bioihbjkbjnl/mcl2 huggingface dataset:
Busulfan Concentration in Saliva and Plasma, and Its Relationship With Salivary Changes and Mucositis in the Digestive Tract of Patients Submitted to Hematopoietic Stem Cell Transplantation
Condition: Bone Marrow Disease
MeSH terms: Mucositis; Bone Marrow Diseases
Study type: Observational [Patient Registry]

Summary: 
      Busulfan (Bu) has been widely used for the treatment of neoplastic and non-neoplastic
      hematological disturbances, with satisfactory results in terms of successful hematopoietic
      stem cell transplantation (HSCT). Individual monitoring of the Bu dosage, which is done by
      means of various blood sample collections, is necessary for the purpose of attaining ideal
      therapeutic levels and minimizing systemic toxicity. This procedure sometimes becomes costly
      to and uncomfortable for the patient. Saliva has been analyzed as a possible alternative
      fluid for this monitoring.
    

Detailed description: 
      The first objective of this project is to verify the feasibility of using the analysis of
      salivary concentration of BU during individual adjustments of this drug in the period that
      precedes HSCT. Another question related to this project is with reference to the effects that
      the Bu concentration in saliva has on the mucosa of the digestive tract, particularly with
      regard to mucositis and salivary changes. Thus, the second objective of this project is to
      verify whether there is any association between salivary changes, cytological changes in the
      oral mucosa, degrees of mucositis and concentration of Bu in saliva. An analysis will be
      performed of the Bu concentration in saliva and in blood, as well as the salivary dosage of
      total proteins, albumin, amylase, antioxidant enzymes (superoxide dismutase, catalase, and
      glutathione reductase) and pro-inflammatory cytokines IL-1β, IL-6 and TNF-α. In addition,
      morphological analysis will be made, and rate of apoptosis of cells of the oral mucosa will
      be analyzed. If the efficacy of saliva for the individual adjustment of the dose of Bu is
      confirmed, this method could facilitate the dissemination of pharmacokinetic monitoring of
      this drug in chemotherapy and HSCT centers. In addition, it is expected that the results of
      the present project will allow establishment of the toxicity indicators of BU detected by
      analysis of saliva and the cells of the oral mucosa, thereby allowing the early adoption of
      preventive actions for reducing the frequency and severity of mucositis, a fact that may have
      a positive impact on the success of HSCT.
    

Intervention name(s): Saliva monitoring
Intervention type(s): Diagnostic Test
Intervention description(s): The first objective of this project is to verify the feasibility of using the analysis of salivary concentration of BU during individual adjustments of this drug in the period that precedes HSCT
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients submitted bone marrow transplantation
Advancing Diabetes Management in Adolescents Using Health Information Technology
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The study will compare three treatment strategies to look at the best clinical outcomes.

      The investigator hypothesizes that the combined approach of a health information technology
      program plus a conflict-management contract will lead to the best outcomes.
    

Detailed description: 
      This study will compare three strategies for enhancing adherence to diabetes care in our
      population. The study will look at which strategy results in the best short-term clinical
      outcomes for the population. Also, the study will look at patient satisfaction of contact
      with his/her health care team, quality of life, and family dynamics.

      The three arms are:

        1. HIT (health information technology) aided approach

        2. Contracted conflict-management strategy

        3. Combination of the HIT-aided approach and the contracted conflict management strategy
    

Intervention name(s): HIT-aided approach; Contracted conflict management system; HIT plus contracted conflict management
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects randomized to this approach will be using the HIT-aided monitor.; Subjects randomized to this arm will be using the behavioral contracted conflict management system.; Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: type 1; diabetes; adolescents; heath information technology
To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate and compare the pharmacokinetic interactions and safety of multiple dose of
      Treatment A and Treatment B alone and in combination
    

Detailed description: 
      The objective of this study was to evaluate pharmacokinetic characteristics and safety after
      oral concurrent administration of Treatment A and Treatment B compared to each single
      administration in Healthy volunteers.
    

Intervention name(s): LivaloV; A; LivaloVA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment A, Tablet, Oral, QD for 7 Days; Treatment B, Tablet, Oral, QD for 10 Days; Treatment C, Tablet, Oral, QD for 7 Days
Other intervention name(s): Period I; Period II; Period III
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: open label, multiple dose, Fixed sequence, 3 Period design
Masking: None (Open Label)
Primary purpose: Other
Biomarker-guided Implementation of the AKI Bundle
Condition: Acute Kidney Injury (Nontraumatic)
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      There is no specific therapy for acute kidney injury. It is presumed that supportive measures
      improve the care and outcome of patients with acute kidney injury.

      The investigators hypothesize that the implementation of a bundle of supportive measures
      adapted to patients undergoing cardiovascular surgery reduces the occurence of AKI.

      A Randomized prospective multicenter trial is needed to investigate whether the
      implementation of the bundle of measures is effective to prevent AKI in high risk patients
      undergoing cardiac surgery. In this feasibility trial the investigators will analyze the
      compliance rate to the trial protocol in a multicenter, multinational cohort in preparation
      for a large randomized controlled trial.
    


Intervention name(s): Intervention
Intervention type(s): Other
Intervention description(s): Implementation of the cardiovascular AKI bundle (see arm description)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: cardiac surgery; KDIGO-Guideline
The People Like Us Evaluation Study
Condition: HIV/AIDS; Sexually Transmitted Infection; Homosexuality; Health Behavior; Stigma, Social; Health Care Seeking Behavior
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The study is a pragmatic, randomized controlled trial design to evaluate an online video
      series developed by a community-based organization in Singapore for gay, bisexual and queer
      men.

      A total of 300 HIV-negative, gay, bisexual and queer men in Singapore aged 18 to 29 years old
      will be recruited with the assistance of the partner community-based organization (CBO),
      Action for AIDS Singapore. Recruitment will utilize both online and offline channels, and
      with the help of other CBOs in Singapore. Participants should also not have watched the video
      prior to their participation in this study, which will be ascertained through a
      questionnaire.

      Participants will subsequently be randomized into the intervention arm (n=150) and the
      control arm (n=150). The treatment group (n=150) will be assigned the intervention along with
      sexual health information via a pamphlet, while the control group (n=150) will be assigned
      only the sexual health information via a pamphlet. This will be conducted through block
      randomization.
    


Intervention name(s): People Like Us Online Video Series Intervention; Sexual Health Pamphlet (Standard of Care)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): People Like Us miniseries incorporates key sexual health messages to:
Increase viewers' knowledge and perceptions of HIV and other STI risk;
Address homophobia and sexual orientation disclosure;
Increase safer-sex negotiation self-efficacy;
Promote positive attitudes towards condom use and other safe sex behaviors;
Build skills and self-efficacy for practicing safer sex;
Provide information on HIV and other STI testing and its benefits;
Provide information on resources for HIV/STI testing and other mental health services;
Model appropriate behaviors around practicing safer sex.
Each video in the six-part series ends with an educational video segment featuring the managers of Action for AIDS and Gayhealth.sg, who provide a brief synopsis of the episode and cover key points relevant to mental and sexual health for GBQ men.; The control group will be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Testing; STI Testing; Homophobia; eHealth; Singapore
A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the
      effects on vision of six months of daily dosing of 5 mg tadalafil or 50 mg sildenafil
      compared with placebo.
    


Intervention name(s): tadalafil
Intervention type(s): Drug
Other intervention name(s): LY450190; Cialis; IC351
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Healthy Volunteers
Comparing the Effect of Online and Conventional Oral Health Education in Egypt
Condition: Knowledge; Attitude to Health; Practice
Study type: Interventional

Summary: 
      This study aims to compare the results of online oral health education and conventional oral
      health education methods in terms of their effectiveness towards improving the knowledge and
      practice of oral hygiene in primary school children in Egypt.

      This study is done in two schools in Egypt, in 3rd and 4th grade respectfully. The classrooms
      in each grade will be randomly assigned to each of the two groups (online and conventional
      oral health education). A questionnaire that assesses knowledge and attitude towards self
      oral care will be administered by the primary investigator before and after the oral health
      education sessions. The pre and post questionnaires will be compared in terms of results to
      evaluate the effectiveness of both methods.
    


Intervention name(s): Oral health education
Intervention type(s): Behavioral
Intervention description(s): oral health education sessions that aims to improve both knowledge of primary school children regarding bacteria, caries, number of teeth, plaque formation and attitude of primary school children regarding tooth brushing techniques, number of times per day, dietary instructions to avoid dental caries.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: oral health education; oral health promotion; school children
A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a 2- part, phase 1, open-label, single center, single ascending dose study to
      investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of
      subcutaneous (SC) and intravenous (IV) administration of CSL312 in healthy adult Japanese and
      Caucasian subjects.
    


Intervention name(s): CSL312
Intervention type(s): Biological
Intervention description(s): Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
Other intervention name(s): Factor XIIa antagonist monoclonal antibody; garadacimab
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Behavioral Activation - From Inpatient to Outpatient Services
Condition: Inpatient Facility Diagnoses; Psychiatric Disorders; Depressive Symptoms
MeSH terms: Depression; Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of Behavioral Activation and
      Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts
      during inpatient care and can continue in an outpatient facility if the patients are
      discharged before 12 sessions has been completed.
    

Detailed description: 
      Psychiatric inpatient care is reserved for individuals with the most acute mental health
      problems. The period after discharge is associated with increased risk for relapse,
      non-adherence and suicide. Delivering high quality psychosocial interventions during and
      after acute psychiatric inpatient care is known to be a difficult challenge. This study will
      investigate the effectiveness of adding either Behavioral Activation or Supportive Therapy to
      the standard acute psychiatric inpatient care. Subjects with different psychiatric diagnoses
      and elevated depressive symptoms are assessed and randomized after admission. Therapists from
      the nearest outpatient facility initiate 12 sessions of Behavioral Activation or Supportive
      Therapy as soon as possible. The 12 sessions are delivered twice weekly at the inpatient unit
      or at the outpatient facility, depending on whether the patient is admitted or discharged.
      Treatment as usual interventions(medications, nursing etc.) are not manipulated in the study.
      The main assessment points are pre-, post, 6 months follow-up and 12 months follow-up. The
      main outcome measure and some process measures are also administered at session 3, 6 and 9.
    

Intervention name(s): Behavioral Activation; Supportive Therapy
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Inpatient Psychiatry; Continuity of Care; Behavioral Activation; Depression
Homeopathic Ear Drops for Otitis Media Study
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a commercially available homeopathic ear drop
      preparation is effective in reducing symptoms in children 6 months - 11 years old with acute
      otitis media in whom the health care provider has recommended that antibiotics not be
      immediately administered. A total of 150 study patients with otitis media will be randomized
      to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It
      is postulated that children using the ear drops will have more rapid resolution of symptoms
      and need fewer antibiotics than those randomized to not receive the ear drops.
    


Intervention name(s): Hyland's earache drops
Intervention type(s): Drug
Intervention description(s): 3-4 drops in affected ear 3 times a day as needed for up to 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: otitis media; children; homeopathy
Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus
Condition: Type-2-diabetes Mellitus; New Onset
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with
      12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic
      control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and
      2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin
      level, lipid profile, and body weight.
    

Detailed description: 
      There will be two groups of treatment in this study who will receive DLBS3233 or placebo of
      DLBS3233 (with lifestyle modification) for 12 weeks of therapy.

      Clinical and physical examination to evaluate the efficacy and safety as well as measurement
      of fasting and 2-hour post-prandial plasma glucose level will be performed at baseline and
      every 6-weeks-interval. Other clinical and laboratory examinations will be performed at
      baseline and at the end of study.
    

Intervention name(s): Placebo of DLBS3233; DLBS3233; Lifestyle modification
Intervention type(s): Drug; Drug; Other
Intervention description(s): Placebo of DLBS3233 once daily for 12 weeks; 100 mg DLBS3233 once daily for 12 weeks; Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.
Other intervention name(s): Placebo of Inlacin; Inlacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DLBS3233; new onset; type-2-diabetes mellitus; oral anti-hyperglycemic agent
Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness
Condition: Occasional Sleeplessness
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study was conducted to investigate the impact of diphenhydramine hydrochloride on
      the ability to initiate sleep.
    

Detailed description: 
      Diphenhydramine hydrochloride (herein referred to as diphenhydramine) is an antihistamine of
      the ethanolamine classes with known sleep-inducing properties and is approved by the Food &
      Drug Administration to reduce the time to sleep onset in individuals having difficulty
      falling asleep. The goal of the study is to investigate diphenhydramine versus placebo with
      regard to several sleep parameters, including time to sleep onset, in healthy adult subjects
      suffering from occasional sleeplessness.
    

Intervention name(s): Diphenhydramine Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 mL at bedtime; 30 mL at bedtime
Other intervention name(s): Zzzquil; placebo comparator
Intervention MeSH terms: Diphenhydramine; Promethazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle
Condition: Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the diffusion area (cephalic, lateral, medial and caudal points) of the
      botulinum toxin type A in the frontal muscle for usual concentrations and dilutions of the
      drug. A basal line control and After the application control will be made, and the
      investigators will evaluate the drug effects, based on clinical aspects, photographic
      registers and through electromyography exam (EMG).

      Considering the results of our investigation, the investigators may propose a pattern of
      application of BOTULINUM TOXIN TYPE-A Botox® in the frontal area.
    


Intervention name(s): Botulinum Toxin Type-A (day 0); Botulinum Toxin Type-A (day 0); Botulinum Toxin Type-A (day 0)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Botulinum Toxin Type-A 1 unit. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
Botulinum Toxin Type-A 1 unit. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
Botulinum Toxin Type-A 1 unit. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.; Botulinum Toxin Type-A 2 Units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
Botulinum Toxin Type-A 2 units. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
Botulinum Toxin Type-A 2 units. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.; Botulinum Toxin Type-A 3 units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
Botulinum Toxin Type-A 3 units. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
Botulinum Toxin Type-A 3 units. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Botulinum toxin type A; Hyperfunctional forehead lines; Randomized controlled trial; Double-blinded trial; Electromyogram (EMG); Electromyographic activity; Frontal Area