bioihbjkbjnl/mcl2 huggingface dataset:
Bisphosphonate Therapy for Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta; Osteoporosis; Paget Disease of Bone
MeSH terms: Osteoporosis; Osteogenesis Imperfecta; Bone Diseases; Osteitis Deformans
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for
      Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine,
      are characterizing the changes effected by oral bisphosphonate therapy and comparing them to
      a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in
      children with other disorders that result in low bone mass and fractures.
    

Detailed description: 
      The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for
      Osteogenesis Imperfecta (OI)." OI is an inherited disorder of collagen synthesis. Collagen is
      the major structural protein of the matrix of tendons, skin, and bones. Affected persons have
      low bone mineral density (and experience multiple fractures and progressive bony deformity).
      In its most severe form, the disorder is lethal in infancy. We plan to characterize the
      changes effected by oral bisphosphonate therapy and compare them to a regimen of intravenous
      bisphosphonate therapy in a group of children with OI.

      Additionally, we have begun to treat patients with OI and other conditions of low bone
      mineralization for age who are not eligible for the standard protocol (too young, history of
      abdominal pain, etc.) with bisphosphonate. We also plan to screen the parents and siblings of
      our patients diagnosed with osteogenesis imperfecta, in order to determine if they also have
      osteoporosis.
    

Intervention name(s): Alendronate; Pamidronate
Intervention type(s): Drug; Drug
Other intervention name(s): fosamax
Intervention MeSH terms: Alendronate; Pamidronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteogenesis Imperfecta; Fractures; Pediatric; Osteoporosis; Juvenile Pagets
Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor
Condition: Hemophilia A or B With Inhibitors; Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study was to determine the efficacy, safety, and health-related quality of
      life benefits with FEIBA NF prophylactic treatment as compared with on-demand treatment.
    


Intervention name(s): Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated); Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)
Intervention type(s): Biological; Biological
Intervention description(s): 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period; FEIBA NF dose and dosing interval as prescribed by the treating physician
Other intervention name(s): FEIBA NF; FEIBA NF
Intervention MeSH terms: Factor VIII; Anti-inhibitor coagulant complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia A; Factor VIII Inhibitor; Factor IX Inhibitor; Hemophilia B
Effect of Curodont Repair in Patients With Early Approximal Carious Lesions
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the
      treatment of early approximal carious lesions compared to no treatment.
    

Detailed description: 
      All study participants must have two early approximal carious lesions in need of a treatment
      but not of an invasive treatment (split-mouth design). One lesion will be treated with
      Curodont Repair and the other will not undergo a treatment as control. Study duration is 12
      months. For assessment x-ray pictures are used.
    

Intervention name(s): Curodont Repair; No treatment - control
Intervention type(s): Device; Other
Intervention description(s): Single application on Day 0
Other intervention name(s): P11-4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dental caries; Curodont Repair; P11-4
Pilot Study for Cell Based Therapies in Patients With Asthma
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The aim of this study is to investigate the immunomodulatory potential of Isolated
      Plasmacytoide Dendritic Cells (pDCs) and Regulatory T-cells (TREGs) isolated with clinical
      grade magnetic bead isolations techniques (MACS®) on the antigen presenting cell-induced
      proliferation of lymphocytes after allergen uptake in an in vitro cell culture system.
    

Detailed description: 
      pDCs as well as TREGs will be co-incubated with generated allergen presenting cells,
      lymphocytes, and allergen. For in vitro experimentation immune cells will be collected from
      blood of grass mix or house dust mite sensitized atopic/asthmatic patients.
    

Intervention name(s): Blood donation
Intervention type(s): Other
Intervention description(s): In experimental part 1 to generate preclinical data 250 ml of blood will be donated at day 1 by 10 subjects to induce allergen presenting cells (APCs).
In experimental part 2 to transfer the isolation of pDC or TREGs to a GMP (good manufacturing Practice) compliant clinical grade isolation system, leukapheresis will be performed with the blood from 5 subjects.
In experimental part 3 for potency testing of the clinical grade isolation system of pDC or TREGs, 250 ml of blood will be collected at day 1 from 3 subjects.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of multiple oral doses of itraconazole, on the
      pharmacokinetics of etrumadenant when etrumadenant is administered as a single dose in
      healthy adult participants.
    


Intervention name(s): Etrumadenant; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Capsule; Capsule
Other intervention name(s): AB928
Intervention MeSH terms: Itraconazole
Intervention model: Sequential Assignment
Intervention model description: The study consists of 2 periods with participants sequentially receiving Treatment A (etrumadenant) in Period 1, followed by Treatment B (etrumadenant + itraconazole) in Period 2.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Etrumadenant; Itraconazole; Healthy participants; Pharmacokinetics; Drug-Drug Interaction; AB928
NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome
MeSH terms: Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative
      haploidentical transplantation for the treatment of high-risk acute myeloid diseases.
      Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early
      stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free
      neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28
      patients will be enrolled for a total of 43 patients. Patients will be followed for disease
      response for 2 years.
    

Detailed description: 
      A reduced intensity conditioning using Fludara, Cytoxan, and irradiation will start on day
      -22, followed by infusion of donor NK (natural killer) cells on day-17, 6 doses of
      interleukin-2 (IL-2) to promote NK expansion (day -17 to day -7), 2 doses of ATG for
      additional immunosuppression to promote engraftment (day -5 to -4), and infusion of a TCR
      α/β-depleted same donor graft on day 0.
    

Intervention name(s): Preparative Regimen; NK Cells; Interleukin-2; CD34 Graft/Anti-thymocyte globulin; Donor TCR α/β-depleted Graft/ATG
Intervention type(s): Drug; Biological; Drug; Biological; Biological
Intervention description(s): Preparative Regimen:
1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant, 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pretransplant, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pretransplant,; CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pretransplant.; Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion; Single donor filgrastim mobilized CD34+ selected peripheral blood stem cell graft (minimum cell dose of 5 x 10^6/kg) on day 0. Rabbit anti-thymocyte globulin (ATG) will be administered on day -1 (0.5 mg/kg) and day +1 and +2 (2.5 mg/kg) pretransplant per institutional guidelines. ATG dosing not identical for all patients.; Single donor TCR α/β-depleted filgrastim-mobilized peripheral blood stem cells (PBSC) graft (minimum cell dose of 5 x 10^6/kg) on day 0. ATG will be administered on days -6 and -5 (3mg/kg) for most patients.
Other intervention name(s): Fludara; Cytoxan; radiation; Natural Killer cells; IL-2; ATG; stem cell graft
Intervention MeSH terms: Interleukin-2; Antilymphocyte Serum
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-myeloablative haploidentical transplant; hematopoietic cell transplant; natural killer cells; adoptive cellular therapy
Testosterone and Vascular Function in Reproductive-Aged Females With Chronic Kidney Disease
Condition: Chronic Kidney Diseases; Cardiovascular Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases
Study type: Observational

Summary: 
      Cardiovascular disease (CVD) is the leading cause of death among women and women with chronic
      kidney disease are at an even greater risk of CVD. The aim of this observational study is to
      examine the relationship between total testosterone levels and measures of vascular function
      (pulse wave velocity, aortic augmentation index, flow mediated dilation and velocity time
      integral) in reproductive-aged women living with chronic kidney disease.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will include stable females of reproductive age (18-51 years of age)
        with chronic kidney disease. Subjects will require permission of their primary nephrologist
        or primary care provider to participate
Study of Belimumab Administered Subcutaneously to Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the amount of belimumab in the blood when given as an
      injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of
      multiple injections under the skin in healthy subjects.
    

Detailed description: 
      This study is designed to evaluate the absolute bioavailability, pharmacokinetics,
      tolerability, and safety of a single dose (groups 1-4) or multiple doses (groups 5-6) of
      belimumab administered subcutaneously (SC) to healthy subjects.
    

Intervention name(s): Single Dose Group: Belimumab IV 240 mg; Single Dose Group: Belimumab SC 2 x 120 mg; Single Dose Group: Belimumab SC 1 x 240 mg; Single Dose Group: Belimumab SC 1 x 200 mg; Multiple Dose Group: Belimumab SC 2 x 120 mg weekly; Multiple Dose Group: Belimumab SC 1 x 200 mg weekly
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Belimumab IV 240 mg administered on Day 0; Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0; Belimumab SC 240 mg x 1 injection on Day 0; Belimumab SC 200 mg x 1 injection on Day 0; Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21; Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
Other intervention name(s): BENLYSTA™; BENLYSTA™; BENLYSTA™; BENLYSTA™; BENLYSTA™; BENLYSTA™
Intervention MeSH terms: Belimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Belimumab; Injections, Subcutaneous; Drug Administration Routes; Injections; Lupus Erythematosus, Systemic; Lupus; SLE; Systemic Lupus Erythematosus; Antibodies; Autoimmune Disease; Biological Therapy; Immune System Diseases; Pharmacokinetics; Biological Availability
Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal
Condition: Efficacy of Oropharyngeal Seal Pressure
Study type: Interventional

Summary: 
      To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and
      Proseal LMA) and to observe any associated complications.
    

Detailed description: 
      Condition:

      The study focuses on the comparison of the ease of insertion, oropharyngeal leak pressure,
      fiberoptic position and ease of gastric tube placement between the Guardian LMA and the LMA
      Proseal in paralyzed, anesthetized patients.

      Device: Guardian Laryngeal Mask Device: LMA Proseal

      Study Type:

      Interventional

      Study Design:

      Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel
      Assignment Masking: Single Blind (Subject)
    

Intervention name(s): Guardian Laryngeal Mask; Proseal Laryngeal Mask Airway
Intervention type(s): Device; Device
Intervention description(s): Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.; Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Airway Cuff; Guardian; Proseal; Cuff Pressure; laryngeal Mask Airway
Does Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether active parent involvement in deliberation
      and choice improves subsequent medication persistence for their child with ADHD.
    


Intervention name(s): Choice; Recommendation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parent and teacher reports of child behavior and side effects observed during a 4-week trail of placebo and methylphenidate at lower, medium, and higher dosages will be summarized in a decision aid. Parent treatment preferences will be elicited and parents will receive coaching in deliberation about striking a balance between benefit and tolerable side effects. Parent will then choose the week that was best for their child and plan their next steps. Parents will also receive a consultation report that contains a physician dosage recommendation.; Parent and teacher reports of child behavior and side effects observed during a 4-week trail of placebo and methylphenidate at lower, medium, and higher dosages will be summarized in a consultation report that also contains a physician dosage recommendation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Decision Aid; Informed Choice; Adherence
The Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Recent improvements in cell culture systems have led to a shift in in vitro fertilization
      (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer.
      Blastocyst culture and transfer could theoretically provide better synchronization between
      the embryo and the uterine endometrium. The purpose of this study is comparing pregnancy
      rates and implantation rate following transfer of thawed cleavage embryos and blastocysts
      cultured from thawed cleavage embryos.
    

Detailed description: 
      The proposal of this study approved by our institutional review boards and institution's
      ethical committee, and all participants will sign a written consent before enter to study.
      All patients will be randomly divided into two groups of thawed cleavage embryo transfers and
      transfers of blastocysts from thawed cleavage embryos. Embryos will be transferred in hormone
      replacement cycles. Preparation of the endometrium will be started in the second day of
      menstruation and will be continued according to their transfer type (blastocyst or cleavage).
      βhCG will be assessed 14 days after embryo transfer. Treatment cycle outcomes will be
      compared between 2 groups.
    

Intervention name(s): Blastocyte Transferring; Embryo Transferring
Intervention type(s): Procedure; Procedure
Intervention description(s): Intra-uterine transferring of blastocyst from thawed cleavage embryo in infertile women.; Inta-uterine transferring of thawed cleavage embryo transfer in infertile women.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cleavage stage blastocyst transfer cryopreservation
Study Investigation Pharmacokinetics and Pharmacodynamics of CS1
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      SAD study:

      Eighteen subjects will be included in the SAD study (single dose) in 3 parallel arms, each
      with 6 subjects. The 3 arms will receive a single dose of one of the CS1 formulations I, II
      or III. The result of the pharmacokinetics analysis from the 6 first subjects is defined as
      SAD Pilot and will be used to evaluate the timing of PK sampling. Based on pharmacokinetic
      evaluations from all 18 subjects one of the formulations I (275 mg), II (276 mg) or III (276
      mg) will be chosen to proceed into the MAD study. If none of the formulations show the
      desired PK properties the formulations may be re-dosed with a slightly different timing of
      the dose, i.e the IMP to be administered earlier or later during the evening.

      MAD study:

      Fifteen subjects will be included in a dose escalating study with 2 dose levels. The subjects
      will receive the lowest dose level (275 or 276 mg depending on the outcome of SAD) for the
      first 2 weeks before the dose is doubled (550 or 552 mg depending on the outcome of SAD) for
      the following 2 weeks.
    


Intervention name(s): CS1-Sodium Valproate
Intervention type(s): Drug
Intervention description(s): Single and multiple dose evaluation of CS1
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Safety, pharmacokinetics and pharmacodynamics of CS1
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tissue-plasminogen activator (t-PA); plasminogen-activator inhibitor 1 (PAI-1); fibrinolysis; thrombosis
Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long term efficacy, safety, and tolerability of
      repeated administration of adalimumab in participants with Crohn's disease.
    


Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): Adalimumab pre-filled syringe, administered by subcutaneous injection
Other intervention name(s): Humira; ABT-D2E7
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease