bioihbjkbjnl/mcl2 huggingface dataset:
Novel Medication as a Potential Smoking Cessation Aid
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to provide preliminary information assessing if levomilnacipran
      may be effective at increasing smoking cessation rates.
    


Intervention name(s): Levomilnacipran; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Fetzima
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Title: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 1

Summary: 
      The rationale of our study is to compare the efficacy of natural honey base preparation with
      other commercially available mouthwashes i.e chlorhexidine base in prevention of dental
      plaque formation as honey is readily available and cost effective and organic in nature. This
      study will help to provide the data of our community and positive result may provide a new
      method of oral hygiene maintenance with fewer side effects. We will be able to deliver the
      best anti-plaque agent.
    

Detailed description: 
      In this study, participants will assigned into 2 group those who will fulfilled the inclusion
      and exclusion criteria. After the informed consent, they were divided into 2 group. Group A
      will received Chlorhexidine mouthwash and Group B will provided with honey based mouthwash.
      The participant will blinded as solution will be provided in dark color bottle to mask the
      study. After which the baseline plaque index will be taken followed by recording plaque index
      on 7th, 14th, and 21st day. The statistical analysis will be done to compare the mean
      difference between these 2 groups
    

Intervention name(s): Natural honey; Chlorhexidine mouthwash
Intervention type(s): Other; Drug
Intervention description(s): Natural Sidr honey based mouthwash used as intervention group B (Arm Group B) for the reduction of plaque index; Chlorhexidine gluconate 0.12% mouthwash is used as intervention in Group A (Arm Group A) for the comparison of plaque reduction among group A and B
Other intervention name(s): Sidr Honey; Chlorhexidine Gluconate
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants divided into two groups. one group will received honey based oral rinses and other group received chlorhexidine mouthwash and will evaluate the reduction of dental plaque
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dental plaque, Honey, Chlorhexidine
Evaluation of Labor Related Pelvic Floor Changes: A 3D Transperineal Ultrasound Study
Condition: Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders
Study type: Observational

Summary: 
      The aim of the study was the define changes LAM morphology, biometric measurements of the LAM
      and genital hiatus at immediate evaluation of pelvic floor and at 3 month after delivery was
      evaluated. We also sought to define the optimal time for evaluation of pelvic floor after
      childbirth
    

Detailed description: 
      Sixty four of 72 primiparous women who vaginally delivered singleton babies that eligible for
      trial were examined within 36 h of delivery and at 3rd months after delivery.Parameters such
      as age, episiotomy, mode of delivery, duration of labor, birthweight and antenatal biparietal
      diameter (BPD) measures were obtained from the clinical files. The length of the first stage
      of labor was calculated from the beginning of regular and at least three strong uterine
      contractions in 30 min according to the women's statements, tocography and palpations to full
      dilatation. All static ultrasound volume acquisitions were performed by the same experienced
      sonographer trained in pelvic floor ultrasound within 36 h of delivery. Same patients invited
      for second evaluation.Two 3-D volumes (one at rest, one on Valsalva maneuver) were recorded
      in the supine position after voiding.The effectiveness of valsalva was ascertained by
      observing 2-D ultrasounds before acquiring volumes.. LAM thickness is determined at the plane
      of minimal hiatal dimensions rather than 1-1.5 cm above the actual LAM hiatus where LAM
      thickness is maximal as described by Dietz et al.(15). The following parameters were assessed
      for this study: maximum diameters of the LAM hiatus (anteroposterior and transverse) at rest
      and on Valsalva maneuver; area of the LAM hiatus at rest and on Valsalva; and pubovisceral
      muscle thickness (left and right of the rectum), difference in anteroposterior and transverse
      diameter of hiatus and LAM hiatus area between rest and Valsalva
    

Intervention name(s): Transperineal 3D Ultrasound
Intervention type(s): Device
Intervention description(s): Imaging was performed with women in lithotomy position with empty bladder. The probe was covered with a sterile film and placed on the perineum in the sagittal plane. The field of view angle was set to a maximum of 70° in the sagittal plane and the volume acquisition angle to 85° in the axial plane. Analysis of stored volumes was conducted offline by another experienced investigator blinded to clinical and delivery data.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primiparous women who vaginally delivered singleton babies that eligible for trial were
        examined within 36 h of delivery
      
Keywords: levator avulsion; transperineal ultrasound; levator hiatus
Transcranial Brain Stimulation in Vegetative State Patients
Condition: Vegetative State; Minimally Conscious State
MeSH terms: Persistent Vegetative State
Study type: Interventional

Summary: 
      The aim of this study is to determine whether transcranial brain stimulations, such as
      repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current
      stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients
      in vegetative and minimally conscious state.
    


Intervention name(s): Transcranial direct current stimulation (tDCS); Repetitive Transcranial Magnetic Stimulation (rTMS); Transcranial Direct Current Stimulation (SHAM); Repetitive Transcranial Magnetic Stimulation (SHAM)
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex.; Frequency of stimulation: 10Hz. Interstimulus interval: 1 min. Number of stimuli per session: 300. Number of sessions per week: 4 Total number of stimuli: 1.200; The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off.; The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Autosomal Dominant Retinitis Pigmentosa: Prevalence of Known Genes Identification of New Loci / Genes
Condition: Autosomal Dominant Retinitis Pigmentosa
MeSH terms: Arthrogryposis; Retinitis; Retinitis Pigmentosa
Study type: Interventional

Summary: 
      Identify new genes responsible for autosomal dominant retinitis pigmentosa (ADRP), one of the
      most common causes of hereditary diseases of the retina, and thus better understand the
      mechanisms involved of the disease."
    

Detailed description: 
      Two hundred and fifty samples from unrelated patients, from which 150 were provided by the
      national reference center of rare disease in Montpellier and 100 recruited in the 9
      participating centers over a period of two years."To identify the missing genes, we proceed
      in two steps. A first step in selecting families negative for the 8 major genes genes, by
      systematic sequencing of exons most frequently involved. A second step in finding new loci /
      genes by locus exclusion using microsatellite markers and SNP genotyping.
    

Intervention name(s): genetic analysis
Intervention type(s): Genetic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Autosomal dominant retinitis pigmentosa; Rare disease; Genetics
Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium, Administered Add-on Therapy
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy and the tolerability of oral
      parnaparin sodium (210mg), administered in extended-release tablets identified as
      CB-01-05-MMX™.
    


Intervention name(s): Sigmoidoscopy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ulcerative colitis; Left-sided, mild to moderate ulcerative colitis
Incidence of Acute Lung Injury in Children
Condition: Acute Lung Injury; Children
MeSH terms: Lung Injury; Acute Lung Injury; Wounds and Injuries
Study type: Observational

Summary: 
      Acute lung injury in children is a syndrome of rapid onset of acute respiratory failure and
      require admission into intensive care units (ICU) for advanced life support. There are almost
      no information on epidemiology of acute lung injury. Published studies do not have
      information for an entire year and none of them have evaluated the degree of oxygenation
      failure under standard ventilator settings. The investigators will perform a 1-year
      prospective audit of all patients admitted with acute lung injury in a network of pediatric
      ICUs in Spain.
    

Detailed description: 
      We will evaluate oxygenation under standard ventilator settings (FiO2 0.5 and 1 on PEEP 5 or
      10 cmH2O) in pediatric acute respiratory distress syndrome.

      Outcome measures will include: overall ICU mortality, number of patients meeting ARDS
      criteria at 24 hours, and stratification of patients depending on PaO2/FiO2 ratio at 24 h of
      meeting acute respiratory distress syndrome criteria.
    

Intervention name(s): Evaluation oxygenation under standard ventilator settings
Intervention type(s): Other
Intervention description(s): Measure of PaO2 under standard FiO2-PEEP
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children from 1 month to 18 years old, admmitted into ICU, and meeting the
        American-European Consensus Conference definition for acute lung injury (ALI).
      
Keywords: acute lung injury; incidence; lung damage; PaO2/FiO2 ratio
A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Overweight; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose
      control and weight loss effects, as well as to further explore the safety profile of MEDI0382
    


Intervention name(s): MEDI0382 low dose; MEDI0382 mid dose; MEDI0382 high dose; Placebo; Liraglutide
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution Route of administration: subcutaneous; Pharmaceutical form: solution Route of administration: subcutaneous; Pharmaceutical form: solution Route of administration: subcutaneous; Pharmaceutical form: solution Route of administration: subcutaneous; Pharmaceutical form: solution Route of administration: subcutaneous
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, parallel, double-blind, placebo-controlled study with an open-label active comparator.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, and pharmacokinetics of telmisartan and amlodipine
      following single administration of 40 mg telmisartan/5 mg amlodipine and 80 mg telmisartan/5
      mg amlodipine, and subsequently, following multiple administration of 40 mg telmisartan/5 mg
      amlodipine and 80 mg telmisartan/5 mg amlodipine once daily for 10 days
    


Intervention name(s): Telmisartan low; Telmisartan high; amlodipine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Telmisartan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Overall Compliance and Duration of Zomacton® Treatment With the Zomajet® Needle-free Device
Condition: Turner's Syndrome; Human Growth Hormone Deficiency
MeSH terms: Turner Syndrome; Gonadal Dysgenesis
Study type: Observational

Summary: 
      The purpose of this strictly observational, prospective, longitudinal study is to evaluate
      with sufficient precision the rate of overall treatment compliance from one year to 3 years
      of follow-up of the patients.

      Somatotropin is indicated in the long-term treatment of children with growth retardation
      related to a deficiency in secretion of growth hormone and in the long-term treatment of
      growth retardation related to Turner's syndrome confirmed by chromosomal analysis. These are
      the two indications of Zomacton® 4 mg and 10 mg injection solution.

      The use of the Zomajet® needle-free device (Zomajet® 2 Vision, reserved for the
      administration of Zomacton® 4 mg or of the Zomajet® Vision X needle-free device, reserved for
      the administration of Zomacton® 10 mg), allows the product to be administered by percutaneous
      transjection (needle-free) and can be used by the child directly or by the family after an
      initial training.

      In April 2004, the CEPP (Commission for the Evaluation of Products and Services) requested a
      follow-up of the cohort of patients using the Zomajet® 2 Vision system measuring the
      compliance and duration of use of the device.

      The number of patients initiated on Zomacton treatment using the Zomajet® needle-free device
      is estimated to 30. Over a period of inclusion of 3 years, we therefore estimate that 90
      patients will be treated. In the cohort studied the patients will be followed-up for 1 year
      at least and for 3 years at the maximum.

      The rate of treatment compliance will be evaluated according to the ratio of the actual
      duration of administration over the total duration recommended by the physician during the
      observation period.
    


Intervention name(s): Somatropin
Intervention type(s): Drug
Intervention description(s): 4 mg or 10 mg delivered by needle-free device
Other intervention name(s): human growth hormone; Zomacton
Intervention MeSH terms: Hormones
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who meet the criteria of the Treatment Information Sheet (growth hormone
        deficiency or Turner's syndrome) for which treatment is initiated with Zomacton® 4 mg using
        the Zomajet® 2 Vision needle-free device or with Zomacton® 10 mg using the Zomajet® Vision
        X.
      
Keywords: Turner's syndrome; somatropin; human growth hormone deficiency
Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 study Comparing the effects on glucose control of MEDI0382 in combination with
      Dapagliflozin and Metformin compared to placebo in combination with Dapagliflozin and
      Metformin in overweight/obese participants with Type 2 Diabetes Mellitus (T2DM).
    

Detailed description: 
      This is an exploratory randomized, double-blind, placebo-controlled study to evaluate the
      efficacy and safety of MEDI0382 versus placebo in overweight/obese participants with T2DM
      treated with metformin and dapagliflozin dual therapy. The study will enroll participants
      with T2DM treated either with metformin monotherapy or with metformin and dapagliflozin dual
      therapy. After the screening period, participants treated with metformin monotherapy only
      will enter a 4-week run-in period where participants will be administered oral dapagliflozin
      10 mg a day, which will be provided by the sponsor. Enrolled participants that are already
      treated with metformin and dapagliflozin dual therapy will continue this dual therapy
      throughout the study and can be randomized after the screening period without entering the
      run-in period. All participants (ie, on monotherapy and dual therapy) entering the
      double-blind treatment period will receive dapagliflozin 10 mg a day, which will be provided
      by the sponsor.

      Participants in this study will participate for up to 20 weeks including a screening period
      of up to 60 days, a 4-week run-in period (for participants on metformin monotherapy only), a
      4-week treatment period, and a 4-week follow-up post-treatment period.
    

Intervention name(s): MEDI0382; Placebo; Dapaglifozin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous dose of MEDI0382 (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days).; Subcutaneous dose of placebo matched to MEDI0382.; Oral dose of dapaglifozin 10 mg tablet.; Oral dose of metformin tablet (maximum tolerated dose [MTD] > 1 g).
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Efficacy and Safety of MEDI0382 versus Placebo in Overweight/Obese Participants with Type 2 Diabetes Mellitus Treated with Dapagliflozin and Metformin
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 0382; T2DM
Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat
      content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR)
      index, and anthropometric measurements (body mass index and waist circumference)in
      non-diabetic subjects with non-alcoholic fatty liver disease.
    

Detailed description: 
      Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and
      malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver
      disease (NAFLD) is controversial.

      This randomized double blind clinical trial was performed in non-diabetic dyspeptic patients
      with positive antibody to HP and the evidence of fatty liver in ultrasonography. After
      excluding other causes, participants with persistent elevated serum aminotransferase levels
      were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and
      positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle
      modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy
      (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was
      performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting
      serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase,
      triglyceride, cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric
      measurements (body mass index and waist circumference) were checked at baseline and six weeks
      post-treatment.
    

Intervention name(s): H.pylori eradication
Intervention type(s): Drug
Intervention description(s): Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)
Other intervention name(s): H.pylori treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Steatohepatitis,; Helicobacter pylori,; Insulin resistance,; Alanine aminotransferase,; Aspartate aminotransferase,
A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy
Condition: Postoperative Pain; Opioid Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives:

      Primary objective:

        -  To demonstrate that the treatment with OXN PR tablets up to 72 hrs after surgery is
           superior to the treatment with OxyPR with regards to constipation in subjects with
           postoperative pain after laparoscopic hysterectomy based on interviews 24h, 72 h and 1
           week postoperatively.

      The secondary objectives:

        -  Analgesic effect (including registration during the first 24 hrs)

        -  To asses the frequency of pain rescue mediation use (in the double-blind phase, 0-72
           hrs)

        -  Frequency of nausea and vomiting

        -  Frequency of other adverse events

        -  Appetite

        -  Mobilization

      The exploratory objectives:

        -  Overall patient satisfaction at 24, 72 hrs and 1 week
    


Intervention name(s): naloxone; oxycodone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxycodone; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention