bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis
Condition: Lymphoma, Non-Hodgkin; Diffuse Large B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to measure the rate of complete response (CR and UCR) at the end
      of a course of immuno-chemotherapy:

        -  before cerebral radiotherapy for PCL

        -  after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal
           involvement Toxicity of the protocol Overall survival Survival without relapse Long-term
           incidence of neurocognitive toxicity
    


Intervention name(s): Rituximab; Cytarabine
Intervention type(s): Drug; Drug
Intervention description(s): 375 mg/m2 D1; 50 mg D3
Intervention MeSH terms: Cytarabine; Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lymphoma; cerebral lymphoma; central nervous system; cytarabine; rituximab; Diffuse large B-cell lymphomas, with cerebral or neuromeningeal involvement
Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate local tumor control and survival rate after repeated transarterial
      chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC)
      patients.
    


Intervention name(s): transarterial chemoembolization
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hepatocellular carcinoma; Transarterial chemoembolization; Gemcitabine
Barriers and Facilitators to Vegetable Intake
Condition: Overweight; Obese
MeSH terms: Overweight
Study type: Observational

Summary: 
      The purpose of this study is to find out why people do or do not eat vegetables.
    

Detailed description: 
      The Dietary Guidelines for Americans (DGA) stress the importance of a diet high in fruits and
      vegetables (FV) to achieve health benefits. Despite the recommendations, adherence is low;
      only 12% of the population meets the recommendation for fruits and even less of the
      population (9%) meets the recommendation for vegetables. Recently, it was found that
      vegetable consumption increased when individuals were provided the recommended daily amounts
      while participating in a clinical study, but returned to pre-study low levels when vegetables
      were no longer supplied. This result suggests that habitual consumption of FV is strongly
      regulated by behaviors influenced by social, environmental, and/or individual factors.
      Therefore, identifying regulatory factors of vegetable consumption will greatly assist in
      developing successful strategies to increase vegetable intake to achieve health benefits. The
      overall objective of this study is to examine both barriers and facilitators to adherence to
      consuming DGA-recommended amounts of vegetables in participants who completed a randomized
      controlled trial with provided vegetables or who were in a control group, using the Nominal
      Group Technique (NGT).
    

Intervention name(s): Barriers; Facilitators
Intervention type(s): Other; Other
Intervention description(s): NGT sessions identifying barriers to vegetable intake.; NGT sessions identifying facilitators to vegetable intake.
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Recruitment will be limited to contacting participants who previously took part in a study
        (NCT02585102) and upon completion of that study indicated willingness to be contacted for a
        follow-up study. The original study recruited overweight or obese adults who reported
        consuming not more than 1 serving of vegetables per day. In that study, participants were
        provided vegetables or were in a control group. Research staff will send invitations to
        participate in one of the NGT sessions.
      
Keywords: Vegetable Intake
Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals'
      GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy
      infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a
      booster dose of GSK Biologicals' Menitorix™ at 12 months of age.
    

Detailed description: 
      This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The
      Study design section is impacted by this amendment.
    

Intervention name(s): GSK2197870A; Prevenar™; Menitorix™; Pediacel™; Menjugate™
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3 doses given at 2, 3 and 4 months of age; 3 co-administered doses, intramuscular into right thigh; 1 booster dose at 12 months of age; 3 doses given at 2, 3 and 4 months of age; 2 doses given at 3 and 4 months of age
Other intervention name(s): GSK Biologicals' combined diphtheria; tetanus; acellular pertussis; polio; HiB and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine.; Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine; GSK Biologicals' combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine.; Sanofi-Pasteur-MSD's combined DTPa-inactivated polio-Haemophilus influenzae type b vaccine.; Novartis' meningococcal serogroup C CRM197 protein conjugated vaccine.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: combined; Vaccines
Acute Haemodynamic Study of TPN171H in Patients With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a phase IIa proof-of-concept study to evaluate the effect of single-dose
      TPN171H tablets on acute haemodynamic parameters in patients with pulmonary arterial
      hypertension.The trial is expected to include 60 patients, divided into 6 groups, according
      to 1:1:1:1:1:1 into the placebo group and the test drugs 2.5mg, 5mg, 10mg group, tadalafil
      tablets 20mg, 40mg group, each group 10 cases.
    

Detailed description: 
      This study is a multi-center, randomized, placebo and positive controlled phase IIa
      proof-of-concept study to evaluate the effect of single-dose TPN171H tablets on acute
      hemodynamic parameters in patients with pulmonary arterial hypertension.The trial is expected
      to include 60 patients, divided into 6 groups, according to 1:1:1:1:1:1 into the placebo
      group and the test drugs 2.5mg, 5mg, 10mg group, tadalafil tablets 20mg, 40mg group, each
      group 10 cases. During the screening period, the tube placement period, and the observation
      period, the patients will conduct various inspections and evaluation observations as
      required.

      The Swan-Ganz floating catheter and echocardiography were used to evaluate the efficacy of
      TPN171H; PK parameters: including Tmax, Cmax, AUC0-t , t1/2,CL/F, Vz/F, λz; Safety evaluation
      indicators include: vital signs, physical examination, laboratory examination (blood routine,
      blood biochemistry, blood gas analysis), 12-lead ECG, adverse events.
    

Intervention name(s): TPN171H; Placebo; Tadalafil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets; Oral; Single dose; Tablets; Oral; Single dose; Tablets; Oral; Single dose
Other intervention name(s): Simmerafil; ADCIRCA
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pulmonary arterial hypertension; Acute Haemodynamic Study; PK/PD study; TPN171H; Simmerafil
Comparative Clinical Trial to Evaluate Bioequivalency and Safety of Monoclonal Antibody Injection and Adalimumab in Chinese Healthy Volunteers
Condition: Healthy
MeSH terms: Necrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study is a phase 1 study which carried out to establish the pharmacokinetic
      equivalence and equal safety of human recombinant anti-tumor necrosis factor alpha monoclonal
      antibody injection and Adalimumab when used as a single subcutaneous injection in healthy
      volunteers.
    

Detailed description: 
      This is a comparative, open, randomized clinical study. The purpose of the study is to
      demonstrate that human recombinant anti-tumor necrosis factor alpha monoclonal antibody
      injection is equivalent to adalimumab in terms of pharmacokinetics and safety after single
      subcutaneous injection in Chinese healthy volunteers.The study will enroll 180 healthy
      volunteers, who will be randomized into 2 groups.
    

Intervention name(s): human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection; adalimumab
Intervention type(s): Drug; Drug
Intervention description(s): human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, 40mg,subcutaneous injection,once; adalimumab, 40mg,subcutaneous injection,once
Intervention MeSH terms: Adalimumab; Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tumor necrosis factor-a blocker; pharmacokinetics; safety
Effects of Early Oral Feeding After Resection of Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to determine whether early oral feeding after curative resection for
      gastric cancer would be tolerable and give an effect on the recovery.
    

Detailed description: 
      Most patients who undergo gastric resection for gastric cancer have maintained going on a
      fast of over three days after operation. Surgeons have believed that early oral feeding might
      worsen patients' condition by prolonged postoperative ileus. Therefore, patients received
      nothing by oral route until resolution of the ileus. However, the current trend toward
      minimal operative injury and early discharge from hospital. In addition, development of
      operative technique and instrument make the operation time to be short and the patients to be
      fast recovery, and thus it is possible to feed early in less than two days after operation.
      The aim of this study is to determine whether early oral feeding after curative resection for
      gastric cancer would be tolerable and give an effect on the recovery.

      We collect fifty-eight patients for this study and divide into two groups using randomization
      method. In the early feeding group, patients will receive the liquid diet two day after
      operation followed by soft diet postoperative three day. Meanwhile, the patients who
      categorized into control group will start the liquid diet postoperative four day followed by
      soft diet postoperative six day. We evaluate the morbidity or mortality rate and laboratory
      findings. Of course, it is supposed to be same in amount of fluid and calories between two
      groups.
    

Intervention name(s): Conventional feeding; Early oral feeding
Intervention type(s): Other; Other
Intervention description(s): Procedure of Conventional feeding group: Patients are supplied water on day 3 after operation, liquid diet on day 4 and 5 and soft diet on 6 day.; Procedure of Early oral feeding group: Patients are supplied water on day 1 after operation, liquid diet on day 2 and soft diet on day 3 day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastrectomy; Oral feeding; Nutrition; Gastric cancer
Evaluation of Safety, Tolerability, and Immunogenicity Study of GLS-6150 in Healthy Volunteers and in Persons Previously Treated for Hepatitis C Virus Infection
Condition: HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Hepatitis C virus (HCV) is an enveloped, single strand, positive sense RNA flavivirus.
      Infection by HCV is typically chronic, although an estimated ~10-20% may spontaneously clear
      the virus. HCV affects between 1.3 - 2 billion individuals, or 2-3% of the global population.
      HCV has a seroprevalence of approximately 1% in developed countries such as the US and Korea.
      Chronic HCV infection leads to hepatic fibrosis and cirrhosis. This Phase I study will
      evaluate the safety, tolerability and immunogenicity of GLS-6150 administered intradermally
      (ID) followed by electroporation at 1.0 mg and 2.0 mg/dose assessing 3 and 4-dose regimens.
    

Detailed description: 
      HCV-003 will assess the safety and immunogenicity of GLS-6150 in those previously treated for
      HCV infection and who have achieved a sustained virologic response (SVR). This study will
      provide information as to whether GLS-6150 may be useful to prevent re-infection for those
      successfully cleared of HCV infection. GLS-6150 is a DNA plasmid vaccine that expresses the
      NS3/4A gene of HCV, NS4B gene of HCV, the NS5A gene of HCV and IL-28B. GLS-6150 will be
      administered at one of two dose levels (1 mg or 2 mg) and given as a 2 or 3 vaccination
      priming regimen with a boost vaccination given at 6 months. Immune T cell and serologic
      responses will be determined after each dose.
    

Intervention name(s): GLS-6150
Intervention type(s): Biological
Intervention description(s): Group 1: GLS-6150 2.0 mg at 0, 4, 12, and 24 weeks (N=8, healthy volunteers); Group 2: GLS-6150 1.0 mg at 0, 4, 12, and 24 weeks (N=8, previously treated for HCV infection); Group 3: GLS-6150 2.0 mg at 0, 4, 12, and 24 weeks (N=8, previously treated for HCV infection); Group 4: GLS-6150 2.0 mg at 0, 8, and 24 weeks (N=8, previously treated for HCV infection)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis C Virus; HCV; Vaccine; DNA
Comparison of Platelet Rich Fibrin as Graft & Membrane Vs Hyaluronic Acid & Amniotic Membrane in the Treatment of Interradicular Defects
Condition: Furcation Defects
MeSH terms: Furcation Defects
Study type: Interventional

Summary: 
      This study is intended to compare the efficacy of platelet-rich fibrin as a graft and a
      membrane versus hyaluronic acid(Gengigel) and amniotic membrane in the treatment of
      mandibular grade II furcation defects.
    

Detailed description: 
      Platelet-rich fibrin is a fraction of plasma that provides a rich source of growth factors
      and may enhance the stabilization and revascularization of the flaps and grafts.

      Hyaluronic acid is a naturally occurring non-sulfated high molecular weight glycosaminoglycan
      that forms a critical component of the extracellular matrix and contributes significantly to
      tissue hydrodynamics, cell migration and proliferation. Hence its administration to
      periodontal wound sites could achieve beneficial effects in periodontal tissue regeneration.

      Amniotic membrane is being used for various regenerative procedures as it is a rich source of
      various collagen and non-collagen proteins such as laminin, fibronectin and proteoglycan.
    

Intervention name(s): Conventional Flap surgery
Intervention type(s): Procedure
Intervention description(s): After administering local anaesthetic a full thickness flap will be raised and reflected to expose the furcation defects. The furcation defects would then be debrided and the graft and membrane secured in position. Later the flap would be sutured back.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be equally divided into two test groups, Group A and Group B after phase I therapy. The group A patients will be treated with conventional flap surgery and the furcation would be debrided, following which platelet-rich fibrin will be placed as a graft and a membrane. The flap will then be sutured back. The group B patients will also be treated with conventional flap surgery after furcation area is debrided, and hyaluronic acid (gengigel)will be placed as a graft over which amniotic membrane will be placed. The flap would then be sutured.
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of Ilaprazole Based Bismuth-containing Quadruple Regimen for the First-line Treatment of Helicobacter Pylori Infection
Condition: Helicobacter Pylori Eradication Antibiotic
MeSH terms: Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple
      regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg, Clarithromycin
      500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID on the first line eradication treatment of
      H.pylori.

      Participants are defined as persons who have endoscopically confirmed on gastric or duodenal
      ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive
      patients in the biopsy and UBT test. For 14 days, participants treated as Esoprazole based
      bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth
      Potassium Citrate 220mg, Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID.
      After treatment, the healing rate was evaluated in the UBT test and Biopsy at 49±5days from
      the first day dosing.
    

Detailed description: 
      This study compared efficacy and safety of Ilaprazole based bismuth-containing quadruple
      regimen therapy including Ilaprazole 5mg, Bismuth Potassium Citrate 220mg，Clarithromycin
      500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of
      H.pylori.

      Participants are defined as persons who have endoscopically confirmed on gastric or duodenal
      ulcer(including scar stage), gastritis and dyspepsia confirmed to be H.pylori positive
      patients in the biopsy and UBT test. For 14 days, Participants treated as Esoprazole based
      bismuth-containing quadruple regimen therapy therapy including Esoprazole 20mg, Bismuth
      Potassium Citrate 220mg，Clarithromycin 500mg and Amoxicillin Cap (Amoxicillin) 1000mg BID.
      After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from
      the first day dosing.
    

Intervention name(s): Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy; Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy
Intervention type(s): Drug; Drug
Intervention description(s): Ilaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid; Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis
Condition: Hemiplegic Stroke; Hemiplegic Cerebral Palsy
MeSH terms: Stroke; Cerebral Palsy
Study type: Observational

Summary: 
      We plan to investigate whether the Isolated Orthosis for Thumb Actuation (IOTA) can
      effectively facilitate the ability of participants to perform a specific set of clinically
      relevant tasks conducted in a clinic setting.
    

Detailed description: 
      Many Activities of Daily Living involve precision grasp and fine motor manipulation, such as
      putting toothpaste on a toothbrush or feeding oneself. However, children afflicted by stroke,
      cerebral palsy, or traumatic brain injury may lose the ability to actively (and accurately)
      control the thumb, and specifically abduct/adduct the carpometacarpal (CMC) joint and
      flex/extend the metacarpophalangeal (MCP) joint. We are testing the Isolated Orthosis for
      Thumb Actuation (IOTA), a device developed at the Wyss Institute at Harvard University in
      collaboration with Children's Hospital Boston, for assisting opposable thumb grasping tasks.
      The IOTA contains an adjustable brace fitted to the thumb and dorsum of the hand that is easy
      to put on and facilitates grasping motions through flexible cable-driven actuators that
      assist with CMC joint abduction and MCP joint extension.

      In this pilot study, we plan to investigate whether the IOTA can effectively facilitate the
      ability of participants to perform a specific set of clinically relevant tasks conducted in a
      clinic setting.

      The hypothesis for this work is that the IOTA will significantly improve the participant's
      performance on clinically relevant tasks.
    

Intervention name(s): Isolated Orthosis for Thumb Actuation (IOTA)
Intervention type(s): Device
Intervention description(s): In this pilot study, we plan to investigate whether the IOTA can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting. The IOTA is a device developed at the Wyss Institute at Harvard University, in collaboration with Children's Hospital Boston, for assisting opposable thumb grasping tasks. The IOTA contains an adjustable brace fitted to the thumb and dorsum of the hand that is easy to put on and facilitates grasping motions through flexible cable-driven actuators that assist with joint abduction and extension.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with hemiplegic cerebral palsy or hemiplegic stroke.
      
Keywords: Robot; Thumb; Orthosis; Hemiplegia; Hemiplegic Stroke; Hemiplegic Cerebral Palsy; Stroke; Cerebral Palsy; Grasp assistance