bioihbjkbjnl/mcl2 huggingface dataset:
Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer
Condition: Neoplasms,; Metastatic Cancer,; Non-Small Cell Lung Cancer; Advanced Solid Malignancies
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study will be to investigate the safety and tolerability of AZD6244
      given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients
      with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung
      Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following
      the combination regimen dose escalation phase (Part A) of the study additional patients may
      be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability,
      pharmacokinetics and biological activity of the combination in this patient population.
    

Detailed description: 
      The objective of the combination therapy part of this study will be to investigate the safety
      and tolerability of AZD6244 given in combination with docetaxel as 2nd line therapy in
      Japanese patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage
      IIIB-IV). In addition, the pharmacokinetic profile of AZD6244 and docetaxel will be
      investigated.

      The objective of the monotherapy part of this study will be to investigate the safety and
      tolerability of AZD6244 given as a monotherapy in Japanese patients with advanced solid
      malignancies. In addition, the pharmacokinetic profile of monotherapy AZD6244 will be
      investigated.
    

Intervention name(s): AZD6244
Intervention type(s): Drug
Intervention description(s): Tablet Oral bid
Other intervention name(s): Selumetinib (AZD6244)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer,; Tumour,; Metastatic,; Lung cancer,; Non-Small Cell Lung Cancer
Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies
Condition: Relapsed or Refractory Haematological Malignancies Including; Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; High Risk Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia; Richter's Syndrome; B-cell Non-Hodgkin Lymphoma; T-cell Non-Hodgkin Lymphoma; Small Lymphocytic Lymphoma; Multiple Myeloma
MeSH terms: Lymphoma; Leukemia; Leukemia, Myeloid; Multiple Myeloma; Leukemia, Myeloid, Acute; Neoplasms; Lymphoma, Non-Hodgkin; Preleukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelomonocytic, Chronic; Lymphoma, B-Cell; Lymphoma, T-Cell; Leukemia, Myelomonocytic, Juvenile; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hematologic Neoplasms; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK),
      pharmacodynamics (PD) and preliminary antitumor activity of AZD4573 in subjects with relapsed
      or refractory haematological malignancies.
    


Intervention name(s): AZD4573
Intervention type(s): Drug
Intervention description(s): AZD4573 will be administered as a intravenous (IV) infusion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a multicentre, open-label, first in human, non-randomized, dose-escalation study including an intra-subject ramp-up. The study will consist of two, parallel dose escalation arms
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed or refractory haematological malignancies; AZD4573; CDK9i; Acute Myeloid Leukemia (AML); Acute Lymphocytic Leukemia (ALL); Chronic lymphocytic Leukemia (CLL); High risk Myelodysplastic syndrome (MDS); Chronic Myelomonocytic Leukemia (CML); Richter's syndrome; B-cell Non-Hodgkin Lymphoma (B-cell NHL); T-cell Non-Hodgkin Lymphoma (T-cell NHL); Small lymphocytic Lymphoma (SLL); Multiple Myeloma (MM)
Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.
Condition: Luteal Phase Defect
Study type: Observational

Summary: 
      This study aims to compare the efficacy, in terms of progesterone levels and clinical
      outcomes, of two different presentations of micronized vaginal progesterone (400 mg vs. 200
      mg) used in endometrial preparation in artificial cycle (AC) for embryo transfer.

      This is a non-inferiority, retrospective case-control study, with at least 200 cycles
      analyzed (at least 100 per arm) and the primary outcome is the serum progesterone level on
      the day of the embryo transfer.
    


Intervention name(s): Vaginally administered progesterone
Intervention type(s): Drug
Intervention description(s): The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day)
Intervention MeSH terms: Progesterone
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The population will be selected among those patients who have undergone embryo transfer
        treatment with endometrial preparation in a artificial cycle at the Instituto Bernabeu.
      
