bioihbjkbjnl/mcl2 huggingface dataset:
Suction Based Characterization of Healthy and Diseased Skin
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse
Study type: Interventional

Summary: 
      The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based
      measurements. The negative pressure needed to gain a certain tissue elevation, tissue
      elevation in response to a certain negative pressure as well as the time of retraction of
      tissue will be recorded and analyzed. Mesurments will be done with the new developed
      Aspiration Device_Nimble and with the CE-certified Cutometer MPA 580.
    

Detailed description: 
      Patients with systemic sclerosis (SSc) show a thickening of the skin due to massive
      deposition of collagen and temporary edema in the dermis. The clinical palpation method is
      currently the only diagnosis method. For an objective detection a non-invasive skin
      elasticity measurement can be performed. The widely used approach is based on local tissue
      suction. This study aims at an identification and quantification of mechanical and structural
      properties of human skin. The results will then be compared in age- and gender matched
      control groups. For evaluation of the skin elasticity measurement the results will be
      compared to the clinical parametar validated, modified Rodnan skin score (mRSS).

      The mechanical properties of healthy and diseased skin will be assessed by suction based
      measurements. The negative pressure is needed to gain a certain tissue elevation. Tissue
      elevation in response to a certain negative pressure as well as the time of retraction of
      tissue will be recorded and analyzed. (The different parameters depend on
    

Intervention name(s): Measurment with Aspirational Medical Device; Measurment with Cutometer MPA 580
Intervention type(s): Device; Device
Intervention description(s): The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.; The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Primary outcome:
Mechanical characterization of healthy and diseased skin using novel aspiration device and comparing it to the already validated Cutometer® MPA 580. Comparison of mechanical skin properties of healthy to patients' skin tissue (control vs. examined group).
Secondary outcome:
Defining predictors of the skin worsening.
Masking: None (Open Label)
Primary purpose: Other
Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of
      AVP-786 in healthy volunteers.
    


Intervention name(s): AVP-786 Dose 1; AVP-786 Dose 2; AVP-786 Dose 1/Q Dose 1; AVP-786 Dose 1/Q Dose 2; AVP-786 Dose 2/Q Dose 2; AVP-923
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Pharmacokinetics; Healthy Volunteers; dextromethorphan with quinidine; deuterated dextromethorphan
Endometrial Local Injury and Implantation Failure
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the influence of endometrial biopsy on increasing
      implantation rate in patients with recurrent implantation failures, 93 women with at least
      two implantation failures were evaluated. In case group endometrial biopsy was obtained from
      48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy
      rate were compared with 45 patients in control group. The results suggest that in vitro
      fertilization or intracytoplasmic sperm injection after endometrial biopsy increase pregnancy
      outcome.
    

Detailed description: 
      In a randomized control trial study, 93 women with at least two implantation failures were
      evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase
      of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients
      in control group.

      The implantation rate was determined as 10.9% in biopsy group compared with 3.38% in
      controls. Clinical pregnancy rate was significantly higher in case group than controls (27.1%
      and 8.9% respectively
    

Intervention name(s): Endometrial biopsy; Endometrial Biopsy
Intervention type(s): Procedure; Procedure
Intervention description(s): Endometrial biopsy was done at luteal phase on the day 21-26 of spontaneous menstrual cycles, when GnRH agonist uses begun. Endometrial samples were taken by a biopsy catheter; Biopsy catheter
Other intervention name(s): biopsy catheter (Pipelle de Cornier, Prodimed, France; Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Endometrial biopsy; IVF/ICSI; Pregnancy outcome; Recurrent implantation failure
Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy and safety of Arotinolol Hydrochloride
      and Metoprolol succinate on morning blood pressure, heart rate and target organ damage in
      patients with essential hypertension. To provide evidence for hypertension treatment.

      A group: Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks. B group: Metoprolol
      succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks.
    

Detailed description: 
      Compare the efficacy and safety of Arotinolol Hydrochloride and Metoprolol succinate on
      morning blood pressure, heart rate and target organ damage in patients with essential
      hypertension.
    

Intervention name(s): Arotinolol Hydrochloride; Metoprolol succinate sustained-release tablet
Intervention type(s): Drug; Drug
Intervention description(s): Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.; Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.
Other intervention name(s): Almarl; Betaloc tablet
Intervention MeSH terms: Metoprolol; Arotinolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Essential Hypertension; Arotinolol; Morning Blood Pressure
A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis
Condition: Healthy; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin
      irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the
      safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.
    


Intervention name(s): Crisaborole ointment 2%; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Crisaborole ointment 2%; Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Long-Term Follow Up Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The LTFU study will conduct a naturalistic follow up of the well characterized CAN-BIND study
      population of patients every six months and continuing over a five-year period. This will
      provide information on the longitudinal progress in mood, functioning, and quality of life of
      the CAN-BIND sample with a view towards long-term outcome and treatment.
    

Detailed description: 
      This is a long-term follow up study of the 'Canadian Biomarker Integration Network in
      Depression' (CAN-BIND) study. The CAN-BIND study examines biological markers of
      antidepressant treatment response. The examined biomarkers included clinical, imaging, and
      genetic components. The Long Term Follow up (LTFU) study will continue to follow the patients
      in this study each six months over a five year period. By doing so, a comprehensive clinical
      outcome data on a well characterized cohort of depressed patients will be obtained.

      The research team will conduct a naturalistic study of CAN-BIND participants and will monitor
      the longitudinal progress in mood, functioning, and quality of life, with a view towards
      advising future treatment options. Each patient completing CAN-BIND will be asked to
      participate in the LTFU study.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Each patient completing the 16 weeks of CAN-BIND who have previously met DSM-IV-TR criteria
        for Major Depressive Episode (MDE) in MDD as determined by MINI.
      
Keywords: major depression; major depressive disorder; biomarkers; MDD; long term follow up
Bioavailability and Vascular Effects of Apple Polyphenols
Condition: Healthy
Study type: Interventional

Summary: 
      The main purpose of this study is to determine the oral bioavailability of flavanols
      (polyphenolic compounds) from apple granules and an apple extract delivered in a water based
      beverage at two different doses. We will also investigate the effects of apple flavanols on
      nitric oxide production.
    

Detailed description: 
      This study is a randomized four phase crossover trial investigating the bioavailability of
      apple flavanols and the effects on nitric oxide products, a surrogate marker for changes in
      endothelial function. Each test phase will comprise a 3 day period of intervention which will
      be identical in nature (except for the test product consumed) and separated by a minimum of 1
      week. On days 1-3 of each test phase volunteers will consume a low flavanol diet. After
      consumption of the test product on the morning of day 2, blood and urine samples will be
      collected at regular intervals for the next 24h.
    

Intervention name(s): Apple extract delivering 70 mg epicatechin; Apple extract delivering 140 mg epicatechin; Apple granules delivering 70 mg epicatechin; Water delivering no epicatechin
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Delivered as a flavoured water based beverage; Delivered as a flavoured water based beverage; Delivered as a puree; Delivered as flavoured water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Dietary intervention; bioavailability; Healthy volunteers
The Effect of Probiotics on Infections in Toddlers
Condition: Diarrhoea; Respiratory Diseases
MeSH terms: Infections; Respiratory Tract Diseases; Respiration Disorders; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Probiotics has been known as a dietary supplement for a long period. Recent clinical trials
      indicate that probiotics might have an effect in preventing common infection diseases in
      children.

      The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a
      daily intake of a suspension containing probiotics in a period of 9 months, the incidence of
      diarrhoea and respiratory diseases can be reduced.
    

Detailed description: 
      Probiotics has been known as a dietary supplement for a long period. Recent clinical trials
      indicate that probiotics might have an effect in preventing common infection diseases in
      children.

      Our hypothesis is: if young healthy children in the age of 6 month to 15 mdr. has a daily
      intake of a suspension containing probiotics( BB12 and TH4) in a period of 9 months, the
      incidence of diarrhoea and respiratory diseases can be reduced.
    

Intervention name(s): probiotics; probiotics
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): placebo; 0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Probiotics; Infections; Children
Effect of Oral Isotretinoin on Muscle Strength in Patients With Acne Vulgaris: A Prospective Controlled Study
Condition: Muscle Strength
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      BACKGROUND: Musculoskeletal side effects related to isotretinoin are frequently reported.
      This study aimed to investigate the effect of oral isotretinoin treatment on muscle strength.
      Our second aim was to evaluate whether there was a correlation between the serum creatine
      phosphokinase (CPK) level, a specific marker of muscle breakdown, and muscle strength.

      METHODS: This study included 30 patients who presented to our hospital and were started on
      oral isotretinoin treatment for acne vulgaris and 30 patients in the control group who were
      given local treatment. Age, gender, height and weight of the patients were recorded, and the
      body mass index (BMI) was calculated. The hamstring and quadriceps muscle strengths of the
      non-dominant side were evaluated in all patients using an isokinetic dynamometer, and the
      peak torque (PT) values were recorded. In the isotretinoin group, isokinetic measurements
      were performed again in those that completed six-month drug treatment and compared with the
      initial PT values.
    

Detailed description: 
      BACKGROUND: Musculoskeletal side effects related to isotretinoin are frequently reported.
      This study aimed to investigate the effect of oral isotretinoin treatment on muscle strength.
      Our second aim was to evaluate whether there was a correlation between the serum creatine
      phosphokinase (CPK) level, a specific marker of muscle breakdown, and muscle strength.

      METHODS: This study included 30 patients who presented to our hospital and were started on
      oral isotretinoin treatment for acne vulgaris and 30 patients in the control group who were
      given local treatment. Age, gender, height and weight of the patients were recorded, and the
      body mass index (BMI) was calculated. The hamstring and quadriceps muscle strengths of the
      non-dominant side were evaluated in all patients using an isokinetic dynamometer, and the
      peak torque (PT) values were recorded. In the isotretinoin group, isokinetic measurements
      were performed again in those that completed six-month drug treatment and compared with the
      initial PT values.
    

Intervention name(s): Isokinetic device (Biodex System 4)
Intervention type(s): Device
Intervention description(s): The measurement of muscle strength with isokinetic device
Other intervention name(s): serum creatinine phosphokinase level
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Isotretinoin; muscle strength; isokinetic; creatinine phosphokinase
An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients
Condition: Acute Myeloid Leukemia (AML); Acute Lymphoblastic Leukemia (ALL); Myelodysplastic Syndrome (MDS)
MeSH terms: Leukemia; Leukemia, Myeloid, Acute; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization,
      assess plasma drug levels, asses serum copper levels, and assess drug levels in urine.

      Efficacy and Safety will be assessed in all patients enrolled to the study.
    

Detailed description: 
      This study is an open-label, single-arm, Phase II, PK and pharmacodynamic (PD) trial of
      CPX-351 in patients with documented acute leukemia (AML or ALL) or MDS (IPSS score ≥ 1.5) and
      suitable for treatment with intensive chemotherapy. Each patient will be screened for hepatic
      impairment. Hepatic impairment will be assessed using the Child-Pugh system and only patients
      with a Child-Pugh score <7 points will be eligible for this study. Patients will receive up
      to two inductions and four consolidation courses. Patients will be monitored for safety
      (early deaths, adverse events, metabolic changes, etc.) and efficacy (response for AML, ALL,
      and MDS) while on the study.
    

Intervention name(s): CPX-351
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Newly Diagnosed AML; Secondary AML; Relapsed/Refractory AML; Relapsed/Refractory ALL; MDS
Efficacy and Safety of FTY720 for Acute Stroke
Condition: Stroke; Vascular Accident; Cerebral Stroke; Ischemic Cerebrovascular Accident; Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      Stroke is one of the main severe disease of public health importance. Increasing evidence
      suggests that inflammatory mechanisms plays a significant role in stroke. So, immune targets
      are supposed to be an effective one. The sphingosine-1-phosphate receptor regulator
      Fingolimod(FTY720)is an effective immunology modulator which has been widely used in
      autoimmune disease and has been testified effective on stoke animal models.
    

Detailed description: 
      This study will enroll 87 stroke patients who have been diagnosed with stroke and meet the
      inclusion criteria.

      After successfully meeting initial screening criteria, investigators will contact the family,
      explain the study, and send a consent form for their review.

      After that, patients will be given 0.5mg/day oral fingolimod over a course of 3 consecutive
      days , then investigators will make a neurofunctional assessment before and 7days, 30 days
      and 90days after oral fingolimod. And Magnetic Resonance of the brain before, 7days, 14days
      and 90days after oral fingolimod. Furthermore 5ml intravenous blood for flow cytometry is
      also taken before and 1day,3days,7days after fingolimod use.
    

Intervention name(s): Fingolimod
Intervention type(s): Drug
Intervention description(s): A sphingosine-1-phosphate receptor regulator
Other intervention name(s): FTY720
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke,Fingolimod(FTY 720), treatment
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan
      (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting
      diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting
      systolic blood pressure [SSBP] ≥ 95th percentile ).
    


Intervention name(s): Valsartan 0.25 mg/kg; Valsartan 1.0 mg/kg; Valsartan 4.0 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once daily; once daily; once daily
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Children; pediatrics; High Blood Pressure; Hypertension; Valsartan
Effects of Omega-3 Fatty Acids in Ambient Air Pollution Exposure in Healthy Adults
Condition: Health Effects of Ambient Air Pollution
Study type: Observational

Summary: 
      This observational study recruits healthy individuals who have been routinely taking high
      amount (at least 3 g/wk) of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid
      (DHA), and those who don't, and examines the efficacy of dietary EPA and DHA in ameliorating
      the cardiopulmonary effects of exposure to ambient air pollution.
    

Detailed description: 
      Purpose: To examine the relationship between blood levels of dietary eicosapentaenoic acid
      (EPA) and docosahexaenoic acid (DHA) and cardiopulmonary responses to environmental air
      pollution in healthy adults. EPA and DHA are two important omega-3 fatty acids that are
      mainly found in seafoods and fish oils and associated with beneficial effects to human
      physiology.

      Participants: Healthy 35-55 year-old male and female subjects will be screened for their
      dietary intake of EPA and DHA. Qualified volunteers will be divided into two groups, group 1:
      individuals voluntarily taking at least 3 g/wk of EPA and DHA from dietary sources including
      fish oil supplements and ocean fish/shellfish consumption for a period of at least 6 months
      prior to enrollment in the study; group 2: individuals who have consumed no more than 1
      serving size (4-6 oz)/month of ocean fish/shellfish, or no more than 1 pill/month of fish oil
      supplement during the 6 month period preceding enrollment.

      Procedures (Methods): In this observational panel study, subjects will come to the U.S. EPA
      Human Studies Facility for up to 5 sessions, each consisting of 2 consecutive visit days. The
      following endpoints will be collected: blood pressure, heart rate variability measurements,
      blood biomarkers, endothelial cell function, retinal venule and arteriole diameter, and lung
      function. Air pollution exposure will be assessed using area-specific air quality data
      derived from local air monitoring stations interfaced with activity monitoring and GPS
      tracked location for each subject.
    

Intervention name(s): omega-3 fatty acids
Intervention type(s): Dietary Supplement
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy 35-55 year-old male and female subjects
      
Keywords: Eicosapentaenoic Acid; Docosahexaenoic Acid; Ambient Air Pollution