bioihbjkbjnl/mcl2 huggingface dataset:
Aerobic Training in Pregnant Women With Gestational Diabetes and Chronic Hypertension
Condition: Pregnancy; Gestational Diabetes Mellitus; Chronic Hypertension in Obstetric Context
MeSH terms: Diabetes, Gestational; Hypertension; Diabetes Mellitus
Study type: Interventional

Summary: 
      The aim of the present study is verify glycated hemoglobin (HbA1c) and HOMA behavior in
      pregnant women with gestational diabetes or chronic hypertension after an aerobic training in
      cycle-ergometer. The sample is composed by 64 pregnant and sedentary women, 20 weeks'
      pregnant.

      Two experimental groups (gestational diabetes and chronic hypertension, n = 16 each) will
      perform a low-intensity aerobic training in cycle-ergometer, three times/week, for 45 minutes
      each session. Two control groups (gestational diabetes and chronic hypertension, n = 16 each)
      will perform an unique session/week of relaxation and stretching.

      Outcomes: first ventilatory threshold, HbA1c,HOMA, type of delivery, weight and height of the
      newborn.
    

Detailed description: 
      The statistical analysis will consist of:

        -  descriptive statistic;

        -  Levene's test

        -  Shapiro Wilk's normality test

        -  Parametric or non-parametric test

        -  a=0.05

        -  SPSS 17.0
    

Intervention name(s): Aerobic exercise; Stretch exercise
Intervention type(s): Other; Other
Intervention description(s): Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week; Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Glycated hemoglobin; HOMA; Pregnancy; aerobic exercise
Safety and Tolerability Study of Xisomab 3G3 in Healthy Adult Subjects
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of xisomab 3G3 in healthy adult subjects.
    


Intervention name(s): xisomab 3G3- Dose 1; xisomab 3G3-Dose 2; xisomab 3G3-Dose 3; xisomab 3G3- Dose 4; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Participants will receive a single intravenous dose of 0.1 mg/kg xisomab 3G3.; Participants will receive a single intravenous dose of 0.5 mg/kg xisomab 3G3.; Participants will receive a single intravenous dose of 2.0 mg/kg xisomab 3G3.; Participants will receive a single intravenous dose of 5.0 mg/kg xisomab 3G3.; Participants will receive a single intravenous dose of placebo.
Other intervention name(s): AB023- Dose 1; AB023- Dose 2; AB023- Dose 3; AB023- Dose 4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Gene Expression in Tissue From Patients With Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer
      may help doctors identify biomarkers related to cancer.

      PURPOSE: This laboratory study is looking at gene expression in tissue from patients with
      acute lymphoblastic leukemia enrolled in clinical trial ECOG-2993.
    

Detailed description: 
      OBJECTIVES:

        -  Identify genes involved in specific biologic processes or molecular functions that
           contribute to the mechanisms by which the BCR/ABL tyrosine kinase induces a leukemic
           phenotype using RNA banked from patients with BCR/ABL-positive acute lymphoblastic
           leukemia (ALL) enrolled on ECOG-2993.

        -  Compare patterns of mRNA expression of BCR/ABL fusion protein in patients with B-lineage
           ALL vs patients with ALL and no cytogenetic abnormalities enrolled on ECOG-2993.

        -  Determine both shared and differing expression patterns in patients with
           BCR/ABL-positive and cytogenetically negative ALL with respect to achievement of
           complete remission and duration of disease-free and overall survival.

      OUTLINE: This is a multicenter study.

      Total RNA is isolated from stored tissue samples and integrity is verified by reverse
      transcription-polymerase chain reaction (RT-PCR). cDNA libraries are created from total RNA
      and gene expression is analyzed via microarray analysis.

      Genes of interest are further analyzed by flow cytometry and RT-PCR.

      PROJECTED ACCRUAL: A total of 137 patients will be accrued for this study.
    

Intervention name(s): microarray analysis; reverse transcriptase-polymerase chain reaction; flow cytometry
Intervention type(s): Genetic; Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E2993
      
Keywords: adult acute lymphoblastic leukemia in remission
Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Condition: Type II Diabetes Mellitus; Dyslipidemia
MeSH terms: Diabetes Mellitus; Dyslipidemias; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of pitavastatin with that of
      atorvastatin in patients with type II diabetes mellitus (type II DM) and combined
      dyslipidemia.
    


Intervention name(s): Pitavastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Pitavastatin 4 mg QD; Atorvastatin 20 mg
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kowa; Type II Diabetes Mellitus; Combined Dyslipidemia; pitavastatin; NK-104; Atorvastatin
Factors Affecting Patients With Myofascial Temporomandibular Disorders
Condition: Myofascial Temporomandibular Disorder; Bruxism, Sleep; Sleep Disturbance; Jaw Spasm; Headache
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Bruxism; Sleep Bruxism; Dyssomnias; Parasomnias; Headache
Study type: Observational

Summary: 
      The aim of the study was to assess and compare the relationship between jaw function, neck
      disability, sleep quality, fatigue, and headache in patients with myofascial
      Temporomandibular Disorder (TMD) with Sleep Bruxism (SB) and without (non-SB).
    

Detailed description: 
      The study was conducted on TMD patients who were willing to participate in the study between
      January and December 2020.

      The case-control study included patients diagnosed with myofascial TMD by dental
      practitioners at regional hospitals referred for physiotherapy. Total of 200 myofascial TMD
      patients, comprising 91 identified as SB and 109 as non-SB were included in the study.

      The Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep
      Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales
      and indexes were used for both groups.

      The effect of Sleep Bruxism (SB) on jaw function, neck problems, sleep quality, fatigue, and
      tension headache were evaluated.

      The interactions of these factors and the importance of taking SB into consideration when
      evaluating and treating patients with TMD were examined.
    

Intervention name(s): Scales and indexes
Intervention type(s): Other
Intervention description(s): Patients with TMD regardless of diagnosis with sleep bruxism were assessed with the Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a chief complaint of pain and functional limitation at the temporomandibular
        region were assessed by dentists at regional hospitals. Those who were diagnosed with
        myofascial TMD according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
        participated in the study.
      
Keywords: Temporomandibular Disorders; Sleep bruxism; Neck Disability; Sleep; Headache
Electromyographic Biofeedback Muscle Recovery Meniscectomy
Condition: Feedback, Psychological
Study type: Interventional

Summary: 
      Electromyographic biofeedback (EMG-BF) is a therapeutic technique that has been used
      success-fully in rehabilitation of injuries. Although it has been applied in athletes, its
      use in this field is not very widespread. The objective of this study is to analyze its
      effectiveness in the recovery of electromyographic activity of the quadriceps after
      meniscectomy, evaluated through isometric contraction of the vastus lateralis. The sample
      comprised ten professional footballers in the Spanish League (2nd Division A) who had
      previously suffered a meniscus injury in their knee and had undergone a meniscectomy. The
      intervention consisted of EMG-BF treatment lasting between 6 and 10 sessions. The
      electromyographic signal was recorded using a Thought Tech-nology ProComp Infiniti 8-channel
      biofeedback unit with a sampling rate of 2048 sam-ples/seconds. For each session a
      within-subject ABA design of 6 or 10 trials per session was used, with three pre- and three
      post-measures, which determined the gain for each session.
    


Intervention name(s): Electromyographic Biofeedback
Intervention type(s): Other
Intervention description(s): The players performed 10 work sessions with EMG-BF. Each session was divided into three phases: (a) three trials without receiving feedback, (b) between six and ten trials with feedback of electromyographic activity, (c) three trials without feedback. In each trial, isometric contractions of the vastus lateralis were performed.
During maximum effort isometric contraction, the software associated with the ProComp Infiniti biofeedback unit collects the amplitude, the mean and maximum electromyographic signal, and also the contraction and tightening times. The contrac-tion time comprises the interval between the start of the contraction and achievement of the desired muscle tension. The tightening time is the period in which the tension voluntarily reached is maintained. For this study, the maximum and mean elec-tromyographic activity values were considered, calculated during the muscle tension time and maintained during each trial.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Evaluation of Adolescent Smoking Cessation Programs
Condition: Smoking Status
Study type: Interventional

Summary: 
      The purpose of this study was to determine if a school-based multi-session group smoking
      cessation program is more effective than a single session group program.
    

Detailed description: 
      The investigators reformatted two group smoking cessation programs (the NOT program of the
      American Lung Association and Kicking Butts), both of which involve 50 minute sessions
      delivered once weekly, into a program that could be delivered during school lunch periods
      (25-30 minutes) twice weekly. Smoking status was subsequently assessed over the 12 month
      period following the intervention,
    

Intervention name(s): NOT program; NOT controls; Kicking Butts intervention; KB controls
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Students in this arm of the study received the reformatted NOT intervention; Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets; Students in this arm of the study were randomized to receive the reformatted Kicking Butts intervention; Students in this arm were randomized to receive a single group session on smoking cessation and were given youth oriented informational pamphlets
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adolescents; smoking; smoking cessation; tobacco use
A Phase 1b Study With Volociximab in Combination With Carboplatin and Paclitaxel in First-line, Advanced Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to examine the safety of volociximab in combination with
      a standard treatment of carboplatin and paclitaxel in subjects previously untreated with
      chemotherapy for advanced stage (IIIB/IV) non-small cell lung cancer (NSCLC).
    

Detailed description: 
      This Phase 1b, multicenter, open-label, dose-escalation study will evaluate the safety and
      pharmacokinetics (PK) of volociximab in combination with carboplatin and paclitaxel (C/P) as
      first-line treatment in subjects with Stage IIIB or IV non-small cell lung cancer (NSCLC).
      Volociximab doses of 10, 20, and 30 mg/kg (or 15 mg/kg if 20 mg/kg is not tolerable) with
      carboplatin/paclitaxel chemotherapy will be tested for determining the maximum tolerated dose
      (MTD). Subjects will be dosed once very 3 weeks for up to 6 cycles.

      Volociximab is a high-affinity, chimeric monoclonal antibody that specifically binds to α5β1
      integrin, a cell-surface receptor for fibronectin. Volociximab blocks the binding of α5β1 to
      fibronectin, thereby inhibiting a pivotal interaction required for angiogenesis.

      More than 170 subjects with various solid tumor types have received volociximab in Phase 1
      and Phase 2 single and combination studies. At the doses tested, there has not been a dose
      limiting toxicity (DLT) or a maximum tolerated dose (MTD) defined.
    

Intervention name(s): M200 (Volociximab), Carboplatin, Paclitaxel
Intervention type(s): Drug
Intervention description(s): Volociximab will be administered via IV infusion at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels during the first cycle. Volociximab will be given for at least 6 cycles (3 weeks/cycle) and subjects who have stable disease at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All three drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.
Other intervention name(s): Volociximab (M200)
Intervention MeSH terms: Paclitaxel; Carboplatin; Volociximab; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cancer; carcinoma; chemotherapy; monoclonal antibody therapy; anti-angiogenesis
Cognitive Effects of Transcranial Direct Current Stimulation in Older Adults
Condition: Aging
Study type: Interventional

Summary: 
      This research is being done to determine whether transcranial direct current stimulation
      (tDCS) can improve certain mental abilities. In this research, a 9 volt battery is used to
      deliver very weak electrical current to the surface of the scalp while participants complete
      cognitive tasks. Our aim is to find out whether tDCS will improve task performance in adults
      over the age of 55.
    

Detailed description: 
      Participants enrolled into this study may be asked to do the following:

        -  Grant permission for the researchers to view medical records associated with their
           language/cognitive difficulties (if applicable).

        -  Complete a questionnaire, provide a health history, and take some pencil-and-paper tests
           of problem-solving and memory in order to verify eligibility to participate and to able
           to safely undergo the experimental procedures.

        -  Complete several tasks (i.e., saying words out loud, naming objects, drawing designs,
           remembering lists of words, searching for images or letters, and/or completing puzzles)
           based upon a number of cognitive functions such as language, memory, vision, processing,
           and perception.

        -  Wear electrodes that will be placed on the scalp with a large rubberized band. These
           electrodes will administer very weak electrical current (tDCS) from a 9 volt battery for
           20 to 60 minutes.

        -  Participate in several study conditions. The exact conditions and their order will be
           randomized. Under some conditions, participants may receive active stimulation (tDCS)
           and under other conditions, they may receive sham stimulation.

