bioihbjkbjnl/mcl2 huggingface dataset:
Text-Messaging to Motivate Walking in Older African Americans
Condition: Physical Activity; Motor Activity
Study type: Interventional

Summary: 
      This study examined the impact of using a motivational mobile text messaging intervention to
      increase step count among older community-dwelling African Americans. Secondary aims were to
      study the effects of text messaging on self-reported leisure time exercise behavior.

      Hypothesis:

      Participants in the motivational mobile text messaging group will have an increase step count
      after 6-weeks.
    

Detailed description: 
      Background: Older minority populations can benefit from increased physical activity,
      especially walking. Text messaging interventions have the potential to encourage positive
      changes in health behavior in these groups.

      Purpose: To examine if a six week program of motivational text messaging increases physical
      activity (step count) among older African Americans in an urban setting.

      Design: Randomized, controlled trial pilot study with assignment to motivational text
      messaging group or a control group.

      Setting/Participants: Thirty-six African Americans aged 60 to 85.

      Intervention: The intervention group received motivational text messages three times a day,
      three days a week, for six weeks. Both groups received pedometers and walking manuals to
      record step counts. Study was conducted and analyzed in 2011.

      Main Outcome Measures: Primary outcome measure was step count. Secondary outcome measure was
      perceived activity levels assessed by the Leisure Time Exercise Questionnaire (LTEQ).

      Results/Conclusion: In press - American Journal of Preventive Medicine (Jan 2013)
    

Intervention name(s): Motivational text messaging
Intervention type(s): Behavioral
Intervention description(s): Motivational text messaging was given for participants in the intervention group - 3 times a day, 3 times a week, for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
DMTA07 Combine With Amlodipine Treatment in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the different dose of DMTA07 (DM) combine with
      amlodipine in the treatment of mild to moderate essential hypertension, and to define the
      optimized dose of DM in the combination therapy.
    

Detailed description: 
      To compare the different dose of DM combine with amlodipine in the treatment of mild to
      moderate essential hypertension, and to define the optimized dose of DM in the combination
      therapy.

      The purpose of this study is to compare the antihypertensive efficacy and tolerability of
      different dose of DM combines with amlodipine treatment, further to explore the optimized
      combination dose of DM.
    

Intervention name(s): AM 5 + DM 0; AM 5 + DM 2.5; AM 5 + DM 7.5; AM 5 + DM 30
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Amlodipine 5 mg + DMTA07 0mg, once daily; Amlodipine 5 mg + DMTA07 2.5mg, once daily; Amlodipine 5 mg + DMTA07 7.5mg, once daily; Amlodipine 5 mg + DMTA07 30mg, once daily
Other intervention name(s): Amlodipine (AM); DMTA07 (DM); Amlodipine (AM); DMTA07 (DM); Amlodipine (AM); DMTA07 (DM); Amlodipine (AM); DMTA07 (DM)
Intervention MeSH terms: Amlodipine
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: amlodipine; DMTA07; hypertension
A Proof of Concept Study of Intravenous Sodium Nitroprusside in Adults With Symptomatic Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to investigate whether a single infusion of
      intravenous sodium nitroprusside (0.5 μg/kg/min for 4 hours) is superior to placebo (5%
      dextrose solution) at in treating positive and negative symptoms of schizophrenia
    

Detailed description: 
      This is a phase II proof of concept (POC), multi-center, prospective, randomized,
      placebo-controlled, Sequential Parallel Comparison Design (SPCD) study, in which a total of
      60 subjects with schizophrenia will be enrolled.

      The study will be conducted in two stages. The study treatment will be administered in a
      double-blind fashion for all subjects throughout both stages of the study. A total of 60
      subjects with schizophrenia will be randomized in a 1:1:1 ratio to drug-drug sequence [n=20;
      i.v. sodium nitroprusside (0.5 μg/kg/min for 4 hours) at week 0 and week 2], placebo-drug
      sequence [n=20; i.v. placebo at week 0 and i.v. sodium nitroprusside (0.5 μg/kg/min for 4
      hours) at week 2], and placebo-placebo sequence [n=20; i.v. placebo at week 0 and again at
      week 2]. The 4-week double-blind phase of treatment will be divided into two phases: Phase 1,
      from week 0 to week 2, and Phase 2 from week 2 to week 4. At the end of Phase 1 (week 2), the
      randomized subjects will be assessed and categorized into responders and non-responders,
      based on 20% or more reduction from baseline in their PANSS total score as per the
      evaluations at Randomization Visit (week 0). The data from the patients deemed placebo
      non-responders in phase 1 who go on to either stay on placebo or to receive treatment with
      sodium nitroprusside will be pooled with the data from Phase 1 from all subjects, according
      to SPCD.
    

Intervention name(s): sodium nitroprusside; Placebo
Intervention type(s): Drug; Other
Intervention description(s): intravenous; Placebo
Other intervention name(s): Nitropress; 5% dextrose
Intervention MeSH terms: Nitroprusside
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Berry Extract Administration on Cognitive Health
Condition: Cognitive Impairment; Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of daily supplementation of Brainport
      for a period of 6 months on cognitive health.
    


Intervention name(s): Brainport high dose; Brainport low dose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): berry extract, high dose. Daily ingestion of capsule; Berry extract, low dose. Daily ingestion of capsule; Maltodextrin. Daily ingestion of capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
How Total Knee Prosthesis Dessigns Influence in Quality of Live
Condition: Osteoarthritis Knee; Total Knee Replacement
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      The purpose of this study is to determine whether different kind of prostesis designs
      influences in the quality of life of patients
    

Detailed description: 
      Objectiu Criteris d'inclusió Mesura dels resultats
    

Intervention name(s): Total Knee Arthroplasty
Intervention type(s): Procedure
Other intervention name(s): Total Knee Prostesis
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients operated Total Knee Arthroplasty 6 months previously the observational study
      
Keywords: Osteoarthritis Knee; Total Knee Arthroplasty; Quality of Life
Fetal Thymus Volume of Dichorionic Diamniotic Twin
Condition: Twin Pregnancy, Antepartum Condition or Complication; Fetal Thymus Volume; Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      In some studies of fetal thymus volume, fetal stress factors; infection, preterm premature
      premature rupture of membranes, preeclampsia, preterm delivery risk.

      Generally, there is a direct correlation between fetal growth and thymus volume and it was
      observed that thymus volume decreased in pregnancies accompanied by fetal stress factors.The
      aim of this study was to measure fetal thymus volume in second trimester twin pregnancies and
      to investigate whether there is a statistically significant correlation between preterm birth
      risk pregnancies.
    


Intervention name(s): assesment of thymus volume
Intervention type(s): Other
Intervention description(s): assesment of thymus volume
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Symbicort in Airway Predominant Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of the study is to see if using anti-inflammatory to patients with airway
      disease chronic obstructive pulmonary disease (COPD) phenotype will be more effective than
      using these treatments in patients with loss of lung tissue. Symbicort plus
      ipratropium/albuterol will be used for 12 weeks in an open-label study in subjects with
      airway predominant COPD.
    

Detailed description: 
      Subjects from the COPDGene study who have airway-predominant COPD on chest CT scan will be
      enrolled; a total of 40 subjects is planned.

      Subjects will all have background ipratropium-albuterol administered four times daily.
      Subjects will be randomized to receive budesonide (180 ug twice daily) or
      formoterol-budesonide (160/4.5 ug twice daily) for 12 weeks.

      The main objective is to explore novel outcomes: blood biomarkers and chest CT scan. Outcomes
      include lung function, walk distance, respiratory disease-specific health status, and
      expiratory chest CT scan gas trapping as an exploratory outcome.

      The primary outcome measure will be FEV1 pre-bronchodilator 12 hours after the last dose of
      study medication at the end of 12 weeks of treatment. FEV1 will be measured in the morning 6
      hours after the last dose of ipratropium/albuterol and 12 hours after the last dose of
      budesonide and budesonide/formoterol
    

Intervention name(s): Budesonide; budesonide/formoterol; Ipratropium/albuterol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed; Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily; Inhaled ipratropium/albuterol combination 2 puffs four times daily
Other intervention name(s): Pulmicort Flexhaler®; Symbicort®; Combivent®
Intervention MeSH terms: Budesonide; Albuterol; Formoterol Fumarate; Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and
      Prolia® (denosumab)
    

Detailed description: 
      This is a multinational, multicenter, randomized, double-blind study to demonstrate similar
      efficacy and safety of TVB-009 compared to Prolia® administered subcutaneously at doses of 60
      mg every 26 weeks. Approximately 326 postmenopausal women with osteoporosis will be
      randomized to receive either TVB-009 or Prolia®. At week 52, patients in the Prolia® arm will
      be re-randomized 1:1 to either continue with a third dose of Prolia® or transition to TVB-009
      and receive a single dose of TVB-009 in the transition period to assess immunogenicity and
      safety after a transition from Prolia® to TVB-009. The total treatment duration for each
      patient is 78 weeks.
    

Intervention name(s): TVB-009; Prolia®
Intervention type(s): Combination Product; Combination Product
Intervention description(s): TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS); Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant
      emulsion versus MF59 alone in HIV-negative volunteers.

      One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine
      the immunogen with an adjuvant.
    

Detailed description: 
      One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine
      the immunogen with an adjuvant.

      Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant
      emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended
      12/19/96).
    

Intervention name(s): MF59; rgp120/HIV-1 SF-2
Intervention type(s): Biological; Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV-1; Adjuvants, Immunologic; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
iGrow Readers Nutrition and Physical Activity Curriculum Efficacy
Condition: Pediatric Obesity; Knowledge, Attitudes, Practice; Physical Activity; Diet Modification
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The objective of this study was to determine the efficacy of the iGrow Readers curriculum in
      changing diet and physical activity knowledge among preschool-aged children. The secondary
      objective of this study was to better understand the relationship between diet and physical
      activity related outcome variables in preschool aged children and their primary caregivers.
    

Detailed description: 
      The objective of this study was to determine the efficacy of the iGrow Readers curriculum in
      changing diet and physical activity knowledge among preschool-aged children. The secondary
      objective of this study was to better understand the relationship between diet and physical
      activity related outcome variables in preschool aged children and their primary caregivers.

      iGrow Readers was created to support literacy development among preschoolers, while promoting
      nutrition and physical activity messages. This program utilizes the social cognitive theory
      because it focuses on different environments influencing individual's behaviors and knowledge
      acquisitions, primarily through observing others within the context of social interactions
      and experiences. Developmentally appropriate preschool-aged children books, including
      relevant Native American books, facilitate the themes of healthy physical activity and
      nutrition practices. The program, a 6-8-week educational curriculum, helps young children
      understand the benefits of making healthy decisions involving nutrition and physical
      activity.
    

Intervention name(s): iGrow Readers Curriculum
Intervention type(s): Other
Intervention description(s): As part of the iGrow Readers curriculum, the primary teacher first reads a book as a group with a specific health behavior theme. Then, children participate in nutrition and physical activities that relate and reinforce the lessons learned in the book. Informational newsletters highlighting healthy behaviors from the stories' themes are provided to parents. All implementation strategies are reinforced by research to promote positive choices in young children's health behaviors through the use of literature and language strategies and modeling of others in the children's microsystems.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Obesity; Physical Activity; Nutrition; Curriculum; Preschool; Literacy
Neural, Behavioral and Physiological Correlates of Feeding in Humans
Condition: Magnetic Resonance Imaging, Functional
Study type: Observational

Summary: 
      The overarching goal of this project is to understand how nicotine addiction interacts with
      feeding behaviors and brain representation of food reward. The current proposal is part of a
      larger effort to begin a program of research to elucidate similarities and differences in
      perception of, and behavioral and neural response to, food and cigarette aromas as a function
      of 1) smoking status (smokers, ex-smokers who do gain weight, ex-smokers who do not gain
      weight, non-smokers), 2) internal state (hungry, full), and 3) cigarette deprivation (acute,
      chronic). A general hypothesis is that there are overlapping neural mechanisms governing food
      reward and cigarette reward in smokers and that this overlap includes incentive salience
      encoding.
    

Detailed description: 
      Weight gain frequently follows smoking cessation. Fear of weight gain is cited as a key
      reason not to quit and actual weight gain is a primary reason for relapse, especially among
      women. Although the causes of weight gain following smoking cessation are complex, increased
      caloric intake is recognized as one of the primary sources. One explanation for increased
      caloric intake is that, there are common neural mechanisms for food and cigarette reward and
      hence food reward can substitute for cigarette reward and vice versa. An alternative
      explanation for weight gain following smoking cessation is that there is an overall decrease
      in brain reward function during nicotine withdrawal, which leads to a decrease in the reward
      value of food and consequent increase in intake to maintain the total amount of reward
      obtained by food. The success of the proposed studies relies upon our ability to deliver
      odorants in the fMRI scanner and to measure neural activation in regions such as the
      amygdala, which are susceptible to inhomogeneity artifacts.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults in the New Haven, CT area.
      
Biospecimen description: 
      saliva samples were obtained and are stored using a coded ID in a secure part of our facility
    
Keywords: smoking; fMRI; odors; taste
Health Care Associated Infection Surveillance in NICU
Condition: Health Care Associated Infection
MeSH terms: Infections; Communicable Diseases; Cross Infection
Study type: Observational

Summary: 
      Healthcare - Associated Infection Surveillance In Neonatal Intensive Care Unit of Assiut
      University Children's Hospital.The objective of study is to determine the incidence,
      infection sites, causative organisms and risk factors related to healthcare-associated
      infections in NICU in Assiut University Children hospital.
    

Detailed description: 
      Nosocomial infections (NIs) are a major public health problem worldwide . Nosocomial
      infections are those acquired in or associated with hospitals. They are also known as
      hospital-acquired or healthcare-associated infections. The usual deﬁnition of a
      hospital-acquired infection is one that was not present or incubating when the patient was
      admitted to a hospital or healthcare facility; where there is doubt, a cut-off period of 48
      hours after admission is used.The terms hospital-acquired and healthcare-associated are often
      used interchangeably, but 'healthcare-associated' also has the wider meaning of any infection
      acquired as a result of healthcare in any setting.

      Nosocomial infections are common, and may be serious or fatal. Some are unavoidable but
      doctors' duty of care to their patients extends to fundamental matters such as basic hygiene,
      which may prevent patients becoming infected, and avoidance of unnecessary antibiotics, to
      discourage development of resistance Health care-associated infections (HC-AIs) are a major
      cause of morbidity and mortality in neonatal intensive care units (NICUs) and lead to
      increases in hospital length of stay and treatment cost. Higher nosocomial infection
      incidence in NICUs was related to longer duration of hospital stay, and invasive
      interventions and medical treatments. HC-AIs, especially device-associated health
      care-associated infections (DA-HAIs), were also common in newborns because of their
      insufﬁcient immune system and mechanical barriers, as well as lack of protective ﬂora
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective clinical study covered a period of 12 months in a tertiary neonatal
        intensive care unit in NICU of Assiut university children's hospital.
Iron Absorption Trial
Condition: Iron Absorption; Bariatric Surgery; Roux- en -y Gastric Bypass
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: There are indications that the absorption of oral iron supplementation is
      reduced after a Roux- en -Y gastric bypass. Nevertheless, oral preparations are used as
      standard therapy for iron deficiency, even in patients who underwent a Roux- en -Y gastric
      bypass. Our goal is to evaluate if iron absorption is disturbed after a RYGB, which leads to
      a insufficient treatment of oral iron suppletion.

      Methods: an iron absorption test will be performed pre- and postoperatively in 24 patients.
      Two groups will be created.

      Preoperatively group 1 receives a daily dose of ferrous fumarate (600mg) and group 2 receives
      a daily dose Losferron (1390mg).

      Before intake of the medicines, a fasting blood sample is taken (baseline), serum iron
      including ferritin, transferrin and transferrin saturation will be measured. After intake of
      losferron/ferrous fumarate blood samples will be taken 1, 2, 3, 4, 5 and 6 hours after
      intake, using a drip. An increase of 80 microgram/l is representative for a sufficient iron
      absorption. All patients undergo a Roux- en -Y gastric bypass.

      Postoperatively; one month postoperatively the same absorption test will be repeated in the
      same patients.
    


Intervention name(s): Ferrous fumarate; Ferrous gluconate
Intervention type(s): Drug; Drug
Intervention description(s): one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate; One group receives ferrous fumarate and one group receives ferrous fumarate.
Other intervention name(s): Losferron
Intervention MeSH terms: Ferrous fumarate; Ferrous gluconate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic