bioihbjkbjnl/mcl2 huggingface dataset:
Ultrafiltration Profiling and Outcomes Among Individuals on Maintenance Hemodialysis
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The rate of fluid removal (ultrafiltration, UF) during hemodialysis (HD) may contribute to
      cardiovascular morbidity and mortality among individuals receiving maintenance HD. More rapid
      UF rates are associated with higher morbidity and mortality. Ultrafiltration profiling, the
      practice of varying UF rates to maximize fluid removal during periods of greatest hydration
      and plasma oncotic pressures, is one treatment modification that may reduce UF-related harm
      without necessitating reduction in interdialytic fluid intake or longer HD treatments. To
      date, UF profiling has not been adequately studied independent of sodium profiling.

      This study investigates the comparative effect of UF profiling versus non-profiled
      conventional HD on select cardiovascular and patient-reported outcomes. Participants will
      complete two phases of UF profiling and two phases of conventional HD and will act as their
      own controls.
    


Intervention name(s): UF profiling during HD; Conventional HD
Intervention type(s): Other; Other
Intervention description(s): Experimental arm: Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; pre-programmed "profile 2" on a Fresenius 2008K machine, the machine used in all participating clinics). Ultrafiltration profiling will be performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions.; Control arm: Conventional HD (routine care) is the participant's standard HD prescription without UF profiling.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a 4-phase crossover trial in which participants are successively alternated between conventional HD and conventional HD + linear UF profiling across 4 phases with intervening wash-out periods. The study compares conventional HD (the participant's standard HD prescription with no UF profiling) to conventional HD + linear UF profiling. Participants will be randomly allocated to conventional HD or conventional HD + linear UF profiling for phase 1. Participants will undergo 9 treatments during each phase for a total of 18 conventional HD treatments and 18 UF profiled treatments. Participants will undergo 3 wash-out HD treatments between phases.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultrafiltration profiling; Hemodialysis; Dialysis; Cardiovascular outcomes; Patient-reported outcomes; Crossover study design; End Stage Renal Disease; Ultrafiltration; Echocardiogram; Blood pressure; Hypotension; Symptoms
Nasal Physiologic Reactivity of Nonallergic Rhinitics to Cold Air Provocation
Condition: Vasomotor Rhinitis
MeSH terms: Rhinitis; Rhinitis, Vasomotor
Study type: Interventional

Summary: 
      This study seeks to compare patients with vasomotor rhinitis ("perennial nonallergic
      rhinitis," "idiopathic rhinitis") with normal controls with respect to their nasal
      physiologic reactivity to cold air challenge. Ten vasomotor rhinitis (VMR) patients with
      nasal symptoms triggered predominantly by cold air, four VMR patients with symptoms triggered
      predominantly by chemicals, and ten nonallergic, non-rhinitic control subjects will be
      studied.
    

Detailed description: 
      After initial screening and verification that subjects can cooperate with active posterior
      rhinomanometry, subjects will be scheduled for two 15-minute exposure sessions with either:
      cold-dry air, or warm-moist air. Subjects will rate symptoms (and have their nasal airway
      resistance measured in triplicate) prior to exposure and at 15-min. intervals post-exposure
      until an hour has passed.
    

Intervention name(s): Cold-dry air provocation; Warm-moist air provocation
Intervention type(s): Other; Other
Intervention description(s): 15 minute exposure to cold-dry air by nasal mask; 15 minute exposure to warm-moist air by nasal mask
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: rhinitis; non-allergic rhinitis; rhinomanometry; cold air; triggers: cold, dry air inhalation; warm, most air inhalation; Nonallergic rhinitis; normal controls
Optimizing Assisted Communication Devices for Children With Motor Impairments Using a Model of Information Rate and Channel Capacity
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      For children who depend on devices to communicate, the rate of communication is a primary
      determinant of success. For children with motor impairments, the rate of communication may be
      limited by inability to contact buttons or cells rapidly or accurately. It is therefore
      essential to know how to adjust the device interface in order to maximize each child's rate
      of communication. The optimal rate of communication is determined by the Channel Capacity,
      which is the maximum value of the Information Rate for all possible keyboard button or cell
      layouts for the communication device. We construct a mathematical model for the information
      rate based on the relationship between movement time and the number of buttons per screen,
      the size of the buttons, and the length of a sequence of buttons that must be pressed to
      communicate each word in the vocabulary. We measure the parameters of the model using a
      custom-programmed touch-screen interface.
    


Intervention name(s): reprogramming assisted communication device interface
Intervention type(s): Device
Intervention description(s): The subjects were required to touch targets on the iPad® screen with the index finger of their preferred (less-affected) arm. The experimental task consisted of 180 targets divided in 4 blocks: 45 targets each block with a 1-minute interval between trials to avoid fatigue. Targets appeared at 1 of 9 different locations on the screen, and subjects moved their finger sequentially from one target to the next.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 3 Trial of Serbian Seasonal Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent,
      split, inactivated influenza vaccine produced by InstituteTorlak.
    

Detailed description: 
      This is a phase 3, double-blind, randomized, placebo- controlled trial with two groups of
      participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1;
      A/H3N2 and B) or placebo (phosphate buffered saline). A total of about 480 healthy male and
      female adults 18 through 65 years of age; 320 participants will be randomized to receive
      vaccine and160 will receive placebo (a 2:1 ratio). At least 25% of the participants (N=120)
      will be >/= 45 years of age (80 vaccine and 40 placebo recipients).

      Safety will be assessed in all participants through Day 91. Immunogenicity will be assessed
      in serum samples obtained at baseline and 21 days after vaccination in a subset of at least
      100 individuals randomized to study vaccine and 50 placebo recipients.
    

Intervention name(s): Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Seasonal trivalent split, inactivated influenza vaccine 15 mcg hemagglutinin antigen (HA) of each of A/H1N1; A/H3N2 and B strains; 0.5 mL by IM injection; Phosphate buffered saline, 0.5 mL by IM injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: seasonal influenza; vaccine
Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma
Condition: Asthma, Bronchial; Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.
    


Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Tacrolimus; Immunosuppressant; Anti-asthmatic drug; Administration, inhalation
A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)
Condition: Hepatitis C; HCV; Chronic Hepatitis C Infection; Hepatitis C Genotype 1
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072
      and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus
      (HCV) infection.
    

Detailed description: 
      This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a
      regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a
      or 1b) infected treatment-naïve participants.
    

Intervention name(s): ABT-450; ABT-072; Ribavirin; Ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablets; tablets; tablets; capsules
Other intervention name(s): Norvir
Intervention MeSH terms: Ritonavir; Ribavirin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Investigation of Robotic Single-port System
Condition: Prostate and Kidney Cancer
MeSH terms: Kidney Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To determine the feasibility of representative urologic procedures as measured by the rate of
      conversions
    


Intervention name(s): da Vinci Sp Surgical System - Robotic
Intervention type(s): Device
Intervention description(s): robotic assisted laparoscopic single-port system
Intervention model: Single Group Assignment
Masking: None (Open Label)
PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel
Condition: HIV Prevention
Study type: Interventional
Phase: Phase 1

Summary: 
      PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel
    

Detailed description: 
      A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of
      Dapivirine/Levonorgestrel
    

Intervention name(s): 200 mg of DPV + 320 mg LNG; 200 mg of DPV
Intervention type(s): Combination Product; Combination Product
Intervention description(s): DPV VR, containing 200 mg DPV; DPV-LNG VR, containing 200 mg of DPV + 320 mg LNG
Other intervention name(s): Dapivirine; Dapivirine/Levonorgestrel
Intervention MeSH terms: Dapivirine; Levonorgestrel
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dysregulation of FSH in Obesity: Functional and Statistical Analysis
Condition: Obesity; Fertility
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Excess maternal weight, especially obesity, influences almost every aspect of fertility, from
      conception to problems during pregnancy. The investigators will use novel statistical methods
      to clarify the hormonal changes behind reproductive health conditions. A better understanding
      of reproductive hormonal changes in obese women may offer a way to identify new treatments.
    

Detailed description: 
      Hypothesis. Insufficient FSH (Follicle-stimulating hormone) pulsatility, as seen in obesity,
      results in inadequate folliculogenesis and reduced ovarian steroid and protein production.

      AIM: To test the hypothesis that insufficient FSH pulsatility, as seen in obesity, results in
      inadequate folliculogenesis and reduced ovarian steroid and protein production. The
      investigators will determine if exogenous FSH administered in a pulsatile fashion results in
      a significant increase of ovarian hormones in obese women. Serial inhibin B and E2 levels
      will be measured in obese and normal weight women undergoing frequent blood sampling studies
      before and after GnRH (Gonadotropin-releasing hormone) antagonist blockade.
    

Intervention name(s): Degarelix (GnRH antagonist); recombinant FSH; Cetrorelix
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist degarelix will be given subcutaneously.; Day-2: Blood samples will again be obtained every 10 minutes for 10 hours. Repeated boluses of exogenous recombinant FSH (rFSH) will be given by IV during this 10 hour visit.; Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist Cetrorelix will be given subcutaneously.
Other intervention name(s): Firmagon; rFHS; Cetrotide
Intervention MeSH terms: Cetrorelix
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: obesity; fertility; infertility; reproductive hormones
Selective Use of Episiotomy: the Impact on Perineal Trauma.
Condition: Perineal Tear; Episiotomy Wound; Delivery; Injury, Maternal
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      Vaginal delivery is commonly accompanied by trauma of the genital tract. Perineal trauma is
      classified into four degrees based on anatomic structures involved and severity of
      lacerations according to the American College of Obstetricians and Gynaecologists (ACOG) and
      the Royal College of Obstetricians and Gynaecologists (RCOG). Episiotomy is an intentional
      perineal incision performed by midwifes or obstetricians to enlarge vaginal opening during
      the second stage of childbirth and has become the most common surgical procedure worldwide. A
      routine use of episiotomy was proposed to prevent severe spontaneous lacerations, although it
      failed to to demonstrate a clear protective role with no benefits both for mother and baby.
      Therefore the guidelines changed in a selective use of episiotomy, and we have introduced it
      in our routine obstetrics care. Nevertheless, second-degree lacerations comprise a wide range
      of lesions, from a minimal involvement to a massive damage of the perineal muscles.
      Therefore, it was never confirmed that selective use of episiotomy reduce the perianal trauma
      in the range of second degree lesions.

      We designed a prospective observational study with the introduction of a new classification
      of perineal trauma recorded with the usual data retrieved in delivery ward register. The aim
      is to definitively investigate if selective use of episiotomy reduce the overall perineal
      trauma.
    


Intervention name(s): Classification of perineal tears based on new classification; Selective use of Episiotomy
Intervention type(s): Other; Procedure
Intervention description(s): Classifications according to the American College of Obstetricians and Gynaecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists (RCOG) and sub classification of second-degree lacerations based on the assumption that episiotomy involves the same anatomic structures of a second-degree laceration (perineal muscle, mucosa and skin), and divides them in two sub-groups, named A (if spontaneous vaginal tear is smaller than episiotomy) and B (if spontaneous vaginal tear is bigger than episiotomy).; Standardized selective use of Episiotomy as recommended by guidelines.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Unassisted vaginal delivery of the study period.
      
Keywords: Episiotomy; Vaginal delivery; Perineal trauma; Laceration; Classification of second-degree laceration
Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of adalimumab induction and maintenance
      treatment in subjects with moderately to severely active Crohn's disease in China.
    


Intervention name(s): adalimumab; placebo
Intervention type(s): Biological; Other
Intervention description(s): subcutaneous injections of adalimumab; subcutaneous injections of placebo
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: China; Tumor necrosis factor (TNF)-alpha; Biologic
Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
Condition: Thalassemia; Sickle Cell Disease
MeSH terms: Anemia; Anemia, Sickle Cell; Thalassemia; Iron Overload
Study type: Observational

Summary: 
      Iron overload impaired growth in Thalassemia patients due to iron deposition in the endocrine
      glands, including the hypophysis and gonads. The issue of iron overload in Sickle Cell Anemia
      is recently studied more extensively and preliminary studies shows that endocrine damage is
      rarer in those patients.

      Growth velocity was not systematically studied in patients with Iron Overload, even in
      thalassemia patients in spite several studies that assess the endocrine function in those
      patients. In Sickle Cell Patients this issue was not studied.

      The purpose of this study is to assess the growth velocity in a cohort of Thalassemia Major
      and Intermedia patients and compare the results to another group of Sickle Cell patients,
      including Sickle cell thalassemia.
    

Detailed description: 
      Growth velocity, endocrine function and iron overload status will be studied in the patients
      that are in follow up at the Pediatric Hematology Unit, at the Ha'Emek Medical Center.

      Patients who were lost from follow up or insufficient data about growth in the past will not
      included in the study.
    

Intervention name(s): Medical Chart Summary
Intervention type(s): Other
Intervention description(s): Summary of the Medical Files including annual growth velocity, endocrine function and iron overload status.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        150 patients suffering from hemoglobinopathies are treated at the Pediatric Hematology
        Unit, Ha'Emek Medical Center. This include Thalassemia Major blood transfused and treated
        by chelators, Thalassemia Intermedia patients ussualy not transfused, some of them treated
        by Hydroxyurea, and two groups of Sickle cell patients, Sickkle cell homozygous and Sickle
        cell thalassemia. Most of the Sickle cell patients are treated with Hydroxyurea.
      
Keywords: Thalassemia Major; Thalassemia Intermedia; Sickle Cell Anemia; Sickle Cell Thalassemia; Iron Overload; Growth Velocity
Phase I/IIa Dose-escalation Clinical Study of VAC-3S
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic
      vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with
      undetectable viral loads.
    


Intervention name(s): VAC-3S; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Comparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart; Comparison with experimental vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV-1; HIV; immunotherapy; active immunotherapy; vaccine; virulence; innate immunity; NK cells
To Explore the Anti-oxidative Effects and Inflammation Effects of Soy Protein to Renal Function of End Stage Diabetes Nephropathy Patients
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

Summary: 
      This study investigated the beneficial effects of soybean on the renal function, oxidative
      stress, and inflammatory responses in patients with end-stage diabetic nephropathy (DN).
    

Detailed description: 
      DN outpatients were recruited from Tung's Taichung MetroHarbor Hospital (Taichung City,
      Taiwan). They were randomly separated into two groups; one group was given soy protein drink
      and the other group was given casein drink for 4 months. The blood pressure, plasma glucose,
      lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory
      factor levels were analyzed at the baseline and at the end of the study.
    

Intervention name(s): soy protein drink; casein protein drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The calories oral nutrition supplements were 100 kcal, which included 8.4g of protein and phosphorous was excluded in two oral nutrition supplements formula.
Each participant had two packs of nutrition supplement per day for 4months. The 24-h dietary record, blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory factor levels were analyzed at the baseline and at the 4th month of the study.
The participants were followed up until the 7th month of the study.; The calories oral nutrition supplements were 100 kcal, which included 8.4g of protein and phosphorous was excluded in two oral nutrition supplements formula.
Each participant had two packs of nutrition supplement per day for 4 months. The 24-h dietary record, blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory factor levels were analyzed at the baseline and at the 4th month of the study.
The participants were followed up until the 7th month of the study.
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment