bioihbjkbjnl/mcl2 huggingface dataset:
Motivational Incentives for Enhanced Drug Abuse Recovery: Methadone Clinics. - 1
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the utilization of incentive values (considerably lower
      than those typically used in research clinics) to motivate clients to attend treatment and
      initiate and sustain abstinence.
    

Detailed description: 
      The purpose of the proposed research is to implement and systematically evaluate, in
      community treatment settings, motivational incentive procedures that have been well
      researched and have proven efficacious in a variety of treatment research clinics. The study
      will determine if motivational incentives along with standard care therapy is more effective
      than standard therapy alone for the treatment of patients using cocaine or methamphetamine
      and entering a substance abuse treatment program.
    

Intervention name(s): Behavior Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment
Keywords: substance use disorders
Using Iron Supplementation to Decrease Iron Deficiency Anemia in Infants and Young Children in India
Condition: Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      The purpose of this study is to determine the smallest dose of Sprinkles, a single-serving
      package of iron and other micronutrients, to treat infants with iron deficiency anemia in
      India. Results have implications for programs using Sprinkles worldwide because lower doses
      of iron may have fewer side effects.
    

Detailed description: 
      Iron deficiency anemia affects two thirds of children in most developing nations, and even
      mild anemia can have serious implications for child development. In India, government
      programs within India have been ineffective in controlling this public health problem due to
      the lack of effective iron supplements reaching children.

      Our research group developed 'Sprinkles', an inexpensive micronutrient supplement which is a
      single-serve sachet of tasteless powder that contain encapsulated iron and other
      micronutrients. Parents can be easily instructed to mix the contents of one sachet into a
      bowl of any complementary food.

      This study is part of a partnership and capacity development between interdisciplinary
      research groups at The Hospital for Sick Children, University of Toronto, Canada and the King
      Edward Memorial Hospital in India, aimed at developing a long-term program of research that
      will address iron deficiency anemia among infants and young children in India. For Sprinkles
      to be implemented into national programs in India, a comprehensive strategy is needed which
      includes a single, safe and effective iron dose for the Indian population.

      This specific study is to conduct a community-based, randomized clinical trial in India to
      determine the appropriate dose of supplementation required for the target age group.
    

Intervention name(s): iron supplement, iron drops
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: anemia; iron deficiency; iron drops; iron supplement; malnutrition; pediatrics
VL-3 Training Study
Condition: Hypertension; Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The primary endpoints for this study are mean and standard deviation error measurements for
      the VLDBPM versus manual auscultation.
    

Detailed description: 
      This is a prospective, controlled, single-arm clinical evaluation. Five hundred thirty-two
      (532) subjects are planned to be evaluated. Each subject's blood pressure will be measured
      using the VLDBPM and manual auscultation. Each subject will be observed while undergoing a
      series of blood pressure perturbation challenges. Means measurement differences from the test
      sensor and the reference auscultation measurements will be used to validate the accuracy of
      the VDBPM software system.

      Screening data will be reviewed to determine subject eligibility. Subjects who meet all
      inclusion criteria and none of the exclusion criteria will be entered into the study.

      Total duration of subject participation will be 1 to 1.5 hours. Total duration of the study
      is expected to be 6 months.

      Following medical history and patient eligibility assessments, eligible patients will be
      offered participation in the study. Once subjects are consented/enrolled, measurements will
      be performed in accordance with Data Collection Procedure section below.
    

Intervention name(s): The Vital Labs Digital Blood Pressure Monitor
Intervention type(s): Device
Intervention description(s): The Vital Labs Digital Blood Pressure monitor is a software-as-a-medical device (SaMD) that is capable of determining blood pressure, after calibration, using waveform changes observed in photoplethysmogram signals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Echocardiographic Screening of Healthy Neonates for Measuring Pulmonary Artery Pressure
Condition: Pulmonary Hypertension of Newborn
MeSH terms: Hypertension, Pulmonary
Study type: Observational

Summary: 
      The aim of the present prospective study was to evaluate dynamic changes in both pulmonary
      artery pressure and ductus arteriosus during the first 72 hours after birth.
    

Detailed description: 
      Healthy newborn infants born in Alexandria University Children's Hospital were studied.
      Dynamic changes during the first 72 hours after birth were evaluated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy newborn infants born in Alexandria University Children's Hospital were studied.
        Dynamic changes in both pulmonary artery pressure and ductus arteriosus during the first 72
        hours after birth were evaluated.
Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics
Condition: Parkinson Disease; Dyskinesias
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's
      disease appearing at different levels of levodopa infusion dose. The hypothesis is that
      different dyskinesias (dystonia, chorea) correlate to different levels of levodopa
      concentrations, as detected in plasma.
    

Detailed description: 
      By using duodenal infusion of levodopa/carbidopa, the plasma concentration of levodopa can be
      kept fairly constant. Different doses, 10-20% higher or lower than the individually optimized
      dose will be used. Motor performance is captured by video recordings to be compared
      to/correlated with plasma levodopa concentrations.
    

Intervention name(s): levodopa/carbidopa
Intervention type(s): Drug
Intervention description(s): intestinal gel, for continuous daytime infusion
Other intervention name(s): Duodopa
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dyskinesias; Duodenal levodopa infusion; Dose optimization; Pharmacokinetics; Pharmacodynamics
In-Situ Simulation Different Debriefing Methods
Condition: Nursing Caries; Satisfaction; Simulation of Physical Illness
Study type: Interventional

Summary: 
      The goal of this pre-test-post-test randomized controlled experimental study is to examined
      the effects of the learning conversation (LC)-based, 3D model-based, and standard debriefing
      methods on critical thinking, debriefing experience, and satisfaction after in-situ
      simulation among intensive care unit (ICU) nurses.

      A total of 186 ICU nurses working in a training and research hospital participated in the
      study. Researchers will compare learning conversation (LC)-based, 3D model-based, and
      standard debriefing methods on critical thinking, debriefing experience, and satisfaction.
    


Intervention name(s): LC-Based Debriefing; 3D Model-Based Debriefing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): LC-based debriefing encourages reflection by allowing learners to identify and explore topics of particular interest. The model is defined as a structured post-event LC, which is useful for improving competence, professional development, and clinical judgment among intensive care unit and trauma nurses. The model is useful not only for one recipient by allowing reflection on positive and negative experiences but also for the whole group by allowing them to make connections to their own practice that day or to previous experiences, supporting teamwork. It also helps them understand what good practice is by doing their own self-assessment with peers' benchmarking.; The model has three parts: defusing, discovering, and deepening. The experiential learning theory on which this model is based facilitates learning goals. This model allows its participants to create new mental models for future practice, develop critical thinking skills, and identify knowledge gaps. In the model, a debriefing session starts with preliminary information and ends with a summary of what has been learned. Participants' gaps in understanding and learning are identified, and how they can apply their learnings to practice is discussed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: in-situ simulation; critical thinking; debriefing; nurse; intensive care
Pharmacokinetics, Pharmacodynamics and Safety Study of Z-213 to Iron Deficiency Anemia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The safety, tolerability, pharmacokinetics and pharmacodynamics of Z-213 will be investigated
      in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500
      mg, 800 mg or 1,000 mg iron).
    


Intervention name(s): Z-213
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Z-213, Ferric carboxymaltose, Iron, Iron-deficiency-anemia
Reconstruction of Digital Nerve Lesions With Muscle-in-Vein Conduits
Condition: Peripheral Nerve Injury Upper Limb
MeSH terms: Peripheral Nerve Injuries
Study type: Observational

Summary: 
      Muscle-in-vein conduits (MVCs) provide an alternative for bridging digital nerve defects when
      tension-free suture is not possible. Low donor site morbidity and absence of additional costs
      are favorable advantages compared to autografts or conduits. 37 patients with 43 defects of
      proper palmar digital nerves were retrospectively enrolled. Primary repair by MVCs was
      performed in 22 cases while 21 underwent secondary reconstruction. Recovery of sensibility
      was assessed by static and moving two-point discrimination (2PDs, 2PDm) and Semmes-Weinstein
      monofilaments (SWM). Results were compared with contralateral side serving as intraindividual
      control. Outcome data were stratified according to international guidelines and evaluated for
      differences in terms of age, gap length, time of reconstruction and concomitant injuries.
    


Intervention name(s): Nerve reconstruction
Intervention type(s): Other
Intervention description(s): Nerve bridging with muscle-in-vein conduits
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The mean age of all patients was 38.0 years (SD 18.4, range 6-72). All patients aged
        younger than 18 years were males whereas patients older than 60 years tend to be females.
A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral
      administration of four dosing regimens of posaconazole relative to placebo and terbinafine,
      in the treatment of toenail onychomycosis.
    


Intervention name(s): SCH 56592; SCH 56592; SCH 56592; SCH 56592; Terbinafine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.; Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.; Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.; Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.; Terbinafine 250 mg QD for 12 weeks.; Placebo for 24 weeks.
Other intervention name(s): Posaconazole; Noxafil; Posaconazole; Noxafil; Posaconazole; Noxafil; Posaconazole; Noxafil
Intervention MeSH terms: Posaconazole; Terbinafine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study to Investigate the Effects of Krill Oil on Fasting Serum Triglycerides
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of 12 weeks of daily supplementation with
      Superba(TM) Krill Oil on fasting serum triglyceride levels and omega-3 index in subjects
      whose habitual fatty fish and seafood intake is low and who have borderline high or high
      fasting serum triglyceride levels.
    


Intervention name(s): Krill Oil
Intervention type(s): Dietary Supplement
Intervention description(s): 4 Capsules twice daily providing 0 (placebo), 0.5, 1.0, 2.0, or 4.0 g krill oil/day for a period of 12 weeks
Other intervention name(s): Superba(TM) Krill Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Maintenance of normal blood triglyceride levels
A Clinical Bite Force Study of Two Marketed Adhesives Against no Adhesive
Condition: Denture Retention
Study type: Interventional

Summary: 
      The objective of this study will be to compare bite force (BF) measurements over a 12-hour
      period of a currently marketed denture adhesive cream based on carbomer technology (test),
      with a positive control and a negative/no treatment control.
    

Detailed description: 
      This will be a single centre, randomized, crossover, 3-treatment, 3-period study to compare
      BF measurements over a 12 hour period of a currently marketed denture adhesive cream based on
      carbomer technology (test), with a positive control, and a negative/no treatment control. A
      short questionnaire regarding the flavor and texture characteristics of each denture adhesive
      after a single use will also be used to generate data for these attributes. This study
      included four visits: Visit 1 (screening visit), Visit 2, 3, 4 (treatment visits).
    

Intervention name(s): Test Product; Positive Contol; Negative Control
Intervention type(s): Other; Other; Other
Intervention description(s): Five strips of test adhesive cream for upper denture, as per application instructions.; Three dabs of positive control adhesive cream for upper denture, as per application instructions.; No adhesive
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance
Condition: Collagen Synthesis; Rate of Force (RFD) Development
Study type: Interventional

Summary: 
      Determine whether supplementation with a combined dose of 20 g of hydrolyzed collagen and 50
      mg vitamin C, along with a power training exercise program, increases rate of force
      development (RFD) and performance in athletes
    


Intervention name(s): Collagen and Vitamin C powder mix nutritional intervention; Maltodextrin placebo powder; Maximum power training exercise
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): 20 g collagen + 50 mg vitamin C daily, 60 min prior to exercise; 20 g maltodextrin placebo daily, 60 min prior to exercise; Explosive/power-based exercise training program 3 times/week at home consisting of drop jumps, box jumps, weighted jump squats loaded in a progressive manner weekly for 3 weeks. At baseline and at the end of each of the 3 weeks, measures of explosive performance are assessed in the lab (maximal isometric squat, counter-movement jump and squat jump)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: exercise; performance; athletes
The Study of Olanzapine Plus Fluoxetine in Combination for Treatment of Treatment Resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of this study are to determine:

        -  Whether olanzapine plus fluoxetine in combination will help patients with
           treatment-resistant major depression.

        -  The safety of olanzapine plus fluoxetine in combination, plus and any side effects that
           might be associated with the combination.

        -  The effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine
           alone.
    


Intervention name(s): Olanzapine; Fluoxetine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Genes are the "blueprints" for our bodies. Some people are born with an abnormal copy
      ("mutation") of a gene. These people may have a higher chance of getting a disease. Different
      mutations in different genes cause different diseases. Some women get breast cancer because
      they are born with an abnormal copy of a gene called BRCA1 or BRCA2. These women also have a
      higher chance of getting ovary cancer. Women with breast cancer and an abnormal copy of BRCA1
      or BRCA2 also have a higher chance of getting a second breast cancer in their other breast.
      Because of this, women who might have a mutation may have genetic testing soon after their
      breast cancer diagnosis to learn about their risks of getting another cancer.

      Genetic testing may be done right after a woman has been diagnosed with breast cancer. It may
      also be done later, after surgery is done to treat the cancer. The investigators do not know
      when it is best to do genetic testing. The investigators are doing this study to try to
      understand whether women prefer testing before or after surgery. The investigator also want
      to find out how they feel about their choice later on, when their diagnosis in more in their
      past.
    


Intervention name(s): BRCA testing and questionnaire assessments
Intervention type(s): Genetic
Intervention description(s): If they consent to enroll, they will complete an instrument evaluating their beliefs regarding the value of genetic testing (Assessment 1). After that, they will decide whether they wish to attend an information session on genetic predisposition. If they do, after completing that information session they will complete a follow-up instrument (Assessment 2), and will then decide to either immediately donate a sample for immediate testing, or to defer the decision until after surgery. Women will be given the results of their genetic testing in the context of a standard results counseling session, after which they will continue with clinical care. They will be followed for clinical decision, especially whether or not they undergo CPM.
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective study of women who meet a subset of the NCCN criteria for genetic
        testing and are presenting to the Breast Surgery Clinic for treatment of a newly diagnosed
        breast cancer.
      
Biospecimen description: 
      peripheral blood leucocytes and/or mouthwash-collected buccal epithelial cells)
    
Keywords: Genetic testing; BRCA testing; Ashkenazi descent; 11-086
Stereotactic Radiosurgery for Patients With Hepatic Metastases.
Condition: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and
      cause less damage to normal tissue.

      PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic
      radiosurgery in treating patients with liver metastases.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the maximum tolerated dose of fractionated stereotactic radiosurgery in
           patients with hepatic metastases.

        -  To determine the dose-limiting toxicity of stereotactic radiosurgery in these patients.

        -  To assess the tumor response in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive 3-5 fractions of stereotactic radiosurgery over 14 days in the absence of
      disease progression or unacceptable toxicity.

      Cohorts of 9-13 patients receive escalating doses of stereotactic radiosurgery until 60 Gy is
      reached or the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
      preceding that at which > 33% of patients experience dose-limiting toxicity.

      After completion of study therapy, patients are followed at 6 weeks, every 3 months for 1
      year, every 6 months for 2 years, and then annually for 2 years.
    

Intervention name(s): stereotactic radiosurgery
Intervention type(s): Radiation
Allocation: Non-Randomized
Primary purpose: Treatment
Keywords: liver metastases; unspecified adult solid tumor, protocol specific
A Study of AZD4205 in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the safety, tolerability, pharmacokinetics of AZD4205 following
      single and multiple ascending dose in healthy adult subjects, and to assess the effect of
      food on the pharmacokinetics of AZD4205.
    


Intervention name(s): AZD4205; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days; Single dose in SAD and once daily for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment