bioihbjkbjnl/mcl2 huggingface dataset:
Microbiome and Endometrial Receptivity in Obese Infertile Women
Condition: Endometrial Receptivity
MeSH terms: Infertility
Study type: Observational [Patient Registry]

Summary: 
      The objective of this project is the identification and quantification of the main bacterial
      communities present in the endometrial microbiota in obese infertile patients, to assess if
      there is an alteration of their composition dependent on the body mass index, and if such
      alteration it could influence the reduction of endometrial receptivity, demonstrated in obese
      women. If obese patients have an altered digestive microbiota and, at the same time, a lower
      endometrial receptivity, the investigator want to assess whether such reduction in
      receptivity may depend on an alteration in the endometrial microbiota, which in non-obese
      infertile patients has been shown to negatively influence the reproductive results
    

Detailed description: 
      The main objective of our study is to compare the composition of the endometrial microbiota
      between patients with normal weight and patients with obesity.

      A. Secondary Objectives/research questions

        -  To analyze the composition of the digestive microbiota through samples of saliva and
           feces in infertile patients with normal weight and obesity.

        -  To assess whether there is a relationship between the body mass index (normal weight,
           obesity Class I, Class II, Class III) and the main bacterial species detected in
           endometrial fluid samples from infertile patients.

        -  To evaluate the influence of the digestive microbiota on the composition of the
           endometrial microbiota according to the body mass index in infertile patients.

        -  To evaluate if there is an influence of the endometrial microbiota on the results of
           endometrial receptivity analyzed with the non-invasive Endometrial Receptivity Array
           test (niERA)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile patients with normal weight (BMI: between 18.50 and 29.99) and obesity (Class I:
        BMI between 30 and 34.99 Kg / m2, Class II: BMI between 35 and 39.99 Kg / m2, Class III:
        BMI> 40 Kg / m2) subjected to Hormonal Replacement Therapy (HRT).
      
Biospecimen description: 
      Samples of saliva, feces and endometrial fluid.
    
Keywords: Endometrial microbiome; Obesity; Bacterial pathogens; Dysbiosis; Endometrial receptivity
Safety and Efficacy of Fentanyl Citrate in Children
Condition: Children
Study type: Interventional
Phase: Phase 2

Summary: 
      Title: Safety and efficacy of fentanyl citrate in combination with midazolam in critically
      ill children with mechanical ventilation

      Objective: To evaluate the safety and efficacy of fentanyl citrate in combination with
      midazolam in children with mechanical ventilation.

      Design: Double-blind randomized controlled study

      Patients: Patients age 2 months through 18 years who are admitted in Seoul National
      University Hospital pediatric intensive care unit, and applied with mechanical ventilation.

      Interventions: After enrollment of patient, blind reagent (fentanyl citrate or normal saline)
      is prepared by assigned pharmacist. Investigators, caregivers, patient, and parents of the
      patient don't know whether the blind reagent is fentanyl citrate or not, but only preparing
      pharmacist knows that.

      Protocol: All enrolled patients receive continuous infusion of midazolam and blind reagent.
      The start time of study is when the continuous infusion of midazolam and blind reagent are
      begun. Assigned research nurse check Comfort behavior scale of the patient every hour
      regularly, and whenever the patient seem to be overactive. Endpoint of the study is 48 hours
      after begining. If there is any adverse effect or unexpected event, however, the study can be
      early terminated.
    

Detailed description: 
      Comfort behavior scale consists of 7 components of alertness, calmness, respiratory response,
      crying, physical movement, muscle tone, and facial tension. Because intubated patients cannot
      be evaluated 'crying', however, we use 6 components among total of all 7 components, except
      'crying'.

      Adverse effect of fentanyl include hypotension, coma, and ileus. Unexpected event means the
      situation which study cannot last in, such as withdrawal of consent, necessity of drugs which
      can affect the level of consciousness of the patient, emergent interventional procedure, etc.
    

Intervention name(s): midazolam and fentanyl citrate infusion; midazolam and normal saline infusion
Intervention type(s): Drug; Drug
Intervention description(s): comparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care; comparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care
Other intervention name(s): midazolam injection; fentanyl citrate injection; midazolam injection
Intervention MeSH terms: Midazolam; Fentanyl; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Mechanical Ventilation; Sedation; Fentanyl; Midazolam; Comfort behavior scale
Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fed condition in normal,
      healthy, adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Bisoprolol Fumarate Tablet 10 mg of Ipca Laboratories Limited, India and the corresponding
      Reference Product: Zebeta® (Bisoprolol Fumarate) Tablets 10 mg of Duramed Pharmaceuticals
      Inc., USA under fed condition in normal, healthy, adult, human subjects in a randomized
      crossover study.

      The study was conducted with 24 healthy adult subjects. In each study period, a single 10 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 15 days including washout period of at
      least 10 days between administrations of study drug in each study period.
    

Intervention name(s): Bisoprolol Fumarate Tablet 10 mg; Bisoprolol
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg tablet once a day; 10 mg tablet once a day
Other intervention name(s): Test Product; Zebeta®
Intervention MeSH terms: Bisoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders; Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the
      migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of
      migraine.
    


Intervention name(s): eletriptan
Intervention type(s): Drug
Intervention MeSH terms: Eletriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability DS-1971a Suspension and Tablets and Food Effect on DS-1971a Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, 3 treatment, 3 period crossover study. This study is
      designed to assess the relative bioavailability of DS 1971a from a tablet formulation and a
      reconstituted oral suspension and the effect of a high fat meal on the relative
      bioavailability of DS 1971a from the tablet formulation.
    


Intervention name(s): DS-1971a suspension; DS-1971a tablet
Intervention type(s): Drug; Drug
Intervention description(s): DS 1971a will be supplied as a powder or crystals and prepared at the study site for administration as an oral suspension with a taste masking agent.; A 200 mg DS 1971a tablet for oral administration
Intervention MeSH terms: DS-1971a
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics
Dual and Single Switching Monopolar RFA Using Separable Clustered Electrode for Treatment of HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      This study was conducted to prospectively compare the efficacy, safety and mid-term outcomes
      of dual-switching monopolar (DSM) radiofrequency ablation (RFA) with those of conventional
      single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).
    

Detailed description: 
      Recently, dual switching monopolar RFA (DSM-RFA) was developed to enhance further the
      efficiency of the single switching monopolar RFA (SSM-RFA) in creating ablation zone; Yoon et
      al. reported that DSM-RFA allowed significantly greater RF energy delivery to target tissue
      per given time, and then, created significantly larger ablation zone than the SSM-RFA in ex
      vivo and in vivo animal experiments. A retrospective comparative study by Choi et al.
      reported that the DSM-RFA created significantly larger ablation volume than, but seemed to
      show similar LTP rate to the SSM-RFA. Still, whether the physical differences between SSM-RFA
      and DSM-RFA translate into better clinical outcomes remains an open question. Regarding that
      the choice of equipment is an essential factor to consider in planning image-guided tumor
      ablation procedure, we thought that the prospective comparison between DSM-RFA and the
      SSM-RFA would be helpful for improving results of RFA.

      Therefore, the purpose of this study was to prospectively compare the efficacy, safety and
      mid-term outcomes of DSM-RFA with those of conventional SSM-RFA in the treatment of HCC.
    

Intervention name(s): DSM; SSM; Separable clustered electrodes
Intervention type(s): Device; Device; Device
Intervention description(s): Monopolar RFA using dual switching mode (DSM); Monopolar RFA using single switching mode (SSM); A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.
Other intervention name(s): Octopus®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RFA
Mastoid Bone Autograft for Dorsal Nasal Augmentation
Condition: Nose Deformities, Acquired
MeSH terms: Nose Deformities, Acquired
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of mastoid bone autograft
      for dorsal nasal augmentation in rhinoplasty.
    

Detailed description: 
      INTRODUCTION: Several grafts and/or implants have been used for dorsal augmentation. In some
      cases, especially the traumatic, non-caucasian, and multi-operated ones, the amount of
      augmentation is higher than the usually available from septal and auricular conchal
      autografts.

      OBJECTIVE: To evaluate the safety and efficacy of mastoid bone autograft for dorsal nasal
      augmentation in rhinoplasty.

      DESIGN: A prospective study of 15 consecutive patients submitted to dorsal nasal augmentation
      with mastoid bone, during a 2-year period.

      SETTING: One major academic medical center.
    

Intervention name(s): Rhinoplasty
Intervention type(s): Procedure
Intervention description(s): Mastoid bone autograft for dorsal nasal augmentation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nasal acquired diseases; Nasal congenital diseases; Rhinoplasty; Grafts
Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs
Condition: Migraine
MeSH terms: Hyperacusis; Hyperalgesia
Study type: Observational

Summary: 
      Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has
      been noted in several studies that in patients with migraine, seventy nine percent of the
      patients experienced allodynia on the facial skin on the same side as the headache.
      Understanding more about the occurrence of phonophobia (increased sensitivity to sound) and
      allodynia may help us understand how the pain system works in migraine. It is hoped that the
      knowledge gained from this trial may enable us to more effectively treat patients with
      migraine headache.
    


Intervention name(s): Sounds
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult women and men with a diagnosis of episodic migraine
Cisplatin or Carboplatin and Sorafenib in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth and by blocking blood flow to the tumor. Infusing chemotherapy directly into
      the liver and giving it together with sorafenib may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects of infusing cisplatin or
      carboplatin directly into the liver and giving it together with sorafenib in treating
      patients with liver cancer that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the safety of intrahepatic arterial infusion of cisplatin or carboplatin in
           combination with sorafenib tosylate in patients with unresectable hepatocellular
           carcinoma.

      Secondary

        -  To assess the time to tumor progression in patients treated with this regimen.

        -  To assess the overall and progression-free survival of patients treated with this
           regimen.

      OUTLINE: Patients receive intrahepatic arterial infusion of cisplatin or carboplatin over
      30-45 minutes on day 1 and oral sorafenib tosylate twice daily on days 8-35. Treatment
      repeats every 42 days for up to 12 courses in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed periodically.
    

Intervention name(s): Carboplatin; Cisplatin; Sorafenib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.; Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.; Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Intervention MeSH terms: Carboplatin; Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; advanced adult primary liver cancer
Factors Influencing Pediatric Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple
      physiologic, environmental and social conditions impact the prevalence and severity of
      asthma. Even when diagnosed, effective control can be impeded by improper use of medication,
      not understanding or being unable to avoid environmental triggers, lack of continuity in
      follow-up care, and lack of an asthma action plan. American Indians are especially at-risk
      for health problems related to asthma. American Indians have the highest asthma rate among
      single-race groups; 18.5% of American Indians are diagnosed with asthma, while only 11% are
      diagnosed with asthma in the general population but little is known about why this is true.
      Asthma is a prototypic example of the interaction of biologic, environmental and psychosocial
      influences on disease and this study investigated the possible improvement in asthma control
      from an intensive educational intervention.
    

Detailed description: 
      The primary aim of this study was to test the hypothesis that intensive patient education
      regarding self-directed, stepped care will result in reduced morbidity and medical care
      utilization, while increasing quality of life.

      One half (54) of the identified cases will be randomized to receive the previously
      established "BREATHE" study educational program, emphasizing patient-centered, self
      management of asthma. Periodic follow-up through personal contact and surveillance of IHS
      RPMS or other medical provider records was conducted.
    

Intervention name(s): Intensive Asthma Education
Intervention type(s): Behavioral
Intervention description(s): One half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: asthma; pediatric; american indian; children
Study to Investigate Efficacy and Safety of a New Oral Contraceptive
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic
      preparation in the prevention of pregnancies in a large group of volunteers.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): EV/DNG (Qlaira, BAY86-5027, SH T00658K)
Intervention type(s): Drug
Intervention description(s): per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
Condition: B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, non-randomized clinical study to evaluate the safety and efficacy of
      C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.
    

Detailed description: 
      This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066.
      Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.

      The study will include the following sequential phases: Screening, Pre- Treatment (Cell
      Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.
    

Intervention name(s): CD20-directed CAR-T cells
Intervention type(s): Biological
Intervention description(s): Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously
Other intervention name(s): C-CAR066
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B cell lymphoma received prior CD19 CAR-T therapy
The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg
      or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the
      pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were
      assessed. Blood samples were collected for the analysis of the effect of secukinumab and
      canakinumab on select biomarkers.
    


Intervention name(s): Secukinumab 10 mg/kg; Canakinumab 10 mg/kg; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Secukinumab was prepared in a sterile water solution.; Canakinumab was prepared in a sterile water solution.; The placebo solution for infusion contained 5% glucose.
Other intervention name(s): AIN457; ACZ885
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dry eye; IL17/ IL-1β; Biologic