bioihbjkbjnl/mcl2 huggingface dataset:
Quetiapine for Bipolar Disorder and Alcohol Dependence
Condition: Bipolar Disorder; Alcohol Dependence
MeSH terms: Alcoholism; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find out whether an investigational drug called quetiapine
      can treat bipolar disorder, improve mood and reduce alcohol use and craving.
    

Detailed description: 
      The primary aim in the study is to determine if quetiapine treatment is associated with
      greater reduction in alcohol use than placebo in outpatients with bipolar disorder and
      alcohol dependence. We will also examine if quetiapine treatment is associated with greater
      reduction in alcohol craving than placebo in outpatients with bipolar disorder and alcohol
      dependence and if quetiapine treatment is associated with greater improvement in depressive
      symptoms than placebo in outpatients with bipolar disorder and alcohol dependence.
    

Intervention name(s): Placebo; Quetiapine
Intervention type(s): Drug; Drug
Intervention description(s): Inactive ingredient matching the active medication in appearance.; Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Other intervention name(s): Sugar-pill; Seroquel; Xeroquel; Ketipinor
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bipolar disorder; alcohol dependence; mania; manic disorder; depression
Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy
Condition: Pain Threshold; Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Study type: Interventional

Summary: 
      Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder. MSA is dominated by
      autonomic/urogenital failure which may be associated with either Parkinsonism (MSA-P subtype)
      or with cerebellar ataxia (MSA-C subtype). The prognostic of this disease is bad because it
      ended with the patient's death few years later. No neuroprotective treatment has shown a real
      efficacy. 50% of patients suffering of MSA frequently experienced painful sensation. The
      origin of this pain is unknown. In Parkinson disease (PD) ; arguments suggest the implication
      of dopamine neuromediator pathway in integration and modulation of pain. Several studies
      suggest the existence of various influences with dopamine implication in the appearance of
      painful sensation and that would be inhibitory. That's why observed painful symptoms in MSA
      and PD could be due to a decrease of pain appearance threshold, secondary to a lost of
      control of sensitizes centres, to Parkinson control.

      It is interesting to determine if MSA as PD is responsible for a decrease of pain threshold
      and to characterise the levodopa effect on the patient's pain threshold. Better
      physiopathology knowledge of pain in MSA is necessary to improve the therapeutic care.
      Because the efficacy of others treatments is low, it's important to improve the research for
      a better comfort of patients with a better understanding, analysing and treating of the pain.
    


Intervention name(s): Levodopa test; determination of objective and subjective pain threshold
Intervention type(s): Drug; Procedure
Intervention description(s): Each patients with PD and MSA will be evaluated in two conditions : OFF (without dopaminergic treatment since 12h) and ON condition (after a L-DOPA dose. This dose will be 150% of the DOPA morning dose. The healthy volunteers will be evaluated in only one condition (without L-DOPA administration); Test without levodopa intake
Intervention MeSH terms: Levodopa
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: subjective pain; Multiple System Atrophy
Methylation Biosignature in Childhood Chronic Kidney Disease
Condition: Chronic Kidney Disease; Cardiovascular Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Cardiovascular Diseases
Study type: Observational

Summary: 
      Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan.
      Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric
      oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase
      inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as
      a methylation biomarker.

      In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may
      affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor.
      S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase
      (MTHFR), a folate metabolism enzyme can regulate methylation pathway.

      The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene
      methylation can serve as biosignature to predict CVD in children with CKD children.
    


Intervention name(s): Methylation biosignature
Intervention type(s): Other
Intervention description(s): Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged <18 years visit pediatric nephrology clinic during study period
      
Keywords: chronic kidney disease; cardiovascular disease; nitric oxide; homocysteine; asymmetric dimethylarginine; methylation
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
Condition: Volume Defects in the Mid-face
Study type: Interventional

Summary: 
      To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
    


Intervention name(s): YVOIRE Y-Solution 720
Intervention type(s): Device
Intervention description(s): Hyaluronic acid dermal filler
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Randomised, Cross-over, Relative Bioavailability Study of Nicotine Delivery and Nicotine Extraction From Oral Products
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study is a randomised cross-over, open-label, confinement study conducted in 24 male or
      female snus and cigarette consumers. The study investigates 5 different nicotine containing
      products in a cross-over fashion. The study incorporates pharmacokinetics evaluation,
      nicotine extraction evaluation, subjective questionnaire assessments as well as safety
      evaluation.

      During the study participation, subjects come for two visits to the clinic, including a 5-day
      confinement period.
    


Intervention name(s): A; B; C; D; E
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes; Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes; Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes; Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes; Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes
Other intervention name(s): Product A; Product B; Product C; Product D; Product E
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Patient Perception of Mammogram Guidelines
Condition: Attitude; Practice Guideline; Breast Cancer
Study type: Interventional

Summary: 
      The purpose of this study was to determine attitudes regarding the 2009 USPSTF Guidelines for
      breast cancer screening for women in their 40's and assess the effect of one of two newspaper
      articles on their attitudes. The population studied was women seeing their private
      gynecologist for annual exams in the 39-49 year old age group.
    

Detailed description: 
      Subjects completed a baseline questionnaire listing demographics, previous experience with
      mammograms, and acquaintances with breast cancer. They then were randomly assigned one of two
      articles (one favorable and one unfavorable) that had been published in the newspaper
      regarding the USPSTF breast cancer screening guidelines. Their attitudes towards the safety
      of the guidelines and their willingness to comply with them was then measured.
    

Intervention name(s): read unfavorable article prior to answering questions; read favorable article prior to answering questions
Intervention type(s): Other; Other
Intervention description(s): article title: "Taking a hit on healthcare- why that's women's work"; read "A Backlash of Mistrust"
Other intervention name(s): Boston Globe, November 19, 2009; Section A17. Joan Vennochi.; Washington Post; November 25, 2009. Ellen Goodman.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: U.S. Preventive Services Task Force; Patient attitude; Mammogram; Guideline
Relative Bioavailability of AR10 Compared to Reference Product
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the relative bioavailability of Acetylcysteine Effervescent Tablets
      (AR10) and Reference N-acetylcysteine. Patients will receive both products in an Open Label,
      Randomized, Two-Arm, Single-Dose, Two-Period, Crossover design.
    

Detailed description: 
      An Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study Relative
      Bioavailability Study. The present study is intended to compare and evaluate the relative
      bioavailability of a single 11 gram dose of AR10 (acetylcysteine effervescent tablets for
      oral solution (two 0.5 g and four 2.5 g]), and the reference Listed Drug (acetylcysteine
      solution; oral 20% [200 mg/mL] of American Pharmaceutical Partners) in healthy adult, human
      subjects under fasting conditions. A balanced block randomization schedule will be generated
      before the start of dosing.
    

Intervention name(s): AR10; acetylcysteine
Intervention type(s): Drug; Drug
Intervention description(s): effervescent tablet; oral solution
Other intervention name(s): acetylcysteine; reference product
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Relative Bioavailability
Smoking Termination Opportunity for inPatients
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the
      opportunity that is provided by admission for acute smoking related illness, to assist
      patients through withdrawal by use of a combination of:

        -  the new medication Champix with

        -  best practice counselling

        -  initiated in an inpatient setting

      to achieve:

        -  sustained smoking abstinence

        -  reduced hospital bed and health service utilisation

        -  reduced inpatient smoking and craving prior to discharge
    

Detailed description: 
      A national standard in public hospitals for the management of smoking in patients admitted
      with smoking related acute illnesses is lacking. Where such patients have continued to smoke
      up until the time of admission, it can be assumed that "primary" prevention has failed.

      Once admitted, there is a vastly under-utilised opportunity, by use of a structured and
      systematic approach, to intervene with a secondary prevention attempt. This takes advantage
      of the synergy of:

        1. the smoker is a "captive audience" and may be receptive to considering lifestyle factors
           that have lead to the admission, and

        2. best practice medication and counselling can be initiated prior to discharge. If proven
           to be cost-effective in our analysis, a systematic roll-out of this secondary prevention
           initiative would be advocated. ie translation of research into practice.
    

Intervention name(s): Champix; Counselling alone
Intervention type(s): Drug; Behavioral
Intervention description(s): Standard MIMS dosage (including period of titration) will be used. 0.5mg daily for 3 days 0.5mg b.d. for 4 days
1mb b.d. for 70 days (full course 3 months); Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period
Other intervention name(s): varenicline tartrate; Chantix; Quitline counselling service
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Cardiovascular Diseases; Peripheral Vascular Diseases; Cerebrovascular Stroke; Lung Diseases, Obstructive; Asthma; Tobacco Use Disorder; Smoking; Smoking Cessation
Correlation of SpO2/FIO2 Ratio With PaO2/FIO2 Ratio in ARDS Patients in the ICU of H. Adam Malik Hospital
Condition: Ards
Study type: Observational [Patient Registry]

Summary: 
      This study to apprehend the relation of SpO2/FiO2 to PaO2/FiO2 in ARDS patients.
    

Detailed description: 
      Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition that requires
      immediate treatment. The measurement of the PaO2/FiO2 (P/F) ratio is the main choice for
      assessing the severity of ARDS with an invasive method that requires arterial blood gas (ABG)
      analysis. This study was conducted to determine the relationship between the SpO2/FiO2 ratio
      and the PaO2/FiO2 ratio in ARDS patients at HAM General Hospital. This observational study
      used a cross-sectional research method with the total sample of 29 intubated ICU patients
      diagnosed with ARDS. Patients with congestive heart failure, anemia, and systolic blood
      pressure <90 mmHg were excluded from the study. The results of this study showed a positive
      correlation between the PaO2/FiO2 and SpO2/FiO2 ratios with a correlation coefficient of
      0.955 and a p-value of 0.001. There was a relationship between the S/F ratio and the P/F
      ratio in assessing the severity of ARDS with a p-value of <0.05. This study shows that the
      SpO2/FiO2 (S/F) ratio has a good correlation with the PaO2/FiO2 (P/F) ratio in patients with
      ARDS, so it can be used as a predictor of ARDS and can be beneficial in clinical practice. It
      should be noted that the SpO2/FiO2 ratio has several factors that can affect its accuracy, so
      careful assessment is needed.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Intubated patients in ICU
      
Biospecimen description: 
      Blood Gas Analysis
Acute Treatment of Migraine With e-TNS
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The main objective of this study is to assess the efficacy of the Cefaly® device as an acute
      treatment of migraine attack in adult patients. The patients will be applied either an active
      or placebo external neurostimulation for 1 hour during a migraine attack, and will report the
      pain on a visual analog scale before and after the treatment.
    


Intervention name(s): CEFALY Active; CEFALY Placebo
Intervention type(s): Device; Device
Intervention description(s): Active external trigeminal nerve stimulation; Placebo external trigeminal nerve stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the drug behavior and safety of a single dose of the 22 milligram
      tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken
      after eating a high fat meal (the effect of food). This will be compared to the drug behavior
      and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release
      formulation when taken after a 10 hour fast.
    


Intervention name(s): Tofacitinib MR 22 mg (Fed); Tofacitinib MR 22 mg (Fasted)
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal; A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: food effect; pharmacokinetics; healthy volunteers
Adhese One F Upgrade in Direct Filling Therapy
Condition: Dental Adhesive
Study type: Interventional

Summary: 
      Investigation on the clinical performance of a new dental adhesive when used in direct
      filling therapy after phosphoric acid etching.

      Hypothesis: The new adhesive shows an acceptable clinical performance and allows a good
      filling quality.
    


Intervention name(s): Adhese One F Upgrade
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: total etch protocol; direct filling therapy
A Study of JZP150 in Adults With Posttraumatic Stress Disorder
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter
      study of the safety and efficacy of JZP150 in the treatment of adult participants with
      post-traumatic stress disorder (PTSD).
    

Detailed description: 
      JZP150 is an oral, highly selective inhibitor of fatty acid amide hydrolase (FAAH). In this
      phase 2 study, participants with PTSD will receive either placebo or 1 of 2 doses of JZP150.
      The primary objective of the study will assess the change in PTSD symptoms from baseline to
      Week 12 using the Clinician Administered PTSD Scale (CAPS-5).
    

Intervention name(s): JZP150; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of JZP150 once daily in the morning; Oral administration of placebo once daily in the morning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Post Traumatic Stress Disorder; JZP150
Efficacy of Cardioviva™ Probiotic Yogurt Formulation
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Background: Several studies have reported limited or no reduction in serum lipid
      concentrations in response to probiotic formulations. More recently, probiotics have shown
      promise in treating metabolic disease, due to improved strain selection and delivery
      technologies.

      Objective: To evaluate the lipid lowering efficacy of a yogurt formulation containing
      microencapsulated Bile Salt Hydrolase (BSH)-active Lactobacillus reuteri cardioviva, taken
      twice per day over 6 weeks, in subjects with hypercholesterolemia.

      Design: This is a double-blinded, multi-centric, placebo-controlled, randomized, parallel-arm
      study. The study will last a total of 10 weeks including 2-week wash-out, 2-week run-in, and
      6- week treatment period.
    


Intervention name(s): Cardioviva™ yogurt; Placebo yogurt
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks; yogurt, twice per day (BID), 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: yogurt; probiotic; cholesterol
Long-term Effects of the Addition of Diathermy by Emission of Radiofrequency to Therapeutic Exercise in Patellofemoral Pain Syndrome Patients
Condition: Patellofemoral Pain Syndrome; Patellofemoral Pain; Patello Femoral Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      Introduction: the management of Patellofemoral Pain (PFP) is focused on therapeutic exercise
      (TE) to improve muscle strength and motor control. Recent studies suggest that the addition
      of radiofrequency diathermy (RFD) obtain greater short-term improvements in knee pain than TE
      alone. As there is no follow up data, the aim of this research is to assess the long-term
      effects of adding RFD to TE on pain, function and quality of life on PFP patients.

      Methods: a single-blind randomized controlled trial will be conducted. Participants diagnosed
      of PFP will be allocated in either a TE group or a RFD+TE one. Sociodemographic data, knee
      pain, and lower limb function will be collected. Each group will performed 20 min of daily
      knee and hip supervised TE along three weeks with the addition of ten sessions of RFD for the
      RFD+TE group.
    


Intervention name(s): Diathermy by emission of Radiofrequency; Therapeutic exercise
Intervention type(s): Device; Other
Intervention description(s): Applied only to experimental group; Applied to both arms/groups
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind Randomized Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee pain; electrophysical agents