bioihbjkbjnl/mcl2 huggingface dataset:
Screening Protocol for Research Participants
Condition: Schizophrenia; Substance Abuse; Cocaine Abuse; Tobacco Use Disorder
MeSH terms: Substance-Related Disorders; Tobacco Use Disorder; Cocaine-Related Disorders; Schizophrenia
Study type: Observational

Summary: 
      The Screening Protocol is a system devised to evaluate potential research participants for
      National Institute on Drug Abuse/Maryland Psychiatric Research Center (NIDA/MPRC) studies.
    

Detailed description: 
      The MPRC/NIDA collaborative research program attempts to: elucidate the nature of serious
      mental illnesses, drug abuse and addiction; determine the potential use of new therapies,
      both pharmacological and psychosocial; and decipher the long-term effects of drugs of abuse
      on the development, maturation, function, and structure of the brain and other organ systems.
      In support of this work, the scientific goal of this screening protocol is to assess
      potential research participants' eligibility for research studies. Screening will include
      medical and psychological tests and procedures. The data collected during screening are a
      unique and valuable source of information that aids in the research mission. Therefore, a
      secondary goal of this protocol is to obtain data that characterizes the population of
      subjects contacting NIDA about research participation and to analyze data so obtained, such
      as that on the prevalence and consequences of HIV/AIDS, viral hepatitis, and related diseases
      and issues of selection and sample bias in clinical research.

      The screening process will be done in two stages, a telephone interview and an in-person
      evaluation. The telephone interview will last approximately 20 minutes and be conducted
      solely via the NIDA call center. Answers provided during the phone interview will indicate
      whether a caller is eligible for in-person screening. Those who appear eligible will be given
      an appointment at either NIDA or MPRC. This protocol pertains only to the in-person
      participants at MPRC. Written informed consent will be obtained when the person arrives. The
      screening process can involve up to 5 visits to MPRC.
    

Intervention name(s): Various Screening psychiatric and medical assessments
Intervention type(s): Behavioral
Intervention description(s): Possibly blood draws, urine samples, toxicology screens, computer-based and written psychological, psychiatric, and behavioral questionnaires and assessments.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Population will see an advertisement in the community and call the NIDA call center. If
        they appear to meet the qualifications for one or more NIDA/MPRC studies, they will be
        scheduled to be screened.
      
Keywords: screening; research participation; substance abuse; Schizophrenia; nicotine; Healthy; cigarettes; smoking; marijuana; cocaine
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to assess: 1 safety and tolerability of adenovirus serotype 26
      (Ad26) prime and Modified Vaccinia Ankara (MVA) boost versus placebo in participants on
      suppressive antiretroviral therapy (ART) that was initiated during acute Human
      Immunodeficiency Virus (HIV) infection; 2) Measure the frequency and duration of sustained
      viremic control after receiving Ad26 prime/MVA boost or placebo, defined as greater than 24
      weeks with plasma HIV ribonucleic acid (RNA) lesser than (<)50 copies/ml after antiretroviral
      (ARV) analytical treatment interruption (ATI).
    


Intervention name(s): Ad26.Mos.HIV; MVA-Mosaic; Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.; Recombinant live attenuated MVA virus-vectored vaccine that has been genetically engineered to express 2 mosaic Gag, Pol, and Env sequences (Mosaic 1 and Mosaic 2). Total dose is 10^8 plaque-forming unit per 0.5 mL injection administered intramuscularly.; Participants will receive placebo intramuscularly Weeks 0, 12, 24 and 48.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Exploration Of Key Targets And Biomarkers Involved In An Allergic Response In Subjects With Allergic Rhinitis (Hay Fever)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed at validating key therapeutic targets and biomarkers associated with
      allergic rhinitis. The therapeutic target expression will be investigated after a 7 day
      course of corticosteroid treatment followed by allergen challenge.
    


Intervention name(s): Fluticasone Propionate
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Hay fever; biomarkers
Genetic Biomarkers of Executive Stress
Condition: Stress
Study type: Observational

Summary: 
      The purpose of this study is to examine whether stress predicts telomere length in
      individuals who hold executive-level positions. Telomeres are the caps at the end of each
      strand of DNA that may affect how cells age. Subjects will complete an online
      survey/interview and provide one blood sample or saliva samples. The goal is to understand
      whether stress predicts genetic markers of longevity.
    

Detailed description: 
      The primary aim of this study is to evaluate the relationship between overall levels of
      stress and telomere length. It is hypothesized that the high stress group (based on the
      Perceived Stress Scale)compared to low stress group will have shorter telomere length. A
      secondary aim is to evaluate whether different types of stress have differing degrees of
      association with telomere length. An exploratory aim is to assess for gender differences in
      the association between stress and telomere length. The investigators are collecting a number
      of other measures, including demographics, work sector, perceived social support, and medical
      history, in order to adjust for potential confounders in the analysis.

      This study is an extension of earlier work Dr. Rasgon has done with Dr. Elizabeth Blackburn
      at UCSF on the relationship between telomere length and mood outcomes. The investigators hope
      this study will add to the growing body of literature on stress and genetic markers of
      longevity, specifically how stress level and type is associated with telomere length. The
      increased understanding gained through this study may provide leads for predicting
      age-related diseases and early mortality in adults, thus benefiting others in the future.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 subjects - individuals who hold executive-level positions. Participants are males and
        females, 18 or older, may be of any ethnic background. The investigators aim to recruit a
        diverse sample, reflective of the broader population.
      
Biospecimen description: 
      Saliva or blood samples
Menopause and Oral Health
Condition: Menopause; Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Observational [Patient Registry]

Summary: 
      Menopause is characterized by major physiological and concomitant psychological changes. The
      study aimed to evaluate the association between oral health parameters, bone mineral density
      (BMD) and physiological or psychological symptoms in post-menopausal women (PMW), compared
      with regularly menstruating women (RMW). Inflammatory biomarker levels in gingival crevicular
      fluid, saliva, serum and determination of microbial niches in subgingival plaque samples were
      further aimed. The participants were asked to complete the Women's Health Questionnaire to
      measure emotional and physical well-being.

      A total of 148 women (PMW, n=76,RMW, n=72) received a comprehensive medical assessment and a
      full-mouth oral examination. The corresponding bone mineral density (BMD) and body mass
      indices (BMI) were obtained from their medical records.
    


Intervention name(s): Periodontal clinical examination and gingival crevicular fluid, saliva, dental plaque, serum sampling
Intervention type(s): Diagnostic Test
Intervention description(s): Probing pocket depth was defined as the distance in millimeters from the gingival margin to the base of the gingival sulcus measured using a manual probe (Michigan 0 probe with Williams Markings) in all the teeth present except for third molars. Similarly, clinical attachment level (CAL) was measured as distance from cementoenamel junction to the base of pocket and recorded manually to the nearest millimeter marking on probe.
1 mililiter of saliva was obtained by each participant. Subgingival dental plaque was collected with sterile endodontic paperpoints from mesial sides of each natural teeth without a prostethic restoration. Gingival crevicular fluid samples were collected with absorbent paper strips. Serum samples were also collected at the time of visit.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study population comprised of two main groups as postmenopausal women (PMW) and regularly
        menstruating women (RMW). The women in the PMW group were included if they were under 65
        years of age and had a history of spontaneous amenorrhea for the last 12 months.
Effect of Breakfast or Omission of Breakfast in T2D
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      The investigators will explore the effect of omission of breakfast on postprandial
      hyperglycemia and insulin and intact GLP-1 response after subsequent meals in type 2 diabetic
      patients
    

Detailed description: 
      In obesity and in type 2 diabetes eating behavior especially the lack of breakfast promote
      weight gain, increase hunger and carbohydrate craving.

      The present study is designed to address whether in T2D, a change in meal timing;
      specifically, by adding calories, protein and carbohydrates to the breakfast vs.the omission
      of breakfast will influence the postprandial elevation of glucose, insulin, intact GLP-1,
      glucagon and free fatty acids (FFA) after subsequent meals at lunch and dinner.

      The investigators expect that compared to the day with breakfast condition the day when the
      breakfast will be omitted the postprandial glucose , free fattly acids, and glucagon response
      after lunch and dinner will be significative higher while insulin and intact GLP-1 response
      after lunch and dinner will be reduced
    

Intervention name(s): Omitted Breakfast; Breakfast
Intervention type(s): Other; Other
Intervention description(s): Experimental:The patients in Omitted Breakfast day will omit the breakfast and will continue the overnight fast until lunch. They will eat only lunch (700 kcal) at 13:30 and dinner (700 kcal) at 19:00; In the Active Comparator: The patients in the Breakfast day will consume breakfast (700 kcal) at 8:00 , lunch (700 kcal) at 13:30 and dinner (700 kcal) at 19:00
(YesB): The patients in YesB will eat all three mealswill consume three meals:
Other intervention name(s): Omission of Breakfast; Breakfast consupmtion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy Volunteers
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this trial is to compare biphasic insulin aspart
      70 (NN2000-Mix70) in subjects with type 2 diabetes with that of biphasic insulin aspart 30
      (NN-X14Mix30) in healthy volunteers.
    


Intervention name(s): biphasic insulin aspart 70; biphasic insulin aspart 30
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted; Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open label randomized 24 week crossover trial assessing the treatment burden of a
      weekly growth hormone injection regimen (somatrogon) compared to a daily growth hormone
      injection regimen (Genotropin). Approximately 90 children with growth hormone deficiency who
      have been stable on treatment with daily Genotropin will be enrolled.
    

Detailed description: 
      Subjects will be randomized to one of two sequences, either 12 weeks of continued treatment
      with daily Genotropin followed by 12 weeks of treatment with weekly somatrogon, or 12 weeks
      of treatment with weekly somatrogon followed by 12 weeks of treatment with daily Genotropin.
      Subjects will have study visits at Baseline, Weeks 6, 12, 18, and 24. Subjects will also be
      followed up by phone 8 to 12 days after each treatment period begins (Week 1 and Week 13).
      Subjects and caregivers (as a Dyad) will complete questionnaires assessing treatment burden
      at baseline and at the end of each 12 week treatment period. All subjects/caregivers will
      receive a follow up phone call at Week 28.
    

Intervention name(s): Genotropin; somatrogon
Intervention type(s): Drug; Drug
Intervention description(s): Genotropin (dose [mg] at time of enrollment) given subcutaneously once daily; 0.66 mg/kg/week given subcutaneously once weekly
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Exercise in Genetic Cardiovascular Conditions
Condition: Hypertrophic Cardiomyopathy; Long QT Syndrome
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Long QT Syndrome; Syndrome; Hypertrophy
Study type: Observational [Patient Registry]

Summary: 
      The goal is to determine how lifestyle and exercise impact the well-being of individuals with
      hypertrophic cardiomyopathy (HCM) and long QT syndrome (LQTS).

      Ancillary study Aim: To understand how the coronavirus epidemic is impacting psychological
      health and quality of life in the LIVE population
    

Detailed description: 
      Yale is the central site for this multicenter study. Patients with HCM and LQTS will be
      recruited via high-volume HCM and LQTS sites, patient-groups, and websites. Information about
      exercise participation will be acquired via interview and online instruments at enrollment
      and every six months for three years. Quality of Life questionnaires will be filled out at
      enrollment and at the end of the study. Participants will receive a Fitbit (pedometer) and
      will wear it initially for two weeks and then one week every three months. The Fitbit is used
      for assessment of exercise level only. Clinical records will be obtained from treating
      physicians. Participants will also be asked to call the central site if they experience
      syncope, appropriate ICD (implantable cardioverter defibrillator) shock, or resuscitated
      arrest. Information regarding the patient's activity at the time of event will then be
      obtained by phone interview. Follow-up clinical records will be obtained as indicated to
      corroborate endpoints.

      The Ancillary study is optional. This will include all of the baseline questionnaires,as well
      as selected questions from the Epi-Pandemic Impacts Inventory.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with Hypertrophic Cardiomyopathy or Long QT Syndrome between the ages of 8-60.
      
Keywords: Hypertrophic Cardiomyopathy (HCM); Long QT Syndrome (LQTS)
Treatment of Periorbital and Perioral Wrinkles With the Applications of the Iluminage Diode Laser
Condition: Peri-orbital Wrinkles; Peri-oral Wrinkles
Study type: Interventional

Summary: 
      The Diode laser system is being used in this marketing study for the treatment of wrinkles
      around the eyes and mouth.
    


Intervention name(s): Illuiminage ® Diode Laser
Intervention type(s): Device
Intervention description(s): Diode laser for treatment of peri-orbital and peri-oral wrinkles
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Empagliflozin an SGLT2-Inhibitor on Healthy Volunteers With Induced Hypotonic Hyponatremia - the DIVE Study
Condition: Inappropriate ADH Syndrome
MeSH terms: Inappropriate ADH Syndrome; Hyponatremia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-Inhibitor, which is a
      new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is
      expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered
      glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent
      osmotic diuresis. This mechanism could result in a therapeutic effect in patients with
      hypotonic hyponatremia as in the syndrome of inappropriate antidiuretic hormone (ADH)
      secretion (SIAD). Because patients with SIAD usually have several comorbidities and different
      medications, studies investigating the physiological effects are difficult to interpret.
      Therefore a model to study the possible physiological effect of SGLT2-inhibitors in hypotonic
      hyponatremia as in SIAD is needed.

      The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on
      serum sodium levels of healthy volunteers with induced hypotonic hyponatremia.
    


Intervention name(s): Induced hypotonic hyponatremia - SIAD model; Empagliflozin 25mg Tbl; Placebo P-Tablet
Intervention type(s): Other; Drug; Drug
Other intervention name(s): Induced hypotonic hyponatremia
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyponatremia; SGLT2 inhibitor
Health Effects From Removal of Amalgam Restorations in Patients With Symptoms Allegedly Related to Dental Amalgam
Condition: Adverse Effects; Dental Restoration, Permanent
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the project is to study changes in symptom load after removal of all dental
      amalgam restorations in patients with symptoms allegedly related to amalgam.
    

Detailed description: 
      Patients referred from dentists and physicians in the period 1993 to 1999 to the Dental
      Biomaterials Adverse Reaction Unit, Department of Health, UNIFOB AS, for symptoms related to
      amalgam restorations are randomized into treatment group (n=20) or reference group (n=20).
      All patients in the treatment group are followed 3, 12, 36 and 60 months after completion of
      amalgam removal with questionnaires on health outcomes, Minnesota Multiphasic Personality
      Inventory-2 (MMPI-2) and laboratory tests.
    

Intervention name(s): Removal of dental amalgam restorations
Intervention type(s): Procedure
Intervention description(s): Removal of dental amalgam restorations by patient's own dentist. Fillings will be replaced with e.g. resin based filling material, metalloceramic restorations, and ceramic materials. Rubber dam will be used during removal of amalgam restorations.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glucose Control in Severely Burned Patients
Condition: Burns
Study type: Interventional

Summary: 
      The central aim of this application is to determine whether improved outcomes with tight
      euglycemic control are due to insulin-specific responses. The investigators hypothesize that
      improving insulin resistance will lead to decreased inflammatory and hypermetabolic
      responses, as well as restored glucose metabolism, and so result in improved clinical outcome
      of severely burned patients.
    


Intervention name(s): Humulin R; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Humulin R (U-100) will be given i.v. The dose given will be adjusted in order to achieve a blood glucose level of 130-140 mg/dl.; Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Thermal injury; Chemical Burn; Flame Burn