bioihbjkbjnl/mcl2 huggingface dataset:
Early Detection of Polyps and Colon Cancer by Fluorescence Imaging - a Dose-finding Study
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patients referred for colon inspection (colonoscopy) due to suspicion of colon polyps/cancer
      will receive local administration of hexaminolevulinate (HAL) prior to colon inspection. Blue
      light illumination will induce red fluorescence of polyps and tumours, improving detection of
      the polyps and tumors. Different HAL doses will be tested to find the optimal image
      conditions. Tolerability measurements will be performed to ensure patient safety.
    

Detailed description: 
      Colonoscopy is regarded as the "gold standard" for diagnosis of colorectal cancer. The
      sensitivity is uncertain but proposed to be (75-95%), however flat adenomas which are easily
      missed, are often not recognised. Fluorescence imaging may increase the sensitivity of
      standard white light colonoscopy by identifying more polyps and flat adenomas which will make
      the resection of adenomas more complete.

      In this study hexaminolevulinate (HAL) will be administered locally as a photosensitiser,
      using different doses to find the optimal imaging conditions as well as making patient safety
      assessments.

      Both standard white light and blue light (fluorescence) inspection will be performed.
    

Intervention name(s): hexaminolevulinate
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
An Open-Label Treatment Protocol to Provide Continued Elvucitabine Treatment
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Extension study for participants currently participating in Protocols ACH443-015 and
      ACH443-018.
    

Detailed description: 
      Human immunodeficiency virus (HIV)-1-infected, clinically stable, treatment-naïve adult
      participants who have completed 96 weeks of elvucitabine therapy and whose HIV ribonucleic
      acid (RNA) levels remain below 50 copies/milliliter (mL) at the 92-week assessment in
      Protocol ACH443-015 or participants who have completed 48 weeks of elvucitabine therapy and
      continue to maintain an HIV-1 RNA viral load below their baseline level upon entry into
      Protocol ACH443-018.
    

Intervention name(s): Elvucitabine
Intervention type(s): Drug
Intervention description(s): 10 milligrams (mg) elvucitabine daily as part of an ART regimen
Intervention MeSH terms: Dexelvucitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extension study; HIV-1 infection; Treatment naive
Phase 3 Study of BK1310 in Healthy Infants
Condition: Immunization; Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to:

        -  (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of
           BK1310.

        -  (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a
           control in healthy infants.
    

Detailed description: 
      <Cohort 1>

        -  Arm: BK1310-High. Intervention: DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous
           injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13
           months.

        -  Arm: BK1310-Low. Intervention: DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous
           injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13
           months.

      <Cohort 2>

        -  Arm: BK1310-High or Low. Intervention: DPT-IPV-Hib-High(Combined Vaccine) or
           DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the
           3-8weeks intervals.

        -  Arm: ActHIB® and Tetrabik. Intervention: Hib vaccine and DPT-IPV 0.5mL, subcutaneous
           injection, 3 times with the 3-8weeks intervals.
    

Intervention name(s): DPT-IPV-Hib-High（Combined Vaccine）; DPT-IPV-Hib-Low（Combined Vaccine）; Hib vaccine; DPT-IPV
Intervention type(s): Biological; Biological; Biological; Biological
Other intervention name(s): BK1310-High; BK1310-Low; ActHIB®; Tetrabik
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Haemophilus influenza type b; Adsorbed Diphteria-purified Pertussis-Tetanus-Inactivate poliovirus combined vaccine; Hib; DPT-IPV
Study to Assess the Effect of E-OA-07 on Acute Pain Response in Subjects Suffering From Knee OA
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Acute Pain
Study type: Interventional

Summary: 
      The repetitive motions associated with active life and many sports can increase the wear and
      tear to the joints that leads to decrease in flexibility and joint pain finally heading its
      way to osteoarthritis. Activities such as jumping, running can wear away the cartilage that
      supports and cushions the joints of hands and knees, causing bones to rub against each other.
      Injuries stemming from repetitive motions can also cause and worsen the joint pain.

      Joint pain is discomfort that arises from any joint . Irrespective of the underlying
      mechanisms, joint pain usually originates in activation of nociceptors, or free nerve
      endings. Complex neuronal activation occurs, which involves not only local sensitization of
      joint nociceptors but also modifications in central pain pathways.

      Even though, the numerous pharmacological interventions are available for joint pain, there
      is much debate amongst clinicians about the best approach to the treatment of joint pain.
      NSAIDs which is frequently used for treatment in such cases, carries concerns related to
      gastro-intestinal system, cardiovascular system as well as central nervous system .

      Hence there is a need of a safer alternative treatment option for relieving acute joint pain
      which is comparable to the modern medicines, without posing concerns to the subject's general
      well being.

      Herbs are known to be used since ages in traditional literature and do not pose any potential
      health concern. Inspite of such positive attributes herbs are not employed in treatment of
      acute pains as there is lack of evidence proving the same.

      In order to address the need of the hour Enovate Biolife has invented a novel poly herbal
      formulation E-OA-07 (Lanconone). Lanconone has been studied previously in patients with
      osteoarthritis has been proven efficacious . It has a good history of marketing and is sold
      in the United States, with no reported adverse event related to the product. However there is
      no concrete evidence proving the product's acute pain relieving dynamics, hence the current
      study has been employed to comprehend the effect of lanconone in joint acute pain.
    


Intervention name(s): E-OA-07 (Lanconone); Ibuprofen
Intervention type(s): Other; Drug
Other intervention name(s): Investigational Product; Comparator
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute pain; Herbal; VAS; Stop watch
Risperidone for the Treatment of Cocaine Dependence - 7
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate clinical safety and pharmacological efficacy in the
      treatment of cocaine dependence, to evaluate impact of treatment on craving, and to correlate
      evidence of baseline neurotoxic damage of cocaine with treatment outcome and clinical
      side-effects.
    


Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
Augmenting Cognitive Training In Older Adults
Condition: Aging
Study type: Interventional

Summary: 
      A two-phase adaptive randomized clinical trial will examine the individual and combined
      impact of pairing cognitive training with transcranial direct current stimulation (tDCS).
      tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions
      involved in active cognitive function and could enhance neural plasticity when paired with a
      training task. We will compare changes in cognitive and brain function resulting from CT and
      ET combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal
      neuroimaging assessment of brain structure, function, and metabolic state. Functional
      magnetic resonance imaging (FMRI) will be used to assess brain response during working
      memory, attention, and memory encoding; the active cognitive abilities trained by CT. Proton
      magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including GABA
      concentrations sensitive to neural plasticity. We hypothesize that: 1) tDCS will enhance
      neurocognitive function, brain function, and functional outcomes from CT, with combined CT
      and tDCS providing the most benefit; 2) Effects of tDCS on CT will be maintained up to 12
      months following training, and 3) Neuroimaging biomarkers of cerebral metabolism, neural
      plasticity (GABA concentrations) and functional brain response (FMRI) during resting vs.
      active cognitive tasks will predict individual response to tDCS.
    


Intervention name(s): Cognitive Training; tDCS (active stimulation); tDCS (sham stimulation); Educational Training
Intervention type(s): Behavioral; Device; Device; Behavioral
Intervention description(s): Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.; A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).; Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.; Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of a Natural Extract on Glucose Fluxes After Consumption of a Wheat Product
Condition: Healthy
Study type: Interventional

Summary: 
      This study is to quantify the effect of a natural fruit extract added to a wheat product on
      the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE
      * Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)
    


Intervention name(s): Natural fruit extract; Placebo; Glucose solution
Intervention type(s): Dietary Supplement; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Blood glucose
Assessment of Postoperative Pain in Children With Facial Expression Analysis
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The present study was conducted to evaluate the use of computer-aided facial expression
      analysis to assess postoperative pain in children. The study population consisted of patients
      in the age group of 7-18 years who underwent surgery at Bursa Uludağ University Faculty of
      Medicine Health Application and Research Hospital Pediatric Surgery Clinic between November
      2019 and June 2021. The sample of the study consisted of total 83 children who agreed to
      participate in the study and who met the sample selection criteria. Data were collected by
      the researcher using the Wong Baker Faces (WBS) pain rating scale and Visual Analog Scale
      (VAS). Data were collected from the child, mother, nurse, and one external observer. Facial
      action units associated with pain were used for machine estimation. OpenFace was used to
      analyze the child's facial action units and Python was used for machine learning algorithms.
      Intraclass correlation coefficient, Kappa coefficient, and linear regression analysis were
      used for statistical analysis of the data. The pain score predicted by the machine and the
      pain score assessments of the child, mother, nurse, and observer were compared.
    


Intervention name(s): The facial expressions analyzed
Intervention type(s): Other
Intervention description(s): The facial expressions associated with pain were analyzed by the researchers in the OpenFace program. The patient's pain scores were estimated in the Python program by combining the numerical outputs of facial expression analyses with machine learning algorithms.
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        The study sample consisted of 7-18 age group patients who underwent surgery in the
        pediatric surgery clinic of a university hospital.
      
Keywords: children; facial expression analysis; machine learning; pain assessment
Study of Estrogen Levels in Premenopausal Women Who Have Undergone Surgery for Breast Cancer and Are Receiving Triptorelin and Tamoxifen Citrate or Exemestane on Clinical Trial IBCSG 24-02
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may
      help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane
      works in lowering estrogen levels.

      PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have
      undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or
      exemestane on clinical trial IBCSG-2402.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Describe estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) at
           different time points during the first 4 years of treatment with triptorelin in
           combination with either tamoxifen citrate or exemestane on clinical trial IBCSG-2402 in
           premenopausal women with resected breast cancer.

        -  Assess whether there is a suboptimally estrogen-suppressed subgroup of patients who
           receive exemestane.

      Secondary

        -  Compare estrogen levels (E2, E1, E1S) at different time points during treatment with
           triptorelin in combination with either tamoxifen citrate or exemestane.

        -  Examine potential predictive factors of ineffective estrogen suppression (e.g., age,
           chemotherapy [yes/no], type of chemotherapy received, smoking history, BMI, and evidence
           of menses at study entry).

        -  Investigate the predictive value of optimal estrogen suppression during the first 6 and
           12 months of treatment with regard to long-term estrogen suppression (4-year period).

        -  Compare disease-free survival of suboptimally estrogen-suppressed patients treated with
           exemestane with that of patients with optimal suppression (exploratory analysis).

        -  Examine related endocrine function (FSH and LH) to further elucidate causes of
           suboptimal estrogen suppression.

      OUTLINE: This is a multicenter study.

      Blood samples are collected at baseline and at 3, 6, 12, 18, 24, 36, and 48 months for
      measurement of estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) by
      gas chromatography-mass spectrometry and measurement of endocrine function (FSH and LH).
    

Intervention name(s): gas chromatography / tandem mass spectometry
Intervention type(s): Other
Intervention description(s): Determination of estrogen levels through gas chromatography.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer
Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
Condition: Central Precocious Puberty; Sexual Precocity
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to determine the specificity, sensitivity and diagnostic efficiency
      of the Triptorelin Test in the assessment of CPP compared to GnRH test as gold standard.

      Hypothesis: Aqueous Triptorelin Acetate is so efficient as GnRH to CPP assessment.

      Study population are girls with suspicious clinical features of precocious puberty
    

Detailed description: 
      GnRH stimulation is the gold standard to distinguish between isolated premature thelarche
      (PT) and CPP. However, intravenous GnRH for testing is not fully available in all countries.
      To evaluate the diagnostic accuracy of a novel Triptorelin-test in the assessment of CPP
      compared to the GnRH test, a validation study was performed. Girls who presented thelarche
      with accelerated growth and/or advanced bone age were included. All girls underwent the two
      tests in a randomized order. CPP was ascertained according to LH response under GnRH (gold
      standard test).
    

Intervention name(s): Triptorelin acetate and Gonadorelin acetate; Gonadorelin acetate and Triptorelin acetate
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.; Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.
Intervention MeSH terms: Triptorelin Pamoate; Prolactin Release-Inhibiting Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Triptorelin acetate; precocious puberty; premature thelarche; GnRH analog; Diagnostic validation study
Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol
Condition: Neuromyelitis Optica Spectrum Disorders; Pain
MeSH terms: Neuromyelitis Optica
Study type: Interventional

Summary: 
      Abstract Background Neuropathic pain is a common complication in neuromyelitis optica
      spectrum disorder (NMOSD), which seriously affects the quality of life of NMOSD patients,
      with no satisfactory treatment. Through the previous literature study and clinical
      observation, we found that acupuncture has good curative effect in the treatment of pain,
      especially electric acupuncture, but thestudies on acupuncture intervention in pain of NMOSD
      are still scare.

      Objective To evaluate the clinical efficacy of electroacupuncture on NMOSD patients with
      pain.

      Materials and Methods In this exploratory randomized controlled study, NMOSD patients with
      pain were recruited from March 21, 2022 to February 21, 2023. Patients meeting the inclusion
      and exclusion criteria were randomly assigned to the electroacupuncture group (experimental
      group) and the sham electroacupuncture group (control group) by simple random method
      (envelope method) according to the inclusion order. Totally, there are 20 patients enrolled.

      The experimental group received electroacupuncture therapy and the control group received
      sham electroacupuncture therapy. A total of 8 sessions were given twice a week for 30 minutes
      each. On the baseline, demographic information, medication history, specimens of routine
      blood, blood biochemistry, liver function, IL - 6, TNF-α were collected, the brain, cervical
      and thoracic MRI were perfected and collected, patients filled in the SF - MPQ, NRS, SF - 36,
      SAS, SDS, EDSS. After the treatment, specimens of routine blood, blood biochemistry, liver
      function, IL - 6, TNF-α were collected again, patients filled in the SF - MPQ, NRS, SF - 36,
      SAS, SD, EDSS. The main outcome indicators were SF-MPQ, and the secondary outcome indicators
      were EDSS, NRS, SAS, SDS, SF-36, IL-6, and TNF-α.

      Conclusion This is the first exploratory randomized controlled study to evaluate the efficacy
      of electroacupuncture on pain in patients with NMOSD. The study will provide clincial
      evidence of the practice of electroacupuncture on NMOSD with pain.

      Key Words neuromyelitis optica spectrum disorders; pain; electroacupuncture
    


Intervention name(s): electroacupuncture
Intervention type(s): Behavioral
Intervention description(s): electroacupuncture were inserted into bilateral Zusanli (ST36), Sanyinjiao (SP6), Hegu (LI4) and Quchi (LI11), and Yintang (EX-HN3). Electroacupuncture parameters selected the sparse wave, the frequency was 4 Hz, the stimulation intensity was tolerated by the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group)
Masking: Single (Participant)
Primary purpose: Treatment