bioihbjkbjnl/mcl2 huggingface dataset:
Alveolar Ridge Preservation Using Different Bone Substitutes
Condition: Alveolar Ridge Enlargement
MeSH terms: Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to compare the efficacy of using allograft,
      autogenous tooth graft, and beta-tricalcium phosphate for alveolar ridge preservation (ARP)
      by examining the alveolar ridge height and width at baseline and 3 months after the ARP both
      clinically and radiographically. The secondary objective was to evaluate the quality of the
      newly formed bone using histomorphometric analysis.
    

Detailed description: 
      This randomized controlled clinical trial included thirty patients. ARP was performed using
      either Allograft (Allograft group n=10), Tooth graft (Toothgraft group n=10), and beta
      tri-calcium- phosphate (beta tri-calcium group n=10). Changes in alveolar ridge dimensions
      were evaluated clinically and radiographically using cone beam computed tomography at
      baseline and 3 months. Core bone biopsy samples were obtained 3 months post-extraction during
      implant placement for histomorphometric analysis.
    

Intervention name(s): Toothgraft; Allograft; Alloplast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Particulate dentin; Mineralized corticocancellous allograft; Beta tri-calcuim phosphate
Other intervention name(s): Mineralized corticocancellous allograft; Beta tri-calcuim phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alveolar ridge preservation, Allograft, Toothgraft, Allopast
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a
      pregabalin controlled release tablet as compared to multiple doses of the pregabalin
      immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin
      controlled release tablet as compared to multiple doses of pregabalin immediate release
      capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin
      controlled release tablet as compared to multiple doses of the pregabalin immediate release
      capsule.
    

Detailed description: 
      Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a
      pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate
      release capsule
    

Intervention name(s): Pregabalin controlled release, 82.5 mg; Pregabalin immediate release, 25 mg
Intervention type(s): Drug; Drug
Intervention description(s): 82.5 mg controlled release tablet administered once daily for four days.; 25 mg immediate release capsules administered three times daily for four days
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregabalin; pharmacokinetics; bioavailability; bioequivalence
Biofeedback for Second Stage of Labor
Condition: Labor Long; Labour;Obstructed
MeSH terms: Dystocia
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether transperineal ultrasound as visual
      biofeedback can be used during labor as an effective tool for shortening the second stage of
      labor and reducing the need for instrumental delivery, in a prospective randomized design.
    

Detailed description: 
      Biofeedback provides patients with better control of their body and their physiological
      reactions respective of the examined process, such as stress/anxiety, sports activity, labor,
      etc.

      Women under epidural anesthesia, may frequently feel lack of control over the birthing
      process and difficulty in bearing down effectively, which is a very significant part of the
      second stage of labor.

      Transperineal ultrasound during labor is a standard procedure in many medical centers in the
      world, mainly used to assist obstetricians in evaluating the progress of labor, fetal head
      position and assessing the chances of successful operative delivery. One of the most common
      tools used in transperineal ultrasound in measurement of the angle of progression, which has
      been suggested as a subjective method for assessing fetal station and for predicting
      successful vaginal delivery. A preliminary non-randomized study raised the possibility that
      the use of transperineal ultrasound during labor as a biofeedback tool may shorten the second
      stage of labor.

      The purpose of this study is to examine whether this tool can be used during labor as an
      effective tool for shortening the second stage of labor and reducing the need for
      instrumental delivery, in a prospective randomized design.
    

Intervention name(s): Visual biofeedback
Intervention type(s): Other
Intervention description(s): Patient will observe the descent of the fetal head as they push during contractions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label randomized control trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biofeedback; Second stage of labor; Operative delivery; Transperineal ultrasound
Evaluating the Impact of a Culinary Coaching Tele-medicine Program
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Introduction: Obesity is a major public health problem and adopting healthy lifestyle habits,
      while effective, is challenging in real-world settings. Culinary coaching is a behavioral
      intervention that aims to improve nutrition and overall health by facilitating home cooking
      through an active learning process that combines culinary training and health coaching. Our
      goal is to evaluate whether a culinary coaching telemedicine program (twelve 30-minute
      sessions) will significantly improve outcomes among subjects with overweight or obesity.

      General hypothesis: A culinary coaching telemedicine program will result in significant
      weight loss, and improvement in culinary attitude and self-efficacy, nutritional intake, and
      metabolic outcomes.

      Methods: This is a two-site, 36-month randomized controlled trial in which study participants
      between the ages of 25 to 70, with 27.5 ≤ BMI ≤ 35 Kg/m2 will be randomly assigned to
      nutritional counseling combined with a structured culinary coaching program or to nutritional
      counseling group (18 intervention, 18 control at each site). Intervention will include a
      3-month culinary coaching telemedicine program with outcome data collected periodically for
      12 months. The pre-defined primary outcome is body weight loss at 6 months, and secondary
      outcomes include change in body weight and composition at 1 year, as well as culinary
      attitudes and self-efficacy through a validated questionnaire, nutritional intake, lipid
      profile, blood pressure, and HgA1c (glycated hemoglobin); and participants' perception of the
      program.

      Potential impact: The investigators believe that this program has a potential to be a viable
      tool in promoting effective and scalable home cooking interventions aimed at improved
      nutrition and health outcomes in overweight and obesity.
    


Intervention name(s): CCTP; Nutritional counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Twelve weekly one-on-one 30-minute tele-sessions through video conference. At the first session, subjects identify their vision regarding home cooking and 3-month goals. During each subsequent meeting, subjects will review their progress towards reaching the prior week's culinary goals and identify goals for the coming week, using a self-discovery process. When patients detect a new culinary skill that is necessary for their progress, s/he will either be taught through discussions or referred to active learning from a Culinary Resource Center.; Two 30-minute nutritional counseling sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Home cooking; Telemedicine; Nutrition; Health coaching
Efficacy of a Probiotic Lozenges in Chronic Periodontitis Patients.
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Periodontal disease is an infectious disease resulting in inflammation within supporting
      tissues of the teeth, progressive attachment loss, and bone loss. Epidemiological studies
      reveal that about 10% of the adult population suffer from severe periodontitis.It comprises
      of two distinct but interconnected etiologic components: the periodontopathic bacteria
      adjacent to the periodontal tissues, and the host-mediated connective tissue-destructive
      responses to the causative bacteria and their metabolic products. In the arena of
      periodontics, the probiotics pose a great potential of plaque modification, halitosis
      management, altering anaerobic bacteria colonization, improvement of pocket depth, and
      clinical attachment gain.

      Aim of the study is to analyze the beneficial effect of probiotic lozenges as an adjunct to
      Scaling and Root Planing, on clinical and biochemical parameters.
    


Intervention name(s): Probiotic (Inersan); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2; Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety of Intravenous Lidocaine Infusions
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Observational

Summary: 
      The purpose of this study is to prospectively determine the side effects profile in adults
      with neuropathic pain receiving intravenous infusions of lidocaine 5 mg per kg of lean body
      weight, infused over 45 minutes.
    

Detailed description: 
      Eligibility Criteria:

      Adults > 18 yrs with chronic central or peripheral neuropathic pain at the St Joseph's Health
      Care Pain Clinic between June and December 2009.

      Outcome measures: All side effects spontaneously reported. Sedation, nausea, dizziness by
      Visual Analog Score Q 15 minutes; hemodynamic data q 5 minutes during and after infusion for
      30 minutes.

      Daily diary of side effects and Visual Analogue score of Pain for 7 days post-infusion.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult outpatients attending St Joseph's Chronic Pain Clinic in one of two time periods who
        have been diagnosed with chronic neuropathic pain by clinical history and examination and
        are scheduled to receive a lidocaine infusion for pain management
      
Keywords: Lidocaine,Intravenous Infusions,Neuropathic Pain,Side Effects
Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1
Condition: Melanoma - Currently Enrolling; Non-small Cell Lung Cancer - Enrollment Completed; Sarcoma - Enrollment Completed
MeSH terms: Melanoma; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of
      ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel
      immunotherapy agent designed to target dendritic cells and stimulate the body's immune system
      to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1
      protein. Patients with melanoma, sarcoma, ovarian cancer, or small cell lung cancer that
      express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305
      with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1
      therapy.
    

Detailed description: 
      ID-LV305 is an agent designed to specifically target dendritic cells within the patient and
      induce them to stimulate and generate cytotoxic T cell responses against the NY-ESO-1
      protein, a molecule which is often expressed in certain types of cancer cells. This is a
      first in human study of ID-LV305. The primary purpose of the study is to determine what dose
      ID-LV305 can be given safely to patients with advanced cancers that express NY-ESO-1 protein.
      ID-LV305 will be administered by intradermal injection every three weeks times four doses.
      The study will have two phases. In Part 1, Dose Escalation, which has been completed, three
      sequentially enrolled cohorts of patients were treated at one of four dose levels of ID-LV305
      using a standard escalation design. Followed by Part 2 expansion where an additional 27
      subjects were enrolled. In Part 2SA, Site-specific Amendment, patients with unresectable
      and/or metastatic melanoma with an inadequate response to anti-PD-1 MAb therapy, defined as
      SD or PD using RECIST criteria following at least 2 months of therapy. Patients with PD have
      a tumor measurement increase of <2-fold from the time of starting anti-PD-1 therapy, must not
      be symptomatic or have worsening of Eastern Cooperative Oncology Group (ECOG) performance
      status due to their disease progression, and cannot have new CNS lesion. Patients must also
      meet the lactic acid dehydrogenase (LDH), ECOG status, and no tumor size criteria are used in
      Part 2SA.
    

Intervention name(s): ID-LV305
Intervention type(s): Biological
Intervention description(s): pembrolizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma
The Effect of Propofol on Dexamethasone-induced Perineal Pruritus
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Early Phase 1

Summary: 
      patients may appear serious perineal itching, after injection of dexamethasone sodium
      phosphate injection its incidence is about 25% ~ 100%, and the incidence of the discomfort in
      females was much higher than that of the maleTo investigate the effect of propofol
      pretreatment on perineal pruritus induced by dexamethasone sodium phosphate injection and
      explore the possible machanisms.
    

Detailed description: 
      40 patients scheduled for selective surgery,aged 18-65years,ASA physical status I~II,BMI
      18~30kg/m2 were selected in this study.The patients were equally randomized into two groups:
      propofol (P) group and normal saline (N) group, 20 cases in each group. Before anesthesia
      induction, M group received intravenous injection of 0.3mg/kg propofol , while N group
      received corresponding intravenous normal saline of the same volume. After 1 min, both groups
      received intravenous injection of dexamethasone sodium phosphate injection of 10mg. The
      anesthesiologist assessed perineal irritation in both groups and recorded Ramsay scores,the
      number of cases, visual analogue scale(VAS) scores ,duration of itching and observed the
      occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in
      the two groups.
    

Intervention name(s): Propofol; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg.; Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: propofol (P) group and normal saline (N) group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: propofol; Dexamethasone; pruritus
High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
Condition: Platelet Reactivity
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups
      of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin
      325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Platelet
      reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration immediately
      prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing (in PRU) will
      be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12 function assay.
    


Intervention name(s): Prasugrel 100mg loading dose; Prasugrel 60mg loading dose
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 60mg loading dose
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: prasugrel; ST elevation myocardial infarction
Oxytocin Effects on Cytokines and Endocrine Parameters After LPS Induced Systemic Inflammatory Effects in Healthy Volunteers
Condition: Sepsis
MeSH terms: Sepsis
Study type: Observational

Summary: 
      The aim of this study is to determine if oxytocin administration is able to blunt LPS induced
      increase of cytokines (TNF-α) and if there is a change in the endocrine response after
      lipopolysaccharide administration in humans.
    


Intervention name(s): oxytocin
Intervention type(s): Drug
Intervention MeSH terms: Oxytocin
Time perspective: Prospective
Keywords: oxytocin; tnf; sepsis; lps
Plaque Psoriasis Study in Pediatric Subjects
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the safety, efficacy and calcium metabolism of up to
      8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice
      daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.
    


Intervention name(s): calcitriol ointment; placebo comparator
Intervention type(s): Drug; Drug
Intervention MeSH terms: Calcitriol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
Condition: Drug-Related Side Effects and Adverse Reactions
MeSH terms: Nasopharyngeal Carcinoma; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional

Summary: 
      This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy
      combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.
    


Intervention name(s): Cisplatin; Docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): radiotherapy combined with Chemotherapy Drugs, Cancer; Docetaxel
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: locally advanced nasopharyngeal carcinoma; Concurrent chemoradiotherapy; Toxic reaction
Biomarkers for the Diagnosis of Transient Ischemic Attack
Condition: Cerebrovascular Disorders; Ischemic Attack, Transient
MeSH terms: Ischemic Attack, Transient; Cerebrovascular Disorders; Ischemia
Study type: Interventional

Summary: 
      A transient ischemic attack (TIA) should be considered an emergency prevention opportunity in
      order to avoid recurrence as cerebral infarction (CI) serious (fatal or disabling). Indeed,
      about 20% of patients who have IC had in previous days or weeks, a TIA, which can be defined
      as a brief episode of cerebral dysfunction (or eye) do not result in permanent brain damage
      and thus no sequelae. Moreover, about 20% of ischemic events observed in practice are AIT.
      Despite the progress achieved in the treatment in the acute phase of an IC, prevention
      remains the most effective way to fight against this disease. This prevention can be put in
      place before the occurrence of a first IC, or after a first IC, especially when minor as a
      TIA.

      However, the diagnosis of TIA remains particularly difficult and it is necessary now to
      identify new tools for the diagnosis of transient ischemic attack. Our study focused on the
      identification of one or more molecules (called biological markers or biomarkers) present in
      the bloodstream of patients, which will serve to facilitate the differential diagnosis of
      patients with TIA.
    


Intervention name(s): protein expression
Intervention type(s): Biological
Intervention description(s): Differential protein expression between the period of acute cerebral ischemia and the control period
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: biological markers