bioihbjkbjnl/mcl2 huggingface dataset:
Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization
Condition: Infertility; Endometritis; Abortion, Spontaneous
MeSH terms: Infertility; Abortion, Spontaneous; Abortion, Habitual; Endometritis
Study type: Observational

Summary: 
      Chronic endometritis is a persistent inflammation of the endometrium. Chronic endometritis is
      asymptomatic or little symptomatic. Sometimes, patient with chronic endometritis can have
      genital bleeding, pelvic chronic pain, pain during sexual relations, persistent vaginal white
      loosing. The hysteroscopy can detect the presence or absence of chronic endometritis.

      Some studies showed that the endometritis could have an impact on the embryo implantation and
      could explain recurrent miscarriages or repeated embryo implantation failures.

      The goal of this study is to evaluate the frequency of the chronic endometritis in patients
      with recurrent miscarriages or repeated embryo implantation failures
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population with recurrent miscarriage or repeated embryo implantation failures.
      
Keywords: In vitro fertilization; Hysteroscopy; Endometrial biopsy
Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the impact of an exercise programme organized into
      supervised walking groups on metabolic control, functional capacity and overall quantity of
      physical activity in subjects with type 2 diabetes.
    

Detailed description: 
      Regular, moderate-intensity physical activity can attenuate hyperglycemia in subjects with
      type 2 diabetes. In addition, these programmes may favourably affect several other
      cardiovascular risk factors in these subjects. However, it still remains unclear how this
      evidence can be transferred into clinical practice, considering the very large number of
      diabetic patients and the characteristics of this population, made up predominantly of
      elderly, sedentary and overweight patients. In this regard, a realistic approach to this
      issue requires simple and easily available intervention models.

      Walking is a typical mild-moderate aerobic physical activity which is easy to organize and
      does not require specific skills or preliminary sophisticated medical evaluations. This
      activity could therefore fit well with the need of involvement of large numbers of patients
      in different logistic situations. However, it has been reported that, due to the low walking
      speed typical of type 2 diabetic subjects, self-paced walking is inadequate to obtain a
      significant metabolic improvement in these subjects.
    

Intervention name(s): Supervised walking; Standard counselling procedure
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.; Verbal and written information about the benefits of exercise and instructions aimed to encourage physical activity. In addition, one group session of counselling on these issues.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise, Walking, Type 2 diabetes, Therapy
Pressure-limited Ventilation Versus Volume-targeted Ventilation in Term Newborns
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      A randomised controlled trial comparing volume-targeted ventilation to pressure-limited
      ventilation in infants born at or near term.
    

Detailed description: 
      Aims: There is increasing evidence that volume-targeted ventilation (VTV) holds benefits for
      preterm infants in comparison to pressure-limited ventilation. It is not known whether the
      same is true in the case of infants born at term. This study aims to compare pressure-limited
      to VTV in term-born infants.

      Hypothesis: Volume-targeted will be associated with significantly earlier extubation compared
      to pressure-limited ventilation Primary outcome: Time to extubation. Methods: Ventilated
      infants 34 weeks or more gestational age at birth were recruited and randomly allocated to
      receive either pressure-limited or VTV. Adjustments to ventilator settings were made
      according to the trial protocol. Infants were deemed to have met failure criteria if they
      required HFOV or peak pressures of more than 30 cm of water. Analysis will be by
      intention-to-treat.
    

Intervention name(s): Ventilation delivered by SLE5000 ventilator
Intervention type(s): Device
Intervention description(s): In pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination.
In volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neonatal; respiratory; mechanical ventilation
Single Dose Study to Evaluate the Safety, and Efficacy of S-1226 (8%) in Subjects With Mild Atopic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the safety and tolerability of a single dose of S-1226 (8%) in subjects with mild
      atopic asthma.
    

Detailed description: 
      Phase IIa, placebo-controlled, randomized, double-blind, crossover single dose study to
      evaluate the safety, tolerability and efficacy of S-1226 (8%) administered by nebulization in
      subjects with mild atopic asthma
    

Intervention name(s): S1226(8%); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The drug S1226(8%), consists of Perflubron (PFOB) and 8% CO2 delivered as an aerosol/vapour/gas mixture with a Circulaire nebulizer. The drug is administered as a single dose during the early phase asthmatic response for 2 minutes.; Normal saline nebulized with compressed medical air for 2 minutes during the early phase asthmatic response
Other intervention name(s): PFOB nebulized with 8% CO2 in medical gas mixture; normal saline nebulized with compressed medical air
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Chronic bronchitis; Cystic fibrosis; Bronchoconstriction; Perfluorocarbons; Carbon dioxide
'Real Life' Monitoring of COPD no ICS Patients
Condition: COPD
Study type: Observational

Summary: 
      The aim of the study will be to assess in patients with mild-to-moderate COPD the role of
      inflammation in the patient's therapeutic management and follow-up.
    

