bioihbjkbjnl/mcl2 huggingface dataset:
Study on Tolerability of Levodopa/Carbidopa in Children With Angelman Syndrome
Condition: Angelman Syndrome
MeSH terms: Angelman Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to determine the highest dose of levodopa/carbidopa that can be
      tolerated without any serious side effects by children with Angelman syndrome.

      It has been hypothesized that levodopa may lead to an improvement in the neurodevelopment and
      abnormal movements (e.g. tremors) in children with Angelman syndrome.

      Data from this study will be used to design a phase II trial to determine the efficacy of
      levodopa in treating children with Angelman syndrome.
    

Detailed description: 
      Levodopa is a prodrug that "delivers" dopamine to the brain. It is usually given with
      carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.
      Animal studies have suggested that levodopa can reverse the excess phosphorylation of some
      enzymes involved in synaptic and neuronal function, including calcium/calmodulin-dependent
      kinase type 2 (CaMKII).

      Recently, it was shown that excess phosphorylation of CaMKII may be responsible for some of
      the neurological deficits seen in Angelman syndrome. Therefore, it is hypothesized that
      levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g.
      tremors) in children with Angelman syndrome.

      Although many children have used levodopa for a variety of medical conditions over the last
      30 years, it has not been approved by the Food and Drug Administration (FDA) for use in
      children, and it has not been formally studied in children with Angelman syndrome, so we do
      not know what dose of levodopa is most appropriate for children with Angelman syndrome.

      Therefore, the purpose of this study is to find out the highest dose of levodopa that
      children with Angelman syndrome can tolerate without any serious side effects.

      Once we know the dose of levodopa that can be tolerated by children with Angelman syndrome,
      we will conduct a larger follow-up study to find out whether levodopa will lead to an
      improvement in their development and tremor.
    

Intervention name(s): Levodopa/Carbidopa (4:1)
Intervention type(s): Drug
Intervention description(s): Dosages are based on levodopa.
Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.
Other intervention name(s): Sinemet; L-dopa
Intervention MeSH terms: Levodopa; Carbidopa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Angelman syndrome; Levodopa; Carbidopa; L-dopa
The Effect of Natural Food Flavourings on Gastrointestinal and Cardiovascular Physiological Responses.
Condition: Gastric Emptying; Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether 3 g cinnamon was sufficient to delay the
      gastric emptying rate of a high-fat solid meal and subsequently reduce postprandial blood
      glucose and lipid responses, oxidative stress, arterial stiffness and satiety responses in a
      healthy adult population.
    

Detailed description: 
      Cinnamon has been shown to delay gastric emptying (GE) of a high-carbohydrate meal and reduce
      postprandial glycaemia in healthy adults. However, it is dietary fat which is implicated in
      the etiology and is associated with obesity, type 2 diabetes (T2D) and cardiovascular disease
      (CVD). We aimed to determine the effect of 3 g cinnamon on GE, postprandial lipemic and
      glycemic responses, oxidative stress, arterial stiffness, as well as appetite sensations and
      subsequent food intake following a high-fat (HF) meal.

      The effect of acute oral administration of 3 g cinnamon on gastric emptying of a high-fat
      pancake test meal and subjective appetite sensations by visual analogue scale will be
      measured for six hours postprandially. During this time course, measurements of postprandial
      lipemic, glycemic, oxidative stress and arterial stiffness responses will be collected.
      Subsequently, food intake will be measured using an ad libitum buffet meal. The study will be
      conducted in a randomized, placebo-controlled, single-blinded manner in 9 healthy subjects.
    

Intervention name(s): Cinnamon; Placebo control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): acute oral administration of 3 g cinnamon; 3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Antioxidants; Glucose Intolerance prevention and control; Diabetes Mellitus prevention and control
Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36
Condition: Anti Obesity Agent
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects
    

Detailed description: 
      PYY3-36 and GLP-1 are two classical gastrointestinal peptides, which are released into the
      circulation during meals from L-cells of the distal gut; there is compelling evidence that
      each participates in the control of appetite regulating individual meal sizes in healthy
      subjects, but also in patients with obesity or diabetes type II. The regulation of human
      eating habits is, however, highly complex and our understanding of appetite control is far
      from complete. In many areas our knowledge is rather rudimentary; little is known, to give an
      example, about the importance of individual signals and their interactions.

      From studies in animals and humans it is known that individual satiety signals can interact:
      contributions of glucagon and CCK produced functionally synergistic inhibitions of feeding in
      rats, that is, simultaneous injection of the two peptides inhibited feeding significantly
      more than the sum of their individual effects. In contrast, we have been unable to show in
      healthy volunteers any interaction between GLP-1 and CCK33; the simultaneous infusion of
      CCK33 and GLP-1 resulted in an infra-additive reduction in meal size, which led us to suggest
      that the two peptides could even interact antagonistically.

      To further explore potential interactions between these two well-known satiety signals, we
      plan to investigate the effects of individual doses of PYY3-36 and GLP-1, and their
      interaction in the control of food intake and satiety in healthy male subjects.
    

Intervention name(s): Placebo tablet
Intervention type(s): Drug
Intervention description(s): Control arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Appetite, energy consumption, gastrointestinal hormones
Validation of the Turkish Version of the Modified Early Obstetric Warning Systems (MEOWS) Charts
Condition: Validation
Study type: Observational

Summary: 
      It was aimed to study MEOWS on patients in the obstetrics clinic and to evaluate the
      performance of this scale as a screening tool and to contribute to its usability in Turkey by
      translating MEOWS into Turkish.
    

Detailed description: 
      The Modified Early Obstetric Warning System (MEOWS) is a score-based or color-coded system
      used to detect changes in physiological parameters and enable earlier recognition and
      management of deteriorating patients.It was first validated by Sigh et al., then its validity
      and reliability were demonstrated in many countries, especially in countries with low
      socio-economic status.Early warning systems are not routinely used in obstetrics clinics in
      Turkey, and there is no Turkish version of MEOWS in the literature. In this study, it was
      aimed to study MEOWS on patients in obstetrics clinics and to evaluate the performance of
      this scale as a screening tool and to validate MEOWS by translating it into Turkish.

      The study was carried out in 3 stages. The first stage is the translation of MEOWS into
      Turkish and its cultural adaptation, the second stage is the use of the study scale and the
      elimination of deficiencies by conducting a pilot study on 30 patients, and the third stage
      is the collection and evaluation of patient data until the specified sample size is reached.
    

Intervention name(s): patient-administered questionnaires
Intervention type(s): Other
Intervention description(s): patient-administered questionnaires (MEOWS): Obstetric early warning systems are recommended to provide timely recognition, treatment and early referral of critically ill or developing patients. The development of early warning systems from simple bedside observation charts arose from the knowledge that physiological disturbances precede critical illness. Thanks to these charts, the fact that the patient's findings are in the risky value ranges allows the clinician to evaluate the patient earlier and in detail. MEOWS is a simple screening tool for maternal morbidity.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients whose pregnancy is older than 28 weeks and between 6 weeks postpartum
      
Keywords: validation; MEOWS; chart; Turkish
Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following a Dietary Supplement-based Intervention
Condition: Health Behavior
Study type: Interventional

Summary: 
      Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study
      extends an earlier study in which an increase in skin carotenoid scores (SCS) was observed in
      subjects who increased their intake of fruits and vegetables. The scores were determined
      using the Raman Spectroscopy. In that study subjects were assigned to one of four groups
      based on their baseline SCS. For unknown reasons, the groups with the highest and lowest
      baseline SCS failed to show an increase whereas the two intermediate groups did. One possible
      explanation might be that intakes varied more than expected and was not obvious due to
      self-reporting of intake of fruits and vegetables with different contents.
    

Detailed description: 
      This current project will be an interventional, non-invasive study examining changes in skin
      carotenoid levels over time in individuals who increase their carotenoid intake by taking a
      dietary supplement containing a known amount of carotenoids. After a two-week control period
      eating their normal diet, forty medical students meeting study inclusion criteria will be
      asked to take a dietary supplement over an eight week period of time. Students will be given
      twin-sachet packets of LifePak Nano supplements containing five capsules (dry ingredients)
      and two CR-6 Liponutrient softgel capsules (liquid ingredients, including omega-3 fatty acids
      and nanosized carotenoids). These will be taken twice a day with eight ounces of liquid at
      the morning and evening meal. SCS will be measured every 2 weeks. At the end of this period,
      the students will be asked to discontinue dietary supplement intake and follow their usual
      diet for 2 weeks then their SCS measured again.
    

Intervention name(s): LifePak Nano
Intervention type(s): Dietary Supplement
Intervention description(s): Two twin-sachet packets of seven (7) supplements twice per day, for the entire eight-week experimental period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: antioxidants; carotenoids; diet
Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and
      MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up
      to 125 mg/day for 14 days were well tolerated with adverse events not occurring in greater
      prevalence than placebo, and no significant abnormal vital sign, ECG, or clinical laboratory
      findings. Pharmacokinetic parameters were linear and approximately dose proportional over the
      range of doses administered. Single doses of 50 mg - 150 mg GSK962040 significantly increased
      the rate of gastric emptying up to 40% as measured by the 13C octanoic acid stable isotope
      breath test. A similar effect of 50 mg and 125 mg on gastric emptying was observed throughout
      repeated dosing to healthy volunteers for 14-days.

      The aims of the present investigation (MOT114479) are to assess the pharmacodynamic effects
      (gastric emptying and symptoms), safety, tolerability, and pharmacokinetics of GSK962040
      after 28 days of once-daily dosing in Type I and Type II diabetic subjects with
      gastroparesis. An additional aim is to characterize the dose/exposure - pharmacodynamic
      effect relationship.
    


Intervention name(s): GSK962040 (5 mg tablet); GSK962040 (25 mg tablet); GSK962040 (125 mg tablet); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5 mg tablet; 25 mg tablet; 125 mg tablet; matching placebo tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tolerability; pharmacokinetics; 13 C oral breath test; Type I and II Diabetes mellitus; gastroparesis; gut motility; phase II; pharmacodynamics; repeat dose; gastric emptying; symptoms; GSK962040
Procalcitonin in Cirrhotic Patients at High Risk for Sepsis
Condition: Cirrhosis; Ascites; Sepsis
MeSH terms: Sepsis; Toxemia; Fibrosis; Ascites
Study type: Observational

Summary: 
      Infections are frequent life-threatening events in patients with cirrhosis, occurring at
      least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among
      cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no
      clear-cut clinical and biochemical features are helpful in diagnosing and prognostically
      stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker
      presenting high sensibility and specificity in diagnosing bacterial infections in different
      clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and
      prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All ascitic cirrhotic patients admitted to our third level Liver Unit.
      
Biospecimen description: 
      Serum
    
Keywords: Cirrhosis; Ascites; Decompensation; Bacterial infection; Sepsis; Procalcitonin; PCT
Efficacy of Education Programs in Patients With Chronic Airway Diseases
Condition: COPD; Asthma
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The objective of this study is to determine whether the systematic education on air way
      disease and inhalers in outpatient settings contributes to improve the quality of life.

      Education has been known to be effective for management of chronic airway disease. However,
      the real benefits remain unclear. An organized education on the chronic airway disease is
      directed by primary care physicians, and the investigators evaluate the effectiveness of the
      education.
    

Detailed description: 
      The present study is a prospective and interventional study comparing the outcomes of
      education program for one month.

      A one month education program is composed of three visits (every two weeks follow-up ) during
      which subjects were taught about their diseases, action plans in acute exacerbation, and
      inhaler technique.

      To evaluate the effectiveness of systematic education, questionnaires evaluating quality of
      life and satisfaction of education will be examined after each visit.

      Asthma control test (ACT) in asthma, chronic obstructive pulmonary disease (COPD) assessment
      test (CAT) in COPD subjects were compared before and after education as an index of quality
      of life.

      Educational effects were also measured, associated with improvement of their knowledge for
      chronic airway disease itself, proper use of inhaler technique, and satisfaction of subjects
      after education.
    

Intervention name(s): Education
Intervention type(s): Behavioral
Intervention description(s): 3 times systemic education program will be provided to patients were diagnosed as asthma or COPD by their physicians.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal
      Remodeling System for the treatment of patients with poorly controlled Type 2 Diabetes.
    

Detailed description: 
      The purpose of this protocol is to evaluate the initial safety profile of the Fractyl System
      and its effect on participants with Type 2 Diabetes. This will be determined through the
      monitoring of adverse events and outcome measures including Mixed Meal Tolerance Test (MMTT).
    

Intervention name(s): Fractyl Duodenal Remodeling System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（ALTER-L029）
Condition: Non-Small Cell Lung Cancer Stage III
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the efficacy and safety of Anlotinib following concurrent chemoradiation in patients
      with stage III unresectable non-small cell lung cancer
    

Detailed description: 
      Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug
      Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing
      Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with
      multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
    

Intervention name(s): Anlotinib
Intervention type(s): Drug
Intervention description(s): Anlotinib 12mg p.o, qd
Other intervention name(s): AL3818
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Stress Management Training Provided to Obese Women
Condition: Obese Women; Stress; Training
Study type: Interventional

Summary: 
      Introduction: Obesity, which is an important public healthcare issue, can affect women's
      physical, mental, social health, stress level, and coping negatively.

      Aim: The present study was conducted to determine the effects of stress management training
      provided to obese women on eating attitudes, stress, and coping with stress.
    

Detailed description: 
      Methods: The sampling of the randomized controlled experimental study based on the pre-test
      and post-test model consisted of 70 women (experimental = 35; control = 35) with a Body Mass
      Index ≥30, who applied to a Community Healthcare Center Obesity Unit in primary care in
      Turkey. The data were collected by using Personal Information Form, Perceived Stress Scale,
      Stress Coping Styles Scale, Dutch Eating Behavior Questionnaire, and height-weight
      measurements.
    

Intervention name(s): The stress management training
Intervention type(s): Other
Intervention description(s): The women in the experimental group were provided with stress management training to help cope with stress conditions how to use positive coping in conditions in case of stress and tension.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: women; obesity; stress; stress management training; eating attitude
Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die. It is not yet known if radiation therapy is more effective with or without combination
      chemotherapy for endometrial cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or
      without combination chemotherapy following surgery in treating patients who have stage I or
      stage II endometrial cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the relapse-free survival in patients with stage I or II endometrial cancer
           treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total
           abdominal hysterectomy and bilateral salpingo-oophorectomy.

        -  Compare the patterns of recurrence and the acute and late toxicity profiles associated
           with these treatment regimens in this patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      disease stage (IC-IIA vs IIB). Patients are randomized to one of two treatment arms.

        -  Arm I: Within 8 weeks after surgery, patients receive radiotherapy once daily 5 days a
           week for 5.5 weeks.

        -  Arm II: Within 8 weeks after surgery, patients receive radiotherapy as in arm I
           concurrently with cisplatin IV over 2-4 hours on days 1 and 28. After completion of
           radiotherapy, patients receive paclitaxel IV over 3 hours followed by cisplatin IV over
           2-4 hours on days 56, 84, 112, and 140.

      Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 436 patients (218 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): cisplatin; paclitaxel; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Paclitaxel; Cisplatin
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage I endometrial carcinoma; stage II endometrial carcinoma; endometrial adenocarcinoma; endometrial adenosquamous cell carcinoma; endometrial adenoacanthoma; endometrial clear cell carcinoma; endometrial papillary serous carcinoma