bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant Supported Overdenture
Condition: Prosthesis User
Study type: Interventional

Summary: 
      This study aims to evaluate the clinical and radiographic outcomes for mandibular
      implant-supported overdenture using two different types of locator attachment after 3 years
      of using the two types of locator attachments
    


Intervention name(s): implant supported overdenture
Intervention type(s): Procedure
Intervention description(s): patients would be delivered mandibular implant overdenture using conventional locator and Locator RTX attachments
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All patients in this study will be divided into two equal groups Group I (control): patients who would be delivered mandibular implant overdenture using conventional locator attachments.
Group II (study): patients who would be delivered mandibular implant overdenture using Locator RTX attachments
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy
Condition: Type 1 Diabetes Mellitus With Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the investigators study was to determine the effect of dietary protein
      restriction on survival and progression to end stage renal disease (ESRD) in diabetic
      nephropathy.
    

Detailed description: 
      The study was a prospective, randomized, unmasked, controlled trial carried out at the Steno
      Diabetes Center. With concealed randomization the patients were (in blocks of two according
      to the level of GFR) assigned to receive either a usual-protein diet or a low-protein diet.

      After randomization an iso-caloric low-protein diet of 0.6 g/kg/day was prescribed to
      patients in the low-protein diet group. The usual-pro tein diet consisted of the patients'
      pre-study diet.

      The planned duration of follow-up was four years, scheduled visits every three-months. All
      patients gave complete history of medication, underwent examination of weight, urinary
      albumin-, sodium- and urea excretion, serum albumin, serum urea, hemoglobin, hemoglobin A1c,
      blood pressure, serum total-cholesterol, high-density lipoprotein (HDL) cholesterol.

      GFR, serum triglycerides,calcium and phosphorous, anthropometric measurements, nutritional
      status and smoking habits were evaluated every six months.

      Dietary protein intake was estimated on the basis of three consecutive 24-hour urine samples
      completed before each visit, using urinary excretion of urea nitrogen.

      GFR was measured by plasma clearance of 51Cr-EDTA over a 4 hour period and standardized for
      1.73m2 body surface area using the same surface for each patient during the study.
    

Intervention name(s): low protein diet; normal protein diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): An iso-caloric low protein diet of 0.6 g/kg/day was prescribed during the whole study duration.
The same dietician gave nutritional advices at least every three months during the whole study period. Patients were also seen by the same doctor during each visit for the whole study period.
Supplementation of Calcium of 500mg/day.
Urine albumin losses >= 2 g/day wre replaced by increasing dietary protein on a gram-for-gram basis, only if the patient was compliant with the prescribed low-protein diet.; The patients pre-study diet during the whole study period
Patients were also seen by the same doctor during each visit for the whole study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: survival; protein restriction; diabetic nephropathy; type 1 diabetes; GFR; ESRD; progressive renal disease
Unrelated Stem Cell Transplantation for Adults With Hematopoietic Disorders
Condition: CML; ALL; AML; Myelodysplasia; Lymphoma; Myeloproliferative Disorders
MeSH terms: Preleukemia; Myeloproliferative Disorders; Myelodysplastic Syndromes
Study type: Observational

Summary: 
      This study performs HLA matched stem cell transplantation from unrelated donors in adults who
      require stem cell transplantation but do not have a matched related donor available. The
      incidence of graft-versus-host disease in unrelated stem cell transplantation is recorded.
      This study also monitors the activity and toxicity of total body irradiation and
      cyclosphosphamide followed by stem cell transplantation from matched unrelated donors.
    

