bioihbjkbjnl/mcl2 huggingface dataset:
Prediction of Delivery With Transperineal Ultrasound in Women With Prolonged Labour. Multicentre Study
Condition: Failed Labor
Study type: Observational

Summary: 
      Objectives

        1. To assess if head-perineum distance and angle of progression measured with transperineal
           ultrasound by the obstetrician on call can predict delivery mode in primiparous women
           with prolonged first stage of labour.

        2. To compare ultrasound assessments and clinical examinations.
    

Detailed description: 
      Variables Digitally assessed cervical dilatation, fetal station and position Ultrasound
      measured fetal head-perineum distance. Ultrasound measured angle of progression Ultrasound
      assessed position

      Possible confounders Ethnicity, maternal age, gestational age, BMI, induction of labour,
      augmentation, epidural analgesia, birth weight, head circumference

      A two-dimensional ultrasound measurement will be obtained with the ultrasound device
      available in the delivery department. Fetal head descent is measured as the shortest distance
      between the outer bony limit of the fetal skull and the perineum with a curved transabdominal
      transducer placed transperineally between the labia in a transverse view (1).

      The fetal descent will also be assessed measuring "angle of progression" as suggested by
      Barbera et al. The ultrasound transducer will be placed on the perineum in a mid-sagittal
      position between the labia below the pubic symphysis. The angle between a line through the
      symphysis and a line from the posterior part of the symphysis tangentially to the fetal skull
      contour will be measured (2)

      A transabdominal scan will also be performed determining the fetal position as described
      previously. Positions ≥ 02.30 and ≤ 03.30 hours should be recorded as left occiput transverse
      and positions ≥ 08.30 and ≤ 09.30 as right occiput transverse. Positions > 03.30 and <08.30
      should be recorded as occiput posterior and positions > 09.30 and < 02.30 as occiput
      anterior.(3).
    

Intervention name(s): ultrasound examination
Intervention type(s): Procedure
Intervention description(s): transabdominal and transperineal ultrasound examinations
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        primiparous women in labor
      
Keywords: prolonged labor; cesarean section; duration of labor
Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized controlled trial is designed to evaluate safety, effectiveness and
      pharmacokinetic-pharmacodynamic (PK/PD) relationships associated with three different
      Nitazoxanide (NTZ) treatment regimens added to Tenofovir Disoproxil Fumarate (TDF), Tenofovir
      Alafenamide (TAF) or Entecavir (ETV) in treating Chronic Hepatitis B (CHB).
    


Intervention name(s): Placebo Oral Tablet; Nitazoxanide
Intervention type(s): Drug; Drug
Intervention description(s): Number of placebo tablets administered orally depends on the arm; Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
Other intervention name(s): NTZ, NT-300
Intervention MeSH terms: Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized 1:1:1:1 (12 subjects per group)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Human Fetal Liver Cell Transplantation in Chronic Liver Failure
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Liver Failure; End Stage Liver Disease; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The herein study consists in the transplantation of liver progenitor cells isolated from
      human fetal liver tissue with the aim of improving conventional liver therapy and broadening
      therapeutical options other than liver transplantation.
    

Detailed description: 
      One of the major clinical problems in transplantation medicine is the discrepancy between the
      growing number of liver chronic disease patients and the lack of organs. Research and
      development of new liver failure treatments thus have a high clinical significance.
      Regenerative medicine and results recently achieved in the field of stem cell biology may
      provide a remedy to this emerging problem.

      Our project aims at developing new generation cell transplantation methodologies through an
      interdisciplinary research project created from a collaboration between ISMETT, Palermo and
      the University of Pittsburgh (UPMC-USA).

      Adult hepatocyte transplantation has been in use for several years already and has proved to
      be safe for patients and able, especially in pediatric patients, to improve liver function
      indices and delay the need for liver transplantation. Studies have been limited until now by
      the use of already differentiated hepatocytes and therefore unable to proliferate and develop
      a suitable liver mass to support a decompensated liver.

      The hypothesis of our project, supported by in vitro studies and studies on experimental
      animal models, is based on the possibility to generate an ectopic liver system in the spleen
      through the experimental use of hepatic cell progenitors obtained from human fetal liver
      tissues. Human fetal liver cell transplantation will be performed in the spleen through
      arterial injection.

      The final endpoint of the project is to develop an innovative and safe treatment for patients
      with end-stage chronic liver failure
    

Intervention name(s): Human Fetal Liver Cell Transplantation
Intervention type(s): Other
Intervention description(s): Human Fetal Liver Cell Transplantation. Cell source: Non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.
Infusion technique: Isolation and incannulation of the femoral artery.Splenic artery infusion under radiological guidance.
Cell infusion: between 5 and 10x10^8 cells. Number of sessions: up to 2.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver cirrhosis; Fetal stem cells; Stem cell transplantation; Liver transplant candidate
A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy in patients with major
      depressive disorder.
    

Detailed description: 
      The screening phase is intended for diagnosing and assessing the patient for possible
      inclusion in the study and for providing an adequate washout period. The following study will
      be conducted in two parts. Part I is an open-label study, multiple center and dose escalation
      evaluation in twelve patients. Six subjects each will be evaluated for safety and efficacy
      assessments at 1 or 2 capsules TID dose for 28 days, sequentially. Each of them will be
      assessed twice in the first week after administration of PDC-1421 Capsules and once a week in
      the following treatment.

      Part II is a randomized, double-blind, placebo-controlled, parallel-group study. 60 subjects
      will be randomly assigned on a 1:1:1 basis to one of the three arms (1 PDC-1421 Capsule plus
      1 placebo TID, 2 PDC-1421 Capsules TID, 2 placebo TID) for 6 weeks and evaluated the safety
      and efficacy every two weeks during the treatment period.
    

Intervention name(s): PDC-1421 Capsule; placebo
Intervention type(s): Drug; Drug
Intervention description(s): PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.; Placebo contained corn starch.
Other intervention name(s): BLI-1005
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part I is a open label, dose escalation with two dosage levels study. Part II is a randomized (1:1:1), double-blind, placebo-controlled, parallel groups with three treatment arms.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
Condition: Candidiasis
MeSH terms: Candidiasis; Liver Diseases
Study type: Observational

Summary: 
      The purpose of this study is to describe the real world effectiveness of anidulafungin in
      clinical practice in a large Liver Unit in the United Kingdom.
    

Detailed description: 
      All subjects that have been treated with Anidulafungin according to its licence during the
      period of July 2009 and September 2010 will be included.
    

Intervention name(s): anidulafungin
Intervention type(s): Drug
Intervention description(s): A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Other intervention name(s): ECALTA, ERAXIS
Intervention MeSH terms: Anidulafungin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital
        (United Kingdom) who are prescribed anidulafungin.
      
Keywords: Ecalta; Eraxis; Candida; Candidemia; Systemic Candidiasis; ICU; Intensive Care Unit; Critical Care Unit
A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open-label, multicenter, Phase 1b/2 study of lenvatinib alone and in combination
      with everolimus in subjects with unresectable advanced or metastatic renal cell carcinoma
      following one prior VEGF-targeted treatment.
    


Intervention name(s): Lenvatinib; Everolimus
Intervention type(s): Drug; Drug
Intervention description(s): taken orally, once a day; taken orally, once a day
Other intervention name(s): E7080, Lenvima, Kisplyx; Afinitor
Intervention MeSH terms: Everolimus; Lenvatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unresectable advanced or metastatic renal cell carcinoma
A Nurse Caring Behavior Protocol on Postoperative Cardiac Patient Satisfaction
Condition: Nurse-Patient Relations; Patient Satisfaction; Caring
Study type: Interventional

Summary: 
      the study aimed to evaluate the impact of implementing a nurse caring behavior (NCB) protocol
      on postoperative cardiac patient satisfaction.
    

Detailed description: 
      Critical care nurses need to comply with caring behaviors when caring for postoperative
      cardiac patients. Furthermore, patient satisfaction is a key indicator of nursing care
      quality. As such, this study focused on these critical issues considering the limited
      research available on the impact of caring behaviors on postoperative cardiac patient
      satisfaction. The study aimed to evaluate the impact of implementing a nurse caring behavior
      protocol on postoperative cardiac patient satisfaction. The study was conducted at a cardiac
      surgery intensive care unit of Alexandria Main University Hospital, Egypt. Sixty adults,
      conscious cardiac surgery patients, were included during the first 2 days following surgery.
      Patients were randomly assigned to either a control group, which received routine nursing
      care, or a protocol group, which received nursing care based on nurse care behaviors protocol
      through a simple randomization method. One tool was used "Postoperative Cardiac Patient
      Satisfaction with Nurse Caring Behaviors Evaluation Questionnaire". At the end of the second
      day, patients were asked regarding their satisfaction with the nursing care received based on
      caring behaviors. These nursing care included intensive care unit admission and orientation
      processes, physical care, psychological care, and social interaction between patient and
      nurse, providing health teaching, and maintaining a safe healing environment.
    

Intervention name(s): A nurse caring behavior protocol; Routine nursing care
Intervention type(s): Other; Other
Intervention description(s): Nursing interventions based on caring behaviors protocol was provided as follows:
Caring behaviors during ICU admission and orientation processes included orienting patients to time, place, and person.
Caring behaviors during physical care informing patients regarding the purpose and expected duration of mechanical ventilator use.
Caring behaviors during psychological care included offering religious sound meditation.
Caring behaviors during social interaction included maintaining eye contact during nurse-patient interaction.
Caring behaviors during health teaching included providing health teaching for patients.
Caring behaviors during maintaining a safe healing environment included providing patients with an explanation regarding nursing activities.; Routine nursing care was concentrated mainly on hard skills of physically demanding care such as monitoring vital signs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cardiac patient; Nurse caring behaviors; Satisfaction
Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine
Condition: Patients Undergoing Ankle Surgery
Study type: Interventional

Summary: 
      Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve
      block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa
      nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg
      2008;106:1916-20), but unfortunately the patients still often experience moderate to severe
      pain after the block wears off. The investigators wish to study two additives that may
      prolong the period of analgesia provided by the nerve block. The additives will be studied in
      the context of a standardized postoperative multimodal analgesic pathway.

      Primary outcome:

      Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a
      popliteal fossa nerve block?
    


Intervention name(s): A. Control Nerve Block. IV Dexamethasone (4 mg).; B. Nerve Block with Dexamethasone (4 mg). IV saline.; C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg); D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).; E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A. Control Nerve Block. IV Dexamethasone (4 mg).; B. Nerve Block with Dexamethasone (4 mg). IV saline.; C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg); D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).; E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Buprenorphine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesia; Duration; Popliteal Fossa Nerve Block; Dexamethasone; Buprenorphine; Additives; Ankle surgery
Integrated Smoking Cessation Treatment for Low Income Community Corrections
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      This study recruited cigarette smokers under supervision in community corrections (e.g.,
      probation, parole, drug courts, etc.) in the Birmingham, Alabama area. Smokers received 12
      weeks of bupropion treatment and brief physician advice to quit smoking or 12 weeks of
      bupropion treatment and 4 sessions of intensive counseling around smoking cessation. The
      study was stratified on race such that equal proportions of African Americans and Caucasians
      were enrolled in the two study groups. It was hypothesized that smokers receiving intensive
      counseling will have higher quit rates compared to smokers receiving brief advice to quit.
    


Intervention name(s): counseling vs. advice
Intervention type(s): Behavioral
Intervention description(s): 1 session of brief physician advice to quit smoking plus bupropion (12 weeks) compared to 4 sessions of intensive counseling plus bupropion (12 weeks)
Other intervention name(s): counseling; wellbutrin; bupropion; zyban
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Paclitaxel and Carboplatin in Treating Patients With Locally Advanced or Metastatic Renal Cell Cancer
Condition: Kidney Cancer
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug
      may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin
      works in treating patients with locally advanced or metastatic collecting duct renal cell
      cancer that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response rate in patients with locally advanced or metastatic collecting
           duct renal cell cancer treated with paclitaxel and carboplatin.

      Secondary

        -  Determine the tolerability of this regimen in these patients.

      OUTLINE: This is an open-label, multicenter study.

      Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
      Treatment repeats every 21 days for up to 6 courses in the absence of unacceptable toxicity
      or disease progression.

      Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

      PROJECTED ACCRUAL: A total of 14-22 patients will be accrued for this study within 4.5 years.
    

Intervention name(s): carboplatin; paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer
Subgingival Microbiota Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Periodontitis Patients
Condition: Aggressive Periodontitis, Generalized
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Observational

Summary: 
      The investigators planed to observe the microbiome of an aggressive periodontitis patient,
      during mechanical treatment, surgery(if indicated) and implant placement. The investigators
      designed to observe the changes after mechanical treatment.Then, the investigators will
      compare the sub-mucosa microbiome of implant and the subgingival community. The investigators
      expected a different community after treatment, and there could be similarity between implant
      and nature teeth.
    


Intervention name(s): mechanical treatment(mainly scaling and root planing), periodontal surgery(if indicated), implant placement.
Intervention type(s): Procedure
Intervention description(s): The investigators shall follow the regular procedure to these patients.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        aggressive periodontitis patients with defection of dentition or shall extracted hopeless
        teeth, and intended to implant treatment.
      
Biospecimen description: 
      some bacteria DNA from subgingival. No need for human DNA.
    
Keywords: mechanical treatment; implant
Evaluation of a Noninvasive Fetal RHD Genotyping Test
Condition: Rhesus D Genotype
Study type: Observational

Summary: 
      This study will collect whole blood samples from pregnant subjects who are RhD negative by
      serology to develop an assay for RHD determination of the fetus.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant subjects who are RhD negative and between 10 and 28 weeks gestation.
      
Biospecimen description: 
      Whole blood collected, processed to plasma and buffy coat for DNA extraction.
    
Keywords: RhD negative; RhD disease; fetal nucleic acid; fetal DNA; cell free fetal DNA; Fetal RHD genotype
Effect of Amlodipine on the Lipid Profile of Newly Diagnosed Hypertensive Patients
Condition: Hypercholesterolemia; Hypertension; Cholesterol Deposition
MeSH terms: Hypertension; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, Amlodipine has been used to study its effects in newly diagnosed hypertensive
      patients.
    

Detailed description: 
      The incidence of hypertension is on the rise in developing countries like Pakistan. Different
      medications are used to decrease blood pressure with Amlodipine as one of the first-line
      drugs. It was proposed that due to interaction with calcium and thus luminal cholecystokinin
      releasing factor; Amlodipine might increase the cholesterol level and thus cause
      dyslipidemia.

      Objective: In this regard, this study was conducted to look into the effects of Amlodipine in
      newly diagnosed cases of hypertension that had received no medication previously.

      Methodology: Experimental study with a healthy control group with the sample size calculated
      out to be 80, comprising of an equal number of enrolment into case and control groups.
    

Intervention name(s): Amlodipine
Intervention type(s): Drug
Intervention description(s): 5mg/day in two divided doses
Other intervention name(s): Norvasc
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Case with healthy control
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Hypertension