bioihbjkbjnl/mcl2 huggingface dataset:
Anti-Carbamylated Protein Antibodies in Psoriatic Arthritis
Condition: Psoriasis; Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis
Study type: Interventional

Summary: 
      Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of
      the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein
      antibody and who may therefore have psoriatic arthritis. The investigators hypothesized that
      detection of anti-CarP antibodies in serum may be useful for diagnosis of psoriatic
      arthritis.
    


Intervention name(s): Serum anti-CarP antibodies detection
Intervention type(s): Diagnostic Test
Intervention description(s): Serum anti-CarP antibodies detection using an enzyme-linked immunosorbent assay (ELISA) from Inova Diagnostics.
Intervention MeSH terms: Antibodies
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Allogeneic Stem Cell Transplantation for Advanced Neuroblastoma Using MHC Mismatched Related Donors
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Allogeneic stem cell transplantation has been explored for patients with high risk
      neuroblastoma. Results have been mixed, with only small series and case reports. Recent
      reports, however, especially with haploidentical transplantation have been more encouraging.
      Eradication of neuroblastoma may be mediated by both components of the innate immune system
      (natural killer cells) and through the adaptive immune system via T-cell cytotoxicity and the
      development of a humoral response to tumor specific antigens and minor histocompatibility
      antigens. To overcome restrictions created by unavailability of Human leukocyte antigen (HLA)
      matched donors, stem cell grafts from haploidentical related donors have been explored.
      Historically, the use of full haplotype mismatched family member donors has been limited by
      the development of severe graft-versus-host disease and the high rate of graft failure. Graft
      failure can now be overcome by increasing immunosuppression and increasing the number of
      transplanted stem cells. The most effective means of graft versus host disease (GVHD)
      prophylaxis is T cell depletion of the donor marrow. A 3-4 log depletion will reduce the risk
      of developing significant GVHD to less than 10%. Methods to mobilize stem cells from the bone
      marrow into the peripheral blood and collect these stem cells by apheresis now increase the
      availability of stem cells by a magnitude. Selection devices have been developed that will
      prepare extremely pure populations of these CD34 cells with upwards of 5 logs depletion of
      contaminating T cells. The CliniMACS CD34 Reagent System is a medical device designed to
      select CD34+ hematopoietic cells from heterogeneous hematologic cell populations. The
      investigators intend to provide mismatched related hematopoietic stem cell transplantation to
      up to 10 patients with relapsed refractory neuroblastoma. Harnessing the potential for innate
      and adaptive immune responses through allogeneic Hematopoietic stem cell transplantation
      (HSCT) may provide cure for some patients with this tumor.
    


Intervention name(s): CD34+ cells selected with the Miltenyi Clinimacs machine
Intervention type(s): Device
Intervention description(s): Haploidentical allogeneic stem cell transplant following sub-myeloablative conditioning and cell selection using the Miltenyi Clinimacs device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Neuroblastoma; Relapsed; Refractory
Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the
      acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will
      be tested by pretreating healthy individuals with PREG, and then assessing their responses to
      Dronabinol (THC).
    


Intervention name(s): Active Dronabinol; Active Pregnenolone; Placebo Dronabinol; Placebo Pregnenolone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20 mg capsule of Dronabinol will be administered orally; 1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue); Control: Placebo pill (no active cannabinoids) administered orally; Control: Placebo given sublingually (under the tongue)
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cannabis; Marijuana; THC; Dronabinol; Pregnenolone; PREG; Psychotic Disorders
A Single Dose Escalation Study of PCSK9 Inhibitor (JS002) in Health Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      JS002 is a recombinant humanized Anti- PCSK9 monoclonal antibody; This is a phase Ia,
      randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of a single subcutaneous injection of JS002 in healthy
      subjects.

      In this study, the dose ascending design includes five dose level cohorts (15 mg, 50 mg, 150
      mg, 300 mg, and 450 mg) administered by subcutaneous injection, and three intravenous
      administration cohorts (15 mg, 150 mg, and 450 mg). Each cohort will enroll 8 to 12 subjects
      (distribution of study drug and placebo in a 3:1 ratio).

      The duration of the study is 84-day per subjects.
    


Intervention name(s): JS002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JS002, Subcutaneous or intravenous injection of a single dose of JS002, dose cohort according to ascending dose design; Placebo,Subcutaneous or intravenous injection of a single dose of placebo, dose cohort according to ascending dose design
Other intervention name(s): Recombinant humanized Anti- PCSK9 monoclonal antibody; Placebo of Recombinant humanized Anti- PCSK9 monoclonal antibody
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Safety Study of Sirolimus and Hydroxychloroquine in Women With Lymphangioleiomyomatosis
Condition: Lymphangioleiomyomatosis
MeSH terms: Lymphangioleiomyomatosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Specific Aim 1: To investigate whether, in Lymphangioleiomyomatosis (LAM) patients, the
      combination of sirolimus and hydroxychloroquine is safe and well tolerated

      Specific Aim 2: To investigate whether, in LAM patients, 6 months of combination therapy with
      sirolimus and hydroxychloroquine results in improvement of indicators of disease, and whether
      the gains are sustained after stopping therapy.

      Specific Aim 3: To investigate the potential role of a LAM-specific peripheral blood
      signature to predict rates of disease progression and determine responsiveness to combination
      therapy.

      This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted
      to keep trough levels between 5-15 ng/ml) and hydroxychloroquine (200 mg or 400 mg) taken
      orally daily. Up to 18 adult women with LAM will be enrolled.
    

Detailed description: 
      This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted
      to keep trough levels between 5-15 ng/ml) and hydroxychloroquine (200 mg or 400 mg) taken
      orally daily for 6 months. The study is to be conducted at 2 sites. Up to 18 adult women with
      LAM will be enrolled, and each recruiting site will recruit between 8-12 subjects. The
      protocol will use the following eligibility criteria.
    

Intervention name(s): "Sirolimus" and "Hydroxychloroquine" 200 mg; "Sirolimus" and "Hydroxychloroquine" 400 mg
Intervention type(s): Drug; Drug
Intervention description(s): This will be a phase I dose escalation study of the combination of "Sirolimus" (2 mg adjusted to keep trough levels between 5-15 ng/ml) and "Hydroxychloroquine" 200 mg taken orally daily.; Once safety is established with the lower dose, (Sirolimus and Hydroxychloroquine 200 mg), subjects will receive Sirolimus 2 mg (adjusted to keep trough levels between 5 to 15 ng/ml) and hydroxychloroquine 200 mg twice a day.
Other intervention name(s): sirolimus(rapamune), hydroxychloroquine (plaquenil); Sirolimus (Rapamune), Hydroxychloroquine (plaquenil)
Intervention MeSH terms: Sirolimus; Hydroxychloroquine; Temsirolimus; MTOR Inhibitors
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LAM; TSC; lymphangioleiomyomatosis
Comparison of Inelastic and Elastic Lumbosacral Orthoses on Low Back Pain Prevention in Hospital Nurses
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The main objective of this study is to investigate the efficacy of two different design
      characteristics of lumbar support for low back pain prevention in hospital nurses.
    

Detailed description: 
      Low back pain occurs frequently and is one of the most costly health problems affecting
      industry and society. Prevention of low back pain is important both for the individual
      patient and from an economic perspective. Therefore, there are many measures available that
      claim to reduce low back pain and its recurrence. The most commonly used preventive
      strategies are fitness exercises, lumbar supports, education on back mechanics and lifting
      techniques, and ergonomic adjustments. However, their efficacy is still uncertain. The main
      objective of this study is to investigate the efficacy of two different design
      characteristics of lumbar support for low back pain prevention in hospital nurses.
      Investigators hope that those two types of lumbar support will reduce the incidence of low
      back pain and sick leave days. In addition, Investigators hypothesize that there are some
      differences on outcome measures between those two types of lumbar support. Enrolled subjects
      will be randomly assigned to one of the following three groups. The first group will wear an
      inelastic lumbar support for 6 months. The second group will wear an elastic lumbar support
      for 6 months. The third group will receive no intervention. After the completion of 6-month
      intervention, a further 6 months fellow-up will be added.
    

Intervention name(s): QUIKDRAW Pro, Aspen Medical Products; MUELLER 4581, Mueller Sports Medicine
Intervention type(s): Device; Device
Intervention description(s): Wearing an inelastic lumbar support (QUIKDRAW Pro, Aspen Medical Products) for 6 months; Wearing an elastic lumbar support (MUELLER 4581, Mueller Sports Medicine) for 6 months
Other intervention name(s): Lumbar belt, Lumbar orthoses, Lumbar brace; Lumbar belt, Lumbar orthoses, Lumbar brace
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Low Back Pain; Braces; Prevention
Dietary Linoleic Acid for Secondary Prevention of Coronary Heart Disease and Death in the Sydney Heart Study: an RCT
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The substitution of polyunsaturated fatty acids (PUFA) for saturated fatty acids (SFA) is a
      cornerstone of worldwide dietary advice for coronary heart disease (CHD) risk reduction.
      However, clinical CHD benefits specific to the omega-6 PUFA linoleic acid (LA), and distinct
      from omega-3 PUFAs, have not been established. The Sydney Diet-Heart Study (SDHS; 1966-1973)
      was a randomized controlled secondary CHD prevention trial testing whether selectively
      increasing omega-6 LA from safflower oil in place of SFA reduced CHD and improved survival. A
      full analysis of mortality outcomes has not been published. The investigators recovered the
      original SDHS dataset, which included detailed longitudinal dietary, smoking and coded
      mortality data, permitting evaluation of smoking relapse rates, and all-cause, CVD and CHD
      mortality outcomes by nutrient intake and duration of diet exposure. Data recovery also
      permitted the first complete meta-analysis of LA intervention trials on mortality outcomes.

      Objectives are (1) to evaluate whether increasing dietary linoleic acid alters CVD and CHD
      mortality, and (2) to assess whether changes in smoking relapse rates contribute to observed
      mortality differences.
    


Intervention name(s): Safflower oil
Intervention type(s): Other
Intervention description(s): Liquid safflower oil and safflower oil polyunsaturated margarine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer
Condition: Metastatic Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety of PD-1 knockout engineered T cells in treating
      metastatic non-small cell lung cancer. Blood samples will also be collected for research
      purposes.
    

Detailed description: 
      This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1
      knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to
      determine the maximal tolerant dose. After the lower number of cycles are considered
      tolerant, an arm of the next higher number of cycles will be open to next patients.
      Biomarkers and immunological markers are collected and analyzed as well.
    

Intervention name(s): Cyclophosphamide; PD-1 Knockout T Cells
Intervention type(s): Drug; Other
Intervention description(s): To deplete Tregs before collecting peripheral blood; Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
Other intervention name(s): Cytoxan
Intervention MeSH terms: Cyclophosphamide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung cancer; immune checkpoint; PD-1; CRISPR; autologous cell infusion
Physical Exercise Controls Gestational Weight Gain
Condition: Pregnancy
MeSH terms: Weight Gain; Gestational Weight Gain
Study type: Interventional

Summary: 
      An estimated two-thirds to three- quarters of women experience gestational weight gain
      outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30%
      inadequate gain. Not gaining the adequate weight gain is strongly associated with several
      maternal and fetal complications..
    

Detailed description: 
      The aim of this study was to assess the role of a supervised exercise programme on the
      control of maternal gestational weight gain and its consequences.
    

Intervention name(s): Exercise group
Intervention type(s): Behavioral
Intervention description(s): The physical conditioning program included a total of three 50-55 minute sessions per week. Pregnant women started at 9 weeks and finished at 38-39 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.
Each session included 10 min of warm up and 10 min of cool down which included an specific pelvic floor muscles training. The core section of the exercise session lasted from 25 to 30 min and included moderate-intensity aerobic exercises once a week and resistance exercises twice a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; Aerobic; Resistance training; Pregnancy; Maternal weight gain; IOM recommendations
A Study in People With Mild Hypertension
Condition: Mild Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to test the hypothesis that LY518674, administered for
      6 weeks to patients with mild hypertension, reduces Systolic Blood Pressure, compared with
      placebo.
    


Intervention name(s): PPAR alpha; Hydrochlorothiazide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Telemedicine for CPAP Therapy Control in OSA
Condition: OSA
Study type: Interventional

Summary: 
      Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure
      (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is
      complex. New communication technologies and the current health challenges, such as aging and
      high health care costs have encouraged the interest in new strategies.

      As showed recently, telemedicine is an alternative (Isetta, Thorax 2015) in patients that use
      internet and mobile technologies usually. However, there is a significant percentage of
      patients that does not use Internet and mobile technologies, only the 58% of patients over 65
      years uses them (Dorsey, NEJM 2016). Although evidence regarding telemedicine is conflicting,
      it suggest that it's applicability depends in patient's characteristics and it is necessary
      to personalize it to make it safe and effective (Takahashi, Arch Intern Med 2012). That's why
      the investigators believe that the next step should be to choose those patient's that doesn't
      use Internet or mobile technologies and to verify the applicability of a telematic system
      that could facilitate the extra hospital management of this patient's.

      The aim of the study is to evaluate the telematic management of various outcomes that are
      emitted by CPAP machine, and by an app where the patient's will answer different questions
      regarding their treatment during the three months of study period.
    

Detailed description: 
      We include OSA patient's that are not familiarized with the use of internet and mobile
      technologies and with CPAP prescription. They follow up an adaptation session where an
      automatic CPAP machine is delivered. Patient's are titrated with this automatic device in 5-7
      days and are treated with the automatic device during 3 months.

      The other part of the follow up consists on a voicemail where the patient can contact the
      sleep unit 24h a day and on a tablet, with an special app where the patient's answer a
      questionnaire once two weeks.
    

Intervention name(s): Telematic follow up
Intervention type(s): Other
Intervention description(s): Follow-up of OSA patients through automatic CPAP with data transmission (Dreamstation; Philips Respironics), a 24-hour voice mailbox available for questions or problems, and an Internet-connected (4G) tablet with a friendly mobile application for simple questionnaires.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: OSA; CPAP management; Telemedicine
Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate efficacy and safety of methylphenidate hydrochloride extended
      release compared to placebo in adult patients with childhood-onset attention
      deficit/hyperactivity disorder (ADHD).
    


Intervention name(s): Placebo; Ritalin LA 20 mg; Ritalin LA 30 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo Comparator: Placebo; Ritalin LA (a racemic mixture of d- and l-thre-Methylphenidate Hydrochloride (MPH), extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg.; Ritalin LA (a racemic mixture of d- and l-thre-Methylphenidate Hydrochloride (MPH), extended release hard capsules) taken orally once daily in doses of 60, or 80 mg.
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit /Hyperactivity Disorder, hyperactivity
A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      The study in the labeled and real conditions of prescription of Actonel will investigate the
      satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also
      measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12
      weeks of treatment with risedronate 35 mg Once A Week.
    


Intervention name(s): Risedronate Sodium
Intervention type(s): Drug
Intervention MeSH terms: Risedronic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment