bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Reduced Noise Levels and Cycled Light on Visual and Neural Development in Preterm Infants
Condition: Preterm Infants
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Noise is a hazard for newborn. In 1997, the American Academy of Pediatrics determined that
      safe sound levels in the neonatal intensive care unit (NICU) should not exceed 45 dB which
      has been rarely achieved. High intensities of noise have several negative effects on preterm
      newborns. Also, they are exposed to either continuous bright light continuous near darkness
      or unstructured combination of the two during their hospitalizations. The investigators
      primary objective is to determine the impact of reduced noise levels and cycled light on
      growth parameters and visual development in preterm infants.
    


Intervention name(s): Noise reduction and cycled light
Intervention type(s): Behavioral
Intervention description(s): Reduced noise exposure (sound levels <45 dB) and cycled light (approximately 12 hours of light on and 12 hours of light off).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: noise; sound; cycled light; preterm infants; neonatal care; growth; visual development
Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      A randomized study to demonstrate how animal-based protein-rich food sources can be used by
      older adults to increase protein intake within pre-existing dietary patterns.
    

Detailed description: 
      Current dietary patterns of older Americans will be augmented by readily available quality
      protein sources. Investigators will observe the effects of recommended and common protein
      intakes on the maintenance of whole-body protein balance and potential for muscle protein
      anabolism.

      3 groups of 10 older subjects will be studied during daily protein intakes. Study duration
      per subject will be about 2 weeks.
    

Intervention name(s): Recommended Dietary Allowance of Protein; Habitual protein intake; Optimal Protein Intake
Intervention type(s): Other; Other; Other
Intervention description(s): 0.8 g/kg/day protein intake; 1.0 g/kg/day protein intake; 1.5 g/kg/day protein intake
Other intervention name(s): RDA; NHANES; OPI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: muscle loss; protein; animal-based protein
Phase I Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of DA-7218 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase I clinical trial for evaluating the pharmacokinetics and
      safety/tolerability of DA-7218 in healthy male volunteers.
    


Intervention name(s): DA-7218; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tedizolid phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
Condition: Malaria; Pregnancy Malaria; Cardiotoxicity; Cardiac Safety; Parasitemia
MeSH terms: Malaria; Parasitemia; Cardiotoxicity
Study type: Interventional
Phase: Phase 2

Summary: 
      Sulfadoxine-pyrimethamine (SP) is currently recommended by the World Health Organization for
      use as intermittent preventive treatment against malaria in pregnancy (IPTp) in areas of
      moderate to high malaria transmission. However, in some locales malaria parasites have lost
      sensitivity to SP, compromising its protective effect. Dihydroartemisinin-piperaquine (DP) is
      a candidate replacement for SP. This trial is designed to confirm the cardio-safety of DP
      compared to SP amongst pregnant women in Tanzania.
    

Detailed description: 
      The trial hypothesis is that DP will increase the time between the start of the Q wave and
      the end of the T wave in the heart's electrical cycle, a phenomenon referred to as QT
      prolongation, in the study population. However, if QT prolongation is observed, it is
      expected to be time-limited and of no clinical consequence.

      The QT interval, measured in milliseconds (MS) will be corrected (QTc) to account for natural
      heart rate (HR) extremes. The Fridericia formula will also be used to correct (QTcF) for
      variation in cardio-contraction. As part of the electrocardiogram (ECG), the period from the
      beginning of the P wave to the beginning of the QRS complex (PR interval) will be measured,
      as well as the ST-segment which connects the QRS complex and the T wave.

      Prolongation of the QT interval will be estimated when peak drug-concentrations are most
      likely to be found in the peripheral blood as measured using pharmacokinetic (PK) techniques.
      Polymerase chain reaction (PCR) methods will be used for genetic sequencing of molecular
      markers (A581G) associated with malaria parasite drug resistance to SP. The rapid diagnostic
      test (RDT) CareStart™ will be used to screen pregnant women attending antenatal care.
    

Intervention name(s): sulfadoxine-pyrimethamine (SP); dihydroartemisinin-piperaquine (DHA-PQP)
Intervention type(s): Drug; Drug
Intervention description(s): Women in Groups 1 and 2 will be provided the following SP regimen as directly observed therapy:
3 tablets total of 500 mg sulphadoxine and 25 mg pyrimethamine; 1 day of dosing.; Women in Groups 3 and 4 will be provided the following DHA-PQP regimen as directly observed therapy 3 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine daily; 9 tablets total; 3 days of dosing.
Other intervention name(s): Fansidar / Akacia Healthcare Ltd (South Africa); Eurartesim / Sigma-Tau (Italy)
Intervention MeSH terms: Pyrimethamine; Piperaquine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Sub-Saharan Africa; Dihydroartemisinin; Piperaquine; Sulphadoxine-Pyrimethamine; Antimalarials
Managing Dysfunctional Breathing and Exercise-induced Laryngeal Obstruction in Adolescent Athletes
Condition: Exercise Induced Laryngeal Obstruction (EILO)
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      This study aimed to assess if a multidimensional individually tailored intervention,
      including Norwegian Psychomotor Physiotherapy (NPMP), elements of cognitive behavioural
      therapy and a rehabilitation plan, helped reduce inspiratory distress and dysfunctional
      breathing in adolescent athletes with EILO. A mixed methods design, which combined
      qualitative and quantitative research, was used. Data, including subjective experiences of
      respiratory distress, findings from NPMP body examinations and objective measurements of lung
      function and aerobic capacity were gathered before and after a five month intervention
      involving 18 participants.
    


Intervention name(s): Norwegian psychomotor physiotherapy
Intervention type(s): Other
Intervention description(s): The intervention consisted predominantly of Norwegian Psychomotor Physiotherapy (NPMP) in which participants received individually tailored treatment based on the body examination and reported respiratory distress. NPMP addresses bodily tension, postural de-alignments and dysfunctional breathing patterns. The consultations also included a cognitive dimension, that is a conversation, in which thoughts and behaviours about training and competing were addressed and where participants were provided with "self help" measures that could improve breathing during training and competing. A rehabilitation plan for each participant was designed to limit further impairments and maintaining aerobic capacity without intensifying EILO symptoms. The intervention lasted 5 months.
Other intervention name(s): Elements of cognitive behavioural therapy; Rehabilitation plan
Intervention model: Single Group Assignment
Intervention model description: A mixed methods design, which combined qualitative and quantitative research, was used. Data, including subjective experiences of respiratory distress, findings from physiotherapeutic body examinations and objective measurements of lung function and aerobic capacity were gathered before and after a five month intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EILO; Physiotherapy intervention; Dysfunctional breathing; Adolescent athletes; Diaphragmatic breathing; Postural alignment
Effect of Periodontal Treatment on Adipokine Levels
Condition: Periodontitis; Diabetes Mellitus, Type 2
MeSH terms: Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT)
      on serum and salivary adipokine and interleukin-1β levels in periodontitis patients with or
      without type 2 Diabetes Mellitus (T2DM).
    

Detailed description: 
      The present study aimed to determine the effect of non-surgical periodontal treatment (NSPT)
      on serum and salivary adipokine and interleukin (IL)-1β levels in periodontitis patients with
      or without type 2 Diabetes Mellitus (T2DM). A total of 80 patients; 20 healthy, 20 T2DM with
      periodontitis (P), 20 T2DM periodontally healthy, 20 systemically healthy with P were
      included in this study. At baseline, serum and saliva samples were collected and the whole
      mouth clinical periodontal parameters were recorded. Periodontitis patients received NSPT in
      4 sessions. Clinical parameters were re-measured and samples were re-collected at 1 and 3
      months after treatment. Serum and salivary levels of adipokines and IL-1β were analyzed using
      a flow cytometry-based technique of Lumina® map™. Data were analyzed using appropriate
      statistical tests.
    

Intervention name(s): Non-surgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): Non-surgical periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adipokines; diabetes mellitus; inflammation; periodontitis
Increased Dietary Protein and Meal Frequency Reduces Total and Abdominal Body Fat During Weight Maintenance and Weight Loss
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of the current study was to examine the impact of macronutrient intake (PRO, 15%
      vs. 35%) and meal frequency (3 vs. 6 meals/day) on body composition, postprandial
      thermogenesis and plasma adipokines before and after 28days each of EB (28days) and ED (25%;
      28days) in overweight individuals. We hypothesize that HP will elicit more favorable body
      composition, thermogenic, and cardiometabolic changes than HC intakes and the magnitude of
      change will be greatest in those consuming HP meals more frequently.
    


Intervention name(s): protein and meal frequency
Intervention type(s): Other
Intervention description(s): comparison of different levels of protein intake and meal frequency on body composition in obese adults
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: high protein; high carbohydrate; meal frequency; abdominal body fat; postprandial thermogenesis
Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
Condition: Postoperative Kidney Injury
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of a standard volume replacement called
      HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an
      alternative to pure fluid replacement solutions that are associated with problems after
      surgery including fluid overload and respiratory difficulties. The safety of HES 130/0.4
      (Voluven) will be evaluated by examining its effects on kidney function, and coagulation
      parameters and platelet (part of the blood that help it clot) function.

      Participants will be randomized (like flipping a coin) to receive one of two possible volume
      replacements during surgery, if fluid volume decreases enough to need replacement with one of
      the fluids. The two possible volume replacements are Voluven (a starch-containing fluid) or
      human albumin 5% (a protein-containing solution).

      To examine kidney function, urine will be-sampled when the participant is put under general
      anesthesia, before surgical incision, within one hour of arrival to the ICU and 24 hours
      after completion of surgery. Two tubes (2 teaspoons) of blood (from an already established
      line) will be taken the morning of the surgery, within one hour of arrival to the ICU, 24
      hours after surgery and every morning during the participants postoperative ICU stay.

      Additionally, health and recovery information will be recorded from the participant's medical
      record. We will phone participants around 90 days and one year after surgery to ask a few
      questions about one's health and recovery. We will also record blood sample analysis results
      from follow up appointments within the first year after surgery. If this analysis is not
      conducted at the Cleveland Clinic, with permission, we will obtain the results from a
      treating physician.
    


Intervention name(s): human albumin 5%; HES 130/0.4 (Voluven)
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Role of a Device to Evaluate the Neuromuscular Function in Assessing Muscle in Facial Paralysis Patients
Condition: Facial Nerve Palsy
MeSH terms: Bell Palsy; Facial Paralysis; Facial Nerve Diseases; Paralysis; Facies
Study type: Interventional

Summary: 
      The objective of the research is to determine whether the MyotonPRO has a valid and reliable
      application in facial, head and neck surgery. In addition, the study aims to compare this new
      technology with current electromyography.
    

Detailed description: 
      Facial paralysis has significant aesthetic, functional and psycho-social morbidity. The
      diagnosis and monitoring of neuromuscular recovery is limited to clinical examination,
      electromyography (EMG) and electroneurography (ENoG). EMG and ENoG is invasive for the
      patient and has practical and cost disadvantages. The MyotonPRO is a handheld device, which
      is pain-free and quick to use. Therefore this research is assessing MyotonPRO technology for
      this clinical application and may be effective at evaluating rehabilitative and surgical
      interventions. Phase 1 - Variation of measurements Phase 2 - Mimic muscle dysfunction
      assessment Phase 3 - Peri-operative Mimic and temporalis muscle assessment Phase 4 - Phase 3
      including electromyography Phase 5 - Temporalis and mimic muscle assessment following facial
      reanimation surgery
    

Intervention name(s): MyotonPRO; non-invasive electromyography (EMG)
Intervention type(s): Device; Device
Intervention description(s): MyotonPRO measurements of the biomechanical properties of facial mimic muscles; Gold standard technique for measuring muscle
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Population-based Study of Drug Exposures and Adverse Pregnancy Outcomes in China (DEEP)
Condition: Pregnancy; Congenital Malformation; Drug Exposure
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      The DEEP cohort is the first population-based cohort of pregnant population in China that
      longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy
      outcomes.
    

Detailed description: 
      The DEEP cohort is the first population-based cohort of pregnant population in China that
      longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy
      outcomes. The main goal of the study aims to monitor and evaluate the safety of drug use
      through the pregnancy life course in the Chinese setting. The DEEP cohort is developed
      primarily based on the population-based data platforms in Xiamen, a municipal city of 5
      million population in southeast China. Based on these data platforms, a pregnancy-centered
      registry was developed that documented health care services and outcomes in the maternal and
      other departments. For identifying drug uses, a drug prescription database was specifically
      developed by using electronic healthcare records documented in the platforms across the
      primary, secondary and tertiary hospitals. By linking the pregnancy registry and prescription
      database through a unique identifier, the DEEP cohort was developed. All the pregnant women
      and their offspring in Xiamen are provided with health care and followed up according to
      standard protocols in the region, including antenatal care, delivery care, postpartum
      follow-up and childhood follow-ups. The primary adverse outcomes - congenital malformations -
      are collected using a standardized Case Report Form.
    

Intervention name(s): chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs
Intervention type(s): Drug
Intervention description(s): medication (i.e., chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs ) exposure through the pregnancy life course
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        From January 2013, all pregnant women who registered at the Maternal and Child Health
        Management in Xiamen was included in this cohort.
      
Keywords: Cohort study; drug exposures; congenital malformation; pregnancy; population-based
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine(s) GSK3206641A and GSK3206640A Administered in Adults 18 to 64 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of different
      formulations of GSK Biologicals' H7N9 influenza vaccine in subjects 18 to 64 years of age.
    


Intervention name(s): Investigational H7N9 vaccine GSK3206641A; Investigational H7N9 vaccine GSK3206640A; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21; One dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 0 and the second dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 21; One dose of placebo administered IM at the deltoid region of arm at Day 0 and the second dose of placebo administered IM at the deltoid region of arm at Day 21
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: H7N9; Influenza; Safety; Adults; Adjuvant; Immunogenicity
Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of the
      investigational drug, MRG-201, in healthy volunteers. MRG-201 is designed to mimic the
      activity of a molecule called miR-29 that decreases the expression of collagen and other
      proteins that are involved in scar formation. MRG-201 is being studied to determine if it can
      limit the formation of fibrous scar tissue in certain diseases.

      MRG-201 will be tested in healthy volunteers by injection into intact skin or adjacent to a
      short skin incision. Volunteers may receive one or several doses of MRG-201, and will be
      monitored for local reactions in the skin, signs or symptoms of adverse effects on the body,
      and for the levels of MRG-201 in the blood over time. Skin biopsies will also be collected to
      study how cells in the skin respond when exposed to MRG-201.
    

Detailed description: 
      Study Design:

      Cohorts of 3-6 healthy male volunteers, ages 18-45, will receive single or multiple ascending
      doses of MRG-201 by intradermal injection at one site and placebo at a second site over a
      period of up to 15 days, with follow-up for up to 28 days after the last dose to determine
      the maximum tolerated dose in intact or incised normal skin and the tendency for active drug
      to diffuse through the skin.
    

Intervention name(s): MRG-201; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intradermal injection of single ascending doses and multiple ascending doses in healthy volunteers.; Intradermal injection of placebo at a second site in healthy volunteers. Each subject will serve as their own control.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)
Condition: PKDL
Study type: Interventional
Phase: Phase 2

Summary: 
      Miltefosine efficacy will be >85%
    


Intervention name(s): Miltefosine; Miltefosine
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 mg/kg/day for 12 weeks; 2.5 mg/kg/day for 8 weeks
Intervention MeSH terms: Miltefosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PKDL; miltefosine