bioihbjkbjnl/mcl2 huggingface dataset:
Performance and Tolerability of a New Medical Device Gel, a Randomized, Open Label, Parallel-group, Multicentre Study
Condition: Tooth Disease
MeSH terms: Tooth Diseases
Study type: Interventional

Summary: 
      Medical device study for efficacy and tolerability of a HA gel in the management of teething
      symptoms
    

Detailed description: 
      Due to the potential toxicity that can result from the use of topical anesthetics to relieve
      the symptoms associated with gingival inflammatory conditions or gums trauma in infant,
      recently, products containing Hyaluronic Acid (HA) have been marketed in Europe. In
      particular, Bioplax Limited is developing several high molecular weight HA medical devices
      characterized by the absence of preservatives, alcohol and dyes; therefore, the
      administration of these products in infants is safe and can help creating a natural
      protective layer on the gingival tissue. In previous clinical trials with these high
      molecular weight HA medical devices it was noted a periodontal tissue/fluid balance with
      accelerated healing and repair properties that could be of interest either for accelerating
      the wound healing process or for treating the complex physical symptoms (i.e. soreness and
      swelling of gums, crying, sleeplessness) related to the teething in infants. These data were
      confirmed by a recent pilot study on 18 infants suffering by teething where the two
      formulation of the tested high molecular weight HA medical device evidenced, at the end of
      treatment period, a statistically significant reduction of pain, swelling, gingival rush,
      hyper-salivation and redness, from baseline.
    

Intervention name(s): HA BPX V3.3; Dentinox-Gel N
Intervention type(s): Device; Other
Intervention description(s): medical device containing HA; Anaesthetic gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: teething in infants and children; oral gels; paediatric dentistry
Craniofacial Morphology And Sella Turcica Bridging Associated With Third Molar Agenesis.
Condition: Tooth Agenesis
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      The aim of this retrospective study is to analyze the third molar agenesis with respect to
      sella turcica bridging and other craniofacial patterns in patients asking for orthodontic
      consultation. The main question[s] it aims to answer are:

        -  is there a relationship between third molar agenesis and sella turchina bridging?

        -  is there a relationship between third molar agenesis and craniofacial patterns?
    

Detailed description: 
      Patients referring for orthodontic consultation at the Unit of Orthodontics and Pediatric
      Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric
      Sciences, University of Pavia, 27100 Pavia, Italy, will be enrolled for the study according
      to the inclusion criteria. For each patient, lateral cephalometric radiograph and panoramic
      radiograph will be performed. For each lateral cephalometric radiograph, a cephalometric
      tracing will be performed with DeltaDent software (version 2.5.12, Outside Format, Pandino,
      Italy). Riedel's ANB angle [Riedel 1952] has been chosen to determine patients' skeletal
      class. Steiner's SN^GoGn angle [Steiner 1953] has been chosen to evaluate skeletal
      divergence. Facial axis (BaNa^CCGn), Lower Facial Height (LFH) and mandibular plan angle
      (FH^GoMe) from Rickett's analysis [Rickett's 1961] have been adopted to determine facial
      growth. According to Jaraback's cephalometric analysis [Jaraback 1985], saddle angle,
      articular angle, upper gonial angle, lower gonial angle will be measured to assess the growth
      pattern. Linear measurements of sella depth, sella diameter and interclinoid distance
      [Silverman 1957; Kisling 1966] will be calculated. Linear regressions between craniofacial
      patterns, sella turcica bridging and third molar agenesis will be calculated. A control group
      with no third molar agenesis will be provided.
    

Intervention name(s): Radiographic evaluation
Intervention type(s): Diagnostic Test
Intervention description(s): Panoramic and lateral cephalometric radiographs with cephalometric analysis will be performed.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referring to the Unit of Orthodontics and Pediatric Dentistry for orthodontic
        consultation.
A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether oral etrasimod is a safe and effective
      treatment for active eosinophilic esophagitis (EoE) in adult participants.
    


Intervention name(s): Etrasimod; Placebo; Etrasimod
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods.; Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.; Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period.
Other intervention name(s): APD334; APD334
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Eosinophilic esophagitis; Esophageal eosinophilia; Etrasimod; APD334; EoE; Eosinophilic oesophagitis
Memory and Picture Viewing Study
Condition: Healthy; Brain Reactivity of Non-smokers Undergoing fMRI Scanning
Study type: Observational

Summary: 
      The purpose of this study is to obtain a database of brain function from a sample of
      non-smokers while they do tasks in an MRI (magnetic resonance imaging) machine. Our
      hypothesis is that among nonsmokers, reactivity to smoking cues will be highly similar to
      control cues but may vary as a function of attitudes toward smoking and/or family history of
      smoking. We also hypothesize that brain activity during the n-back task will be more similar
      to data collected during this task when smokers are not abstinent.
    

Detailed description: 
      Thirty six non-smokers will undergo functional magnetic resonance imaging (fMRI) scanning.
      During scanning participants will complete the n-back task-a measure of working memory-and
      the cue-reactivity task-a measure of responses to smoking cues. Before scanning, participants
      will complete a training session where they will be familiarized with the tasks.

      All participants will have to pass a screening visit in order to be included in the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        generally healthy, right-handed non-smokers, between the ages of 18-55, having smoked less
        than 50 cigarettes in their lifetime
      
Biospecimen description: 
      saliva, blood
    
Keywords: fMRI; non-smokers
St. John's Wort Versus Placebo in Social Phobia
Condition: Phobic Disorders
MeSH terms: Phobic Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of St. John's Wort as compared to
      placebo (an inactive substance) in the treatment of outpatients with social phobia.
    

Detailed description: 
      Social Phobia is a prevalent and debilitating condition, with a lifetime prevalence rate to
      be 13.3 percent. Socially phobic patients have been found to be functionally impaired in the
      areas of education, employment and social relationships, to have poorer quality of life, and
      increased suicidal ideation and psychiatric comorbidity. Double-blind studies have found
      benzodiazepines, selective and non-selective MAOI inhibitors, several SSRIs, and the
      anticonvulsants pregabalin and gabapentin to be effective. However, side effects with these
      compounds suggests the need for better tolerated compounds, e.g., in the paroxetine
      multi-center trial (the only drug with an FDA approved indication), 27 percent reported
      somnolence, 26 percent nausea, and 37 percent of males reported delayed ejaculation; 34
      percent of patients discontinued the trial early. There has been considerable worldwide
      interest in St. John's Wort (SJW) (Hypericum perforatum) as a treatment of mild to moderate
      depression. There have been 23 randomized trials suggesting SJW is more effective than
      placebo for the treatment of outpatients with mild to moderate depression. SJW is very well
      tolerated with mild side effects observed in only 2.5 percent of cases in a large (3250
      patients) drug monitoring study. Pharmacokinetic studies have found Hypericum to have
      affinity for serotonin, dopamine and GABA alpha and GABA beta receptors, each of which have
      been implicated in social phobia, thus there is a suggestion that SJW may be effective for
      this disorder.

      This will be a 12-week, double blind, placebo-controlled trial, designed to generate effect
      size data that will be used to determine sample size needed to power a definitive study.
      Forty patients will be randomized to either SJW (LI 160) or matching placebo. This will be a
      flexible-dose design, starting at 300 mg tid to a maximum of 1800 mg total per day. An
      intent-to-treat analysis will be employed. Subjects will be evaluated weekly for two weeks,
      then bi-weekly thereafter. The primary outcome measure will be the change from baseline to
      endpoint on the Liebowitz Social Anxiety Scale.
    

Intervention name(s): St. John's Wort
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Social phobia; Social anxiety; Anxiety; St. John' Wort; Wisconsin; Psychiatric; Mental health
A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to estimate the relative bioavailability and food effect
      of a PF-05089771 capsule.
    


Intervention name(s): PF-05089771; PF-05089771
Intervention type(s): Drug; Drug
Intervention description(s): Oral dispersion TS formulation- fasted; Capsules TS formulation- fasted
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Treatment of Fractures of the Humerus With a Plate.
Condition: Fracture
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      The purpose of this study is to study with the use of clinical and radiological parameters
      the treatment of three-part and four-part fractures with the Winsta PH osteosynthesis device
      (Fischer Medical).
    

