bioihbjkbjnl/mcl2 huggingface dataset:
Dental Implant Approach for Crestal Sinus Elevation; A Novel Technique.
Condition: Maxillary Sinus; Dental Implant; Maxillary Sinus Lift; Maxillary Sinus Elevation
Study type: Interventional

Summary: 
      Vertical bone height reduction after extraction in the posterior maxilla is inevitable and
      complicates the treatment plan. Crestal sinus elevation, using implants and different
      grafting procedures are considered some of the proposed treatment protocols. Ever since the
      introduction of implant dentistry and implant placement in the posterior maxilla has been a
      dilemma. The choice of the type of bone, anatomical landmarks and reduced remaining bone
      height are all obstacles faced when placing implants in this area. Vertical bone height
      reduction occurs post extraction of the maxillary molars and premolars by maxillary sinus
      pneumatization. Many protocols were suggested to overcome this phenomenon; placing short
      implants, 2nd premolar occlusion and finally maxillary sinus elevation.

      A recent systematic review evaluated osteotomes mediated sinus floor elevation with or
      without grafting material. It concluded a high long term survival rate in both procedures,
      however only one comparative study was used in the analysis that involved 12 participants
      only. Another systematic review assessed the survival of implants placed with lateral versus
      crestal sinus approach in 4-8 mm ridge height. It concluded that the ability of the less
      invasive crestal sinus approach to replace one-stage lateral approach, however, only one
      randomized control trial was presented that involved 4o patients, and were followed-up for 5
      years. This emphasizes the gap of knowledge in literature with high quality evidence
      concerning these approaches.

      The purpose of the present study is to evaluate the radiographic vertical gain in bone height
      as well as the implant stability after implant placement without the use of bone grafts in
      posterior maxilla following sinus elevation using the crestal implant approach technique.
    


Intervention name(s): Dental Implant Approach for Crestal Sinus Elevation
Intervention type(s): Procedure
Intervention description(s): Crestal Sinus Elevation by elevating the sinus membrane with a blunt ended dental implant approach
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MOMENTUM 3 Continued Access Protocol
Condition: Advanced Refractory Left Ventricular Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The objective of the study is to continue to evaluate safety and clinical performance of the
      HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following
      completion of enrollment in the the MOMENTUM 3 IDE Study.
    

Detailed description: 
      Enrollment in the CAP cohort ended shortly after approval for the long-term indication was
      received from the FDA in October 2018. As a condition of approval, all patients enrolled in
      the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study
      requirement.
    

Intervention name(s): HeartMate 3 LVAS
Intervention type(s): Device
Intervention description(s): Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure; LVAS; Ventricular Dysfunction; Cardiomyopathy; Heart Disease; Cardiovascular Disease; Heart-assist devices; Thoratec Corporation
Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The survey is a phase IV, prospective randomized clinical trial to determine whether an
      immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional
      status and reduce postoperative infection and surgery-induced immune suppression in patients
      with gastric cancer or GIST undergoing major surgery in a single medical center.
    

Detailed description: 
      Primary Objective:

        1. The primary end points:

           To evaluate the effect of immunomodulating diets on the postoperative inflammatory
           response: including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis
           factor-α (TNF-α).

        2. Secondary Objectives:

      (1). Biochemistry parameters: glucose,blood urine nitrogen, creatinine, aspartate
      aminotransferase, alanine aminotransferase, triglycerides, cholesterol, low-density
      lipoprotein, high-density lipoprotein, sodium, and leukocyte count.

      (2). Nutritional status: albumin, prealbumin, BMI (3). Adverse events (4). Clinical outcomes:
      postoperative complications, time to first bowel action and length of hospital stay after
      surgery.

      Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to
      reach 15 patients at least in each.

      Plan of the Study:

        1. This is a randomized, comparative, double blinded study in 2 arms.

        2. Study Schedule Study date: the time getting approval letter issued by both regulatory
           authority and institutional review board (IRB). Duration of the study: 5 years.

        3. Duration of Treatment: Treatment was administered before curative surgery for gastric
           adenocarcinoma or gastric GIST, and postoperative day 5-14 or to discharge whichever
           occurred first, or consent withdrawal during any time of the study, when the patient
           would be withdrawn.
    

Intervention name(s): immunomodulating nutrients enriched diet; standard diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): neo-mune
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: immunomodulating nutrients
A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing
      (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or
      arm continuously and repeatedly to the same site for a period of 21 days.
    

Detailed description: 
      This is an open-label, single-arm, randomized, evaluator-blinded repeat insult patch testing
      (RIPT) study wherein test product is applied under an occlusive dressing to the upper back or
      arm continuously and repeatedly to the same site for a period of 21 days. Three
      concentrations of PBI-100 Topical Cream and vehicle (placebo cream) will be applied to the
      skin of each subject. In addition, one site will be treated with a positive control and
      another site will be treated with a plain cotton cloth patch and will serve as a negative
      control.
    

Intervention name(s): PBI-100 Topical Cream; Positive Control - Sodium laurel sulfate (SLS); PBI-100 Topical Cream, Vehicle; Negative Control
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): A dose of approximately 560 ug (approximately 0.4 mL of each of the three concentrations to 3 different sites) of PBI-100 was applied daily (excluding weekends) to the skin test sites.; Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site.; Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site.; A blank patch was applied daily (excluding weekends) as a negative control test site.
Other intervention name(s): SLS
Intervention model: Single Group Assignment
Intervention model description: The order of test product patch placement is randomized.
Masking: None (Open Label)
Primary purpose: Other
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization
Condition: Sensitivity, Contact
MeSH terms: Dermatitis, Contact
Study type: Interventional

Summary: 
      This is a clinical study for health care product safety assessment. The research will be
      conducted with 92 subjects, aged 18 to 59 years. The product will be applied on the right
      and/or left back of the research participants for 3 consecutive weeks. After 10 days, will
      have another application of the same product, which will be removed in 48 hours. Medical
      evaluation will be available throughout the study to assess possible adverse events.

      The objective of the study is to observe the effects of the application of the product on the
      skin and prove the absence of irritability and/or allergy.
    

Detailed description: 
      92 subjects, aged 18 to 59 years, phototypes I to IV (according to Fitzpatrick
      classification). The patch test will be used to verify the absence of primary and cumulative
      dermal irritation reactions and sensitization allergic reactions by the investigational
      products. The products will be applied as they are over semi-occlusive dressings.
    

Intervention name(s): Health care product
Intervention type(s): Other
Intervention description(s): Health care product (gel) - to be applied on the participant's skin
Intervention model: Single Group Assignment
Intervention model description: Clinical trial, single-arm
Masking: None (Open Label)
Primary purpose: Screening
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin's or Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give
      higher doses of chemotherapy and kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      peripheral stem cell transplantation in treating children who have recurrent or refractory
      Hodgkin's lymphoma or non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Estimate the failure-free survival rate in a cohort of relapsed Hodgkin's lymphoma and
           non-Hodgkin's lymphoma patients after retrieval therapy which includes peripheral blood
           stem cell transplantation (PBSCT) in patients who achieve a complete remission or
           partial remission.

        -  Estimate the post complete/partial remission failure-free survival rate in these
           patients.

        -  Characterize the time to recovery of normal bone marrow function after transplantation
           in these patients.

      OUTLINE: Patients receive 2 courses of reinduction chemotherapy followed by bone marrow
      biopsy and aspirate prior to peripheral blood stem cell (PBSC) harvest. If marrow involvement
      is still present at harvest, then 2 additional courses of induction chemotherapy are given.

      The PBSC transplantation preparative regimen should begin within 2 weeks of completing
      reinduction therapy course, consisting of the following:

        -  Carmustine IV over 3 hours on days -8, -7, and -6

        -  Etoposide continuous IV over days -8, -7, and -6

        -  Cyclophosphamide IV over 1 hour daily on days -5, -4, -3, and -2

        -  Mesna as a 15 min infusion before each dose of cyclophosphamide then at 3, 6, 9, and 12
           hours after initiation of each cyclophosphamide dose Methylprednisolone IV is given to
           protect lungs from the toxic effects of carmustine.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued in each subgroup.
    

Intervention name(s): carmustine; cyclophosphamide; etoposide; mesna; peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Procedure
Other intervention name(s): BCNU; NSC-409962; Cytoxan; NSC-26271; VP-16; VePesid; NSC-141540; Mesnex; NSC-113891
Intervention MeSH terms: Cyclophosphamide; Carmustine; Etoposide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent childhood lymphoblastic lymphoma; childhood diffuse large cell lymphoma; childhood immunoblastic large cell lymphoma; recurrent/refractory childhood Hodgkin lymphoma; recurrent childhood small noncleaved cell lymphoma; recurrent childhood large cell lymphoma
Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      One in three Americans are obese. Obese subjects may or may not need higher doses of the
      anti-flu drug known as Tamiflu (oseltamivir). The current study is being done to see if the
      FDA approved dose of oseltamivir will achieve similar concentrations in obese healthy
      volunteers compared to that previously shown in non-obese volunteers.
    

Detailed description: 
      The incidence of obesity has increased dramatically over the past two decades in the United
      States (US). Twenty-five percent of adult Americans are now classified as obese. Obesity is
      associated with physiological alterations that can affect drug clearance and volume of
      distribution. Obese subjects are often excluded from phase 1 pharmacokinetic studies. As a
      result, drug dosing regimens developed for clinical use may not be appropriate for the obese
      population. Use of fixed dosing regimens may result in under dosing of obese patients. In
      contrast adjustment of drug dosing based on total body weight may lead to over dosing of
      obese patients. Oseltamivir phosphate (Tamiflu®) is an antiviral agent that is currently
      dosed as 75 mg once daily for chemoprophylaxis and twice daily for treatment of influenza in
      adults.

      Oseltamivir is rapidly converted to its active metabolite, oseltamivir carboxylate by
      esterases. The clearance of oseltamivir carboxylate is dependent on tubular secretion and
      glomerular filtration. Given that these drug elimination pathways may be enhanced in obese
      individuals, oseltamivir carboxylate plasma exposures may be lower in obese subjects compared
      to normal weight subjects. Although a specific plasma exposure target for oseltamivir
      carboxylate has not been established, lower oseltamivir carboxylate exposures may predispose
      obese patients to treatment failure and increase the probability for emergence of
      oseltamivir-resistant influenza virus. The current study proposes to characterize the plasma
      oseltamivir carboxylate concentration-time profile after multiple doses of oral oseltamivir
      in a cohort of healthy morbidly obese subjects. The study will be performed using a phase 1,
      open-label,multiple dose, pharmacokinetic study design in twenty obese adult subjects. This
      pilot study will provide pharmacokinetic data that may be incorporated into existing
      oseltamivir carboxylate population pharmacokinetic models to define appropriate doses of
      oseltamivir in obese patients.
    

Intervention name(s): Oseltamivir
Intervention type(s): Drug
Intervention description(s): Capsule, 75 mg by mouth for 9 doses
Other intervention name(s): Tamiflu
Intervention MeSH terms: Oseltamivir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Oseltamivir; Obesity; Influenza; Pharmacokinetics in Obesity
Impact on the Length of Stay in Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: .
Condition: Sickle Cell Disease; Pediatric
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      In this prospective observational study among sickle cell children aged 7 to 17 years, who
      face many experience of pain, pain will be assessed during incentive spirometry sessions.
      Then a relation between, inspiratory volume, pain and the length of hospital stay will be
      identified .

      Currently, there is no scientific data regarding the correlation between acute pain during
      vaso-occlusive crisis, incentive spirometry and the impact on length of hospital stay. In
      fact, physiotherapist experience's in the pediatric department suggests that the pain
      expressed by the child is not always correlated with inspiratory capacity.

      The absence of pain is one of the reasons for hospital discharge after decompensation in
      patients with sickle cell disease. However, no scientific study has linked incentive
      spirometry, pain and length of hospital stay.

      Investigator assume that these children underestimate the real pain and its impact on
      breathing pattern, and presume that the maximal inspiratory volume during spirometry sessions
      will be a better reflect of pain than standard pain scale.

      The aim of this study is to show that inspiratory volume would be a better indicator of
      discharge from hospitalization than actual pain scales.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        sickle cell children admitted to the paediatric department at the CHR of Orléans
      
Keywords: Sickle cell disease; incentive spirometry; pain; children
A Study of Efficacy of New Doses of Xolair to Protect From Allergen Challenge in Groups of Asthma Patients Defined by IgE Levels
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was intended to demonstrate that patients with standard and high immunoglobulin E
      (IgE) levels can be protected from allergen induced broncho-constriction by Xolair
    


Intervention name(s): Xolair; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;; Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; allergen challenge; bronchoprovocation; Methacholine challenge; serum Immunoglobulin E; Nitric Oxide; skin prick test
Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults
Condition: Helicobacter Pylori; Gastritis; Gastric Cancer; Gastroduodenal Ulcers; Lymphoma
MeSH terms: Gastritis; Peptic Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to investigate the safety and immunogenicity of Chiron's
      investigational H. pylori (HP3) vaccine
    


Intervention name(s): helicobacter pylori vaccine; helicobacter pylori vaccine; helicobacter pylori vaccine; helicobacter pylori vaccine; Placebo; helicobacter pylori vaccine; helicobacter pylori vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly; Seven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 month schedule (alum control was administered at 4 months), administered intramuscularly; Seven subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly; Eight subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,4 month schedule (alum control was administered at 2 months), administered intramuscularly; Nine subjects, alum control (placebo comparator), 0,1,2,4 month schedule (served as control for arms 1-4), administered intramuscularly; Nine subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 10 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly; Ten subjects, experimental H. pylori vaccine including NAP, CagA and VacA antigens (abbreviated HP3), 25 micrograms of each antigen, 0,1,2 week schedule, administered intramuscularly
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The management of chronic diseases requires a constant monitoring of treatment adherence, in
      order to obtain an optimal disease control. However, this is often difficult to achieve,
      especially in pediatric age.

      In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca"
      developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel
      whether the patient does the inhalation, and to register it on a specific application.

      The present randomized trial aims to compare the treatment adherence between asthmatic
      children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or
      Symbicort Turbohaler without Turbo+.
    


Intervention name(s): Symbicort Turbohaler plus Turbo+; Symbicort Turbohaler without Turbo+
Intervention type(s): Device; Drug
Intervention description(s): Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.; Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.
Intervention MeSH terms: Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery
Condition: Heart Valve Disease
MeSH terms: Heart Valve Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting
      patient outcome following cardiovascular surgeries. Propofol, an intravenously administered
      anesthetic with antioxidant properties, protects organs from I/R injury. This study aimed to
      investigate the ability of propofol to protect kidneys against I/R injury in the patients
      undergoing valvular heart surgery.
    


Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): Induction of anesthesia: Propofol 1 mg/kg, sufentanil 1.0-3.0 µg/kg and rocuronium 50 mg IV Maintenance of anesthesia (pre CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Maintenance of anesthesia (during CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 IV infusion Weaning from CPB: Sufentanil 50 µg IV Maintenance of anesthesia (post CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Propofol infusion rate is titrated using bispectral index (40-60).
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention