bioihbjkbjnl/mcl2 huggingface dataset:
Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy
Condition: Acute Leukemia
MeSH terms: Nausea; Vomiting
Study type: Observational

Summary: 
      Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy.
      Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during
      treatment reported by paediatric cancer survivors. Complete prevention of both nausea and
      vomiting is the goal of anti-vomiting and nausea medications. It is important to understand
      whether or not certain chemotherapeutic treatments are more or less likely to cause these
      symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal
      methotrexate is an important part of chemotherapy for the prevention and treatment of central
      nervous system leukemia over the 2.5 to 3.5 years of the treatment program for leukemia. The
      likelihood that intrathecal methotrexate administered as monotherapy will cause nausea and
      vomiting has not yet been described in children. Knowledge of the likelihood that intrathecal
      methotrexate will cause nausea and vomiting will therefore be important to optimize treatment
      for these side-effects of chemotherapy. The primary aim of this prospective study is to
      evaluate the potential of intrathecal methotrexate to cause nausea and vomiting in paediatric
      cancer patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Receiving intrathecal methotrexate in the context of maintenance therapy for acute
        lymphoblastic leukemia and as dosed by age per protocol. Patients will also receive their
        protocol driven maintenance chemotherapy which includes oral 6 mercaptopurine and may
        include IV vincristine and an oral steroid pulse (prednisone or dexamethasone). Oral
        methotrexate is typically held the weeks that patients receive intrathecal methotrexate
        during maintenance therapy.
      
Keywords: Acute Leukemia; Pediatrics; Intrathecal methotrexate; Chemotherapy; Nausea; Vomiting
Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      To compare between local anesthesia combined with intravenous Dexmedetomidine and epidural
      analgesia as regard the effectiveness and patient satisfaction during percutaneous
      transforaminal endoscopic discectomy.
    

Detailed description: 
      Percutaneous transforaminal endoscopic discectomy. under LA is recommended in consideration
      of safety. Under LA, patients keep conscious during the process of PTED, and the surgeon can
      obtain feedback directly from the patients if the nerve is interfered. Dexmedetomidine, a
      highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing
      sedation and analgesia. Due to its central sympatholytic action, Dexmedetomidine produces
      dose-dependent sedation, antinociception and anxiolysis. Epidural anesthesia is another major
      method which can keep patients awake during surgery and the surgeons can check the function
      of the nerve from the maintained motor function of patients' lower limbs
    

Intervention name(s): Dexmedetomidine Hydrochloride 'Precedex' combined with; Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'; General anesthesia; Local infiltration with Lidocaine HCL 1%'Debocaine'
Intervention type(s): Drug; Procedure; Procedure; Drug
Intervention description(s): Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist; The epidural insertion point will be 2 segments upper than the surgical procedure level, 10 ml of Bupivacaine 0.25% will be injected in the epidural space to adjust the sensory level; Propofol 2-3 mg/kg'Diprivan 1%', Fentanyl 'Fentanyl' 2 μg/kg, and Cisatracurium 'Cisatracure' 0.2 mg/kg will be administered to facilitate endotracheal intubation, and ventilation will be controlled to maintain the end-tidal carbon dioxide (CO2) between 32-38 mmHg, to maintain anesthesia, 2-3% Sevoflurane 'Sevoflurane', and 0.05 mg/kg of the muscle relaxant Cisatracurium will be added at 40-minute intervals according to the conditions of the operation. No other medication will be administered; Lidocaine 1% which is a local analgesic as local infiltration
Intervention MeSH terms: Lidocaine; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of a Proteomic Signature and Assessment of Viremia in Children With Fever Without Source
Condition: Infectious Disease; Fever; Viremia
MeSH terms: Communicable Diseases; Infections; Viremia; Fever
Study type: Observational

Summary: 
      The study is an observational blinded Validation study in pediatric patients below 3 years
      old with a diagnosis of Fever Without Source (FWS). In this study the investigators aim to
      validate the performance of a proteomic signature aiding the physicians to discriminate
      between viral and bacterial infections in febrile children. The study will also assess the
      prevalence of Human Enteroviruses (HEV), Human Parechoviruses (HPeV), Adenovirus (AdV) and
      Human Herpesvirus type 6 (HHV-6) viremia, as well as Kingella Kingae bacteremia in the study
      cohort.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients below three years old which were presented with a diagnosis of fever
        without source to the emergency room in the Children's Hospital, Geneva University
        Hospitals
      