Detailed description: 
      Studies have already shown that the risk of severe exacerbations in patients with COPD is
      associated with eosinophilic inflammation (1) and that patients with this type of
      inflammation have an increased risk of exacerbations if ICS administration is discontinued
      (2), but this indication does not appear in the latest GOLD recommendations to date.

      The aim of the study will be to evaluate in patients with mild-to-moderate COPD the role of
      induced sputum and peripheral inflammation in the patient's therapeutic management and
      follow-up. For this purpose, the investigators will assess inflammation at the bronchial and
      systemic level by induced sputum and haemochrome at time 0 (recruitment), after 6,12, 18 and
      24 months after therapy administration according to the updated 2017 GOLD recommendations.
    

Intervention name(s): Therapy Change from Baseline
Intervention type(s): Other
Intervention description(s): The patient will be followed up from the point of view of therapy according to symptoms and flare-ups irrespective of systemic or peripheral eosinophil assessment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with COPD diagnosis in therapy with LABA or LAMA or LABA/LAMA
      
Biospecimen description: 
      induced sputum blood samples
Healthy Homes/Healthy Families
Condition: Chronic Diseases
MeSH terms: Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to learn how to make homes more supportive of healthy eating and
      physical activity. As part of the study, participants will be randomly assigned to one of two
      groups. One group will receive materials with information on healthy eating and physical
      activity. The materials will be mailed 3 times over a 5 month period. The other group will
      work with a coach to make their homes more supportive of healthy eating and physical
      activity. Working with a coach involves 3 home visits and 4 coaching telephone calls over a 5
      month period. This group will also receive materials by mail 4 different times. All
      participants will be asked to complete 7 telephone interviews over a 1 year period.
      Participants will also be asked to wear an accelerometer, a small portable device that tracks
      movement from physical activity, for 7 days at 2 different points in the study.
    


Intervention name(s): Healthy Homes/Healthy Families; Health Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the intervention group will work with coaches to make their homes more supportive of healthy eating and physical activity. Each intervention participant will receive a tailored home environment profile, and will select from a "menu" of healthy actions to make changes in their home. The intervention will be delivered over the course of 5 months, with 3 home visits, 4 coaching calls, and 4 support mailings.; Study participants in this group will receive health education materials by mail (3 times over the course of 5 months).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Efficacies of Antimicrobial Susceptibility-Guided Versus Empirical Therapy for Rescue Treatment of Helicobacter Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections; Disease Susceptibility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test
      guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then
      comparing it with 14-day empirical therapy according to personal medication history.
    

Detailed description: 
      Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been
      classified as the first risk factor of gastric cancer. Strong evidence supports that H.pylori
      eradication is an effective approach to reduce the incidence of those pathological processes.
      Antimicrobial susceptibility test can pick out sensitive drugs to kill H.pylori, and reduce
      secondary drug resistance. However, there is a lack of high quality RCT to evaluate its
      efficacy in the rescue treatment of Helicobacter infection.

      The investigator's study aims to assess the efficacy of 14-day antimicrobial susceptibility
      test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection.
      Then, comparing this regimen with 14-day empirical therapy according to personal medication
      history to tell which one is better in clinic practice.
    

Intervention name(s): two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline); one proton pump inhibitor, colloidal bismuth pectin; two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive a 14-day quadruple therapy for the H.pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.; All patients need these two drugs.; Patients will receive a 14-day quadruple therapy according to personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient hasn't been treated with levofloxacin previously, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone.
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Metronidazole; Clarithromycin; Levofloxacin; Ofloxacin; Tetracycline; Tinidazole; Antibiotics, Antitubercular; Furazolidone; Bismuth; Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antimicrobial Susceptibility Testing; Rescue Therapy
The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether oral cinnamon extract are effective in
      reducing insulin resistance parameters in women with polycystic ovary syndrome.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing
      age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming
      pregnant. The syndrome can also be associated with more serious conditions such as heart
      disease, diabetes, or cancer of the uterus.

      Although no one knows the cause of the syndrome, scientific studies showed that having too
      much insulin can be one of the reasons. In fact, almost every overweight woman with PCOS has
      been found to have high insulin levels.

      Medications that lower the body's insulin level used to treat people with diabetes mellitus
      have also been used very successfully to treat some of the symptoms of PCOS such as irregular
      periods.

      Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may
      also reduce the body's insulin level. Another study showed that daily use of cinnamon for
      forty days lowered the blood sugar level in patients with diabetes. The purpose of this study
      is to see if cinnamon can lower the insulin level in women with PCOS. If so, it can also be
      used as a treatment for irregular periods as well.

      Half of the patients in the study will take premade cinnamon extract pills twice a day while
      the other half will take placebo pills (pills with no cinnamon extract) twice a day for eight
      weeks. Blood tests measuring insulin, substances important for insulin action, cholesterol,
      and glucose (sugar) will be taken before and after the eight weeks of medication. A total of
      three separate visits will be needed to finish the study. At the end of the study, we will
      then compare the blood glucose, insulin, and cholesterol levels between the patients that
      took cinnamon and the patients that took placebo.
    

Intervention name(s): Oral Cinnamon Extract; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A purified aqueous abstract of cinnamon in a 500mg tablet will be taken by each patient before lunch and dinner, making a total of one gram per day for eight weeks.; Placebo pills in likeness of the cinnamon extract
Other intervention name(s): Cinnamon Extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: polycystic ovary syndrome; insulin resistance; cinnamon
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in
      inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the
      phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy
      (2 Gy x 33 F, 5 F per week).
    


Intervention name(s): Tarceva; Radiotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): Tarceva 150 mg/day; 66 Gy/33 F/5 F per week for 5 weeks
Intervention MeSH terms: Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung cancer; Non-small cell lung cancer; Tarceva; Radiotherapy; Local-regionally advanced non-small cell lung cancer
Risk Factors of Delirium in Sequential Sedation Patients in Intensive Care Unit
Condition: Delirium; Mechanical Ventilation; Sedation
MeSH terms: Delirium
Study type: Observational

Summary: 
      Delirium is one of main adverse events in ventilated patients who receive long-term usage of
      mono-sedative. Sequential sedation may reduce these adverse effects. This study aimed to
      evaluate incidence and risk factors for delirium in sequential sedation patients.
    

Detailed description: 
      Previous studies have showed that patients under mechanical ventilation have a higher risk
      for experiencing delirium than nonmechanically ventilated patients (20%-50%). Its occurrence
      is also more frequent in elder patients. More than that, it is often hard to identify
      delirium by physicians, leading to unreasonable management of ICU patients.

      And delirium is one of main adverse events in ventilated patients who receive long-term usage
      of mono-sedative. Sequential sedation may reduce these adverse effects.

      However, few present studies focus on delirium in sequential sedation patients. Thus, in this
      study, we aimed to determine the factors of delirium in patients who received sequential
      sedation in ICU.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients with an age greater than 18 years old and less than 80 years old, who were
        expected to receive mechanical ventilation longer than 72 hours and accepted sedation
        therapy were recruited on admission to the ICU.
A Study of Oral Seltorexant as an add-on Medication to an Antidepressant on On-road Driving Performance in Participants With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of seltorexant, compared to placebo, as an
      add-on medication to an antidepressant, on next-day driving performance as assessed by the
      mean difference of standard deviation of lateral position (SDLP) from an on-road driving test
      in participants with major depressive disorder (MDD).
    


Intervention name(s): Seltorexant Dose 1; Seltorexant Dose 2; Placebo; Zopiclone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive Dose 1 of seltorexant OD from Day 1 to Day 8 as part of Treatment A as per assigned treatment sequence.; Participants will receive Dose 2 of seltorexant OD from Day 1 to Day 8 as part of Treatment D as per assigned treatment sequence.; Participants will receive placebo of seltorexant OD from Day 1 to Day 8 as a part of Treatment A and C and from Day 2 and Day 7 as a part of Treatment B as per assigned treatment sequence.; Participants will receive Dose 3 of zopiclone OD from Day 1 to Day 8 as a part of Treatment B as per assigned treatment sequence.
Other intervention name(s): JNJ-42847922; JNJ-42847922
Intervention MeSH terms: Zopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients
Condition: Erythemato-telangiectatic Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of
      treatment as compared to an active control and vehicle in patients with
      erythemato-telangiectatic rosacea.
    


Intervention name(s): BFH772 1% ointment; Vehicle ointment; Noritate® 1% cream
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BFH772; rosacea; erythemato-telangiectatic rosacea
The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated.
      Blood samples for s-clozapine monitoring should be drawn 12 hours post dose.

      The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine
      within the range of 10-14 hours after the last administration of clozapine .
    

Detailed description: 
      Several factors can influence s-clozapine and thereby the occurence of dose-related adverse
      reactions and level of treatment response. The role of Therapeutic Drug Monitoring (TDM) in
      clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring are
      recommended to be drawn 12 hours post dose. Uncertainty regarding the timing of blood
      sampling and the individual pharmakokinetics for clozapine +/- 2 hours from the 12-hour
      timepoint, leads to uncertainty regarding the comparability of serum concentrations and the
      information hold within them.

      The scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine
      within the range of 10-14 hours after the last administration of clozapine .

      In addition we want to investigate if any of the following covariates might affect the change
      of s-clozapine and s-N-desmethyl-clozapine: Sex, age, BMI, co-medications, signs of
      infection, caffeine intake and smoking.
    

Intervention name(s): Blood sampling; Clozapine
Intervention type(s): Procedure; Drug
Intervention description(s): blood samples for s-clozapine and s-desmethyl-clozapine analysis are collected at 10, 11, 12, 13 and 14 hours post evening-clozapine-administration; Registration of the exact time of drug administration. Also postponement of any morning clozapine administration until ended blood sampling.
Other intervention name(s): Leponex
Intervention MeSH terms: Clozapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Schizophrenia, Clozapine, TDM, Serum Concentration