bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin B Complex Improved Exercise Performance and Anti-fatigue
Condition: Exercise Performance; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aim of the present study was to evaluate potential beneficial effects of TTFD® EX PLUS
      (Prince Pharmaceutical Co., Ltd., Yunlin County, Taiwan) on fatigue and ergogenic functions
      following physiological challenge. The test used a double-blind crossover design and
      supplementation for 28 days. 32 male and female 20-30 year-old subjects were divided into two
      groups in a balanced order according to each individual's initial maximal oxygen uptake and
      were assigned to receive a placebo with equal gender (non TTFD® EX PLUS with same color/day,
      n=16, 8 male and 8 female) or TTFD® EX PLUS (600mg/tablet/day, n=16, 8 male and 8 female)
      every morning. After the intervention, there were 28 days of wash-out, during which time the
      subjects did not receive further interventions.
    


Intervention name(s): Placebo; EX plus
Intervention type(s): Other; Other
Intervention description(s): Microcrystalline α-cellulose, shellac, calcium hydrogen phosphate, edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, palm wax.; Furanthiamine hydrochloride (vitamin B1), pyridoxine hydrochloride (vitamin B6), cyanocobalamin (vitamin B12), DL-alpha-tocopheryl acetate 50% (DL-alpha-tocopheryl acetate, sucrose, caprylic acid) Sodium alkenyl succinate starch, corn starch, water, sodium aluminosilicate), shellac, calcium hydrogen phosphate, edible yellow No. 4, edible yellow No. 5, γ-oryzanol (γ-oryzanol, rice bran powder ), sucrose, silica, inositol, taurine, talc, oxidized starch, gelatin, magnesium stearate, calcium panpolyate, microcrystalline α-cellulose, riboflavin (vitamin B2), palmar wax.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection
Condition: Intraabdominal Infections
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin
      in a pediatric population 3 months to <18 years old. Approximately 450 pediatric subjects
      with a complicated intra-abdominal infection will be enrolled in the study and treated with
      either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem
      (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.
    


Intervention name(s): Moxifloxacin (Avelox, BAY12-8039); Ertapenem; Amoxicillin/Clavulanate; Moxifloxacin placebo; Ertapenem placebo; Amoxicillin/Clavulanate placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): For subjects 12 to less than (<) 18 years of age and weighing at least 45 kilograms (kg), the dose of moxifloxacin will be 400 milligrams (mg), once daily (OD). Subjects 12 to < 18 years of age and weighing less than 45 kg, the dose of moxifloxacin will be 4 mg/kg twice daily (BID), every 12 hours (q12h), not exceeding 400 mg/day. Subjects 6 to < 12 years of age the dose of moxifloxacin will be 4mg/kg, q12h, not exceeding 400 mg/day. Subjects 2 to less than 6 years of age the dose of moxifloxacin will be 5mg/kg, q12h, not exceeding 400 mg/day. Subjects 3 months to less than 2 years of age the dose of moxifloxacin will be 6mg/kg q12h IV, not exceeding 400 mg/day. Subjects who were switched from IV to PO therapy, 400 mg or 50 mg moxifloxacin tablets were provided.; For subjects 13 to <18 years of age, the dosage of ertapenem was 1 gram (g) OD. For subjects 3 months to < 13 years of age, the dosage was 15 mg/kg q12h not to exceed 1 g/day.; Subjects 2 years to < 18 years of age who were switched from IV to PO therapy receive amoxicillin/clavulanate suspension. The dosage of clavulanate was 3.2 mg/kg q12h. (maximum dose of clavulanate was 125 mg q12h). The dosage of amoxicillin was 22.5 mg q12h (a maximum dose of 875 mg amoxicillin q12h must not be exceeded).; Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV moxifloxacin. Tablets containing inactive ingredients were used as the placebo for PO moxifloxacin 400 mg and 50 mg tablets.; Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV ertapenem.; Suspension containing inactive ingredients was used as the placebo for PO amoxicillin/clavulanate suspension.
Intervention MeSH terms: Amoxicillin; Moxifloxacin; Clavulanic Acid; Clavulanic Acids; Ertapenem; Amoxicillin-Potassium Clavulanate Combination; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intra-abdominal infection; Pediatric infection
CRT Pilot Study for Children With Heart Failure
Condition: Chronic Pediatric Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      To collect information on pediatric patients receiving Cardiac Resynchronization Therapy
      (CRT) with permanent biventricular pacing (BVP) as a method of treating chronic heart
      failure.
    


Intervention name(s): CRT device implant
Intervention type(s): Device
Intervention description(s): The purpose of this study is to collect information on patients with chronic heart failure who have already been identified by their physician as candidates for CRT. All tests, including device implantation are standard of care for patients undergoing CRT. The only test involved in this study that is not standard of care is the quality of life questionnaire. Patients who undergo CRT system implant will be followed post-implant (up to 1 week), and at one month, three months, six months and twelve months. The only test involved in this study that is not standard of care is the quality of life questionnaire.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
Disturbances of Kynurenine Pathway of Trytophan Metabolism in Schizophrenia: A Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      In this pilot study, the investigators propose to characterize the pattern of activation of
      the kynurenine pathway of tryptophan metabolism in peripheral macrophages of patients with
      schizophrenia. To do this, the investigators will measure the gene expression of several
      major enzymes in this pathway in macrophages, including the key enzyme involved in tryptophan
      to kynurenine metabolism, IDO, by means of quantitative reverse-transcription polymerase
      chain reaction (RT-PCR). The focus on enzyme mRNA expression as opposed to serum or
      cerebrospinal fluid levels of metabolites provides a possibly more sensitive characterization
      of the activation of this metabolic pathway.
    

Detailed description: 
      In this pilot study, we propose to characterize the pattern of activation of the kynurenine
      pathway of tryptophan metabolism in peripheral macrophages of patients with schizophrenia. To
      do this, we will measure the gene expression of several major enzymes in this pathway in
      macrophages, including the key enzyme involved in tryptophan to kynurenine metabolism, IDO,
      by means of quantitative reverse-transcription polymerase chain reaction (RT-PCR). The focus
      on enzyme mRNA expression as opposed to serum or cerebrospinal fluid levels of metabolites
      provides a possibly more sensitive characterization of the activation of this metabolic
      pathway.

      Primary hypotheses: We hypothesize that patients with schizophrenia will differ in their
      expression of macrophage IDO mRNA, reflecting activation of this pathway compared to normals.
      We further hypothesize that patients with deficit syndrome will have higher degrees of enzyme
      activation.

      Secondary hypotheses: Serum tryptophan levels will be lower in patients with schizophrenia
      compared to controls, and they will correlate with measures of dysphoria. Serum kynurenine
      levels will be elevated in patients with schizophrenia, particularly in deficit syndrome
      patients. mRNA expression levels of enzymes downstream from IDO will differ between patients
      and controls. Measures of immune activation will be influenced by medical disease burden
      (medical comorbidities).
    

Intervention name(s): Phlebotomy
Intervention type(s): Procedure
Intervention description(s): Single blood draw
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Schizophrenia patients
      
Biospecimen description: 
      Whole blood
    
Keywords: Schizophrenia; Immune System; Kynurenate; tryptophan metabolism; NMDA receptor; indolamine 2,3-deoxygenase (IDO)
First Study in Humans With GSK206136
Condition: Depressive Disorder and Anxiety Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first study in humans with GSK206136 to evaluate what effects: good or bad, the
      drug has on human health (safety and tolerability) and the amount of drug which gets into the
      bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to
      investigate the penetration of the drug in the human brain by using PET (Positron Emission
      Tomography) imaging technology
    


Intervention name(s): GSK206136; PLACEBO; PET
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): GSK206136 2mg, 10mg, 50mg, 100mg capsule; Placebo to match 206136 2mg, 10mg, 50mg, 100mg capsule; Each subject will undergo 3 PET Scans ; one at Baseline and the others following dosing with GSK206136 at approximately 2 hours post-dose and 24 hours post-dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Nk1 Antagonist and SSRI; Safety; First Time in Humans; Healthy Subjects
Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in South Africa. The aim of this trial is to investigate Long term
      safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes previously treated in
      trial BIAsp-1240.
    


Intervention name(s): biphasic insulin aspart 30
Intervention type(s): Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin)
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Condition: Hemodialysis; Hyperphosphatemia; Cardiovascular Events
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis
      patients to achieve full-scale of medical care, including reduction of atherosclerotic risk
      factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.
    


Intervention name(s): Sevelamer HCl; Calcium-based phosphate binder
Intervention type(s): Drug; Drug
Intervention description(s): Non-metal phosphate binder
Other intervention name(s): Renagel Tablets; Calcium carbonate; Calcium acetate
Intervention MeSH terms: Calcium, Dietary; Calcium Carbonate; Calcium; Sevelamer; Calcium acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Phosphate binder
Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray
      (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages
      6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD
      were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.
    


Intervention name(s): Mometasone furoate nasal spray; Beclomethasone dipropionate nasal spray; Placebo nasal spray; Chlorpheniramine maleate syrup
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): intranasal administration; intranasal administration; intranasal administration; oral administration
Other intervention name(s): Nasonex®; MK-0887; SCH 032088; Vancenase®; ChlorTrimeton Syrup
Intervention MeSH terms: Mometasone Furoate; Chlorpheniramine; Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Adductor Canal Block With Posterior Capsular Injection for Total Knee Replacement
Condition: Pain; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      To compare early ambulation and ability to participate in rehabilitation in patients
      undergoing total knee replacement using two different nerve block techniques for pain
      control. The 2 methods are 1) Adductor canal block with posterior capsular injection 2)
      femoral nerve block with tibial nerve block
    

Detailed description: 
      Early mobilization in the postoperative period is important to the success of surgery
      following total knee replacement. However, severe post-operative pain is an impediment to
      early implementation of rehabilitaion program. The use of femoral nerve block combined with
      tibial nerve block as part of a multimodal analgesic program provides effective pain control
      but causes weakness of the operative extremity preventing patients from bearing weight,
      exercising the leg and increasing the risk of falls thereby delaying early participation in
      rehabilitation. Adductor canal block is a new technique that has been described to provide
      pain control after total knee arthroplasty (1). The advantages of this block is that it could
      potentially minimize lower extremity weakness because the target nerve (saphenous nerve)
      blocked in this technique is a purely sensory nerve and does not provide any motor
      innervation to any muscle groups. Adductor canal block lends itself easily to providing
      prolonged analgesia because a perineural catheter can be inserted and the block maintained by
      a continuous infusion of dilute local anesthetic solution for days. A disadvantage of this
      method is that it may not provide adequate analgesia for posterior knee pain in the early
      postoperative period. By combining adductor canal block with ultrasound guided posterior and
      antero-medial knee injection, the posterior knee pain can be controlled effectively.
      Posterior and antero-medial knee injection of local anesthetic solution has been used as a
      method of controlling posterior knee pain after total knee arthroplasty (2).
    

Intervention name(s): Canal Block and Capsular Injection; Femoral with Tibial Nerve Block
Intervention type(s): Procedure; Procedure
Intervention description(s): Continuous Adductor canal block with 15-30ml of ropivacaine 0.1% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30 ml ropivacaine 0.1% with epinephrine 1:400,000.; Continuous femoral nerve block with 15 ml of ropivacaine 0.1% followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.1% up to 15 ml.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: early ambulation; knee arthroplasty
Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue
Condition: Obesity, Morbid; Suture, Complication; Suture Rupture
MeSH terms: Obesity, Morbid; Rupture
Study type: Interventional

Summary: 
      Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable
      cost-effective alternative procedure. However, no pre-clinical data are currently available
      on human tissue. We aimed to evaluate whether traditionally suturing without the use of
      surgical stapling may produces a comparable bursting pressure on human gastric tissue.
    

Detailed description: 
      Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable
      cost-effective alternative procedure. However, no pre-clinical data are currently available
      on human tissue. We aimed to evaluate whether traditionally suturing without the use of
      surgical stapling may produces a comparable bursting pressure on human gastric tissue.

      A prospective cohort of consecutive patients underwent LSG was divided in two groups to
      compare a barbed extramucosal running suture (stapler-less) versus a standard stapler line. A
      burst pressure test was applied to the gastric specimen employing high-resolution manometric
      catheter. Type, location and features of the leak were described.

      In human ex-vivo model, traditional surgical suture (i.e. running hand-sewn) produced an
      effective temporary closure, with superior resistance to increasing volume and pressure. How
      this may impact on clinical LSG outcomes needs further evaluations and was not the object of
      this study.
    

Intervention name(s): Stapler-less gastrectomy; Suture
Intervention type(s): Other; Other
Intervention description(s): After the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube.; No reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the gastric specimen were immediately randomly allocated to the two groups
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Sleeve gastrectomy; stapler-less; burst pressure; leaks
Evaluation of Gynecological Acceptability of a Health Care Product
Condition: Atrophic Vaginitis; Vaginal Diseases
MeSH terms: Vaginitis; Atrophic Vaginitis; Vaginal Diseases
Study type: Interventional

Summary: 
      The research will be conducted with a product for use in the intimate region in up to 75
      research participants who will use the investigational product for 28 ± 2 days. Will be
      evaluated and followed up throughout the study by a gynecologist to verify the safety and
      effectiveness of the product and possible adverse events.

      The study will evaluate the non-interference of a topical use product on the intimate area,
      helping to preserve the natural defenses. In addition, the epithelial hydration and pH of the
      intimate area will be evaluated.
    

Detailed description: 
      74 female participants, 18 to 59 years of age, healthy with complaints of vaginal dryness.
      The subjects will be submitted to gynecological evaluation in which pH measurements,
      hydration measurements and bacterioscopic collection will be performed. Then they will be
      guided to answer the questionnaires of Perceived Efficacy and Quality of Sexual Life. Next,
      participants will receive the product for home use, under real conditions of use, for 28 ± 2
      days. After 28 ± 2 days of use, subjects will return to the institute, and undergo further
      evaluations with the gynecologist. New pH measurements, hydration measurements (chronometry),
      bacterioscopic collection will be performed and the participants will answer the Perceived
      Efficacy and Quality of Sexual Life questionnaires.
    

Intervention name(s): Health care product (intimate gel)
Intervention type(s): Other
Intervention description(s): heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days
Intervention model: Single Group Assignment
Intervention model description: Clinical trial, single-arm
Masking: None (Open Label)
Primary purpose: Treatment
Imaging Biomarkers of Tissue Microstructure and Vasculature as Predictors of Glioblastoma Multiforme
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Observational

Summary: 
      This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is
      being treated with bevacizumab. This study will use a new MRI technique to compare the images
      of blood vessels and tumor structure to the effectiveness of bevacizumab.
    

Detailed description: 
      This study is for subjects with a diagnosis of a brain tumor called glioblastoma that is
      being treated with bevacizumab. Bevacizumab is a drug that your doctor believes is the best
      treatment option available to subjects at this time for this type of tumor. Bevacizumab
      affects the growth of blood vessels by tumors such as glioblastoma, thus effectively starving
      the tumor of oxygen and food.

      Magnetic Resonance Imaging (MRI) is a test done by a machine in the radiology department that
      takes pictures of your body using special magnets, rather than X-rays. With a new MRI scan
      technique the investigators can take very, very detailed images of the vessel and tumor
      structure. This project will allow us to compare the images of vessel and tumor structure to
      the effectiveness of Bevacizumab as a treatment option. With this project the investigators
      will hopefully develop an accurate way to predict whether or not Bevacizumab will be an
      effective treatment option for patients.
    

Intervention name(s): Magnetic Resonance Imaging (MRI)
Intervention type(s): Radiation
Intervention description(s): Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female subjects, 18-80 years old with progressive glioblastoma who receive
        bevacizumab
      
Keywords: Glioblastoma; Imaging Biomarkers; Bevacizumab; MRI