bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Iron and Omega-3 Fatty Acid Supplementation on Cognition and Immune Function in Iron Deficient Children
Condition: Iron Deficiency; Anemia
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The aim of this study is to determine if providing iron and a mixture of DHA and EPA, alone
      and in combination, to children with iron deficiency and poor n-3 fatty acid intake will
      improve their cognitive performance, activity levels and immune system.

      Additionally, the effects on iron and fatty acid status, and gut microbiota, will be
      assessed.
    

Detailed description: 
      In populations of low socio economic status, such as found in South Africa, iron deficiency
      coexisting with a low intake of n-3 fatty acids could synergistically compromise both the
      intellectual performance and immune system of children.

      Therefore, specific cognitive processes (domains) and specific immunization status markers
      and immune function modulators, that have been found to be affected by iron and n-3 fatty
      acid deficiency in children in previous studies will be assessed.

      This will be the first human study that assesses the interactions of iron and n-3 fatty acid
      supplementation to iron deficient children in a two-by-two factorial, randomized,
      double-blind, placebo-controlled trial.
    

Intervention name(s): DHA and EPA Fish Oil capsule; Iron tablet; Placebo tablet; Placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): 2 DHA/EPA capsules on 4 days per week containing totally 420 mg DHA and 80 mg EPA, providing an average dose of 285.7 mg n-3 fatty acids per day; 1 iron tablet containing 50 mg of iron as ferrous sulfate will be administered on 4 days per week, providing an average iron dose of 28.6 mg iron per day.; Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.; Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.
Other intervention name(s): Provided by Burgerstein AG (Rapperswil, Switzerland); Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany); Provided by Lomapharm (Paul Lohmann GmbH, Emmertal, Germany); Will be provided by R.P. Scherer GmbH (Eberbach, Germany)
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Outpatient Birth: Pilot Study
Condition: Outpatient Birth
Study type: Interventional

Summary: 
      The diminution of the average length stay (ALS) in French maternity is a clear evolution, the
      objective of the draft law on social security is to reduce the ALS to equal other OECD
      countries. The over-medicalization of maternal health raises the question of relevant and
      iatrogeny of Professional practices. Furthermore, pregnant woman, future parents expressed
      their wish for an individual support and more physiological respectful. A more-effective
      Professional coordination is expected where the midwife is a major player.
    

Detailed description: 
      The aim of the study is to identify and evaluate an outpatient birth path during the first 24
      hours after the birth.
    

Intervention name(s): Outpatient birth
Intervention type(s): Other
Intervention description(s): Maternity out the same date or the next day of the birth and home-based follow up with a liberal midwife
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study
Condition: Primary and Secondary Coxarthrosis; Dysplasia Coxarthrosis; Post-traumatic Necrosis of the Femoral Head
MeSH terms: Osteoarthritis, Hip; Necrosis
Study type: Observational

Summary: 
      The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck
      Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith & Nephew GmbH, Marl,
      Germany) by measuring the migration of the implant using the model-based roentgen
      stereophotogrammetric analysis (MBRSA).
    


Intervention name(s): Total Hip Arthroplasty
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients identified in the primary care clinic with need for total hip arthroplasty
      
Keywords: Nanos; THA; MBRSA
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
Condition: Adult Growth Hormone Deficiency; Growth Hormone Disorder
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of
      once weekly dosing of somapacitan (administered with an investigational pen) with daily
      Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in
      previously human growth hormone (hGH) treated adults with growth hormone deficiency.
    


Intervention name(s): somapacitan; somatropin
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) with an investigational pen once weekly for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.; Administered subcutaneously (s.c., under the skin) with a prefilled pen (Norditropin® FlexPro®) daily for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective annual release study is designed to evaluate the safety of 1 new influenza
      virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza
      season.
    

Detailed description: 
      This prospective, randomized, double-blind, placebo-controlled release study will enroll
      approximately 300 healthy adults 18 to 49 years of age (not yet reached their 50th birthday).
      Eligible participants will be randomly assigned in a 4:1 fashion to receive a single dose of
      monovalent vaccine or placebo by intranasal spray. Randomization will be stratified by site.
      This study will be conducted at 2 sites in the United States of America. Each participant
      will receive 1 dose of investigational product on Day 1. The duration of study participation
      for each participant is the time from study vaccination through 180 days after study
      vaccination.
    

Intervention name(s): Monovalent Influenza Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): A single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 FFU of each of 1 ca, att, ts 6:2 reassortant influenza strain] will be administered as intranasal spray on Day 1.; A single dose of placebo matching with monovalent influenza vaccine will be administered as intranasal spray on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Trivalent; Influenza; FluMist Quadrivalent; Vaccine; Prevention; Healthy; Monovalent
Engendering Healthy Masculinities to Prevent Sexual Violence
Condition: Violence; Sexual Assault
Study type: Interventional

Summary: 
      Sexual violence (SV) and adolescent relationship abuse (ARA) are prevalent among adolescents
      and associated with poor health. Global health organizations highlight engaging men and boys
      in preventing violence against women as a potentially impactful public health strategy. This
      study aims to test, via a two arm cluster randomized controlled trial, a "gender
      transformative" SV/ARA perpetration prevention program among African American adolescent
      males ages 13-19 (target is high school age) implemented in a community-based setting.
      "Gender transformative" refers to a theory- and evidence-based approach to alter gender norms
      that foster SV/ARA while promoting bystander intervention (i.e., giving boys skills to
      interrupt abusive behaviors they witness among peers) to reduce SV/ARA perpetration. As the
      acceptance of SV and involvement in unhealthy sexual behaviors are associated with SV/ARA
      perpetration, this program integrates analysis of social norms that condone violence against
      women, sexual health promotion, and skills in bystander intervention -- an approach that has
      been implemented in multiple non-U.S. settings among young adult males with reductions in
      violence, development of more equitable gender attitudes, and less risky sexual behaviors.
      This will be the first test of such a gender transformative program among adolescent males in
      the U.S. Via a 2-arm cluster-randomized trial in youth-serving agencies (16 clusters, N=840
      adolescent males ages 14-19), this study will assess the effectiveness of "Manhood 2.0"
      (proposed name for this gender transformative program) compared to a job skills curriculum.
      Three months after the end of the program (Time 2), compared to controls, youth will
      demonstrate increased positive bystander intervention behaviors (secondary outcome).
      Intermediate outcomes are: condom use self-efficacy; contraception use attitudes; recognition
      of abusive behaviors; gender-equitable attitudes; and intentions to intervene with peers.
      Nine months after intervention completion (Time 3), youth will report less perpetration of SV
      and ARA toward females (Primary Outcome) compared to controls. This study will provide
      urgently needed information about the effectiveness of a gender transformative program that
      combines healthy sexuality skills, gender norms change, and bystander skills to interrupt
      peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent
      males.
    


Intervention name(s): Intervention Program (Manhood 2.0); Control Program (Job Skills Training)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Observational Study to Evaluate Lipid-lowering Drug Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.
Condition: Complex Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      1. Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who
           has done exogenous visit or hospitalization from Jan 2010 to June 2014.

        2. Study objective:

             1. The objective of this study is to Identifying the lipid parameter variation when
                treating patients who have dyslipidemia of type 2 diabetes for 3±1 months.

             2. After treating patients who have dyslipidemia of type 2 diabetes for 3±1 months,
                identifying the reason why changing method of drug dosage and pharmacotherapy.

             3. If the drug dosage and pharmacotherapy have been changed, Identifying the lipid
                parameter variation when treating patients by altered drugs for 3±1 months,
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        1. Base-line (The starting time of treating lipid-lowering drug within 3 months period of
             2010 ~ 2013 years)

               -  Background of Patients: Basic information(Height, Weight), Smoking, Drinking and
                  other related illness.

               -  Hypoglucemic agent, Diabetes test(Fasting blood glucose, GL test, Glycated
                  Hemoglobin)

               -  At the time of Starting the treating lipid-lowering drug, total Cholesterol, TG,
                  LDL-C, HDL-C checked before treating lipid-lowering drug.

          2. After 3±1 months from base-line

               -  Hypoglycemic agent, Diabetes test

               -  Total Cholesterol, TG, LDL-C at the point of 3±1 months from treating changed
                  lipid-lowering drug, and the reason of drug dosage and pharmacotherapy

          3. After 3±1 months from treating by changed lipid-lowering drug

               -  Hypoglycemic agent, Diabetes test

               -  Total Cholesterol, TG, LDL-C, HDL-C at the point of 3±1 months from treating
                  changed lipid-lowering drug.
A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment
      compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB)
      neurocognitive composite score (excluding social cognition domain). The primary estimand used
      a Hypothetical Strategy and compared participants as though the participant had continued on
      the assigned treatment and to evaluate the safety and tolerability of ASP4345 compared to
      placebo. This study also evaluated the effects of ASP4345 compared to placebo on functional
      capacity using the University of California San Diego Performance-based Skills Assessment-2
      Extended Range (UPSA-2-ER) total score and evaluated the pharmacokinetic profile of ASP4345.
    

Detailed description: 
      Participants received oral doses of ASP4345 or matching placebo QD (once daily) for 12 weeks.
      All participants were administered the first dose of blinded study drug at the site following
      randomization and provided with web-based applications that provided supplemental cognitive
      training and recorded treatment compliance. Participants returned to the clinic weekly for
      safety, efficacy, and/or pharmacokinetic procedures. Participants continued the participant's
      antipsychotic treatment for the entire study and were followed for 14 days after the
      participant's last dose of study drug.
    

Intervention name(s): ASP4345; placebo; risperidone; quetiapine; olanzapine; ziprasidone; aripiprazole; brexpiprazole; paliperidone; lurasidone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral administration; oral administration; oral or depot administration; oral administration; Oral or depot administration; Oral or depot administration; Oral or depot administration; Oral administration; Oral or depot administration; Oral administration
Other intervention name(s): Risperdal; Seroquel; Zyprexa; Geodon; Abilify; Rexulti; Invega; Latuda
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Paliperidone Palmitate; Ziprasidone; Lurasidone Hydrochloride; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aripiprazole; ziprasidone; lurasidone; schizophrenia; ASP4345; quetiapine; olanzapine; brexpiprazole; risperidone; paliperidone
Tricaprilin Phase 2 Pilot Study in Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of
      tricaprilin as AC-SD-03 compared with placebo for the reduction of migraine in participants
      with frequent migraine.
    


Intervention name(s): Tricaprilin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
Each dosing unit of 12.5 g of AC-SD-03 contains 5 g of the active ingredients (tricaprilin); Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
Other intervention name(s): AC-SD-03; AC-SD-03P
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Balance System Study in Type 2 Diabetic Patients
Condition: Type 2 Diabetes; Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and performance of the BALANCE System in treating patients who have
      type 2 diabetes and are overweight. Impact on blood glucose levels, weight loss, blood
      pressure and other clinical and metabolic parameters will be studied.
    

Detailed description: 
      The BALANCE System stimulates the duodenum in a specialized way to strengthen the natural
      contractions and mimic the sensation of fullness (satiety). The patient is expected to feel
      full after eating smaller amounts of food than normal. In addition, duodenal stimulation has
      been shown to induce favorable changes in postprandial glucose levels, glucose tolerance
      testing and insulin levels.

      The target population type II diabetic patients uncontrolled with oral medications, and with
      overweight (BMI >30). The Balance System may overcome the known disadvantages of insulin
      therapy and allow early treatment of these patients, potentially preventing the progression
      of obesity and diabetes.
    

Intervention name(s): BALANCE System intestinal electrical stimulator
Intervention type(s): Device
Intervention description(s): The BALANCE System stimulates the duodenum in a specialized way to strengthen the natural contractions and mimic the sensation of fullness (satiety). The patient is expected to feel full after eating smaller amounts of food than normal. In addition, duodenal stimulation has been shown to induce favorable changes in postprandial glucose levels, glucose tolerance testing and insulin levels.
Other intervention name(s): BALANCE System
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Body weight; Signs and symptoms; Obesity; Metabolic disease; Diabetes mellitus type 2; Diabetes mellitus; Nutrition disorder; Endocrine system diseases; Overweight; Overnutrition; Glucose metabolic disorder
Influence of Assistive Device Use While Performing Dual Task in Patients With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The primary purposes of the this three-year research proposal are to investigate the
      influence of assistive device use on dynamic balance and the associated attentional demands
      during standing and walking in patients with stroke
    

Detailed description: 
      Research has shown the effectiveness of using ambulatory assistive devices to increase
      standing stability of patients with stroke in clinical practice (Maeda et al., 2001).
      However, literature has also suggested that manipulation of ambulatory assistive devices in
      dynamic motor tasks, such as walking, inevitably requires additional attention, even in
      healthy adults (Wright & Kemp, 1992). Given that the majority of patients with stroke suffer
      from balance control difficulty, which subsequently increases their attentional demands
      associated with maintaining balance (Brown et al., 2002), it remains an important question as
      to whether the use of ambulatory assistive devices would take away some attentional resources
      that would otherwise be used for maintaining balance.
    

Intervention name(s): Standard cane
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Hemiplegia; Assisstive device; Walking; Dynamic equilibrium; Reaction time; Attention; Dual task
MRI Evaluation of Iron Overload in the Heart, Liver and Pancreas in Patients Receiving Multiple Blood Transfusions.
Condition: Iron Overload
MeSH terms: Iron Overload
Study type: Observational

Summary: 
      Sickle cell anemia and Sickle cell β thalassemia patients require multiple transfusions in
      order to avoid chronic anemia sequel. This regimen entails intrinsic deleterious effects, the
      majority of which are related to iron deposition in the reticuloendothelial system. Thus,
      iron is deposited in hepatic, myocardial and endocrine glands tissues. Tools available for
      iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are
      non specific.

      The purpose of this work is to compare iron overload in the liver, heart and pancreas in
      Sickle cell anemia and Sickle cell β thalassemia patients using T2* MRI sequences.
    

Detailed description: 
      Sickle cell anemia and Sickle cell β thalassemia patients recieving multiple transfusions are
      exposed to the effects of iron deposition in the reticuloendothelial system, including
      cardiac muscle, liver and pancreas. Tools available for iron load evaluation include serum
      ferrtin levels, liver biopsy and echocardiography, all are non specific.

      The purpose of this work is to compare iron overload in the liver, heart and pancreas in
      Sickle cell anemia and Sickle cell β thalassemia patients using T2* MRI sequences.

      Patients and Methods: 27 Sickle cell anemia and 28 Sickle cell β thalassemia will undergo
      transthoracic echocardiography, cardiac MRI using T2* sequences and clinical and laboratory
      evaluation for iron overload including ferritin levels and oral glucose tolerance test

      .
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sickle cell anemia and Sickle cell β thalassemia patients from dedicated outpatient
        hospital clinic.
      
Biospecimen description: 
      No biosepcimens retained
    
Keywords: iron overload; Thalassemia; Anemia, Sickle Cell; Magnetic Resonance Imaging