bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of Part A is to investigate basic pharmacokinetics of BI 685509 and total
      radioactivity, including mass balance, excretion pathways and metabolism following
      administration of BI 685509 to healthy male subjects.

      The main objective of Part B is to determine the absolute bioavailability of BI 685509 after
      administration to healthy male subjects.
    


Intervention name(s): [¹⁴C] BI 685509 formulation 1; [¹⁴C] BI 685509 formulation 2; BI 685509 formulation 3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): [¹⁴C] BI 685509 formulation 1; [¹⁴C] BI 685509 formulation 2; BI 685509 formulation 3
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: The study has two parts:
Part A: open-label, single-arm, single dose trial, Part B: non-randomised, open-label, fixed sequence crossover trial.
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of LCZ696 in Subjects With Mild and Moderate Renal Impairment Compared to Healthy Subjects With Normal Renal Function
Condition: Mild and Moderate Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and
      its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety
      of LCZ696 in this population.
    


Intervention name(s): LCZ696
Intervention type(s): Drug
Intervention description(s): LCZ696 400 mg once daily
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal Impairment,; LCZ696
Tactile Stimulus, Music Play and Virtual Reality Video Watching During Non-Stress Test on Maternal Anxiety and Fetal Parameters
Condition: Fetal Heart Failure; Fetal Movement Disorder
MeSH terms: Movement Disorders
Study type: Interventional

Summary: 
      The research was carried out to determine the effects of tactile stimulation, music listening
      and virtual reality video watched during the non-stress test on maternal anxiety level and
      fetal parameters.
    


Intervention name(s): tactile stimulation group; listen music; virtual reality group
Intervention type(s): Other; Other; Other
Intervention description(s): The tactile stimulation group will be asked to touch their own abdomen during the NST procedure.; Pregnant women in the music group will listen to a song they want with headphones during the NST procedure.; Pregnant women in the virtual reality group will be shown a nature walk video with nature sounds (stream, bird, etc.) during the NST procedure.
Other intervention name(s): maternal touch; music group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: nursing; fetal health; women; women health
Effect of Nutritional Products in Subjects With Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This is a randomized, double blinded, multi treatment, crossover study intended to compare
      the glycemic and insulinemic response after consuming liquid nutritional products in people
      with type 2 diabetes.
    


Intervention name(s): Standard ONS; Diabetes specific ONS 1; Diabetes specific ONS 2
Intervention type(s): Other; Other; Other
Intervention description(s): One serving (237 ml) standard oral nutritional beverage; One serving (237 ml) diabetes oral nutritional beverage; One serving (296 ml) diabetes oral nutritional beverage
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
High and Low Laser for Subacromial Impingement Syndrome
Condition: Subacromial Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Shoulder pain is the third most common musculoskeletal problem after lumbar and neck diseases
      in clinical practice, and the most common cause of shoulder pain is subacromial impingement
      syndrome. The main goal of treatment is to reduce pain and to solve the mechanical problem
      that causes functional impairment. Low-level laser treatment is an increasingly used
      treatment modality in the treatment of subacromial impingement syndrome as in many
      musculoskeletal diseases, as it promotes cell proliferation and tissue regeneration by its
      anti-inflammatory and photobiostimulation properties. Also, High-intensity laser therapy is a
      treatment method that is gaining popularity in the recent years. These ultra-short impulses
      effect a deep action in the biological tissue (3-4 cm), with a homogeneous distribution of
      the light source in the irradiated soft tissue, but without excessive thermal enhancements.
      It reduces pain and edema with photomechanic effects in deep tissues. As far as the
      investigators know, there are no studies comparing these two treatment modalities in
      subacromial impingement syndrome yet. This study was planned to compare the efficacy of
      High-intensity laser therapy and low-intensity laser therapy in treatment of patients with
      subacromial impingement syndrome.
    


Intervention name(s): high intensity laser in addition to traditional physical therapy exercises; low level laser in addition to traditional physical therapy exercises; traditional physical therapy exercises
Intervention type(s): Other; Other; Other
Intervention description(s): high intensity laser will be used with 1064 nm wavelength and maximum of 25 W power. Analgesic and biostimulant modes were used in the present study.
Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.; patients will receive low level Laser Therapy in addition to traditional physical therapy exercises.
diode laser device with a wavelength of 850nm, power output of 100mV, continuous wave and 0.07cm2 spot area laser will be used. The laser will be applied with a dosage of 5 joule/cm2 (totally 15-20 joule) at the most 5 painful points for 1 minute at each point over subacromial region of the shoulder.
Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.; Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1b Trial to Evaluate Safety and Effect of SAR443122 on Immune System in Severe COVID-19
Condition: Corona Virus Infection
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To evaluate the effect of SAR443122 relative to the control arm on the hyperinflammatory
      state as measured by C-reactive protein (CRP) levels in adult patients hospitalized with
      severe coronavirus disease 2019 (COVID-19)

      Secondary Objectives:

        -  To evaluate the time to onset of effect of SAR443122 relative to the control arm on the
           hyperinflammatory state as measured by CRP levels

        -  To evaluate the time to onset of effect of SAR443122 relative to the control arm on
           oxygenation status

        -  To evaluate the effect of SAR443122 relative to the control arm on oxygenation status

        -  To evaluate the effect of SAR443122 relative to the control arm on total duration of
           supplemental oxygen requirement

        -  To evaluate the effect of SAR443122 relative to the control arm on length of ventilator
           support needed

        -  To evaluate the effect of SAR443122 relative to the control arm on laboratory markers of
           severe COVID-19

        -  To evaluate the effect of SAR443122 relative to the control arm on mortality

        -  To evaluate the effect of SAR443122 relative to the control arm on need for thrombolytic
           therapy

        -  To evaluate the effect of SAR443122 relative to the control arm on need for vasopressor
           treatment

        -  To evaluate the safety of SAR443122 as compared to the control arm up to End of Study

        -  To evaluate the effect of SAR443122 relative to the control arm on total duration
           without high flow supplemental oxygen requirements
    

Detailed description: 
      Study duration per participant is approximatively 32 days including a 14-day treatment period
    

Intervention name(s): SAR443122; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:capsule Route of administration: oral; Pharmaceutical form:capsule Route of administration: oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Determining the Glycemic Effects of Three Types of Spaghetti
Condition: Potential Abnormality of Glucose Tolerance; Appetitive Behavior
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This study investigated the effects of thee types of spaghetti No7 on the glycemic response
    

Detailed description: 
      This study aimed to 1. determine the glycemic index and glycemic load of thee spaghetti No7
      types (regular, whole wheat and high fiber-low carbohydrates) and 2. investigate the effects
      of these spaghetti types on postprandial glycemic response in healthy subjects
    

Intervention name(s): Glucose as reference food; White bread; Regular spaghetti; Whole wheat spaghetti; High fibre - low carbohydrates spaghetti
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g glucose diluted in 300ml water, tested two times, in different visits, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from white bread, along with 300ml water, tested two times, in different visits, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from regular spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from whole wheat spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Fourteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from high fibre - low carbohydrate spaghetti No 7, along with 300ml water, tested once, within 10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: blood glucose; spaghetti; glycemic index; glycemic load
Optimising Health in Type 1 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the
      beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency,
      whereby blood glucose levels rise and diabetes develops. When there is severe insulin
      deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin
      replacement therapy; dietary intervention is a also cornerstone of glucose management.

      The Optimise Diet is a multi-pronged diet based on "best health" principles: to minimise
      blood glucose rises after eating, reduce the immune cells involved in destruction of the
      insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In
      this study, its effects will be compared to the Standard Diabetes Diet that is currently
      recommended in Australia and internationally.
    

Detailed description: 
      The rationale for this study is to determine whether a diet based on recent scientific
      advances in diet-induced inflammation, will improve diabetes care in people with type 1
      diabetes.
    

Intervention name(s): Novel diet; Standard diet
Intervention type(s): Other; Other
Intervention description(s): Novel diet to optimise glucose levels and minimise systemic inflammation: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.; Standard diabetes diet recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glucose; inflammation
The Effect of Massage on Stress in Premature Babies
Condition: Stress; Cortisol
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The practices of the neonatal intensive care unit that reduce the stress of premature babies
      and respond to behavioral cues have a positive effect on the development of newborns. The
      stress experienced by premature infants affects the baby's behavior and laboratory findings.
      Massage is an effective application in facilitating the adaptation of premature babies to
      extrauterine life and ensuring that they are least affected by adverse environmental
      conditions. Massage in premature babies has an important place in reducing stress and
      supporting psychological, mental and physiological development as a healthy tactile stimulus.
    

Detailed description: 
      This study was planned to examine the effects of massage on stress behaviors and salivary
      cortisol levels in premature infants. The research was planned on a randomized controlled
      experimental. In the research, the group to which massage will be procedure is the
      experimental group, and the group to which the swaddling procedure will be the control group
      will form.
    

Intervention name(s): Massage; Swaddling
Intervention type(s): Other; Other
Intervention description(s): The babies in the massage group were given a massage once a day.; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Massage; Premature; Stress
The Efficacy of Kinesio Taping on Lymphedema Following Head and Neck Cancer Therapy
Condition: Lymphedema; Head and Neck Cancer; Kinesio Taping; Therapy
MeSH terms: Head and Neck Neoplasms; Lymphedema
Study type: Interventional

Summary: 
      Purpose off the study is investigating to efficacy of kinesio taping on neck lymphedema after
      the head and neck cancer therapy.
    

Detailed description: 
      The neck lymphedema is a multidirectional process that depends on lymphatic circulation
      issues. The lymphedema can be treated using such as therapies, drugs or surgeries. There are
      few techniques for treatment of neck lymphedema and also in our best knowledge the kinesio
      taping therapy on lymphedema following neck cancer therapy had not been investigated or
      published. The study will assess the efficacy of kinesio taping in neck lymphedema with
      manual therapy after the head and neck cancer treatment.
    

Intervention name(s): Kinesio Tex Gold
Intervention type(s): Device
Intervention description(s): The Kinesio Tex Gold is a kinesio tape that had been certified and patented.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kinesio taping; neck; lymphedema; head; cancer; therapy
Study on Tolerance, Pharmacokinetics and Drug Interaction of YK-1169 in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of multiple doses of YK-1169 in healthy subjects, the
      pharmacokinetic characteristics of multiple doses in healthy subjects, and the drug
      interaction between cefepime and avibactam.
    

Detailed description: 
      A randomized, single-blind, placebo-controlled, dose-escalation, single-center clinical trial
      design was used. A total of 5 dose groups A1, A2, A3, A4 and A5 were set in the test,
      including A1 YK-1169 0.5g group (containing cefepime 0.4g and avibactam 0.1g), A2 YK-1169
      1.25g group (containing cefepime 1.0g and avibactam 0.25g), A3 YK-1169 2.5g (containing
      cefepime 2.0g and avibactam 0.5g), A4 YK-1169 3.75g (containing cefepime 3.0g and avibactam
      0.75g) and A5 YK-1169 5.0g (containing cefepime 4.0g and avibactam 1.0g).

      A single-center, randomized, open, three-period three-crossover 3 × 3 Latin square trial
      design was used. To study the effect of intravenous infusion of this product, cefepime for
      injection or avibactam for injection on the disposition process of the drug in the human
      body, so as to study whether there is a pharmacokinetic drug interaction in this product.
    

Intervention name(s): Group 1:YK-1169; Group 2:YK-1169/Placebo Injection; Group 3:YK-1169/Placebo; Group 4:YK-1169/Placebo; Group 5:YK-1169/Placebo Injection; Group 6:YK-1169/Cefepime hydrochloride for injection/Avibactam for injection
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): YK-1169 0.5g (containing cefepime 0.4g, avibactam 0.1g) single intravenous infusion for 2 hours; YK-1169 1.25g (containing cefepime 1.0g, avibactam 0.25g) / placebo single intravenous infusion for 2 hours; On the first day, YK-1169 2.5 g (containing cefepime 2.0 g, avibactam 0.5g) was single intravenously infused for 2 h. On the third day, YK-1169 2.5 g (containing cefepime 2.0 g, avibactam 0.5g) was single intravenous infusion for 2 h, three times a day at 8-h intervals, until the morning dose on the tenth day; On the first day, YK-1169 3.75 g (containing cefepime 3.0 g, avibactam 0.75g) was single intravenously infused for 2 h. On the third day, YK-1169 3.75 g (containing cefepime 3.0 g, avibactam 0.75g) was single intravenous infusion for 2 h, three times a day at 8-h intervals, until the morning dose on the tenth day; YK-1169 5.0g (containing cefepime 4.0g, avibactam 1.0g) / placebo single intravenous infusion for 2 hours; YK-1169 2.5g (containing cefepime 2.0g, avibactam 0.5g)/cefepime hydrochloride for injection 2.0g/avibactam for injection 0.5g, three-cycle three-cross single intravenous infusion for 2 hours
Intervention MeSH terms: Cefepime; Avibactam
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The whole trial is conducted by dose escalation from low to high.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: YK-1169
The Influences of Long Periods of Pneumoperitoneum and Head up Position on the Variation of Heart-rate Corrected QT Interval During Robotic-assisted Laparoscopic Gastrectomy - Observational Study
Condition: Stomach Cancer
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      Sympathetic activity could be increased during robot-assisted laparoscopic gastrectomy, which
      is performed in a head up position under CO2 pneumoperitoneum.

      Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the
      susceptibility to life threatening cardiac arrhythmias.

      Thus the investigators decided to evaluate the heart-rate corrected QT interval (QTc
      interval) during robotic-assisted laparoscopic gastrectomy.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were undergoing robot- assited laparoscopic gastrectomy
Reproducibility of Ankle Brachial Index After Maximal Exercise
Condition: Normal Subjects
Study type: Observational

Summary: 
      Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise.
      The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it
      appears important to know whether automatic assessment of ABI is as reliable and reproducible
      as the manual method.
    

Detailed description: 
      Two methods are mainly used to determine the blood pressure at rest, in a non-invasive way,
      in order to calculate the Ankle-Brachial Index (ABI). The first method, using a manual
      sphygmomanometer coupled with a Doppler probe, is considered as the reference method. The
      second method requires at least one automatic sphygmomanometer. Data from the literature show
      that these two methods are reproducible to assess ABI at rest. Some authors have reported a
      better reproducibility of measurements with automatic tool. Others consider that the current
      accuracy of automatic measurement is insufficient to replace the reference method Doppler.
      Thus, the aime of the present study is to evaluate whether automatic assessment of ABI is as
      reliable and reproducible as the manual method.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        health volunteers over 18 years old
      
Keywords: Ankle Brachial Index; Maximal exercise
Injectable Filler for Cheek Flattening
Condition: Malar Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if Radiesse injections to the cheeks result in an
      altered and improved first impression and self esteem.
    


Intervention name(s): Calcium hydroxylapatite
Intervention type(s): Drug
Intervention description(s): Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
Other intervention name(s): Radiesse; CaHA
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cheek; Cheek flattening; Malar deficiency; Filler