bioihbjkbjnl/mcl2 huggingface dataset:
Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
Condition: Oral Cancer; VEGFR2 Inhibitor; Programmed Cell Death 1 Inhibitor; Inductive Therapy
MeSH terms: Carcinoma, Squamous Cell; Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 1

Summary: 
      In patients with locally advanced oral squamous cell carcinoma (OSCC), due to the large tumor
      burden and neck lymph node metastasis, comprehensive treatment is recommended, including
      surgery, radiotherapy, chemotherapy and others. Pre-operative inductive therapy can reduce
      tumor volume, increase organ retention rate, and reduce distant metastasis rate. Vascular
      endothelial growth factor (VEGF) receptor in head and neck squamous cell carcinoma is
      over-expressed and associated with disease invasion and poor prognosis. The use of targeted
      therapy against VEGF can not only inhibit tumor neovascularization, but also make the
      effectiveness of chemotherapeutic agents. VEGF and VEGFR are closely related to immune
      escape. Tumor growth requires new blood vessels to supply nutrients and oxygen, and VEGF can
      stimulate neovascularization. However, tumor neovascularization is often abnormal and
      distorted, which prevents immune active substances from reaching the tumor site. After tumor
      hypoxia, high expression of VEGF will induce tumor cells to express programmed cell death
      protein-1 (PD-1), which further leads to immune escape. Targeted drugs against angiogenesis
      can relieve immunosuppression to a certain extent, and theoretically have a synergistic
      effect with anti-PD-1 immunotherapy. The innovation of this study is the combination of
      immune checkpoint inhibitor, Camrelizumab, and targeted drug against VEGFR, Apatinib, as an
      inductive therapy to treat the patients with locally advanced OSCC, followed with radical
      surgery and post-operative radiotherapy/chemoradiotherapy, the major pathologic response and
      safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and
      local recurrence rate will be the second endpoints.
    


Intervention name(s): Camrelizumab; Apatinib; Radical surgery; Post-operative radiotherapy/chemoradiotherapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention description(s): Inductive therapy with Camrelizumab of 200mg, iv, qd, on day 1, 15, 29.; Inductive therapy with Apatinib of 250mg, po, qd, initiating on day 1, ending on the fifth day before surgery.; Radical surgery will be performed on the 42th-45th after initiation of inductive therapy; Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathologic diagnosis.
Other intervention name(s): Humanized anti-PD-1 inhibitor; VEGFR2 inhibitor
Intervention MeSH terms: Apatinib; Immune Checkpoint Inhibitors
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis
      (ABA) parent training using video modeling to teach parents of children with Autism
      techniques to apply to their children in order to improve eye contact and joint attention
      behaviors.

      Our hypothesis is that children with Autism whose parents will be trained by videomodeling
      will have better eye contact and joint attention behaviors compared to children with Autism
      whose parents will not be trained.
    

Detailed description: 
      Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating
      impairments on social functioning and daily-life activities of individuals with Autism
      Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an
      increasing demand of families non-served in the public health system.

      Our main objective is to standardize and test the efficacy of a model for parent training
      using video modeling for teaching eye contact and joint attention behaviors in children with
      ASD. These two behaviors are essential to develop adequate social interaction, the core
      impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal
      de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample
      will be composed of 70 children divided in control and intervention groups that will be
      randomly chosen. The intervention should be carried out in 21 weeks.
    

Intervention name(s): ABA parent training
Intervention type(s): Behavioral
Intervention description(s): A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks
Other intervention name(s): Applied Behavior Analysis parent training using videomodeling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism; videomodeling; behavioral therapy; parental training
Effects of Training Based on the Pilates Method on the Blood Pressure of Hypertensive Women
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The main objective of this study is to evaluate and compare the effect of the Pilates method
      associated with aerobic exercise and the traditional Pilates method on the blood pressure of
      hypertensive medicated women. In addition, we aim to analyze and compare the chronic effects
      of training on cardiac autonomic modulation, on cardiorespiratory fitness, functionality and
      quality of life.
    

