bioihbjkbjnl/mcl2 huggingface dataset:
Outcomes of Renal Function in Hepatorenal Syndrome (HRS) Determined By Comparison of Target Mean Arterial Pressure (MAP) of 65 - 70 Mmhg Versus ≥ 85 Mmhg
Condition: Hepatorenal Syndrome
MeSH terms: Hepatorenal Syndrome; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Comparing renal outcomes based on a Mean Arterail Pressure (MAP) of 65-7085mmhg versus a MAP
      of greater than or equal to 85mmhg
    

Detailed description: 
      Main hypothesis:

      The investigators propose that there will be no difference clinical outcomes as evidenced by
      a significant difference in urine output or change in creatinine between the MAP target ≥
      85mmhg and the MAP target of 65-70 mmhg.

      Primary end point:

      To determine if High MAP or Low MAP will provide the most optimal renal function. The primary
      endpoints will be 96h UOP and change in creatinine levels. UOP will be calculated as cc/24
      hours. The investigators will compare the change in urinary output of day 1 versus day 4.
      Creatinine will be measured daily and the change from initiation to completion of the study
      will be recorded. The mean values of these will be compared.

      Secondary end point:

      To determine if High MAP or Low MAP will decrease the occurrence of cardiac events
      (arrhythmias and myocardial infarctions) and vascular events (limb or intestinal ischemia).

      Study Design:

      This is a prospective, unblinded, randomized, Two-arm treatment, pilot study. Patients will
      undergo block randomization to receive either a MAP ≥ 85mmhg or a MAP 65-70mmhg.
    

Intervention name(s): Norepinephrine (Levophed); Norepinephrine (Levophed)
Intervention type(s): Drug; Drug
Intervention description(s): Titrate norepinephrine to MAP 65-70; Titrate norepinephrine to MAP 85 or greater
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Analyze the Effect of Acupuncture on Mobility And Quality of Life in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this two-center study is to examine the effectiveness of acupuncture
      treatments in addressing mobility deficits, sensorimotor impairment, and quality of life
      (QOL) limitations in persons with Multiple Sclerosis (MS). It is hypothesized that
      acupuncture will result in an improvement in these limitations.
    

Detailed description: 
      This research study will examine the effects of acupuncture on various symptoms experienced
      by persons with MS. Persons with MS often use acupuncture as a way of controlling the
      symptoms of the disease. However, there is little research on whether or not acupuncture has
      any effect on MS symptoms related to movement. This study intends to look at the effects of
      acupuncture treatment on walking, balance, and mood in persons with MS.
    

Intervention name(s): Standard of Care with no acupuncture; Acupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): The control group will lie on a treatment table in the acupuncturist's office for the same amount of time that the treatment group did, but receive no acupuncture; The first set consists of core point selection, used in an MS Standard of Care (SOC). The second set of points will be individualized to the patient's needs as determined by the acupuncturist. SOC treatment will be based upon Traditional Chinese Medicine (TCM) interpretation of 4 phases of MS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Digital Respiratory Game in Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study aims to examine the effects of a digital game designed for respiratory training in
      childhood asthma. Fifteen children aged 8-14 years with asthma were included in the study.
      There were two groups a digital game group (n=9) and a control group (n=6). Respiratory
      training was given to the digital game group with a digital game. The control group was
      followed with medication. Both groups were evaluated at baseline and after 3 weeks.
    

Detailed description: 
      Asthma is a chronic obstructive disease that is common in children worldwide. This study aims
      to examine the effects of a digital game designed for respiratory training in childhood
      asthma.

      Fifteen children aged 8-14 years with asthma were included in the study. There were two
      groups a digital game group (n=9) and a control group (n=6). Demographic information of the
      children was recorded. Pulmonary function test (PFT) was evaluated with a portable spirometer
      (Spirobank MIR), the quality of life of the children was evaluated with the Paediatric Asthma
      Quality of Life Questionnaire and psychological status was evaluated with the child
      depression scale. Respiratory training was given to the digital game group with a digital
      game. The control group was followed with medication. Both groups were evaluated at baseline
      and after 3 weeks.
    

