bioihbjkbjnl/mcl2 huggingface dataset:
Scopolamine Patch Pharmacokinetics in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The study to be performed will utilize already FDA-approved marketed products in healthy
      adults for the purpose to generate data for establishing rate of drug delivery of Transderm
      Scop® TDDS (transdermal drug delivery system) in healthy adults and to ensure safety of
      individuals utilizing these types of products.
    

Detailed description: 
      Transdermal drug delivery systems (TDDS) available in the form of patches are convenient,
      attractive, and easy to use systems. Scopolamine patches are very popular TDDS available on
      the United States market today. Accurate determination of the rate and extent of drug release
      and absorption is crucial to ensure the safety of individuals using these and other types of
      patches. Delivery rate can be determined early in the development process by using in vitro
      skin flux permeation studies, and later in humans by accurately quantifying residual drug
      from patches post-wear and in pharmacokinetic studies. In this proposal, the investigators
      will employ two types of evaluation to determine the rate and extent of drug release and
      absorption from RLD (reference listed drug) Transderm Scop® TDDS (transdermal drug delivery
      system), namely residual drug analysis post-wear and pharmacokinetic analysis in healthy
      adult volunteers. In addition, the investigators will compare the plasma drug concentrations
      following patch and intravenous administration of Scopolamine, in order to determine the
      absolute bioavailability of these patches. The investigators will conduct residual drug
      analysis of TDDS following in vivo wear using highly sensitive validated quantification
      methods. Positive outcomes of this project will identify appropriate methods to determine the
      rate and extent of drug release and absorption from TDDS, and will help regulatory agencies
      in the development of Guidances for Industry regarding the characterization of drug release
      and absorption kinetics to ensure the safety of individuals utilizing these types of products
    

Intervention name(s): Transderm Scop®; Intravenous scopolamine hydrobromide
Intervention type(s): Drug; Drug
Intervention description(s): TDDS dosage is 1.5 mg/72 hrs; 0.4 mg via intravenous injection
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Peer Review; Research
Screening for Preeclampsia With Various Markers in Low-risk Pregnancy Populations
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators
      established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of
      Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down
      syndrome screening.
    

Detailed description: 
      A prospective study was carried on in Cha hospital. Serum samples for Down syndrome screening
      were assayed to estimate pregnancy-associated plasma protein-A (PAPP-A), alpha-fetoprotein ,
      unconjugated estriol, human chorionic gonadotrophin , and inhibin-A. Women screened for Down
      syndrome were offered UtA Doppler at 20-24 weeks of gestation and then collected serial serum
      samples for sFlt-1/PlGF ratio at two time points (24-27 and 34-37 weeks' gestation).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        low risk women who had not a risk factor of preeclampsia.
      
Keywords: preeclampsia
Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass
      (the "heart-lung machine"). Approximately 35 to 50% of these children will have "acute kidney
      injury," or damage to the kidneys, after the procedure. We currently have few medications to
      prevent this kidney injury. The hypothesis of this study is that giving aminophylline after
      heart surgery can decrease the acute kidney injury.
    

Detailed description: 
      Patients are randomized to receive aminophylline or placebo for 72 hours, in a blinded
      fashion. Serum theophylline levels monitor for safety of aminophylline dose. Goal
      theophylline levels is 5-7 mcg/ml. Laboratory results will be faxed directly to the pharmacy
      who will adjust subsequent aminophylline dosing to maintain appropriate theophylline levels.
      Urine output and serum creatinine levels will be monitored to assess acute kidney injury.
      Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) levels will also be monitored.
    

Intervention name(s): Aminophylline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours; Normal Saline
Other intervention name(s): treatment
Intervention MeSH terms: Aminophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Kidney Injury (AKI); Cardiopulmonary bypass (CPB)
Investigation of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This research will evaluate the impact of blocking central and peripheral glucocorticoid
      receptors on stress sensitivity and the risk of relapse to cocaine use in treatment-seeking
      cocaine-dependent individuals. Mifepristone (RU-486) will be the glucocorticoid antagonist
      used.
    

Detailed description: 
      This study attempts to reduce relapse risk by blocking glucocorticoid receptors, and thus
      allow some of the changes in the brain caused by cocaine to redress themselves
    

Intervention name(s): Mifepristone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mifepristone 600mg, 3x/wk for 4 weeks; placebo
Other intervention name(s): RU486
Intervention MeSH terms: Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine Dependence
Transversus Thoracic Muscle Plane Block for Open Heart Surgery
Condition: Pain, Acute; Pain, Chest
MeSH terms: Acute Pain; Chest Pain
Study type: Interventional

Summary: 
      Poststernotomy pain is a complication of cardiac surgery. Poorly controlled pain is
      associated with myocardial ischemia, cardiac arrhythmias, hypercoagulability, pulmonary
      complications, and increased rates of delirium and wound infection.

      The transverse thoracic muscle plane (TTMP) block is a novel plane block that provide pain
      for sternotomy. The aim of this study was to evaluate the analgesic effect of ultrasound
      guided TTMP block in patients undergoing open heart surgery.
    


Intervention name(s): Bupivacaine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound guided 20 ml % 0.250 bupivacaine injection to transverse thoracic muscle plane bilaterally; Ultrasound guided 20 ml % 0.9 saline injection to transverse thoracic muscle plane bilaterally
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Emotion Regulation Group Skills Training for Eating Disorders
Condition: Eating Disorders; Emotions; Skill, Coping
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Emotion regulation difficulties appear to play a role in the development and maintenance of
      several eating disorders. This pilot study aims at examining whether a short add-on group
      skills training in emotion regulation for young adults with different eating disorders is
      feasible in a psychiatric clinical setting. We also investigate if the treatment increases
      knowledge of emotions, and decreases self-reported difficulties with emotion regulation,
      alexithymia, symptoms of eating disorder, anxiety and depression, as well as clinical
      impairment.

      Six skills training groups were piloted with a total of 29 participants (M = 21.41 years, SD
      = 1.92). The treatment consists of five sessions dealing with psychoeducation about emotions
      and emotion regulation skills training. Paired samples t-test was used to compare differences
      between before-and-after measures.
    


Intervention name(s): An Adjunctive Emotion Regulation Skills Training
Intervention type(s): Behavioral
Intervention description(s): The adjunctive emotion regulation skills training is delivered in a group format once a week during 5 weeks to young adults with eating disorders together with treatment as usual
Intervention model: Single Group Assignment
Intervention model description: A pilot study without randomization or controlled design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eating disorders; young adults; emotion regulation skills
Taste and Palatability of Orfadin Suspension
Condition: Hereditary Tyrosinemia, Type I
MeSH terms: Tyrosinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to verify that pediatric patients, especially those who are not
      old enough to swallow capsules, accept the taste and palatability of a new suspension.
    

Detailed description: 
      This is an open, non-randomized, non-controlled, multiple-dose study in 18 pediatric
      patients. The treatment period is three days, and during the study the subjects will rate the
      taste and palatability of the suspension or (for younger children) their parents will rate
      the child´s acceptance of the suspension.

      The study consists of a screening period, a 3 day treatment period and a 1 week follow-up
      period.
    

Intervention name(s): Nitisinone
Intervention type(s): Drug
Intervention description(s): Oral suspension
Intervention MeSH terms: Nitisinone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nitisinone; Orfadin; suspension; taste; acceptability
Effects of Oxytocin and Vasopressin on Moral Decision Making
Condition: Healthy
Study type: Interventional

Summary: 
      To determine whether the neuropeptide oxytocin (OXT) and vassopressin (AVP) influence moral
      decision making
    

Detailed description: 
      In a double-blind, between- subject placebo (PLC) controlled design, subjects will first
      complete a series of questionnaires in terms of mood, clinical symptoms, and traits. After
      that their moral judgment and emotion towards both verbal descriptions of moral dilemma
      scenarios and pictures of specific interpersonal ones will be assessed and the effect of
      intranasal OXT and AVP between both male and female healthy subjects will be investigated.
    

Intervention name(s): Oxytocin; Vasopressin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intranasal administration of oxytocin (24 IU); intranasal administration of vasopressin (20 IU); intranasal administration of placebo
Intervention MeSH terms: Vasopressins; Arginine Vasopressin; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: moral decision making; oxytocin; vasopressin
Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear
      infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops. The
      patient or caregiver will measure the amount of ear pain before and after the ear drops to
      establish if the medicated ear drops decrease the amount of pain more than the placebo ear
      drops. The subject may leave the clinic 60 minutes after the first dose. The ear drops can be
      used up to 4 days, as needed for ear pain.
    

Detailed description: 
      The study involves the initial clinic visit, using the ear drops at home and keeping a diary
      about the ear pain experienced and medications taken. The patient will return to the clinic 4
      days later for evaluation and to return the ear drops and diary. The clinic staff will call
      to follow-up about the patient's condition seven days after the initial visit.
    

Intervention name(s): AR01; Glycerin ear drops
Intervention type(s): Drug; Drug
Intervention description(s): drops administered an needed for pain; placebo drops administered for ear pain
Other intervention name(s): benzocaine; placebo
Intervention MeSH terms: Benzocaine; Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Otitis Media; Pain; Ear Pain; Ear Ache; Ear infection; middle ear infection
The Effectiveness of Ozone (O2-O3) Injections in the Treatment of Myofascial Pain Syndrome
Condition: Myofascial Pain Syndrome; Myofascial Trigger Point Pain
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      Ozone (O2-O3) has been used as a supportive therapy in various musculoskeletal diseases such
      as lumbosacral disc herniation, knee osteoarthritis, meniscus injury, shoulder
      pathologies.The aim of this study is to investigate the effectiveness of ozone (O2-O3)
      injection applied to the trigger point in the treatment of myofascial pain syndrome.
    

Detailed description: 
      The study was designed as a prospective, randomized, controlled trial. Fourty six people who
      met the inclusion criteria will randomized into two groups of 23 people. The first group will
      be designated as ozone therapy group and patients in the second group will be designated as
      the lidocaine injection group. Patients will be evaluated with visuel analog scale
      (10cm-VAS), Neck Disability Index (NDI), Pain Score (PS) and neck lateral flexion measurement
      before and after treatment at 4 and 12 weeks.
    

Intervention name(s): Ozone therapy; Lidocaine injection group
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients in the ozone therapy group will be treated with ozone (O2-O3) in a volume of 5 ml and a dose of 10 µg / ml for three consecutive weeks in a weekly session to the most painful trigger point.; Patients in the lidocaine injection group will be applied to the most painful trigger point in a volume of 2 ml of 1% lidocaine for three consecutive weeks, once a week.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: myofascial pain syndrome; trigger point pain; ozone; lidocaine
Study of AT-752 in Healthy Subjects
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in
      healthy subjects
    

Detailed description: 
      A First-in Human, Randomized, Double-blind, Placebo controlled Single and Multiple Ascending
      Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy
      Subjects
    

Intervention name(s): AT-752; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Parallel Assignment; Parallel Assignment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Phase 1 Multicenter Open-label Study to Evaluate the Safety Tolerability and PK of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies
Condition: Advanced Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open label, first-in-human dose-escalation study of MEDI0680 (AMP-514)
      to evaluate the safety, tolerability, PK, immunogenicity (IM), and antitumor activity in
      adult subjects with solid tumors.
    


Intervention name(s): MEDI0680 (AMP-514)
Intervention type(s): Drug
Intervention description(s): Study has planned dose escalation cohorts
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Imaging the Dopamine Systems in Bulimia Nervosa
Condition: Eating Disorders
MeSH terms: Bulimia; Feeding and Eating Disorders; Bulimia Nervosa
Study type: Observational

Summary: 
      This study will use positron emission tomography imaging to investigate the dopamine systems
      in people with bulimia nervosa.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will include people with bulimia nervosa seeking inpatient or
        outpatient treatment and people who will act as healthy control participants
      
Keywords: Bulimia Nervosa; PET Imaging; Dopamine
Total Knee Arthroplasty Comparing Cementless to Cemented Fixation
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if there are any clinical or radiographic
      differences in cemented and cementless fixation in total knee replacement.
    

Detailed description: 
      Out comes measures were to determine:

        1. whether the knee and function scores and the radiographic results of the knees with a
           Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless
           prosthesis.

        2. whether the patients with a Nexgen cemented knee prosthesis would have a better range of
           knee motion than those with an Nexgen cementless prosthesis.

        3. whether patient satisfaction and preference would be better in the patients having a
           Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee
           prosthesis

        4. whether complication rate would be less in the knees with a Nexgen cemented knee
           prosthesis than in the knees with an Nexgen cementless prosthesis.
    

Intervention name(s): Cementless (Nexgen); Cemented (Nexgen)
Intervention type(s): Device; Device
Intervention description(s): Cementless fixation of Nexgen CR TKR; Cemented fixation of Nexgen CR TKR
Other intervention name(s): Cementless Nexgen; Cemented Nexgen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; cemented; cementless; fixation; posterior stabilized; cruciate retaining
Multi Modal Imaging: An MRI Study to Investigate Differences in the Structure and the Function of the Brain at Rest.
Condition: Irritable Bowel Syndrome; Cyclical Vomiting Syndrome; Ulcerative Colitis; Vulvodynia; Crohn's Disease
MeSH terms: Crohn Disease; Irritable Bowel Syndrome; Vulvodynia; Syndrome; Vomiting
Study type: Observational

Summary: 
      The structural/RSN study involves Structural and Resting State Neuroimaging. The purpose of
      Structural Neuroimaging is to use MRI technology to identify cortical and white matter
      morphometric differences between patients with chronic pain conditions and healthy control
      subjects.

      The purpose of the Resting State Neuroimaging study is to use functional MRI to identify
      possible disease related differences in various resting state networks in the brain.

      In addition we are looking at the effect gut microbiota on brain function in healthy and IBS
      participants.

      The overall goal is to identify structural and functional brain differences in persons with
      chronic pain conditions such as Irritable Bowel Syndrome (IBS, Cyclical Vomiting
      Syndrome(CVS) and vestibulodynia/vulvodynia. We are also looking at Inflammatory Bowel
      Disease(ulcerative colitis and Crohn's disease. We will be comparing differences between
      these conditions and matched healthy control subjects.
    

Detailed description: 
      The study involves 2 visits. The screening visit is about 90 minutes and involves signing the
      consent, completing questionnaires, a medical history, modified physical exam and
      psychological interview to identify stressors, anxiety, depression and other conditions.

      The second visit is the MRI visit (both functional and structural) and also will take about
      90 minutes, with the scanning lasting about 45 minutes. There are questionnaires and a
      measure of skin conductance also.

      We have added a single stool sample for microbiota analysis and a food frequency
      questionnaire in the healthy control and IBS populations.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects will be recruited from clinics, community in and around Los Angeles Area.
      
Keywords: fMRI; resting state; structural MRI; functional MRI
A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate
      the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in
      subjects with active Rheumatoid Arthritis despite Methotrexate therapy.
    


Intervention name(s): LBAL; Humira®
Intervention type(s): Drug; Drug
Intervention description(s): Adalimumab; Adalimumab
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vaporized Nicotine and Autonomic Control
Condition: Electronic Cigarette Use
Study type: Interventional
Phase: Early Phase 1

Summary: 
      E-cigarettes are marketed as an alternative to smoking for those who want to decrease the
      health risks of tobacco. Tobacco cigarettes increase heart rate (HR) and arterial pressure,
      while reducing muscle sympathetic nerve activity (MSNA) through sympathetic baroreflex
      inhibition. The acute effects of e-cigarettes on arterial pressure and MSNA have not been
      reported: our purpose was to clarify this issue. Using a randomized crossover design,
      participants inhaled on a JUUL containing nicotine (59 mg/ml) and a similar placebo
      e-cigarette (0 mg/ml).
    


Intervention name(s): Electronic Cigarette containing nicotine; Electronic Cigarette without nicotine
Intervention type(s): Device; Device
Intervention description(s): Non-smokers used an electronic cigarette containing nicotine; Non-smokers used an electronic cigarette without nicotine
Other intervention name(s): JUUL (brand name); Smok (brand name)
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Repeated Measures
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: E-cigarette; Autonomic Control; Muscle Sympathetic Nerve Activity