bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Influenza in Routine Clinical Practice
Condition: Influenza; Acute Upper Respiratory Infection
MeSH terms: Infections; Influenza, Human; Respiratory Tract Infections
Study type: Observational

Summary: 
      This study evaluates the statistics of influenza and acute respiratory viral infections
      (ARVI) management in outpatient sites in Russia, Armenia, Moldova and Georgia (epidemiology:
      disease severity and bacterial exacerbations; patients demography; treatment duration and
      timelines; safety; quality of treatment) in routine clinical practice with focus on drug
      therapy and usage of interferons' inducers.
    

Detailed description: 
      This non-interventional study covers more than 15000 patients from outpatient sites in
      Russia, Armenia, Moldova and Georgia.

      Influenza and acute respiratory viral infections (ARVI) diagnosis validate according to
      "World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic
      Influenza A (H1N1) 2009 and other Influenza Viruses". All patients' examinations are carried
      out according to the local routine clinical practice and local and international standards of
      care.

      The following data will be collected and analyzed after the end of treatment:

        -  demography

        -  disease severity

        -  body temperature

        -  chills and fever (no/mild/severe)

        -  weakness (no/mild/severe)

        -  muscle or joint pain (no/mild/severe)

        -  rhinitis (yes/no)

        -  throat irritation (no/mild/severe)

        -  headache (no/mild/severe)

        -  cough (no/mild/severe)

        -  conjunctivitis (no/mild/severe)

        -  timelines: disease onset, first visit to physician, start of treatment

        -  therapy (drug name, dose, with focus on interferons' inducers)

        -  bacterial exacerbations (yes/no)

        -  therapy of bacterial exacerbations (drug name)

        -  adverse events

        -  results of treatment satisfaction questionnaire for medication (TSQM-9), if completed by
           patient
    

Intervention name(s): Kagocel
Intervention type(s): Drug
Intervention description(s): Investigators could prescribe other drugs in frame of routine clinical practice
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with confirmed diagnosis of influenza or influenza-like illness caused by a
        different type of virus which are on anti-flu therapy
      
Keywords: influenza; flu; acute respiratory viral infection; ARVI; acute upper respiratory infection; AURI
The Effect of Prolotherapy on Balance and Lumbar Flexibility in the Patients With a Sacralized L5 Vertebra
Condition: Lumbosacral Transitional Vertebra
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of prolotherapy on balance and lumbar
      flexibility in the patients with a sacralized L5 vertebra. Evaluations for ability on balance
      include sensory organization test (SOT,) rhythmic weight shifting (RWS) and limits of
      stability (LOS.)
    

Detailed description: 
      Lumbosacral transitional vertebra (LSTV) is a congenital variety of vertebral bony
      construction, which is most frequently presented as sacralized L5 or lumbarized S1. LSTV
      would alter the kinetics of the spine thus induce inadequate mobility and dynamic
      compensation. Patients with LSTV were commonly found when they visited clinicians for
      treatment of low back pain. Prolotherapy is a technique that stimulates the body to repair
      the painful area by assistance of injecting an otherwise non-pharmacological and non-active
      irritant solution into the body.
    

Intervention name(s): Prolotherapy
Intervention type(s): Procedure
Intervention description(s): inject normal saline and 50% glugose water with 1:1 ratial in volumn
Other intervention name(s): Proliferative Injection Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prolotherapy
Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease
Condition: Celiac Disease; Intestinal Disease; Malabsorption Syndromes; Gastrointestinal Disease; Digestive System Diseases; Metabolic Disease; Coeliac Disease; Gluten Sensitivity
MeSH terms: Celiac Disease; Gastrointestinal Diseases; Digestive System Diseases; Malabsorption Syndromes; Intestinal Diseases; Metabolic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled clinical study in non-homozygous human
      leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).
    

Detailed description: 
      A Phase 1, randomized,double-blind, placebo-controlled clinical study of Nexvax2, in adult
      subjects with confirmed CeD who, have been following a gluten free diet for at least 12
      consecutive months prior to screening. The study will evaluate the safety and tolerability of
      Nexvax2 administered subcutaneously and will compare the bioavailability of subcutaneous
      versus intradermal administration. The study plan consists of 3 periods: a screening period
      of 3 to 5 weeks, a 46-day treatment period, and a 30-day post-treatment observational
      follow-up visit.
    