Keywords: Frozen embryo transfer; endometrial preparation; artificial cycle; progesterone
A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis
Condition: Exercise
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      The primary objective of the investigation is to determine whether the addition of exercise
      (resistance training or modified physiotherapy) improves functional capacity in Multiple
      Sclerosis (MS) participants undergoing Disease Modifying Therapy (DMT) treatment. We
      hypothesize that the Progressive Resistance Training (PRT) will improve functional capacity
      without increasing the risk of relapses in participants undergoing standard DMT treatment.
      The secondary objectives are to determine whether exercise (resistance training or
      physiotherapy) improves fatigue, mood and Quality of Life (QoL) in MS participants undergoing
      DMT treatment. Also as a secondary objective, the study aims at determining whether exercise
      (resistance training or modified physiotherapy) has an impact on Expanded Disability Status
      Scale (EDSS), time to first relapse, number of relapse free participants, and immunological
      factors. We hypothesize that the exercise (resistance training) will improve fatigue, mood
      and QoL and that an impact on immunological factors will be seen in participants even though
      they are undergoing standard DMT treatment.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients on AVONEX 3-6 months after treatment initiation
      
Keywords: Capacity for Work Questionnaire; exercise; AVONEX; SDMT: Symbol Digit Modalities Test; FSMC: Fatigue Scale for Motor and Cognitive functions; effects of exercise; EDSS: Expanded Disability Status Scale
Premature Coronary Artery Disease (CAD) in Severe Psoriasis
Condition: Psoriasis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Psoriasis
Study type: Observational

Summary: 
      The purpose of this study is to compare the prevalence and severity of CAD (coronary artery
      disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular
      risk factors.
    

Detailed description: 
      To establish the relationship between psoriasis and coronary disease by comparing the
      prevalence and severity of CAD (coronary artery disease) in patients with and without severe
      psoriasis, otherwise matched for cardiovascular risk factors, as determined by CT coronary
      calcium scoring and Coronary CT angiography.
    

Intervention name(s): CCTA Scan (Coronary CT Angiogram)
Intervention type(s): Procedure
Intervention description(s): CCTA scan will be performed to study and evaluate the prevalence and severity of coronary artery disease (CAD).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with severe psoriasis will be selected prospectively from the clinics of the
        University of Michigan, Dept. of Dermatology.

        The comparison group (subjects without psoriasis) will be targeted in the Dermatology
        clinic by screening for matching variables before enrollment. This group will be matched by
        age and gender to the psoriasis population, and on Framingham risk score.
      
Biospecimen description: 
      31 ml of blood will be drawn in conjunction with this study.Lipid, Glucose and Lipoprotein
      will be drawn in one SST tube = 7 ml. Insulin (INS) will be collected in one Green top tube =
      7 ml. HSCRP- will be collected in on SSS tube = 7 ml. IL-6 will be collected in Red or
      Lavender top tube = 7 ml. An additional 3 ml will be drawn for ICAM testing. (The blood for
      the ICAM testing and IL- 6 will be drawn and frozen until funding has been obtained to run
      these tests). Specimens will be be properly disposed of after testing is completed.
    
Keywords: psoriasis; coronary arteriosclerosis; coronary events; rheumatoid arthritis; arthritis
The Guardcontrol Trial: Study to Assess if Type 1 Diabetics Can Improve Using the Real-time Values of Guardian RT
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The objective of the study is to determine whether patients with poor glycemic control can
      improve metabolic control using the real-time values of the Guardian® RT compared to
      conventional self-monitoring blood glucose finger-sticks.
    

Detailed description: 
      Finger-stick based self-testing (SBGM), as well as diagnostic continuous glucose monitoring
      (CGMS®) allow diabetic patients to find a balance between the two hyper- and hypoglycemic
      extremes. Nevertheless, there are still patients who fail to achieve good control due to fear
      of hypoglycemia, or who underestimate post-prandial hyperglycemias.

      The Guardian® RT Telemetered Glucose Monitoring System is indicated for continuous or
      periodic monitoring of real-time interstitial blood glucose values and low/high blood glucose
      alarms (when pre-set levels are reached) in persons with diabetes mellitus. The glucose
      values calculated by the device will be used to trigger hypo- and hyperglycemia alerts and
      will be displayed every 5 minutes. The Guardian® RT stores up to 21 days of data.

      The overall primary objective of the study is to determine whether patients with poor
      glycemic control as evidenced by HbA1c > 8.1% can achieve improved metabolic control using
      the real-time values of the Guardian® RT compared to conventional self-monitoring blood
      glucose finger-sticks (control group) after 12 weeks of continuous use.
    

Intervention name(s): Guardian RT; SMBG only
Intervention type(s): Device; Device
Intervention description(s): SMBG only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes
Aerobic Training On Spasticity And Gross Motor Function In Children With Diplegic Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      To determine the effects of aerobic training on spasticity and gross motor function in
      children with diplegic Cerebral palsy.Cerebral palsy (CP) is a neurodevelopmental disorder
      characterized by abnormalities of muscle tone, movement and motor skills, and is attributed
      to injury to the developing brain. . The spastic CP is found to be the commonest presentation
      followed by athetoid, ataxic and mixed types. Children with cerebral palsy (CP) have
      decreased capacity to participate in play and sports activities .Reduced capacity to perform
      typical childhood activities contributes to low habitual physical activity and declining
      gross motor function in adolescence. Exercise opportunities are restricted in the population
      of cerebral palsy with spasticity, and so muscle strength may be reduced by disuse. Aerobic
      Training via Lower-extremity cycling is a rehabilitation tool used by physical therapists to
      improve spasticity, gross motor function and cardio-respiratory fitness, appears well-suited
      as a therapeutic intervention for children with CP. The tools used will be GMFM-66 and
      Modified Ashworth Scale. Study will be conducted on Thirty two patients in two Groups. Group
      A will be Control Group that will be provided with conventional physiotherapy (Stretching
      exercises , Trunk control training, walk and breathing exercises) and Group B will be
      Experimental Group that will be provided with conventional physiotherapy with cycling for 30
      minutes with three sessions per week over the period of 12 weeks. Data will be analyzed using
      spss 22.0.
    


Intervention name(s): Aerobic Training; Conventional Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): This group will be administered with the cycling exercises in addition to the complete plan of care that is being administered to the control group. The cycling intervention will be performed 3 times per week, for 30 minutes, within a 12-week period; This group will be administered with Conventional Physiotherapy that includes 5 minutes of stretching exercises for quadriceps, hamstrings and gastrocnemius, 5 minutes of trunk control training, 5 minutes walking in the hall with and without the therapist assistance, walker or crutches, and finally 5 minutes of breathing exercises for Relaxation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Aerobic Training; Gross Motor Function; Stationary Cycle; Diplegic Cerebral Palsy
Clinical Disease Activity With Long Term Natalizumab Treatment
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Observational

Summary: 
      The primary objective of the study is to retrospectively investigate the proportion of
      participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions
      over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants
      with regular MRI follow-up, who have received natalizumab ≥24 month from two different
      observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2)
      approximately 70 participants from Belgium. The secondary objectives of this study are as
      follows: Brain volume change by various measures; Changes in the number and volume of
      magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and
      without brain volume change.
    

Detailed description: 
      Natalizumab will not be provided to participants by Biogen as a part of this study.
      Participants will remain on natalizumab therapy as prescribed by their physician.
    

Intervention name(s): natalizumab
Intervention type(s): Drug
Intervention description(s): Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Other intervention name(s): BG00002; Tysabri
Intervention MeSH terms: Natalizumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Participants who have been receiving treatment with natalizumab for ≥24 months.
      
Keywords: RRMS; MRI
Pilot Feasibility of the Pediatric Cancer Resource Equity (PediCARE) Intervention
Condition: Other Cancer
Study type: Interventional

Summary: 
      The goal of this new intervention is to make it easier for families to meet their basic
      household needs during childhood cancer treatment. The investigators want to learn how to
      best use PediCARE to help care for families.
    

Detailed description: 
      The investigators know from previous studies that in addition to the basic worries about a
      child's cancer therapy, many families experience financial stress during their child's
      treatment. Financial stress may include difficulty paying the rent or mortgage, keeping the
      electricity or heat on, or putting food on the table. One of the investigators' research
      goals is to find ways to decrease the financial impact of treatment on each family, and make
      sure that financial stress does not impact a child's experience during treatment.

      The investigators have developed a new supportive care intervention called PediCARE (which
      stands for Pediatric Cancer Resource Equity) which provides support for groceries (using an
      online grocery delivery service called Instacart) and transportation to and from the hospital
      (using rides through services such as Uber and Lyft). The investigators have evaluated the
      PediCARE support program in a small group of parents and used feedback from these parents to
      improve PediCARE. The investigators are now ready to do a feasibility study to find out
      whether the investigators can reliably deliver the PediCARE intervention to families.

      This type of study is called a feasibility study. The goal of this research study is to learn
      whether the investigators can successfully give the PediCARE support program to families-in
      other words, whether most families are interested in participating in a randomized study
      about the PediCARE support program and whether they use the PediCARE support program during
      the study. The investigators will also begin to understand whether the PediCARE support
      program reduces financial stress for families during therapy. Long-term, the investigators
      plan to test the PediCARE support program in a larger group of randomized families to answer
      the question of whether PediCARE reduces financial stress for families and improves outcomes
      during cancer treatment
    

Intervention name(s): PediCARE; Usual Care
Intervention type(s): Other; Other
Intervention description(s): PediCARE provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through RideHealth).; Standard care per hospital guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pedi Care
The Relationship Between Serum Gasdermin-D Levels and Pyroptosis and Preterm Labor
Condition: Gasdermin D Levels in Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional

Summary: 
      In this study, the investigators aimed to investigate the relationship between Gasdermin D
      levels measured from the maternal serum of patients diagnosed with preterm labor and
      spontaneous preterm labor in pregnant women.
    

Detailed description: 
      This prospective case- control study was conducted between 15 July 2021 and 15 July 2022 at
      Bursa Yüksek İhtisas Training and Research Hospital. The study was conducted with pregnant
      women between the ages of 18-45 who were idiopathic preterm labor. Pregnant women between the
      ages of 18-45 who were diagnosed with preterm labor between 24-37 weeks of gestational were
      included. This study was conducted with 160 pregnant women who were diagnosed with idiopathic
      preterm labor and 167 healthy pregnant women who were in the same gestational week as these
      pregnant women and were not diagnosed with preterm labor. Group 1 patients diagnosed with
      preterm labor between 24-37 weeks( study group) (n:160), Group 2 consisted of healthy
      pregnant women who were not diagnosed with preterm labor between 24-37 weeks ( control group)
      (n: 167) . In group 1, 80 patients were diagnosed with early preterm (between 24-34 weeks )
      and 80 patients with late preterm labor (34-36+6 weeks).
    

Intervention name(s): Gasdermin-d
Intervention type(s): Other
Intervention description(s): Maternal serum Gasdermin-D levels in preterm labor and healthy pregnant women.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Gastermin D and Pentaxin 3 levels were measured in the patients participating in the study. These are not routinely checked markers. Participants were assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on preeclampsia or HELLP related outcomes. Due to this, our work is interventional.
Masking: None (Open Label)
Primary purpose: Other
Keywords: gasdermin D; preterm labor; pyroptosis
Dose Effects of SCF on Calcium Metabolism and GI Microflora in Adolescents
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Soluble corn fiber (SCF) has been shown to enhance calcium utilization and bone properties in
      rats and in adolescent boys and girls.
    

Detailed description: 
      The growing knowledge of non-digestible oligosaccharide (NDO)-related health benefits has led
      to the identification of other fermentable carbohydrates which may improve bone balance and
      bone health parameters. One such carbohydrate is the corn derivative, soluble corn fiber
      (SCF). Already known for its association with improved intestinal health and influence on
      colonic microflora content, we have been studying the effects of SCF on calcium absorption
      and bone health. First we found that soluble corn fiber (SCF) greatly enhanced calcium
      utilization and bone properties in a growing rat model. Results from this study demonstrated
      that SCF was capable of increasing bone mineral content, density and bone strength parameters
      in 4-week old, male rats. Our study in adolescent boys and girls showed a 12% increase in
      calcium absorption after consuming 12 g SCF for 21 days compared to a control period in a
      crossover design using a controlled feeding metabolic balance approach. Given these profound
      changes on calcium absorption and in bone, a logical next step is to study a dose-response
      effect of SCF on calcium absorption, bone turnover, and gut microflora in free-living
      adolescents.
    

Intervention name(s): 0 grams SCF; 10 grams SCF; 20 grams SCF
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Given in snack foods (muffins and flavored beverage); Given in snack foods (muffins and flavored beverage); Given in snack foods (muffins and flavored beverage)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Calcium absorption; Osteoporosis; Bone Health; Adolescent