bioihbjkbjnl/mcl2 huggingface dataset:
Topical Ketamine Analgesia in Children Undergoing Tonsillectomy: a Clinical and Serum Level Assays Study.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two
      different doses in pediatric patients undergoing tonsillectomy operations
    

Detailed description: 
      In this double-blinded, clinically-controlled trial, 100 child will be randomized into four
      groups of 25 patients each; control group, intravenous ketamine group received 0.5mg iv.
      ketamine, and two local ketamine groups receiving local ketamine by nebulization in two
      different doses; 1 and 2mg/kg. The verbal rating pain scale, time to first postoperative
      analgesic request, total analgesic consumption during 1st 24 h postoperative, serum ketamine
      levels, intra operative blood loss, postoperative bleeding, and adverse effects were
      evaluated.
    

Intervention name(s): Intravenous ketamine0.5mg/kg; Nebulized Ketamine 1mg/kg; Nebulized Ketamine 2mg/kg; saline placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.; Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.; Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.; Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.
Other intervention name(s): Katalar; Katalar; Katalar; Saline
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix
Condition: Cervix Carcinoma
MeSH terms: Carcinoma; Adenocarcinoma; Adenocarcinoma in Situ
Study type: Interventional

Summary: 
      The goal of this clinical research study is to learn if it is possible to get high-resolution
      microendoscopy (HRME) images of AIS tissue and/or tissue from microinvasive carcinoma right
      before a biopsy of the cervix. Researchers also want to learn if HRME images can show the
      difference between cancerous tissue and normal cervical tissue.
    

Detailed description: 
      If you agree to take part in this study, after you are in the operating room and under
      general anesthesia, proflavine hemisulfate solution (contrast dye) will be applied to the
      cervix. Images will be collected with the probe from the HRME device. The HRME probe is a
      long thin tube with a camera at the tip. This probe will be applied to the cervix and images
      obtained. These images will be used for research. This should add about 10 minutes to the
      total time you are in the operating room.

      There will be no change to the planned standard-of-care colposcopy and biopsy.

      Follow-Up:

      A member of the research team will call you within 30 days after the procedure to ask how you
      are feeling and if you are having any symptoms. This call should last about 5 minutes.

      Length of Study:

      Your active participation in this study will be over after the biopsy.

      This is an investigational study. The goal of this clinical research study is to learn if it
      is possible to get high-resolution microendoscopy (HRME) images of AIS tissue and/or tissue
      from microinvasive carcinoma right before a biopsy of the cervix. Researchers also want to
      learn if HRME images can show the difference between cancerous tissue and normal cervical
      tissue.
    

Intervention name(s): Proflavine; High-Resolution Microendoscopy (HRME) Imaging
Intervention type(s): Drug; Procedure
Intervention description(s): 0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.; in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.
Other intervention name(s): HRME
Intervention MeSH terms: Proflavine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cervix Carcinoma; Cervical adenocarcinoma in situ; AIS; Cervical intraepithelial neoplasia; CIN; microinvasive carcinoma of the cervix; cold knife cone of the cervix; CKC; High-Resolution Microendoscopy; HRME; Proflavine
A Study of WXFL10030390 in Patients With Advanced Solid Tumors or Lymphoma
Condition: Advanced Cancer
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      WXFL10030390 (WX390) is a novel oral small molecular that inhibits phosphoinositide-3 kinase
      (PI3K) and mammalian target of rapamycin (mTOR) and has demonstrated potent inhibitory
      effects on multiple human tumor xenografts. The first-in-human study is conducted to assess
      the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the
      pharmacokinetics, safety and preliminary anti-tumor activity of WX390 at single dose and
      multiple doses.
    

Detailed description: 
      This study will be an open-lable, phase Ⅰ study and will evaluate the safety and
      pharmacokinetics of WX390 after a single administration followed by a 28-day continuous
      course of therapy; evaluate the safety and preliminary efficacy in an open-lable
      administration of WX390 at the MTD.
    

Intervention name(s): WXFL10030390
Intervention type(s): Drug
Intervention description(s): WXFL10030390 is a tablet in the form of 0.1mg and 0.5mg, oral, once a day.
Other intervention name(s): WX390
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phosphoinositide-3 kinase (PI3K); mammalian target of rapamycin (mTOR)
Aerobic Exercise in Postexercise Cardiovascular Responses in Resistant Hypertension: a Cross-over Trial
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Aerobic exercise has the potential to diminish blood pressure values. The aim of this study
      is to determine whether this potential is also applicable for those with resistant
      hypertension and whether exercise intensity plays a role in this context. We hypothesize that
      performing an aerobic exercise session reduces blood pressure values in resistant
      hypertensive patients in a dose-response relation with exercise intensity.
    

Detailed description: 
      Exercise prescription is gathering great importance in preventive health. Several
      organizations endorse the performance of at least 150min/wk of moderate intensity or 75min/wk
      of higher intensities in order to achieve better health parameters in different contexts.
      Aerobic exercise is known to be an effective way to diminish BP levels post-session. These
      responses are widely applicable in hypertensive subjects, acting in aid of BP management
      treatment. Although these benefits of aerobic exercise are well known, few studies explore
      the potential of this intervention in resistant-to-treatment patients. Moreover, the effects
      different intensities of aerobic exercise in this population is scarce. Thus, the aim of this
      study is to determine the magnitude of BP responses, if there is any, of resistant
      hypertensive subjects to two different intensities of aerobic exercise, compared with a
      control session. For that, subjects will be enrolled for one pre-intervention cardiopulmonary
      exercise testing and three randomized intervention sessions: control, 50%HRmax and 75%HRmax.
      Prior and immediately after all intervention sessions (during 1h), forearm blood flow and
      reactive hyperemia will be assessed by venous occlusion plethysmography. After the sessions,
      24h blood pressure will be assessed with an ambulatory blood pressure monitoring system.
    

Intervention name(s): aerobic exercise
Intervention type(s): Other
Intervention description(s): aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Resistant Hypertension; Aerobic Exercise
Effect of Formula on Growth of Infants From Overweight or Obese Mothers
Condition: Infant Nutrition
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether infants, from overweight or obese mothers,
      fed a formula with proteins and calories different than a standard infant formula have a
      different growth
    


Intervention name(s): standard infant formula; Test formula
Intervention type(s): Other; Other
Intervention description(s): standard infant formula given from 3 to 12 months of age, as per standard requirement; Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: infant formula; obesity; growth
The Effect of STarT Back Screening Tool
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The aim of this study is to examine the effectiveness of StArt Back Tool test in determining
      prognosis and loss of workforce in patients presenting with low back pain complaints in the
      acute-subacute period and to examine the relationship between StArt Back Tool test and
      kinesophobia.
    

Detailed description: 
      Low back pain (LBP) is a common disorder that affects about 80% of adults at least once in a
      period of their life. 10% of low back pain becomes chronic and can affect the quality of life
      negatively and lead to disability. The STarT-Back-Tool was developed to identify people with
      poor prognosis, such as difficulty returning to work, loss of work force, disability. It has
      been reported that it would be beneficial to categorize patients according to their risk
      levels with this tool and plan treatment in primary care treatment centers. Being able to
      identify patients with a high probability of becoming chronic in the early period is very
      important to reduce or prevent disability that may occur. The aim of this study is to examine
      the effectiveness of StArt Back Tool test in determining prognosis and loss of workforce in
      patients presenting with low back pain complaints in the acute-subacute period and to examine
      the relationship between StArt Back Tool test and kinesophobia.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        outpatient clinic
      
Keywords: sTart back secreening tool; low back pain
Bioequivalence Study of Test and Reference 400 mg Ibuprofen Coated Tablets in Healthy Volunteers
Condition: Bioequivalence; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a comparative bioavailability study performed to assess bioequivalence between
      Test medicinal product (Darfen 400, 400 mg ibuprofen coated tablets [512 mg ibuprofen sodium
      dihydrate], manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and Reference
      medicinal product (marketed medicinal product Nurofen® Forte Express, 400 mg ibuprofen coated
      tablets [512 mg ibuprofen sodium dihydrate], manufactured by Reckitt Benckiser [Poland] S.A.)
      in healthy volunteers.
    


Intervention name(s): Darfen 400, 400 mg ibuprofen coated tablets (512 mg ibuprofen sodium dihydrate); Nurofen® Forte Express, 400 mg ibuprofen coated tablets (512 mg ibuprofen sodium dihydrate)
Intervention type(s): Drug; Drug
Intervention description(s): Oral, a nonsteroidal anti-inflammatory drug; Oral, a nonsteroidal anti-inflammatory drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two-period, two-sequence, two-way crossover single dose study
Masking: None (Open Label)
Primary purpose: Other
Keywords: healthy subjects; ibuprofen; pharmacokinetics; bioequivalence
A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate efficacy and safety of tacrolimus in the patients with
      non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with
      tacrolimus (Prograf) or placebo.
    


Intervention name(s): Tacrolimus; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Prograf; FK506
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tacrolimus; Prograf; Calcinurin inhibitor; Albuminurea; Proteinurea; FK506
Transcutaneous Electric Muscle Stimulation (TEMS) in Septic Patients
Condition: Septic Shock
MeSH terms: Shock, Septic
Study type: Interventional

Summary: 
      A growing number of critically ill patients survive intensive care to be discharged from
      hospital. However, critical illness and prolonged bedrest are associated with muscle wasting
      with subsequent implications for recovery of normal physical function. Thus, one year after
      discharge, survivors of septic shock have reported prolonged and severe impairment of
      physical function.

      Early interventions employed in the ICU to counteract loss of muscle mass may potentially
      improve physical outcome and reduce the overall burden of critical illness. As a potential
      supplement to physical therapy, transcutaneous electric muscle stimulation (TEMS) is a
      non-invasive method directed at maintaining skeletal muscle function through artificially
      induced contractions that are independent of patient efforts. TEMS has previously proven
      effective at preventing loss of muscle mass and force in a number of non-ICU patient groups,
      but has only been assessed sparsely in an ICU population where both immobilisation and
      systemic inflammation are present.

      Therefore, the aim of the present study was to assess the effect of early TEMS on muscle
      volume in patients admitted to the intensive care unit with septic shock. The investigators
      hypothesized that this intervention would preserve muscle volume during septic shock.
    

Detailed description: 
      To ensures baseline comparability, eliminates many of the inter-individual confounding
      factors often present in ICU patients and enhances statistical strength we designed a study
      where we included a well-defined group of patients with septic shock in a single-legged
      exercise design, using the contralateral leg as the (paired) control and used a two-channel
      stimulation approach with 3-D evaluation of muscle volume changes based on CT scans.

      After randomization of the quadriceps muscles TEMS is applied on the intervention side for 7
      consecutive days, 60 minutes per day. All patients undergoes CT scans of both thighs before
      and immediately after the 7-day treatment period. The quadriceps muscle is then manually
      delineated on the transverse CT slices, and muscle volumes are calculated after 3-D
      reconstruction.
    

Intervention name(s): Transcutaneous electrical muscle stimulation
Intervention type(s): Device
Intervention description(s): After randomization of the quadriceps muscles TEMS is applied on the intervention side for 7 consecutive days, 60 minutes per day.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: muscular atrophy; recovery of function; rehabilitation; Intensive care unit
The Effect of the COVID-19 Pandemic on Primary Bladder Cancer Presentations
Condition: Bladder Cancer; Covid19
MeSH terms: COVID-19; Urinary Bladder Neoplasms
Study type: Observational

Summary: 
      In this study, investigators aim to reveal how the COVID-19 pandemic process affects primary
      bladder cancer presentations, tumor stages and degrees, the time elapsed between diagnosis
      and intervention, tumor recurrence and progression, which are oncological results.
    

Detailed description: 
      The rapid spread of the 2019 coronavirus disease (COVID-19) caused by a novel betacoronavirus
      known as the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has had dramatic
      effects on individuals and health systems around the world. Beyond those infected with
      SARS-CoV-2, the intense demand for limited health system resources has led to reduced
      capacity, rapid depletion of healthcare systems, and hospitals becoming a source of virus
      transmission.

      Urology associations and reference centers have issued recommendations to inform urology care
      during the COVID-19 outbreak. It is essential that urologists give priority to patient
      safety. Potential delays in the diagnosis and treatment of urological conditions and the
      additional burden on healthcare resources must be balanced against the risks of exposure to
      COVID-19. While this situation aims to conserve healthcare resources, it has created the risk
      of delaying cancer treatment. As a result, the transformation of health services and the
      increasing interest of the public in avoiding exposure to the disease has led to a decrease
      in the number of hospital admissions.

      The effects of the pandemic on patients with bladder cancer due to a decrease in emergency
      room and urology clinic admissions are not clear. During the COVID-19 outbreak, the EAU
      (European Association of Urology) panel of non-muscle invasive bladder cancer published an
      evidence-based guideline. According to this guideline, four priority groups were formed and a
      certain period of delaying treatment was defined for patients in each group according to
      their priorities.
    

Intervention name(s): COVID-19 pandemic
Intervention type(s): Behavioral
Intervention description(s): Patients diagnosed with primary bladder cancer by transurethral resection in the urology clinic during and before the COVID-19 pandemic will be retrospectively evaluated and compared.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with primary bladder cancer by transurethral resection in the urology
        clinic.
      
Keywords: Bladder cancer; COVID-19; Transurethral resection
Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to determine whether armodafinil treatment, at a dosage
      of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood
      stabilizers for treatment of adults with major depression associated with bipolar I disorder.
    


Intervention name(s): Armodafinil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.; Matching Placebo, also in tablet form taken orally, once daily in the morning.
Other intervention name(s): Nuvigil; CEP-10953
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar I Disorder
Method Optimization for the Quantification of the NAD
Condition: NAD
Study type: Observational

Summary: 
      Method optimization for the quantification of the NAD metabolome in human whole blood, and
      evaluation of baseline inter and intra-subject variability.
    

Detailed description: 
      Whole blood from healthy participants will be collected to optimize analytical method based
      on liquid chromatography tandem mass spectrometry (LC-MS/MS) for the analysis of the NAD
      metabolome in biological samples. Parameters such as collection volume and anti-coagulants
      will be investigated for optimal quantification. Moreover, inter- and intra-subject
      variability of NAD metabolite levels in whole blood will be evaluated. Plasma and urine will
      also collected for method development and variability measurements.
    

Intervention name(s): Laboratory method validation
Intervention type(s): Other
Intervention description(s): Test several sampling conditions
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: NAD quantification in blood and urine
EpiCor Clinical Study on Rapid Immune Modulating Effects
Condition: Immune Surveillance
Study type: Interventional

Summary: 
      Clinical verification study evaluating the effects of a nutraceutical product. This study
      involves thirty participants composed of healthy adults, who will be taking either a placebo
      or nutraceutical supplement at different times. Testing for immune status, cytokine levels,
      and immune responsiveness will be conducted to determine the acute impact of the
      nutraceutical on immune function compared to a placebo.
    

Detailed description: 
      Clinical study comparing the acute immune effect of a nutraceutical product and a placebo.
      The nutraceutical supplement is a postbiotic whole food fermentate produced using yeast.

      30 subjects will participate in a placebo-controlled, double-blind, randomized, cross-over
      design, wherein they will be taking a placebo, or nutraceutical product, each separated by a
      1-week washout period to evaluate effects within 3 hours of consumption.

      Blood samples will be taken 1 hour after participants arrive, then the dose is administered.
      Samples are taken 1 hour, 2 hours, and 3 hours following administration.

      A series of immune panels will be used to determine the acute impacts on immune surveillance,
      immune cell activation status, and cytokine profiles. Ex vivo immune challenges will be used
      to determine the direct impacts on immune cells.
    

Intervention name(s): Yeast Fermentate (EpiCor)
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary Supplement: Yeast Fermentate (EpiCor): Postbiotic whole food fermentate made using yeast. Composed of proteins, polyphenols, vitamins, minerals, amino acids, polysaccharides, fibre, and other nutrients.
Placebo: Substance with no therapeutic value to facilitate blinding
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Placebo-controlled, randomized, double-blind, cross-over design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science