bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Safety and Pharmacokinetics of Ricolinostat
Condition: Peripheral Nervous System Diseases
MeSH terms: Nervous System Diseases; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, phase I clinical study to evaluate the safety and
      pharmacokinetics of ricolinostat in healthy Chinese adult subjects.
    

Detailed description: 
      This study is an open-label, phase I clinical study to evaluate the safety and
      pharmacokinetics of ricolinostat in healthy Chinese adult subjects.

      12 subjects are planned to be enrolled, both male and female, and all will receive the
      investigational drug.
    

Intervention name(s): ricolinostat
Intervention type(s): Drug
Intervention description(s): This study is an open-label, single-dose phase I clinical study to evaluate the safety and pharmacokinetics of ricolinostat in healthy Chinese adult subjects.
12 subjects are planned to be enrolled, both male and female, and all will receive the investigational drug.
This study includes the screening period, baseline period, dosing/observation period, discharge and follow-up period.
Intervention MeSH terms: Ricolinostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Randomized Clinical Trial for Toddlers With ASD
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This research is being done to test the effectiveness of two treatments aimed at increasing
      language and social skills in children with autism spectrum disorder. If children show
      improvement in these treatments, we hope that the availability of public services for
      minority and low income families will be increased. Minority and low income families with
      children between 22 and 33 months of age with Autism Spectrum Disorders may join.
    


Intervention name(s): Social Communication; Social communication
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Center-Based classroom intervention focuses on providing children with an invigorating, motivating learning environment in which emerging skills and knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement week may offer the children experiences that they would not otherwise have (Ramey & Ramey, 1998). Parent training sessions will focus on strategies aimed at improving child social engagement and communication and on topics related to autism characteristics, learning styles, interventions, and resources.; Parent training sessions will focus on teaching parents strategies for enhancing their child's social engagement and communication. Since parents will be using these strategies across all activities throughout the day, there is an increased likelihood of generalization. For parents of minority and underserved children, this may be the first exposure to responsive interaction strategies (Rudy & Grusec, 2001).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; language; social; toddlers
Iron Babies Pilot Supplementation Trial
Condition: Iron-deficiency; Anaemia in Early Infancy
MeSH terms: Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      2-arm, double blind, placebo controlled, randomised trial, with 50 6-week-old infants per arm
      randomized to 98 days of daily iron (1.5mg/kg/day as ferrous sulphate) or placebo drops
    

Detailed description: 
      Healthy infants will be randomised to receive daily supplementation from 6-20wks of either a)
      iron drops or b) placebo drops. Infants with significant illness or any clinical syndromes
      that would affect interpretation will be excluded. Low birthweight infants and infants born
      prematurely will not be excluded. Venous blood samples will be collected at enrollment (age 6
      weeks) and after 14 weeks (98 days) of iron/placebo supplementation.

      Participants will be visited daily in their villages by Fieldworkers (FW) to administer the
      iron/placebo dose and will interview mothers to complete a short health questionnaire. The
      iron will be dosed at 75% of WHO guideline dose (ie 1.5mg/kg/day). Weekly, a more detailed
      morbidity and breastfeeding questionnaires will be administered. Infants will be weighed and
      measured monthly, along with a faecal sample being taken.

      During the daily visits, the FWs will record any adverse events (AEs) and ensure the safety
      of participants. If a child is found unwell or if the mother/guardian reports that the child
      is unwell, the study nurse will check on the child and decide on treatment/referral to the
      nearest health centre
    

Intervention name(s): Iron drops/Ferrous sulphate; Placebo drops
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): participant will consume daily drops of iron; Participants will consume daily drops of placebo
Other intervention name(s): Ferrous Sulphate syrup; Sorbitol Solution 70%
Intervention MeSH terms: Sorbitol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Daily iron (7.5mg/day as ferrous sulphate) or placebo drops starting from six to ten weeks of age for 98 days.
Please note that the daily iron supplement is the intervention product/drug
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: anaemia, infant
Computerized Eye-tracking Attention Training for Children With Special Needs
Condition: ADHD; ASD; Learning Disorders
MeSH terms: Learning Disabilities
Study type: Interventional

Summary: 
      Children with special needs (e.g. autistic spectrum disorder, attention deficit hyperactivity
      disorder) are found to have sustained attention problems. Several behavioral interventions
      have been carried out in the past to improve this situation. However, these interventions are
      often involved a high administration cost. Recently, researchers have been focusing on
      training the eye gaze fixation using the eye-tracking training games, as some of the research
      studies reported a correlation between atypical eye gaze patterns with poor sustained
      attention. The objective of the present study is to evaluate the effectiveness of a
      computerized eye-tracking attention training. Two batches of 48 primary school students will
      be recruited from email and the subject pool of the Department of Psychology of The Chinese
      University of Hong Kong. Participants are dividedly randomly and equally into either
      intervention or control group. Participants in both groups will undergo pre- and
      post-assessments measuring the executive function and attention before and after the
      intervention, respectively. However, there will be eight eye-tracking training sessions for
      the intervention group, but only the assessments are received in the control group. It is
      hypothesized that after the training, the performance of the training games and assessments
      will improve, indicated by increasing accuracy rates, as well as the reaction time of the
      tasks. The results would provide important information on the value of computerized eye gaze
      training and would guide the direction of interventions that target on improving the
      sustained attention and impulse control of children with special needs.
    


Intervention name(s): Computerized training program; Placebo
Intervention type(s): Other; Other
Intervention description(s): Eye-gaze fixation computer based training program; Pac-Man, Zookeeper, Tetris
Other intervention name(s): Computerized program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sustained attention; Impulse control; Eye-tracking; Special needs; Computerized training
Effects of a Personalized Web-based Antenatal Care Planner
Condition: Pregnancy
Study type: Interventional

Summary: 
      Many women are turning to the Internet to meet their health information needs, but the large
      amount of information available, as well as the unknown reliability and applicability of
      information can be overwhelming. Studies in specific patient populations have determined that
      patients given access to personalized, on-line medical information are more satisfied with
      their care than patients provided generalized information. None of these studies have looked
      at whether this type of patient education would be helpful for pregnant women. This study is
      being done to determine whether pregnant women who have access to their own health records
      and personalized health information over the Internet are more satisfied with their prenatal
      care, and if they are more compliant with health visits and tests, compared to pregnant women
      who receive only generic pregnancy information on the Internet and from pamphlets
    

Detailed description: 
      Many women are turning to the Internet to meet their health information needs, but the large
      amount of information available, as well as the unknown reliability and applicability of
      information can be overwhelming. Studies in specific patient populations have determined that
      patients given access to personalized, on-line medical information are more satisfied with
      their care than patients provided generalized information. None of these studies have looked
      at whether this type of patient education would be helpful for pregnant women. This study is
      being done to determine whether pregnant women who have access to their own health records
      and personalized health information over the Internet are more satisfied with their prenatal
      care, and if they are more compliant with health visits and tests, compared to pregnant women
      who receive only generic pregnancy information on the Internet and from pamphlets

      Women are being randomly assigned to receive secure access to pregnancy health information
      links chosen by the centre's physicians, or to receive these links with access to their
      online personal health that includes the antenatal record and a section of their care
      planner, from the centre's electronic medical record
    

Intervention name(s): personalized web prenatal information; general web prenatal information
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: medical record; pregnancy; Internet
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for
      each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following
      initial injection.
    

Detailed description: 
      Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat
      is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of
      the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).
    

Intervention name(s): Mesenchymal stem cells low-dose group; Mesenchymal stem cells mid-dose group; Mesenchymal stem cells high-dose group
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use; Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use; Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Other intervention name(s): Adipose tissue derived mesenchymal stem cells; Adipose tissue derived mesenchymal stem cells; Adipose tissue derived mesenchymal stem cells
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial of Digoxin Before Second-Trimester Abortion
Condition: Induced Abortion
Study type: Interventional

Summary: 
      The purpose of our study is to determine the optimum route for the injection of digoxin prior
      to second-trimester surgical abortion.
    

Detailed description: 
      Of the 1.2 million abortions each year in the U.S., approximately 12% take place in the
      second trimester of pregnancy. The preferred technique for second-trimester pregnancy
      termination is dilation and evacuation, or D&E. In 2006, 144,000 D&Es were performed in the
      U.S. Clinicians often achieve preoperative fetal asystole by a maternal transabdominal
      injection of digoxin. Prior to D&E, providers use digoxin to induce fetal death 1) for
      providers' preference to facilitate surgical delivery of the fetus, and/or 2) for patients
      who express a desire for fetal death prior to the abortion.

      The use of digoxin to achieve preoperative fetal asystole is widespread, yet there are no
      evidence-based standards for how to best achieve fetal asystole prior to D&E. Digoxin has
      been administered by intracardiac, intrathoracic, intrafetal and intra-amniotic routes, with
      doses varying from 0.25 to 2mg. Clinicians who use digoxin usually inject it one to two days
      before the D&E. Only one study has assessed the effectiveness of digoxin at varying dosages ;
      this was a retrospective and nonrandomized analysis. Published failure rates are based on
      small numbers of patients and are therefore imprecise. Intrafetal digoxin injection may be
      more effective, but is a technically more difficult procedure than intra-amniotic injection.
      The pharmacodynamics of digoxin when used for feticide are also unknown. The objective of
      this study is to determine the optimum route for digoxin injection (intrafetal or
      intra-amniotic) that will maximize patient safety while maintaining effectiveness.
    

Intervention name(s): intra-fetal digoxin injection; intra-amniotic digoxin injection
Intervention type(s): Drug; Drug
Intervention description(s): Single transabdominal injection of digoxin 1 mg into the fetus; Single transabdominal injection of digoxin 1 mg into the amniotic fluid
Other intervention name(s): Lanoxin; Lanoxin
Intervention MeSH terms: Digoxin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: abortion
Health Related Lifestyle and Quality of Life in Children With Cerebral Palsy
Condition: Cerebral Palsy; Quality of Life; Physical Activity; Physical Disability; Parenting; Sleep Disorder
MeSH terms: Paralysis; Cerebral Palsy; Sleep Wake Disorders
Study type: Interventional

Summary: 
      The primary aim of this study is assessing physical activity, the quality of sleep and health
      related quality of life in children with cerebral palsy, and parenting stress of caregivers
      of the children with cerebral palsy in Korea.
    

Detailed description: 
      Monitor the physical activity, health related quality of life, parenting stress according to
      GMFCS level in children with cerebral palsy in Korea.

        1. Physical activity and quality of sleep are monitored by wearing Actigraph for a week.

        2. Health related quality of life is checked by parents withChild Health Questionnaire
           Parent Form 50 (CHQ-PF50).

        3. Parenting stress is monitored with Korean Parenting Stress Index-Short Form (K-PSI-SF)
           by parents.
    

Intervention name(s): interventional study
Intervention type(s): Other
Intervention description(s): The participants wear a monitoring equipment (Actigraph) for a week. And parents do Child Health Questionnaire Parent Form 50 (CHQ-PF50), and Korean Parenting Stress Index-Short Form (K-PSI-SF)
Other intervention name(s): Wear a monitoring equipment (Actigraph) for a week
Intervention model: Single Group Assignment
Intervention model description: Non-randomized single group Accelerometer was weared for a week to check physical activity and sleep in children with cerebral palsy.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cerebral palsy; Health-Related Quality Of Life; Physical Activity
A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this randomized, double-blind, placebo-controlled study is to assess the
      safety and efficacy of PRX-00023 in patients with major depressive disorder.
    

Detailed description: 
      Patients with major depressive disorder who meet all of the eligibility criteria will be
      randomly assigned to receive twice daily doses of either placebo or PRX-00023. Study drug
      will be taken for up to approximately 9 weeks. Patients will have periodic office visits for
      the purpose of monitoring safety and tolerability, as well as efficacy assessments.
    

Intervention name(s): PRX-00023; Placebo for PRX-00023
Intervention type(s): Drug; Drug
Intervention description(s): Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.; Doses taken two times per day. dose increased at scheduled intervals from 40 mg to 80 mg to 120 mg.
Intervention MeSH terms: Naluzotan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder; Major Depression; MDD
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and Fed
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet under Fasting and
      Fed.
    


Intervention name(s): Lisinopril 40 mg Tablet (Zestril) under fed conditions.; Lisinopril 40 mg Tablet under fasting conditions.; Lisinopril 40 mg Tablet under fed conditions.
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lisinopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is:

        -  To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg
           tablets in healthy, adult, human subjects under fed conditions with a washout period of
           16 days.

        -  To monitor adverse events and ensure the safety of subjects.
    

Detailed description: 
      A randomized, open label, two treatment, two period, two sequence, single dose crossover,
      bioequivalence study of nabumetone 750 mg tablets of Dr. Reddy's Laboratories Limited and
      Relafen® 750 mg tablets of Glaxosmithkline research triangle park, in healthy, adult, human
      subjects under fed conditions.
    

Intervention name(s): Nabumetone; Relafen
Intervention type(s): Drug; Drug
Intervention description(s): Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited; Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.
Other intervention name(s): Relafen® 750 mg Tablets
Intervention MeSH terms: Nabumetone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Nabumetone
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1
      (Intravenous dose) and Part 3 (Subcutaneous dose) and potential for reversibility of
      JNJ-64179375 induced Pharmacodynamic effects on coagulation parameters and platelet function
      (Part 2) in healthy male participants.
    


Intervention name(s): JNJ-64179375; Placebo; 4 Factor Prothrombin Complex Concentrate (PCC)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): During part 1, participants will receive a single ascending Intravenous dose of JNJ-64179375 ranging from (0.03 mg/kg to 5.0 mg/kg). In Part 2, participants will receive a 2.5 mg/kg or highest tolerable dose if lower than 2.5 mg/kg of JNJ-64179375. In Part 3, participants will receive a Single Subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375.; Participants will randomly receive matching placebo in all 3 Parts on day 1 administered via IV Route (for Part 1 and 2) and SC route (for Part 3).; Following a single dose of JNJ-64179375, participants will receive a single IV dose of 4 factor-PCC.
Intervention MeSH terms: Thrombin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Dextrose Prolotherapy on Isokinetic Power in the Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis; Dextrose Prolotherapy Injection; Physical Therapy
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Osteoarthritis is a degenerative joint disease characterized by erosion of the articular
      cartilage, bone hypertrophy at the margins of the joint, subchondral sclerosis, and some
      biochemical and morphological changes in the synovial membrane and joint capsule. It is the
      most common joint disease that causes serious morbidity and its prevalence increases with
      age. It is known that there is a decrease in the muscle strength around the knee in knee
      osteoarthritis, which creates difficulties in daily living activities.

      Prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal
      pain, in which an irritating solution is injected, often hypertonic dextrose, into painful
      ligament and tendon attachments and adjacent joint spaces.

      In this study, it is aimed to investigate the effect of dextrose prolotherapy application in
      and around the knee on pain, range of motion and knee flexor/extensor muscle strength.
    


Intervention name(s): Dextrose prolotherapy injection; conventional physical therapy
Intervention type(s): Drug; Combination Product
Intervention description(s): 15% dextrose prolotherapy injection into the knee and 15% dextrose prolotherapy injection will be applied to the painful adhesions of the ligaments around the knee.; 4 weeks (20 sessions) physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment