bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Memantine on Cognitive Impairment in Patients With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the efficacy of memantine on improving the cognitive impairment in patient with
      epilepsy
    

Detailed description: 
      Epilepsy is a complex disorder, which involves much more than seizures, encompassing a range
      of associated comorbid health conditions that can have significant health and quality-of-life
      implications. Of these comorbidities, cognitive impairment is one of the most common and
      distressing aspects of epilepsy.

      Excito-toxicity, mediated by glutamate acting on N-methyl-D-aspartate (NMDA) receptors in the
      hippocampus, can cause memory dysfunction in epilepsy .

      Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type
      glutamate receptor . It also has antioxidant property and increases production of brain
      derived neurotropic factor (BDNF)
    

Intervention name(s): Memantine Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type glutamate receptor .Memantine hydrochloride tablet was started at the dose of 5 mg once daily orally, and the same dose was given for 3months and dose is titrated to 10 mg once daily orally for the remaining 3months. Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.; Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.
Other intervention name(s): Memantine
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 100 patients divided into two groups each group 50patients
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Adjunct Photodynamic Therapy in Chronic Periodontitis Among Cigarette-smokers.
Condition: Chronic Periodontitis; Smoking
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      This study evaluates the efficacy of scaling and root planing with and without adjunct
      antimicrobial photodynamic therapy (aPDT) in the treatment of chronic periodontitis (CP)
      among cigarette-smokers and never-smokers.
    

Detailed description: 
      The following inclusion criteria were entailed: (a) Self-reported habitual cigarette-smokers;
      (b) self-reported never-smokers; (c) patients with CP (presence of at least 30% sites with ≥
      3 mm of CAL and PD ≥ 3 mm 18, 19 ). The exclusion criteria were as follows: (a) patients with
      systemic diseases such as acquired immune deficiency syndrome/HIV and diabetes mellitus; (b)
      habitual smokeless tobacco product and alcohol users; (c) third molars and fractured teeth
      with embedded root remnants and edentulous individuals; (d) patients with misaligned teeth;
      and (e) patients that reported to have used antibiotics, non-steroidal anti-inflammatory
      drugs and/or steroids within the past 90 days.

      Demographic information was collected using a questionnaire. Cigarette-smokers (group-1) and
      never-smokers (group-2) with chronic periodontitis were included. Treatment wise, these
      individuals were divided into two subgroups as follows: (a) SRP alone and (b) SRP with
      adjunct aPDT. Periodontal parameters (plaque index [PI], bleeding on probing [BOP], clinical
      attachment loss [CAL] and probing pocket depth ≥4mm [PD] were measured at baseline and at 1
      month and 3 months' follow-up.
    

Intervention name(s): Photodynamic therapy; Scaling and root planing (SRP)
Intervention type(s): Device; Procedure
Intervention description(s): In groups 1 and 2, aPDT was performed after SRP. The protocol for aPDT is described elsewhere. Briefly, using a blunt needle, 0.005% of Methylene blue was applied into the periodontal pocket and left in place for 10 seconds. The dye was then irradiated with a diode laser (670 nanometers) at 150 milliwatts. In each dye filled periodontal pocket, laser irradiation was performed for one minute using a flexible tip. In the present study, aPDT was performed once, at baseline, by a trained dentist.; In both groups, SRP was performed in one session under local anesthesia using handheld Gracey curettes No. 5/6. One trained dental hygienist blinded to the study groups and subgroups made 9 to 10 strokes in a vertical (apico-coronal) direction and the inclination between scaler tips and roots was maintained as zero. When the curved explorer indicated a smooth and hard dental surface, SRP was judged as completed. In all individuals, SRP was done in one session without any assigned time limit for completion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Unilateral Ultrasound Guided Paravertebral Block as Perioperative Analgesia For Lower Limb-Sparing Surgery In Adult Cancer Patients
Condition: Unilateral U/S PVB
Study type: Interventional
Phase: Phase 4

Summary: 
      Ultrasound imaging has revolutionized the practice of regional anesthesia in that the
      operator can visualize and identify the paravertebral space, needle during its passage
      through the tissues, as well as deposition and spread of local anesthetic into the desired
      spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration
      with the added advantage of decrease in drug dosage, reduction in incidence of local
      anesthetic toxicity, increase success rate, reduction in procedure pain and better patient
      satisfaction.
    

Detailed description: 
      Paravertebral block targets drug delivery to the site of pain, thus decreasing opioids use.
      It can provide greater overall comfort with lower pain scores and greater tolerance of
      physical activity during the initial postoperative period.

      Ultrasound imaging has revolutionized the practice of regional anesthesia in that the
      operator can visualize and identify the paravertebral space, needle during its passage
      through the tissues, as well as deposition and spread of local anesthetic into the desired
      spaces. The usage of ultrasound may facilitate more rapid block onset and prolong duration
      with the added advantage of decrease in drug dosage, reduction in incidence of local
      anesthetic toxicity, increase success rate, reduction in procedure pain and better patient
      satisfaction.

      To the best of researchers' knowledge, evaluation of unilateral ultrasound guided
      paravertebral block as perioperative analgesia for lower limb-sparing surgery in adult cancer
      patients was not investigated before.
    

Intervention name(s): Paravertebral group (group P):
Intervention type(s): Drug
Intervention description(s): In both groups, one reading of mean arterial pressure and heart rate were taken before induction of general anaesthesia and were defined as baseline readings and then were recorded intra-operatively at 15 min intervals.
Additional bolus doses of fentanyl 0.5µg/kg were given when the mean arterial blood pressure or heart rate raised above 20% of baseline levels.
Other intervention name(s): Control group (group C):
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized controlled double-blind study.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Acute and Chronic Metabolic Flexibility in Individuals Living With Obesity: The i-FLEX Study
Condition: Obesity; Obesity; Endocrine; Insulin Sensitivity; Exercise
MeSH terms: Obesity; Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      Regular exercise is a cornerstone in the prevention and the management of cardio-metabolic
      risk factors. Some of the beneficial effect of exercise training occurs through metabolic
      flexibility' enhancement. Metabolic flexibility is the ability to respond or adapt to
      conditional changes in metabolic demand, and previous literature has shown that individuals
      living with obesity have an impaired metabolic flexibility compared to lean individuals.
      However, there is a lack of empirical evidence on the impact of sprint interval training on
      metabolic flexibility and whether this translates into clinically meaningful outcomes.

      This study will evaluate the impact of 4-week sprint interval training in normal weight
      individuals as well as individuals living with obesity on acute and chronic metabolic
      flexibility, irisin secretion and insulin sensitivity.
    


Intervention name(s): Sprint Interval Training
Intervention type(s): Behavioral
Intervention description(s): The 4-week sprint interval intervention will consist of a work-rest ratio of four 30-s intervals of exercise at maximal capacity and 4-min of passive recovery at 50% of maximal capacity between intervals. There will be three sessions per week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Individuals living with obesity (BMI ≥ 30 km/m2; n=15) as well as normal weight (BMI ≥ 18.5 < 25.0 km/m2; n=15) adults (aged between 19 to 60 years) will be recruited to participate in the study. All participants will be asked to come in for a total of two visits and participate in a 4-week intervention.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Metabolic flexibility; Insulin sensitivity; Sprint interval training; Obesity; Exercise intensity
Unhealthy Alcohol Drinking and Anesthetic Requirement in Women
Condition: General Anesthesia
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Unhealthy alcohol drinking is negatively influencing health of people and costing a large
      number of annual finance via "secondhand" effects. Additionally, unhealthy alcohol use covers
      a spectrum that is associated with varying degrees of risk to health. The investigators
      hypothesized that unhealthy alcohol drinking resulted in significant increase in anesthetic
      requirement during general anesthesia. This investigation would clarify the association
      between unhealthy alcohol use and the intraoperative consumption of anesthetics, and provide
      clinical evidence for preoperative assessment with respect to the alcohol drinking habit.
    


Intervention name(s): Alcohol drinking; Alcohol drinking; Alcohol drinking; Alcohol drinking; Alcohol drinking
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Never drinking of alcohol; Mild drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"; Moderate drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"; Severe over drinking of alcohol assessed by "alcohol use disorders identification test (AUDIT)"; Alcohol-dependent assessed by "alcohol use disorders identification test (AUDIT)"
Other intervention name(s): Ethanol use; Ethanol use; Ethanol use; Ethanol use; Ethanol use
Intervention MeSH terms: Ethanol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Anesthetics; Sedatives; Analgesics
Study to Evaluate Properties of Radiprodil Given in Oral Solution to Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics (PK) profile of Radiprodil in suspension form in healthy
      adult subjects.
    

Detailed description: 
      UP0027 is a Phase 1, single-center, open-label study to investigate the safety, tolerability,
      and PK profile of radiprodil in healthy adult male and female subjects after a single fasting
      oral dose of radiprodil 30 mg suspension formulation. A total of 10 subjects will be enrolled
      in the study.

      The primary objective of the study is to evaluate the PK profile of oral radiprodil in
      suspension form in healthy adult subjects.

      The secondary objective of the study is to evaluate the safety and tolerability of oral
      radiprodil in suspension form in healthy adult subjects.

      The exploratory objectives of the study are to evaluate the comparative PK profile of
      radiprodil from samples collected using 2 alternative microsampling techniques (MITRA™ and
      Drummond capillary tubes) with that of conventional venous blood samples, and to test the
      perception of the taste and texture of the oral radiprodil suspension.
    

Intervention name(s): Radiprodil oral
Intervention type(s): Drug
Intervention description(s): Active Substance: Radiprodil
Pharmaceutical Form: dry granules for oral suspension
Concentration: 30 mg
Route of Administration: oral use
Other intervention name(s): UCB3491
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: UCB3491; Phase 1; Pharmacokinetics; Radiprodil; Healthy volunteers
Multi-Center Pre-Bariatric Weight Loss Study
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients
      who require weight loss prior to their Bariatric surgery.
    

Detailed description: 
      This is a randomized, patient blinded, prospective study.Patients will receive either a
      device or a sham procedure. Patients will be evaluated for the study and randomized to a
      treatment group if they qualify for the study. Throughout the study their weights will be
      obtained and various laboratory tests collected. A comparison of weight loss between the two
      groups will be assessed as the primary outcome measure.
    

Intervention name(s): GI Sleeve Implantable weight loss device (EndoBarrier); Sham Procedure
Intervention type(s): Device; Procedure
Intervention description(s): device for weight loss; Weight loss
Other intervention name(s): endobarrier; Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Weight Reduction
Effect of Sufentanil and Ropivacaine
Condition: Anesthesia Complications
Study type: Interventional

Summary: 
      The investigators study the efficacy of epidural sufentanil/ropivacaine for analgesia labor
      in primiparas so as to decrease perinatal complications of analgesia labor.
    

Detailed description: 
      A prospective study of 120 full-term parturients receiving labor analgesia were randomly
      assigned into 2 groups: the 0.5Sufen group (N=60), the 0.25Sufen group (N=60).
    

Intervention name(s): 0.25 sufentanil; 0.5µg/ml sufentanil; 0.1% ropivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): with different dosage; 0.5µg/ml sufentanil; 0.1% ropivacaine
Other intervention name(s): opiods; opiods; Local Anesthetics
Intervention MeSH terms: Sufentanil; Dsuvia; Ropivacaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Epidural; Analgesia labor; Perinatal; anesthesia
The Effect of BiosLife on Serum Lipids
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      This is a double-blind, placebo-controlled study to assess the effectiveness of BiosLife in
      lowering serum LDL cholesterol and raising HDL cholesterol. BiosLife is a natural supplement
      (mixed in water and taken twice daily) which contains guar gum and other natural soluble
      fibers, phytosterols, policosanol, and a proprietary chrysanthemum extract. Approximately 100
      subjects with baseline LDL cholesterol of 110-190 mg/dL will be randomized in a 2:1 ratio to
      BiosLife or a look-alike placebo. Changes in lipids from baseline will be assessed at 6 weeks
      and 12 weeks.
    


Intervention name(s): BiosLife Complete; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LDL cholesterol; HDL cholesterol; natural supplement; guar gum; phytosterols; policosanol; chrysanthemum
Nivolumab Combined With Anlotinib as Re-challenge Treatment in Advanced NSCLC
Condition: NSCLC Stage IV; Checkpoint Inhibitor
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase Ib/IIa, open-label, single center study, aiming to investigate safety and
      efficacy of nivolumab (administered intravenously) in combination with anlotinib
      (administered orally) in immunotherapy-treated advanced NSCLC. The study has been designed to
      allow an investigation of the optimal combination dose and schedule while ensuring the safety
      of patients with intensive safety monitoring. There are two main parts to this study; Part A,
      combination dose finding and Parts B, dose expansion. Part B will either be initiated if RP2D
      reached in Part A, or not initiated if RP2D was not reached in Part A.

      Part A has been designed to identify the recommended dose of combination of nivolumab plus
      anlotinib for further clinical evaluation based upon assessment of the safety and
      tolerability data collected during the first 21 days (cycle 1, 21 days per cycle). The 21-day
      assessment period was selected as the major toxicities leading to cessation of dose
      de-escalation in such Phase I oncology studies (haematological, gastrointestinal, liver
      enzymes) are anticipated to present within this duration. "3+3"design was used in the dose
      finding cohort.

      If RP2D was reached in Part A, eligible patients would be enrolled and receive nivolumab
      (360mg q3w, intravenously) plus anlotinib (RP2D, QD from day 1 to 14 of a 21-day cycle) till
      disease progression (PD) withdraw of consent, or unacceptable toxicity to further evaluate
      the safety, tolerability and efficacy in terms of ORR , DCR, DOR, PFS and OS. The tumor
      response will be evaluated according to RECIST Version 1.1 every 6 weeks.
    


Intervention name(s): Nivolumab Combined with Anlotinib
Intervention type(s): Drug
Intervention description(s): In combination dose finding phase, Phase 1b will begin with Dose Level 1; anlotinib 12 mg/day orally (from days 1 to 14 in a 21-day cycle) and nivolumab (360mg q3w, intravenously) will be administered to eligible subjects on a 21-day treatment cycle. Two dose de-escalation steps are included: Dose Level 2 (anlotinib 10 mg/day orally, from days 1 to 14 in a 21-day cycle) and nivolumab 360mg q3w, intravenously) and Dose Level 3 (anlotinib 8 mg/day orally, from days 1 to 14 in a 21-day cycle) and nivolumab 360mg q3w, intravenously).If RP2D was reached in Part A, eligible patients would be enrolled and receive nivolumab (360mg q3w, intravenously) plus anlotinib (RP2D, QD from day 1 to 14 of a 21-day cycle) .
Intervention MeSH terms: Nivolumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSCLC; Nivolumab; Anlotinib
Palonestron, Granisetron and Ramosetron for Prevention of Postoperative Nasea and Voming After Laparoscopic Abdominal Surgery
Condition: Female Patients Undergoing Laparoscopic Abdominal Surgery
Study type: Observational

Summary: 
      We compared the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT3
      antagonist, granisetron and ondansetron in patients at high-risk for postoperative nausea and
      vomiting after laparoscpic abdominal surgery.

      This study was conducted to determine the efficacy of three 5-HT3 receptor antagonists in the
      prevention of PONV for laparoscopic surgery in patients receiving PCA IV.
    

Detailed description: 
      Occurrences of nausea and vomiting, the severity of nausea (VAS), rescue antiemetic drug use,
      and amount of PCEA infusion and rescue pethidine were monitored after the end of surgery
      during four time periods: 0-2 h; 2-6 h; 6-24 h; and 24-48 h. Nausea was defined as the
      subjectively unpleasant sensation associated with awareness of the urge to vomit; vomiting
      included retching (defined as the laboured spastic, rhythmic contraction of the respiratory
      muscles without the expulsion of the gastric contents) and vomiting (defined as the forceful
      expulsion of gastric contents from the mouth) [11]. A complete response was defined as no
      PONV and no need for rescue anti-emetic drug. If two or more episodes of PONV occurred during
      the study period, a rescue anti-emetic (metoclopramide 10 mg) was given IV. The primary
      outcome was the incidence of nausea during the study period.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The sample size was determined based on the ability to detect a difference in the primary
        outcome variable, the incidence of nausea. With 30 patients in each group there was 80%
        power at an a of 0.05 to detect a 30% difference in the number of patients with nausea up
        to 24 h after surgery.
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Study will evaluate if a combination of saxagliptin and dapagliflozin added concurrently to
      metformin in combination with diet and exercise is superior to sitagliptin added to metformin
      in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26
      weeks.
    


Intervention name(s): Saxagliptin; Dapagliflozin; Sitagliptin; Placebo matching with Saxagliptin; Placebo matching with Dapagliflozin; Placebo matching with Sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): administered orally once daily; administered orally once daily; administered orally once daily; administered orally once daily; administered orally once daily; administered orally once daily
Intervention MeSH terms: Sitagliptin Phosphate; Dapagliflozin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment