bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Tolerability and Pharmacokinetics of Jiashen Tablets in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Jiashen Tablets as an oral, compound traditional chinese medicine prepatations, have an
      effect on improvement of the heart failure. This study will assess the safety, tolerability
      and pharmacokinetics (PK) of Jiashen Tablets, following oral administration of single and
      multiple ascending dose of Jiashen Tablets.
    

Detailed description: 
      This study will include a randomized, double-blind, placebo-controlled, single ascending dose
      design study (Part A), and an open-label SDAD pre-multiple daily ascending dose (MDAD) study
      (Part B) and an open-label MDAD study (Part C) study.

      The study will be conducted in healthy participants and performed at a single study center.
      70 healthy participants are planned to be included in the study.

      Part A will include six cohorts, 40 participants. Within each cohort, 2 participants will be
      randomized to receive placebo and other participants randomized to receive Jiashen Tablets.
      Each participant will receive Jiashen Tablets at the selected dose level or placebo by oral
      administration in a fasted state once daily.

      Part B will include two cohorts, 6 participants, minimum dose group and maximum dose group
      respectively depending on the findings. Within each cohort, participant will receive Jiashen
      Tablets at the selected dose level by oral administration in a fasted state once daily.

      Part C will include three cohorts, 24 participants. Within each cohort, participant will
      receive Jiashen Tablets at the selected dose level by oral administration in a fasted state
      once daily for 7 days.
    

Intervention name(s): Jiashen Tablets; Jiashen Tablets; Jiashen Tablets; Jiashen Tablets; Jiashen Tablets; Jiashen Tablets; Jiashen Tablets Placebo; Jiashen Tablets Placebo; Jiashen Tablets Placebo; Jiashen Tablets Placebo; Jiashen Tablets Placebo; Jiashen Tablets Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet; 2 tablets; 4 tablets; 6 tablets; 8 tablets; 9 tablets; 1 tablet; 2 tablets; 4 tablets; 6 tablets; 8 tablets; 9 tablets
Other intervention name(s): treatment group 1; treatment group 2; treatment group 3; treatment group 4; treatment group 5; treatment group 6; control group 1; control group 2; control group 3; control group 4; control group 5; control group 6
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to
      provide respiratory support in children with moderate to severe bronchiolitis.

      However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN
      is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of
      acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently
      the need of PICU transfer.
    

Detailed description: 
      Open label, non-blinded multi-centre, randomised controlled trial comparing standard care
      including oxygen delivery via HFN versus standard nasal oxygen therapy in infants admitted to
      hospital with moderate-to-severe bronchiolitis.
    

Intervention name(s): High-flow nasal canula oxygen therapy; Low-flow oxygen therapy with standard nasal canula
Intervention type(s): Device; Device
Intervention description(s): High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (F&P, NZ) at initial flow to 3l/kg/min (up to a maximum of 20l/min), FiO2 adjusted for SpO2 > 94%.; flow adjusted to SpO2 > 94% (up to a maximum of 2l/min).
Other intervention name(s): Optiflow; Low-flow oxygen therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: infant; oxygen therapy; High flow nasal canula oxygen therapy; Bronchiolitis
Effects of Septorhinoplasty on Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      Allergic rhinitis (AR) is a chronic inflammatory disease that affects almost 30% of adult
      population. Some patients associate septal deviation, main cause of chronic nasal
      obstruction, and AR. Current literature about AR treatment with septoplasty (STP) is still
      contradictory, because is thought that patients with AR are not able to appreciate
      improvement after surgery.

      Patients diagnosed with allergic rinitis and septal deviation were evaluated to determined
      life quality and airflow obstruction evolution after STP.
    

Detailed description: 
      This is a prospective quasi experimental study. After being informed about the study,
      patients that signed written informed consent were included in the study. In week 0 before
      surgery, all measurements and questionnaires were performed. 1 month after surgery,
      measurements were repeated.

      After screening, patient´s obstruction was evaluated by anterior rhinomanometry (RNMa), and
      quality of life scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire
      about daily life activity, sleep, psycology and perception of affection by allergic rhinitis.
      Symtoms were evaluated with visual analogue scale (VAS) and clinical history. Symptoms like
      sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal
      corticosteroid, antileucotrienos, antihistamines eye drops , antishistamines) frequency use
      was registered.
    

Intervention name(s): Septorhinoplasty
Intervention type(s): Procedure
Intervention description(s): This intervention will be performed by the same surgeon, after signing of patient inform consent.
Intervention model: Single Group Assignment
Intervention model description: A prospective study with 1 months period follow up. Patients with septal deviation and allergic rhinitis diagnosis will be included. Obstruction airflow will be evaluated before and after surgery with rhinomanometry (RNM). Life quality will be assessed with VAS and ESPRINTquestionnaires.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Septoplasty; VAS; quality of life; allergic rhinitis; nasal obstruction
Study to Evaluate IMG-004 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Orally Administered IMG-004
      to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose in
      Healthy Participants.
    

Detailed description: 
      The study is a Phase 1, randomized, double-blind, placebo-controlled study of orally
      administered IMG-004 to evaluate the safety, tolerability, and pharmacokinetics of single
      ascending doses in healthy participants. Five dosing cohort levels are planned to be
      evaluated.
    

Intervention name(s): IMG-004 or placebo; IMG-004 or placebo; IMG-004 or placebo; IMG-004 or placebo; IMG-004 or placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Each participant will be randomized to receive either a single dose of 30mg IMG-004 oral capsule(s) or a single dose of matching placebo.; Each participant will be randomized to receive either a single dose of IMG-004 oral capsule(s) or a single dose of matching placebo.; Each participant will be randomized to receive either a single dose of IMG-004 oral capsule(s) or a single dose of matching placebo in the fasted and fed condition.; Each participant will be randomized to receive either a single dose of IMG-004 oral capsule(s) or a single dose of matching placebo.; Each participant will be randomized to receive either a single dose of IMG-004 oral capsule(s) or a single dose of matching placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Acute Intake of Ketones on Performance in Professional Road Cyclists
Condition: Ketoses, Metabolic; Ketosis
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      Randomized, controlled, double-blind, crossover clinical trial, depending on the product
      consumed, to analyze the efficacy on physical performance of a sports supplement consumed
      prior to and during competition or training.
    

Detailed description: 
      Subjects who meet the selection criteria will be randomly assigned to each of the study
      groups (investigational product or placebo, depending on the group to which they have been
      assigned). On the second day, participants will consume the product that subjects did not
      consume on the first day.

      The product to be consumed will be ketone monoester. Participants will consume 800 mg/kg body
      weight, distributed in two intakes. The first one, half an hour before exercise and the same
      dose will be consumed one hour and a half after the first dose. The intakes will be
      accompanied by carbohydrates and bicarbonate.

      The tests that the cyclists will perform are a time trial on a cycloergometer to measure
      performance, as well as a 30" sprint. Afterwards, the cyclists will do a 4 and a half hour
      training session at competition pace. After this training session, the participants will do
      the same time trial and the 30'' sprint.
    

Intervention name(s): Ketone monoester; Control product consumption
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of 800mg/kg body weight of ketone monoester, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, every hour they should consume 90g of carbohydrates.; Consumption of placebo product (carbohydrates) masked with citric, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, 90g of carbohydrates should be consumed every hour.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Incretin Effect in Lean and Obese Subjects
Condition: Incretin Effect; Insulin Resistance; Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Observational

Summary: 
      The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the
      notion that this deficiency is a consequence of the diabetic state. However, the impact of
      insulin resistance on the incretin effect in obese individuals who uphold a normal glucose
      tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary
      aim of the present study is to evaluate the separate impact of one of the cornerstones of
      type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean
      and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of
      healthy control subjects.
    


Intervention name(s): Oral glucose tolerance test (OGTT); Isoglycemic intravenous glucose infusion
Intervention type(s): Other; Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Lean and obese patients with type 2 diabetes; and matched healthy control subjects.
      
Biospecimen description: 
      Blood samples
A Randomized, Study to Evaluate the Iovera° Device in Treating Pain Associated With Total Knee Arthroplasty
Condition: Arthritis of the Knee
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      This study will evaluate the iovera° device in treating pain associated with total knee
      arthroplasty (TKA). This study will also assess if overall pain medication is reduced
      following TKA and will investigate the relationship between patients treated with the iovera°
      device and length of hospital stay, pain, patient satisfaction and improved rehabilitation.
    


Intervention name(s): iovera°; iovera° Sham
Intervention type(s): Device; Device
Intervention description(s): Use of iovera° device to administer treatment Focused Cold Therapy; iovera° device used for sham treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders
Condition: Lower Back Pain
MeSH terms: Musculoskeletal Diseases; Low Back Pain
Study type: Interventional

Summary: 
      The main objective of this study is to evaluate in patients with chronic low back pain
      (lasting for more than 3 months and not postoperative) the effect of an instrumental
      rehabilitation using the I-Moove ® device compared to a conventional physiotherapy
      rehabilitation for ambulatory postural stability (mean and standard deviation of excursions
      from the center of gravity) without visual control, 6 weeks after the start of the
      rehabilitation protocol. We focus on the relative variation between the values obtained on
      day 0 versus 6 weeks, via measures performed on a force platform. The results will be
      stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).
    

Detailed description: 
      The secondary objectives of this study are to evaluate and compare the two physical therapy
      techniques at 6 weeks and 6 months after the start of the rehabilitation protocol in terms
      of:

      A - improving postural stability and visual control on an unstable surface (with and without
      visual control)

      B - improving levels of abdominal strength (Ito test) and erector spinae (Sørensen test)

      C - the impact of back pain on daily life using questionnaires (Dallas, Québec, FABQ and
      Tampa questionnaires/scores)

      D - Improvement of pain (Visual Analog Scale),
    

Intervention name(s): Routine Physical Therapy; I-Moove Physical Therapy
Intervention type(s): Other; Device
Intervention description(s): Patients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions).; Patients randomized to this arm will participate in a physical therapy program using the I-Moove device (15 weeks, a total of 15 sessions).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proprioception
Identify Possible Errors on Home Use Blood Pressure Monitors by Usability Reasoning
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Medical devices are designed and manufactured by subjective design process that was only
      based on engineers' direct concepts to essential principles sets for the device. A home user
      may not easily use or operate the piece of medical device through the interfacing components
      as the designer's expected such as the meaning when pushing a button or switching a knob,
      even the required procedure needed when a certain display shown to fulfill some knowledge
      dependent judgment. In addition, the incompatible interfacing designed communication between
      a user and the device may cause possible errors that may trigger further negative
      consequences during the use of the device to a innocent home user.

      The aim of this research is to closely understand the consequent results of human factor
      engineering or usability engineering practices of various types or models of marketed
      home-use blood pressure monitors (BPM) in real use.
    

Detailed description: 
      The aim of this research is to closely understand the consequent results of human factor
      engineering or usability engineering practices of various types or models of marketed
      home-use blood pressure monitors (BPM) in real use. Participants of the intended user
      population interact with marketed BPMs in research to assess ease of learning, ease of use,
      effectiveness and efficiency of use, memorability, safety, and/or user appeal among the many
      possible attributes of interest. With these understanding and analysis of human factors
      engineering / usability engineering (HFE/UE) practiced status, it can help manufacturers to
      capture the required and diversified HFE/UE essences with the minimum or limited professional
      technical resources in hand some more efficiently.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults who are able to operate general healthcare devices (eg thermometer, electronic blood
        pressure measures)
      
Keywords: hypertension; device; errors; human factor engineering; usability engineering
A mRUS Validation Study for Nail-treated Fractures of Long Bones and a TUS Exploratory Study for Nail and Plate-treated Fractures of Long Bones
Condition: Delayed Union Fracture; CT-scan; X-Ray; Bone Fracture; Fracture Healing; Validation Studies
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      Early intervention attempts to shorten protracted delayed union (DU) or prevent non-union
      (NU) fractures are hampered by lack of validated quantitative assessment tools for bone
      fracture healing during normal and delayed healing processes. In actual practice, sequential
      X-rays usually follow a pre-determined time interval in patients with fractures.They
      constitute the best available state of the art used by surgeons to assess the fracture
      healing course.

      In an attempt to improve between raters reliability of radiographic assessment of healing,
      studies have explored a novel radiographic assessment for tibial shaft fractures, the
      Radiographic Union Scale for Tibial Fractures (RUST). The RUST assesses the presence of
      bridging callus and a fracture line on each of four cortices (seen on anterior-posterior and
      lateral views). This callus based scoring system has been since extended to other bones than
      the tibia in a retrospective case series. It has been renamed modified radiological union
      score (mRUS) and has shown potential value in bone healing measurement.

      Based on an initial retrospective study in nail-treated fractures, the first objective of the
      present investigation is to prospectively validate mRUS as a tool to identify patients at
      increased risk of DU and NU within the first 75-110 days after fracture occurrence. This
      prospective validation will be performed on a retrospective cohort of patients having
      sustained long bone fractures, including both upper and lower extremities. A further
      objective of the present investigation is to apply the scoring system to tomographic imaging
      in case of nail/plate treated fractures, deriving a tomographic union score (TUS) and first
      assess its potential value in bone healing for fractures treated by nails/plates.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Long bone fracture
      
Keywords: mRUS; validation tool; Impaired fractures
Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia
Condition: Dental Anesthesia Efficacy
Study type: Interventional
Phase: Phase 1

Summary: 
      This blinded randomized, crossover, three period study aim to evaluate the anesthetic
      efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3%
      prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the
      maxillary right canine, in 32 volunteers.
    


Intervention name(s): Prilocaine
Intervention type(s): Drug
Intervention description(s): 1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine
Other intervention name(s): Citocaína®
Intervention MeSH terms: Prilocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Liposome; Prilocaine; Dental anesthesia
A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy of a treatment with TMC435 in
      combination with peginterferon alfa-2a and ribavirin in patients who did not clear their
      hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial
      conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed
      against hepatitis C virus (HCV) were evaluated for short periods of time.
    

Detailed description: 
      This is a roll over trial of TMC435 for patients with genotype-1 HCV infection who
      participated in the control (placebo; substance containing no active medication) group of a
      TMC435 trial or who received a treatment for up to 14 days with antivirals directed against
      HCV in a previous Tibotec trial. Patients in this study will receive TMC435 in combination
      with peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) followed by peginterferon
      alfa-2a and ribavirin alone. The total treatment duration will be 24 or 48 weeks, depending
      on how the patients respond to treatment and which was their previous response to
      peginterferon alfa-2a and ribavirin alone. The study doctor will inform each patient about
      how to take their study medication and when they should stop taking it. After a patient stops
      taking study medication, they will contiue to come to the doctor's office for study visits
      until 24 weeks (in some cases up to 48 weeks) after end of treatment. The total duration of
      the study is 78 weeks (including screening). Patients will be monitored for safety throughout
      the study. Study assessments at each visit may include but are not limited to: blood and
      urine collection for testing, electrocardiogram (ECG) assessments (a measurement of the
      electrical activity of the heart) and physical examinations. TMC435 will be taken as an oral
      capsule of 150 mg once per day. Peginterferon (Pegasys) will be given as an injection of 180
      µg once each week. Ribavirin will be taken as tablets (Copegus) twice each day and the dose
      will depend on patient's body weight.
    

Intervention name(s): TMC435
Intervention type(s): Drug
Intervention description(s): Type=exact number, unit=mg, number=150, form=capsule, route=oral use, once daily for 12 weeks in addition to peginterferon alfa-2a peginterferon and ribavirin for 24 or 48 weeks
Intervention MeSH terms: Simeprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC435-TiDP16-C213; TMC435-C213; TMC435; HCV; Hepatitis C