bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of Three Seasonal Trivalent Influenza Vaccines in China Military
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of three seasonal
      trivalent influenza vaccines (TIVs)manufactured by Glaxosmith Kline (GSK), Beijing Sinovac
      Biotech (Sinovac) and Shenzhen Sanofi Pasteur (Pasteur) in Chinese healthy servicemen. Using
      imported GSK's TIV as control, to compare it with other two domestic TIVs in Chinese healthy
      servicemen.
    

Detailed description: 
      This study is a 1:1:1 randomized, double-blinded, controlled phase Ⅳ clinical trial in a
      military command in Beijing. Healthy individuals aged between 18～34 years who had not
      received any influenza vaccine during recent three years will be enrolled and administrated
      one dose TIV. Safety data will be collected for whole study (Day 0 to Day 30).Blood samples
      will be collected for immunogenicity assessments before injection and 21 days after
      vaccination.
    

Intervention name(s): Seasonal trivalent influenza vaccine, Anflu®; Seasonal trivalent influenza vaccine, VAXIGRIP; Seasonal trivalent influenza vaccine, Fluarix
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Seasonal trivalent influenza vaccine manufactured by Sinovac Co., Ltd.; Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur; Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals
Other intervention name(s): Anflu®; VAXIGRIP; Fluarix
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza Vaccine; Safety; Immunogenicity
Bioinformation Therapy for Pancreatic Cancer
Condition: Unresectable Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is the synergistic effect of cancer ablation and life information
      rehabilitation therapy on unresectable pancreatic cancer.
    

Detailed description: 
      By enrolling patients with unresectable pancreatic cancer adapted to enrolled criteria, this
      study will document for the first time the synergistic effect of cancer ablation and life
      information rehabilitation therapy. The efficacy will be evaluated according to local relief
      degree, progress free survival (PFS) and overall survival (OS).
    

Intervention name(s): Cancer ablation; Life information rehabilitation therapy
Intervention type(s): Device; Drug
Intervention description(s): Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound; Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other intervention name(s): Cryoablation or irreversible electroporation; "Qilisheng" Immunoregulatory Oral Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer ablation; Life information rehabilitation therapy
Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONAL: Simmitecan is an anticancer ester prodrug, which involves activation to
      chimmitecan. Chimmitecan，a novel CPT derivative, exhibited potent antitumor activities both
      in vitro and in vivo by inhibiting topoisomerase I. Also exerted comparable effects on
      topoisomerase I compared with topotecan and SN38 and possessed improved anticancer potency
      and pharmacologic profiles, compared with the clinically available CPT analogues.

      PURPOSE: to determine the maximum tolerated dose, the safety profile and pharmacokinetics of
      Simmitecan.
    


Intervention name(s): Simmitecan Hydrochloride for Injection
Intervention type(s): Drug
Intervention description(s): Either at 12.5 mg, 25 mg、50 mg、80 mg、120 mg、160 mg、200 mg
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tolerability; Pharmacokinetics
An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors
Condition: Cancer: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the maximum tolerable dose (MTD) and the related
      effects of E7080 administered to patients with solid tumors that are resistant to approved
      existing anti-tumor therapies, or for which no appropriate treatment is available.
    


Intervention name(s): E7080
Intervention type(s): Drug
Intervention description(s): E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
Intervention MeSH terms: Lenvatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer, solid tumors
Risperidone in the Treatment of PTSD in Women Survivors of Domestic Abuse and Rape Trauma
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      This medical study is an assessment of clinical response in women with Posttraumatic Stress
      Disorder (PTSD) due to domestic violence or rape trauma when treated with risperidone.
      Response to risperidone or placebo (inactive drug) is measured by Clinician Administered PTSD
      Scale (CAPS) and Treatment Outcomes PTSD Scale (TOP-8). Second, the effect of risperidone on
      depressive and anxiety symptoms will be assessed using the Hamilton Rating Scale for Anxiety,
      Hamilton Rating Scale for Depression and the Clinical Global Impression.
    

Detailed description: 
      Risperidone is an atypical antipsychotic that has been shown to be effective in both the core
      PTSD symptoms and psychotic symptoms associated with combat-induced PTSD in males. Case
      series have shown that risperidone is possibly effective in monotherapy or adjunctively in
      treating PTSD patients. However, risperidone has never been tested in women with severe PTSD.
      Thus, we propose extending and expanding this research to another antipsychotic, risperidone,
      in a cohort of women who suffer PTSD as a consequence of domestic violence and/or rape
      trauma.
    

Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Evaluation of Dose-effect of a New Fermented Food in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to assess the safety and tolerance of a new fermented food versus a
      control product in healthy adults during the 4-week consumption period.
    


Intervention name(s): Fermented dairy product; milk-based non-fermented dairy product
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: healthy adults
Asthma Control in Elderly Patients With Montelukast
Condition: Persistent Asthma; Elderly
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the efficacy of combination therapy of montelukast plus low dose inhaled
      budesonide and single therapy of medium dose inhaled budesonide on asthma control such as
      inflammatory markers and clinical indicators and to compare treatment response according to
      leukotriene related genotypes in elderly patients with asthma
    


Intervention name(s): Combination of low ICS and montelukast; Monotherapy of medium dose ICS
Intervention type(s): Drug; Drug
Intervention description(s): Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m and take orally a tablet of Singulair® 10mg one time per day.; Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m. and between 7 p.m. and 10 p.m. two times per day
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma control in elderly patients; age 60-75
Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which Arm (capecitabine + irinotecan versus
      capecitabine + cisplatin) shows higher response rates in the treatment of advanced
      gastric-oesophagal cancer

      Furthermore, comparison of progression-free survival, 1-year survival, Quality of Life and
      safety
    

Detailed description: 
      capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO
      2006)
    

Intervention name(s): Cisplatin, Irinotecan, Capecitabine
Intervention type(s): Drug
Intervention MeSH terms: Capecitabine; Irinotecan
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cisplatin; capecitabine; gastric; irinotecan; metastatic; chemotherapy
Study of ALXN2050 in Participants With Renal Impairment
Condition: Renal Impairment; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the impact of impaired renal function on the plasma
      pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future
      indications in individuals with impaired renal function.
    

Detailed description: 
      The study will initiate (Part 1) with participants with severe impaired renal function
      (Cohort 1) and their matched healthy control participants (Cohort 4). Following data review,
      the study may proceed (Part 2) with participants with moderate (Cohort 2) and mild (Cohort 3)
      impaired renal function if deemed necessary.
    

Intervention name(s): ALXN2050
Intervention type(s): Drug
Intervention description(s): ALXN2050 (120 milligrams) will be administered orally twice daily on Days 1 through 3, with an additional dose (120 milligrams) administered orally on the morning of Day 4.
Other intervention name(s): ACH-0145228 (formerly)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Factor D Inhibitor; Pharmacokinetics; Pharmacodynamics; Safety; ALXN2050
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Condition: Postbariatric Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study will evaluate whether taking an investigational drug called exendin 9-39
      is safe, well-tolerated, and helps to prevent low blood sugar in people who have had
      bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).
    

Detailed description: 
      This is a Phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study
      in patients with refractory PBH.

      Participants will be randomized and assigned in a 1:1 ratio to one of two treatment arms. All
      participants will receive 2 dosing regimens of exendin 9-39 and matching placebo
      self-administered via subcutaneous (SC) injection.

      Participants will undergo in-clinic mixed meal tolerance test (MMTT) provocation with
      concomitant blood draws and symptom assessments.
    

Intervention name(s): exendin 9-39; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.; Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
Other intervention name(s): Avexitide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pharmaceutical Care for Diabetes Type 2 Patients: a Randomised Controlled Trial
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the therapeutic effectiveness and cost-effectivity
      of pharmaceutical care for diabetes type 2 patients. Patients will be randomly allocated to
      the control group ( = no input from pharmacist) or intervention group ( = with pharmaceutical
      care at baseline and follow-up visits over 6 months).
    


Intervention name(s): Pharmaceutical care at baseline and follow-up visits over 6 months
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
Condition: Coagulation Dysfunction in Septic Shock; Hemodynamic Improvement Induced by Hydrocortisone
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out whether stress doses of hydrocortisone attenuate
      coagulation dysfunction in patients with septic shock. And discuss the probable mechanism by
      which little doses of hydrocortisone influence coagulation system in sepsis.
    

Detailed description: 
      Patients were randomized to receive either low-dose hydrocortisone or matching
      placebo.Severity of coagulopathy was estimated using ISTH DIC score. We determined the
      complications and mortality in two groups, and analyzed the relationship between
      hydrocortisone and coagulopathy.
    

Intervention name(s): Hydrocortisone
Intervention type(s): Drug
Intervention description(s): Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: coagulopathy; hydrocortisone; organ failure
Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study will determine the effectiveness of educating pediatricians about attention
      deficit hyperactivity disorder treatment guidelines in improving child behavior and
      pediatricians' adherence to medication guidelines.
    

Detailed description: 
      The most effective treatment for improving the core symptoms of inattention, impulsivity and
      hyperactivity in children with attention deficit hyperactivity disorder (ADHD) involves the
      use of stimulant medications. Most children with ADHD are treated by pediatricians, but the
      treatment provided is often less than optimal. This study is designed to see if training for
      pediatricians in following guidelines for management of first-line medicines for ADHD leads
      to improvement in child behavior, and whether the physicians can adhere to the guidelines.

      Over 100 studies have shown that stimulant medications are effective for improving the core
      symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Approximately 70% of children
      who receive ADHD medications are treated by their primary care pediatrician, but studies show
      that management is not always optimal. The present study is designed to see if child behavior
      can be improved by training pediatricians in the use of guidelines for treating ADHD, and
      whether the physicians can adhere to the guidelines. Twenty-four pediatric practices were
      randomized to a treatment as usual or specialized care (receiving training in guidelines and
      computer assisted monitoring of patient progress and medication titration). Children are
      assessed with parent and teacher reports at baseline, 4-, 9-, and 12-months post initiation
      of treatment, and classroom observations of behavior are assessed at baseline, 6-, and
      12-months. Approximately 400 children are to be enrolled.
    

Intervention name(s): Physician training
Intervention type(s): Behavioral
Intervention description(s): Physicians are trained in guidelines for medication management.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Hyperactivity Disorder
A Multiple Dose Study of DWP05195 in Healthy Adult Subjects
Condition: Healthy Adult Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and
      pharmacodynamics of multiple administered DWP05195 in healthy volunteers
    


Intervention name(s): DWP05195
Intervention type(s): Drug
Intervention description(s): tablets, oral administration, multiple administration
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
Condition: Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this trial is to investigate whether the Menostar patch is as safe and effective
      in the prevention of bone loss in postmenopausal women as raloxifen, a drug already
      registered for prevention and treatment of osteoporosis.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Menostar (Estradiol, BAY86-5435); Raloxifene
Intervention type(s): Drug; Drug
Intervention description(s): Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day); Raloxifene tbl. (60 mg/day)
Intervention MeSH terms: Raloxifene Hydrochloride; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Deoxycholic Acid Injection for the Treatment of Superficial Lipomas
Condition: Lipoma
MeSH terms: Lipoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research is to compare the safety and effectiveness of 4 different
      concentrations of deoxycholic acid injection against a placebo in the treatment of
      superficial lipomas.
    

Detailed description: 
      A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the
      purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas
      on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not
      treated.)
    

Intervention name(s): Deoxycholic Acid Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered via intralipomal injection.; Administered via intralipomal injection.
Other intervention name(s): ATX-101; Sodium deoxycholate
Intervention MeSH terms: Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Analgetic Effect of Preoperative Pregabalin in Patients Undergoing Nephrectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing
      elective nephrectomy. Postoperatively, patients receive a patient controlled analgesia device
      for self delivering opioids. Morphine consumption in the first 48 hours is documented.

      Hyperalgesia is measured by von-Frey-Filaments.
    


Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 300mg pregabalin orally 1 hour before operation; Placebo
Other intervention name(s): Lyrica; Control
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients
Condition: Trichuris Infection; Helminthiasis
MeSH terms: Helminthiasis; Trichuriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      There are four species of intestinal worms collectively known as soil-transmitted
      helminthiasis (STH): Ancylostoma duodenale and Necator americanus (hookworms), Ascaris
      lumbricoides (roundworms), and Trichuris trichiura (whipworms). These parasites affect over
      two billion people and contribute to significant morbidity and disability, especially in high
      risk groups, for example children, agricultural workers and pregnant women. In children, STH
      are associated with impaired nutritional status evidenced by stunting, thinness and
      underweight.

      As is the case in most Latin America, STH are a public health problem in Honduras. The World
      Health Organization (WHO) informs that more than 2.5 million children (under 15 years of age)
      in the country are at risk of infection. To control these infections Honduras has established
      a national deworming program that operates since 2001 but despite these efforts, the
      prevalence of STH infections remains unacceptably high. This is especially true in rural
      communities where prevalence can be as high as 70% of the children population.

      Ivermectin (IVM) in combination with albendazole (ALB) has demonstrated the capacity to
      improve efficacy compared to any of these drugs in monotherapy; the efficacy is however,
      still inadequate in terms of cure rate, although egg reduction rates are significant.

      The purpose of the current trial is to assess the safety and efficacy of 3 experimental
      regimens for the treatment of infections by Trichuris trichiura in children in comparison
      with the current standard of practice in Mass Drug Administration (MDA) campaigns. The
      experimental regimens will explore the effect of multiple day regimens and high dose
      ivermectin.

      Treatment arms:

        -  Group 1: single dose of ALB 400 mg. (active control arm). N:39

        -  Group 2: single dose ALB 400mg + IVM 600µg/Kg. N: 57

        -  Group 3: daily dose ALB 400mg for 3 consecutive days. N:24

        -  Group 4: daily dose ALB 400mg + IVM 600µg for 3 consecutive days. N:57

      Total Study Population: 177
    


Intervention name(s): Ivermectin; Albendazole
Intervention type(s): Drug; Drug
Intervention description(s): Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.; Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.
Intervention MeSH terms: Ivermectin; Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: TRICHURIS; STH; IVERMECTIN; ALBENDAZOLE