bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity nOPV2 With and Without bOPV
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label randomized clinical trial that will compare immune responses among
      infants who receive either novel monovalent oral poliovirus vaccine type 2 (nOPV2) alone,
      bivalent oral poliovirus vaccine (bOPV) alone, or co-administered nOPV2 and bOPV.
    

Detailed description: 
      It is expected that nOPV2 would replace mOPV2 for responding to type 2 outbreaks. Outbreak
      response for cVDPV2 also offers the opportunity to close immunity gaps to polioviruses types
      1 and 3. Furthermore, GPEI might have to respond to two poliovirus outbreaks in the same
      geography. For either scenario, it would be important to get data on the immunogenicity of
      co-administered nOPV2 and bOPV, compared to either vaccine given alone.

      This clinical trial assesses and compares the immunogenicity of nOPV2 given with or without
      bOPV. Healthy infants 6 weeks of age will be enrolled in Dhaka, Bangladesh, and randomized to
      one of three study arms â " Arm A: nOPV2 only, Arm B: nOPV2 and bOPV, or Arm C: bOPV only.
      Infants will be followed-up until 18 weeks of age through clinic and household visits. Blood
      specimens will be collected to test for immunological response. Stool specimens will be
      collected from infant vaccine recipients and one sibling household contact each to assess
      viral recombinants and nOPV2 household transmission.
    

Intervention name(s): Novel monovalent oral poliovirus vaccine type 2 (nOPV2); Bivalent oral poliovirus vaccine (bOPV)
Intervention type(s): Biological; Biological
Intervention description(s): nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3) is a live-attenuated serotype-2 poliovirus that was derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells. To improve genetic stability, nucleotide sequence modifications were made in the major determinant for attenuation in the Sabin 5'-untranslated region. Additionally, two modifications in the polymerase 3D were made to further improve stability of the attenuation, and a key replication element from the 2C coding region was relocated to the 5'-untranslated region to inhibit recombination.; The live types 1 & 3 oral polio vaccine (bOPV) is a bivalent vaccine containing suspension of types 1 & 3 attenuated Polio viruses (Sabin strains).
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: oral poliovirus vaccine; immunization; antibodies; poliovirus vaccines
Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary
      for their growth. Giving bortezomib as maintenance therapy after autologous stem cell
      transplantation may kill more cancer cells and prolong remission.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of adjuvant
      bortezomib as maintenance therapy and to see how well it works in treating patients who have
      undergone stem cell transplantation for intermediate or advanced multiple myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine response rate, as defined by resolution of bone marrow plasmacytosis and
           monoclonal paraproteinemia, in the first year after autologous peripheral blood stem
           cell transplantation in patients with intermediate or advanced multiple myeloma treated
           with adjuvant bortezomib.

        -  Compare progression-free survival of patients treated with adjuvant bortezomib with
           historical controls treated with autologous transplantation alone.

        -  Determine the toxicity of this drug in these patients (phase I).

      OUTLINE: This is a multicenter, dose-escalation study.

      Patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 8
      courses in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2 years.
    

Intervention name(s): bortezomib
Intervention type(s): Drug
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II multiple myeloma; stage III multiple myeloma
Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)
Condition: Benign Prostatic Hyperplasia (BPH); Enlarged Prostate
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the
      treatment of BPH (benign prostatic hyperplasia) versus finasteride.
    

Detailed description: 
      Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.
    

Intervention name(s): 2.5 mg NX-1207; 0.125 mg NX-1207; finasteride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207; Low dose; single intraprostatic injection of 0.125 mg NX-1207; Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Benign Prostatic Hyperplasia; BPH; Enlarged Prostate
Comparison of Outcomes After Laparoscopic Versus Open Appendectomy in Acute Appendicitis
Condition: Appendectomy; Pain, Postoperative; Length of Stay
MeSH terms: Appendicitis; Pain, Postoperative
Study type: Interventional

Summary: 
      A comparison study was performed between laparoscopic appendectomy and open appendectomy in
      acute setting in tertiary hospital to access the outcome of postoperative pain and hospital
      stay. As the popularity of laparoscopic appendectomy has failed in major tertiary hospital
      due to huge amount of patient load in which open appendectomy was performed.This study was
      performed to prove that outcome of laparoscopic appendectomy are far better than open
      appendectomy and to increase the use of laparoscopic surgery in acute settings
    

Detailed description: 
      Introduction:

      Open appendicectomy has been a safe and usually opted mode of operation for acute
      appendicitis for more than a century, but since last 10 years laparoscopic appendicectomy is
      gaining popularity, although still not as popular as laparoscopic cholecystectomy. Comparison
      of these two is studied in terms of pain outcome as patient perceives and length of hospital
      stay.

      OBJECTIVES:

      The objective of this study was to compare the outcome of open appendectomy and laparoscopic
      appendectomy in patients with acute appendicitis.

      STUDY DESIGN: Randomized control trial

      SETTING:

      Surgical Unit I, Services Hospital, Lahore

      DURATION OF STUDY:

      Duration of my study was six months after the approval of synopsis i.e 21-02-2015 to
      20-08-2015.

      SAMPLE SIZE:

      Was calculated using WHO method of calculating sample size.

      SAMPLING TECHNIQUE:

      Non probability consecutive sampling.

      DATA COLLECTION PROCEDURE:

      All patients fulfilled the inclusion criteria was admitted through the emergency after taking
      approval from hospital Ethical committee. A detailed history had been taken including
      demographic data (age, address). Patients was requested to sign an informed consent. They had
      been assured regarding confidentiality and expertise used for the procedure. All procedures
      was done by a single operating surgical team to control bias. All the data/variables was
      recorded on a specially designed Performa attached which are post-op pain at 12hrs and 24
      hrs, post-Op stay and patient satisfaction score.
    

Intervention name(s): Appendectomy
Intervention type(s): Procedure
Intervention description(s): removal of acutely inflamed appendix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open Appendectomy; Laparoscopic Appendectomy; post-operative pain; Hospital stay
Does Caffeine Reduce Dipyridamole-Induced Protection Against Ischemia-Reperfusion Injury?
Condition: Cardiovascular Disease; Ischemia-Reperfusion Injury
MeSH terms: Cardiovascular Diseases; Reperfusion Injury; Ischemia; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this project is to explore the interaction between caffeine and dipyridamole
      on ischemia-reperfusion injury in the forearm.
    

Detailed description: 
      Dipyridamole has been proven to reduce targeting of Annexin A5 in responses to ischemic
      exercise, indicating protection against ischemia-reperfusion injury in humans
      (pharmacological preconditioning). Dipyridamole increases the endogenous adenosine level by
      inhibition of the nucleoside transporter (ENT-1). Activation of the adenosine receptor
      protects against ischemia-reperfusion injury. We hypothesize that endogenous adenosine
      mediates the protective effect of dipyridamole against ischemia-reperfusion injury. Therefore
      the adenosine receptor antagonist caffeine will reduce the benefit of dipyridamole on forearm
      ischemia-reperfusion injury.
    

Intervention name(s): Dipyridamole; caffeine
Intervention type(s): Drug; Drug
Intervention description(s): Dipyridamole 2x200mg 7day per os; caffeine 4mg/kg iv
Other intervention name(s): persatin
Intervention MeSH terms: Dipyridamole; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ischemia-reperfusion injury; adenosine; dipyridamole; caffeine
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
Condition: CKD Anemia in Dialysis Participants
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD)
      participants to evaluate the efficacy and relative safety of different dosing regimens of
      roxadustat over a 36-week treatment period.

      There are 3 study periods:

        -  Screening Period (up to 4 weeks)

        -  Treatment Period (36 weeks)

      Part 1: Correction/Conversion Period (Weeks 1-20)

      Part 2: Hemoglobin (Hb) Maintenance Period (Weeks 21-36)

        -  Follow-up Period (4 weeks)
    

Detailed description: 
      Approximately 102 erythropoiesis stimulating agents (ESA)-naïve participants and 204
      ESA-treated participants will be enrolled and randomized respectively in a 1:1 ratio to
      receive roxadustat at one of 2 starting doses as below:

        -  Low weight-based dosing: 70 milligrams (mg) 3 times a week (TIW) for body weight <60
           kilograms (kg) or 100 mg TIW for body weight ≥60 kg

        -  Standard weight-based dosing: 100 mg TIW for body weight <60 kg or 120 mg TIW for body
           weight ≥60 kg

      After 20 weeks of treatment, all eligible participants whose last 2 Hb levels ≥105 grams
      (g)/liter (L) and change in Hb over the most recent 4 weeks is > - 10 g/L will switch to
      receive roxadustat for another 16 weeks to evaluate the efficacy and safety of new dosing
      regimens.

      At the end of Week 36, all participants will discontinue roxadustat and enter a 4-week
      Follow-up Period.
    

Intervention name(s): Roxadustat
Intervention type(s): Drug
Intervention description(s): Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Other intervention name(s): FG-4592
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anemia; Chronic Kidney Disease Dialysis; hemoglobin; End stage renal disease
Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in
      HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy.
      Subjects will be randomly assigned to receive a single intravenous (IV) infusion of one of
      four dose levels of CCR5mAb004 or matching placebo. A minimum of 10 subjects will be
      randomized to each cohort at a ratio of 4:1 (active:placebo). A minimum of 40 and maximum of
      60 subjects will be enrolled. This study will be conducted at up to 10 sites in the United
      States.

      Subjects in each cohort will be followed for 56 days after study agent administration. The
      safety, tolerability, and immunogenicity of CCR5mAb004 will be evaluated based on physical
      examination, adverse event (AE) reporting, and clinical laboratory tests. Blood will be
      collected at specified times for the determination of CCR5mAb004 serum concentrations, HIV-1
      RNA levels, and CD4+ and CD8+ cell counts. If CD4+ cell counts are less than 200 during the
      study period, the subject should be offered standard-of-care per HIV treatment guidelines
      that may include the initiation of appropriate anti-retroviral therapy (AVR). CCR5mAb004
      pharmacokinetic (PK) and pharmacodynamics (PD) will be measured over the 56-day study period.
      Anti-CCR5mAb004 antibody titers will be assessed prior to dosing on Day 0 and on Day 28 and
      Day 56.
    


Intervention name(s): CCR5mAb004
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: HIV; Treatment Naive
Sun Protection Factor (SPF) / UVA Protection Factor Study
Condition: Sunscreen Agents
Study type: Interventional

Summary: 
      Evaluation of the effectiveness of sunscreen products by determining its Sun Protection
      Factor (SPF) against UV-B and UV-A
    

Detailed description: 
      Sunscreen is intended to protect the skin from sun burn but since the amount of protection
      needed varies among individuals, sunscreen manufactures offer consumers difference levels of
      protection. These different levels of protection are expressed as a numerical value called
      the sun protection factor or SPF. The SPF is the ratio between the minimal erythema dose
      (MED) of sunscreen product of the protected skin and the MED of the unprotected skin. The
      minimal erythema dose in human skin is defined as the lowest ultraviolet B (UV-B) dose
      produces the first perceptible unambigous erythema with defined border appearing over most of
      the field of UVB exposure 16 - 24 hours after UVB exposure.

      The UVA protection factor is the ratio between the Minimal Persistent Pigmentation Darkening
      Dose (MPPDD) of sunscreen product of the protected skin and the MPPDD of the unprotected
      skin. The threshold response will be taken as an unequivocal pigment darkening with distinct
      border which persisted for at least 2 hours.

      The test products are Day Gel-0120-C and Day Gel-0120-D with active ingredients ethylhexyl
      methoxycinnamate, Diethylamino hydroxybenzoyl hexyl benzoate
    

Intervention name(s): Day Gel-0120; P5 Reference Standard (SPF 35 reference)
Intervention type(s): Other; Other
Intervention description(s): Two milligrams of test article applied to the test area. The test products are Day Gel-0120C and Day Gel-0120-D. The products are applied together on the test area with; The reference product is P5 according to ISO 24444:2019. The application of reference product is similar with test product.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sun Protection Factor; Sunscreen
Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil
      in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing
      radical prostatectomy.
    


Intervention name(s): Placebo; Avanafil; Avanafil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One dose 30 minutes prior to initiation of sexual activity; One dose 30 minutes prior to initiation of sexual activity; One dose 30 minutes prior to initiation of sexual activity
Other intervention name(s): TA-1790; Stendra; TA-1790; Stendra
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; E.D.
Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Condition: Heart Transplantation; Liver Transplantation; Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness and safety of zoledronic acid with
      alendronate in the prevention of bone loss after organ transplantation. Zoledronic acid is
      given as a single intravenous infusion. Alendronate is given as a weekly pill. Both are
      expected to be very effective, but it is not known which one will work best.
    

Detailed description: 
      Patients who have undergone heart or liver transplantation are usually required to remain on
      medications, such as Prednisone and Cyclosporine A or Tacrolimus, that prevent the body from
      rejecting the transplanted organ. These medications may cause bone loss which leads to
      thinning of the bones (osteoporosis) and therefore greatly increase the risk of having broken
      bones (fractures) after transplantation. Several published studies have shown that 14% to 35%
      of heart transplant patients develop fractures (spine, ribs and hip) during the first year
      after transplantation. We have previously shown that alendronate (Fosamax), a drug approved
      by the FDA for prevention and treatment of postmenopausal osteoporosis and prednisone-induced
      osteoporosis, prevents bone loss after heart transplantation. We are conducting this study to
      determine whether a newer drug, zoledronic acid, is as effective as alendronate.

      This study is a randomized, double-blind, placebo-controlled 2-year study. Participants will
      receive one dose of active zoledronic acid during the first month after heart or liver
      transplantation and weekly placebo alendronate pills or one dose of placebo zoledronic acid
      and weekly active alendronate pills for the first year after transplant. Over 2 years,
      participants will provide blood samples on nine occasions. Bone density will be performed 4-5
      times and spine xrays will be performed twice.
    

Intervention name(s): Zoledronic acid; Alendronate; Placebo Zoledronic Acid; Placebo Alendronate
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Drug is administered through 5 mg intravenous infusion over 20 minutes; Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal; Infusion of placebo zoledronic acid during the first 5 weeks after transplantation; Placebo alendronate 70 mg once weekly
Other intervention name(s): Zometa; Fosamax
Intervention MeSH terms: Zoledronic Acid; Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Heart Transplantation; Liver Transplantation; Immunosuppression; Bone Density/drug effects; Alendronate; Zoledronic acid; Comparative study; Humans
Immune Molecular and Inflammatory Cytokines Dysfunction Analysis in Gout Patients With Different Urate Levels
Condition: Primary Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of study was to assess the efficiency and safety of oral IL-1βinhibitor in
      combination with urate lowering therapy on joint pain intensity,urate control, global
      assessments of disease activity, self-monitored gouty acute flare times, inflammatory markers
      and symptoms improving related life quantity in gouty patients.
    

Detailed description: 
      This was a randomized single-dose, open-label and active-controlled study which was carried
      out in 96 primary gout patients. Subjects and doctors have no access to randomization
      sequence which is determined by the primary investigator.All patients received an open-label
      febuxostat 40mg daily during the whole study. Healthy control were 32 age-matched men from
      volunteers in the medical health center.Two primary end points included pain intensity
      measurement which was recorded at each visit and subsequently acute flare times which was
      recorded at home and reported to investigator.
    

Intervention name(s): Diacerein; Colchicine; Febuxostat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration of IL-1βinhibitory; Colchicine is a toxic natural product and secondary metabolite, originally extracted from plants of the genus Colchicum (autumn crocus, Colchicum autumnale, also known as "meadow saffron"). It was used originally to treat rheumatic complaints, especially gout as the positive control; A urate lowering drug, an inhibitor of xanthine oxidase that is indicated for use in the treatment of hyperuricemia and gout
Other intervention name(s): Diacetylrhein; Colcrys; Generics; No other names
Intervention MeSH terms: Diacerein; Colchicine; Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment