bioihbjkbjnl/mcl2 huggingface dataset:
Risperidone and Olanzapine for the Schizophrenic Patients With Neuroleptic-Induced Tardive Dyskinesia
Condition: Neuroleptic-Induced Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 4

Summary: 
      We initiate a study with research grant from department of health and Taoyuan mental hospital
      and choose risperidone and olanzapine as study medications. We compare the effects of these 2
      drugs in schizophrenic spectrum patients of Han ethnics with neuroleptic-induced tardive
      dyskinesia to test the hypothesis that these two medications have different effects in
      improving tardive dyskinesia.
    

Detailed description: 
      Objective: First generation antipsychotics would induce tardive dyskinesia in some
      schizophrenic patients. Second generation antipsychotics were the choices for these patients.
      But which one of second generation antipsychotic was the better choice did not have
      definitive results. We compared risperidone and olanzapine in schizophrenic patients with
      neuroleptic-induced tardive dyskinesia to see their effects in improving tardive dyskinesia.
      We also collected the data of average dose of risperidone and olanzapine to help the dosing
      strategy guidelines for the schizophrenic patients with neuroleptic-induced tardive
      dyskinesia.

      Method: This randomized, rater-blind, parallel group, flexible dose study enrolled patients
      from Taoyuan Mental Hospital from July 2000 to December 2003. Schizophrenia, schizophreniform
      or schizoaffective disorder (DSM-IV) patients who met the research criteria of
      neuroleptic-induced tardive dyskinesia research criteria of DSM-IV and no less than moderate
      severity (> or =4) of global impression of extrapyramidal syndrome rating scale (ESRS). 60
      patients were random assignment to risperidone or olanzapine for 24 weeks. The primary
      outcome was to compare the change of total scores of abnormal involuntary movement scale from
      baseline to study endpoint.
    

Intervention name(s): risperidone; olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): 0.5-6 mg/day; 2.5-20 mg/day
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Risperidone; Olanzapine; Tardive dyskinesia
Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Dyssomnias; Parasomnias; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for
      the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in
      patients with mild to moderate Parkinson's Disease (PD).
    

Detailed description: 
      Inclusion required an Epworth Sleepiness Scale (ESS) score greater than 10 and any subjective
      nocturnal sleep concern, usually insomnia. An acclimation and screening polysomnogram was
      performed to exclude subjects with sleepdisordered breathing. The following evening, subjects
      underwent another polysomnogram, followed by an evaluation with the Unified Parkinson Disease
      Rating Scale (UPDRS) while practically defined off ("off") PD medications, ESS (primary
      efficacy point), Pittsburgh Sleep Quality Inventory, and Fatigue Severity Scale. Subjects
      then started sodium oxybate therapy, which was titrated from 3 to 9 g per night in split
      doses (at bedtime and 4 hours later) across 6 weeks, and returned for subjective sleep
      assessments. They then returned at 12 weeks after initiating therapy for a third
      polysomnogram, an offmedication UPDRS evaluation, and subjective sleep assessments. Data are
      expressed as mean (SD).
    

Intervention name(s): sodium oxybate
Intervention type(s): Drug
Intervention description(s): 4.5 to 9.0 grams per night
Other intervention name(s): Xyrem
Intervention MeSH terms: Sodium Oxybate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: excessive daytime somnolence; Parkinson disease; sleep disturbance
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12
      weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus
      (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or
      treatment-experienced.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), open-label (all people
      know the identity of the intervention), multicenter study. The study will consist of a
      screening phase up to 6 weeks, open-label treatment phase of 8 weeks or 12 weeks, and
      post-treatment follow up phase up to 24 weeks after end of treatment. Approximately 300
      participants will be randomly allocated in a 1:1 ratio to receive 150 mg simeprevir in
      combination with 400 mg sofosbuvir once daily either for 12 weeks (Arm 1) or 8 weeks (Arm 2).
      Safety evaluations will include assessment of adverse events, clinical laboratory tests,
      vital signs, and physical examination. The maximum study duration for each participant will
      be approximately 42 weeks.
    

Intervention name(s): Simeprevir; Simeprevir; Sofosbuvir; Sofosbuvir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 12 weeks in Arm 1.; 150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 8 weeks in Arm 2; 150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks in Arm 1.; 150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks in Arm 2.
Intervention MeSH terms: Sofosbuvir; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Virus Infection; Simeprevir; Sofosbuvir; HCV; Cirrhosis
Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
Condition: Tattoo; Pigmentation
Study type: Observational

Summary: 
      An Open-Label, Single-Center, Prospective, Observational, Clinical Use Study Evaluating the
      Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
    

Detailed description: 
      Study product will be applied at the baseline visit by a skilled tattoo artist. The tattoo
      design will be approximately 2 inches x 2 inches and will consist of line work. No filling or
      shading will be included in the design.
    

Intervention name(s): Vibrancy Assessment
Intervention type(s): Other
Intervention description(s): Additionally, important medical events that may not result in death, be life threatening, or require hospitalization may be considered SAEs when, based on appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Adults
Endoscopic Stenting in Crohn Related Strictures
Condition: Intestinal Strictures Related to Crohn´s Disease
MeSH terms: Crohn Disease; Constriction, Pathologic
Study type: Interventional

Summary: 
      Prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon
      dialtation only for the endoscopic treatment of benign strictures related to Crohn´s disease.
    


Intervention name(s): Self-expandable metal stent; Balloon dilatation
Intervention type(s): Procedure; Procedure
Intervention description(s): Endoscopic stenting of intestinal stricture related to Crohn´s disease; Endoscopic balloon dilatation of intestinal stricture related to Crohn´s disease
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation
      of schizophrenia.
    


Intervention name(s): ALK3831; Olanzapine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daily dosing; Daily dosing; Daily dosing
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Acute Exacerbation of Schizophrenia
Tracheal Intubation in Morbidly Obese (BMI>35) and in Lean (BMI<30) Patients Using McGrath MAC X-Blade
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were
      enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The
      demographic and airway variables of patients and insertion and intubation times with these
      dievices, need for optimisation maneuvers, hemodynamic changes and minör postoperative
      complications were recorded.
    

Detailed description: 
      80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were
      enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The
      demographic and airway variables of patients were recorded. Airway management variables
      Cormack-Lehan grades, insertion and intubation times, need for optimization maneuvers (
      cricoid pressure, re-inserting, drawback) , hemodynamic changes in heart rate , blood
      pressure and minor postoperative complications such as sore throat, dysphasia, hoarseness
      were recorded.
    

Intervention name(s): lean; obese
Intervention type(s): Device; Device
Intervention description(s): Videolaryngoscope used in intubation; Videolaryngoscope used in intubation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: videolaryngoscope; Airtraq; McGrath MAC; Morbid obesity; intubation
Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes
Condition: Dental Plaque
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to compare two commerical oral products for the treatment of gingivitis.
    


Intervention name(s): Fluoride; Triclosan; Fluoride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brush teeth two times daily for 6 weeks; Brush two times daily for 6 weeks; Brush two times daily for 6 weeks
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This multiple-center, nonrandomized, open label, parallel group, single dose study will be
      conducted in male and female subjects with normal renal function or severe (eGFR <30
      mL/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the
      pharmacokinetics (PK) of TD 4208.
    


Intervention name(s): TD-4208
Intervention type(s): Drug
Intervention description(s): A single inhaled dose of TD 4208 (175 mcg)
Other intervention name(s): revefenacin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal Impairment; Renal Insufficiency
Overcoming Learned Non-Use in Chronic Aphasia
Condition: Stroke-induced Aphasia
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      In this study the investigators are examining the effectiveness of intensive speech therapy
      in chronic moderate-to-severe stroke-induced aphasia under two conditions - responses
      "constrained" or unconstrained to speech. Both treatments involve massed practice
      communicating, using intensive language action therapy 3 hours/day, 5 days/week for two
      weeks, followed by six months of a home practice program. One treatment stresses spoken
      responses as the preferred expressive modality during intensive therapy. Before and after
      treatment, and following the home practice program and a period of no practice, the
      investigators will administer several tests and discourse samples to examine changes
      associated with the treatments. Participants will also undergo structural and functional MRI
      testing at these time points. The investigators will also attempt to quantify the degree to
      which improvements following intensive language therapy and home practice correlate with
      changes in Quality of Life measures as perceived by both participants with aphasia and their
      significant others. It is hypothesized that, whereas both treatments will lead to
      improvements in naming practiced words and communicating, outcomes will be enhanced for the
      group randomly assigned to the "constraint" condition. Moreover, performance will be enhanced
      on words practiced during the home practice program, including those that were not practiced
      during intensive therapy. Improved naming will correlate with modulation of 'signature'
      language and attentional networks, whose variability will depend on remaining viable brain
      structures. Initial severity and site/extent of lesion should predict patients' ability to
      transfer gains in naming to improvements in discourse.
    


Intervention name(s): Intensive Language Action Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: aphasia; anomia; speech therapy; rehabilitation; neuroplasticity; fMRI; quality of life
The Relationship of PRL and Polycystic Ovary Syndrome (PCOS) in Taiwan's Women
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Hyperprolactinemia; Syndrome
Study type: Observational

Summary: 
      Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder of reproductive-age
      women. According to Rotterdam 2003 criteria: at least two of three criteria are met,
      hyperandrogenism, chronic anovulation, and polycystic ovary. PCOS will cause irregular
      menstrual cycle, infertility, acne, hirsutism, obesity, or/and metabolic syndrome, diabetes
      that may increase risk of cardiovascular disease.

      Hyperprolactinaemia is also a common problem in reproductive aged women. Both
      hyperprolactinaemia and PCOS had endocrine disorder and irregular menstrual cycle.
      Investigators hope to collect clinical data from PCOS and prolactinemia patients followed in
      Wang Fang hospital for many years in endocrinological and metabolical aspects for comparison.
      Investigators at the same time would like to understand more about other similarities and
      differences between these two endocrinological dysfunction for future study.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Polycystic Ovary syndrome(PCOS)
      
Keywords: PCOS; hyperprolactinemia; obesity; hyperandrogenic
Early-Phase Safety of Proton Therapy Equipment
Condition: Malignant Glioma; Hepatocellular Carcinoma; Head and Neck Malignant Tumor; Prostate Cancer
MeSH terms: Glioma
Study type: Interventional

Summary: 
      The main purpose of this study is to collect the safety data of Sumitomo Heavy Industries'
      proton therapy equipment for the treatment of solid cancer patients in Linkou Chang Gung
      Memorial Hospital, including the patients' early-stage adverse reactions and the efficacy on
      tumors, as well as to assess the operating functionality of the proton therapy system.
    

Detailed description: 
      The main purpose of this study is to collect the safety data of Sumitomo Heavy Industries'
      proton therapy equipment for the treatment of solid cancer patients in Linkou Chang Gung
      Memorial Hospital, including the patients' early-stage adverse reactions and the efficacy on
      tumors, as well as to assess the operating functionality of the proton therapy system.

      In this study, solid cancer subjects will be treated with Sumitomo's proton therapy system.
      Safety and operating functionality data will be collected during the treatment and
      following-up.
    

Intervention name(s): proton therapy
Intervention type(s): Radiation
Intervention description(s): proton therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Direct Current Stimulation for Primary Progressive Aphasia
Condition: Primary Progressive Aphasia
MeSH terms: Aphasia; Aphasia, Primary Progressive; Pick Disease of the Brain; Frontotemporal Dementia
Study type: Interventional

Summary: 
      In the present sham-controlled study, the investigators examine whether tDCS could be used to
      enhance language abilities (e.g., picture naming) in individuals with primary progressive
      aphasia (PPA) primarily characterized by difficulties with speech production.
    

Detailed description: 
      Primary Progressive Aphasia (PPA) is a neurodegenerative condition characterized by insidious
      irreversible loss of language abilities. Prior studies suggest that transcranial direct
      current stimulation (tDCS) directed toward language areas of the brain may help to ameliorate
      symptoms of PPA. In the current study, the investigators are examining whether tDCS could be
      used to enhance language abilities (e.g., picture naming) in individuals with PPA variants
      primarily characterized by difficulties with speech production (non-fluent and logopenic).
      Participants are being recruited from the Penn Frontotemporal Dementia Center to receive 10
      days of both real and sham tDCS (counter-balanced, full-crossover design; participants are
      naïve to stimulation condition). A battery of language tests are being administered at
      baseline, immediately post-tDCS (real and sham), and six weeks and twelve weeks following
      stimulation. Real tDCS may improve language performance in some individuals with PPA.
      Specifically, the investigators expect that tDCS will be more effective in people whose
      baseline performance is worse based on previous research. Severity of deficits at baseline
      may be an important factor in predicting which patients will respond positively to
      language-targeted tDCS therapies.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The stimulation involves 20 minutes of constant stimulation at 1.5 mA.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
Condition: Chronic Spontaneous Uriticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a Phase III, multicenter, randomized, double-blind, placebo-controlled,
      parallel-group study to evaluate the efficacy and safety of omalizumab administered
      subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12
      - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who
      remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.
    


Intervention name(s): Omalizumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.; Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic spontaneous uriticaria; Omalizumab
Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease
Condition: Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases
MeSH terms: Parkinson Disease; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Brain Diseases; Central Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blind, placebo-controlled, Phase IV trial , comparing HMS 90® versus placebo
      (soy protein) as add-on (adjuvant) therapy in subjects with idiopathic Parkinson's Disease.

      The principal objective is to evaluate the changes in biomarkers of oxidative stress
      and,plasma amino acids, as well as improvement of clinical symptoms and brain function
    


Intervention name(s): Whey protein; Soy protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 sachect (10 g) 2times/ day; 1 sachect (10g) 2times/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care