bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
Condition: Immune System Diseases; Autoimmune Diseases; Lupus Erythematosus, Systemic; Skin and Connective Tissue Diseases; Connective Tissue Disease
MeSH terms: Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.
    


Intervention name(s): CDP7657; Placebo
Intervention type(s): Biological; Other
Intervention description(s): CDP7657 100 mg/ ml solution
30 mg/ kg initial dose
15 mg/ kg every other week
10 weeks; Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Lupus; SLE
Improving the Assessment of Hypersomnolence
Condition: Disorders of Excessive Somnolence
MeSH terms: Disorders of Excessive Somnolence; Sleepiness
Study type: Observational

Summary: 
      The overall purpose of this study is to employ a pragmatic, multidimensional assessment of
      hypersomnolence that "piggybacks" on routine clinical care in patients with suspected
      disorders of central nervous system (CNS) hypersomnia, to determine whether these additional
      objective and subjective assessments are useful in the diagnosis and management of these
      patients.
    


Intervention name(s): Pupillometry; Psychomotor Vigilance Task; Auditory Evoked Potential; Hypersomnia Severity Index
Intervention type(s): Device; Behavioral; Other; Behavioral
Intervention description(s): Measures pupillary dynamics in darkness and light conditions; Response time task measuring neurobehavioral alertness; Measure of electroencephalographic response to standardized auditory tones; Self-report measure of hypersomnolence
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred for polysomnography and multiple sleep latency test at the University of
        Wisconsin-Madison
Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
Condition: Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is designed to assess the safety and efficacy of flibanserin in the treatment of
      premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard
      diagnostic criteria.

      Efficacy for flibanserin will be assessed vs. a parallel placebo group.
    


Intervention name(s): flibanserin; flibanserin 50mg; flibanserin 100mg; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): flibanserin 25 mg b.i.d; flibanserin 50mg qhs/b.i.d.; flibanserin 50 mg b.i.d/100mg qhs; placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate the Efficacy and Safety of PAC-14028 Cream in Rosacea Patients
Condition: Erythematotelangiectatic Rosacea; Papulopustular Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the efficacy and safety of PAC-14028 1% cream of
      Amorepacific Corporation in patients with erythema-telangiectatic or papulopustular rosacea
    


Intervention name(s): PAC-14028 cream 1%; Vehicle; Rozex gel 0.75%
Intervention type(s): Drug; Other; Drug
Intervention description(s): Participants received topical PAC-14028 cream 1% twice daily for 8 weeks; Participants received topical Vehicle twice daily for 8 weeks; Participants received topical Rozex gel 0.75% twice daily for 8 weeks
Other intervention name(s): PAC-14028; Vehicle of PAC-14028 Cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Feelings Club: Evaluating a School-based Intervention for Children at Risk for Depression and Anxiety Disorders
Condition: Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      Anxiety and mood disorders are among the most prevalent mental health problems in childhood.
      They have severe long-term morbidity, and associated academic and social impairment.

      Building on the investigators' experience with outcome evaluation in clinically anxious or
      depressed children, they propose to evaluate within the school system a cognitive behavioral
      therapy (CBT) intervention for children in grades 3 to 6 with elevated symptoms of anxiety or
      depression on standardized questionnaires.

      The participant's outcomes will be compared with those of similar children randomly assigned
      to an activity control group.

      Hypothesis 1a): Children in the intervention condition will show greater symptom reduction
      relative to children in the control condition (primary outcome: anxiety symptoms).

      Hypothesis 1b): Children in the intervention condition will show fewer symptoms during
      follow-up relative to children in the control condition.

      Hypothesis 2: Children with anxious or depressive symptoms treated in the school setting
      using CBT have a lower risk of developing internalizing disorders within 1 year of treatment
      than children in a control condition.

      Hypothesis 3: Self-esteem, anxiety and depression-related impairment, and academic
      functioning will improve more in intervention participants than in controls.

      Hypothesis 4: School characteristics, child age, and attitudes of participating personnel are
      predictive of treatment response.
    


Intervention name(s): Cognitive Behavioral Therapy; School-based CBT; activity control condition
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 12-session, weekly, school-based protocol based on cognitive restructuring, tailored to children Grades 3 to 6; comparison with activity control condition of equal duration.; 12 sessions, weekly; weekly games & activities x 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Impact of the Fecal Flora Transplantation on Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that
      the intestinal flora is involved in the disease and it has been show that patients with
      Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The
      purpose of this study is to determine the effect of the fecal flora transplantation on
      Crohn's disease.
    

Detailed description: 
      Introduction : Crohn's disease (CD) is an relapsing inflammatory bowel disease relatively
      frequent. Its prevalence is about 1 for 700 in France, affecting predominantly young adults.
      Its treatment is based on immunosuppressants that might be associated with potentially severe
      complications such as infection and cancers. Moreover, these treatments are expensive. The
      gut microbiota being involved in the disease pathogenesis, it can be considered as a
      potential therapeutic target.

