bioihbjkbjnl/mcl2 huggingface dataset:
PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a open-label study, 2-treatment, 2-period, single sequence design. Period 1 will
      examine the pharmacokinetics of TMC207 in the absence of rifapentine or rifampicin. Subjects
      will receive a single 400-mg dose of TMC207 administered alone on Study Day 1. Period 2 will
      examine the effects of repeated doses of either rifapentine or rifampicin on TMC207
      pharmacokinetics and will begin on Study Day 20. During Period 2, subjects will receive 22
      daily doses of either 600 mg rifapentine or rifampicin from Study Day 20 through Study Day
      41. A single 400-mg dose of TMC207 will be administered on Study Day 29. Subjects will be
      confined to the clinic from Study Day-1 to Study Day 2 in the morning of Period 1, and Study
      Day 19 to Study Day 30 in the morning of Period 2. The study hypothesis is to determine
      whether Rifapentine affects the pharmacokinetics of TMC207 as measured by effects on Cmax and
      AUC(0-t) to a lesser degree than rifampicin.
    


Intervention name(s): TMC207; rifapentine; rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This is a two group, 2 period study design with both groups in the first period receiving TMC207 alone, followed by one group in the second period receiving TMC207 in the presence of dosing with rifapentine and the other group receiving TMC207 in the presence of dosing with rifampicin. All treatments details specified under "Arms" description.
Other intervention name(s): bedaquiline
Intervention MeSH terms: Rifampin; Rifapentine; Bedaquiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tuberculosis; PK; TMC207; bedaquiline; rifapentine; rifampicin; drug drug interaction
The VIBLOK SAfety and perFormancE Trial
Condition: HSV-2 Infection; Genital Herpes
MeSH terms: Herpes Genitalis
Study type: Interventional

Summary: 
      Genital herpes has a high prevalence in industrialized as well as developing countries.

      Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be
      transmitted mother to child during birth with possible serious consequences.

      Medical treatments and condoms only partially reduce the risk for transmission from/ to
      sexual partners. Genital herpes transmission despite use of condoms is thought to be due to
      transfer via skin-to-skin contact in unprotected areas, and HSV-2 transmission may be
      enhanced by current shaving habits in the genital area leading to micro lesions (lacerations)
      of the skin.

      VIBLOK™ is a cream designed to impede the passage of viruses, such as HSV-2, across the skin.
      Bench and animal experiments indicate that it can block virus transmission such as HSV-2 over
      80%.

      The objective of the SAFE trial is to assess the safety and performance of VIBLOK in adults
      with HSV-2 infection by comparing virus detection in the extra-genital area before and after
      application of the barrier cream.
    


Intervention name(s): VIBLOK barrier cream
Intervention type(s): Device
Intervention description(s): VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.
Intervention model: Single Group Assignment
Intervention model description: Trial participants take extra-genital swabs before and after application of the barrier cream.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Barrier cream
Effect of a Single Oral Dose of Moxidectin on the Cardiac QT Interval of Healthy Volunteers
Condition: QT Effects in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effect of a single oral dose of moxidectin on the QT interval
      associated with moxidectin plasma concentrations.

      The effect of moxidectin on other ECG intervals, and on safety, will also be assessed, as
      will preliminary pharmacokinetics and metabolism
    

Detailed description: 
      Moxidectin is being developed as a treatment for Onchocerciasis (river blindness), a serious,
      debilitating, disease caused by a parasitic worm, Onchocerca volvulus.

      Five dose levels of moxidectin will be administered to healthy volunteers and ECG assessments
      undertaken at pre-specified pharmacokinetic time points to correlate QT interval with
      moxidectin concentration in plasma.
    

Intervention name(s): Moxidectin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Moxidectin is a broad spectrum macrocyclic lactone endectocide
Intervention MeSH terms: Moxidectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will establish the bioequivalence of the 20%, milled, roller compaction final
      market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib
      tablets.
    


Intervention name(s): etoricoxib; Comparator: etoricoxib
Intervention type(s): Drug; Drug
Intervention description(s): Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.; Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fibered Platinum Coils vs Vascular Plugs in Pelvic Varices Embolization for the Treatment of Pelvic Congestion Syndrome
Condition: Pelvic Congestion Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      This prospective randomized study compares the safety and efficacy of two different
      embolizing agents for the treatment of pelvic congestion syndrome: fibered platinum coils and
      vascular plugs.
    

Detailed description: 
      This prospective randomized study compares the safety and efficacy of two embolizing agents
      for the treatment of pelvic congestion syndrome: fibered platinum coils (Nester coils; Cook
      Medical) and vascular plugs (Amplatzer vascular plugs II; St. Jude Medical).
    

Intervention name(s): Fibered platinum coils; Vascular plugs
Intervention type(s): Device; Device
Other intervention name(s): Nester coils; Amplatzer vascular plugs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pelvic Congestion Syndrome; Pelvic Venous Insufficiency; Chronic pelvic pain
Study of Experimental Models of Pain and Inflammation.
Condition: Pain; Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The experimental pain model studied in this proposal show characteristics of an inflamed
      wound with a pro-inflammatory response. This study will help discover candidate genetic
      and/or proteomic pain biomarkers that could provide objective and mechanism based tests to
      diagnose, monitor or quantify pain. We also hope to determine the measurable effects of a
      known non-steroidal anti-inflammatory drug (NSAID) on biomarkers of pain and inflammation.
    


Intervention name(s): Ibuprofen; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): 800 mg oral one time only; Placebo tablet oral one time only
Other intervention name(s): Ibuprofen, generic; Placebo
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
ClearPath DS-120 Clinical Study Protocol
Condition: Ophthalmic, Healthy Eyes
Study type: Observational

Summary: 
      The goal of this study is to measure lens fluorescence in normal subjects at various
      chronological ages that could serves as a guide to clinicians in determining changes in eye
      health. A measure of lens fluorescence can be used by clinicians as an indication of
      degenerative changes occurring in the lens of the eye.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy, normal subject population with healthy eyes as determined by standard
        comprehensive ophthalmic examination.
      
Keywords: Ophthalmic, healthy eye, fluorescence, lens
Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects
Condition: Memory Functions
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and
      cognitive functions in healthy humans.
    


Intervention name(s): Salbutamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single oral administration, 4 mg; single oral administration
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Trial of CM-AT in Children With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether CM-AT is safe and effective in treating the
      core symptoms of autism.
    

Detailed description: 
      Autism is currently a significant cause of disability in the pediatric population. Treatment
      is based upon the observation that many children with autism do not digest protein. CM-AT is
      a proprietary enzyme that is designed as a powder taken three times a day.
    

Intervention name(s): CM-AT; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days; Single unit dose powder of non-active substance administered 3 times per day for 90 days
Other intervention name(s): 900mg CM-AT (pancreatic enzyme concentrate, 720mg; 900mg (Sucanate (98% w/w), Citric Acid (2% w/w)
Intervention MeSH terms: Citric Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism
A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 in Healthy Subjects
Condition: Health, Subjective
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and
      safety of HIP1701 in healthy subjects.
    


Intervention name(s): HIP1701; HGP1809
Intervention type(s): Drug; Drug
Intervention description(s): Vildagliptin; Vildagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Piezoelectric Periodontal Surgery Effects on Orthodontic Treatment: a Prospective Pilot Study
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      INTRODUCTION: Dentoalveolar surgeries such as piezocision, have been developed with the aim
      to accelerate the tooth movement and therefore reduce the length of orthodontic treatment.
      Although this surgical technique seems to present several advantages, such as decreased risk
      of decalcification or orthodontic relapse, its use as a routine practice is not yet
      recommended. The main purpose of this study is to determine the duration of orthodontic
      treatment by using the piezocision. The secondary objectives are to evaluate the effect of
      this surgical technique on bone density, root resorption, osteoclast activity, inflammatory
      events and pain assessment. MATERIAL AND METHODS: The investigators will conduct a
      prospective study. The experimental group will consist of 14 adults, subjects from 18 to 40
      years-old (10 women, 4 men). The control group will consist of 30 matched patients, who have
      been already treated in the orthodontic clinic of the University of Montreal. The
      reliabilities of Intra and Inter assesors will be measured for each doctor. After completion
      of the surgical guides from CBCT, the Piezocision will be performed the same day of the
      bracket indirect placement. The surgical procedure will be standardized and did it by the
      same surgeon. The appointments will be every 2 weeks for 4 months, then every month. The
      investigators will make an assessment of pain by using a numerical visual scale, during the
      first 7 days after surgery. Analysis of inflammatory markers (IL-1) and osteoclast activity
      (RANKL, OPG) will be evaluated from the gingival sulcus fluid collected at day 0, 1, 3, 5, 8,
      12, 16 and 24 weeks. At the end of the treatment, the overall quality evaluation of treatment
      using the "American Board of Orthodontics' grading system" would be realized by two blind
      external observers to limit bias.
    

Detailed description: 
      EXPECTED RESULTS Orthodontic treatment accelerated by piézocicison will be completed within
      one year and will be 50% faster than a traditional treatment. The ratio benefit / risk of
      performing the piezocision will be acceptable for the patient and the orthodontist. We expect
      the following results: low pain, and absence of dental and periodontal deleterious effect (no
      root resorption, no tooth vitality loss and no bone loss). The same cohort can be used in
      future studies to assess the long term stability of the treatment.
    

Intervention name(s): Piezocision
Intervention type(s): Procedure
Intervention description(s): Flapless corticotomies
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rapid orthodontics; accelerated orthodontics; Piezocision; flapless corticotomies; minimaly invasive
Substrate Utilization and Hormonal Status in Women
Condition: Substrate Utilization
Study type: Observational

Summary: 
      Women sexual hormones (i.e. estrogen) are involved in the regulation of substrate utilization
      and storage. Being under oral contraception (OC) may conduct to metabolic and hormonal
      modifications, but results are confused regarding the impact on substrate utilization. In the
      present study, the aim is then to explore the effect of hormonal status on substrate
      utilization during sous-maximal exercise, comparing women with and without OC.

      We hypothesised that women under OC have a lower Respiratory Exchange Ratio (RER) at exercise
      than women without contraception underlying a greater reliance on fat oxidation.
    

Detailed description: 
      24 healthy young women (12 with OC and 12 without any contraception) will complete a maximal
      test on an ergometer cycle to obtain their maximal oxygen consumption (VO2max).Their body
      composition will be assessed by DXA. They will be asked to complete 3 experimental sessions.

      During a first session the volunteers will remain inactive, and only a breakfast will be
      offered. During the second session, a breakfast will be offered and they will have to
      complete a sub-maximal exercise set at 60% of their VO2max 3 hours after breakfast. And the
      third session will consist in the realisation of exercise on fast state. Those three sessions
      will be realized in a randomized order. Several blood (catheter) and salivary samples will be
      collected during the three sessions, throughout the experimental day.
    

Sampling method: Probability Sample
Study population: 
        24 healthy young women (12 with OC and 12 without any contraception) will complete a
        maximal test on an ergometer cycle to obtain their maximal oxygen consumption
        (VO2max).Their body composition will be assessed by DXA. They will be asked to complete 3
        experimental sessions
      
Keywords: Women; Hormonal status; Exercise; Substrate utilization; Women Hormonal Status (with oral contraception or without any contraception)
Web-based Family History Tool
Condition: Gynecologic Cancer; Breast Cancer; BRCA1 Mutation; BRCA2 Mutation
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine if a web-based tool that collects family
      health history is useful for patients being seen in a gynecologic oncology office setting.
      This research study is being done because collecting a comprehensive family health history is
      critical as it allows physicians to appropriately refer patients for genetic counseling and
      genetic testing. However, prior research indicates that the family health history collected
      in clinical settings is often inadequate to truly assess the risk of genetic disease.
      Therefore we plan to explore a web-based program that guides patients through the collection
      of their family health history and uses this information to create clear concise pedigrees
      (family tree information) and risk assessment models that can be used by a physician during
      the office visit.
    

Detailed description: 
      Patients presenting for a new patient visit with a gynecologic oncologist will be randomized
      to one of three methods of collection of family health history (Arm 1 - standard of care
      consisting of interview with the physician; Arm 2 - completion of a web-based family health
      history tool completed in the clinic waiting room on a computer; Arm 3 - completion of a
      web-based family health history tool completed prior to the visit and accessed by an email
      link). A new 4th arm was added with 200 chart reviews to retrospectively look back at how
      previous family health history was taken for new patients in 2019. The study will evaluate
      the quality of the family health history collected, the resulting referral to genetic
      services and patient and physician satisfaction.
    

Intervention name(s): Web-based family health history tool
Intervention type(s): Other
Intervention description(s): Web-based tool that collects subject's family health history through a series of questions and generates a pedigree which documents a risk assessment report for the physician to use. The risk assessment report uses standard, validated risk scores including GAIL , CLAUS, BRCAPRO which measure breast cancer risk, and MMRPRO which measures endometrial cancer risk, MELAPRO which measures melanoma cancer risk, and PANCPRO which measures pancreatic cancer risk
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Coronary Artery Bypass and Nitrate Oral Supplementation
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether oral sodium nitrate administration prior to
      coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition,
      plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.
    

Detailed description: 
      Nitric oxide (NO) is an important mediator in the cardiovascular system and has been shown to
      have protective properties in ischemia-reperfusion injury. Inorganic nitrate, an oxidation
      product from endogenous NO production and also a constituent in green leafy vegetables, can
      be recycled, via nitrite, back to bioactive NO in the body. Recent research has shown
      beneficial effects of nitrate and nitrite in animal models of myocardial ischemia-reperfusion
      injury. Moreover, dietary nitrate reduces blood pressure and oxygen cost during exercise in
      humans.

      During coronary bypass surgery the heart undergoes ischemia-reperfusion injury and troponin T
      is most often released from the myocardium. The aim of the present study is to investigate if
      preoperative inorganic nitrate, in doses easily achievable from the diet, can affect troponin
      T release as well as other surrogate markers of injury to the liver, kidneys and the brain.
      In addition, plasma and urine samples will be collected for markers of oxidative stress and
      inflammation (sCRP and cytokines). Patients planned for bypass surgery who give their written
      informed consent will, the night before surgery, get a standardized, low-nitrate meal where
      after they receive sodium nitrate on two occasions preoperatively; the night before and in
      the morning before surgery. Plasma and urine samples will be collected at various time points
      up to 72 hours after surgery.
    

Intervention name(s): Sodium nitrate; Sodium chloride
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery; Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: sodium nitrate; coronary artery bypass surgery; ischemia-reperfusion; myocardial injury