bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine
      the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with
      DSM-5 schizophrenia who are in an acute exacerbation phase. The primary objective of the
      study is to assess the efficacy of KarXT (a fixed combination of xanomeline and trospium
      chloride) (xanomeline 125 mg/trospium 30 mg twice daily [BID]) versus placebo in reducing
      Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a
      Diagnostic and Statistical Manual-Fifth Edition (DSM-5) diagnosis of schizophrenia. The
      secondary objectives of the study are to assess overall safety and tolerability of KarXT in
      adult inpatients with a DSM-5 diagnosis of schizophrenia.
    


Intervention name(s): Xanomeline and Trospium Chloride Capsules; Placebo Capsules
Intervention type(s): Drug; Drug
Intervention description(s): Xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-34 unless the subject is experiencing adverse events from the xanomeline 100 mg/trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/trospium 20 mg depending on clinical response and tolerability. Dosing must not change after Visit 7 of the study (at 21 ± 2 days of dosing) and may be decreased for tolerability reasons no more than once during the study.; Placebo Capsules
Other intervention name(s): KarXT
Intervention MeSH terms: Xanomeline; Trospium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
The Cognitive Effects of 6- and 12-weeks Administration of a Food Supplement Containing Phosphatidylserine in Healthy Children Aged 8 to 12 Years
Condition: Cognitive Change
Study type: Interventional

Summary: 
      The purpose of this study is to assess the cognitive effects (attention, learning, and
      memory) of 6 and 12 weeks administration of a supplement containing phosphatidylserine in
      comparison to a placebo in healthy children aged 8 to 12 years old. The study will utilize
      Rey Auditory Verbal Learning Test (RAVLT) and Computerised Mental Performance Assessment
      System (COMPASS, Northumbria University) for a broad assessment of cognitive
      function/learning, and actigraphy to monitor sleep.
    


Intervention name(s): Phosphatidylserine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Phosphatidylserine containing supplement (2 x chewable gummies/day; Total daily dose of 100 mg elemental phosphatidylserine); Placebo comparator (2 x chewable gummies/day, matched to shape and color without active ingredient)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cognition; Phosphatidylserine; Memory; Learning; Attention
Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      An extension study for subjects with prior participation in previous resonator studies using
      low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease.
    


Intervention name(s): Resonator Device
Intervention type(s): Device
Intervention description(s): active pico-tesla magnetic fields treatment for Parkinson's disease individuals
Sampling method: Non-Probability Sample
Study population: 
        Previous participants enrolled in one of two prior pico-tesla Magnetic Therapies Resonator
        device studies using magnetic fields for treating Parkinson's Disease (PD) symptoms.
Project Sexual Awareness for Everyone (SAFE)
Condition: Sexually Transmitted Disease; Secondary Prevention; Behavioral Modification; Public Health
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial randomizes young Mexican American and African American women with a sexually
      transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus
      control with the goal of preventing recurrent sexually transmitted infections.
    

Detailed description: 
      Participants are interviewed, examined, and offered treatment at 0, 6, 12 months and as
      necessary.
    

Intervention name(s): SAFE Behavioral Intervention; Control
Intervention type(s): Behavioral; Other
Intervention description(s): Group cognitive behavioral intervention sessions; Individual Sexually Transmitted Infection Risk Reduction Counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sexually Transmitted Infections; Secondary Prevention; Cognitive Behavioral Intervention
Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil
      for initial treatment of chronic lymphocytic leukemia
    

Detailed description: 
      Patients will be assessed for response after three cycles of treatment. Two additional cycles
      are recommended for CR, PR or SD patients, up to a maximum limit of six cycles in total.
      Patients will be followed up every three months until disease progression or death.
    

Intervention name(s): Bendamustine hydrochloride injection; Chlorambucil
Intervention type(s): Drug; Drug
Intervention description(s): d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles; d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles
Intervention MeSH terms: Bendamustine Hydrochloride; Chlorambucil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Lymphocytic Leukemia; Bendamustine Hydrochloride; Chlorambucil
The Effects of JNJ-39393406 on Psychometric Performance and Residual Depressive
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on psychometric
      performance and residual depressive symptoms in patients who have been diagnosed with
      unipolar and bipolar depression but currently DO NOT meet criteria for an episode of Major
      Depression or Manic Episode.
    

Detailed description: 
      To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on psychometric
      performance and residual depressive symptoms in patients who have been diagnosed with
      unipolar and bipolar depression but currently DO NOT meet criteria for an episode of Major
      Depression or Manic Episode.

      Hypothesis: Allosteric modulation of the a7nAChR with JNJ-39393406 improves psychometric
      performance and residual depressive symptoms in patients with unipolar major depression
      disorder (MDD) or bipolar depression (BPD).

      Outcome measurements:

        -  BACS

        -  MADRS

        -  BNSS

        -  CGI-S- BP,

        -  Questionnaire on smoking urges (QSU) and time to the first cigarette after waking up in
           the morning,

        -  Readiness for discharge scale.
    

Intervention name(s): JNJ-39393406; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial; JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Dietary Fiber on Glucose & Lipids in Non Insulin Dependent Diabetes Mellitus (NIDDM)
Condition: Non-Insulin-Dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Effect of Dietary Fiber on glucose, lipid, and mineral metabolism in patients with non
      insulin dependent diabetes mellitus.
    

Detailed description: 
      Two diets will be compared,a low fiber diet and a high fiber diet. These two diets will
      differ only in the content of total dietray fiber derived from natural food products. The
      diets will be identical in terms of total energy, percentage of total energy as proteins, fat
      and carbohydrates.
    

Intervention name(s): High Fiber and Moderate Fiber Diets
Intervention type(s): Other
Intervention description(s): Dietary
Other intervention name(s): Dietary Fiber Study
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; lipids; fiber
Use of Acupuncture In Children With Autistic Spectrum Disorder
Condition: Autism; Autistic Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study of the efficacy of acupuncture in children with autism.
    

Detailed description: 
      Autism Spectrum Disorder (ASD) or autism is a neurodevelopmental disorder with unknown
      etiology. ASD consisted of 3 core features: 1) disorder of language or communication; 2)
      disorder of social interaction; and 3) obsessive and stereotypic behavior.

      Acupuncture had been practiced in China for over two millennia. In Traditional Chinese
      Acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions.
      The approach in TCM, in sharp contrast to western medical concept, was a "holistic" approach
      with a philosophical background of balancing the "Yin-and-Yang". The main objective of TCM
      was to improve health of body and mind by deblocking the flow of "Qi" in the body. The
      pathophysiological basis of TCM aimed to improve "energy" or "body-flow" or "Qi" ["de-qui" in
      Chinese]. The effect of acupuncture was had been proven in animal and human studies to be due
      to direct neural stimulation, changes in neurotransmitters such as endorphin, immunological
      markers or endocrinological signals. Thus, acupuncture is especially effective in chronic
      disorders, especially neurological ones.

      As there is no TCM concept of mental retardation or autism, we propose that ASD is part of
      the spectrum of the TCM concept of the "Four Delayed Syndrome" in children with "delay in
      motor skills, speech, hair and teeth eruption" according to TCM concept. Thus, we approach
      ASD according to TCM concept as part of the lower intelligence due to imbalance of "Heart
      meridian and Kidney meridian" (i.e. yin-yang imbalance) resulting in communication problem
      and "Liver meridian" (yin-yang imbalance) leading to behavioral problems.

      Our objective is to use a different approach in looking at ASD and to assess the efficacy of
      TCM model in improving the functional status of these children. Specific acupoints
      corresponding to various organs and meridians were used for ASD. The organ and meridian
      concept in TCM model has been as a fundamental basis to improve the behavior, cognition and
      communicative ability in children with ASD.
    

Intervention name(s): Tongue Acupuncture (Procedure)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Traditional Chinese Medicine (TCM); Alternative Medicine (AM); Tongue Acupuncture (TAC); Autism Spectrum Disorder (ASD); Autism; Children
Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy
Condition: Pain
Study type: Interventional

Summary: 
      Comparing patients receiving subanesthetic doses of Ketamine vs placebo to see if it can
      reduce narcotic needs for patients receiving a tonsillectomy and adenoidectomy
    


Intervention name(s): ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single IV dose of 0.1 mg/kg of ketamine; Saline given of equal volume to drug
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain
Effect of RYGB on Alpha- and Beta Cell Function and Sensitivity to Incretins in Patients With Type 2 Diabetes
Condition: Type2 Diabetes; Obesity, Morbid
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Morbid
Study type: Interventional

Summary: 
      The aim of the study is to investigate the effect of Roux-en-Y gastric bypass (RYGB) on
      pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in
      patients with pre-operative type 2 diabetes.

      Primary hypotheses:

        -  After RYGB, the sensitivity to GLP-1 and GIP is improved (improved insulinotropic
           effect).

        -  After RYGB, the insulin secretion improves during an oral glucose tolerance test within
           3 months postoperatively.

        -  After RYGB, the insulin secretion during intraveneous stimulation with glucose or
           non-glucose (arginin) is unchanged.
    

Detailed description: 
      Design: 12 patients with type 2 diabetes will be recruited.

      All subjects will undergo 11 study visits: four visits before, three visits at 1 week after
      surgery and four visits at 3 months postoperatively:

        -  Oral glucose tolerance tests (OGTTs) with measurement of GLP-1 and GIP secretion will be
           performed before and 3 months post-surgery.

        -  Hyperglycemic clamps with co-infusion of saline, GLP-1 or GIP will be performed in a
           randomised order at three separate study visits in randomized order before, 1 week and 3
           months after surgery.
    

Intervention name(s): Oral Glucose Tolerance Test; Hyperglycemic clamp with infusion of saline, GLP-1 or GIP
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Standard test of glucose tolerance with ingestion of 75 g glucose followed by blood sampling.; Blood glucose kept at 15 mmol/L via iv 20% glucose infusions.
Primed co-infusion of either:
Saline
GLP-1 (Prime dose 6 pmol/kg, infusion 1 pmol/kg/min)
GIP (Prime dose 3 pmol/kg, infusion 1.5 pmol/kg/min).
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Prospective evaluation of gastric bypass patients, who will be examined before, 1 week and 3 months after the gastric bypass operation.
Masking: Single (Participant)
Primary purpose: Basic Science
Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain
Condition: Traumatic Hemothorax and Pneumothorax
MeSH terms: Pneumothorax; Hemothorax
Study type: Interventional

Summary: 
      The purpose of this trial is to study the role of small bore chest drains in draining
      traumatic hemothorax and pneumothorax.
    

Detailed description: 
      The precise role of small bore chest drains in treating post traumatic pleural collections,
      especially hemothorax is not well established. This trial is conducted to study the efficacy
      and safety profile of small bore chest drains in trauma patients with hemothorax and
      pneumothorax.
    

Intervention name(s): Intercostal drainage
Intervention type(s): Device
Intervention description(s): Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of the recombinant
      live attenuated tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in
      healthy adults, adolescents, and children in Dhaka, Bangladesh.
    

Detailed description: 
      Dengue viruses (DENV) are the leading arboviral infection globally, with over 2 billion
      people at risk of infection worldwide. The first dengue fever outbreak in Bangladesh occurred
      in 2000, and since then, dengue fever has had a continued presence throughout Bangladesh.
      This study will evaluate the safety and immunogenicity of the recombinant live attenuated
      tetravalent dengue virus vaccine admixture TV005 (TetraVax-DV T005) in healthy adults,
      adolescents, and children in Dhaka, Bangladesh.

      The study will enroll four cohorts of participants: adults, adolescents, children, and young
      children. Study researchers will evaluate study data for each cohort before enrolling the
      subsequent cohort.

      Participants will be randomly assigned to receive either TV005 vaccine or placebo at study
      entry (Day 0). Additional study visits will occur on Days 7, 14, 28, 56, 180, 360, 720, and
      1080. Study visits will include blood collection, physical examinations, and clinical
      assessments. Participants will record and monitor their temperature and symptoms until Day
      14. Study staff will contact participants daily until Day 14; after Day 14, study staff will
      contact participants weekly (and after Day 180, monthly) throughout the study for follow-up
      health monitoring.
    

Intervention name(s): TV005 vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Delivered by subcutaneous injection; contains 10^3 PFU of rDEN1Δ30, 10^4 PFU of rDEN2/4Δ30(ME), 10^3 PFU of rDEN3Δ30/31, and 10^3 PFU of rDEN4Δ30.; Delivered by subcutaneous injection
Other intervention name(s): TetraVax-DV T005
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Virus
Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
Condition: Pain, Postoperative; Postoperative Nausea and Vomiting; Scoliosis
MeSH terms: Scoliosis; Vomiting; Pain, Postoperative; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      There will be two groups in this study: one group will be given the standard infusion of
      naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the
      other group will receive a higher dose. The trial is designed to determine if a higher dose
      of naloxone infusion will reduce side effects from opioid therapy in patients who have
      undergone spine fusion for scoliosis.
    

Detailed description: 
      Currently, patients undergoing spinal fusion for scoliosis are routinely given patient
      controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically
      combined with an ultra low dose naloxone infusion because of the established benefit of
      reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone
      infusion may lead to further improvement in pruritis and nausea and may improve GI function.
      Improvement in bowel function could lead to faster initiation of oral intake as well as
      transition to oral pain medication and even decreased length of stay.
    

Intervention name(s): Naloxone; Naloxone
Intervention type(s): Drug; Drug
Intervention description(s): Naloxone infusion 0.5 mcg/kg/hr; Naloxone infusion 2.5 mcg/kg/hr
Other intervention name(s): Narcan; Narcan
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Narcotic Antagonists; Naloxone infusion; Postoperative pruritis; Patient controlled analgesia; Pediatric; Children
An Investigator-initiated Trial to Assess the Effectiveness of Three Different Gummies (Curcumin Gummies, Vitamin C Gummies, and Vitamin B Complex Gummies) in Healthy Children
Condition: Healthy Children
Study type: Interventional

Summary: 
      An Open-Label, Three-Arm, Parallel, Investigator-Initiated Trial of Three Different Gummies
      (Curcumin Gummies, Vitamin C Gummies, and Vitamin B Complex Gummies) in Healthy Children.

      A sufficient number (maximum of 48, (16 children/arm)) of children subjects will be recruited
      to ensure a total of 45 subjects (15 children /arm) complete the study.
    

Detailed description: 
      Qualifying siblings within the same household are permitted in the study. The potential
      subjects will be screened as per the inclusion and exclusion criteria only after obtaining
      written parental informed consent and from the subjects and subjects' legal parent/legal
      guardian.

      The subject's parents will be instructed to visit the facility as per the below visits:

        -  Visit 01 (Day 01): Screening, Enrolment Visit

        -  Visit 02 (Day 30): Evaluations, End of Study Visit Subjects will be pre-screened by the
           screening department of NovoBliss Research. Subjects will be called on the telephone by
           the recruiting department prior to the enrolment visit.

      Assessment of safety, efficacy and organoleptic properties will be done on Day 01 as a
      baseline before test product usage to Day 30 after test product usage.

      Reduction in frequency of getting the sickness. Consumer feedback-subjective questionnaires -
      Health Questionnaire Product Perception Questionnaire - Organoleptic parameters.
    

Intervention name(s): Curcumin Gummies; Vitamin C Gummies; Multivitamin Gummies
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Chew gummies thoroughly and completely before swallowing.; Chew gummies thoroughly and completely before swallowing.; Chew gummies thoroughly and completely before swallowing.
Other intervention name(s): curcumin; Vitamin C; Multivitamin
Intervention MeSH terms: Vitamins; Ascorbic Acid; Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An Open-Label, Three-Arm, Parallel, Investigator-Initiated Trial of clinical study
Masking: None (Open Label)
Primary purpose: Supportive Care