bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)
Condition: HIV Infections
MeSH terms: HIV Infections; AIDS-Related Complex; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to test the drug zidovudine (AZT) in children, including study of drug
      levels in various parts of the body fluids, safety of the drug, and its effect on different
      parts of the body.

      The effects of any drug, the way a drug enters the bloodstream, the way it is used by the
      body, and the way the body eliminates the drug may be very different in children compared
      with adults. The largest group of children who have AIDS are those who are less than 2 years
      of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT
      show that it might be useful in the treatment of AIDS. Thus it is important to study the
      effects of the drug in children.
    

Detailed description: 
      The effects of any drug, the way a drug enters the bloodstream, the way it is used by the
      body, and the way the body eliminates the drug may be very different in children compared
      with adults. The largest group of children who have AIDS are those who are less than 2 years
      of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT
      show that it might be useful in the treatment of AIDS. Thus it is important to study the
      effects of the drug in children.

      Patients are hospitalized for 8 weeks to receive AZT through the intravenous (IV) route at 1
      of 2 doses. Patients are then discharged from hospital and take AZT by mouth for 4 more
      weeks.
    

Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Evaluation; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine
Anti-CD19 and Anti-CD22 Immunotoxins in Treating Patients With Refractory or Relapsed B-Cell Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Immunotoxins, such as anti-CD19 and anti-CD22, can find cancer cells that express
      CD19 and CD22 and kill them without harming normal cells. This may be an effective treatment
      for B-cell acute lymphoblastic leukemia.

      PURPOSE: This phase I trial is studying the side effects and best dose of anti-CD19 and
      anti-CD22 immunotoxins in treating patients with refractory or relapsed B-cell acute
      lymphoblastic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of deglycosylated ricin A chain-conjugated
           anti-CD19 and anti-CD22 immunotoxins (Combotox) in patients with refractory or relapsed
           B-cell acute lymphoblastic leukemia.

        -  Determine the toxicity of Combotox in these patients.

        -  Determine the pharmacokinetic (PK) profile of Combotox in these patients.

        -  Determine any antitumor activity of Combotox, in terms of the percentage of blasts in
           bone marrow and peripheral blood.

        -  Determine the levels of human antimouse and human anti-dgA antibodies in patients
           treated with Combotox.

        -  Determine if there is a correlation between PK parameters and toxicity of Combotox in
           these patients.

        -  Determine if the expression of the CD19 and CD22 cell surface antigens is affected by
           Combotox.

      OUTLINE: This is a dose-escalation study.

      Patients receive deglycosylated ricin A chain-conjugated anti-CD19 and anti-CD22 immunotoxins
      (Combotox) IV over 4 hours on days 1, 3, and 5 in the absence of disease progression or
      unacceptable toxicity.

      Cohorts of patients receive escalating doses of Combotox until the maximum tolerated dose is
      determined.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): deglycosylated ricin A chain-conjugated anti-CD19/anti-CD22 immunotoxins
Intervention type(s): Biological
Intervention MeSH terms: Immunotoxins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell adult acute lymphoblastic leukemia; recurrent adult acute lymphoblastic leukemia
Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes
Condition: Diabetes Mellitus; Dyslipidemia
MeSH terms: Atherosclerosis; Diabetes Mellitus; Dyslipidemias
Study type: Observational

Summary: 
      This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and
      several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic
      patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites.
    

Detailed description: 
      MC MD
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        360 patients who has diabetic mellitus with dyslipidemia
      
Biospecimen description: 
      Whole blood and serum, urine
    
Keywords: cIMT; hs CRP (C-reactive protein); DM (Diabetic Mellitus); Korea; Corelation between cIMT (carotid intima media thickness); Cardio Vascular risk in Diabetic Mellitus
The Impact of Background Music in Reducing Stress in Preclinical Dental Labs
Condition: Stress-related Problem
Study type: Observational [Patient Registry]

Summary: 
      This study was designed to evaluate students' level of stress and impact of background music
      on their efficiency of work, performance and learning ability during pre-clinical lab.
    

Detailed description: 
      The reported high level of stress among dental students and its consequences, considering the
      known benefits of background music. This study was designed to evaluate students' level of
      stress and impact of background music on their efficiency of work, performance and learning
      ability during pre-clinical lab.

      METHODOLOGY: In this cross-sectional questionnaire study, 61 preclinical students from the
      college of dentistry, Ajman university-Fujairah campus who met the defined inclusion criteria
      participated.

      After a semester of the normal lab without BM (Background Music), various genres of BM were
      introduced in the lab. Psychological stress assessment was done using P.S.S (Perceived Stress
      Scale).Students were asked to fill up a written feedback questionnaire at the end of six
      weeks of BM. Descriptive statistics and Chi-square test were used in order to study the
      statistical relationships among groups.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): students were involved in the pre-clinical prosthodontic lab. Participation in these labs were mandatory and it involved crown and bridge preparations on typodont models. There were 2 sessions of these labs per week, one for each gender. Each session lasted for 3 hours.
The study was conducted in 2 phases. At the beginning of the first phase of the study, the labs were conducted without any BM for 4 weeks. PSS(perceived stress scale), a standardized and validated, self-reporting international test was used for measuring the level of psychological stress were administered to all participants.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population were both male and female students aged between 18-23 yrs who were
        students of Ajman University dental campus,they are attending preclinical dental labs and
        belong to the 2nd and third year of the dentistry program
      
Keywords: Dental labs; genre; music; perceived stress scale; stress
A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of multiple doses of BMS-986322 on the
      pharmacokinetics (PK) of Loestrin components in healthy female participants.
    


Intervention name(s): BMS-986322; Loestrin
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BMS-986322; Loestrin; Combined oral hormonal contraceptive; Ethinyl Estradiol; Norethindrone; Drug-drug interaction
A Single Dose Study to Determine the Safety and Pharmacokinetics of FP01 Lozenges in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and pharmacokinetics of FP01 in healthy
      volunteers.
    


Intervention name(s): FP01
Intervention type(s): Drug
Intervention description(s): comparison of different dosages
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Safety and Pharmacokinetics of FP01 in Healthy Volunteers
Study of VX-985 in Subjects With Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study it to evaluate the safety and tolerability of VX-985 in HCV
      subjects. This study will also evaluate the antiviral activity and pharmacokinetic profile of
      VX-985.
    


Intervention name(s): VX-985 or matching placebo; VX-985 or matching placebo; VX-985 or matching placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): low dose; high dose; dose TBD
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of High Cost Monitoring During Letrozole Ovulation Induction
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate monitoring methods during ovulation induction
      cycles with letrozole and their effect on pregnancy rates. Monitoring ovulation induction
      cycles with letrozole can be done with a variety of methods, the two most commonly utilized
      are home-based urinary LH kits (or ovulation predictor kits) and office-based midcycle
      follicular ultrasound. Letrozole coupled with follicular monitoring by ultrasound may add
      extra cost per cycle with no improvement in fecundability (pregnancy rates per cycle).
    

Detailed description: 
      The study will be a randomized controlled trial of adult women with primary and secondary
      infertility seen at the University of Michigan Health System undergoing ovulation induction
      (OI) with letrozole as part of their standard clinical care. Patients who are undergoing OI
      with letrozole as per standard clinical care will be randomized to urinary luteinizing
      hormone (LH) ovulation predictor kit use versus mid-cycle ultrasound with administration of
      hCG when appropriate for timing of intercourse or intrauterine insemination. Patients who
      have been prescribed letrozole as per routine clinical care will be approached to determine
      willingness to participate in this study. Study period involves up to three ovulation
      induction cycles or until pregnancy occurs.
    

Intervention name(s): Midcycle ultrasound + hCG injection; Urinary LH kits
Intervention type(s): Other; Other
Intervention description(s): Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate.; Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination.
Other intervention name(s): Ovidrel; ClearBlue Easy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: letrozole; ovulation monitoring; pregnancy rate
Disease Perception and Oral Health Impact Profile (OHIP) Before and After Non-surgical Periodontal Treatment
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Observational

Summary: 
      The presence of periodontal diseases in patients has been associated to a worsened quality of
      life overall. Many different indices have been proposed over time in order to evaluate
      patient's centred outcomes. In particular, the most thorough questionnaire proposed so far is
      the Oral Health Impact Profile 49 (OHIP-49), which is composed of 49 questions. Despite its
      validity being unquestionable, OHIP-49 was found to be too time-consuming for the clinical
      scenario and, therefore, its shortened 14-question version has been proposed. A more in-depth
      knowledge of how these parameters change before and after periodontal treatment could enable
      clinicians to tailor the treatment plan according to the patients' needs.
    


Intervention name(s): Questionnaires
Intervention type(s): Other
Intervention description(s): Patients will be asked two sets of questions:
questionnaire about their perception of periodontal disease (Brief Illness Perception Questionnaire; 9 questions, answers will be registered on a scale of 0 to 10);
Oral Health Impact Profile 14 (OHIP-14) questionnaire.
All these two sets of questions will be asked before and after non surgical periodontal therapy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with a diagnosis of Periodontitis will be eligible for the inclusion in the
        study.
      
Keywords: Oral Health Impact Profile 14; OHIP 14; non surgical periodontal treatment; brief-Illness Perception Questionnaire
Gluten and (Extra-)Intestinal Symptoms in NCGS
Condition: Non-celiac Gluten Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The goal of this randomized, double-blind, placebo-controlled study is to investigate the
      effect of expectancy related to gluten consumption versus actual gluten intake on overall GI
      symptoms in individuals with non-coeliac gluten sensitivity (NCGS)

      The main questions it aims to answer are:

        -  what is the effect of consumer expectancy, related to either gluten-containing or
           gluten-free oat bread, on short-term (within 8 hours) overall GI symptoms in individuals
           with NCGS?

        -  what is the effect of actual gluten intake on short-term (within 8 hours) overall GI
           symptoms in individuals with NCGS

      Participants will be randomised into four groups:

        1. Participants with the expectation of receiving gluten-containing bread and actually
           receiving gluten-containing oat bread during the test day. (E+ G+)

        2. Participants with the expectation of receiving gluten-containing bread, but actually
           receiving gluten-free oat bread during the test day. (E+ G-)

        3. Participants with the expectation of receiving gluten-free bread but actually receiving
           gluten-containing oat bread during the test day. (E- G+)

        4. Participants with the expectation of receiving gluten-free bread and actually receiving
           gluten-free oat bread during the test day. (E- G-)
    

Detailed description: 
      One on-site test, starting with baseline measurement (T = 0). Thereafter, subjects are told
      that they will receive two slices of gluten-containing bread (E+) or gluten-free bread (E-).
      Consequently, they receive breakfast with two slices of bread (gluten-containing (G+) or
      gluten-free (G-)).

      After breakfast, questionnaires will be completed every hour for 8 hours. After T = 4 hours,
      participants receive lunch with two slices of the same bread, combined with the same
      expectancy, that they received at breakfast.

      Follow-up measurements include the same questionnaires at the end of day 1 (from end of test
      day until they go to sleep), at the end of day 2 and at the end of day 3.
    

Intervention name(s): Expectancy and gluten
Intervention type(s): Other
Intervention description(s): Effect of expectancy to receive gluten and/or actual gluten intake
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Non-Coeliac Gluten Sensitivity; NCGS; Gluten; Gastrointestinal symptoms
Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases
Condition: Breast Cancer Stage IV
MeSH terms: Breast Neoplasms; Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly
      diagnosed or progressing Brain Metastases
    

Detailed description: 
      T-DXd will be administered at a dose of 5.4 mg/kg body weight once every three weeks in
      patients with newly diagnosed or progressive HER2 positive breast cancer brain metastases.
      Response rate by RANO-BM is defined the primary study endpoint.
    

Intervention name(s): Trastuzumab deruxtecan
Intervention type(s): Drug
Intervention description(s): Trastuzumab-deruxtecan 5.4 mg/kg body weight i.v. on day 1 once every three weeks until progression or death
Other intervention name(s): Ds8201a; Enhertu
Intervention MeSH terms: Trastuzumab; Trastuzumab deruxtecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and
      effective in the treatment of distal subungual onychomycosis of the toenail.
    

Detailed description: 
      The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and
      effective in the treatment of distal subungual onychomycosis of the toenail.
    

Intervention name(s): NB-002; Vehicle control
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic persistent infection of the nail bed or plate
Patients With Chemotherapy-induced Polyneuropathy Are Treated With an Integrated Program Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises or With Whole-body Vibration Platform Training
Condition: Polyneuropathy
MeSH terms: Polyneuropathies
Study type: Observational

Summary: 
      In a Phase-III Study Patients With Chemotherapy-induced Polyneuropathy (NCI CTC Grade 2/3)
      Are Randomized for an Integrated Program (IP) Including Massage, Mobilization in Posture and
      Transport Layers, Physical Exercises (Standard) or With Whole-body Vibration (WBV) Platform
      Training (Experimental).
    

Detailed description: 
      Subjects with a haematological malignancy or solid and a diagnosis of a chemotherapy-induced
      polyneuropathy. In a phase-III study patients with chemotherapy-induced polyneuropathy (NCI
      CTC grade 2/3) are randomized for an integrated program (IP) including massage, mobilization
      in posture and transport layers, physical exercises (standard) or with whole-body vibration
      (WBV) platform training (experimental). 15 training sessions in a time period of 12 to 15
      weeks were intended. Evaluation included locomotor and neurological tests and
      self-assessment-tools. The primary objective of the study was the physical fitness and
      coordination assessed by the chair-rising test (CRT).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with a haematological malinancy or solid and a diagnosis of a chemotherapy-induced
        polyneuropathy.
Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      While telemental health (TMH) programs are increasing nationally to address the inequity of
      access to psychiatric services, there are few reports of their efficacy, particularly with
      children. The current proposal will complete the second stage of our program development. In
      the first stage, we established the feasibility of a TMH service and its acceptability to
      families and PCPs. In the second stage of program development we will conduct a randomized
      clinical trial (RCT) that will determine whether it is possible to use technological advances
      to: 1) improve clinical outcomes for children with ADHD over outcomes achieved in usual PC;
      and 2) adhere to an EBT protocol implemented through TMH. Future studies will examine whether
      other types of complicated psychiatric disorders and EBTs are amenable to delivery via TMH.

      The overall goal of this study is to determine whether an evidence-based model of care can be
      faithfully implemented when delivered using TMH to children with ADHD living in rural areas
      and can improve outcomes over treatment as usual (TAU) in PC. ADHD is an excellent focus for
      assessment of TMH, as PCPs encounter this disorder frequently, EBT guidelines are available,
      pharmacotherapy is the core treatment and is easily delivered in PC through
      videoconferencing, and stabilization may be readily achieved for most youth.
    


Intervention name(s): CATMH intervention
Intervention type(s): Other
Intervention description(s): This intervention is comprised of 6-tandem-sessions of pharmacotherapy and a behavioral intervention conducted over 4-5 months. The telepsychiatrist makes prescribing decisions during the intervention following consensus guidelines for ADHD treatment. The telepsychiatrist also provides education about how neurobiological deficits of ADHD relate to observed behavioral learning and difficulties. After the 6th session, the PCP resumes care of the patient. The behavioral intervention component is delivered by therapists at each participating clinic. The therapists are trained and supervised remotely by a telepsychologist . The 6-session behavioral intervention consists of approaches to managing children's behaviors and coordination with schools and other community agencies to advocate for the child.
Other intervention name(s): Childrens' Telemental Health Service
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: ADHD; telemental health; TMH; telepsychiatry; rural mental health services for children