bioihbjkbjnl/mcl2 huggingface dataset:
Psychological Impact of Institutional Quarantine
Condition: Quarantine
Study type: Observational

Summary: 
      Quarantine separates persons who have been potentially exposed to an infectious agent (and
      thus at risk for disease) from the general community. However, it may create psychological,
      emotional, and financial problems for some persons. The experience of those placed under
      quarantine in terms of compliance, difficulties, emotional response and psychological impact
      remains under-researched. In view of the increasing cases of COVID-19 in India and the rising
      numbers of people being quarantined as a precautionary measure, it was imperative to assess
      those quarantined for the psychological impact of the concerns regarding this illness and the
      quarantine procedure. In India, no such study had been undertaken and our study thus filled
      the research gap. The cross-sectional observational study aims at assessing the psychological
      impact of quarantine on Indian BSF jawans (n=100). They would be assessed for depression,
      anxiety, perceived stress level of impact, and impact of life events using Beck Depression
      Inventory, State Trait Anxiety Inventory, Perceived Stress Scale, and Impact of Events
      Scale-Revised. A qualitative interview schedule will also be carried out. Data would be
      analysed.
    

Detailed description: 
      Institutional quarantine separates persons who have been potentially exposed to an infectious
      agent (and thus at risk for disease) from the general community. This may create
      psychological, emotional, and financial problems for some persons. The experience of those
      placed under quarantine in terms of compliance, difficulties, emotional response and
      psychological impact remains under-researched.

      In view of the increasing cases of COVID-19 in India and the rising numbers of people being
      quarantined as a precautionary measure, it was imperative to assess those quarantined for the
      psychological impact of the concerns regarding this illness and the quarantine procedure. In
      India, no such study had been undertaken and our study would thus fill the research gap.

      The cross-sectional observational study is aimed at assessing the psychological impact of
      quarantine on Indian Border Security Force (BSF) soldiers (n=100).

      The participants will be assessed for depression, anxiety, perceived stress level of impact,
      and impact of life events using Beck Depression Inventory, State Trait Anxiety Inventory,
      Perceived Stress Scale, and Impact of Events Scale-Revised respectively. A qualitative
      interview schedule will be carried out.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Jawana quarantined at Border Security Force Facility as a precautionary measure for
        COVID-19
A Drug Interaction Study of SLM0807 and HKB0701 in Healthy Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to assess whether HKB0701 alters pharmacokinetics of SLM0807.
    


Intervention name(s): Period I : SLM0807, Period II : HKB0701 and SLM0807; Period I : HKB0710 and SLM0807, Period II : SLM0807
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Methylphenidate on Decision-making Ability of Attention Deficit Hyperactivity Disorder (ADHD) Adults
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to assess the effect of Methylphenidate on cognitive performance and
      decision-making ability of ADHD adults, and to compare this effect to the effect on healthy
      control adults.
    

Detailed description: 
      Two matched groups of adults - with and without ADHD diagnosis - will perform a battery of
      computerized tasks assessing sustained attention,working-memory,non-verbal IQ,and
      decision-making ability. In each group,half of the participants will perform the tasks after
      receiving a capsule containing methylphenidate (MPH), and the other half will perform the
      tasks after receiving placebo. Task performance measures will then be compared in order to
      assess the effect of MPH on these domains.
    

Intervention name(s): methylphenidate; sweetener pill
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): a single doses of 10-20 mg in each one of two visits; a capsule containing a sweetener pill
Other intervention name(s): Ritalin; sukrazit
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Use of Dietary Supplements in Patients at Risk of Abortion Treated With Progesterone.
Condition: Pregnancy, High Risk
Study type: Interventional

Summary: 
      The trial aims to investigate the effect of supplementation with hyaluronic acid,
      alpha-lipoic acid, magnesium, vitamin D and vitamin B6 in progesterone-treated pregnant women
      with risk factors for abortion.
    


Intervention name(s): HA
Intervention type(s): Dietary Supplement
Intervention description(s): hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Standing on Glycemia in Prediabetic Adults
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The study is a crossover, pilot trial examining the acute effects of standing on blood sugar
      in prediabetic, working adults. Participants will complete oral glucose tolerance testing,
      once while sitting and once while standing. They will also wear a continuous blood sugar
      monitor once while sitting at their desk for a week and once while using their desk as a
      sit-stand desk with a goal of standing intermittently for at least half of the work day.
      Physical activity levels will be measured with an accelerometer. The primary study hypothesis
      is that blood sugar will differ between the sitting and standing conditions for each of the
      tests performed.
    


Intervention name(s): Sitting OGTT; Standing OGTT; Sitting CGM; Standing CGM
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: prediabetes; physical inactivity; sedentary; standing
The Physical Fitness Cohort Study in the Community-dwelling Elderly in the WanHwa Area.
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The aims of this study are to establish the cohort of elder population based on parameters of
      health-related fitness, body compositions, blood biochemistry, blood biomarker, balance,
      quality of life, and musculoskeletal ultrasonography; and to evaluate the association between
      fitness parameters and disease incidence with those data.
    

Detailed description: 
      The aims of this study are to establish the cohort of elder population based on parameters of
      health-related fitness, body compositions, blood biochemistry, blood biomarker, balance,
      quality of life, and musculoskeletal ultrasonography and to evaluate the association between
      fitness parameters and disease incidence with these data. We expect to recruit 1200 adults
      who attend the annual health check-up in National Taiwan University, BeiHu Branch in 2016 and
      2017 and to train 60 individuals having sarcopenia with strengthening exercise. This study
      will establish the urban elderly cohort, measure both physical and functional parameters,
      find the risk factors for aging, and validate the role of strength training for those
      sarcopenia patients. We hope this study will be widely cited in related fields in the future.
    

Intervention name(s): exercise and nutrition
Intervention type(s): Other
Intervention description(s): Exercise:muscle strengthening exercise Nutrition: 7.2 g branched chain amino acid every day and 1200 mg Ca+800 IU Vitamin D3
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators invited around 60 persons with sarcopenia by telephone to attend the study and randomly assigned them to group A and B (around 30 persons in each). Group A first accepted exercise and nutrition intervention and then was given the education course. Group B was treated in the reversed order.
Masking: None (Open Label)
Primary purpose: Other
Keywords: physical fitness,body composition,sarcopenia
Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to describe the single- and multiple-dose
      pharmacokinetic profiles of two novel formulations of topiramate and commercially available
      immediate release topiramate, all dosed with immediate release phentermine.
    


Intervention name(s): topiramate; phentermine; topiramate; phentermine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25 mg modified-release capsules; 7.5 mg immediate-release capsules; 100 and 25 mg immediate-release tablets; 37.5 and 7.5 mg immediate-release tablets
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity
Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such
      as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by
      killing the cells or by stopping them from dividing. Giving rituximab together with
      cyclophosphamide may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with
      cyclophosphamide works in treating patients with high risk, refractory, or relapsed multiple
      myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the effect of rituximab and high-dose cyclophosphamide on the growth of
           myeloma stem cells in patients with high-risk, refractory, or relapsed multiple myeloma.

      OUTLINE: Patients receive rituximab IV on days -10 and -7; once weekly for 4 weeks (after
      completion of high-dose cyclophosphamide); and then once in months 3, 6, 9, and 12. Patients
      also receive high-dose cyclophosphamide on days -3 to 0.

      PROJECTED ACCRUAL: Not specified.
    

Intervention name(s): rituximab; cyclophosphamide
Intervention type(s): Biological; Drug
Other intervention name(s): Rituxan; Cytoxan
Intervention MeSH terms: Cyclophosphamide; Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma
Quantification of Ketosis After Intake of Coconut Oil and Caprylic Acid-With and Without Glucose-After a 12-hour Fast
Condition: Aged
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      In a cross-over design, 15 participants, age 65-75, will be tested in six different arms in a
      randomised order. After a 12-hour fast participants will be served 2.5 dl coffee with 15 g
      cream + 30-50 g of different fatty acids, with or without 50 g glucose. Blood ketones and
      other biomarkers will be measured during 4 hours.
    

Detailed description: 
      In the metabolic state ketosis, beta-hydroxybutyrate (BHB) and acetoacetate are synthesised
      from fatty acids in the liver, resulting in higher circulating levels. Ketosis can be induced
      by fasting or adherence to a low-carb-high-fat diet, but also by intake of-at least
      some-medium-chain-triglycerides (MCT). MCT are built from fatty acids with a chain of 6-12
      carbon atoms. Caprylic acid (C8) is well known to be ketogenic, but the effect of lauric acid
      (C12)-constituting about 50% of coconut oil-is less clear.

      The aim of this study is to assess ketosis, as a combined effect of an extended overnight
      fast, and intake of coconut oil or C8, and to study how ketosis is affected by simultaneous
      glucose intake. Sunflower oil is used as control, expected to not break fasting ketosis,
      although not being ketogenic in itself. Some sunflower oil is also added to C8 to make that
      arm isocaloric with coconut oil, with a roughly similar proportion of MCT.

      Coffee with cream will be used as a vehicle, and although coffee has been reported to be
      mildly ketogenic, this effect is expected to be negligible and equally distributed between
      arms.
    

Intervention name(s): Coconut oil; Caprylic acid; Sunflower oil; Glucose
Intervention type(s): Other; Dietary Supplement; Other; Other
Intervention description(s): Coconut oil given in coffee with cream; Caprylic acid given in coffee with cream; Sunflower oil given in coffee with cream; Glucose dissolved in water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effects of Soy Protein on Serum paraoxonase1 Activity and Lipoproteins in Postmenopausal Women
Condition: Postmenopausal; Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      paraoxonase 1 is involved to prevent LDL and HDL oxidation,so increase of it's activity leads
      to lower risk of coronary heart disease.In postmenopausal women ,we have decrease of
      paraoxonase1 activity and soy proteins may increase paraoxonase1 activity
    

Detailed description: 
      In a double blind clinical randomised clinical trial with parallel design this study was
      done.52 postmenopausal women were randomly assigned to 50 g/d soy protein or placebo for 10
      weeks.serum lipoproteins and pon1 activity were measured at baseline and 10th week.There were
      significant increase in PON! activity and significant decrease in LDL-C,LDL-C/HDL-C,TC/HDL-C
      and TG/HDL-C in soy group compare to placebo group.
    

Intervention name(s): soy consumption
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: paraoxonase1 activity; LDL; HDL; postmenopausal women; postmenopausal women and hyperlipidemia
Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures
Condition: Laxity of Skin
Study type: Interventional

Summary: 
      The purpose of this pilot research study is to collect information on the safety and
      effectiveness of an experimental device used to treat and improve the appearance of the skin
      by reducing the visibility of wrinkles and by reducing the looseness of skin.
    


Intervention name(s): AuraLevée treatment
Intervention type(s): Device
Intervention description(s): A single treatment, on day 0, on each of no more than two treatment sites, using the AuraLevée device. Treatment sites are the face, abdomen, upper arm, thigh or neck.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of
      Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable
      Suspension compared to the reference product, Faslodex in healthy female subjects.
    

Detailed description: 
      This is a Phase 1, open-label, parallel group study in healthy female subjects. The study is
      designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of
      Fulvestrant for Injectable Suspension vs. the reference drug, Faslodex, administered in the
      gluteal muscle.
    

Intervention name(s): Fulvestrant for Injectable Suspension; Faslodex (Reference)
Intervention type(s): Drug; Drug
Intervention description(s): Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area; Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas
Intervention MeSH terms: Fulvestrant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Pro-adrenomedullin as a Prognostic Marker in Neonatal Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Observational

Summary: 
      The aim of this study was to clarify the prognostic value of serum pro-Adrenomedullin level
      in neonatal sepsis. Eighty term and preterm neonates with sepsis were enrolled in this study.
      Eighty healthy matched neonates served as a control group.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm and term neonates with sepsis were enrolled in this study including 80 cases.
      
Keywords: Pro-adrenomedullin; Neonatal sepsis; Prognosis; Sepsis marker; Clinical sepsis; Proven sepsis
Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the effect of multiple oral doses of itraconazole on the single dose
      pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib
      alone and when co-administered with itraconazole will also be assessed.
    


Intervention name(s): pyrotinib tablet; Itraconazole capsule
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose of SHR6390 or co-administered with itraconazole; 200 mg itraconazole QD
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Intervention model description: Pyrotinib alone and then combined with itraconazole
Masking: None (Open Label)
Primary purpose: Basic Science
The Journey of Children With Cow's Milk Protein Allergy in Mexico.
Condition: Cow's Milk Protein Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity; Milk Hypersensitivity
Study type: Observational

Summary: 
      To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and
      Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the
      methodology used by Mexican Health Care Professionals (HCPs) in the clinical practice (i.e.
      diagnosis and dietary management) of CMPA in Mexican children (≤24 months) diagnosed with or
      suspected of CMPA.
    


Intervention name(s): Frisolac Gold Intensive HA
Intervention type(s): Other
Intervention description(s): Regular medical care
Other intervention name(s): Frisolac Gold PEP AC
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Mexican children (≤24 months) diagnosed with or suspected of CMPA.
Adductor Canal Blockade vs Femoral Nerve Blockade on Muscle Strength, Mobility and Pain After TKA
Condition: Mobility After Total Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the effect of a Adductor Canal Blockade (ACB) vs a
      Femoral Nerve Blockade (FNB), on muscle strength, mobility and pain in patients with severe
      pain (VAS pain score > 60) after Total Knee Arthroplasty (TKA.
    

Detailed description: 
      The patients will be included after surgery (the first 2 postoperative days). Patients
      reporting VAS > 60 during active flexion of the knee can be included. All included patients
      will receive 2 blockades at the same time - an ACB and a FNB, one blockade with 30ml
      ropivacaine 0,2% and the other with 30ml saline according to randomization.

      Prior to, and after, the blockades VAS pain scores will be obtained, muscle strength
      (quadriceps and adductors) will be measured using a handheld dynanometer and a Timed Up and
      Go test will be performed.

      The study is registered at clinicaltrials.gov after inclusion of the first patient. The
      reason for this is that we recently became aware of that some journals do not accept a
      EudraCT registration. The study was registered at EudraCT (2012-004554-28)prior to enrollment
      of patients.
    

Intervention name(s): Ropivacaine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Naropin; Saline
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; Adductor Canal Blockade; Us-guided nerve blockade