bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Bioavailability and Food Effect of JNJ-39439335 in Healthy Adult Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of
      a single dose of 3 capsule formulations of JNJ-39439335 in healthy adult male volunteers. The
      effect of food on the pharmacokinetics of one of the capsule formulations of JNJ-39439335
      will also be evaluated during the study.
    

Detailed description: 
      This is an open-label (the name of the study drug will be known to the healthy volunteers
      participating in this study as well as to all study staff), randomized (volunteers will be
      assigned by chance to 1 of 6 possible treatment sequences of a single dose of 3 different
      capsule formulations of JNJ-39439335) to evaluate the pharmacokinetics (blood levels of drug)
      and relative bioavailability (i.e., the rate and extent of absorption of the drug in the
      body) of JNJ-39439335 (Part 1 of the study). The effect of food on the administration of
      JNJ-39439335 will then be evaluated on 1 capsule formulation of JNJ-39439335 (Part 2 of the
      study). The safety and tolerability of JNJ-39439335 will be monitored throughout Part 1 and 2
      of the study. In Part 1, healthy volunteers will be randomly assigned to 1 of 6 treatment
      sequences and will receive a total of 3 single doses of JNJ-39439335. Each dose (2 capsules)
      will be separated by 21 days. In Part 2, healthy volunteers will be randomly assigned to 1 of
      2 treatment sequences and will receive a total of 2 single doses of one formulation selected
      from Part 1; each dose will be separated by 21 days. Doses will be administered to healthy
      volunteers under fed and fasted conditions.
    

Intervention name(s): JNJ-39439335; JNJ-39439335
Intervention type(s): Drug; Drug
Intervention description(s): Part 2:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods.; Part 1:Type=1, unit=mg, number=25, form=capsule, route=oral use. One capsule (25 mg/day) taken once on Day 1 in 3 treatment periods.
or Part 1:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules (25 mg/day) taken once on Day 1 in 3 treatment periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: 39439335EDI1013; Bioavailability; Pharmacokinetics
Efficacy of PRF Application on Clinical Parameters and GCF Platelet-derived Growth Factor-BB and Periostin Levels
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      Determine the efficacy of the non-invasive application of PRF on periodontal clinical
      parameters(pocket reduction) and the levels of PDGF-BB and Periostin in the gingival
      crevicular fluid.
    

Detailed description: 
      The adjunctive use of PRF with conventional ScRp may improve clinical healing, decrease
      tissue morbidities such as pain and discomfort, increase patient acceptance, reduce treatment
      time. Since PRF can be utilized as a safe, natural method to repair tissues at a low cost.
      Our aim is to evaluate the effectiveness of the non-invasive application of PRF as an adjunct
      to ScRp in patients with stage III grade B periodontitis through measurements of gingival
      crevicular fluid levels of PDGF-BB and Periostin before and after treatment and compare it
      with ScRp alone. A split-mouth procedure will be performed to reduce confounders as possible.
    

Intervention name(s): Platelet rich fibrin
Intervention type(s): Other
Intervention description(s): Intravenous blood (obtained by venipuncture of the antecubital vein) will be collected in two 10-mL sterile tubes without any anticoagulants and will be immediately centrifuged at 3,000 revolutions (400 × g) per minute for 10 minutes.
A structured fibrin clot in the middle of the tube, just between the red corpuscles (RBCs) at the bottom and the acellular plasma at the top, will be separated from the RBCs using sterile tweezers and scissors and transferred on a sterile PRF box.
The PRF will be then brought to a thickness of 1 mm by gently compressing in PRF box. Standardized PRF pieces will be obtained by measuring by a periodontal probe and cutting into 3 × 5 mm dimensions.
The PRF pieces will be inserted into the periodontal pockets by filling the pockets from the base up to the gingival margin. A modified gingivectomy knife, of which the tip is made blunt, will be used.
The PRF volume will be calculated by recording how many pieces will be inserted.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A split-mouth procedure will be formed. Two quadrants in each participant will be selected; the sites will be divided into two groups: control site( will treat by ScRp only) and test sites( will treat by ScRp and PRF)
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PRF; PDGF-BB; Periostin
A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma
Condition: Healthy Study Participants; Participants With Mild Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the pulmonary safety of Staccato alprazolam in healthy
      study participants and in and study participants with mild asthma
    


Intervention name(s): Alprazolam; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Study participants will receive Staccato alprazolam Dose 1 and Staccato alprazolam Dose 2 at pre-specified time points in Part A. Study participants will receive single dose of Staccato alprazolam at pre-specified time points in Part B.; Study participants will receive Staccato placebo at pre-specified time points in Part A and Part B matching the pre-specified Staccato alprazolam dosing.
Other intervention name(s): UCB7538; PBO
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part A of the Study will be 3-Way Crossover Design and Part B will be a Parallel Design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Study Participants; Staccato alprazolam; Phase 1; Pulmonary Safety; Alprazolam; STAP-001; Mild asthma
Community Based Strategies to Reduce Maternal Mortality in Northern Nigeria
Condition: Maternal Mortality
MeSH terms: Maternal Death
Study type: Interventional

Summary: 
      The objective of this cluster randomized controlled trial is to assess the impact of several
      community-based interventions that address the key factors underlying the high maternal
      mortality, as well as neonatal mortality and morbidity in northern Nigeria. The
      interventions, include:

        1. a Voluntary Health Worker Program (VHW)

        2. the VHW program with provision of a safe birth kit

        3. the VHW program with community folk media activities.
    


Intervention name(s): Voluntary Health Worker (VHW) Program; Safe Birth Kit; Community Folk Media Campaigns
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Voluntary Health Workers will conduct door-to-door campaigns on maternal and child health, and will visit pregnant women regularly to to educate and to encourage use of antenatal care and facility-based deliveries.; A safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women.; Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy; maternal mortality; neonatal mortality; community intervention; voluntary health worker; safe birth kit; maternal child health
Characterization of the Metabolic Fate of an Oral Arginine Form
Condition: Overweight; Hypertriglyceridemic Waist
MeSH terms: Overweight; Hypertriglyceridemic Waist
Study type: Interventional

Summary: 
      The purpose of this study is to compare the metabolic fate of two oral forms of L-Arginine in
      healthy subjects featuring metabolic syndrome related risk factors
    

Detailed description: 
      The study is a randomized crossover study including 16 healthy subjects with risk factors for
      metabolic syndrome and 16 healthy control subjects. According a double crossover design, each
      subject received two oral forms of L-arginine (A and B) in random order, and participated in
      a exploration day on the first day of arginine administration and after one week of
      supplementation with this arginine form. The two weeks of arginine supplementation were
      separated by a washout period of 2 weeks at least.

      Each exploration extended over 24 hours after administration of the first arginine dose.
      Blood tests were performed at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 h after administration of the
      first dose. During explorations after the supplementation period, we also collected urine (0,
      2, 4, 8, 12, 24 h after the first dose).
    

Intervention name(s): A form Arginine; B form Arginine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 capsules containing 0.5g of A form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week; 3 capsules containing 0.5g of B form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: arginine; supplementation; metabolic syndrome; nitric oxide
Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition
Condition: Detrusor Hyperreflexia
MeSH terms: Reflex, Abnormal
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and effectiveness of an anticholinergic drug treatment
      administered by transdermal patch to treat overactive bladder in children who have a
      neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
    

Detailed description: 
      This study will use a multicenter, randomized, open-label, active-controlled, dose-titration,
      parallel group design, in approximately pediatric patients with detrusor overactivity
      associated with a neurological condition.
    

Intervention name(s): Oxybutynin; Oxybutynin
Intervention type(s): Drug; Drug
Intervention description(s): 1.3, 2.6, 3.9 mg/day transdermal; 5 to 15 mg/day immediate release or extended release tablets, or syrup
Other intervention name(s): Oxytrol; Ditropan, Ditropan XL, Oxybutynin
Intervention MeSH terms: Mandelic Acids; Oxybutynin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients
      with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization
      period for glucose control, patients will be randomized to one of 5 groups to receive
      a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po
      qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is < 3 months,
      and the target sample size is 100-500 individuals.
    


Intervention name(s): Placebo; RO5027838; RO5027838; RO5093151; RO5093151
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): po bid for 4 weeks; 200mg po qd for 4 weeks; 50mg po bid for 4 weeks; 400mg po bid for 4 weeks; 10mg po bid for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neuraxial Labor Analgesia and the Incidence of Postpartum Depression
Condition: Parturition; Analgesia, Obstetrical; Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Observational [Patient Registry]

Summary: 
      Postpartum depression (PPD) affects approximately 15% of women during the first year after
      giving birth, and is common across cultures. The etiology of postpartum depression is not
      totally clear. The severe pain experienced during childbirth was reported to be associated
      with the development of postpartum depression. The purpose of the present study is to
      evaluate whether use of neuraxial labor analgesia can reduce the incidence of postpartum
      depression.
    

Detailed description: 
      Postpartum depression (PPD) affects approximately 15% of women during the first year after
      giving birth, and is common across cultures. In postpartum Chinese women, the reported
      incidence ranged from 6.5% to 29.5%.

      The etiology of postpartum depression is not totally clear. Identified risk factors include
      previous maternal blues, unplanned pregnancy, lack of marital or social support, and previous
      psychiatric illnesses. Furthermore, the severe pain experienced during childbirth was
      reported to be associated with the occurrence of postpartum depression.

      A recent study of the investigators found that use of epidural analgesia during labor was
      associated with decreased risk of postpartum depression. However, several limitations existed
      in that study and further evidence is needed to reconfirm the finding. The purpose of the
      present study is to reevaluate whether use of neuraxial labor analgesia can reduce the
      incidence of postpartum depression.
    

Intervention name(s): No neuraxial labor analgesia; Neuraxial labor analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.; Epidural or combined spinal-epidural labor analgesia will be performed when the cervix is dilated to 1 cm or more and continued until the cervix is fully dilated to 10 cm.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primiparae between 18 and 34 years of age with term single cephalic pregnancy who are
        preparing to deliver vaginally during the daytime hours.
      
Keywords: primipara; childbirth; neuraxial labor analgesia; postpartum depression
ED90 of Remimazolam Loading Dose for Sedation in Patients Under Monitored Anesthetic Care
Condition: Remimazolam; Orthopedic Procedures; Sedatives
Study type: Interventional
Phase: Phase 4

Summary: 
      Currently used drugs for monitored general anesthesia include propofol, midazolam, and
      dexmedetomidine. Each drug has different advantages and disadvantages. Remimazolam causes a
      relatively small decrease in blood pressure, and it has no injection pain. In addition,
      remimazolam has a very short onset time, and even after the continuous infusion, the onset of
      remimazolam is fast, and even after continuous injection, the effect disappeared very quickly
      due to the short context-sensitive half time. nd through continuous infusion, the patient's
      depth of anesthesia can be maintained constant. In addition, the short duration of action and
      the ability to quickly reverse the effect of flumazenil suggest that remimazolam can be used
      effectively under general anesthesia as well as under general anesthesia. Remimazolam can be
      used as a continuous infusion for general anesthesia. However, it has also been reported to
      be used for sedation by continuous infusion or divided intravenous infusion. However, the
      effective infusion dose of remimazolam for supervised general anesthesia without mechanical
      ventilation has not been established.

      In this study, the ED90 of the loading dose to induce loss of consciousness in patients when
      supervised general anesthesia is performed through continuous infusion of Remimazolam is to
      be obtained.
    


Intervention name(s): Remimazolam
Intervention type(s): Drug
Intervention description(s): A beginning dose of remimazolam is 1mg/kg/hr. When sedation is not achieved in 10 minutes, the dose will be increased by 0.1mg/kg/hr in the next patient. When sedation is successful, the same dose will be used with the probability of 0.89, or the dose will be decreased by 0.1mg/kg/hr with the probability of 0.11 in the next patient. (maximal dose: 2mg/kg/hr)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: remimazolam, sedative effect
A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicenter
      study to evaluate the safety and efficacy of Rituximab in adults with RRMS.
    


Intervention name(s): rituximab
Intervention type(s): Drug
Intervention MeSH terms: Rituximab
Primary purpose: Treatment
Keywords: Relapsing remitting multiple sclerosis
Impact of Commercial "Sleep Lotion" on Salivary Melatonin Levels and Sleep Quality in Undergraduates
Condition: Sleep
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test an over-the-counter "sleep lotion" in healthy
      undergraduate college students. The main questions it aims to answer are:

        -  Does an over-the-counter "sleep lotion" containing melatonin actually increase melatonin
           levels in participants compared to a placebo (control) lotion?

        -  Does an over-the-counter "sleep lotion" containing melatonin improve the quality of
           participants' sleep compared to a placebo (control) lotion?

      Participants will:

        -  provide three saliva samples on each of two nights

        -  apply melatonin-containing "sleep lotion" on one night and a placebo (control with no
           melatonin) lotion on the other night

        -  answer questionnaires about gender, race, ethnicity, medication use, exercise, and sleep
           quality
    

Detailed description: 
      Melatonin is a hormone secreted by the pineal gland in the brain that regulates sleep. There
      are many over-the-counter products such as bubble baths, room sprays, and lotions that claim
      they contain melatonin and promote sleep. This study is a randomized, controlled,
      double-blind crossover trial to compare the impact of a commercial "sleep lotion" vs. a
      control lotion on melatonin levels detectable in saliva in healthy undergraduate students.
      Participants will provide saliva samples on two nights, one week apart, one hour before
      bedtime. The sample collections will take place just before and twice after applying 1) a
      melatonin lotion and 2) a placebo control lotion (order randomized). The investigators will
      determine whether the melatonin lotion affects the natural rise of melatonin before bedtime.
      A second dependent variable will be the quality of sleep on both nights. Potential
      confounding independent variables, such as gender, race, ethnicity, medication use, and
      exercise will also be assessed.
    

Intervention name(s): Melatonin sleep lotion; Placebo control lotion
Intervention type(s): Other; Other
Intervention description(s): 7 g of lotion applied to hands and arms one hour before bedtime; 7 g of lotion applied to hands and arms one hour before bedtime
Other intervention name(s): Dr. Teal's Sleep Lotion; Dr. Teal's Lavender Essential Oils Lotion
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized to either the melatonin lotion first or the placebo control lotion first, and then each participant will receive the other treatment second.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: melatonin; lotion
The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.
Condition: Hyponatremia; Metabolic Bone Disease
MeSH terms: Bone Diseases; Bone Diseases, Metabolic; Epilepsy; Hyponatremia
Study type: Interventional

Summary: 
      The study investigates the association between normalization of serum sodium levels and bone
      markers in patients with epilepsy and chronic hyponatremia.

      The study is a randomized, single blinded, placebo controlled study where participants will
      be randomized to either treatment with salt tablets or placebo tablets through 4 months. At
      the beginning and end of the 4 months bone markers will be measured.

      The investigators null-hypothesis is that there will be no difference in bone markers before
      or after the intervention.
    


Intervention name(s): Sodium chloride; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Sodium chloride tablets, 250 mg; Starch tablets
Other intervention name(s): Strarch tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
This Phase 2, Double Blind, Placebo-controlled, Randomized Study is to Assess the Safety and Efficacy of Miricorilant in Obese Adult With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications.
Condition: Antipsychotic-induced Weight Gain (AIWG)
MeSH terms: Weight Gain; Schizophrenia; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and
      efficacy of miricorilant in obese adult with schizophrenia treated with antipsychotic
      medications.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study that will assess the safety,
      efficacy, and PK of miricorilant in obese patients with schizophrenia or bipolar disorder who
      are currently taking oral or injectable atypical antipsychotic medication.

      Patients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to
      receive 600 mg miricorilant or placebo for 12 weeks.
    

Intervention name(s): Miricorilant; Miricorilant
Intervention type(s): Drug; Drug
Intervention description(s): Miricorilant 600mg; Placebo tablets for once daily oral dosing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antipsychotic-induced weight gain (AIWG); Obesity; Weight Gain; Mental disorders; Schizophrenia; Risperidone; Quetiapine; Olanzapine; Bipolar Disorder