bioihbjkbjnl/mcl2 huggingface dataset:
Tailored Mobile Text Messaging to Reduce Problem Drinking
Condition: Alcohol-Related Disorders; Alcohol Use Disorders; Alcohol Drinking; Alcoholism; Alcohol Abuse
MeSH terms: Alcoholism; Alcohol-Related Disorders; Alcohol Drinking
Study type: Interventional

Summary: 
      This study is designed to develop and test a tailored adaptive text messaging/short message
      service (SMS) intervention for individuals interested in stopping or reducing their alcohol
      consumption; and test and compare it to tailored but static, once a day messaging, gain
      framed messaging, and ecological momentary assessment only.
    

Detailed description: 
      The proposed development study entitled, Tailored Mobile Text Messaging to Reduce Problem
      Drinking is designed to develop and test a tailored adaptive text messaging/short message
      service (SMS) intervention for individuals interested in stopping or reducing their alcohol
      consumption. This intervention includes messages tailored to baseline assessment results
      (including drinking times) that are adaptive to ongoing drinking patterns and goal
      achievement via interactive ecological momentary assessment (EMA). Other features include
      participant initiated help messaging and support network alerts. We will conduct beta
      research with 40 problem drinkers to assess messaging preferences and acceptability, and then
      conduct a pilot test with 10 PDs. In Stage 1b, we aim to test this intervention and
      understand the mechanisms of action of different text messaging interventions with 200
      problem drinkers over a 12-week period. We propose to compare four types of messaging: 1)
      Tailored content and timed messaging adaptive to the participants current state (Stage 1a
      intervention); 2) Tailored content messaging (not adaptive or timed) sent at 3 pm every day;
      3) Untailored consequence based messages sent at 3 pm every day; and 4) Brief feedback and
      EMA only. Assessments will be completed at baseline, through weekly EMA via SMS and at week
      12 via a web-based follow-up assessment. Primary outcomes include drinks per drinking day,
      days of heavy drinking, and average drinks per week as measured through weekly EMA.
      Additional outcomes will include drinking related consequences, goal commitment and
      intervention satisfaction. Outcomes will be used to modify the intervention and to prepare
      for a larger Stage 1c RCT.
    

Intervention name(s): Adaptive Tailored Intervention; Consequence-based Intervention; Tailored, not adaptive, based Intervention; Assessment only
Intervention type(s): Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Adaptive; Loss Framed; Baseline tailored not adaptive; EMA only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drinking; Heavy Drinking; Technology; Mobile Phone; Text Message; Problem Drinking; Alcohol Problems; Alcoholism; Moderation-Oriented Treatment; Controlled Drinking; Reduced Drinking
Using the Electronic Health Record to Guide Management of Newborn Weight Loss
Condition: Breastfeeding; Breastfeeding, Exclusive; Morbidity;Perinatal; Feeding, Bottle
Study type: Interventional

Summary: 
      Weight loss is normal for healthy newborns in the first few days, especially for those
      exclusively breastfed, who may have low enteral intake for several days. Although most
      newborns tolerate this early period of weight loss well, those with pronounced weight loss
      become at increased risk of feeding problems and hyperbilirubinemia, which are the two most
      common causes of neonatal readmission. To facilitate the assessment of risk for an individual
      newborn, the Newborn Weight Tool (NEWT) has been developed to categorize each infant's weight
      loss according to population norms, so that formula can be administered when weight loss is
      pronounced and avoided when weight loss is normal. The Healthy Start study will be a
      randomized, controlled trial testing whether displaying NEWT to clinicians providing newborn
      care can improve neonatal health outcomes including formula use, weight loss and readmission.
      Newborns will be randomly assigned either to display weight with NEWT weight categorization
      to their providers in the electronic health record (EHR) or to usual care (weight displayed
      without NEWT categorization).
    


Intervention name(s): NEWT; Usual care
Intervention type(s): Other; Other
Intervention description(s): The Newborn Weight Tool (NEWT) is publicly available at www.newbornweight.org. For this intervention, NEWT will be embedded into the electronic medical record along with a flag for weight loss greater than or equal to the 75th centile of birth weight.; The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight.
Other intervention name(s): Newborn Weight Tool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: formula
N-of-1 Trials In Children With Hypertension
Condition: Pediatric Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The single patient (n-of-1) randomized trial is an underused approach to resolving
      therapeutic uncertainty by using a patient's own data to inform an individualized treatment
      plan. The proposed research is designed to assess whether the n-of-1 trial approach improves
      blood pressure control compared to usual care. This trial aims to advance learning about not
      only the treatment of pediatric hypertension but also the use of a neglected type of
      randomized trial to optimize the care of each patient.
    

Detailed description: 
      Pediatric hypertension, a growing problem, often requires prescription of antihypertensive
      medication. Pediatric hypertension specialists lack an evidentiary base on which to establish
      definitive clinical practice guidelines for first-line therapy. Significant practice
      variation is an unsurprising consequence. Routine choice of the same first-line therapy for
      most patients with hypertension, absent testing other options, may delay correction of blood
      pressure for months or years. Failure to incorporate patient preferences in medical
      decision-making may also contribute to decreased patient satisfaction and adherence.

      Large parallel-group, comparative effectiveness trials are likely not on the horizon for this
      population. Moreover, heterogeneity of treatment effects would minimize the generalizability
      of such a trial to all patients.

      This is a parallel-group, randomized clinical trial to compare the n-of-1 trial approach to
      usual care in normalizing blood pressure while minimizing exposure to compliance-reducing
      side effects.
    

Intervention name(s): NICHE method; Usual care; Amlodipine; Lisinopril; Hydrochlorothiazide; Losartan
Intervention type(s): Other; Other; Drug; Drug; Drug; Drug
Intervention description(s): Based on underlying comorbidities at enrollment, patients will be assigned to either an unrestricted protocol (amlodipine versus lisinopril) or a restricted protocol (losartan versus lisinopril). Two drugs are tested in randomized order. Failure to achieve BP control at maximum doses of the first two drugs will result in augmentation with a diuretic (hydrochlorothiazide). BP control is assessed with 24 hour ambulatory monitoring at the end of each 2 week treatment period. Side effect tolerability is assessed with a questionnaire.; Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.; Calcium-channel blocker; antihypertensive; Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive; Thiazide diuretic; antihypertensive; Angiotensin II receptor blocker (ARB); antihypertensive
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide; Lisinopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions
Condition: Short Term Treatment of Insomnia
Study type: Interventional

Summary: 
      The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon
      Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a
      single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design
    


Intervention name(s): Zaleplon
Intervention type(s): Drug
Intervention MeSH terms: Zaleplon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban Over 5 Days in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological
      conditions and with 40 mg Pantoprazole
    


Intervention name(s): Lefradafiban tablet; Lefradafiban double chamber sachet; Pantoprazole
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Chemoembolization Versus Radioembolization in Treating Patients With Liver Cancer That Cannot Be Treated With Radiofrequency Ablation Or Surgery
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and
      keeping chemotherapy drugs near the tumor. Radioembolization kills tumor cells by blocking
      the blood flow to the tumor and keeping radioactive substances near the tumor. It is not yet
      known which treatment regimen is more effective in treating patients with liver cancer.

      PURPOSE: This randomized phase II trial is studying radioembolization to see how well it
      works compared with chemoembolization in treating patients with liver cancer that cannot be
      treated with Radiofrequency Ablation or removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare and contrast TACE and Y90 in order to determine either equivalence or
           superiority as measured by time-to-progression.

      Secondary

        -  Characterize the safety and toxicity profile of these regimens.

        -  Determine the need for subsequent treatment in these patients.

        -  Determine tumor response in these patients

        -  Characterize change in quality of life and functional status in these patients.

        -  Determine time to progression in these patients.

      OUTLINE: Patients are randomized to receive either TACE or Y90

        -  Arm I (radioembolization): Patients undergo radioembolization with yttrium Y 90 glass
           microspheres by hepatic artery infusion for approximately 1-3 courses.

        -  Arm II (transarterial chemoembolization [TACE]): Patients undergo TACE with mitomycin C,
           doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately
           1-3 courses.

        -  In both arms, treatment modifications may apply according to response.

      After completion of study treatment, patients are followed every 3 months.
    

Intervention name(s): yttrium Y 90 glass microspheres; Doxorubicin
Intervention type(s): Radiation; Drug
Intervention description(s): Patients undergo radioembolization.; 75mg fixed dose
Other intervention name(s): Radioembolization; Doxorubicin hydrocholoride; Adriamycin; Chemoembolization (TACE)
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer; adult primary hepatocellular carcinoma
Study of Pharmacokinetic Interaction Between Combivir® (ZDV+3TC) and BILR 355 BS Plus Ritonavir in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the effect of BILR 355/r on Combivir® pharmacokinetics and the effect of
      Combivir® on BILR 355 BS pharmacokinetics.
    


Intervention name(s): BILR 355 BS; Combivir®; Ritonavir
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): NORVIR®
Intervention MeSH terms: Ritonavir; Lamivudine, zidovudine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CALERIE: Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy
Condition: Aging
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that two years of sustained 25% caloric
      restriction (CR) in men age 21-50 (inclusive) and women age 21-47 (inclusive) will slow aging
      and protect against age-related disease processes.
    

Detailed description: 
      The overall aim of CALERIE Phase 2 is to test the hypothesis that two years of sustained
      caloric restriction (CR), involving a reduction in energy intake to 75% of baseline (25% CR),
      in healthy, non-obese men aged 21-50 (inclusive) and women aged 21-47 (inclusive), will
      result in the same adaptive changes that were observed in a wide variety of animal studies.
      Particular emphasis is on the adaptive responses thought to be involved in slowing the aging
      process and protecting against age-related disease processes. Primary outcomes include core
      body temperature and resting metabolic rate. Secondary outcomes include risk factors for
      cardiovascular disease, inflammatory markers, immune function, psychological and physical
      function; oxidative changes in lipids, proteins, and DNA; and, risk factors for age-related
      conditions such as diabetes and body composition. An important secondary aim is to identify
      potential adverse effects of CR in humans.

      The study will be conducted as a multi-center, parallel-group, randomized, controlled trial
      (RCT). A sample of 200 participants will be enrolled, and assigned to either the CR
      intervention or a control group. Control participants will be advised to simply continue
      their current diets. Participants in both treatment arms will be followed over a period of 24
      months. A comprehensive set of evaluations will be performed prior to initiating the
      intervention, with follow-up evaluations at 1, 3, 6, 9, 12, 18 and 24 months afterwards.
    

Intervention name(s): Caloric Restriction (CR); Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months; Participants continue their current diet for 24 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: dietary restriction; disease /disorder prevention /control; nutrition of aging; bioenergetics; cardiovascular function; disease /disorder proneness /risk; insulin sensitivity / resistance
Effectiveness of Buccal Infiltration During Vital Pulpotomy After Administering Two Analgesic Premedications
Condition: Anesthesia, Local
Study type: Interventional

Summary: 
      This Randomized study was designed to assess and compare the effect of two analgesic
      premedications (Ibuprofen BP 100 mg/5 ml and Paracetamol 200 mg/5ml.) on the anesthetic
      efficacy of buccal infiltration in vital pulpotomy of primary mandibular molars in children .
      A multivitamin with the same color as the twp tested medications will be administered to
      children in the control group. Parents of eligible children will be informed about the nature
      of the procedure, the purpose of the study, any possible discomfort or risks and a signed
      informed consent will be obtained from them prior to enrollment.
    

Detailed description: 
      A total of 60 healthy children will be recruited from the outpatient clinic of the Pediatric
      Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University.

      Inclusion Criteria include: age group 7-9 years Without systemic or mental disorders. Who
      could be categorized as cooperative according to Wright's classification for child behavior
      Ability of child to understand the use of pain scales; Having at least one lower second
      primary molar with deep caries indicated for pulpotomy; Absence of any periapical or
      furcation radiolucency on radiographs, Absence of any signs of internal or external
      resorption on radiographs, A vital coronal pulp on access opening.

      . Patients who had taken analgesics within 12 hours before administration of the study drugs
      or those having active pain, pulpitis or abscess related to the designated mandibular molar
      will not be included.

      To ensure randomization and allocation concealment, children will be randomly assigned to the
      three groups using computer-generated numbers.

      One operator will do pulpotomy for all participants and to ensure blinding, another author (
      will give the premedication to children.Pain during pulpotomy will be assessed using Wong
      Baker FACES pain assessment tool.
    

Intervention name(s): Brufen; Cital; Placebo for Brufen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brufen Syrup; Cital Cyrup; Sansovit Syrup
Other intervention name(s): Advil; Nurfen; Paramol; Placebo for Cital
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Evaluation of a Single Vaccination With a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
Condition: Staphylococcal Infections
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of a single
      vaccination of an investigational vaccine against Staphylococcus aureus (SA4Ag) in healthy
      adults aged 18 to <65 years.
    


Intervention name(s): SA4Ag vaccine; Blood sample
Intervention type(s): Biological; Procedure
Intervention description(s): Subjects receive 1 intramuscular injection (0.5 mL) of the SA4Ag vaccine.; Blood for immunogenicity will be collected from all subjects at various timepoints.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Staphylococcus aureus vaccine; Staphylococcal infection
Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually
      active healthy adults.
    


Intervention name(s): Vilazodone 20 mg; Vilazodone 40 mg; Paroxetine 20 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration, once per day.; Oral administration, once per day.; Oral administration, once per day.; Oral administration, once per day.
Other intervention name(s): Viibyrd; Viibryd; Paxil
Intervention MeSH terms: Paroxetine; Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Viibryd
Usability of HPV Vaccine Reminders
Condition: Human Papilloma Virus (HPV)
MeSH terms: Papilloma
Study type: Interventional

Summary: 
      This study will assess the usefulness of parent-targeted strategies in improving care seeking
      among parents of 11-12 year old adolescents. Specifically, the study team will focus on
      reminders (postcard or text message) and motivational interviewing to improve adolescent
      vaccination.
    

Detailed description: 
      Despite the impressive cancer preventing potential of human papillomavirus (HPV) vaccines,
      HPV vaccine coverage rates in the United States remain substantially lower than other
      vaccines and Healthy People 2020 targets. HPV vaccine initiation can be improved through
      targeted reminders that motivate parents. Our long-term goal is to maximize HPV vaccination
      rates among girls and boys within the United States using efficient and sustainable
      strategies. The objective of this protocol is to evaluate the usefulness of a tiered strategy
      of a parent-targeted strategies in improving care seeking and receptiveness to vaccine
      recommendations. Strategies include HPV vaccine reminders via postcard or text message and
      phone-based Motivational Interview sessions. The central hypothesis is addressing key health
      beliefs (e.g., perceived benefits and barriers) will increase parental acceptance and, thus,
      HPV vaccine initiation.
    

Intervention name(s): Text Message; PostCard; Standard of Care; Motivational Interview
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Vaccine reminder notification sent via text; Vaccine reminder notification sent via standard mail; No additional information given to parents; Phone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: vaccine
First Line Therapy for High Risk Acute GVHD
Condition: aGVHD; Stem Cell Transplant Complications
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib
      With Corticosteroids as First Line Therapy for the Treatment of High risk aGVHD(acute
      graft-versus-host disease )
    

Detailed description: 
      Acute graft-versus-host disease (aGVHD) is treated with systemic corticosteroid
      immunosuppression as first line therapy. Many patients with high risk aGVHD do not respond to
      primary therapy, high-dose systemic corticosteroids; therefore, survival for those patients
      remains particularly poor. Here we determine the efficacy and safety of combined Ruxolitinib
      With Corticosteroids as First Line Therapy for the Treatment of High risk aGVHD.
    

Intervention name(s): Ruxolitinib; Corticosteroid
Intervention type(s): Drug; Drug
Intervention description(s): Participants began oral administration of ruxolitinib at 5 mg QD;Methylprednisolone: 1mg/kg/d , iv or iv gtt for at least 5 days, then taper according to the clinical response.; Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 3 days, then taper according to the clinical response. 1mg/kg/d , iv or iv gtt for at least 5 days, then taper according to the clinical response.
Other intervention name(s): New; Traditional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aGVHD