        -  The experimental sessions will last approximately 2 hours and participants may be asked
           to have more than one testing session in a day or to return for additional sessions.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Procedure
Intervention description(s): delivery of transcranial direct current stimulation or sham stimulation for 20 to 60 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cognitive Enhancement; tDCS; stimulation; elderly; older adults
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
Condition: Diabetes Mellitus, Insulin-Dependent; Hypercholesterolemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Children with type1 diabetes (T1DM) have increased risk for cardiovascular disease (CVD) due
      to chronic increase in the blood sugars and inflammation. If there is also increased in
      cholesterol, it creates a highly abnormal environment not fully corrected by improved control
      of the blood sugars. CVD remains the principal risk of mortality in T1DM, and its prevention
      and treatment, compelling in children. This grant proposal encompasses 3 separate, yet
      interrelated projects addressing different aspects of CVD risk in children with T1DM. Project
      #1: a randomized controlled trial on the safety and efficacy of a class of drugs called
      "statins", which lower bad cholesterol in the body, in children with diabetes and elevated
      bad cholesterol. We will measure changes in concentration of blood inflammatory markers and
      for the 1st time, correlate levels of these markers with changes in blood sugar as measured
      by continuous glucose sensors, instruments that measure the blood sugar continuously through
      a small needle under the skin. Project #2: is a laboratory study to investigate the genetics
      and concentration of key molecules that participate in the inflammatory cascade and
      atheromatous plaque formation that causes CVD. Expression levels in children with T1DM will
      be compared with those in healthy controls for the 1st time. Project #3: examines the use of
      abdominal aortic MRI to measure damage to the arteries in children with T1DM and healthy
      age-matched controls. The results of these studies will likely provide important new data on
      the use of statins in children with diabetes.
    


Intervention name(s): Atorvastatin; Atorvastatin Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 or 20 mg daily; 10 or 20 mg daily
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Children; Statins; Hypercholesterolemia; Lipoproteins; C reactive protein; Continuous glucose monitors; Adolescence; Abdominal magnetic resonance imaging; Toll like receptors; Receptors of advanced glycation end products; Nutrition
Study of SDMB (2,2 Dimethylbutyrate, Sodium Salt) in Beta Thalassemia Intermedia in Thailand
Condition: Beta Thalassemia Intermedia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Beta thalassemia intermedia is an inherited blood disease caused by molecular mutations which
      reduce the beta globin protein chain of adult hemoglobin A, the protein in red blood cells
      which carries oxygen throughout the body. Beta thalassemias cause progressively severe
      anemia, widespread organ damage, and often require blood transfusions. There is no FDA
      approved therapeutic to treat the underlying cause of beta thalassemia. Fetal hemoglobin is
      another type of endogenous hemoglobin which can replace the reduced beta globin protein,
      reduce the anemia, and even abolish transfusion requirements. This type of hemoglobin is
      normally suppressed in infancy.

      Sodium 2,2 dimethylbutyrate (ST20, or HQK-1001) is a small molecule which stimulates
      production of fetal hemoglobin in nonhuman primates and in human patients in Phase I/II
      trials.

      This is a Phase 2 open-label trial to evaluate the ability of this oral therapeutic to reduce
      anemia in patients with beta thalassemia intermedia, when administered once daily for 26
      weeks. All participants will receive the study drug.
    

Detailed description: 
      This trial will:

        1. Determine the proportion of patients in which treatment with the study drug results in
           an increase in total hemoglobin by 1.5 g/dl above baseline levels when administered for
           26 weeks in Thai patients with beta thalassemia intermedia, including Hemoglobin E beta
           thalassemia.

        2. Determine the number and proportion of participants in whom treatment with the study
           drug results in an increase in fetal hemoglobin.

        3. Determine the number of participants who have adverse events.
    

Intervention name(s): sodium 2,2 dimethylbutyrate
Intervention type(s): Drug
Intervention description(s): Oral capsule, dose 20 mg/kg/day, daily, for 26 weeks
Other intervention name(s): HQK-1001, ST20
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thalassemia; Anemia; Fetal hemoglobin