bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Functional Pillow on Neck Pain, Disability, Quality of Sleep and Life
Condition: Neck Pain; Posterior Cervical Pain; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Neck Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of functional cervical pillow on
      inpatients with neck discomfort.
    

Detailed description: 
      50 inpatients with neck discomfort(NRS>4) will be randomly allocated to 2 groups. The
      experimental group was treated with functional cervical pillow and the control group was
      treated with general pillow. All applications of pillow were limited to 3-4 weeks. Primary
      outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to
      measure primary outcomes at baseline, 3 day, per weeks until the duration of admission.
      Satisfaction levels of the patient's current status, Neck disability Index(NDI) PSQI, EQ-5D
      will also be collected. The applicants will also get thru the diagnosis of range of motion by
      X-ray(flexion, neutral, extension of their neck position)
    

Intervention name(s): Functional pillow; Placebo general pillow
Intervention type(s): Device; Device
Intervention description(s): streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position
Other intervention name(s): Functional pillow (Jaseng-chuna pillow™)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Neck pain; functional pillow; sleep; cervical lordosis
Effect of the Intake of Corbella Extra Virgin Olive Oil on the Microbiota-gut-brain Axis in Healthy Adults (HEVOOC)
Condition: Healthy Nutrition
Study type: Interventional

Summary: 
      The consumption of the improved extra virgin olive oil (EVOO) of the Corbella variety could
      have a beneficial effect on the microbiota-intestine-brain axis (MGBA). Olive oil contains
      polyphenols that are not present in other oils, notably oleocanthal and oleacein, which
      behave similarly to ibuprofen and have a protective effect on some neurodegenerative
      diseases. The polyphenols of the oil present prebiotic characteristics, at the level of the
      intestinal microbiota, which metabolizes them forming bioactive metabolites that can have a
      modulating effect on the MGBA, improving brain health. In this study, the researchers seek to
      identify the benefits of the consumption of Corbella variety EVOO on MGBA in healthy
      participants. The overall benefit of the study would be to achieve knowledge that would allow
      its future applicability to prevent and improve certain diseases and in general contribute to
      optimal health.
    

Detailed description: 
      To evaluate possible effects on MGBA, a randomized, controlled, crossover nutritional trial
      will be conducted. Thirty healthy adult participants (between 18 and 35 years of age, with
      50% male and 50% female) will be included according to the estimated sample size.
      Participants will consume a daily amount of 0.7 g Corbella EVOO/kg body weight plus their
      normal diet (experimental intervention) and 0.7 g refined olive oil (ROO)/kg body weight plus
      their normal diet (control intervention) for 1 month. Biological samples (plasma, peripheral
      blood mononuclear cells, serum, 24-hour urine, feces and saliva) will be obtained at baseline
      and at the end of each trial arm.
    

Intervention name(s): EXTRA VIRGIN OLIVE OIL; OLIVE OIL LOW POLYPHENOL
Intervention type(s): Other; Other
Intervention description(s): Participants will consume a daily amount of extra virgin olive oil. Can consume the oil either raw or cooked; Participants will consume a daily amount of olive oil low polyphenol. Can consume the oil either raw or cooked
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: EXPERIMENTAL: Extra virgin olive oil (EVOO): should add 0.7 g of Corbella EVOO/ kg body weight to their usual diet per day, either raw or cooked, for one month
CONTROL: Olive oil low in polyphenols (OOLP): should add 0.7 g of OOLP/ kg body weight to their usual diet per day, either raw or cooked, for one month
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Extra virgin olive oil; Microbiota; Polyphenol; MGBA
The Study of Serum Melatonin Rhythm Levels in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      One of the main points in the biological trends is, the circadian rhythm and disturbance in
      this cycle, which cause mood disorders and irregularity in this bio clock, to get depression.
      The pineal gland with the precise regulation of circadian rhythm of melatonin regulates the
      brain haemostasis. The abnormal function of this gland gives rise to psychiatric disorders.

      In the period of youth and early of middle-age cause biochemical changes and disturbance in
      biorhythm including melatonin secretion.

      This process can change the peak of melatonin phase. In addition, a decrease in the level of
      serum melatonin, can change the function of immune system of depressed patients. This
      function facilitates the process of cancerous cell formation and tumor growth.

      With respect to the conflicting results and that the positive and negative roles of melatonin
      in the creation of depression is unknown, the aim of this study was to compare the morning
      and nocturnal serum melatonin rhythm levels in the patients with Major Depressive Disorder.
      The second purpose was to measure the morning and nocturnal serum melatonin levels in the
      depressed and healthy men and women.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The individuals were chosen who referred to the industrial medical unit of one of big
        company.
      
Keywords: Melatonin; Periodicity; Depressive disorder, major; Serum; Depression
Intragastric pH and Bismuth Effect for H. Pylori Eradication
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      Gastric cancer is one of the leading causes of cancer-related deaths worldwide. In Taiwan,
      there are around 3800 fresh cases annually, with about 5% of total cancers cases. Gastric
      cancer development is known to follow a multistate process from non-atrophic gastritis,
      atrophic gastritis, intestinal metaplasia, dysplasia, and carcinoma; H. pylori infection
      plays the key role of this carcinogenic process. Although H. pylori eradication would result
      in a marked gastric cancer reduction, treatment success using standard regimens has become
      more difficult in recent years, and increased antibiotic resistance is considered the most
      important reason for decreased treatment efficacy. As no specific new medications have been
      introduced in recent years, novel treatment regimens have been created using different
      combinations, durations and sequences of available medications. The addition of bismuth
      improved the cure rates despite a high prevalence of resistance, and resistance of H. pylori
      to bismuth has not been reported. Bismuth absorption is not required for efficacy in H.
      pylori treatment regimens, suggesting a local mechanism of action. The mechanisms of bismuth
      with responsible for rapid destruction of H. pylori within the stomach remain unclear.
      Knowledge of the mechanism of action of bismuth compounds against H. pylori would be
      beneficial in the development of improved treatment regimens in this era of declining
      eradication success rates. We conduct the pilot study to evaluate the bacteria fragments of
      H. pylori in specimen through electron microscopy after bismuth therapy and provide insight
      into the mechanism of action of pH on bismuth therapy. We also help to develop optimal H.
      pylori therapeutic strategies.
    


Intervention name(s): (A)Bismuth; (B)Bismuth; (C)Bismuth; (D)Esomeprazole and Bismuth; (E)Esomeprazole and Bismuth; (F)Esomeprazole and Bismuth; (G)Control
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Other
Other intervention name(s): (A)Active Comparator-Bismuth; (B)Active Comparator-Bismuth; (C)Active Comparator-Bismuth; (D)Active Comparator-Esomeprazole and Bismuth; (E)Active Comparator-Esomeprazole and Bismuth; (F)Active Comparator-Esomeprazole and Bismuth; (G)Other-Control
Intervention MeSH terms: Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Electron Microscopy; Helicobacter pylori; Bismuth
Pharmaceutical Care of Ambulatory Elderly Diabetes Patients
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This trial will try to perform pharmaceutical care on ambulatory elderly diabetes patients.
      To provide appropriate diabetes education administration, identify and resolve drug-related
      problems, assess the appropriateness of their medications, establish the mechanism of
      medication consultations. Each patient will be assessed by the MMSE(Mini-Mental State
      Examination) and GDS(Geriatric Depression Scale). The effectiveness of pharmacist's
      intervention will be assessed by lab data and some questionnaires.
    


Intervention name(s): Pharmaceutical care; Usual care
Intervention type(s): Other; Other
Intervention description(s): The Pharmacist provided Pharmaceutical care on the ambulatory elderly Diabetes patients, provided recommendation to the physician and reffered the patients to other diabetes-care-team members, including the CDEs and dietitians.; Control patients received usual care directed by their physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pharmaceutical care; Diabetes Mellitus
Practicability and Acceptability of Stylomax® in Children
Condition: Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      to evaluate the practicability and acceptability of STYLOMAX®, a new injection device for
      MAXOMAT®, in children, for 1 year.
    


Intervention name(s): somatropine
Intervention type(s): Drug
Intervention description(s): subcutaneous injections, 20 % less than the dosage of Maxomat 1.3 mg
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Face Reconstruction by Allotransplantation of Composite Tissues
Condition: Reconstruction of the Face
Study type: Interventional
Phase: Phase 2

Summary: 
      To show the feasibility of face transplantation in patients
    

Detailed description: 
      Most facial defects can be reconstructed with autologous tissues using standard plastic
      surgical techniques. However, when the circular facial muscles (eg. orbicularis oculi and
      orbicularis oris) are destroyed by burns, ballistic traumas, tumors, or congenital
      deformities there are no conventional surgical solutions. The study was designed following
      the advice of the French National Ethics Advisory Committee for life sciences and health
      (CCNE). The objectives are to study the feasibility and efficacy of face CTA transplantation,
      functional results, and influence on quality-of-life, as well as the management of
      immunosuppression.
    

Intervention name(s): Feasibility ot face transplantation
Intervention type(s): Procedure
Intervention description(s): Feasibility ot face transplantation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allotransplantation:composite tissue; Face transplantation
Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      The 18F-FDG-PET scan is currently being used for cancer diagnosis, staging, identifying
      hidden metastasis, and assessment of treatment responses in clinical oncology. Although there
      are important studies suggesting potential associations between PET-based parameters and
      oncologic outcomes, the calculation and official documentation of individual PET-based
      parameters might not be routine in clinical practice because these processes usually require
      time- and labor-consuming processes for the radiologists. In this study, the investigators
      prospectively determined clinical 18F-FDG-PET type according to degree of FDG-uptake in
      pancreatic cancer and compare oncologic outcomes between the types.
    


Intervention name(s): PET-CT
Intervention type(s): Device
Intervention description(s): PET-CT will be done before operation and that is routine treatment procedure for pancreatic cancer.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Tertiary Referral Hospital
Endothelial Progenitor Cells and Pulmonary Idiopathic Arterial Hypertension
Condition: Pulmonary Idiopathic Arterial Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Endothelial dysfunction ultimately represents an imbalance between the magnitude of injury
      and the capacity for repair.

      Current evidence established that endothelial progenitor cells (EPC) participate in several
      models of vascular disease as acute coronary syndromes, stroke, diabetes, peripheral artery
      disease, etc. However EPC in the setting of PAH is less well established. The target of this
      study is to demonstrate if the number of EPC is increased in a mexican population of patients
      with PAH.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with IPAH between 18 and 70 years of age of either gender were invited to
        participate in the study
      
Biospecimen description: 
      whole blood.
Impacts of Aquatic vs Land Walking on Vascular Health and Exercise Tolerance in Patients With Peripheral Artery Disease
Condition: Peripheral Artery Disease; Vascular Function; Exercise Tolerance; Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study was to examine the impacts of a 12-week aquatic walking exercise
      program on body composition, vascular function, cardiorespiratory capacity, exercise
      tolerance, muscular strength, and physical function in patients with peripheral artery
      disease (PAD). The effects of the 12-week aquatic walking exercise program were also compared
      to the effects of a 12-week land-based walking exercise program.
    


Intervention name(s): Aquatic walking exercise program group 1; Aquatic walking exercise program group 2; Land-based walking exercise group
Intervention type(s): Other; Other; Other
Intervention description(s): 12 week aquatic walking exercise program; 12 week aquatic walking exercise program; 12 week land-based walking exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: aquatic walking exercise intervention group 1 vs. control group; aquatic walking exercise intervention group 2 vs. land-based walking exercise group
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: arterial stiffness; cardiorespiratory capacity; exercise tolerance; VO2max
Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      To evaluate the differences between three-Dimensional heads-Up surgery system and traditional
      surgery methods of cataract surgery
    

Detailed description: 
      To evaluate the differences between three-Dimensional heads-Up surgery system and traditional
      surgery methods of cataract surgery.Prospective research.One eligible eye from patients
      having cataract surgery performed using the 3-D head-up technique were included in the study
      as an experimental group,in the meanwhile eyes performed cataract surgery by traditional
      microsurgery included as a control group.All eyes in the study are operated by the same
      doctor. Corneal incision form,corneal endothelial cell density and best corrected visual
      acuity are included to evaluate the results of cataract surgery.
    

Intervention name(s): heads-up method
Intervention type(s): Procedure
Intervention description(s): 3D surgical video system, which includes Alcon NGENUITY 3D visualization system (Alcon, Fort Worth, TX) and Leica M822 and M844 microscopes (Leica Microsystems, Wetzlar, Germany),can be used to perform head-up phacoemulsification combined with intraocular lens implantation surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: three-dimensional surgery; microsurgery; phacoemulsification
A Phase IIa Clinical Trial on TSG-01 in the Treatment of Chronic Heart Failure in Patients With Coronary Heart Disease.
Condition: Chronic Heart Failure
MeSH terms: Heart Failure; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, efficacy and optimal dose of TSG-01, an
      innovative drug with ginsenosides as its main components, in the treatment of patients with
      chronic heart failure(CHF). Preclinical studies have revealed that TSG-01 promote myocardial
      energy metabolism and ATP production, reduce the damage of human pulmonary microvascular
      endothelial cell connection, resist arrhythmia, and regulate the lipid metabolism disorder
      caused by myocardial ischemia. Results from CHF animal models(dog, rat) showed that TSG-01
      significantly increase coronary blood supply, improve myocardial contractility, reduce heart
      expansion and pulmonary edema. Besides its potency of improving heart function, TSG-01 was
      found to induce diuresis without obvious effect on urine potassium in rats. TSG-01 has been
      approved by CFDA for a clinical trial on the treatment of CHF (Approval No. 2018L03012). A
      randomized, double-blind, multicenter, placebo-controlled phase IIa clinical trial is now
      being conducted in 5 hospitals in China. A total of 90 cases of CHF caused by coronary heart
      disease are included and randomly divided into three groups: high-dose, low-dose of TSG-01
      and placebo group. NYHA functional class, 6-minute walk test(6MHWT) distance, NT-proBNP, left
      ventricular ejection fraction(LVEF), echocardiographic parameters (LVESV, LVEDV, and heart
      size) and MLHFQ score are measured before, during and after treatment to evaluate the
      benefits of TSG-01 therapy in patients with CHF.
    


Intervention name(s): TSG-01; TSG-01 and Placebo; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two tablets of TSG-01 (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; High dose group.; One tablet of TSG-01 (0.35g/tablet) and one tablet of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; Low dose group.; Two tablets of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Stimulation of Cingulo-opercular Alertness Network
Condition: Lewy Body Disease; Lewy Body Variant of Alzheimer Disease; Lewy Body Dementia With Behavioral Disturbance
MeSH terms: Alzheimer Disease; Dementia; Lewy Body Disease; Problem Behavior
Study type: Interventional

Summary: 
      Fluctuations in alertness are very common in persons with Lewy body dementias and are a major
      source of disability. Changes in a chemical messenger molecule called acetylcholine within
      certain brain regions may play a role in these fluctuations. We propose to test this
      hypothesis and also determine whether a non-invasive way of stimulating affected brain
      regions may be of relevance for future management of these fluctuations.
    

Detailed description: 
      The central premise of the research study is that cholinergic system changes in specific
      neural network regions underlie cognitive fluctuations in patients with LBD. The
      cingulo-opercular task control (COTC) neural network is believed to play a role in
      maintenance of alertness but this remains uncertain in LDB. This critical knowledge gap forms
      the basis of our first aim. The study proposes to use transcranial direct current stimulation
      (tDCS) to "excite" critical cholinergic denervation components of the COTC as an adjunct to
      cholinergic pharmacotherapy in a target engagement study. tDCS is an emerging non-invasive
      neurostimulation technology that may improve a range of neurological symptoms, including
      cognition. The study will evaluate whether target engagement by tDCS excitation of
      cholinergic denervated COTC hubs may affect cognitive fluctuations in LBD subjects.
    

Intervention name(s): HD-tDCS
Intervention type(s): Device
Intervention description(s): Participants will receive HD-tDCS at up to 4 mA per channel for 20 minutes for 10 sessions. Dose determined through individualized computational models.
Intervention model: Single Group Assignment
Intervention model description: Eligible participants receive individualized intervention/stimulation based on their fMRI and PET imaging.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lewy Body Dementia; Cognitive; Thinking; Cognition; Cognitive Rehabilitation; Brain Stimulation; Imaging; Lewy Body; Dementia
Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in
      plasma following single and multiple-dose topical application of 8% TV-45070 ointment.
    


Intervention name(s): TV-45070; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TV-45070 8% ointment; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other