bioihbjkbjnl/mcl2 huggingface dataset:
An Ascending Multi-Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers
Condition: Diabetes Mellitus; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerance of multiple intravenous
      (through a vein) doses of trodusquemine (MSI-1436) in obese or overweight, type 2 diabetics.
    

Detailed description: 
      Different amounts of trodusquemine (MSI-1436) will be given to each volunteer group
      throughout the study. Another purpose is to evaluate the pharmacokinetics (PK - the study of
      the way the drug enters and leaves the blood and tissues over time) of trodusquemine
      (MSI-1436). Finally, this study will also determine whether trodusquemine (MSI-1436) has any
      effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that
      may change in response to the study drug).
    

Intervention name(s): Trodusquemine (MSI-1436); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of Trodusquemine (MSI-1436) will be administered every 72 hours on Days 0, 3, 6, 9, 12, 15, 18 and 21. Doses are 3mg/m2 in cohort 1, 6mg/m2 in cohort 2 and 10mg/m2 in cohort 3.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Feasibility of Speech Phenotyping for Remote Assessment of Neurodegenerative and Psychiatric Disorders
Condition: Alzheimer Disease; Mild Cognitive Impairment; Dementia With Lewy Bodies; Dementia, Vascular; Frontotemporal Dementia; Primary Progressive Aphasia; Parkinson Disease; Motor Neuron Disease; Major Depressive Disorder; Bipolar Disorder; Amyotrophic Lateral Sclerosis
MeSH terms: Parkinson Disease; Alzheimer Disease; Dementia; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Aphasia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Lewy Body Disease; Dementia, Vascular; Depressive Disorder; Cognitive Dysfunction; Depressive Disorder, Major; Bipolar Disorder; Mental Disorders; Problem Behavior
Study type: Observational [Patient Registry]

Summary: 
      The primary objective of the study is to evaluate the feasibility of eliciting continuous
      narrative speech in different neurodegenerative and psychiatric indications, using remote,
      self-administered speech tasks, as measured by the average length of speech elicitation for
      each speech task during the first week of self-assessment. Secondary objectives include (1)
      evaluating the reliability of speech tasks in the remote self-administered setting, as
      measured by the intra- and inter-subject variance; (2) accessing the adherence of speech
      tasks in this setting, as measured by the subject average fraction of days during the first
      week, where at least one task response is submitted; (3) evaluating the feasibility of using
      speech tasks in the setting of a telemedicine videoconference, as measured by the average
      length of speech elicited in each group; (4) evaluate whether a set of acoustic and
      linguistic patterns can detect each indication, compare to either a control group or all
      other indications, as measured by the area under the receiver operating characteristic curve
      (AUC), sensitivity, specificity and Cohen's kappa of the relevant binary classifier; (5)
      evaluating how the performance of such algorithms can be impacted by speaker and environment
      covariates, as measured by the Kendall rank correlation coefficient of the AUC of each
      classifier and each of age group, gender and speech-to-reverberation modulation energy ratio.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study population is UK-based.
      
Keywords: Speech; Acoustic; Language; Linguistic; Machine Learning; Artificial Intelligence
An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)
Condition: Infections; Pelvic Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections; Pelvic Infection; Pelvic Inflammatory Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect of an approved medication for adults for
      an investigational use in pediatric patients 3 months to 17 years for the treatment of
      complicated intra-abdominal infections or acute pelvic infections.
    

Detailed description: 
      The duration of treatment is 18 months.
    

Intervention name(s): MK0826, ertapenem sodium; Comparator: Ticarcillin/Clavulanate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clavulanic Acid; Clavulanic Acids; Ertapenem; Ticarcillin
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intra-abdominal infections; Acute pelvic infections
Healthy Beat Accupunch (HBA) Exercise Program for Community Older Adults
Condition: Perceived Health Status; Sleep Quality
Study type: Interventional

Summary: 
      This study aimed to test the effects of a 12-month Healthy Beat Accupunch (HBA) exercise
      program on the perceived health status and sleep quality of the community-dwelling older
      adults.
    

Detailed description: 
      Phase I: A cluster randomized controlled trial was used to test the effects of a six-month,
      instructor-led Healthy Beat Accupunch (HBA) exercise program on the perceived health status
      and sleep quality of the community-dwelling older adults. Through the use of convenience
      sampling strategy, eight community care centers with 232 older adults in Kaohsiung were
      recruited and randomly assigned based on their community care centers to a HBA experimental
      group or a wait-list control group. Participants in the experimental group received the HBA
      exercise program led by trained and certified instructors, three times per week, 40 minutes
      per practice for six months; participants in the wait-list control group continued with their
      regular daily activities. One pre-test and two post-tests, three months apart, were
      conducted. Phase II: Using the same method as in the phase I, participants from the phase I
      continued practicing the HBA exercise program, but guided by a DVD, for another six months.
      The feasibility, compliance, and effectiveness of the DVD-led HBA exercise program on the
      community-dwelling older adults were tested, and another two post-tests, three months apart,
      were conducted on the same outcome measurements as in the phase I.
    

Intervention name(s): Healthy Beat Accupunch (HBA) exercise program; Control
Intervention type(s): Other; Other
Intervention description(s): HBA has three phases and takes 40 minutes to complete.; Participants maintain their daily acitvities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Skin Manifestations
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted to characterize pharmacokinetics, pharmacodynamics, safety, and
      tolerability of anifrolumab given via the subcutaneous (SC) route of administration in adult
      Systemic Lupus Erythematosus (SLE) subjects with a type I Interferon (IFN) test high result
      and active skin manifestations while receiving Standard of Care (SOC) treatment. In addition,
      the efficacy of anifrolumab on SLE skin manifestations will be characterized.
    


Intervention name(s): Anifrolumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous administration every 2 weeks from week 0 to week 50; subcutaneous administration every two weeks from week 0 to week 50
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat
Condition: Hepatitis C; HIV
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to provide the evidence that 150mg of cobicistat will have the same effect on
      the pharmacokinetics of daclatasvir 30mg QD as 100mg of ritonavir, when given together with
      atazanavir 300mg.
    

Detailed description: 
      Approximately 20-25% of the total number of HIV-infected patients is co-infected with HCV
      which translates to 6-8 million persons worldwide. Combined treatment of HIV and HCV is
      complicated by the risk of drug-drug interactions as both the direct acting antiviral agents
      (DAAs) for HCV as the antiretroviral agents for HIV are substrates of cytochrome P450
      (CYP450) or various membrane transporters, and also have the capacity to influence these
      systems. A careful selection of the appropriate regimens and if needed adjusted doses is key
      for optimal treatment of both viral infections.

      Daclatasvir is a recently approved anti-HCV agent that is a CYP3A4 substrate but does not
      affect CYP450 itself. It is also a moderate inhibitor of various membrane transporters such
      as organic anion-transporting polypeptide (OATP1B1), P-glycoprotein (P-gP), and organic
      cation transporters (OCT2).

      Atazanavir/ritonavir is one of the preferred antiretroviral agents in all international
      guidelines. Ritonavir is used as a boosting agents based on its inhibitory effects on CYP3A.
      This also inhibits CYP3A-mediated metabolism of daclatasvir and when atazanavir/ritonavir is
      combined with daclatasvir, it is recommended to reduce the dose of daclatasvir from 60mg QD
      to 30mg QD.

      Cobicistat has recently been approved as an alternative booster of atazanavir at a dose of
      150mg QD. It is expected that cobicistat will inhibit CYP3A mediated metabolism of
      daclatasvir in a similar manner as ritonavir does, but there are no clinical data to support
      this. As cobicistat lacks some of the adverse events associated with ritonavir use, the use
      of cobicistat, including as a booster of atazanavir, is likely to increase.

      This study aims to provide the evidence that 150mg of cobicistat will have the same effect on
      the pharmacokinetics of daclatasvir 30mg QD as 100mg of ritonavir, when given together with
      atazanavir 300mg.
    

Intervention name(s): Daclatasvir; Atazanavir; Ritonavir; Cobicistat
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Daklinza; Reyataz; Norvir; Tybost
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Cobicistat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hepatitis C; HIV; atazanavir; ritonavir; daclatasvir; cobicistat
Supplementation of Phosphatidylserine (PS) and n-3 Long Chain Fatty Acids (EPA, DHA) in Children With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine whether supplementation of omega-3 long-chain polyunsaturated fatty acid
      conjugated to phosphatidylserine rather than triglycerides (fish oil) could affect
      Attention-deficit/hyperactivity disorder symptoms in children.
    

