Direct Current Stimulation; PEERS Social Skills Training
Intervention type(s): Device; Device; Behavioral
Intervention description(s): 14 weekly social skills training sessions for all participants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autism; Adolescent; Social skills