Biospecimen description: 
      Serum, Plasma, whole blood
Faecal Microbiota Transplantation in Ulcerative Colitis
Condition: Ulcerative Colitis; Inflammatory Bowel Disease
MeSH terms: Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is
      safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting
      a randomised controlled trial
    

Detailed description: 
      This study involves the assessment of the safety and efficacy of FMT in the treatment and
      induction of remission for patients with mild to moderate ulcerative colitis. It is a double
      blind study with patients randomised in a 1:1 manner to either active or placebo therapy
    

Intervention name(s): FMT infusions; Placebo infusion
Intervention type(s): Biological; Other
Intervention description(s): Active FMT derived from healthy anonymous pre-screened donors; Placebo infusion not containing any donor microbial material
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; Inflammatory Bowel Disease; Fecal Transplantation; Fecal Microbiota Transplantation
The Role of SNP rs2910164 in Patients Treated With Immune Checkpoint Inhibitors
Condition: Cancer
Study type: Observational

Summary: 
      The objective of this study is to investigate whether the SNP rs2910164 in the pre-miR-146a
      gene is associated with outcome and toxicity of immune checkpoint inhibitor therapy.
    

Detailed description: 
      The single nucleotide polymorphism (SNP) rs2910164 within the gene for microRNA-146a
      (miR-146a) reduces miR-146a expression. Previous studies of the investigators demonstrated
      that this SNP was associated with increased acute GvHD severity in patients undergoing
      allogeneic hematopoietic stem cell transplantation. In this prospective, observational study
      the investigators aim to analyze, whether SNP rs2910164 is associated with severity of
      immune-related adverse events of immune checkpoint inhibitor therapy. Moreover, association
      of rs2910164 with outcome parameters will be studied.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients with cancer undergoing immune checkpoint inhibitor therapy
      
Biospecimen description: 
      The rs2910164 genotype will be assessed using DNA isolated from peripheral blood samples and
      Taqman realtime PCR assays.
    
Keywords: immune checkpoint inhibitor; single nucleotide polymorphism; microRNA
An Open-Label Evaluation of the Dose Proportionality of OROS� Hydromorphone HCL Tablets 8mg, 16mg, 32mg, 64mg
Condition: Analgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to examine the OROSÂ® Hydromorphone HCL
      pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile
      for dose proportionality after administration of 8mg, 16mg, 32mg and 64 mg tablets.
    

Detailed description: 
      This was a randomized (patients are assigned different treatments based on chance),
      open-label, four-way crossover study performed in normal, healthy adult patients. Each
      patient received the following orally administered treatments of OROS® Hydromorphone HCL (a
      different treatment during each dosing phase): Treatment A: 8mg; Treatment B: 16mg; Treatment
      C: 32mg; Treatment D: 64mg; A naltrexone 50mg dose was administered 12 hours prior to, at the
      time of, and 12 after study drug administration; Patients received a fourth dose of
      naltrexone 50mg 24 hours after the 64mg study drug administration. There was a 7-day washout
      period between study drug dosing phases.Venous blood sampling times were 0 (prior to dosing),
      2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, and 48 hours after each study drug
      administration. Three additional blood samples (at 56, 64, and 72 hours after dosing of study
      drug) were drawn from those patients receiving the 64 mg tablets; LC/MS/MS (Liquid
      Chromatography/Mass Spectroscopy/Mass Spectroscopy) techniques were employed for the analysis
      of plasma hydromorphone concentrations.The primary endpoints of interest were: Area under the
      concentration-time curve from zero to infinity; Area under the concentration-time curve from
      zero to time t; Peak plasma concentration; the secondary endpoint parameters were: Time to
      peak plasma concentration; Terminal half-life. OROS hydromorphone HCL tablets of 8mg, 16mg,
      32mg, and 64mg were given orally, a different dosing treatment during each dosing phase. One
      naltrexone HCL 50mg tablet was given orally 12 hours prior to, at the time of, and 12 hours
      after hydromorphone administration during each dosing phase. Patient received a fourth dose
      of naltrexone 50mg 24 hours following the 64mg study drug administration; It was a four week
      treatment and there was a seven-day washout period between dosing phases.
    

