bioihbjkbjnl/mcl2 huggingface dataset:
Glycosade v UCCS in the Dietary Management of Hepatic GSD
Condition: Glycogen Storage Disease
MeSH terms: Glycogen Storage Disease
Study type: Interventional

Summary: 
      To compare efficacy of Glycosade® with uncooked corn starch (UCCS for the dietary management
      of hepatic glycogen storage diseases (GSD).
    

Detailed description: 
      'Glyde' is a prospective, randomised, double-blind, crossover trial to compare the effects of
      two different starches used in the dietary management of GSD.

      The study will recruit 64 patients from six centres in the UK, USA, France and The
      Netherlands. The planned duration per participant is 2 years.

      Participants will be randomised into two equally sized groups:

      Arm A- Glycosade intake given first, followed by UCCS 1-6 weeks later Arm B- UCCS intake
      given first, followed by Glycosade 1-6 weeks later.

      The objective of this trial is to establish whether Glycosade® improves outcomes for patients
      with GSD compared to UCCS therapy by comparing the duration of normal blood sugars, lactate
      and ketone levels of patients with hepatic GSD (Types I, III, VI and IX) post equivalent
      intakes of UCCS and Glycosade®.

      The first part consists of two (blinded) 12 hour starch load tests administered randomly
      within a maximum 6 week period. Participants will be randomised to receive either UCCS or
      Glycosade® for the initial intervention period crossing over to the other product for the
      second intervention period (part 1).

      The second part (unblinded) is a 24 month open follow up whereby participant's will continue
      on the product considered most suitable by the clinician and patient.
    

Intervention name(s): Medical Food - Glycosade
Intervention type(s): Dietary Supplement
Intervention description(s): double blind randomised crossover of 2 starches - glycosade and UCCS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma
Condition: Hodgkin Disease
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome
      patients that have a first line chemotherapy treatment failure due to refractoriness, partial
      response or relapsed.

      In the same way, mortality, global survival and free-progression survival after O-ESHAP
      treatment and TAPH will also analyzed.
    

Detailed description: 
      In addition to the above:

        -  To asses the complete response rate after O-ESHAP.

        -  To asses the toxicity of O-ESHAP regimen

        -  To asses the stem cells mobilization capacity of O-ESHAP regimen

        -  To evaluate the final results of the whole procedure (O-ESHAP followed by high-dose
           chemotherapy and ASCT): transplant-related mortality (TRM), overall survival (OS), and
           progression free survival (PFS)

        -  To investigate the correlation between the overall response and CD20 expression by
           tumoral cells.
    

Intervention name(s): Ofatumumab
Intervention type(s): Drug
Intervention description(s): Ofatumumab in addition with ESHAP therapy
Other intervention name(s): ARZERRA
Intervention MeSH terms: Ofatumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin; Ofatumumab; Lymphoma
Psychological Distress in Emerging Adulthood: A Longitudinal Study
Condition: Psychological Distress
Study type: Observational

Summary: 
      Emerging adulthood (18-29 years) is a critical stage in lifespan development. During this
      stage, people experience instability: shifts from their families of origin, breakups of
      relationships and job changes are frequent before most young adults stabilize their lives and
      make more lasting decisions. This study seeks to understand the psychological distress of
      emerging adults in Quito, Ecuador and define how it varies over a year.
    

Detailed description: 
      Emerging adulthood is often a period of some instability with relationship changes and often
      a series of job changes before life trajectories clarify and more lasting decisions are
      possible. These changes often produce distress and they might explain why most of the
      symptoms that impact the individual's mental health throughout their lives appear at this
      stage, although full-blown disorders are often only diagnosed subsequently. There are several
      studies that describe the prevalence of mental disorders in this age group, however, there
      are few studies that refer to how psychological distress changes during this phase of
      emotional, social, and financial instability. The few existent studies refer mostly to
      college student populations, with relative neglect of the non-student populations.

