bioihbjkbjnl/mcl2 huggingface dataset:
A Study of DPC 817 in HIV-Infected Males
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate DPC 817. The safety, dosages, and how the body
      responds to the drug will be studied.
    

Detailed description: 
      The study will consist of two parts. Patients in Part A will receive a single dose of DPC 817
      on two separate occasions and a placebo (a solution or tablet without the drug) on one
      occasion. Patients in Part B will receive two separate doses of DPC 817. Patients will be
      admitted to the clinical study unit the day before dosing (Day -1) and remain there for at
      least 48 hours after taking the study drug. Patients will return to the clinical study unit
      on Day 8 and Day 28 following the dose in the last treatment period. During the study there
      will be medical and medication histories taken, physical examinations, vital sign
      measurements, and routine clinical laboratory tests.
    

Intervention name(s): DPC 817
Intervention type(s): Drug
Intervention MeSH terms: Dexelvucitabine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV; Phase I
Validity Reliability of 3 Meter Backward Walk Test in Stroke Patients
Condition: Stroke Syndrome; Balance; Distorted; Walking, Difficulty
MeSH terms: Stroke; Mobility Limitation
Study type: Interventional

Summary: 
      The 3 m walk-back test is used to assess neuromuscular control, proprioception, protective
      reflexes, fall risk, and balance. In a study of healthy elderly adults, a 3-m walk-back test
      showed better diagnostic accuracy compared to the most commonly used measurement methods for
      falls in the past year. Reliability is extremely important, especially for research and
      clinical applications. In order to assess the risk of falling, measurement methods need to be
      reliable and change accurately over time. 3 m walk back test was found to be reliable in
      healthy elderly individuals. However, there are no studies investigating the validity and
      reliability of this test in stroke patients.
    

Detailed description: 
      Balance; within the limits of the stability of the center of gravity can be controlled on the
      surface. Balance can be affected due to muscle weakness after stroke, abnormal muscle tone,
      loss of deep sensation and disturbances in vestibular mechanisms. Among all sensorimotor
      results of stroke, it is stated that the balance of postural control has the greatest effect
      on daily living activities and gait. Accurate assessment of balance in stroke patients is
      important in identifying appropriate aids for mobility, choosing an effective treatment
      program, determining safe and unsafe activities, and setting rehabilitation goals. The most
      common risk factor for falls is one of the most important risk factors for stroke. Therefore,
      reliable and accurate measurement of dynamic gait balance is an important issue in stroke
      patients.The 3 m walk-back test is used to assess neuromuscular control, proprioception,
      protective reflexes, fall risk, and balance. In a study of healthy elderly adults, a 3-m
      walk-back test showed better diagnostic accuracy compared to the most commonly used
      measurement methods for falls in the past year. Reliability is extremely important,
      especially for research and clinical applications. In order to assess the risk of falling,
      measurement methods need to be reliable and change accurately over time. 3 m walk back test
      was found to be reliable in healthy elderly individuals. However, there are no studies
      investigating the validity and reliability of this test in stroke patients.
    

Intervention name(s): stroke patinets
Intervention type(s): Other
Intervention description(s): 3-m backwards walk test, timed up and go test, 10 m walk test, Berg BalanceTest, Functional Reach Test
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a
      meningococcal vaccine formulation in adolescents.
    


Intervention name(s): Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine; Meningococcal (group B) multicomponent recombinant adsorbed vaccine; Tdap
Intervention type(s): Biological; Biological; Biological
Intervention description(s): The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine; Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine; Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Meningococcal disease; vaccines; adolescents; prevention; Meningitis
Skills Training for Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The proposed study will be an initial test of a cognitive-behavioral intervention for
      adolescents with ADHD who are receiving medication treatment. It is based on our successful
      work with adults with ADHD who have been treated with medicines but are still having
      symptoms. It involves learning skills for organization and planning, attention, and mood.
    

Detailed description: 
      Attention Deficit Hyperactivity Disorder (ADHD) is a prevalent, distressing, and interfering
      condition that affects between 2% and 6% of adolescents. Although medications have been
      widely used as an effective treatment for many years as the sole treatment for ADHD, for
      many, clinically significant and interfering continued symptoms remain. Even after medication
      treatment, adolescents still experience residual ADHD symptoms and continue to have problems
      with inattention, concentration, disorganization, and other symptoms. However, research
      suggests that adolescents who have received some benefit from medication treatment can then
      experience further symptom reduction from participation in skills-based cognitive behavioral
      therapy. This study, adapted from a similar research study for adults with ADHD, will examine
      whether cognitive behavioral therapy (CBT) plus medication is more effective at treating ADHD
      than medication therapy alone in adolescents with ADHD.

      Eligible participants will be randomly assigned to receive twelve weekly treatment sessions
      either immediately upon enrolling in the study or after a four-month waiting period.
      Questionnaires (that participants complete and ones that are done with an interviewer) will
      be used to assess participants' ADHD symptoms at study entry, after receiving the treatment,
      and at 4 month follow-up. Parents will have some involvement in therapy.

      Note: participants must be able to come to Boston or another study location in the Greater
      Boston area for 4 assessment visits and 12 weekly therapy visits in order for participation
      to be feasible.
    

Intervention name(s): Cognitive Behavioral Therapy (CBT)
Intervention type(s): Behavioral
Intervention description(s): Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
Other intervention name(s): Compensatory executive skills training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent; ADHD
Testing Alcohol Interventions Among Job-seekers
Condition: Hazardous Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the randomized controlled trial was to test two behavioral interventions among
      job-seekers with risky drinking. The interventions differed in their theoretical background:
      Intervention A was tailored to the stage of change, and Intervention B was
      non-stage-tailored. Over 12 months, job-seekers were pro-actively screened for risky drinking
      at three job-agencies. Job-seekers with risky drinking were asked to participate in the
      study. All three groups were assessed at baseline, and 3, 6 and 15 months later. The baseline
      assessment was self-administered using handheld computers. The follow-up assessments by
      interviews on the phone, primarily. Both intervention groups received individualized computer
      generated feedback letters at baseline and 3 months later.
    


Intervention name(s): Stage-tailored intervention; Non-stage-tailored Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Based on the Trans-Theoretical Model of intentional behavior change (TTM). According to their stage of change, participants received two computer generated feedback letters on their risky drinking, stage of change, processes of change, self-efficacy, and decisional balance. The first letter included normative feedback (interpersonal comparison with other individuals in the same stage), and was sent out by mail after baseline. The second letter included normative and ipsative feedback (intrapersonal comparisons: baseline vs. 3 months later), and was sent out by mail three months later.; Based on the Theory of Planned Behavior (TPB). Participants received two computer generated feedback letters on their risky drinking, beliefs (behavioral, normative, control), attitude, subjective norm, perceived behavioral control, intention, and they were asked to fill in a where-when-how to change plan. The first letter included normative feedback (interpersonal comparison with other women/ men), and was sent out by mail after baseline. The second letter included normative and ipsative feedback, and was sent out by mail three months later.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Risky drinking; Brief intervention; Computer-generated feedback; Stage-tailored; Non-stage-tailored
Intranasal Insulin for COVID-19-related Smell Loss
Condition: Anosmia; Smell Loss; Paraosmia; Hyposmia; COVID-19
MeSH terms: COVID-19; Anosmia; Olfaction Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study was to quantify the improvement in olfaction of 27 post-COVID-19
      patients, after three intreventions of intranasal insulin during a four week period, with the
      help of the Threshold, Discrimination and Identification (TDI) score evaluated with Sniffin
      Sticks®.
    


Intervention name(s): Insulin
Intervention type(s): Drug
Intervention description(s): Gelfoam® cottonoids soaked in 40 IU of NPH insulin were placed on the nasal roof (between the nasal septum and the middle meatus) of each nostril. These remained in place for 15 minutes and were later removed. This procedure was performed in three visits one week apart. During the fourth and last visit (one week after the previous visit), olfaction was reevaluated using the measures previously described.
Other intervention name(s): intranasal insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anesthetic Optimization in Scoliosis Surgery
Condition: Adolescent Idiopathic Scoliosis; Respiratory Depression; Postoperative Pain
MeSH terms: Scoliosis; Respiratory Insufficiency
Study type: Interventional

Summary: 
      The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery
      will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest
      opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid
      respiratory depression and allow patients to respond quickly either during intraoperative
      testing or at the conclusion of surgery.
    

Detailed description: 
      As part of this study, anesthesiologists will be given additional data on the expected drug
      effects based on a computer simulation. The data will be provided as a suggestion and will be
      used together with all the other information normally used to keep the study subjects safely
      asleep during surgery. In addition, data will be collected from the medical history and on
      postoperative pain control and medication side effects for the first 24 hours. Specifically,
      study subjects will be asked to rate their pain on a 10-point scale after they wake up from
      surgery and once they arrive in the pediatric intensive care unit. Measures of the time from
      the end of surgery until the study subjects are awake and out of the operating room will also
      be collected.
    

Intervention name(s): pharmacokinetic simulation
Intervention type(s): Other
Intervention description(s): The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Adolescent Idiopathic Scoliosis; Scoliosis surgery; Pharmacokinetic simulation
Efficacy and Safety of Berberine in the Treatment of Diabetes With Dyslipidemia
Condition: Diabetes Mellitus, Type 2; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Berberine has showed effective in lowering blood sugar levels in db/db mice and
      anti-dyslipidemia in human. These findings have not been tested in a clinical trial. This
      randomized, double blind, placebo controlled and multi-center study has demonstrated that
      berberine is effective in lowering plasma glucose concentrations, reducing serum HbA1c and
      anti-dyslipidemia in type 2 diabetic patients with dyslipidemia.
    

