bioihbjkbjnl/mcl2 huggingface dataset:
Nebulized Dexmedetomidine Versus Neostigmine/Atropine in Postdural Puncture Headache
Condition: Postdural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      In our study, we will compare a new route of nebulization for effectiveness between
      dexmedetomidine, neostigmine/atropine and saline placebo for females complained of postdural
      puncture headache (PDPH) after cesarean section.
    

Detailed description: 
      A written informed consent will be taken from the patients. The study will involve female
      adults (age 18-40years) of American society of anesthesiologists (ASA) I-II who are listed
      for elective cesarean section under spinal anesthesia and suffer from postoperative postdural
      puncture headache (PDPH). Patients will be assigned randomly to three groups (30 subjects
      each) after PDPH diagnosis was established. First 90 patients developed PDPH will be assessed
      for study eligibility.

      Group D (patients will receive ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in
      4 mL saline) twice daily for three days. Group N (patients will receive nebulization of 20
      µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days. Group S
      (patients will receive nebulization of saline placebo in 4 ml) twice daily for three days.
    

Intervention name(s): Dexmedetomidine; Neostigmine/atropine; Saline placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.; nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.; nebulization of saline placebo in 4 ml) twice daily for three days.
Other intervention name(s): Precedex; Normal saline
Intervention MeSH terms: Atropine; Dexmedetomidine; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Placebo Controlled Trial of a Titanium Dioxide Semiconductor Toothbrush on Mild-to-moderate Gum Disease
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The effects on indices of gingivitis/periodontitis will differ between study arms in which
      the titanium dioxide semiconductor toothbrush is used, compared to an otherwise identical
      toothbrush with an inert resin core in place of the titanium dioxide semiconductor.
    

Detailed description: 
      Organic acid producing anaerobic bacteria are implicated in the development and progression
      of gingivitis and periodontal disease (Brill, 1962; Kleinberg, 1974). The disease process
      manifests as periodontal inflammation and tissue destruction (Oliver et al, 1969). Although
      relatively crude methods are used for routine clinical diagnosis and monitoring of
      periodontal disease (eg, probing for gingival pocket depth and bleeding), sensitive and
      reproducible measures of periodontal disease have been validated (Oliver et al, 1969; Löe et
      al, 1965; Egelberg, 1964; Golub et al, 1976; Borden et al, 1977).

      By the Lewis definition, an acid is an electron pair acceptor. In the presence of light &/or
      electrical induction, valence electrons from a wetted titanium dioxide (TiO2) semiconductor
      will donate electron pairs to neutralize organic acids. Whereas a tooth surface is negatively
      charged, plaque has a net positive charge, and in part, ionic attraction contributes to the
      adherence of plaque to the tooth surface. Donating electrons to the plaque will alter
      polarity and diminish the ionic attraction between the plaque and the tooth surface
      (iontophoretic effect).

      Thus, in addition to the established mechanical benefits of brushing, the flow of electron
      pairs for disrupting ionic bonding of plaque to the tooth surface and neutralizing bacterial
      organic acids, may confer an advantage over a conventional toothbrush (Hoover et al, 1992;
      Niwa et al, 1989; Kusunoki et al, 1986). There is some evidence that the electrons may also
      interact with bacterial coenzyme-A to have an antibacterial effect (Morioka et al, 1988;
      Onoda et al, 1996).
    

Intervention name(s): Soladey-3 toothbrush; Placebo Soladey-3 toothbrush
Intervention type(s): Device; Device
Intervention description(s): subject to brush with experimental Soladey-3 brush for 4 week; subjects will brush with placebo Soladey-3 toothbrush for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontal disease; toothbrush; titanium dioxide semiconductor; mild-to-moderate periodontal disease; adult patients 18 to 70 years of age
Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions
Condition: Skin Neoplasms
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      This study is designed to monitor patient safety after excision of skin lesions and
      subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5
      for controlling bleeding in skin wounds.
    

Detailed description: 
      This is a randomized, controlled single-blind pilot study to evaluate the safety and
      performance of AC5 following excision of lesions from the trunk or upper limbs under local
      anesthetic, in patients currently prescribed or not prescribed antiplatelet monotherapy.

      Each patient had sequential shave excision of two lesions (one treatment, one Control) at the
      same sitting. The sequence of wound treatment (AC5 first or Control first) was randomized.

      Study and Control treatments were administered immediately after lesion excision, followed by
      determination of time to hemostasis (TTH), and application of an occlusive water-resistant
      dressing
    

Intervention name(s): AC5 Topical Hemostatic Device
Intervention type(s): Device
Intervention description(s): Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: topical hemostat; self-assembling peptide barrier
Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
Condition: Thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy of antioxidant cocktails on the
      alleviation of oxidative stress and iron overload in beta-thalassemia/Hb E patients.
    

Detailed description: 
      60 cases of beta-thalassemia/Hb E patients. All patients will be diagnosed with hemoglobin
      typing of beta-thalassemia/Hb E disease and not receive blood transfusion or any treatment at
      least 3 months prior study. The study will be randomized controlled trial that designed
      before and after treatment with antioxidant cocktail. The antioxidant cocktail consists of
      vitamin E 400 IU/day, curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50
      mg/kg/day. All patients will receive antioxidant cocktail daily for 12 months. The patients
      will be regularly followed up and analyzed biochemical parameters every two months during
      treatment and after withdrawal for 3 months.
    

Intervention name(s): curcuminoids, N-acetylcysteine, deferiprone and vitamin E; Curcuminoids and alpha-tocopherol
Intervention type(s): Drug; Drug
Intervention description(s): receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day; group 1: receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day group 2: receiving vitamin E 400 IU/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day
Other intervention name(s): curcuminoids 500 mg brand name Anti-Ox; N-acetylcysteine 200 mg brand name Mysoven; deferiprone 50 mg/kg/day brand name GPO-L-ONE; vitamin E 400 IU/day brand name Natural
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Acetylcysteine; N-monoacetylcystine; Deferiprone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Thalassemia; Oxidative stress; antioxidant cocktail
Microbes and Bariatric Surgery
Condition: Obesity; Diabetes; Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Observational

Summary: 
      The investigators will study people who are obese and will be treated by bariatric surgery.
      The investigators will test the hypothesis that some of the features of obesity are related
      to the bacteria in the gastro-intestinal tract.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with obesity who are already accepted for treatment by bariatric surgery in
        Syracuse NY
      
Biospecimen description: 
      Bacterial samples from dental plaque and feces, and serum
    
Keywords: Obesity; Diabetes; Periodontal disease
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily
      doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal
      women with an intact uterus.
    


Intervention name(s): Ospemifene (Dose 1); Ospemifene (Dose 2); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopausal symptoms; Urogenital atrophy; Vulvar and vaginal atrophy in menopausal women; Vaginal atrophy
Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
Condition: Cholelithiasis; Choledocholithiasis; Cholecystolithiasis; Pancreatitis; Cholangitis
MeSH terms: Pancreatitis; Cholangitis; Cholelithiasis; Cholecystolithiasis; Gallstones; Choledocholithiasis
Study type: Interventional

Summary: 
      This study aims to evaluate post-operative pain in single-incision laparoscopic
      cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators
      hypothesize that SILC is non-inferior in post-operative pain.
    

Detailed description: 
      As above
    

Intervention name(s): SILC; LC
Intervention type(s): Procedure; Procedure
Intervention description(s): Underwent single-incision laparoscopic cholecystectomy; Underwent conventional 4-port laparoscopic cholecystectomy
Other intervention name(s): Single-incision laparoscopic cholecystectomy; Conventional laparoscopic cholecystectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis
Condition: Autoimmune Thyroiditis
MeSH terms: Thyroiditis; Thyroiditis, Autoimmune; Hashimoto Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether low-level Laser therapy is effective in
      ameliorating the thyroid function of patients with hypothyroidism caused by chronic
      autoimmune thyroiditis.
    

Detailed description: 
      Chronic autoimmune thyroiditis (CAT) is the most common cause of hypothyroidism in
      iodine-replete areas. An autoimmune dysfunction causes humoral and cellular responses that
      lead progressively to thyroiditis. There is no effective therapy available that can change
      the natural history of CAT, which presents a high incidence of hypothyroidism and requires
      continuous treatment with levothyroxine (LT4).

      Laser light can be valuable since the local and systemic actions of low-level laser therapy
      (LLLT) have been shown to be effective in treating autoimmune diseases, such as rheumatoid
      arthritis and Sjogren's syndrome. There is also evidence suggesting that LLLT can facilitate
      regeneration of various tissues and, in animal thyroids, can lead to improvement in
      microcirculation and increases in serum triiodothyronine (T3) and thyroxine (T4) levels.
      Since the LLLT is a non-invasive, cost-effective and painless procedure, the objective of
      this randomized clinical trial was to evaluate the effectiveness of LLLT in patients with
      hypothyroidism caused by chronic autoimmune thyroiditis, based on patients' thyroid function,
      their concentration of thyroid autoantibodies, and the parameters of their ultrasonography
      study.
    

Intervention name(s): Low-level Laser therapy
Intervention type(s): Device
Intervention description(s): A continuous wave (CW) diode laser device (830nm, infrared) with a beam area of 0.2827cm2 and using the punctual method, continuous emission mode, output power of de 50mW and fluence of 70J/cm2 (40 seconds at the point of application).
Other intervention name(s): Low intensity Laser therapy; Low power Laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autoimmune Thyroiditis, Laser, Therapy, Thyroid, Ultrasound
Phase III Study of ASP2151 in Herpes Simplex Patients
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.
    

Detailed description: 
      A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to
      evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial
      herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint
      defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment"
      to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on
      adverse events, laboratory tests, vital signs, and ECGs.
    

Intervention name(s): ASP2151; ASP2151 placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg once daily; once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional
Phase: Phase 4

Summary: 
      We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with
      effusion.
    

Detailed description: 
      Treatment groups would be:

        1. Cefpodoxime + oxymetaxoline drops + levocetirizine

        2. Fluticasone intranasal spray

        3. Short term oral steroids

        4. Wait and watch
    

Intervention name(s): Mometasone 50 Mcg/Inh Nasal Spray; Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%); Steroid Drug (prednisolone)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One spray in each nostril once daily for one month; Children in this group will be treated with antiboitics (syp cefpodoxime) at 10 mg/kg/day in two divided dose for a week, plus antihistamine and nasal decongestants. Oral levocetirizine (Syrup levocet 2.5 mg/5ml) 1.25 mg once daily for age up to six years, 2.5 mg once daily for elder children for a month, plus oxymetazoline (Nasivion) 0.025%, 4 drops twice daily for two weeks; This group will be treated with steroid drugs. Oral prednisolone, 1 mg/kg body weight daily in two divided dose for 1 week followed by half mg/kg/day in two divided dose for next one week.
Other intervention name(s): Metaspray nasal spray; Syp Cefpodoxime, Syrup levocetirizine 2.5mg/ml; Nasivion drop
Intervention MeSH terms: Mometasone Furoate; Cetirizine; Anti-Bacterial Agents; Cefpodoxime; Prednisolone; Phenylephrine; Oxymetazoline; Nasal Decongestants; Levocetirizine; Histamine Antagonists; Histamine H1 Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Effect Of Virtual Reality Glasses On The Behavior Of Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The aim of this study is to determine whether the use of virtual reality glasses showing an
      immersive video simulation of the dental visit will help decrease anxiety at future
      appointments by decreasing the element of surprise and increasing the patient's familiarity
      and comfort level with a specific dental practice environment.
    

Detailed description: 
      After an initial baseline data collection visit to the dental clinic, patients will be placed
      in the virtual reality (VR) group or the no VR group. Caregivers in the VR group will be
      given VR glasses. They will be instructed how to access the video and use the glasses. The
      child/wearer of the glasses will feel immersed in the three-dimensional environment and be
      able to look around the room as they move down the hallways in the video. The caregiver will
      be encouraged to have the child wear the VR glasses as often as possible and record the
      number of times the video is watched. The caregiver will fill out a "records form" which will
      include the date and time the video was watched. Both groups will then return to the clinic
      for follow up data collection visit.
    

Intervention name(s): Simulated dental office visit
Intervention type(s): Behavioral
Intervention description(s): An immersive first-person point of view (POV) video simulation of the dental office in the three-dimensional environment (using a virtual reality headset) which allows participant to look around the room as they move down the hallways which is to be watched/experienced by the participant as often as possible between the initial visit and the follow up visit
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Study is parallel design with control group having the option of receiving treatment after study data is collected from initial treatment group
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effects of EED on Zn Absorption and Retention in Children From a MNP
Condition: Environmental Enteric Dysfunction; Zinc Deficiency
Study type: Interventional

Summary: 
      The overall objective is to determine the impact of EED on total daily zinc absorption of
      young Bangladeshi children (18-24 months of age) in an austere setting with high rates of
      diarrhea, stunting, and micro-nutrient deficiencies..
    

Detailed description: 
      Participating children are screened for EED using the lactulose:mannitol ratio test and
      assigned to one of two groups: +EED or -EED. After assignment to one of the two groups,
      proposed subjects will be randomized to one of four supplement groups: Micronutrient powder
      (MNP) with 15 mg Zn, MNP with 10 mg Zn, MNP with 5 mg Zn, and MNP with 0 mg Zn. Children will
      receive the supplement once with a meal on Day 8 of the study. Absorption of zinc from the
      supplement and from other non-supplemented meals will be determined using zinc stable isotope
      technology.
    

Intervention name(s): Micronutrient Powder (MNP) + 15 mg Zn; MNP + 10 mg Zn; MNP + 5 mg Zn; MNP without Zn
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Children will have the supplement powder added to one meal on study day 1. Absorption of zinc from this meal will be measured using zinc stable isotope techniques.; Same as above except MNP will contain 10 mg Zn; Same as above except MNP will contain 5 mg Zn; Same as above except MNP will not contain Zn
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: environmental enteric dysfunction; environmental enteropathy; zinc absorption; Bangladesh; toddlers; zinc isotope
Effect of AN-PEP Enzyme on Gluten Digestion in Gluten Sensitive Individuals
Condition: Non-coeliac Gluten Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      In this trial, the effect of a low and a high dose AN-PEP will be investigated in gluten
      sensitive individuals. Volunteers receive a breakfast with background (0.5 g) gluten.
      Capsules are taken in the morning within 5 min after start of breakfast. Gastrointestinal
      fluid will be sampled over 3 hours to measure gluten degradation. After 5 volunteers have
      completed 3 test days, a blind interim analysis is performed by a third party based on which
      it is decided whether to proceed with the low AN-PEP dose.
    


Intervention name(s): AN-PEP; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two pills are consumed in the morning with a breakfast
Other intervention name(s): Aspergillus Niger-Prolyl Endopeptidase
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: enzyme; gluten; food intolerance