Intervention name(s): OROS® Hydromorphone HCL; OROS® Dilaudid; Dilaudid SR (slow release); Naltrexone (an opioid antagonist).
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone; Hydromorphone; Narcotic Antagonists
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Analgesia
A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Condition: Moderate Hepatic Impairment; Normal Hepatic Function
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK
      and safety.
    


Intervention name(s): Rivipansel
Intervention type(s): Drug
Intervention description(s): A single dose of IV Rivipansel over 20 minutes
Other intervention name(s): GMI-1070
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hepatic Impairment; Rivipansel
Auranofin PK Following Oral Dose Administration
Condition: Amoebiasis
MeSH terms: Amebiasis; Dysentery, Amebic
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, open-label study in 15 healthy adult subjects receive 6 mg of auranofin orally once
      every 24 hours for 7days. Blood samples will be taken for 17 weeks following the last dose of
      auranofin for determination of terminal phase pharmacokinetic parameters. Stool samples will
      also be obtained for the measurement of gold.
    

Detailed description: 
      Auranofin is a gold-containing chemical salt, granted as an orphan drug status for use in the
      treatment of amebiasis. Amebiasis is a parasitic infection caused by the protozoon Entamoeba
      histolytica. It affects about ten percent of the world's population, being especially common
      in areas with poor health infrastructure. This is a Phase I open label, multiple dose study
      to evaluate the pharmacokinetics of Auranofin following oral dose administration for 7 days
      to healthy subjects. 15 healthy male and female volunteers age 18-45 years, inclusive
      enrolled in one site. The study duration is 48 weeks and up to 23 weeks of subject
      participation. The primary objective characterizes the pharmacokinetics of gold, given as
      auranofin, during and after 7 days of once daily oral dose administration. The secondary
      objective monitor the safety of Auranofin during and after 7 days of oral administration.
    

Intervention name(s): Auranofin
Intervention type(s): Drug
Intervention description(s): Auranofin is a gold-containing chemical salt available as 3mg capsules. Cohort 1 receives 6mg oral dose of auranofin once every 24 hours for 7 days
Intervention MeSH terms: Auranofin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amebiasis; auranofin; pharmacodynamics; pharmokinetics
Effect of Hip Abductors Versus Knee Extensor Strengthening in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study will try to answer the following question:

      Would strengthening of hip abductors be equal to, or more effective than, knee extensors
      strengthening in improving pain, function and knee extensors isometric strength in patients
      with knee Osteoarthritis
    

Detailed description: 
      A total of 70 patients with knee Osteoarthritis will be recruited All patients who will
      participate in the study will be referred by orthopedists. Patients with knee osteoarthritis
      will be included with age ranges from 50-70. They will be randomized into 2 groups; hip
      abductors strengthening (HAS) group a will receive hip abductors strengthening exercises, and
      knee extensors strengthening (KES) group will receive quadriceps strengthening exercise.

      All patients who will meet the study criteria will get a complete knowledge of the objectives
      and procedures of the study.

      Inclusion criteria:

        1. Patients with knee Osteoarthritis grade II- III Kellgren- Lawrence scores

        2. Their age is 50-70[Wang et al.,2019].

        3. Body mass index (BMI) 25-30.

      Exclusion criteria:

        1. Patients who had surgical intervention in the knee and/or hip.

        2. Fracture in the lower limbs.

        3. Malignancy

        4. Any associated ligamentous injuries in knee or ankle.

        5. Spinal Cord Injury.

        6. Hormonal imbalance or on hormonal therapy

        7. Knee injection within the last 6 months prior to the study. Outcome parameters including
           Quadriceps Muscle Strength, the arabic version of Western Ontario and McMaster
           Universities Arthritis Index questionnaire total score and 3 subscales and Timed Up and
           Go test score
    

Intervention name(s): Exercises
Intervention type(s): Other
Intervention description(s): already included in arm/group descriptions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups; hip abductors strengthening (HAS) group a will receive hip abductors strengthening exercises, and knee extensors strengthening (KES) group will receive quadriceps strengthening exercise.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis AND Hip Abductors AND Quadriceps
Efficacy Study of Betahistine on Body Weight in Obese Female Subjects
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effect of betahistine on body weight in obese
      female subjects
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dose finding, multicenter study. The
      study will consist of 3 treatment groups (48 mg/day, 96 mg/day, and matching placebo).
      Approximately 180 subjects (60 per treatment group) will be randomized into this 12-week
      study.

      A screening visit will be used to determine subject suitability for inclusion in the trial.

      One week after the screening visit subjects who meet all inclusion criteria and none of the
      exclusion criteria will be randomly assigned to 1 of the following treatment groups:

        -  Betahistine 24 mg twice a day (BID) (48 mg/day total),

        -  Betahistine 48 mg BID (96 mg/day total),

        -  Matching placebo.

      All subjects will be prescribed a nutritionally balanced mildly hypocaloric diet. The
      prescribed diet will contain approximately 30% of calories from fat, 50% of calories from
      carbohydrates, and 20% of calories from protein. The individual subject's estimated total
      daily energy expenditure minus 600 kcal will be used to determine each subject's daily
      caloric intake value during the study. The total daily energy expenditure will be estimated
      for each subject from the basal energy expenditure multiplied by a correction factor of 1.3
      to account for the amount of energy needed in mild to moderate daily activity for obese
      subjects.

      Double-blind treatment will continue for 12 weeks. Study medication (betahistine and/or
      matching placebo) will be orally administered BID about 1-2 hrs prior to meals (at 10:00 and
      at 17:00). During this period, 4 additional study visits (at 2, 4, 8, and 12 weeks) will take
      place.
    

Intervention name(s): betahistine dihydrochloride; betahistine dihydrochloride; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): (24mg tablet Betahistine + placebo tablet) BID per os 12 weeks; (24mg tablet Betahistine + 24mg tablet Betahistine) BID per os 12 weeks; (placebo tablet + placebo tablet) BID per os 12 weeks
Other intervention name(s): Betahistine; Betahistine
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obese females; Weight loss; Betahistine
Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this phase 1b study is to evaluate the safety and tolerability of
      blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum
      tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with
      continuous intravenous infusion (cIV) blinatumomab.
    


Intervention name(s): Blinatumomab; AMG 404; Dexamethasone Premedication
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Blinatumomab will be administered as a continuous intravenous infusion (cIV).; AMG 404 will be administered as an intravenous infusion (IV).; Dexamethasone will be administered orally or intravenously prior to blinatumomab treatment, as needed.
Other intervention name(s): Blincyto
Intervention MeSH terms: Dexamethasone; Blinatumomab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blinatumomab; AMG 404; Leukemia
Cardiovascular Risk Evaluation in Psoriasis Treated With Photochemotherapy
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      Ultraviolet (UV) phototherapy is a standard treatment for many inflammatory dermatological
      diseases, including psoriasis. The systemic effects of UV phototherapy are still not well
      studied. There are several factors that may affect patient's cardiovascular (CV) risk during
      UV phototherapy. Atherosclerosis is now known to have an inflammatory origin and to be
      frequently associated with psoriasis. In this study the investigators aim at studying the
      effect of psoralen-UVA phototherapy on several biomarkers of CV risk in patients with
      psoriasis with or without atherosclerosis.
    


Intervention name(s): PUVA
Intervention type(s): Radiation
Intervention description(s): 36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psoriasis; photochemotherapy; atherosclerosis; metabolic syndrome; cardiovascular risk
Safety and Effectiveness of the CLEAR + BRILLIANT TOUCH(R) Diode Laser 1440-nm and 1927-nm Combination Wavelength Treatment
Condition: Photoaging
Study type: Interventional

Summary: 
      This is a prospective study of up to 30 subjects designed to assess the safety and
      effectiveness of a non-ablative fractional laser combination wavelength treatment for general
      resurfacing of photoaged skin. All study subjects will be treated on the whole face with the
      CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces. Subjects will be treated with a
      consecutive series of four (4) treatments spaced 1 month apart, along with follow-up study
      visits at one (1) and three (3) months after final treatment.
    


Intervention name(s): CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.
Intervention type(s): Device
Intervention description(s): CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment