bioihbjkbjnl/mcl2 huggingface dataset:
Drug Interaction Study of Digoxin and BI 10773
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to investigate the relative bioavailability of digoxin after
      concomitant multiple oral administration of BI 10773 and a single dose of digoxin in
      comparison to digoxin given alone to healthy male and female subjects.
    


Intervention name(s): Digoxin plus BI 10773; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Digoxin 0.5 mg as single dose, BI 10773 medium dose once daily; Digoxin 0.5 mg as single dose
Intervention MeSH terms: Empagliflozin; Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Facilitating Engagement in Evidence-Based Treatment for Early Psychosis
Condition: Psychotic Disorders
MeSH terms: Psychotic Disorders
Study type: Interventional

Summary: 
      The purpose of this mixed methods study is to evaluate a peer-delivered decision support
      intervention with emerging adults newly enrolled in an early intervention program, also known
      as coordinated specialty care (CSC). It is hypothesized that participants will experience a
      reduction in decision-making needs after participating in the intervention, and that study
      and intervention procedures will demonstrate feasibility and acceptability.
    

Detailed description: 
      The overarching goal of this study is to pilot test a peer-delivered decision support
      intervention (in the form of decision coaching) that is designed to enhance emerging adults'
      treatment decision-making and service engagement after enrollment in a coordinated specialty
      care (CSC) program. Based on an experimental therapeutics approach, this mixed methods pilot
      trial will assess feasibility, acceptability, and the intervention's potential impact on key
      decision-making needs (i.e., decision-making targets). We will track feasibility data related
      to study and intervention procedures, and collect acceptability and outcome data from 20
      emerging adults who will participate in the intervention after enrollment in the CSC program.
      Quantitative analysis related to decision-making targets will provide preliminary evidence
      regarding whether the intervention impacts these targets, while qualitative analysis will
      explain how it may do so. Merged results from these two sets of data will inform intervention
      refinement by providing a nuanced understanding of the intervention's potential to engage
      decision-making targets from the perspective of emerging adults.
    

Intervention name(s): Peer-Delivered Decision Support Intervention
Intervention type(s): Behavioral
Intervention description(s): An intervention provided by a trained peer interventionist to facilitate treatment decision making among emerging adults with early psychosis. Specific components of this intervention may include facilitating access to information, clarifying values, helping a person obtain the needed support to make a decision, and screening for implementation barriers. Due to having lived experience of a mental health condition, the peer interventionist will also be able to provide unique types of information and support within the coaching process.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Decision Support Techniques, Young Adult
Phase I/II Clinical Trial of NPF-08 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Japanese male healthy volunteers will receive NPF-08. The efficacy of NPF-08 will be assessed
      by intestinal cleaning degree. The safety of NPF-08 will be evaluated based on adverse events
      and adverse drug reactions observed from the date of administration to 7 days after
      administration.
    


Intervention name(s): NPF-08
Intervention type(s): Drug
Intervention description(s): Drug: NPF-08 Arms: NPF-08 oral sulfate solution
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Adaptive Study of IL-2 Dose Frequency on Regulatory T Cells in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Type 1 diabetes (T1D) is the most common severe autoimmune disease worldwide and is caused by
      the body's immune destruction of its own insulin producing pancreatic beta cells leading to
      insulin deficiency and development of elevated blood sugars. Currently, medical management of
      T1D focuses on intensive insulin replacement therapy to limit complications (retinopathy,
      nephropathy, neuropathy); nevertheless clinical outcomes remain suboptimal. There are
      intensive efforts to design novel immunotherapies that can arrest the autoimmune process and
      thereby preserve residual insulin production leading to fewer complications and better
      clinical outcomes.

      Genetics are in part the cause of T1D and the majority of genes contributing to T1D produce
      proteins involved in immune regulation (called "tolerance"). A key player in immune tolerance
      is a molecule called interleukin-2 (IL-2) which enhances the ability of cells called T
      regulatory (Treg) cells to suppress the destruction the insulin producing beta cells.
      Aldesleukin is a human recombinant IL-2 product produced by recombinant DNA technology using
      a genetically engineered E. coli strain expressing an analogue of the human IL-2 gene. There
      is substantial data to suggest that ultra-low doses (ULD) of IL-2 (aldesleukin) can arrest
      the autoimmune mediated destruction of pancreatic beta cells by the induction of functional
      Treg cells.

      The former study "Adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes"
      (DILT1D) (NCT 01827735) was a single dose mechanistic study designed to establish the doses
      of IL-2 (aldesleukin) required to induce a minimal Treg increase (0.1 fold from baseline) or
      to induce a slightly larger Treg increase (0.2 fold from baseline) (maximal increase).
      Following on from the DILT1D study, the goal of the DILfrequency study is to use an adaptive
      design to determine the optimal dose and frequency of ULD IL-2 (aldesleukin) to maximize Treg
      function by frequently injecting ultra-low doses of IL-2 (aldesleukin). The responsiveness of
      each T1D participant to a particular frequency of IL-2 (aldesleukin) administration informs
      the frequency of dosing given to the next patient. This strategy focuses on improving the
      function of regulatory T cells that are exquisitely sensitive to IL-2 (aldesleukin).
    


Intervention name(s): Aldesleukin
Intervention type(s): Drug
Other intervention name(s): Proleukin; IL-2
Intervention MeSH terms: Aldesleukin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Interleukin 2; Type 1 diabetes; T regulatory cells; Adaptive trial
The Influence of a Bupivacaine Digital Nerve Block Using Rev G.
Condition: Patients Undergoing Spine Surgery
Study type: Interventional

Summary: 
      The investigators are proposing to continue investigation to improve the accuracy of the SpHb
      (continuous hemoglobin monitoring device) by administering an intermediate acting digital
      nerve block in the finger connected to the SpHb, specifically bupivacaine 0.25% in patients
      undergoing spine surgery. Bupivacaine is FDA approved and in routine use.
    

Detailed description: 
      Patients undergoing spine surgery will be randomized to receive (or not) the bupivacaine
      digital block on the finger attached to the new limited release version of the hemoglobin
      sensor, RevG. The SpHb reading will be compared to a blood hemoglobin level analyzed in the
      UCSF Clinical Laboratories.
    

Intervention name(s): intermediate-acting digital nerve block
Intervention type(s): Other
Intervention description(s): non-therapeutic Bupivacaine digital nerve block to assess effect on accuracy of diagnostic readings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: SpHb; hemoglobin monitoring;bupivacaine digital nerve block
Signaling Mechanisms and Vascular Function in Patients With Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to learn how blood vessel function is altered by diabetes. We are
      studying an investigational drug, Ebselen, to see if it can improve the ability of blood
      vessels to relax (widen).
    

Detailed description: 
      A major cause of death and disability in patients with diabetes mellitus is atherosclerosis.
      Endothelial dysfunction is an important, if not primary, factor in atherogenesis. Nitric
      oxide is an important substance made and released by the endothelium. Many prior studies in
      animals and humans have shown that the ability of the blood vessel to dilate is impaired in
      diabetes. This process of vasodilation is mediated by a substance, nitric oxide, which is
      thought to be highly susceptible to destruction by oxidant molecules. In previous studies, we
      found that acute administration of the antioxidant, vitamin C, improves endothelium-dependent
      vasodilation in blood vessels of patients with type 1 and type 2 diabetes. This suggests that
      by scavenging oxidants, such as superoxide, vitamin C may reduce the destruction of nitric
      oxide and thereby preserve endothelial function. Additional mechanisms, including activation
      of a substance called protein kinase C, and oxidant stress from excess soluble peroxides may
      be present in diabetes and interact with oxidant stress to cause endothelial dysfunction in
      patients with diabetes. Accordingly, we would like to study both of these mechanisms to
      determine their contribution to endothelial dysfunction.
    

Intervention name(s): Ebselen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg BID for 2 weeks; Placebo 1 po BID for 2 weeks
Intervention MeSH terms: Ebselen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Supportive Expressive Therapy for Depressed and Anxious Adolescents
Condition: Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the effectiveness of providing Supportive
      Expressive Therapy to adolescents who are depressed and/or anxious.
    

Detailed description: 
      Supportive Expressive Therapy (SET; a 16 session manualized form of psychodynamic therapy)
      has been well utilized with adult clients. To date, there is no known systematic study into
      the benefit of this method of therapy with adolescents who are depressed and/or anxious. It
      is thought that SET would be useful for this population as it is similar in principle to
      Interpersonal Relationship Therapy (IPT), which has been shown to be effective for use with
      depressed adults and youth. Both IPT and SET help clients explore the role they play within
      challenging relationships in their lives. SET, however, allows for the exploration of more
      relationships within the adolescents' circle. Moreover, SET explores the adolescents'
      perceptions of themselves, others, and their wish in relationships. Further, the SET method
      is more easily individualized in that it affords greater flexibility in design and
      possibility for change over time. Accordingly, the purpose of this study is to explore the
      feasibility of utilizing this method of therapy with adolescents who are depressed and
      anxious. We will be exploring the effectiveness of SET through the resolution of depressed
      and/or anxious adolescents' conflictual relationships thereby reducing their symptomatology.
    

Intervention name(s): Supportive Expressive Therapy
Intervention type(s): Other
Other intervention name(s): therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Anxiety; Adolescents; Treatment; Supportive Expressive Therapy
A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to collect additional pharmacokinetic and safety data of voriconazole
      in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help
      establish voriconazole dosing recommendations for adolescents.
    


Intervention name(s): Voriconazole
Intervention type(s): Drug
Intervention description(s): Voriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.
Other intervention name(s): Vfend
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pharmacokinetics and safety data of voriconazole in immunocompromised adolescents
A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory
      trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in
      patients from 16 to 65 years with epilepsy suffering from partial onset seizures.
    


Intervention name(s): Levetiracetam 250 mg; Levetiracetam 500 mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Active Substance: Levetiracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 250 mg
Route of Administration: Oral Use; Active Substance: Levetiracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 500 mg
Route of Administration: Oral Use; Active Substance: Placebo
Pharmaceutical Form: Film-coated tablet
Concentration: 250 mg and 500 mg
Route of Administration: Oral Use
Other intervention name(s): Keppra; Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsies, Partial,; Keppra, levetiracetam
Visceral Adiposity and CVD Risk in Women
Condition: Cardiovascular Diseases; Heart Diseases; Obesity; Diabetes Mellitus
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To investigate the influence of total body fat and visceral fat on risk factors of diabetes
      and cardiovascular disease (CVD) in black and white women.
    

Detailed description: 
      BACKGROUND:

      Obesity is associated with increased morbidity and mortality. Concern about obesity has
      increased as the prevalence and severity have increased and the age of onset has decreased.
      It has also become clear that the location of fat may play an important role in determining
      the risk associated with obesity. Intra-abdominal fat has been shown to have particularly
      adverse consequences related to cardiovascular risk factors. Of interest is the fact that a
      number of studies have shown that the impact of overall adiposity differs by race. For each
      unit increase in adiposity, blacks appear to have less of an increase in blood pressure and
      triglycerides and less of a decrease in HDL cholesterol compared to whites. This racial
      difference in the relationship of adiposity to cardiovascular risk status may be related to
      differences in the distribution of fat. It is hypothesized that for a given level and
      increase in total body fat (measured by DEXA) black women will have less intra-abdominal fat
      (measured by magnetic resonance imaging).

      The cohort to be studied is a defined group of black and white women who were initially
      recruited into the study as children at age nine or 10 years as part of the National Heart,
      Lung and Blood Institute National Growth and Health Study. The cohort has been maintained and
      studied continuously over the past 11 to 12 years with about 75 percent of the original
      cohort remaining.

      DESIGN NARRATIVE:

      Subjects will be studied at age 23 and again at age 25 years. At each examination, subjects
      will have measurement of total fat (DEXA), intra-abdominal fat (MRI), fasting lipids and
      lipoproteins, insulin and glucose, blood pressure, and left ventricular mass (by
      echocardiography). In addition, the timing of pubertal maturation and dietary intake of fat
      and sucrose will be evaluated as potential determinants of intra-abdominal fat using data
      previously collected from age nine years to age 22 years. Study of this cohort provides a
      unique opportunity to evaluate whether differences in deposition of intraabdominal fat are
      related to racial differences in the relationship between adiposity and cardiovascular risk
      factors. It will also allow evaluation of childhood and adolescent determinants of adult
      intra-abdominal adiposity. The results of this investigation may provide insight into the
      prevention of intra-abdominal fat accumulation and ultimate lowering of risk for
      cardiovascular disease.
Using Mobile Application for Rehabilitation in Patients With Chronic Neck Pain
Condition: Neck Pain; Chronic Pain
MeSH terms: Chronic Pain; Neck Pain
Study type: Interventional

Summary: 
      The aim of this study is to reduce pain, increase range of motion, increase the endurance of
      deep cervical flexors muscles, and increase quality of life with mobile application in the
      treatment of patients with chronic neck pain. Although many benefits of exercises have been
      proven, the effectiveness, follow-up and continuity of exercise will be investigated with
      mobile application tracking.
    

Detailed description: 
      One of the important factors in mechanical chronic neck pain is the decrease in the endurance
      of the deep cervical flexor muscles. As a result of this decrease, an increase to the
      activation of M. Scalenus Anterior and M. Sternocleidomastoid muscles is observed. It is
      known that patients avoid some movements due to pain, and as a result, loss of muscle
      strength and endurance in the neck, upper back, around the scapula and shoulder occurs. The
      loss in strength and endurance, combined with the severity of pain, may affect the stability
      of the upper extremity has been considered.

      Patients with chronic neck pain may experience a number of problems due to the predisposition
      to accompany pain or some problems caused by neck pain. It is known that all these problems
      affect the quality of life of patients by limiting their daily living activities.

      With the developing technology, mobile health applications have started to be used more and
      more in our lives. In addition to preventing disease, reducing risk factors, increasing
      physical activity and quality of life, mobile applications are used in many different areas
      such as diagnosis, treatment, feedback and monitoring.
    

Intervention name(s): Exercise follow up with mobile application; Home-Based Exercise Program followed by paper booklet; Electrotherapy
Intervention type(s): Other; Other; Procedure
Intervention description(s): Exercises will be followed by mobile application. Electrotherapy will be performed.; Exercise will be followed by paper booklet. Electrotherapy will be performed.; Electrotherapy will be performed.
Other intervention name(s): Exercise with Mobile Application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neck Pain; Chronic Pain; mobile Health; Mobile Apps; Quality of Life
Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region
Condition: Soft Tissue Augmentation
Study type: Interventional

Summary: 
      The present study is a human, prospective, single centre, single blind randomised controlled
      clinical tria conducted to explore the feasibility and efficacy of self-inflating hydrogel
      expander (Osmed®) to gain keratinised tissue around the dentulous area. The trial is in
      accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
    

Detailed description: 
      Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for
      the study. A detailed, thorough medical and dental history was obtained and each patient was
      subjected to comprehensive clinical and radiological examination. All patients were informed
      about the nature of the study, surgical procedure involved, potential benefits and risks
      associated with the surgical procedure and a written informed consent was obtained from all
      patients.

      All the patients were implanted with self-inflating hydrogel expander (Osmed®) in
      subperiosteal positions using the pouch technique in the mandibular anterior region. The
      clinical parameters were recorded at baseline, two weeks post expander retrieval, three
      months and six months post-operatively.
    

Intervention name(s): Osmed® hydrogel expander implantation
Intervention type(s): Device
Intervention description(s): Under local anaesthesia, a small vertical incision, adapted to the diameter of the Osmed® sself-inflating hydrogel expander, was made with #15 scalpel blade at the mesial line angle of the adjacent tooth which started below the gingival margin extending from the keratinized tissue above the MGJ to the non-keratinized tissue beyond the MGJ. A minimally invasive preparation of a subperiosteal pouch was performed with KPA tunnelling knife. Size of the pouch was controlled with the specific surgical template to ensure the device easily fits into the prepared pouch without tension. Expanders were secured in the correct position with a bone fixation screw, at the flat end, which does not possess an expansion capability. The wound was closed with 3-0 silk suture using simple interrupted sutures.
Intervention model: Single Group Assignment
Intervention model description: All the patients were implanted with self-inflating hydrogel expander in subperiosteal positions using the pouch technique in the mandibular anterior region.
Masking: None (Open Label)
Primary purpose: Treatment