bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Non Digestible Carbohydrate on Production of Phenolic Acids From Strawberry Juice
Condition: Healthy
Study type: Interventional

Summary: 
      This is an acute human bioavailability study in self-reported healthy participants aged 20-70
      years old. We hypothesize that combination of dietary polyphenolics and non-digestible
      carbohydrates (NDC) will increase the production of phenolic acids by bacteria in the human
      colon and these will be detected in urine. Participants will attend for three arms in a
      randomised order: Strawberry juice (a high polyphenol food), Inulin (NDC) or Mixture of
      strawberry juice and inulin.
    

Detailed description: 
      Polyphenol rich plant foods have been associated with several health benefits but their
      bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in
      the small intestine and enter the colon where the colonic microbiota metabolise them to
      release a range of phenolic acids, which are now thought to be the main bioactive components
      related to the reduction in disease risk. Very little is known about the impact of other
      constituents of the diet on the metabolism and bacterial catabolism of these polyphenols. The
      colonic microbiota are key agents in the release of the bioactive molecules from polyphenols
      but also ferment non-digestible carbohydrates (NDC) such as dietary fibre to short chain
      fatty acids. It is likely that there are key interactions in the colonic bacteria metabolism
      of fibre and phenolics. We hypothesize that combination of polyphenolics and non-digestible
      carbohydrates (NDC) will increase the urinary output of bioactive phenolic acids.

      This study will enable a better understanding of how to deliver combinations of ingredients
      and nutrients to achieve maximum nutritional value and health benefits.
    

Intervention name(s): Strawberry juice with Inulin; Strawberry Juice; Inulin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Mixture of polyphenols and non digestible carbohydrates; Source of Polyphenols; Source of non digestible carbohydrate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Acute human bioavailability studies with a cross-over design will be given to subjects in the form of a drink in one of three combinations
Strawberry juice alone
Inulin alone
Mixture of strawberry juice and inulin
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Self-reported healthy adults
Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals
Condition: Dietary Modification; Bread; Gastrointestinal Microbiome; Hematologic Tests; Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      Bread is the most common grain product in the world, with consumption surpassing 3 billion
      individuals per year. Sourdough whole-grain bread is considered a healthy alternative to
      white, refined-wheat bread.

      This cross-over study will test the effect of consumption of sourdough bread compared to
      white bread following a short dietary intervention period (one week) on multiple clinical
      parameters and gut microbiota.
    


Intervention name(s): Consumption of sourdough bread; Consumption of white bread
Intervention type(s): Other; Other
Intervention description(s): Participants will be given sourdough bread to consume instead of other wheat products. 145g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods); Participants will be given white bread to consume instead of other wheat products. 110g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bread; Microbiome; Blood tests; Sourdough bread; Dietary intervention
D-Light Intervention
Condition: 25-hydroxyvitamin D Concentration (Vitamin D Status)
Study type: Interventional

Summary: 
      Vitamin D insufficiency has become a global concern, with low vitamin D status associated
      with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and
      Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude,
      increased use of sunscreen, decreased sun exposure and a high level of cloud cover. A recent
      survey in the UK showed that more than 50% of UK adults have insufficient vitamin D status,
      with lower levels noted in the winter months. Variations in vitamin D status have been known
      to vary between summer and winter, owing to our northern latitude (52-55°N) the Ultraviolet
      (UV)-B intensity in Northern Ireland is inadequate to promote the dermal synthesis of vitamin
      D during the winter months, causing us to rely on dietary sources. The aim of this
      intervention is to investigate the main effects of vitamin D3-fortified milk and supplemental
      vitamin D3 on vitamin D status and functional health outcomes during the winter, and how this
      intervention will affect subsequent dermal synthesis of vitamin D from UV exposure.
      Participants will be recruited from the local community. Blood samples will be collected from
      each participant at two timepoints (September/October and March/April). Pre- and
      post-intervention blood pressure, grip strength, height, weight, waist and hip circumferences
      will be measured, in addition participants will undergo a dual energy x-ray absorptiometry
      (DXA) scan to assess body composition and bone mineral density. Information on general
      health, lifestyle, physical activity, dietary intake and typical behaviours in the sun will
      be collected. Following the dietary intervention, a subset of participants will be invited to
      participate in a follow-up study, examining UV exposure during the summer months, when they
      will wear a personal wrist dosimeter for 1 month, complete a sun dairy and provide 2
      additional blood samples.
    


Intervention name(s): Fortified milk (10µg vitamin D3); Unfortified milk (placebo); 10µg vitamin D3 supplement; Placebo supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; Fortified milk; Supplementation; UV exposure; Winter; Healthy adults; Body Composition; Muscle function; Blood pressure
Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 3

Summary: 
      Anthroponotic Cutaneous Leishmaniasis (ACL) is a parasitic disease caused by Leishmania
      tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been
      used as a standard treatment for leishmaniasis for last 80 years. Systemic antimonial
      injection is painful, toxic, not affordable and moreover is not always effective. Many
      different modalities are used to treat the disease with a limited success. Intra-lesional
      injections of antimonials are used for the treatment of patients with a few lesions but no
      data is available on the rate of efficacy. In this study the efficacy of intra-lesional
      injections of Glucantime weekly is compared with intra-lesional injections of Glucantime
      twice weekly.
    


Intervention name(s): Meglumine antimoniate; Meglumine antimoniate
Intervention type(s): Drug; Drug
Intervention description(s): Intra-lesional injection once a week, 0.1/cm2; Intra-lesional injection twice a week, 0.1/cm2
Other intervention name(s): Glucantime; Glucantime
Intervention MeSH terms: Meglumine Antimoniate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Anthroponotic Cutaneous Leishmaniasis; L. tropica; Meglumine antimoniate (Glucantime)
Regional Anesthesia for Percutaneous Transluminal Angioplasty
Condition: Peripheral Artery Occlusive Disease; Percutaneous Transluminal Angioplasty
MeSH terms: Peripheral Arterial Disease
Study type: Observational [Patient Registry]

Summary: 
      In this study, the effects of regional anesthesia method applied in patients who will undergo
      percutaneous transluminal angioplasty for lower extremity revascularization will be
      investigated comparatively.
    


Intervention name(s): Near Infrared Spectroscopy (NIRS)
Intervention type(s): Device
Intervention description(s): We will place Near Infrared Spectroscopy (NIRS) electrode on the foot to evaluate regional tissue oxygen saturation in both lower extremities before the performing regional anesthesia (popliteal sciatic nerve block) and then during the procedure.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ASA I-III patients over the age of 18 who have been decided to perform elective PTA as a
        treatment method for peripheral arterial disease will be included in the study.
      
Keywords: percutaneous transluminal angioplasty; tissue oxygenation
A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule
      formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with
      other anti-HIV drugs.

      SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is
      still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule
      form may be safer and more effective than other protease inhibitors.
    

Detailed description: 
      Clinical trials in adults and children suggest that SQV-SGC has advantages over other
      protease inhibitors in terms of tolerability, safety, and effectiveness in patients who have
      failed therapy with other protease inhibitors. [AS PER AMENDMENT 11/24/99: Pharmacokinetic
      data from this study demonstrate lower than expected plasma SQV exposures, particularly in
      Arm 1. Based on these data, patients in the study will be offered the opportunity to adjust
      their doses. Ritonavir added to the Arm 1 regimen is expected to significantly increase
      SQV-SGC plasma levels and allow twice-daily dosing for SQV-SGC.]

      Patients are randomized to one of two study arms. Patients in Arm 1 receive SQV-SGC plus two
      [AS PER AMENDMENT 11/24/99: one or two] NRTIs of choice. Patients in Arm 2 receive SQV-SGC
      plus NFV plus one or two NRTIs of choice. All participants are evaluated by physical
      examinations and laboratory tests during the study and are followed for incidence of death,
      cancer, or fetal abnormality. NRTIs are not provided as part of this study. [AS PER AMENDMENT
      11/24/99: This study is closed to accrual. All subjects on follow-up (Cohort 1) are given the
      option of either discontinuing participation in ACTG 397 or participating in the next phase
      of the study (version 2.0). Those electing to continue participation constitute Cohort 1A.
      The adjusted Arm 1 regimen consists of SQV-SGC plus ritonavir plus one or two NRTIs.
      Ritonavir is not provided as part of this study. The Arm 2 regimen study drugs have not
      changed but the maximum allowable dose of SQV-SGC has increased from 1,200 mg twice-daily to
      1,600 mg twice-daily. Participants continue to be followed with physical examinations and
      laboratory evaluations that include an intensive pharmacokinetics study on Day 14 of the new
      regimen.]
    

Intervention name(s): Ritonavir; Nelfinavir mesylate; Saquinavir
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Nelfinavir; Saquinavir
Primary purpose: Treatment
Keywords: Saquinavir; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load
Trans Alveolar Pressure Measurement as an Index for Lung Recruitment.
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      the study is conducted on hypoxic adult patients underwent open heart surgery after arrival
      to the intensive care unit and stabilization of patients' hemodynamics to assess the efficacy
      of transalveolar pressure measurement as an index for lung recruitment.
    

Detailed description: 
      After one hour from the patient's ICU admission and after stabilization of the patient's
      haemodynamics, alveolar recruitment will be done for hypoxic patients with hypoxic index less
      than 250.

      The recruitment will be started in the adaptive ventilation mode (AVM mode) using modified
      stepwise staircase recruitment maneuver in which every 2 minutes positive end-expiratory
      pressure (PEEP) is increased in increments of 2 cmH2O and the driving pressure will be
      regulated by AVM mode.

      The increase in PEEP will be guided by improvement of dynamic compliance, oxygen saturation
      and transalveolar pressure (PTA) till near overdistention.

      Overdistension will be detected if there are decrease in the mean arterial pressure 25% from
      the base line value reported after stabilization of the patient's haemodynamics, or decreased
      oxygen saturation or sudden decrease in dynamic compliance, or inspiratory PTA more than15 cm
      H2O.

      Then PEEP is decreased 2 cm H2O every 3 minutes till a decrease expiratory PTA less than 1 cm
      H2O, or a decrease in dynamic compliance or a decrease in oxygen saturation ≥ 1% from maximum
      oxygen saturation is observed (the derecruitment point) then return to a PEEP level 2 cm H2O
      above the derecruitment point (the optimal PEEP).

      Alveolar recruitment will be done once.
    

Intervention name(s): lung recruitment protocol
Intervention type(s): Other
Intervention description(s): lung recruitment protocol applied to postcardiac surgery hypoxic adult patients with measurement of trans alveolar pressure as an index for lung recruitment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: post cardiac surgery,; lung recruitment; trans alveolar pressure
Does First Oral Intake After Emergence Predict the Incidence of Post-operative Vomiting in Children?
Condition: Post-operative Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Second only to pain, nausea and vomiting are the most uncomfortable complications of surgery
      and anesthesia. Unfortunately, our best defense against post-operative nausea and vomiting, a
      medicine called ondansetron (Zofran), is in dire national shortage. Consequently,
      non-pharmacological methods of prevention and treatment for post-operative nausea and
      vomiting have increased import. Following emergence from general anesthesia, children often
      request food and drink. There have been no studies to date that definitively determine the
      optimal first food or drink choice for these children. This study proposes to randomize
      children to either water or juice first intake following surgery. The investigators expect to
      find that children who consume glucose are less likely to vomit than those who first receive
      water.
    


Intervention name(s): Apple Juice; Water
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: post-operative vomiting
A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aimed to determine whether PATH-wSP, a vaccine against a germ that causes
      pneumonia, is safe and induces immune responses in adults and toddlers. The study vaccine was
      compared to placebo. First adults received 2 injections of a lower dose of the vaccine or
      placebo, 28 days apart. Since the lower dose was considered safe, a higher dose was tested.
      Once the safety was established in adults the lower and higher dose was tested in toddlers,
      starting with the lower dose and then the higher dose.
    

Detailed description: 
      S. pneumoniae whole cell vaccine (SPWCV) is a vaccine candidate made from whole
      unencapsulated pneumococcal cells and adsorbed to aluminum hydroxide adjuvant (Alum). After
      adsorption of the Alum to SPWCV, the vaccine is referred to as PATH-wSP. PATH-wSP has been
      previously tested in Phase 1/2 studies in healthy US adults (VAC-002), and in healthy Kenyan
      adults and toddlers (VAC-010) and showed a favorable safety, tolerability, and immunogenicity
      profile. The SPWCV and Alum used in previous Phase 1/2 trials were supplied separately in a
      two-vial configuration; the SPWCV was manufactured at Walter Reed Army Institute of Research
      and the Alum at Instituto Butantan. A single-vial formulation of PATH wSP, an adsorbed
      suspension of SPWCV and Alum, has now been manufactured by PT Bio Farma, Indonesia. The
      purpose of this study was to assess the safety and tolerability of this new formulation.
    

Intervention name(s): PATH-wSP; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide; Normal Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine
Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This study tried to prove that children given food supplements containing vitamin A would
      have better liver vitamin A stores than children given food supplements without vitamin A
      over a 5 month period.
    

Detailed description: 
      The study wanted to assess the effect of fortification of home based complementary foods on
      vitamin A status in Ghanaian children who receive food supplements known as Sprinkles. The
      study assessed the vitamin A status and body pool size in children using a test known as the
      modified relative dose response test (MRDR) tests and stable 13C2 retinol as a tracer, among
      those who receive Sprinkles with or without vitamin A through home fortification of
      complementary foods.
    

Intervention name(s): Vitamin A supplements; Sprinkles without Vitamin A
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sprinkles with Vitamin A; Active comparator
Intervention MeSH terms: Vitamins; Vitamin A; Retinol palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vitamin A, complementary foods, malnutrition, children
Amphotericin B Treatment in Visceral Leishmaniasis
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional

Summary: 
      This study is being conducted to assess the safety and efficacy of amphotericin B
      deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given
      in the conventional way every alternate day against the daily administration regimen being
      tested.
    

Detailed description: 
      This study is being conducted to assess the safety and efficacy of amphotericin B
      deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given
      in the conventional way every alternate day against the daily administration regimen being
      tested.
    

Intervention name(s): Amphotericin B deoxycholate given as daily administration
Intervention type(s): Drug
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: visceral leishmaniasis; amphotericin B; Kala-azar
Ultrasound Guided Investigation Of The Anatomical Features For Caudal Block In Children With Sacral Dimple
Condition: Sacrococcygeal Disorder
Study type: Interventional

Summary: 
      When dimples are detected in the sacral region, most practitioners consider it to be a sign
      of spinal anomaly and avoid caudal block. Ultrasound guided investigation of the anatomical
      features for caudal block in normal children and in children with sacral dimple will be
      informative for practitioners.
    

Detailed description: 
      A dimple over the sacrum may be an isolated finding or a sign of underlying spinal
      abnormality. Therefore, most practitioners are confused to perform a caudal block.
      Ultrasonography is a safe and cost effective screening tool in pediatric patients. Ultrasound
      guided investigation of the anatomical features of sacral region may play a key role to
      eliminate suspicions. It is possible to detect spinal abnormalities and also measuring dural
      sac level, distance between dural sac and estimated needle insertion site or needle entry
      angle. In this study, we will examine whether there is a difference between normal children
      and children with dimple in the sacral region.
    

Intervention name(s): ultrasound evaluation
Intervention type(s): Device
Intervention description(s): ultrasound evaluation of normal patients and patients who have a sacral dimple
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups were formed as those with and without dimples in the sacral region.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: pediatric, sacral dimple, ultrasound