bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Kinetin 0.1% for Treatment of Skin Photoaging
Condition: Cutaneous Photoaging
MeSH terms: Skin Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the change in the severity and clinical signs of skin
      photoaging among Filipino patients using Kinerase cream (Kinetin 0.1%). This study will
      recruit 132 subjects from dermatological clinics in a tertiary hospital in the Philippines
      for a period of 3 months (12 weeks). Changes in severity will be documented using physician
      evaluation, self-evaluation, and through VISIA complexion analysis system.
    

Detailed description: 
      This study is a single-arm, open-label, split-face trial in subjects with mild to moderate
      photoaged facial skin. The study will enroll around 132 subjects from selected private
      dermatology clinics in a tertiary hospital in the Philippines.

      Patients from selected private dermatology clinics of a tertiary hospital will be screened
      and recruited to participate. They will be provided a written consent form (Appendix I)
      before they will be included in the study.

      Following enrollment, subjects will return for outpatient visits at weeks 4, 8, and 12 for
      assessment.

      The whole study will be conducted from July 2013 to November 2013. The first month would
      involve recruitment of patients. Qualified patients will start the 12-week treatment period
      and will be asked to follow up every 4 weeks. The last two months would be for data analysis,
      interpretation and writing of the scientific report.
    

Intervention name(s): Kinetin, N6-furfuryladenine, 0.1%
Intervention type(s): Other
Other intervention name(s): Kinerase cream
Intervention MeSH terms: Kinetin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of 4
      weeks therapy with FK788 in subjects with chronic hepatitis C virus (HCV) infection. Also, to
      assess the effect of FK788 on serum ALT concentration and hepatitis C viral level during
      therapy and for four weeks following therapy.
    

Detailed description: 
      This is a multi-center, randomized, investigator and subject blinded, placebo-controlled
      eight week study, including a four week treatment period and a four week follow-up period.
      Three cohorts of HCV positive subjects will be studied in a sequential manner.
    

Intervention name(s): FK788
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HCV
CT-guided Radioactive I-125 Seeds Implantation for Early Stage Lung Cancer
Condition: Early Stage Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      This study observes the efficacy and side effects of CT-guided radioactive iodine-125 seed
      brachytherapy in inoperable early stage non-small cell lung cancer retrospectively, and
      analyzes the influence of clinical and dosimetric factors on the outcomes.
    

Detailed description: 
      Radioactive Iodine-125 seed brachytherapy is a conventional treatment in Peking University
      Third Hospital. Radioactive Iodine-125 seed brachytherapy is the implantation of Iodine-125
      seed into tumors.The radioactive Iodine-125 seed can release low dose of irradiation
      persistently which kills tumors cell and causes less damage to normal tissue at the same
      time. This study collects the data of patients with early stage (stage I-II, N0) non-small
      cell lung cancer who underwent CT-guided radioactive Iodine-125 seed implantation from 2010
      to 2018. The investigators evaluate the dose that covers 90% target volume(D90) and other
      parameters after the implantation. The efficacy and adverse effects were observed. Local
      control(LC) time and overall survival(OS) time are evaluated.
    

Intervention name(s): CT-guided Radioactive I-125 Seeds Implantation
Intervention type(s): Radiation
Intervention description(s): The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. The treatment was performed under CT monitoring.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients with early stage non-small cell lung cancer who were treated with CT-guided
        radioactive iodine-125 seeds implantation during December 2010 to December 2018 were
        included in the study.
      
Keywords: radioactive iodine-125 seeds implantation; non-small cell lung cancer; early stage
Yang Yin Fu Zheng Jie Du Therapy in Recurrence of Hepatocellular Carcinoma Less Than 3 cm in Diameter
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Recurrence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Clinical research of Yang Yin Fu Zheng Jie Du therapy in recurrence of Hepatocellular
      Carcinoma less than 3 cm in diameter.The purpose of this study is to observe the efficacy of
      routine medical care combined with Yang Yin Fu Zheng Jie Du therapy in 1 year recurrence for
      patients belong to Hepatocellular Carcinoma less than 3 cm in diameter.
    


Intervention name(s): Yang Yin Fu Zheng Jie Du therapy; Routine medical care
Intervention type(s): Drug; Other
Intervention description(s): Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.; Routine medical care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nicotinic Receptors and Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The study determines if a new preparation of a drug designed to treat schizophrenia is more
      slowly released into the body.
    

Detailed description: 
      3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and
      300 mg. The capsules will be administered singly and eventually bid to determine if sustained
      blood levels comparable to steady state blood levels seen in previous studies can be
      determined. Safety and EEG effects will be measured.
    

Intervention name(s): Pharmacokinetic
Intervention type(s): Drug
Intervention description(s): Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
Other intervention name(s): GTS-21
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: receptors nicotinic
Pivotal Bioequivalence FDC Nifedipine / Candesartan vs. Loose Combination of Single Components, Fed
Condition: Hypertension, Essential
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, open label, single dose, 2-way crossover study to investigate the bioequivalence
      of a new fixed dose combination (FDC) tablet of nifedipine GITS and candesartan with the
      corresponding loose combination under fed conditions.
    

Detailed description: 
      Clinical pharmacology
    

Intervention name(s): Nifedipine/Candesartan (BAY 98-7106); Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)
Intervention type(s): Drug; Drug
Intervention description(s): Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period); Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Nifedipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: essential hypertension, blood pressure, nifedipine, candesartan, FDC
How Parents Can Help Babies Learn to Talk With Picture Books.
Condition: Language Development
Study type: Interventional

Summary: 
      The aim of this project is to test whether giving parents advice about book reading is
      effective in promoting language learning for infants from a range of socio-economic
      backgrounds.
    

Detailed description: 
      Children from disadvantaged families tend to have limited language skills compared to their
      advantaged peers. While many factors contribute to language ability, two aspects of the early
      caregiving environment are known to be correlated with child language outcomes 1)
      caregiver-child book reading and 2) caregiver contingent talk. Contingent talk refers to a
      style of communication whereby the caregiver talks about what is in their infant's current
      focus of attention. This style of talking can be facilitated when parents read books with
      their babies. The aim of this research is to establish whether asking parents to engage in
      contingent talk in the context of book reading promotes vocabulary learning. This study will
      compare the effects of an intervention to promote contingent talk against a control where
      parents are given books but not given any training in how to read them in a contingent
      manner. The study will include children from socio-economically advantaged and disadvantaged
      families.
    

Intervention name(s): Contingent Reading Intervention; Book Provision Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Caregivers will be provided with 6 picture books. They will be trained to use contingent talk when looking at picture books with their infants. They will be asked to spend 10 mintues each day engaging in contingent talk while looking at picture books. The intervention will run for 4 months. Parents will be asked to keep a daily reading diary.; Caregivers will be provided with 6 picture books. They will not be trained to read with their child. They will receive information from other sources (e.g. health visitors and Book Start schemes) as normal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vocabulary; Book reading; Infancy; Parenting
Serum Lipid Levels and Lp-PLA2 in Chronic Periodontitis
Condition: Chronic Periodontitis (Disorder)
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Observational

Summary: 
      To assess the association between periodontal parameters, serum lipid profile and Lp-PLA2
      level in systemically healthy Chronic Periodontitis subjects and healthy controls.
    

Detailed description: 
      Seventy five participants were divided into 3 groups. The groups consisted of GROUP I-
      generalized severe chronic periodontitis, GROUP II- generalized moderate chronic
      periodontitis and GROUP III- systemically and periodontally healthy volunteers who served as
      control. The selected patients were then evaluated for periodontal parameters, lipid profile
      and Lp-PLA2.
    

Intervention name(s): serum lipid levels and Lp-PLA2
Intervention type(s): Diagnostic Test
Intervention description(s): Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis
Other intervention name(s): Biological marker
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The study population was selected from the Department of Periodontology, Meenakshi Ammal
        Dental College
      
Keywords: chronic periodontitis; lipids; Lp-PLA2
Efficacy and Safety of HSK21542 in Inducing Postoperative Analgesia in Undergoing Elective Laparoscopic Surgery
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, two-stage phase II
      clinical study. The main objective is to evaluate the efficacy and safety of HSK21542
      injection and explore the recommended dose and administration frequency for subsequent Phase
      II studies in conjunction with the pharmacodynamic (PD) and pharmacokinetic (PK)
      characteristics.
    


Intervention name(s): Experimental: stage I：HSK21542 0.4 μg/kg; Experimental: stage I：HSK21542 1 μg/kg; Experimental: stage I：HSK21542 0.5μg/kg; Experimental: stage I：HSK21542 1μg/kg; Experimental: stage II：HSK21542 0.5μg/kg; Experimental: stage II：HSK21542 1μg/kg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations; Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations; once each at 0, 8, and 16 h postoperative, for a total of 3 administrations; once each at 0, 8, and 16 h postoperative, for a total of 3 administrations; once each at 0, 8, and 16 h postoperative, for a total of 3 administrations; once each at 0, 8, and 16 h postoperative, for a total of 3 administrations; once each at 0, 8, and 16 h postoperative, for a total of 3 administrations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Acute and Chronic Effects of Dynamic Apnea in Healthy Untrained Subjects
Condition: Apnea
MeSH terms: Apnea
Study type: Interventional

Summary: 
      The inclusion of short periods of apnea (several seconds) during exercise (i.e. dynamic
      apnea) induces a significant decrease in blood oxygenation and muscle tissue. To date, the
      immediate effects ("acute apnea") of this decrease in the quantity of oxygen available at the
      muscle and brain level are poorly understood. Moreover, a physical training during which
      these short periods of apnea ("chronic apnea") would be included could lead to physiological
      adaptations and to improvement in physical performance similar to those obtained during
      altitude training.

      The purpose of this study is to evaluate the effects of acute dynamic apnea on metabolism.
    


Intervention name(s): Program of training with exercises including apnea; Program of training with exercises without apnea
Intervention type(s): Other; Other
Intervention description(s): 16 training session on cycle ergometry with exercises including apneas.; 16 training session on cycle ergometry with exercises without apnea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dynamic apnea; muscle oxygenation; physical performance
Pediatric Health Promotion Program
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model
      benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their
      young patients.
    


Intervention name(s): Provider Advice, Framed Messaging
Intervention type(s): Behavioral
Intervention description(s): The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Assess Effect of Exercise Program Provided by Smartphone Application on the Body Composition
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The primary objective of this study is to explore the effect of an exercise program combining
      aerobic and resistance exercises provided by mobile healthcare applications (hereinafter
      referred to as "app") on the body composition in app-using exercise group compared to
      non-exercise group.
    


Intervention name(s): Exercise; No exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exercise program; No exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Exercise program; Smartphone application
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Condition: Hip Osteoarthritis; Noninflammatory Degenerative Joint Disease; Avascular Necrosis; Correction of Functional Deformity; Rheumatoid Arthritis
MeSH terms: Osteoarthritis; Joint Diseases; Osteoarthritis, Hip; Necrosis
Study type: Interventional

Summary: 
      This is a single center, prospective, randomized controlled study. The primary objective of
      this study is to measure migration over two years with RSA. Patients will be randomized in
      two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip
      stem.
    

Detailed description: 
      A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will
      receive a G7 limited hole acetabular cup with E1 liner.

      All potential study subjects will be required to participate in the Informed Consent process.
    

Intervention name(s): Taperloc Complete Microplasty stem; Taperloc Complete Reduced Distal stem
Intervention type(s): Device; Device
Intervention description(s): Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner; Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
Other intervention name(s): Total hip arthroplasty; Total hip arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 assignment of treatment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Total Hip Arthroplasty; Medical Device; Performance; Safety; Hip prosthesis; Roentgen Stereophotogrammetric Analysis
Benefit of CFAE Ablation
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly
      defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation
      in addition to pulmonary vein isolation and linear ablations improves single procedural
      success rate over a 12 month follow up period.
    


Intervention name(s): Radiofrequency catheter Ablation; Radiofrequency catheter ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): In this arm, catheter ablation would be performed in the left atrium and would include pulmonary vein isolation and linear ablations (roof and mitral isthmus lines); In this arm, catheter ablation would be performed in the left atrium, including pulmonary vein isolation, linear ablations (roof and mitral isthmus lines) and Complex Fractionated Atrial Electrograms (CFAE) ablation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: catheter ablation; atrial fibrillation; pulmonary vein isolation; linear ablation; CFAE ablation
Evaluation of Three Potential Central Nervous System (CNS) Pretreatments for Soman Exposure on Human Performance
Condition: Biomarkers, Pharmacological
Study type: Observational

Summary: 
      The primary objective of this study is to determine whether huperzine A, donepezil, and
      galantamine impact militarily relevant aspects of neurocognitive performance in humans,
      compared to placebo.
    

Detailed description: 
      The primary objective of this study is to determine whether huperzine A, donepezil, and
      galantamine impact militarily relevant aspects of neurocognitive performance in humans,
      compared to placebo.

      Secondary: Secondary objectives are to correlate neurocognitive performance effects with
      degree of inhibition and therefore sequestration of red blood cell AChE by huperzine A,
      donepezil, and galantamine, and to monitor the safety of the study drugs in healthy adult
      (18-39 years) males and females.

      In a double-blind, randomized, placebo-controlled, parallel-groups design, normal, healthy,
      adult male and female volunteers will be administered one of the drug/doses. They will be
      tested prior to and periodically for militarily relevant performance tasks for up to 8 hours
      post-dose and for cholinesterase levels via finger prick.
    

Intervention name(s): Huperzine A; Donepezil; Galantamine; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): dosage form: tablet dose frequency: once only; dosage form: tablet dosage frequency: once only; dosage form: tablet dosage frequency: once only; dosage form: tablet dosage frequency: once only
Intervention MeSH terms: Huperzine A; Donepezil; Galantamine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy adults (18-39 years) males and females, military or civilian
      
Keywords: Central nervous system; Cholinesterase; Neurocognitive performance testing
Different Arm Positions During Single Leg Squat
Condition: Knee Injuries and Disorders
MeSH terms: Knee Injuries
Study type: Observational

Summary: 
      The aim of this study is to compare the effects of different arm positions on muscle activity
      during single leg squat.
    

Detailed description: 
      The aim of our study is to examine the effect of different positions of the arms on lower
      extremity muscle activations during Single Leg Squat (SLS). This prospective cross sectional
      study included single leg squat test assessments in different arm positions: 1) Arms free, 2)
      Arms flexed 90 degrees, 3) Hands on hip, 4) Arms across the chest. Inclusion criteria were
      being a young adult (20-30 years old), physical activity level of at least 4 on the Tegner
      Activity Scale, and volunteering to participate in the study. Those with a history of lower
      extremity injury in the last 1 year will be excluded from the study. Our study will
      contribute to distinguishing SLS variations for clinicians and researchers and choosing the
      appropriate SLS for evaluation and treatment.
    

Intervention name(s): Single Leg Squat
Intervention type(s): Other
Intervention description(s): After initial data collection (Demographic data, Inclusion criteria), surface electromyography EMG assessments will be obtained from 1 muscle ( Vastus Medialis). EMG evaluation will be done in different arm positions during the single leg squat. These records will be taken in 4 different situations: 1) Arms free, 2) Arms flexed to 90 degrees, 3) Hands on hips, 4) Arms across the chest.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy Volunteers
      
Keywords: healthy subject; movement analysis; muscle activity; kneeling