bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Effectiveness Study of Paliperidone Palmitate in Chinese Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study will be to evaluate the safety and treatment response of
      paliperidone palmitate administered to Chinese patients with schizophrenia.
    

Detailed description: 
      This study is a single-group, open-label (name of study drug is known to patients),
      multicenter study to evaluate the safety and efficacy/treatment response of paliperidone
      palmitate administered for 25 weeks as once-monthly injections to Chinese patients with
      schizophrenia who previously received treatment with oral antipsychotic medications. A target
      of 353 patients (inpatients or outpatients) with schizophrenia will be enrolled in the study
      and will receive injections of study drug (paliperidone palmitate) on Days 1 and 8, and
      thereafter at a monthly flexible dose, based on patients' tolerability and/or efficacy. The
      study will consist of a screening period of up to 1 week before treatment, a 25-week
      treatment period, and a follow-up period approximately 30 days after the last injection of
      study drug. Upon meeting the entry criteria for the study, patients will receive a total of 8
      intramuscular (IM) injections of paliperidone palmitate during the treatment period as
      follows: 150 mg equivalent (eq) on Day 1, 100 mg eq on Day 8, and subsequent monthly IM
      injections with a flexible dose range of 75-150 mg eq. If the patient reports any signs or
      symptoms of worsening of schizophrenia, the investigator may prescribe a rescue medication
      (quick-relief or fast-acting medications that usually work right away to relieve symptoms)
      such as lorazepam (an antianxiety drug) to control agitation, irritability, restlessness, and
      hostility. Safety will be monitored throughout the study.
    

Intervention name(s): Paliperidone Palmitate
Intervention type(s): Drug
Intervention description(s): Paliperidone Palmitate is injected with a dose of 150 mg eq. on Day 1 and 100 mg eq. on Day 8 in the deltoid muscle, followed by a monthly flexible dose range of 75 - 150 mg eq. for injection, based on patients' tolerability and/or efficacy. Monthly doses can be administered in either the deltoid or gluteal muscle alternatively. All the antipsychotics should be discontinued prior to the first dose of study drug. Other antipsychotics are prohibited across this study.
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone; Safety; Effectiveness; Chinese
Dermacyd Teen Care Tangerina Mix - Compatibility
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of irritation potential (primary
      dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the
      product Dermacyd Teen Care Tangerina Mix.
    


Intervention name(s): Lactic acid
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via
      intravenous drip infusion once a day in the patients with ALS based on the changes in the
      revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in
      double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186
      to the ALS patients.
    


Intervention name(s): MCI-186; Placebo; MCI-186 in open label phase
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).; Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).; All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis (ALS)
Questionable Health Behaviors and Their Distal and Proximal Correlates
Condition: Questionable Health Behaviors and Their Distal and Proximal Correlates
Study type: Observational

Summary: 
      The goals of the study:

        1. to investigate the frequency of Traditional, Complementary and Alternative Medicine use
           (TCAM) and intentional Non-adherence to medical recommendations (iNAR) in the general
           population in Serbia, as well as their mutual relations.

        2. to examine the distribution of irrational beliefs in the general population;

        3. to explore the relationships between TCAM and iNAR behaviors on the one hand and
           variables of personality, thinking styles and cognitive reflection on the other, with a
           major assumption that these relationships will be mediated by the domain of irrational
           beliefs and socio-political attitudes.

      Participants will respond to a battery of instruments assessing TCAM use and iNAR, as well
      as, sociodemographics and health-related variables (such as health status, chronic diseases,
      BMI, etc.), distal psychological (i.e. personality, thinking disposition and styles) and
      proximal psychological, variables, (i.e. the irrational mindset, as well as socio-political
      beliefs and attitudes).

      Data will be collected on the probabilistic household sample representative for the general
      population in Serbia (N=1043).
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        general population
      
Keywords: TCAM/ iNAR/ distal predictors /proximal predictors / irrational mindset
Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery
Condition: Bleeding
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      The aim of the study is to evaluate if there is an association between platelet inhibition
      and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual
      antiplatelet therapy.
    

Detailed description: 
      Blood for measuring platelet function is drawn before induction of anesthesia
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients needing emergent cardiac surgery under dual antiplatelet therapy
      
Keywords: Emergent; Cardiac surgery; On-pump; Platelet function
Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in COPD Patients
Condition: COPD; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk
      test and the 3 minute step test, for COPD patients.
    

Detailed description: 
      The 6 minute walk test (6MWT) is the best field test to determine oxygen desaturation during
      effort, in COPD patients. However, the test need a 30m corridor.

      The 3 minute step test (3MST) is a other field test used in COPD patients. But no study shows
      that 3MST can be used to determine oxygen desaturation.

      The aim of this study is to compare oxygen desaturation during these to tests : the 6MWT and
      the 3MST.

      50 patients will be included in this study.

      Patients realize two 6MWT and two 3MST, with rest between each test.

      Oxygen saturation, heart rate are registered during the tests, dyspnea, leg peniblility are
      notified before and after each test, distance or number of steps are noted.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        COPD patients hospitalized for pulmonary rehabilitation program
      
Keywords: Pulmonary rehabilitation; COPD; Evaluation; oxygen desaturation; exercise capacity
Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Observational

Summary: 
      Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be
      assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter
      monitor.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with symptomatic hypertrophic cardiomyopathy versus controls (patients undergoing
        coronary angiography and FFR
      
Keywords: Index of Microvascular Resistance; Microvascular dysfunction
Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2
      mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States
      Pharmacopeia (USP), 2 mg (Mylan Pharmaceuticals Inc.) are bioequivalent.
    

Detailed description: 
      The specific aim was to conduct a single dose, open-label, randomized, two period crossover
      pivotal study to determine the bioequivalence of two formulations containing haloperidol 2 mg
      in healthy males and females under fasting conditions

      A total of 32 healthy female and male volunteers (age 18 to 55 years old) were entered into
      the study. Volunteers were determined to be free of significant medical conditions as
      assessed by medical history, physical examination, and blood and urine tests. Volunteers were
      randomly allocated to a treatment sequence, before administration of investigational
      medicinal product (IMP) under fasting conditions.

      A wash-out period of at least 14 calendar days (minimum number of days based on half-life of
      the analyte) between consecutive administrations of the IMP was maintained.

      Blood samples were collected at at pre-dose (0 hours), at 30 minutes, at 1 hour, 1 hour 30
      minutes, 2 hours, 2 hours 30 minutes, 3 hours, 3 hours 30 minutes, 4 hours, 4 hours 30
      minutes, 5 hours, 5 hours 30 minutes, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours, 30
      hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours and 192 hours
      post-dose (total: 26 samples per treatment period).
    

Intervention name(s): Haloperidol Tablets, Mylan Pharmaceuticals Inc.; Haloperidol Tablets, Cycle Pharmaceuticals Ltd
Intervention type(s): Drug; Drug
Intervention description(s): single dose, 2 mg Haloperidol tablet; single dose, 2 mg Haloperidol tablet
Other intervention name(s): Benztropine Mesylate Tablets; Benztropine Mesylate Tablets
Intervention MeSH terms: Haloperidol; Benztropine; Haloperidol decanoate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to understand nitrous oxide effects in post traumatic stress
      disorder (PTSD)
    

Detailed description: 
      Post traumatic stress disorder (PTSD) is a disabling mental health disorder that impacts the
      lives of individuals. This study aims to understand nitrous oxide's effects in PTSD.
    

Intervention name(s): Nitrous Oxide
Intervention type(s): Drug
Intervention description(s): One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation
Intervention MeSH terms: Nitrous Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD
Changing Chat: Diaper Tips to Improve Language Development
Condition: Healthy Infants
Study type: Interventional

Summary: 
      This randomized trial has two sets of diapers-- a normal one and one that has tips for how to
      talk to and engage your toddler. The investigators are hoping that the intervention improves
      language development.
    


Intervention name(s): Changing chat
Intervention type(s): Device
Intervention description(s): Diapers with tips
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: language development; parental interaction
Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair
      improves knee biomechanics and function, but neuromuscular dysfunction persist for years
      despite rehabilitation, hindering resumption of normal activities, increasing risk of further
      injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA).
      Our goal in this research study is to evaluate the utility of neuromuscular electrical
      stimulation (NMES), initiated following injury and maintained through the early post-surgical
      period, to prevent muscle atrophy and intrinsic contractile dysfunction compared to active
      control intervention of micro-electrical stimulation.
    


Intervention name(s): Neuromuscular electrical stimulation; Microstimulation
Intervention type(s): Device; Device
Intervention description(s): Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.; Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Glucophage Immediate Release (GIR) China Bioequivalence Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the bioequivalence between single doses of glucophage immediate release
      (GIR) test tablets and GIR reference tablets under fed and fasted state in healthy subjects.
    


Intervention name(s): Test GIR; Reference GIR
Intervention type(s): Drug; Drug
Intervention description(s): Participants received 500 milligrams (mg) test GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).; Participants received 500 mg reference GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
Other intervention name(s): Metformin; Metformin
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes Mellitus; Glucophage Immediate Release (GIR); Bioequivalence Study
A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of
      both mania and depression more than treatment with mood stabilizer alone, in patients with a
      mixed episode of bipolar I disorder.
    


Intervention name(s): olanzapine; placebo; divalproex
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).; placebo, capsules, by mouth every evening, daily, for 6 weeks.; dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).
Other intervention name(s): LY170053; Zyprexa
Intervention MeSH terms: Valproic Acid; Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mixed episode associated with Bipolar I
Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension
Condition: Sarcoidosis; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Sarcoidosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hypothesis: Ambrisentan (Letairis ®) is safe and effective in treating pulmonary hypertension
      in patients with Sarcoidosis
    

Detailed description: 
      Primary Endpoint: Change in 6 minute walk distance.
    

Intervention name(s): Ambrisentan
Intervention type(s): Drug
Intervention description(s): ambrisentan 5 mg/day for month month, then 10 mg/day for 3 additional months
Other intervention name(s): Letairis
Intervention MeSH terms: Ambrisentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sarcoidosis; pulmonary hypertension; dyspnea; sarcoidosis associated pulmonary hypertension
Therapeutic Exercises and Stabilization Exercises Given After Manual Therapy
Condition: Patients With Non-Specific Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The study was conducted to determine and compare the effects of the therapeutic exercises and
      stabilization exercises given to the patient after the manual therapy session on pain, neck
      range of motion, daily living activities and quality of life.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): After manuel therapy, the patients were allocated into two groups as Stabilization Exercise Group and Therapeutic Exercise Group randomly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Intracellular Content From Lactobacillus Casei CRL-431 on Antioxidant Capacity of Breast Milk
Condition: Mothers; Lactation
Study type: Interventional

Summary: 
      The objective of the present study was to evaluate the effect of the consumption of the
      intracellular content of Lactobacillus casei CRL-431 on the antioxidant capacity of breast
      milk
    

Detailed description: 
      A double blind randomized controlled clinical study of an 30-d intervention with 16 nursing
      mothers was carried out to evaluate the effect of the consumption of the intracellular
      content of Lactobacillus casei CRL-431 on the antioxidant capacity of breast milk. Once
      obtained the informed consent; volunteers were ramdomized into two groups (n=8) to either
      receive 5 mL daily: edible gel with intracellular content of Lb. casei CRL-431 (intervention
      group) or edible gel without intracellular content of Lb. casei CRL-431 as control (placebo).
      Both gels were consumed daily. Participants were asked not to change their diet or lifestyle
      during the intervention. We applied intention to treat for those participants who did not
      have good adherence and those who withdraw the study. The outcomes between groups were
      analyzed using a independent samples student t-test, with P value of 0.05 or less (two sided)
      when there was a statistical differences. Non-parametric data were analyzed with Mann-Whitney
      test; using statistical software.
    

Intervention name(s): Postibiotic formulation; Placebo formulation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431; 5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nursing mothers; Breast milk; Lactobacillus; intracellular content; antioxidant capacity
Immediate Effects of Kinesio Tape on Median Nerve's Mechanosensitivity
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to verify the immediate effects of Kinesio Tape on median
      nerve's mechanosensitivity, measured by the upper limb neurodynamic test 1 (ULNT1) in healthy
      participants.
    

Detailed description: 
      After completing the socio-demographic and clinical questionnaire, the participants will be
      randomly assigned into two designated groups, the Intervention Group (IG; n = 30) (Kinesio
      tape throughout the median nerve course) and the Control Group (CG; n = 30) (remained at rest
      for 5 minutes), using the software www.graphpad.com/quickcals.
    

Intervention name(s): Kinesio Tape
Intervention type(s): Device
Intervention description(s): The beige Kinesio Tape (Prim Tape®) will be applied, from distal to proximal, 5cm wide, cut in "I" and with tension below 50%. The Kinesio Tape will be placed along the entire path of the median nerve, from the wrist to the armpit. The participants will remain in the supine position on a treatment table (Posturarte® Olympic), without inclination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research