bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
Condition: B-cell Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4
      cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg
      alemtuzumab s.c. in patients with B-CLL disease in 1st and 2nd relapse after any primary
      treatment or with disease refractory to any therapy in 1st or 2nd line (including
      Fludarabine, ). This regimen is preceded by an escalation phase with 3-10-30 mg of
      alemtuzumab s.c.

      After the first phase (completed treatment of 7 patients) an interim analysis of safety and
      efficacy will be performed. In case of a sufficient risk benefit assessment followed by the
      enrollment of further 21 patients. Final analysis of safety and preliminary efficacy will be
      based on all patients enrolled.
    


Intervention name(s): Fludarabine phosphate; Alemtuzumab
Intervention type(s): Drug; Drug
Intervention description(s): orally, 40 mg/m2 d1-3 q4w, x4 cycles; subcutaneous, starting dose 3 mg and escalation to 10 mg, then 30 mg, followed by 30 mg thrice weekly for 16 weeks in escalated dose
Other intervention name(s): Fludara®; MabCampath®
Intervention MeSH terms: Fludarabine; Fludarabine phosphate; Alemtuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-CLL; refractory; molecular profiling; alemtuzumab; fludarabinephosphate
Reliability and Validity of the ISNCSCI in Patients With Non-traumatic Spinal Cord Lesions
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      Aim of the study is to assess the psychometric properties of the International Standards for
      Neurological Classification of Spinal Cord Injury in subjects with non traumatic lesions.
    

Detailed description: 
      All patients with non-traumatic SCI consecutively admitted to three Italian SCI centers
      (IRCCS Fondazione Santa Lucia, Montecatone Rehabilitation Hospital and Istituti Clinici
      Scientifici Maugeri IRCCS of Pavia) between January 1st 2017 and June 30th 2020 have been
      prospectively enrolled in the study.
    

Intervention name(s): rehabilitation
Intervention type(s): Other
Intervention description(s): Patients underwent ususal rehabilitation treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with non traumatic spinal cord lesions
      
Keywords: non traumatic spinal cord injury; ISNCSCI; inter-rater reliability; rehabilitation
Sodium Sensitivity in African Americans
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the effects of two levels of dietary sodium on blood pressure in Black men and
      women, and to determine what factors predict the degree of response.
    

Detailed description: 
      BACKGROUND:

      The study permitted a more precise estimate of the effects of sodium chloride on blood
      pressure in Blacks and a systematic examination of sodium sensitivity defined by various
      methods. The results had significance in answering questions about risk factors for blood
      pressure in Blacks and for defining sodium sensitivity.

      DESIGN NARRATIVE:

      Double-blind, two-period cross-over. All participants were given six weeks of intensive
      nutritional counseling to lower 24-hour urine sodium output from an estimated 165 mEq/24
      hours at baseline to less than 140 mEq/24 hours. Only those participants who excreted less
      than 140 mEq /24 hours after six weeks of intensive dietary sodium intervention and had
      greater than 70 percent adherence to study capsules were eligible for randomization. Eligible
      subjects were assigned to one of two treatment sequences: 100 mEq of sodium chloride capsules
      per day during period one followed by placebo capsules during period two; placebo capsules
      during period one followed by 100 mEq of sodium chloride capsules per day during period two.
      The major endpoint was change in diastolic and systolic blood pressure. A number of other
      measures were carried out, including blood chemistries, glucose tolerance (glucose and
      insulin), insulin resistance, urinary kallikrein, serum renin, and plasma norepinephrine.
      Other major aims of the trial included testing general new diagnostic criteria for sodium
      sensitivity, examining predictors of sodium sensitivity, and examining how changes in sodium
      intake influenced change in specific metabolic parameters. The trial design incorporated
      careful control of the dietary changes and strict standardization of blood pressure
      measurement with a random-zero device. The study was extended through June 1997 on FY 1995
      funds.
    

Intervention name(s): sodium, dietary
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This randomized controlled trial will examine changes in some hormonal markers associated
      with acne among adults with moderate/severe acne randomized to a low glycemic index and
      glycemic load diet or usual eating plan for two weeks.
    

Detailed description: 
      The objectives of this randomized controlled trial are to investigate the impact of a low
      glycemic index/load eating plan on endocrine aspects of acne. Specifically, this study will
      examine changes in blood biochemical markers of acne among adults with acne following a
      modified carbohydrate (low glycemic index/load) eating plan or their usual eating plan for
      two weeks. An external sponsor, Nutrisystem®, will provide some low glycemic index/load foods
      to the study participants randomized to the intervention group for two weeks. Study outcomes
      include changes in glucose, insulin, insulin resistance, insulin-like growth factor-1, and
      insulin-like growth factor binding protein-3 concentrations.
    

Intervention name(s): Low Glycemic Load Diet; Usual Eating Plan
Intervention type(s): Other; Other
Intervention description(s): Participants received a diet education on a low glycemic load diet.; Participants received a diet education to continue with their usual eating plan.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet; glycemic index; glycemic load; Acne Vulgaris
Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea
Condition: Infectious Diarrhoea
MeSH terms: Communicable Diseases; Infections; Dysentery; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo
      Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMX
      technology (CB-01-11) in the treatment of infectious diarrhoea.
    

Detailed description: 
      To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo
      Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMXTM
      technology (CB-01-11) in the treatment of infectious diarrhoea.

      Primary end points to determine:

      • The safety and preliminary efficacy data of the three doses of the new rifamycin SV
      formulation tested based upon the time elapsed from the ingestion of the 1st dose of study
      medication to the passage of the last unformed stool (TLUS), in compliance with the relevant
      guidelines

      Secondary end-points to determine:

        -  The number of patients showing improvement in diarrhoea during a 24-h interval, i.e. >50
           % reduction of bowel movements.

        -  The number of unformed stools passed per 24-h interval, after dosing.

        -  The number of patients who are declared to be "well". Wellness is defined as the patient
           having 48 hours with no unformed stools, a maximum of two soft stools and no clinical
           symptoms of infectious diarrhoea.

        -  The number of treatment failures. A treatment failure is defined as clinical
           deterioration or worsening of symptoms or illness continuing after 120 h following the
           first dose.

        -  The number and percentage of patients recovered from diarrhoea. Patients were considered
           to have recovered if fewer than three unformed stools were passed in the previous 24
           hours and no symptom of enteric infection were present.
    

Intervention name(s): 400 mg Rifamycin SV dosage; 800 mg Rifamycin SV dosage; 1200 mg Rifamycin SV dosage
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rifamycins; Rifamycin SV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Infectious diarrhoea; rifamycin SV; rifamycin SV MMX; MMX
Food Rheology and Feeding in Lean and Obese Humans
Condition: Obesity; Overweight; Diabetes
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The 2010 National Health Objectives call for a reduction in the prevalence of obesity. The
      marked recent increase in overweight and obesity prevalence implicates behavioral factors in
      the etiology of the epidemic. The present proposal hypothesizes the trend is attributal, in
      part, to increasing consumption of energy-yeilding beverages since they are a significant and
      increasing source of dietarty energy and they elicit weaker appetitive and dietary responses
      than solid foods.
    

Detailed description: 
      Three human studies are propsed to more fully characterized attributes of liquids and solids
      that may account for the differential appetitive responses they elicit, potential
      contributory mechanisms as well as the dietary implications of their consumption. Study 1
      will contrast the acute effects of fluid and solid foods varying in macronutrient content on
      satiation, satiety and feeding. Study 2 will determine if the pattern of fluid and solid
      ingestion influences satiety and feeding by monitoring appetitive and dietary responses to
      energy and macronutrient matched fluid and solid loads ingested as meal components or between
      meal snacks. To better assess the clinical implications ofdiets incorpprating liquid or solid
      supplements. Study 3 will entail chronic ingestion of matched energy yeilding fluid or solid
      loads with concurrent measurement of appetite, dietary intake, energy expenditureand body
      weight/composition.
    

Intervention name(s): food in fluid form; food in solid form
Intervention type(s): Other; Other
Intervention description(s): dietary intake of fluid forms of vegetables; dietary intake of solid forms of vegetables
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: obesity; food intake; human; energy balance; beverage
Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This project tests the feasibility and preliminary proof of concept for a
      mindfulness-enhanced adaptation of Pivotal Response Treatment on parenting stress and child
      communication, using a randomized controlled design.
    

Detailed description: 
      One of the core features of Autism Spectrum Disorder (ASD), social communication impairment,
      presents in a variety of ways, including reduced functional language use and social
      initiations, which often warrant intensive intervention services. Additionally, parents of
      children with ASD demonstrate increased levels of parenting stress when compared to parents
      of typically developing children and children with developmental delays. Elevated parenting
      stress has been shown to diminish positive treatment outcomes, which lends support to develop
      methodologies to concomitantly target child and parent behaviors. The current randomized
      control trial (RCT) uses a dual-pronged approach to directly target both child communication
      deficits and parenting stress within a group format. This RCT combined an empirically
      supported behavioral therapy, Pivotal Response Treatment (PRT), with components from
      Acceptance and Commitment Therapy and Mindful Parenting for reducing parenting stress.
      Caregivers and their minimally or pre-verbal child with diagnosed or suspected ASD were
      randomly assigned to one of the following supplemental conditions: mindfulness-enhanced PRT
      (mPRT) or psychoeducation-enhanced PRT (pPRT) as an active control condition. The current
      study assessed feasibility and acceptability in addition to demonstrating proof of concept in
      regard to additive effects of mPRT compared to pPRT.
    

Intervention name(s): Pivotal Response Treatment
Intervention type(s): Behavioral
Intervention description(s): Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer.
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine the effect of enzalutamide and dutasteride or finasteride on the time to
      prostatic-specific antigen level increase in patients age 65 or older.
    

Detailed description: 
      The primary objective of this study is to determine the effect of enzalutamide and
      dutasteride or finasteride on the time to prostatic-specific antigen progression in patients
      aged 65 or older receiving this combination as first line treatment for systemic prostate
      cancer.

      To determine the safety and toxicities of the study drug combination.

      To determine the time to prostatic-specific antigen nadir from the start of study treatment
      and to evaluate the absolute prostatic-specific antigen nadir as a result of the study drug
      combination
    

Intervention name(s): Enzalutamide and Dutasteride or finasteride
Intervention type(s): Drug
Intervention description(s): Use of either two oral drugs together
Enzalutamide by mouth daily and dutasteride by mouth daily or
Enzalutamide by mouth daily and finasteride by mouth daily
Intervention MeSH terms: Finasteride; Dutasteride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate
A Study to Compare the NexGen CR and CR-Flex Knee Implants
Condition: Total Knee Arthroplasty; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to test for significant differences in functional outcomes,
      specifically pre-operative ROM and post-operative ROM obtained by using a NexGen CR versus a
      NexGen CR-Flex knee implant. Specifically, it is predicted that an increase in post-operative
      range of motion will be experienced by patients treated with the NexGen CR-Flex knee implant.
    

Detailed description: 
      This study will compare the clinical results of the NexGen CR femoral component with the
      higher flexion potential of the NexGen CR-Flex femoral component in all patients with
      degenerative joint disease that require total knee arthroplasty. The primary variable of
      interest is post-operative range of motion achieved with the two devices, which are implanted
      with slightly different surgical techniques in patients who may also be subjected to
      different rehabilitation programs depending on the device they are assigned.
    

Intervention name(s): NexGen CR-Flex Fixed Bearing Knee; NexGen CR Knee
Intervention type(s): Device; Device
Intervention description(s): NexGen CR-Flex Fixed Bearing femoral component; NexGen Complete Knee Solution Cruciate Retaining femoral component
Other intervention name(s): CR-Flex Knee; CR Knee
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; Osteoarthritis; Knee
Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women
Condition: Vasomotor Symptoms; Menopausal Symptoms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a two-part study designed to evaluate the effect of Estetrol (E4) 15 or 20 mg, or
      placebo on the severity and frequency of vasomotor symptoms (VMS) (Efficacy Study Part) and
      the safety of E4 20 mg (Safety Study Part).
    

Detailed description: 
      This is a two-part study:

        -  The first part is the Efficacy Study mainly designed to evaluate the frequency and
           severity of vasomotor symptoms [VMS] in both hysterectomized and non hysterectomized
           postmenopausal participants after treatment with two doses of E4 (15 mg or 20 mg) or
           placebo for 12 consecutive weeks. Thereafter, treatment will proceed for a total
           duration of up to 53 weeks, to continue the evaluation of secondary efficacy, safety and
           the effect on the endometrium. For endometrial protection, all non-hysterectomized
           subjects will receive treatment with 200 mg progesterone (P4) once daily for 14
           consecutive days, after completion of the E4/placebo treatment.

        -  The second part is the Safety Study designed to evaluate the general safety, secondary
           efficacy (lipid and glucose metabolism, health-related quality of life [HRQoL] and
           treatment satisfaction [TS]) after treatment with E4 20 mg for up to 53 weeks in
           hysterectomized and non hysterectomized postmenopausal participants. For endometrial
           protection, all non-hysterectomized subjects will receive treatment with 200 mg
           progesterone (P4) once daily for 14 consecutive days, after completion of the E4
           treatment.
    

Intervention name(s): Estetrol oral tablet; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Estetrol oral tablet will be administered orally once daily.; Placebo oral tablet will be administered orally once daily.
Other intervention name(s): E4 oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 3 blinded arms in the Efficacy part and 1 open-labeled arm in the Safety part.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Estetrol; Hot Flushes; Vasomotor symptoms
Weekly Dosing of Malarone ® for Prevention of Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Malarone ®, which is a drug approved to
      prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.
    

Detailed description: 
      In this study, two groups of volunteers will be exposed to malaria through the bites of
      infected mosquitoes. In one group, volunteers will be randomly assigned to one of 5 arms.
      Each of these arms will receive a different dose of Malarone®, a drug known to prevent
      malaria when taken daily. Each of these doses will be lower than the maximum approved dose of
      this medicine. The other group will not be treated with any drug that could prevent symptoms
      or infection.

      After exposure, both groups will be monitored for a period of approximately 3 months to see
      if they develop symptoms of malaria. Any subjects who do so will be treated with appropriate
      medications. Subjects in both groups will have their blood checked regularly during this
      period for the presence of malaria parasites. At the completion of the study, results will be
      analyzed to determine whether any of the doses of Malarone might effectively prevent malaria
      if taken weekly rather than daily.
    

Intervention name(s): Atovaquone Proguanil; Procedure - malaria challenge
Intervention type(s): Drug; Other
Intervention description(s): Volunteers will receive doses of atovaquone/proguanil (Malarone) or matching sugar pills.; 2) Procedure- Malaria Challenge- Volunteers will be exposed to bites of infectious mosquitoes with the intention of causing malaria infection. Volunteers infected with malaria will undergo approved treatments for malaria.
Other intervention name(s): Malaria; Prophylaxis; Atovaquone; Malarone; Challenge; Malaria; Prophylaxis; Atovaquone; Malarone; Challenge
Intervention MeSH terms: Atovaquone; Proguanil; Atovaquone, proguanil drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Malaria; Prophylaxis; Atovaquone; Malarone; Challenge
KineSpring® System Patient Preference Study
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis, Knee
Study type: Observational

Summary: 
      The primary objectives of the survey are to obtain patient preference information that can be
      useful during the benefit-risk assessment of the KineSpring System.
    

Detailed description: 
      Well-established, quantitative research methods were employed to understand the relative
      importance of effectiveness, safety, and other characteristics of orthopedic surgical
      treatments and develop a benefit-risk model to inform regulatory decision making.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Internet panelists, who self-reported that they or another adult in their household has osteoarthritis, were sent an email invitation to the survey site.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Males and females aged 25 to 80 years old diagnosed with osteoarthritis in the knee