bioihbjkbjnl/mcl2 huggingface dataset:
Lactoferrin Versus Ferrous Sulphate for Treatment of Iron Deficiency Anaemia During Pregnancy
Condition: Iron Deficiency Anemia of Pregnancy
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy and tolerability of lactoferrin in contrast to ferrous
      sulphate in the context of iron deficiency anemia with pregnancy.

      Half of participants will receive lactoferrin, while the other half will receive ferrous
      sulphate.
    

Detailed description: 
      Lactoferrin and Ferrous sulfate are used to treat iron deficiency anemia in pregnancy.

      Ferrous sulphate is the most commonly used treatment for iron deficiency anemia.

      Lactoferrin is a new generation oral iron that has long been recognized as a member of the
      transferrin family of proteins and an important regulator of the levels of free iron in the
      body fluids and has the ability to enhance iron binding. Preliminary evidence suggests that
      lactoferrin may represent a promising new strategy for oral iron replacement.
    

Intervention name(s): Lactoferrin; ferrous sulphate + folic acid (vitamin B9)
Intervention type(s): Drug; Drug
Intervention description(s): (Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.; (Ferrofol capsules, Eipico, Egypt): Dried ferrous sulphate 150 mg + Folic acid (Vitamin B9) 150 mg at least 1 hour before or 2 hours after meals three times a day for 4 weeks.
Other intervention name(s): Pravotin; MamyVital; Ferrofol
Intervention MeSH terms: Folic Acid; Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: iron deficiency anemia of pregnancy - lactoferrin
Bioequivalence of Two Insulin Aspart Formulations (100 U/mL Versus 200 U/mL)
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to test if there is
      bioequivalence between the insulin aspart 100 U/mL (U100) formulation and the new insulin
      aspart 200 U/mL (U200) formulation.
    


Intervention name(s): insulin aspart
Intervention type(s): Drug
Intervention description(s): A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Kinesio Taping With &Without Craniosacral Therapy in Pregnant Females With SIJ Dysfunction.
Condition: Sacral Disorder
Study type: Interventional

Summary: 
      SIJ dysfunction adversely affects quality of life and causes functional impairment and
      disability. Although, K taping and craniosacral therapy were previously affective in treating
      SI joint dysfunction, the combined affects of these intervention have not been compared
      previously to K taping alone.
    

Detailed description: 
      This study is a randomized controlled trial and have 30 pregnant women suffering from SIJH
      dysfunction. There is 2 groups and both have received treatment for 6 weeks. The data on pain
      is collected through VAS and the data on disability is collected through Oswestry Disability
      Index, and data on quality of life will be collected using SF-36. Measurements will be taken
      at the beginning of the study and at the end of the 4th week, at the completion of the study.
      Data will be analyzed using SPSS.
    

Intervention name(s): kinesiotaping without craniosacral therapy; kinesiotaping with craniosacral therapy
Intervention type(s): Other; Other
Intervention description(s): The first treatment group will receive kinesio taping for 6 weeks atleast 4 times per week; The second treatment group will receive kinesio taping with craniosacral therapy for 6 weeks atleast 4 times per week with each session lasting for 60 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sacro-iliac dysfunction
PK, Safety, and Tolerability Study of RBP-7000 of Different Molecular Weight Polymer in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective: To assess the relative bioavailability of RBP-7000 formulated with 2
      different molecular weights (MW) (low and high MW as test treatments) of poly
      (DL-lactide-co-glycolide) with a carboxylic acid end group (PLGH) polymer compared to
      intermediate MW PLGH polymer following single subcutaneous (SC) injection of RBP-7000 in
      subjects with stable schizophrenia.

      Secondary Objective:

      To evaluate the safety and tolerability of single SC injections of RBP-7000 using a PLGH
      polymer of 2 different MW (low and high MW as test treatments) compared to intermediate MW
      polymer in subjects with stable schizophrenia.
    

