bioihbjkbjnl/mcl2 huggingface dataset:
Development of a Behavioral Observer for Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Development of a bio-behavioral stochastic model-predictive controller (SMPC) for use as an
      artificial pancreas in T1DM requires fundamental behavioral and physiology studies, as well
      as translational modeling and engineering development. In order to be successful, closed-loop
      control in Type 1 Diabetes Mellitus (T1DM) must adapt to individual physiologic
      characteristics and to the behavioral profile of each person. An essential part of this
      adaptation is biosystem (patient) observation. The investigators propose to lay the
      foundation for a closed-loop control system which will include algorithmic observers of
      patients' behavior and metabolic state.
    

Detailed description: 
      This intensive descriptive study will follow 60 adults with T1DM who are currently
      experienced with insulin pump use for a two-week training period plus a one month active
      study period during which the DexCom SEVEN® PLUS Continuous Glucose Monitor (CGM) will be
      used in tandem with the OmniPod® Insulin Management System. The OmniPod® has a built in
      FreeStyle glucometer that allows tagging of food and activity-related treatment behaviors
      with each self-monitoring blood glucose (SMBG) value. The OmniPod® personal digital assistant
      (PDA) also stores information about insulin delivery and meal size in relation to the
      carbohydrate content. Parallel recording of CGM and behavioral data, as well as psychometric
      instruments will produce a rich synchronized data set for each person that will ultimately
      lead to the development of a behavioral event generator for use in future open-loop and
      closed-loop control algorithms for intelligent insulin dosing.
    

Intervention name(s): Focus Group
Intervention type(s): Behavioral
Intervention description(s): Focus group methodology was chosen to obtain qualitative and quantitative data on participants' desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile
Condition: Clostridium Difficile
MeSH terms: Clostridium Infections; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients who have received antibiotics and thereafter developed diarrhea are investigated for
      presence of Clostridium difficile toxin. Primary treatment is given with oral
      metronidazole/vancomycin. In case of relapse, secondary treatment is given with either
      cultured gut microbiota rectally or oral vancomycin in sequence. In those cases where
      secondary treatment with vancomycin fails cultured gut microbiota is given as final
      treatment. As an extension treatment, all failures were treated with cluttered gut microbiota
      through the upper route. In both cases As an alternative cultured gut microbiota may be given
      via the duodenal route. Follow-up is carried out after 7, 30 and 90 days with interview and
      stool collection for analysis of Clostridium difficile.
    


Intervention name(s): Cultured human intestinal microbiota; Vancomycin; Metronidazole
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Secondary treatment for C diff in replacement for regular vancomycin.; Active comparator to treatment with ACHIM; Primary treatment for C diff in all treatment arms
Other intervention name(s): Anaerobic cultured human intestinal microbiota (ACHIM)
Intervention MeSH terms: Metronidazole; Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Antibiotic-induced diarrhea; Clostridium-difficile toxin; Pseudomembranous colitis
Pilates in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      This study was planned to examine and compare the effectiveness of two different pilates
      exercise methods (mat pilates vs reformer pilates) in individuals with Ankylosing
      Spondylitis(AS).
    


Intervention name(s): Pilates
Intervention type(s): Behavioral
Intervention description(s): Pilates exercises were applied twice a week for 4 weeks in both groups. The sessions were supervised by an Australian Physiotherapy and Pilates Institute (APPI) certified physiotherapist as 5 minutes of warm-up, 45 minutes of exercise and 5 minutes of cool-down periods.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive and Behavioral Effects of Lacosamide
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      Null hypothesis: A 24-week trial of adjunctive Lacosamide does not produce a decline in
      cognitive, mood or quality of life measures.

      To determine the cognitive and behavioral side effects of lacosamide in patients with partial
      epilepsy and follow them for a period of 24 weeks using a neuropsychological test battery
      drawing on tests commonly used and designed to maximize sensitivity to drug effects.

      Secondary Objectives:

      To determine if any significant changes in cognitive, mood or quality of life measures are
      dependent upon changes in seizure severity, neurotoxicity, adverse events, or Lacosamide
      dosage.
    

Detailed description: 
      The investigators will examine a group of patients with partial epilepsy (chronic seizures
      arising from one particular part of the brain) whose seizures have not been controlled. If
      they consent to the study, they will be followed for 4 weeks to get a baseline seizure
      frequency. The patients will take a battery of tests assessing attention, memory, cognitive
      speed, and language, and fill out some inventories to assess their mood and quality of life.
      They will then receive a new anti-epileptic drug, lacosamide, to add to whatever epilepsy
      medications they are currently taking. They will be closely followed for 24 weeks with
      regular doctor's visits to monitor their physical health and seizure control, and will
      complete an inventory assessing the frequency and severity of their seizures. During that
      period of time, the other medication will remain unchanged. At the end of the 24-week period
      they will re-take the battery of cognitive tests and mood and quality of life inventories.
      The cognitive, mood, and quality of life variables will be analyzed to determine if they
      change for the better or worse after the course of lacosamide treatment. Any changes will
      also be analyzed with respect to seizure frequency and severity and to adverse events or side
      effects from the addition of the lacosamide, as well as to lacosamide dosage. The
      investigators chose this design since it closely represents what the investigators do in
      clinical practice.
    

Intervention name(s): Lacosamide; Lacosamide
Intervention type(s): Drug; Drug
Intervention description(s): Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period. Dose Adjustments allowed up to 400 mg/day.; Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period.
Other intervention name(s): Vimpat; Vimpat
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Partial Epilepsy
Multiplex Testing for Evaluation of Breast Cancer Risk, Longitudinal Study
Condition: BRCA1/2 Negative
Study type: Interventional

Summary: 
      The overall goal of the proposed research is to evaluate the uptake of testing and
      longitudinal risks and benefits of multiplex testing for cancer susceptibility in BRCA1/2
      negative patients. This model will inform the selection of the outcomes and potential
      mediators and moderators of these outcomes, to inform the debate over utility, risks, and
      benefits of clinical incorporation of multiplex testing for breast cancer susceptibility.
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention model: Single Group Assignment
Primary purpose: Screening
Keywords: patients
Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections
Condition: Recurrent Urinary Tract Infection
MeSH terms: Infections; Urinary Tract Infections; Recurrence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Recurrent urinary tract infections are quickly becoming a public health obstacle in our aging
      population. Almost 50% of women have at least one urinary tract infection in their lifetime;
      following this first infection, there is a 25-35% chance that she will have another infection
      in the subsequent 3-6 months. With each documented infection, a patient receives anywhere
      from a three to seven day course of antibiotics for treatment. Repeated courses of
      antibiotics often lead to the development of multi-drug resistant infections that are
      difficult to treat with our arsenal of oral medications. It is theorized that most, if not
      all, urinary tract infections are caused by bacteria from the gastrointestinal tract. If
      there is a generalized gut dysbiosis due to repeated courses of oral antibiotics, it will
      likely be difficult to ever adequately treat repeat urinary tract infections. This same
      theory led to the development and utilization of fecal microbiota transplantation in the
      treatment of refractory Clostridium difficile diarrhea. There are now several studies that
      have reported on the efficacy of fecal transplantation in the treatment of C.difficile
      infections as well as the correction of gut dysbiosis. Given this positive response in
      treatment of refractory infectious diarrhea, the investigators propose that the correction of
      gut dysbiosis can also treat refractory recurrent urinary tract infections. Therefore, the
      investigators propose this pilot study to determine the effectiveness of fecal
      transplantation in the treatment of refractory, recurrent urinary tract infections.
    


Intervention name(s): Fecal Microbiota Transplantation
Intervention type(s): Biological
Intervention description(s): This is a single arm study. All participants will receive a single fecal transplant to determine effectiveness in treating refractory recurrent urinary tract infections.
Other intervention name(s): FMT; Fecal Transplant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Response, Food Intake and Satiety in Children
Condition: Diabetes Prevention; Obesity Prevention
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine the effects of fluid dairy products on blood glucose
      and insulin, satiety and energy intake in normal weight and overweight/obese children in the
      age range of 9-14 y. Experiment 1: The specific objective is to examine the effects of
      isocaloric and isovolumetric amounts of 2% M.F. milk, 1% M.F. chocolate milk, 1.5% M.F.
      yogurt drink, tropical punch and water consumed before and within a pizza meal 60 min later
      on appetite and food intake. Experiment 2 will compare the effects of 2% M.F. milk and
      tropical punch consumed before and with a pizza meal 60 min later on food intake, blood
      glucose, and appetite hormone response.
    


Intervention name(s): Dietary Intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Food intake; Appetite; Blood glucose; Insulin; Dairy; Milk
Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives as stated in the study protocol were as follows:

        -  To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202
           (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male
           volunteers). Part A

        -  To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA
           3-202 in healthy young males. Part A

        -  To investigate the safety and tolerability of a single multiple dose regimen (dose to be
           determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B

        -  To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single
           multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy
           elderly volunteers. Part B
    

Detailed description: 
      This was designed as a single centre, phase I, double-blind, randomised, placebocontrolled
      study of three multiple rising doses in three sequential groups of 8 young male healthy
      volunteers (Part A) and a single group of healthy elderly volunteers (Part B).

      In Part B, 12 healthy elderly volunteers were to be enrolled. Ten were to be randomly
      allocated to BIA 3-202 and two to placebo.
    

Intervention name(s): BIA 3-202; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water.; Matched placebo was administered in the form of oral tablets, given with 200 ml potable water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; Nebicapone
Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the therapeutic effect of Dapsone and Placebo gel in the treatment of acne
      vulgaris.
    

Detailed description: 
      A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group study comparing
      Dapsone to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne
      Vulgaris
    

Intervention name(s): Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd); ACZONE® (dapsone) gel, 7.5% (Allergan, INC.); Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)
Intervention type(s): Drug; Drug; Other
Intervention description(s): Topical gel; Topical gel; Topical gel
Intervention MeSH terms: Dapsone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A multi-center, double-blind, randomized, three-arm, placebo-controlled, parallel-group study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne vulgaris
RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE
Condition: Breast Cancer
MeSH terms: Dermatitis; Radiodermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation
      therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to
      its direct physical complications and the resulting impact on overall quality of life, it can
      also be a dose-limiting toxicity requiring changes to the prescribed course of radiation
      therapy. The most common strategy employed in an attempt to prevent or minimize radiation
      dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the
      area clean, and minimizing exposure to potential mechanical irritants, such as scratching and
      rough clothing. However, this strategy has been shown to lack clinically significant
      efficacy. Consequently, there is a clinical need for new treatments that are effective in
      protecting against radiotherapy-induced oxidative stress and the subsequent development of
      radiation dermatitis.

      Based on data from previous studies in animals and humans, Reata believes that omaveloxolone
      (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology
      patients undergoing radiation therapy.

      This randomized, double-blind, vehicle-controlled, parallel-group trial will study the
      efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3%
      and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is
      recommended.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): Omaveloxolone Lotion 0.5%; Omaveloxolone Lotion 3%; Vehicle Lotion; 3D conformal radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): Omaveloxolone lotion 0.5% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy; Omaveloxolone lotion 3% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy; Lotion vehicle manufactured to mimic RTA 408 lotion will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy; 45 50.4 Gy in 1.8 Gy per day, in addition to 10 - 16 Gy boost or 46 - 50 Gy in 2 Gy per day, in addition to 10 - 16 Gy boost, at the physician's discretion
Other intervention name(s): RTA 408 Lotion 0.5%; RTA 408 Lotion 3%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: RTA 408; RTA 408 Lotion; Breast cancer; Radiation therapy; Radiation dermatitis; Oxidative stress; Inflammation; omaveloxolone
A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders
Condition: Neurodevelopmental Disorders
MeSH terms: Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      Diagnosis and characterization of neurodevelopmental disorders are considered challenging
      processes because of their complexity, multi-factoriality and heterogeneity. The present
      project will consider two of the most common neurodevelopmental disorders (i.e. autism
      spectrum disorders (ASD) and language disorders (LD)), with the aim to overcome these
      difficulties, by: a) deeply investigating their neuronal correlates; b) identifying
      multi-domain biomarkers (electrophysiological, genetic, environmental and clinical); c)
      developing a machine learning algorithm for early diagnosis. To achieve the above mentioned
      aims a multi-domain dataset will be used, comprising data collected from typically developing
      infants, infants at high risk for ASD and infants at high risk for LD. The data that will be
      used have been already collected within other trials performed at the Scientific Institute E.
      Medea.
    


Intervention name(s): EEG; DNA samples; clinical data; environmental data
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Other
Intervention description(s): resting state EEG; genotypings of twelve CNTNAP2 SNPs from DNA obtained by saliva samples; standardized scales measuring the infants' cognitive, motor and linguistic development administered at 6, 12 and 18. Measures available at 6 and 12 months: a) Bayley Scales of Infant and Toddler Development- Third Edition; b) Griffiths mental development scales (0-2) (GMDS-R); Measures available at 18 months: c) Language Development Survey (LDS); d) "Il PRIMO VOCABOLARIO DEL BAMBINO" (PVB); e) CHILD BEHAVIOR CHECKLIST (CBCL); (f) Modified Checklist for Autism in Toddlers (M-CHAT).; questionnaires administered to parents related to the following environmental factors: a) information about the presence of a clinical diagnosis of neurodevelopmental disorders within first-degree relatives; b) gestational age; c) birth weight; d) parental age and education; e) socio-economic status
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Neurodevelopmental disorder; EEG; Multi-domain data; Machine Learning
Safety and Efficacy of Intratympanic Application of Dexamethasone Via Catheter in Patients With Sudden Hearing Loss
Condition: Sudden Deafness
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sudden
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of an intratympanic
      continuous two-week application of dexamethasone compared to placebo using a temporarily
      implanted catheter in patients with severe to profound sudden sensorineural hearing loss and
      insufficient recovery after initial systemic prednisolone therapy.
    

Detailed description: 
      Patients suffering from unilateral severe to profound sudden sensorineural hearing loss
      (ISSNHL) or anacusis with no or insufficient recovery after 12-21 days after onset will be
      treated for 14 days with Dexamethasone or placebo delivered intratympanically via a
      micro-catheter temporarily implanted into the round window niche and an external mini-pump.

      Due to the relatively unknown risks of intratympanic treatment by catheter implantation, a
      significant spontaneous recovery rate and an existing standard therapy for ISSNHL in Germany
      (systemic glucocorticoids), patients will only be enrolled into the study if no or
      insufficient recovery of hearing threshold could be observed after initial systemic therapy.

      The study will be carried out until 10 patients per group have been randomized regardless in
      which study center they have been randomized. After the last patient of these 10 patients per
      group has reached the endpoint an interim analysis will be done. The statistical estimation
      of the total number of subjects to be randomized will be completed after this interim
      analysis by the responsible statistician.
    

Intervention name(s): Dexamethasone-dihydrogenphosphate (4mg/ml)
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sudden Hearing Loss; intratympanic; steroids