bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic and Safety Evaluation of L-tetrahydropalmatine (l-THP) With Cocaine Exposure in People With a History of Cocaine Use
Condition: Cocaine Use
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety and pharmacokinetic profile of l-THP with cocaine exposure in
      people who have a history of cocaine use. The subject will be admitted to the Brief Stay Unit
      (BSU), an inpatient facility at the Maryland Psychiatric Research Center, used for short term
      drug abuse or clinical trial studies. The participant will stay for 4 nights and 5 days.
      He/she will be randomized to either placebo or l-THP for three days. On the morning of Day 4,
      the subject will receive one cocaine dose (40 mg intranasal) and have testing for
      pharmacokinetic parameters for the following 10 hours. The subject will stay over one more
      night and will be discharged the following day. Approximately 40 subjects will be randomized
      to enroll the target sample of 30 (N=15 placebo, N=15 l-THP). In summary, each subject will
      come for a screening visit(s), then a 5-day, 4-night stay on a secure research unit. After
      cocaine administration day, the participant will stay overnight for one more day of
      observation and to permit substantial l-THP elimination from the body. The following morning
      we will get one additional blood specimen for l-THP (Day 5 at 24 hours after last dose (7:30
      am); then the participant will be discharged. A visit with blood collection on Day 6 at 55
      hours after last dose (2:30 pm) will be scheduled. A final follow-up visit will be scheduled
      4-7 days after unit discharge to ensure no persisting side effects.
    


Intervention name(s): l-THP (l-tetrahydropalmatine); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will arrive the first day (Day 1) for admission and morning l-THP dosing. The l-THP will be dosed as one capsule 30 mg twice daily (matching placebo or l-THP) (total 60 mg daily). Participants will receive 7 total l-THP doses: two doses on Day 1 (morning and evening), two doses on Day 2 (morning and evening), 2 doses on Day 3 (morning and evening) and one dose the morning of Day 4 (cocaine administration day).; Subjects will arrive the first day (Day 1) for admission and morning l-THP dosing. The l-THP will be dosed as one capsule 30 mg twice daily (matching placebo or l-THP) (total 60 mg daily). Participants will receive 7 total l-THP doses: two doses on Day 1 (morning and evening), two doses on Day 2 (morning and evening), 2 doses on Day 3 (morning and evening) and one dose the morning of Day 4 (cocaine administration day).
Other intervention name(s): l-tetrahydropalmatine
Intervention MeSH terms: Tetrahydropalmatine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine Use
Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with
      the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773
      in healthy participants.
    


Intervention name(s): RO7017773; [11C] Ro15-4513
Intervention type(s): Drug; Other
Intervention description(s): RO7017773 will be administered orally. The doses to be tested will be determined by review of PET scan, PK, and safety results from the previous dose level.; At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer [11C]Ro15-4513.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a formulation feasibility study to to compare relative bioavailability of indacaterol
      and glycopyrronium after administration of single doses of 3 Easyhaler test products and
      Ultibro Breezhaler. The study treatments will be administered with concomitant oral charcoal
      to block absorption via gastrointestinal tract and to assess pulmonary absorption only.
    


Intervention name(s): Indacaterol/glycopyrronium
Intervention type(s): Drug
Intervention description(s): In each period, subjects receive single dose of indacaterol/glycopyrronium consisting of 2 inhaled doses via Easyhaler or 2 capsules inhaled via Ultibro Breezhaler.
In addition to study treatments, activated charcoal will be administered on each study period before and after study drug administration.
Other intervention name(s): Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A with charcoal; Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B with charcoal; Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C with charcoal; Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule with charcoal
Intervention MeSH terms: Glycopyrrolate; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of study drug known as LY3209590
      compared to insulin glargine administered in participants with type 2 diabetes mellitus
      (T2DM). Side effects and tolerability will be documented. The study will last almost six
      months and 21 visits for each participant including screening period.
    


Intervention name(s): Insulin Glargine; LY3209590
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Intervention MeSH terms: Insulin Glargine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Strength and Function Following Total Hip Arthroplasty
Condition: Total Hip Arthroplasty
Study type: Interventional

Summary: 
      To determine if patients who receive an 8 week, comprehensive, multi-component rehabilitation
      program (CMC) have better strength and functional performance compared to a control group
      (CON).

      The investigators hypothesize that functional performance and strength in the muscles
      surrounding the hip and the knee will be greater in the multi-component rehabilitation group
      compared to the control group.
    

Detailed description: 
      The participants will be enrolled and following surgery, randomized into one of two treatment
      groups (CMC or CON). Prior to randomization, both groups will participate in two weeks of
      home rehabilitation consisting mobility training and activities of daily living. After
      randomization, the CMC group will receive physical therapy 2x/ week for 8 weeks from a
      licensed physical therapist and member of the investigative team starting 2 weeks after Total
      Hip Arthroplasty (THA). The CON group will continue activities provided by their home
      rehabilitation therapist for 8 weeks. The CON group will then participate in the CMC
      intervention beginning 10 weeks after THA. These patients will complete pre-operative and
      post-operative testing as described above.

      The CMC group will receive a multi-component program focused on rehabilitation of the
      abdominal and core musculature, neuromuscular re-education through therapeutic exercise as
      well as hip and knee muscle strengthening beginning 2 weeks after THA. The CON group will
      participate in physical therapist recommended activities based on their home rehabilitation
      and then will complete the same multi-component rehabilitation intervention beginning 10
      weeks after THA.
    

Intervention name(s): Multi-Component Rehabilitation (CMC); Control (CON)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Hip Arthroplasty; Muscle Strength; Hip Osteoarthritis
Zurig (Febuxostat) 40mg Efficacy and Safety Trial
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Febuxostat is a potent, nonpurine, selective inhibitor of Xanthine oxidase that exhibits
      antihyperuricemic activity by reducing the formation of uric acid. The investigators
      conducted an interventional, two-arm, randomized, open label pilot study on patients with
      serum urate level ≥ 6.8 mg/dL. Patients were treated with Febuxostat 40 mg Tablets or
      Allopurinol 300 mg Tablets once daily dose for 90 days to determine the efficacy and safety
      of Febuxostat in comparison with Allopurinol in Hyperuricemic Subjects with or without Gout.
    

Detailed description: 
      Patients with hyperuricemia (with or without Gout) were randomized into two groups. One was
      treated with Febuxostat 40 mg Tablets and other with Allopurinol 300 mg Tablets once daily
      for 3 months period.

      Gender, age, height, weight, creatinine and ALT levels, co-morbidities and other
      complications were monitored at screening and as per eligibility criteria 50 patients were
      enrolled in the study. Efficacy was determined by monitoring serum uric acid levels during
      and at the end of treatment. The safety profile has also been monitored during the treatment
      period. Investigator collected and recorded all the data of visits in CRF which was analyzed
      through SPSS version 20.
    

Intervention name(s): Febuxostat; Allopurinol
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of two anti-hyperuricemic molecules; Comparison of two anti-hyperuricemic molecules
Other intervention name(s): Zurig
Intervention MeSH terms: Allopurinol; Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Febuxostat; Efficacy; Safety; Allopurinol; Hyperuricemia; Zurig; Getz Pharma
MENTAL PRACTICE IN MOTOR LEARNING OF BRUSHING AND PARKINSON DISEASE
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease (PD) is characterized by dopaminergic neurons degeneration of the
      substantia nigra, in the midbrain, resulting in the presence of motor disorders, such as
      tremor, rigidity, bradykinesia, and postural instability. Researches have shown that mental
      rehearsal in learning motor skills through mental practice (MP), which associates the
      physical practice to somatosensory imagination to action, causes positive effects in several
      motor tasks, such as the speed of motion, muscle strength performance and accuracy. Thus,
      this study aims to report the effects of MP as a tooth brushing training strategy in people
      with Parkinson's disease. This project was approved by the Ethics Committee in Research with
      Human beings of UFPE and attempt to compare the presence of bacterial biofilm before and
      after 8 weeks of brushing through the mental practice training, based on O'Leary's index. The
      sample consisted of 35 people, divided into two groups: Intervention Group consists of 17
      people with Parkinson's, in stages I to III of the disease, who underwent brushing
      orientation associated with PM, and the control group people without the disease, who
      received only orientation brushing. Then, the data were evaluated by factorial ANOVA 2x2 and
      post hoc Tukey test considering p <0.05. It was observed that after the intervention was a
      significant improvement of the control dental biofilm.
    


Intervention name(s): Mental practice and brushing guidance in patients with Parkinson Disease
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of TLR4 on Lipid-induced Insulin Resistance
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether pharmacologic inhibition of Toll-like
      receptor 4 (TLR4) with eritoran for injection (E5564) prevents lipid-induced insulin
      resistance in lean, normal glucose tolerant (NGT) subjects.
    

Detailed description: 
      E5564 = Eritoran
    

Intervention name(s): Eritoran; D5W (5% Dextrose in water)
Intervention type(s): Drug; Drug
Intervention description(s): Eritoran = E5564 Eritoran is a pharmacologic inhibitor of TLR4.; D5W = 5% Dextrose Water Vehicle
Other intervention name(s): E5564; Vehicle
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insulin signaling and glucose disposal in muscle; Hepatic insulin sensitivity; TLR4 signaling and inflammatory gene expression; Plasma cytokine concentration; Intramyocellular diacylglycerol and ceramide content
Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the hypothesis that in patients with type 2 diabetes,
      the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour
      period, compared with placebo.
    


Intervention name(s): exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week; subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week
Other intervention name(s): Byetta; AC2993; synthetic enxendin-4
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: exenatide; diabetes; Amylin; Lilly
Effect of a Locally Delivered Probiotic in Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Saccharomyces boulardii is commonly employed as a live non-pathogenic probiotic microbial
      feed or food supplement. S. boulardii reduces the secretion of key pro inflammatory cytokines
      and promotes the production of anti-inflammatory cytokines such as IL-10, which is pertinent
      in the context of pathogenic mechanisms in periodontitis.
    

Detailed description: 
      One method of altering the subgingival environment is by using probiotics. Probiotics are
      live microorganisms, which when administered in adequate amounts, confer a health benefit on
      the host by passively occupying a niche that may otherwise be colonized by pathogens. This
      tends to limit a pathogen's ability to bind to tissue surfaces and to produce virulence
      factors.8 In the past few years, probiotics have been investigated for periodontal health.
      Studies have shown that certain gut bacteria can exert beneficial effects in the oral cavity
      by inhibiting pathogenic species. Teughels et al., in a study showed that application of
      beneficial oral bacteria subgingivally after scaling and root planing led to a more host
      compatible subgingival microbiota which may also effect the promotion of a beneficial host
      response.10 Studies have revealed that probiotic Lactobacillus strains (L. reuteri, L
      salivarius, L. casei, L. acidophilus) were useful in reducing gingival inflammation and the
      number of black-pigmented rods, including Porphyromonas gingivalis, in the saliva and
      subgingival plaque. Streptococcus sanguinis & S. uberis were found to inhibit the growth of
      periodontopathogens & a strong negative between Aggregatibacter actinomycetemcomitans and S.
      sanguinis. Weissella cibaria isolates in the form of probiotic rinse possess the ability to
      inhibit biofilm formation, both in vitro and in vivo.
    

Intervention name(s): Study site; Control site
Intervention type(s): Procedure; Procedure
Intervention description(s): The probiotic is in the form of a lyophilized powder containing approximately 5 billion colony forming units (CFU) of the Saccharomyces boulardii. At the time of administration, the probiotic mixture was mixed with fructooligosaccharide in the ratio of 4:1 to induce growth and activity in S boulardii. This was applied after scaling and root planing.; Only Scaling and Root planing was done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of 99mTc-NTP 15-5 Uptake on Cartilage, a New Proteoglycan Tracer
Condition: Osteoarthritis, Knee; Breast Cancer
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is a phase I clinical trial aimed to determine the recommended dose of 99mTc-NTP
      15-5 to obtain the best tracer joints contrast on images without any toxicity.
    


Intervention name(s): 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg; 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg; 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg (D0); 1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg (D0); 1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: dose escalation model
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cartilage; proteoglycan tracer
Bangladesh Vitamin E and Selenium Trial
Condition: Non-melanoma Skin Cancer
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in
      preventing non-melanoma skin cancers.
    


Intervention name(s): Selenium; vitamin E
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 200 ug Selenium daily; 100 mg Vitamin E daily
Intervention MeSH terms: Vitamin E; Selenium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Effect of GSK704838 In Healthy Volunteers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK704838C is a potent, pan-active mAChR antagonist, which is being developed for once-daily
      treatment of chronic obstructive pulmonary disease (COPD).
    


Intervention name(s): GSK704838
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Anticholinergic,; Plethysmography; Muscarinic Receptor Antagonist,; COPD,; FTIH,
Web-based Management of Female Stress Urinary Incontinence
Condition: Female Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether treatment of female stress urinary
      incontinence using a web-based programme is effective.
    

Detailed description: 
      Female urinary incontinence is very common and affects up to one fourth of grownup women. It
      may reduce quality of life for those affected and costs for society are high. The most common
      type of urinary incontinence is stress urinary incontinence (SUI), i.e leakage when coughing,
      sneezing or jumping. There is no association between SUI and serious medical conditions. Thus
      investigation can be kept to a minimum, including structured history taking and a bladder
      diary for correct diagnosis. Treatment with lifestyle intervention and pelvic floor muscle
      training (PFMT) give improvement or cure in 60-70% of women. A small study indicates that
      treatment with cognitive behavioural therapy (CBT) may improve incontinence-related quality
      of life and symptoms of urinary incontinence. Web-based management of SUI has as far as we
      know never been evaluated in a randomized controlled study. The aim of this study is to
      determine if web-based management of female SUI, with a treatment using PFMT and elements of
      CBT is effective compared to treatment supported by a pamphlet. The duration of the treatment
      programme is three months, follow-up at four months, 1 year and two years.
    

Intervention name(s): Web-based treatment with PFMT and elements of CBT; Pamphlet treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 125 women with stress urinary incontinence(SUI) participate in web-based treatment for 3 months. Treatment consists of information, PFMT and uses elements of CBT. It includes regular email contact with urotherapist.; 125 women with SUI receive a pamphlet with information and a programme for PFMT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: female; stress urinary incontinence; treatment; pelvic floor muscle training; cognitive behavioral therapy; internet; life style; pamphlet; eHealth
Randomized Study of Obicetrapib in Combination With Ezetimibe
Condition: Dyslipidemias; High Cholesterol; Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a placebo-controlled, double-blind, randomized, phase 2 study in
      participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of
      obicetrapib and ezetimibe combination therapy.
    

Detailed description: 
      This study will be a placebo-controlled, double-blind, randomized, phase 2 study in
      participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of
      obicetrapib and ezetimibe combination therapy. The screening period for this study will take
      up to 2 weeks. Following the screening period, eligible patients will be randomized to
      placebo, 5 mg obicetrapib + 10 mg ezetimibe; 5 mg obicetrapib + placebo ezetimibe; or placebo
      obicetrapib + 10 mg ezetimibe for an 8 week treatment period. After the treatment period,
      patients will continue for a 4 week safety follow-up and a 8 week PK follow-up.
    

Intervention name(s): Obicetrapib 5mg; Ezetimibe 10mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): tablet; tablet; tablet
Other intervention name(s): CETP inhibitor; Antihyperlipidemic
Intervention MeSH terms: Ezetimibe; Hypolipidemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-Controlled, Double-Blind, Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obicetrapib; statin; LDL-C; cholesterol; atherosclerosis