bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Efficacy Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency for Acne Scar
Condition: Acne; Scar
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar
      radiofrequency treatment for acne scar.
    

Detailed description: 
      Efficacy and safety of microneedling radiofrequency for acne scar Efficacy and safety bipolar
      radiofrequency treatment for acne scar compare the efficacy and safety profile of
      microneedling radiofrequency and that of bipolar radiofrequency treatment for acne scar
    

Intervention name(s): microneedling radiofrequency device; bipolar radiofrequency
Intervention type(s): Device; Device
Intervention description(s): Microneedling radiofrequency device is composed of 49 insulated microneedle which emit radiofrequency from the needle tip. This radiofreqeuncy generates dermal heat which evokes biological effect.; bipolar radiofrequency instrument gives out bipolar radiofrequency from the hand piece tip. This bipolar radiofrequency generates dermal heat which has a lot of bilogical effect.
Other intervention name(s): INFINI(Lutronics, Goyang, Korea); Polaris(syneron, israel)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne; acne scar; microneedling radiofrequency; bipolar radiofrequency
Social Skills Group Training ("KONTAKT") for Children and Adolescent With High-functioning Autism Spectrum Disorders
Condition: Autism Spectrum Disorder (ASD); Attention Deficit Hyperactivity Disorder (ADHD); Anxiety; Depression
MeSH terms: Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      This trial investigates the behavioral effects of manualized social skills training (KONTAKT)
      in children´s and adolescents with high-functioning autism spectrum disorder with psychiatric
      comorbidity in a RCT, multicenter study. N = 288 are recruited from 10 child and adolescent
      psychiatric clinics in Stockholm County. The examination of genetic variants as predictors
      for outcome and a qualitative study of KONTAKT complete the trial.
    

Detailed description: 
      There are few randomized controlled trials of social skills group training for the Children's
      and adolescents with high functioning autism spectrum disorders (HFA)(1). The Objective of
      this trial is to investigate the behavioral effects of the manualized social skills group
      training KONTAKT (2,3) and the role of genetic variants for training effects.
    

Intervention name(s): Social skills group training, KONTAKT
Intervention type(s): Behavioral
Intervention description(s): KONTAKT is a manual-based social skills group training for children with high functioning autism spectrum disorder (ASD). The program is based on cognitive behavioral therapy (CBT) principles and knowledge of social cognition. The group treatment includes exercises in social skills as well as discussions of social cognition, social interaction, self-reflection and description of themselves and others. The children are training to make contact, to understand and follow social rules, to become aware of themselves and others, to perceive verbal and nonverbal signals in a communication, to develop problem solving skills and coping strategies to manage conflict and to enhance their self-confidence. Intervention includes 12 (brief intervention) and 24 (long intervention) sessions. Each group consists of 4-8 children/adolescents ant two group leaders. The treatment are conducted in cooperation with both parents and teachers.
Other intervention name(s): Social skills training; Social skills group training; KONTAKT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism spectrum disorder; Social skills training; Group training; Comorbidity; Intervention; Evidence-based
Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Weight Gain; Gestational Weight Gain
Study type: Interventional
Phase: Phase 3

Summary: 
      Insulin has many disadvantages for mothers with GDM including the need to give injections,
      frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite,
      weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to
      insulin for women with GDM who are unable to cope with the increasing insulin resistance of
      pregnancy.

      This study aim to compare maternal weight gain during pregnancy in women with gestational
      diabetes, treated by insulin versus metformin.
    


Intervention name(s): Insulin; Metformin; Assessment of weight gain
Intervention type(s): Drug; Drug; Other
Intervention description(s): Women with GDM will receive insulin and tailored according to their blood glucose levels to achieve glycemic control. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.; Women with GDM will receive metformin and tailored according to their blood glucose levels to achieve glycemic control. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.; Body weight will be measured monthly from the start of treatment till delivery.
Other intervention name(s): Cidophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety Study of Recombinant Interferon Variant(PEG-IFN-SA) to Treat HCV Disease
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether PEG-IFN-SA is safe, tolerant and effective
      in the treatment of HCV patients.
    

Detailed description: 
      Chronic infection with the hepatitis C virus (HCV) is a significant public health problem in
      china. Progressive liver disease, as a result of chronic HCV infection, usually develops
      slowly over 20-50 years and may lead to cirrhosis, hepatocellular carcinoma, liver failure
      and eventual death. Symptoms are typically mild and non-specific but nevertheless can cause a
      decrease in quality of life. Peginterferon alfa and ribavirin combination therapy is
      currently used in the china for treatment of chronic HCV. Successful treatment is considered
      to be attainment of a sustained virological response (SVR), defined as undetectable serum HCV
      ribonucleic acid (RNA) 6 months after cessation of treatment.

      PEG-IFN-SA is a new recombinant interferon variant. Its N-terminus is modified by 20KD
      molecular weight single-methoxy polyethylene glycol (PEG). It consists of 171 amino acids
      before modification. PEG-IFN-SA is reorganization, unnatural existence and a new type of
      interferon (171Arg126Asp171IFN) after modification. The safety, tolerance and antiviral
      activity of PEG-IFN-SA was tested in adults with HCV infection.

      PEG-IFN-SA was injected subcutaneously one times per week for 12 times. Peginterferon alfa-2a
      (Pegasys) is the positive control drug. 80 patients were randomly assigned to eight groups
      (PEG-IFN-SA 1.0μg/kg, Peginterferon alfa-2a 180 μg, PEG-IFN-SA 1.5 μg/kg，PEG-IFN-SA 2 μg/kg，
      PEG-IFN-SA 3 μg/kg，PEG-IFN-SA 1.5μg/kg + ribavirin 0.45g/bid group，Intergen 15μg/48hours for
      7 times and ribavirin 0.45g/bid for 10 times).

      Clinical and biological adverse effects were recorded every week such as headache, nausea and
      vomiting. HCV RNA level was tested by COBAS Taqman HCV Test system of Roche. Blood cell
      counts were tested using an automatic cell counter such as WBC, neutrophil, PLT and HGB.
      Biochemical indicators were tested by automatic biochemical analysis instrument.
    

Intervention name(s): interferon
Intervention type(s): Drug
Intervention description(s): PEG-IFN-SA (new interferon) was injected subcutaneously one times per week for 12 times.
Intervention MeSH terms: Interferons
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recombinant interferon, tolerated, effective
Efficacy of Teeth Whitening Product Offerings in Adults
Condition: Tooth Discoloration
MeSH terms: Tooth Discoloration
Study type: Interventional

Summary: 
      This is a 30 day randomized, parallel comparative trial where participants with tooth shade
      of C2 or darker will be assigned to one of five groups. The participants will be evaluated
      for the difference in tooth shade, as determined by the digital VITA Easyshade V (provided by
      GLO) before the respective whitening regimen (baseline), immediately following the treatment
      period, and at 30 days (~4 weeks) from end of the treatment intervention.
    


Intervention name(s): Hydrogen peroxide teeth whitening gel; GLO Brilliant Teeth Whitening Device; GLO Lit Teeth Whitening Device; GLO Science Professional Teeth Whitening Device
Intervention type(s): Other; Device; Device; Device
Intervention description(s): Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%; Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.; Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.; Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
Intervention MeSH terms: Hydrogen Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Teeth whitening; Teeth bleaching; Tooth discoloration
Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that
      will be administered every 4 weeks.
    

Detailed description: 
      Sample size calculation will be done by means of Simon's method in 2 stages for phase II
      studies and will be based on the principal aim of the study (evaluation of the rate of
      objective response).

