bioihbjkbjnl/mcl2 huggingface dataset:
NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia
Condition: Leukemia, Lymphocytic, Acute
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and
      antileukemic response during the initial 3 months of individualised therapy of children and
      young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual
      toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used
      in the two-months post-remission treatment phase of lower risk childhood ALL. This will be
      performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m^2)
      every 3rd week. Thus, the trial will also test the feasibility of this particular drug
      combination.
    

Detailed description: 
      In addition to the details above we will also explore

        -  the relationship of the post-HD-MTX MRD-levels with the dose of 6MP, TPMT-activity,
           DNA-6TGN, E-6TGN, E-MeMP, E-MTX, and presence of ASP-antibodies,

        -  the early development of anti-ASP antibodies during continuous PEG-ASP therapy.

      The study could improve the understanding of the pharmacodynamics of the 6MP/HD-MTX
      interaction in combination with PEG-ASP.
    

Intervention name(s): 6-mercaptopurine
Intervention type(s): Drug
Intervention description(s): Standard dose 25 mg/m^2/day. Can be increased up to 75 mg/m^2/day if the myelosuppression is acceptable (ANC>0.5 T-count >50)
Other intervention name(s): PURINETHOL
Intervention MeSH terms: Mercaptopurine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leukemia, Lymphocytic, Acute [C04.557.337.428.511]; 6-mercaptopurine; methotrexate; asparaginase
A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of baricitinib on the levels of digoxin
      in the blood stream and how long it takes the body to remove digoxin. This study will also
      look at how safe and well-tolerated baricitinib is when given at the same time as digoxin in
      healthy participants. This study will last approximately 3-4 weeks.
    


Intervention name(s): Baricitinib; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3009104
Intervention MeSH terms: Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study is to investigate the efficacy and safety of three different
      doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period
      of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia
    


Intervention name(s): Aripiprazole Low (2 mg/day); Aripiprazole Mid (6 - 12 mg/day); Aripiprazole High (24 - 30 mg/day)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): administered 2 mg once daily for 6 weeks; administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg; administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
Other intervention name(s): Aripiprazole; Aripiprazole; Aripiprazole
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schyzophrenia, pediatric patients
The Effect of Metamin 3D on the Lipid and Glucose in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effect of Metamin 3D on improvement of glucose and lipid on Taiwanese
      subjects with metabolic syndrome.
    

Detailed description: 
      The Metamin 3D consists of mixed extractives of nature plants, including soy bean protein,
      bitter melon, red yeast rice, green algae and trisodium glycyrrhizinate. the improvement of
      lipid and glucose was reported respectively previously. We design a prospective,
      double-blinded and placebo-controlled study to evaluate the improvement on metabolic
      syndrome.
    

Intervention name(s): Metamin 3D
Intervention type(s): Drug
Intervention description(s): Metamin 3D is composed by red yeast rice, bitter gourd, chlorella, soy peptide and licorice extract is a commercial product designed by Uni-President enterprises corp in Taiwan
Other intervention name(s): 3D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hyperglycemia; dyslipidemia; Hypertension; Obesity
Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in
      cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance
      therapy with lactulose and/or rifaximin or metronidazole.
    

Detailed description: 
      Subjects receive FMT from a single donor by colonoscopy at Week 0 and by enema at Weeks 1-4.
      HE is measured by Inhibitory Control Test and Stroop as well as serum ammonia levels.
    

Intervention name(s): Fecal Microbiota Transplant
Intervention type(s): Biological
Intervention description(s): Fecal transplant processed from routinely screened universal donors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to demonstrate the efficacy of SPD489 compared with
      placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating
      Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as
      days during which at least 1 binge episode occurs) per week as assessed by clinical interview
      based on subject diary
    


Intervention name(s): SPD489 (Lisdexamfetamine dimesylate); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 or 70 mg administered orally, once-daily for up to 12 weeks; Administered once-daily, orally, for up to 12 weeks
Other intervention name(s): Vyvanse, Venvanse, LDX
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Consumption of Pomegranate Juice on Carotid Intima-Media Thickness
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      Increases in carotid artery intima-media thickness (IMT) are correlated with increased risk
      of stroke and myocardial infarction. The purpose of this study is to assess if pomegranate
      juice will retard the carotid (IMT) progression rate in men and women who have one or more
      existing cardiovascular risk factors (current cigarette smoking, hypertension, low
      HDL-cholesterol, and/or high LDL-cholesterol) upon entrance into the study.
    

Detailed description: 
      Previous studies in atherosclerotic mice have shown that pomegranate supplementation reduced
      their macrophage oxidative stress and attenuated the development of their atherosclerosis.
      Further research in hypertensive humans demonstrated that pomegranate juice had an
      angiotensin converting enzyme (ACE)-inhibitory effect and significantly decreased systolic
      blood pressure.

      This study will use a randomized, double-blind, placebo-controlled design with eight clinic
      visits (one screening visit [week -4 to -1], one baseline visit [week 0], and six treatment
      visits [weeks 13, 26, 38, 52, 65, and 78]).
    

Intervention name(s): PomWonderful Juice; Placebo juice
Intervention type(s): Drug; Drug
Intervention description(s): 8 oz per day each day for 78 weeks; 8 oz per day for 78 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coronary artery disease, carotid intima-media thickness
Residential Cognitive and Interpersonal Therapy for Social Phobia
Condition: Social Phobia
MeSH terms: Phobic Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is twofold: (1) to compare the effectiveness of two promising
      treatments for social phobia, a new cognitive therapy model (Clark & Wells, 1995; Borge et
      al., 2001) and interpersonal therapy (Lipsitz, Markowitz, & Cherry, 1997), adapted for
      inpatient groups; and (2) to study the empirical change processes in these therapies and
      compare them with the cognitive and interpersonal models of change.
    

Detailed description: 
      Social phobia typically leads to severe impairment in work and other social life, and -
      without treatment - it can persist for decades. Given its prevalence, severity, and
      chronicity, effective treatment methods are strongly needed. However, traditional
      psychological and pharmacological treatments have had statistically significant, but
      clinically limited effects (Taylor, 1996).

      Based on an empirical analysis of the cognitive processes in social phobia, Clark and Wells
      (1995) have developed a new cognitive model. Cognitive therapy (CT) derived from this model
      has been found to be superior to a combination of fluoxetine and self-exposure (Clark et al.,
      2003).

      Social phobic symptoms may be viewed as a result of more general interpersonal difficulties
      and interpersonal psychotherapy (IPT) can be a reasonable alternative for social phobia
      (Lipsitz & Markowitz, 1996). A clinical case series indicates that social phobic patients
      improve during interpersonal psychotherapy for social phobia (IPT-SP; Lipsitz et al., 1999.
    

Intervention name(s): Cognitive Therapy, Interpersonal Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Social Phobia; Cognitive Therapy; Interpersonal Therapy; Efficacy; Process-Outcome
Analgesic Efficacy & Safety of Intravenous (IV) Acetaminophen Versus Placebo for the Treatment of Postop Pain
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This research study will look at the pain relieving ability and safety of using repeated
      doses of intravenous (into the vein [IV]) acetaminophen in the treatment of moderate
      postoperative pain after planned or elective abdominal laparoscopic surgery, such as a
      laparoscopic abdominal hysterectomy or laparoscopic cholecystectomy (removal of the gall
      bladder).
    

Detailed description: 
      To assess the analgesic efficacy of repeated doses of intravenous acetaminophen (IV APAP)
      versus Placebo in the treatment of moderate postoperative pain after abdominal laparoscopic
      surgery.
    

Intervention name(s): IV Placebo; IV Placebo; IV Acetaminophen; IV Acetaminophen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IV, every 6 hours for 24 hours (4 doses total); IV, every 4 hours for 24 hours (6 doses total); IV, every 6 hours for 24 hours (4 doses total); IV, every 4 hours for 24 hours (6 doses total)
Other intervention name(s): placebo; placebo; APAP; IV APAP; APAP; IV APAP
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Abdominal Laparoscopic Surgery
Predictive Factors for a Clinical Diagnosis of Irritable Bowel Syndrome in a Large Cohort of Young Adults.
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      The prevalence of IBS in the community has been reported in numerous cross-sectional surveys.
      However, less is known about the incidence of IBS ,mainly due to its slow development and to
      patients under-reporting. Furthermore, only one study has analyzed data concerning potential
      risk factors for the diagnosis of IBS. The investigators will examine the incidence of IBS in
      a large cohort of young adults and will look at the association of socioeconomic,
      anthropometric and occupational factors with IBS incidence.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of Israeli men and women aged 18-39 years who served in
        active military service (mandatory and career service) between the years 2005-2011
      
Keywords: Irritable bowel syndrome; Epidimiology; Deterioration in the severity of irritable bowel syndrome
Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness
Condition: Substance Use; Victimization
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The SAFE study examines the effects of brief mindfulness-based cognitive-behavioral
      intervention aimed at improving risk-related attention skills (risk detection, problem
      solving, assertiveness, and help seeking) in order to reduce substance use and victimization
      among young people (ages 18-21) experiencing homelessness.
    

Detailed description: 
      Youth (ages 18-21) living at a local youth shelter will be recruited and randomly assigned to
      receive the SAFE intervention (plus usual case management) or to receive usual case
      management only. Those assigned to SAFE will receive 12 mindfulness-based,
      cognitive-behavioral modules through a 3-day intensive group intervention provided by an
      agency intern and a hired project staff member. The intervention uses mindfulness-based
      cognitive-behavioral approaches to augment youth attention to risk-related processes,
      including risk detection, problem solving, assertiveness, and help seeking skills. It is
      hypothesized the intervention will result in reduced substance use and victimization and that
      these effects will be explained, at least in part, by improved risk-related attention skills
      (risk detection, problem solving, assertiveness, and help seeking skills). Post baseline
      interview, participants will be randomly assigned and will participate in a posttest
      interview (1 week post baseline) and follow up interviews at 6-weeks, 3-months, and 6-months
      post baseline interview.
    

Intervention name(s): Safety Awareness For Empowerment (SAFE)
Intervention type(s): Behavioral
Intervention description(s): SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: substance use; victimization; homeless youth; youth experiencing homelessness
This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down Midazolam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate safety and tolerability of BI 705564 in
      healthy male subjects, following oral administration of multiple rising doses.

      Secondary objectives are the exploration of the pharmacokinetics, including dose
      proportionality and investigation of linearity.
    


Intervention name(s): BI 705564; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film-coated tablet; Film-coated tablet; Solution for injection
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Study to Evaluate the Effect of IV ACHN-490 Injection on the QT/QTc Interval in Healthy Volunteers
Condition: Cardiac Effects in Normal Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the study drug, ACHN-490 Injection, affects the
      QT interval in normal volunteers. The hypothesis is that the drug will not cause an increase
      in the QT interval.
    


Intervention name(s): ACHN-490 Injection; ACHN-490 Injection; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20mg/kg IV 30 minute infusion given once; 15mg/kg IV 30 minute infusion given once; 400mg oral pill given once; Placebo oral pill given once
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Thorough QT
A Study of a Moisturizing Cream and Baby Wash in the Management of Mild to Moderate Atopic Dermatitis in Infants, Toddlers and Children
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness (assessed by clinical evaluation
      of eczema/atopic dermatitis severity and parent-perceived benefits) and tolerability
      (assessed by clinical grading and parent-perception) of the investigational cream when used
      in conjunction with a baby wash in babies, toddlers, and children with mild to moderate
      atopic dermatitis.
    


Intervention name(s): Wash IP; Cream IP
Intervention type(s): Other; Other
Intervention description(s): Parent participant will bathe the child participant with the investigational wash at least 3 times per week, but no more than once daily, for 4 weeks.; Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Mesenchymal Stem Cells for Alveolar Bone Tissue Engineering for Cleft Lip and Palate Patients
Condition: Cleft Lip and Palate
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      The aim of this study is to perform the bone tissue engineering to reconstruct the alveolar
      bone defect in cleft lip and palate patients using mesenchymal stem cells from deciduous
      dental pulp associated with a collagen and hydroxyapatite biomaterial (Geistlich Bio-Oss®)
      through prospective qualitative and quantitative analysis of bone neoformation.
    

Detailed description: 
      The reconstruction of the craniofacial skeleton in development between 2 and 10 years old,
      remains a major challenge for reconstructive plastic surgery. Local autogenous bone is
      practically unavailable, the distant bone graft has significant morbidity and use of
      alloplastic materials is incompatible with the growing facial skeleton. With the advent of
      bioengineered tissue, however, osteogenesis induced by the use of mesenchymal stem cells
      associated with biomaterials has become a potential solution to the shortage bone-related
      morbidity and donor bone in the region in pediatric patients.

      The association of mesenchymal stem cells to biomaterials has provided new bone formation and
      a significant reduction of morbidity, for rehabilitation of the alveolar bone in patients
      with cleft lip palate.

      To perform the rehabilitation of alveolar bone cleft, other donor regions of bone (iliac
      crest, ribs, skull) suffer morbidity for obtaining bone to be used in alveolar bone grafting.
      In order to eliminate the morbidity at the bone donor region for these patients and reduce
      costs of patient permanence in the operating room the aim of this study is to perform the
      bone tissue engineering to reconstruct the alveolar bone defect in cleft lip and palate
      patients using mesenchymal stem cells from deciduous dental pulp associated with a collagen
      and hydroxyapatite biomaterial (Geistlich Bio-Oss®) through prospective qualitative and
      quantitative analysis of bone neoformation.
    

Intervention name(s): maxillary alveolar graft by tissue engineering; Bone tissue engineering using mesenchymal stem cells
Intervention type(s): Procedure; Procedure
Intervention description(s): Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;; Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.
Other intervention name(s): alveolar bone graft; bone tissue engineering; bone tissue engineering using mesenchymal stem cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cleft lip and palate; Deciduous dental pulp stem cells; mesenchymal stem cells; tissue engineering; bone tissue engineering; bioengineering