bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of plasma exchange with 5%
      albumin in beta-amyloid peptide clearance in cerebrospinal fluid, and its effects in patients
      with mild-moderate Alzheimer's disease.
    

Detailed description: 
      A phase II study was conducted primarily to determine whether plasma exchange with 5% human
      albumin is able to modify the concentration of beta-amyloid peptide in cerebrospinal fluid
      (CSF) in patients with AD.

        -  There was two weeks for screening and randomization of both groups (treatment and
           control).

        -  The subjects were randomized in a 1:1 proportion.

      After screening and randomization, treatment proceeded as follows:

        -  three weeks of intensive treatment with two plasma exchanges per week

        -  followed by a month and a half of maintenance treatment with one weekly plasma exchange,
           and

        -  finally, three months of treatment with one plasma exchange every two weeks.

      The control group followed the same program, except for the plasma exchanges. After the
      treatment period ended, subjects followed-up for a 6-month period of time.

      The trial comprises a global multicenter (Spain and US), blind, randomized, controlled
      design. The trials key coordination is based in Spain where Dr. Boada (see Study
      Officials/Investigators) is the main study official.
    

Intervention name(s): Albutein 5%; Control
Intervention type(s): Biological; Other
Intervention description(s): 18 Plasma Exchanges using Albutein 5%:
three weeks of intensive treatment with two plasma exchanges per week
six weeks of maintenance treatment with one weekly plasma exchange
three months of maintenance treatment with one plasma exchange every two weeks; Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's; Dementia; Senile; Loss of cognitive abilities; Old age; Elderly; Aging; Albumin; Caregiver; amyloid; beta amyloid; Central Nervous System Diseases; Brain Disease; Mental Disorders; Plasma Exchange
A Double-Blind, Placebo Controlled, Single, Escalating Dose Study to Evaluate the Preliminary Pharmacokinetics, Safety and Tolerability of LNK-754 in Healthy Elderly Volunteers
Condition: Healthy Elderly Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the single-dose plasma pharmacokinetics of LNK-754
      as well as safety and tolerability in normal healthy male and female elderly volunteers
    


Intervention name(s): LNK-754
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Effect of Ginger on Nausea and Vomiting During Acute Gastroenteritis in Children
Condition: Nausea; Vomiting
MeSH terms: Gastroenteritis; Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The acute gastroenteritis is a very common problem in children. The frequency and duration of
      this condition involves a high discomfort for the child and his family, and significant
      costs, in connection with the purchase of therapeutic aids, medical visits, days of work lost
      by parents, requiring hospitalization. Vomiting is a typical symptom of the majority of the
      cases of acute gastroenteritis and is very often the cause of failure of oral rehydration use
      and hospitalization.

      To limit vomiting and facilitate oral rehydration have been proposed several pharmacological
      strategies. Unfortunately, these therapies are unsuccessful (domperidone), expensive and side
      effects (ondansetron and metoclopramide) and therefore contraindicated in patients of
      pediatric age.

      The administration of some medicinal herbs is able to induce an effective anti-emetic power.
      Among the various types of plants studied, the rhizome of Zingiber officinale, commonly known
      as ginger is used as an antiemetic in various traditional systems of medicine for over 2000
      years. There are several scientific evidence on the beneficial properties of ginger,
      including antioxidant, antimicrobial, anti-inflammatory and anti-allergic . It was also
      demonstrated that ginger is effective in resolving the post-operative nausea and vomiting and
      in pregnant. A recent meta-analysis has confirmed that ginger is effective in
      non-pharmacological treatment of nausea and vomiting in the early periods of pregnancy.

      To date there are several formulations of the ginger on the market in Italy, and their use is
      fairly widespread in children for the treatment of vomiting by acute gastroenteritis in the
      absence of clinical evidence of efficacy.

      The purpose of the proposed study is to demonstrate the effectiveness of treatment with
      ginger in reducing episodes of vomiting associated with acute gastroenteritis in children.
    


Intervention name(s): Ginger; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): ginger; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether internet-based cognitive behavioral therapy
      (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The
      investigators hypothesis is that children and adolescents who have been offered ICBT show
      significant better performance on outcome measures compared with patients in control group.
    


Intervention name(s): Internet-based cognitive behavioral therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dental Fear; Dental Phobia; Internet based cognitive behavioral therapy; specific phobia; children and adolescents anxiety; Self Efficacy
Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Patients With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to learn more about the immune response to etanercept produced
      using a modified process in patients with plaque psoriasis.
    

Detailed description: 
      This is a multicenter, open-label, single-arm phase 4 study in patients with plaque psoriasis
      who are etanercept-naïve and who are not receiving methotrexate therapy. The study will
      consist of a screening period of up to 30 days, a 24-week treatment period and a 30-day
      follow-up period for safety. Etanercept dosing will follow the recommended label dosing for
      patients with plaque psoriasis.
    

Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention description(s): Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.
Other intervention name(s): Enbrel®
Intervention MeSH terms: Etanercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gelsemium Sempervirens in Anticipatory Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effectiveness of Gelsemium sempervirens 5CH et 15CH on anticipatory provoked
      anxiety, in healthy volunteers.
    

Detailed description: 
      State-anxiety can appear during banal events without objective harrowing factors. It is
      preponderant in particular situations as exams and competitive examination for example, and
      may be responsible of failures, notably at school. Particularly, a form of anxiety said
      anticipatory (largely named nerves) is focused on a coming performance. This anticipative
      anxiety, maximal before the beginning of the test, disappears during this test to let place
      to relief. Even if phenomenon of habituation exists, it can be responsible of social and
      professional failures.

      Numerous therapeutics exists to fight against anxiety, non medicinal first but the resort to
      drugs are sometime necessary. The reference is the class of benzodiazepines. Many patients
      try non conventional medicines, like homeopathy.

      Gelsemium sempervirens would be active on sensible et emotional persons, reducing anxiety in
      some situations. A large used of Gelsemium sempervirens is the case of a situation of
      provoked stress in particular exam. That is the reason why the drug is particularly intended
      to a population of young adults who don't want to use " traditional " tranquillizing. But
      this drug, largely used, has never showed his effectiveness on provoked anxiety, in
      biomedical research. That is why we proposed in this study to compare the effectiveness of
      Gelsemium sempervirens 5CH, Gelsemium sempervirens 15CH and placebo, in a situation of
      provoked anxiety in young adult healthy volunteers.
    

Intervention name(s): Gelsemium Sempervirens; Gelsemium Sempervirens; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.; 15CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.; placebo, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stress provoked; healthy volunteers; gelsemium; homeopathy
Q-Trial in Patients With Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to translate laboratory findings that Quercetin, a bioflavonoid, is
      safe and has antiviral activity in people with hepatitis C.
    

Detailed description: 
      Chronic hepatitis C (HCV) is a serious chronic condition in the United States affecting
      millions of people and is the cause of rates of hepatocellular carcinoma recently doubling in
      the US. Treatment of hepatitis C is proven to be an effective secondary prevention of liver
      cancer. Current standard antiviral treatments exclude 70-80% of hepatitis C patients from
      therapies due to intolerable side effects. Our laboratory efforts identified a potential
      novel approach to hepatitis C treatment and hepatocellular carcinoma prevention with
      Quercetin, a heat shock protein inhibitor.

      This is a Phase I study evaluating the safety and tolerability of Quercetin in hepatitis C
      patients who have contraindications to standard antiviral treatment (both treatment naïve
      patients who decline standard therapy, patients who previously had standard treatments with
      relapse, as well as those who had intolerable side effects previously). The investigators
      recently demonstrated that the flavonoid Quercetin inhibits hepatitis C viral production in
      tissue culture, at least partially through its inhibition of heat shock protein expression.
      This represents a novel mechanism for treating hepatitis C infection. Quercetin also has low
      toxicity. These promising characteristics motivate the proposed Phase I study. Patients will
      be recruited through the UCLA Pfleger Liver Institute and treated on an outpatient basis.
      Toxicity will be closely monitored and reported. Viral load response will be evaluated as a
      secondary endpoint. The anticipated total number of patients enrolled in the trial will be
      20. All patients will be followed for 8 months after taking this first dose of study
      medication. Patients exhibiting a viral load response will have extended follow-up, ranging
      from a total follow-up of 12-24 months, to determine persistence of this response.
    

Intervention name(s): Quercetin
Intervention type(s): Dietary Supplement
Intervention description(s): Bioflavonoid
Intervention MeSH terms: Quercetin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Treatment naive; Contraindications to standard therapies; Alternative hepatitis C therapy
Acamprosate Added to Escitalopram and Behavioral Treatment for Comorbid Depression and Alcoholism
Condition: Major Depressive Disorder; Alcohol Abuse; Alcohol Dependence
MeSH terms: Alcoholism; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study about treatment for people who suffer from both major depression and alcohol
      abuse or dependence. The study will examine whether the addition of acamprosate to
      escitalopram and behavioral interventions will improve outcomes for this population.
    

Detailed description: 
      Depression and alcohol use disorders contribute to a significant proportion of the burden of
      disease, in the United States and abroad. Patients who suffer from co-morbid depression and
      alcohol abuse/dependence have illnesses that are more severe, persistent and costly than
      people with either depression or an alcohol use disorder alone. The treatment of these
      patients remains controversial. Several studies have demonstrated that antidepressants can be
      safe and efficacious in the treatment of depression in people who continue to drink, and it
      is now considered the standard of care to provide such treatment. Other studies have shown
      that pharmacotherapy with naltrexone or acamprosate can help reduce drinking in alcoholics
      without co-morbid depression. A logical extension of these findings would be to study the
      treatment of depressed alcoholics with dual pharmacotherapy, combining an anti-depressant
      with a medication aimed at treating the alcohol use disorder. We will conduct a randomized,
      double-blind, placebo controlled trial of escitalopram plus acamprosate and behavioral
      treatment vs. escitalopram plus placebo and behavioral treatment in 20 depressed alcoholics.
      Outcome measures will include depression, alcohol use and global functioning.
    

Intervention name(s): acamprosate; escitalopram; Medical management; Placebo
Intervention type(s): Drug; Drug; Behavioral; Drug
Intervention description(s): Acamprosate 333mg, 2 capsules by mouth (i.e., PO), three times per day (i.e., TID), for 12 weeks.; Escitalopram is given for 12 weeks. Dosing is flexible, starting at 10mg PO once per day (i.e., QD) with the possibility of increasing to 30mg PO QD.; Based on the COMBINE study. 1 hour of medical management / behavioral intervention at every study visit (7 times over 12 weeks).; Placebo, 2 capsules PO TID, for 12 weeks
Other intervention name(s): Campral; Lexapro; Campral and Lexapro; Campral and Lexapro
Intervention MeSH terms: Acamprosate; Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder; Alcoholism; Alcohol abuse; Alcohol dependence
ShenFu Injection for Myocardial Protection in Patients With Acute ST Segment Elevation Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Reperfusion Injury; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether perioperative use of Shenfu Injection could
      reduce myocardial injury (enzymatic infarct size and infarct volume according to cardiac
      magnetic resonance imaging) in patients with STEMI after primary PCI
    


Intervention name(s): Shenfu Injection; 5% Glucose Injection
Intervention type(s): Drug; Drug
Other intervention name(s): Shenfu Zhusheye
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shenfu Injection; Reperfusion Injury; Myocardial Protection; Percutaneous Coronary Intervention
Comparing the Impact of 2 Different Techniques in Management of Hydrosalpinx on Pregnancy Rates Following ICSI
Condition: Hydrosalpinx
Study type: Interventional

Summary: 
      Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic
      tubal occlusion and laparoscopic salpingectomy before ICSI.
    

Detailed description: 
      Hydrosalpinx has a detrimental effect on the rates of implantation, pregnancy and early
      pregnancy loss following IVF. A meta-analysis demonstrated that the implantation rate and
      clinical pregnancy rate decreased by 50% in patients with hydrosalpinx. The negative
      consequences could be due to embryotoxic properties, a decrease in endometrial receptivity,
      and hydrosalpinx fluid mechanically flushing the embryo from the uterus.

      Although laparoscopic salpingectomy and laparoscopic proximal ligation increase ongoing
      pregnancy rates in women with hydrosalpinges, those interventions are invasive and carry
      anaesthetic and surgical risks, especially in the presence of extensive adhesions, often seen
      in women with hydrosalpinges. In view of the possible adverse effects of laparoscopic
      surgery, an alternative less-invasive treatment for hydrosalpinges prior to IVF would be
      useful.

      The effectiveness of hysteroscopic tubal occlusion when compared with salpingectomy has not
      been established. Randomized clinical trials comparing both procedures prior to IVF are
      lacking.

      The present study was designed to compare hysteroscopic tubal occlusion and laparoscopic
      salpingectomy in the treatment of hydrosalpinges prior to IVF.

      This study hypothesized that in women scheduled for IVF/ICSI hysteroscopic proximal occlusion
      of hydrosalpinges would be non-inferior to laparoscopic salpingectomy in terms of ongoing
      pregnancy rates following IVF/ICSI.
    

Intervention name(s): Laparoscopic salpingectomy; Hystroscopic proximal tubal occlusion
Intervention type(s): Procedure; Procedure
Intervention description(s): 39 patients with hydrosalpinx will have laparoscopic salpingectomy; 39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Clinical Efficacy of Conventional and Diode Laser-Assisted Frenectomy in Patients With Abnormal Different Frenum Insertions: A Retrospective Study
Condition: Frenulum; Elongation
Study type: Observational

Summary: 
      Aim: The aim of this retrospective study was to assess the frenum attachment recurrence and
      evaluate clinical parameters after conventional and diode laser-assisted frenectomy in
      patients with different abnormal frenum insertions.

      Methods: Data records of 429 patients treated with maxillary labial frenectomy between
      January 1, 2016 and January 1, 2018 were screened. Records of 70 patients meeting the
      inclusion criteria were evaluated. Data were analyzed in terms of gender, age, category of
      frenum, presence of diastema, operation technique, type of periodontal disease. The distance
      between frenum attachment and mucogingival junction (FMGJ), plaque index (PI), gingival index
      (GI) and probing depth were assessed.
    


Intervention name(s): Diode laser; Conventional
Intervention type(s): Device; Procedure
Intervention description(s): In the laser-assisted frenectomy, a diode laser device (GIGA Cheese II®, China) (λ= 810 nm) with a 400 µm diameter, plain-ended optical ﬁber tip was used for the procedure maintaining contact with oral mucosa at 2,5 W, 70 Hz frequency with a short pulse (140 microseconds) duration.; In the conventional frenectomy, the incisions were applied using a scalpel blade no.15 on the upper and lower surface of the haemostat until the frenum was excised.
Other intervention name(s): frenectomy; frenectomy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study utilized treatment records of patients treated with maxillary labial frenectomy
        in the Clinics of Periodontology, Faculty of Dentistry, Marmara University.
      
Keywords: labial frenum; laser therapy; recurrence; oral hyigiene
Alpha as a Predictive Biomarker
Condition: Pain
Study type: Interventional

Summary: 
      The investigators will use non-invasive recordings of brain activity to measure pain as a
      proxy to self-report. Participants will undergo testing for about 3 hours on two separate
      days. The testing will involve experiencing painful heat.
    

Detailed description: 
      Neurophysiological investigations of pain have suggested that electroencephalograph (EEG)
      measures of peak alpha frequency might provide a means of pain assessment. In healthy
      subjects, increased peak alpha frequency is strongly correlated with pain self-reports after
      exposure to acute noxious heat. Conversely, chronic pain patients compared to healthy control
      display decreased peak alpha frequencies higher in alpha power. Measures of peak alpha
      frequency also show a negative relationship with disease duration, suggesting that peak alpha
      frequency may not only index ongoing pain but also disease progression. The overall aim is to
      determine the predictive accuracy, reliability, and specificity of EEG alpha activity in
      acute pain and a model of neuropathic pain in healthy subjects.
    

Intervention name(s): Painful Stimuli
Intervention type(s): Other
Intervention description(s): warm or painful heat administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: EEG; healthy subjects
Effect of Fluconazole on Pharmacokinetics of SHR2554 in Healthy Subjects
Condition: Malignant Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conduct to evaluate fluconazole effect of on SHR2554 in condition of
      single-canter, open-label, single-dose in healthy subjects. To explore the SHR2554
      pharmacokinetics change under use of fluconazole and insure the safety with SHR2554 combined
      with fluconazole.
    


Intervention name(s): SHR2554 Tablets; Fluconazole Capsules
Intervention type(s): Drug; Drug
Intervention description(s): SHR2554 Tablets+ Fluconazole Capsules; SHR2554 Tablets+ Fluconazole Capsules
Intervention MeSH terms: Fluconazole
Intervention model: Single Group Assignment
Intervention model description: Single-center, open-label, single-dose, self-control
Masking: None (Open Label)
Primary purpose: Treatment