Detailed description: 
      Subjects will be allocated randomly in three groups: (1) Traditional Pilates group, which
      will perform only exercises based on the traditional Pilates method, (2) Modified Pilates
      group, which will perform exercises based on the Pilates method alternated with active rest
      periods on treadmill ergometer, (3) Control group: will not perform any physical exercise
      during the trial period. The sessions will be performed two times a week, during 16 weeks.
      Subjects will be evaluated before and after 16 weeks of intervention.
    

Intervention name(s): Traditional Pilates group; Modified Pilates group
Intervention type(s): Other; Other
Intervention description(s): The participants will perform only exercises based on the traditional Pilates method, 2 times a week, for 50 minutes, for 16 weeks.; The participants will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, 2 times a week, for 50 minutes, for 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pilates method; Blood pressure; Autonomic heart rate modulation
The Effect of LipoCol Forte® Capsules on the Pharmacokinetics of Nifedipine After Administering Single-dose Combination to Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to evaluate the effect of LipoCol Forte® Capsules on the
      pharmacokinetics of nifedipine after administering single-dose combination to healthy
      subjects using a 2x2 crossover design.
    

Detailed description: 
      Healthy subjects were randomly allocated to receive a single dose of either one 5 milgram
      (mg) nifedipine capsule or one 5 milgram (mg) nifedipine capsule plus one 600 milgram (mg)
      red yeast rice capsule; after 7-day washout period, they received a single dose of the
      alternative drug. The subjects were fasted at least 10 hour before dosing. The
      investigational products were administered with 240 milliliter (mL) of water with the subject
      in an upright position. The blood samples were collected at prior to the drug administration
      (T0), and 0.167, 0.333, 0.500, 0.750, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 14, 16 and 24
      hours after dosing.
    

Intervention name(s): Nifidipine & LipoCol
Intervention type(s): Drug
Intervention description(s): The effect of LipoCol Forte® capsules on the pharmacokinetics of nifedipine after administering single-dose combination in healthy subjects.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nifidipine; red yeast rice; drug-drug interaction
Umbilical Cord Blood Therapy for Children With Global Developmental Delay
Condition: Global Developmental Delay
Study type: Interventional

Summary: 
      This open-label study aims to evaluate the safety and efficacy of umbilical cord blood
      therapy for children with global developmental delay.
    

Detailed description: 
      Global developmental delay (GDD) is a subset of developmental disabilities defined as
      significant delay in two or more of the following developmental domains: gross/fine motor,
      speech/language, cognition, social/personal, and activities of daily living.

      Umbilical cord blood has been used for inherited metabolic diseases that feature global
      developmental delay and many experimental animal studies have revealed umbilical cord blood
      is useful to repair neurological impairments in brain.
    

Intervention name(s): Umbilical Cord Blood administration; Active Rehabilitation
Intervention type(s): Biological; Other
Intervention description(s): The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.; All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
Other intervention name(s): Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Global developmental delay; Umbilical cord blood; Rehabilitation
CKD-397 Drug-drug Interaction Study (B)
Condition: Healty Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate to effect of tadalafil on the pharmacokinetic
      properies of tamsulosin
    

Detailed description: 
      This study is a randomized, open-label, mutiple dosing, 2-way crossover design to evaluate
      the pharmacokinetic effect of tadalafil(5mg) on tamsulosin(0.2mg) in healthy male subjects
      Subjects will receive repeated dose of tamsulosin (0.2mg*1t/day) or tamsulosin (0.2mg*1t/day)
      / tadalafil (5mg*1t/day) for 5days Each treatment period was separated by a washout period of
      at least 10 days. Each period of study will enroll 14 healthy male subjects. Blood samples
      for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be
      assessed by measurement of blood pressure, heart rate, safety laboratory data, and review of
      adverse events.
    

Intervention name(s): Harnal-D Cap. 0.2mg; Cialis Tab. 5mg
Intervention type(s): Drug; Drug
Other intervention name(s): Tamsulosin 0.2mg; Tadalafil 5mg
Intervention MeSH terms: Tadalafil; Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.
Condition: Postoperative Behaviour
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate whether intraoperative music application has a
      positive impact on postoperative behavior in children and adolescents.
    

Detailed description: 
      After induction of anesthesia, paralyzation of the patient and subsequent intubation, a
      caudal block is applied. After positioning of the patient, headphones are placed on the
      patients head and in case of the interventional group, music is played. Previously, the
      volume of the music is adjusted to a range from 50 to 60 decibel. Headphones are removed
      before extubation.

      Postoperative behaviour is evaluated by parents and by caretaking personnel in the recovery
      room at arrival, after 15 minutes and before discharge to the ward and at home by parents
      after one, two and four weeks using questionnaires.

      sample size calculation: n = minimal number of required probands π = 70% (proportion of
      interest) → 0.7 π0 = 50% (null hypothesis proportion) → 0.5 μ = (100% - 90%power) → 1.28 v =
      1.96 (level of significance p=0.05)

      n > [ μ√ π(1- π) + v√ π0(1- π0)]2 / (π - π0) n > 61.4 + correction for drop-outs (+10%) n =
      70 per group → 140 probands in total
    

Intervention name(s): music application; only headphones; a caudal block
Intervention type(s): Other; Other; Drug
Intervention description(s): music is applied during anaesthesia using headphones; music is not applied, only headphones are placed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Music Therapy
Additional Post Hoc Analysis and Clinical Data Collection
Condition: Neurological Observations
Study type: Observational

Summary: 
      The purpose of this study is to collect additional Investigational cognitive tasks and
      additional clinical data for subjects tested with ElMindA's Brain Network Activation (BNA™).
    

Detailed description: 
      To collect additional Investigational cognitive tasks and additional clinical data for
      subjects tested with ElMindA's Brain Network Activation (BNA™).

      The BNA™ technology was developed and is utilized by ElMindA Ltd. The (BNA™) Analysis System
      is cleared for use by qualified medical professionals for the post hoc statistical analysis
      of the human electroencephalogram ("EEG"), utilizing evoked response potentials ("ERP').
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who completed a BNA test with the Auditory Oddball Task, from both genders, aged
        3-99 years.
      
Keywords: Neurology
A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      This 2 arm study will assess the impact of bone marker feedback (BMF), using serum
      carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on
      adherence to once monthly ibandronate (150 milligrams [mg] per oral [po]) in women with
      post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants
      will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The
      anticipated time on study treatment is 3-12 months.
    


Intervention name(s): Ibandronate
Intervention type(s): Drug
Intervention description(s): Participants will receive ibandronate 150 mg QM orally for 6 months.
Other intervention name(s): Bonviva; Boniva
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does a Single Shot Femoral Nerve Block Alone Produce Appropriate Pain Relief?
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to compare the efficacy of the analgesic effect of the preoperative
      femoral nerve block alone versus combined femoral, sciatic, obturator and lateral femoral
      cutaneous nerve blocks in patients after TKA in the immediate postoperative period.
    

Detailed description: 
      Bupivacaine will be used for all the nerve blocks.
    

Intervention name(s): Femoral Nerve Block; Combined nerve blocks; Patient-controlled analgesia
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Preoperative Bupivacaine 0.5%, perineurally as single shot; Preoperative Bupivacaine 0.5%, perineurally as single shot; Patient controlled analgesia with morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Oral Calcium in Pregnant Women With Hypertension
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Pre-Eclampsia; Pregnancy Toxemias; Vascular Diseases
MeSH terms: Toxemia; Eclampsia; Pre-Eclampsia; Hypertension; Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine of providing calcium supplementation to women with pre-existing hypertension
      reduces the level of blood pressure, requirement for antihypertensive drugs, and incidence of
      pre-eclampsia.
    

Detailed description: 
      BACKGROUND:

      Maternal and fetal complications are more likely to occur in pregnant women with preexisting
      hypertension. Alterations in calcium metabolism, the renin angiotensin system, and
      intracellular free calcium concentration have been identified in this high risk population.
      The beneficial effects of calcium supplementation on blood pressure and the incidence of
      superimposed pre-eclampsia may be due to correction of the hormonal and cellular basis for
      vasoconstriction. The trial sought to prove that oral calcium lowered parathyroid hormone,
      reduced intracellular free calcium, and decreased vascular endothelin production, resulting
      in vasodilation and compensatory stimulation of the renin-angiotensin system.

      DESIGN NARRATIVE:

      Randomized. Double blind. In this observational study, subjects were assigned to two grams of
      supplemental elemental calcium or to placebo at 13 to 15 weeks gestation. The trial
      determined the effect of oral calcium supplementation on: the level of blood pressure; the
      need for antihypertensive drugs; forearm and peripheral vascular resistance; the incidence of
      maternal complications, including pre-eclampsia and eclampsia; and plasma levels of vitamin
      D3, ionized calcium, parathyroid, renin activity, angiotensin II, endothelin,
      nitrate/nitrite, prostacyclins, and intracellular calcium concentrations in lymphocytes and
      platelets. These variables were measured prior to randomization and every two months
      throughout pregnancy and the postpartum. Support ended in July 1999.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): dietary supplements; calcium
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: Calcium
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia
Condition: Hyperlipidaemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

Summary: 
      AZD8233 is a PCSK9-targeted ASO for the reduction of circulating levels of LDL-C. This study
      aims to evaluate safety, efficacy and tolerability of AZD8233.
    

Detailed description: 
      This is a randomized parallel, double-blind, placebo-controlled Phase 2b study in
      approximately 376 participants with hyperlipidaemia. The primary objective of the study is to
      assess the safety and tolerability of AZD8233 as compared with placebo, and the effect of
      AZD8233 versus placebo on relative change in LDL-C. The study will be conducted at up to 100
      sites in up to 8 countries.

      The screening period starts up to 28 days before the randomization visit and ends on Day -1.
      Eligible participants will attend 1 enrollment visit and 15 visits during the treatment
      period and 2 additional visits during the safety follow up period.
    

Intervention name(s): AZD8233; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.; Placebo solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AZD8233; Efficacy; PK; PD; Safety; Tolerability
Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
Condition: Anemia of Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP)
      inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and
      tolerability of JTZ-951 when administered alone and one hour after the administration of
      lapatinib.
    


Intervention name(s): JTZ-951; Lapatinib
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lapatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: JTZ-951; Lapatinib; Pharmacokinetics
Predictive Equations for Resting Energy Expenditure
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Predictive equations are the main clinical tool for determining resting energy expenditure
      (REE). Thus, it is important to investigate the accuracy and agreement of these equations in
      different populations and context of diseases. The purpose of this study is to investigate
      the accuracy and agreement of predictive equations of REE in overweight women with polycystic
      ovary syndrome (PCOS). The REE of all participants was measured (mREE) by means of indirect
      calorimetry and predicted (pREE) through ten equations basing on the anthropometric
      parameters (Harris & Benedict, WHO/FAO/UNU including weight, WHO/FAO/UNU including weight and
      height, Owen, Mifflin-St. Jeor, Institute of Medicine, Ireton-Jones, Müeller, De Luis and
      Lazzer).
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Polycystic ovary syndrome patients, as defined according to the Rotterdam criteria
        (ESHRE/ASMR, 2004): the presence of at least two of the following factors: chronic
        anovulation, clinical or biochemical signs of hyperandrogenism and presence of polycystic
        ovaries;
      
Keywords: Resting energy expenditure; Predictive equations; Overweight