      The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate
      of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment
      when the rate of response targets be lower than 35 %. In this case, considering an alpha
      error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study
      would continue if more than 5 objective responses were found. The total number of patients to
      including in the study would be 44. The results will be significant if they find at least 20
      objective responses.

      Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.
    

Intervention name(s): Liposomal Doxorubicin; Cyclophosphamide; Trastuzumab
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Caelyx; Cytoxan; Herceptin
Intervention MeSH terms: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HER2 positive breast cancer; Metastatic breast cancer
Effectiveness of the Nicotine Patch in Suppressing Nicotine Withdrawal Symptoms in Women Versus Men - 1
Condition: Smoking Cessation; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Women typically have a more difficult time quitting smoking than men. Little research has
      been done to understand the differences between men and women that may cause this
      distinction. This study will assess whether the reduced effectiveness of nicotine replacement
      therapy in women is caused by gender differences in the withdrawal suppression induced by
      nicotine replacement therapy.
    

Detailed description: 
      Smoking can cause a variety of cancers, cardiovascular disorders, and other health problems.
      Quitting smoking greatly decreases one's risk for these problems. Studies have shown,
      however, that quitting smoking is more difficult for women than men. Despite that knowledge,
      little research has been done to try to understand the mechanistic differences between men
      and women that may cause this distinction. This study will assess whether the reduced
      effectiveness of nicotine replacement therapy in women is caused by physical and
      psychological gender differences in the withdrawal suppression induced by nicotine
      replacement therapy.

      Participants in this double-blind study will attend 4 treatment sessions, each approximately
      6.5 hours long and each corresponding to one of four transdermal nicotine replacement patch
      doses (0, 7, 21, or 42 mg). Sessions will be separated by at least 48 hours to avoid
      carryover effects. Immediately following arrival at each session, participants' expired air
      carbon monoxide (CO) levels will be measured to verify that the participant has not smoked
      for at least 8 hours prior to the visit. If the CO level meets the necessary criteria to
      proceed, a baseline blood sample will be obtained, followed by additional blood samples every
      30 minutes. Baseline nicotine withdrawal levels will be assessed using questionnaires.
      Computerized recordings of physiological responses will also commence and will continue
      throughout the session. These response measures will include heart rate, percent oxygen
      saturation, skin temperature, systolic and diastolic blood pressure, and mean arterial
      pressure. Upon completion of baseline measures, participants will receive a randomly assigned
      dose of nicotine replacement therapy, in the form of three patches placed on the
      participants' back. The patches will be removed after 6 hours and the participant will be
      assessed for any residual effects from the medication.
    

Intervention name(s): nicotine transdermal system
Intervention type(s): Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: tobacco
Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's Disease
Condition: Parkinson Disease; Neurodegenerative Diseases
MeSH terms: Parkinson Disease; Neurodegenerative Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Study AFF011 is a randomized controlled parallel Group phase I study to investigate the
      safety and tolerability of two doses of the vaccine AFFITOPE® PD03A given to patients with
      early Parkinson's disease.

      In total 36 patients will be enrolled in 3 independent groups (2 treatment groups, 1 Placebo
      group), each consisting of 12 patients. The patients will be randomized to either receive
      15µg or 75µg AFFITOPE® PD03A formulated with adjuvant or the reference substance without
      active component (Placebo). Over a study duration of 52 weeks, the study participants receive
      4 injections as basic immunization in a 4-weekly interval and 1 boost immunization 36 weeks
      after the first injection. Male and female patients aged 45 to 70 years can participate in
      the trial. 2 study sites in Austria (Innsbruck and Vienna) will be involved.

      AFF011 is part of a project SYMPATH funded by the European Commission
      (FP7-HEALTH-2013-INNOVATION-1 project; N° HEALTH-F4-2013-602999).
    


Intervention name(s): Low dose AFFITOPE® PD03A + Adjuvant; High dose AFFITOPE® PD03A + Adjuvant; Adjuvant without active component
Intervention type(s): Biological; Biological; Biological
Intervention description(s): s.c. injection; s.c. injection; s.c. injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The COMBINE clinical trial is a pilot study evaluating the effects of nicotinamide and
      lanthanum carbonate on serum phosphate and fibroblast growth factor 23 (FGF23) in patients
      with Chronic Kidney Disease (CKD) stages 3-4.
    


Intervention name(s): Nicotinamide; Lanthanum Carbonate; Placebo (for Nicotinamide); Placebo (for lanthanum carbonate)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sugar pill manufactured to mimic Nicotinamide 750 mg capsule; Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Quality of Life Validation in Laryngitis
Condition: Laryngopharyngeal Reflux (LPR)
MeSH terms: Laryngitis; Gastroesophageal Reflux; Laryngopharyngeal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study was to establish the psychometric properties of a new
      disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the
      questionnaire that were evaluated were: validity, reliability, and responsiveness to change
      (as a measure of treatment effect).
    


Intervention name(s): Omeprazole; Quality of Life questionnaire
Intervention type(s): Drug; Behavioral
Other intervention name(s): Losec
Intervention MeSH terms: Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Laryngopharyngeal reflux (LPR); Omeprazole; Losec; Quality of Life; Laryngitis
Mindfulness-Based Cognitive Therapy (MBCT) and Cognitive Behavioral Therapy (CBT) for Depression in Diabetes Patients
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether mindfulness-based cognitive therapy
      (MBCT)and cognitive behavioral therapy (CBT)are effective in reducing depressive symptoms in
      patients with diabetes.
    

Detailed description: 
      Depression is a common co-morbidity of diabetes, negatively affecting physical performance,
      glycemic control, adherence to medication, and dietary, and exercise recommendations.
      Modalities of psychotherapy like cognitive behavioral therapy (CBT) and mindfulness-based
      cognitive therapy (MBCT) can reduce depressive symptoms in patients with medical conditions.
      However, proper designed randomized trials assessing and comparing effectiveness of these
      psychological interventions are rare.

      This longitudinal study aims to investigate the effectiveness of CBT and MBCT in reducing
      depressive symptoms in diabetes patients. Furthermore, potential moderators and mediators of
      treatment effect will be explored, as well as the role of common factors and treatment
      integrity.
    

Intervention name(s): Mindfulness-Based Cognitive Therapy (MBCT); Cognitive Behavioral Therapy (CBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.; The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 45 to 60 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy of FSGM Cloud-based Remote Intervention for Insulin-dEpendent Diabetic Patients (FRIEND)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      To investigate the efficacy of remote intervention by medical staff based on a cloud system
      of continuous glucose monitoring data in patients with insulin-dependent diabetes using flash
      sensor-based glucose monitoring (FSGM).
    

Detailed description: 
      -  Previous studies have been reported on the efficacy of CGM or FSGM and education on
           glucose control in insulin-dependent diabetes patients.

        -  This study aims to investigate whether it is more effective to receive remote
           intervention by medical staff based on a cloud system, than only to use FSGM and receive
           general education on FSGM.

        -  Trial design : parallel group, allocation ratio 1:1, a superiority study design
    

Intervention name(s): Intervention by medical staff based on a cloud system
Intervention type(s): Other
Intervention description(s): Remote intervention by medical staff (between Visit 1 and Visit 2; Week 2, 4, 6, 8, 10) : analyzing continuous glucose monitoring data for last two weeks in the cloud system
- Intervention contents
Diet, exercise pattern
Causes of hypoglycemia
Causes of hyperglycemia
Causes of glycemic variability
Counseling for improvement plans for the cause
Counseling to strengthen lifestyle modification
Counseling for insulin administration
Counseling for Insulin dose adjustment (adjusted dose)
Counseling for how to use a FSGM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Remote intervention; Flash sensor-based glucose monitoring; Type 1 diabetes mellitus; Insulin-dependent diabetes mellitus