bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Rapeseed and Sunflower Oils on Proteomic Biomarkers of Diseases.
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study will test the impact of vegetable oils with contrasting fatty acids composition on
      biomarkers of health (cardiovascular, kidney diseases and diabetes) after twelve weeks
      supplementation. We will use sunflower oil (high in PUFAs), rapeseed oil (high in MUFAs,
      locally produced) and a non-intervention control. We have developed a sensitive and selective
      urinary proteomic biomarker of cardiovascular disease which we will use in a double-blinded
      randomised study.
    

Detailed description: 
      The intervention follows a parallel double-blind randomised control design. The intervention
      duration is 12 weeks, with a mid-point assessment at 6 weeks. Randomisation to groups;
      rapeseed oil, sunflower oil or habitual diet is performed using a block stratified allocation
      based on age (under or over 45) and BMI (under or over 30kg/m2) and is carried out remotely
      via phone.

      Participants allocated to either oil groups are instructed to consume the oils uncooked, as a
      partial replacement to their habitual fat intake. Participants in the control group are asked
      to not change any aspect of their diet.

      Spot urine samples are collected from all participants at all time points for measurement of
      the primary outcome (proteomic biomarker score). Urine is collected in a plastic tube,
      mid-flow, as the second urination of the day at baseline, 6 and 12 weeks.

      Fasting venous blood is collected for the assessment of secondary outcomes, at baseline, 6
      weeks and 12 weeks. Participants are also asked to complete a 2-day food diary at weeks 0, 6
      and 12
    

Intervention name(s): Rapeseed oil; Sunflower oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 20mL of rapeseed oil to be consumed daily in replacement to habitual oil; 20mL of sunflower oil to be consumed daily in replacement to habitual oil
Other intervention name(s): RO; SO
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blind, placebo-controlled trial
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: rapeseed oil; sunflower oil; proteomics; cardiometabolic; cardiovascular; fatty acids; monounsaturated fatty acids; seed oils; dietary fat
Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus
Condition: Keratoconus; Keratoconus Posterior
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      Our purpose is to analyze the changes induced in the posterior corneal surface in patients
      implanted with intracorneal ring segments for treatment of keratoconus. Patients are assessed
      with corneal imaging device preoperatively and at 1, 3, 6 and 12 months postoperatively.
    

Detailed description: 
      Procedure: Femtosecond laser assisted implantation of intracorneal ring segments in
      keratoconus patients Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA),
      refraction, keratometric (K) readings of the anterior and posterior surface, corneal
      asphericity (Q value) of the anterior and posterior surface, and anterior and posterior
      elevations are evaluated using a corneal imaging device preoperatively and at 1, 3, 6 and 12
      months after surgery.
    

Intervention name(s): Intracorneal ring segment implantation
Intervention type(s): Procedure
Intervention description(s): Surgical procedure for keratoconus treatment. A tunnel is created in the corneal stroma with femtosecond laser and ring segments are implanted in the corneal stroma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: keratoconus; intracorneal ring segments; posterior corneal surface
Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Helicobacter Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-center, randomized, open-label phase Ic/IIb clinical study to evaluate the
      efficacy and safety of TNP-2198 capsules, rabeprazole sodium enteric-coated tablets and
      amoxicillin capsules combined with multiple doses of rabeprazole sodium enteric-coated
      tablets and amoxicillin capsules compared with multiple doses of rabeprazole sodium
      enteric-coated tablets and amoxicillin capsules combined with multiple doses in Helicobacter
      pylori infection-positive population.
    


Intervention name(s): TNP-2198; Rabeprazole Sodium; Amoxicillin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Group A, TNP-2198 capsules 400mg(4 capsules),BID, 14days Group B, TNP-2198 capsules 600mg(6 capsules),BID, 14days Group C , TNP-2198 capsules 600mg(6 capsules),TID, 14days Group D, TNP-2198 capsules 600mg(6 capsules),TID, 7days; Group A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days; Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days
Other intervention name(s): Rifasutenizol
Intervention MeSH terms: Amoxicillin; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Malaria Active Epidemiology and Treatment Study
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      An observational cohort and malaria treatment study in Cambodia.
    

Detailed description: 
      This is an active observational Cohort Study of malaria epidemiology with a nested two arm,
      randomized, open label Treatment Study comparing the efficacy, safety, tolerability and
      pharmacokinetics of a two versus three day course of Dihydroartemisinin-Piperaquine (DP) for
      those developing uncomplicated malaria. At the conclusion of the Cohort Study, a subset of
      volunteers with documented exposure to Plasmodium vivax during the study will be treated with
      primaquine as presumptive anti-relapse therapy directed against the exoerythrocytic malaria
      stages of P. vivax, and followed passively for an additional 6 months.
    

Intervention name(s): Dihydroartemisinin piperaquine
Intervention type(s): Drug
Intervention description(s): 40/320 mg tablets, 9 tablets total
Other intervention name(s): Artekin, Duo-cotexcin
Intervention MeSH terms: Piperaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plasmodium falciparum, Plasmodium vivax
Staphylococcus Aureus Nasal Carriage
Condition: Nasal Carriage of Staphylococcus Aureus
MeSH terms: Staphylococcal Infections
Study type: Observational

Summary: 
      The repeated exposition to S. aureus is considered as a determining factor of acquisition of
      the nasal colonization. The healthcare professionals are regularly in touch with this
      pathogenic bacterium. Prevalence of the nasal carriage of S. aureus in this population was
      the object of several studies but little took into account the respect for the rules of good
      hygienic practice. The results of our previous study carried out during the international
      congress of staphylococci (ISSSI, Lyon in August 26-30th, 2012) showed an association between
      the work in a hospital environment and the increase of the risk of nasal carriage. On the
      contrary, the use of the hydro-alcoholic solutions had a protective effect against this
      carriage. However, sized of the health care population of our study was limited.

      The goal of this study is to confirm our previous results on a larger cohort of healthcare
      professionals. The main objective is to estimate the prevalence of nasal carriage according
      to the professional category and by taking into account the degree of conformity with good
      hygiene practices including the use of hydro-alcoholic solutions.
    


Intervention name(s): nasal swabs will be collected
Intervention type(s): Other
Intervention description(s): After formal consent, nasal swabs are collected for each participant. SA nasal carriage and its susceptibility to methicillin is determined using a rapid PCR technique (GenExpert, Cepheid). Each participant is asked to complete a short questionnaire regarding some demographic variables, smoking habits, long-term medication, sector of activity, and direct manipulation of the pathogen.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Employees of a teaching hospital in Lyon-France
      
Keywords: nasal carriage; Staphylococcus aureus; good hygiene practices
Red Clover and Lifestyle Changes to Contrast Menopausal Symptoms in Premenopausal Breast Cancer Patients Given Tamoxifen
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A prospective double-blind randomized trial of red clover extract (Promensil) vs placebo in
      surgically-treated premenopausal women with estrogen receptor-positive breast cancer taking
      tamoxifen
    

Detailed description: 
      Premenopausal women with ER-positive breast cancer treated by surgery and receiving
      postoperative tamoxifen with or without LHRH analogues, who may have received pre or
      postoperative chemotherapy, or immunotherapy (for HER2-positive disease), are recruited to a
      double-blind randomized clinical trial, to receive either a dry extract of red clover
      (Promensil) as one tablet/day orally containing 80 mg isoflavones (treatment group), or one
      oral tablet/day without active principle (placebo group) for 24 months. All patients receive
      a diet-lifestyle intervention involving meetings with a dietician (physician) scheduled once
      a month for the first 6 months, and every 3 months thereafter. The dietician encourages
      patients to adhere to a macronutrient-balanced, low glycaemic load Mediterranean-type diet
      with personalized recommendations to increase intakes of unrefined cereals, pulses,
      vegetables, unrefined vegetable fats (e.g. olive oil, nuts, oil-containing seeds), and fish,
      and reduce intake of high-glycaemic-index foods and saturated animal fats. Patients are also
      encouraged to undertake regular physical activity. Outcomes are Menopausal Rating Score
      (MRS), body mass index (BMI), waist and hip girth, insulin resistance, and levels of
      cholesterol, triglycerides, and sex hormones.

      The safety of the red clover preparation is assessed by pelvic ultrasound and mammograms for
      endometrial thickness and breast density, and by evaluation of the effects of the serum from
      treated and placebo patients on ER-positive BC cell lines.
    

Intervention name(s): Promensil; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet (80 mg) /day of MCE-11 (Promensil) taken orally for 24 months; Placebo tablet (80 mg) (without active principle) given once a day for 24 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, double-blind clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function
Condition: Hepatic Insufficiency; Healthy Subjects
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being
      conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib
      following administration of a single oral dose in subjects with varying degrees of hepatic
      impairment compared to healthy matched control subjects with normal hepatic function(matched
      by age, weight, and sex).
    


Intervention name(s): Jaktinib Hydrochloride Tablets
Intervention type(s): Drug
Intervention description(s): A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.
Other intervention name(s): Jaktinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Insulin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety and tolerability of AZD1656 after multiple
      repeated oral doses in patients with type 2 diabetes on top of insulin.
    


Intervention name(s): AZD1656; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days.; Dosing to match AZD1656
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 2 diabetes
The USGI Medical ESSENTIAL Study for Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This is a multicenter, randomized, evaluator and subject blinded, parallel-group, controlled
      study intended to evaluate the safety and efficacy of treating obese patients with the
      placement of g-Cath EZ suture anchors followed by a structured diet and exercise plan as
      compared to a sham procedure followed by the same diet and exercise plan. Subjects will be
      randomly assigned in a 2:1 ratio to the treatment procedure followed by diet and exercise or
      the sham procedure followed by diet and exercise. After un-blinding at 12 months
      post-treatment, sham patients can choose to have the treatment procedure as well.
    


Intervention name(s): placement of g-Cath EZ suture anchors; Sham procedure; Diet and Exercise
Intervention type(s): Device; Procedure; Behavioral
Intervention description(s): A structured diet and exercise plan
Other intervention name(s): g-Cath EZ™ Suture Anchor Delivery Catheter (USGI Medical)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Body Weight Loss
Switch to Ticagrelor in Critical Limb Ischemia Anti-platelet Study
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb
      loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a
      major cause of death and disability (secondary to myocardial infarction, stroke and
      amputation). The mortality in patients with CLI approaches 13-25% and 50% at one and five
      years respectively. High on-treatment platelet reactivity (HPR) in patients treated with
      aspirin and clopidogrel is associated with increased risk of recurrent cardiovascular events
      after percutaneous coronary interventions and coronary syndromes. Preliminary studies suggest
      that the prevalence of HPR in patients with critical limb ischemia treated with aspirin and
      clopidogrel is as high a 78.5%. In patients with coronary artery disease ticagrelor overcomes
      non-responsiveness to clopidogrel. However, the antiplatelet effect of ticagrelor in patients
      with critical limb ischemia is unknown.
    

Detailed description: 
      Study Aim: This pilot study aims to investigate platelet function after switching from
      clopidogrel to ticagrelor in patients with critical limb ischemia.

      Fifty patients with diagnosis of CLI (Rutherford class IV-VI) treated with clopidogrel 75 mg
      and aspirin 81 mg daily will be tested for inhibition of platelet aggregation using the
      VerifyNow P2Y12 and VASP assays before and 6±1 hours after their daily clopidogrel dose. All
      patients will then be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks
      and the VerifyNow and Vasodilator-Stimulated Phosphoprotein (VASP) platelet reactivity assays
      repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose. For
      exploratory analysis, patients will be divided in two groups based on the P2Y12 reaction
      units (PRU): Group 1. High on treatment platelet reactivity on clopidogrel (HPR), defined as
      P2Y12 reaction units (PRU) ≥208 and Group 2. Appropriate platelet inhibition on clopidogrel
      (API), defined as P2Y12 reaction units (PRU) <208. If subjects are withdrawn from the study
      prior to completion due to the high co-morbidity rate of this population, additional subjects
      will be enrolled to reach a total of 50 completed subjects for data analysis.
    

Intervention name(s): Ticagrelor
Intervention type(s): Drug
Intervention description(s): All patients will be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and VASP platelet reactivity assays repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose.
Other intervention name(s): Brilinta
Intervention MeSH terms: Ticagrelor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Critical Limb Ischemia, ticagrelor, Brilinta
The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multinational, multicenter, randomized, double-blind, parallel-group,
      placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and
      tolerability of two doses of oral administration of laquinimod in participants with RRMS. The
      study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months)
      and Period 2, the active treatment period (24 months).
    


Intervention name(s): Laquinimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Laquinimod will be administered as per the dose and schedule specified in the respective arms.; Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Demand-driven Management of Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of tremor control using various strategies for
      implementing demand-driven thalamic deep brain stimulation (DBS) for essential tremor.
      Therapeutic stimulation at the Vim nucleus of the thalamus will be initiated and modulated
      using signals derived from external sensors (e.g. EMG, accelerometer) and cortical or
      thalamic electrodes.
    

Detailed description: 
      Essential tremor is effectively treated with deep brain stimulation of the ventralis
      intermedius nucleus of the thalamus, presumably because high-frequency stimulation disrupts
      aberrant cerebellar-thalamic input. For the most part, patients with essential tremor have a
      kinetic tremor that is present or worsened with movement. However, DBS therapy is currently
      continuous, and thus, stimulation occurs when the patient will not benefit symptomatically
      from treatment. This exposes the patient to unnecessary stimulation, which can lead to
      unnecessary usage of battery, unnecessary exposure to stimulation side-effects, and can
      possibly contribute to tolerance to DBS therapy.

      One possible solution is selective stimulation when movement is required. This study will
      determine signals predictive of motor activity using external sensors such as EMG, and
      cortical biomarkers of real and imaginary movement that are well-characterized.

      The primary aim is to demonstrate successful initiation and modulation of DBS therapy using
      the Activa PC+S system and implanted cortical or thalamic electrodes. Putative improvements
      in battery usage related to stimulation on-time and definition of coupling signals between
      thalamus and cortex that characterize tremor state are secondary outcomes.
    

Intervention name(s): Activa PC+S
Intervention type(s): Device
Intervention description(s): Implementation of closed loop DBS for essential tremor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Essential tremor; closed-loop DBS
Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin,
      5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with
      saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted
      and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin
      in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and
      metformin, 1000-mg XR tablets administered together in both the fasted and fed states.
    


Intervention name(s): Saxagliptin/metformin fixed-dose combination (FDC); Saxagliptin; Metformin extended-release (XR); Saxagliptin/Metformin FDC; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day; Tablet, oral, 5 mg, once on Day 1 only, 1 day; Tablet, oral, 500 mg, once on Day 1 only, 1 day; Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day; Tablet, oral, 1000 mg, once on Day 1 only, 1 day
Other intervention name(s): Onglyza/Glucophage extended release (XR); Onglyza; Glifage XR; Onglyza/Glucophage XR; Glifage XR
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)