bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Fat Quality on Glycemic Regulation and Gut Microbiota After a Short-time Intervention in Healthy Individuals
Condition: Postprandial Blood Glucose; Gut Microbiota; Satiety
Study type: Interventional

Summary: 
      The overall aim is to investigate effects of saturated versus polyunsaturated fat on glycemic
      regulation and satiety in a postprandial study with healthy individuals. The potential
      effects will be related to changes in gut microbiota, the circulating levels of short chain
      fatty acids, inflammation and gene expression in peripheral mononuclear blood cells.
    

Detailed description: 
      The intervention study will have a randomized, double blinded, cross-over design with
      different test meals consisting of saturated or polyunsaturated fat. The amount of fat will
      be identical in the test meals, but the fat quality will vary. The test meals are in the form
      of muffin and spread.

      All participants will consume two muffins and minimum 20 g of spread a day for three
      consecutive days, consisting of either a high proportion of saturated fat or a high
      proportion of polyunsaturated fat. At day one (visit 1 and 3) and day four (visit 2 and 4) of
      the intervention week, the participants will perform a postprandial glucose test (OGTT, 75 g
      glucose in 100 ml water) at Oslo Metropolitan University. Blood samples will be taken before
      and at different time points after the glucose test. One week prior to the intervention week
      and during "wash-out" (11 days), the participants will consume the control products which are
      high in saturated fat.

      At the screening visit (visit 0) the participants will be asked to limit the intake of
      dietary fat and fiber from oat and barley one week prior to visit 1 and during the study.
      Otherwise, participants will be asked not to change their diet and exercise habits during the
      study period. Individuals fulfilling the inclusion criteria will also be invited to
      participate in a cross-sectional study for investigating the gut microbiota in a healthy
      population.

      An OGTT will be performed at visit 1, 2, 3 and 4.

      The participants will receive test meals after screening and before visit 1, 2, and 3.
    

Intervention name(s): Saturated fat 14.9 E%; Polyunsaturated fat 13.6 E%
Intervention type(s): Other; Other
Intervention description(s): Dietary cross-over study with saturated fat; Dietary cross-over study with polyunsaturated fat
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Intervention with cross-over design. Two test meals will be tested.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Fat quality; Blood glucose; Gut microbiota; Satiety; Dietary intervention
A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the safety and tolerability of pirtobrutinib
      (LOXO-305) and to look at the amount of the study drug, pirtobrutinib, that gets into the
      blood stream and how long it takes the body to get rid of it when given in healthy adult
      participants. For each participant, the total duration of the study will be 46 days,
      including screening.
    


Intervention name(s): Pirtobrutinib
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): LOXO-305; LY3527727
Intervention MeSH terms: Pirtobrutinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Norwegian Vitamin Trial (NORVIT)
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether the lowering of blood homocysteine levels by
      treatment with B vitamins can prevent cardiovascular disease
    

Detailed description: 
      Observational studies have demonstrated that elevated levels of plasma total homocysteine is
      a risk factor for cardiovascular disease. The purpose of this trial is to evaluate the
      efficacy of homocysteine lowering treatment with B vitamins for secondary prevention in
      patients who have experienced an acute myocardial infarction.

      This controlled, double-blind, multi-centre trial will include 3750 men and women aged 30-85
      who have experienced an acute myocardial infarction within 7 days prior to randomization.
      Participants will be randomized, in a two-by-two factorial design, to receive one of the
      following four treatments: A, folic acid 0.8 mg plus vitamin B12 0.4 mg and vitamin B6 40 mg
      per day; B, folic acid 0.8 mg plus vitamin B12 0.4 mg per day; C, vitamin B6 40 mg per day;
      D, placebo.

      The primary end point during 3.5 years of follow-up is a composite of recurrent myocardial
      infarction and stroke and sudden death attributed to coronary artery disease.
    

Intervention name(s): Folic acid; Vitamin B12; Vitamin B6
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Vitamins; Folic Acid; Vitamin B 12; Vitamin B 6; Pyridoxal; Pyridoxine; Vitamin B Complex
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Homocysteine; B vitamins; Folic acid; Randomized trial; Secondary prevention
Sleep Loss and Glucose Metabolism in People With Family History of Type 2 Diabetes.
Condition: Sleep; Sleep Deprivation; Insulin Resistance; Type 2 Diabetes
MeSH terms: Sleep Deprivation; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when
      people sleep. However, it is still not known if differences in the amount of nighttime sleep
      have an effect on the carbohydrate metabolism of people who have a relative with type 2
      diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis
      that the carbohydrate metabolism of people who have a history of type 2 diabetes in their
      family will be different after they have slept short hours for 10 days in comparison to when
      they have slept longer hours for 10 days.
    

Detailed description: 
      Study participants will complete two 10-day inpatient stays in the sleep laboratory of the
      University of Chicago Clinical Resource Center scheduled at least 4 weeks apart. Bedtime
      duration will be set at 5 hours per night during one of these stays and 8.5 hours per night
      during the other. No daytime naps will be allowed. Study participants will be served regular
      daily meals including breakfast, lunch, dinner, and a bedtime snack. On weekdays all
      participants will engage in simulated "office work" while in the sleep laboratory. During the
      rest of the time participants will maintain their usual indoor and outdoor activities as much
      as possible within the limits of the University of Chicago campus. During the last two days
      of each inpatient stay in the laboratory, participants will undergo two different tests. The
      first test will determine how much insulin does their body produce in response to an
      intravenous glucose infusion lasting several hours. The second test will determine how
      effective is the action of the sugar-processing hormone, insulin, in their body when it is
      infused intravenously together with glucose over a period of several hours.
    

Intervention name(s): 5-hour bedtime; 8.5-hour bedtimes
Intervention type(s): Other; Other
Intervention description(s): 10 days with sleep restricted only to a 5-hour bedtime period at night; 10 days with sleep allowed only during a 8.5-hour period at night
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: short sleep duration; glucose clamp technique; insulin secretion; insulin action; lipid turnover; free fatty acids
Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability
Condition: Work Ability; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Hepatitis C virus infection and interferon treatment have shown to be risk
      factors for depression, distressing, psychosocial burden and poor health-related quality of
      life.

      Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and
      whether health related factors (anxiety and depression) were associated with work ability in
      subjects with chronic hepatitis C treated with Peg-IFN-α and RBV.

      Patients and Methods: In this prospective, randomized, placebo controlled, double blind
      clinical trial, 31 subjects (Group A) with chronic hepatitis, received
      Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects
      (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus
      association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12
      months. All subjects underwent laboratory exams and questionnaires to evaluate depression
      (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work
      ability (Work ability Index - WAI).
    


Intervention name(s): Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg; sugar pill
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin E; Silybin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions
Condition: Peripheral Artery Disease; Occlusion of Artery
MeSH terms: Peripheral Arterial Disease
Study type: Interventional

Summary: 
      There is both a poor life expectancy and a poor prognosis of limb salvage in those patience
      with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number
      of these patients could be helped through medication or surgery. In fact within the first
      year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90%
      have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA
      for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases
      3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year
      primary patency rates up to 30%.

      The primary objective of this study is to compare the performance of atherectomy followed by
      a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo
      infrapopliteal lesions in a prospective, single-center, randomized clinical trial.
    

Detailed description: 
      This is a single-centre, prospective, randomized study to be conducted in Bad Krozingen
      (Germany). A total of 80 subjects will be entered into the study and will be randomized on a
      1:1 basis to either drug-coated balloon angioplasty or atherectomy and drug-coated balloon
      angioplasty for infrapopliteal use in subjects with long de-novo stenosis (≥6cm) and
      symptomatic peripheral artery disease (Rutherford 3, 4, or 5). IVUS of the target lesion
      prior and after intervention will be performed in 15 patients of each group during index
      procedure. All subjects will undergo a repeat angiography at 3 months to assess the primary
      endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 3, 6, 12 months.
    

Intervention name(s): paclitaxel-coated balloon angioplasty; atherectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion; atherectomy (TurboHawk, ev3) followed by paclitaxel-coated balloon angioplasty of the target lesion
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: long infrapopliteal artery lesions; drug-coated balloon angioplasty; atherectomy
The Thai Red Cross Society Prevention of Mother-To-Child Transmission of HIV (TRCS PMTCT) Program
Condition: HIV-infected Pregnant Women Who Request HAART From the TRCSPMTCT
Study type: Observational

Summary: 
      To assess the safety and the efficacy of Highly Active Anti-Retroviral Treatment (HAART) for
      the Prevention of Mother-To-Child Transmission of HIV (PMTCT)
    

Detailed description: 
      1. To describe characteristics of HIV-infected pregnant women who request HAART from the
           Thai Red Cross Society PMTCT (TRCS PMTCT) program

        2. To study adverse pregnancy outcomes among HIV-infected pregnant women who receive HAART

        3. To study adverse events in infants born to women who receive HAART during pregnancy

        4. To evaluate risk factors for HAART-related toxicities and for perinatal HIV transmission

        5. To establish the pilot model of care for HIV-infected pregnant women in middle income
           country
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will be HIV-infected pregnant women who request HAART from the TRCS
        PMTCT program. These pregnant women will be under the care of the health care teams in 30
        hospitals throughout Thailand which have registered with the TRCS PMTCT program since April
        2004
      
Keywords: HIV-infected pregnant women who request HAART from the TRCSPMTCT
Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)
Condition: Metastatic Medulloblastoma; High Risk Supratentorial PNET; Metastatic PNET
MeSH terms: Medulloblastoma; Neuroectodermal Tumors, Primitive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to study the efficacy of the combination of reduced dose
      craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with
      concurrent carboplatin and vincristine administration for metastatic classical histology
      medulloblastomas and high-risk supratentorial PNETs and metastatic PNETs.
    


Intervention name(s): Carboplatin; Vincristine; 24 Gy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Administered concurrently with craniospinal radiation.; Administered concurrently with craniospinal radiation.; Craniospinal radiation.
Intervention MeSH terms: Carboplatin; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of Transcranial Direct Current Stimulation (tDCS)
Condition: Best Comfort and Lowest Skin Irritation
Study type: Observational

Summary: 
      Testing safety and tolerability of transcranial direct current stimulation (2 mA, 20 minutes)
      in four different protocols:

      saline-soaked sponges electrode with electrode gel tap-water-soaked sponges
      tap-water-soaked-sponges + sham stimulation

      Outcome measures are tolerability (comfort rating questionnaire), impedances, skin elasticity
    


Observational model: Case-Only
Sampling method: Probability Sample
Study population: 
        15 healthy volunteers
A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this research is to establish the normal range of diameter and distensibility
      of pylorus and the fasting and postprandial antro-pyloric motility in healthy adults.
    

Detailed description: 
      An Endoflip catheter will be placed through the mouth into the stomach in order to measure
      distal antral contractile activity and pyloric diameter and distensibility during fasting and
      after the ingestion of a standard meal
    

Intervention name(s): Endoflip measurement of gastric and pyloric function
Intervention type(s): Diagnostic Test
Intervention description(s): Endoflip device to measure gastric and pyloric functions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy adults between the ages of 18 and 65 with body mass indices between 18 and 35
        kilograms/meter squared will be recruited for this study
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)
Condition: HPV Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent
      females
    


Intervention name(s): Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501); Comparator: Placebo (unspecified)
Intervention type(s): Biological; Biological
Intervention description(s): V501; Gardasil, 0.5 ml injection in 3 dosing regimen; Placebo 0.5 ml injection in 3 dosing regimen
Other intervention name(s): V501; Gardasil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Prevention of Oral Malodor With an Oral Sticker Containing Herbal Formula
Condition: Halitosis; Oral Malodor; Bad Breath
MeSH terms: Halitosis
Study type: Interventional
Phase: Phase 1

Summary: 
      the use of a herbal formulation containing sage, echinacea,lavender and mastic gum would
      prevent oral malodor if delivered in an appropriate delivery system to enable slow release of
      the active ingredients.
    

Detailed description: 
      Oral malodor (Halitosis, Fetor ex ora) is a common and disturbing condition, affecting
      according to some studies about one quarter of the population. This condition may start at
      any time from early childhood through adolescence, adulthood and old age and vary in
      character and severity.The bacteria responsible for malodor production are for the most part
      Gram negative oral bacteria (2- 4) such as Porphyromonas gingivalis, Fusobacterium nucleatum
      and Prevotella intermedia. These bacteria reside on various locations within the oral cavity
      (e.g. tongue dorsum, interdental space, periodontal pockets, tonsils) and breakdown salivary
      and oral proteins into their amino acid building blocks. Some of these amino acids (e.g.
      methionine, cysteine, tryptophan, lysine) are further metabolized yielding malodorous
      volatile products such as methylmercaptan, hydrogen sulfide, indole, skatole and cadaverine
      (5-7). These are foul smelling compounds, which are released during exhalation and speech.in
      our study we intend to use an aprooved mucosal sticker containing carbopol and
      hydroxypropylcellulose mixed with the herbal ingredients and placed on the palatal
      mucosa.than mesure the volatile sulfur compounds to observe if the composition has
      antimalodor effect and for how long. the herbal ingredients are used for many years for
      medicinal and nutritional purposes. if our hypothesis is right we might have another
      formulation and method of application to prevent oral malodor
    

Intervention name(s): a mucosal sticker with herbal formula
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: malodor; halitosis; herbal formulation; natural medicinals; slow release delivery system
A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
Condition: Cystic Fibrosis; Exocrine Pancreatic Insufficiency
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to determine the safety, effectiveness, and acceptability of 2 methods of
      administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000
      lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic
      insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma
      (formerly Eurand).
    

Detailed description: 
      This is a multicenter, randomized, open-label, crossover study in pediatric participants with
      EPI due to CF. The study will be carried out in infants between 1 and 12 months of age.

      The study comprises of a screening period (up to 10 days) followed by 2 treatment periods (10
      days each). During the screening period, all participants will be administered Zenpep® 5,000
      (pancrelipase) mixed with a small amount of apple sauce. Once determined eligible for
      participation, participants will be randomized into 1 of 2 treatment sequences. Each sequence
      corresponds to taking one treatment in the first period and the other treatment in the second
      period, and were administered EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release
      capsule) 3,000 lipase units capsule either mixed with apple juice using a syringe nurser or
      apple sauce using a spoon.
    

Intervention name(s): EUR-1008 (APT-1008); EUR-1008 (APT-1008)
Intervention type(s): Drug; Drug
Intervention description(s): EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice, will be given orally daily using a syringe nurser at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period. Total dose will not exceed 10,000 lipase units per kilogram (kg) of body weight per day.; EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce, will be given orally daily using a spoon at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period. Total dose will not exceed 10,000 lipase units per kg of body weight per day.
Other intervention name(s): Zenpep® (pancrelipase) delayed release capsules; Zenpep® (pancrelipase) delayed release capsules
Intervention MeSH terms: Pancrelipase; Pancreatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exocrine Pancreatic Insufficiency; Infants with CF