Detailed description: 
      This protocol identifies a standard-of-care method for unrelated stem cell transplantation in
      adults. Performing this service in a consistent and documented fashion allows investigators
      to obtain informed consent from recipients. Data is tabulated locally for quality-control
      comparisons with nationally-reported standards. As a condition of maintaining transplant
      center status and to have acess to NMDP-registered donors, UCSF submits clinical and outcome
      data to the NMDP. As a result, UCSF is contributing to the resolution of remaining
      uncertainties regarding particular transplantation practices.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Hematopoeietic Disorders
      
Keywords: AML; ALL; CML; Lymphoma; Myelodysplasia; Unrelated stem cell transplantation; Hematopoietic disorders
ICCAC-ToNF & Tinnitus
Condition: Tinnitus, Subjective
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Prevalence of chronic subjective tinnitus is rising with age and associated with maladaptive
      oscillatory changes in auditory as well as non-auditory regions of the brain such as the
      insula and the anterior cingulate cortex which are known to be key points within the salience
      and distress networks of the brain.Thus, we are conducting a clinical trial by implementing
      those auditory as well as non-auditory regions into a tomographical neurofeedback Training
      (ToNF) -protocol.

      Prior to 12 electroencephalography (EEG) -based ToNF-trainings with 36 older participants
      using standardized Low Resolution Electromagnetic Tomography Software (sLORETA,
      Pascual-Marqui 2002), participants' brains will be measured using structural magnet resonance
      imaging (sMRI) in order to identify potential structural markers for training success (e.g.
      cortical thickness).

      Training success will be measured by oscillatory change via EEG before and after the training
      period as well as by means of follow-up measures. Furthermore, a comprehensive battery of
      behavioral and psychometric standardized self-report questionnaires will be applied.

      Based on this multifocal (Insula, dorsal anterior cingulate cortex & auditory cortex) ToNF we
      expect oscillatory changes resulting in decreased tinnitus symptoms such as perceived
      loudness and distress.
    


Intervention name(s): tomographic EEG Neurofeedback Training
Intervention type(s): Other
Intervention description(s): EEG-Electrodes are placed on the patients head to record the brain activity, EEG-recordings are processed by the standardized Low Resolution Brain Electromagnetic Tomography algorithm (sLORETA) to calculate the frequency spectrum in the auditory cortex, the insula and the anterior cingulate cortex and deliver feedback for the patient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
To Evaluate Whether Acetyl Salicylic Acid (Aspirin) and Darexaban (YM150) Interact in Their Effects
Condition: Pharmacodynamic and Pharmacokinetic Interaction; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate whether ASA and darexaban which have
      different effects on blood coagulation influence each other in their effects. Also it will be
      investigated whether the blood levels of either drug are influenced by the presence of the
      other drug. In addition, the safety and tolerability of each drug and the combination of the
      drugs will be investigated.
    


Intervention name(s): Darexaban; Acetyl Salicylic Acid (ASA)
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): YM150; Aspirin
Intervention MeSH terms: Aspirin; Salicylic Acid; Salicylates; Darexaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacodynamics; pharmacokinetics; darexaban; Acetyl Salicylic Acid; darexaban glucuronide; YM150; YM-222714; Phase 1
Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to explore the efficacy and safety of DA-4001 after topical
      application in male patients with androgenetic alopecia

      Design : Randomized, double-blind, active-controlled study

      Investigational Product : Finasteride, minoxidil
    


Intervention name(s): DA-4001C; 5% minoxidil
Intervention type(s): Drug; Drug
Intervention description(s): 1ml by topical application twice a day; 1ml by topical application twice a day
Other intervention name(s): minoxyl
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Developing of Virtual Reality Based Neurologic Examination Teaching Tool(VRNET)
Condition: Medical Students
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of the virtual reality based neurologic
      examination teaching tool(VRNET) for medical students. VRNET is a new teaching tool for
      neurologic examinations by offering different neurologic signs of the face, with which
      medical students can experience more realistic patients.
    


Intervention name(s): Standard patients with VRNET; standard patients
Intervention type(s): Other; Other
Intervention description(s): In group of standard patients with VRNET, the medical students examine the standard patient of neurologic deficits. When they examine, they get some information of neurologic signs via the VRNET which presents neurologic deficits directly by alternating facial expressions. The students should interpret that signs to have a diagnosis.; In group of standard patients, those neurological deficits are presented only by words or pictures which are not realistic.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: standardized patients with VRNET
standardized patients
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Pharmacokinetics And Relative Bioavailability Study Of Oxycodone
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      To estimate the pharmacokinetics and relative bioavailability of oxycodone after
      administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution
    

Detailed description: 
      This study will estimate the PK and relative bioavailability of oxycodone following single
      oral 40-mg doses of 3 modified PF-00345439 Formulations B, C, and D compared with the
      reference Formulation A under fed conditions.
    

Intervention name(s): Oxycodone; Oxycodone; Oxycodone; Oxycodone; Oxycodone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1X40 mg PF-00345439 formulation A capsule with water and under fed condition; 1X40 mg PF-00345439 formulation B capsule with water and under fed condition; 1X40 mg PF-00345439 formulation C capsule with water and under fed condition; 1X40 mg PF-00345439 formulation D capsule with water and under fed condition; 40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; relative bioavailability; oxycodone
Oral Bioavailability of Two Solid Formulations of GLPG0634
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the amount of compound present in the blood (relative
      bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in
      fasted conditions in male healthy subjects.

      Also, the effect of food on the bioavailability of the tablet formulation will be studied as
      well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule
      or tablet.
    


Intervention name(s): 200 mg GLPG0634 as capsules, fasted; 200 mg GLPG0634 as tablets, fasted; 200 mg GLPG0634 as tablets, fed
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral dose of 200 mg GLPG0634 given as capsules in fasted condition; single oral dose of 200 mg GLPG0634 given as tablets in fasted condition; single oral dose of 200 mg GLPG0634 given as tablets in fed condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Anesthesia on Force Application During Colonoscopy
Condition: Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases
MeSH terms: Colonic Diseases
Study type: Observational

Summary: 
      The aim of the study is to determine if more force is used during colonoscopy when patients
      receive monitored anesthesia with propofol versus conscious sedation. Force measurements will
      be performed using the colonoscopy force monitor (CFM). This device measures the magnitude
      and direction of force applied to the insertion tube of a standard colonoscope during
      colonoscopy.
    

Detailed description: 
      Randomized factorial design of colonoscopy with either propofol administered anesthesia or
      conscious sedation. Twelve experienced endoscopists from community and academic centers will
      perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for
      each endoscopist for a study total of 144 patients. An equal number of male and female
      patients will be included in each group.
    

Intervention name(s): Colonoscopy Force Monitor
Intervention type(s): Device
Intervention description(s): Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.
Other intervention name(s): CFM
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All adult male and female patients between the ages of 30 and 75 presenting to the
        participating sites for screening or diagnostic colonoscopy to be performed by any of the
        investigators will be considered for inclusion.
      
Keywords: Colonoscopy; Force; Monitor; Endoscopist; Conscious; Sedation; Propofol
Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme
Condition: Malignant Glioma
MeSH terms: Glioblastoma; Glioma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the
      treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme.
    


Intervention name(s): NPC-08
Intervention type(s): Drug
Intervention description(s): Polifeprosan 20 with Carmustine 3.85%
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NPC-08; carmustine; nitrosourea; safety
Comparison of O-type Hybrid Knife and IT Knife in ESD
Condition: Esophageal Cancer; Esophageal Dysplasia; Stomach Cancer; Stomach Dysplasia
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      By combining injection and dissection capability together, O-type Hybrid knife could possibly
      shorten the endoscopic submucosal dissection procedure for upper gastrointestinal neoplasms.
    

Detailed description: 
      Endoscopic submucosal dissection (ESD) has been accepted as an minimal invasive alternative
      to surgery for localized early upper gastrointestinal neoplasms recently. However, the
      procedure remains to be technically challenging and time consuming. Many modified methods or
      newly developed devices were developed to simplify the procedure. A new insulated tip
      dissecting knife (O-type Hybrid knife) has been recently developed with both injection and
      lateral cutting capability. The aim of this study was to investigate whether ESD procedure
      could be shortened with this new device.
    

Intervention name(s): Hybrid knife; IT knife
Intervention type(s): Device; Device
Intervention description(s): Use Hybrid knife in ESD procedure; Use IT knife in ESD procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cancer; endoscopy; endoscopic submucosal dissection
Clinical Application of Er:YAG Dental Laser System
Condition: Laser Therapy
Study type: Interventional

Summary: 
      The study aim was to evaluate the effectiveness of Er:YAG dental laser treatment modality for
      cavity, sensitive teeth, abnormal frenum attachment and peri-implantitis.
    

Detailed description: 
      There are four indications will be included in this plan. They are Cavity, Sensitive Teeth,
      Abnormal Frenum Attachment and Peri-implantitis. Each indication has different procedures
      which are listed as below:

      Cavity: history records, affected range check, X-ray&photo, treatment, pain index check,
      return visit check after two weeks. Sensitive Teeth: history records, sensitive check,
      X-ray&photo, treatment, pain index and effectiveness check, return visit check after two
      weeks. Abnormal Frenum Attachment: history records, abnormal position check, photo, cutting,
      pain index check, return visit check after three, five and seven days. Peri-implantitis:
      History records, measure periodontal pocket depth, anaerobes collect, X-ray, photo, CT,
      treatment, pain index check, return visit check after one week, two weeks, four weeks and
      three months, six months check the effectiveness and collect anaerobes during every return
      visit. In the last return visit, X-ray and CT would be included.
    

Intervention name(s): Er:YAG dental laser
Intervention type(s): Device
Intervention description(s): To treat Cavity, Sensitive Teeth, Abnormal Frenum Attachment and Peri-implantitis by using Er:YAG Dental Laser system which manufactured by LightMed Dental Technology Corp
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Er:YAG; dentistry
Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal
      product in seasonal allergic rhinitis patients.
    


Intervention name(s): bepotastine besilate nasal product - low dose; bepotastine besilate nasal product - medium dose; bepotastine besilate nasal product - high dose; placebo comparator nasal product
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sterile nasal product; sterile nasal product; sterile nasal product; sterile nasal product
Intervention MeSH terms: Bepotastine besilate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the persistence of immune response 5 years and 6 years after the first vaccine
      dose.
    

Detailed description: 
      Open, randomised, long-term antibody persistence studies, conducted in 2 centers. Immune
      persistence was compared between subjects who received two doses of GSK Biologicals combined
      hepatitis A and hepatitis B vaccine at either 0, 6 month schedule or 0, 12 month schedule.
      These long-term follow-up studies involved taking blood samples at approximately 5 and 6
      years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody
      persistence and a retrospective safety follow-up.
    

Intervention name(s): Combined Hepatitis A and B vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Topiramate Bioequivalence Study Brazil - Fast
Condition: Epilepsy, Tonic-Clonic
MeSH terms: Epilepsy, Generalized; Epilepsy, Tonic-Clonic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods. The volunteers received, in each period, the
      reference or the test formulation, according to the randomization list, under fasting
      conditions, in order to evaluate if the reference and test formulations are bioequivalent.
    

Detailed description: 
      This study is prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 seuqences and 02 periods. The objective is to confirm if two formulations of
      topiramate 100 mg, coated tablet, are bioequivalent, after oral, single-dose administration
      under fasting conditions. The test product is topiramate 100 mg produced by Dr. Reddy's
      Laboratories Ltd. and the reference product is Topamax® marketed by Janssen-Cilag
      Farmacêutica Ltda. Twenty-eight healthy male volunteers were evaluated. The volunteers
      received, in each period, the test or the reference formulation, according to the
      randomization list. In each period, blood samples are collected in the following times: 00:00
      (prior to the administration of medication); 00:20; 00:40; 01:00; 01:30; 02:00; 02:30; 03:00;
      03:30; 04:00; 05:00; 06:00; 08:00; 12:00; 16:00; 20:00; 24:00; 48:00; 72:00; 96:00; 120:00;
      144:00; 168:00; 192:00. The comparative bioavailability of the two formulations was evaluated
      based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data
      of drug concentrations in blood.
    

Intervention name(s): Topiramate coated tablet; Topamax® coated tablet
Intervention type(s): Drug; Drug
Intervention description(s): Test formulation; Reference formulation
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other