bioihbjkbjnl/mcl2 huggingface dataset:
Synergistic Immunomodulatory Effect of Synbiotics Pre and Postoperative Resection of Pancreatic Ductal Adenocarcinoma
Condition: Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this interventional study was to evaluate the synergistic effect of symbiotics (a
      combination of probiotics and prebiotics) compared to probiotics alone in terms of their
      impact on anti-tumor immunomodulation in patients with pancreatic ductal adenocarcinoma
      (PDAC). The study also aimed to assess the effects of these interventions on postoperative
      complications and outcomes. In the study, a probiotic agent (Nowfoods, USA), containing ten
      strains of bacteria with a total dosage of 25 billion colony-forming units (CFU) was
      administered. This probiotic regimen involved taking two capsules once daily, starting two
      weeks before the surgery and continuing for one month after the surgery. For the synbiotic
      group, in addition to the probiotic agent, two capsules per day of inulin supplement
      (HERBAMAMA, USA) were also taken.

      The study included three groups: the synbiotics group, the probiotics group, and the placebo
      group. The researchers compared the pathological status of immune cell infiltration
      (specifically CD8 cells) and interferon-gamma expression, as well as the levels of
      interleukins 10, 6, and 10 in the participants' serum. Four blood samples were collected from
      each participant: one taken 14 days before the surgery, one on the surgery date, one two
      weeks after the surgery, and one 30 days after the surgery.

      The main research question addressed by the study was whether there was a significant
      difference in the immunomodulatory effect and postoperative complications between the
      synbiotics group and the probiotics group. The placebo group likely served as a control to
      compare the effects of the interventions against no intervention.
    


Intervention name(s): probiotic agent 25 Billion CFU (Nowfoods, USA) , ). Inulin capsules 1000mg Herbamama USA
Intervention type(s): Dietary Supplement
Intervention description(s): probiotic agent 25 Billion CFU (Nowfoods, USA), composed of ten strains of bacteria (Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus plantaLactobacillus paracasei, Bifidobacterium breve, Streotococcus thermophiles, Lactobacillus salivarius, and Bifidobacterium longum),
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
An Open-label, Randomized, 2-Period, Crossover, Pharmacokinetics Study
Condition: Pregnancy Prevention
Study type: Interventional
Phase: Phase 2

Summary: 
      An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative
      Pharmacokinetics of LSP-5415 and NuvaRing® in Healthy Adult Females
    

Detailed description: 
      This is an open-label, randomized-sequence, two-period, single-center, crossover,
      pharmacokinetic study in 40 healthy adult female subjects (18- 40 years). All subjects will
      receive LSP-5415 (28 days) and NuvaRing (28 days) under fasted conditions. There will be a
      28-day washout period after ring removal in Treatment Period 1 and ring insertion in
      Treatment Period 2.
    

Intervention name(s): LSP-5415 (etonogestrel/ethinyl estradiol vaginal ring); NuvaRing Vaginal Ring
Intervention type(s): Drug; Drug
Intervention description(s): To prevent pregnancy; To prevent pregnancy
Other intervention name(s): LSP-5415; NuvaRing
Intervention MeSH terms: Ethinyl Estradiol; Etonogestrel; NuvaRing; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All subjects will receive LSP-5415 (28 days) and NuvaRing (28 days) under fasted conditions. There will be a 28-day washout period after ring removal in Treatment Period 1 and ring insertion in Treatment Period 2.
Masking: None (Open Label)
Primary purpose: Prevention
Endurance Training in Young Persons With Cerebral Palsy; Evaluation of Training Method and Effect
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The hypotheses of the study are that children / youth with CP will by possibly use of
      technical aids be able to perform high intensity endurance training by walking / running on a
      treadmill, and that this training will improve their health by increased aerobic capacity and
      quality of life.
    


Intervention name(s): Endurance training intervention
Intervention type(s): Other
Intervention description(s): High intensive interval training of walking / running on treadmill for 1 1/2 - 4 minute,repeated minimum 4 times, at an intensity equalling at least 80% of maximal heart frequency. Performed 2-5 times per week for 4-8 weeks, totally 24 sessions.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eyelash Line Resection for Entropion Associated With Down's Syndrome
Condition: Down's Syndrome
MeSH terms: Down Syndrome; Entropion; Syndrome
Study type: Interventional

Summary: 
      Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of
      superficial punctate keratopathy and score of wearing glasses to correct refractive errors
      were measured.
    


Intervention name(s): Eyelash line resection
Intervention type(s): Procedure
Intervention description(s): Eyelash resection surgery was performed for entropion with Down's syndrome
Other intervention name(s): Lid plastic surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Down's syndrome; entropion; lid plasty
Efficacy and Safety of Everolimus and (STZ-5FU) Given One Upfront the Other Upon Progression in Advanced Pancreatic Neuroendocrine Tumor (pNET)
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare STZ vs everolimus as first line treatment for
      advanced pNET and to elucidate which sequence of streptozotocin (STZ) based chemotherapy and
      the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms
      of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic
      NETs.
    

Detailed description: 
      STZ based chemotherapy, STZ-5FU, is the actual standard of care for advanced pancreatic
      Neuroendocrine tumours (pNETS) in the European Union. Everolimus has been recently approved
      for its use in advanced pNETs by the Food and Drug Administration (FDA) and in Europe by the
      European Medical Agency (EMA).

      A randomized study is needed to have a clear knowledge about the best sequence for its
      administration; this is, before or after palliative chemotherapy.

      There may or may not be any benefits from giving first each other treatment of the study. The
      information obtained from this study will help the physician improve the treatment and
      management of patients with advanced pNET.

      This study was planned to compare STZ-5FU chemotherapy followed by everolimus upon
      progression versus the reverse sequence. However sequential studies with pNETs are hard to be
      managed in terms of time and costs. Therefore the protocol was amended to have PFS1
      (progression free survival after course 1) as primary endpoint and PFS2 (i.e. progression
      free survival after both STZ based chemotherapy and Everolimus or the reverse order) as
      secondary endpoint. This information will be extremely valuable for the day to day clinical
      practice of NET oncologists
    

Intervention name(s): Drug: Everolimus; STZ-5FU
Intervention type(s): Drug; Drug
Intervention description(s): 10mg/daily, oral. Number of Cycles: until progression or unacceptable toxicity develops.; 0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-5 every 6 weeks (Moertel) or 0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-3, and then 1 day with 1g/m2 and 1 day 400mg/m2 5-FU every 3 weeks (Uppsala).
Number of Cycles: until progression or unacceptable toxicity develops.
Other intervention name(s): Afinitor; STZ based Chemotherapy
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced pNET; everolimus; STZ-5FU; treatment sequence
Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
Condition: X-linked Hypophosphatemia
MeSH terms: Familial Hypophosphatemic Rickets; Osteomalacia; Hypophosphatemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to establish the effect of KRN23 treatment on
      improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid
      volume/bone volume, OV/BV).
    


Intervention name(s): burosumab
Intervention type(s): Biological
Intervention description(s): solution for subcutaneous injection
Other intervention name(s): KRN23; UX023; Crysvita
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: KRN23; Fibroblast growth factor 23 (FGF23); XLH; X-linked Hypophosphatemia
Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection
Condition: Malnutrition; Malaria; Lower Respiratory Tract Infection; Diarrhoea
MeSH terms: Infections; Communicable Diseases; Malaria; Respiratory Tract Infections; Malnutrition; Child Nutrition Disorders; Diarrhea
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether 14 days nutritional supplementation with
      Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection
      will prevent malnutrition and reduce the frequency of morbidity.
    

Detailed description: 
      Anorexia due to infection might lead to weight loss. In many settings total recovery is
      problematic what might result in a permanent lower weight. A short period high quality food
      supplementation could improve weight gain after an infection.

      A complete high quality food will be tested, but also micronutrients alone as there is no
      information on what children with an infection exactly need as a supplement.

      Children aged 6-59 months presenting with diarrhoea, malaria or lower respiratory tract
      infection (LRTI) are provided for 2 weeks with

        -  RUTF supplement (Plumpynut®) of 500 kcal/day

        -  Multi-micronutrient powder (MNP)

        -  Placebo to MNP

      The followup period is 6 months. Anthropometric indicators and morbidity are assessed
      monthly. Participants are invited to attend the study clinic if any signs of disease are
      noticed.
    

Intervention name(s): Ready to Use Therapeutic Food (RUTF); Micronutrient Powder (MNP)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia); 2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)
Other intervention name(s): RUTF: Nutriset; MNP: DSM
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Supplementation; RUTF; Micronutrients; Plumpynut; Mixme; sprinkles; convalescence; weight; morbidity
A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary study objective is to demonstrate the superiority of APF530 500 mg given
      subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a
      maximum of 16 mg) in the delayed-phase (> 24-120 hours) complete response (CR) rate (defined
      as no emesis and no use of rescue medications) in subjects receiving highly emetogenic
      chemotherapy (HEC) as defined by the 2011 ASCO CINV guidelines
    


Intervention name(s): APF530; Ondansetron; Ondansetron placebo; APF530 placebo; Fosaprepitant; Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Dexamethasone; Ondansetron; Fosaprepitant; Aprepitant; Granisetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Highly emetogenic chemotherapy (HEC); Chemotherapy-Induced Nausea and Vomiting (CINV)
Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
Condition: End Stage Renal Disease; Chronic Kidney Disease Stage 5; ESRD
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the study drug is safe, tolerable and active in
      reducing fluid overload/weight gain between dialysis sessions for patients with End Stage
      Renal Disease on Hemodialysis.
    

Detailed description: 
      This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to
      evaluate the safety, tolerability, and pharmacodynamics of the study drug in male and female
      patients with end-stage renal disease on hemodialysis. The study consists of a 2 week
      treatment-free run-in period where entry criteria are verified, a 4-week treatment period, of
      which the first week of treatment will be performed as an in-patient study in a clinical
      pharmacology unit (CPU) and the remaining three weeks of treatment will performed as an
      out-patient study, and a 2-week treatment-free follow-up period.

      Safety assessments will be performed at regular intervals and will include clinical and vital
      signs, clinical laboratory evaluations, ECGs, and AE monitoring. Pharmacodynamic assessments
      will include, but are not limited to, interdialytic weight gain (IDWG), blood pressure, and
      stool sodium excretion. Pharmacokinetic assessments will include blood sampling for
      measurement of study drug plasma concentrations.
    

Intervention name(s): AZD1722 (in-patient); Placebo (in-patient); AZD1722 (out-patient); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting; Placebo, size and color matched to experimental drug administered in a CPU; doses between 5 and 45 mg BID; Placebo, size and color matched to experimental drug
Other intervention name(s): RDX5791; Tenapanor; Tenapanor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemodialysis
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      In real life, the investigators will be using different strategies including SMART therapy or
      other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.
    

Detailed description: 
      1. All not-well controlled asthma patients would include the study.

        2. We will compare three ways of asthma control including SMART, fixed doses with regular
           doses and fixed doses with higher doses

        3. We will evaluate the efficacy/safety for these not-well controlled patients.
    

Intervention name(s): Seretide
Intervention type(s): Drug
Intervention description(s): Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety
Other intervention name(s): Symbicort compared with Seretide
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; SMART; fixed dose
Safety, Tolerability and Pharmacokinetics of Estetrol (E4) After Single and Multiple Oral Doses in Healthy Female Volunteers
Condition: Contraception; Menopause
Study type: Interventional
Phase: Phase 1

Summary: 
      Estetrol (E4) is being developed in two indications supporting women health care: first E4 is
      combined with a progestin, [drospirenone (DRSP)] and is used as a new combined oral
      contraceptive (COC) for the prevention of pregnancy and secondly, E4 is used alone as new
      hormone replacement therapy (HRT) for the treatment of menopause related symptoms.

      The current clinical trial is designed to collect more detailed information about the PK
      profile, safety and tolerability of different dosages of E4, given orally as a solid tablet.
    

Detailed description: 
      This is an open-label, single-center, randomized, two-period, single and multiple oral dose
      study in 27 healthy female volunteers.

      After a screening period, eligible subjects (n=27) will receive a single oral dose of 5, 15,
      or 45 mg E4 (Period 1). After at least 14-day washout, 18 subjects will continue the study
      (Period 2). They will receive 15 mg E4 once daily for 14 consecutive days.
    

Intervention name(s): 5 mg E4 single-dose; 15 mg E4 single-dose; 45 mg E4 single-dose; 15 mg E4 multiple-dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single oral dose of 5 mg E4 will be administered during Period 1 of the study.; A single oral dose of 15 mg E4 will be administered during Period 1 of the study.; A single oral dose of 45 mg E4 will be administered once orally during Period 1 of the study; 15 mg E4 will be administered once daily orally for 14 consecutive days during Period 2 of the study
Other intervention name(s): 5 mg estetrol; 15 mg estetrol; 45 mg estetrol; 15 mg estetrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to find out if weekly Avonex works as well as three times a week
      Rebif in subjects with relapsing multiple sclerosis.
    

Detailed description: 
      This is a Phase 4, multicenter, prospective and retrospective, long-term observational study
      of Avonex® and Rebif® to determine the efficacy, tolerability, and safety in subjects with
      relapsing MS.
    

Intervention name(s): Interferon beta-1a; Interferon beta-1a
Intervention type(s): Drug; Drug
Intervention description(s): injection once a week; injection three times a week
Other intervention name(s): Avonex; Rebif
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Observational model: Case-Only
Sampling method: Probability Sample
Study population: 
        subjects with relapsing remitting Multiple Sclerosis taking AVONEX® or Rebif®.
      
Keywords: Multiple Sclerosis; Interferon beta 1a; Avonex
Blood Pressure Monitor Clinical Test (Cuff Range: 13.5 Cm-22cm)
Condition: Blood Pressure
Study type: Observational

Summary: 
      The purpose of this study is to monitor the blood pressure level of the patient using a
      preformed cuff ranged 13.5 cm-22 cm.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        resident of a community
      
Keywords: BP
Effect of Dolutegravir on Metformin Pharmacokinetics in Healthy Adult Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a phase 1, open label, parallel group, three period crossover study to
      evaluate the effect of dolutegravir (DTG) on the steady state pharmacokinetics of metformin
      and on the safety and tolerability of dolutegravir and metformin. Subjects will have a
      screening visit within 30 days prior to the first dose of study drug, three treatment
      periods, and a follow up visit 7-14 days after the last dose of study drug. Eligible subjects
      will be assigned to one of the two treatment cohorts. Subjects will receive metformin 500
      milligram (mg) after every 12 hours (q12h) for 5 days in Period 1; metformin 500 mg q12h plus
      dolutegravir 50 mg after every 24 hours (q24h) (Cohort 1) or 50 mg q12h (Cohort 2) for 7 days
      in Period 2; and metformin 500 mg q12h for 10 days in Period 3. There will be no washout
      periods between treatments. All doses of study drug will be taken following a meal. Safety
      evaluations will be collected during each period. Serial pharmacokinetic (PK) samples will be
      collected for metformin on the last day of each period and for dolutegravir on the last day
      of Period 2.
    


Intervention name(s): Metformin 500 mg q12h; Dolutegravir 50 mg q24h; Dolutegravir 50 mg q12h
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Metformin will be supplied as 500 mg tablet to be administered orally.; Dolutegravir will be supplied as 50 mg tablet to be administered orally. To be taken once a day in the morning in Period 2 (Total daily dose 50 mg per day for Cohort 1 only); Dolutegravir will be supplied as 50 mg tablet to be administered orally. To be taken 50 mg tablets every 12 hours in Period 2 (Total daily dose 100 mg per day for Cohort 2 only).
Intervention MeSH terms: Metformin; Dolutegravir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dolutegravir; drug interaction; metformin; pharmacokinetics; healthy volunteers
Use of Oxygen Nebulizer for Preventing Post-operative Sore Throat
Condition: Pain, Postoperative
MeSH terms: Pharyngitis; Pain, Postoperative
Study type: Interventional

Summary: 
      Rationale: Delivery dry gas during anesthesia is associated with post-operative sore throat
      (POST). Oxygen nebulizer therapy increases humidity to the airway, especially
      post-extubation.

      Objective: To investigate the effect and complications of oxygen nebulizer therapy on POST.
    


Intervention name(s): Oxygen
Intervention type(s): Other
Intervention description(s): Oxygen mask 40% 8 LPM for 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: nebulizer; oxygen; post-operative sore throat