Intervention name(s): Digital Game Application; Use of medication for asthma
Intervention type(s): Device; Drug
Intervention description(s): The digital game contains brief information about the respiratory system adapted to children, and it is a game whose duration can be adjusted manually to follow the treatment process of the patient, taking into account the ½ ratio in the inhalation and exhalation process in the clinic.; The children continued to take their current asthma medication on the same schedule. The drugs used by the children were zespira and ventolin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Digital game; Pediatric asthma; Quality of life; Respiratory training; Psychological status
The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Spinal anaesthesia results in blockade of sympathetic efferent neurones. Patients with higher
      baseline sympathetic activation have been shown to have more marked hypotension after spinal
      anaesthesia. Anxiety causes generalized sympathetic activation. It was aimed to find the
      effect of preoperative anxiety on the duration and efficacy of neuraxial anaesthesia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        It is planned to enroll healthy individuals undergoing elective surgery under spinal
        anaesthesia.
EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection
Condition: Endoscopic Hemostasis; Colonic Polyps
MeSH terms: Colonic Polyps
Study type: Interventional

Summary: 
      Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment
      techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common
      complication following EMR. Several endoscopic hemostasis methods are currently in use
      including metallic hemoclip. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new
      hemostasis material was previously used for surgical hemostasis, but the therapeutic effect
      and safety in endoscopic application remains unknown. This randomized controlled study has
      been designed to compare PAPH with metallic hemoclip in their hemostatic effect of
      intra-procedure bleeding control and rebleeding prevention during and after EMR.
    


Intervention name(s): Hemoclip; EndoClot
Intervention type(s): Procedure; Procedure
Intervention description(s): Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding.; EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
Other intervention name(s): metallic hemoclip (Cat# HX-610-090L, Olympus); EndoClot® Absorbable Polysaccharide Hemostat (Cat# Y2007090722, Starch Medical Inc)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endoscopic Hemostasis; metallic hemoclip; EndoClot Absorbable Polysaccharide Hemostat; Colonic Polyps
After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
Condition: Arthroplasty, Replacement, Knee; Acute Kidney Injury; Tourniquets; Knee Osteoarthritis
MeSH terms: Acute Kidney Injury; Renal Insufficiency
Study type: Interventional

Summary: 
      This study analize the incidence of acute renal failure after performing total knee
      arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in
      a randomized clinical trial
    

Detailed description: 
      This study analize the incidence of acute renal failure after performing total knee
      arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb
      cuff (half of patients for each group) in a randomized clinical trial
    

Intervention name(s): total knee arthroplasty; Tourniquet limb cuff; Intaarticular lidocain
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Total knee arhroplasty; Tourniquet limb cuff and regular anesthesia; 20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)
Other intervention name(s): TKA; lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical Trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Evaluating the Efficacy and Safety of Transitioning Patients From Natalizumab to Ocrelizumab
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The primary objective of this study is to assess the efficacy of Ocrelizumab (OCR) in
      Relapsing Multiple Sclerosis patients who have been previously treated with natalizumab (NTZ)
      by evaluating relapse rate, progression on MRI and disability progression.
    

Detailed description: 
      This is a multicenter, prospective, open-label, Phase IV clinical trial. Patients with
      relapsing forms of Multiple Sclerosis (MS), ages 18 to 65, who have received 12 or more
      continuous infusions of NTZ, and have been free of relapses, disability worsening or Magnetic
      Resonance Imaging (MRI) progression 6 months prior to the transition screening visit will be
      eligible for the study. After informed consent to participate has been obtained, the patient
      will have physical exam (PE), non-blinded Expanded Disability Status Scale (EDSS), MRI,
      Multiple Sclerosis Impact Scale (MSIS-29) and labs done for the screening visit to determine
      eligibility. Brain MRI with and without contrast will be performed with the standard MS
      protocol. MRIs will be performed with 3mm slice thickness with no gaps between slices.
      Patients will receive their first dose of OCR 4 to 6 weeks after the last dose of NTZ. Other
      baseline measures, including physical exam, EDSS, MSIS-29, and labs will be performed within
      4 weeks of screening. Physical exam, non-blinded EDSS, and labs will be performed at month 3,
      month 6, month 9, and month 12. MSIS-29 will be performed at months 6 and 12. In addition,
      MRIs will be performed at months 3, 6, and 12.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients with relapsing forms of MS, ages 18 to 65, have received 12 or
        more continuous infusions of NTZ, and have been free of relapses, disability worsening or
        MRI progression 6 months prior to switching from NTZ to OCR therapy are eligible to
        participate.
      
Keywords: Multiple Sclerosis; MS; ocrelizumab; OCREVUS; Natalizumab; Tysabri
The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will be conducted in Phase I/II clinical trials. In Phase I, subjects with
      moderate to severe glabellar lines are enrolled and those who are judged to be eligible for
      this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five
      sites of the glabellar lines. Safety is assessed after 12 weeks. In Phase II, subjects with
      moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the
      "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter,
      efficacy and safety are assessed by comparing with BOTOX®.
    


Intervention name(s): PROTOXIN; Botox®
Intervention type(s): Biological; Biological
Intervention description(s): Botulinum toxin Type A; Botulinum toxin Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Glabellar Lines; Botulinum toxin; Botulinum toxin type A
Fludarabine, Cyclophosphamide, Doxorubicin and Rituximab for the Treatment of Post-transplant Lymphoproliferative Disease (PTLD)
Condition: Post-transplant Lymphoproliferative Disease (PTLD); Non Burkitt
MeSH terms: Lymphoproliferative Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Fludarabine may be of benefit to prevent rejection of grafted solid organs in children during
      chemo-immunotherapy treatment for post transplant lymphoproliferative diseases (PTLDs).
    

Detailed description: 
      Eligible to this study were patients less than 18 years old, presenting with non Burkitt,
      aggressive, CD20 positive PTLD, after solid organ transplants.

      Induction therapy consisted of two cycles of a combination of Fludarabine(30mg/sqm/day, days
      1,2,3), Cyclophosphamide (750 mg/sqm/day, day 1), Doxorubicin (30 mg/sqm/day, day 1)and
      Rituximab (375 mg/sqm/day, day 4).

      Thereafter consolidation therapy was given as follows: two blocks for stage II or III with
      LDH less than 500 IU/L; three blocks for stage III with LDH >500 and < 1000 IU/L or stage IV
      with LDH < 1000 IU/L; four blocks for stage III or IV with LDH > 1000 IU/L. Blocks given were
      modified BFM blocks used for treatment of non Hodgkin B-lymphomas, as follows:

      Block 1: High Dose Methotrexate (HDMTX) 1.5 gr/sqm; Vincristine (VCR,1.5 mg/sqm); Cytarabine
      (from 120 to 150 mg/sqm x4); Ifosfamide (600 mg/sqm/day x5); VP-16 (80 mg/sqm/day x2);
      Dexamethasone (DXM,10 mg/sqm/day for 5 ays); Intrathecal
      Methotrexate-Cytarabine-Methylprednisolone(TIT).

      Block 2:HDMTX (3 gr/sqm); VCR (1.5 mg/sqm); Daunomycin (20 mg/sqm/day x2); Cyclophosphamide
      (160 mg/sqm/day x5); DXM (10 mg/sqm/day x5); TIT

      Block 3:Vindesine (3 mg/sqm); Cytarabine (3000 mg/sqm q 12 hours x4); VP-16 (100 mg/sqm q 12
      hours x4); DXM (20 mg/sqm/day x5);

      Block 4 as Block 1.

      Outcome measures are: achievement of complete remission after induction therapy; incidence of
      infectious episodes; neurological toxicity; incidence of graft rejection; duration of
      complete remission.
    

Intervention name(s): fludarabine, cyclophosphamide, doxorubicin, rituximab
Intervention type(s): Drug
Intervention description(s): Fludarabine i.v.(30 mg/sqm/day,day 1,2,3); Cyclophosphamide i.v.(750 mg/sqm, day 1); Doxorubicin i.v.(30 mg/sqm, day 1); Rituximab i.v. (375 mg/sqm, day 4).
Intervention MeSH terms: Cyclophosphamide; Rituximab; Doxorubicin; Fludarabine
Intervention model: Single Group Assignment
Primary purpose: Treatment
The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk
Condition: Blood Pressure; Platelet Function; Inflammation
MeSH terms: Cardiovascular Diseases; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of berry consumption on indicators of
      cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).
    

Detailed description: 
      The study has a randomized crossover design. It consists of two 8-wk dietary treatments, with
      no washout period between periods. The participants are blinded to treatments. The subjects
      are randomly assigned to either a berry diet or a control diet which they follow for 8 weeks.
      After that they are crossed over to the other diet for another 8 weeks. The main visits to
      the study site are at baseline and after 8 and 16 weeks (for blood pressure measurement/
      cardiovascular measurements and sample collection). The additional visits are at 4 and 12 wk;
      these visits are for compliance checks, meeting the study nurse and receiving the study
      products. The subjects are asked to maintain their normal dietary and lifestyle habits, as
      well as to keep alcohol intake and physical activity constant during the study.
    

Intervention name(s): berry products; control products
Intervention type(s): Other; Other
Intervention description(s): effects of berry consumption on cardiovascular indicators
two portions daily; two portions daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: human; intervention; blood pressure; cardiovascular risk factors; polyphenols; bioavailability
The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine
Condition: Vitamin B1 Deficiency; Thiamine Deficiency
MeSH terms: Thiamine Deficiency; Beriberi
Study type: Interventional
Phase: Phase 4

Summary: 
      In Part 1, subjects will be administered thiamine, thiamine with metformin, and thiamine with
      trimethoprim. Part 2 will expand on Part 1 and subjects will be administered thiamine and
      thiamine with trimethoprim. The goal is to determine whether taking a drug and a vitamin
      together affects the body's ability to absorb, distribute, and eliminate thiamine (Vitamin
      B1).
    

Detailed description: 
      Thiamine is an essential vitamin meaning humans must consume thiamine from their diet in
      order to stay healthy. Low thiamine levels can lead to adverse events. Thiamine is absorbed
      in the intestine by a transporter protein. This is made by the SLC19A3 gene. The SLC19A3 gene
      provides instructions for making the thiamine transporter protein, which moves thiamine into
      cells. Certain drugs, like metformin and trimethoprim, have been shown to interrupt function
      of the SLC19A3 gene.

      Metformin is a first-line therapy for patients with Type 2 diabetes and is associated with
      improvements in diabetic complications. Trimethoprim is an anti-bacterial drug that is often
      prescribed to treat infections such as urinary tract infections. At different phases of this
      study, participants will be administered thiamine, thiamine with metformin, and/or thiamine
      with trimethoprim to determine whether taking a drug and a vitamin together affects the
      body's ability to absorb, distribute, and eliminate thiamine. The levels of thiamine in the
      participants' blood and urine will be measured before and after taking thiamine or thiamine
      in combination with metformin and/or trimethoprim.
    

Intervention name(s): Trimethoprim; Metformin; Vitamin B1
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): 300mg of trimethoprim will be given in combination with 5mg thiamine and compared to 5mg thiamine only for both Parts 1 and 2 of the study.; 1000mg of metformin will be given in combination with 5mg thiamine and compared to 5mg thiamine only in Part 1 of the study.; 5mg of thiamine will be given alone and in combination for both Parts 1 and 2 of the study.
Other intervention name(s): Primsol; Glucophage; Thiamine
Intervention MeSH terms: Thiamine; Metformin; Trimethoprim
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part 1: Three-arm randomized crossover study design Part 2: Two-arm randomized crossover study design
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-induced vitamin deficiency
Prevalence Of Keratoconus Among Patients With Thyroid Gland Dysfunction
Condition: Keratoconus in Thyroid Gland Dysfunction
MeSH terms: Keratoconus; Thyroid Diseases
Study type: Observational

Summary: 
      Hormonal imbalances are likely to affect the corneal metabolism and may be also associated
      with Keratoconus. Among the various endocrinologic dysfunctions assumed so far, thyroid gland
      dysfunction (TGD) (hypo- or hyperthyroidism; comprised as TGD) is frequently associated with
      eye diseases such as Graves disease
    

Detailed description: 
      Aim of the work

      We aim to examine the prevalence of KC among patients already diagnosed by endocrinologist
      with TGD.

      Materials and methods

      Our Screening for KC will include evaluation of the demographic data and complete
      ophthalmological examination of the patients using:

      VA Refraction K reading Slit lamp examination Pentacam Study design Epidemiological study

      Inclusion citeria All patients diagnosed as thyroid gland dysfunction Control group

      Exclusion criteria Uncooperative patients
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        we will enroll all patients who meet the inclusion criteria and signed a written informed
        consent form
      
Biospecimen description: 
      blood sample to measure thyroid profile