bioihbjkbjnl/mcl2 huggingface dataset:
3 Month Outcome of Ziv-aflibercept for DME
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with
      intravitreal ziv-aflibercept.
    

Detailed description: 
      Multi-studies have shown that Intravitreal aflibercept (Eylea) is effective and safe in
      diabetic macular edema (DME) treatment and has gained FDA approval but it is expansive where
      ziv aflibercept (ZALTRAP) has the same molecule but with high osmilar buffer solution which
      is FDA approved for colon rectus cancer treatment and it is cost effective.

      Studies have shown that intravitreal ziv aflibercept is safe and nontoxic despite the high
      osmolarity and even has short term effect in wet age related macular degeneration.
    

Intervention name(s): Ziv aflibercept
Intervention type(s): Drug
Intervention description(s): Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks
Other intervention name(s): ZALTRAP
Intervention MeSH terms: Aflibercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DME; Anti VEGF; VEGF trap; Diabetes; Diabetic retinopathy; ZALTRAP; Ziv aflibercept
Sun Protection Factor Assay (SPF Assay 199/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987516
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z46-092)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Early Mobilization in Cardiac Surgery
Condition: Nursing Caries; Ambulation Difficulty
MeSH terms: Mobility Limitation
Study type: Observational

Summary: 
      This study was planned to determine the mobilization process and factors affecting this
      process in patients who underwent open heart surgery and were admitted to the cardiovascular
      surgery intensive care unit.
    

Detailed description: 
      Mobilization; It is defined as "standing up, walking, being able to move and walking around,
      especially after the operation, when the patient stands up and walks around". Postoperative
      mobilization is a basic human need and one of the basic principles of nursing care. In the
      postoperative period, with the delay of mobilization, the patient's insulin resistance
      increases, muscle weakness and muscle mass loss occur, problems in pulmonary functions are
      experienced and the risk of thromboembolism increases.

      Surgery of patients admitted to cardiovascular ICUs after open heart surgery close monitoring
      afterwards, maintenance of cardio-respiratory functions, healing is supported. During care in
      the intensive care unit Preparation of materials that may be needed by the patient, general
      condition of the patient and vital information monitoring symptoms, performing breathing
      exercises, evaluating pain and management, monitoring fluid-electrolyte balance, monitoring
      hemodynamic parameters, surgical wound dressing, getting the patient up as soon as possible
      and in bed increasing mobility. In this process, while the mobilization process of the
      patients is planned, the patient's The general condition and tolerance regarding mobilization
      should be evaluated. patient's general Depending on the suitability of the condition, turning
      in bed, foot-leg exercises, deep breathing and gradual mobilization, such as cough exercises,
      sitting in bed, standing up, and walking inform the patient and the patient's family about
      the methods, plan the mobilization process, The patient should be evaluated before, during
      and after mobilization. Early postoperative mobilization is an important component of nursing
      care.

      Early mobilization of patients after open heart surgery, although the recommendations to
      increase the mobility are getting stronger, the mobilization levels of the patients are still
      not at the desired level. Although studies examining the early mobilization process of
      patients after open heart surgery have been conducted so far, findings regarding the clinical
      factors affecting this process are very limited.
    

Intervention name(s): None intervention
Intervention type(s): Other
Intervention description(s): None intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Undergoing open heart surgery patients
The Clinical and Prognostic Features of PRES
Condition: Posterior Reversible Encephalopathy Syndrome; Pregnancy Outcomes; Preeclampsia; Eclampsia
MeSH terms: Brain Diseases; Posterior Leukoencephalopathy Syndrome; Pre-Eclampsia; Eclampsia; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to determine the features of clinical imaging, disease severity
      and pregnancy outcomes in posterior reversible encephalopathy syndrome with preeclampsia or
      eclampsia.
    

Detailed description: 
      The investigators retrospectively collected data (General information, clinical data,
      biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman
      diagnosed with PRES with preeclampsia or eclampsia to analyze features of clinical imaging,
      disease severity and pregnancy outcomes during 2012 to 2021.Then, the investigators grouped
      all the patients into early onset group and late onset PE group according to gestational
      weeks to analyze differences of clinical imaging. Finally, the investigators grouped all the
      patients into good pregnancy outcomes group and poor pregnancy outcomes group according to
      diagnostic criteria, including the incidence of stillbirth and premature birth, to analyze
      differences of clinical imaging .
    

Intervention name(s): PRES in PE or E
Intervention type(s): Diagnostic Test
Intervention description(s): patients diagnosed with posterior reversible encephalopathy syndrome with preeclampsia or eclampsia
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant woman diagnosed with PRES with preeclampsia or eclampsia
Pilot Study for Determination of Total Energy Expenditure and Fat Oxidation in Children
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study is to determine energy expenditure and fat oxidation in 2 year old
      children.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        10 toddlers born from mothers of the Glowing study (NCT01131117)
Effect of Creatine Monohydrate on Functional Muscle Strength in Children With FSHD
Condition: Facio-Scapulo-Humeral Dystrophy; FSHD2; FSHD1
MeSH terms: Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional

Summary: 
      This multi-centre, randomised, double-blind, placebo-controlled crossover trial will compare
      changes in strength-related motor function following treatment with creatine monohydrate to
      treatment with placebo, as measured by the Motor Function Measure, from baseline to 12 weeks.
      Eligible subjects will undergo baseline assessments then will be randomised to either
      creatine monohydrate therapy or placebo for three months, followed by a six week wash-out
      period, then crossover to a further three months of therapy with either placebo or creatine.
      Subjects will undergo clinical assessments and study safety assessments at the beginning and
      end of each treatment period. The study will begin recruitment in early 2017.
    


Intervention name(s): Creatine Monohydrate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Synthetically produced dietary supplement Creatine Monohydrate will be used in powder form reconstituted to a drink. The dosage will be 100mg/kg/day up to a maximum of 10 grams daily.; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fshd; creatine monohydrate; children; pediatrics; Facio-Scapulo-Humeral Dystrophy
Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative
      Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys
      laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under
      Fasting Conditions.
    

Detailed description: 
      Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Cross
      Over, and Comparative Oral Bioavailability study in healthy, adult, human, male subjects
      under Fasting Conditions.
    

Intervention name(s): Cetirizine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Cetirizine Hydrochloride Tablets 10 mg
Other intervention name(s): Zyrtec Tablets 10 mg
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of the Effects of Exercise on Gene Expression
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators have previously shown that mild exercise training at the level of lactate
      threshold (LT) intensity (60 min/day, 5 days/week) improves peripheral insulin sensitivity
      and insulin-independent glucose disposal of glucose effectiveness, without changes in body
      weight and body fat (Nishida et al, Diabetes Care, 2001; Nishida et al, Diabetes, 2004). Thus
      these beneficial effects are likely related to a number of adaptations that occur in skeletal
      muscle as response to exercise. In the current study, the investigators hypothesised that a
      single bout of mild exercise performed at LT would be a physiological stimulator of skeletal
      muscle PGC-1alpha gene, and the repetition of this exercise stimulating PGC-1alpha gene
      (i.e., training) for 12 weeks would induce coordinated increases in a large number of
      metabolic genes, as well as other genes potentially important in the prevention of insulin
      resistance and metabolic syndrome.
    


Intervention name(s): exercise training
Intervention type(s): Other
Intervention description(s): 60 min of low-intensity exercise, 5 days/week, 12 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: gene expression; skeletal muscle; Healthy men
Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      This study, E-COMPASSII is a phase IV clinical trial designed as a multicenter, randomized,
      double-blind, placebo-controlled, parallel-group study. This study will enroll 80 subacute
      stroke patients with severe motor involvement. Primary objective is to demonstrate the
      efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio
      of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of
      FMA at baseline) in patients with subacute stroke. Secondary objectives are to evaluate the
      safety profile of cerebrolysin and to test the hypothesis that subacute stroke patients with
      severe motor involvement randomized to administration of Cerebrolysin combined with
      rehabilitation for 3 weeks show better outcome on global function (Korean version Modified
      Barthel Index, K-MBI), severity of stroke (National Institute of Health Stroke Scale, NIHSS),
      cognitive function (Korean Version of Mini-Mental State Exam, K-MMSE; Korean version Montreal
      Cognitive Assessment, K-MoCA), upper limb function (Action Research Arm Test, ARAT; Box and
      block test, B&B) and neuroplasticity measure (resting-state functional MRI(rsfMRI), diffusion
      tensor image(DTI), and motor evoked potential(MEP)) at 3 months after stroke.
    

Detailed description: 
      Randomized double-blinded, placebo-controlled multicenter study with two treatment groups

      Number of Patients: 80 patients (n = 40 per group) 5 study centers will participate in this
      study.

      Group 1(Cerebrolysin): cerebrolysin 30 ml with 100 ml dilution/day * 21 days with
      rehabilitation

      Group 2(Placebo): saline 100 ml/day * 21 days with rehabilitation
    

Intervention name(s): Cerebrolysin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation; Placebo- saline 100 ml/day * 21 days with rehabilitation
Other intervention name(s): Porcine brain peptide; Saline
Intervention MeSH terms: Cerebrolysin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebrolysin, stroke, motor function
To Investigate the Effects of AZD1981 on the QT Interval
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to evaluate the effect of AZD1981 on the electrical
      activity of the heart, in particular when the heart muscle is relaxed during a heart beat
      cycle. The effect of AZD1981 will be compared to a licensed antibiotic (moxifloxacin) which
      is well known to affect the electrical activity of the heart, but this effect is known to be
      at levels that are safe at the dose used in this study. The investigators will also compare
      the effects of AZD1981 with a "dummy drug" (placebo). The investigators will also be
      evaluating how safe and well tolerated AZD1981 is and how much AZD1981 enters the blood
      circulation by collecting blood during the study.
    


Intervention name(s): AZD1981, 2000mg; AZD1981, 200mg; Moxifloxacin, 400mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose, tablets; Single oral dose, tablets; Single oral dose, capsule; Single oral dose, tablets
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Oblimersen and Doxorubicin in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
Condition: Liver Cancer
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy such as doxorubicin use different ways to stop tumor
      cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of
      doxorubicin by making tumor cells more sensitive to the drug.

      PURPOSE: Phase II trial to study the effectiveness of combining oblimersen with doxorubicin
      in treating patients who have locally advanced, recurrent, or metastatic hepatocellular
      carcinoma (liver cancer).
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of oblimersen and doxorubicin in patients with
           advanced hepatocellular carcinoma or other incurable solid tumor (closed to accrual as
           of 11/7/03). (Phase I completed as of 1/16/04.)

        -  Determine the efficacy of this regimen, in terms of objective response rate, in these
           patients.

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the time to progression, response duration, progression-free survival, median
           survival, and overall survival rates in patients treated with this regimen.

      OUTLINE: This is a dose-escalation, multicenter study. (Phase I completed as of 1/16/04.)

      Patients receive oblimersen IV continuously on days 1-7 and doxorubicin IV over 5 minutes on
      day 5. Treatment repeats every 4 weeks for up to 10 courses in the absence of disease
      progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of oblimersen and doxorubicin until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
      which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
      determined, additional patients*, including 6 patients with hepatocellular carcinoma (HCC),
      are treated at the recommended phase II dose. (Phase I completed as of 1/16/04.)

      NOTE: *Other solid tumors closed to accrual as of 11/7/03; only accruing HCC patients

      PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for the phase I portion of this
      study within 6 months (phase I completed as of 1/16/04). A total of 30 patients will be
      accrued for the phase II portion of this study within 10-15 months.
    

Intervention name(s): oblimersen sodium; doxorubicin hydrochloride
Intervention type(s): Biological; Drug
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Oblimersen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult primary hepatocellular carcinoma; advanced adult primary liver cancer; localized unresectable adult primary liver cancer; recurrent adult primary liver cancer
Low-Dose Galantamine to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine
Condition: Basic Science Study of the Mechanisms of Attentional Enhancement by Compounds Acting on the Nicotinic Receptor
Study type: Interventional

Summary: 
      The aim of this study is to test whether the attention-enhancing effects of low-dose nicotine
      can be enhanced by the drug galantamine, FDA-approved for the treatment of Alzheimer's
      disease. This proof-of-principle study is performed in healthy non-smokers and involves two
      single exposures to a nicotine patch (7 mg/24 hrs) and two single exposures to galantamine (4
      mg). The dose of galantamine is substantially lower than the clinical dose range of 16-24
      mg/day. The hypothesis is that performance-enhancing effects of nicotine are greater in the
      presence of this low dose of galantamine.
    

Detailed description: 
      Healthy non-smokers will be screened for study eligibility and receive training on three
      different attention tasks. Over four test session, participants will then perform these tasks
      after receiving (1) a placebo patch and a placebo capsule, (2) a nicotine patch (7 mg/24 hrs)
      and a placebo capsule, (3) a placebo patch and a galantamine capsule, and (4) a nicotine
      patch and a galantamine capsule. The four test session are performed on separate days and
      take approximately 7 hours each. During the first 5 hours, the participant may read or watch
      TV while nicotine and/or galantamine are being absorbed. During the last two hours, the
      participant will perform the attention tasks on a computer. The investigators hypothesize
      that performance-enhancing effects of nicotine, which were documented in previous research,
      will be larger in the presence than in the absence of galantamine. This proof-of-concept
      would have implications for the development of drugs for the treatment of conditions such as
      Alzheimer's disease or schizophrenia.
    

Intervention name(s): Placebo patch & placebo capsule; Placebo patch & galantamine capsule; Nicotine patch & placebo capsule; Nicotine patch and galantamine capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule.; On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.).; On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule.; On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.).
Intervention MeSH terms: Galantamine; Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: nicotine; galantamine; attention; cognition; non-smoker
Comparison of Lymph Drainage and Connective Tissue Massage in Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The present study was designed to analyze and compare the effects of Manual Lymph Drainage
      Therapy and Connective Tissue Massage in females with Fibromyalgia (FM).
    

Detailed description: 
      The lack of specific disease mechanisms is reflected in the fact that no cure has been found
      for the disease. Thus, the many interventions which are advocated in FM are targeted against
      the more general characteristics of pain and disability. Current pharmacological
      interventions have limited efficacy. There is an increasing consensus that therapy should
      also include non-pharmacological approaches. Manual therapy techniques are composed of a
      variety of procedures directed at the musculoskeletal structures in the treatment of pain.
      Two major subcategories exist that divide these techniques into those which produce joint
      motion and those which do not. The first subcategory includes manipulation, mobilization, and
      manual traction. The second subcategory involves both generalized soft tissue therapies, such
      as the many types of massage, and focal soft tissue therapy (10).

      Consequently, there is currently no recognized effective treatment for FM patients. In
      addition, there is limited number of study dealing with the effect of manual therapy
      techniques on FM. Although, there were some studies about Manual Lymph Drainage Therapy
      (MLDT) and Connective Tissue Massage (CTM) in FM. There wasn't found any study concerning the
      comparison of the effects of MLDT and CTM. In this study, MLDT and CTM were used for FM,
      which are included in the second subcategory of manual therapy techniques.

      Based on positive results of some studies about MLDT and CTM in FM, this study was planned to
      test and compare the effects of MLDT and CTM in terms of pain, health status and HRQoL in
      females with FM using a randomized control trial.
    

Intervention name(s): Manual Lymph Drainage Therapy and Connective Tissue Massage
Intervention type(s): Other
Intervention description(s): The treatment program was carried out five times a week, during a 3-week period for both Manual Lymph Drainage Therapy and Connective Tissue Massage groups
Other intervention name(s): No drug was used
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Manual Lymphatic Drainage; Connective Tissue Massage; Pain; Health Related Quality of Life; Randomized Controlled Trial