bioihbjkbjnl/mcl2 huggingface dataset:
Dual Therapy With High Doses of Ilaprazole and Amoxicillin for Helicobacter Pylori Infection
Condition: Helicobacter Infections
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study assessed eradication rate of dual therapy with high doses of Ilaprazole 40mg BID
      and Amoxicillin 750mg QID for 14 days on Helicobacter pylori infection.
    

Detailed description: 
      The study performed to assess the eradication rate of H.pylori after 14 days treatment. The
      treatment is defined as those participants who confirmed on gastric or duodenal ulcer
      (including scar stage) or gastritis by endoscopy or the participants who received endoscopic
      treamtment for gastric polyp, gastric adenocarcinoma, confirmed to be H.pylori positive
      patients by the Biopsy or CLO test or Serological Diagnosis.

      Patients administered Ilaprazole 40mg BID and Amoxicillin 750mg QID for 14days. The
      eradication rate on High dose dual therapy assessed by UBT test at Day 49±7.
    

Intervention name(s): Ilaprazole + Amoxicillin
Intervention type(s): Drug
Intervention description(s): Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule
Other intervention name(s): Ilaprazole; Amoxicillin
Intervention MeSH terms: Amoxicillin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: helicobacter pylori; ilaprazole; eradication; dual therapy; high dose therapy
Pediatric Glittre ADL-test in Children With Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Observational

Summary: 
      The aim of the study is to investigate reliability, validity, of the Glittre ADL Test in
      children with Asthma.
    

Detailed description: 
      The TGlittre-P is an adaptation of the TGlittre test for pediatric patients. It consists of
      completing a circuit while carrying a backpack with a variable weight of 0.5 kg to 2.5 kg,
      according to the child´s age and sex. This weight range follows the guidelines of the World
      Health Organization, which states that the younger the female child is, the lighter the
      backpack should be, in order to assure the school children´s health condition. The following
      tasks should be carried out; from a sitting position, the child stands up and walks along a
      10m-long flat course, going up and down a 2-step rise (17 cm high x 27 cm wide) about halfway
      along that distance, to reach a bookshelf with three 0.5 kg objects (i.e. colorful plastic
      bowling pins filled with sand). The objects are placed on the top shelf at eye level, which
      should be removed, one by one, to the lower shelf at the level of the umbilicus, and then to
      the ground. Next, the objects should be placed on the lower shelf and then back to the top
      shelf. The child walks back along the same route. (S)he sits down, stands up and immediately
      starts the next lap. The following verbal instructions are given during the test: "sit" and
      "stand." The time required to walk five laps is registered; the less the time spent, the
      better the performance is. The test performance was evaluated by comparing the patient´s data
      with the data predicted by the equation, in his study with healthy children. The equation for
      girls is "time in TGlittre-P = 3.781-0.083 x AGE"; and boys, "time in TGlittre-P =
      4.025-0.123 x AGE".
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children with asthma who apply to Gazi University, Department of Physiotherapy and
        Rehabilitation will be invited to this study.
      
Keywords: Daily Living Activities; Exercise
Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study were to analyze the immunogenicity and reactogenicity of
      DTP/HB/Hib (Bio Farma) combination vaccine.
    

Detailed description: 
      This trial was randomized, double blind, prospective intervention and multi centers. Total
      600 subject (6-11 weeks of ages) followed this trial, divided into 3 groups, each group
      consists of 200 subjects. A number of 342 subjects were recruited in Bandung, while 258
      subjects were recruited in Jakarta.
    

Intervention name(s): DTP/HB/Hib Vaccine
Intervention type(s): Biological
Intervention description(s): DPT/HB/Hib vaccine (Bio Farma)
Other intervention name(s): Pentavalent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Combined pentavalent DTP/HB/Hib vaccine; Infants; Primary vaccination
Effect of a Commonly Used Antibiotic, Doxycycline, in Women With Polycystic Ovarian Syndrome
Condition: Polycystic Ovarian Syndrome (PCOS); Irregular Menstrual Cycles; Androgen Excess
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline,
      on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian
      Syndrome (PCOS).
    

Detailed description: 
      Polycystic ovarian syndrome (PCOS) is one of the leading causes of female infertility,
      affecting 5-10% of reproductive-age women . This heterogeneous disorder is characterized by
      anovulatory infertility, androgen excess, an increase in the ratio of LH to FSH, and
      morphologic polycystic changes to the ovaries. Obesity and insulin resistance are also
      metabolic factors associated with PCOS that further increase the morbidity in these patients.
      Inducing fertility in patients with PCOS can be a challenge, as it most often involves
      ovulation induction that can lead to ovarian enlargement, hyperstimulation, and
      multiple-birth pregnancies. This study is designed to determine novel effective strategies to
      promote normal cycling in this patient population.
    

Intervention name(s): doxycycline; Sugar Pill
Intervention type(s): Drug; Other
Intervention description(s): 200mg/day in divided doses of 100mg twice daily; 1 pill twice a day
Other intervention name(s): Placebo
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic Ovarian Syndrome; Irregular Menstrual Cycles; Androgen Excess in Women
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Data suggest that intestinal microbiota might be critically involved both in autoimmunity and
      in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch
      (HAMS-AB) that increases beneficial short chain fatty acid (SCFA) production has been safe
      and effective in disease prevention in mouse type 1 diabetes (T1D) models. The objective of
      this application is to assess the effect of administering a prebiotic, such as HAMS- AB, on
      the gut microbiome profile, glycemia and β-cell function in humans with T1D.
    

Detailed description: 
      This is a pilot, single center clinical trial to evaluate the effect of using the prebiotic,
      HAMS-AB, on the gut microbiome profile, glycemia and β-cell function in children and
      adolescents ages 12-16 years with recently diagnosed type 1 diabetes.

      Approximately 12 participants will be randomized first to take the supplement or follow a
      diabetic diet for 4 weeks and then cross-over after a 4 week washout period.

      The primary objective is to determine the effect of using the prebiotic on the gut microbiome
      profile in youth with T1D.

      The secondary objectives are to determine the effect of using the prebiotic on SCFA
      production, glycemia and β-cell health and function.

      Exploratory outcomes include changes in MAIT cells.
    

Intervention name(s): Acetylated and Butyrylated High Amylose Maize Starch
Intervention type(s): Drug
Intervention description(s): Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner
Other intervention name(s): Hylon™ VII Butyrate, Hylon™ VII Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pembrolizumab Activity in Patients With Homologous Recombination Competent and Deficient Tumors
Condition: Solid Tumor, Adult
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II trial in which patients with metastatic solid tumors experiencing progression after
      first line standard chemotherapy or for which there is no standard chemotherapy, and for
      which pembrolizumab does not have an FDA or compendia listing approved indication, will
      receive pembrolizumab intravenously at a dose of 200 mg every 3 weeks.
    

Detailed description: 
      Patients with metastatic or recurrent solid malignancy who have progressed on first line
      standard of care treatment or for which defined standard of care does not exist or is not
      readily available are eligible to participate on this trial. Patients for which pembrolizumab
      has an FDA approved indication and for whom pembrolizumab is covered by their insurance
      should receive standard commercial pembrolizumab and will not be eligible for this trial.

      The primary objective of this trial is to evaluate the Immune-Related Objective Response Rate
      (IR-ORR) achieved with pembrolizumab in patients with Fanconi Anemia Repair Pathway
      functionally competent and functionally deficient tumors.

      Trial treatment should be administered on Day 1 of each cycle after all
      procedures/assessments have been completed. Trial treatment may be administered up to 3 days
      before or after the scheduled Day 1 of each cycle due to administrative reasons.

      All trial treatments will be administered on an outpatient basis.

      Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Target
      infusion timing is 30 minutes.

      Expansion Cohort:

      Ten (10) additional subjects with the diagnosis of metastatic or recurrent endometrial
      carcinoma will be enrolled in the trial at the conclusion of regular enrollment.
    

Intervention name(s): Pembrolizumab 200 mg Q3W
Intervention type(s): Drug
Intervention description(s): Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
Other intervention name(s): Pembrolizumab 200 mg
Intervention MeSH terms: Pembrolizumab
Intervention model: Single Group Assignment
Intervention model description: Eligible participants will receive pembrolizumab intravenously at a dose of 200 mg every 3 weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solid tumor, Pembrolizumab,
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment
Condition: Breast Abnormalities
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in
      combination with full field digital mammography (FFDM) has the potential to reduce
      significantly baseline screening recall rates without a loss in the detection of cancers. The
      primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline
      screening mammography recall rates in negative examinations by at least 20%.
    

Detailed description: 
      The FFDM images and the FFDM images with the DBT images will be interpreted independently by
      two experienced radiologists under standard clinical screening procedures. Recommended recall
      rates will be assessed and compared as a result of each of the two interpretations.
    

Intervention name(s): tomosynthesis and screening mammography
Intervention type(s): Device
Intervention description(s): All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.
Other intervention name(s): digital breast tomosynthesis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: digital breast tomosynthesis; baseline screening mammography; recall rates
Magnetoencephalography (MEG), Attention and Conscience
Condition: Change in Sustained Attention; Awareness; Reaction Time
Study type: Observational

Summary: 
      The tight relationship between attention and conscious perception makes them difficult to
      study in isolation and has led many scientists to closely link these two processes. However,
      while some authors argue that conscious perception cannot occurs without attention,
      magnetoencephalography (MEG) and fMRI studies had shown that attention and consciousness are
      two distinct brain processes.

      If endogenously triggered attention and consciousness are dissociated, it has been proposed
      that orienting of exogenous attention is a necessary, though not sufficient, antecedent of
      conscious perception.

      In the present study we used MEG to explore the neural correlates of exogenous attention and
      consciousness during visual processing.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Young adults living in Paris or around fulfilling the eligibility criteria
Memantine and Naltrexone Treatment for Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor
      antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified
      heroin-dependent individuals.
    

Detailed description: 
      The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA
      receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent
      individuals maintained on naltrexone.

      This double-blind, 12-week trial will include heroin-dependent patients who completed
      detoxification. Participants will be randomly assigned to one of three conditions: naltrexone
      and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid).
      Naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be
      taken at home. In addition, twice each week patients will receive a psychosocial intervention
      that will include motivational interviewing and cognitive-behavioral relapse prevention. The
      goal of the psychosocial intervention is to improve compliance with medication and maintain
      abstinence. Baseline assessments will be taken and compared to those completed at study
      visits, which will occur 3 times each week.
    

Intervention name(s): Memantine; Naltrexone
Intervention type(s): Drug; Drug
Intervention description(s): One arm receives 30 mg bid and the other arm receives receives 15mg bid; Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
Intervention MeSH terms: Naltrexone; Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heroin; Opiates; naltrexone; memantine
Check Brain Temp Trial
Condition: the Focus of the Clinical Trial is on the Brain Temperatures in Normal Human Subjects
Study type: Observational

Summary: 
      Despite some controversial results, many patients and animal studies have suggested
      significant benefit of using hypothermia treatment in stroke patient population. However,
      certain questions for how to applying this therapy properly such as when to start, what is
      the optimal temperature, how long is the duration, and what is the best hypothermia
      technology that may avoid the complications including focal soft tissue injuries are still
      remain questioned.

      In this study, we will utilize the linear relationship of temperature vs. chemical shift in
      MR Spectroscopy to measure the brain temperatures in normal men.
    

Detailed description: 
      Brain temperature has an interactive relationship with brain cell metabolism. Hypothermia is
      a known neuronal protectant therapy. It has been proven to be effective in reducing the brain
      injury in patients post cardiac arrest. However, the role of hypothermia in brain or spinal
      cord injury such as in either hemorrhagic or ischemic condition remains unclear. Many
      questions on hypothermia are unanswered. For example, what is the optimal low temperature in
      order to have the maximum therapeutic effect? How long should hypothermia be applied for? Is
      there a regional temperature difference between different parts of brain in physiological or
      pathological conditions? In order to answer these questions, the first step is to have a
      reliable way of measuring brain temperature accurately. However, invasive technique such as
      inserting temperature probe to different parts of brain is not practical. Using body core
      temperature to estimate the intracranial temperature is inaccurate.

      To establish a noninvasive means to obtain and monitor brain temperature in a dynamic
      environment is the essential step in order to studying hypothermia and answering the
      questions mentioned earlier. MRI brain thermometry is a fast, direct and non-invasive method
      to estimate the brain temperature with great accuracy. This technique is based on several
      temperature dependent physical properties in our brain such as chemical shift between
      metabolites and water. Currently, there is no standard MRI brain thermometry in physiological
      and pathological conditions such as stroke. We plan to explore and establish MRI brain
      thermometry. The first step is to establish temperature correlation on measured water
      temperature.

      Then temperature of different regions of brain will be used to compare to the standardized
      water temperature in normal people.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        normal and healthy Men
      
Keywords: MR Thermometry; Human brain temperature; MR spectroscopy; normal brain
12-Week Study of Pristiq (Desvenlafaxine) Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the
      symptoms of Generalized Social Anxiety Disorder (SAD).
    

Detailed description: 
      Social Anxiety Disorder (SAD) is recognized as a prevalent, chronic and disabling condition.
      Lifetime prevalence has been estimated at 13% in the National Comorbidity Survey. There is
      good reason to think that Pristiq® would be effective in Social Anxiety Disorder. Effexor XR,
      which is mechanistically similar to Pristiq®, was found effective for subjects with
      Generalized Social Anxiety Disorder in all five of the placebo controlled trials in which it
      was studied.
    

Intervention name(s): Pristiq; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Flexible dose, 50-100mg QD, for 12 weeks.; Matching placebo, taken QD for 12 weeks.
Other intervention name(s): desvenlafaxine
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; Social Phobia; SAD
Simvastatin and Metformin in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This randomized controlled clinical trial compares efficacy of 1.2% simvastatin with 1%
      metformin in chronic periodontitis subjects.
    

Detailed description: 
      Aim: To compare the efficacy of locally delivered 1.2% SMV gel and 1% MF gel in treatment of
      intrabony defects in chronic periodontitis subjects and compare it with placebo gel.

      Methods: Ninety subjects were categorized into three treatment groups: 1.2% Simvastatin
      (SMV), 1% Metformin (MF) and placebo gel after Scaling and root planning (SRP). Clinical
      parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI),
      modified sulcus bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment
      level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth
      reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided
      software

      Results: Mean PPD reduction and mean CAL gain was found to greater in SMV group than MF and
      placebo group at all visits. The DDR% was greater in SMV group as compared to MF and placebo
      group.

      Conclusion: There was greater decrease in mSBI and PPD and more CAL gain with significant IBD
      depth reduction at the sites treated with SMV and MF as an adjunct to SRP in chronic
      periodontitis subjects with intrabony defects as compared to placebo. The effect was greater
      in case of SMV group, however there was no significant defect depth reduction as compared to
      MF.
    

Intervention name(s): Placebo gel; 1% Metformin; 1.2% Simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.; 1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.; 1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
Other intervention name(s): Placebo group; 1% Metformin group; 1.2% Simvastatin group
Intervention MeSH terms: Metformin; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Simvastatin, Metformin, Chronic periodontitis
Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the acceptance range with which two
      Symbicort Turbohaler batches could be declared bioequivalent in a bioequivalence setting. The
      secondary objective is to compare pharmacokinetic parameters of the reference product batches
      and Budesonide/formoterol Easyhaler.
    


Intervention name(s): Symbicort Turbohaler; Budesonide/formoterol Easyhaler
Intervention type(s): Drug; Drug
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment