bioihbjkbjnl/mcl2 huggingface dataset:
Patient and Parent Preferences for an On-Body Automated Insulin Delivery System
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The goal of this study is to learn more about patient and family preferences regarding use of
      advanced diabetes technologies. Young persons with type 1 diabetes (ages 8-25) and parents of
      young persons with type 1 diabetes will complete one study visit involving a semi-structured
      interview and surveys. The results of the study will be used to assist in the design of a new
      automated insulin delivery system.
    

Detailed description: 
      Type 1 diabetes remains the most common chronic disease of childhood and affects millions of
      children and adults globally. The minority of persons with type 1 diabetes achieve the
      recommended glycemic targets. Currently approved and unapproved automated insulin delivery
      systems require patients to carry and wear multiple devices (pumps, tubing, blood glucose
      meters, mobile devices, etc.). There is a need to design automated insulin delivery systems
      that reduce the burden of diabetes management for young persons and their families in an
      effort to improve glycemic control as well as other biomedical and psychosocial outcomes.

      The purpose of this study is to conduct separate semi-structured interviews with young
      persons with type 1 diabetes and parents of youth with type 1 diabetes (not necessarily the
      parents of the youth participants) regarding their preferences for an automated, on-body
      insulin delivery system. Youth and parents will also complete short surveys related to
      perceived burden of diabetes self-care, quality of life, acceptance of diabetes, and worries
      about hypoglycemia. The feedback received from the interviews and surveys will help inform
      the design of a new on-body automated insulin delivery system.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from the clinic populations of the 2 study sites.
      
Keywords: artificial pancreas; pediatric; parents; adherence
GAD-Alum (Diamyd) Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes (DIAGNODE-1)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the main study is to:

        -  Evaluate the safety of giving GAD-Alum (Glutamic acid decarboxylase) (Diamyd) directly
           into lymph glands in combination with an oral vitamin D regimen

        -  Evaluate how the above mentioned treatments influence the immune system and endogenous
           insulin secretion.

      The objective of the sub-study is to:

        -  Evaluate safety after a fourth injection with 4 μg GAD-Alum direct into an inguinal
           lymph gland in 3 adult patients from the main study

        -  Evaluate how the above mentioned treatment influences the immune system and endogenous
           insulin secretion.
    

Detailed description: 
      Eligible patients will be treated with 4 µg GAD-Alum into an inguinal lymph gland at three
      occasions, with one month intervals in combination with Vitamin D (14 000 IU/week) for 4
      months, starting 1 month prior to first GAD-Alum injection.

      A sub-study will include three adult patients from the main study and evaluate safety after a
      fourth injection with 4 μg GAD-Alum into an inguinal lymph gland in combination with oral
      vitamin D intake. The Prolonged Extension Study Period is 12 months and will start 30,5
      months after baseline.
    

Intervention name(s): GAD-Alum; Vitamin D
Intervention type(s): Drug; Drug
Other intervention name(s): Diamyd; Calciferol
Intervention MeSH terms: Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diamyd; Diabetes; Juvenile Diabetes; Diabetes Type 1; Type 1 Diabetes; Autoimmune Diabetes; Insulin Dependent Diabetes; Type 1 Diabetes Mellitus; rhGAD65 (Recombinant Human GAD with molecular mass 65,000); GAD65; GAD-Alum; Diabetes Mellitus; Diabetes mellitus Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Vitamin D
Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain
Condition: Smoking Cessation; Weight Loss
MeSH terms: Body Weight; Weight Loss; Weight Gain
Study type: Interventional

Summary: 
      The purpose of this research study is to better understand (1) why people gain weight when
      they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking)
      counseling combined with the nicotine patch help people quit smoking and gain less weight.
    

Detailed description: 
      This is a randomized clinical trial of the efficacy of a behavioral activation intervention
      to smoking cessation and to post-cessation weight gain (BAS+) plus transdermal nicotine (TN)
      compared to standard smoking cessation counseling (SC) plus TN in treatment-seeking smokers.
      After completing an Intake Visit (~week -3), eligible smokers will be randomized (stratified
      by nicotine dependence, BMI and gender) to participate in 8 individual sessions of BAS+ or SC
      over a 10-week treatment period with two sessions prior to the target quit date (weeks -2,
      -1) and six sessions post-target quit date (TQD [week 0] and weeks 1, 2, 4, 6, and 8).
      Standard, 8-week; open-label TN will begin on the TQD. Moderators will be assessed
      pre-treatment. Mediating mechanisms will be assessed before, during, and at the end of
      treatment (EOT, week 8). Smoking will be assessed by self-report and biochemically confirmed
      (Carbon Monoxide [CO] < 5) at all in-center visits after quitting, at EOT (week 8), and at
      the 12- and 26-week follow-ups. Weight will be assessed at these same time points. Food
      intake will be measured by three consecutive days of 24-hour food recalls at Baseline [week
      -2] and 4-, 8-, and 12- and 26-weeks post-TQD. Smoking cessation and post-cessation weight
      gain (PCWG) are the primary outcomes and food intake is a secondary outcome at 26-weeks
      post-TQD. Consistent with intent-to-treat (ITT) analyses, the investigators will measure
      smoking cessation and weight gain in the full sample at the 26-week follow-up, evaluating a
      smoking status by treatment interaction for the PCWG analysis.
    

Intervention name(s): BAS+; SC
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.; Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Smoking Cessation; Weight Loss
Safety Study of Black Cohosh Use by Postmenopausal Women on the Liver
Condition: Menopause
Study type: Interventional

Summary: 
      Black Cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective
      in controlling bothersome hot flushes, while avoiding the dangers of using hormones. Recent
      case reports pointed to potential toxicity of black cohosh on the liver. The investigators
      are trying to verify or refute such allegations.
    

Detailed description: 
      The aim of this prospective longitudinal clinical trial is to evaluate changes in total
      hepatic blood flow and liver functions among postmenopausal women using black cohosh
      (cimicifuga racemosa) extract for twelve consecutive months for relief of vasomotor symptoms.

      Prior to using a daily dose of 40 mg of a dry extract preparation of cimicifuga racemosa
      (Klimadynon®) and twelve months after, total hepatic blood flow will be assessed by color
      Doppler ultrasound. Moreover, prothrombin time & concentration, serum albumin, bilirubin,
      gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), alanine aminotransferase (ALT)
      and aspartate aminotransferase (AST) will also be measured.
    

Intervention name(s): Cimicifuga racemosa extract for the group
Intervention type(s): Drug
Intervention description(s): 40 mg of Cimicifuga racemosa extract daily dor 12 months
Other intervention name(s): Klimadynon®
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cimicifuga racemosa; liver blood flow and functions
Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms
Condition: NALP3 Mutation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and
      pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients
      with NALP3 mutations whose clinical symptoms are either untreated or insufficiently treated
      and require medical intervention.
    


Intervention name(s): canakinumab
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACZ885; NALP3 mutations; Interleukin-1beta; Muckle-Wells Syndrome
Treatment of Cerebral Radiation Necrosis (CRN) With Nerve Growth Factor (NGF)
Condition: Cerebral Necrosis; Nashopharyngeal Cancer; Nerve Growth Factor
MeSH terms: Necrosis
Study type: Observational

Summary: 
      Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy
      for cancers, and may have a devastating effect on the patient's quality of life (QOL).
      However,CRN was once regarded as a progressive and irreversible disease, no standard therapy
      has been suggested for CRN. In our clinical practice, we have used nerve growth factor(NGF)
      to treat CRN, and found that GM1 can successfully reverse CRN. A case report has been
      published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this prospective
      study to test the efficacy of NGF for CRN.
    


Intervention name(s): NGF group
Intervention type(s): Drug
Intervention description(s): This group will be treated with NGF 18u per day im for 60 days
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients must have undergone definitive RT for histologically confirmed NPC years before.
        They were required to have at least two consecutive magnetic resonance imaging (MRI) study
        supporting the diagnosis of CRN with an interval of 3-4 months, with the second MRI showing
        progressive disease compared with the first MRI. The necrotic mass shown on MRI must be
        measured in two dimensions in order to define the response to treatment. Other radiologic
        studies were also required to support the non-existence of local or regional recurrence,
        distant metastasis. Patients must have undergone mental status examinations and had
        progressive neurologic symptoms or signs. In addition, they were required to have a
        Karnofsky performance status of at least 70 and were supposed to live more than 6 months.
Drug-Disease Interaction in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective: To determine the effect of C-reactive protein (CRP) status, and infliximab
      treatment on the pharmacodynamics and pharmacokinetics of verapamil, a model drug for L-type
      calcium channel blocking, in Crohn's disease (CD) patients compared to healthy patients.

      Hypotheses:CD patients will have elevated plasma verapamil concentrations, but diminished
      dromotropic response to verapamil; the concentration of circulating norepinephrine, used as a
      surrogate marker of sympathetic nervous activity, will be similar between the healthy
      patients and the CD patients; the sympathetic nervous system of the heart will be similar to
      healthy patients; Crohn's disease patients with normal CRP will have higher drug response
      compared to high CRP (>3 mg/l) patients; and that infliximab-treated patients will have
      higher verapamil response than those with similar symptom profiles who are not infliximab
      treated.
    


Intervention name(s): verapamil
Intervention type(s): Drug
Intervention MeSH terms: Verapamil
Keywords: inflammation; receptor downregulation; reduced response; calcium channels; PK-PD relationship
Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double blind single site vehicle controlled study. The following activities will be
      conducted at each visit.

      Baseline Research Center Visit Obtain a signed and dated, written ICF prior to any
      study-related procedures.· Obtain demographic data· Assign subject number based on the order
      in which subjects present to the research center· Obtain medical/surgical history· Obtain
      concomitant medications· Assess eligibility based on inclusion/exclusion criteria· Collect
      blood and urine samples for clinical laboratory tests and send to the central laboratory·
      Perform serum pregnancy test in all women of child bearing potential (WOCBP)· Obtain vitals·
      Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and
      symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for baseline
      visit· Randomize subject and dispense Investigational Study Medication and use instructions
      along with compliance diary· Schedule return visit

      Week 2 Phone Call· Reassess medical/surgical history· Reassess concomitant medications·
      Assess adverse events· Assess compliance

      Weeks 4, 8 Research Center Visit Reassess medical/surgical history· Reassess concomitant
      medications· Assess adverse events· Collect a urine sample from female subjects of
      childbearing potential for a urine pregnancy test· Obtain vitals· Assess IGA, inflammation,
      erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform
      Columbia Suicide Severity Rating Scale (C-SSRS) for return visits· Assess compliance diary
      and Investigational Study Medication, collect used Investigational Study Medication and
      redispense as necessary· Schedule return visit

      Week 12 Research Center Visit· Reassess medical/surgical history· Reassess concomitant
      medications· Assess adverse events· Collect a urine sample from female subjects of
      childbearing potential for a urine pregnancy test· Collect blood and urine samples for
      clinical laboratory tests and send to the central laboratory· Obtain vitals· Assess IGA,
      inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms
      assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for return visits·
      Assess compliance diary and Investigational Study Medication· Collect diary and
      Investigational Study Medication· Release subject from study participation
    


Intervention name(s): Roflumilast Cream
Intervention type(s): Drug
Intervention description(s): Topical Cream
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single site double blind vehicle controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Progesterone and Brain Imaging Study
Condition: Nicotine Dependence; Nicotine Withdrawal
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase
      was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving
      progesterone or a matched placebo.
    

Detailed description: 
      The purpose of this study is to learn whether a sex hormone called progesterone is helpful in
      reducing cigarette smoking and craving for cigarettes. This study also includes brain imaging
      to measure possible effects of progesterone on certain neurochemicals. These neurochemicals
      are called gamma-aminobutyric acid (or GABA for short) and glutamate. Both nicotine and
      progesterone affect these brain chemicals.

      Individuals wishing to participate in this study must be medically healthy men or women who
      smoke at least 10 cigarettes per day or greater. Participants must not suffer from a mental
      illness or use drugs other than nicotine and marijuana. Participants cannot have any
      implanted metallic devices such as pacemakers, orthodontic braces, or shrapnel. Participants
      must not have peanut allergies and must never have had a reaction to progesterone. Finally,
      participants cannot be taking any medications for anxiety, depression or insomnia.
    

Intervention name(s): Progesterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.; Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
Other intervention name(s): Prometrium
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nicotine; Smoking
Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
Condition: Pregnancy
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      This research study is being conducted at over 12 pregnancy research centers in the US. The
      study will compare an investigational treatment with a placebo (a treatment without
      medication). Neither the investigators nor the patients in the trial will know which
      treatment has been assigned. All study medications will be given vaginally once a day.
      Treatment will begin before pregnancy week 23 and will continue until the end of pregnancy
      week 36.
    

Detailed description: 
      Patients who participate are to have:

        -  A single baby pregnancy (no twins or triplets allowed)

        -  Patients will start treatment before pregnancy week 23

        -  Patients must have a previous preterm birth (a "preemie")

        -  Patients must be 18-45 years of age
    

Intervention name(s): 8% progesterone vaginal gel; Placebo Vaginal Gel
Intervention type(s): Drug; Drug
Intervention description(s): Progesterone 8% Vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation; Placebo vaginal gel, once daily, maximum duration from 18 07 weeks gestation to 37 0/7 weeks gestation
Other intervention name(s): Prochieve; Crinone
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pregnancy,; prevention of preterm birth,; prevention of preterm labor,
Glenohumeral Internal Rotation Deficit (GIRD)
Condition: Glenohumeral Internal Rotation Deficit (GIRD)
Study type: Interventional

Summary: 
      A loss of mobility in the shoulder in direction of internal rotation is associated with
      shoulder tendon pathology. Cause-effect relationship between these two is still not clear. It
      is suspected that this loss of mobility reduces the size of the tunnel in which this shoulder
      tendon is lying, namely the subacromial space. Overhead athletes frequently show glenohumeral
      internal rotation deficit (GIRD) while being healthy and free of shoulder pain. This makes
      this population interesting to investigate. This study wants to look at shoulders of overhead
      athletes with GIRD and measure the size of the subacromial space. After this, the athletes
      will be instructed to perform a home stretching program and at the end the effect of this on
      mobility and the size of the subacromial space will be measured.60 athletes will be recruited
      and randomly allocated to the control group and the stretching group. Before they start
      stretching, subacromial space size will be measured by use of ultrasound. This is a safe and
      non-invasive measuring tool. Mobility will be measured by use of a digital inclinometer. This
      also is safe and non-invasive. Patients will be instructed a stretching exercise, which they
      will be performing at home once a day during 6 weeks. At the end all outcome measures will be
      reassessed.
    


Intervention name(s): home stretching program
Intervention type(s): Procedure
Intervention description(s): A home stretching program (sleeper's stretch): 3 x 30 seconds, once a day for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
Condition: Meningococcal Infection
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32
      to 40 Months of Age
    


Intervention name(s): Meningococcal C conjugate vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention of meningococcal infection
Treatment of Bile Acid Malabsorption With Liraglutide
Condition: Bile Acid Malabsorption
MeSH terms: Malabsorption Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparing the effect of Liraglutide on bile acid malabsorption, with colesevelam
    

Detailed description: 
      The overall objective of the present study is to provide proof of concept that treatment with
      the GLP-1 receptor agonist liraglutide is efficacious (as assessed by symptom relief, i.e.
      response to treatment) and safe (as assessed by adverse effects) in the management of BAM and
      that it improves bile acid reabsorption (as assessed by SeHCAT) in these patients.
    

Intervention name(s): Liraglutide 6 MG/ML; Colesevelam
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide as injections.; 3 x 625 miligram 2 times a day.
Intervention MeSH terms: Liraglutide; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science