bioihbjkbjnl/mcl2 huggingface dataset:
One-year Prospective Observational Study of BMI Change Effect of 5-alpha Reductase Inhibitor in Korean BPH Patients
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Observational

Summary: 
      It is widely-accepted that serum testosterone level and BMI (body mass index) representative
      of the degree of obesity has negative correlation. Considering the fact that obesity is being
      mentioned as a risk factor for development of prostate cancer as well as other various
      life-threatening diseases (example: cardiovascular problems), the effect of BPH treatment
      agents on BMI is a subject that should certainly be elucidated. Meanwhile, to our knowledge,
      no prospective study has so far been performed on such issue in Asian population. Prior to
      generating hypothesis of the effect of 5 alpha reductase inhibitor on BMI, the real effect of
      5 alpha reductase inhibitor on BMI change in Korean BPH patients has to be observed in real
      clinical practice. This study will test the effects of one-year medication of 5 alpha
      reductase inhibitor on BMI among Korean men with BPH.
    

Detailed description: 
      This study is a prospective, 1-year follow-up, observational study. We are planning to enroll
      100 Korean patients with BPH. At each visit, patients' height, weight, abdominal
      circumference will be checked. Laboratory parameters including fasting glucose, HbA1c, serum
      testosterone, free testosterone, sex hormone-binding globulin, estradiol, maximum flow rate
      (measured by flowmetry) will be tested. Blood test will be performed twice (at baseline and
      at the end of study). 5mL of blood will be needed at each time from one subject. And total
      IPSS score will be evaluated after 1 year of treatment of 5 ARI. At every visit, use of above
      prohibited medicines and other medications will be investigated. In addition, any surgical
      procedures undertaken during study period will be asked and recorded.

      Subjects of study will be allocated into 3 separate groups. Group 1 will be those taking 5
      alpha reductase inhibitor (dutasteride) only for 1 year. Group2 will be those who switch from
      alpha blocker to dutasteride and take dutasteride for 1 year. Group 3 will be composed of
      those taking both alpha blocker and dutasteride for 1 year.

      composed of
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We recruited men aged 45-75 years with moderate to severe symptomatic BPH (IPSS > 7 and a
        peak urinary flow rate of < 15 mL/s),an enlarged prostate (≥30 mL on TRUS), a PSA level of
        <10 ng/mL, and no evidence of prostate cancer (on a DRE or TRUS) among patients who visited
        our clinic.
      
Keywords: dutasteride; body mass index; testosterone
A Comparison of the Metabolic Effects of Fructose, Glucose, High Fructose Corn Syrup and Sucrose at Normal Population Consumed Levels in Adults Aged 20-60 Years Old
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the acute and chronic effects of consumption
      fructose containing sugars and glucose in a real word setting when consumed in a manner and
      amount typical in the American diet.
    

Detailed description: 
      Fructose is known to be metabolized differently than the other common monosaccharides. In
      addition to the well know lipogenic effects, more recent evidence has shown that the acute
      changes in hormones and metabolic parameters that control appetite and energy regulation when
      with fructose consumption may promote caloric overconsumption and, in the long-term, weight
      gain. However, fructose is rarely consumed in isolation, but instead is consumed in
      combination with other sugars (with glucose in the case of the two most common sources of
      fructose: high fructose corn syrup (HFCS) and sucrose, or as part of a mixed macronutrient
      meal. As such, the practical significance of these short-term findings of isolated
      monosaccharide consumption is limited.

      AIM 1: investigate the response to ten weeks of daily consumption of different fructose
      containing sugars and glucose at typical intake levels on various metabolic parameters and on
      fat content of the liver and skeletal muscle.

      AIM 2: To investigate whether ten weeks of daily consumption changes the acute metabolic
      response when these sugars are consumed as part as mixed nutrient meals.
    

Intervention name(s): Dietary Compliance
Intervention type(s): Behavioral
Intervention description(s): Incorporation of sugar sweetened milk into the usual diet. Instruction on how to account for additional calories provided by sugar sweetened milk Weekly compliance checks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Fructose; High fructose corn syrup; Energy regulation; Ectopic fat; Understanding; potential
OCTA and Retinal Angiomatous Proliferation
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      To investigate, using optical coherence tomography angiography, the retinal vascular features
      in patients affected by RAP.
    

Detailed description: 
      Retinal vascular anomalous complex represents a distinct form of neovascularization in
      patients with age-related macular degeneration.

      The study investigated the changes in retinal vascular network using optical coherence
      tomography angiography, a novel and non invasive diagnostic technique that allows to better
      understand the pathophysiologic mechanism of this neovascularization.
    

Intervention name(s): optical coherence tomography angiography
Intervention type(s): Diagnostic Test
Intervention description(s): optical coherence tomography aniography is a non-invasive, fast, diagnostic imaging technique that evaluates the retinal vascular network
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 65 years with diagnosis of age-related macular degeneration
        and in particular retinal angiomatous proliferation and reticular pseudodrusen.

        They did not present other ophthalmological diseases.
Bryostatin Treatment of Moderately Severe Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety, tolerability, and long-term efficacy of bryostatin 1 (hereafter
      referred to as bryostatin) for the treatment of moderately severe Alzheimer's disease (AD).
    

Detailed description: 
      This is a randomized double-blind placebo-controlled, Phase 2 study comparing bryostatin-1 to
      placebo for long-term efficacy in the treatment of moderately severe AD (Mini Mental State
      Examination, 2nd edition scores of 10-18 at baseline) in the absence of memantine. Eligible
      subjects will receive 7 doses of bryostatin (i.v., 20μg) or matching placebo during the first
      12 weeks. A second course of treatment consisting of 7 doses will begin 30 days after the
      final dose of the first treatment period. Cognitive tests will be assessed at intervals
      during the study and 4 months after the final dose of study drug. The primary endpoint is the
      total SIB score assessment obtained at Week 28, following completion of 2 courses of
      treatment.
    

Intervention name(s): Bryostatin 1; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks, followed by a second identical course of treatment beginning 30 days after completion of the first 7-dose course.; Placebo administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks, followed by a second identical course of treatment beginning 30 days after completion of the first 7-dose course.
Intervention MeSH terms: Bryostatin 1
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study subjects will be randomized 1:1 to receive either the active treatment, bryostatin-1, or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in the United States of America (USA) and Canada. This trial is
      designed to show the effect of treatment with liraglutide when added to existing
      rosiglitazone and metformin combination therapy and to compare it with the effects of therapy
      with rosiglitazone and metformin alone.
    


Intervention name(s): liraglutide; rosiglitazone; metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Liraglutide; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prospective Research of Outcomes After Salpingo-oophorectomy
Condition: BRCA1 Gene Mutation; BRCA2 Gene Mutation
Study type: Observational

Summary: 
      PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2 mutations
      who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or nonsurgical
      management. The investigators will compare the change in cardiovascular health, bone health,
      sexual function, quality of life, and menopausal symptoms over 3 years of follow-up between
      women who undergo RRSO (baseline just prior to surgery) and age-matched controls that do not
      undergo RRSO.

      The investigators hypothesis is that women who undergo a premature surgical menopause induced
      by RRSO have worse cardiovascular health and bone health compared with women who do not
      undergo RRSO.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants will be women 35-50 years old with a confirmed diagnosis of a
        deleterious BRCA 1/2 mutation recruited through UCSF.
      
Biospecimen description: 
      whole blood; serum; EDTA Plasma
Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy
Condition: Pregnancy Related; Benzodiazepines Causing Adverse Effects in Therapeutic Use; Congenital Anomaly
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      This is a nationwide cohort study to assess maternal and neonatal outcomes following exposure
      to benzodiazepines during pregnancy.
    

Detailed description: 
      Benzodiazepines are widely used in pregnant women; however, their safety on congenital
      malformations in a real-world setting is still uncertain. We aimed to assess the association
      between benzodiazepine use in early pregnancy and the risk of congenital malformations. We
      will conduct a retrospective nationwide cohort study using the Health Insurance Review and
      Assessment (HIRA) database of South Korea, which covers the entire South Korean population.
    

Intervention name(s): Benzodiazepine
Intervention type(s): Drug
Intervention description(s): Exposure to benzodiazepine during early pregnancy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Pregnant women who gave birth in South Korea between 2011 and 2018
Modality of Induction of Labor in Obese Women at Term (MODOBAT)
Condition: Induction of Labor Affected Fetus / Newborn; Obese
Study type: Observational

Summary: 
      In normal-weight patients, numerous studies show an equivalence of efficacy between
      dinoprostone and balloon to induce labor. In obese patients, this efficacy is not known,
      although inductions of labor are more frequent. MODOBAT aims to describe the ability to
      obtain a vaginal delivery of two modality of induction of labor (vaginal dinoprostone and
      single balloon Foley catheter) in obese women at term.
    

Detailed description: 
      Obesity has for several decades become a global epidemic in developed countries. In case of
      pregnancy, obesity leads to an increased risk of obstetric complications, the indications of
      induction of labor are then more frequent. Unfortunately the rate of failed induction is also
      higher and therefore the risk of caesarean section is increased in obese women compared to
      normal-weight patients when induction of labor is indicated. However, in this context
      effectiveness of each mode of induction is not known. Some retrospective studies would
      suggest that the balloon would be more effective because it would not be affected by the
      increase in fat mass but this result are not , but the to confirm this hypothesis.

      The aim of this study is to describe the caesarean section rate in induction of labor by
      vaginal dinoprostone and single balloon Foley catheter in obese women. Patients in the
      vaginal dinoprostone arm will be included retrospectively and patients in the single balloon
      Foley catheter arm will be included prospectively.
    

Intervention name(s): Dinoprostone 10mg; single balloon Foley catheter
Intervention type(s): Drug; Device
Intervention description(s): Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina; A single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os
Intervention MeSH terms: Dinoprostone
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients of the level III maternity of university hospital center of Besançon and level IIB
        maternity of regional hospital of Trevenans, France.
      
Keywords: Induction of Labor; BMI; Obesity; caesarean; C-section; Pregnancy; Balloon; Dinoprostone
A Switch Study of BMS-337039 in Schizophrenic Out-patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this clinical research study is to evaluate the safety and tolerability of two
      switching strategies from risperidone to aripiprazole over a period of 12 weeks in
      out-patients who are treated in a general psychiatric practice setting and who are currently
      experiencing efficacy and/or safety/tolerability issues while on risperidone.
    


Intervention name(s): Aripiprazole; Aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.; Tablets, Oral, Uptitration: 5 mg (week 1), 10 mg (week 2 and 3), 15 mg(week 4 and 5) flexible 10-30mg from week 6-12, once daily, 12 weeks.
Other intervention name(s): Abilify; Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigating the Use of Complex Pulse Shapes for DBS in Movement Disorders
Condition: Parkinson Disease; Essential Tremor
MeSH terms: Parkinson Disease; Movement Disorders; Essential Tremor
Study type: Interventional

Summary: 
      Parkinson's disease and essential tremor are chronic movement disorders for which there is no
      cure. When medication is no longer effective, deep brain stimulation (DBS) is recommended.
      Standard DBS is a neuromodulation method that uses a simple monophasic pulse, delivered from
      an electrode to stimulate neurons in a target brain area. This monophasic pulse spreads out
      from the electrode creating a broad, electric field that stimulates a large neural
      population. This can often effectively reduce motor symptoms. However, many DBS patients
      experience side effects - caused by stimulation of non-target neurons - and suboptimal
      symptom control - caused by inadequate stimulation of the correct neural target. The ability
      to carefully manipulate the stimulating electric field to target specific neural
      subpopulations could solve these problems and improve patient outcomes. The use of complex
      pulse shapes, specifically biphasic pulses and asymmetric pre-pulses, can control the
      temporal properties of the stimulation field. Evidence suggests that temporal manipulations
      of the stimulation field can exploit biophysical differences in neurons to target specific
      subpopulations. Therefore, our aim is to evaluate the effectiveness of complex pulse shapes
      to reduce side effects and improve symptom control in DBS movement patients.
    

Detailed description: 
      The study had three stages. In the first stage, a wide range of investigatory pulse shapes in
      a small number of patients. The effect of the pulses on the therapeutic window will be
      assessed.

      Stage 2 will perform a short-term chronic evaluation in a larger number of patients of the
      complex pulse shape selected as most interesting from stage 1.

        -  ET patients will first be assessed after 3 hours of the cathodic or complex pulse
           (double-blind design).

        -  PD patients will only be assessed after 1 week of each pulse.

      Stage 3 will then focus on long-term evaluation (upto 2 years). Outcomes: see stage 2.
    

Intervention name(s): Boston Scientific: Study tool computer
Intervention type(s): Device
Intervention description(s): compare clinical outcome measurements of complex pulse shapes to standard clinical pulse shape
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, crossover, double-blinded design
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
GP VS TP in the Treatment of Advanced Nasopharyngeal Carcinoma in Northwest China
Condition: Nasopharyngeal Squamous Cell Carcinoma; Toxicity Due to Radiotherapy
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study is a randomized, control, phase II study of locally advanced nasopharyngeal
      carcinoma (NPC) in Northwest China treated with Gemcitabine plus cisplatin regimen (GP) or
      Docetaxel plus cisplatin regimen (TP) induction chemotherapy followed by concurrent
      chemoradiotherapy. The population consists of stage III-IVb nasopharyngeal carcinoma (NPC).
      The effectiveness, side effects and quality of life will be evaluated according to Standard
      WHO response criteria, NCI-CTC AE V3.0 and EORTC QLQ-C30 and H&N35 questionnaire.
    

Detailed description: 
      Nasopharyngeal carcinoma has an unique geographic distribution, and has different
      pathological types, natural history, treatment modalities in endemic and non-endemic regions.
      Nasopharyngeal carcinoma is both radiosensitive and chemosensitive. Chemoradiotherapy is the
      main therapy choice for the locoregionally advanced nasopharyngeal carcinoma. However,the
      optimal chemoradiotherapy regimen has not been determined. Many new drugs including docetaxel
      and gemcitabine have been incorporated in the induction chemotherapy phase of NPC. The
      investigators designed the present study with induction chemotherapy follow by CCRT for
      locoregionally advanced NPC in non-endemic Northwest China, comparing induction chemotherapy
      regime of TP and GP. The primary objectives were overall response rate (ORR), acute toxicity,
      tolerance; second objective were overall survival (OS), progression free survival (PFS), rate
      of distant metastases,late adverse events and quality of life.
    

Intervention name(s): gemcitabine and cisplatin; docetaxel and cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Drug: gemcitabine and cisplatin The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT.; Drug: Docetaxel and cisplatin The TP regimen consists of docetaxel at a dose of 75 mg/m2/day on day 1,and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT.
Other intervention name(s): GP; TP
Intervention MeSH terms: Cisplatin; Gemcitabine; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced Nasopharyngeal Carcinoma; treatment; Northwest China
Study on Treatment for Patients With Symptomatic Oral Lichen Planus
Condition: Lichen Planus, Oral
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional

Summary: 
      The primary objective of this study was to compare the therapeutic efficacy of Tacrolimus gel
      versus an anti-inflammatory mouthwash in an oral solution for the management of patients
      suffering from symptomatic OLP. The secondary objective was to analyze which one of the two
      treatments induced a greater risk of developing side effects.
    

Detailed description: 
      Thirty nine patients were assigned, through a randomized design, to receive tacrolimus
      ointment 0.1% or a mouthwash composed of calcium hydroxide 10%, hyaluronic acid 0,3%,
      umbelliferone and oligomeric proanthocyanidins, or an anti-inflammatory mouthwash (mouthwash
      which contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric
      Proanthocyanidins) for 3-months. At baseline (T0) and after 3 months (T1), patients were
      subjected to clinical and oral assessments and were evaluated for the symptoms (Numerical
      Pain Scale, NRS score) and signs (Thongprasom's score) of OLP. Data were calculated using
      T-test for the dependent variable, Wilcoxon test and Mann-Witney u test.
    

Intervention name(s): Oral lichen clinical Healing evaluation
Intervention type(s): Drug
Intervention description(s): Treatments were topically applied for 5 days
Other intervention name(s): Topical drug tacrolimus or mouthwash application
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment