bioihbjkbjnl/mcl2 huggingface dataset:
Identification of Microbial DNA in Maternal Plasma After PPROM
Condition: Preterm Rupture of Membranes
MeSH terms: Premature Birth; Fetal Membranes, Premature Rupture; Rupture
Study type: Observational

Summary: 
      This study evaluates the use of metagenomic next generation sequencing in identifying
      microbial DNA in plasma samples of patients with preterm premature rupture of membranes.
    

Detailed description: 
      Although preterm premature rupture of membranes (PPROM) occurs in only 3% of pregnancies, it
      accounts for 30% of preterm births (PTB) and is associated with serious maternal and neonatal
      morbidity. An important factor in the underlying pathophysiology of PPROM and subsequent PTB
      is subclinical infection, which promotes a cascade of events that contribute to synthesis of
      prostaglandins, release of proinflammatory cytokines, infiltration of neutrophils, and
      activation of metalloproteases. Over time, enhanced activity of these infectious and
      inflammatory pathways contributes to the development of spontaneous labor and/or overt
      intraamniotic infection (IAI). Unfortunately, the majority of patients with PPROM do not
      manifest signs and symptoms of infection that are detectable by clinical examination,
      laboratory evaluation, and traditional microdiagnostic tests, and attempting to predict
      length of latency period and/or timing of delivery remains a clinical challenge. We propose
      the use of metagenomic next-generation sequencing (mNGS) to identify microbial DNA in
      maternal plasma following PPROM. We hypothesize that the presence and abundance of microbial
      DNA is associated with a shorter latency period and that an increase in the abundance of
      microbial DNA precedes delivery.
    

Intervention name(s): mNGS
Intervention type(s): Diagnostic Test
Intervention description(s): Metagenomic next generation sequencing for microbial DNA
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant patients with preterm premature rupture of membranes and gestational-age-matched
        controls
      
Biospecimen description: 
      Maternal plasma
The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients
Condition: Systemic Lupus Erythematosus; Arthritic Psoriasis; Psoriasis; Inflammatory Bowel Diseases
MeSH terms: Arthritis, Psoriatic; Inflammatory Bowel Diseases; Psoriasis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of BMS-986165 in combination with an
      oral contraceptive in healthy female patients.
    


Intervention name(s): BMS-986165; Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of specified dose on specified days; Oral Contraceptive
Intervention MeSH terms: Deucravacitinib; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Estradiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Can we Improve Preoxygenation by Using Adjustable Pressure Limiting Valve (APL) ?
Condition: Preoxygenation
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of setting airway pressure release valve
      (APL valve) on the anesthesia workstation to 5 cmH2O during spontaneous breathing on
      preoxygenation. In this prospective study healthy volunteers are randomized in cross-over
      between spontaneous breathing with the APL valve on spontaneous position or spontaneous
      breathing with the APL valve on 5 cmH2O or CPAP (continous positive airway pressure) mode
      with 5 cmH2O PEEP (positive end expiratory pressure).
    

Detailed description: 
      There are several methods to improve preoxygenation but most of them require advanced
      anesthesia workstations. Therefore the investigators planned an an experimental study on
      healthy volunteers to investigate the effects of a simple method on preoxygenation.

      Healthy volunteers are randomized in cross-over between spontaneous breathing with the APL
      valve on spontaneous position or spontaneous breathing with the APL valve on 5 cmH2O or CPAP
      mode with 5 cmH2O PEEP.

      The volunteers will breath through an anesthesia face mask. The fresh gas flow rate is 12
      L/min, inspiratory fraction of oxygen is 100%. The exhaled gas (oxygen and carbon dioxide)
      are monitored. The inspiratory and end expiratory fraction of oxygen will be recorded every
      10 seconds.

      The primary endpoint is the time to achieve end expiratory fraction of oxygen of 90% or
      more.The secondary endpoint is the proportion of subject with end expiratory fraction of
      oxygen of 90% or more after a 3 min period and the end expiratory fraction of oxygen at the
      third minute.
    

Intervention name(s): preoxygenation with 100% O2, fresh gas flow rate 12 L/minute
Intervention type(s): Procedure
Intervention description(s): volunteers will be placed in supine position, fresh gas flow rate will be set at 12 L/min and delivered oxygen concentration will be set at 100%.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: preoxygenation; CPAP(continuous positive airway pressure); APL (airway pressure release) valve
Adequate Dairy Intake on Weight Change in Girls
Condition: Obesity
Study type: Interventional

Summary: 
      SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to
      recommended levels with dairy foods in adolescent females with habitually low calcium intake
      and above-the-median body mass index (BMI) for sex and age will decrease body fat gain
      compared to similar females who continue their low calcium intake. .

      HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume
      dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in
      percent body fat, as measured by dual energy absorptiometry, during one year than
      post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.
    


Intervention name(s): counseling on increasing calcium intake; observation
Intervention type(s): Behavioral; Other
Intervention description(s): The American Academy of Pediatrics recommends that adolescents ingest at least four servings of dairy food and at least 1300 mg calcium per day.; observe normal dairy intake
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Multicenter Retrospective Study) III
Condition: Aortic Dissection
MeSH terms: Aortic Dissection
Study type: Observational

Summary: 
      Anatomopathological classifications have been well identified in aortic dissection with
      important therapeutic implications. The authors evaluated the inflammatory response in
      patients with aortic dissection (AD) and assessed the presence of distinct inflammatory
      subphenotypes within this disease.
    


Intervention name(s): inflammatory response
Intervention type(s): Biological
Intervention description(s): laboratory data (leukocyte, neutrophils, monocyte, lymphocytes, platelet, fibrinogen, D-dimer, neutrophils-lymphocyte ratio, platelet-lymphocyte ratio, lymphocyte-monocyte ratio)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients underwent venipuncture during primary evaluation in the Emergency Department.
        Venous blood samples were immediately sent to the laboratory for analysis.
      
Keywords: Aortic Dissection; Inflammatory Response
Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, parallel group, placebo controlled trial to
      compare the safety and effectiveness of a single injection of Cingal® to a single injection
      of Triamcinolone Hexacetonide (TH) to achieve pain relief and other symptoms of
      osteoarthritis of the knee.
    

Detailed description: 
      To determine the contribution of Triamcinolone Hexacetonide (TH) when combined with sodium
      hyaluronate for pain relief, both in terms of magnitude and duration, when used as single
      injection, as compared to a single injection of TH alone in subjects diagnosed with
      osteoarthritis of the knee.

      A saline placebo is included within the trial to set the expectation of a return to Baseline
      pain for the subjects.
    

Intervention name(s): Cingal; Triamcinolone Hexacetonide (TH); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single intra-articular injection of Cingal into the knee.; Single intra-articular injection of TH into the knee.; Single intra-articular injection Placebo (0.9% Saline) into the knee.
Other intervention name(s): HA + TH; TH; Saline
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)
Condition: Secondary Malignant Neoplasm of Vertebral Column
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      The main purpose of this study is to utilize a comprehensive, prospective clinical database
      to collect patient, diagnostic and treatment variables along with disease specific and
      generic health related quality of life (HRQOL) data on consecutively treated patients with
      metastatic spine tumors. The objectives are to determine the validity and reliability of the
      Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor outcomes,
      to determine if the Spine Instability Neoplastic Score (SINS) Classification is a valid tool
      for predicting the stability of spine in metastatic spine disease, and to determine the
      efficacy of surgery versus radiotherapy for the treatment of impending instability secondary
      to metastatic disease of the spine.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with metastatic spine disease
Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality
Condition: Meningioma
MeSH terms: Meningioma
Study type: Interventional

Summary: 
      Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of
      the following two groups. After anesthesia induction but before skull-pin insertion, one
      group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will
      receive scalp nerve blocks with 0.9% saline. The patients' postoperative recovery quality,
      which is evaluated by KPS score, peri-operative inflammatory responses, and post-operative
      pain degree will be evaluated and compared between the two groups.
    

Detailed description: 
      Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of
      the following two groups. After anesthesia induction but before skull-pin insertion, one
      group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will
      receive scalp nerve blocks with 0.9% saline. The patients' KPS scores at 3d after surgery and
      at discharge, serum levels of TNF-α、IL-6，IL-1β at 24h after surgery, satisfaction score after
      recovery, and VAS scores at 1, 2, 3 days post-surgery will be evaluated and compared between
      the two groups.
    

Intervention name(s): ropivacaine; saline
Intervention type(s): Procedure; Procedure
Intervention description(s): To perform scalp nerve blocks with ropivacaine; To perform scalp nerve blocks with saline
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension
Condition: Pulmonary Hypertension Associated With Connective Tissue Disease
MeSH terms: Hypertension, Pulmonary; Hypertension; Connective Tissue Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Sildenafil is a selective pulmonary vasodilator; in patients with a special kind of pulmonary
      hypertension it is approved for treatment. The trial seeks to find out, whether the acute
      response to this treatment (= vasoreactivity testing) given intravenously is effective and
      allows prediction of therapy success during a following oral treatment.
    


Intervention name(s): Sildenafil
Intervention type(s): Drug
Intervention description(s): oral Sildenafil 3 x 20 mg for 90 days
Other intervention name(s): Revatio; CAS15 number 139755-83-2; EV Substance code SUB10517MIG
Intervention MeSH terms: Sildenafil Citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vasoreactivity testing; Sildenafil; precapillary pulmonary hypertension; connective tissue disease; mean pressure in the pulmonary artery 25 mmHg or more; mean pulmonary capillary wedge pressure below 16 mmHg
A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumors; Neoplasms, Colorectal
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety of RAD001 when given together with cetuximab and irinotecan
    


Intervention name(s): RAD001, Cetuximab, Irinotecan
Intervention type(s): Drug
Intervention MeSH terms: Irinotecan; Cetuximab; Everolimus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumors; Neoplasms, Colorectal
Dipeptidyl Peptidase-4 Link With Oral Cancer and Premalignant Lesions
Condition: Oral Premalignant Lesions as Leukoplakia and Lichen Planus; Oral Cancer
MeSH terms: Mouth Neoplasms; Precancerous Conditions; Leukoplakia; Lichen Planus
Study type: Observational

Summary: 
      Aim: The current study targets linking serum and salivary dipeptidyl peptidase-4 with oral
      squamous cell carcinoma and comparing it with potentially malignant lesions and control to
      validate dipeptidyl peptidase-4 as a diagnostic marker for early detection of oral cancer and
      to reveal its possible role in carcinogenesis.

      Methodology: A total of 45 patients were recruited and subdivided into 2 groups: Group I: 15
      patients having oral squamous cell carcinoma. Group II: 15 patients with potentially
      malignant lesions (leukoplakia and oral lichen planus) compared to 15 systemically healthy
      participants having no oral mucosal lesions acting as a control group (Group III). Serum and
      whole unstimulated salivary samples were collected from all participants to evaluate
      dipeptidyl peptidase level in different groups using enzyme linked immune-sorbent assay
      (ELISA) kit. ROC analysis was done to reveal area under the curve, sensitivity, specificity
      and diagnostic accuracy of DPP-4 among different groups.
    


Intervention name(s): serum and unstimulated salivary samples
Intervention type(s): Diagnostic Test
Intervention description(s): Participants were told to cease smoking, eating, or drinking before the collection of samples by about half an hour. Obtaining the sample was done by demanding the individual to swallow then incline his head forward to expectorate saliva in a sterile tube for about 3 min. Afterwards the samples were coded by serial numbers then stored at -20°C until being assessed.
Under aseptic circumstances and using plain tubes, 5ml peripheral venous blood samples were collected from all participants by standard venipuncture. Samples were transported to biochemistry laboratory and centrifuged followed by filtration of the clarifying supernatant and then stored at -20ºC
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult individuals entering in the out patient clinics of oral medicine and diagnosis
        department
      
Keywords: oral cancer; saliva; serum; dipeptidyl peptidase; potentially malignant lesions.
Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an exploratory study to evaluate the effectiveness, safety and tolerability of
      three concentrations of GW786034 ointment following treatment to small areas of stable
      psoriatic plaques. Dosing will proceed using a microplaque approach, where small volumes of
      ointment will be applied under full occlusion to representative psoriatic plaques. The
      effectiveness of topical GW786034 treatments and controls will be explored using visual
      intensity assessments in addition to dermal imaging and histological surrogates of disease
      activity.
    


Intervention name(s): Pazopanib; Pazopanib vehicle; Betamethasone valerate; Calcipotriol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pazopanib will be available in dosing strengths of 0.1, 0.5 and 1 percent.; Pazopanib vehicle will be given to subjects.; Betamethasone valerate ointment with 0.1 percent concentration will be given to subjects.; Calcipotriol ointment with 0.005 percent concentration will be given to subjects.
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: tolerability; safety; angiogenesis; vascular endothelial growth factor; pharmacodynamics; pharmacokinetics; microplaque; VEGF; GW786034
Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
Condition: Pregnancy
Study type: Observational

Summary: 
      The specific goal of the proposed research is to develop a reliable, non-invasive fetal and
      maternal heart rate and contraction monitor that is unaffected by obesity and requires less
      nursing intervention than the tocodynamometer and Doppler ultrasound.
    

Detailed description: 
      The majority of obstetric deliveries in the US undergo electronic monitoring and continuous
      uterine activity and fetal heart rate (FHR) monitoring is the standard of care. Typically,
      external transducers are employed, the reliability of which depends on their proper
      positioning, which may be disturbed by patient or fetal movement. The tocodynamometer (strain
      gauge, toco for short) provides frequency and timing of contractions, but requires
      transmission of tension from the uterus to the sensor. Fetal heart rate is acquired with an
      external Doppler ultrasound transducer. The reliability of this monitor depends on the
      ability to obtain a window to the fetal heart.

      In some patients, particularly the obese, the toco and ultrasound may fail to monitor
      consistently. In others both transducers require frequent repositioning by the nursing staff,
      and the Doppler may erroneously report maternal heart rate instead of fetal.

      The alternative uterine activity monitor is an intrauterine pressure catheter (IUPC), which
      is placed through the cervical os in the adequately dilated patient with ruptured membranes.
      While this monitor usually provides a more reliable signal than the toco, as well as
      quantitative information regarding intrauterine pressure, it is invasive and there is an
      increased risk of infection. The alternative FHR monitor is via fetal scalp electrode (FSE),
      which is applied transvaginally to the fetal presenting part, also requiring adequate
      cervical dilation and ruptured membranes. While the FSE usually provides a more reliable
      signal, it is similarly invasive and increases risk of infection.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Laboring women in Labor and Delivery ward
      
Keywords: Maternal Fetal Monitoring
Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control
Condition: Cesarean Section; Dehiscence
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators designed a prospective randomized study to investigate the efficacy of
      intravenous (IV) preemptive paracetamol on postoperative pain scores, patient satisfaction,
      total morfin consumption and the incidence of morfin-related side effects in patients
      undergoing cesarean section.
    


Intervention name(s): paracetamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol, patients in group S (n = 30) received 100 ml iv %0.9 NaCl
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients
      with schizophrenia.
    


Intervention name(s): SM-13496 (lurasidone HCl); SM-13496 (lurasidone HCl); Placebo; Risperidone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lurasidone HCl: 40 mg/day; Lurasidone HCl: 80 mg/day
Intervention MeSH terms: Risperidone; Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The objective of this investigation is to evaluate whether pulmonary vein isolation using the
      VytronUS ablation system is safe and effective acutely and at 3 months.
    


Intervention name(s): VytronUS Ablation System
Intervention type(s): Device
Intervention description(s): Pulmonary vein isolation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment