bioihbjkbjnl/mcl2 huggingface dataset:
Therapeutic Effects of Berberine in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether berberine is effective in the treatment of
      type 2 diabetes.
    

Detailed description: 
      Type 2 diabetes is health threats worldwide. However, treatment of this disease is limited by
      availability of effective medicines. All of the existing oral hypoglycemic agents have
      secondary failure after long term administration. Thus, new oral medicines are needed for
      long term control of blood glucose in patients with type 2 diabetes. In diabetes care,
      dietary approaches have drawn more and more attention in the prevention and treatment of
      hyperglycemia. Generally regarded as safe (GRAS) plants have been widely used for their
      benefits in antioxidation, anti-inflammation, anticancer, anti-obesity and anti-diabetes.
      Numerous botanical products such as pigments that include anthocyanins and flavonoids have
      been consumed or studied for anti-obesity and anti-diabetes. However, most of these botanical
      products are mixtures of multiple compounds. It is difficult to control their quality in the
      study or production. Up to now, as a single purified compound, berberine is demonstrated to
      have hypoglycemic effect in vitro and in vivo. Berberine is the main active component of
      Coptis chinensis French, which was used for thousands of years in China in the treatment of
      human diseases including diabetes.

      Comparison(s): Effects of berberine compared with metformin in newly diagnosed type 2
      diabetic patients.
    

Intervention name(s): Berberine; Metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Berberine; Type 2 diabetes; Treatment
Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability, and to explore the
      possible benefit of extended-release niacin (Niaspan®) in attempting to improve the recovery
      of patients after ischemic stroke.
    

Detailed description: 
      The investigators are interested in extended-release niacin (Niaspan®) and its potential
      restorative role after ischemic stroke. At Henry Ford Hospital in Detroit, Michigan,
      extended-release niacin (Niaspan®) has been shown to improve the functional outcomes of rats
      when administered during the first two weeks after ischemic stroke onset. Such results are
      encouraging and warrant further investigation in humans. The specific aims of this study are
      to prospectively evaluate the use of extended-release niacin (Niaspan®) in a phase II
      clinical trial in patients with subacute ischemic stroke. The investigators will assess the
      safety and tolerability of Niaspan® and evaluate outcomes among treated patients at 24 weeks
      after ischemic stroke onset. This will be a randomized, double-blinded, placebo-controlled,
      safety, tolerability, and exploratory efficacy study of extended-release niacin (Niaspan®) in
      subacute ischemic stroke patients with both low HDL-C and normal HDL-C in cohort sizes of 16
      patients. A total enrollment of 48 patients is planned. Patients who are between 72 hours and
      7 days from stroke onset will receive Niaspan® 500mg, 1000mg, or placebo daily for a period
      of 24 weeks. Evaluation of potential safety and tolerability in subacute ischemic stroke
      patients will be made during the course of treatment and at formal visits at 6, 12, and 24
      weeks. The primary safety measures will be death, recurrent stroke, myocardial infarction,
      and neurological worsening during treatment. Exploratory analysis will include functional
      outcomes on the NIHSS scores, modified Rankin scores, and Barthel indices at 24 weeks. The
      goal of this study is to improve the outcomes from ischemic stroke, using a safe and
      effective novel strategy of restoration, which has been translated from basic laboratory
      studies.
    

Intervention name(s): Extended-Release Niacin; Extended-Release Niacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500mg tablet once daily; 1000mg tablet once daily; Placebo tablet once daily
Other intervention name(s): Niaspan®; Niaspan®
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic Stroke; Recovery of Function; Extended-release niacin
The Mass Balance and Biotransformation of [14C]Donafenib in Healthy Adult Man
Condition: Healthy Male Adult
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to evaluate the mass balance and biotransformation after single-dose
      of [14C]Donafenib orally in Chinese healthy adult male volunteers, revealing the overall
      pharmacokinetic characteristics of Donafenib in humans, and providing a reference for the
      rational administration.
    


Intervention name(s): [14C]Donafenib
Intervention type(s): Drug
Intervention description(s): Each volunteers received a single 300 mg dose of [14C]donafenib (toluene sulfonic acid) containing a radioactivity dose of 120 μCi as an oral suspension, in fasting within 5 minutes.
Intervention model: Single Group Assignment
Intervention model description: single arm with single dose of 300mg Donafenib, containing about 120μCi [14C]Donafenib
Masking: None (Open Label)
Primary purpose: Other
Safety of and Immune Response of a 2-dose Regimen of rDEN1delta30 Dengue Virus Vaccine
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue fever, caused by dengue viruses, is a major health problem in tropical and subtropical
      regions of the world. The purpose of this study is to evaluate the safety of and immune
      response to a 2-dose regimen of a new monovalent dengue virus vaccine. This study will test
      the dengue virus vaccine DEN1delta30 in healthy adults.
    

Detailed description: 
      Dengue viruses account for more than 50 million cases of dengue fever and one half million
      cases annually of dengue hemorrhagic fever/shock syndrome. Dengue virus infections can cause
      illness ranging from mild, self-limited febrile illness to life threatening diseases. The
      goal of dengue vaccine development is to induce a long-lived antibody response against all
      four dengue serotypes. The rDEN1delta30 vaccine is a live attenuated dengue virus vaccine
      that may be protective against dengue serotype 1 (DEN1). The purpose of this study is to
      evaluate the safety, reactogenicity, and immunogenicity of a 2-dose regimen of rDEN1delta30
      dengue virus vaccine. The regimen will differ in when the second booster shot of the vaccine
      is given.

      This study will last 162 days (about 23 weeks) for those participants in Cohort 1, and 222
      days (about 32 weeks) for those in Cohort 2. Participants in Cohort 1 will be randomly
      assigned to receive rDEN1delta30 vaccine or placebo on Study Day 0 and Study Day 120.
      Participants in Cohort 2 will be randomly assigned to receive rDEN1delta30 vaccine or placebo
      on Study Day 0 and Study Day 180.

      There will be a total of 25 visits for each cohort. For both cohorts, the first and second
      vaccination days will include a physical exam and blood and urine collection, vital signs
      measurements, and receipt of the vaccine. A 30 minute observation period will follow
      vaccination. Participants will take their temperature at home three times a day for the first
      16 days and report it in a diary. At all other study visits, vital signs measurements, a
      physical exam, and blood and/or urine collection will occur. At selected study visits,
      participants will turn in their diary cards.

      Some participants may be asked to join an optional skin biopsy substudy.
    

Intervention name(s): rDEN1delta30; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated rDEN1delta30 vaccine at a dose of 10^3 PFU; Placebo for rDEN1delta30
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dengue Fever; Dengue Vaccine; Dengue Virus; Dengue Hemorrhagic Fever; Dengue Shock Syndrome
Effect of Kinesiotaping on Muscle Activity
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the investigator's study is to analyze the effect of kinesiotaping (KT) on the
      electrical activity of the muscle by using time and frequency domain analysis of the
      electromyography (EMG) signals.
    

Detailed description: 
      The kinesiotaping (KT) is a taping technique that is commonly used to improve muscle
      performance and facilitate or inhibit muscle activity in rehabilitation. A study reported
      that KT application did not change electrical activity in the early period (immediately after
      KT, 5th and 10 minutes after KT). However, another study showed that EMG activity increased
      24 hours after KT application. A study revealed that the KT produced more EMG activity
      compare to placebo taping. In conclusion, the effect of KT on electrical muscular activity
      was arguable in the literature.
    

Intervention name(s): Kinesiotaping
Intervention type(s): Other
Intervention description(s): For kinesiotaping, the elbow positioned in 30°-45° flexion and kinesiotaping facilitation technique is applied origin to insertion of biceps brachii muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: kinesiotaping; EMG
Effects of Vocational Rehabilitation Group Intervention on Motivation and Occupational Self-Awareness in Individuals With Intellectual Disabilities
Condition: Intellectual Disability
MeSH terms: Intellectual Disability
Study type: Interventional

Summary: 
      This study is an intervention study that investigates the effects of a group-based approach
      to motivation and occupational self-awareness of individuals with intellectual disability
      (ID).

      The intervention method was developed by following the intervention mapping method.

      An 8 weeks group intervention (twice a week) was applied to individuals with ID which
      includes; Introduction to intervention and meeting with other group members self-awareness
      training occupational self-awareness taking responsibility group work and labor division
      problem identification problem-solving

      The entire program was structured and guided by the prepared manual (available upon request
      from the authors). The manual was prepared by the authors of this study to ensure consistency
      between different sessions and groups. All sessions were diffusively explained in the manual
      as well as the individual session booklets. The supervisors were able to follow the structure
      of the sessions from those booklets. Additionally, there were visual materials for each
      session as in; presentations, graphics, and photographs. The program supervisors (therapists)
      met once every week to discuss the progress, participation, and overall status of each
      participant.

      Homework assignments were utilized to facilitate learning. Families were not included
      directly in the group sessions, however were informed about the homework assignments.
      Homework assignments consisted of very basic mental practice and reenactment regarding the
      session's topic and concepts. Families were also included in the final week's sessions since
      graduation certificates were handed out during these sessions and also small celebrations
      were carried out.
    


Intervention name(s): The Entering Employment and Sustaining Work Program; vocational rehabilitation
Intervention type(s): Other; Other
Intervention description(s): A structured, motivation and self-awareness based group intervention; An individual based, focused on desired job or occupation, face-to-face intervention
Other intervention name(s): Occupational therapy - vocational rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind, randomized control study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: self awareness; occupational therapy; vocational rehabilitation; intellectual disability; motivation
Pulsed Electromagnetic Fields for Multiple Chemical Sensitivity
Condition: Multiple Chemical Sensitivity
MeSH terms: Hypersensitivity; Multiple Chemical Sensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether pulsed electromagnetic fields(PEMF) is
      effective in the treatment of multiple chemical sensitivity in terms of life impact,
      symptoms, psychological distress, markers of central sensitization and the immune system, and
      quality of life.
    


Intervention name(s): Pulsed electromagnetic fields; w/o pulsed electromagnetic fields
Intervention type(s): Device; Device
Other intervention name(s): Re5 Independent System; Re5 therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple chemical sensitivity, re5 therapy, pulsed electromagnetic fields
Probiotic Supplementation to Improve the GUT Microbiota of Very Low Birth Weight Preterm, a Pilot Study
Condition: Other Preterm Infants; NEC
MeSH terms: Premature Birth; Birth Weight
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This pilot trial is designed to investigate the benefits of the use of probiotics in GUT
      microbiota development and/or immunological biomarkers and how this can be related with the
      clinical status of very low birth weight preterms during their first weeks of life at the
      neonatal intensive care unit(NICU).
    

Detailed description: 
      This pilot trial is designed to investigate the benefits of the use of mixtures of probiotics
      isolated from human milk in GUT microbiota development and/or immunological biomarkers.
      Furthermore, the relationship between evaluated parameters and the clinical status of very
      low birth weight preterms during their first weeks of life at the NICU will be analysed.
    

Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): blood and fecal samples were collected from five VLBW preterms which were supplemented with a probiotic mixture of Bifidobacterium breve / Lactobacillus salivarius isolated from human milk
Other intervention name(s): "Bifidobacterium breve / Lactobacillus salivarius mixture"
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: VLBW preterm; GUT microbiota; probiotics supplementation; immune compounds
Effects of Manual Therapy Versus Stretching Exercise Versus Routine Physical Therapy on Work-related Pain, Among Chefs
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this research is to analyze the effect of Mulligan technique versus stretching
      techniques and versus routine physical therapy on pain, range of motion and functional
      disability among restaurant chefs presenting with non-specific chronic pain.
    

Detailed description: 
      A Randomized Control Trail study will be conducted, at Riphah International University
      Faisalabad after the approval of synopsis. Purposive sampling will be used to enroll the
      patients. Patients will be selected according to the pre-defined inclusion and exclusion
      criteria. The patients who will meet the inclusion criteria are allocated into three groups.
      The patients of group A will receive Routine physical therapy only. Group B will receive
      manual therapy and routine physical therapy while Group C will receive stretching exercises
      and routine physical therapy. The outcomes will be measured by the Neck Disability Index,
      visual analogue scale and bubble inclinometer. The data of patients will be recorded
      pre-treatment and post-treatment. The comparison between pre-treatment and post-treatment
      data will be done after 3 months. Informed consent will be taken from each patient. Data
      entry and analysis will be done with Statistical Package of Social Sciences Version 20
      software.
    

Intervention name(s): Routine Physical Therapy; Manual Therapy And Routine Physical Therapy; Stretching Exercises And Routine Physical Therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Routine Physical Therapy treatment with hot pack, TENS, and ultrasound helps in improving and relaxing the muscle spasm and soft tissue elasticity along pain reduction.; Mulligan is consider one of the most effective technique of mobilization.it is also important treatment for neck pain so that many physiotherapist used mulligan by including several methods such as Natural Apophyseal Glides or Sustained Natural Apophyseal Glides.; Regular stretching helps increase your range of motion in the joints, improves blood circulation and posture and alleviates muscular tension throughout the body.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Manual Therapy; Stretching Exercises; Routine Physical Therapy; Non Specific Chronic Neck Pain; Restaurant Chefs
Group Education Curriculum for Older Teens With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      SMART T1D is a research study that offers interactive diabetes education for teens with type
      1 diabetes in peer groups led by diabetes nurse educators. Participants in the study will be
      randomly assigned to either receive three of the group sessions in addition to their routine
      clinic care or to receive their usual diabetes clinic care.
    

Detailed description: 
      The objective of this 12-month pilot randomized controlled trial is to evaluate the impact of
      a 3-session group educational curriculum, compared to standard care, on self-care adherence
      and transition readiness in adolescents with type 1 diabetes in the Boston Children's
      Hospital (BCH) Diabetes Program. Adolescents (15-18 years) with T1D will be randomized to
      receive a 3-session group curriculum ("SMART T1D" - Self-Management, Adherence and Readiness
      for Transition in T1D) in addition to usual care (intervention group) or to receive usual
      care with individual diabetes visits (control group) and electronic newsletters to match for
      attention.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Patients randomized to the intervention group will attend 3 SMART T1D group curriculum sessions over the study period, in addition to usual diabetes clinic care. Each interactive group session will last 2 hours and will be facilitated by a diabetes nurse educator.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a 12-month randomized controlled trial evaluating the impact of a health care delivery intervention ("SMART T1D" - a 3-session group educational curriculum), compared to standard care, on self-care adherence and transition readiness in adolescents with type 1 diabetes. Intervention (group sessions) and control (standard care) subjects will complete the study on a parallel timeline.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes Mellitus, Type 1; Adolescence
RDEA3170 PK/PD Study
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of
      RDEA3170 when given as single or multiple doses
    


Intervention name(s): RDEA3170 4.5 mg; RDEA3170 6 mg; RDEA3170 12 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Verinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Exergaming Intervention in ALL Patients
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional

Summary: 
      This is a pilot feasibility study to collect preliminary data for a large-scale exergaming
      intervention in children undergoing maintenance therapy for Acute Lymphoblastic Leukemia
      (ALL). Patients, ages 5-17 years will be randomized to the intervention or non-intervention
      control group. The intervention will consist of 30 minute sessions of exergaming 3-5 times a
      week for 6 months, with weekly assessment of exercise level and phone calls by kinesiology
      graduate students for safety and compliance. Physical activity at baseline and at the end of
      study will be assessed using accelerometers. Outcome measures will include: anthropometrics,
      blood pressure, body composition, visceral fat, vascular function, fasting insulin, fasting
      glucose, LDL-cholesterol, HDL- cholesterol, triglycerides, functional mobility and endurance,
      and strength.
    


Intervention name(s): Exergaming Program
Intervention type(s): Behavioral
Intervention description(s): Participants will exercise through exergaming play.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Acute Lymphoblastic Leukemia; ALL; fitness intervention
Ginseng and Ginkgo Biloba Effects on Cognition as Modulated by Cardiovascular Reactivity
Condition: Blood Pressure; Cognition
Study type: Interventional
Phase: Early Phase 1

Summary: 
      There is some evidence to suggest that ginseng and Ginkgo biloba can improve cognitive
      performance, however, very little is known about the mechanisms associated with such
      improvement. Here, we tested whether cardiovascular reactivity to a task is associated with
      cognitive improvement.
    


Intervention name(s): Placebo; Ginseng; Ginkgo Biloba
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Study subjects received, in a double blind fashion, placebo pills identical to the drug (drug 1-ginseng, group 1; drug 2-ginkgo biloba-group 2); The ginseng group received two capsules containing either 1000 mg or 500 mg of Panax Ginseng extract standardized to 3% of ginsenosides (GNC, USA) or similarly looking placebo capsules over a period of three days of testing.; The ginkgo group received two capsules containing either 240 mg or 120 mg of ginkgo biloba extract standardized to 24% ginkgo flavone glycosides and 6% terpene lactones (GBE24/6) or similarly looking placebo capsules over a period of three testing days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Ginseng; Ginkgo Biloba; cardiovascular reactivity; cognition