bioihbjkbjnl/mcl2 huggingface dataset:
Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Body Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effect of the baseline body mass index (BMI)
      on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with
      newly diagnosed type 2 diabetes
    


Intervention name(s): Metformin XR
Intervention type(s): Drug
Intervention description(s): Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intraprostatic Injection of Botulinum Toxin A Versus Ethanol for Treatment of Patients With Benign Prostatic Hyperplasia
Condition: Male; Ultrasonography; Botulinum Toxins, Type A; Injection; Complications, Infection; Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      To compare safely and efficacy of intraprostatic injection of botulinum toxin A versus
      ethanol for treatment of benign prostatic hyperplasia (BPH).
    

Detailed description: 
      To compare safely and efficacy of transrectal intraprostatic injection of botulinum toxin A
      versus ethanol for treatment of symptomatic benign prostatic hyperplasia (BPH) refractory to
      medical treatment.
    

Intervention name(s): Botulinum toxin A; Ethanol
Intervention type(s): Procedure; Procedure
Other intervention name(s): onaBONT/A; botox; onabotulinumtoxinA; dehydrated ethanol
Intervention MeSH terms: Ethanol; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ethanol ablation of the prostate; Benign prostatic hyperplasia (BPH); Prostate; Ethanol; Transrectal; BPH; onaBoNT-A; Botox; Lower urinary tract symptoms; Botulinum toxin; OnabotulinumtoxinA; Quality of life; IPSS; Randomised controlled study
Safety, Efficacy and Pharmacokinetics of Subcutaneous ACZ885 in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
Condition: Arthritis, Juvenile Rheumatoid
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a multi-center, open label, repeated dose, range finding study to evaluate the
      safety, tolerability, immunogenicity, pharmacokinetics and efficacy of ACZ885, a fully human
      anti-interleukin-1B (anti-IL-1B) monoclonal antibody, given subcutaneously in pediatric
      subjects with active SJIA.
    


Intervention name(s): ACZ885
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic Juvenile Idiopathic Arthritis; Immunogenicity; Pharmacokinetics; Anti-IL-1ß Monoclonal Antibody; ACZ885; SJIA; Pediatrics
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With ADRD
Condition: Anxiety; Caregiver Burden
MeSH terms: Caregiver Burden
Study type: Interventional

Summary: 
      The purpose of the study is to test if Acceptance and Commitment Therapy (ACT), a behavioral
      intervention designed to increase psychological flexibility in the face of challenges,
      reduces anxiety associated psychological distress in dementia caregivers compared to the
      control group who will receive self-help and educational materials. This version of ACT is
      delivered over the phone in six primary sessions and one booster session.
    


Intervention name(s): Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias
Intervention type(s): Behavioral
Intervention description(s): A telephone-based acceptance and commitment therapy for caregivers
Other intervention name(s): TACTICs
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to receive either the TACTICs telephone therapy or the minimally enhanced usual care packet of information.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dementia; Alzheimer's disease; Caregiving; Caregiver; Anxiety; Telehealth
The Effect of Acupressure on the Anxiety Level
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This randomized controlled study evaluates the effect of acupressure application on the
      anxiety level of senior nursing students.The hypothesis of this study is that acupressure
      reduces anxiety levels.
    

Detailed description: 
      Methods: In the study, 52 senior nursing students were randomly assigned to the study and
      control groups. The study group (n = 26) included Shen Men, the 7th acupuncture point (HT7)
      of the heart meridian located between the ulna and pisiform bones on the radial side of the
      flexor carpi ulnaris tendon, EX-HN3 (Yintang) located in the middle of the beginning of both
      eyebrows and the thumb and the LI4 points located in the space between the index finger
      (between the 1st and 2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal
      bone on the radial side) will be applied for an average of 10 minutes. No intervention will
      be made to the control group (n = 26). In order to avoid ethical problems, both groups will
      be given an informative training on acupressure and anxiety content at the end of the study.
      The primary outcome of the study is the effect of acupressure on the state anxiety level of
      senior nursing students. The secondary outcome of the study is the effect of acupressure on
      trait anxiety level in senior nursing students. The results will be collected before the
      acupressure and in the 4th week of the last intervention.
    

Intervention name(s): Acupressure
Intervention type(s): Other
Intervention description(s): Before starting the application, the students will be asked to rub the area around the area to be pressed for 20-30 seconds with their palms. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in the area of warming, relaxing and preparatory will be reduced and the tissue will be relieved. . The students will be asked to press the designated point manually with their thumb, index or middle finger for 5 seconds with a depth of 1-1.5 cm, rest for 2 seconds and continue the practice for 2 minutes
Other intervention name(s): Acupress
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, two-arm randomized controlled clinical trial
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Acupressure; Nursing students; Anxiety; COVID-19
Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD
Condition: Congenital Heart Defects; Down Syndrome; Gross Motor Development Delay
MeSH terms: Down Syndrome; Heart Defects, Congenital; Syndrome
Study type: Observational

Summary: 
      Congenital heart diseases (CHD) are detected in 40-60% of individuals with Down syndrome (DS)
      and increase the risk of developmental delay in the presence of syndromes. The aim of the
      study was to compare cardiopulmonary parameters, gross motor development and hand grip
      strength in DS children with and without CHD. Demographic variables, cardiopulmonary
      parameters and echocardiographic values were recorded. Gross motor development was evaluated
      with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the
      Baseline Pneumatic Bulb Dynamometer.
    


Intervention name(s): evaluation of cardiopulmonary parameters, gross motor development and hand grip strength
Intervention type(s): Diagnostic Test
Intervention description(s): Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer. Cardiopulmonary parameters values was evaluated with echocardiography.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children with down syndrome
      
Keywords: congenital heart defects; Down syndrome; motor skills
Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effect of treatment with fingolimod on the immune response
      following seasonal influenza vaccination and tetanus booster injection in patients with
      relapsing MS.
    


Intervention name(s): Fingolimod; Placebo; Seasonal influenza vaccine; Tetanus toxoid vaccine
Intervention type(s): Drug; Drug; Biological; Biological
Intervention description(s): Fingolimod 0.5 mg capsules for oral administration.; Matching placebo capsules for oral administration.; Commercially available injectable influenza vaccine for the 2010/11 influenza season.; Commercially available tetanus toxoid vaccine booster injection.
Other intervention name(s): FTY720; Agrippal (TM); Tetanol (TM)
Intervention MeSH terms: Vaccines; Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Relapsing multiple sclerosis; MS; Immune response
Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis
Condition: Late Onset Neonatal Sepsis
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Interventional
Phase: Phase 3

Summary: 
      Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature
      organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to
      narrow-spectrum antibiotics like ampicillin and gentamicin and require introduction of new
      agents with a wider spectrum of activity.

      Meropenem has activity against wide variety of Gram-negative and Gram-positive bacteria. It
      is well tolerated by children and neonates, including preterm babies, and allowing
      monotherapy instead of combined therapy.

      Severe neonatal infections with increasing antibiotic resistance are major problems affecting
      morbidity and mortality in the NICU. Few number of new antibacterial agents entering the
      clinic and new agents for multi-drug resistant Gram-negative bacteria will unlikely be
      available in the near future.
    

Detailed description: 
      More research into existing antibiotics with novel mechanisms of action are required to
      combat the increased resistance and decreased development of antibiotics. Efforts were
      exerted to maximize antibiotic efficacy by optimal dosing based on pharmacodynamic and
      pharmacokinetic properties of antibiotics.

      Meropenem is administered mostly via a 30-min infusion, as some data indicate rapid
      degradation after reconstitution. Dose recommendations from two pediatric studies using Monte
      Carlo simulation have emphasized that a 4-h infusion may be needed if microorganisms showed
      increased minimal inhibitory concentrations (MICs), more specifically, for Pseudomonas
      aeruginosa. A prolonged-infusion strategy has not been tested in neonates, although some data
      suggest that extremely small infusion volumes may significantly affect the drug amount
      actually delivered.

      Aim of work:

      The objective of our study is to compare the clinical and bacteriological efficacy of
      conventional intermittent dosing of meropenem to the prolonged infusions in critically-ill
      neonates, with a proactive focus on reducing ventilator days in ventilated patients, length
      of stay in NICU, and neonatal mortality.
    

Intervention name(s): Meropenem.
Intervention type(s): Drug
Intervention description(s): Infants in both groups will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection
Intervention MeSH terms: Meropenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: meropenem; infusion; late-onset sepsis; newborn; management
Effects of Physical Training and Isoflavone Supplementation On Pelvic Floor in Women in the Postmenopausal Period
Condition: Pelvic Floor
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effect of Physical Training and Supplementation of Isoflavone About
      Pelvic Floor Musculature in Women in the Postmenopausal period, and it has two groups the
      intervetion.
    

Detailed description: 
      The practice of physical exercise and isoflavone supplementation are ways of treating
      symptoms of climacteric, there is a lack of evidence as to whether these therapeutics when
      associated are useful for improving the strength, function, contraction pressure, electrical
      activity of the pelvic floor musculature of women in the Postmenopausal period.
    

Intervention name(s): Exercise; isoflavone; placebo
Intervention type(s): Other; Other; Other
Intervention description(s): The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.; Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).; Daily supplementation in 1 capsule per day containing starch of corn.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: pelvic floor; climateric; exercise; Supplementation of Isoflavone
Hibiscus Sabdariffa and Centella Asiatica in the Treatment of Anemia by Iron Deficiency
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      The study aims to investigate the prevalence of genetic polymorphisms in adults with iron
      deficiency and anemia, and the responses to two different treatments: iron sulphate and a
      composite herbal medicine (Hibiscus sabdariffa plus Centella asiatica). The main outcome will
      be hemoglobin, measured before and after 6 weeks.
    


Intervention name(s): Herbal medicine; Iron
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive a combination of Hibiscus sabdariffa (powdered dry plant), 200 mg, BID, and Centella asiatica tincture, 40 drops, BID, for 6 weeks.; Patients will receive iron sulphate, 500 mg, BID, plus orange juice, for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: iron; anemia; herbal medicine; phytotherapy; Centella asiatica; Hibiscus sabdariffa
Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Social difficulties are serious and frequent complicating factors in the treatment of
      post-traumatic stress disorder (PTSD). To better understand how treatment of post-traumatic
      stress disorder impacts neural mechanisms of social cognition, the investigators are
      examining behavior and brain processes associated with response to Trauma Management Therapy.
      Understanding the behavioral and neural impact of psychotherapy may contribute to development
      of more effective treatments for PTSD.
    

Detailed description: 
      PTSD is associated with significant interpersonal difficulties that interfere with
      functioning. As such, this work is intended to evaluate the empirical support for a novel
      treatment that fills a significant gap in the treatment options available to Veterans with
      PTSD who suffer with interpersonal difficulties. In this study the investigators will (i)
      evaluate the efficacy of Trauma Management Therapy (TMT) for treating PTSD-related
      interpersonal dysfunction, as well as PTSD-related fear and anxiety, and (ii) evaluate neural
      mediators of clinical improvements associated with TMT.

      This work will provide insights into the mechanisms by which treatments may lead to
      improvements in social functioning, informing both the biological basis of psychotherapy and
      the development and refinement of alternative therapeutic interventions targeting social
      impairments.

      Treatment seeking Veterans with PTSD will be randomized to one of two treatments: (i) Trauma
      Management Therapy, consisting of 12 sessions of individualized exposure therapy followed by
      24 sessions of group-based social and emotional rehabilitation, or (ii) Exposure + Comparison
      Treatment Group consisting of 12 sessions of individualized exposure therapy followed by 24
      sessions of group-based psychotherapy. Veterans enrolled in both the TMT and EXP+GRP arms
      will undergo functional neuroimaging as they engage in an emotional image viewing task, as
      well as two social interaction tasks. Neurobehavioral assessments will be made prior to and
      following completion of treatment.
    

Intervention name(s): Trauma Management Therapy; Exposure Therapy with Psychotherapy group
Intervention type(s): Other; Other
Intervention description(s): Trauma Management Therapy (TMT) consists of a combination of 12 sessions of individualized exposure therapy and 24 sessions of group-based social and emotion rehabilitation.; Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.
Other intervention name(s): TMT; EXP+GRP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: PTSD; neuroimaging; fMRI; veterans; exposure therapy; treatment
Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      Oral carvedilol administered in escalating doses in patients with atrial fibrillation among
      patients with AF with fast ventricular rate.
    

Detailed description: 
      Patients with AF with FVR of any etiology were evaluated and given escalating doses of oral
      carvedilol in doses - 3.125mg OD, then 3.125 bid, then 6.25mg bid, then 12.5mg bid. The ECG
      was recorded regularly and analysed for rate reduction or control.
    

Intervention name(s): oral carvedilol
Intervention type(s): Drug
Intervention description(s): oral carvedilol in escalating doses for reducing ventricular rate in AF patients
Other intervention name(s): oral carvedilol in esclating doses
Intervention MeSH terms: Carvedilol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; rate reduction
Correlation Between Core Temperature and Skin Temperature in Pediatrics
Condition: Temperature Change, Body; Anesthesia; Children, Only
MeSH terms: Body Temperature Changes
Study type: Observational

Summary: 
      During general anesthesia, temperature monitoring is critical especially in pediatrics.
      Recently developed 3M™ Bair Hugger™ skin temperature which is applied on temporal artery is
      correlated with core temperature measure by esophageal prove in several studies. Conventional
      skin temperature over carotid artery is also correlated with core temperature in several
      studies. The purpose of this study is comparing 2 methods of temperature monitoring in
      pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second,
      3M™ Bair Hugger™ applying on carotid artery.
    

Detailed description: 
      Core temperature should be monitored under general anesthesia. Because patients are prone to
      hypothermia during surgery, besides, pediatric patients are more vulnerable in temperature
      control. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But
      some of them are invasive and impossible in sometimes. Recently developed 3M™ Bair Hugger™
      skin temperature which is applied on temporal artery is correlated with core temperature
      measured by esophageal prove in several studies. Its mechanism is making zero heat flux on
      skin applied. But it also cannot apply in head or facial surgery. Other studies showed
      conventional skin temperature over carotid artery is also correlated with core temperature.
      The investigators hypothesized using 3M™ Bair Hugger™ on carotid artery could be alternative
      method measuring core temperature. The purpose of this study is comparing 2 methods of
      temperature monitoring in pediatrics. First, conventional core temperature measure by
      esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.
    

Intervention name(s): Esophagus temperature monitoring; Carotid artery temperature monitoring
Intervention type(s): Other; Other
Intervention description(s): Measuring core temperature by esophageal stethoscope; Measuring temperature on skin near to carotid artery using 3M™ Bair Hugger™ temperature monitoring system
Other intervention name(s): core temperature; 3M™ Bair Hugger™ temperature monitoring
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients aged 1 to 5 years old who scheduled surgery under general anesthesia.
        Who need esophageal temperature monitoring for routine monitoring.
      
Keywords: pediatric; temperature; general anesthesia