bioihbjkbjnl/mcl2 huggingface dataset:
A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)
Condition: Osteoporosis; Vitamin D Deficiency
MeSH terms: Osteoporosis; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the safety, tolerability, and effectiveness of an
      investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and
      deficiency during treatment of osteoporosis in men and postmenopausal women.
    


Intervention name(s): MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks
Intervention type(s): Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D; Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic
      parameters of CellCept in patients undergoing primary kidney transplantation, in order to
      assess the impact on clinical outcome and the risks of acute rejection. All patients will
      receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters
      will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24
      weeks.
    


Intervention name(s): mycophenolate mofetil; antibody induction; Cyclosporine; corticosteroid
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 g PO BID for 24 weeks; According to manufacturer recommendation; According to manufacturer recommendation; According to manufacturer recommendation
Other intervention name(s): CellCept
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Antibodies; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Enhancing Inhibition With tDCS in Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This cross-over study intends to use consecutive days of active versus sham transcranial
      direct current stimulation (tDCS) to enhance descending inhibition and look at resulting
      clinical effects in people with low back pain.
    


Intervention name(s): High-Definition Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Device uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Umbilical Cord Blood Stem Cell Transplantation in Adults With Advanced Blood Disorders or Cancer
Condition: Hematologic Neoplasms
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Umbilical cord blood is an important source of stem cells and can be used to treat blood and
      immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord
      blood have been shown to be effective in treating illness in children, but more research is
      needed to confirm the benefit of this procedure in adults. The purpose of this study is to
      examine the immune system response to cord blood stem cell transplantation in adults with
      advanced blood disorders or cancer.
    

Detailed description: 
      The use of umbilical cord blood stem cells to treat blood disorders and cancer is an
      important medical advance; currently, more than 45 disorders can be treated with this method.
      While bone marrow transplants are the most common method for stem cell donations, research
      has shown that there are many advantages to using allogeneic grafts of stem cells obtained
      from umbilical cord blood. Cord blood stem cells are relatively easy to obtain. Additionally,
      a perfect donor match is not necessary, thereby decreasing the likelihood of
      graft-versus-host disease (GVHD), a serious side effect in which donor stem cells attack the
      recipient's tissues. Cord blood has been used successfully in pediatric patients but its
      benefit in adults remains untested. The purpose of this study is to evaluate the
      effectiveness of umbilical cord blood stem cell transplantation in adults with advanced blood
      disorders or cancer. Upon receiving an allogeneic stem cell transplant using umbilical cord
      blood, participants will be observed for successful engraftment in which the transplanted
      stem cells "take" and begin producing new blood cells. The incidence of GVHD and the overall
      immune system's response will also be examined. In turn, these findings may guide future
      umbilical cord blood stem cell clinical trials.

      This 1-year study will enroll individuals with advanced blood diseases or cancer.
      Participants will receive an allogeneic umbilical cord blood stem cell transplant and will be
      closely monitored while in the hospital to determine when engraftment occurs and if GVHD
      develops. Study visits will occur at Months 1, 2, 3, 6, 9, and Year 1. At each visit,
      participants will have blood drawn for laboratory testing and for evaluation of immune system
      response. Quality of life questionnaires will also be completed at each visit.
    

Intervention name(s): Stem Cell Transplantation
Intervention type(s): Procedure
Intervention description(s): Allogeneic umbilical cord blood stem cell transplant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematological Malignancies; Leukemia; Lymphoma; Myelodysplasia; Multiple Myeloma
Effect of Endoplasmic Reticulum Stress on Metabolic Function
Condition: Insulin Resistance; Diabetes; Obesity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Normally, the hormone insulin works to help keep blood sugar normal. However, as a person
      gains weight, insulin does not work as well and blood sugar tends to be a little higher than
      normal. This is called "insulin resistance".

      Two investigational drugs (not approved by the Food and Drug Administration) for the
      treatment of high lipid levels or insulin resistance are being examined in this study: one
      drug is called tauroursodeoxycholic acid (TUDCA), the other is called sodium phenylbutyrate
      (PBA). This study is designed to test if TUDCA and/or PBA is effective in people who are
      obese with insulin resistance and high lipids. We hypothesize that pharmacologically-induced
      decreases in ER stress will improve insulin action and hepatic lipid metabolism in obese
      subjects.
    

