bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes
Condition: DIABETES MELLITUS TYPE 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of sustained walnut consumption on
      endothelial function and lipid markers in patients with Type 2 diabetes mellitus.
    

Detailed description: 
      Evidence-based guidelines for the management of type 2 diabetes mellitus and related
      cardiovascular disease (CVD) refer to cardioprotective dietary fatty acid proportions.
      Several studies demonstrate the hypocholesteremic effects of walnuts in energy restricted
      diets. To our knowledge, the health benefits accrued as a result of addition of walnuts to an
      ad libitum diet in type 2 diabetic subjects have not been studied. Addition of walnuts to an
      ad libitum diet represents a practical way to achieve the recommended fatty acid proportions.
      The proposed study will examine whether a total dietary pattern inclusive of walnuts, will
      result in amelioration of cardiac risk as measured by improvement in endothelial function and
      glycemic control in type 2 diabetics. Results of the study will have important implications
      for clinicians and dietitians in dietary management of type 2 diabetes. Demonstrating that
      walnuts can be regarded as beneficial components of dietary management of type 2 diabetes is
      of relevance to the walnut industry as well. The study employs a pragmatic approach to
      approximate dietary practices in a real world setting thus enhancing the external validity of
      the study. If positive, the study results can inform future marketing efforts of the
      California Walnut Commission. Demonstrating that addition of walnuts to an ad libitum diet
      can potentially lead to improvement in endothelial function, improve lipid profiles, glycemic
      control and reduce the risk of CVD complications in diabetic patients has important
      applications for dietary management of diabetes.
    

Intervention name(s): Walnut supplementation; Ad lib diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Eight weeks of walnut supplementation; Eight weeks without walnut supplementation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this trial is to evaluate the effect of Aquamin F versus placebo on NSAID
      (non-steroidal anti-inflammatory drug) dose reduction in subjects with osteoarthritis of the
      knee.

      Hypothesis 1: After 12 weeks of treatment, subjects taking Aquamin F will use significantly
      less NSAID medications for symptoms of osteoarthritis versus placebo alone.

      Hypothesis 2: No significant differences will be seen for adverse events between the subjects
      taking Aquamin F or placebo.
    


Intervention name(s): Aquamin F; Placebo (maltodextran)
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Osteoarthritis; Clinical trial; Aquamin F; NSAID
Postoperative Adjuvant Therapy of HCC Based on PD-1
Condition: Hepatocellular Carcinoma; RFS
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      For the treatment of hepatocellular carcinoma, liver resection is still one of the optimal
      options, but the recurrence rate is as high as 70% five years after the operation, and the
      prognosis of patients with high-risk recurrence factors such as portal vein tumor thrombus
      and microvascular invasion is even worse, so it is particularly urgent to find effective
      postoperative adjuvant treatment. The role of PD-1 inhibitors in preventing the postoperative
      recurrence of HCC requires further study.
    

Detailed description: 
      We conducted a prospective cohort study comparing the efficacy of PD-1-based adjuvant therapy
      and transarterial chemoembolization in patients with high-risk factors for recurrence
      undergoing radical surgery. After surgery, patients received the appropriate adjuvant therapy
      according to the type of high-risk recurrence factor. Patients with high-risk factors for
      recurrence who received PD-1-based adjuvant therapy were included in the exposure cohort;
      patients with high-risk factors for recurrence who received 1 TACE adjuvant therapy were
      included in the control cohort. The primary endpoint of this study was disease-free survival,
      and the overall survival and adverse events were considered as the second endpoint.
    

Intervention name(s): PD-1 inhibitors; TACE
Intervention type(s): Drug; Procedure
Intervention description(s): For patients with PVTT, they received adjuvant therapy of PD1 (200mg intravenously every 3 weeks for a total of 18cycles) plus Lenvatinib (8mg orally once a day for 1 year) 2-4 weeks after surgery; for patients with other high-risk factors for recurrence, they PD-1(200mg intravenously every 3 weeks for a total of 9cycles) monotherapy 2-4 weeks after surgery.; Patients with high-risk factors for recurrence received 1 TACE about a month after surgery.
Other intervention name(s): Lenvatinib
Intervention MeSH terms: Lenvatinib; Immune Checkpoint Inhibitors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients had HCC and underwent radical liver resection (R0), postoperative pathology
        confirmed that they were associated with high-risk factors for recurrence. Depending on the
        type of recurrence factor, they were treated with appropriate postoperative adjuvant
        therapy. Patients who received PD-1-based adjuvant therapy or TACE adjuvant therapy were
        included in this prospective cohort study.
      
Biospecimen description: 
      Cancer tissues were collected after surgery. The genetic differences between the responding
      and non-responding lesions to PD-1-based adjuvant therapy were compared using transcriptomic
      and proteomic analyses.
    
Keywords: PD-1; Disease-free survival rate; adjuvant therapy; Lenvatinib
Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus
Condition: Hepatitis C Virus Infection, Response to Therapy of; Human Immunodeficiency Virus
MeSH terms: Hepatitis A; Virus Diseases; Hepatitis C; Acquired Immunodeficiency Syndrome; HIV Infections; Hepatitis; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human
      immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of
      400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular
      antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12
      weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
    

Detailed description: 
      To achieve the goal of elimination of hepatitis C in 2030 as set forward by the world health
      organization (WHO) a main group requiring treatment are subjects co-infected with HIV. These
      subjects offer a particular challenge as they are receiving ART which frequently interferes
      with hepatitis treatment. The number of pills they are already taking also limits the
      compliance of these patients.

      In order to evaluate the efficacy of a fixed-dose combination pill combined of 400 mg
      sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular ART medicine
      being used by the patient - a multi-center study of 200 co-infected patients has been
      designed.

      The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those
      with cirrhosis.

      The study is one of the pilots being run for hepatitis C elimination in Iran.
    

Intervention name(s): sofosbuvir and daclatasvir
Intervention type(s): Drug
Intervention description(s): Depending on the ART received by each patient one of the fixed-dose combination pills below will be used:
Daclatasvir 30 mg and sofosbuvir 400 mg
Daclatasvir 60 mg and sofosbuvir 400 mg
Daclatasvir 90 mg and sofosbuvir 400 mg
Other intervention name(s): Sovodak 30/400; Sovodak 60/400; Sovodak 90/400
Intervention MeSH terms: Sofosbuvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted
      with Avaira toric silicone hydrogel contact lenses over 1 week of wear.
    

Detailed description: 
      This is a 60-subject, single masked, bilateral, parallel study design comparing the fitting
      characteristics of enfilcon A toric lenses against the subjects habitual hydrogel toric
      lenses (omafilcon A, ocufilcon D or methafilcon B wearers). Subject's habitual toric lenses
      will be evaluated at the first visit and then re-fitted with a pair of Avaira toric lenses.
      After 1 week of daily wear, subjects will return for a second and final evaluation.
    

Intervention name(s): enfilcon A
Intervention type(s): Device
Intervention description(s): Silicone hydrogel toric lenses.
Other intervention name(s): enfilcon A/Silicone Hydrogel Lens
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Evaluation of Stool Microbiome Using HyGIeaCare Prep
Condition: Stool Microbiome
Study type: Interventional

Summary: 
      Stool samples will be collected before and during the HyGIeaCare procedure and the samples
      will be sent for microbiome evaluation.
    

Detailed description: 
      Patients will have the HyGIeaCare procedure as originally prescribed by their physician.
      Before and during the procedure stool samples will be collected and sent to a lab for
      microbiome evaluation.

      It is anticipated that stool samples collected from the HyGIeaCare prep will provide more
      microbiological and biochemical information on the gut interior than using traditional stool
      samples.
    

Intervention name(s): HyGIeaCare Prep
Intervention type(s): Other
Intervention description(s): Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents.
Other intervention name(s): Stool sample evaluation
Intervention model: Single Group Assignment
Intervention model description: Patients between 18 and 80 years old who do not have any known health issues and who have not taken antibiotics within the last two months.
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Investigate the Whole Body Distribution and Radiation Dosimetry of the Positron Emission Tomography Ligand Fluoride-18 (18F)-JNJ-64326067 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the whole-body distribution and radiation dosimetry
      of 18F-JNJ-64326067 in healthy participants.
    


Intervention name(s): 18F-JNJ-64326067
Intervention type(s): Drug
Intervention description(s): 18F-JNJ-64326067 will be administered intravenously between a dose of 185 Megabecquerel (MBq) to 370 MBq.
Intervention MeSH terms: JNJ-64326067
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
18850 - Human Photoallergy Test
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Photoallergic
Study type: Interventional

Summary: 
      To evaluate the potential of a test material to produce a photoallergic response.
    


Intervention name(s): Sunscreening Sport Spray Rest (BAY987519); Untreated skin
Intervention type(s): Drug; Other
Intervention description(s): 50 μl/ cm*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.(Formulation Number - RB# Y51-002 ); One site is patched without treatment as control
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Accumulative Effects of Talus Mobilization
Condition: Ankle Sprains; Ankle Fractures; Ankle Dislocations; Ankle Bruises; Achilles Tendon Rupture
MeSH terms: Rupture; Ankle Injuries; Ankle Fractures
Study type: Interventional

Summary: 
      The purpose of this study is to verify the effect of anteroposterior talus mobilization on
      range of motion, pain, and functional capacity in participants with sub-acute and chronic
      ankle injuries.
    

Detailed description: 
      The purpose of this study was to verify the acute effect (one session) and chronic (six
      sessions) and follow-up of the anteroposterior talus mobilization Maitland's grade III on
      range of motion, pain, and functional capacity in participants with sub-acute and chronic
      ankle injuries. Thirty eight volunteers subjects (male and female) participated of this study
      with minimum 18 and maximum 59 years old. The volunteers were allocated in two groups:
      experimental and control. The variables related to range of motion, pain and functional
      capacity were measured by biplane goniometer, Visual Analog Scale and Foot and Ankle Ability
      Measure respectively in four moments: 1- baseline; 2- after the first intervention; 3- after
      the sixth intervention (two weeks); 4- follow-up (one month). The experimental group received
      anteroposterior articular mobilization of the talus and the control group received manual
      contact.
    

Intervention name(s): joint mobilization; manual contact
Intervention type(s): Other; Other
Intervention description(s): The experimental group received joint mobilization (anteroposterior mobilization of the talus - Maitland grade III). During the mobilization cyclic movements were applied in an anteroposterior direction from the first tissue resistance barrier until the end of the accessory range of motion without any pain or discomfort. This mobilization maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.; The placebo group received only manual contact. This maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mobilization; Joint Range of Motion; Ankle; Manual Therapy
Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial
Condition: Degenerative Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      This study is to compare the clinical outcome between the biportal endoscopic decompression
      and the unilateral approach bilateral decompression in spinal stenosis
    


Intervention name(s): BESS; ULBD
Intervention type(s): Procedure; Procedure
Intervention description(s): Biportal endoscopic surgery; Unilateral laminotomy bilateral decompression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose
      and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total
      single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each
      dose is administered under fasted conditions. Safety and tolerability of these regimens will
      also be evaluated.
    

Detailed description: 
      This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose
      and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total
      single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each
      dose is administered under fasted conditions. Fifty-four healthy, non-smoking, non-obese,
      18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion
      to receive each of three fenofibric acid dosing regimens in sequence with a 7 day washout
      period between dosing periods. On the morning of the first day of each dosing period, after
      an overnight fast of at least 10 hours, subjects will receive single doses of fenofibric acid
      (1 x 35 mg tablet), fenofibric acid (3 x 35 mg tablets - 105 mg total dose), or fenofibric
      acid (1 x 105 mg tablet). Fasting will continue for 4 hours after dose administration. Blood
      samples will be drawn from all participants prior to dosing and for 72 hours post-dose, at
      times sufficient to adequately define fenofibric acid pharmacokinetics. Subjects will be
      monitored throughout their participation for adverse reactions to the study drug and/or
      procedures. Seated blood pressure and pulse will be measured prior to each dose and
      approximately 2 hours after each dose to coincide with peak plasma concentrations. All
      adverse experiences, whether elicited by query, spontaneously reported, or observed by clinic
      staff, will be documented in the subject's case report form.
    

Intervention name(s): Fenofibric Acid 35 mg Tablet; Fenofibric Acid 35 mg Tablet; Fenofibric Acid 105 mg Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 x 35 mg tablet administered after an overnight fast of at least 10 hours; 3 x 35 mg tablets administered after an overnight fast of at least 10 hours; 105 mg tablet administered after an overnight fast of at least 10 hours
Intervention MeSH terms: Fenofibric acid; Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy; pharmacokinetics; therapeutic equivalency; fenofibric acid
Cytokines Profile at the Beginning of Pregnancy
Condition: Correlation of Cytokines and Anthropometry in Pregnancy
Study type: Observational [Patient Registry]

Summary: 
      A mechanism by which obesity could influence the increase in obstetric complications as more
      weight is gained, apart from oxidative stress (3) would be the changes in the expression
      profile of T helper (Th) cells. Due to the increase rate of obesity among Mexican women, the
      aim was to determine if there is some association between the weight changes in pregnancy and
      the cytokines Interleukin (IL)-10, IL-4, Interferon gamma (IFN-γ) and Tumor Necrosis Factor
      alpha (TNF-α).
    

Detailed description: 
      Pregnant women older than 18 years old were invited to participate and all were asked to sign
      the informed consent. Women with congenital heart disease, disabling diseases, infectious
      diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost
      were discarded from the final analysis.

      Weight and height were measured using a calibrated using an adult scale (Seca, Hamburg,
      Germany). Blood Pressure (BP; mmHg) was checked by auscultation using a standard
      sphygmomanometer (Riester Big Ben® Square; Jangingen, Germany). All mothers received written
      nutritional guidance depending on the characteristics of each patient.

      The expression levels of IL-10, IL-4, IFN-γ and TNF-α was performed by the ELISA technique.

      Quantitative variables will be represented by measures of central tendency. Once the
      Kolmogorov test is performed for the normality of the variables, either the Student's T test
      or the Mann Whitney U test will be used to compare both groups. With the same criteria for
      normality either Pearson or Spearmen correlation will be used among the cytokines and
      anthropometric variables, considering a significant difference at p ≤ 0.05. The statistical
      analysis will be carried out in the Statistical Package for the Social Sciences (SPSS)
      program, version 19.
    

Intervention name(s): Pregnant women
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women older than 18 years old attender at the "Mónica Pretelini Sáenz"
        Maternal-Perinatal Hospital, located in Toluca City.

        For a population of 8500 pregnant women annually attended, and a margin of error of 11%,
        the sample should be of 79 people.
      
Keywords: IL-10; IL-4; IFN-γ; TNF-α; Pregnancy
Stress, EEG, ECG, and Chiropractic
Condition: Stress
Study type: Interventional

Summary: 
      The Life University Center for Chiropractic Research is conducting a study to better
      understand the relationship between subjective stress measures and brain patterns during
      resting state and an auditory oddball task. A secondary aim is to evaluate the impact of a
      single session of chiropractic care on the resting state and P300 time locked response after
      a one-week wait period. An additional outcome assessment for this study will be the recording
      of an electrocardiogram (ECG) of each participant that will be used to analyze their heart
      rate variability (HRV). Eligible individuals will receive a physical exam to ensure safety
      during all procedures. They will then sit for a 6-minute resting state EEG and an auditory
      oddball task. They will complete a series of questionnaires assessing stress. They will
      receive a chiropractic adjustment using a handheld instrument called an Activator. They will
      return one week later for a follow-up assessment consisting of the 6-minute resting state
      EEG, auditory oddball task, and the questionnaires assessing stress.
    


Intervention name(s): Chiropractic adjustment using an activator
Intervention type(s): Other
Intervention description(s): Chiropractic adjustment using an activator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: stress, chiropractic, EEG, HRV