Intervention name(s): Nexvax2; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Nexvax2 injections: 14 in total at twice weekly intervals; Placebo injections: 14 in total at twice weekly intervals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486
Condition: Induction of General Anaesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to
      evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in
      elective surgery patients.This study is consisted of two cohorts, dose-escalation and
      dose-expansion cohorts. The doses in dose- expansion cohort were selected from
      dose-escalation results.
    


Intervention name(s): HSK3486; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): For induction of general anesthesia In dose escalation cohort: Starting from 0.4mg/kg, up-titration dose by 0.1mg/kg until 0.8mg//kg or down-titration dose by 0.1mg/kg until 0.1mg/kg based on the efficacy and safety results.; For induction of general anesthesia
Intervention MeSH terms: Propofol
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging
Condition: Liver Lesions
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of Sonazoid™ and SonoVue® in
      participants with focal liver lesions (FLLs), by comparing pre-and post-contrast ultrasound
      examination findings with regard to various aspects of lesion diagnosis including diagnosis
      as benign versus malignant, specific lesion diagnosis, confidence in diagnosis, and quality
      of delineation of lesion-related blood vessels (from images obtained during vascular imaging)
      and detection of lesion presence and quality of delineation of the whole liver (from images
      obtained during whole liver imaging).
    


Intervention name(s): Sonazoid™; SonoVue®
Intervention type(s): Drug; Drug
Intervention description(s): Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.; Single Dose of SonoVue® 2.4 mL as I.V. injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Folfoxiri Plus Bevacizumab Followed by Chemoradiotherapy Plus Bevacizumab in Patients With Resectable Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study includes patients affected by advanced and resectable rectal adenocarcinoma. It
      provides an induction chemotherapy with FOLFOXIRI regimen plus Bevacizumab followed by
      Chemoradiotherapy plus Bevacizumab. Surgery with total mesorectal incision must be performed
      within 7-9 weeks after this last treatment. The protocol will be evaluate the disease free
      survival at two years. Translational analyses will be performed to show the presence of VEGF
      polymorphism, CD133 surface markers on colorectal CSCs.
    


Intervention name(s): FOLFOXIRI plus Bevacizumab; Chemoradiotherapy plus Bevacizumab
Intervention type(s): Drug; Other
Intervention description(s): BEVACIZUMAB 5 mg/kg over 30 minutes, day 1
IRINOTECAN 165 mg/sqm IV over 1-h, day 1
OXALIPLATIN 85 mg/sqm IV over 2-h, day 1
L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1
5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1 administered every two weeks for 6 cycles (3 months).; FLUOROURACIL 225 mg/sqm/day by protracted IV continuous infusion or -CAPECITABINE 825 mg/sqm/bid p.o. continuously without interruption for all the duration of radiation treatment;
EXTERNAL-BEAM IRRADIATION 50.4 GY in 28 daily fractions over 5.5 weeks;
BEVACIZUMAB 5 mg/kg over 30 minutes, starting on day 1 of radiation treatment day 1 and then every two weeks (for 3 cycles).
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rectal cancer; FOLFOXIRI; bevacizumab; trust
Quality of Life of Children With Sickle Cell Disease Who Are Getting Chronic Transfusions With a Lifeport
Condition: Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      This study is being done to see what impact having a Lifeport device has on quality of life
      for children with sickle cell who are getting chronic transfusions, from the child's
      perspective.
    

Detailed description: 
      There is a paucity of research that focuses specifically on quality of life (QoL) among
      patients with sickle cell. This study aims to explore the QoL of children who are receiving
      chronic transfusion therapy (CTT) using a Lifeport device, which allows them to undergo
      erythrocytapheresis, rather than standard transfusion therapy. Erythrocytapheresis is less
      time consuming and is associated with less iron overload than conventional transfusion
      therapy; however, little is known about the implications for the child's QoL. This study will
      explore QoL from the child's perspective.
    

Time perspective: Other
Keywords: chronic transfusion therapy; quality of life
Microdose and First-In-Human (FIH) Study of Recombinant Human Placental Alkaline Phosphatase (hRESCAP)
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In the present study human recombinant placental alkaline phosphatase (hRESCAP) will be
      investigated. Alkaline Phosphatase is naturally present in the body and reported to use
      lipopolysaccharde (LPS, bacterial endotoxins) and extracellular nucleotides leaking from
      damaged and ischemic cells as physiological substrates. The LPS-substrate prevalence makes
      alkaline phosphatase an interesting novel therapeutic agent in the treatment of LPS-mediated
      diseases. A bovine homologue of this protein (bovine intestinal alkaline phosphatase, BIAP)
      has previously been investigated for treatment of acute inflammatory responses such as
      sepsis, and was shown to be safe in humans. hRESCAP, which will be investigated in the
      current study, is expected to have a longer half-life in humans than the previously
      investigated BIAP, due to the fact that it is more sialylated. The possibility to increase
      the t1/2 to days instead of minutes enables treatment of chronic diseases.
    

Detailed description: 
      In the current study the peak plasma concentration (pharmacokinetics/elimination) of
      [14C]-labelled hRESCAP in healthy volunteers will be investigated at increasing single doses
      (up to anticipated therapeutic dose), with a microdose (≤30 nmol) as a safe starting dose.

        -  Part 1: To assess the peak plasma concentration of a single microdose (≤30 nmol) of a
           recombinant human protein (hRESCAP), administered intravenously, as a suitable technique
           to predict the pharmacokinetics in humans at pharmacologically relevant doses;

        -  Part 2: To determine the safety and tolerability of single dose of hRESCAP up to 5300 µg
           in healthy male volunteers administered intravenously;

        -  To determine the peak plasma concentration of hRESCAP in healthy male volunteers within
           a pharmacologically relevant dose-range and compare this with BIAP pharmacokinetics with
           emphasis on half-life (t1/2).
    

Intervention name(s): hRESCAP; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): one acute bolus administration of different dosages of hRESCAP (microdose, part 1; and FIH: low dose, 414 µg; medium dose, 2480 µg; high dose, 5300 µg; part 2)
Other intervention name(s): recombinant human placental alkaline phosphatase
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Peak plasma concentration; safety and efficacy; therapeutic agent; LPS-mediated diseases; Pharmacokinetics of administered hRESCAP; Determine half-time
Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA)
Condition: Progressive Supranuclear Palsy; Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Supranuclear Palsy, Progressive; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      In total 20 subjects will be enrolled at one participating site -UMC Ljubljana. The 20
      subjects will be treated with placebo and NBMI 300 mg in a cross-over design. In case of
      subject drop-outs, additional subjects may be enrolled as decided by the Sponsor, to allow
      for expected number of evaluable subjects in each group.
    

Detailed description: 
      · The study's primary objective is: To explore the efficacy of 28 days NBMI treatment on
      motor and non-motor symptoms and heath related quality of life in patients with Progressive
      Supranuclear Palsy or Multiple Systems Atrophy disease.

      The study's secondary objectives are:

        -  to explore safety and tolerability of 28 day NBMI treatment in patients with Progressive
           Supranuclear Palsy or Multiple Systems Atrophy.

        -  to investigate the efficacy of NBMI daily oral administration for 28 days on fatigue in
           MSA and PSP patients,

        -  to investigate the efficacy of NBMI daily oral administration for 28 days on depression
           in MSA and PSP patients.

      The study's exploratory aims are:

        -  to explore the effect of NBMI treatment on patient's brain iron levels as evaluated by
           MRI imaging,

        -  to explore the effect of NBMI on brain metabolism with FDG- PET- CT brain imaging,

        -  to explore the pharmacokinetics of NBMI in patients with PSP or MSA.
    

Intervention name(s): NBMI; Placebo
Intervention type(s): Drug; Other
Intervention description(s): NBMI active treatment; Placebo for comparison
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare experimental evaluation of relative bioavailabilities
      in healthy, human subjects under non-fasting conditions.
    

Detailed description: 
      Open label, balanced, randomized, two-treatment, two-period, two sequence, single dose,
      crossover, comparative oral bioavailability study in healthy, adult, male human subjects
      under non-fasting conditions.
    

Intervention name(s): Nizatidine; Axid
Intervention type(s): Drug; Drug
Intervention description(s): Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited; Axid 300 mg Capsules of Reliant Pharmaceuticals, US
Other intervention name(s): Axid 300 mg Capsules
Intervention MeSH terms: Nizatidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Nizatidine; Crossover
Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: Septic shock leads to high morbidity and mortality in critically ill patients.
      Several lower-case scientific studies have supported the synergistic positive effect of
      vitamin C, thiamine, and hydrocortisone on sepsis-induced organ dysfunction.

      Aim: Our aim was to investigate the effect of vitamin complex on organ failure, laboratory
      parameters, respiratory and antibiotic treatment, intensive care time, and mortality in
      septic shock patients.

      Material and methods: In our retrospective and prospective analysis, we collected parameters
      from 43 (23 vitamin-treated, 20 control) septic shock patients. Patients treated with
      vitamin, they received vitamin C (4x1500 mg), thiamine (2x200 mg) for three days (2). In
      other respects, and for hydrocortisone (200 mg / 24h), both groups of patients received
      treatment according to the European Sepsis Recommendation. SPSS (V-21) data were used for
      data collection, Kolmogorov-Smirnov, Wilcoxon, Mann-Whitney U tests were used for statistical
      analysis.

      Ethical license: 7849-PTE 2019.
    


Intervention name(s): Vitamin C
Intervention type(s): Drug
Intervention description(s): Patients in the intervention group (G1) (n=23) received the combined vitamin therapy: IV vitamin C (1.5 g every 6 hours administered as an infusion over 30 to 60 minutes and mixed in a 100- mL solution of normal saline), hydrocortisone (100 mg in bolus-100 mg in perfusor up to 60 min (200mg 24h),), and thiamine (200 mg every 12 hours administered as an infusion over 30 to 60 minutes and mixed in a 100-mL solution of normal saline) for 3 days.
Other intervention name(s): Thiamine
Intervention MeSH terms: Thiamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sepsis; vitamin-c; thiamine; septic shock
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, 2-injection, 52-week study to
      evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 in subjects
      with chronic, moderate-to-severe osteoarthritis knee pain.
    


Intervention name(s): Placebo; CNTX-4975-05
Intervention type(s): Drug; Drug
Intervention description(s): Receiving Placebo Injection; Receiving CNTX-4975-05 Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Knee Pain
Laparoscopic Adjustable Gastric Banding in Adolescents
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      This study is to determine if the Lap-band system is safe and effective for use in morbidly
      obese adolescents.
    

Detailed description: 
      This study is to determine if the Lap-band system is safe and effective for use in morbidly
      obese adolescents
    

Intervention name(s): Adjustable Gastric Band
Intervention type(s): Device
Intervention description(s): Surgical placement of an adjustable gastric band around the upper portion of the stomach.
Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
Other intervention name(s): Lap-Band
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lap-Band; morbid obesity; adolescents
Surgical Management of Posterior Malleolar Fractures Using the Direct or Indirect Reduction Techniques
Condition: Posterior Malleolus Fractures
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

Summary: 
      Patients with a posterior malleolar fracture were recruited and assigned to the direct
      reduction (DR) group or the indirect reduction (IR) group. Following reduction and fixation
      of the fracture, the quality of fracture reduction was evaluated in radiograph and CT images.
      Functional outcome was evaluated at the last follow-up.
    

Detailed description: 
      Patients with a posterior malleolus fracture were recruited meeting the inclusion criteria of
      unstable and displaced posterior malleolar fractures requiring surgical management. Patients
      with open fractures or pathological fractures were excluded. Preoperative anteroposterior
      (AP), lateral, and mortise view radiographs as well as computed tomography (CT) scans were
      routinely obtained to evaluate the characteristic of the fracture. Patients were then
      assigned to the direct reduction (DR) group or the indirect reduction (IR) group. Following
      reduction and fixation of the fracture using the direct reduction technique or the indirect
      reduction technique, the quality of fracture reduction was evaluated in radiograph and CT
      images. Functional outcome,including AOFAS score, ankle range of motion were evaluated at the
      last follow-up.
    

Intervention name(s): direct fracture reduction and fixation; indirect fracture reduction and fixation
Intervention type(s): Procedure; Procedure
Intervention description(s): In the DR group, the posterior malleolar fracture was reduced and fixed in a direct way via a posterolateral approach with the patients in prone position.; In the IR group, the posterior malleolus was reduced through ligamentotaxis following open reduction and internal fixation of lateral and medial malleolar fractures. Percutaneous cannulated screws were used to fix the posterior malleolar in anterior-to-posterior direction.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment