bioihbjkbjnl/mcl2 huggingface dataset:
Plant-based Nutrition for Patients With Cardiovascular Risk Factors
Condition: Metabolic Syndrome; Cardiovascular Risk Factor; Overweight and Obesity; Hypertension,Essential
MeSH terms: Essential Hypertension; Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      Plant-based nutrition may have positive effects on chronic diseases such as cardiovascular or
      metabolic disorders. This study investigates the effects of a 8 week plant-based diet for
      patients with metabolic syndrom and cardiovascular risk factors.
    


Intervention name(s): Plant-based Diet
Intervention type(s): Other
Intervention description(s): Patients are guided to change their nutrition to a plant-based diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic Syndrom; Plant-based Diet; Nutrition
Circadian Rhythmicity in Cold-induced Thermogenesis
Condition: Healthy; Obese; Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      This study aims to investigate whether maximum cold-induced non-shivering thermogenesis (e.g.
      thermogenesis as a consequence of BAT activity) differs between morning and evening.
    

Detailed description: 
      Brown adipose tissue (BAT) recently emerged as a novel player in energy expenditure (EE) in
      humans as it combusts fatty acids and glucose towards heat. Human BAT can be activated by
      sympathetic stimulation resulting from cold exposure or treatment with sympathomimetic drugs.
      Short-term acclimation to mild cold was shown to reduce fat mass in obese subjects and
      decrease peripheral insulin resistance of patients with T2DM. Recently, in preclinical
      studies the investigators showed that BAT has a circadian rhythm. It is currently unknown
      whether this is also the case in humans. The investigators postulate that BAT activity should
      display a circadian rhythm that adapts to changes in circadian behavior, and may determine
      glucose/lipid levels throughout the day.
    

Intervention name(s): Personalized cooling protocol
Intervention type(s): Procedure
Intervention description(s): As an intervention, a personalized cooling protocol will be used in order to activate BAT and induce non-shivering thermogenesis. During the cooling procedure, subjects will be exposed to mild cold (approx. 14°C) for 150 min. Since the onset temperature of shivering shows a high interindividual variation, we will use a personal cooling protocol to ensure maximum non-shivering EE (and thus an equal maximum activation of BAT). The right temperature will be determined via a subjective method, e.g. to ask the subject if he or she experiences shivering. The time needed to achieve the right temperature is approximately 30-60 minutes. Then, the stable cooling period of 90 min is started. During this time the subject will be asked every 15 minutes whether he is experiencing shivering. If so, temperature will be increased with 2-3°C so that shivering just stops.
Intervention model: Single Group Assignment
Intervention model description: The study design encompasses a single-arm randomized intervention study using cold exposure.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lean; young; healthy; overweight; obese
Insulin Glulisine in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of a single injection of glulisine before the main meal added to
      insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs
      in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
    


Intervention name(s): Insulin Glargine; Glimepiride; Insulin Glulisine; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One daily injection at bedtime; At same dosage as during the run-in period; One bolus given before the main meal; At same dosage as during the run-in period
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Glimepiride; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The principal objective is to show noninferiority of nebulized salbutamol through the high
      flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction
      compared to nebulization by the usual method (spray mask).
    

Detailed description: 
      Randomized, comparative, non inferiority study between two nebulization strategies
      bronchodilators, one according to the method tested namely the spray - in across the top
      humidified nasal flow system and the other according to a customary procedure, through a
      mask. A third arm will be evaluated (control arm) to overcome a possible own bronchodilator
      effect of high flow nasal humidified.
    

Intervention name(s): Airvo2 with Aerogen Solo; Mask; arm control Airvo2 without nebulization of salbutamol
Intervention type(s): Device; Device; Device
Intervention description(s): Nebulization of salbutamol with Airvo 2 and Aerogen solo; Usual nebulization of salbutamol with mask; Airvo2 with Aerogen Solo. No nebulization of salbutamol
Other intervention name(s): AirvoNEB
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Assessment of Knowledge, Attitude and Practice of Eligible Couples Regarding Eugenics
Condition: Knowledge, Attitudes, Practice
Study type: Observational

Summary: 
      A Descriptive study to assess the knowledge, attitude and practice regarding eugenics among
      eligible couples of selected area of Ambala, Haryana, India. Eligible couples were the
      married couples where wife is in the age group of 15-45 years planning for conception, have
      conceived and may or may not have any living child.Eugenics are to methods that are adopted
      by eligible couples for having physically and psychologically healthy conception and
      pregnancy.
    

Detailed description: 
      To assess the knowledge, attitude and practice the structured knowledge questionnaire,
      attitude 5-point likert scale and expressed checklist tool were prepared. A sample size of
      318 was calculated by power analysis and eligible couples were selected by Purposive sampling
      technique from rural and urban area of Ambala Haryana, India.

      Each eligible couples (separately husband and wife) data was collected through Self- Report
      technique.one time assessment only done.
    

Observational model: Family-Based
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Eligible couples of rural and urban areas of Ambala Haryana, India
      
Keywords: Eugenics; Eligible Couples; Knowledge; Attitude; Practice
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
Condition: Dyslipidemias; High Cholesterol; Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study
      to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to
      high-intensity statin therapy.
    

Detailed description: 
      This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study
      to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to
      high-intensity statin therapy. The screening period for this study will take up to 2-weeks.
      Afterwards patients will be randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for
      an 8-week treatment period. After the treatment period, patients will continue for a 4-week
      safety follow-up and a 15-week PK follow-up.
    

Intervention name(s): Obicetrapib
Intervention type(s): Drug
Intervention description(s): tablets
Other intervention name(s): CETP inhibitor
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-controlled, double-blind, randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obicetrapib; statin; LDL-C; cholesterol; atherosclerosis
Phospholipid Absorption of a Milk Phospholipid
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to investigate parameters of the lipid metabolism in plasma and feces
      of healthy subjects after a dietary supplementation of different dosages of milk
      phospholipids.
    

Detailed description: 
      To date the mechanisms for the intestinal absorption of glycerophosphates and sphingolipids
      are not completely investigated. It is assumed, that sphingolipids and sterols compete for
      intestinal absorption. In addition it is unclear, if a dietary phospholipid supplementation
      may influence the phospholipid concentration in plasma.

      To evaluate the effect of a dietary phospholipid supplementation 15 healthy female subjects
      received over 10 days daily 3 g of milk phospholipids stirred in a dairy product. During the
      following 10 days the subjects were supplemented with daily 6 g milk phospholipid. Finally,
      the subjects received over 10 days 6 g of the milk phospholipid in a dairy product and 2 g of
      plant sterols serving a commercial product.
    

Intervention name(s): Milk phospholipid
Intervention type(s): Dietary Supplement
Intervention description(s): During day 1 until 10 the subjects were supplemented with daily 3 g milk phospholipids, during the day 11 and 20 the supplementation was increased to daily 6 g, and during the day 21 and 30 the subjects received daily 6 g milk phospholipids and 2 g of plant sterols.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: glycerophosphates; sphingomyelins
Quality of Recovery After Unplanned and Planned Cesarean Deliveries - an Application of ObsQoR-10
Condition: Quality of Recovery
Study type: Observational

Summary: 
      In Canada, 29.1% of annual births are via cesarean deliveries (CD). The literature shows that
      almost 24% of CDs are unplanned. Existing evidence suggests that unplanned cesarean delivery,
      compared to elective cesarean, may be associated with poor maternal recovery, longer
      postpartum hospital stays and more opioid requirements after surgery. Since the establishment
      of the Enhanced Recovery After Cesarean protocols, specific care pathways have been
      implemented with the aim of optimizing recovery after CD and to reduce the costs to the
      health care system. However, the majority of unplanned cesarean receive the same
      postoperative anesthetic, obstetric and nursing care as the elective CDs.

      Looking at the actual information about maternal recovery after unplanned CD, the
      investigators found that there is a paucity of literature examining this topic utilizing
      validated, patient-oriented quality of recovery tools. Recently, Obstetric Quality of
      Recovery-10 scoring tool (ObsQoR-10), a new patient-focused outcome instrument for postpartum
      recovery, it has been validated for all types of deliveries, in the inpatient setting.
      ObsQoR-10 tool aims to measure quantitatively functional recovery at 24 hours postpartum. It
      includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of
      narcotics and the perception of recovery by the patient.

      The aim of this study is to determine the quality of recovery from unplanned cesarean
      deliveries compared to planned ones using a validated tool for recovery after cesarean
      delivery (ObsQoR-10 tool).

      The investigators hypothesize that quality of recovery as measured by the Obs-QoR10 for
      unplanned cesarean deliveries will be lower than the planned CDs.
    


Intervention name(s): Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool
Intervention type(s): Other
Intervention description(s): The ObsQoR-10 tool aims to quantitatively measure functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.
Other intervention name(s): ObsQoR-10©
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who deliver by planned or unplanned cesarean section at Mount Sinai Hospital
      
Keywords: Cesarean delivery; ObsQoR-10©
Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With Primary Hypercholesterolemia and Coronary Heart Disease (P03396)
Condition: Hypercholesterolemia; Atherosclerosis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Atherosclerosis; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to evaluate the efficacy and safety of coadministration of ezetimibe
      10 mg with atorvastatin 10 mg in untreated subjects with primary hypercholesterolemia and
      coronary heart disease for whom diet and exercise have failed. The primary variable is
      LDL-cholesterol (LDL-C), and the secondary variable is total cholesterol (TC), HDL-C, and
      triglycerides (TG). The following variables were used to assess the safety and compliance of
      the drug: vital signs and laboratory values. Variables were measured before the first
      administration of the drug and at the last administration of the drug, after 6 weeks of
      treatment. Adverse events were also assessed.
    


Intervention name(s): Ezetimibe + Atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks; oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
Other intervention name(s): SCH 58235; Zetia; Lipitor; Lipitor
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immediate Implant vs.Socket Shield Technique in Esthetic Zone
Condition: Bone Loss
Study type: Interventional

Summary: 
      immediate implant placement versus socket shield approach
    

Detailed description: 
      This study was a randomized controlled clinical trial; patients were randomly allocated to
      two groups: the study group: ten dental implants were placed in the maxillary esthetic zone,
      implants were placed using the socket shield technique with immediate loading; and the
      control group: ten implants were placed immediately with immediate loading. Preoperative and
      6 months postoperative CBCT were performed for both groups to assess the dimensional changes
      in the labial bone plates. Implant stability quotients (ISQs), pink esthetic scores and
      attachment loss were measured at the time of implant placement and 6 months postoperatively.
    

Intervention name(s): socket sheild
Intervention type(s): Procedure
Intervention description(s): the socket shield technique, in which a partial root fragment was retained around an immediately placed implant with the aim of avoiding tissue alterations after tooth extraction. Histologic evaluation in a beagle dog showed no resorption of the root fragment and new cementum formed on the implant surface.
Other intervention name(s): partial extraction therapies
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study group (socket shield) vs. Control group (immediate implants)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: socket shield
Registry of Right-to-left Shunt Detection by Contrast-enhanced Transcranial Doppler in Chinese Population
Condition: Right-to-left Shunt; Migraine; Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the study is to evaluate the prevalence and extent of right-to-left shunt
      (RLS) in Chinese migraineurs, and the morbidity of silent cerebral infarction in migraineurs.
    

Detailed description: 
      This is a prospective multicenter study of Chinese population. Participants (normal
      individuals without migraine and migraineurs) are included after standardized diagnostic
      procedures (TCD and c-TCD). For migraineurs with large RLS further examinations (c-TTE and
      brain MRI) are required. Up to 10 study sites nationwide will be needed to recruit the
      planned participant population during a 1-year period.

      The information of each participants will be registered, including basic facts, the
      longitudinal headache history, frequency, location, quality, intensity, duration, accompanied
      symptoms, precipitating and exacerbating factors, with or without aura, MIDAS and HIT-6
      questionnaire.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We detect RLS through contrast-enhanced transcranial Doppler (c-TCD). The normal
        individuals will be selected to group 1, while those who suffer from migraine will be
        selected to group 2. Patients of group 2 with large RLS are required to take TTE and brain
        MRI.
      
Keywords: right-to-left shunt; contrast-enhanced transcranial Doppler; migraine; silent cerebral infarction
The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Application of "Evicel" hemostatic matrix during operation for unilateral total knee
      replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a
      reduction in transfusion requirements, and less reduction of hemoglobin.
    

Detailed description: 
      No additional data desired
    

Intervention name(s): Evicel fibrin sealant
Intervention type(s): Drug
Intervention description(s): Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: osteoarthritis; total knee replacement
Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the current study is to investigate the efficacy, safety and tolerability of
      Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to
      metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with
      insufficient glycaemic control.
    


Intervention name(s): Placebo; Linagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Placebo matching linagliptin tablets once daily; Linagliptin tablets once daily
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Online Resilience Intervention in Older Adults
Condition: Health Promotion Program
Study type: Interventional

Summary: 
      Resilience in older adults is important for Healthy aging. The purpose of this study was to
      examine the effectiveness of an on-line program of resilience interventions among older
      adults.
    

Detailed description: 
      Healthy aging not only free from illness but also need to maintain healthy physical and
      mental function, be active in social life and contribute to society. Aging bring
      comprehensive impacts toward family, society and country, especially in individual.
      Resilience intervention can improve the intrinsic health and well-being for older adults.
      Good physical activity benefits to healthy aging. The purpose of this study was to examine
      the effectiveness of an on-line program of resilience interventions among older adults.
    

Intervention name(s): online resilience intervention
Intervention type(s): Radiation
Intervention description(s): online resilience intervention were presented in four 60-minute sections, once a week for four weeks embracing four sections
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: control group and experimental group
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: resilience intervention; physical activity; well-being; older adult
Use of Two Deep Brain Stimulation (DBS) Electrodes to Treat Post-Traumatic Tremor
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional

Summary: 
      The purpose of this research study is to:

        1. Determine whether deep brain stimulation (DBS) with two leads (very thin coiled wires)
           placed unilaterally (on one side of the brain) is beneficial to patients with multiple
           sclerosis (MS) tremor.

        2. Compare the two different locations of the DBS lead placement in effectiveness for
           treatment of muscle tremors that do not respond to treatment with medication caused by
           multiple sclerosis.

        3. Evaluate any side effects that may result from the two DBS leads.
    

Detailed description: 
      Surgical treatment of disabling multiple sclerosis (MS) tremor that does not respond to
      medication has proven difficult. To date, there have been no prospective blinded studies to
      evaluate efficacy of surgical treatments for these tremors. Based on prior data, this study
      will examine the use of 2 DBS electrodes on the same side of the brain in the thalamus region
      (one at an area referred to as the "ventralis intermedius nucleus/ventralis oralis posterior
      nucleus border," or "VIM," and one at a region called the "ventralis oralis anterior
      nucleus/ventralis oralis posterior nucleus border," or "VO") for treatment of MS tremor. This
      study will test the effectiveness of VIM combined with, and independent of, VO DBS, and
      characterize safety, benefits and side effects of this procedure for treatment of MS-related
      tremors.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment