bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability of Risperidone Implants
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A one year, open-label, study to evaluate the safety and tolerability of risperidone implants
      as a maintenance treatment in patients with schizophrenia
    

Detailed description: 
      The trial is to evaluate the 48-week safety and tolerability of risperidone implants as
      maintenance therapy in subjects with schizophrenia. This will be measured by the incidence of
      psychotic symptoms exacerbation/impending relapse, PANSS, CGI-I, CGI-S, adverse events, vital
      signs, clinical laboratory, physical exam and ECG findings, Abnormal Involuntary Movement
      Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Scale (SAS) and
      Investigator assessments.
    

Intervention name(s): Risperidone implant
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics (how the drug effects certain target sites of activity in the body) of
      escalating doses of oral PF-04308515 in healthy volunteers for 14 days as well as one oral
      dose of a tablet formulation administered for 1 day.
    


Intervention name(s): PF-04308515; Placebo; PF-04308515 Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF-04308515 will be provided as an oral solution administered at doses of 3, 10, 30 and 100 mg. If an optional cohort is needed the dose would not exceed the established toxicokinetic exposure limits. Solution will be administered orally once daily for 14 days.; Placebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days.; Tablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; Pharmacokinetics/Pharmacodynamics; Rheumatoid Arthritis; healthy volunteers
3K3A-APC for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2 open label trial to investigate the safety and potentially efficacy of 3K3A-APC in
      patients with Amyotrophic Lateral Sclerosis (ALS).
    

Detailed description: 
      This Phase 2 open label trial seeks to investigate whether a novel therapy named 3K3A-APC is
      safe and potentially effective in patients with Amyotrophic Lateral Sclerosis (ALS). A total
      of 16 patients with ALS will be enrolled into 2 dose cohorts with five doses of 15mg or 30mg
      doses given 12 hours apart in each cohort. The primary study outcomes are to ensure the
      safety and tolerability of 3K3AAPC in ALS patients, and to determine whether 3K3A-APC is able
      to reduce the pathological changes that might possibly cause ALS.
    

Intervention name(s): 3K3A-APC Protein
Intervention type(s): Drug
Intervention description(s): 3K3A-APC with intravenous dosing of five doses of either 15mg or 30mg at 12 hourly interval. The first 8 patients will receive 15mg dose, and the next 8 patients will receive 30mg dose.
Other intervention name(s): 3K3A-APC
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALS; Amyotrophic Lateral Sclerosis; MND; Motor Neurone Disease; 3K3A-APC
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese
      migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously
      self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
      The first dose will be self-administered at the trial site under the supervision of the
      investigator and the second dose will be self-administered at home.
    


Intervention name(s): Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Intervention type(s): Drug
Intervention description(s): Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Survey of Tourniquet Use in a Combat Support Hospital
Condition: Vascular Injury
MeSH terms: Vascular System Injuries
Study type: Observational

Summary: 
      Data will be collected on the type of tourniquet and circumstances of its use. Patients with
      penetrating extremity injury will have clinical and pre-clinical hospital data collected.
    

Detailed description: 
      This is a performance improvement project that is a prospective observational cohort design
      with subgroup analyses. This project meets the criteria of research with its intent to
      publish. No data is generated and only existing data are used. No interventions are made and
      the comparisons will be with within subgroups in the cohort.

      Aim 1. Describe the number of tourniquets which were appropriately used (wound required a
      tourniquet and tourniquet was placed properly) as assessed by treating physician

      Aim 2 &3. Describe if limbs wounds with tourniquets were bleeding upon admission,
      resuscitation, and following tourniquet removal

      Aim 4. Describe if mortality for the cohort of patients with tourniquets is different than
      the mortality predicted by various injury scoring systems

      Aim 5. Compare patient outcomes between those in which a tourniquet was indicated but not
      used and those for whom a tourniquet was indicated and used

      Aim 6. Determine if patients that received tourniquets for an extended time period exhibit
      any known tourniquet complications
    

Intervention name(s): CAT (Combat Arms Tourniquet)
Intervention type(s): Device
Intervention description(s): device
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Combat soldiers on whom tourniquet was applied.
      
Keywords: tourniquet; extremity injury; hemostatic device
Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children
Condition: Typhoid Fever
MeSH terms: Typhoid Fever; Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates whether XDR Typhoid fever in children can be effectively treated with
      monotherapy (meropenum alone), or a combination (meropenum and azithromycin).
    

Detailed description: 
      Complicated XDR Enteric fever is a very serious systemic disease, caused by an extremely
      resistant mutant strain of Salmonella Typhi ( the H58 S. Typhi superbug,) that as the name
      suggests is resistant to not only the first but also the second tier drugs conventionally
      used for treatment of the same. And as such, warrants immediate antibiotic therapy, but in
      view of the extended antimicrobial resistance the treatment options are limited to only two
      effective drugs viz Carbepenem and Azithromycin, as per culture sensitivity.

      So far, in the absence of universal standardized treatment protocols for XDR complicated
      typhoid fever in children, random use of either one or both in combination is the current
      practice.

      However, keeping antibiotic stewardship in mind, it is imperative to ascertain whether
      meropenum alone is effective or should be combined with azithromycin in the treatment of this
      serious disease.

      Our study therefore compares the efficacy of monotherapy with meropenum or combination with
      azithromycin based on clinical and microbiologic remission, shortened hospital stay and less
      chances of relapse in order to then formulate a standardized protocol to treat complicated
      XDR typhoid in children thus preventing yet further antimicrobial resistance.
    

Intervention name(s): Meropenem Injection; Azithromycin Powder
Intervention type(s): Drug; Drug
Intervention description(s): inj meropenum for 10 days; syp azithromycin for10days
Other intervention name(s): meroneum; penro; azomax; zetro
Intervention MeSH terms: Azithromycin; Meropenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: XDR TYPHOID FEVER
Obesity Effect on Stroke and Cardiovascular Events
Condition: Stroke, Acute
MeSH terms: Stroke; Obesity
Study type: Observational

Summary: 
      The relation between obesity and stroke recurrence is still under debate. In this study it
      has been sought whether baseline obesity is associated with recurrent stroke and major
      cardiovascular events in a long-time period.
    

Detailed description: 
      Five-years follow-up data of Ege Stroke Registry for stroke recurrence and cardiovascular
      events regarding to obesity were analyzed. Data include age, gender, stroke severity,
      neuroimaging studies, cardiovascular risk factors. Within the inclusion period, all of the
      included patients were followed until censoring (10th of December 2011) or readmission
      because of recurrent stroke, cardiovascular event or death, whichever came first. The
      Kaplan-Meier method was used for survival analysis. Cox proportional hazard model was applied
      to identify predictors of recurrent vascular events.
    

Intervention name(s): Obesity assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Body mass index (BMI (kg/m2) was calculated from measurements of weight to the nearest kg and height
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All stroke patients enrolled in the prospective cohort registry in Egeanregion.
      
Keywords: obesity; recurrent stroke; ischemic stroke; hemorrhagic stroke; cardiovascular events; vascular death
Evaluation of the Healthy Relationships Plus Program for Youth
Condition: Mental Health Wellness 1
Study type: Interventional

Summary: 
      Adolescent risk behaviours, such as violence and substance use, are prevalent public health
      concerns in Canada. Further, these behaviours often co-occur, and are associated with poor
      mental health. However, the majority of prevention programs focus on preventing single issues
      and do not consider mental health, and also neglect the importance of relationships when
      promoting positive youth development. To address this gap, the Centre for Addiction and
      Mental Health (CAMH) Centre for Prevention Science designed the Fourth R Healthy
      Relationships Plus Program, a small group program focused on the promotion of positive mental
      health and the reduction of violence and substance use, via the development of improved
      communication, interpersonal and help-seeking skills. The purpose of this study is to
      evaluate the Fourth R Healthy Relationships Plus program using both outcome (randomized
      controlled trial design with follow-up at pre-test, post-test, and 4, 8 and 12 months) and
      process evaluation tools.

      The primary study hypothesis is that participation in the Fourth R Healthy Relationships Plus
      program will be associated with positive growth in treatment participants' psychological
      well-being from pre-test to 12-month follow-up, as compared to control participants. In
      secondary analyses, the study will explore if treatment participants report less substance
      use, peer violence, bullying and dating violence at 12-month follow-up than control
      participants. Since certain person-level (e.g., sex, personality, executive functioning) and
      program-level (e.g., implementation quality) variables may moderate treatment-outcome
      relationships, these associations will also be explored. The final hypothesis is that
      treatment participants will report better attitudes, knowledge and assertive communication at
      post-test compared to control participants, and that these improvements will mediate the
      association between program participation and 12-month outcomes.
    


Intervention name(s): Healthy Relationships Plus Program (HRPP); Control Condition (Classroom Activities)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Healthy Relationships Plus Program (HRPP) is an out-of-school time program that is facilitated by a teacher or other youth leader. HRPP sessions use interactive teaching strategies to discuss healthy relationships, dating violence, personal values/boundaries, communication skills, emotional health and well-being, and helping friends.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Mental health; Violence; Substance use; Adolescent; Prevention
To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to quantify the effect of multiple doses of PF-04531083 on the
      pharmacokinetics (PK) of co-administered single dose simvastatin.
    

Detailed description: 
      observational- quantify any effects of PF_04531083 on the PK of Simvastatin
    

Intervention name(s): PF-04531083; simvastatin; PF-04531083; simvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.; Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.; PF-04531083: a dose to be selected depending on results from Cohort 1 to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.; Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics; drug-drug interaction
Study of the Safety of KSP Heptapeptide (KSP-910638G)
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of orally administered KSP-910638G, a
      topically administered li-cor IRDye800CW labeled heptapeptide specific for human epithelial
      growth factor receptor 2 (HER2).
    

Detailed description: 
      This is a Phase IA study of the safety of an orally administered KSP-910638G heptapeptide for
      detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans.
      The investigators intend to enroll 25 evaluable subjects. The investigators expect to be able
      to enroll about 1-2 subjects per week, so the study should take about 4-6 months to complete.

      Interested, healthy subjects ages 25-100 who respond to recruitment advertising on
      UMHealthResearch.org and appear to be eligible based responses to inclusion/exclusion
      criteria questions will be scheduled for a study visit at MCRU. At the study visit, the
      subjects will review and sign the informed consent and eligibility will be confirmed. If
      eligible, subjects will provide a blood sample for clinical labs and a urine sample for
      urinalysis. A negative urine pregnancy test for women of child-bearing potential is required
      to be eligible. Eligible subjects will consume the reconstituted KSP-910638G. After 5
      minutes, subjects will drink a minimum 4-8 ounces of tap water and vital signs will be taken.
      Subjects will remain in MCRU for observation for 30 minutes. Vital signs will be recorded
      after 30 minutes. Subjects are required to return to MCRU to have a repeat blood draw for
      clinical labs and urinalysis within 24 to 48 hours after KSP-910638G ingestion. The study
      team will conduct a verbal assessment for toxicity at this visit.
    

Intervention name(s): KSP-910638G, 0.4 mg; KSP-910638G, 1.2 mg
Intervention type(s): Drug; Drug
Intervention description(s): The investigational agent to be used in this study is KSP heptapeptide, which is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached via a 5 amino acid linker to a near-infrared fluorophore, IRDye800CW. (0.4 mg dose); The investigational agent to be used in this study is KSP heptapeptide, which is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached via a 5 amino acid linker to a near-infrared fluorophore, IRDye800CW. (1.2 mg dose)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Treatment of Bronchial Asthma With Borage and Echium Seed Oils
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this trial is to determine the efficacy of a combination of two botanicals oils,
      borage seed oil and echium seed oil, as a potential treatment for bronchial asthma.
    

Detailed description: 
      Leukotrienes are important in the pathogenesis of inflammation, and leukotriene modifying
      drugs are now an established treatment for bronchial asthma and rhinitis. Drugs that inhibit
      the biosynthesis of leukotrienes are likely to be more effective than the currently available
      drugs that antagonize a single leukotriene receptor. Dietary supplementation with gamma
      linolenic acid (GLA) in borage seed oil provides effective inhibition of leukotriene
      generation but also increases circulating free arachidonic acid (AA), which has
      pro-inflammatory potential. The n-3 fatty acid, eicosapentaenoic acid (EPA), prevented the
      conversion of GLA to AA. However, EPA is extracted from fish oil, is not well-tolerated due
      to its taste, and at higher doses appeared to blunt the inhibition of leukotriene
      biosynthesis by GLA. Stearidonic acid (SDA) is a precursor of EPA that is extracted from
      Echium plantagineum; it is converted to EPA in humans and it does not have the organoleptic
      properties of EPA.

      We recently completed a dose-ranging study in which we determined the dose of SDA that is
      sufficient to inhibit the rise in circulating levels of arachidonic acid while maintaining
      effective inhibition of leukotriene generation.

      The goal of the present study is to test the efficacy of dietary supplementation with GLA and
      SDA (provided in borage seed oil and echium seed oil) in treating bronchial asthma.
    

Intervention name(s): Borage Seed Oil and Echium Seed Oil; Corn Oil
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 2 g/day of borage seed oil and 7 g/day of echium seed oil to provide 1.6 g/day of GLA and 0.9 g/day of SDA.; 9 g/day of corn oil
Other intervention name(s): CROSSENTIAL GLA TG40; INCROMEGA V3
Intervention MeSH terms: Borage oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Fatty acids; Leukotrienes; Diet
A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: Sleep Apnea, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiration Disorders
MeSH terms: Lung Diseases; Apnea; Sleep Apnea Syndromes; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive; Respiration Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to determine whether lemborexant increases the apnea
      hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater
      than or equal to [>=] 45 to less than [<] 65 years; elderly >=65 to 90 years) with moderate
      to severe obstructive sleep apnea (OSA) compared with placebo, and using pulse oximetry
      determine whether lemborexant decreases the peripheral oxygen saturation (SpO2) during total
      sleep time (TST) on Day 8 of treatment in adult and elderly participants (adults >=45 to <65
      years; elderly >=65 to 90 years) with moderate to severe chronic obstructive pulmonary
      disease (COPD) compared with placebo.
    


Intervention name(s): Placebo; Lemborexant 10 mg; Placebo; Lemborexant 10 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): OSA: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.; OSA: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.; COPD: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.; COPD: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.
Other intervention name(s): E2006; E2006; E2006; E2006
Intervention MeSH terms: Lemborexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: E2006; Lemborexant; Peripheral Oxygen Saturation; Apnea Hypopnea Index
Effect of Massage Therapy and Occlusal Splint Therapy on the Electromyographic Activity and Mandibular Range of Motion in Individuals With Temporomandibular Disorder
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The objectives of this study were to investigate the effects of massage therapy and occlusal
      splint therapy in the electromyographic activity and mandibular range of motion (ROM) in
      individuals with temporomandibular disorder (TMD) and compare the results with those obtained
      in a group of individuals without this disorder. Twenty-eight volunteers with TMD were
      randomly distributed into two groups, massage therapy and occlusal splint. Both treatments
      lasted 4 weeks. Fourteen individuals without TMD were consecutively allocated to the control
      group. The Fonseca's anamnestic index was used to characterize TMD and allocate the
      volunteers to either the intervention groups or control group. The electromyographic activity
      and Mandibular ROM was evaluated before and after treatment using a digital caliper. Two-way
      analysis of variance with the Bonferroni test was used for inter and intragroup comparisons
      (level of significance was set to 5%). Cohen's d was used to calculate the effect size.
    


Intervention name(s): Massage; Occlusal splint
Intervention type(s): Other; Other
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physical Therapy Modalities; Facial Pain; Orthodontic Appliances