bioihbjkbjnl/mcl2 huggingface dataset:
Omega-6/Omega-3 Ratio and Neural Development in Preterm Infants.
Condition: Impaired Psychomotor Development
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      It's known that Docosahexaenoic acid DHA and all Polyunsaturated Fatty Acids PUFA are
      important in neurodevelopment of term and preterm infants. This study tried to determine the
      utility of a balanced contribution of DHA and Arachidonic acid AA (omega-6/omega-3) in milk
      formula, with a ratio similar to that found in breastfeeding, equal to 2, in very premature
      infants less than 1500 grams and / or less than 32 weeks of gestational age. To evaluate
      values of fatty acids they have in blood and psychomotor development they achieve.
    

Detailed description: 
      The study took place in a single-center; it is a prospective randomized study of preterm
      infants less than 1500 grams and/or less than 32 weeks gestational age, admitted to the
      Neonatal Intensive Care Unit in the University Clinical Hospital of Santiago de Compostela.
      They were recruited for a period of 14 months (from July 2010 to august 2011) and followed
      from birth until 2 years of life.

      40 children were included and followed in the study. Patients will be assigned randomly into
      two groups depending on the type of formula they are receiving. The group A of children will
      receive a formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2. And
      group B will receive other formula with DHA and ARA, but with a ratio of 1/1.

      The classification of group A and B was made by simple random way; one birth in every group,
      continuously.

      Implementation of breastfeeding will be promoted and will be fortified after 7 days of life,
      when the total amount of breast milk will be more than 1/2 of the total.

      When breastfeeding will be insufficient or nonexistent, special formulas for premature babies
      will be given

      During the follow-up of patients, will be measured:

        1. - Levels of fatty acids in blood in the first week of life, 3 months, 6 months and 12
           months.The determination will be carried out in collaboration with the Hospital de
           Cruces, Bilbao, Spain.

        2. - Evaluation of psychomotor development by Brunet-Lezine scale at 2 years of corrected
           age.
    

Intervention name(s): Preterm infants formula
Intervention type(s): Dietary Supplement
Intervention description(s): The group 1 of children will receive a preterm infants formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2/1 during the first 3 months of life. And group 2 will receive other Preterm infants formula very similar, but with a ratio of DHA and AA=1/1 also during the first 3 months of life.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Keywords: Omega-3; Omega-6
mFOCUS (Multilevel FOllow-up of Cancer Screening)
Condition: Cancer
Study type: Interventional

Summary: 
      To evaluate the effectiveness of the system, team and individual components of mFOCUS vs.
      standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals
      who are due for follow-up of an abnormal cancer screening test.
    

Detailed description: 
      Standard care consists of well-characterized existing decision support and systems for
      follow-up in these three participating primary care networks and their affiliated integrated
      delivery systems (Brigham and Women's Hospital, Massachusetts General Hospital, and Dartmouth
      Hitchcock Health, the largest health care provider in New Hampshire). The primary outcome
      will be whether an individual receives follow-up, defined based on the type of screening
      abnormality and organ type (breast, cervical, lung or colorectal cancer), within 120 days of
      becoming eligible for mFOCUS. Secondary comparisons will assess multi- and cross-level
      (individual, team, system) outcomes. The study design will allow us to examine the marginal
      effectiveness of system, team and individual-level enhancements, and exploratory analyses
      will address subgroups defined by race/ ethnicity, socioeconomic status and cancer type.
    

Intervention name(s): mFOCUS
Intervention type(s): Other
Intervention description(s): To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All individuals in this study will receive the current standard of care at Massachusetts General Hospital, Brigham and Women's Hospital, and Dartmouth Hitchcock for the follow-up of abnormal cancer screening tests (Arms 1-4). In addition to this standard of care, we will test 3 additional arms of increasing intensity of intervention: Arm 2-access to an IT platform to facilitate updates to HM modifiers and problem lists for visit-based reminders; Arm 3- the IT platform in addition to automated reminders to patients between visits and the care team; Arm 4-the IT platform, automated reminders, and administrative outreach and navigation to help with scheduling and to address social barriers to care.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Abnormal Screening Results
Genetic Variation in CLTCL1 and Whole-body Glucose Control
Condition: Glucose Control
Study type: Interventional

Summary: 
      Maintaining stable blood glucose concentrations after eating has important implications for
      health. Individuals who are better able to maintain stable blood glucose concentrations after
      consuming carbohydrate have a lower risk of mortality from cardiovascular disease. Muscle is
      the primary tissue for glucose disposal following a meal, and responsiveness of this tissue
      to insulin is dictated by GLUT4 translocation to the muscle cell membrane. Clathrin heavy
      chain isoform 22 (CHC22) is a protein that plays a key role in intracellular GLUT4 action,
      and it may play an important role in whole-body glucose control. Genetic variation in the
      gene which codes for CHC22 may be able to explain differences in glucose control at the
      whole-body level.
    

Detailed description: 
      The ability to maintain relatively stable blood glucose concentrations after eating has
      important implications for health. Individuals who are better able to maintain stable blood
      glucose concentrations after consuming carbohydrate have a lower risk of mortality and
      morbidity from cardiovascular disease. Muscle is the primary tissue for glucose disposal
      after a meal and the ability to tolerate a glucose load is largely dependent on the ability
      of muscle to respond to insulin by translocating the glucose transporter, GLUT4, to the
      muscle cell membrane, facilitating glucose import into muscle from the circulation.
      Therefore, by understanding the mechanisms that explain why some people are better able to
      maintain glucose control can give insight into how to target physiological pathways (such as
      muscle glucose uptake) to reduce disease risk and improve health.

      Clathrins are cytoplasmic proteins that play essential roles in cell membrane trafficking
      pathways. Pilot data indicate that the clathrin heavy chain isoform 22 (CHC22) plays a key
      role in intracellular targeting of GLUT4 and may therefore play an important role in
      whole-body glucose control. Cell-based studies suggest that genetic variation in the CLTCL1
      gene (which encodes for CHC22) at SNP rs1061325, influences GLUT4 retention. It is currently
      unknown whether genetic variation in CHC22 has consequences for whole-body glucose control in
      humans.
    

Intervention name(s): Oral glucose tolerance test
Intervention type(s): Diagnostic Test
Intervention description(s): Participants will ingest 75 g anhydrous glucose dissolved in water and the blood responses will be measured over the following 2-hours using a venous cannula.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glucose; Genetic variation; CHC22; CLTCL1
Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus
Condition: Schizophrenia; Schizoaffective Disorder; Delusional Disorder
MeSH terms: Diabetes Mellitus; Schizophrenia; Psychotic Disorders; Schizophrenia, Paranoid
Study type: Observational

Summary: 
      This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes
      mellitus in patients with schizophrenia. As part of the study, we collect
      neuroendocrine-immune data on patients with first episode, treatment naive psychosis,
      patients with newly diagnosed schizophrenia and normal healthy controls.

      Regardless the treatment status, we collect the same neuroendocrine-immune data on the
      participants after 2 months.
    

Detailed description: 
      This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes
      mellitus in patients with schizophrenia. As part of the study, we collect
      neuroendocrine-immune data on patients with first episode, treatment naive psychosis,
      patients with newly diagnosed schizophrenia and normal healthy controls.

      Regardless the treatment status, we collect the same neuroendocrine-immune on the
      participants (patients and controls) after 2 months. Thus, our study does not control
      treatment. Patients take treatment in consultation with their physician. Some of them even
      decide not to take any medications. At the 2nd visit, we do ask them about the the
      medications they are taking if any.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with psychosis
      
Biospecimen description: 
      blood samples are collected, stored at minus 70 degree C and analyzed in batches.
    
Keywords: schizophrenia, psychosis, type 2 diabetes mellitus
The Relationship of DASH and Mediterranean Diet Score With Serum Adiponectin Levels in Patients With Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      The aim of this study is to reveal the relationship of DASH and Mediterranean diet score with
      anthropometric measurements and serum adiponectin level in individuals with spinal cord
      injury. This research was planned as a cross-sectional, case-control study. With the data to
      be obtained from the research, information will be obtained about the hormonal or biochemical
      basis of metabolic disorders such as atherosclerosis and insulin resistance that may occur in
      individuals with spinal cord injury in the long term.

      20 individuals with Spinal Cord Injury will be included in the study, and the results of the
      patients will be compared with 20 healthy individuals. In order to determine the food
      consumption status of the patients, a 1-day food consumption record will be requested. DASH
      diet score and Mediterranean diet score will be calculated from dietary records. After 8
      hours of fasting, 3 ml of peripheral blood will be taken for the measurement of adiponectin
      between 08:00 and 09:00 in the morning from the individuals in the study and control groups.
      Adiponectin level will be measured and its correlation with DASH diet score and Mediterranean
      diet score will be examined.
    


Intervention name(s): Keeping a 1-day food consumption record by the patient; Measurement of adiponectin level
Intervention type(s): Other; Other
Intervention description(s): Checking and receiving the 1-day food consumption record recorded by the patient by the researcher; Adiponectin level will be measured for each group
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients admitted to hospital Healthy population from patient care givers of hospital staff
      
Keywords: Adiponectin
Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects
Condition: Antithrombic Drug
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's
      test product relative to that of reference product after single oral dose administration in
      normal, healthy, adult, human subjects under fasting condition and to assess the
      bioequivalence.
    


Intervention name(s): Apixaban 5MG; Eliquis 5 mg
Intervention type(s): Drug; Drug
Intervention description(s): Each film-coated tablet contains 5 mg apixaban; Each film-coated tablet contains 5 mg apixaban
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Renal Fractional Flow Reserve in Renal Artery Stenting
Condition: Renal Artery Stenosis; Hypertension
MeSH terms: Renal Artery Obstruction; Hypertension; Constriction, Pathologic
Study type: Interventional

Summary: 
      The purpose of the study is to determine potential utility of renal fractional flow reserve
      in prognosis predicting after renal stent implantation.
    


Intervention name(s): Renal artery stenting
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fractional flow reserve; Revascularization; Prognosis; Hemodynamics; Hypertension
A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered
      orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.
    


Intervention name(s): Pomalidomide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions; Placebo capsule
Other intervention name(s): CC-4047
Intervention MeSH terms: Pomalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Pomalidomide; safety; tolerability; pharmacokinetics
The Effect of Novel High-intensity Interval Training on Physical Fitness in Older Adults
Condition: High-intensity Interval Training
Study type: Interventional

Summary: 
      High-intensity interval training (HIT) has been demonstrated to be an effective strategy to
      improve markers of health and fitness across a wide range of healthy and clinical
      populations. Currently however, there is only limited evidence which has examined the
      effectiveness of HIT in older adults (>50 years). HIT is an appealing strategy in this group
      as it has the potential to impact both cardiorespiratory and muscular fitness, which both
      play an important role in maintaining functional fitness and quality of life in a
      time-efficient manner. Developing an understanding of novel strategies for delivering this
      type of exercise training may ultimately provide a viable alternative to traditional modes of
      exercise training for a broader range of participants. As such, the purpose of this study is
      to evaluate the effects of a novel, high-intensity interval training exercise protocol to
      improve physical fitness in adults aged over 50 years. This research also aims to evaluate if
      this type of training intervention is feasible in this population, through analysis of
      adherence and intervention fidelity.
    


Intervention name(s): Novel high-intensity interval training
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: High-intensity interval training; Functional fitness; Quality of life; Older adults
Couples HIV Counseling and Testing for Male Couples in the United States
Condition: HIV
Study type: Interventional

Summary: 
      This is a study to determine whether testing for HIV together as a couple, as opposed to
      testing separately, in acceptable to men in male couples, and is a safe prevention service.
      Testing of couples together has been provided for decades in Africa, but has never been
      tested in the United States. In this study, male couples will be enrolled and randomly
      assigned to be tested together in the same room, or separately. At the time of testing,
      investigators will ask questions about how they felt about the service they received. Three
      months later, investigators will survey the men again, and determine whether they had any
      problems after the testing, like violence in the relationship or the relationship breaking
      up. The main outcomes are being satisfied with the testing service, and safety (lack of
      intimate partner violence or relationship termination). Although the study is not designed to
      determine if the service reduces risk behaviors for HIV transmission, investigators will
      examine data on risks just to explore that topic. The main hypotheses are: (1) men will be at
      least as satisfied with couples testing as they are with individual testing; and (2) men
      tested as couples will not experience higher rates of intimate partner violence or
      relationship dissolution, relative to men tested separately.
    


Intervention name(s): Couples Voluntary HIV Counseling and Testing; Individual Counseling and Testing
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Couples HIV Testing and Counseling
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Homosexuality, Male
Influence of Respiratory Muscle Training in Elderly Hypertensive Women With Respiratory Muscle Weakness
Condition: Hypertension
MeSH terms: Muscle Weakness; Paresis; Hypertension
Study type: Interventional

Summary: 
      This study aims to evaluate pulmonary function and respiratory muscle strength in a group of
      elderly women with hypertension before and after a respiratory muscle training.
    

Detailed description: 
      It is a respiratory muscle training using the Threshold for 5 weeks, with a load of 30% of
      maximal inspiratory pressure obtained in manometer for 30 minutes daily. Furthermore, the
      assessment includes: test 6-minute walk, the quality of life questionnaire, MINICHAL, the
      IPAQ short version, manometer and spirometry.
    

Intervention name(s): Threshold
Intervention type(s): Device
Intervention description(s): The load adjustment was done weekly by a single examiner.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension
124I-FIAU Imaging in EBV and KSHV Associated Cancers
Condition: Hodgkin Lymphoma; Non Hodgkin Lymphoma; Kaposi's Sarcoma; Gastric Cancer; Nasopharyngeal Cancer
MeSH terms: Sarcoma, Kaposi; Lymphoma; Sarcoma; Stomach Neoplasms; Hodgkin Disease; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
Study type: Interventional

Summary: 
      This research is being done to determine whether viral thymidine kinase (TK) expression in
      Epstein-Barr virus (EBV) and Kaposi's sarcoma herpesvirus (KSHV) virus-associated tumors is
      sufficient to image.
    

Detailed description: 
      EBV and KSHV are associated with a variety of malignancies including some lymphomas,
      carcinomas and other malignancies. We anticipate that viral TK expression will differ among
      tumor types and will be adjusted with standard chemotherapies and some investigational
      agents. This exploratory study is aimed in part at evaluating whether standard regimens or
      investigational regimens might bring about sufficient activation of the EBV-TK or KSHV-TK in
      tumors to be therapeutically useful if used in conjunction with FIAU as a
      radiopharmaceutical.
    

Intervention name(s): FIAU-PET-CT-2; FIAU-PET-CT-4
Intervention type(s): Other; Other
Intervention description(s): 1-3 days after chemotherapy, subject get I-FIAU 2 mCi, then have FIAU-PET-CT done 2 - 4 hours after I-FIAU; 1-3 days after any chemotherapy that may activate viral TK, 4 mCi, rather than 2 mCi, of I-FIAU are administered, followed 2 - 4 hours later by FIAU-PET-CT
Other intervention name(s): FIAU; I-FIAU; PET-CT; FIAU-PET-CT; FIAU; I-FIAU; PET-CT; FIAU-PET-CT
Intervention MeSH terms: Fialuridine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: EBV+ malignancies; KSHV+ malignancies; HIV-associated lymphomas; Hodgkin Lymphoma; nonHodgkin Lymphoma or; nonHodgkins Lymphoproliferative Disease; Primary Effusion Lymphoma; Kaposi's Sarcoma; Gastric Cancer; Nasopharyngeal Cancer
Porphyromonas Gingivalis and Alzheimer's Disease
Condition: Alzheimer's Disease; Dementia; Periodontitis
MeSH terms: Periodontitis; Alzheimer Disease
Study type: Observational

Summary: 
      With this study the investigators would like to analyze the the role of periodontal disease
      and especially the role of Porphyromonas gingivalis in initiation and progression of
      Alzheimer's Disease.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 Patients with Dementia (30 with Alzheimer's and 30 with another Dementia) 30 cognitive
        healthy patients
      
Biospecimen description: 
      GCF, Liquor, Serum
Use of Music and Voice Stimulus on Coma Patients
Condition: Coma
MeSH terms: Coma
Study type: Interventional

Summary: 
      Objectives: (1) To check music and voice message influence on vital signs and facial
      expressions of patients in physiological or induced comas; (2) To connect the existence of
      patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale.

      Method: This was a randomized controlled clinical trial with 30 patients, from two Intensive
      Care Units, being divided in 2 groups (control and experimental). Their relatives recorded a
      voice message and chose a song according to the patient's preference. The patients were
      submitted to 3 sessions for 3 consecutive days.
    

Detailed description: 
      The relatives elaborated a voice recorded message and choose a music according to the patient
      preference, which were recorded in the same Compact Disc. Two identical CD's were made at the
      same recorded time; one with and another one without stimulus in order to make the random
      division of the groups. The patients were evaluated according to one of the Scales; they used
      earphones. During the sessions, the data relating to the vital signs and the face expression
      were recorded in a data collection instrument.
    

Intervention name(s): Music and message
Intervention type(s): Other
Intervention description(s): Experimental group: music and message Control group: silence
Other intervention name(s): Patients in state of coma or induced coma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Communication; Complementary Therapies; Intensive Care; Ethics