bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Atorvastatin on Renal Function in Healthy Subjects During Normal and High Sodium Intake
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 4

Summary: 
      We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium
      handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans
      during normal and high sodium intake.
    

Detailed description: 
      We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium
      handling, renal hemodynamics, tubular function and vasoactive hormones in healthy humans
      during normal and high sodium intake.

      We wanted to analyze if changes in renal hemodynamics, tubular function, hormones, blood
      pressure and HR under acute treatment with atorvastatin depends on sodium intake.
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): 80 mg atorvastatin on two following days each
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atorvastatin; healthy; sodium excretion; hemodynamics; tubular function
Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening
      (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid
      in symptomatic asthma patients.
    


Intervention name(s): BI 671800; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 671800; Placebo matching BI 671800
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Condition: Breast Cancer; Neutropenia
MeSH terms: Breast Neoplasms; Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized open label dose finding study to evaluate the efficacy and safety of
      F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment.
    

Detailed description: 
      This is a randomized, multi-center, dose finding, open label, positive controlled Phase II
      study of the efficacy and safety of once-per-cycle of F-627 compared with Neulasta®
      (pegfilgrastim) in women with breast cancer who are receiving myelotoxic chemotherapy (TC:
      docetaxel + cyclophosphamide or TAC: docetaxel + doxorubicin + cyclophosphamide).

      The primary objective of this study is to evaluate the efficacy and safety of various single
      cycle doses of F-627 as compared with the standard dosing of Neulasta® (pegfilgrastim) in
      breast cancer patients experiencing myelotoxic chemotherapy. Myelotoxicity in this study will
      be defined by the duration of moderate neutropenia; the number of days in which the patient
      has had an absolute neutrophil count (ANC) < 1.0 × 10^9/L during the first cycle of their
      chemotherapy treatment (each chemotherapy cycle is expected to last 21 days). This, by
      definition, includes grade 3 (moderate) and grade 4 (severe) neutropenia. Doses of F-627 to
      be tested for subjects receiving TC chemotherapy are 80 µg/kg/dose, 240 µg/kg/dose, and 320
      µg/kg/dose. For subjects receiving TAC chemotherapy, only 240 µg/kg/dose and 320 µg/kg/dose
      are to be tested.
    

Intervention name(s): F-627; Neulasta® (pegfilgrastim)
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection given 1 per chemotherapy.; Single dose injection given once per chemotherapy cycle.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Taxotere Chemotherapy; Neulasta; efficacy and safety; single cycle doses of F-627; pegfilgrastim
Bone UltraSonic Scanner (BUSS): Validation Study
Condition: Osteoporosis; Osteopenia
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Observational

Summary: 
      The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus
      densitometry (DXA) in osteoporosis detection.
    

Detailed description: 
      Study will conduct measurements in a group of postmenopausal women and use their DXA
      examination data as a control. BUSS data will be able to discriminate between postmenopausal
      women with osteoporosis compared with no osteoporosis defined by DXA measurements.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Postmenopausal women
      
Keywords: Osteoporosis; ultrasound; sonometer; DXA
Immediate Effects of Upper Thoracic Manipulation on Skin Surface Temperature of T3 Vertebral Region and Biceps Brachii Muscle
Condition: Myofascial Dysfunction
Study type: Interventional

Summary: 
      The aim of the present study was to assess the immediate effects of upper thoracic
      manipulation on skin surface temperature in the region of the T3 vertebra and biceps brachii
      muscle in healthy women. It is a randomized controlled blind study. Twenty-six healthy women
      of the university community were randomly allocated to an experimental group (n = 13) and a
      placebo group (n = 13). A single session of the upper thoracic spine manipulation (segment
      T3)was performed. Infrared thermography was used to determine changes in skin surface
      temperature in the region of T3 and the biceps brachii muscle, which would indirectly reflect
      sympathetic activity. Images were taken prior to manipulation, immediately after and both
      five and 10 minutes after manipulation. Repeated measures ANOVA with the post hoc Bonferroni
      test and the independent samples t-test were used for the intragroup and intergroup
      comparisons, respectively, with the level of significance set to 5%.
    


Intervention name(s): Spine manipulation; Manipulation sham
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thermography; Skin Temperature; Manipulation, Spinal; Physical Therapy Modalities
Influence of Different Sugary Beverages on Thirst Sensation
Condition: Thirst
Study type: Interventional

Summary: 
      The purpose of this study is to determine if water and three different sugary beverages
      (milk, Orange juice and iced tea) have the same effect on thirst.
    

Detailed description: 
      Participants should be in the laboratory at 8.00 in order to collect the values of weight,
      height, total body water, intracellular water and extracellular water in a Segmental Multi
      Frequency Body Composition Monitor (TANITA MC 180 MA®). Then, a blood sample will be
      collected for analysis of blood glucose, osmolality and plasmatic sodium. They will sit at
      individual tables for the duration of the session and were allowed to read, listen to music
      with earphones, or use their portable computers with the exception of internet access to
      minimize visual cues (e.g., unwanted publicity for beverages or visiting Web sites showing
      pictures of food and drinks), which may have effect on thirst. Breakfast will be served at
      9.30 on every occasion and preload stimuli will be offered exactly 60 minutes after breakfast
      (at 10.30). Lunch will be provided at 13.00. Motivational ratings will be first obtained at
      the end of collection of blood sample (baseline or time 0) and every 30 minutes thereafter
      until the lunch time (times 1 through 7). After lunch (time 8), participants will complete
      the last set of ratings and will bring a food diary to record all food and fluid intake until
      00.00 that day.
    

Intervention name(s): Effect of ingestion of different Sugary Beverages on Thirst Sensation
Intervention type(s): Behavioral
Intervention description(s): The participants will drink Water (control group),Non-fat Milk, Orange Juice and Iced Tea. The beverages will be presented chilled but without ice in 330 ml portions in opaque plastic containers and participants will be asked to consume the entire amount within 15 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Droperidol and Cardiac Repolarization
Condition: Cardiac Repolarization
Study type: Interventional
Phase: Phase 4

Summary: 
      For many years droperidol has been used in prophylaxis and therapy of PONV. Information that
      it can provoke disorders of cardiac ventricular rhythm reduced its popularity. However those
      data didn't base on solid examinations confirming torsadogenic action of droperidol. It is
      known that droperidol prolongs time of repolarisation, but there wasn't any data confirming
      its impact on transmural dispersion of repolarisation. Only estimation both of those actions
      in one time allows to define for sure arrhythmogenic role of droperidol.

      The aim of this study was to answer the questions:

      6. Does droperidol make an significant prolongation of heart repolarisation, expressed as
      corrected QT interval?

        1. Does droperidol cause increase of transmural dispersion of repolarisation?

        2. Does possible torsadogenic acting of droperidol depend on dose of drug?

        3. Does ondansetron cause changes of electrical heart function, suggesting its
           possibilities to induce TdP tachycardia?

        4. What is torsadogenic potential of droperidol and ondansetron used in prophylaxis PONV in
           people not suffering from cardiovascular diseases?
    


Intervention name(s): Xomolix 0.625 mg intravenously; Xomolix 1.25 mg; Zofran 8 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intravenous administration of 0.625 mg droperidol; intravenous administration of 1.25 mg droperidol; intravenous administration of 8 mg ondansetron
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate safety,
      tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and
      pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male
      subjects
    


Intervention name(s): semaglutide; placebo; semaglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.; Placebo (oral) administered once daily for 10 weeks.; Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.
Other intervention name(s): NN9924
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effectiveness of Portable Electronic Vision Enhancement Systems (p-EVES) for Near Vision in Visual Impairment
Condition: Moderate or Severe Vision Impairment, Both Eyes
MeSH terms: Vision Disorders; Vision, Low
Study type: Interventional

Summary: 
      Over 1 million people in the UK suffer from untreatable visual impairment, many of them
      elderly. The major complaint of visually impaired people is their inability to carry out
      simple tasks, especially those involving reading. It is known that this activity limitation
      is a major cause of depression in an older population, and it is reflected in reduced quality
      of life. Low vision clinics, mostly based within hospital ophthalmology departments, dispense
      optical magnifiers to allow patients to carry out these tasks again, but these devices do
      have limitations (unusual posture, short working distance, monocular viewing). Although
      electronic magnifiers have been around since the 1960s, they were initially very large and
      expensive. Recent advances in technology have brought about an explosion in the number and
      range of portable and moderately-priced aids, which can be used binocularly, in a natural
      working position: these are currently not available through the NHS. Evidence is needed as to
      whether these portable hand-held electronic magnifiers could offer a significant benefit to
      the majority of patients, and therefore whether they should be routinely dispensed in low
      vision clinics.

      The proposed study is a two-arm randomised crossover trial with existing users of optical
      magnifiers being assigned to use a hand-held electronic magnifier in addition to their
      existing devices for 2 months. Reading and task performance will be measured with the aid,
      and compared to the performance with optical aids, and the patient will be asked to report on
      the comparisons between the aids.
    


Intervention name(s): portable electronic magnifier; optical aids
Intervention type(s): Procedure; Procedure
Other intervention name(s): electronic video magnifier; portable CCTV; electronic vision enhancement system; EVES; magnifiers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: portable electronic magnifiers
This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas
Condition: Pediatrics; Solid Tumors
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study of eribulin mesylate in pediatric participants with recurrent or
      refractory solid tumors (excluding CNS), including lymphomas. Eribulin mesylate will be
      administered intravenously, once per day on Days 1 and 8 of a 21-day cycle. This study aims
      to determine the maximum tolerated dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of
      this regimen in Part A1 (participants greater than or equal to [>=] 12 months and less than
      [<] 18 years). Part A2 will enroll infants (greater than [>] 6 months and <12 months) one
      dose level behind the dose level at which participants in Part A1 are enrolling, in order to
      maximize safety for infant participants. Additionally, this study aims to describe the
      toxicities and the pharmacokinetics of eribulin mesylate when administered to children. In a
      preliminary manner, the antitumor effect of eribulin mesylate will also be described.
    


Intervention name(s): Eribulin Mesylate
Intervention type(s): Drug
Intervention description(s): Eribulin mesylate will be administered intravenously on Days 1 and 8 of each 21-day cycle.
Other intervention name(s): E7389
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tumors; Lymphomas; Solid Tumors; Pediatric
Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin N and Huminsulin® Basal
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new
      human isophane Insulin, Julphar Insulin N, and the already approved reference Insulin,
      Huminsulin® Basal. All participants will receive both study treatments on two separate dosing
      days.
    

Detailed description: 
      Daily injections of insulin are a necessity for many patients with diabetes mellitus in order
      to treat hyperglycemia. Julphar Insulin N and Huminsulin® Basal are both intermediate-acting
      human isophane insulins, i.e. consist of a suspension containing a crystalline precipitate of
      isophane human insulin (NPH) complexed with protamine sulphate and zinc. The new insulin,
      Julphar Insulin N, is biosimilar to Huminsulin® Basal. Demonstration of similar absorption
      (PK) and effects (PD) are necessary to achieve market approval of Julphar Insulin N.
    

Intervention name(s): Julphar Insulin N (human isophane insulin); Huminsulin® Basal (NPH, human isophane insulin)
Intervention type(s): Drug; Drug
Intervention description(s): investigational insulin: Julphar N (human isophane insulin), biosimilar; marketed reference product: Huminsulin® Basal (NPH, human isophane insulin)
Other intervention name(s): Julphar Insulin N; Huminsulin® Basal
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: intermediate-acting human isophane insulin, biosimilar
Effect of Oocyte Denudation Time and Intracytoplasmic Sperm Injection Time on Embryo Quality
Condition: Fertility Disorders
Study type: Observational

Summary: 
      An observational analytic retrospective study was conduct using cross-sectional study. The
      subject were oocytes from in-vitro fertilization procedures using the ICSI method at the
      assisted reproductive technology clinic in a private hospital in Bandung for the period 2017
      - 2019. Three variables were oocyte denudation time, ICSI time and embryo quality collected
      from samples that met the research criteria.
    

Detailed description: 
      This study analyses the different oocyte denudation time after ICSI on all embryos generated
      during IVF procedures between 1 Januaryr 2017 and 31 December 2019. All oocytes arer
      categorised on how many hours their denudation times were and these were then assessed for
      their qualities.
    

Intervention name(s): intracytoplasmic sperm injection
Intervention type(s): Procedure
Intervention description(s): injection of sperm into an oocyte in assisted reproductive technology
Other intervention name(s): ICSI
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Oocytes are derived from patients enrolled in IVF
      
Keywords: infertility; assisted reproductive technology; embryo quality; oocyte denudation; intracytoplasmic sperm injection
Physical Performance Levels and Social Participation in Elderly Living In Urban and Rural Areas
Condition: Eldrely
Study type: Observational

Summary: 
      Purpose: This study aims to investigate the effect of physical performance levels of elderly
      living in rural and urban areas on social participation, social functioning, and quality of
      life.

      Method: A total of 418 volunteer elderly aged 65 and over living in rural (42.3%) and urban
      (57.7%) areas participated in this study. The Mini-Mental State Examination, Short Physical
      Performance Battery, the World Health Organization Quality of Life Scale for Older Adults,
      Leisure Time subscale of the Social Functioning Scale and the Community Integration
      Questionnaire were applied to participants.
    


Intervention name(s): Short Physical Performance Battery
Intervention type(s): Other
Intervention description(s): The SPPB was applied to determine the physical performance levels of the elderly. This test is a valid and reliable test that measures the performance of the lower extremities and can be applied for elderly. The SPPB included three sections: getting up from a chair, standing balance, and walking speed. At the end of these tests, the scores of the three sections were calculated and higher scores were evaluated as reflecting higher levels of physical performance
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study was carried out with the participation of elderly residing in the provinces of
        Isparta, Burdur, and Antalya in the Mediterranean region of Turkey
Monopolar Radiofrequency Ablation Using a Dual Switching System and a Separable Clustered Electrode (Octopus®)
Condition: HCC; Metastasis
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      Increasing ablative zone is an essential part to improve technical success and long term
      outcome in patient treated with radiofrequency ablation (RFA).

      A combination of dual switching system and separable clustered electrode has been reported to
      create large ablative zone in preclinical study.

      Based on preclinical study, the investigators conducted a preliminary study in eligible 60
      patients to measure whether this combination (dual switching system and separable clustered
      electrode) improves technical success rate and local tumor progression rate over a year, in
      comparison with historical control group.
    

Detailed description: 
      Increasing ablative zone is an essential part to improve technical success and long term
      outcome in patient treated with radiofrequency ablation (RFA).

      A combination of dual switching system and separable clustered electrode has been reported to
      create large ablative zone in preclinical study.

      Based on preclinical study, the investigators conducted a preliminary study in eligible 60
      patients to measure whether this combination (dual switching system and separable clustered
      electrode) improves technical success rate and local tumor progression rate over a year, in
      comparison with historical control group using propensity score matching.
    

Intervention name(s): DSM; separable clustered electrode
Intervention type(s): Device; Device
Intervention description(s): Monopolar RFA using dual switching mode (DSM); A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.
Other intervention name(s): Octopus(R)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RFA