bioihbjkbjnl/mcl2 huggingface dataset:
Hemodialysis and Erythrocyte Fatty-Acid Status: a Lipidomics Study
Condition: Fatty Acid Metabolism; Erythrocytes; Lipidomics; Hemodialysis
Study type: Interventional

Summary: 
      Hypotension with potentially serious consequences for organ perfusion is a common
      complication in extracorporeal procedures such as hemodialysis / hemofiltration. The exact
      reasons for this are still insufficiently clarified. Probably periinterventional vasorelaxant
      released substances play a crucial role in these procedures. These substances could be due to
      contact of blood cells with the Membrane in the dialyzer / hemofilter arise. In this project
      the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during
      hemodialysis and thus act as potential candidate products for the result of hypotonic phases
      in the Dialysis.

      We will determine differences in RBC fatty acids profiling in hemodialysis patients before
      and after dialysis intervention. Furthermore a matched control group of healthy individuals
      will be profiled. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass
      spectrometry.

      It is believed that during hemodialysis / HLM / CVVH there is an increase in EETs / DHETs in
      the serum and in the erythrocytes. It is believed that shear forces play an important role in
      the release of erythrocyte EETs / DHETs.
    

Detailed description: 
      Differences in Erythrocyte Fatty-Acid Status Profiling in:

        -  before and after hemodialysis intervention

        -  in hemodialysis patients and healthy individuals Venous blood will be collected from
           each subject in the sitting position
    

Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): blood sample before and after a single HD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetic Evaluation of MDZ028
Condition: Midazolam
Study type: Observational

Summary: 
      Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults
      recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose,
      randomised, open-label two-peiod crossover bioavailability study, respectively. Data were
      analysed using non-linear mixed effect modeling.
    

Detailed description: 
      In the absence of a licensed formulation in many countries worldwide, ADV6209, an innovative
      2mg/ml oral solution of midazolam containing cyclodextrin, has been developed for moderate
      sedation in paediatric patients. Population pharmacokinetics for ADV6209 is reported.

      Plasma concentration data were collected from 37 paedriatic patients and 12 healthy adults
      recruited in a single dose, open-label phase II pharmacokinetic study and in a single dose,
      randomised, open-label two-peiod crossover bioavailability study, respectively. Data were
      analysed using non-linear mixed effect modeling. Plasma concentrations of midazolam were
      discribed by a two-compartement model. An additional one-compartement model was added for a
      α-hydroxymidazolam.
    

Intervention name(s): Midazolam
Intervention type(s): Drug
Intervention description(s): All subjects received a sigle 0.3mg/kg midazolam dose os ADV6209
Other intervention name(s): midazolam dose of ADV6209
Intervention MeSH terms: Midazolam
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The planned enrollment is 36 children, stratified in two groups: 24 children between 6
        months and 11 years, and 12 children between 12 and 17 years. Age is considered in years
        past by the date of inclusion. Children aged between 6 months and 11 years old should be
        homogenous in both age groups 6-23 months and 2-11 years. For example, at least 4 children
        in the 6-23 month age group will be recruited.

        Children likely to be included will be hospitalized in the pediatric surgery department at
        Amiens University Hospital.

        Children who will be included in this study will not be able to participate in another
        study within 3 months of their inclusion in this study.
      
Keywords: pharmacokinetics; child; cyclodextrin; moderate sedation
Effects of Soy Consumption on Symptoms of Menopause
Condition: Menopause
Study type: Observational

Summary: 
      The purpose of this study is to examine the way soy consumption affects menopausal symptoms
      in middle-aged Japanese women.
    

Detailed description: 
      For the past 20 years, Japanese women have reported fewer menopausal symptoms than their
      North American counterparts. One explanation for the disparity is the differences in diet.
      Evidence suggests that Japanese women consume large amounts of soy, a phytoestrogen that is
      structurally similar to the hormone estrogen. However, there is a lack of menopause-related
      research data from non-Western populations. This study will be a long-term observation of the
      effects of soy consumption in menopausal Japanese women.

      This study will last 6 months. Participants will complete a dietary log and a menopausal
      symptom checklist daily. There will be three or four study visits. During these visits,
      participants will complete a diet questionnaire, have a blood sample collected, and be
      interviewed about their menopausal symptoms. Six months after study completion, participants
      will be sent a questionnaire about any recent menopausal symptoms they may have experienced.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: Women; Soy Foods; Middle Aged
International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
Condition: Non-invasive Fat Reduction
Study type: Interventional

Summary: 
      This study aims to generate data that conveys participant's experiences such as their overall
      satisfaction with the CoolSculpting® treatment for their belly and love handles. By doing
      this, the study will provide insights for doctors to better inform participants about the
      expected outcomes.
    


Intervention name(s): CoolSculpting® System
Intervention type(s): Device
Intervention description(s): A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Behavioral Weight Loss Via Electronic Handheld Device
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Standard behavioral treatment (SBT) for obesity is often effective, but weight losses are
      highly variable, and patients sometimes fail to achieve a "successful" weight loss of 5-10%
      of their starting weight. It has been suggested that the "one size fits all" approach of SBT
      may be responsible for many treatment failures because the intervention is not sufficiently
      tailored to address the unique needs of each patient. Moreover, treatment is delivered in the
      clinic, not in the settings and the times when it is needed most. The primary aim of the
      proposed research is to develop and pilot test a behavioral weight loss intervention that
      combines in-person sessions with treatment delivered via an electronic handheld device to
      provide highly individualized weight loss treatment in patients' natural environment. In a
      critical departure from previous research using cell phone technology, the portion of
      intervention that is delivered via handheld device will be of equal sophistication and
      importance to the portion of the intervention that is delivered in face-to-face treatment
      sessions. The proposed study seeks to determine the feasibility and preliminary efficacy of
      an individually tailored behavioral weight loss program that integrates clinic-based care and
      smartphone technology.
    


Intervention name(s): Lifestyle Counseling
Intervention type(s): Behavioral
Intervention description(s): Participants receive instructions for making healthy changes to their diet and physical activity habits.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Behavior Therapy; Lifestyle; Technology; Cellular Phone
Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial
Condition: Acute Ischaemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized,controlled, double-blinded, phase 3 clinical study to evaluate the
      efficacy and safety of recombinant human urokinase(rhPro-UK) versus basic treatment for
      patients with acute ischaemic stroke in 4.5-6 hours after stroke onset.
    


Intervention name(s): Recombinant human urokinase; Aspirin; rhPro-UK simulation agent; Aspirin simulation agent
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.; Aspirin 300mg is taken orally at the beginning of thrombolysis.; Patients receive rhPro-UK simulation agent 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.; Aspirin simulation agent 300mg is taken orally at the beginning of thrombolysis.
Other intervention name(s): rhPro-UK
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Investigate Pharmacokinetics and Pharmacodynamics of CJ-12420 After Single and Multiple Dose Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of CJ-12420
      after single and multiple dose administration according to H. pylori infection.
    

Detailed description: 
      1. Cohort 1: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the
           multiple dose administration in H. pylori negative volunteers.

        2. Cohort 2: To investigate the pharmacokinetics and pharmacodynamics of CJ-12420 after the
           single dose administration in H. pylori positive volunteers.
    

Intervention name(s): CJ-12420 50mg(HP-); CJ-12420 100mg(HP-); CJ-12420 50mg(HP+); CJ-12420 100mg(HP+)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CJ-12420 50mg in H. pylori negative subject; CJ-12420 100mg in H. pylori negative subject; CJ-12420 50mg in H. pylori positive subject; CJ-12420 100mg in H. pylori positive subject
Other intervention name(s): not yet determined; not yet determined; not yet determined; not yet determined
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Melatonin on Sleep Quality in Patients Dementia
Condition: Sleep Disorders; Dementia
MeSH terms: Dementia; Sleep Wake Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the
      metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in
      dementia.

      Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep
      quality.

      Design: A single-center randomized, double-blinded, placebo-controlled study carried out on
      outpatients with dementia and sleep alterations.

      Participants: The investigators calculated a 40 individuals aged 65 years or over with a
      diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2).

      Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every
      night for 8 weeks.

      Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality
      Index (PSQI).
    

Detailed description: 
      This is a single-center study. The study protocol, informed consents, and amendments were
      approved in writing by the appropriate local site Independent Ethics Committee
      (IEC)/Institutional Review Boards (IRB) (Ethics Committee of the Universidad Autónoma de
      Nuevo León, School of Medicine).

      The patients were recruited as outpatients from the Geriatrics Clinic. A total of 67 patients
      were screened out of which 40 male and female patients diagnosed with mild to moderate
      dementia were recruited to the study. Following inclusion, all patients underwent
      randomization to treatment with melatonin (5 mg orally) or placebo for 8 weeks. To prevent
      bias, matching placebo tablets, which were identical in appearance, taste, and odor, were
      used. The treatment was double-blinded, with two parallel treatment groups. Selection for a
      treatment group was determined by a computer-generated randomization list, in a 1:1 ratio
      using the randomized permuted blocks method.
    

Intervention name(s): Melatonin 5 mg; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Benedorm
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blinded, placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: melatonin; sleep; dementia; cognition
A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Liver Disease and in Age-, Weight- and Gender-matched Healthy Participants
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which
      the heart has trouble pumping blood through the body. Liver impairment which co-occurs in
      patients with heart failure is a common condition in which the liver is not removing the
      drugs from the blood as well as it should.

      The goal of the study was to learn more about the safety of vericiguat (BAY1021189), how it
      was tolerated and the way the body absorbed, distributed and excreted the study dug given as
      a single oral dose of 2.5 mg tablet in participants with liver impairment and healthy
      participants matched for age-, gender-, and weight.

      The participants stayed at the trial site for about 5 days. During this time, the doctors
      took blood and urine samples and checked the participants' health. About 7 after the
      participants took vericiguat (BAY1021189), the researchers checked the participants' health
      again and asked about any medical problems they had.
    


Intervention name(s): Vericiguat (BAY1021189)
Intervention type(s): Drug
Intervention description(s): Oral single dose of 2.5 mg (2 x 1.25 mg immediate release tablet)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Inositol Treatment in Different Type of PCOS Phenotype
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the
      phenotype (according to the Rotterdam Criteria)
    


Intervention name(s): Myo-inositol
Intervention type(s): Dietary Supplement
Intervention description(s): Myo-inositol (4g/die)
Intervention MeSH terms: Inositol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study to Determine Biomarkers of Response to a Gamma Secretase Inhibitor
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the transcriptional signature of Notch Inhibition
      by testing hair and blood samples on healthy male volunteers who have received MK0752 vs
      placebo for possible future biomarkers in the treatment of cancer or Alzheimers Disease
    


Intervention name(s): MK0752; Comparator: MK0752.; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose MK0752 capsules, 1000 mg: there will be a 7-day washout period between treatments.; Single dose MK0752 capsules, 350 mg: there will be a 7-day washout period between treatments.; Single dose placebo capsules: there will be a 7-day washout period between treatments.
Other intervention name(s): MK0752
Intervention MeSH terms: 3-(4-((4-chlorophenyl)sulfonyl)-4-(2,5-difluorophenyl)cyclohexyl)propanoic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Biomarkers of Notch inhibition
Impact of Neuromodulation on Language Impairments in Stroke Patients
Condition: Stroke; Aphasia
MeSH terms: Stroke; Aphasia; Language Disorders
Study type: Interventional

Summary: 
      Up to 40% of stroke survivors suffer from aphasia, making recovery of language abilities a
      top priority in stroke rehabilitation. Conventional speech and language therapy may have
      limited effectiveness. Leveraging multimodal data (behavioral, neuroimaging, and genetics),
      this study aims to 1) evaluate the efficacy of combining tDCS with speech therapy, 2) examine
      neural changes associated with recovery, 3) identify factors influencing response to
      treatment.
    

Detailed description: 
      Approximately one million people in the United States are living with aphasia, an acquired
      neurological disorder affecting the ability to use and/or understand language. This
      communication impairment affects up to 40% of stroke patients. Stroke victims usually
      prioritize speaking, writing, and walking as the three most important rehabilitation goals,
      two of these goals therefore involving communication. Conventional speech therapy strategies
      have nevertheless limited effectiveness in post-stroke aphasia. Indeed, approximately half of
      those affected will remain in this state despite intensive speech therapy. Effective novel
      treatment is therefore warranted to improve recovery in these patients. Recent evidence
      suggests that transcranial direct current stimulation (tDCS), a non-invasive, low-cost
      neuromodulation technique, applied in conjunction with speech therapy may be more effective
      in promoting language recovery than behavioral intervention alone.

      A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke
      aphasics. Participants will be assigned to either the tDCS group or to the sham (placebo)
      group and will receive 20 minutes of concurrent speech and language therapy by a trained
      speech therapist over five consecutive days. Behavioral, EEG, and MRI data will be acquired
      within one week before and after intervention. Genetic samples will be collected once.
      Secondary behavioral outcome measures will be performed again 3 months following tDCS/sham
      intervention to assess long-term benefits.
    

Intervention name(s): tDCS; Speech and language therapy
Intervention type(s): Device; Behavioral
Intervention description(s): Anodal or sham tDCS will be applied to the scalp.; A trained speech pathologist will administer the speech and language therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind quasi-randomized controlled design
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial direct current stimulation; stroke; aphasia; speech therapy; neurorehabilitation; neuromodulation; language function; neuroplasticity; neuroimaging; EEG; MRI; genetics; language disorders
Efficacy of Adding LLL Therapy to Postural Correction Exercises on Postnatal SIJ Pain
Condition: Sacroiliac Joint Pain
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      the purpose of the study will be to to examine the effect of low level laser therapy on pain
      and function disability in postnatal women with sacroiliac joint pain.
    

Detailed description: 
      Women are more susceptible to sacroiliac joint pain than men because the physiological
      changes associated with childbearing (e.g. pregnancy associated with weight gain, exaggerated
      lumber lordosis, hormone-induced ligamentous laxity and the mechanical trauma associated with
      childbirth) may result in sacroiliac joint pathology .

      Low level laser is effective for treatment of various musculoskeletal pain disorders. It
      releases local neurotransmitters such as serotonin and endorphins. Additionally, the
      analgesic effect of LLLT is thought to be related to its anti-inflammatory action. Laser
      irradiations also relieve pain by alleviating and removing swelling and by increasing
      oxygenation of the tissues, thus results in reduction of the pain .
    

Intervention name(s): LLL therapy , postural correction ex
Intervention type(s): Other
Intervention description(s): study group: will receive low level laser therapy 2 sessions per week for 6 weeks in addition to posture correction exercises.
control group: will be treated by posture correction ex only.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study to Assess the Safety and Immunogenicity of the Drug CAT-354 in Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety of the administration of the drug (CAT-354) in healthy Japanese
      subjects.
    

Detailed description: 
      The study design allows a gradual escalation of dose with safety monitoring to ensure the
      safety of the subjects.
    

Intervention name(s): CAT-354; CAT-354; CAT 354
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 mg CAT-354 or placebo given SC on Day 1; 300 mg CAT-354 or placebo given SC on Day 1; 600 mg CAT-354 or placebo given SC on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Topic Compatibility Dermacyd Wipes - Lactoserum - Hygiene
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the absence of irritation potential (primary
      dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the
      product Dermacyd wipes.
    


Intervention name(s): lactoserum
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment