bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen
      Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of
      this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to
      measure the effect of HBOT on specific chemicals in their blood that may play a role in the
      child's behavior.
    

Detailed description: 
      During the study's 20-week duration, all children will receive Hyperbaric Oxygen Treatment
      (HBOT) for two eight-week sessions, with a four week session between. Therefore, all children
      will participate in the study for 20 weeks, and will receive HBOT for 16 weeks. This is an
      open label study. This means that there will not be a placebo group in the study. All study
      participants will receive the same treatment of HBOT in a hard shell chamber. Normal air
      contains about 24% oxygen at a pressure of about 1 atmosphere absolute (ATA). The chamber
      will contain 100 percent oxygen at a pressure of 1.5 ATA, which is equivalent to the pressure
      at a depth of 15 feet in sea water. Each subject will complete the first 40 treatments during
      one hour sessions on 5 separate days in each of the first 8 weeks. They will then take a
      4-week break before they begin their next 40 treatments, which will also occur during one
      hour sessions on 5 separate days in each of the last 8 weeks. The entire study will last 20
      weeks. The child's behavior will be measured and evaluated at the MIND Institute at the
      beginning of the study, at week 8, and at week 20.
    

Intervention name(s): Hyperbaric Oxygen Treatment (HBOT)
Intervention type(s): Other
Intervention description(s): 1.5 ATA at 100% Oxygen of HBOT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relevance and Salience During Attention Task
Condition: Healthy
Study type: Interventional

Summary: 
      In this line of research, the researchers are examining the influence of relevance of a
      salient item on task performance, depending on overall task set.
    

Detailed description: 
      When finding a target item during visual search (looking for a pencil), a salient item can
      capture attention (your phone flashing from a message). Typical attention studies only
      examine salient items when shown as distractor during search, to ensure any attention to the
      items are driven by salience alone. However, the impact of salience may interact with the
      relevance of the item for the search task (e.g. how likely the salient item is to be the
      target). Here, the researchers investigate these interactions in a basic science study when
      participants perform an easy task or a difficult search task.
    

Intervention name(s): Relevance (Likelihood Salient Item is Target)
Intervention type(s): Behavioral
Intervention description(s): The proportion of trials, when the salient visual item is present in the array, where the salient item is the search target.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants receive each level of task (easy singleton detection task, hard feature search task) and salient item presence (present, absent during search). Groups differ based on the likelihood of the salient item being the search target when present(0%-100%, in 25% increments).
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: attention; visual search
Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years
Condition: Prophylaxis of Avian Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months
      to 17 years compared to seasonal flu vaccination
    


Intervention name(s): H5N1 Influenza Vaccine; H5N1 Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).; Two 0.25mL or 0.5mL injections of H5N1 influenza vaccine, administered 3 weeks apart, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass).
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bird flu; seasonal influenza vaccine; influenza vaccine; prepandemic vaccine; virus strain with the potential to cause pandemic; toddlers; children; adolescents
COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
Condition: Modified Release Oral Formulation; Left Ventricular Systolic Dysfunction; Chronic Heart Failure; History of Chronic Heart Failure; Left Ventricular Ejection Fraction; Pharmacokinetics; Echocardiogram
MeSH terms: Heart Failure; Ventricular Dysfunction, Left; Systolic Murmurs
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are (i) to select an oral modified release (MR)
      formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults
      with heart failure and left ventricular systolic dysfunction and (ii) to characterize its
      pharmacokinetics (PK) over 20 weeks of treatment.
    

Detailed description: 
      Omecamtiv mecarbil (AMG 423, CK-1827452) is a novel small molecule that increases cardiac
      contractility by selectively and directly activating the enzymatic domain of cardiac myosin
      heavy chain, the force-generating motor protein of the cardiac sarcomere. This is a
      randomized, placebo-controlled, multicenter, phase 2 study, consisting of a dose escalation
      phase to select 1 of 3 omecamtiv mecarbil oral formulations in 2 dose escalation cohorts,
      followed by an expansion phase to evaluate 20 weeks of administration of the selected
      omecamtiv mecarbil formulation at 2 target dose levels, compared with placebo.

      This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due
      to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021
      and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics,
      Cytokinetics is now listed as the sponsor.
    

Intervention name(s): Omecamtiv Mecarbil Matrix F1 Formulation; Omecamtiv Mecarbil Matrix F2 Formulation; Placebo; Omecamtiv Mecarbil Swellable Core Technology F2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Modified release tablets for oral administration; Modified release tablets for oral administration; Modified release tablets matching to omecamtiv mecarbil; Modified release tablets for oral administration
Other intervention name(s): AMG 423; CK-1827452; AMG 423; CK-1827452; AMG 423; CK-1827452
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Omecamtiv mecarbil; AMG 423; Double-blind; Randomized; Placebo-controlled; Oral forumlation; CK-1827452; Cardiac myosin activator
Evaluation of Immunobiogram® as a Tool in Adjustment of Immunosuppressant Therapy for Renal Transplant
Condition: Kidney Transplantation
Study type: Observational

Summary: 
      The trial is an observational, multi-center study to determine if a new blood test
      (Immunobiogram®) done after renal transplant can help predict how well the immune system is
      working and responding to a new kidney. These blood tests could, in the future, potentially
      guide how doctors manage patient's anti-rejection medication.
    

Detailed description: 
      Rejection in renal transplants is a major problem unsolved in the long term, as 30-50% of
      patients lose their kidney due to rejection, or rejection mechanisms are involved elsewhere.
      One of the presumed key factors that may deliver such bad outcomes is the difficulties to
      personalise immunosuppressive treatment; a medical need that currently relies on
      immunosuppressive levels for some medications (pharmacokinetics), clinical guideline
      recommendations, adverse events profiles and some expensive biomarkers which are not widely
      used. Immunobiogram® (IMBG) is a tool that evaluates the sensitivity/resistance profile of
      patients to each of the most widely used and representative immunosuppressant drugs (IM).
      Thus, IMBG offers information that could become pivotal in clinical management of renal
      transplanted patients, if its potential benefits are proven. In this clinical study, a
      technology validation will be performed in which the robustness of the bioassay will be
      evaluated; and a correlation between the current clinical prognoses of each patient and
      resistance patterns will be explored.
    

Intervention name(s): NA-Observational only
Intervention type(s): Other
Intervention description(s): NA-Observational only
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male and female subjects <25 to < 70 years in age who have had a renal transplant performed
        at least one year before inclusion in the study
TPVB, PECSB, ESPB for Postmastectmy Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Aim of the work The aim of the study is to compare between the effects of ultrasound guided
      thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management
      of pain during cancer breast surgeries. The hypothesis of the study is that the three groups
      will give comparative results.
    


Intervention name(s): Ultrasound guided block; IV morphine
Intervention type(s): Procedure; Drug
Intervention description(s): Giving one regional block; given when VAS>3
Other intervention name(s): Us guided paravertebral block; Us guided erector spinae block; Us guided PECs 1 and 2
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
A Study of Flovent in Patients With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effects (both good and bad) of high dose swallowed
      fluticasone propionate (Flovent) in subjects with eosinophilic esophagitis (EoE).
    


Intervention name(s): Flovent; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 1760 mcg daily; Placebo
Other intervention name(s): Fluticasone propionate
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eosinophilic Esophagitis
Tanezumab in Osteoarthritis of the Knee
Condition: Arthritis; Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
    


Intervention name(s): tanezumab; tanezumab; tanezumab; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): IV tanezumab 10 mg at 1 dose every 8 weeks; IV tanezumab 5 mg at 1 dose every 8 weeks; IV tanezumab 2.5 mg at 1 dose every 8 weeks; IV placebo to match tanezumab at 1 dose every 8 weeks
Intervention MeSH terms: Tanezumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: monoclonal antibody; RN624; PF-04383119; nerve growth factor; anti-nerve growth factor; OA; pain
Dose Escalation TTHX1114 Ophthalmic Solution
Condition: Corneal Epithelial Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      Dose escalation 3+3 design with accelerated titration 4 dose levels
    

Detailed description: 
      This is a 28-day open-label dose-escalation study. TTHX1114(NM141) Ophthalmic Solution: 1
      drop (gtt) to the Study Eye (SE) twice daily for a total of 7 days. Four planed dose levels,
      accelerated titration DL1 and DL2, standard 3+3 design.
    

Intervention name(s): TTHX1114(NM141) Ophthalmic Solution
Intervention type(s): Drug
Intervention description(s): Eye drop twice daily
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
Condition: Herpes Zoster; Shingles; Genital Herpes
MeSH terms: Herpes Simplex; Herpes Zoster; Herpes Genitalis
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Valacyclovir
      Hydrochlorothiazide Caplet under fasting conditions.
    


Intervention name(s): Valacyclovir Hydrochloride
Intervention type(s): Drug
Intervention description(s): 1000 mg caplet
Other intervention name(s): Valtrex
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Ketanserin After LSD Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      LSD (lysergic acid diethylamide) is a serotonergic (5-HT) hallucinogen widely used for
      recreational and/or ethnomedical purposes. LSD is thought to induce its prototypical
      psychedelic effects primarily via stimulation of the 5-HT2A receptor. This study investigates
      whether an LSD experience can be attenuated and shortened using 5-HT2A receptor antagonist
      ketanserin administration after LSD once the psychedelic effects have established.
    

Detailed description: 
      LSD is a so-called "classic" or serotonergic hallucinogen or psychedelic.The effects of LSD
      have been frequently investigated in the past in both healthy participants and patients. In
      these studies, LSD produced acute transient alterations in waking consciousness including
      visual perceptual alterations, audio-visual synesthesia, derealization and depersonalization.
      Moreover, several of these studies described robust and sustained effects of LSD in patients
      suffering from addiction, anxiety and depression.

      Its psychedelic effects are mainly attributed to its potent partial 5-HT2A receptor agonism.
      Consistently, administration the 5-HT2A receptor antagonist ketanserin (40 mg) prior to the
      administration of LSD (100 μg) almost completely prevented the acute effects of LSD in
      another study of our research group (NCT03321136). The present study hypothesis is that
      ketanserin (40 mg) administered 1h after LSD shortens and reduces the acute subjective
      effects of LSD (100 μg) compared to LSD alone (100 μg) followed by placebo in healthy humans.
      Such a finding would confirm a primarily competitive antagonism of ketanserin and LSD at the
      5-HT2A receptor in vivo and indicate that LSD produces its psychedelic effects only when
      present at the receptor.
    

Intervention name(s): Lysergic Acid Diethylamide; Ketanserin Placebo; Ketanserin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A moderate dose of 100 μg LSD will be administered.; Mannitol capsules instead of capsules containing Ketanserin.; A dose of 40 mg Ketanserin will be administered.
Other intervention name(s): LSD
Intervention MeSH terms: Ketanserin; Lysergic Acid Diethylamide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, placebo-controlled, random-order 2-period cross-over design with 2 treatment conditions:
100 μg LSD + ketanserin (40 mg)
100 μg LSD + placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Alzheimer's Disease Stem Cells Multiple Infusions
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to test the safety, possible side effects, and possible
      effectiveness of mesenchymal stem cell infusions when given to people with a diagnosis of
      mild to moderate Alzheimer's disease.
    


Intervention name(s): Approximately 100 million cells allogeneic hMSC
Intervention type(s): Biological
Intervention description(s): Umbilical cord-derived, allogeneic hMSC administered intravenously at a dose of approximately 100 million cells per infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dementia; Stem cells; Alzheimer's Disease
Exercise Intervention and Dexterity in Parkinson
Condition: Parkinson
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The investigators conducted an intervention based in proprioceptive exercises and balance
      tasks. The investigators also carried out a brief intervention in manual dexterity.

      The study hypothesis is that a brief intervention in upper extremities and a exercise program
      can increase functionality in Parkinson.
    

Detailed description: 
      Motor symptoms in Parkinson frequently affect upper extremities. This has been associated in
      previous studies with limitation in the performance of activities of daily living and,
      consequently, with a decrease in quality of life. The possibility that a brief intervention
      improves eye-hand dexterity in Parkinson's, may be a therapeutic option to improve the
      performance of activities of daily living. The investigators also conducted an intervention
      based in proprioceptive exercises and balance tasks to improve functionality.
    

Intervention name(s): Exercise program; Control intervention
Intervention type(s): Other; Other
Intervention description(s): Exercise program An brief exercise session including proprioceptive and dexterity activities; Active upper limb range of movement exercises for 15 minutes.
Other intervention name(s): Plaster of resistance activities
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Parkinson.; Dexterity.; Balance.; Exercises.
Study to Assess the Inhibition of Plaque Formation in Subjects With a Gingival Index ≤1.5
Condition: Inhibition of Plaque Formation (by Gingivitis-Index ≤1.5)
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study is to demonstrate the superiority of 0.1% octenidine mouthwash
      (Octenidin Mundspüllösung, OML) to placebo (PLAC) in the inhibition of plaque formation. The
      study will consist of a 14-day screening period and a 5-day treatment period.
    


Intervention name(s): Octenidinedihydrochlorid; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days; Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
Other intervention name(s): 0.1% Octenidine Mouthwash; OML
Intervention MeSH terms: Octenidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Addressing Health Disparities in Chronic Low Back Pain With Patient-Clinician Relatedness
Condition: Chronic Low-Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The primary objective of the current research is to assess the effect of an enhanced
      patient-clinician relationship when compared to a limited patient-clinician relationship on
      measures of chronic low back pain and objective functional measures.

      The second objective is to examine racialized disparities in chronic low back pain among
      individuals who identify as non-Hispanic Black and non-Hispanic White using a qualitative
      approach.

      Lastly, the study team will explore relationships between psychosocial components of low back
      pain, pain and functional outcomes, and patient-clinician relationship measures.
    


Intervention name(s): Limited Relationship; Enhanced Relationship
Intervention type(s): Other; Other
Intervention description(s): In this group, participants will share information regarding their low back pain history to a clinician who is not providing eye-contact, has farther physical distance, and is not directly facing the participant. The clinician will not provide verbal affirmations or ask clarifying questions about the patient's low back pain history. Instead, more time will be spent on completion of documentation.; A condition in which the clinician is providing enhanced relatedness with consistent eye contact, closer physical distance, facing the patient, and providing non-verbal affirmations (i.e. nodding, smiling), as the participant shares their low back pain history. The clinician will provide empathic verbal affirmations and will ask clarifying questions about the patient's low back pain history.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Patient-Clinician Relationship; Back Pain; Chronic Pain; Biopsychosocial; Health Disparities
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the Safety,
      Tolerability,Pharmacokinetics (the exposure of the trial drug in the body) and
      Pharmacodynamics (the effect of the investigated drug on the body) of subcutaneous
      NNC0143-0406 A 0.6 mmol/L in Subjects with Type 1 Diabetes
    


Intervention name(s): NNC0143-0406; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Subject will receive one single dose only Subcutanesously (s.c., under the skin); Subject will receive one single dose only. Subcutanesously (s.c., under the skin)
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment