bioihbjkbjnl/mcl2 huggingface dataset:
Chronic Obstructive Pulmonary Disease (COPD) and Domestic Endotoxin (CODE)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This project aims to characterize the independent effect of domestic endotoxin exposure on
      health status, as well as pulmonary and systemic inflammation, in former smokers with COPD.
      Positive findings from this study would be clinically relevant, as they would provide
      evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD.
      The investigators also hope to make a methodological advance in the field of endotoxin
      exposure assessment by elucidating whether settled dust and/or airborne endotoxin
      measurements are the more relevant exposure of interest in epidemiological studies of
      respiratory disease. To fulfill the specific aims, the investigators will conduct a
      longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air
      monitoring, in-home settled dust collections, home inspections as well as assessments of
      health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both Male and Female 40 years and older
      
Biospecimen description: 
      blood, sputum
    
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
The Investigation of the Neonates With or With Risk of COVID-19
Condition: Neonatal Infection; Perinatal Problems; Infectious Disease
MeSH terms: Communicable Diseases; Infections
Study type: Observational

Summary: 
      Since December 2019, there has been an outbreak of novel coronavirus pneumonia in China. As
      of February 18, 2020, 72,530 cases confirmed with 2019 coronavirus disease(COVID-19) have
      been reported and 1,870 deaths were declared. Until now, cases of COVID-19 have been reported
      in 26 countries. This observational study aims to analysis the clinical features of neonates
      with COVID-19 and the neonates born to mother with COVID-19.
    

Detailed description: 
      Given that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and
      is contagious to the general population, all the suspected or confirmed newborns will be
      admitted to the neonatal departments in designated hospitals of China. In this study, the
      diagnosis of neonatal SARS-CoV-2 infection is based on the criterion provided by National
      Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee. All samples will
      be treated as biohazardous material. SARS-CoV-2 will be tested in blood, cord blood, amniotic
      fluid, placenta, respiratory tract, stool, urine from mothers or neonates. The medical
      information questionnaires are classified into maternal and neonatal version, which include
      demographic details, epidemical history, clinical manifestations, tests collected time and
      results, imaging performed time and results and therapeutic data. Two researchers
      independently checked and recorded the data to ensure the accuracy of the data.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study participants will be recruited from all the designated hospitals in in 31
        provinces/municipalities of the mainland of China during SARS-CoV-2 epidemic.
The Immediate and Longterm Immune Responses of UK Infants and Young Children to a Booster Dose of Hib Vaccine
Condition: Haemophilus Influenzae Type b
Study type: Interventional
Phase: Phase 4

Summary: 
      To measure the magnitude and persistence of the antibody response to a booster dose of Hib
      conjugate vaccine given between 9 months and 4 years of age to UK children who had completed
      primary immunisation with 3 doses of Hib vaccine given at 2/3/4 months of age either as a
      combined D/T/wholecellpertussis/Hib or D/T/acellularpertussis/Hib vaccine.
    


Intervention name(s): Hib conjugate vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Creatine Supplementation as Compared to Glucosamine/Chondroitin Sulfate Supplementation in Addition to Exercise and Physical Therapy in the Management of Knee Osteoarthritis.
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Osteoarthritis (OA) is one of the most common joint disorders, affecting not only the joints
      but also the surrounding muscles, which become weak. Resistance exercise reduces pain and
      improves function in patients with OA of the knee. Nonsteroidal anti-inflammatory drugs
      (NSAIDs) are widely used by patients with OA to reduce pain and thereby maintain the ability
      to perform daily activities. However, there is accumulating evidence for a negative effect of
      NSAIDs, thus many patients with OA are treated with dietary supplementations such as
      glucosamine and chondroitin sulfate, and some studies show a beneficial effects on cartilage
      and pain. However, their effect on OA symptoms and cartilage remains controversial. On the
      other hand creatine supplementation has also been observed to show promising effects when
      combined with resistance training exercise in the elderly, but the evidence is limited in
      terms of knee osteoarthritis. For this reason the purpose of this study is to determine the
      effects of creatine supplementation as compared to glucosamine/chondroitin sulfate in the
      management of knee osteoarthritis when combined with resistance training exercise.
    


Intervention name(s): Creatine Supplementation; Glucosamine and Chondroitin sulfate supplementation; Supervised Exercise training; Home Exercise Program; Electrotherapy + Heating; Joint Mobilization
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other; Procedure; Procedure
Intervention description(s): Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks; Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day; Lower Extremity Resistance Exercise Training Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM)
3 times supervised exercise for 4 weeks leg press, leg extension, Sit to stand squat (mini squats) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)
3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval; 2 sets of 10 repetitions/day of
AROM isolated knee extension and knee flexion Isometric isolated knee extension and knee flexion Isometric terminal knee extension Sit to stand squat Isometric knee terminal extension; Interferential Current therapy (2P), in combination with heating pad for 20 minutes; Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Condition: Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Published studies on omega 3 fatty acids in the treatment of bipolar disorder and
      schizophrenia have shown reductions in time to recurrence, a decrease in the positive and
      negative symptoms of schizophrenia, and improvements in Clinical Global Impression Scale,
      Young Mania Rating Scale, and HAM-D scores. The following are the hypotheses:

        -  Omega 3 fatty acids will be superior to placebo in the acute treatment of global autism.

        -  Omega 3 fatty acids will be superior to placebo in improving aggression and irritability
           associated with autism.

        -  Omega 3 fatty acids will be superior to placebo in improving functional ability.
    

Detailed description: 
      This study is an innovative treatment approach to autism. It adapts a promising adjunct
      therapy for bipolar disorder and schizophrenia to a new population, that of children and
      adolescents with autism. It will analyze the possible relationship between dosage of omega 3
      fatty acids and treatment outcomes. Finally, it will attempt to identify which specific
      subgroups of subjects will respond to this intervention, which components and associated
      features are most responsive and whether this impacts subjects' quality of life. The data
      generated by this study is intended to support the rationale for a full scale, large
      multi-site clinical trial.
    

Intervention name(s): Omega 3 fatty acids; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.; Same dosage as that of omega 3 fatty acids
Other intervention name(s): DHA and EPA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aggression; Irritability; Global severity
Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, randomized, multiple dose IIR study to evaluate the effect of Lysteda™
      on bruising following QWO™ injections to the buttocks in female subjects presenting with
      moderate to severe cellulite.

      Following determination of eligibility based on inclusion/exclusion assessment, the subjects
      will be randomized to either Cohort A, Cohort B, or Cohort C, based on order of enrollment.
      Each Cohort will receive 3 Qwo™ treatments spaced 21 days apart, with 1300 mg of Lysteda™ TID
      PO at one, two, or all three treatments of Qwo™. Cohort A will be given tranexamic acid at
      the first treatment, Cohort B at the first and second treatment, and Cohort C at all three
      treatments. All buttock CCH injections will follow the on-label injection protocol.

      Subjects will participate in the study for 65 days total, with an additional screening period
      of 14 days. There will be a total of 11 visits (Screening, Day 1, Day 4, Day 14, Day 22, Day
      26, Day 36, Day 43, Day 47, Day 57, Day 65).
    


Intervention name(s): Collagenase Clostridium Histolyticum-Aaes; Lysteda 650 MG Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): subjects will be injected with up to 0.84 mg of QWO as 12 subcutaneous injections (0.3-mL injection administered as three 0.1-mL aliquots per injection), dependent on the amount of dimples (0.3 ml per dimple).; Subjects will be given the therapeutic dose of tranexamic acid for menorrhagia, which is 1300 mg PO TID for up to 5 days during menstruation
Other intervention name(s): QWO
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
tDCS Effects on GABA Concentration and Brain Functional Connectivity in Young Adults
Condition: Healthy Young Adults
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a
      decrease of GABA concentration and alterations of functional brain connectivity in younger
      people, compared to sham tDCS.
    


Intervention name(s): Transcranial direct current stimulation (tDCS); sham-tDCS
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Pharmacokinetic Characteristics of DP-R206 in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is compare the pharmacokinetic characteristics of DP-R206 (150mg
      Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Bonviva (150mg Ibandronate, qd)
      after oral administration in healthy adult volunteers.
    

Detailed description: 
      The number of patient is eighty-four. Patients were randomly assigned either a Bonviva
      tablet(150mg Ibandronate, qd) first, DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex
      tablet, qd) Second or DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd)
      first, Bonviva tablet(150mg Ibandronate, qd) second.
    

Intervention name(s): bonviva
Intervention type(s): Drug
Intervention description(s): 150mg Ibandronate once a month
Other intervention name(s): DP-R206 : DP11012; bonviva : B1184B01
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)
Condition: Metabolic Syndrome; Dyslipidemia
MeSH terms: Metabolic Syndrome; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the effect of treatment with rosuvastatin on the
      capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting
      step in reverse cholesterol transport.
    


Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Metabolic Syndrome; Dyslipaemia
Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective is to evaluate the safety and immunogenicity of AZD1222 given in combination
      with (either before or after) rAd26-S, for the prevention of COVID 19 in adults ≥ 18 years of
      age.
    


Intervention name(s): AZD1222; rAd26-S
Intervention type(s): Biological; Biological
Intervention description(s): Participants will receive 1 intramuscular (IM) injection of 5 ×1010 viral particles (vp) (nominal) of AZD1222 on Day 1 followed by rAd26-S 1×1011 viral particles (vp) (nominal) on Day 29 of the study; Participants will receive 1 IM injection of rAd26-S on Day 1 followed by AZD1222 on Day 29
Other intervention name(s): Sputnik V
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: COVID-19 Prevention; AZD1222 vaccine; rAd26-S; Sputnik V
Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma
Condition: Glioblastoma; Anaplastic Astrocytoma
MeSH terms: Glioblastoma; Astrocytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      In this multinational dose finding Phase IIb study the efficacy and safety of two doses of AP
      12009 compared to standard chemotherapy (temozolomide or PCV) is investigated in adult
      patients with confirmed recurrent high-grade glioma.
    

Detailed description: 
      The purpose of this study is to compare the safety and efficacy of two doses of AP 12009 and
      standard chemotherapy in adult patients with recurrent high-grade glioma (anaplastic
      astrocytoma [AA], WHO grade III; or glioblastoma [GBM], WHO grade IV). AP 12009 is a
      phosphorothioate antisense oligodeoxynucleotide specific for the mRNA of human transforming
      growth factor-beta2 (TGF-beta2). The growth factor TGF-beta plays a key role in malignant
      progression of various tumors by inducing proliferation, invasion, metastasis, angiogenesis
      and escape from immunosurveillance. It has been shown that in a number of tumor types the
      degree of TGF-beta production strongly correlates with tumor grade and stage. In patients
      with high-grade glioma, the TGF-beta2 overexpression is associated with disease stage,
      clinical prognosis and the immunodeficient state of the patients.
    

Intervention name(s): AP 12009 10 µM; AP 12009 80 µM; temozolomide or PCV; Drug delivery system for administration of AP 12009; Placement of Drug Delivery System
Intervention type(s): Drug; Drug; Drug; Device; Procedure
Intervention description(s): 10 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks; 80 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks; temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle; PCV (procarbazine, CCNU, vincristine): standard regimen; Drug delivery system for Convection Enhanced Delivery consists of a portable pump with drug reservoir and infusion line. Main implanted parts are the port access system and the intratumoral catheter.; Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.
Other intervention name(s): Temodar; Temodal; TMZ; lomustine; Cecenu; CeeNU
Intervention MeSH terms: Temozolomide; Lomustine; Trabedersen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glioblastoma; Anaplastic astrocytoma; Antisense; Cancer; Transforming growth factor beta2 (TGF-beta2); Targeted therapy; Immunotherapy; Brain tumor; Central nervous system (CNS); Convection-enhanced delivery (CED) / microperfusion; Locoregional application
To Explore the Safety and Efficacy of Hypidone Hydrochloride Tablets in Treatment of Patients With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of Hypidone Hydrochloride
      tablets in treatment of patients with major depressive disorder (MDD) by evaluating the
      change of MADRS total score from baseline to week 6.
    

Detailed description: 
      A total of 40 major depressive disorder (MDD) subjects between the ages of 18-65 who have
      current major depressive disorder diagnosed by DSM-5 will be recruited, Subjects will be
      accepted into the protocol after an opportunity to review and provide voluntary written
      informed consent and completion of a comprehensive medical and psychiatric history, physical
      examination, mental status examination, and routine laboratory assessments The subjects will
      accept the drug treatment twice daily orally for 6 weeks, During the treatment follow up will
      occur at 8±1 days after treatment, 15±1 days after treatment, 29±2 days after treatment ,43±2
      days after treatment to evaluate the safety and efficacy of the drug.
    

Intervention name(s): Hypidone Hydrochloride tablets
Intervention type(s): Drug
Intervention description(s): Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic
      hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER
      platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular
      immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a
      hepatitis C virus infection. In-depth research in recent years has shown that the cellular
      immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV
      vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together
      with a supportive helper T cell response (PeviPRO). This virosome-based technological
      combination in a single product represents a new generation of modular therapeutic vaccines.
    


Intervention name(s): PEV2A PEV2B
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Hepatitis C; Liver disease; Viral infection; Virosome; Vaccine; therapeutic vaccine; Chronic hepatitis C virus infection
Clinical Study to Evaluate the Role of Microdialysis for the Comparison of Topical Products
Condition: Bioequivalence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators hypothesize that a technique called microdialysis can be used to measure
      the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin.
      Microdialysis uses a small device called a 'probe' to determine the amount of drug which
      enters a body tissue. The small device is placed directly in the fatty tissue and samples are
      taken at specific times. The investigators will determine whether site of application affects
      the availability of the drug.
    


Intervention name(s): Reference, Patch location thigh, batch 1; Test, Patch location thigh, batch 2; Reference, Patch location abdomen, batch 1; Test, Patch location abdomen, batch 2
Intervention type(s): Drug; Device; Drug; Device
Intervention description(s): Reference, Patch location thigh, batch 1; Test, Patch location thigh, batch 2. Three probes will be inserted at each visit.; Reference, Patch location abdomen, batch 1; Test, Patch location abdomen, batch 2. Three probes will be inserted at each visit.
Other intervention name(s): Flector patch; Microdialysis probe; Flector Patch; Microdialysis probe
Intervention MeSH terms: Diclofenac hydroxyethylpyrrolidine; Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science