bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension
Condition: Clinically Significant Portal Hypertension
MeSH terms: Hypertension, Portal; Hypertension
Study type: Interventional

Summary: 
      Carvedilol has emerged as the preferred non-selective β-blocker (NSBB) for treating portal
      hypertension. However, there is still a debate in dosing regimen, specially regarding dose
      interval, with a potential lower bioavalability in once daily regimens. The aim of this study
      is to assess the acute effects of carvedilol posology in patients with clinically significant
      portal hypertension (CSPH), as a surrogate marker of bioavailability.

      In this experimental study, patients with CSPH receiving carvedilol twice daily were asked to
      supress the night dose of carvedilol, in order to have a dose interval of approximately 24
      hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and
      compared with SSM prior or under treatment. Same procedure was applied to liver stiffness
      measurement (LSM).
    


Intervention name(s): supress the night dose of carvedilol
Intervention type(s): Drug
Intervention description(s): already described
Intervention MeSH terms: Carvedilol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: portal hypertension; carvedilol; elastography
Femoral Blockade and Low-dose Spinal Anesthesia in Outpatient Knee Arthroscopy
Condition: Meniscus Lesion
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators of the current study aimed to evaluate the effect of spinal anesthesia with
      low dose bupivacaine combined with femoral blockade on duration of anesthesia and time of
      first analgesic requirement during postoperative period
    

Detailed description: 
      Fifty patients undergoing arthroscopic meniscus repair were included to the current study.

      The patients were allocated to two groups as the spinal anesthesia with conventional dose of
      heavy bupivacaine or spinal anesthesia with low dose heavy bupivacaine combined with femoral
      blockade.

      Blood pressures and heart rates were recorded at the beginning, at the 0th minute following
      femoral block, at the 0th minute and in two-minute intervals following spinal anesthesia for
      20 minutes and in five-minute intervals till the end of surgery.

      The sensorial block and motor block in both extremities were recorded in two-minute intervals
      following spinal anesthesia and in five-minute intervals till the end of surgery The time of
      sensorial blockade to reach T12, maximum level of sensorial blockade level and the time to
      reach maximum level of sensorial blockade and the time for regression of sensorial blockade
      to L2, the time for regression of motor blockade were recorded.
    

Intervention name(s): Femoral blockade; Intrathecal anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): Spinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine; Spinal anesthesia with heavy bupivacaine
Other intervention name(s): Marcaine; Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: femoral blockade; bupivacaine
A Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of THDB0206 Injection in Healthy Chinese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, single-dose, open-label, positive-controlled, randomized,
      three-cycle, crossover 8-hour euglycemic clamp study to evaluate the PK, PD, safety and
      tolerability of THDB0206 injection after subcutaneous injection in healthy Chinese subjects.
      This trial will enroll 39 subjects to receive the investigational medicinal products.
    


Intervention name(s): THDB0206 injection; Humalog®; BC222insulin lispro injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall; 0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall; 0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
Condition: Gout and Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients
      with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg
      once daily, respectively will result in greater reduction of sUA compared to placebo.
    


Intervention name(s): RDEA3170; Allopurinol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Treatment; Oral Treatment; Oral Treatment
Other intervention name(s): Allopurinol 200mg Sawai
Intervention MeSH terms: Allopurinol; Verinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Renal and Hormonal Effects of Pioglitazone
Condition: Diabetes; Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study examines the effects of pioglitazone on renal sodium handling in subjects prone to
      insulin resistance, i.e. diabetic and/or hypertensive subjects.
    

Detailed description: 
      Aim: Glitazones are powerful insulin sensitizers prescribed for the treatment of type 2
      diabetes. Their use is however associated with fluid retention and an increased risk of
      congestive heart failure. We previously demonstrated that pioglitazone increases proximal
      sodium reabsorption in healthy volunteers. This study examines the effects of pioglitazone on
      renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or
      hypertensive subjects.

      Methods: In this double-blind, randomized, placebo-controlled, four-way, cross-over study, we
      examined the effects of pioglitazone (45mg daily during 6 weeks) or placebo on renal,
      systemic and hormonal responses to changes in sodium intake in 16 individuals, 8 with type 2
      diabetic and 8 with hypertension.
    

Intervention name(s): Pioglitazone; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance; placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance
Other intervention name(s): Actos; Glucophage; Glumetza; Fortamet; Riomet
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; blood pressure; pioglitazone; sodium; insulin resistance, renal function, sodium, pioglitazone
Acupuncture in Infantile Colic
Condition: Infantile Colic
MeSH terms: Colic
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether acupuncture influences:

        -  the rate of infants who still fulfil the colic criterion after three intervention weeks

        -  the time when the infants are crying, fussing or have intense bouts of colicky symptoms
    

Detailed description: 
      Infantile colic is a common problem. Both the baby and the parents are suffering and there is
      a risk that the early relationship is disturbed. There is no known treatment that is both
      effective and harmless. Acupuncture releases different neurotransmitters and hormones, gives
      pain reduction and affects digestion. Acupuncture in infantile colic has not been studied in
      a scientific way even though the method is used in many countries. In this randomised study
      we will investigate if acupuncture affects symptoms in infantile colic.
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse is alone with the infant for five minutes. Infants in the acupuncture group get acupuncture. One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: infantile colic
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure
      requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety
      evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving
      MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
    


Intervention name(s): MenACWY-CRM (Menveo)
Intervention type(s): Biological
Intervention description(s): One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: conjugate vaccine; phase IV clinical trial; Neisseria meningitidis
A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, randomized, four-way crossover study. Subjects will
      receive the four study treatments once, followed by in-clinic monitoring and extensive
      pharmacokinetic analysis. Dosing occurs ~48 hours apart from patch application, in randomized
      order. Subjects will have final assessment and be dismissed from the study.
    

Detailed description: 
      This is a single-center, open-label, randomized, four-way crossover study. Each subject will
      receive each of the four study treatments once, followed by in-clinic monitoring and
      extensive blood sample collection for pharmacokinetic analysis.

      Dosing will occur approximately 48 hours apart from the time of patch application, until
      completion of dosing in randomized order per the treatment sequence schedule. Plasma samples
      from the dosing days will be sent to the analytical laboratory for analysis and tolerability
      for each of the dose levels will be summarized.

      After completion of the four dosing days, subjects will be assessed one final time and
      dismissed from the study.
    

Intervention name(s): M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches); M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups); M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups; Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "Sled" coater and packaged in foil pouches; M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "MACAP" coater and packaged in foil cups; M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "miniMac" coater and packaged in foil pouches; Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose
Other intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Zomig Nasal Spray
Intervention MeSH terms: Zolmitriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects are randomized to receive one of four treatment sequences of four open-label treatments 48 hours apart.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Healthy; Volunteer
Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients suffering from Irritable Bowel Syndrome with predominant constipation will be
      provided with the study medication. The study medication will be evaluated for its efficacy
      in relieving the symptoms
    


Intervention name(s): Itopride HCI 50 mg; Itopride HCI 100 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Variable dosing; Variable dosing; Variable dosing
Other intervention name(s): ABT-654; Itopride HCI; Ganaton; ABT-654; Itopride HCI; Ganaton
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CKDu Treated With Intra-arterial Infusion of Autologous SVF Cells
Condition: Chronic Renal Failure of Unknown Cause
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an interventional study to treat 18 patients with chronic kidney disease of unknown
      cause (CKDu), formerly known as Mesoamerican nephropathy (MeN), with autologous adipose
      tissue-derived stromal vascular fraction (SVF) cells transplanted by intra-arterial injection
      both kidneys.

      This study assesses: (1) safety and tolerability, (2) preliminary evidence of efficacy, (3)
      exploratory evidence of clinical effects.
    

Detailed description: 
      Patients under go 24 hours of preoperative hydration combined with N-actyl cysteine 300 mg IV
      for prevention of nephrotoxicity. Under general anesthesia 200-300 cc of lipoaspirate is
      collected into a sterile processing cannister (GID SFV-1, Louisville, CO, USA). The tissue is
      washed and dissociated with collagenase (Worthington CLS-1, Lakewood, NJ, USA) at a
      concentration of 200 CDU/ml of total volume for 50 minutes at 39°C. This is followed by
      inactivation using 40 cc of human serum albumin. SVF cells are separated via centrifugation
      for 10 minutes at 800 g. The cell pellet is extracted and resuspended in Harmann solution
      with an aliquot (10 µl) removed for counting and viability assessment of resulting total
      nucleated cells (YNC) through and image cytometer (ADAM MC, Portsmouth NH, USA).

      Femoral artery catheterization is performed permitting advancement of a 100 cc balloon-tip
      catheter into the renal artery under fluoroscopic control, with position confirmation using 1
      cc of OrtoRay® 320 contrast diluted 1:4 with Hartmann solution. SVF cells are then admixed
      with 200 cc Hartmann solution warmed to 37°C and in fused using a DRE infusion pump (DRE
      Medical, Louisville, KY, USA) over a 15 minute period with constant agitation. On the 1st
      pos-operative day creatinine and glomerular filtration rate are checked and the patient is
      discharged.

      Follow-up studies include clinical assessment, chemistries, and renal ultrasound to assess
      intra-parenchymal renal volume, renal blood flow distribution, and hilar artery vascular
      resistance.
    

Intervention name(s): Adipose-derived stromal vascular fraction cells
Intervention type(s): Genetic
Intervention description(s): Kidney structural and functional changes in 18 patients after 36 months of treatment with SVF cells.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stromal vascular fraction; Mesenchynmal stem cells; Chronic kidney disease; Adipose stem cells
Biomarker Development in Sturge-Weber Syndrome
Condition: Sturge-Weber Syndrome
MeSH terms: Sturge-Weber Syndrome; Brain Stem Infarctions; Klippel-Trenaunay-Weber Syndrome; Syndrome
Study type: Observational

Summary: 
      This is a study of 40 individuals with Sturge-Weber Syndrome (SWS) brain and/or eye
      involvement. It will examine the test-retest reliability of the following clinical tests:

        1. Quantitative EEG

        2. Transcranial Doppler

        3. Medical Rehabilitation Scales

        4. Optical Coherence Tomography
    

Detailed description: 
      Sturge-Weber Syndrome (SWS) is a rare disorder presenting at birth with a facial port-wine
      birthmark and later in infancy with seizures and strokes that result in weakness on one side
      of the body, cognitive disabilities, glaucoma, and visual field deficits. Approximately
      10-50% of infants born with a facial port-wine birthmark on the upper part of the face will
      also have SWS brain and/or eye involvement. Early detection and treatment of the disease is
      necessary to improve an SWS patient's outcome, and early biological indicators need to be
      discovered to make this possible. We believe the following tests can serve as non-invasive
      biomarkers to improve early diagnosis, monitor response to treatment, and to predict outcome:

        1. Quantitative EEG

        2. Transcranial Doppler

        3. Medical Rehabilitation Scales

        4. Optical Coherence Tomography The first step of this process is to determine how much the
           results of these tests vary between individual tests.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Individuals with SWS and brain involvement (Aims 1-3): for the purposes of this study
             SWS brain involvement is defined as having shown on MRI imaging evidence of the
             typical vascular malformation which includes the following: leptomeningeal angioma,
             choroid plexus glomus, and associated venous angioma/malformation.

          2. Individuals with SWS and eye involvement (Aim 4): for the purposes of this study SWS
             eye involvement is defined as individuals with a portwine birthmark in the V1
             dermatomal distribution

          3. Able (or parents able) to provide informed consent

          4. Able to cooperate with tests

          5. Age 6 months to 21 years (Aims 1-3 only)
      
Keywords: Sturge-Weber Syndrome; Biomarkers; Quantitative EEG; Transcranial Doppler Ultrasound; Medical Rehabilitation Scales; Optical Coherence Tomography
Pre-op Use of Incentive Spirometry in Obese Patients
Condition: Lung Function; Bariatric Surgery
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as
      an aid to improve postoperative lung function. The hypothesis is that application of a
      standardized protocol of preoperative respiratory care teaching and exercise will improve
      lung performance that will subsequently result in prevention of postoperative pulmonary
      complications and that increasing the duration of preoperative use better improves lung
      mechanics postoperatively. The investigators propose to compare a patient population that
      uses IS as currently prescribed in the routine course of care (only to be familiar with
      preoperatively, but use postoperatively) against a population that uses IS with a
      standardized regimen for at least 3 days prior to the operation in terms of preoperative IS
      volumes, intraoperative pulmonary mechanics, postoperative IS volumes, and incidence of
      postoperative pulmonary complications.
    


Intervention name(s): Incentive Spirometry
Intervention type(s): Procedure
Intervention description(s): helps patient monitor their inspiratory tidal volume and assists in the preventing lower airway collapse
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: incentive spirometry; bariatric surgery; obesity
Chart Review of the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Observational

Summary: 
      The purpose of this study is to determine if toenail onychomycosis can be reduced by means of
      exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.
    

Detailed description: 
      This is a retrospective, open-label, single-centre study for the collection of clinical data
      on the efficacy and safety of the Cutera® GenesisPlus 1064 nm Nd:YAG laser for the treatment
      of nail fungus (onychomycosis). Safety and efficacy of treatment with the GenesisPlus laser
      will be evaluated by (1) assessment of subject's great toenail photographs at baseline and
      after two treatments with GenesisPlus Laser utilizing planimetry measurement of infected vs.
      clear nail area in target toenail photographs, (2) by clinical and subjective review of acute
      and follow up adverse events that may have resulted from laser treatment of the target
      toenails.
    

Intervention name(s): GenesisPlus 1064 nm Nd:YAG laser
Intervention type(s): Device
Intervention description(s): Genesis Plus 1064 nm Nd: YAG laser to treat onychomycosis
Other intervention name(s): Cutera®
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        100 participants at primary clinic
Telmisartan Plus Hydrochlorothiazide in Subjects With Mild-to-moderate Hypertension Who Failed to Respond to Telmisartan Monotherapy
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      An eight week study to compare the effect of a fixed dose combination of Telmisartan 40 mg
      plus hydrochlorothiazide (HCTZ) 12.5 mg to Telmisartan 40 mg alone on diastolic and systolic
      blood pressure in patients who fail to respond adequately to telmisartan monotherapy.
    


Intervention name(s): Telmisartan + hydrochlorothiazide; Telmisartan; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Telmisartan; Telmisartan, hydrochlorothiazide drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment