bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Lifestyle Behaviors on In Vitro Fertilization (IVF) Outcome
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Many women undergoing in vitro fertilization (IVF) ask their doctor if there are any
      behaviors they should avoid, or any behaviors they should emphasize during their IVF cycle.
      This study examines the effects of health habits surrounding exercise, smoking, alcohol,
      sleep, caffeine, herbal medications, acupuncture, and diet on pregnancy rates during IVF
      cycles. The purpose of this study is to determine if lifestyle behaviors have a significant
      impact on pregnancy rates during treatment with IVF.

      This is an observational study conducted at a private academically-affiliated infertility
      clinic and includes 118 women ages 44 and below scheduled to undergo IVF treatment. All
      subjects were asked to complete a health history survey at the time of enrollment and a daily
      survey during each day of their IVF cycle. The primary outcome is clinical pregnancy rate.
    


Intervention name(s): There was no intervention; this was a survey only study
Intervention type(s): Behavioral
Intervention description(s): There was no intervention; this was a survey only study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women about to undergo an in vitro fertilization cycle at Boston IVF
      
Keywords: IVF; Lifestyle habits
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Condition: Palmoplantar Pustulosis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Evaluate the Efficacy and
      Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
    


Intervention name(s): RIST4721; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RIST4721 oral solution; Placebo oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PPP
Effects of a CT-100 DiNaMo Component on Cognitive Functioning and Mood Symptoms
Condition: Multiple Sclerosis; Mild Cognitive Impairment; Cancer
MeSH terms: Multiple Sclerosis; Cognitive Dysfunction
Study type: Interventional

Summary: 
      CT-100 is a platform that provides an interactive, software based therapeutic component that
      may be used as part of a multimodal treatment in supplementary or standalone prescription or
      nonprescription software-based digital therapeutics (PDT/DTx), being developed by Click
      Therapeutics, Inc.
    

Detailed description: 
      CT-100 is a platform that provides an interactive, software based therapeutic component
      (CT-100-001) that may be used as part of a multimodal treatment in future prescription or
      non-prescription software-based digital therapeutics (PDT/DTx). CT-100-001 contains a class
      of Digital Neuro-activation and Modulation (DiNaMo) component. This DiNaMo component targets
      key neural systems (including, but not limited to, systems related to cognitive control,
      sensory-, perceptual-, affective-, pain-, attention-, social-, and self-processing) to
      optimally improve patients' cognitive and mental health. The CT-100-001 DiNaMo component is
      designed to improve cognitive impairments and mood challenges.

      The purpose of the proposed basket study is to evaluate the initial effects of the
      CT-100-001, a DiNaMo component (the Study App) on cognitive functioning and related outcomes
      compared to Care-As-Usual across several non-DSM-5 indications. These indications have known
      high prevalence of cognitive impairments due to the illness and/or treatments. such as in
      Multiple Sclerosis, Breast or Lung Cancer, and Mild Cognitive Impairment.
    

Intervention name(s): CT-100 DiNaMo; Care-as-Usual
Intervention type(s): Other; Other
Intervention description(s): Active Treatment (Study App); Care-As-Usual control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active Intervention Device vs. Care-as-Usual Control
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Digital therapeutics; Phone app; Virtual study
Quality of Life And Psychological Symptoms In Children With Cyclic Vomiting Syndrome (CVS)
Condition: Vomiting Syndrome
MeSH terms: Syndrome; Vomiting
Study type: Observational

Summary: 
      The primary aim of this study is to characterize the quality of life of youth with Cyclic
      Vomiting Syndrome (CVS) as well as the strategies they use to cope with stress, their
      strengths and vulnerabilities, and to assess symptoms of depression and anxiety in these at
      risk youth. The impact of CVS on the child's parent and family will also be assessed.

      A second aim is to evaluate the associations among coping strategies, personal strengths and
      vulnerabilities and the frequency and intensity of CVS attacks to determine if particular
      coping styles and personal characteristics are associated illness severity, psychiatric
      co-morbidity and quality of life
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Youth who meet consensus criteria for CVS as determined by Dr. B. Li and their parents will
        be recruited from those being seen in the weekly outpatient CVS clinic at Children's
        Hospital of Wisconsin
      
Keywords: Youth; consensus; criteria; CVS
Mechanisms for Alcohol Treatment Change [MATCH] Study
Condition: Alcohol Consumption
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      A 5-arm randomized trial to determine what components of a text message intervention are
      necessary to reduce hazardous drinking among young adults and mechanisms through which these
      changes occur.
    

Detailed description: 
      Young adults ages 18-25 have high rates of hazardous alcohol use and alcohol-related
      consequences. The Emergency Department (ED) provides an important opportunity to identify
      young adult hazardous drinkers who could benefit from interventions. A Text Message (TM)
      intervention was shown to reduce alcohol consumption among young adult ED patients, showing
      durable effects over 9-months. The TM intervention uses behavior change techniques with the
      largest effect sizes in an alcohol intervention meta-analysis: "goal commitment" and
      "self-monitoring", along with real-time "feedback". However, the unique effect of these
      ingredients, and mechanisms (processes occurring within the individual) through which they
      operate to reduce drinking remain unclear, a critical gap addressed by this project. Young
      adult ED patients (ages 18-25) who screen positive for hazardous drinking will be recruited
      to participate in a randomized trial to determine how best to help individuals reduce
      hazardous drinking. All participants will be asked to complete web-based surveys at baseline,
      12 and 24 weeks after enrollment, complete brief psychomotor tasks weekly for 14 weeks, and
      respond to text messages each Thursday and Sunday for the next 12 weeks. Those randomized to
      the TM interventions will additionally receive feedback on their text reports. The four TM
      intervention arms are: (1) Drinking Cognition Feedback (DCF), (2) Alcohol Risk Feedback
      (ARF), (3) Adaptive Goal Support (AGS) and (4) a combination of DCF, ARF, and AGS=COMBO).
      Study results have implications for designing efficient mobile interventions, and developing
      a dynamic theory of behavior change.
    

Intervention name(s): Drinking Cognition Feedback (DCF); Alcohol Risk Feedback (ARF); Adaptive Goal Support (AGS); COMBO
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk).; 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend).; 12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).; 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers
Condition: Tobacco Abuse Smoke
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The hypothesis underlying the proposed study is that the blunted endothelium-dependent
      vasodilation seen in the airway of current smokers is also present in the brachial artery,
      and that the same inhaled corticosteroid (ICS) treatment regime that reversed endothelial
      function in the airway of current smokers will also restore endothelium-dependent relaxation
      in the brachial artery. Non-smokers will be used as controls and will not receive any
      intervention or treatment.
    

Detailed description: 
      Cigarette smoking can lead to systemic endothelial dysfunction. Since the airway circulation
      is exposed to a high concentration of cigarette smoke constituents, we reasoned that airway
      vascular endothelial dysfunction could be present in healthy smokers without systemic
      endothelial dysfunction.

      The purpose of this study was to compare airway and systemic endothelial function and measure
      markers of systemic inflammation in lung-healthy current smokers. Since endothelial
      dysfunction in smokers has been related to systemic inflammation, we also investigated its
      response to an inhaled glucocorticosteroid (ICS).

      Vascular endothelial function was assessed in the airway by the airway blood-flow (Qaw)
      response to inhaled albuterol (ΔQaw) and in the extrapulmonary circulation by brachial
      arterial flow-mediated vasodilation (FMD). Venous blood was collected for C-reactive protein
      and IL-6.

      Qaw was measured with a noninvasive inhaled soluble gas uptake technique. The uptake of the
      gas from the anatomical deadspace reflecting airways perfused by the airway circulation was
      quantitated.

      Qaw was express as μL/min normalized for anatomical deadspace: μL/min/mL.
    

Intervention name(s): Fluticasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 220 ug twice a day for 3 weeks; Placebo for 3 weeks
Other intervention name(s): flovent; sugar pill
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: smokers; inhaled corticosteroids; brachial flow; airway blood flow; albuterol; spirometry; endothelial dysfunction
Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS Patients (COPP-MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      Multiple Sclerosis (MS) is most prevalent among women of childbearing age. The post-partum
      (PP) period is a critical phase in MS patients, during which a recrudescence of disease
      activity is expected. Different strategies have been assessed in the prevention of
      post-partum relapse. High dose methylprednisolone was evaluated in a case control study with
      historical controls but the positive results have not been confirmed.

      In this study, the main objective will be to compare the risk of relapse in the 6 months PP
      period between patients treated systematically by high dose methylprednisolone after delivery
      compared to patients who didn't receive a systematic treatment.

      The second objective will be focused on the comparison of the disease activity and disability
      progression in patients who have resumed early a Disease Modifying Drug (DMD) after delivery
      vs patients who haven't.
    

Detailed description: 
      Even if two small case control studies underlined the positive effect of high dose
      methylprednisolone on the relapse risk in the PP period in MS, these data have to be
      confirmed by a larger study. The impact of such a strategy remains also uncertain concerning
      the risk of long term disability. In this project, the investigators will also analyze the
      influence of the delay of DMD reintroduction after delivery on the relapse risk but also on
      the risk of disability. The results will have an important role in the therapeutic management
      of the post-partum period in MS patients.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        relapsing MS patients with at least one full pregnancy with live birth between 01/2007 and
        01/2017 after the beginning of the MS diagnosis
      
Keywords: post-partum; corticosteroids; relapse; disease modifying drugs (DMD)
NIDDM and IR in Combination Therapy for CHC
Condition: Chronic Hepatitis C; Insulin Resistance
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Insulin Resistance
Study type: Interventional

Summary: 
      The influence of insulin sensitivity and glucose tolerance on the effects of antiviral
      therapy for HCV remains unclear. The aim of the present study was (1) To elucidate the
      clinical and virological factors associated with sustained viral response in patients with
      combination therapy with PEG-IFN and ribavirin. (2) To clarify the influence of diabetes
      mellitus (DM), impaired glucose tolerance test (IGT) and insulin resistance (IR) on the HCV
      response to combination therapy with PEG-IFN and ribavirin. (3) To test the influence of
      combination therapy on HOMA IR
    

Detailed description: 
      Total 300 treatment-naïve chronic hepatitis C patients will be enrolled. The prevalence of
      NIDDM, IGT and IR will be explored in this hospital-based study among the clinically defined
      chronic hepatitis C Taiwanese. The clinical manifestations of chronic hepatitis C in the
      biochemical, virological and histopathological aspects will be evaluated. Liver enzymes will
      be measured on a multichannel autoanalyzer. Virological markers for HCV including serum HCV
      RNA detected using a standardized automated qualitative PCR assay, HCV RNA genotypes
      determined for genotypes 1a, 1b, 2a, 2b and 3a and serum HCV RNA levels measured by using the
      branched DNA assay. The liver histology will be assessed for scoring the disease activity
      grade quantitatively according to the histological activity index (HAI). Patients are
      assigned a diagnosis of DM if there was documented use of oral hypoglycemic medication or
      insulin, random glucose in excess of 200 mg/dL, or fasting glucose greater than 126 mg/dL on
      two occasions. A standard oral glucose tolerance test (OGTT) will be performed. In addition
      to an OGTT, a history of diabetes mellitus by chart review and/or questionnaire will be also
      obtained. Standard antiviral therapy will be carried out with PEG-IFN, given subcutaneously
      weekly plus 1,000-1,200 mg of oral ribavirin daily. Patients will receive another 24 week of
      follow-up period to determine the virological response.
    

Intervention name(s): pegylated interferon alpha and ribavirin
Intervention type(s): Drug
Intervention description(s): standard pegylated interferon alpha and ribavirin
Other intervention name(s): PEG-IFN-alpha
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; diabetes; Insulin resistance; combination therapy
Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children
Condition: Group A, C Polysaccharide Meningitis; Type b Haemophilus Influenza
MeSH terms: Haemophilus Infections; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Haemophilus influenzae is an important pathogen which can cause primary infection and
      respiratory viral infection in infants and leaded to secondary infections. The infection of
      haemophilus is a major cause of morbidity and mortality in infants and children. At present,
      the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine
      can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused
      by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal
      immune programming.

      Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent
      years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus
      polysaccharide vaccine with a relatively poor immune response in the infants under the age of
      two, and the remaining 60% with a low antibody level and a short duration.

      According to the present immunization schedule, to reach the median level of antibody levels
      there are at least 4 doses in need. So it is meaningful to improving vaccine immunogenicity,
      to provide high levels of long-term protection and to reduce the number of injections.

      After the phase I study which was conducted in August, 2011, the safety profile of this
      vaccine is proved to be acceptable. The phase III study is aimed to further evaluate the
      safety and the immunization of the vaccine. The objective of this study is to evaluate the
      safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal
      conjugate vaccine.
    


Intervention name(s): A+C+hib Conjugate Vaccine; Placebo; A+C Vaccine; Hib vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): The group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine (Wuxi Royal Biological Co., LTD, 20110101) will be administered intramuscularly on one arm, per 0.5ml dose; Placebo will be administered intramuscularly on the other arm, per 0.5ml dose; The group A, C polysaccharide meningococcal vaccine (Wuxi Royal Biological Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose; The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: immunogenicity; safety; group A, C polysaccharide meningitis; type b haemophilus Influenza; conjugate vaccine
A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety and tolerability and to characterize the
      pharmacokinetics of multiple ascending dose (MAD) of LY03003 following intramuscular
      injections.
    


Intervention name(s): LY03003 ( Rotigotine, extended-release microspheres); Placebo, extended-release microspheres
Intervention type(s): Drug; Drug
Intervention description(s): Patients to be enrolled to 70 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week and then 70 mg in the next 5 weeks.
Patients to be enrolled to 84 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week, 70mg in the fifth week and then 84 mg in the next 5 weeks.; Patients to be enrolled to 70 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week and then 70 mg in the next 5 weeks.
Patients to be enrolled to 84 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week, 70mg in the fifth week and then 84 mg in the next 5 weeks.
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: parkinson disease; LY03003
Comparison of Different Methods of Enamel Preparation Before Pit and Fissure Sealants
Condition: Enamel Lesions; Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study concerns the prevention of dental caries by sealing pits and fissures of permanent
      molars with a photopolymerizable resin. It must compare these three techniques Microdentisty
      (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities
      in the enamel and / or the outer third of the dentin. These three commonly used techniques
      have never been compared by retaining as endpoint retention of sealant. These techniques are
      painless and do not require local anesthesia.
    


Intervention name(s): air abrasion; sono abrasion; dental bur
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin; already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin; already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: suspected caries; initial enamel lesions