Detailed description: 
      BACKGROUND Attention-deficit/hyperactivity disorder (ADHD) encompasses a broad constellation
      of behavioral and learning problems, clinically describes inattentive, impulsive, and/or
      hyperactive children. These patients are characterized by low blood LC-PUFA (LC-PUFA) levels;
      however the LC-PUFA supplementation effect on ADHD symptoms is not clear.

      METHODS Eighty-three ADHD children (3:1 boys:girls), 8-13 years old, were assigned in a
      randomized, double-blind, placebo-controlled parallel design to receive 250 mg/d of
      eicosapentaenoic acid + docosahexaenoic acid provided as phosphatidylserine (300 mg/d
      PS-Omega3), or fish oil or placebo for 3 months. Stimulant medication or other dietary
      supplements were prohibited. The measured outcomes were inattention and impulsivity,
      evaluated by Test of Variables of Attention (TOVA) and blood lipids profile.
    

Intervention name(s): Phosphatidylserine-Omega3
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: behavioral problems; learning problems; inattentive; impulsive; hyperactive; children; phosphatidylserine; long-chain polyunsaturated fatty acid; eicosapentaenoic acid; docosahexaenoic acid; omega3:omega6 ratio; eicosapentaenoic acid:arachidonic acid ratio; Test of Variables of Attention; ADHD index scores
Perceived Lactose Intolerance
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Observational

Summary: 
      The goal of this study was to examine the effects of self-perceived lactose intolerance
      (SPLI) as it relates to calcium intake and specific health problems that have been attributed
      to reduced intake of calcium and foods from the dairy group in a nationally representative
      multi-ethnic sample of adults.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        white, black, and Hispanic adults; 18-50 years of age
      
Keywords: perceived lactose intolerance; calcium/dairy consumption; specific health outcomes
A Physical Dependence Study in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether or not people with schizophrenia who take
      LY2140023 become physically dependent on it, and experience a series of symptoms such as
      craving to have the drug when they stop using it.

      This trial consists of two phases: An open-label phase consisting of up to 4 weeks and a
      double-blind phase consisting of up to 3 weeks.
    

Detailed description: 
      This was a short-term, multicenter, placebo-controlled, randomized withdrawal study comparing
      LY2140023 with placebo in the treatment of outpatients with Diagnostic and Statistical Manual
      of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR [APA 2000]) schizophrenia.
      Patients were male or female outpatients, 18 to 65 years of age (inclusive) at study entry,
      with a diagnosis of schizophrenia as defined in the DSM-IV-TR

      The primary objective of this study was to assess whether LY2140023, when administered in an
      acute-treatment trial with flexible doses (40 mg or 80 mg) BID, was associated with physical
      dependence, as measured by the occurrence of withdrawal symptoms during a randomized
      withdrawal phase in patients diagnosed with schizophrenia. Assessment was to be based on a
      comparison of randomized LY2140023-treated patients with those on placebo, as measured by the
      maximum of the 3-day moving average of the patient's total score on the Discontinuation
      Symptom Checklist-Modified Rickels (DSCMR).
    

Intervention name(s): LY2140023; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): pomaglumetad methionil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia, LY2140023, pomaglumetad methionil
Pulse Analysis for Cholecystitis Patients Before and After Cholecystectomy
Condition: Cholecystitis; Cholecystectomy
MeSH terms: Cholecystitis; Acalculous Cholecystitis
Study type: Observational

Summary: 
      The aim of this study is to record the radial pressure pulse(RPP) of the patients with
      cholecystitis compared preoperative and postoperative pulse changes in an attempt to
      determine the relationship between cholecystitis and pulse.
    

Detailed description: 
      A total of 20 patients were recruited according to the inclusion and exclusion criteria. The
      patients, aged 32-76 years, were given a diagnosis of cholecystitis by a general surgeon from
      Taiwan's Taichung Tzu Chi Hospital. All eligible patients included in the study agreed to
      participated and signed the informed consent form and the study procedures were approved by
      the ethical committee of Taichung Tzu Chi general hospital (REC110-12). By measuring and
      recording the RPP preoperatively and postoperatively, the mean values of the spectral energy
      (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) were obtained for comparison with the preoperative
      white blood cell (WBC) count.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with cholecystitis and recieve cholecystectomy
      
Keywords: radial pressure pulse (RPP)
A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the response of several doses of LY2148568 (exenatide) and assess the
      effect on glucose control and safety and tolerability in Japanese patients with type 2
      diabetes.
    


Intervention name(s): exenatide (LY2148568); exenatide (LY2148568); exenatide (LY2148568); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks; subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks; subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks; subcutaneous injection twice daily, 0.02 mL to 0.04 mL
Other intervention name(s): Byetta; Byetta; Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diabetes; exenatide; LY2148568; Lilly; Amylin; Japan
Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to select the safest and most effective number of repeat doses
      of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the
      progression of Parkinson's disease (PD).
    

Detailed description: 
      Single site phase IIa study of allogeneic MSC in a double blind randomized control trial as
      disease modifying therapy for PD. The design includes three treatment arms with 45 patients.
    

Intervention name(s): MSC+placebo; MSC; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 infusions of 10 X 10^6 MSC/kg and 1 placebo every 3 months.; 3 infusions of 10 X 10^6 MSC/kg every 3 months.; 3 infusions of placebo every 3 months. Placebo will be identical to the investigational product but will not contain MSCs.
Other intervention name(s): allogeneic mesenchymal stem cell or similar placebo; allogeneic mesenchymal stem cell; Similar placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Stem Cells; Mesenchymal stem cells; Inflammatory markers
Diarrhea and Bivalent Oral Polio Vaccine Immunity
Condition: Seroimmunity; Diarrhea; Polio
MeSH terms: Poliomyelitis; Diarrhea
Study type: Interventional

Summary: 
      Global eradication of poliomyelitis has proven to be elusive. Although 99% of cases have been
      eliminated since 1988, outbreaks continue to occur, and new tools are needed to accelerate
      eradication. One concern in this effort is that some populations have decreased
      immunogenicity to oral poliovirus vaccine (OPV). Past studies have shown decreased
      seroimmunity to trivalent OPV (tOPV) in children with diarrhea. In 2009, bivalent OPV (bOPV)
      was recommended for use in immunization campaigns, and will likely replace tOPV in routine
      immunization in 2016. However, the effect of diarrhea on seroconversion to bOPV has not been
      studied.

      This project evaluated the effect of diarrhea on seroconversion to bOPV among infants who
      reside in Nepal. The investigators conducted a prospective, interventional study that
      assessed immune response to bOPV among infants with and without diarrhea. Immune responses
      were compared among infants with and without diarrhea.

      This study will result in a better understanding of the factors that decrease the ability of
      some children to seroconvert to OPV and be protected from poliomyelitis infection.
    


Intervention name(s): bivalent oral polio vaccine
Intervention type(s): Biological
Intervention description(s): vaccine given during immunization campaigns
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: seroconversion; oral polio vaccine; OPV; poliomyelitis; diarrhea; seroimmunity
Cryotherapy Effectiveness in Individuals With End Stage Knee Osteoarthritis - a Case Series
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this case series will be to provide a detailed description of a standardized
      short-term cryotherapy application protocol using validated functional outcome measures in
      individuals with end stage KOA
    

Detailed description: 
      There are no studies determining the efficacy of cryotherapy in pain, function and quality of
      life for patients with end stage Knee Osteoarthritis (KOA). This case series describes a
      standardized treatment program for end stage patients with KOA and outcomes over a 12-week
      period.
    

Intervention name(s): Cryotherapy
Intervention type(s): Other
Intervention description(s): Crushed ice (1kg) inside a plastic bag (24x34x0,08 cm). The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the ice bags, they will be fixed with an elastic bandage (compression). To protect the skin against frost bites, all the knee surface will be covered with a moistened operative field (45x50x0,01 cm, 100% cotton)
Other intervention name(s): Cold Therapy; Ice Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee; Cryotherapy; Physiotherapy; Physical Agent