      The objective of this study is to analyze the intraindividual changes in psychological
      distress of emerging adults over one year. These changes will be compared between those
      participants who are college students and those who are not. Sociodemographic data will be
      recorded in the first assessment and the last assessment, while psychological distress and
      health-related quality of life will be monitored bimonthly for seven assessment points in
      total. Everyday relevant events will be also recorded bimonthly for seven assessment points,
      and this information will be used as a time-varying covariate. An electronic survey will be
      used for data collection through formr system (https://formr.org/).

      The results of this research will show if the distress changes significantly in the studied
      population for one year and it will be possible to identify some of the events and variables
      that are related to these changes. This knowledge might help to create interventions that are
      tailored to the needs of this population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population will be emerging adults from Ecuador students and non-students as one
        objective is to compare psychological distress variability between both populations.
      
Keywords: Young Adult; Life Change Events; Students; Mental Health; Observational Study; Longitudinal Studies; Surveys and Questionnaires; Self Report
A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effect of FTY720 on the lung function of patients with moderate
      asthma
    


Intervention name(s): FTY720; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma, adrenergic beta agonists, multiple sclerosis, pulmonary function tests, forced expiratory volume
LAS41005 in Hyperkeratotic Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to
      cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch
      biopsies).
    


Intervention name(s): Cryotherapy; LAS41005
Intervention type(s): Procedure; Drug
Intervention description(s): 1-2 times during the treatment time; once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Health Benefits of Physical Activity Recommendations in the Dietary Guidelines
Condition: Obesity; Sedentary Lifestyle; Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The overall goal of this study is to determine the health benefits associated with the 2005
      Dietary Guidelines physical activity prescription in healthy, peri-menopausal women. The 2005
      Dietary Guidelines specifically state that to avoid unhealthy weight gain, adults should
      participate in 60 minutes of moderate to vigorous intensity physical activity on most days of
      the week.
    

Detailed description: 
      This study will be a randomized controlled trial conducted over a 6 to 7 month period.
      Subjects will be enrolled by cohorts and randomly assigned to one of two groups.

        -  Group 1 (PA): physical activity intervention that will consist of brisk walking or other
           aerobic-type activities (6 days per week), resistance exercise (using free weights,
           resistance bands or weight stacks for weight lifting, 3 days per week), and 'active
           lifestyle' activities such as gardening, dancing, participation in sporting activities.
           The total time spent in these activities will add up to ~60 min/day for 6 days/week
           (~360 minutes per week).

        -  Group 2 (CON): control group will maintain their usual level of physical activity and
           participate in testing protocols, record keeping, and interviews on the same schedule as
           PA. This group will be offered an opportunity to have a gym membership/access to the
           training facility after completion of the 6-month period of serving as controls.

      The specific aims of this pilot study are to:

        -  Assess each participant's level of compliance/adherence

        -  Assess the dietary habits of study participants as they become more physically active.

        -  Identify barriers to physical activity in this specific population.

        -  Measure changes in body composition, physical fitness and energy expenditure.

        -  Evaluate changes in chronic disease risk factors.

        -  Determine if regular physical activity reduces chronic stress.
    

Intervention name(s): Physical Activity; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Physical activity intervention that will consist of brisk walking or other aerobic-type activities (6 days per week), resistance exercise (using free weights, resistance bands or weight stacks for weight lifting, 3 days per week), and 'active lifestyle' activities such as gardening, dancing, participation in sporting activities. The total time spent in these activities will add up to ~60 min/day for 6 days/week (~360 minutes per week).; The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Obesity; Sedentary lifestyle; Body weight; Physical fitness
Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Condition: Biliary Cannulation; Endoscopic Retrograde Cholangiopancreatography
Study type: Interventional

Summary: 
      Selective cannulation is considered the most challenging step for most of endoscopic
      retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique
      for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used.
      With one guidewire occupying pancreatic duct(PD) , the following cannulation of CBD with a
      sphincterome preloaded with another guidewire often becomes feasible.

      When performing DWT, a sphincterotome should enter the common duct of papilla through a small
      orifice and be placed in the left and upper direction of PD guidewire. Then another guidewire
      can be advanced into bile duct. As an advanced cannulation technique, DWT can be successfully
      performed in up to 80% of difficult patients. However, it can be technically difficult,
      especially for trainees or endoscopists without adequate experience.

      Here we planned to prospectively record the procedures of double-wire cannulation by two
      trainees without prior experience of DWT. This study aims to delinate the learning curve of
      DWT and its safety by trainees.
    


Intervention name(s): DWT learning curve
Intervention type(s): Procedure
Intervention description(s): trainees learn to perform DWT after unsuccessful initial cannulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ERCP; double guidewire technique; learning curve
Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding
Condition: Surgical Wound
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage; Surgical Wound
Study type: Interventional

Summary: 
      There were many approaches for patients with obscure gastrointestinal bleeding (OGIB).
      Capsule endoscopy (CE), double-balloon endoscopy, deep small-bowel spiral enteroscopy,
      laparoscopy, computed tomography and angiography have been recommended as investigation.
      However, of these techniques, the evaluation and management of patients with OGIB remains a
      formidable challenge. We compared the diagnostic yield and long-term outcomes of patients
      with OGIB randomized to angiogram combination laparoscopy or angiogram alone.
    

Detailed description: 
      Consecutive patients who presented with OGIB to the second people's hospital of GuangDong
      province between January 2003 and November 2008 were recruited. This study was approved by
      the ethical committee of the Second people's Hospital of GuangDong Province and was designed
      according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. All
      patients gave written informed consent before beginning the study. As a standard protocol,
      all patients presented with melena or hematochezia would receive at least 2 times upper
      gastrointestinal endoscopy before admission. Patients who had nondiagnostic upper GI
      endoscopy were also offered at least 2 times colonoscopy before admission. All
      gastrointestinal endoscopies were performed by experienced endoscopists (hanning Wang). OGIB
      were defined as patients who had nondiagnostic upper endoscopy and colonoscopy.

      Patients who were < 18 years, pregnant, in moribund conditions, or with terminal malignancy
      were excluded. Patients with contrast allergy and impaired renal function (serum creatinine >
      150 µmol/l) were also not eligible for this study. All patients were randomized to receive
      either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio.
      Randomization was performed computer-generated list using a randomly permuted block design.
      To ensure concealed randomization, the randomization code was put in opaque envelope and kept
      by researchers not performing angiography or angiography combination laparoscopy. Both
      patients and investigators were unaware of the randomization sequence.
    

Intervention name(s): rebleeding
Intervention type(s): Other
Intervention description(s): Those who developed rebleeding during the observation would be crossed over to the other investigation modality.
Other intervention name(s): angiography; laparoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: obscure gastrointestinal bleeding; laparoscopy; angiography
Concurrent Chemotherapy Based on Genetic Testing in Patients With High-Risk Salivary Gland Tumors
Condition: Salivary Gland Tumors; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Salivary Gland Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The role of postoperative concurrent chemotherapy (CCT) has not been established for salivary
      gland tumors (SGTs). This prospective study was conducted to evaluate the feasibility and
      safety of customized CCT regimens based on the gene targets of SGTs.
    


Intervention name(s): Docetaxel; Intensity-modulated radiotherapy; Pemetrexed; Cisplatin
Intervention type(s): Drug; Radiation; Drug; Drug
Intervention description(s): Docetaxel only: 80 mg/m2 on day one, every 21 days if; a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks; Pemetrexed only: 500 mg/m2 on day one, every 21 days; Cisplatin only: 70 mg/m2 on day one to day three, every 21 days
Intervention MeSH terms: Docetaxel; Pemetrexed
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Salivary Gland Tumors; Head and Neck Cancer; concurrent chemotherapy; genetic testing
Pharmacokinetic Study in Cerebral Spinal Fluid After a Single Dose of AVI-4020
Condition: West Nile Virus
Study type: Interventional
Phase: Phase 1

Summary: 
      During a clinical study of people with severe West Nile virus infections, it was determined
      that the drug AVI-4020 crossed the blood-brain barrier. This study will assess the amount of
      drug that goes across the blood-brain barrier and the drug levels measured in both the blood
      and urine.

      The objective of this study is to find out how much and how fast this drug crosses this
      barrier.
    

Detailed description: 
      AVI-4020 was designed to interfere with West Nile virus translation, and has been shown to
      cross the blood-brain barrier in both normal and inflamed meninges in a clinical study in
      patients with severe West Nile virus disease.

      At issue, is whether this observation is limited to AVI-4020 PMO drug, or is observed with
      other PMO drugs. This study is one of three to assess the specific ability of PMO drugs to
      cross the blood-brain barrier, using similar dosing, and PK assessment time points. In order
      to rigorously assess the pharmacokinetics, this study is being performed in healthy
      volunteers at a single point in time.

      The ability of other PMO drugs to cross the blood-brain barrier will set the stage for future
      studies that exploit this product characteristic.
    

Intervention name(s): AVI-4020 Injection
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: WNV; West Nile virus; WNV meningoencephalitis
Antenatal Vitamin D3 Dose-finding and Safety Study
Condition: Pregnancy; Nutritional Status; Vitamin D
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a preliminary study of oral vitamin D3 supplementation in pregnant and non-pregnant
      women of reproductive age in Bangladesh. The primary objective of the study is to identify a
      dose of vitamin D3 that can safely be administered during pregnancy to improve the vitamin D
      status of the mother and infant.
    

Detailed description: 
      Vitamin D deficiency is common among pregnant and non-pregnant Bangladeshi women. The
      consequences of vitamin D deficiency during pregnancy are unknown, but increasing evidence
      suggests it may compromise fetal growth and development of the immune system. We hypothesize
      that vitamin D deficiency in pregnant women has an adverse effect on the newborn's defenses
      against infectious diseases in early infancy, and thus contributes to the high rates of
      neonatal mortality in South Asia. Randomized controlled trials of antenatal vitamin D
      supplementation are needed to test this hypothesis. However, preliminary studies are first
      necessary to establish a safe and efficacious dose of vitamin D to be used in such trials. In
      the proposed study, we will measure the response of the 25-hydroxyvitamin D serum
      concentration (a biomarker of vitamin D status) to oral vitamin D3 supplementation in
      pregnant women and non-pregnant women of reproductive age. The goal is to establish a safe,
      efficacious and feasible weekly vitamin D supplementation regimen for use in future trials.
      Five groups of approximately 15 women (3 groups of pregnant and 2 groups of non-pregnant
      women; total up to 75 women) will be supplemented and followed closely for 10 weeks
      (non-pregnant women) or until delivery (pregnant participants). The primary outcomes will be
      the change in 25-hydroxyvitamin D concentrations following vitamin D supplementation, and
      safety parameters that reflect calcium regulation (serum albumin-adjusted calcium
      concentrations and urine calcium excretion) and fetal development.
    

Intervention name(s): Vitamin D3; Vitamin D3; Vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin D3 oral liquid 70,000 IU once; Vitamin D3 oral liquid 70,000 IU as loading dose, then 35,000 IU weekly thereafter for 10 weeks (non-pregnant) or until delivery (pregnant); Vitamin D3 14,000 IU per week by mouth, starting at 27-30 weeks gestation and continued until delivery.
Other intervention name(s): Cholecalciferol; Vigantol Oil; Cholecalciferol; Vigantol Oil; Cholecalciferol; Vigantol Oil
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pharmacokinetics; safety
Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors
Condition: Gastro-Entero-Pancreatic Tumors (GEPs)
MeSH terms: Neuroendocrine Tumors; Pancreatic Neoplasms
Study type: Interventional

Summary: 
      Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived
      from the primitive gut and include digestive and bronchial NETs.

      Historically, the gold standard in their functional exploration is the "conventional"
      somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This
      reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity
      is moderate (60 %), because of its intrinsic detection limits, which could delay the
      diagnosis or lead to inappropriate therapy.

      The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68
      (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has
      improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS.
      Furthermore, patient irradiation and imaging protocol are significantly reduced.
    


Intervention name(s): PET-CT
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic