bioihbjkbjnl/mcl2 huggingface dataset:
Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the current study was to compare the effects of three ready-to-eat mixed meals,
      with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic
      response in patients with Type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      The current study followed a prospective, three-way, cross-over design. Twenty four patients
      with T2DM consumed three ready-to-eat mixed meals, i.e. "wild greens pie" (meal 1), "chicken
      burgers with boiled vegetables" (meal 2) and "vegetable moussaka" (meal 3) and an oral
      glucose load, all providing 50g of carbohydrates. Venous blood was collected at 0, 30, 60, 90
      and 120 minutes postprandial for serum glucose and insulin measurements.

      The test meals were consumed by study participants between 8:30 to 9:00 am and within 10-15
      minutes under a researcher's supervision, following collection of the fasting blood sample.
      No parallel fluid intake was allowed. The portion size in the case of each one of the three
      test meals was adjusted to contain 50g of carbohydrates. However, the three test meals were
      considerably differentiating among them with respect to their content in calories and the
      remaining macronutrients.
    

Intervention name(s): ready to eat mixed meal 1; ready to eat mixed meal 2; ready to eat mixed meal 3; oral glucose load
Intervention type(s): Other; Other; Other; Other
Intervention description(s): wild greens pie providing 50g of carbohydrates; chicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates; vegetable moussaka providing 50g of carbohydrates; glucose load providing 50g of carbohydrates
Other intervention name(s): Sunday's Catering Company; Sunday's Catering Company; Sunday's Catering Company
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: glycemic response; diabetes; insulinemic response; mixed meals; glycemic index
Pharmacokinetic, Safety, Tolerability, and Clinical Effect of Topical Umeclidinium in Primary Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double blind (sponsor unblind), repeat dose, randomized, parallel group, placebo
      controlled study to assess the pharmacokinetic parameters, safety, tolerability, and clinical
      effect of topically applied umeclidinium following once daily topical administration to
      axilla for 14 days in subjects with primary axillary hyperhidrosis. This study will determine
      whether topically applied umeclidinium can decrease hyperhidrosis without systemic
      anticholinergic effects (ie. in the range or lower to those obtained after inhaled route) at
      the highest possible concentration.

      Subjects will be dosed by site staff each night immediately before bedtime for 14 days.
      Subjects will complete gravimetric and Hyperhidrosis Disease Severity Scale (HDSS)
      measurements, patient reported outcomes (PRO), safety assessments, and/or pharmacokinetic
      sampling. Follow up visits will occur on days 15, 16, 19, 23 and 28. The total duration of
      the study will be approximately 6 to 8 weeks. The study is planned to enroll approximately 24
      subjects.
    


Intervention name(s): Umeclidinium; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Umeclidinium (GSK573719) 1.85% will be supplied as a clear, colorless solution, free from visible particulates, for topical application. This formulation will be available at a concentration of 18.5 milligrams (mg) umeclidinium parent per gram. 2 mg of this formulation will be applied per square centimeter of the axilla, once a day at night before going to bed for 14 days. The total amount of formulation applied daily to both axillae is expected to range between approximately 204 and 680 mg. Total daily dosage of the active pharmaceutical ingredient (umeclidinium parent) to both axillae will range between approximately 3.8 and 12.6 mg. If certain pre-specified criteria for safety and tolerability are met, consideration will be given to decreasing the dose by decreasing the concentration of the topical formulation to 1.15% for the remaining subjects. This lower strength formulation will contain 11.5 mg parent per gram.; The vehicle will be supplied as a clear, colorless solution, free from visible particulates, for topical application. This formulation will be similar to the umeclidinium formulation except that it will be devoid of the umeclidinium parent. 2 mg of the vehicle will be applied per square centimeter of the axilla, once a day at night before going to bed for 14 days. The total amount of vehicle applied daily to both axillae is expected to range between approximately 204 and 680 mg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary Axillary Hyperhidrosis; GSK573719; Hyperhidrosis Disease Severity Scale (HDSS); Topical; PRO; Hyperhidrosis Symptom Severity Measure (HSSM); Umeclidinium
Mangafodipir as an Adjunct to Percutaneous Coronary Intervention
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The present feasibility study is designed to find out whether pre-treatment with the compound
      mangafodipir (PP-099) provides an additional reduction in myocardial infarct size in patients
      treated with primary percutaneous coronary intervention (PCI) during acute myocardial
      infarction (AMI).
    

Detailed description: 
      Mangafodipir, manganese (Mn) dipyridoxyl diphosphate (MnDPDP) and its lipophile metabolite Mn
      dipyridoxyl diethylene diamide (MnPLED), are catalytic antioxidants and iron chelators. In
      preclinical studies these agents reduce oxidative stress induced injuries related to
      chemotherapy of cancer and to reperfusion/reoxygenation of ischemic/hypoxic myocardium.
      Accordingly, in an in vivo pig model of AMI metabolite MnPLED applied at end of ischemia and
      during reperfusion reduced myocardial infarct size by 55 %. Mangafodipir most likely
      activates salvage pathways and prevents lethal reperfusion injuries.

      Other advantages are that mangafodipir is already approved as a contrast agent for MRI of
      liver, and that the experience for more than a decade reveals a high safety with minor and
      tolerable side-effects.

      The present study will include 20 patients treated for their first documented AMI. They will
      after admission to hospital undergo primary PCI. Reopening of an occluded coronary artery
      will be preceded by iv. infusion of mangafodipir or placebo in two groups , each consisting
      of 10 patients. The primary endpoint will be release to plasma of commonly accepted
      biomarkers of myocardial injury (Troponin T and CK-MB) measured at admission and 6 hours
      after PCI. The secondary endpoints include the accumulated release of plasma biomarkers over
      48 hours and direct measurement of the final myocardial infarct size at 6-10 weeks after PCI.
    

Intervention name(s): Mangafodipir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered dose: 2 µmol/kg b.w. Administration form: Ready-to-use formulation (solution). Mangafodipir or placebo (0.2 ml/kg b.w.) will be administered as an intravenous (iv.) infusion over 2-5 min prior to reopening of occluded coronary artery during PCI
Other intervention name(s): Teslascan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mangafodipir; Primary Percutaneous Coronary Intervention; Myocardial infarction; Troponin; CK-MB; Magnetic Resonance Imaging
Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL
      may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.
    

Detailed description: 
      The clinical efficacy (confirmed objective response rates, progression-free survival, overall
      survival), and treatment-related toxicities of this novel regimen will be examined as the
      first-line treatment in patients with nonresectable or recurrent/metastatic gastric cancer.
    

Intervention name(s): Cetuximab Plus P-HDFL
Intervention type(s): Drug
Intervention description(s): Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.
Intervention MeSH terms: Cetuximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Combination; Chemotherapy; Gastric cancer
Piperacillin/Tazobactam in Critically Ill Patients With Severe Sepsis and Septic Shock
Condition: Early Phase of Severe Sepsis and Septic Shock
MeSH terms: Sepsis; Toxemia; Shock, Septic; Shock; Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      This is prospective study to assess the pharmacodynamics (t>MIC) of 4.5 g every 6 h of
      piperacillin/tazobactam in patients with early phase of severe sepsis/septic shock following
      administration by a 30 min infusion.

      Clinical and laboratory data such as age, sex, body weight, electrolyte, vital signs, APACHAE
      II score, BUN, Cr and fluid balance will be collected.

      Fifty patients will be enrolled in this study. Piperacillin pharmacokinetic study will be
      carried out during the piperacillin/tazobactam therapy.

      Each patient received 4.5 g every 6 h of piperacillin/tazobactam within 24 h of severe sepsis
      or septic shock, blood samples (approximately 3 ml) will be obtained by direct venipuncture
      at the following time: 0, 0-0.5, 0.5-2, 2-4 and 4-6 h after piperacillin/tazobactam therapy.

      Concentration of piperacillin in plasma will be simulated in Monte Carlo technique to get
      PK/PD index and reported to % PTA and % CFR.
    


Intervention name(s): Piperacillin-tazobactam
Intervention type(s): Drug
Intervention description(s): 4.5 g of piperacillin/tazobactam in 100 ml of normal saline solution was administered via an infusion pump at a constant flow rate 30 min every 6 h and blood sample were obtained by direct venepuncture at 0, 0-0.5, 0.5-2, 2-4 and 4-6 hour after drug administration
Intervention MeSH terms: Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: piperacillin/tazobactam; critically ill; severe sepsis; septic shock
Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
Condition: Obesity; Eating Disorder
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The aims of the current study are: 1) to pilot a manualized intervention (INSPIRE - Inspiring
      Nutritious Selections and Positive Intentions Regarding Eating and Exercise) to determine
      feasibility and acceptability, and 2) to evaluate the preliminary effectiveness of INSPIRE on
      physical and psychological variables.
    

Detailed description: 
      The purpose of the current study is to implement an evidence-based prevention program to
      promote positive health behaviors among young adult women. It will be one of the first to
      intentionally execute a prevention program targeting well-established risk factors for both
      obesity and eating disorders in this high-risk population. Intervention content focuses on
      promoting body size diversity and emphasizing positive health and behavior change in order to
      reduce stigmatization and remain sensitive to weight-related issues. The manual was developed
      by integrating two successful existing prevention programs and expanding on previous
      prevention efforts. Specifically, the diversity of beauty ideals were highlighted to enhance
      relevance among ethnic minority women, and distress tolerance and emotion regulation skills
      training were included to target the maladaptive coping mechanisms young adults use to manage
      the stress associated with transitioning to college.
    

Intervention name(s): INSPIRE
Intervention type(s): Behavioral
Intervention description(s): Eight week program of weekly group sessions with homework assignments addressing beauty ideals, establishing a healthy relationship with food and exercise, and tolerating and managing uncomfortable emotions. Participants will complete questionnaires are separate time points (one week before the program, one week after the program, and 1 month after the program) to evaluate the impact of the program on various behavioral and psychological outcomes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Mulligan's Technique in Subjects With Shoulder Impingement Syndrome
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Participants will be initially assessed for their suitability for inclusion in the study and
      will undergo a physical screening of the affected shoulder and cervical spine by an
      experienced physiotherapist. After, participants will be attended 72 hours after data
      recording of the baseline measures (range of motion with a goniometer, pressure pain
      threshold with a algometer, and peak force with a dynamometer) for four sessions per week
      with 24 hours of interval between sessions. At each experimental week session, each
      participant will receive one of the two treatment conditions (MWM or sham) and then will
      repeats the assessment. In the following week, there will be a crossover condition of each
      individual and 24 hours after the last treatment session, the examiner will do the last
      assessment.
    


Intervention name(s): Mobilization with Movement (MWM) condition/ Sham condition; Sham condition/ Mobilization with Movement (MWM) condition
Intervention type(s): Other; Other
Intervention description(s): The treatment condition consists in the application of a posterolateral glide (MWM) in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the humerus head anterior aspect. A posterior glide will be applied to the humeral head. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. Sham condition will replicate treatment condition except for the hand positioning. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed.; The Sham condition consists in the application of a simulated anterior glide in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. The treatment condition will replicate treatment condition except for the hand positioning. The therapist will place one hand over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior humerus head. A posterior glide will be applied to the humeral head.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Shoulder Impingement Syndrome; Mulligan's Mobilization with Movement; Physical Therapy
Remembered Meal Satisfaction, Satiety and Later Snack Food Intake
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study examined whether remembered meal satisfaction (encompassing memory for meal liking
      and satiety) can be manipulated in the laboratory and whether this influences later food
      intake.
    

Detailed description: 
      This study examined whether remembered meal satisfaction (encompassing memory for meal liking
      and satiety) can be manipulated in the laboratory and whether this influences later food
      intake. In a between-subjects design participants consumed a fixed lunch and then rehearsed
      the satisfying or dissatisfying aspects of the meal, or a neutral experience (control), in
      order to manipulate memory for meal satisfaction. Three hours later, in a second visit to the
      laboratory, participants completed a bogus taste-test to measure food intake and meal memory
      measures.
    

Intervention name(s): Satisfying rehearsal task; Dissatisfying rehearsal task; Neutral rehearsal
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants rehearsed satisfying aspects of the lunchtime meal they just ate.; Participants rehearsed dissatisfying aspects of the lunchtime meal they just ate.; Participants rehearsed their journey to campus that day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: food intake; memory; remembered satisfaction; memory for recent eating; satiety; eating behavior
Project Breast47: Effect of an Educational Intervention
Condition: Breast Neoplasm; Primary Prevention; Risk Factors; Telemedicine
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer is the most frequently diagnosed malignant tumor in women. In 2018, in Spain,
      the estimated incidence was 101/100,000 women.

      Screening strategies and greater knowledge of risk factors by the population have contributed
      to a better prognosis. Specifically, in the case of behavioral factors, making women aware of
      their influence enables them to establish preventive measures themselves.

      Technologies are becoming a channel of communication, from a healthcare perspective, between
      the population and healthcare personnel. There are even specific terms like eHealth or
      mHealth. There is beginning to be evidence that collects the benefits and ways of using
      web-apps to achieve modification of risky behaviors and/or behaviors to prevent pathologies
      are acquired.

      The use of digital media, such as a web-app, to publicize BC risk factors makes it possible
      to specifically establish measures aimed at reducing its prevalence, which in turn will
      contribute to reducing the number of cases of BC. CM.

      On the other hand, making women aware of their BC risk factors, as well as quantifying the
      risk of developing the tumor, is useful for them to become aware of the magnitude of the
      problem and adopt measures to minimize their risk.

      Since there is no digital strategy in Asturias that informs and reduces the risk of
      developing breast cancer, through the modification of the main risk factors, in young women,
      the present study has been proposed with the aim of evaluating the effectiveness and
      feasibility of an educational intervention for BC risk prevention through the use of a
      Web-App in women residing in health area VII of the Principality of Asturias.
    


Intervention name(s): Web access
Intervention type(s): Other
Intervention description(s): The intervention group will have access to the website where the information is provided. The control group will not have this access.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Study of a Stationary Cycling Intervention for Children With Spastic Diplegic Cerebral Palsy
Condition: Spastic Diplegic Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      The study is about the effect of an exercise program using stationary bicycling for children
      with the spastic diplegic form of cerebral palsy. Spastic diplegia is a type of cerebral
      palsy that involves spasticity or "tightness" of the leg muscles. We hope to learn whether
      this type of exercise will allow the children to develop improved strength in the muscles
      that bend and straighten their knees, enhance their level of physical fitness, improve their
      ability to walk and improve their ability to perform other activities that are important to
      them. We hypothesize that children who participate in the stationary cycling intervention
      will gain strength in the muscles that bend and straighten their knees, will be able to
      complete a 600 yard walk run test (a test of endurance) more rapidly, and will improve their
      score on a test of function called the Gross Motor Function Measure (a test designed
      specifically for children with cerebral palsy).
    


Intervention name(s): Stationary Cycling
Intervention type(s): Other
Intervention description(s): Use of a stationary bicycle for exercise
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spastic Diplegia; Cerebral Palsy; Children; Adolescents; Strengthening; Endurance