Detailed description: 
      We shall measure the following clinical parameters with the help of the Constant Shoulder
      Score (CSS) and Western Ontario Osteoarthritis of the Shoulder Index (WOOS):

        1. Pain

        2. Activities of Daily Living (ADL)

        3. Range of Motion (ROM)

        4. Muscle strength

      We shall measure the following radiologic parameters:

        1. Healing (migration) of tuberculum majus and minus measured with use of MB-RSA

        2. Plate migration with use of MB-RSA

        3. Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry
           (DEXA)

        4. Correlation between bone density and prosthesis migration (and tuberculum migration)
    

Intervention name(s): Winsta PH osteosynthesis device
Intervention type(s): Procedure
Intervention description(s): The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.
Other intervention name(s): Winsta PH osteosynthesis device (Fischer Medical)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will be included at 2 orthopaedic departments at 2 hospitals
      
Keywords: fracture; shoulder; bone density; healing
Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia
Condition: Idiopathic Scoliosis; Spondylolisthesis
MeSH terms: Scoliosis; Spondylolisthesis; Hyperalgesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to:

      1. Establish whether ketamine can decrease opioid consumption and modulate the onset of
      opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years
      to 18 years, undergoing posterior spinal fusion and instrumentation.
    


Intervention name(s): Ketamine; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h; Normal saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
Other intervention name(s): Ketanest, Ketaset, and Ketalar; 0.90% NaCl
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: opioid tolerance; hyperalgesia; scoliosis; pupillometry
Phase II Exploratory Clinical Study of KUX-1151
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of
      multiple oral administration of KUX-1151 in patients with hyperuricemia including gout.
    


Intervention name(s): KUX-1151
Intervention type(s): Drug
Keywords: Hyperuricemia
Metabolic Effects of Early Time-restricted Carbohydrate Consumption
Condition: Diabetes Mellitus, Type 2; Obesity; Nutrition, Healthy; Weight Loss
MeSH terms: Diabetes Mellitus, Type 2; Weight Loss
Study type: Interventional

Summary: 
      In this clinical trial, the investigators aim to examine the impact of a 12-week early
      time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in
      patients with overweight/obesity and type 2 diabetes
    


Intervention name(s): eTRC diet; Control diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) focusing on the distribution of macronutrients within the day so as to avoid carbohydrate consumption after lunch; 12-week dietary prescription with moderate energy restriction (approximately 200 kcal/day) without any recommendations on the distribution of macronutrients within the day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Physical Actitvity and Blood Pressure Among Ambulance Personnel During Work and Leisure
Condition: Blood Pressure; Work-Related Condition
Study type: Observational

Summary: 
      The aim is to describe physical activity and blood pressure during work and leisure time
      among Swedish ambulance personnel, and to relate this to work- and lifestyle factors.
    

Detailed description: 
      The work environment for ambulance personnel consists of several factors that might have
      negative effect on health, for example shift work, long working hours, stress and physical
      demanding work. Associations between these work-related factors and increased risk of
      disease, for example cardiovascular- and musculoskeletal disease, have been observed in
      several studies. However, few studies have specifically been focusing on ambulance personnel.

      There is lack of knowledge regarding how work environment factors affect physical activity
      during work and leisure time among ambulance personnel. Further, the knowledge about blood
      pressure during work and leisure time is limited for this group.
    

Intervention name(s): Blood pressure, physical activity, health
Intervention type(s): Other
Intervention description(s): Observational study of work environment, leisure time, blood pressure, physical activity and health
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Nurses and paramedics employed in the ambulance organisation.
Retrospective Database Studies
Condition: All Patients Undergoing Infertility Treatment
MeSH terms: Infertility
Study type: Observational

Summary: 
      Data collection and comparison of relationships between patient demographics, stimulation
      protocols and outcomes, retrieval and transfer outcomes, number and quality of oocytes and
      embryos retrieved and transferred, pregnancy rates and pregnancy outcomes.
    

Detailed description: 
      No patient treatment is associated with the study.
    

Sampling method: Non-Probability Sample
Study population: 
        All patients undergoing infertility treatment in our practice.
      
Keywords: infertility; IVF
First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the strategy of initiating double oral combination
      therapy with bosentan and sildenafil at the time of diagnosis of pulmonary arterial
      hypertension (PAH) in a preliminary way.
    

Detailed description: 
      Current treatment paradigms for PAH suggest adopting goals of therapy with relatively
      objective parameters such as 6 minute walk distance to determine when to add a second oral
      agent (1). This often entails observing deterioration in the patient on a single agent before
      instituting the second one. This strategy could be problematic, as patients may never recover
      the function lost due to progressive PAH (2). In addition, given the malignant nature of the
      clinical course of PAH in many cases and the nature of the underlying proliferative
      vasculopathy, some have argued that altering this paradigm to resemble that used in cancer
      chemotherapy may be more appropriate (3). That is, "induction" therapy at diagnosis with
      multiple agents followed by a maintenance phase of treatment might offer significant benefits
      to the patient.

      This open-label pilot study is the first to investigate the potential efficacy and safety of
      a first-line combination strategy in consecutive patients with PAH in contrast to the
      "add-on" strategy for combination therapy. It will serve as the basis on which to consider
      larger, multicenter investigations of this strategy.

        1. Hoeper M, et al. Eur Respir J. 2005 Nov;26(5):858-63.

        2. Halpern SD, et al. Proc Am Thorac Soc. 2008 Jul 15;5(5):631-5.

        3. Provencher S, et al. Chest. 2005 Dec;128(6 Suppl):622S-628S.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients with idiopathic pulmonary arterial hypertension (IPAH) or PAH
        associated with connective tissue disease that are naive to PAH targeted therapies will be
        enrolled.
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
Condition: Healthy Adult Male
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To determine the mass balance of totalradioactivity following a single IV infusionof
           (14C)-OPC-61815.

        -  To determine routes and rates of elimination of total radioactivity following a single
           IV infusion of (14C)-OPC-61815

        -  To assess the PK of total radioactivity in plasma and whole blood following a single IV
           infusion of (14C)-OPC-61815

        -  To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV
           infusion of (14C)-OPC-61815
    


Intervention name(s): (14C)-OPC-61815
Intervention type(s): Drug
Intervention description(s): On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Extent of Antral Resection on Outcomes of Sleeve Gastrectomy
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity by
      both restrictive and hormonal action.

      Consecutive patients with morbid obesity treated by LSG at our department were evaluated.
      Patients enrolled in the study were randomized into Group I: LSG begin the division 2 cm from
      the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome
      measure was the % of excess weight loss (%EWL); secondary outcomes included operative time,
      day to resume oral feeding, postoperative morbidity and mortality, improvement of
      comorbidity.
    

Detailed description: 
      This prospective randomized study was designed to compare between the beginning of sleeve
      gastrectomy 2 cm versus 6 cm from the pylorus with special regards to intraoperative
      problems, weight loss, improvement of comorbidities, postoperative complications, nutritional
      and elemental deficiencies.

      Consecutive patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy
      (LSG) at the department of general surgery, Mansoura University, Egypt, during the period
      from January 2008 to January 2012, were eligible for the study. The exclusion criteria
      included patients above 60 or below 18 years old, history of upper laparotomy, unfit for
      anaesthesia or laparoscopy, major psychological instability, and drug abuse.

      The operation was done under general anesthesia. Patient was in supine position with
      splitting of the operating table legs.Gastric transection started 2 cm proximal to the
      pylorus using 60 mm, green endo-stapler (Ethicon, USA) (GI) or 6 cm from the pylorus (G II).
      The following staplers were placed approximately 1 cm from the bougie in the direction of the
      gastroesophageal junction.

      Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6
      cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL);
      secondary outcomes included operative time, day to resume oral feeding, postoperative
      morbidity and mortality, improvement of comorbidity.
    

Intervention name(s): LSG started 2 cm from the pylorus; LSG started 6 cm from pylorus
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic sleeve gastrectomy started 2 cm from pylorus; LSG started 6 cm from pylorus
Other intervention name(s): Group I; Group II
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bariatric surgery, sleeve gastrectomy, gastric leak