      CD pathogenesis remains poorly understood but involves an inappropriate immune response
      toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts. The complete
      replacement of a dysbiotic microbiota by a "healthy" one is thus an attractive strategy.
      Fecal transplantation (FT) has been used with success for a long time in the context of
      Clostridium difficile.

      Hypothesis : Fecal transplantation allow the replacement of a dysbiotic microbiota by a "
      healthy " one with favorable impact on CD evolution.

      Primary endpoint : In CD patient with colonic or ileo-colonic involvement put in remission
      with corticosteroids, Evaluate if FT can modify a dysbiotic fecal microbiota to be closer of
      the one of a healthy donor.

      Methodology

      For the Receiver :

      Once corticoid-induced remission will be achieved, the patient will be included and
      randomised to receive either FT or sham transplantation during a colonoscopy. The patient
      will be evaluated at week 2, 6, 10, 14, 18 and 24. At week 6, a colonoscopy will be
      performed.

      For the Donor :

      Donors will be recruited by poster advertising. When a receiver will be included, 3 donors
      will be contacted to attend an inclusion visit including physical examination as well as
      blood and stool screening for pathogen. The 3 donors will then come the day of the FT to
      donate their stool.
    

Intervention name(s): Fecal Transplantation; Sham Transplantation
Intervention type(s): Other; Other
Intervention description(s): Fecal microbiota (50-100g of stool from donor resuspended in 250-350ml of physiological serum and filtered) given by infusion in coecum during colonoscopy; 250-350ml of physiological serum given by infusion in coecum during colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Inflammatory bowel disease; Crohn's disease; microbiota; fecal transplantation
Interactive Motivational Media for Perinatal Drug Abuse - 3
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Interactive Motivational Media for Perinatal Drug Abuse
    

Detailed description: 
      The goal of this exploratory/developmental proposal is to develop a low-cost, highly
      adaptable brief motivational intervention for perinatal drug abuse via embedding motivational
      principles in a self-contained interactive computer system. The Motivation Enhancement System
      (MES) will utilize a touch-screen, audio enhancement, and an interactive narrator to guide
      women in the immediate post-partum period through evaluation (thus facilitating self-report)
      and a one-time motivational intervention. A taxi voucher will be provided to further
      facilitate entry into treatment, and multiple tailored self-help mailings will be issued
      following discharge. If validated, this intervention could offer a highly cost-effective,
      replicable, and prescriptive method for increasing self-change and treatment involvement in
      drug abusers. Following development of the MES, a preliminary pilot phase will study the use
      of the MES with post-partum drug-using women and make necessary modifications, using data
      from participant debriefings and a single-case research design. After optimization of the
      MES, a clinical trial will randomly assign 120 post-partum drug-using women into treatment or
      assessment only conditions, with a 3-month blinded follow up to evaluate intervention effects
      on drug use and treatment involvement. Toxicological and self-report measures, as well as
      objective analysis of infant development, will be utilized. Participants will be lower
      socioeconomic status urban women.
    

Intervention name(s): Brief computer-delivered intervention
Intervention type(s): Behavioral
Intervention description(s): Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.

      PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children
      who have refractory solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of
      ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the
      pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of
      this drug in this patient population.

      OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to
      pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV
      over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease
      progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of
      ecteinascidin 743 until the maximum tolerated dose (MTD) is determined. The MTD is defined as
      the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting
      toxicities.

      PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.
    

Intervention name(s): ECTEINASCIDIN 743
Intervention type(s): Drug
Other intervention name(s): ET-743; NSC S648766; IND 50,286
Intervention MeSH terms: Trabectedin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified childhood solid tumor, protocol specific
Effects of Motivational Interviewing in Prison
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      Motivational Interviewing (MI) is a communication style demonstrated to decrease drug and
      alcohol use. A five session MI intervention (BSF) was implemented in the Swedish correctional
      system. The intervention was delivered by counsellors with workshop only MI training (BSF) or
      by counsellors with workshop MI training followed by peer group supervision based on audio
      taped feedback (BSF+).

      Aim was to examine whether BSF in prisons reduces drug and alcohol use more effectively than
      interviews conducted according to the usual planning interview routine (UPI).
    


Intervention name(s): Motivational Interviewing; MI
Intervention type(s): Behavioral
Intervention description(s): MI is a communication style defined as a collaborative, person-centred form of guiding to elicit and strengthen motivation to change. The method is based on four principles: showing empathy; developing discrepancy between the subject's current behaviour and an alternate, more desired, behaviour; reinforcing self-efficacy; and "rolling" with resistance to change. Client arguments for change are elicited and reinforced in an atmosphere that is empathic, collaborative and supportive of autonomy. The choice to change and the responsibility for change remain with the client.
Allocation: Randomized
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inmates with heavy use of alcohol or drugs
Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Moderate to Severe Glabellar Lines
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in
      adults with moderate to severe glabellar lines.
    

Detailed description: 
      Subjects are randomly assigned into the two groups at the ratio of 2:1. The purpose of study
      is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in
      subjects with moderate to severe glabellar lines.
    

Intervention name(s): Neuronox; Botox
Intervention type(s): Drug; Drug
Other intervention name(s): Clostridium Botulinum Toxin A 100 U; Clostridium Botulinum Toxin A 50 U
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Combination With G-CSF in Multiple Myeloma Patients
Condition: Autologous Haematopoietic Stem Cell Transplant
MeSH terms: Multiple Myeloma
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-group treatment, phase IV, open label study to assess the mobilization
      efficacy and safety of plerixafor in combination with G- CSF in male and female participants
      from 18 to 75 years of age with multiple myeloma for autologous transplantation. Study
      Duration-Screening-up to 30-day. Intervention and CD34+cells apheresis up-to 8 day. A follow
      up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative
      chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs
      earlier. Study duration up to 75 days. For treatment phase visit frequency-daily.
    

Detailed description: 
      The study duration consists of: An up-to 30-day screening, an up-to 8-day intervention and
      CD34+ cells apheresis and a follow up for 30 days (+7 days) post last dose of plerixafor, or
      the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue
      procedure, whichever occurs earlier
    

Intervention name(s): plerixafor + G-CSF
Intervention type(s): Drug
Intervention description(s): subcutaneous (SC) injection
Intervention MeSH terms: Plerixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF
Condition: Acute-On-Chronic Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients
      with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active
      study period.
    


Intervention name(s): HepaStem
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute-On-Chronic Liver Failure; ACLF
Pioglitazone Versus Metformin in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Type 2 diabetes is an epidemic. Its long-term consequences translate into enormous human
      suffering and economic costs; however, much of the morbidity associated with long-term
      microvascular and neuropathic complications can be substantially reduced by interventions
      that achieve glucose levels close to the nondiabetic range. However, none of the recent
      intervention studies has demonstrated a benefit of intensive glycemic control on their
      primary CVD outcomes.

      The investigators report the findings of a long-term randomized and comparator-controlled
      clinical trial conducted in patients with newly-diagnosed type 2 diabetes. The investigators
      compared the effect of pioglitazone with that of metformin on circulating endothelial
      cell-derived submicroscopic membranous vesicles, termed microparticles: because of their
      putative role in inflammatory processes and their ability to directly affect endothelial
      functions, they are gaining increasing popularity as a surrogate marker of cardiovascular
      outlook. Metformin was chosen as a comparator because the American Diabetes Association
      recommendations suggest to start therapy in newly-diagnosed type 2 diabetic subjects
      combining a drug (metformin) with lifestyle changes. Moreover, the mechanism of action of
      pioglitazone is distinct from that of metformin.
    


Intervention name(s): Pioglitazone; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): 15-45 mg/die; 500-2000 mg/die
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Health Effects of Mentoring
Condition: Cardiovascular Health
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether mentoring is associated with beneficial
      cardiovascular health effects in both mentors and mentees.
    

Detailed description: 
      Participants are randomly assigned to either being a mentor or a wait list control. These
      participants are drawn from a population of undergraduate students. Participants are also
      randomly assigned to either being a mentee or a wait list control. These participants are
      drawn from a population of Chicago Public School children. In total, there will be 30
      mentors, 30 control mentors, 30 mentees, and 30 control mentees. Participants will come for a
      laboratory visit in which cardiovascular health measures will be taken (details below).
      Visits will occur once at baseline (before the intervention starts), and once
      post-intervention. The protocol will be the same at the two study visits. Participants in the
      intervention group will engage in one-on-one mentoring sessions (between mentors and mentees)
      once a week after school for the school year
    

Intervention name(s): Mentoring
Intervention type(s): Behavioral
Intervention description(s): Youth in the intervention group will participate in one-on-one mentoring sessions (between mentors and mentees) once per week after school. Mentoring sessions will focus on the development of a social bond between mentor and mentee.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: mentoring; children; cardiovascular health
Cardiovascular Events in Chronic Obstructive Pulmonary Disease Patients Initiating Olodaterol or Other Long-acting beta2 Agonists
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Examine the risk of cardiovascular events (cardiac arrhythmia or myocardial ischemia) or
      all-cause mortality in Chronic Obstructive Pulmonary Disease (COPD) patients who are new
      users of Olodaterol or other LABAs available for the treatment of COPD.
    

Detailed description: 
      Purpose:

      Time Perspective:
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        COPD patients