bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Antibacterial Effect of Allium Sativum, Calcium Hydroxide and Their Combination in Infected Mature Teeth
Condition: Drug Effect
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study was to evaluate and compare garlic extract antibacterial effect when used as an
      intra-canal medicament in infected mature anterior teeth with calcium hydroxide and a mixture
      of calcium hydroxide and garlic, using real time PCR analysis.
    

Detailed description: 
      Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male
      children were selected. Teeth were randomly divided into three groups (n=22) according to
      intra canal medications used; group I: Ca OH2, group II: garlic extract and group III:
      mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples
      (S) were taken using sterile absorbent paper points as follows; (S1): were taken before canal
      instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples
      (S3) and forth samples (S4) were taken after placement of the tested intracanal medications
      into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from
      microbiological samples and relative quantitive real time PCR reactions were done to quantify
      the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species.
      Data was statistically analyzed using Kruskal-Wallis and Freidman's tests, followed by
      Mann-Whitney and Wilcoxon singed rank tests at significance level p ≤ 0.05.
    

Intervention name(s): Allium Sativum; Polymerase chain reaction
Intervention type(s): Drug; Device
Intervention description(s): Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male children were selected. Teeth were randomly divided into three groups (n=22) according to intra canal medications used; group I: Ca OH2, group II: garlic extract and group III: mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples (S) were as follows; (S1): were taken before canal instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples (S3) and forth samples (S4) were taken after placement of the tested intracanal medications into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from microbiological samples and relative quantitive real time PCR reactions were done to quantify the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species.; Change in the bacterial load in response to different treatment procedures
Other intervention name(s): Combination of Allium Sativum and Calcium hydroxide; Calcium hydroxide
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Calcium hydroxide; Enterococcus faecalis; Garlic; Intra-canal medication; Streptococcus; Quantitative real-time polymerase chain reaction
Ibuprofen Extended-Release Dental Pain Study
Condition: Pain; Post-Operative Pain; Third Molar Extraction
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of multiple doses of
      Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of
      third molar teeth.
    

Detailed description: 
      This is a single-center, multiple-dose, randomized, placebo-controlled, double-blinded,
      parallel group trial to evaluate the efficacy and safety of multiple doses of Ibuprofen 600
      mg Extended-Release Tablets in a study of dental pain following extraction of third molar
      teeth. The surgery will consist of surgical extraction of 1-2 impacted third molars, of which
      one must be a mandibular impaction that is partially impacted in either tissue or bone.
      Subjects will be stratified according to baseline pain intensity, as rated on an 11-point
      pain intensity numerical rating scale (PI-NRS)and gender.
    

Intervention name(s): Ibuprofen 600 mg Extended-Release Tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.; Placebo: One matching placebo tablet was taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.
Other intervention name(s): Ibuprofen 600 mg ER
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tranexamic Acid Versus Epinephrine During Exploratory Tympanotomy
Condition: Intraoperative Bleeding
MeSH terms: Blood Loss, Surgical
Study type: Interventional

Summary: 
      Exploratory tympanotomy is surgical access to the middle ear, made for diagnosis and
      management of unexplained conductive hearing loss, performed under an oto-microscope across
      the external auditory canal after tympanic membrane elevation to explore the middle ear
      structures
    

Detailed description: 
      Epinephrine is a vasoconstrictor searched intensively for ptimization of the surgical field
      during microscopic ear and sinus surgeries with controversial results given the possible
      cardiovascular complication in case of systemic absorption,especially in vulnerable cardiac
      patients.Tranexamic acid (TXA) as an antifibrinolytic medication is used to treat or prevent
      excessive bleeding in significant trauma, surgery, tooth removal, or nasal bleeding,
      discovered by Japanese researchers. TXA, given either oral or intravenous, is a derivative of
      lysine amino acid; it acts reversibly on the lysine binding sites to block it on the
      plasminogen molecules. TXA consequently hinders the stimulation of plasminogen competitively,
      thus reduces its conversion into plasmin. Plasminogen is the enzyme that leads to the
      degradation of a fibrin clot, fibrinogen, and other plasma proteins, such as factors V and
      VIII. More than 95% of TXA intravenous administered dose eliminated unchanged through the
      urinary system. Twenty-four hours after intravenous administration of TXA has demonstrated
      accumulative excretion of approximately 90%, whereas only 3% is bound to plasminogen. TXA is
      minimally excreted in breast milk while it can freely cross the blood brain barrier and the
      placenta .
    

Intervention name(s): Tranexamic Acid; Epinephrine
Intervention type(s): Drug; Drug
Intervention description(s): received topical 1 gram of TXA diluted in 200 ml of normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.; received Epinephrine 1 mg diluted in 200 ml normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.
Intervention MeSH terms: Epinephrine; Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Effects of Individualized Nutritional Intervention Program in Malnutrition Elderly With Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia; Malnutrition
Study type: Interventional

Summary: 
      To investigate the effects of an individualized nutritional intervention programs (iNIPs) on
      nutritional status and readmission rate in older adults with pneumonia during hospitalization
      and 3 and 6 months after discharge.
    

Detailed description: 
      Method: Eighty-two malnourished older adults with primary diagnosis of pneumonia
      participated. Patients were randomly allocated to either a nutrition intervention (NI) group
      or a standard care (SC) group. Participants in the NI group received an iNIP according to
      energy and protein intake requirements in addition to dietary advice based on face-to-face
      interviews with their family members during hospitalization. After discharge, phone calls are
      adopted for prescribing iNIPs. Anthropometry (i.e., body mass index, limb circumference, and
      subcutaneous fat thickness), blood parameters (i.e., albumin and total lymphocyte count),
      hospital stay, Mini-Nutritional Assessment-Short Form (MNA-SF) score, target daily calorie
      intake, total calorie intake adherence rate, and three-major-nutrient intake were assessed
      during hospitalization and 3 and 6 months after discharge. Both groups received regular
      follow-up through phone calls. Furthermore, the rate of readmission resulting from pneumonia
      was recorded after discharge.
    

Intervention name(s): Assigned Interventions
Intervention type(s): Other
Intervention description(s): Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs.
Other intervention name(s): The SC group was only provided standard nutritional supplements , and patients' family members were not provided dietary advice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: nutritional intervention; malnutrition; respiratory disease
ABC/Trident® Ceramic Post Approval Study
Condition: Arthroplasty, Replacement, Hip
Study type: Interventional

Summary: 
      The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to
      demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with
      the appropriate shell in a cementless application.
    

Detailed description: 
      The ABC/ Trident® study was initiated in 1996 as an FDA IDE pre-market study in the United
      States for alumina bearing THR. PreMarket Approval (PMA)application was approved in February
      3,2003. The Post Approval Study (PAS) involved six surgeon investigators from the original
      IDE study. Subjects who consented to participate in the Post Approval Study continued to be
      followed to collect limited patient reported data regarding status of the hip.
    

Intervention name(s): Trident® Ceramic Insert/Trident® AD HA Acetabular Shell; Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell; OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
Intervention type(s): Device; Device; Device
Intervention description(s): Trident® Ceramic Insert/Trident® AD HA Acetabular Shell; Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell; OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimized Radiological Diagnosis of Hepatic Candidiasis During the Treatment of Acute Leukemias
Condition: Leukemia; Infection
MeSH terms: Candidiasis; Leukemia
Study type: Observational

Summary: 
      Hepatic candidiasis is a frequent complication in patients receiving intensive chemotherapy
      for acute leukemia. Hepatic lesions may be detected by computerized tomographic (CT) scans,
      but there is no standardized CT protocol for the diagnosis and follow-up of hepatic
      candidiasis.

      The investigators compared the size of the fungal lesions in the chest and abdomen CT. The
      current analysis aimed to increase the value of CT for the diagnosis and the follow-up of
      hepatic candidiasis in daily routine.
    


Intervention name(s): Imaging
Intervention type(s): Behavioral
Intervention description(s): CT image validation and lesion measurement, as well as comparison of different CT phases
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with suspected hepatolienal candidiasis.
      
Keywords: Computed tomography
Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program
Condition: Lower Extremity Weakness Distal; Distorted; Balance
Study type: Interventional

Summary: 
      Older adults at high risk of falls will complete the PA Healthy Steps program. This program
      will be implemented by research staff who will follow the training manual and implement the
      program as it was designed to assess the effectiveness of the program. Participants will then
      be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which
      adherence to physician and home safety assessments will be facilitated; and (iii) Healthy
      Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All
      participants will be followed monthly for 6 months through personal and automated telephone
      interview protocols to ascertain falls and injuries.
    

Detailed description: 
      This falls prevention program is offered in 11 senior housing sites. Trained instructors from
      the research team provide the Healthy Steps in Motion exercise classes. Participants provide
      a signed form indicating physician clearance for participation. Falls case management
      involves monthly calls to speak with participants about home safety checks, perceived risk
      for falls, and physician contact or other visits to health care professionals to reduce falls
      risk.

      This study is a pilot. The research team is interested in participation and adherence, as
      well as the primary outcome of falls incidence.
    

Intervention name(s): Assessment and education; Healthy Steps with Falls Case Management; Healthy Steps in Motion
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): PA Healthy Steps program; Counseling to ensure that participants receive a physician assessment and home safety check; Group exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Falls; exercise; safety; injury; Older adults
Ischemic Post-conditioning in Acute Ischemic Stroke Thrombectomy
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate
      reperfusion injury in animal models of stroke. The purpose of this proof-of-concept study is
      to determine the safety and tolerability of ischemic post-conditioning in patients with acute
      ischemic stroke who are treated with mechanical thrombectomy.
    


Intervention name(s): Local ischemic post-conditioning
Intervention type(s): Procedure
Intervention description(s): Direct local ischemic post-conditioning will be applied after successful recanalization of the culprit middle cerebral artery. Local ischemic post-conditioning consists of briefly repeated 4 cycles of occlusion and reperfusion (equal duration) of the initially occluded culprit middle cerebral artery using a balloon. The schedule of advancing duration is 0 " 1 " 2 " 3 " 4 " 5 min.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute ischemic stroke; ischemic postconditioning; endovascular thrombectomy
An Open-Label Clinical Study to Evaluate the Efficacy of a Face Cream and Eye Cream
Condition: Wrinkle; Photoaging; Fine Lines
Study type: Interventional

Summary: 
      This single-center clinical trial is being conducted to assess the efficacy and tolerability
      of an anti-aging eye cream and face moisturizer when used over the course of 12 weeks
      twice-daily by women, 35-65 years, with mild to moderate droopy eyelids, moderate crow's feet
      wrinkles, and moderate global facial photodamage.
    

Detailed description: 
      This was an institutional review board (IRB)-approved study. Female subjects, 35-65 years of
      age, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet
      wrinkles, and moderate global photodamage were recruited. Subjects applied a multi-ingredient
      anti-aging face moisturizer and eye twice-daily for 12 weeks. Subjects were provided with a
      gentle cleansing lotion and a sunscreen SPF 40+ to be utilized during the course of the
      study.

      Clinical grading of efficacy and tolerability parameters, VISIA-CR imaging, raking light
      VISIA analysis, skin pH, Tewameter, and pinch recoil measurements were performed at baseline,
      weeks 4, 8, and 12. Optical coherence tomography (OCT) imaging was performed at baseline and
      week 12.

      A total of 42 subjects completed the study.
    

Intervention name(s): Gentle Cleansing Lotion, Revision Skincare; Aveeno Face Milk SPF 40+
Intervention type(s): Other; Other
Intervention description(s): Gentle cleansing lotion to be used by study participants; Sunscreen to be applied after application of face moisturizer and eye cream in the morning. Participants were asked to apply the sunscreen if sun exposure was more than 30 minutes per day.
Intervention model: Single Group Assignment
Intervention model description: Open-label study. 45 female subjects recruited, 35 to 65 years, Fitzpatrick skin type I-VI, with mild to moderate droopy eyelids, moderate crow's feet wrinkles, and moderate global photodamage.
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of Osmotic Release Oral Delivery System Methylphenidate (OROS MPH) Upon Family of Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether familial relationships and psychological
      status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder
      (ADHD) symptoms of participants can be improved by switching from Immediate-release
      Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH).
    

Detailed description: 
      This is a prospective (study following participants forward in time), single-arm, open-label
      (all people know the identity of the intervention), 8-week, multi-centric (conducted in more
      than 1 center) study. OROS-MPH will be administered orally for 2 months at doses of 18, 36,
      or 54 milligram (mg) to replace IR-MPH. Clinicians will adjust the dose of each participant
      according to participant's clinical responses and/or side effects. During the study period,
      participants will be assessed on Week 2, 4, and 8. Efficacy will be evaluated primarily based
      on change from baseline in Chinese version of the 26-item Swanson, Nolan and Pelham-Fourth
      Edition (SNAP-IV) rating scale assessed by parents and Chinese Health Questionnaire (CHQ).
      Safety will be monitored throughout the study.
    

Intervention name(s): OROS Methylphenidate
Intervention type(s): Drug
Intervention description(s): Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Disorder With Hyperactivity; Methylphenidate; Concerta
Relative Risk of Hypertension Among Obese
Condition: Obesity
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Observational study was conducted to determine the relative risk of hypertension among young
      adult obese population of Pakistan with age between 25-40 years
    


Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): observational study
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Obese young adult population of BMI <25kg/m2
Optimised Recovery With Accelerated Nutrition and GI Enhancement
Condition: Colorectal Liver Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled
      pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS)
      programmes are perioperative care pathways that address systematically these issues (i.e.
      improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to
      promote a faster recovery and a shorter stay. The key treatments that improve outcome within
      an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to
      assess key outcome variables such as return of GI function. This randomised trial will assess
      the potential synergy between early recovery of GI function (laxation) and early
      postoperative oral nutritional support(with associated preoperative preconditioning using
      carbohydrate/fluid loading). The main overall outcome targets being improved recovery of
      gastrointestinal function, postoperative nutritional status and physical function. It will
      validate the use of a novel, objective technique to measure gastric motility (surrogate for
      GI function). Such refinement of ERAS should result in shorter hospital stay and better use
      of limited health care resource.
    


Intervention name(s): Post operative laxation (Magnesium Oxide); Preoperative metabolic conditioning postoperative nutritional supplementation; Standard ERAS group
Intervention type(s): Drug; Dietary Supplement; Other
Intervention description(s): 20 ml of Magnesium Oxide twice daily from the day after surgery until discharge; Nutricia PreOP drinks 800 ml between 8-10 pm the evening before surgery Nutricia PreOP drinks 400 ml completed 2 hours before anaesthesia on the morning of surgery Nutricia Fortisip drinks 2 x 200 ml drinks from the day after surgery until day 30
Intervention MeSH terms: Magnesium Oxide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Perioperative; recovery; nutrition; enhanced; laxative