bioihbjkbjnl/mcl2 huggingface dataset:
IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT (Face Cream)
Condition: Hypersensitive; Reactive and Intolerant Skin; Redness-prone Skin; Stinger Subjects
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      The aim of this study is to assess the dermatological and ophthalmological tolerance of the
      investigational product Crème visage / Face cream RV4941A - RY1987 after 21 days of twice
      daily use on the study areas, under normal conditions of use.

      The aim of this study is also to:

        -  evaluate the cutaneous sensitivity by a stinging test at D1 T0 and D22.

        -  evaluate the cutaneous sensitivity by a sensitive scale at D1 T0, D1 Timm*, D8 and D22.

        -  evaluate the soothing efficacy by an efficacy questionnaire at D1 Timm*, D8 and D22.

        -  evaluate the cosmetic acceptability by a questionnaire at D22.

      This study is conducted as a national, monocentric, non-randomized open trial. The 33
      subjects in this study present hypersensitive, reactive and intolerant skin on face. They are
      stinger subjects, with a normal to combination skin.

      Timm*: 10 to 30 minutes after first application
    

Detailed description: 
      This study is a national, monocentric, non-randomized open trial, conducted in adults
      presenting hypersensitive, reactive and intolerant skin on the face, with a normal to
      combination skin.

      The study includes 3 visits, including subjects' selection:

        -  V1: Baseline inclusion

        -  V2: 1 week, intermediate visit

        -  V3: 3 weeks, study end

      The maximal study duration is 25 days.

      The evaluation is at 3 times: D1 baseline, D8 at 1 week and D22 at 3 weeks of application of
      RV4941A - RY1987 with comparison of each time versus baseline.

      There are twice-daily applications (morning and evening) of the test product on the face.
    

Intervention name(s): Cosmetic product
Intervention type(s): Other
Intervention description(s): RV4941A is a face cream product
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Subjects have been recruited from the panel of the centre. An investigator made a
        dermatological examination of the subjects before inscription in the panel. Data from this
        clinical examination, stored in the computer database with the consent of the subjects, can
        ensure the recruitment; computer software being questioned based on the eligibility
        criteria of the study.
      
Keywords: Hypersensitive skin; Discomfort sensations; Asian skin; Sensitivity reduction
Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of XOMA 052 in
      subjects with stable Type 2 Diabetes Mellitus (T2D).

      The study is a dose-escalation study designed to evaluate route of administration
      (intravenous or subcutaneous), doses, and dosing regimens for future studies.
    


Intervention name(s): XOMA 052; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part 1, Single IV infusion at one of six dose levels (mg/kg).
Part 2, Single SC injection at one of three dose levels (mg/kg).
Part 3, Three biweekly SC injections at one of two dose levels (mg/kg).; Part 1, Single IV infusion at one of six dose levels (mg/kg).
Part 2, Single SC injection at one of three dose levels (mg/kg).
Part 3, Three biweekly SC injections at one of two dose levels (mg/kg).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Type 2; Mellitus
Desflurane and Brain Relaxation in Craniotomy
Condition: Supratentorial Tumor
MeSH terms: Supratentorial Neoplasms
Study type: Interventional

Summary: 
      Optional brain relaxation improves the surgeon's operating conditions and is likely to
      minimize the degree of retraction injury ,with the potential for providing patients with a
      better outcome. The choice of anesthetic drugs can affect intraoperative brain relaxation.
      Propofol suppresses brain metabolism, reduces cerebral blood flow, and provides satisfactory
      brain relaxation. Desflurane is often criticized in neurosurgery due to its cerebral
      vasodilation and potential to increase intracranial pressure, however, it has been found to
      have a little clinical significance. This study intends to compare the effects of desflurane
      with propofol on brain relaxation in patients with supratentorial tumors under mild
      hyperventilation, and to provide new clinical evidence for the use of desflurane in
      neurosurgical anesthesia.
    

Detailed description: 
      To compare the effect of desflurane versus propofol combined with remifentanil anesthesia on
      brain relaxation in patients undergoing supratentorial tumor surgery with mild
      hyperventilation, and compare the emergence time and common complications during recovery.
    

Intervention name(s): Desflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil.; After induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil
Other intervention name(s): inhalational anesthesia; TIVA; total intravenous anesthesia
Intervention MeSH terms: Anesthetics; Propofol; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Clinical Evaluation of Multifocal Toric Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The study
      lenses will be worn in a bilateral and random fashion using a 5x5 crossover Williams design
      with 5 lens types and 5 periods. The subjects will wear each pair of lenses for approximately
      15 minutes with a 15 minute wash-out between each pair. Two lens types will be fit at the
      first visit and three lens types will be fit at the second visit. Using a computer-generated
      randomization scheme, each subject will randomly be assigned to 1 of 10 unique sequences of
      the 5 lens types. Randomization will be stratified by site.
    


Intervention name(s): etafilcon A Investigational Toric Multifocal Contact Lens; etafilcon A Investigational Toric Multifocal Contact Lens; etafilcon A Investigational Toric Multifocal Contact Lens; etafilcon A Investigational Toric Multifocal Contact Lens; etafilcon A Investigational Toric Multifocal Contact Lens
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Test Lens 1; Test Lens 2; Tes Lens 3; Test Lens 4; Control Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Randomized Controlled Trial of Fiber Post Restorations
Condition: Restoration Survival
Study type: Interventional

Summary: 
      This in vivo study examined the contribution of remaining coronal dentin and placement of a
      prefabricated or customized fiber post to the six-year survival of endodontically treated
      premolars. A sample of 345 patients provided 6 groups of 60 premolars in need of endodontic
      treatment. Groups were classified according to the number of remaining coronal walls before
      abutment build-up. Within each group, teeth were allocated to three subgroups: A) no
      post-retention; B) LP; C) ES (N=20). All teeth were protected with a crown. Cox regression
      analysis was applied to assess whether the amount of residual coronal dentin and the type of
      endocanalar retention had a significant influence on failure risk of the restored teeth.
    


Intervention name(s): post placement
Intervention type(s): Procedure
Intervention description(s): placement of an endocanalar post
Other intervention name(s): Prefabricated post DT LightPost, RTD; Customized post, EverStick Post, StickTech
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery
Condition: Pain, Postoperative; Spine Disease
MeSH terms: Spinal Diseases; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Ultrasound guided thoracolumbar interfascial plane (TLIP) block was first described in 2015
      by Hand et al. TLIP block involves injection of local anesthetics between multifidus and
      longissimus muscles at the third lumbar vertebra level and can block the dorsal rami of
      thoracolumbar nerves. In new approach differently, the investigators made the injection
      between longissimus and iliocostalis muscles with a 15 degree angle from medial to lateral.

      The aim of this study is to determine effectiveness of ultrasound guided thoracolumbar
      interfascial plane (TLIP) block in patients undergoing spinal surgery.
    


Intervention name(s): Bupivacaine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 20 ml %0,25 bupivacaine bilaterally; 2 ml saline subcutaneously bilaterally
Other intervention name(s): ultrasound guided thoracolumbar interfascial plane block; ultrasound guided sham block
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Analgesia; Ultrasound guided thoracolumbar interfascial plane block
TD-0903 for ALI Associated With COVID-19
Condition: Acute Lung Injury (ALI) Associated With COVID-19; Lung Inflammation Associated With COVID-19
MeSH terms: COVID-19; Pneumonia; Lung Injury; Acute Lung Injury; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics
      of inhaled TD-0903 compared with a matching placebo in combination with standard of care
      (SOC) in hospitalized patients with confirmed COVID-19 associated acute lung injury and
      impaired oxygenation.
    

Detailed description: 
      Part 1 of the study includes up to 3 ascending dose cohorts, each comprised of 8 subjects (6
      receiving TD-0903 and 2 receiving placebo).

      Part 2 of the study will evaluate one dose of TD-0903 (selected based on the data from Part
      1) as compared with placebo. Part 2 is targeting 198 subjects total.
    

Intervention name(s): TD-0903; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study Drug to be administered by inhalation; Placebo to be administered by inhalation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group, randomized, double-blind, placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute lung injury; ALI; COVID-19; Coronavirus Disease 2019; inflammatory lung conditions; Inflammatory lung disease; ARDS; SARS-CoV-2; Pneumonia
Effect of Two Probiotic Formulations on Mental Health and Mood Biomarkers in Adults With Depressive Symptoms
Condition: Depression, Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      This is a 3-arm, parallel-group, randomized, double-blind, placebo-controlled pilot trial.
      Sixty adults presenting with depressive symptoms will be randomly allocated to one of 3
      groups comprising (1) Bifidobacterium adolescentis or (2) Lactocaseibacillus rhamnosus LGG
      and Bifidobacterium BB-12 or (3) a placebo for 12 weeks.

      At baseline (Visit 2), midpoint (Visit 3) and end-of-study (Visit 4) visits, participants
      meeting eligibility criteria will complete the BDI-II, BAI, DASS-21 and PROMIS Sleep
      questionnaires and blood samples will be collected for biomarker assessments. Fecal samples
      will be collected prior to the baseline and end-of-study visits for microbial profiling.
    

Detailed description: 
      This is a 3-arm, parallel-group, randomized, double-blind, placebo-controlled pilot trial.
      Sixty adults presenting with depressive symptoms will be randomly allocated to one of 3
      groups comprising (1) Bifidobacterium adolescentis or (2) Lactocaseibacillus rhamnosus LGG
      and Bifidobacterium BB-12 or (3) a placebo for 12 weeks.

      At screening (Visit 1), the study design will be explained to participants, following which
      signed GDPR and study informed consent will be obtained. Participants will be assessed for
      eligibility, medical history and concomitant therapies.

      At baseline (Visit 2), midpoint (Visit 3) and end-of-study (Visit 4) visits, participants
      meeting eligibility criteria will complete the BDI-II, BAI, DASS-21 and PROMIS Sleep
      questionnaires and blood samples will be collected for biomarker assessments. Fecal samples
      will be collected prior to the baseline and end-of-study visits for microbial profiling.
    

Intervention name(s): B. adolescentis Bif-038; Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): B. adolescentis Bif-038 (probiotic capsule) delivered orally once daily at a minimum of 5 billion CFU/day; Lacticaseibacillus rhamnosus, LGG® and Bifidobacterium, BB-12® (probiotic capsule) delivered orally once daily at a minimum of 1 billion CFU/day; Placebo capsule delivered orally once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Milk Proteins, Ambulatory Blood Pressure and Vascular Function
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Epidemiological studies demonstrated an inverse associations between cardiovascular events
      and milk and dairy product consumption. Evidence from human intervention studies suggests
      that both whey and casein may be effective in blood pressure-lowering, however there is
      limited data on the impact of milk proteins on vascular function. This research aims to
      compare the potential acute and chronic impacts of the two main milk proteins (whey and
      casein) with maltodextrin on blood pressure and vascular function. Furthermore, the effects
      of these proteins on the markers of insulin resistance, lipid metabolism and inflammatory
      status will also be investigated in 'at-risk' individuals.

      This research includes both an acute and chronic intervention study which have been
      independently powered on the appropriate outcome measures. This has generated different
      sample size requirements for the two studies (Actual participants on the acute study: n=27,
      and on the chronic study: n=38).
    


Intervention name(s): Ca-caseinate; Maltodextrin; Whey protein isolate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Milk proteins; Blood pressure; Vascular function
Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal
      impairment compared to that in subjects with normal renal function.
    


Intervention name(s): NKTR118 Group1; NKTR118 Group 2; NKTR118 Group3; NKTR118
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral dose, 25 mg; Oral dose, 25 mg; Oral dose, 25 mg; Oral dose, 25 mg
Intervention MeSH terms: Naloxegol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Pharmacokinetics; NKTR-118; renal impairment; parallel study; QTcF Interval; AUC(0-t); Cmax; tmax
Sedation Techniques for Outpatient Colonoscopy
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a prospective, randomized, single-blind controlled clinical trial comparing three
      sedative regimens for outpatient colonoscopy.
    

Detailed description: 
      This was a prospective, randomized, single-blind controlled clinical trial comparing
      target-controlled infusion (TCI) with propofol and patient-controlled sedation (PCS) with
      propofol, to conventional combination of midazolam and pethidine, in terms of quality and
      safety of sedation, and patient recovery during outpatient colonoscopy.
    

Intervention name(s): Propofol 10 MG/ML Injection; Midazolam injection; Pethidine Hydrochloride 50 Mg/mL Solution for Injection; target controlled infusion pump; patient-controlled sedation pump
Intervention type(s): Drug; Drug; Drug; Device; Device
Other intervention name(s): propofol; midazolam; pethidine; TCI; PCS
Intervention MeSH terms: Midazolam; Meperidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: TCI propofol; PCS propofol; sedation; colonoscopy
One Step at a Time: An Intervention to Reduce Sedentary Behavior Among Working Adults
Condition: Sedentary Behavior; Exercise; Middle Age; Adult
Study type: Interventional

Summary: 
      The proposed study will test the preliminary efficacy of a novel 12-week social cognitive
      theory-based intervention that will target reducing daily sitting time and increasing
      exercise participation among middle-aged working adults. This is a population highly
      susceptible to excessive sedentary time and low levels of exercise engagement. This two-arm
      randomized controlled trial (RCT) will examine the preliminary efficacy of decreasing
      sedentary time in addition to increasing moderate-vigorous intensity physical activity (MVPA)
      engagement, compared to a group which only receives MVPA promotion.
    


Intervention name(s): Decrease Sedentary Time + Increase MVPA group; Increase MVPA group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise; personalized step count goals to increase daily volume of physical activity and displacement of sedentary time; 12 week home-based exercise program to promote engagement of 150 min/week of moderate-vigorous intensity exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Study of Multiple Ascending Dose of KBL693 in Healthy Participants
Condition: Moderate to Severe Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to investigate the safety and tolerability of KBL693 in healthy
      volunteers. KBL693 has been developed as a potential new treatment for moderate to severe
      asthma..
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, single centre Phase I study.

      Eighteen (18) subjects are planned to be randomised at 1 site across the 2 parts of the study
      as follows:

        -  Cohort 1: 680 mg/day

        -  Cohort 2: 6800 mg/day
    

Intervention name(s): KBL693; KBL693
Intervention type(s): Drug; Drug
Intervention description(s): Part 1: 680 mg/day of KBL693 or Placebo;
Route of Administration: Oral; Part 2: 6800 mg/day of KBL693 or Placebo;
Route of Administration: Oral
Other intervention name(s): Placebo; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy
Condition: Breast Cancer; Neutropenia; Febrile Neutropenia
MeSH terms: Breast Neoplasms; Neutropenia; Febrile Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor
      to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was
      independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have
      shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and
      prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the
      safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following
      chemotherapy in patients with breast cancer.
    


Intervention name(s): Pegylated rhG-CSF 100μg/kg; Pegylated rhG-CSF:150 μg/kg; rhG-CSF 5 μg/kg/day
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).; Patients were administered pegylated rhG-CSF 150 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).; Patients were administered rhG-CSF 5 ug/kg daily during chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy) until (1)continuous injection for 14 days (2)two successive ANC counts exceed 5.0×109/L（3）ANC counts exceed 15×109/L at anytime.
Other intervention name(s): HHPG-19K 100µg/kg; HHPG-19K 150μg/kg; Jie Xin 5 μg/kg/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Neutropenia; Febrile Neutropenia