Detailed description: 
      A 4-week randomized, controlled trial will be conducted to evaluate the following specific
      aims in obese subjects:

      Determine the effect of treatment with TUDCA or PBA on:

        1. Body fat distribution: a) intrahepatic triglyceride (IHTG) content, b) intramyocellular
           triglyceride (IMTG) content, and c) intra-abdominal fat content, assessed by using
           magnetic resonance spectroscopy and magnetic resonance imaging.

        2. In vivo insulin sensitivity in adipose tissue (suppression of lipolysis), liver
           (suppression of glucose production), and skeletal muscle (stimulation of glucose
           uptake), assessed by using the hyperinsulinemic-euglycemic clamp procedure in
           conjunction with stable isotope tracer infusion.

        3. VLDL-triglyceride (TG) and VLDL-apolipoprotein-B100 (apoB-100) secretion rates, assessed
           by stable isotopically labeled tracer infusion methods.

        4. Skeletal muscle intracellular insulin signaling, fatty acid oxidation, and markers of
           inflammation, assessed by evaluating skeletal muscle biopsies ex vivo.

        5. Adipose tissue insulin signaling, ER stress, and inflammation, assessed by evaluating
           adipose tissue biopsies ex vivo.
    

Intervention name(s): tauroursodeoxycholic acid; placebo; sodium phenylbutyrate
Intervention type(s): Drug; Other; Drug
Intervention description(s): 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner.; 7 pills daily for 4 weeks; 20g/day for four weeks.
Other intervention name(s): TUDCA; PBA
Intervention MeSH terms: Ursodoxicoltaurine; 4-phenylbutyric acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: obesity; insulin resistance; type II diabetes
Alpha-Bisabolol Gel With Antihistamine Action
Condition: Wounds and Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      It will be developed and evaluated the antihistamine potential of a gel containing
      alpha-bisabolol. Method: Interventional and cross-sectional study, with convenience sampling,
      conducted with 20 volunteers. The forearm will be sensitized at four points (A, B, C and D).
      Point A: positive control will be sensitized with a drop of histamine at a concentration of
      10 mg / Ml. Point B: histamine will apply and immediately after, the alpha bisabolol gel with
      a concentration of 0.5%. Point C: histamine and gel with 2.5% alpha-bisabolol will apply.
      Point D will be sensitized with a drop of histamine and 5.0% alpha-bisabolol gel. The test
      reading at each point will occur 15 minutes after the procedure. For the analysis of the
      results, the T Test will be applied.
    

Detailed description: 
      Context:. Phytotherapy has been widely used to treat health with a prophylactic, curative and
      palliative purpose due to its easy access and low cost when compared to other available drug
      forms. Some plant species have antiallergic and anti-inflammatory properties that can be used
      to help contain signs and damage in allergic reactions, triggered mainly by histamine such
      as: pain, redness, heat and edema. Alpha-bisabolol, extracted from Candeia, has several
      applications in the treatment of illnesses, however, there are no studies on the therapeutic
      potential for antihistamine. Objective: To develop and evaluate the antihistamine potential
      of a gel containing alpha-bisabolol. Method: Pilot study, interventional, cross-sectional
      study, with convenience sampling, conducted with 20 volunteers. The forearm will be
      sensitized at four points (A, B, C and D). Point A: positive control sensitized with a drop
      of histamine at a concentration of 10 mg / Ml. Point B: histamine will be applied and
      immediately after, the alpha bisabolol gel with a concentration of 0.5%. Point C: histamine
      and gel with 2.5% alpha-bisabolol will be applied. Point D will be sensitized with a drop of
      histamine and 5.0% alpha-bisabolol gel. The test reading at each point will occur 15 minutes
      after the procedure. For the analysis of the results, the T Test will be applied.
    

Intervention name(s): Alpha bisabolol gel
Intervention type(s): Biological
Intervention description(s): Using alpha bisabolol gel with a concentration of 0.5%, 2,5% or 5% to treat sensitized area with histamine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Histamine Antagonists; Phytotherapy; Wounds and injuries; Bites and Stings; Plant Oils
Optimizing Aspirin and Clopidogrel Therapy (BOchum CLopidogrel and Aspirin Plan)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Dual antiplatelet therapy with acetylsalicylic acid (ASA, aspirin) and clopidogrel is of
      great importance for treatment following coronary stenting. Unfortunately the variable
      platelet inhibitory effectiveness compromises the antithrombotic benefit of dual antiplatelet
      therapy. The aim of this prospective single centre study was to reduce the low response
      incidence of dual antiplatelet therapy with ASA and clopidogrel based on a standardized
      therapy algorithm.
    

Detailed description: 
      Platelet function testing using whole blood aggregometry was performed 48 hours following
      coronary stenting (either acute coronary syndromes or stable coronary artery disease). The
      antiplatelet therapy included a loading dose of 600 mg clopidogrel and 500 mg ASA, followed
      by 75 mg clopidogrel and 100 mg ASA once daily. Clopidogrel low-response (CLR) and/or ASA
      (ASA low response) were treated according to a structured therapy plan.
    

Intervention name(s): Optimizing ASA and clopidogrel treatment
Intervention type(s): Drug
Intervention description(s): ASA 100 mg, ASA 300 mg, ASA 500 mg
Clopidogrel 75 mg, Clopidogrel 150 mg, Ticlopidine 2x 250 mg, Prasugrel 10 mg. Intervention List:
In the case of clopidogrel low-response, the maintenance dose was doubled (repeated loading dose followed by 150 mg daily), and when still ineffective ticlopidine or prasugrel, if available and not contraindicated, were used. ASA low-responders were treated by increasing the dose to 300 mg in a first step or to 500 mg ASA when the first modification was not sufficient.
Other intervention name(s): ASA (aspirin), Clopidogrel (Plavix)
Intervention MeSH terms: Clopidogrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clopidogrel; ASA; Low Response; Resistance
Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor
Condition: Epidural Analgesia; Painless Labor; Dexmedetomidine; Fentanyl; Levobupivacaine
Study type: Interventional
Phase: Phase 4

Summary: 
      Central neuraxial analgesia has been extensively used for labor analgesia and is currently
      the gold standard technique for pain control in obstetrics.

      The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives
      to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and
      safety.
    


Intervention name(s): levobupivacaine; Dexmedetomidine; Fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The patients will receive 15 ml of 0.125% levobupivacaine.; The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.; The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes. Each group will include 30 patients.
Group C (Control group): Epidural analgesia with levobupivacaine alone Group D (Dexmedetomidine group): Epidural analgesia with levobupivacaine and dexmedetomidine Group F (Fentanyl group): Epidural analgesia with levobupivacaine and fentanyl
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Global Hip Versus Isolated Abductors Strengthening Exercises in Patients Withsecondary Piriformis Syndrome
Condition: Piriformis Syndrome
MeSH terms: Piriformis Muscle Syndrome; Syndrome
Study type: Interventional

Summary: 
      The study will be a randomized controlled trial. Twenty-four subjects will be assigned
      randomly by using the lottery method into two groups. Group A will be given a hot pack in
      addition to the global hip muscles strengthening exercise while group B is the control group
      which will receive a hot pack in addition to hip abductor strengthening. The time duration
      will be 6 weeks. Pain intensity will be assessed by NPRS.3 sessions per week will be given
      for 6 weeks. Outcome measures will be taken at baseline, in 3rd week, and at the end of the
      6th week.
    

Detailed description: 
      Secondary piriformis syndrome is a common condition of extra-spinal sciatica which is related
      to or around the piriformis muscle and irritates the sciatic nerve. Most cases reported are
      of secondary piriformis syndrome. Secondary piriformis syndrome is caused due to soft tissue
      inflammation, and muscular spasms, which result in nerve compression. Inflammation occurs due
      to trauma on the buttock and piriformis muscle contractures. Strengthening exercise program
      is another physical technique that has been supported by research in numerous areas, which
      has effects on the reduction of pain, range of motion, and lower extremity function. This
      study will aim to compare the effects of global hip muscles and isolated hip abductors muscle
      strengthening exercise programs on pain, range of motion, and lower extremity function in
      patients with secondary piriformis syndrome. The study will be a randomized controlled trial.
      Twenty-four subjects will be assigned randomly by using the lottery method into two groups.
      Group A will be given a hot pack in addition to the global hip muscles strengthening exercise
      while group B is the control group which will receive a hot pack in addition to hip abductor
      strengthening. The time duration will be 6 weeks. Pain intensity will be assessed by NPRS.3
      sessions per week will be given for 6 weeks. Outcome measures will be taken at baseline, in
      3rd week, and at the end of the 6th week. The collected data will be analyzed in the
      statistical package for the Social Sciences (SPSS) 25.Parametric/Non-parametric tests will be
      applied after testing the normality of the data.
    

Intervention name(s): Global hip muscles strengthening exercises; Hip abductors strengthening exercises
Intervention type(s): Other; Other
Intervention description(s): Strengthening exercises will be given to all hip muscles; Strengthening exercises will be given to hip abductor muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Trial Ruxolitinib and Peg-interferon Alpha-2a Combination in Patients With Primary Myelofibrosis RUXOPeg
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase 1/2, open-label, multi-center, trial, aiming at to identify the most efficacious dose
      combination that also satisfies certain safety requirements. It consists in a dose finding
      study to assess the safety of the combination of different doses of both ruxolitinib and
      peg-IFN alpha-2a, and a secondary randomized evaluation of the optimal doses found in the
      first part of the study to a total maximal number of 42 evaluable patients.
    

Detailed description: 
      Part 1 is a dose finding phase 1 trial that assesses the safety of the combination of
      different doses of both ruxolitinib and peg-IFN alpha-2a

      Part 2 is a phase 2 randomized evaluation of the optimal doses found in the first part of the
      study to a total maximal number of 42 evaluable patients.

      It will use the Bayesian Phase 1/2 adaptively randomized design proposed by Yuan and Yin
      (2011) for combined drugs.The trial will examine three doses of ruxolitinib: 10, 15 and 20 mg
      BID and three doses of the peg-IFN alpha-2a: 45, 90, and 135 mcg/week). The starting doses
      for each drug have been selected based on prior monotherapy experience where these doses have
      shown some degree of clinical activity as single agents and pharmacodynamic data supports the
      activity observed. In the interest of patient safety, both of these compounds will start at
      dose levels at or near 50% of their respective maximum tolerated doses.
    

Intervention name(s): Ruxolotinib; peg-IFN alpha -2a
Intervention type(s): Drug; Drug
Intervention description(s): Ruxolitinib is administered orally twice a day (bid) everyday in 28-day treatment cycles. The starting dose is 10 mg BID and may go up to 20 mg BID. Ruxolotinib therapy starts on Cycle 1 day 1.; Peg-IFN-alpha-2a is administered subcutaneously once a week. The doses tested are 45, 90 and 135 mcg/week. .Peg-IFN-alpha-2a therapy starts at Cycle 1Day 15.Of note, Peg-IFN-alpha-2a will only be started if the platelet count is ≥ 50x109/L at C1D15.
Other intervention name(s): Jakavi; Pegasys
Intervention MeSH terms: Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: efficacy; safety
STUDIO DELLE MANIFESTAZIONI CARDIOVASCOLARI A LUNGO TERMINE MEDIANTE TECNICHE DI IMAGING
Condition: Cardiac Complication; COVID-19 Pneumonia
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      The aim of the project is to identify the prevalence and characteristics of long-term
      cardiovascular changes in Covid-19 infection.
    

Detailed description: 
      In the follow-up of patients with Covid-19 infection, persistence of cardiovascular symptoms
      is common. Studies of the acute phase of Covid-19 infection have shown a significant
      prevalence of acute myocardial damage (15-44%), and imaging studies have confirmed the
      presence of structural changes in the pericardium and myocardium several months after the
      acute phase.

      The aim of the project is to identify the prevalence and characteristics of long-term
      cardiovascular changes in Covid-19 infection.

      The study is a continuation of the project "Registry "CARDICoVRISK"" which collected data on
      cardiovascular changes during the acute phase and shortly after the acute phase. The study
      design is retrospective observational. The study plans to enroll 240 patients hospitalized
      during the acute phase of COVID-19 infection. Patients will be collected at three separate
      centers. Enrolled patients will undergo a baseline evaluation by history, physical
      examination, laboratory tests, ECG, 6-minute walking test and echocardiogram.

      If alterations in left ventricular or right ventricular systolic function are found, as per
      the standard clinical approach, a cardiac MRI examination will be evaluated.

      Identification of patients with cardiac changes is of paramount importance as they may
      benefit from early initiation of cardioprotective therapy and may need different follow-up
      strategies.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patient with previous hospitalization for Covid-19 infection