bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 3 Study of Tenapanor to Treat Hyperphosphatemia in ESRD Patients on Dialysis
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3, 26-week, open label study with a 12-week, placebo-controlled, randomized
      withdrawal period followed by an open label long term safety extension will evaluate the
      safety and efficacy of tenapanor to treat hyperphosphatemia in end-stage renal disease (ESRD)
      on hemodialysis and peritoneal dialysis.
    

Detailed description: 
      The study consists of a screening visit, a phosphate binder-free washout period of up to 4
      weeks, a 26-week treatment period, an up to 12-week placebo-controlled, randomized withdrawal
      period, during which patients are randomized 1:1 to either remain on their tenapanor
      treatment or placebo, followed by an open label safety extension period for a total treatment
      period of up to 52 weeks. An active control group, for safety analysis only, will receive
      sevelamer carbonate, open label, for the entire 52-week study period

      Depending on increase in serum phosphate (s-P) levels, subjects can be randomized 2 or 3
      weeks after being taken off their phosphate lowering medication.

      Subjects who qualify to enroll in the study will be randomized 3:1 to either receive
      tenapanor at a dose of 30 mg bid or sevelamer carbonate.
    

Intervention name(s): Tenapanor; Placebo; Sevelamer Carbonate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active Drug; Inactive Drug; Active control
Other intervention name(s): RDX5791, AZD1722; Renvela
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Clinical Efficacy and Safety of gpASIT+TM to Treat Seasonal Allergic Rhinoconjunctivitis
Condition: Grass Pollen Allergy; Hay Fever
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived
      peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.
    


Intervention name(s): gpASIT+TM; gpASIT+TM; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days; entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days; Placebo entero-coated capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Rhinoconjunctivitis; Allergy; Grass pollen; Hypersensitivity; Immune system disorder
Melatonin Effects on Genital Herpes in Brazilian Women
Condition: Genital Herpes
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Interventional
Phase: Phase 4

Summary: 
      Genital herpes is a common and increasingly-common infection worldwide. The annual incidence
      in the United States is 1.75 per 1000 inhabitants. The etiologic agent is the herpes type 1
      and 2 strains simplex virus. Classical Treatment is with acyclovir which decreases the
      duration of the disease and prevents rashes but has no curative effect. Also, studies show
      herpes resistance to acyclovir which has stimulating research into new drugs to treat this
      condition. Authors suggest melatonin way be a therapeutic agent in herpetic disease due to
      its modulatory action in immune and inflammatory responses when administered in adequate
      doses. Therefore, the aim of this study is to evaluate the effects of melatonin in the
      treatment of genital herpes as well as compare it to acyclovir in a double-blind, prospective
      and randomized, investigation. Outcome measures will include clinical evaluation of patients
      and laboratory endpoints.
    

Detailed description: 
      The authors have investigate the relationship of estrogen-dependent malignant tumors with
      reduced levels of melatonin. It is speculated that the indoleamine can be classified as
      anti-estrogenic drug, both by its action on estrogen synthesis with aromatase inhibition and
      by its interference with estrogen receptors. Experimentally melatonin prevents promotion and
      growth of mammary tumors in rodents, probably by interacting with epithelial cell receptor;
      increasing local immunity by acting as an antioxidant agent and by inhibiting telomerase
      activity in tumor cells .
    

Intervention name(s): Melatonin 3 mg; Acyclovir
Intervention type(s): Combination Product; Drug
Intervention description(s): melatonin and placebo; Only acyclovir 200 mg twice a day
Intervention MeSH terms: Acyclovir; Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The patients will be divided into three groups. One group (group A) will receive a bottle with 360 pills of acyclovir 200 mg. These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days. Group B will receive 90 tablets of 30 mg of melatonin, the tablet will be used as 01 tablet daily for 90 days. Group C will receive 90 tablets of melatonin 3mg, and 360 tablets of acyclovir dose is 1 tablet per day for 90 days.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: acyclovir; melatonin
Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
Condition: Primary Immune Deficiency Disorders; Common Variable Immunodeficiency; X-linked Agammaglobulinaemia; Hyper-IgM Syndrome
MeSH terms: Agammaglobulinemia; Hyper-IgM Immunodeficiency Syndrome; Hyper-IgM Immunodeficiency Syndrome, Type 1; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous
      immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a
      28-day dosing interval (AUC0-28) in a cohort of adult subjects.

      The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and
      Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval
      (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and
      Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the
      safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to
      assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to
      investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.
    


Intervention name(s): Gammaplex (5%); Gammaplex 10
Intervention type(s): Biological; Biological
Intervention MeSH terms: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Appetite Suppression Trial With Polydextrose
Condition: Body Weight; Non-restrained Eaters
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Overweight and obesity are a global epidemic, which causes a rapid increase in the frequency
      of diabetes and cardiovascular diseases. Food ingredients that influence the mechanisms that
      regulate satiety may play a role in weight management. Suppression of appetite may reduce
      energy intake, which in return may lead to body weight reduction. This study aims to verify
      the appetite suppressive effect of polydextrose in comparison to a placebo in normal weight
      and overweight women.
    

Detailed description: 
      Polydextrose is a well-tolerated, low calorie glucose polymer (4kJ/g) that can be easily
      incorporated into various food applications to replace sugar and fat (Auerbach et al., 2007).
      Polydextrose is poorly digested in the upper gastrointestinal tract and therefore shows
      fiber-like properties. The addition of polydextrose to foods may increase the satiating
      properties of foods.

      Previous studies have shown that:

        -  Consuming polydextrose-containing preloads (6.25 - 25.0 g polydextrose) resulted in a
           significant lower energy intake at lunch compared to the control (Astbury et al., 2013;
           Ranawana et al., 2013; Hull et al., 2012; King et al., 2005).

        -  Polydextrose is able to modify appetite ratings at low (6.25 - 12.5 g polydextrose)
           (Hull et al., 2012) and high doses (56.7 g/d) (Konings et al., 2013).

        -  Polydextrose (15.0 g) induced enhanced GLP-1 response after a high-fat meal in obese
           participants (Tiihonen et al., 2012).

      Therefore, it is hypothesized that with the consumption of 12.5 g polydextrose as compared
      with the placebo, appetite will be suppressed, resulting in:

        -  a lower consumption at lunch (energy intake at lunch)

        -  change in appetite scores (VAS)

        -  change in satiety hormones (CCK, PYY, GLP-1, ghrelin)

        -  change in glucose and insulin

        -  change in stomach emptying rate

        -  change in gastric wellbeing
    

Intervention name(s): 12.5 g polydextrose; glucose syrup
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Appetite suppressing supplement is added in yogurt and provided with breakfast (four hours before lunch) or 1.5h before lunch. Also yogurt with control (glucose syrup) is tested for its satiating effect.; Glucose syrup is used a control product for the polydextrose
Other intervention name(s): Litesse®Ultra TM
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Breakfast meal with or without polydextrose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: pre-load; satiety; energy intake; appetite
Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to characterize the safety and tolerability of an investigational drug called
      TIMP-GLIA when either one or two intravenous doses are given to subjects with celiac disease.
      The way the body reacts to TIMP-GLIA is being checked by laboratory tests of the blood and
      urine, and study subject health will also be monitored by vital signs such as blood pressure,
      electrocardiogram (ECG), and physical examination.
    

Detailed description: 
      This study is a 2-part, multicenter study. In Part A, eligible subjects will be enrolled into
      escalating dose cohorts (n = 2/cohort for 2 dose levels followed by n = 3/cohort for 4 dose
      levels). TIMP-GLIA will be administered as a single intravenous (IV) infusion on Day 1. A
      staggered dosing strategy will be used in Part A. Subjects will undergo medical observation
      in the clinic for at least 48 hours after dosing and participate in outpatient follow-up
      visits. Adverse events (AEs), vital signs, and electrocardiograms (ECGs) and laboratory data
      (serum chemistry, coagulation, hematology and urinalysis, cytokines) will be assessed by a
      Safety Committee before the next cohort will be dosed at a higher dose level.

      After completion of Part A and confirmation by the Safety Committee to proceed, eligible
      subjects (n=3) will receive two IV infusions of TIMP-GLIA, 7 days apart, on Day 1 and on Day
      8. Each subject in Part B will be observed in clinic for 48 hours after each dose and undergo
      similar testing and follow-up visits as in Part A.

      The safety and pharmacokinetic profile of TIMP-GLIA will be characterized.
    

Intervention name(s): TIMP-GLIA
Intervention type(s): Drug
Intervention description(s): intravenous infusion.
Other intervention name(s): TAK-101
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Single ascending dose followed by repeat dose.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety; tolerability; pharmacokinetics; celiac; gliadin; gluten
Implementing a Comprehensive Handoff Program to Improve Pediatric Patient Safety
Condition: Patient Safety; Resident Workflow; Resident Experience
Study type: Interventional

Summary: 
      The investigators propose to test the hypothesis that implementation of a comprehensive
      handoff program (CHP) - i.e., implementation of a computerized handoff tool along with
      teamwork training for pediatric residents on inpatient units at Children's Hospital Boston -
      will lead to reductions in resident miscommunications / medical errors and improvements in
      workflow and experience on the wards.
    

Detailed description: 
      Following collection of baseline data on two inpatient pediatric wards, teamwork training is
      to be provided to all pediatric residents. On our primary intervention unit, this will be
      accompanied by the introduction of a new computerized handoff tool that facilitates accurate
      transmission of data. The effects of this combined intervention on safety and workflow will
      be assessed on the primary intervention ward as compared with the historical control unit and
      the concurrent unit that received teamwork training without the computerized tool.
    

Intervention name(s): Computerized handoff tool; Team training
Intervention type(s): Other; Other
Intervention description(s): Informatics tool to aid in transfer of patient care information; Teamwork training and revisions of handoff structure to optimize teamwork skills and verbal communications
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Patient Safety; Medical Errors; Handoff; Sign-out; Resident; Intern; Graduate Medical Education
Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center and open-labeled Phase I study, designed to evaluate the safety by observing
      the occurrence of adverse events and change of hematology, liver and renal function after
      vaccination of a meningococcal group A, C, Y, and W135 conjugate vaccine in healthy
      population aged 2 months to 55 years old.
    


Intervention name(s): Meningococcal Group ACYW135 Conjugate Vaccine
Intervention type(s): Biological
Intervention description(s): 1 dose in Stage 1 (2~55 yrs), 2 doses in Stage 2 (7~23 mos), and 3 doses in Stage 3 (2&3 mos)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis, Meningococcal, Serogroup A; Meningitis, Meningococcal, Serogroup C; Meningitis, Meningococcal, Serogroup Y; Meningitis, Meningococcal, Serogroup W135
Efficacy Trial of Raices Nuevas
Condition: Intimate Partner Violence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial will test the impact of a culturally tailored and theory driven primary intimate
      partner violence prevention intervention with Spanish speaking Latino men.
    

Detailed description: 
      In this randomized controlled trial, Spanish speaking Latino men will be recruited from
      community church settings in Southwest Detroit and randomly assigned to: (a) an intimate
      partner violence prevention intervention or (b) a wait-list control condition. Latino men
      assigned to the intervention will receive, in a small group setting, an 8-session, primary
      intimate partner violence prevention intervention based on the Duluth model and culturally
      and linguistically tailored for Spanish speaking Latino men. Measures will be administered at
      pre-test, and at three and six months post-intervention.
    

Intervention name(s): Raices nuevas
Intervention type(s): Behavioral
Intervention description(s): 8 90-minute sessions (once a week) of problem-posing and facilitated discussion on respect, anger, support, trust, negotiating, partnership with your intimate partner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: partner violence, spouse abuse
Educating and Supporting Primary Care Providers in the Implementation of Evidence-based Practices for ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Although numerous studies have demonstrated that a high percentage of primary care providers
      (PCPs) are knowledgeable about the American Academy of Pediatrics' guidelines for managing
      ADHD, many fail to implement these guidelines correctly. The goal of this project is to
      increase the use of evidence-based practices (EBP) for assessing and treating children with
      ADHD between 5 and 12 years in the context of primary care practice. This randomized
      controlled trial will evaluate the whether a 3-part intervention (education about ADHD
      management and communication training, collaborative consultation, and performance feedback
      regarding use of EBPs) is effective in improving EBP use among primary care providers.
    


Intervention name(s): Supporting Practice for ADHD (SPA)
Intervention type(s): Behavioral
Intervention description(s): The SPA intervention will last for 8 months for each study arm (first 8 months of the study for the intervention group, last 8 months for the control group). The intervention includes 3 components: 1) a series of web-based educational presentations to provide education to providers about evidence-based practice for managing ADHD and strategies for promoting effective communication with families 2) Collaborative consultation designed to address clinical issues arising in practice will be provided by members of the study team.
3) Providers will be given systematic performance feedback with regard to their use of evidence-based practices for ADHD every 2 months during the 8-month intervention period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Evidence-Based Practice; Provider Education
Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a
      daily oral dose of LHF-535 administered for 14 days to healthy participants.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study to
      assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of orally
      administered LHF-535 in 24 to 32 healthy adult participants. Three successive escalating
      cohorts, each containing 8 participants, are planned. Within each cohort, 6 participants will
      be randomized to receive an oral dose of LHF-535 once daily for 14 days, and 2 will be
      randomized to receive an oral dose of placebo once daily for 14 days. After a screening
      period of up to 28 days, all participants will be confined to the study center from 1 day
      prior to dosing until at least 24 hours after the 14th day of dosing. Participants will
      return for follow-up evaluations on Day 17 and Day 21 (72 and 168 hours after last dose,
      respectively) and on Day 42. After each cohort, safety data through Day 17 and PK data
      through Day 7 will be reviewed by a blinded Safety Committee prior to dosing of the next
      cohort. The Safety Committee is charged with making one of the following three
      recommendations: (1) proceed with dose escalation as planned, (2) continue the study with
      modification (e.g., proceed with the next cohort at a lower dose level than planned), or (3)
      suspend the study. An additional cohort of 8 participants may be added to evaluate dosing for
      future studies, at the discretion of the Sponsor, in consultation with the Safety Committee.
    

Intervention name(s): LHF-535
Intervention type(s): Drug
Intervention description(s): Oral suspension administered once daily for 14 days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lassa fever; viral hemorrhagic fever
Effects of Bandaging and Kinesiotaping® in Patients With Total Knee Arthroplasty
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The study aimed to compare the effectiveness of elastic bandaging, Kinesio taping, and short
      stretch bandaging techniques on postoperative pain, edema, and functional level in the early
      stage after total knee arthroplasty.
    

Detailed description: 
      The study was conducted on 30 volunteer subjects who underwent unilateral total knee
      arthroplasty surgery. Thirty participants who underwent unilateral total knee arthroplasty
      were divided into the Elastic Bandage Group (n=10), Kinesio Tape group (n=10), and Short
      Stretch Bandage group (n=10). All treatments were stopped on the eighth day. All measurements
      taken preoperatively were repeated postoperative 1st, 3rd, 5th, 8th, 14th, 28th days, 6th
      week, and 3rd month. The functional level was measured in the sixth week and third month.
    

Intervention name(s): Elastic bandaging; Short stretch bandaging; Kinesio taping
Intervention type(s): Other; Other; Other
Intervention description(s): The bandages were wrapped circularly along the extremity from the toes to the groin, drawing an "8" at the ankle with a 50% overlap rate, starting with 80% tension and decreasing the pressure proximally.; Short tension bandage application was started on postoperative day 1 following the removal of the drains. According to the width of the extremity, using short tension bandages of 6, 8 and 10 cm width, starting from the sole of the foot, the first layer was wrapped circularly with 50% overlapping rate, 80% tension, and wrapped from the sole of the foot to the groin.; Kinesio taping was applied in the form of a fan by cutting into 4 longitudinal pieces using the lymphatic correction technique with 15-20% tension, starting from the periphery of the inguinal lymph nodes on the medial, anterior and lateral of the leg, following the removal of the drains from the 1st post-op day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study included a three parallel group of blinded evaluators. These cases were followed up with a planned follow-up program between preoperative and postoperative three months.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: knee arthroplasty; edema; elastic bandages; short stretch bandages; kinesio tape