bioihbjkbjnl/mcl2 huggingface dataset:
ADITEC FLU STUDY: Understanding the Genetic Basis for Immune Responses
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      Infants and young children do not respond as well as adults to the flu vaccines currently
      available in the UK. Fluad, is a different type of influenza vaccine that has been available
      in the European continent for the last decade, and contains an adjuvant known as MF59.

      This vaccine has been used extensively in adults over 65 years of age. It has been
      administered to over 4000 children in previous studies, which have shown that it produces an
      enhanced immune response in children compared with traditional vaccines, and that it is safe
      in this age group. It is, however, not yet licensed for use in children. The reason for this
      new study is to gain a better understanding of the how this vaccine is stimulating the immune
      system, by looking to see which parts of the genetic code are 'switched on' in response to
      immunisation, and to see how this differs from the response to currently used flu vaccines.

      To do this the Oxford Vaccine Group will enrol children aged 14 to 26 months to receive
      either the influenza vaccine with the MF59 adjuvant (ATIV) or one of the influenza vaccines
      currently available in the UK (Agrippal/ Begripal or TIV). The study will also help to find
      out whether it is possible to identify patterns of genetic response which can predict
      responses to immunisation. Being able to do so could potentially enable more rapid
      development of vaccines against influenza and other diseases in the future. We will also
      measure how well the immune system responds to the two vaccines and look at any side effects.

      The study is funded by Aditec is a collaborative research programme that aims to accelerate
      the development of novel and powerful immunisation technologies for the next generation of
      human vaccines.
    


Intervention name(s): TIV (Aggripal); ATIV (Fluad)
Intervention type(s): Biological; Biological
Other intervention name(s): Begripal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth.

      PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given
      together with capecitabine and erlotinib in treating patients with advanced pancreatic
      cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride,
           capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.

      Secondary

        -  Analyze the limiting toxicities according to CTC.

        -  Analyze the toxicity according to CTC.

        -  Determine the recommended dose.

        -  Determine the pharmacokinetic dosages of the three drugs.

        -  Analyze interactions between the drugs.

      OUTLINE: This is a multicenter study.

      Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30
      minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib
      hydrochloride once daily on days 1-28.
    

Intervention name(s): capecitabine; erlotinib hydrochloride; gemcitabine hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Gemcitabine; Capecitabine; Erlotinib Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III pancreatic cancer; stage IV pancreatic cancer; adenocarcinoma of the pancreas; recurrent pancreatic cancer
Effect of Black Tea on Vascular Function
Condition: Vascular Function
Study type: Interventional

Summary: 
      Epidemiological studies indicate that regular consumption of three cups of black tea per day
      reduces the risk of stroke or myocardial infarction. In a number of previous nutrition
      intervention studies tea has been shown to improve vascular function as assessed by Flow
      Mediated Dilation (FMD).
    

Detailed description: 
      The current study tests a specific Black tea extract against a placebo in population that has
      previously show to be sensitive to the effect of black tea on Flow Mediated dilation. A tea
      extract that has previously been shown to improve FMD is included as the positive control.
    

Intervention name(s): Black tea extract; Positive control; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Black tea extract; Positive control; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vascular function; Flow mediated dilation; Tea
Motor Control Exercises vs Standard Exercises in Unspecific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of the present study was to evaluate and compare the effects of motor control
      exercises and standard exercises in the pain, incapacity and medicine intake of subjects with
      unspecific low-back pain.
    

Detailed description: 
      Eighty-four subjects with unspecific low-back pain were randomly recruited for the present
      study. The subjects were randomly allocated into control group (who received one hour of
      standard physiotherapy exercises every days during ten days) or intervention group (who
      received one hour of control motor exercises every days during ten days). One month after
      finishing these ten days, patients should perform a home-based exercises program during two
      months (control group performed home-based standard physiotherapy exercises; intervention
      group performed home-based motor control exercises). Pain (visual analogic scale), incapacity
      index (Roland Morris questionnaire) and medicine intake (diary) were evaluated before the
      intervention, one month and three months after ending the first ten days of intervention.
    

Intervention name(s): Motor control exercises; Standard exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): exercises to strength the lumbar musculature and control the posture; general exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Motor control; Joint mobilization
Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 10 mg in Japanese Healthy Male Adult Subjects
Condition: Clinical Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers in this study wanted to compare the effect of the formulation (orally
      disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban
      (brand name: Xarelto) at dose of 10 mg in Japanese healthy male subjects aged 20 to 40 years.
      Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by
      blood clots. Currently, there are two formulations of Rivaroxaban available on the market in
      Japan and they are film-coated tablets and fine granules. To further improve patients'
      convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form
      designed to be dissolved on the tongue rather than swallowed whole) is under development. The
      goal of this study was to compare the effect of this new formulation with film-coated tablets
      when taken with or without water.

      Participants in this study received one oral dose of rivaroxaban 10 mg ODT either with or
      without water and one oral dose of rivaroxaban 10 mg film-tablet. There were at least 5 days
      between the two doses. Observation for each participant lasted about 6 weeks in total. Blood
      samples were collected from the participants to measure the blood level of the study drug.
    


Intervention name(s): Rivaroxaban (BAY 59-7939, Xarelto) in ODT form; Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg as 1 x 10 mg orally disintegrating tablet (ODT); 10 mg as 1 x 10 mg film-coated tablet
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparitive Study Between Uvb Alone and Uvb With Topical Tacrolimus 0.03% for the Treatment of Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 1

Summary: 
      Vitiligo is a skin disorder that causes substantial social and psychological distress due to
      multiple patches of depigmentation.Disease can target at any age, but it appears to affect
      various parts of body due to loss of melanin. Although the exact cause of the disease is
      unknown, several theories suggest that genetic predisposition, autoimmunity, and increased
      vulnerability of melanocytes to the deleterious effects of harmful metabolites all play a
      role in disease causation. It impacts 0.1%-2% of the general population, with a 30% familial
      prevalence rate.

      Vitiligo treatment still presents a therapeutic challenge for dermatologists despite a
      variety of therapeutic modalities. Topical steroids, ultraviolet B phototherapy (UVB
      280nm-320nm), and photochemotherapy (PUVA i.e., psoralen plus UVA 329nm-400nm) are
      traditional treatment options. Topical calcipotriol and excimer laser are also used.
      According to research, narrowband UVB (NB-UVB) is effective when used alone.

      Few studies, however also, have reported more than 75% re-pigmentation in patients treated
      with NB-UVB in conjunction with other modalities. Topical immunomodulators (tacrolimus,
      pimecrolimus) are considered safe and effective long-term treatments for vitiligo because
      they do not cause skin atrophy, which is associated with long-term use of topical
      corticosteroids. Tacrolimus is an effective treatment for vitiligo when used alone; in one
      study, 61% of patients showed more than 75% repigmentation when treated with tacrolimus
      alone. Another study found that when tacrolimus was combined with NB-UVB, 73% of patients
      experienced more than 50% repigmentation.

      The objective of this research was to present a comparatively new mode of treatment that may
      be beneficial to vitiligo patients.
    


Intervention name(s): 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
Intervention type(s): Drug
Intervention description(s): 0.03% tacrolimus twice daily was applied on group A patients with uvb phototherapy thrice daily
Other intervention name(s): ointment eczemus
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phototherapy; tacrolimus; vitiligo
Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension; Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening disease.
      In many patients, the course of PAH is a steady deterioration and reduced life expectancy.

      Sildenafil was approved by the European Commission for the treatment of PAH in pediatric
      patients in May 2011, making it the first agent to be approved for the treatment of children
      with PAH. The approval was based on the largest placebo-controlled study to be conducted in
      this population. The recommended dose in pediatric patients aged 1 year to 17 years old is 10
      mg TID in patients ≤ 20 kg and 20 mg TID for patients > 20 kg. Higher doses are not
      recommended in pediatrics patients.

      This study is an open-label, multi-center study to investigate safety, efficacy and
      pharmacokinetics of sildenafil citrate in Japanese pediatric patients with PAH.
    


Intervention name(s): Sildenafil
Intervention type(s): Drug
Intervention description(s): Body weight > 20 kg: 20 mg TID (60 mg/day) Body weight ≤ 20 kg: 10 mg TID (30 mg/day) Treatment duration: 16 weeks in Part 1, until until sildenafil obtained marketing approval in Part 2
Intervention MeSH terms: Sildenafil Citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Cinacalcet in Ca, P and iPTH Levels in Patients With Mild, Moderate and Severe SHPT
Condition: Hyperparathyroidism; Secondary, Renal
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 4

Summary: 
      1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL
           in hemodialysis subjects with mild, moderate and severe SHPT;

        2. To explore the impact of Cinacalcet HCL using on the combined use of drugs;

        3. To explore the difference of patients who continued or discontinued Cinacalcet HCL in
           real-world period from 33rd to 52nd week.
    


Intervention name(s): Cinacalcet HCl
Intervention type(s): Drug
Intervention description(s): Administer Cinacalcet HCL to all subjects from 1st to 32nd week. Subjects choose to buy and take Cinacalcet HCL in real-world period from 33rd to 52nd week.
Other intervention name(s): Regpara
Intervention MeSH terms: Cinacalcet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: CKD Hemodialysis Patients with SHPT
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cinacalcet; secondary hyperparathyroidism; calcimimetics; CKD-MBD
Sevoflurane In Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      Ischemic postconditioning can reduce myocardial injury following myocardial infarction.

      A potential pharmacological agent is the anesthetic Sevoflurane. The investigators'
      hypothesis is that sevoflurane during primary percutaneous coronary intervention (PCI) will
      reduce infarct size.
    

Detailed description: 
      Patients with first STEMI that will be treated by primary PCI, will be randomized to sedation
      with Sevoflurane during the procedure or to usual care.
    

Intervention name(s): Oxygen + Sevoflurane; Oxygen (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): Oxygen with end-tidal MAC of Sevoflurane 0.5 during PCI.; Control will receive oxygen only.
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute myocardial infarction; Postconditioning; Sevoflurane
A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim is to check the effect of a single dose of soticlestat in adults with moderate
      or mild liver failure compared to healthy adults with normal liver function.

      Participants will check into the study clinic for 8 days. During the stay, one oral dose of
      soticlestat will be given and the participant will be monitored. The clinic staff will follow
      up with the participant about a week after discharge from the clinic.
    

Detailed description: 
      The drug being tested in this study is called soticlestat (TAK-935). The study will assess
      the safety and tolerability of single oral dose of soticlestat in participants with moderate
      or mild Hepatic Impairment (HI) compared to healthy participants matched by age (mean ±10
      years), sex (±2 per sex), and body mass index (BMI, mean ±10 percent [%]) with normal hepatic
      function.

      The study will enroll approximately 40 participants. Participants will be assigned to
      following study arms:

        -  Arm 1, Moderate HI: Soticlestat 300 milligram (mg) (Child-Pugh Class B)

        -  Arm 2, Mild HI: Soticlestat 300 mg (Child-Pugh Class A)

        -  Arm 3, Normal hepatic function: Soticlestat 300 mg

      All participants will receive single oral dose of study drug. The data will be collected and
      stored in electronic case report form (eCRF).

      This multi-center trial will be conducted in the United States and Hungary. The overall
      duration of the study is approximately 42 days. Participants will be followed up for 14 days
      after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): Soticlestat
Intervention type(s): Drug
Intervention description(s): Soticlestat tablets.
Other intervention name(s): TAK-935
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug Therapy
Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma
Condition: Asthma, Bronchial; Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.
    


Intervention name(s): tacrolimus
Intervention type(s): Drug
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Tacrolimus; Immunosuppressant; Anti-asthmatic drug; Administration, inhalation
Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever
Condition: Familial Mediterranean Fever
MeSH terms: Brucellosis; Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      Establish the safety and efficacy of 3 months treatment with canakinumab in patients with
      colchicine resistant Familial Mediterranean Fever.
    


Intervention name(s): Canakinumab
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Familial Mediterranean Fever; canakinumab; colchicine resistance
Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity
      disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults.

      A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

      This study also has an observational community sample arm in which patients will complete all
      the efficacy measurements via web-based self reporting.
    


Intervention name(s): Atomoxetine hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks; twice a day, by mouth for 12 weeks
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to compare the efficacy and safety of polyethylene glycol (PEG) 3350 with that
      of prucalopride in the treatment of chronic constipation in females. A total of 240 patients
      will be randomly allocated to treatment with one or the other agent. The study consists of a
      14-day run-in period, with treatment subsequently administered for 28 days on a daily basis.
      During the study, patients will fill in a stool diary, samples of faeces will be collected,
      and colonic transit time will be measured prior to therapy, and from days 22 to 28 of
      treatment. The proportion of patients with normalised bowel movements (three or more
      spontaneous movements) during the last week of the study (days 22 to 28 of treatment) will be
      compared between treatments.
    


Intervention name(s): PEG 3350 plus electrolytes; Prucalopride
Intervention type(s): Drug; Drug
Intervention description(s): Each sachet of PEG 3350 is dissolved in 125 mL of water. Patients receive two sachets of PEG 3350 plus electrolytes followed by two placebo tablets for the first 14 days, after which dosage adjustment is permitted, according to effect. Each patient is treated for 28 days in total.; Patients less than 65 years of age receive a solution containing two sachets of reconstituted placebo followed by two prucalopride 1 mg tablets for 28 days.
Patients more than 65 years of age receive a solution containing two sachets of reconstituted placebo followed by one prucalopride 1 mg tablet and one placebo tablet for 28 days.
Intervention MeSH terms: Prucalopride; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Investigation of Acute Effects of Action Observation Training on Upper Extremity Functionality, Reaction Time and Cognitive Functions in Right-handed Healthy Subjects
Condition: Right-handed Healthy Adults
Study type: Interventional

Summary: 
      The aim of the study is to investigate the acute effects of action observation training on
      upper extremity functionality, reaction times, and cognitive functions in right-handed
      healthy subjects.
    


Intervention name(s): Action observation Training; Action Practice; Observation
Intervention type(s): Other; Other; Other
Intervention description(s): Action observation training is a relatively new rehabilitation approach in which the subject is asked to carefully observe the actions presented through a video clip or performed by an operator.; Participants perform an upper extremity functionality test a couple of times.; Participants will watch a slide show of landscape
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment