bioihbjkbjnl/mcl2 huggingface dataset:
An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers
Condition: Tobacco Use; Smoking; Tobacco Dependence; Tobacco Use Disorder; Tobacco Use Cessation; Tobacco Smoking; Smoking Cessation; Smoking, Cigarette; Smoking, Tobacco
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The 2-year research plan will test the Extended Put It Out Project (POP-6) in a pilot
      randomized trial (N=168) compared to TSP-6, as well as comparing POP-6 and TSP-6 to the POP-3
      and TSP-3 interventions from a previously-conducted trial. Participants will be young adults
      who smoke, identify as sexual or gender minorities (SGM), and use Facebook. Primary outcome
      will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary
      outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco abstinence
      at 3 and 6 months.
    

Detailed description: 
      Participants will be randomized to one of two conditions: (1) a 6-month Facebook-delivered
      intervention addressing tobacco use, tailored to SGM young adults; or (2) a 6-month Facebook
      intervention targeting tobacco use. Both interventions will include 180 days of
      Facebook-based messages and activities tailored to participants' readiness to quit smoking.

      Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include
      measures on smoking, thoughts about abstinence, and SGM identity experiences. All
      participants who report no past 7-day smoking will be asked to give biochemical verification
      of smoking status with saliva nicotine test kits that will be mailed to participants.
    

Intervention name(s): POP-6:; TSP-6:
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to SGM young adults
Drug: nicotine patch 14-day supply of nicotine patch; 90 days of Facebook messaging, weekly live sessions targeting tobacco use
Drug: nicotine patch 14-day supply of nicotine patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobacco; Gender Identity Minority; Sexual Identity Minority; Cessation; Intervention; Young Adults; Social Media; Internet; Cigarette
Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The pharmacokinetics of glimepiride and metformin will be compared after single dose intake
      of both combinations in order to answer to the following questions:

        -  Is there a dose proportionality effect between Amaryl M SR 1/500 mg and Amaryl M SR
           2/500 mg?

        -  What is the safety profile of Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?
    


Intervention name(s): Amaryl M SR 1/500 mg; Amaryl M SR 2/500 mg
Intervention type(s): Drug; Drug
Intervention description(s): single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group; single oral administration in period 2 for TR sequential group, and in period 2 for RT sequential group
Other intervention name(s): Amaryl Mex 1/500mg, glimepiride 1mg & metformin HCl 500mg; Amaryl Mex 2/500mg, glimepiride 2mg & metformin HCl 500mg
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: volunteer
Monitored Anesthesia Care Versus Intubated General Anesthesia for Open Heart Surgery Under Cardiopulmonary Bypass
Condition: Monitored Anesthesia Care; Cardiac Surgery; Postoperative Recovery
Study type: Interventional

Summary: 
      Though Cardiac surgery under cardiopulmonary bypass (CPB) under epidural anesthesia in
      conscious patients is associated with increased risk of epidural hematoma. The investigators
      developed a monitored anesthesia care (MAC) platform for cardiac surgery under CPB. In the
      current prospective study, the investigators investigated the safety and effectiveness of the
      MAC platform versus intubated general anesthesia (IGA) in patients receiving elective
      open-heart surgery.

      The study included adult patients who were scheduled to undergo open-heart surgery under CPB
      at Shuguang Hospital between April 2012 and December 2021. MAC consisted of local anesthesia
      at the site of sternotomy, sedation with dexmedetomidine, analgesia with
      remifentanil/sufentanil and electroacupuncture. MAC versus IGA was chosen by the patients.
      The investigators will investigate the safety and effectiveness of the MAC platform versus
      IGA in patients receiving elective open-heart surgery.
    

Detailed description: 
      The detailed description of clinical trial will be published by protocol later.
    

Intervention name(s): Non-intubation and monitoring anesthesia care (MAC)
Intervention type(s): Device
Intervention description(s): Non-intubation and monitoring anesthesia care (MAC) consisted of non-intubation technique, local anesthesia at the site of sternotomy, sedation with dexmedetomidine, analgesia with remifentanil/sufentanil, and electroacupuncture.
Intervention MeSH terms: Anesthetics
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with
      influenza-like illness (ILI). Subjects will enter the study based on listed
      inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza
      virus (IFV).

      Subjects will be randomized into one of three treatment groups: a DAS181 30 mg total dose
      group (DAS181-F02 formulation), a DAS181 60 mg total dose group (DAS181-F04 formulation) or a
      placebo group.

      The modified intent to treat (mITT) analysis set will include subjects with confirmed
      influenza as documented by qPCR or TCID50. The full analysis set will be used for activity
      analysis and will include all randomized subjects with baseline and treatment data. Per
      protocol, the safety analysis sets are described below in statistical methods.

      A subpopulation of 60 participants will also have additional PK and Immunogenicity blood
      samples collected. For this subgroup, PK and Immunogenicity samples will be collected at all
      study visits.
    


Intervention name(s): DAS181-F02 formulation; DAS181-F04 formulation; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Coca-Cola on Iron Absorption
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The aim of this project is to measure the effect of Coca-Cola and Diet Coke, relative to
      mineral water, on non-haem iron absorption. The results from this study will quantify any
      enhancing effect of Coca-Cola or Diet Coke on non-haem iron absorption and will be of use to
      the Coca-Cola Company and the scientific and nutrition community in evaluating the
      nutritional value of these products.
    

Detailed description: 
      Previous studies have suggested that Coca-Cola may enhance absorption of non-haem iron. A
      randomized cross-over trial will be undertaken to compare the absorption of iron added to a
      pizza meal consumed with either Coca-Cola, Diet Coke or mineral water. Pizza containing added
      iron, labelled with an iron stable isotope (Fe-58), will be consumed for lunch on two
      consecutive days with either a Coca-Cola, Diet Coke or mineral water drink. Iron absorption
      from the pizza will be determined using the erythrocyte incorporation technique.

      A baseline blood sample will be taken prior to consuming the first test meal (pizza + drink
      1) and after approximately 15 days, a second fasting blood sample will be taken prior to
      consumption of a second set of test meals (pizza + drink 2). Iron isotope enrichment of the
      blood sample will be used as a baseline for the second set of test meals and to calculate
      absorption from the first set of test meals. A third blood sample will be taken after
      approximately 30 days and the iron isotope enrichment will be used as a baseline for the
      third set of test meals (pizza + drink 3) and to determine absorption from the second set of
      test meals. At about 45 days a final blood sample will be taken to determine absorption from
      the third set of test meals. Iron absorption will be calculated from the isotopic enrichment
      in blood, assuming that 80% of absorbed iron is incorporated into red blood cells. Absorption
      of iron consumed with Coca-Cola and Diet Coke will be compared with iron absorption when
      consumed with mineral water. The order in which the volunteers will be given the drinks will
      be randomised.
    

Intervention name(s): Coca, Cola, Diet Coke
Intervention type(s): Drug
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Iron absorption; Coca-Cola
Understanding Ayurveda Disease Conditions and Treatment Responses
Condition: Type2diabetes; Rheumatoid Arthritis; Osteo Arthritis Knee; Skin Diseases; Gastric Ulcer; Neurodegenerative Diseases
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Knee; Stomach Ulcer; Neurodegenerative Diseases; Skin Diseases
Study type: Observational

Summary: 
      The goal of this observational study is to assess Prakriti & Vikriti in patients visiting OPD
      of IIISM department, SRM hospital.

      The main question[s] it aims to answer are:

        -  To evaluate Prakriti & Vikriti of patients using Prakriti & Vikriti questionnaire and
           with digital devices

        -  To correlate the determined Prakriti and Vikriti with the doctor's assessment along with
           clinical and biochemical parameters Participants will be advised to follow the treating
           physician's advice on medicines
    

Detailed description: 
      The Ayurveda is an ancient documented medical system originated in India. The Ayurveda
      stratified humans into 7 broad categories based on the phenotype features viz. Vata, Pitta,
      Kapha, Vatapitta, Vatakapha, Kaphapitta and Vatapittakapha Prakriti types. Also, the features
      of the disease conditions are clearly described based on the predominance of Vata, Pitta and
      Kapha or its combinations. Presently, the identification of Prakriti type and Vikriti status
      are basically subjective assessment. This study proposes to integrate the subjective
      assessment with objective digital signal parameters. This digital signatures would be useful
      in ML / AI based assessment and prediction of Prakriti type and Vikriti status of the
      patients.
    

Intervention name(s): Personalized Ayurveda treatment protocol
Intervention type(s): Drug
Intervention description(s): The treating physician decided and advised personalized Ayurveda treatment protocol based on disease and patient's condition
Other intervention name(s): No other intervention name
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of various diseases visiting the OPD
      
Biospecimen description: 
      Serum
A Placebo-controlled Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A safety and tolerability study in healthy subjects including examination of how the body
      takes up, distributes, and gets rid of ACT-1014-6470
    


Intervention name(s): ACT-1014-6470; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Soft capsules for oral administration; Soft capsules for oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, double-blind, randomized, placebo-controlled, single- and multiple-ascending dose
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test how the active substances semaglutide and dapagliflozin act in the body
      (in terms of their levels in the blood), when they are taken in the form of a combination
      preparation (a tablet with a fixed dose combination) compared to when oral semaglutide and
      dapagliflozin are given alone.The study will consist of 2 parts. Part 1 will compare
      semaglutide to the fixed dose combination tablet (semaglutide/dapagliflozin) and part 2 will
      compare dapagliflozin to the fixed dose combination tablet (semaglutide/dapagliflozin).
      Participants will take part in either part 1 or part 2.
    


Intervention name(s): Semaglutide; Dapagliflozin; Semaglutide/dapagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet given orally; Tablet given orally; Tablet given orally
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Esomeprazole in PPI Failures - IMPROVE
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess how PPI treated GERD patients with insufficient
      symptom control will benefit from a change in management by providing a more efficient acid
      secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to
      pre-study PPI treatment.
    


Intervention name(s): Esomeprazole; Other PPI marketed in Sweden
Intervention type(s): Drug; Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biomarkers And Neurological Outcome in Neonates (BANON)
Condition: Asphyxia Neonatorum
MeSH terms: Asphyxia Neonatorum; Asphyxia
Study type: Observational [Patient Registry]

Summary: 
      Validation of biomarkers in a human population for their ability to diagnose the severity of
      neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies
      and a preliminary human study.
    

Detailed description: 
      The aim of the study is to validate the application of combinations of several laboratory
      parameters in early postnatal blood samples, for identification of infants, who will suffer
      from early abnormal neonatal neurological outcome, in a population at risk.

      The population at risk is defined as term and late preterm (>36 weeks of gestation) human
      infants following perinatal hypoxia-ischemia with or without postnatal resuscitation, and
      where the combination of laboratory parameters is derived from a preliminary study performed
      in Turkey (AAMBI) using a metabolomics approach.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infants at risk for perinatal hypoxic-ischemic brain injury
      
Biospecimen description: 
      blood plasma
    
Keywords: biomarkers
Theory-Based Interventions for Smoking and Obesity (Challenge) Trial
Condition: Smoking; Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine a new theory for understanding the processes that
      govern behavior change by observing how people's beliefs and feelings about smoking cessation
      or weight loss change as they participate in smoking cessation or weight control programs.
      This study also seeks to improve the ability of treatment programs to help people maintain
      changes in their behavior.
    

Detailed description: 
      The goal of this clinical trial is to examine a new theory for understanding the processes
      that govern short-term versus long-term behavior change. The study will examine how people's
      beliefs and feelings about smoking cessation or weight loss change as they participate in
      either a smoking cessation program or a weight control program. Also, the study will improve
      the ability of treatment programs to help people maintain changes in their behavior. The
      project involves a series of two parallel investigations.

      Study 1 tests the hypothesis that intervention methods that influence cost/benefit
      expectations related to quitting smoking and losing weight will have different effects on
      long-term smoking cessation and weight loss. The participants are randomly selected to
      treatment programs that induce heightened or realistic outcome expectations.

      Study 2 tests the hypothesis that intervention methods that influence perceived satisfaction
      with behavior change will have different effects on long-term smoking cessation and weight
      loss. The participants are randomly selected to treatment programs that induce them to
      evaluate the consequences of behavior change either in comparison to past or ideal outcomes.

      All of the intervention programs used in these studies are based on highly effective
      treatment procedures. The programs differ in how information about weight loss and smoking
      cessation is presented, how the participants are encouraged to think about their achievements
      during the treatment programs, and how much help is given to the participants in organizing
      their thoughts during the programs.
    

Intervention name(s): smoking cessation program; weight control program
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Primary purpose: Treatment
Keywords: smoking; obesity; weight loss; smoking cessation; weight control
Use of Nitrous Oxide Donor for Labor Induction in Women With PreEclampsia
Condition: Preeclampsia; Labor, Premature
MeSH terms: Pre-Eclampsia; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized controlled trial (RCT) of nitric-oxide donor (NOD) isosorbide mononitrate (IMN)
      versus placebo as an adjuvant to misoprostol/ intra-cervical Foley bulb for induction of
      labor to decrease rate of cesarean deliveries in pregnancies complicated by preeclampsia
      (≥24/0 weeks' gestation)
    

Detailed description: 
      The investigators are proposing a double blinded, placebo controlled, randomized clinical
      trial of patients undergoing induction of labor for preeclampsia. Once the decision to induce
      will be taken, the participants will be randomized to receive either intravaginal IMN (40mg)
      or identical appearing placebo placed every 4hrs in the posterior vaginal fornix X 3 doses.
      IMN or placebo will be discontinued when active labor occurs or when the physician decides to
      proceed with augmentation with oxytocin or AROM. Participants will be induced using the
      investigators routine induction agents, Misoprostol (25 mcg every 4 hrs for maximum of 6
      doses) and an intra-cervical foley bulb will be inserted with 2nd dose of IMN or placebo.
      Regarding management of labor, physician decides when to proceed with augmentation with
      oxytocin or AROM.
    

Intervention name(s): Monoket Pill; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor; The pharmacy has compounded an identical appearing placebo
Other intervention name(s): Isosorbide mononitrate
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preeclampsia; Induction
Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis
Condition: Gastroesophageal Reflux; Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate pharmacodynamic comparability between the
      pantoprazole spheroid formulation and the marketed tablet formulation.
    


Intervention name(s): Pantoprazole for approximately 9 weeks
Intervention type(s): Drug
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease (GERD)
Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a booster study in 2 groups of healthy children less than 3 years old to measure the
      reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine,
      when given as a booster or as a two-dose catch-up vaccination.

      This protocol posting deals with objectives and outcome measures of the booster phase. The
      objectives and outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00338351).
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Synflorix; Infanrix Hexa; Havrix
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 1 or 2 doses; 1 Intramuscular injection; 1 Intramuscular injection
Other intervention name(s): DTPa-HBV-IPV/Hib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Immunogenicity; Pneumococcal disease; Safety; Booster vaccination; Pneumococcal vaccine
Bologna IBD Markers
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's
      disease.
    

Detailed description: 
      This trial will be exploratory, open in vitro study on human tissues. 120 patients will be
      enrolled (Caucasian, male/female,18-65 years old) with moderate-severe active Crohns disease
      and with indication for anti-TNF therapy according to the normal clinical practice.

      Simultaneously, 30 no-IBD controls with no GI disorders, as defined by medical history and
      standard clinical chemistry values, afferent to the out-patient clinic will be enrolled.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        120 adult patients with moderate-severe active Crohns disease with indication for anti-TNF
        therapy according to the normal clinical practice

        30 no-IBD controls with no GI disorders, as defined by medical history and standard
        clinical chemistry values, afferent to the out-patient clinic
      
Biospecimen description: 
      Blood, stool, biopsy and urine