Detailed description: 
      This is a multicenter, randomized, open-label, single-dose, parallel-group study in subjects
      with clinically stable schizophrenia who are not currently taking risperidone. A total of
      approximately 48 subjects (16 per group) will be randomized to receive a single subcutaneous
      (SC) injection of RBP-7000 120 mg formulated with PLGH polymer of either 21 kilodaltons (kDa)
      (low MW group), 29 kDa of PLGH polymer (high MW group), or 26 kDa of PLGH polymer
      (intermediate MW group).
    

Intervention name(s): RBP-7000
Intervention type(s): Drug
Intervention description(s): A single subcutaneous injection with doses of RBP-7000 containing 120 mg risperidone and either a low, high, or intermediate molecular weight PLGH polymer.
Other intervention name(s): Risperdal
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Long-acting Risperidone; Atrigel
Prostin and Propess in Induction of Labor
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study was to compare the safety and efficacy of two agents used in
      induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2
      (Dinoprostone vaginal Tablet).
    

Detailed description: 
      A controlled release hydrophilic matrix (Controlled Therapeutics Ltd., East Kilbride,
      Scotland) which provides a gradual release of dinoprostone (prostaglandin E2) was introduced
      in 1995 (Propess, Ferring Pharmaceuticals). This preparation is used for the initiation or
      enhancement of cervical ripening in women at or after term with a singleton pregnancy and a
      cephalic presentation. Prostaglandin E2 causes softening and dilatation of the cervix and
      subsequently produces uterine contractions which may induce labour.
    

Intervention name(s): Propess; Prostin E2
Intervention type(s): Drug; Drug
Intervention description(s): The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation.; 3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation.
Other intervention name(s): Intravaginal PGE2 insert; Dinoprostone (PGE2)vaginal tablets.
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Assessment of the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This is a 12 weeks randomized, double-blind, placebo-controlled clinical study to assess the
      effect of Andrographis Paniculata at low dose of 300 mg/day and high dose of 600 mg/day in
      the study population in the age range of 40-70 years and suffering from mild-moderate OA.
    

Detailed description: 
      In this study, we will assess the efficacy parameters such as effect on various joint health
      parameters (pain, stiffness and physical activity) by using WOMAC scale. The individuals with
      knee OA suffer from an increased impact on their activities of daily living, which leads to
      losses in labor relations, leisure, social life, and sleeping quality, leading also to
      important decrease in their quality of life. Thus, an important outcome to be evaluated in
      this study is quality of life of these individuals which will be assessed by SF-36
      self-reported questionnaire. One of the aims of this study is therefore to investigate the
      levels of different dimensions of fatigue in knee OA and to assess changes in fatigue after
      the treatment targeting pain reduction and physical functioning by the use of FACIT-fatigue
      questionnaire.

      Effect of the treatment on rescue medication consumption which is directly proportional to
      the degree of pain will also be captured via this study. The hepatic (SGOT and SGPT) and
      renal (serum creatinine) safety biomarkers will be assessed to investigate the effect of
      chronic use of Andrographis Paniculata on liver and kidneys.
    

Intervention name(s): Placebo; Andrographis Paniculata; Andrographis Paniculata
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Microcrystalline cellulose; Andrographis Paniculata 150 mg; Andrographis Paniculata 300 mg
Intervention MeSH terms: Andrographolide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo controlled, parallel groups study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Active Video Games on Physical Activity (Main Trial)
Condition: Physical Inactivity in Children
Study type: Interventional

Summary: 
      The purpose of the study is to test the effects of different versions of active video games
      (AVGs) on body composition, cardiometabolic risks, and cognitive functions among
      overweight/obese children over 6 months.
    

Detailed description: 
      The study aims to explore the effects of narrative-enhanced AVG on (1) body composition, (2)
      cardiometabolic risks, and (3) cognitive functioning among overweight/obese 8-12 years old
      children over 6 months.

      A total of 210 children will be recruited from Tufts Floating Hospital, Boston Children's
      Hospital, and Martha Eliot Health Center. The investigators divided the participants into
      three groups to evaluate the effect of using active game consoles and stories to motivate
      children to exercise: A third of them have standard clinical care only; a third of them have
      the same standard clinical care plus an Xbox and active games; the remaining third of them
      have the same standard clinical care, an Xbox and active games, plus the stories delivered to
      their Xbox consoles.

      Each child, accompanied by their guardian, will be asked to visit the Northeastern University
      Exercise Science Laboratory over the 6-month period. Blood samples, body composition (using
      Dual-energy X-ray absorptiometry, or DEXA Scan), and cognitive and affective evaluations of
      the active video games (AVGs) will be collected. Additionally, parents will be asked to fill
      out questionnaires related to their child's physical activity behaviors. Children would also
      be required to wear two accelerometers (essentially, a "smart watch" or activity tracker) on
      their wrist and waist for 7 consecutive days after the three visits within the 6 months.
    

Intervention name(s): Xbox / active video games; Animated cartoon narratives; Standard clinical care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The investigators would expect children to play active video games as a way to reduce their sedentary activities and increase their moderate and vigorous physical activities.; The investigators would expect the animated cartoon narratives to motivate children to play more active video games as a way to reduce their sedentary activities and increase their moderate and vigorous physical activities.; Each clinic will provide standard clinical care to the participants.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Active Video Game; Physical Activity; Narrative; Child Obesity
Using HandTutor With Traumatic Hand Injuries: Characterizing the System
Condition: Hand Injuries
MeSH terms: Wounds and Injuries; Hand Injuries
Study type: Interventional

Summary: 
      HandTutor is a computerized system designed to evaluate and rehabilitate hand function. It is
      composed of a glove with optic sensors detecting the movements of the wrist and the fingers
      with a biofeedback software designed to evaluate and then to exercise the hand movements
      through supplying a variety of computer graphic patterns.

      The HandTutor has been used and tested with a stroke population, and it seems potential to be
      used with hand injuried population. As a first step, it is important to investigate the
      characteristics of the system and how it is matching the hand injuried population.

      The purpose if this study is to characterize the HandTuror system and the focused objectives
      are:

        1. To examine the test-retest reliability of the system when measuring the range of motion
           (ROM) of the the fingers among healthy people (control group).

        2. To examine the correlation between the ROM measured by the HandTutor and the ROM
           measured by conventional assessment tools (goniometer).

        3. To examine the ability of the system to distinguish between healthy people and hand
           injured people.

        4. To examine the correlation between the performance in the HandTutor (in the games part),
           and the performance in functional activities.

        5. To examine the participants feedback for using the HandTutor (degree of enjoyment).
    


Intervention name(s): HandTutor System
Intervention type(s): Device
Intervention description(s): Computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with special sensors detecting the movements of the wrist and the fingers, with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Finger Fractures; Tendon Injuries; Soft Tissue Injuries
Holotranscobalamin Remains Unchanged During Pregnancy
Condition: Vitamin B12 Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Observational

Summary: 
      Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully
      elucidated how this is reflected in the total and cobalamin saturated transport proteins,
      transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin
      into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins
      and cobalamin analogues.

      Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd,
      39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo)
      was measured by in-house ELISA methods.
    

Detailed description: 
      Background and objective: Plasma cobalamins decrease during pregnancy but it is not fully
      elucidated how this is reflected in the total and cobalamin saturated transport proteins,
      transcobalamin (total TC, holoTC) and haptocorrin (total HC, holoHC). TC transports cobalamin
      into the cells. The function of HC is unknown, but in contrast to TC it binds both cobalamins
      and cobalamin analogues.

      Design and methods: Healthy pregnant women (N=141) had blood samples drawn at 18th, 32nd,
      39th gestation week and 8 weeks postpartum. The protein moiety of TC and HC (total and holo)
      was measured by in-house ELISA methods.
    

Time perspective: Prospective
Keywords: Pregnancy; holotranscobalamin; cobalamin; vitamin B12 analogues; reference interval
Study in Healthy Volunteers to Investigate the Effects of Diltiazem on the Pharmacokinetics of Naloxegol
Condition: Drug Induced Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy volunteers to investigate the effects of Diltiazem on the Pharmacokinetics
      of naloxegol.
    

Detailed description: 
      An Open-label, sequential, 3-period study to Assess the Effects of Diltiazem on the
      Pharmacokinetics of Naloxegol in Healthy Subjects
    

Intervention name(s): Naloxegol; Diltiazem XR
Intervention type(s): Drug; Drug
Intervention description(s): Oral 25mg tablet; Oral 240mg tablet
Intervention MeSH terms: Diltiazem; Naloxegol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy male and female volunteers; Drug-drug interaction; Pharmacokinetics; Naloxegol
Evaluation of Physical Fitness and Physical Activity Levels of Pediatric Arrhythmia Patients With Pacemaker
Condition: Pacemaker; Physical Activity
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      The aim of this study was to evaluate physical fitness and physical activity levels of
      pediatric arrhythmia patients with pacemaker compared with their healthy peers.
    

Detailed description: 
      Studies in children with heart diseases suggest that physical activity levels are reduced
      relative to their peers, which in turn increases cardiovascular risk factors and cardiac
      rhythm problems. To the best of our knowledge, physical fitness and objectively measured
      physical activity levels of children with a pacemaker have not been studied. The aim of this
      study was to evaluate physical fitness and physical activity levels of pediatric arrhythmia
      patients with a pacemaker compared with their healthy peers.

      Investigators enrolled clinically stable pediatric patients and used the echocardiogram to
      evaluate cardiac functions of all patients. Physical fitness was assessed using the Munich
      Physical Fitness Test (MFT). The SenseWear Armband metabolic Holter device was used to record
      the physical activity level for consecutive 7 days.
    

Intervention name(s): Physical activity and physical fitness assessment
Intervention type(s): Other
Intervention description(s): Physical fitness was assessed using Munich Physical Fitness Test (MFT). The SenseWear Armband metabolic holter device was used to record the physical activity level for consecutive 7 days. The functional exercise capacity of the individuals was assessed by the six-minute walking test (6MWT) and cardiorespiratory capacity was assessed by maximal exercise test on the treadmill.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with pacemakers who were followed routinely in Hacettepe Hospital, Department of
        Pediatric Cardiology.
      
Keywords: pediatric; pacemaker; physical activity; physical fitness
Assessment of Lung Function After Single Inhalations of a Bronchodilator From 2 Configurations a Dry Powder Inhaler.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being
      developed for the treatment of chronic obstructive pulmonary disease (COPD). The long
      duration of action of GSK573719, when administered via inhalation to humans supports the
      potential for use as a long acting bronchodilator.This is a randomized, double-blind,
      placebo-controlled, 5 period cross-over study in healthy male and female volunteers. The
      study will measure lung function after single inhaled doses from two configurations of the
      Novel Dry Powder Inhaler. Key assessments will include clinical relevant PD parameters: sGaw,
      FEV1
    


Intervention name(s): GSK573719 62.5 mcg (one strip); GSK573719 62.5 mcg(two strips); GSK573719 125 mcg (one strip); GSK573719 125 mcg(two strips); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): GSK573719 62.5 mcg delivered by 1 strip configuration of novel dry powder inhaler; GSK573719 62.5 mcg delivered by 2 strip configuration of novel dry powder inhaler; GSK573719 125 mcg delivered by 1 strip configuration of novel dry powder inhaler; GSK573719 125 mcg delivered by 2 strip configuration of novel dry powder inhaler; Placebo, no active ingredient
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of food on pharmacokinetics, safety and
      tolerability of an experimental Hepatitis C Virus (HCV) protease inhibitor with ritonavir in
      healthy volunteers.
    

Detailed description: 
      This is an open-label, randomized, 2 cross-over period fasting and non-fasting study.
    

Intervention name(s): ABT-450; ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): capsules, QD, 1 dose in each cross-over period; capsule, QD, 1 dose in each cross-over period
Other intervention name(s): ABT-538; Norvir
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food effect