bioihbjkbjnl/mcl2 huggingface dataset:
The Assessment of Microcirculation in Brachial Plexus Block Using Perfusion Index and Capillary Filling Time
Condition: Circulatory; Change
Study type: Observational

Summary: 
      The aim of the present study is to assess the effects of brachial plexus block on
      microcirculation using pefusion index and capillary filling time.
    

Detailed description: 
      Microcirculation is very crucial to evaluate the organ function those working properly in
      human body. The aim of the present study is to assess the effects of brachial plexus block on
      microcirculation using pefusion index and capillary filling time. A total of 50 patients
      whose planned to underwent surgery are performed brachial plexus block using ultrasound, and
      pefusion index, heart rate, blood pressure, capillary filling time are measured at 0, 10th
      and 20th minutes interval and at postoperative 24th hours. All measures will be recorded.
    

Intervention name(s): pefusion index measurement
Intervention type(s): Device
Intervention description(s): perfusion index measurement using massimo radical 7 device
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  American Society of Anesthesiologists score of I and III

          -  ages between 18 and 70

          -  upper extremity surgery
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LINO-1713 in Healthy Korean Female Subjects
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, open-label, parallel-group, phase 1 study to assess the safety,
      tolerability, pharmacokinetics, and pharmacodynamics of LINO-1713 in healthy Korean female
      subjects
    


Intervention name(s): LINO-1713 1 tablet; LINO-1713 once a day for 24 days
Intervention type(s): Drug; Drug
Intervention description(s): LINO-1713 1 tablet is administered once. Oral administration with 200mL of water; Oral administration is performed with 200 mL of water. Instruct subjects to take the drug at the same time as possible.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics (PK) and Safety of 2 Different Doses of Lopinavir/Ritonavir in in HIV/Tuberculosis (TB) Co-infected Patients Receiving Rifampicin Containing Anti-tuberculosis Therapy
Condition: HIV Infections; Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess safety, efficacy and impact of Lopinavir/ritonavir 400/100mg bid or
      Lopinavir/ritonavir 600/150mg bid in combination with rifampicin-containing anti-TB therapy.
    

Detailed description: 
      Fixed dose combination of d4T+3TC+NVP (GPOvir) is widely used in Thai HIV infected since June
      2002. The prevalence of NNRTI resistance has increased since 2005. Tuberculosis can develop
      following NNRTI-based regimen failure or after introduction of a new salvage regimen with a
      boosted PI (immune recovery syndrome). Although, Efavirenz based HAART is preferred in TB/HIV
      with rifampicin containing antituberculosis. However, Efavirenz could not be used in case of
      NNRTI failure, intolerance or toxicity. It remains unknown how to optimally treat HIV /TB in
      populations in which rifampicin has to be used. Moreover, Rifabutin which is recommended when
      use concomitant with boosted PI4, 5, is not feasible in Thailand and other developing
      countries due to cost, toxicity and dosing considerations. If ritonavir-boosted LPV
      demonstrates suitable pharmacokinetics, and is well tolerated, this regimen might prove
      extremely useful and could be widely implemented. LPV/r is potent and widely available
      boosted PI in National Health System in Thailand. We therefore believe that there is a strong
      rationale and impetus for the study of LPV/r 400/100 mg bid versus LPV/r 600/150 mg bid as a
      boosted-PI combination that in the presence of RMP, is able to produce a satisfactory PK
      profile associated with adequate antiretroviral potency, tolerability and efficacy .
    

Intervention name(s): LPV/r
Intervention type(s): Drug
Intervention description(s): LPV/r 400/100 mg BID + 2 NRTI for arm 1 (total 48 weeks) LPV/r 600/150 mg BID + 2 NRTI for arm 2 (total 48 weeks)
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; safety; efficacy; Lopinavir/ritonavir; HIV/TB; rifampicin containing anti-tuberculosis therapy; Pharmacokinetics and safety of Lopinavir/ritonavir with rifampicin containing anti-tuberculosis therapy
Personalized Insemination Treatment Study
Condition: Infertility; Intrauterine Insemination; Reproduction
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended for women undergoing their first cycle of 3 intrauterine
      inseminations. All 3 inseminations will be personalized by using algorithms to determine the
      dose of study medication.
    

Detailed description: 
      Study medication dosage for the first insemination cycle will be based on the woman's age as
      well as her Anti-Mullerian Hormone (AMH) levels.

      Study medication dosage for the second and third insemination will depend on ovarian response
      (number of follicles) during previous insemination cycle and woman's age
    

Intervention name(s): Follitropin delta
Intervention type(s): Drug
Intervention description(s): Study medication doses during all 3 insemination will be personalized using a suggested algorithm
Other intervention name(s): Rekovelle
Intervention MeSH terms: Follicle Stimulating Hormone
Intervention model: Single Group Assignment
Intervention model description: open-label, prospective, dose-finding, single centre pilot study.
Masking: None (Open Label)
Primary purpose: Treatment
Lung Regeneration After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
Condition: Scoliosis Idiopathic Adolescent
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      Adolescent Idiopathic Scoliosis (AIS) is a curvature of the spine that occurs in 1-2% of
      otherwise healthy children, and requires corrective surgery, posterior spinal fusion (PSF) in
      ~10% of cases. Some studies suggest that pulmonary function is reduced in AIS and that PSF
      improves pulmonary function. The lung is composed of a large number of branching airways that
      terminate in gas exchanging units called alveoli, and the number and structure of these
      alveoli are partially dependent upon lung volume and the forces to which they are
      exposed--two factors predicted to be altered in AIS. This study uses MRI imaging of inhaled
      helium to quantify alveolar structure in children with and without AIS before and one-year
      after PSF. The goals of the study are to determine if alveolar architecture or number are
      altered in AIS and whether PSF impacts these same measures.
    

Detailed description: 
      After obtaining informed consent, subjects are trained in a breath holding technique that
      permits obtaining reproducible proton and hyperpolarized helium (HHE) lung images. 3-Helium
      is obtained from a vendor and hyperpolarized using an optical spin transfer device (FDA
      Investigational New Drug (IND) 122,670) and administered through a valved inhalation device
      while in the MRI scanner. Images are obtained during an ~15 second inspiratory breath hold.
      Proton MRI images are similarly obtained during a breath hold with room air using an
      ultrashort echo time sequence. From these MRI images, lung volumes, alveolar sizes, and
      estimated alveolar numbers are derived. Subjects are reimaged at 1 year to evaluate changes
      in these parameters during normal lung growth (controls) or after PSF (AIS subjects).
    

Intervention name(s): Posterior spinal fusion
Intervention type(s): Procedure
Intervention description(s): Surgical procedure that involves placement of spinal rods to correct spinal curvature
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy control and otherwise healthy AIS children and young adults
      
Keywords: Lung Development; Lung Regeneration; Hyperpolarized Helium
External-Beam Radiation Therapy, Capecitabine, and Sorafenib in Treating Patients With Locally Advanced Rectal Cancer
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
      chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells,
      either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth
      of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood
      flow to the tumor. Giving radiation therapy together with capecitabine and sorafenib before
      surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
      removed.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine
      when given together with sorafenib and external-beam radiation therapy and to see how well it
      works in treating patients with locally advanced rectal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the recommended dose of neoadjuvant capecitabine when given together with
           sorafenib tosylate and external-beam radiotherapy in patients with K-ras mutated,
           locally advanced rectal cancer. (Phase I)

        -  Assess the efficacy and safety of this regimen in these patients. (Phase II)

      OUTLINE: This is a multicenter, phase I, dose-escalation study of capecitabine followed by a
      phase II study.

      Patients receive oral capecitabine twice daily and oral sorafenib tosylate once daily on days
      1-33. Patients also undergo external-beam radiotherapy once daily on days 1-5, 8-12, 15-19,
      22-26, and 29-33. Approximately 6 weeks after completion of neoadjuvant therapy, patients
      undergo surgery.

      After completion of study therapy, patients are followed at 8 weeks and then periodically for
      up to 3 years.
    

Intervention name(s): capecitabine; sorafenib tosylate; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Phase II: 2 x 825 mg/m2 per day (during 5 weeks); Phase II: 1 x 400 mg per day (during 5 weeks); Phase II: 1.8 Gy per day in 25 fractions (during 5 weeks)
Other intervention name(s): XELODA; BAY 43-9006
Intervention MeSH terms: Capecitabine; Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the rectum; stage II rectal cancer; stage III rectal cancer
Intensity Modulated Radiation Therapy - Prostate Cancer
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There are several different treatment schedules being used across the world for treatment of
      prostate cancer with radiation therapy. In order to determine the best radiation treatment
      for this disease, a study is being performed by the doctors at the Princess Margaret
      Hospital. This study will try to measure the effectiveness and side effects of an increased
      dose of radiation to the prostate that is also given over a shorter number of weeks than is
      usually done. In order to try to reduce the possible side effects of the radiation therapy
      the treatment will be given using special techniques to shield as much of your normal body
      tissues as possible. This method of treatment is called conformal intensity modulated
      radiation therapy, or IMRT.
    


Intervention name(s): conformal intensity modulated radiotherapy (IMRT)
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Maintenance of Recommended Sodium Intake
Condition: Maintenance of Recommended Sodium Intake
Study type: Interventional

Summary: 
      The overall objective of this study is to assist the general public in achieving and
      maintaining the currently recommended sodium intake of 1500 mg/day through a reduced sodium
      intervention that emphasizes spices and herbs. The investigators hypothesize that after four
      weeks of eating a controlled diet, individuals will acclimate and adhere to a reduced sodium
      intake of 1500 mg/day and their taste preferences will change. The investigators also
      hypothesize that individuals in a low sodium behavioral intervention will maintain greater
      adherence to a dietary sodium intake of ≤ 1500 mg/day than individuals in a self-directed
      control group.
    


Intervention name(s): Behavior and lifestyle counseling
Intervention type(s): Behavioral
Intervention description(s): 20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sodium; Diet; Urinary sodium excretion; Feeding study; Diet maintenance
Safety and Efficacy Study of AV608 in Subjects With Social Anxiety Disorder
Condition: Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to look at the safety and effectiveness of an investigational
      drug (AV608) when used in subjects who have Social Anxiety Disorder. AV608 is an NK-1
      receptor antagonist that exhibits central nervous system activity after oral administration.
      The study will compare AV608 to placebo (a medically inactive substance) to see if AV608
      helps the symptoms of Social Anxiety Disorder. Eligible subjects will be assigned by chance
      to take either AV608 or placebo for 12 weeks. During the study, subjects will be asked about
      their overall health and mood and their Social Anxiety Disorder.
    


Intervention name(s): AV608
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; Social Phobia
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid
      arthritis (RA) on methotrexate (MTX).
    


Intervention name(s): ASP5094; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV); Intravenous (IV)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Rheumatoid arthritis (RA); Methotrexate; ASP5094
Effects of Nitrates and Citrulline Malate on Performance in Professional Professional Soccer
Condition: Supplementation
Study type: Interventional

Summary: 
      Randomized, single-center, parallel, team-stratified, stratified experimental study to
      evaluate the efficacy of a high sports supplement in improving high-intensity intermittent
      exercise performance in professional female soccer players.
    

Detailed description: 
      Subjects who meet the selection criteria will be randomly assigned to each of the study
      groups (investigational product or placebo, depending on the group to which they have been
      assigned).

      The product to be consumed will be Nitrates and Citrulline Malate. Participants will consume
      the product for 30 days. The intake should be done two hours before each training session and
      the same dose will be consumed.

      The women's soccer players will perform a stress test with gas analysis to measure
      performance, as well as a Wingate test without consumption of the products. Five days later,
      the players will perform the Yo-Yo IR1 test in the field and will repeat the same tests
      performed at the beginning of the test after product consumption.
    

Intervention name(s): Nitrates and Citrulline Malate; Control product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Female soccer players should consume the experimental product for 30 days to evaluate the efficacy of a sports supplement high in nitrates combined with citrulline malate in the improvement of performance in high-intensity intermittent exercise.
high intensity; Fruit puree
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Nitrates; Citrulline malate; Soccer
Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities
Condition: Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the
      developed world. Despite available treatment, 25% of children in San Diego County
      appropriately treated for KD develop coronary artery abnormalities that could lead to
      complications later in life, including heart attack. Although investigators can identify
      children with KD that have these coronary artery abnormalities, there is no approved
      additional treatment to decrease coronary artery inflammation and arrest or prevent damage to
      the coronary arteries. Inflammation and damage to the arterial wall is central to these
      coronary artery abnormalities. Statins, a class of drugs that is known for lowering
      cholesterol, have also been shown to decrease inflammation in general as well as at the level
      of the vessel wall. Therefore, the investigators propose to study the safety of the drug
      atorvastatin in children with coronary artery abnormalities from KD.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kawasaki disease
Correlates and Consequences of Increased Immune Activation in Injection Drug Users
Condition: Intravenous Drug Usage
Study type: Observational

Summary: 
      The goal of this study is to learn how injection drug use may affect the immune system.
    

Detailed description: 
      The goal of this study is to learn how injection drug use may affect the immune system. One
      way to measure this is by looking at the blood and the gut, or gastrointestinal tract at the
      same time. It is thought that activating the immune system by injection drug use may increase
      destruction of immune cells in the gut. To test this theory, the investigators are enrolling
      HIV-negative injection drug users, HIV-negative people who do not use drugs and HIV-negative
      former injection drug users.
    

Intervention name(s): Sigmoidoscopy with biopsy
Intervention type(s): Procedure
Intervention description(s): Sigmoidoscopy with biopsy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Group 1: HIV-uninfected, active IDU defined as a minimum of 3 injections of heroin per week
        (N=48)

        Group 2: Non-injecting controls defined as no lifetime use of injection drugs and no
        illicit non-injection opiate or cocaine for at least 3 years (N=48)

        Group 3: Former injectors of heroin with/without other agents will be recruited and
        followed after approximately 1 month (N=48) and 3 months (N=48) from the time of last
        injection.

        All groups will be matched for age, sex, and race/ethnicity. Groups 1 and 3 will be matched
        for Hepatitis C status and HCV RNA levels. Group 1 subjects will be studied twice; at
        baseline, at 1-2 months to assess stability of findings. Group 2 will be studied once;
        Group 3 will be studied at 1 and 3 months after ceasing injections.
      
Biospecimen description: 
      Sigmoidoscopy with biopsy
Efficacy of Intravenous Dexamethasone on Postoperative Caudal Analgesia in Pediatric Orchiopexy
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate postoperative pain control for pediatric patients.
    


Intervention name(s): dexamethasone
Intervention type(s): Drug
Intervention description(s): Intravenous dexamethasone (0.5mg/kg) before incision
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Pediatric patients (6 months-5 years) scheduled elective day-case orchiopexy
Study to Investigate Effects of a Herbal Drug Compared to Placebo on Sleep
Condition: Healthy; Sleep Quality
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the influence of a herbal preparation containing hypericum, passionflower, and
      valerian on sleep structure, improvement of attention, and well-being in comparison to
      placebo.
    

Detailed description: 
      To demonstrate the influence of the herbal combination preparation Neurapas® balance on the
      objective sleep structure in comparison with placebo. A further aim was to investigate
      whether treatment with Neurapas® balance versus placebo brings about an improvement in
      attention and well-being and whether these changes are related to the improvement in the
      sleep structure.

        1. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days
           vs. placebo lead to an improvement in continuity of sleep?

        2. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days
           vs. placebo lead to an improvement in sleep architecture, especially an increase in deep
           sleep?

        3. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days
           vs. placebo lead to an improvement in morning attentional performance?

        4. Does the administration of 3 x 2 Neurapas® balance tablets over a period of three days
           vs. placebo lead to an improvement in morning well-being?
    

Intervention name(s): Neurapas® balance (Herbal product (Hypericum, Passionflower, Valerian)); film-coated sugar-pill
Intervention type(s): Drug; Drug
Intervention description(s): 3 x 2 tablets / day over 3 days; 3 x 2 tablets / day over 3 days
Other intervention name(s): Neurapas balance, film-coated tablet over 3 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep-EEG; sleep architecture; sleep duration; sleep continuity; REM-sleep; vigilance; well-being; Healthy volunteers