bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Structure Modifying Effect of Avocado-Soybean Unsaponifiables in Hip Osteoarthritis
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to assess the long term (three years) ability of ASU (Avocado Soya
      unsaponifiable) to slow the decrease of radiographic JSW (Joint Space Width) in hip
      osteoarthritis (OA). This is a randomized, double blind, comparative, parallel group study
      versus placebo.
    

Detailed description: 
      Inclusion criteria:

      Primary hip OA, fulfilling ACR criteria, patient over 45 y, painful > 1 year, Lequesne's
      index > or equal to 3, with minimum JSW at the target hip > 1 mm and < 4 mm on pelvic
      radiograph.

      Primary criterion of efficacy:

      The main criterion of efficacy is the change of JSW between baseline and end point. JSW is
      measured on the narrowest joint on pelvic or target hip X ray by blinded reader.

      Randomisation is stratified according JSW at baseline (< 2,5 mm or > or equal to 2,5 mm).

      Statistical analysis:

      The Full Analysis Set (FAS) is defined by patients with at least one baseline value and one
      post baseline value.

      The main analysis is scheduled on FAS using a Missing At Random (MAR)with a multiple model
      repeated measure (MMRM)to take in account missing value.

      SAP (Statistical Analysis Plan) schedule to analyse JSW change as quantitative variable using
      an ANCOVA and as qualitative variable (progressors defined as JSW loss upper than 0,5 mm)
      using Mantel Haentzel test.
    

Intervention name(s): ASU
Intervention type(s): Drug
The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood
Condition: Hyperglycemia; Lack of Satiety
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to develop and test modified milk protein products to determine
      the effects of amino acids on food intake, satiety, insulin secretion and glucose control by
      insulin-independent action in healthy adults.
    

Detailed description: 
      1. A total of 33 males and females will participate in the study. Capillary blood samples
           will be collected from all participants to measure plasma glucose over a 3.5 hour
           postprandial study.

        2. Intravenous blood samples will be collected from a subset of 12 (6 males and 6 females)
           participants for determination of insulin, satiety hormones, acetaminophen (gastric
           emptying rates), and determination of amino acid profiles.
    

Intervention name(s): Skim milk products
Intervention type(s): Other
Intervention description(s): Milk treatments will be served with 58g of breakfast cereal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: satiety; glycemia; milk protein
The Effect of Rituximab on the Development of Anti-Donor Antibodies
Condition: Renal Transplant Rejection
Study type: Interventional

Summary: 
      The aim of the study is to find out if Rituximab, which is an antibody against specific white
      cells involved in rejection, when combined with standard anti-rejection treatment can more
      effectively reverse the rejection process.

      Our hypothesis is that with acute rejection there is activation of B cells and the subsequent
      development of anti-donor antibodies that ultimately lead to graft loss. More effective
      therapy targeted at B cells may abort the development of anti-HLA antibodies, prevent renal
      injury and have a favorable effect on long-term graft outcome.
    

Detailed description: 
      This is a two center, randomized pilot study of the effects of Rituximab on treatment of
      acute rejection. A total of 24 patients (including patients transplanted at University of
      California San Francisco and University of Alabama Birmingham) will be enrolled in the study,
      16 randomized to Rituximab and 8 to no-Rituximab (control arm). Fifteen (15) subjects will be
      recruited at UCSF with 10 patients randomized to Rituximab and 5 to no-Rituximab (control
      arm). If either center is a slow enroller the patient mix could be altered.

      Procedures:

      This is an open label trial of patients with rejection with B cell infiltrates on kidney
      biopsy who will be randomized to either receive Rituximab or no Rituximab in and 2:1 ratio.
      Patients who have rejection on kidney biopsy and on immunohistochemistry there is evidence of
      B cells infiltration will be enrolled in the study and randomized 2:1 to receive Rituximab or
      no Rituximab. Rituximab will be administered in 2 doses of 1,000 mg. The first dose will be
      administered while the patient is still in the hospital being treated for rejection and the
      second dose will be administered 2 weeks later in the outpatient facility in the GCRC at
      UCSF. The patients' acute rejection episode will be treated according to standard therapy as
      per the treating transplant physician. Below is the table (table 1) detailing when the
      patient will have blood drawn for flow cytometry, anti-HLA antibodies, PK studies, serum
      creatinine as well as 24 hour urine protein. At 3 months after enrollment in the study, the
      patient will undergo a follow-up biopsy to determine the extent of the resolution of the
      cellular infiltrate.
    

Intervention name(s): Rituximab; No Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): Rituximab infusion on Day 1 and Day 15; No Rituximab
Other intervention name(s): Rituxan
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rituximab; Renal Transplant Rejection; B cells; Patients with biopsy proven acute rejection cellular infiltrate, B cells
Wellness Action Plan Trial Addressing Childhood Obesity
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The objective of this study was to determine the effectiveness of a novel Wellness Action
      Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing
      follow-through with plans and 3) aiding parents in identifying their child's weight category.
    


Intervention name(s): Wellness Action Plan
Intervention type(s): Behavioral
Intervention description(s): The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pediatric Obesity; Body Mass Index; Weight Perception; Counseling; Health Behavior
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall objective of this study is to assess the safety and efficacy of high dose and low
      dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks
      to children and adolescents with mildly-to-moderately active ulcerative colitis.
    


Intervention name(s): Asacol 400 mg; Asacol 400 mg
Intervention type(s): Drug; Drug
Intervention description(s): High dose:
17-<33 kg = 3 Asacol 400mg in morning and 2 Asacol 400 in PM, 33-<54 kg = 5 Asacol 400mg in morning and 4 Asacol 400 in PM, 54-<90 kg = 6 Asacol 400mg in morning and 6 Asacol 400 in PM; Low dose:
17-<33 kg = 2 Asacol 400mg + 1 placebo in morning and 1 Asacol 400 +1 placebo in PM, 33-<54 kg = 3 Asacol 400mg +2 placebo in morning and 2 Asacol 400 + 2 placebo in PM, 54-<90 kg = 3 Asacol 400mg + 3 placebo in morning and 3 Asacol 400mg + 3 placebo in PM
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Determine the Safety, Tolerability, and Pharmacokinetics of GDC-0310 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single and multiple
      orally ascending doses of GDC-0310 administered in healthy participants as 4 parts including
      Part 1- a single dose (SD) part using a powder-in-capsule (PIC) formulation, Part 2- a
      multiple dose (MD) part using a PIC formulation, Part 3- a SD part using a solution
      formulation, and Part 4- a MD part using a solution formulation. Effects of food on
      pharmacokinetics (PK) will also be explored.
    


Intervention name(s): GDC-0310; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.; Participants will receive placebo matched to GDC-0310 as single or multiple oral dose in fasted or fed state.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      This study aims to investigate metabolic effects of a standardized green tea extract,
      containing a defined amount of epigallocatechin-3-gallate (EGCG), in multiple sclerosis
      patients.
    


Intervention name(s): Capsules with 160 mg Teavigo (at least 94% EGCG); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily intake of 600 mg EGCG for 3 months; Daily intake of placebo capsules for 3 months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Multiple sclerosis; Green tea extract; Metabolism
Purpose Project: Reclaiming Life Purpose After Breast Cancer (Feasibility Study)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The Purpose Project intervention is an 8-session progressive structure that was developed
      based on theoretical and scientific evidence from psychology and occupational therapy. The
      goal of the intervention is to provide participants with information, tools, and support that
      help them move towards reclaiming a sense of self-grounded purpose in daily life. The study
      will use a convenience sample of women with breast cancer to evaluate the feasibility of the
      Purpose Project intervention in terms of demand/acceptability, implementation, and
      limited-efficacy testing. Findings will be used to inform a later study to evaluate the
      efficacy of the Purpose Project intervention.
    


Intervention name(s): Purpose Project
Intervention type(s): Behavioral
Intervention description(s): The purpose project intervention 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in life that helps them flourish.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Ivermectin and Human Immunity
Condition: Ivermectin
Study type: Interventional
Phase: Early Phase 1

Summary: 
      We hypothesize that ivermectin, a drug used to treat parasitic worm infections, interacts
      with the human innate immune system and that this contributes to its anti-parasitic effects.
      Participants will donate blood before and after being administered the normal human dose of
      the drug. We will compare the cell types present in the blood and the chemicals known to
      influence the human immune system before and after the drug is given, as well as measuring
      any changes in gene expression in white blood cells 4 and 24hrs after the drug is taken.
    

Detailed description: 
      Subjects will visit the University of Georgia (UGA) Clinical & Translation Research Unit
      (CTRU) twice on consecutive days and blood will be drawn from them. On the first occasion
      they will be weighed and will complete the consent process. They will have been randomly
      assigned to the test (Stromectol) or control (placebo) group, with 8 participants in the test
      group and 4 participants in the control group. Stromectol will be obtained from a medical
      supply distributor and a placebo will be obtained through the UGA School of Pharmacy. Drugs
      will be prescribed by Jonathan Murrow MD. They will be stored in their original packaging at
      room temperature in a drug locker in the lab at CTRU. Participants will be identified by
      number and allocated to groups using a block randomization protocol. Randomization and drug
      dispensation will be done by CTRU. Eighteen ml of blood will drawn in a fasting state and
      they will be administered 150 mcg/kg Stromectol or the equivalent number of placebo tablets
      immediately after blood is drawn. Participants will remain at CTRU for four hours after they
      take the drug, then another 15ml of blood will be drawn. On the second day they will attend
      CTRU at the same time and the third blood sample will be drawn 24 hrs after administration of
      the drug. On each occasion the drawn blood will be coded by CTRU staff prior to being
      collected by a member of the Department of Infectious Diseases and taken to the laboratory
      (Wildlife Health G0007) for the isolation of leukocyte populations (peripheral monocytes,
      lymphocytes and polymorphonuclear cells (PMNs)) and for the preparation of serum. Complete
      blood counts will also be carried out. Sera will be analyzed on the Luminex for
      cytokine/chemokine content. RNA will be isolated from the cell populations for RNASeq
      analysis.
    

Intervention name(s): Ivermectin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 150 mcg/kg ivermectin, by mouth.; An oral placebo will be administered, once
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Fascial Distortion Model With And Without Neck Isometrics In Patients With Cervical Spine Overload
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Cervical spine pain is the one the most common musculoskeletal disorder and spinal overload
      is one of the major causes. Forward tilting of every inch of head increases load on the
      cervical spine and is referred as cervical spine overload. Persistent overloading and
      overburdening results in radiation of pain, weakness of muscles and limitation in joint
      range.

      Psychological factors are also play role in acute, sub-acute or chronic neck pain. Treatment
      commonly used for this pain is NSAID, physiotherapy interventions (mobilisation,
      manipulation, TENS, ultrasound, stretching, isometrics and FDM) and awareness about posture.
      FDM was established in 1991 by Stephan Typaldos and it recommends that musculoskeletal
      ailments are due to disruption in fascia. There are 6 diverse proposed facial distortions and
      diagnosis in this model i.e., trigger band, herniated trigger band, folding distortion,
      continuum distortion, tectonic fixation and cylinder distortion. Main purpose of this
      randomised clinical trial will be to find out the effects of fascial distortion model with
      and without neck isometrics in patients with cervical spine overload.

      Patients will be recruited into study by consecutive sampling technique and after that
      patients will be allocated to the groups by random sampling assignment. NPRS, NDI and
      goniometer will be used as data measuring tool. Treatment will be given to 2 groups. One
      group will get treatment of only FDM and other group will get treatment of FDM and neck
      isometrics as well. Treatment will be given two times a week for 4weeks and duration of the
      session will be of 30 minutes. After collecting data from defined study setting, data will be
      entered and analyzed by using Statistical Package for the Social Sciences (SPSS) for Windows
      software, version 25. After assessing normality of data by Shapiro-Wilk test, it will be
      decided either parametric or non-parametric test will be use within a group or between two
      groups.
    


Intervention name(s): FDM with isometrics; FDM without isometrics
Intervention type(s): Other; Other
Intervention description(s): FDM with isometrics will be done; FDM without isometrics will be done
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      OSTEOFORM, containing recombinant (rhPTH [1-34]), enhances bone mineral density and reduces
      risk for vertebral fracture. This study evaluates the safety and efficacy of OSTEOFORM in the
      treatment of osteoporosis in post-menopausal women.
    

Detailed description: 
      207 post-menopausal women were enrolled for screening at 6 centres, and supplemented with
      daily 1000 mg elemental calcium and 500 IU of vitamin D for 45 days. 82 eligible women with
      osteoporosis were randomly received daily either calcium and vitamin D alone (control group)
      or Osteoform 20 µg subcutaneously with calcium and vitamin D (drug group) for 12 months. End
      points such as percentage of increase in bone mineral density and, changes in bone biomarkers
      (serum osteocalcin, bone specific alkaline phosphatase, and urinary DPD) were evaluated at
      baseline, and 6 and 12 months after supplementation. Besides, safety parameters and adverse
      events were monitored through out the study period.
    

Intervention name(s): Osteoform; SHELCAL
Intervention type(s): Drug; Drug
Intervention description(s): Administer Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days; Administer calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days
Other intervention name(s): Calcium and vitamin D
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rhPTH(1-34); Osteoporosis
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Open Label Extension (CT04 OLEP)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of ascending oral doses
      of CHF 5074 after prolonged administration to patients with mild cognitive impairment.
    


Intervention name(s): CHF 5074 1x; CHF 5074 2x; CHF 5074 3x
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral tablet, 1x, once a day in the morning for 24 weeks; oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 20 weeks; oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 16 weeks
Intervention MeSH terms: 1-(3',4'-dichloro-2-fluoro(1,1'-biphenyl)-4-yl)cyclopropanecarboxylic acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RIRS Versus ESWL for the Treatment of Renal Stones
Condition: Renal Stones
MeSH terms: Kidney Calculi; Nephrolithiasis
Study type: Interventional

Summary: 
      To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL
      (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20
      mm size.
    

Detailed description: 
      European urological guidelines consider RIRS and ESWL the treatments of choice for renal
      stones < 20 mm. RIRS is a endoscopic surgery which allows to rich the kidney from the ureter.
      A flexible ureteroscope is used for these kind of procedure. Through this device a laser
      fiber (Holmium laser) is used to treat the stones. After that, small fragments can be removed
      with a basket. In some cases, according to intraoperative findings, a ureteral stent can be
      push in the kidney to help the drainage of the kidney. ESWL is a procedure which allows to
      treat the stones by shock waves generated by a specific machine which work in direct contact
      with the skin of the patients (extracorporeal). Shockwaves pass all the tissues and finally
      reach the stones. Such energy allows to break the stones in small fragments, that wll be
      spontaneously passed by the patients. Specific parameters of these treatments are discussed
      in "Arms and Interventions". Many studies demonstrated high success rate of RIRS and this
      technique is becoming more and more adopt. One study demonstrated better outcomes of RIRS
      versus ESWL, but only for renal stones located in the inferior calices and smaller then 10
      mm. There are not other studies comparing the two procedures and there are not proofs that
      RIRS ensures better outcomes for other renal stones (neither for size nor for location).
    

Intervention name(s): RIRS; ESWL; Rigid and flexible ureteroscope; Lithotripter; Holmium laser; Basket for fragment removal; General or spinal anesthesia; Intravenous pain medication; X-ray; Ultrasound
Intervention type(s): Procedure; Procedure; Device; Device; Device; Device; Procedure; Drug; Device; Device
Intervention description(s): Treatment by ureterorenoscopy (RIRS) and laser lithotripsy; Treatment by extracorporeal shock waves lithotripsy; If required by the patient; To focus the stone; To focus the stone
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ureterorenoscopy; extracorporeal shock waves lithotripsy