bioihbjkbjnl/mcl2 huggingface dataset:
Investigation of the Effect of Epicondylitis Band and Wrist Orthosis
Condition: Splints
Study type: Observational

Summary: 
      Muscles that are frequently injured in the extensor group are extensor carpi radialis longus,
      extensor carpi radialis brevis, and extensor digitorum communis. Injury of these muscles is
      seen as lateral epicondylitis in the clinic. Physiotherapy techniques are frequently applied
      in the management of diseases related to forearm extensor muscles such as lateral
      epicondylitis. Various orthoses such as lateral epicondylitis band, wrist orthosis, dynamic
      extensor brace are used for this. Studies have been conducted on pain, hand function and
      orthosis satisfaction of different types of lateral epicondylitis orthoses, and the number of
      studies investigating the effects on muscle activation is insufficient.Therefore, the aim of
      the study is to examine the effects of different types of orthoses used for the forearm
      extensor group on extensor muscle activation and upper limb functions.
    


Intervention name(s): epicondylitis band; wrist orhosis
Intervention type(s): Other; Other
Intervention description(s): An off-the-shelf lateral epicondylitis tape in S-M-L dimensions was used distal to the lateral epicondylitis.; Wrist orthosis of the shelf was used in sizes S-M-L, covering the hand and wrist.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy individuals
      
Keywords: surface electromyography; muscle activation; orthosis
A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients
      with relapsing-remitting multiple sclerosis over a 26-week treatment period.
    


Intervention name(s): ONO-4641; ONO-4641; ONO-4641; ONO-4641 placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.15 mg once per day for 26 weeks; 0.1 mg once per day for 26 weeks; 0.05 mg once per day for 26 weeks; Placebo once per day for 26 weeks
Intervention MeSH terms: Ceralifimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; ONO-4641
Effects of Two Sugar Substituted Chewing Gums on Caries and Gingivitis Variables
Condition: Dental Plaque; Saliva Altered; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of three times a day mastication, during
      a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors
      associated with dental caries and gingivitis.
    

Detailed description: 
      The purpose of this paper is to compare the effect of daily consumption of two sugar-free
      chewing gum, one with Recaldent and one with Xylitol, added to traditional hygiene (brushing,
      fluoridated toothpaste and dental floss), in clinical features such as the accumulation of
      plaque and gingival inflammation, microbiological characteristics of saliva as the counts of
      cariogenic microorganisms and facultative anaerobes, and some physicochemical properties of
      saliva such as pH and concentrations of calcium and inorganic phosphate.

      To this there was a general call among dental students at the University of Antioquia and
      those who expressed their intention to participate voluntarily with informed consent, were
      examined clinically and randomly assigned to one of the study groups (Recaldent or Xylitol)
      or the control group.

      After a month of baseline examination and the daily use of the same instruments of oral
      hygiene and chewing of 6 pellets of each chewing gum (in the case of study groups), all
      variables are re-examined.
    

Intervention name(s): xylitol; casein phosphopeptide amorphous calcium phosphate complex
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6 g/day, for a month, by chewing 2g three times daily after meals.; two pieces of the commercial presentation three times daily after meals
Other intervention name(s): sugar alcohol; CPP-ACP complex
Intervention MeSH terms: Calcium; Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention & control; Xylitol; casein phosphopeptide amorphous calcium phosphate complex; Streptococcus mutans; saliva; dental plaque; gingivitis
To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets
Condition: Allergy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg
      tablets.
    


Intervention name(s): Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories); Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clemastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antihistamine
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
Condition: Fetal Alcohol Spectrum Disorders
MeSH terms: Fetal Alcohol Spectrum Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled trial of choline supplementation in
      children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are
      cognitive measures.
    

Detailed description: 
      This project is the third in a series of randomized, double-blind placebo-controlled trials
      of choline bitartrate in children ages 2-5 who have been diagnosed with Fetal Alcohol
      Spectrum Disorders (FASD). Pre-clinical data suggests that choline may attenuate the
      cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). This
      study will evaluate the effects of daily choline supplementation vs. placebo for 9 months.
      Outcome measures include an elicited imitation memory paradigm, global cognitive functioning,
      and aspects of executive functioning. The study will also continue to collect safety and
      tolerability data.
    

Intervention name(s): Choline bitartrate; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Comparison of the Effects of Intraoperative Administration of Metoprolol or Esmolol on General Anesthetic Requirement
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Ischemia
Study type: Interventional

Summary: 
      We will compare three study groups receiving metoprolol, esmolol, or placebo. Level of
      anesthesia will be titrated to achieve the same range of BIS value in all groups. Our
      hypothesis is that the metoprolol and esmolol groups will require a lower level of anesthetic
      agent to achieve the targeted BIS range, compared to the placebo group.

      Our objective is to clarify if metoprolol, in a dose range used for perioperative cardiac
      protection, decreases anesthetic requirement.
    

Detailed description: 
      Beta-receptor antagonists are commonly used in the perioperative setting. These agents have
      been shown to decrease the incidence of perioperative myocardial ischemia and are recommended
      by a recent practice guideline in certain patient groups.1 Besides protection from ischemia,
      there are other situations where beta-receptor antagonists are used intraoperatively such as
      control of the sympathetic response to tracheal intubation and certain types of surgical
      stimuli.

      There is new evidence suggesting that administration of esmolol, a short-acting beta-receptor
      antagonist, might reduce the actual anesthetic requirement. This was initially shown by
      studies in which esmolol decreased the amount of anesthetic required to prevent movement
      after skin incision.2;3 Subsequent studies used bispectral index (BIS) as an endpoint and
      demonstrated decreased BIS values in subjects receiving esmolol during general anesthesia.
      4;5

      This anesthetic-sparing effect observed with esmolol has not been prospectively studied with
      other beta-receptor antagonists. Since perioperative beta-blockade is commonly achieved using
      longer acting agents such as metoprolol or atenolol, it is clinically relevant to understand
      the effects of these medications on anesthetic requirement. We aim to conduct a prospective,
      randomized, controlled, double-blind study to compare the anesthetic-sparing effect of
      metoprolol and esmolol administered intraoperatively.
    

Intervention name(s): Metoprolol; Esmolol; P-Group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration; 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl; 0.9%NaCl dispensed in 60ml & 5ml syringes
Other intervention name(s): M-Group; E-Group; Placebo Comparator
Intervention MeSH terms: Metoprolol; Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety, Tolerability and PK Study of AK0529 in Healthy Human
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and PK of single and multiple
      ascending dose of AK0529 when administered orally in healthy subjects
    

Detailed description: 
      This is a Phase 1, first-in-man, single-center, randomized, double blind, placebo controlled
      single and multiple ascending dose study in healthy male and female volunteers.
    

Intervention name(s): AK0529; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AK0529 capsule for oral administration; Sugar placebo capsule for oral administration
Other intervention name(s): AK0529 capsule; Sugar placebo capsule
Intervention MeSH terms: Ziresovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study for Consolidation Period of Chronic Hepatitis B
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Observational

Summary: 
      The investigators aim to clarify the issue of adequate duration of consolidation period of
      Chronic hepatitis B infection with antiviral treatment with Tenofovir which could strike a
      balance between durable HBeAg seroconversion and avoiding long-term inevitable serological or
      virological recurrence.
    

Detailed description: 
      According to practice guidelines of American Association of the Study of Liver Diseases, in
      patients of HBeAg-positive chronic hepatitis B, treatment should be continued until the
      patient has achieved HBeAg seroconversion and undetectable serum HBV DNA and completed at
      least 6 months of additional treatment after appearance of anti-HBe. Also several other
      current guidelines of anti-viral treatment of chronic hepatitis B infection suggest that
      nucleos (t) ide analogues treatment can be stopped following 6 to 12 months of consolidation
      therapy after HBeAg seroconversion. However, there is a paucity of data available about the
      long-term durability of Tenofovir induced HBeAg seroconversion as well as antiviral treatment
      associated resistance risk.

      2. Primary end points: HBeAg seroconversion was defined as loss of HBeAg with concurrent
      appearance of HBeAb. Serological recurrence was defined as reappearance of HBeAg. Virological
      recurrence was defined as an increase of HBV DNA level to greater than 10,000 copies/mL after
      HBeAg seroconversion with previously HBV DNA levels less than 10,000 copies/mL.

      3. Aims: To clarify the issue of adequate duration of consolidation period which could strike
      a balance between durable HBeAg seroconversion and avoiding long-term inevitable serological
      or virological recurrence.

      4. Study design: A single-center cohort study which randomly allocating two different
      extended TDF treatment periods after HBeAg seroconversion - 12 months, and 18 months across
      patient groups. Then data will be collected about outcomes at a specific follow-up time.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        137 patients
      
Keywords: Hepatitis B virus, Tenofovir
Validation Study of Physical Measurement of Tophi
Condition: Gout
MeSH terms: Gout
Study type: Observational

Summary: 
      The purpose of this study is to determine the inter- and intra-rater reproducibility of
      direct physical measurement of tophus nodules in subjects with gout.
    

Detailed description: 
      Gout is a chronic urate crystal deposition disorder. Left untreated, gout may result in
      progressive disease characterized by joint and bone destruction from tophaceous deposits and
      renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate
      concentration greater than 7.0 milligrams per deciliter (mg/dL), is the underlying metabolic
      aberration leading to urate crystal deposition in gout. Gout has several clinical
      presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of
      monosodium urate monohydrate crystals in joints, bones and even parenchymal organs
      (tophaceous gout); renal impairment; and uric acid nephrolithiasis.1 As serum urate levels
      increase beyond greater than 7.0 mg/dL, the risks for gouty arthritis or for renal calculi
      increase.

      Febuxostat is a 2-aryl-thiazole derivative chemically engineered as a novel xanthine
      oxidase/dehydrogenase inhibitor. Febuxostat is being developed as an orally administered
      agent for the management of hyperuricemia in patients with gout.

      Subjects with palpable tophi >10 millimeters (mm) in length and width and as round as
      possible will have the tophus measured on two separate visits by two different raters to
      assess the inter- and intra-rater reproducibility of direct physical measurement.
    

Intervention name(s): Measurement of Tophi to validate procedure
Intervention type(s): Other
Intervention description(s): Intra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with palpable tophi >10mm in length and width and as round as possible will have
        the tophus measured on two separate visits by two different raters to assess the inter- and
        intra-rater reproducibility of direct physical measurement.
      
Biospecimen description: 
      None taken or retained
    
Keywords: Hyperuricemia; Tophi; Tophus; Drug Therapy
Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Comparative, Open-Label, Randomized, Parallel Group Study to determine Intraperitoneal
      fluids, tissue, and serum concentrations of VML-0501 following five days of daily vaginal
      applications of single dose of VML-0501 (100 mg Danazol), in comparison to five days of
      Danazol treatment administered as an oral capsule (Danatrol) at a daily dose of 600 mg, in
      two groups of twelve each consisting of women with suspected or confirmed endometriosis and
      scheduled for laparoscopy.
    


Intervention name(s): Vaginal Danazol; Oral Danatrol
Intervention type(s): Drug; Drug
Intervention description(s): Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol; Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
Intervention MeSH terms: Danazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Danazol
Quality Control of CE-Certified Phonak Hearing Aids - 2017_27
Condition: Hearing Loss, Bilateral Sensorineural, Progressive
MeSH terms: Hearing Loss; Hearing Loss, Bilateral
Study type: Interventional

Summary: 
      A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted
      on hard of participants with a hearing loss to grant quality control prior to product launch.
      The aim of the investigation series is to ensure a stable overall performance of the new
      hearing systems, a good sound quality during phone calls as well as maximum benefit for the
      participant with the devices.
    

Detailed description: 
      Phonak Hearing Systems pass through different development and study stages. At an early
      stage, feasibility studies are conducted to investigate new algorithms, features and
      functions in an isolated manner. If the benefit is proven, their performance is then
      investigated regarding interdependency between all available algorithms, features and
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a
      result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing
      Systems undergo a final quality control in terms of clinical trials in the way as planned for
      this study ("phase of final inspection"). This will be a clinical evaluation which will be
      conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
    

Intervention name(s): Line extension of the Phonak Audéo B product family
Intervention type(s): Device
Intervention description(s): The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.
Intervention model: Single Group Assignment
Intervention model description: A line extension of the Phonak Audéo B hearing aid product family will be fitted to the participants individual hearing loss.
Masking: None (Open Label)
Primary purpose: Other
Efficacy of Lutein, Zeaxanthine and Trypan Blue to Stain the Anterior Lens Capsule
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 3

Summary: 
      Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during
      cataract phacoemulsification.
    

Detailed description: 
      Twenty patients with cataract (nuclear, entumecente, total) and indication for cataract
      surgery will be selected to participate in this study.
    

Intervention name(s): dye of lutein, zeaxanthin, trypan blue
Intervention type(s): Other
Intervention description(s): dye composed of lutein, zeaxanthin, trypan blue
Other intervention name(s): combination of lutein, zeaxanthin, trypan blue
Intervention MeSH terms: Diminazene aceturate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: lutein; zeaxanthin; trypan blue; dye
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability
      of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of
      age with epilepsy.
    


Intervention name(s): Brivaracetam
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Solution for iv injection
Route of administration: intravenous use
Concentration: 10 mg/ml
Other intervention name(s): Briviact
Intervention MeSH terms: Brivaracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Brivaracetam; Briviact; Open-label; pediatric; intravenous
Bioavailability and Food Effect Study of 3 Types of Carisbamate
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to examine the relative bioavailability of three carisbamate
      formulations (Oral Suspension Type 1, Oral Suspension Type 2, and a 300 mg Oral Tablet) and
      to assess the effect of food on the oral bioavailability of the Oral Suspension Type 2 and
      the 300 mg Oral Tablet.
    

Detailed description: 
      This is a single center, open-label, randomized, 5-period, 10-sequence study designed to
      assess each treatment in 30 healthy subjects enrolled in the study. The five treatments
      tested using a single oral administration will be: (1) Oral Suspension Type 1, 300 mg Oral
      Tablet, Oral Suspension Type 2 all under fasted conditions and (2) Oral Suspension Type 2,
      300 mg Oral Tablet under fed conditions. Each dose is followed by at least a seven-day
      washout period. The sequence and period arrangement will be constructed based on the Williams
      design to ensure the study is balanced with respect to first-order carry-over effects.
    

Intervention name(s): Carisbamate
Intervention type(s): Drug
Intervention description(s): Carisbamate is currently under investigation as an adjuvant antiepileptic therapy in Lennox-Gastaut patients. Lennox-Gastaut syndrome (LGS) is a rare and highly debilitating form of childhood epilepsy that typically is diagnosed between 2 and 8 years of age, with peak onset at 3 to 5 years of age, and frequently persists into adulthood. Treatment options are limited and complicated by the multiple seizure types associated with LGS. Given the breadth of physical and cognitive disabilities associated with LGS, the development of antiseizure medications with appropriate oral dosing forms is needed to ensure administration feasibility and compliance in the target population.
Other intervention name(s): YKP509
Intervention model: Single Group Assignment
Intervention model description: This is a single center, open-label, randomized, 5-period, 10-sequence study designed to assess each treatment in all subjects enrolled in the study. The five treatments tested using a single oral administration will be: (1) Oral Suspension Type 1, 300 mg Oral Tablet, Oral Suspension Type 2 all under fasted conditions and (2) Oral Suspension Type 2, 300 mg Oral Tablet under fed conditions. Each dose is followed by at least a seven-day washout period. The sequence and period arrangement will be constructed based on the Williams design to ensure the study is balanced with respect to first-order carry-over effects.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carisbmate; Lennox-Gastaut syndrome (LGS); Healthy Volunteers