bioihbjkbjnl/mcl2 huggingface dataset:
Impact of an 8-week Linoleic Acid Intake in Soy Oil on Lp-PLA2 Activity in Healthy Adults
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 3

Summary: 
      Self-reported healthy participants (n=150) aged 30-65 years with 18.5 kg/m^2 ≤ BMI < 30
      kg/m^2 were randomly assigned into three groups: a low linoleic acid (LA, 18:2n-6) group
      (n=50) replaced 10 mL soy oil with one apple; a medium LA group (control group, n=50)
      maintained usual food intake; a high LA group (n=50) reduced 1/3 cup of cooked refined rice
      and consumed 9.9g of soy oil capsules daily as a supplement. Plasma fatty acids and
      lipoprotein-associated phospholipase A2 (Lp-PLA2) activity were measured at baseline and 8
      week alongside other cardiovascular disease risk factors.
    


Intervention name(s): Low LA; High LA
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Individuals who replaced 10 mL soy oil with one apple; Individuals who reduced 1/3 cup of cooked refined rice and consumed 9.9g (9 of 1.1g capsules, 3 capsules at every 3 meals a day) of soy oil as a supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Association Between Endometriosis, Obesity and nesfatin1
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The association between endometriosis, obesity and nesfatin1.
    

Detailed description: 
      All women in this study were subjected to all of the following:

        1. Verbal consent was obtained.

        2. History taking:

             1. Personal history.

             2. Menstrual history.

             3. Use of contraception.

             4. Use of any hormonal treatment in the three months prior to the laparoscopy.

             5. History of infertility and its duration and type.

             6. Sexual history.

             7. Past history.

        3. Complete physical examination: general, abdominal and local gynecological examination.

        4. Complete preoperative workout for laparoscopy was done.

        5. Laparoscopy was done postmenstrual, during follicular phase. All patients gave an
           informed consent and were fasting for at least 8 hours prior to the laparoscopy, and
           general anesthesia was used for all patients.

           The pelvis and its structures were observed and checked for presence of endometriotic
           lesions (uterus, tubes, ovaries and ovarian fossae, uterosacral ligaments, Douglas
           pouch, uterovesical pouch, broad ligaments and lateral pelvic walls).

           The Endometriotic patients were then classified into stages I-IV according to the
           revised American Fertility Society scoring system for endometriosis.

        6. Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients
           during the laparoscopy procedure immediately after initial evaluation and before any
           intervention.

        7. Biopsy from lesions suspected as endometriosis was taken during laparoscopy and sent to
           histopathology for confirmation.

        8. The blood samples were centrifuged immediately after their collection at 5000 rpm for 10
           min and serum samples were stored at -20 °C until analysis.

           Patients and Methods

           -67-

        9. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay "ELISA" technique using
           commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits,
           Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        sixty female patients were admitted to the wards to undergo laparoscopy for various
        indications
The Breathe Well Program for Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The Breathe Well Study is a pragmatic, controlled trial to assess the effectiveness,
      cost-effectiveness, and implementation of the Breathe Well intervention, which combines
      evidence-based EHR and interactive behavior-change technologies (IBCT) and team-based care to
      improve asthma outcomes.
    

Detailed description: 
      Breathe Well uses the Kaiser Permanente Electronic Health Record (EHR) to identify asthma
      exacerbation risk factors. For patients with a history of frequent exacerbations or B-agonist
      overuse, the EHR notifies a nurse who uses an EHR-generated tailored clinical report and
      patient directed decision support tool to engage and empower patients to develop an action
      plan in collaboration with providers. EHR-templated notes and order sets facilitate care plan
      execution. Poor controller medication adherence or unaddressed smoking results in the patient
      being automatically enrolled in an IBCT medication refill or smoking cessation program.
      Breathe Well uses multiple EHR functions and a patient and provider team to address barriers
      to evidence-based asthma care for providers.The study will be conducted in 26 primary care
      clinics of Kaiser Permanente Colorado (KPCO) using a pragmatic clinical trial design. Up to
      15,000 high-risk asthma patients will be assigned to Breathe Well or guideline-based usual
      care based on their clinic.
    

Intervention name(s): IVR call/text; Email
Intervention type(s): Behavioral; Behavioral
Intervention description(s): For patients under filling their inhaled corticosteroid or overusing B-agonist, the patient is contacted via IVR call or text; Patients under filling their inhaled corticosteroid or overusing B-agonist, the the patient is contacted via email
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to either 1) usual care or 2) Interactive Voice Response (IVR) or 3) email. Those in the groups 2 or 3 will receive the intervention only if they smoke, underuse controller medication, or overuse rescue medication.
Masking: None (Open Label)
Primary purpose: Health Services Research
Effect of Oleactiv® on LDL Oxidability
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      Oleactiv® have previously demonstrated beneficial effects in an animal model of diet-induced
      atherosclerosis. After a 12-week supplementation, a substantial reduction of aortic fatty
      streak area has been observed. Also, Oleactiv®-supplemented hamsters displayed significant
      decrease of both non-HDL-cholesterol and triglycerides levels. Also, phenolic compounds from
      Oleactiv® demonstrated that increase of cholesterol efflux capacity (CEC) is one of the
      mechanisms that may explain preventive effect on atheroma development.

      These effects observed in animals will thus be investigated in human. The main hypothesis of
      the present study is that phenolic compounds from Oleactiv® may improve LDL oxidability in
      volunteers with moderate hypercholesterolemia after 3 weeks of consumption.
    


Intervention name(s): Plant food supplement; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Food supplements are consumed during 3 weeks by hypercholesterolemic volunteers; Food supplements are consumed during 3 weeks by hypercholesterolemic volunteers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Polyphenols; LDL oxidability
SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      This trial will compare images obtained from a mobile colposcope with those obtained using a
      standard of care.
    

Detailed description: 
      This trial will compare images obtained from a mobile colposcope with those obtained using a
      standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded
      images will be evaluated be experts in colpsocopy and compared
    

Intervention name(s): Mobile OCT M3 scope
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: screeening
Dietary Control of Type 2 Diabetes: Low-Carbohydrate Mediterranean Diet Versus Low-Fat Diet
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The major environmental factors that increase the risk of type 2 diabetes, presumably in the
      setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent
      overweight and obesity. The high rate of weight regain has limited the role of lifestyle
      interventions as an effective means of controlling glycemia long term. The aims of the
      present study were: 1) To compare the effectiveness and safety of two nutritional protocols -
      namely low-carbohydrate Mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive
      overweight patients with type 2 diabetes mellitus. The primary aim of the study was the
      effect on hemoglobin A1c levels; secondary aims were time to introduction of the first
      hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ADA
      goals for risk factors (HbA1c, blood pressure, LDL-cholesterol, percentage of patients with
      HbA1c < 7%.
    


Intervention name(s): Mediterranean diet; Low-fat diet
Intervention type(s): Other; Other
Intervention description(s): The recommended composition of the dietary regimen was as follows: Carbohydrate 40 to 50%, protein 15 to 20%; fat 30 to 40%; saturated fat less than 10%.; The recommended composition of the dietary regimen was as follows: Fat less than 30%; carbohydrate 50 to 60%, protein 15 to 20%; saturated fat less than 10%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Efficacy of Medi-Tate iTind Device
Condition: Benign Prostatic Hyperplasia (BPH)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The study will include an implantation of the iTind device and 4 follow up visits up to 12
      months after the implantation.
    

Detailed description: 
      After screening , eligible patients will undergo an an implantation procedure (operative),
      using the iTind device.

      Implantation will be performed according to the Instructions For Use.

      Between the 5th - 7th days, the iTind will be retrieved through a rigid cystoscope sheath,
      under direct vision. Before retrieval the subject will be asked for subjective discomfort
      evaluation and level of urgency in the past days after device insertion, about any AE and
      then the device will be retrieved.

      The next visits will be at 4 weeks (post device retrieval), 3 months, 6 months, and 12 months
      post implantation with an optional extension of follow up period (up to 36 months). In the
      visits the following will be assessed: Uroflow and residual urine volume tests, AE recording,
      IPSS, and Questions on sex performing capability and ejaculation filled out by the subjects,
      in the local languages.
    

Intervention name(s): TIND System
Intervention type(s): Device
Intervention description(s): An implant
Intervention model: Single Group Assignment
Intervention model description: iTind
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BPH
Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients?
Condition: Hypercholesterolemia; Diabetes; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional

Summary: 
      We aimed to address the issue whether statins affect insulin resistance. To this end, we
      combined the available state-of-the art technology for detailed assessment of both whole-body
      and tissue specific insulin sensitivity in vivo in humans (euglycemic-hyperinsulinemic clamp,
      stable isotope [6,6-2H2]glucose dilution technique, proton nuclear magnetic resonance
      spectroscopy - 1H MRS - of liver and skeletal muscle). Outcome measures were determined
      before and after 8 weeks therapy with 80 mg Simvastatin in hypercholesterolemic patients with
      type 2 diabetes.
    


Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg Simvastatin daily for 8 weeks; The placebo was identical in appearance and was provided by the same manufacturer
Other intervention name(s): Zocord
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Insulin resistance; Statins; Muscle and liver triglycerides
A Study of GWP42006 in People With Focal Seizures - Part A
Condition: Epilepsy; Focal Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo,
      in the presence of other antiepileptic drugs (AEDs).
    

Detailed description: 
      This is a double blind, randomized, placebo controlled, two-part study. Part A only will be
      described in this record.

      Subjects who satisfy all inclusion and none of the exclusion criteria will begin a 14-day
      baseline observation period followed by a 14-day treatment period. Subjects will be required
      to attend six study visits. A follow-up phone call will take place four weeks after last
      dose.

      Part A will enroll three groups of 10 subjects:

        -  Group 1 - subjects on inducer AEDs (and not on inhibitor AEDs)

        -  Group 2 - subjects on inhibitor AEDs (and not on inducer AEDs)

        -  Group 3 - subjects on AEDs that are neither inducers nor inhibitors.

      In each of the three groups subjects will be randomized to receive, in a 4:1 ratio, GWP42006
      400 mg twice daily or matching placebo. Pharmacokinetic (PK) profiles for GWP42006 and
      metabolites will be collected on the first and last day of treatment. Samples will also be
      collected 24h and 72h after the last day of treatment.

      Subjects will be required to record a daily diary with information about their seizures,
      investigational medicinal product (IMP) and concomitant AED administration.
    

Intervention name(s): GWP42006; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Cannabidivarin; CBDV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabidivarin; CBDV; GWP42006
Prevention of Weight Gain
Condition: Obesity; Body Weight Changes
MeSH terms: Body Weight; Weight Gain; Body Weight Changes
Study type: Interventional

Summary: 
      The purpose of this study is to test methods for preventing weight gain in normal-weight and
      overweight women aged 25 through 44. Participants will complete brief questionnaires about
      their health, eating and exercise habits, and use of weight control strategies. They will
      then be randomly assigned to 1 of 3 treatment conditions. All 3 treatments receive
      information on the importance of maintaining a healthy body weight, the components of a
      healthy diet, and ways to increase activity levels. The 3 treatment differ in how this
      information is delivered. At 12, 24 and 36 months after enrolling in the study, participants
      will attend assessment sessions. They will complete questionnaires and have body weight
      measured.
    


Intervention name(s): Weight Gain Prevention for Women Project
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Prevention
Keywords: weight gain
Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to evaluate the antihypertensive efficacy of a fixed combination of
      Irbesartan/HydroChloroThiazide (CoAprovel) in Chinese moderate to severe hypertensive
      patients.

      The secondary objective is to get systolic blood pressure and diastolic blood pressure goal
      attainment rate from CoAprovel in Chinese hypertensive patients.
    


Intervention name(s): irbesartan/hydrochlorothiazide
Intervention type(s): Drug
Intervention description(s): 50/12.5mg for 4 weeks follow 300/12.5mg for 4 weeks and proceed to 300/25mg for 4 weeks
Other intervention name(s): CoAprovel
Intervention MeSH terms: Hydrochlorothiazide; Irbesartan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Peroxisome Proliferator-Activated Receptor-gamma (PPAR-gamma) Agonist in Diabetic End-Stage Renal Disease Patients
Condition: Endstage Renal Disease; Diabetes
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      To test the hypothesis that PPAR-gamma agonist, rosiglitazone, induces carotid plaque
      regression in diabetic ESRD patients on maintenance PD via its anti-inflammatory property.
    

Detailed description: 
      End-stage renal disease (ESRD) patients are at an increased risk of accelerated
      atherosclerosis and cardiovascular morbidity and mortality. Non-traditional risk factors such
      as inflammation and insulin resistance have important contributions to accelerated
      atherosclerosis in ESRD patients receiving long-term peritoneal dialysis (PD). The peroxisome
      proliferator-activated receptor-g (PPAR-g) is a member of the nuclear receptor family of
      ligand-dependent transcription factors. Activation of the PPAR-g has been shown in both
      clinical and experimental studies to have anti-inflammatory and anti-atherosclerotic
      properties other than insulin-sensitizing effects. Recent study also showed that PPAR-g
      agonists reduce plaque inflammation by inhibiting the activation of proinflammatory genes
      responsible for plaque development and growth. Hence, this study aims to examine the effects
      of PPAR-g activation on the progression of carotid plaque in diabetic ESRD patients receiving
      long-term PD using high-resolution magnetic resonance imaging (MRI).
    

Intervention name(s): Pioglitazone; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): oral Pioglitazone 15mg daily for 12 weeks, then 30mg daily for 36 weeks; Placebo comparator
Other intervention name(s): Actos; Placebo
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PPAR-gamma, diabetic, kidney disease, atherosclerosis
Double-Blind, Placebo-Controlled Trial of Vitamin E as Add-on Therapy for Children With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to see if vitamin E helps children with epilepsy have fewer seizures. About
      20-30% of children with epilepsy do not have adequate seizure control with established
      antiepileptic drugs (AEDs). Other options for patients with uncontrolled epilepsy are newer
      antiepileptic medications, ketogenic diet and surgery. However, a small percentage of
      patients are candidates for these options. Therefore, additional treatments are needed to
      improve seizure control in patients with uncontrolled epilepsy. Animal studies have shown an
      association between vitamin E supplementation and seizure reduction. A study in children also
      showed that vitamin E helped reduce seizures. However, a similar study in adults did not show
      a reduction in seizures with vitamin E supplementation. Therefore, this research study is
      being done to help define vitamin E's usefulness and safety as a treatment for epilepsy.
      Fifty patients will be recruited from the Children's Epilepsy Program at The Children's
      Hospital in Denver, Colorado. Qualifying patients will have a confirmed diagnosis of epilepsy
      that is currently uncontrolled with standard AEDs. The study period is 6 months and includes
      the following: Baseline period (1 month), Arm I (2 months), Wash-out period (1 month), and
      Arm II (2 months). Patients must have been on the same AEDs for 2 months before enrollment.
      All medications and complementary therapies must remain constant throughout the study. If at
      any point the physician feels it is not best for the patient to continue the study they will
      be discontinued. Before the study starts, study participants will be asked about seizure
      activity, what they eat and about any complementary and/or alternative medicine they may use.
      The study is two phases. Study participants will be given either vitamin E or placebo (fake
      pill/liquid) in each phase of the study. They will receive both vitamin E and placebo during
      the study. Which phase they receive vitamin E and placebo will be decided by chance (similar
      to rolling dice). Study participants will take liquid vitamin E or placebo two times per day.
      The study participants and study doctors will not know who is taking vitamin E and who is
      taking placebo. Study participants will come to the hospital for 3 outpatient and 2 inpatient
      visits. Health-related quality of life questionnaires will be filled out and blood will be
      drawn at three of the visits. Seizure diaries will be maintained throughout the study.
    


Intervention name(s): Vitamin E
Intervention type(s): Drug
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult Volunteers
Condition: Healthy Subjects; Pharmacokinetics of YM178
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose
      ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone
      and in combination with ketoconazole in healthy adult volunteers.
    

Detailed description: 
      A single oral dose of YM178 OCAS will be administered on 2 separate occasions: alone on Day 1
      of Period 1 and during multiple- dosing of ketoconazole on Day 4 of Period 2. In Period 2, an
      oral dose of ketoconazole will be administered once daily on Days 1-9.
    

Intervention name(s): YM178 OCAS; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): mirabegron; Nizoral
Intervention MeSH terms: Ketoconazole; Mirabegron
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Drugs, Investigational; pharmacokinetics; Urinary Bladder, Overactive; YM178; Mirabegron