bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Low Doses of V24343 in Obese Subjects
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomised, double-blind, parallel group comparison of four dose levels of V24343 and placebo
      to study the effect of V24343 on blood pressure and weight in obese subjects.

      The primary variables, change in blood pressure (BP) and pulse, will be assessed both by
      outpatient ambulatory monitoring of vital signs and by regular clinic monitoring.

      The efficacy of V24343 will be assessed by measurement of body weight, waist circumference,
      bioimpedance assessment of body composition and blood glucose.

      Assay of plasma concentration of V24343 in blood samples collected at intervals after dosing
      will be used to assess the pharmacokinetics of V24343.

      Other safety assessments comprise routine monitoring of adverse events; concomitant
      medication; clinical laboratory safety tests, 12-lead electrocardiograms (ECG) and
      self-completed psychiatric assessments.
    


Intervention name(s): V24343
Intervention type(s): Drug
Intervention description(s): Oral, 1mg, 2 mg, 5 mg or 25 mg, or placebo, once daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Study effects on blood pressure and weight in obese subjects
Evaluation of the Effectiveness of the Teen Options to Prevent Pregnancy (T.O.P.P.) Program
Condition: Pregnancy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of the Teen Options to Prevent
      Pregnancy (T.O.P.P.) program in increasing contraceptive use and reducing repeat pregnancies
      among pregnant and parenting adolescents in central Ohio.
    

Detailed description: 
      The risk for teen pregnancy is especially high among teen mothers, leading, in some cases, to
      unsafe intervals between teen births. The Teen Options to Prevent Pregnancy (T.O.P.P.)
      program is an 18-month clinic-based program that aims to reduce repeat pregnancies among
      pregnant and parenting adolescents by providing telephone-based care coordination and mobile
      contraceptive services to this high-risk population. This study uses a randomized controlled
      design to compare the effectiveness of T.O.P.P. versus usual care provided to patients at
      participating clinics. Study participants will be adolescent mothers between the ages of 10
      to 19 recruited through seven OhioHealth women's health clinics and three OhioHealth
      hospitals covering seven counties in central Ohio. This study is being conducted as part of
      the national Evaluation of Adolescent Pregnancy Prevention Approaches funded by the U.S.
      Department of Health and Human Services' Office of Adolescent Health.
    

Intervention name(s): Teen Options to Prevent Pregnancy (T.O.P.P.)
Intervention type(s): Behavioral
Intervention description(s): Telephone-based care coordination and mobile contraceptive services
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pregnancy prevention; Pregnancy; Birth; Contraceptive use; Adolescents
Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of
      clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.
    


Intervention name(s): DA-8010 5mg; Clarithromycin 500mg; Rifampicin 600mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): [Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg; [Period 2] DA-8010 5mg, Clarithromycin 500mg; [Period 3] DA-8010 5mg, Rifampicin 600mg
Intervention MeSH terms: Clarithromycin; Rifampin; DA-8010
Intervention model: Single Group Assignment
Intervention model description: 3-period
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
Condition: Chronic Arsenic Poisoning
MeSH terms: Keratosis, Actinic; Arsenic Poisoning; Keratosis; Poisoning
Study type: Interventional
Phase: Phase 2

Summary: 
      Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with
      garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic
      load and clinical symptoms. Similar treatment with similar number of arsenic exposed controls
      and healthy volunteers will be included for comparison.
    

Detailed description: 
      Thousands of Bangladeshi are suffering from arsenic-induced keratosis affecting palms and
      soles. Palmer keratosis, particularly in young female, affects the socioeconomic condition.
      Till today there is no effective treatment.

      Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with
      garlic oil in soft capsule (10 mg/day) orally for 12 weeks. Similar treatment will be given
      to 20 arsenic exposed controls and 20 healthy volunteers for comparison. The aim of this
      study is to examine the effectiveness of oral administration of garlic oil to reduce body
      arsenic load and clinical symptoms of arsenical palmer keratosis.
    

Intervention name(s): Garlic oil
Intervention type(s): Dietary Supplement
Intervention description(s): Oral administration
Intervention MeSH terms: Allyl sulfide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arsenic; Arsenicosis; Garlic oil; Keratosis
Efficacy and Safety of TMS for the Preemptive Treatment of Migraine With Aura
Condition: Migraine With Aura
MeSH terms: Migraine Disorders; Epilepsy; Migraine with Aura
Study type: Interventional
Phase: Phase 3

Summary: 
      Assess safety and efficacy of Transcranial Magnetic Stimulation (TMS) for the treatment of
      migraine with aura

      The hypothesis is that TMS treatments delivered to the occipital cortex of the brain can stop
      or interrupt the spreading cortical brain activity that causes or contributes to the migraine
      headache. Two TMS treatments at an intensity of <1 Tesla for ~500 microseconds, approximately
      30 seconds apart, may stop the aura and prevent the subsequent headache.
    

Detailed description: 
      In the Lead-in Phase participants will use a Personal Digital Assistant (PDA) to keep an
      electronic diary of their migraine episodes. During a migraine episode, as well as the time
      in between headaches, the PDA prompts the participant to answer questions. Each evening, the
      participant will place the PDA into an electronic telephone cradle, and the information will
      be transmitted electronically from the PDA to the data management team to assess the
      frequency of migraine episodes and participant proficiency with the PDA. During this one
      month period, the participant must experience at least one migraine with aura episode to
      enter the Treatment Phase.

      After one month, the participant will return to the clinic with their PDA and will enter the
      Treatment Phase to be randomized to either the TMS only group or the Sham stimulation only
      group. Participant will enter information into the PDA for three migraine auras treated or
      three months, which ever comes first.
    

Intervention name(s): Active Transcranial Magnetic Stimulation (TMS) Device; Sham TMS Device
Intervention type(s): Device; Device
Intervention description(s): Transcranial Magnetic Stimulation Device treatment; Simulated Sham treatment without TMS delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Migraine with aura; aura; TMS
Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions).

      The pathological complete response rate obtained in previous studies is around 12%. The
      expected pathological complete response rate in this study is 25%. With an alpha error of
      0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed
      initially. With 2 pathological complete responses, patient recruitment will continue until
      approximately 61 patients are recruited. Twelve pathological complete responses are needed to
      confirm the study hypothesis.
    

Detailed description: 
      Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short
      intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks
      later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six
      weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle).
      After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162,
      169 and 176). Adjuvant chemotherapy and radiotherapy were delivered according to the protocol
      of each participating center. Hormonal treatment was started after the last chemotherapy
      infusion in all patients with positive estrogen and/or progesterone receptor tumors and was
      continued for five years.

      Semiquantitative determination of three molecular markers was carried out by
      immunocytochemical methods. Tissue samples were taken prior to initiation of chemotherapy
      from the core of the primary tumors. Specimens were sent to a central laboratory for analysis
      of Topo II, survivin and p27.
    

Intervention name(s): Doxorubicin; Cyclophosphamide; Docetaxel
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): adriamycin; Cytoxan; Taxotere
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stage II and IIIA breast Cancer.; Neoadjuvant chemotherapy.; Weekly docetaxel.
Emotion Regulation in Preschoolers With Autism and Their Parents
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      In the proposed study, the investigators would like to investigate the emotion regulation
      (ER) strategies children with Autism Spectrum Disorders (ASD) demonstrate, and the influence
      parents have on their children's ER. More specifically, the investigators would like to
      examine what are the ER mechanisms that parents use, what mechanisms of self regulation
      children with autism internalize, and how parents support and improve the ER capabilities of
      their child with ASD. These will be studied in a behavioral level, using micro-analysis of
      parent-child interaction, and in a physiological level, using indexes of stress control and
      affiliation. In addition, in order for parental ER support to be effective, it is important
      to consider more innate neuro-developmental difficulties children with ASD demonstrate that
      strongly affect their ability to regulate themselves. These include sensory regulation
      difficulties, temperament, attention disorders and poor executive functioning.

      Hypotheses:

        1. ER strategies used by children with ASD will be more poorly developed and less
           effective, compared to those of children in the control groups.

        2. Difficult temperament and sensory regulation difficulties will hamper ER in children
           with ASD.

        3. ER strategies of parents of children with ASD will be more poorly developed and less
           effective than those of parents in the control groups.

        4. Good parental self-ER and parental attunement to the child will be predictive of
           improved ER in children with ASD, and in parent-child synchrony, both in the behavioral
           and in the physiological levels.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in the study group will be recrutied from psychiatric clinics, after a
        diagnosis of ASD has been made, and from special education kindergartens.

        participants in the comparison group will be recruited by adds suggesting participiation in
        the study that were published in variose cities and on the internet.
      
Biospecimen description: 
      Saliva used for cortisol and oxytocin extraction
NOLAN: Naproxen or Loratadine and Neulasta
Condition: Bone Pain in Stage I - III Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to estimate the difference in bone pain between breast
      cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic
      intervention, prophylactic naproxen, or prophylactic loratadine.
    

Detailed description: 
      In this study, the investigational products are naproxen, a non-steroidal antiinflammatory
      drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as
      prophylactic medications to reduce the incidence and/or severity of bone pain in breast
      cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and
      pegfilgrastim prophylaxis.

      Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help
      fight infections in patients undergoing chemotherapy.
    

Intervention name(s): Naproxen; Loratadine; Pegfilgrastim; Chemotherapy
Intervention type(s): Drug; Drug; Biological; Drug
Intervention description(s): Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.; The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.
Other intervention name(s): Neulasta®
Intervention MeSH terms: Loratadine; Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; Chemotherapy; Neulasta; Pegfilgrastim; Naproxen; Loratadine; Non-steroidal antiinflammatory drug (NSAID); Anti-histamine; Bone Pain
Peripheral Venous Pressure as an Indicator of Central Venous Pressure in Post Operative Surgical Patients: A Randomised Controlled Trial
Condition: Peripherial Venous Pressure; Central Venous Pressure; Fluid/Volume Status Monitoring of Patient
Study type: Interventional

Summary: 
      The study is aimed at comparing peripherial venous pressure as an indicator of central venous
      pressure in post operative surgical patients.
    


Intervention name(s): Peripherial and central venous access
Intervention type(s): Procedure
Intervention description(s): Passing a peripherial and a central venous catheter/cannula
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Peripherial venous pressure; Central venous pressure
Effects of Exercise Poles on Older Adults During Exercise Walking
Condition: Movement Disorders; Aging
MeSH terms: Movement Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study uses a patented type of exercise poles, developed to assist runners rehabilitating
      from lower body injuries. These poles may offer older adults improved stability, reduced fear
      of falling, and lessened lower body pain when exercise walking.
    

Detailed description: 
      Phase 1 (being concluded as of Feb 2002) used 18 older adults to investigate prototype
      versions of the running poles. Preliminary results, after 3 months of testing, indicate the
      poles are safe and effective. Phase 2 will use improved versions of the poles, which are
      currently in development, with a group of around 125-150 subjects over a longer length of
      time (12 months). Changes in walking gait quality, balance, strength, body composition,
      exercise adherence, and subjective perceptions of wellness will be assessed before, during,
      and after the 12 month exercise session.
    

Intervention name(s): Exercise poles
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fall-Prevention; Balance; Musculoskeletal Systems; Protective Devices; Gait; Equilibrium; Accidental Falls; Frail Elderly
A Study to Compare the Safety and Drug Levels in Blood When Using Various Forms of GSK189075 Given to Healthy Subjects
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to look at concentrations of GSK189075 in blood when
      different long and short acting forms of the drug are taken by mouth. The results will help
      to decide whether a long-acting form of GSK189075 can be made. The effects of the drug on the
      body and safety will also be studied.
    


Intervention name(s): GSK189075 (Modified and immediate release formulations)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics,; healthy male and females,; pharmacodynamics
A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine
Condition: Pneumonia, Bacterial; Healthy Volunteers; Pneumococcal Disease
MeSH terms: Pneumococcal Infections; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3
      different dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13)
      in adults 18 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability,
      and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active
      comparator PCV13 in elderly 65 to 85 years of age. In addition, Stage 2 will evaluate the
      immunogenicity of 3 different dose levels of ASP3772 relative to the response seen following
      administration of Pneumovax® 23 (PPSV23) for the serotypes not included in PCV13.
    

Detailed description: 
      The study population will consist of 3 different groups: Group 1 - Stage 1 PCV13 naïve
      participants randomized within 3 sequential cohorts to ASP3772 or PCV13; Group 2 - Stage 2
      PCV13 naïve participants randomized within 3 sequential cohorts to ASP3772 or PCV13; and
      Group 3 - Stage 2 participants previously vaccinated with PCV13 that will receive PPSV23.
    

Intervention name(s): ASP3772; PCV13; PPSV23
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Participants received a single dose of ASP3772 (ASP3772 low dose, ASP3772 medium dose and ASP3772 high dose) intramuscularly; Participants received a single dose of PCV13 intramuscularly.; Participants received a single dose of PPSV23 intramuscularly.
Other intervention name(s): Prevnar 13; Pneumovax 23
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Pneumococcal vaccine; Vaccine; Pneumococccal Disease; ASP3772
The Effect of Local Anesthetic Injection Depth on Procedural Pain and Discomfort During Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
Condition: Lumbar Radiculopathy Due to Spinal Nerve Compression
MeSH terms: Radiculopathy; Pain, Procedural
Study type: Interventional

Summary: 
      Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral
      radicular pain. But needle handling during the procedure may cause pain and discomfort to the
      patient. At the local skin anesthesia step, local anesthetics injection to the muscle layer
      along the needle pathway as well as the subcutaneous layer may reduce the procedural pain. In
      addition, it can reduce the injection site pain that may occur after the procedure.
    

Detailed description: 
      1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be
           performed after receiving the informed consent of the patient.

        2. This study is single-blind because it is not possible to blind the practitioner
           performing the injection.

        3. Subjects were randomly assigned to the subcutaneous anesthesia group (group A) and the
           muscle anesthesia group (group B) by a random random number table, and the possibilities
           for belonging to any group were all the same and can not be artificially controlled by
           researchers.

        4. After the procedure, a resident who does not know of this study records the patient's
           pain and discomfort. and on follow-up visits, post injection site pain is checked.

        5. Because of the large difference between the skilled and unskilled patients, the
           procedure in this study is performed by only one skilled practitioner
    

Intervention name(s): 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.; 1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.; 1% Lidocaine
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): 1) In group A, 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.; 2) In group B, 1ml of a local anesthetics (1% Lidocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.; 1% Lidocaine
Intervention MeSH terms: Lidocaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: subcutaneous anesthesia group (group A) muscle anesthesia group (group B)
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: epidural steroid injection; procedural pain; local Anesthetic Injection