bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents
Condition: Smoking
Study type: Interventional

Summary: 
      In this multicenter cluster randomized controlled trial stratified by school baseline
      prevalence of smoking will be randomly allocated to the control or intervention group.
      Control schools will receive normal smoking education and intrvention schools will receive a
      four year class-based curriculum intervention (22 Classroom lessons), reinforcement of
      smoke-free school policy, smoking cessation in parents, pupils, and teachers and information
      and annual meeting with parents.

      Study participants will be children aged 12 to 15 years old ; they will be followed to 2
      years after high school. External evaluator and analyst will be blinded to school allocation.

      The aim of this study is to analyze the effectiveness of a complex intervention to reduce the
      prevalence of smoking at 3º ESO (14-15 yrs-old) and 2 years after high school (17-18 yrs-old)
      .
    


Intervention name(s): School intervention
Intervention type(s): Behavioral
Intervention description(s): The ITACA intervention is a cognitive and social-influences approach to prevent tobacco consumption. The intervention is integrated in the curricula of the school, also schools are reinforced to follow a smoke-free school and strictly follow legislation about smoking in schools. The community component include annual meeting with adolescents parents and parents and teachers intensive group for smoking cessation.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates in a group of people with DM 1 the influence in parameters of oxidative
      stress of the treatments with the different current analogs of insulin
    

Detailed description: 
      To evaluate by a randomized study in a group of people with DM 1 the influence in parameters
      of oxidative stress of the treatments with the different current analogs of

      Insulin by analyzing:

        1. - The circulating levels of oxidative stress markers: A) Anti oxidation: Total
           antioxidant capacity (CAT), B) Oxidation: 8-iso-prostaglandin F2 alpha (8-iso-PGF2α),
           acid reactive substances Thiobarbituric (TBARS) and LDL-oxidized.

        2. - The relationship between glycemic control variables (HbA1c and mean glycemia) and
           variability (Standard deviation (SD), coefficient of variation (CV), and MAGE (mean
           amplitude of Glycemic excursions) and oxidative stress parameters analyzed.

      Goal 2:

      Study the activation of cellular pathways associated with processes and oxidation states, by
      means of a Array of expression of up to 50 genes encoding oxidative stress response genes as
      CPT1a (Carnitine Palmitoyl Transferase 1a, mitochondrial oxidizing b limiting enzyme), TAS
      (Fatty acyl synthetase), acetyl-coA carboxylase, Acadm (medium chain acyl dehydrogenase),
      Acadl (long chain acyl dehydrogenase), Acadvl (long chain acyl coA dehydrogenase), SOD1,
      Hmox1 and Glutamine-Cysteine ligase (Gclc).
    

Intervention name(s): Toujeo SoloStar; Tresiba; Humalog Kwikpen; NovoRapid; Apidra
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.; Basal insulin at 16.00h and optimization of this basal doses with objetives of glycaemia before breakfast betwen 80-130 mg/ dl.; Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl; Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl; Ultrarrapid insulin that the patient had already and dose adjustement to obtain postprandial glycaemia levels < 150 mg/dl
Other intervention name(s): Glargina U300; Degludec insulin; Lispro insulin; Aspart insulin; Glulisine insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro; Insulin Aspart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxidation; Insulin analogues; Type 1 diabetes mellitus
Biomarker-based Cockroach Sublingual Immunotherapy Study (BioCSI)
Condition: Rhinitis, Allergic, Perennial; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There is currently no effective way to prevent development of allergic rhinitis (nasal
      allergies) and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in
      which allergens are placed under the tongue, may be a way to control and possibly prevent
      allergic rhinitis and asthma. However, detailed research of this approach is limited. The
      purpose of this study is to evaluate the safety and efficacy of a sublingual cockroach
      extract given to adults with perennial allergic rhinitis, asthma, or both.
    

Detailed description: 
      Over the last two decades, the prevalence of asthma has dramatically increased in many parts
      of the world. Currently, there are no effective ways to prevent the development of nasal
      allergies and asthma, and there are no cures for these diseases. Sublingual immunotherapy
      (SLIT) may help reduce symptoms of allergy and asthma. The purpose of this study is to
      evaluate the safety and efficacy of a cockroach extract given sublingually to adults with
      perennial (year-round) nasal allergies, asthma, or both.

      At study entry, participants will receive a dose of placebo and then up to five incremental
      doses of cockroach extract or placebo at 15-minute intervals while observed by the clinical
      research staff. Doses will continue to be given until a sign or symptom occurs that indicates
      the participant is having difficulty tolerating the drug, or until the maximum study dose is
      reached.

      For the next 6 months, participants will take the maximum study dose of cockroach extract or
      placebo daily at home.

      This study will consist of 8 study visits. Skin tests, breathing tests, and blood collection
      will occur at study screening and other visits during the study. At study entry, participants
      will be taught to use an EpiPen in the event of a severe allergic reaction at any time during
      the study. A physical and oral exam, breathing test, and blood collection will occur at study
      entry and all follow-up visits.
    

Intervention name(s): Glycerinated German Cockroach Allergenic Extract; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Concentrated (1:20 w/v) daily doses of glycerinated German cockroach allergenic extract placed under the tongue to dissolve. The extract is also administered during the preliminary dosing visits in up to five escalating doses or until the maximum study dose (420 microliters, 1:20 w/v) is achieved.; Daily doses of cockroach allergenic extract placebo placed under the tongue to dissolve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Immunotherapy; Asthma; Nasal Allergies; Hypersensitivity
Drug Interaction Study of Rifampin and Warfarin in Healthy Volunteers.
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the importance of uptake drug transporters in the
      drug disposition of warfarin. We predict that the elimination of warfarin will be decreased
      when co-dosed with an inhibitor of uptake drug transporters.
    


Intervention name(s): warfarin plus rifampin; warfarin
Intervention type(s): Drug; Drug
Intervention description(s): warfarin 7.5mg po x 1; rifampin 600mg IV x 1; warfarin 7.5mg po x 1
Intervention MeSH terms: Rifampin; Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: warfarin; pharmacokinetics; drug transporter; healthy volunteer; drug interaction; rifampin
The Use of Cyanoacrylate on Palatal Wound
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The palatal donor site of autogenous free gingival grafts significantly influences the
      patient's morbidity. The purpose of this study was to evaluate the efficacy of cyanoacrylate
      on palatal wound healing and postoperative complaints.
    

Detailed description: 
      A total of 35 patients were included in the study. In the test group (19 patient),
      cyanoacrylate was placed over the palatal wounds; conversely, the 16 control group patients
      were allowed to heal in a conventional way without cyanoacrylate.

      Primary bleeding time, presence of secondary bleeding, postoperative pain and completion of
      epithelization were assessed following free gingival graft operation. As a result, compared
      to the control group it was determined that the cyanoacrylate tissue adhesive could reduce
      the postoperative morbidity and improve the wound healing.
    

Intervention name(s): Free gingival graft; Cyanoacrylate application
Intervention type(s): Procedure; Procedure
Intervention description(s): Free gingival graft was harvested from palatal donor site; Periacyrl was applied on palatal wounds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer
Condition: Wound Healing Disorder
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional

Summary: 
      Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in
      Diabetic Foot Ulcer
    

Detailed description: 
      Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in
      Diabetic Foot Ulcer both sexes were included and intervention will be given for two months,
      wound healing will be assessed by measuring the surface area and the Aerobic microflora will
      be isolated and controlled on the basis of bio-gram and antibiogram at the beginning and at
      the end of treatment.
    

Intervention name(s): polarized light; Medical Care
Intervention type(s): Radiation; Other
Intervention description(s): bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks; Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results
Other intervention name(s): bioptron light therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; foot ulcer; polarized light; ;wound healing
MsFLASH-01: Escitalopram for Menopausal Symptoms in Midlife Women
Condition: Hot Flashes; Menopause; Vasomotor Symptoms
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      The purpose of this study is to test whether a medication reduces the number, severity and
      bothersomeness of menopausal hot flashes. Escitalopram (also called Lexapro®) is a selective
      serotonin reuptake inhibitor (SSRI). It is sold by prescription for depression and general
      anxiety disorder. An SSRI increases serotonin, a brain substance that is believed to
      influence mood. Serotonin may also affect brain levels of estradiol, a hormone related to hot
      flashes. This research study will test whether escitalopram reduces menopausal hot flashes.
    

Detailed description: 
      The MsFLASH-01 study, Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for
      Menopausal Symptoms in Midlife Women is a randomized, double-blind, placebo-controlled,
      parallel arm clinical trial. The design includes: 3 weeks of daily recording of hot flashes
      prior to drug treatment; 8 weeks of double-blind treatment with escitalopram or placebo with
      dose escalation at 4 weeks among non-responders; 1 week of drug taper for those on higher
      dose, followed by 2 weeks with no treatment; and a telephone follow-up post-treatment. This
      study is one of five clinical trials to be conducted as part of the Menopause Strategies -
      Finding Lasting Answers for Symptoms and Health (MsFLASH) study, a network of investigators
      and clinical trials designed to find new ways to alleviate the most common, bothersome
      symptoms of the menopausal transition.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 10 mg (1 pill) escitalopram daily for the first four weeks. Dose increased to 20 mg (2 pills) escitalopram daily if relief from hot flashes has not occurred during the first four weeks of the daily 10 mg dose.; Inactive pill (1 pill or 2 pills) daily for the 8-11 weeks of the trial.
Other intervention name(s): Lexapro®.
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hot flashes; Menopause; Vasomotor symptoms
Tight Closed-loop Systolic Arterial Pressure Control
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this case series is to evaluate the performance of a novel closed-loop
      (automated) vasopressor administration system that delivers norepinephrine using feedback
      from standard operating room hemodynamic monitoring (EV1000 monitoring device, Edwards
      Lifesciences, Irvine, USA).
    

Detailed description: 
      In this case series, the investigators will report the percentage of case time in hypotension
      (defined as systolic arterial pressure (SAP) < 117mmHg). The target mean arterial pressure
      (MAP) will be set at a SAP of 130mmHg in all patients. Definition of Hypotension is target
      SAP - 10% (130mmHg - 13 mmHg = 117 mmHg). We will use the same SAP target in all patients
      even if we used a modified definition of hypotension from the study of Futier and colleagues
      ( JAMA 2017). We won't use a individualized SAP for each patient but the same SAP target in
      all patients.

      The investigators want to demonstrate that the closed-loop system can prevent hypotension at
      this specific set point.

      The Investigators have shown the system works well based on a target MAP but not yet using a
      target of SAP.

      The investigators will test the system in a pilot study of 13 patients undergoing High-risk
      abdominal surgery which require the placement of a arterial catheter, the optimization of
      fluid therapy and a tight SAP control.

      Participants will receive standard patient care in that in no way will their anesthetic or
      surgical procedure will be altered as part of the study, with the exception of vasopressor
      administration ( automatically delivery instead of manually adjustments)

      Fluids will be given as goal directed fluid therapy in order to maintain stroke volume
      variation below 13% (hospital guidelines).
    

Intervention name(s): Closed-loop vasopressor
Intervention type(s): Device
Intervention description(s): The system will adjust the norepineprhine infusion rate based on a target SAP of 130 mmHg in 20 patients
Intervention MeSH terms: Vasoconstrictor Agents
Intervention model: Single Group Assignment
Intervention model description: Single prospective pilot study (12 patients)
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the
      pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in
      healthy adults
    

Detailed description: 
      1. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined
           administration JW0201 and C2103 compared to the case of each single administration in
           healthy adults.

        2. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined
           administration JW0201 and C2104 compared to the case of each single administration in
           healthy adults.
    

Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): JW0201: single administration, Tablet, Oral, BID for 5 days; C2103: single administration, Tablet, Oral, BID for 5 days; JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days; C2104 : single administration, Tablet, Oral, QD for 5 days; JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: A randomized, open-label, multiple-dose, 2x3 crossover clinical trial
Masking: None (Open Label)
Primary purpose: Other
Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake
Condition: Obesity
Study type: Interventional

Summary: 
      SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of
      hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid
      component (long-chain fatty acids). The goal of this combination is to achieve long-acting
      delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release
      of satiety-signals from intestinal cells, and consequently reducing appetite and lowering
      food intake in humans.

      Effects of acute ingestion of SATIOSTAT vs. a control will be examined. On a first and second
      study day, volunteers receive a preload of either SATIOSTAT or a control and then an oral
      glucose load of 75g enriched with C13 sodium acetate. Gastric emptying will be measured by
      means of a breath test, and insulin, glucose and satiation hormones will be assessed. On the
      third and fourth study day, volunteers receive a preload of either SATIOSTAT or a control and
      are then presented a test meal. Total calorie intake is measured as well as subjective
      feelings of satiation. In addition satiation hormones are measured.
    


Intervention name(s): Control treatment + oral glucose; SATIOSTAT treatment + oral glucose; Control treatment + meal intake; SATIOSTAT treatment + meal intake
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Control granulates (maize starch and long-chain fatty acids) with powder; 75g oral glucose load; SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; 75g oral glucose load; Control granulates (maize starch and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water); SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water)
Other intervention name(s): The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.; The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.; The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.; The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Variations in Palatability and Portion Size of Vegetables on Meal Intake of Preschool Children
Condition: Feeding Behavior
Study type: Interventional

Summary: 
      The aim of the study is to determine the effect of varying both the palatability and portion
      size of vegetables served to preschool children at a meal on the outcomes of food and energy
      intake at the meal.
    


Intervention name(s): Plain Vegetables Served in 100% Portion Size; Plain Vegetables Served in 200% Portion Size; Enhanced Vegetables Served in 100% Portion Size; Enhanced Vegetables Served in 200% Portion Size
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables; Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables; Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables; Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Physical Activity Level, Aerobic Capacity and Dietary Habits Among a Cohort of Females With Premenstrual Syndrome
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Observational

Summary: 
      The aim of the study is to investigate the physical activity level, aerobic capacity and
      dietary habits among a cohort of females with premenstrual syndrome
    

Detailed description: 
      premenstrual syndrome can be defined as a recurrent disorder that occurs every month in the
      luteal phase of the menstrual cycle, and subside with the onset of menstruation. It is
      characterized by a complex set of symptoms, which include physical, psychological and
      behavioral changes with varying severity. This can interfere with the lives of females.
      Physical exercise improves PMS through rising endorphin levels, reducing adrenal cortisol
      symptoms, leading to lesser anxiety, depression and greater pain tolerance, as previous
      studies showed that it was effective in decreasing pain as well as mental and physical
      symptoms of PMS. Recently, lifestyle changes have gained more importance than
      pharmacotherapy. Lifestyle changes include many methods including diet regulation and
      exercise. 30 minutes of aerobic exercise is recommended for at least 3 days per week to
      contribute to the regulation of both body composition, mood and to improve physical symptoms.
      Evidence suggests that it can be helpful in reducing symptoms.
    

Intervention name(s): Running anaerobic sprint test and aerobic test
Intervention type(s): Other
Intervention description(s): subjects walk a mile with maximum steps and their heart rate will not exceed 180 beats per minute during the test and the execution time will not be less than 9 minutes (RAST test)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        females with PMS will participate in this study with ages ranging from 20 to 35 years
      
Keywords: physical activity level, aerobic capacity and dietary habits in PMS