Detailed description: 
      Berberine, a natural plant alkaloid, has not been well investigated for clinical application
      in the treatment of diabetes. The present study evaluated the efficacy and safety of
      berberine in the treatment of type 2 diabetic patients with dyslipidemia. 116 patients with
      type 2 diabetes and dyslipidemia were assigned in a randomized, double-blind, and
      placebo-controlled 4-clinical center study to receive berberine (1.0g daily) or placebo for 3
      months. The primary efficacy outcomes were changes in plasma glucose and serum lipid levels.
      The glucose disposal rate (GDR) was measured using a hyperinsulinemic euglycemic clamp to
      assess insulin resistance in a randomly selected subjects of 54 patients. The baseline
      characteristics were similar in berberine and placebo groups. After 3 months, fasting and
      post load plasma glucose levels, HbA1C, triglyceride, total cholesterol and LDL-C levels were
      all significantly reduced in the berberine group compared with the placebo group (p<0.0001,
      p<0.0001, p<0.0001, p=0.002, p<0.0001 and p<0.0001 respectively). The GDR was significantly
      increased after 3 months of berberine (p=0.037), while no change was found in the placebo
      group (p=0.86). BMI, systolic blood pressure and serum IL-6 levels were all significantly
      reduced after treatment in berberine group as compared with the placebo group (p=0.016,
      p=0.041 and p=0.014, respectively). Our results show berberine to be effective and safe in
      the treatment of persons with diabetes and dislipidemia. This agent may be useful in the
      treatment of patients with type 2 diabetes, and could play a role in treatment of metabolic
      syndrome.
    

Intervention name(s): Berberine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Berberine; Type 2 diabetes; Dyslipidemia
Pivotal Response Treatment for Children With Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the application of an evidence-based, manualized
      treatment for children with Autism Spectrum Disorder (ASD) (Pivotal Response Treatment, PRT)
      to children ages four through six years of age with ASD. Specifically, children will be
      randomly assigned to receive either (1) 10 hours per week of intervention services, including
      two hours per week of parent education, and eight hours per week of direct
      clinician-delivered services, or (2) a treatment as usual control. Intervention will focus on
      enhancing the following developmental skills: expressive and receptive language, play, and
      social interaction. Outcome measures will address changes in the aforementioned domains
      during structured observation and standardized assessment.
    


Intervention name(s): Pivotal Response Training
Intervention type(s): Behavioral
Intervention description(s): Behavioral intervention for autism
Other intervention name(s): Pivotal Response Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASD
A Relative Bioavailability Study of Bupropion Sustained Release 150 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of Abrika Bupropion
      150 mg sustained release tablet to that of Wellbutrin SR sustained release tablet after a
      single, one-tablet dose in fasted subjects.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study
      of Bupropion Sustained Release Tablets in Fasted, Normal, Healthy Men.

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Bupropion 150 mg Extended-Released Tablet, single dose; Wellbutrin SR® 150 mg Sustained-Release Tablet, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Abrika formulated products under fasting conditions; B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions
Other intervention name(s): Bupropion; Bupropion
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Bupropion; Healthy subjects
Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the
      effects of other treatments for type 2 diabetes in a normal practice setting. The participant
      will be assigned by chance (like flipping a coin) to one of the following treatment groups:
      Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care
      antidiabetic medication (oral or injectable). The participant has an equal chance of being in
      either of the treatment groups. Neither the participant nor the study doctor or study staff
      will be able to pick which group the participant is in, but the participant will know which
      study drug the participant has been assigned to. The study doctor will provide the
      participant with a prescription for the study diabetes medication based on the treatment
      group the participant is assigned. The participation will last about 2 years.
    


Intervention name(s): Semaglutide; Standard of care
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be prescribed commercially available semaglutide s.c. and will be instructed to initiate treatment with semaglutide s.c. according to the approved label. The study doctor will determine the intended maintenance dose of semaglutide, as well as changes to the maintenance dose thereafter.; Participants will receive standard of care, defined as commercially available oral or injectable antidiabetic medication other than semaglutide. Participants will be prescribed and instructed to initiate commercially available antidiabetic medication according to the approved label and, if relevant for the specific antidiabetic medication, adjusted at the discretion of the study doctor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in ERAS Programs for Radical Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced
      recovery after surgery (ERAS) programs.
    

Detailed description: 
      In recent years, enhanced recovery after surgery (ERAS) programs were applied in gastrectomy
      in areas with a high prevalence of gastric cancer, such as China and Japan, confirming that
      ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without
      increasing the occurrence rate of postoperative complications. However, in most studies on
      ERAS for gastric cancer, patients who received neoadjuvant chemotherapy were excluded.
      Investigators designed this study aimed to evaluate whether patients who receive neoadjuvant
      chemotherapy can enrolled into enhanced recovery after surgery programs for locally advanced
      gastric cancer.
    

Intervention name(s): NAC group; Surgery alone group
Intervention type(s): Procedure; Procedure
Intervention description(s): NAC is the name of a procedure. NAC doesn't mean different interventions are used. Patients in this group need receive this NAC procedure instead of one drug before the gastrectomy and ERAS. The program consists of an intravenous injection of 130 mg/m2 oxaliplatin on day 1, followed by oral administration of 50 mg tegafur gimerac (the name of an anticarcinogen) twice daily on days 1-14, every 3 weeks.; Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a single-center, parallel, open-label randomized controlled trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; neoadjuvant chemotherapy; enhanced recovery after surgery; gastrectomy