bioihbjkbjnl/mcl2 huggingface dataset:
Ovarian Clear Cell Adenocarcinoma Review
Condition: Ovarian Cysts
MeSH terms: Adenocarcinoma; Adenocarcinoma, Clear Cell; Ovarian Cysts
Study type: Observational

Summary: 
      Clear cell carcinoma comprises 5-10% of surface epithelial ovarian cancers, and about 30-40%
      of the patients with clear cell carcinoma are diagnosed in the advanced stage. The
      investigators studied the response to chemotherapy and survival for either
      paclitaxel-platinum based chemotherapy or conventional platinum-based chemotherapy among all
      stages clear cell ovarian carcinoma. Prognostic factors for survival among the patients with
      pure, advanced, clear cell ovarian carcinoma were also evaluated.
    

Detailed description: 
      1. Several authors have reported frequent admixtures of clear cell ovarian carcinoma with
           serous, mucinous, and endometrioid tumors. However, few papers addressed the difference
           in response to chemotherapy and survival between patients with pure and mixed-type
           advanced clear cell carcinoma.

        2. Recent trends in the clinical management of advanced ovarian cancer include increased
           attention to maximal cytoreduction and general acceptance of paclitaxel-platinum-based
           adjuvant chemotherapy.

        3. The introduction of paclitaxel markedly changed the postoperative management of ovarian
           cancer patients, but the results and value of these newer efforts and therapies applied
           to clear cell carcinoma are as yet undetermined.

        4. Today, paclitaxel-platinum-based chemotherapy is becoming the standard regimen for
           ovarian cancer worldwide. Previous research suggests a potential benefit of paclitaxel
           plus carboplatin regimens for stage I clear cell carcinoma. However, few papers
           specifically addressed the efficacy of paclitaxel-platinum-based chemotherapy for
           advanced clear cell carcinoma because clear cell carcinoma occurs only rarely in Western
           countries.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        total 300 patients of ovarian clear cell carcinoma post operation from 8 institution.
      
Keywords: Ovarian cancer; Clear cell carcinoma; Paclitaxel-platinum; Chemotherapy; response to chemotherapy; survival of clear cell ovarian carcinoma; Prognostic factors
Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to to evaluate the safety and immune response of COVI-VAC given
      as a single booster dose in healthy adults previously vaccinated against COVID-19 with an
      authorised mRNA or adenovirus-vectored vaccine. Approximately 30 participants who have been
      fully vaccinated ≥ 3 months ago will be enrolled and receive one dose of COVI-VAC. COVI-VAC
      is administered by drops into each nostril. To assess the safety of the vaccine, each
      participant will record symptoms and oral temperature in a diary daily for 7 days after
      receiving COVI-VAC or placebo.

      During the full study safety laboratory tests, physical exams, and vital signs (including
      oxygen saturation) will be conducted periodically for safety. Adverse events and medication
      use will be recorded.

      Blood samples and intranasal samples will be collected periodically to assess the immune
      response from the vaccine.
    


Intervention name(s): COVI-VAC
Intervention type(s): Biological
Intervention description(s): Intranasal, live attenuated vaccine against SARS-CoV-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Covid-19 vaccines; Covid-19 vaccine booster shot; Heterologous prime boost; COVID-19 vaccination; Vaccines, attenuated
Evaluation of Isostretching Effects in Patients With Mechanical and Postural Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Isostretching is effective in treating chronic back pain to improve pain, quality of life and
      functional capacity.
    

Detailed description: 
      Objective: This study investigated the influence of isostretching on patients with chronic
      low back pain. Methods: It was a randomized, controlled trial with concealed allocation,
      intention-to-treat analysis, and blind assessment. Fifty-four patients with chronic low back
      pain were randomized to an experimental group and a control group. The experimental group
      performed isostretching twice a week for 45 days, while the control group remained on the
      waiting list for physical therapy. Patients were submitted to evaluations at baseline, after
      20 and 45 days of treatment with regard to pain, quality of life, functional capacity, and
      satisfaction. Results: The experimental group exhibited statistically significant
      improvements in comparison to the control group with regard to pain (p = .003), functional
      capacity (p = .026), patient satisfaction (p < .001), and quality of life as determined by
      the functional capacity (p = .012), physical aspects (p = .011) and pain (p = .006) subscales
      of the SF-36. The experimental group used a significantly lesser amount of pain medication
      than the control group (p = .03). Conclusion: Isostretching was effective in reducing pain
      and in improving function, patient satisfaction and some aspects of quality of life in
      patients with chronic low back pain.
    

Intervention name(s): Isostretching
Intervention type(s): Other
Intervention description(s): 12 interventions (two times per week) for 45 minutes
Other intervention name(s): Strengthening and stretching exercise during expiration.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Alocados de forma cega para o grupo de intervenção: 27 pacientes com diagnóstico de lombalgia crônica realizaram o Isostretching e uso de diclofenaco em caso de dor e grupo controle:27 pacientes com lombalgia crônica sem atividade física com uso apenas de diclofenaco em caso dedor Todos foram submetidos à avaliação inicial (T0), com 20 dias (T20) e com 45 dias (T45), por um avaliador cego. Os pacientes foram instruídos nos dois grupos, pelo médico, a utilizar o diclofenaco de sódio 50mg, a cada oito horas de acordo com a dor.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; pain; incapacity; life quality; rehabilitation
Estimation of Injection Volume for Caudal Epidural Block Using Dynamic US Imaging in Children
Condition: Caudal Epidural Block
Study type: Observational

Summary: 
      Caudal epidural block is the most commonly used technique for analgesia in pediatric
      patients. Although there are clinically used doses of local anesthetics for caudal epidural
      block, we do not know exactly how much levels are blocked in young children. Thus, we aimed
      to identify the spreading of injection of local anesthetics for caudal epidural block using
      ultrasound imaging in young children.
    


Intervention name(s): ultrasound guided caudal epidural block
Intervention type(s): Procedure
Intervention description(s): dynamic ultrasound imaging of the spread of local anesthetics
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Among the patients who are scheduled to undergo elective polydactyly / syndactyly /
        polysyndactyly correction surgery in Asan Medical Center, the patients who meet the
        inclusion criteria are included.
Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics
Condition: Hepatitis C; Cirrhosis
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, open label, single center safety and efficacy study. At least 40
      cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir
      and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product).
      Subjects will be randomized in a 1:1 to receive either:

        -  Group A: 16 weeks of DCV/SOF/RBV

        -  Group B: 24 weeks of DCV/SOF/RBV

      Subjects will return to the study center at various time points throughout the 16 or 24 weeks
      of treatment in addition to 12 weeks post taking last dose of study drug to monitor safety
      and efficacy. These visits will be according to standard of care.
    


Intervention name(s): daclatasvir; Sofosbuvir, Sovaldi; Ribavirin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): DCV, BMS-790052, Daklinza; SOF; RBV
Intervention MeSH terms: Ribavirin; Sofosbuvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCV; Genotype 3; Treatment naive; Treatment experienced
Monovision vs Multifocal Lens Insertion in Cataract Patients
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The investigators would like to assess whether monovision correction of multifocal lens
      insertion provides more satisfaction to cataract patients following an uncomplicated
      phacoemulsification surgery.
    


Intervention name(s): Phacoemulsification surgery; Phacoemulsification surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Phacoemulsification surgery with intraocular lens implantation and monovision correction; Phacoemulsification surgery with multifocal intraocular lens implantation
Other intervention name(s): Alcon Infiniti Vision System platform; Visthesia, Carl Zeiss, Germany; Alcon Intraocular lens SN60WF; Alcon Infiniti Vision System platform; Visthesia, Carl Zeiss, Germany; Hoya Intraocular lens PY-60MV
Intervention MeSH terms: Lidocaine; Dipivefrin; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cataract; phacoemulsification; monovision; multifocal lens
Extinction Learning in Youth With Tourette Syndrome
Condition: Tourette Syndrome in Children; Tourette Syndrome in Adolescence; Habit Reversal Training; Tic
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional

Summary: 
      Aversive sensory phenomena such as premonitory urges play a central role in the behavioral
      treatment model of tics. Extinction learning and extinction recall are learning processes
      implicated within this model, but have not been directly evaluated in youth with Tourette
      syndrome (TS). This study examines extinction learning and extinction recall in youth with TS
      using an experimental task. This study will also explore the relationship between extinction
      processes (i.e., extinction learning and extinction recall) and treatment outcomes with
      behavior therapy. Findings from this investigation will be used to update the behavioral
      treatment model, which serves as the basis for evidence-based behavioral interventions.
    


Intervention name(s): Habit Reversal Training
Intervention type(s): Behavioral
Intervention description(s): 4 sessions of habit reversal training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extinction learning; Behavior Therapy; Tourette's Disorder; Habit Reversal Training; Comprehensive Behavioral Intervention for Tics
Prophylaxis Against Metoclopramide-Induced Akathisia
Condition: Akathisia
MeSH terms: Psychomotor Agitation
Study type: Interventional

Summary: 
      ABSTRACT

      Study Objective:

      To compare the effects of midazolam and diphenhydramine for the prevention of metoclopramide
      induced akathisia.

      Methods:

      This randomized, double-blind and controlled trial aimed to investigate co-administered
      midazolam versus diphenhydramine in the prophylaxis of metoclopramide induced akathisia.
      Patients 18 through 65 years of age who presented to the ED with primary or secondary
      complaints of nausea and/or moderate to severe vascular type headache were eligible for this
      study. Patients were randomized to one of the fallowing three groups: (1) metoclopramide 10
      mg + midazolam 1.5 mg (2) metoclopramide 10 mg + diphenhydramine 20 mg (3) metoclopramide 10
      mg + placebo. Metoclopramide was administered as a 2 minutes bolus infusion. Midazolam,
      diphenhydramine and normal saline solution administered as a 15 minutes slow infusion. Whole
      procedure was observed, akathisia and sedation scores and vital changes were recorded.
    


Intervention name(s): midazolam
Intervention type(s): Drug
Intervention description(s): midazolam 1.5 mg
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: metoclopramide; akathisia; midazolam; diphenhydramine; metoclopramide induced akathisia
Face-to-face Tracheal Intubation: a Comparison of Airtraq, Glidescope and Fastrach
Condition: Intubation Difficult
Study type: Interventional
Phase: Phase 4

Summary: 
      Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face
      intubation in an entrapped patient is one of these situations. The investigators want to
      compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face
      intubation in adult patients aged between 18-60 years.
    

Detailed description: 
      The investigators record the demographic and the airway data of the patients (thyromental
      distance, sternomental distance, mallampati score, mandibula protrusions, interincisor
      distance..etc). The hemodynamic data of the patients baseline preoperatively, after
      induction, after insertion of the device, after intubation, and 2 minutes intervals after
      intubation during the ten minutes. Cormack-Lehane grade of the videolaryngoscopes, insertion
      time, intubation time, need of optimisation maneuvers, mucosal damage, teeth and tongue
      damage, postoperative sore throat, hoarseness, dysphagia were recorded.
    

Intervention name(s): Glidescope; Airtraq; Fastrach
Intervention type(s): Device; Device; Device
Intervention description(s): videolaryngoscope used for endotracheal intubation; videolaryngoscope used for endotracheal intubation; intubating laryngeal mask airway used for blind endotracheal intubation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Fasting Bioequivalence Study of 2 Metformin 1000 mg Prolonged Release Tablets in 28 Healthy Male and Female Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective was to compare the rate and extent of absorption of Metformin XR after
      administration of a Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak,
      Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono
      Ltd, UK), administered as a single dose in healthy subjects under fasting conditions.

      The adverse events, physical examinations and vital signs were reported for the evaluation of
      safety.
    

Detailed description: 
      An Open, Comparative, Randomized, Crossover Clinical Trial to Evaluate the Bioequivalence of
      Single Doses of Test Product Metformin 1000 mg Prolonged Release Tablets (JSC Farmak,
      Ukraine) and Reference Product Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono
      Ltd, UK) in Healthy, Adult Male and Female Subjects Under Fasting Conditions.

      Single oral dose of Test of Reference product of Metformin 1000 mg Prolonged Release Tablets
      was administered to volunteers under fasting conditions in the morning of Day 1 of each Study
      Period.

      The study consists of two study periods with a washout period of at least 7 days between
      doses.

      During each study period 21 blood samples were taken: prior to dosing (-1.0) and 1.0, 2.0,
      3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 10.0, 12.0, 16.0, 24.0, 32.0 and
      36.0 hours after IMP administration.
    

Intervention name(s): Metformin 1000 mg Prolonged Release Tablets (JSC Farmak, Ukraine); Glucophage® XR 1000 mg Prolonged Release Tablets (Merck Serono Ltd, UK)
Intervention type(s): Drug; Drug
Intervention description(s): One tablet of the test product was administered orally with 240 ml of water; One tablet of the Reference product was administered orally with 240 ml of water
Other intervention name(s): Diaformin® SR 1000mg tablets (JSC Farmak, Ukraine); Diabufor® XR 1000mg tablets (JSC Farmak, Ukraine); Glucophage® XR 1000 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; pharmacokinetics; generic drugs; Metformin 1000 mg Prolonged Release Tablets; Prolonged Release Tablets; oral dosage form; Metformin
Effects of Glycopyrrolate on Heart Rate and Heart Rate Variability in Patients With Different Basic Heart Rate
Condition: Glycopyrrolate
Study type: Interventional

Summary: 
      Glycopyrrolate is an anticholinergic medication commonly used in respiratory medicine for
      treating chronic obstructive pulmonary disease (COPD), bronchial asthma, and other conditions
      . In the perioperative period, it is often administered before anesthesia to reduce
      secretions in the salivary glands, bronchi, and pharynx . It is used during the recovery
      period to counteract the muscarinic effects of anticholinesterase inhibitors and can also be
      employed to prevent/treat vagal reflexes and related arrhythmias induced by surgery or
      medications .

      Heart rate (HR) is influenced by both the sympathetic and parasympathetic nervous systems.
      The baseline HR of different patients may vary due to differing levels of sympathetic and
      parasympathetic nerve activity within the body. It remains unclear whether patients with
      different baseline HRs exhibit varying degrees of HR elevation after the administration of
      glycopyrrolate(i.e.,the parasympathetic activity in vivo is antagonized). The primary aim of
      this study is to explore the impact of glycopyrrolate administration on HR in patients with
      different baseline HRs. The secondary objective is to investigate the effects of
      glycopyrrolate on heart rate variability (HRV) in patients with different baseline HR.
    


Intervention name(s): Glycopyrrolate; Glycopyrrolate
Intervention type(s): Drug; Drug
Intervention description(s): At the timepoint of 10 min after operation beginning (T1), the basic HR, MAP and the HRV frequency indexes were recorded. Then glycopyrrolate 0.006 mg/kg was injected intravenously in Group L.; At the timepoint of 10 min after operation beginning (T1), the basic HR, MAP and the HRV frequency indexes were recorded. Then glycopyrrolate 0.006 mg/kg was injected intravenously in Group H.
Intervention MeSH terms: Glycopyrrolate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Glycopyrrolate; Heart rate; Heart rate variability; Autonomic nervous system
E2022 Patch Formulation Single Dose Phase I Study
Condition: Japanese Healthy Male Adult Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of a single dose of E2022 in
      healthy Japanese male volunteers.
    

Detailed description: 
      This study is an open-label single site, randomized single dose study in 80 healthy Japanese
      male volunteers. The study consists of Period I to Period III, a total of 3 periods. In
      Period I, E2022 patches will be secured with seal. In Period II, single dose of E2022 5 mg
      tablet will be administered. In Period III, E2022 patches will be applied without seal. The
      features of the 5 patches will be evaluated in this study.
    

Intervention name(s): E2022; E2022; E2022; E2022; E2022
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): E2022 Type A patch; E2022 Type B patch; E2022 Type C patch; E2022 Type D patch; E2022 Type E patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transdermal Administration
Cellular and Humoral Immunity in Elderly After Immunization With a Japanese Encephalitis Vaccine
Condition: Humoral and Cellular Immune Responses
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this project is to investigate humoral and cellular immune responses before and
      after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years
      of age and 18-40 years old subjects.
    


Intervention name(s): IXIARO
Intervention type(s): Biological
Intervention description(s): 2 immunizations (0,5ml) with a 28 day interval
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science