bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of Astaxanthin in Healthy Participants
Condition: Healthy
Study type: Interventional

Summary: 
      Astaxanthin is recognized as a bioactive compound with potential benefits for human health.
      This study aims to evaluate a specific nutritional supplement impact on markers of oxidative
      stress, inflammation, lipid levels, blood flow, visual skin markers, measures of longevity,
      mood and skin condition.
    

Detailed description: 
      A healthy diet is characterized by a high intake of various bioactive compounds usually found
      in natural, organic, and fresh foodstuffs. Among these bioactive compounds, astaxanthin, a
      red carotenoid pigment especially found in seafood, has been recognized in the scientific
      literature as a potential nutraceutical due to its antioxidant, anti-inflammatory, and
      neurotrophic properties. Previous studies have demonstrated reduced markers of oxidative
      stress and inflammation and improved blood rheology. Additionally, astaxanthin help maintain
      healthy skin.

      This randomized, double-blind, placebo-controlled study will evaluate the impact of
      Astaxanthin supplemented for 12 weeks, on oxidative stress, inflammation, lipid levels, blood
      flow, skin hydration, visual skin markers, measures of longevity, mood states and facial skin
      satisfaction in healthy female adult participants.
    

Intervention name(s): Astaxanthin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 8 mg Astaxanthin per capsule, taken once a day with meal; Modified food starch
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization at 1:1 ratio for active or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Inflammation; Antioxidant Effect; C-Reactive Protein; Skin; Oxidative Stress; Cholesterol; Aging
Examining the Effectiveness of the Nicotine Patch in Male and Female Smokers - 2
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Treatment studies have demonstrated that current smoking cessation techniques are less
      effective for women. The purpose of this study is to determine the role that gender plays on
      the effectiveness of nicotine replacement therapy. This may lead to improved cessation
      interventions for all smokers, particularly women.
    

Detailed description: 
      Currently, about 70 percent of smokers who try to quit by using smoking cessation treatments
      are unsuccessful. Treatment studies have demonstrated that current smoking cessation
      techniques are less effective for women. There is no clear explanation for this difference,
      but it may involve a differential response to nicotine replacement treatments (NRTs) and/or
      smoking-related stimuli. For women, NRT may be less effective at suppressing withdrawal or
      blunting the effects of smoking during a quit attempt. Women may also be more sensitive to
      smoking-related stimuli, such as the taste, sight, and smell of smoke. Tailoring treatment to
      the separate needs of subgroups, such as men and women, may produce better outcomes. The
      purpose of this study is to assess the influence of gender on the effectiveness of
      transdermal nicotine treatment in a group of male and female smokers.

      Participants in this double-blind, dose-comparison study will complete separate sessions in a
      random order.

      Each session will last approximately 6.5 hours and will correspond to a specific transdermal
      patch dose (0, 7, 14, or 21 mg). Objectively verified cigarette abstinence will be required
      before each session. Sessions will occur at least 48 hours apart to avoid carryover.
      Cognitive, behavioral, subjective, and physiological measures will occur during study visits.
      Specifically, the NRT dose response to tobacco suppression and cigarette blunting effects
      will be compared in women and men.
    

Intervention name(s): nicotine transdermal system
Intervention type(s): Drug
Intervention MeSH terms: Nicotine
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: tobacco
A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to assess the effect of multiple doses of BMS-663068 on the
      exposure of methadone in subjects on a stable dose of methadone, and the exposure of
      buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and
      norbuprenorphine.
    


Intervention name(s): BMS-663068; Methadone; Buprenorphine and Norbuprenorphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BMS-663068; Methadone; Buprenorphine and Norbuprenorphine
Intervention MeSH terms: Fostemsavir; Buprenorphine; Methadone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
Condition: Menorrhagia Due to Benign Causes
MeSH terms: Menorrhagia
Study type: Interventional

Summary: 
      This is a multi-center, single-arm, non-randomized, prospective clinical study. The clinical
      study is designed as a non-inferiority study to assess the effectiveness of the Aurora
      Endometrial Ablation System compared to an objective standard. Safety will be evaluated by
      determining the number and percentage of subjects who experience one or more of serious
      adverse events.
    


Intervention name(s): Aurora Endometrial Ablation System
Intervention type(s): Device
Intervention description(s): Ablation of the endometrial lining of the uterus using the Aurora System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menorrhagia; Excessive uterine bleeding; Endometrial Ablation
Chronic Alcohol and Brain Stress Circuit Response
Condition: Stress; Alcoholism
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      Alcoholism is among the top three causes of preventable death and disease in the US (Mokdad
      et al., 2004; Room et al., 2005). Stress plays an important role in the development of
      alcoholism and in high vulnerability to alcohol relapse. This study will provide a greater
      understanding of the mechanism by which stress and alcohol consumption interacts to influence
      development of compulsive alcohol seeking and vulnerability to stress-induced drinking, and
      the results will have significant implications for the development of new prevention and
      treatment interventions for alcoholism.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        social drinkers
      
Keywords: social drinkers
Take Off Pounds After Stroke Trial (TOPS)
Condition: Stroke; Obesity; Overweight; Hemiparesis
MeSH terms: Stroke; Paresis; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      The Take Off Pounds after Stroke (TOPS) trial is a Prospective Randomized Open-Label Blinded
      Endpoint (PROBE) study that will test a 12-week high protein, calorie restricted, partial
      meal replacement program, compared to enhanced standard care, for efficacy in achieving
      clinically significant weight loss without impairment of physical function patients with
      elevated body mass index (BMI) following a recent ischemic stroke.
    

Detailed description: 
      The TOPS trial is designed as a PROBE study to test the feasibility, safety, and efficacy of
      a 12-week high protein, calorie restricted, partial meal replacement program, compared to
      enhanced standard care, in achieving clinically significant weight loss without impairment of
      physical function when initiated within 90 days following ischemic stroke in patients with
      BMI 27-to-49.9 kg/m2.

      Participants will be randomized in a 1-1 ratio to the partial meal replacement program (diet
      intervention) or enhanced standard care (control) with randomization stratified by
      recruitment center (BIDMC, Yale) and baseline diet consistency status (Modified Consistency
      Diet vs Regular Consistency Diet). Baseline diet consistency status was selected as a
      stratification factor because it is expected that patients with difficulty swallowing
      (dysphagia) after stroke that results in need for modifications to food/liquids will have a
      different weight loss trajectory than patients who are able to safely consume a regular diet.
      The follow-up duration will be 12 weeks for all subjects.
    

Intervention name(s): Partial meal replacement program; Dietary Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Four meals consist of meal replacements made by OPTAVIA, such as shakes, soups, bars, biscuits, hot drinks, and puddings. Meal replacements will be provided to subjects without charge. For two other daily meals, subjects or their caregivers will be taught how to prepare meals consisting of 5-7 ounces (cooked) of a low-fat protein, 3 servings of non-starchy vegetables, and up to 2 servings of healthy fats.; Participants will receive one 45-minute counseling session on a healthy diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
Condition: Kidney Cancer
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of
      tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the
      tumor. It is not yet known whether interferon alfa-2b is more effective with or without
      bevacizumab in treating advanced renal cell carcinoma (kidney cancer).

      PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to
      see how well they work compared to interferon alfa-2b alone in treating patients with
      advanced renal cell carcinoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the overall survival of patients with advanced renal cell carcinoma treated with
           interferon alfa-2b alone or interferon alfa-2b with bevacizumab.

      Secondary

        -  Compare the time to disease progression and objective response rates in patients treated
           with these regimens.

        -  Determine the toxicity of interferon alfa-2b in combination with bevacizumab in these
           patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
      nephrectomy (yes vs no) and number of risk factors for disease progression (0 vs 1-2 vs 3 or
      more). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive interferon alfa-2b subcutaneously (SC) three times a week.

        -  Arm II: Patients receive interferon alfa-2b as in arm I and bevacizumab IV over 30-90
           minutes on days 1 and 15.

      In both arms, courses repeat every 28 days in the absence of disease progression or
      unacceptable toxicity.

      Patients are followed every 3 months for 2 years and then annually for up to 10 years after
      study entry.

      PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this
      study within 3 years.
    

Intervention name(s): bevacizumab; recombinant interferon alfa
Intervention type(s): Biological; Biological
Intervention description(s): 10mg/kg IV infusion on Days 1 & 15 of each cycle; 9 million units subQ injection 3 x/week for 4 weeks
Intervention MeSH terms: Interferons; Interferon-alpha; Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV renal cell cancer; clear cell renal cell carcinoma; recurrent renal cell cancer
Therapeutic Efficacy of Ramosetron for Treatment of Established PONV After Laparoscopic Surgery
Condition: Abdominal Mass
Study type: Interventional

Summary: 
      Patients who had at least two risk factors of PONV (Postoperative nausea and vomiting) and
      underwent laparoscopic surgeries under general anesthesia were assessed for eligibility.
      Patients who developed PONV within the first 2 hours after anesthesia received intravenously,
      in a randomized double-blind manner, ondansetron 4 mg or ramosetron 0.3 mg. Patients were
      then observed for 24 hours after drug administration. The incidence of nausea and vomiting,
      severity of nausea, requirements for rescue antiemetic and adverse effects at 0-2 and 2-24
      hours after drug administration were evaluated. The primary endpoint was the rate of patients
      exhibiting complete response, defined as no emesis and no further rescue antiemetic
      medication for 24 hours after drug administration.
    


Intervention name(s): Ondansetron; Ramosetron
Intervention type(s): Drug; Drug
Intervention description(s): Ondansetron also has been reported as effective prophylactic and therapeutic 5-HT3 receptor antagonist for the treatment of PONV. Ramosetron has been shown to have a very strong effect for preventing PONV in previous meta-analyses, but in recent report, its clinical significance may be questioned to request for additional study.; Ramosetron is a newly developed selective 5-HT3 (5 hydroxytryptamine 3) receptor antagonist with longer duration of action up to 48hours and higher receptor affinity, than its previously developed congeners, including ondansetron.
Intervention MeSH terms: Ondansetron; Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Protein Kinase 2 (HIPK2) Polymorphisms on rs2058265, rs6464214, and rs7456421
Condition: Kidney Stone
MeSH terms: Kidney Calculi
Study type: Interventional

Summary: 
      In the present study investigators aimed to investigate whether homeodomain interacting
      protein kinase 2 (HIPK2) polymorphism is associated with renal stone formation in Turkish
      population or not.

      One hundred and twenty nine participants with calcium nephrolithiasis and 67 sex and
      age-matched healthy controls were enrolled in this study. For analysis of HIPK2 polymorphism,
      the real-time PCR amplification was performed in a final volume of 20μL reaction mixture,
      including 10 ng of genomic DNA, 5 µL of TaqMan® Universal PCR Master Mix, and 0.5 µL of 40X
      TaqMan® assay. The Rotor-Gene Q Series Software Version Q 2.3.1 (Rotor-Gene Q Series, Ziagen)
      was used for allelic discrimination. Chi square test was utilized to compare the differences
      of the genotype and allele frequencies between patients and controls.
    

Detailed description: 
      Kidney stone incidence depends on geographical, climatic, ethnic, dietary and genetic
      factors. Thus the prevalence rates for urinary stones change from 1% to 20%. 1,2 Genetic
      polymorphism also causes nephrolithiasis. The most known polymorphic genes are the
      calcium-sensing receptor (CASR), vitamin D receptor (VDR), and matrix gla protein (MGP),
      plasminogen activator, urokinase (PLAU). 3,4 Furthermore, the concordance rate of the stone
      disease in monozygotic twins is substantially higher than in dizygotic ones (32.4% vs. 17.3%)
      demonstrating that genetic factors play a vital role in the formation of nephrolithiasis. 5
      Homeodomain interacting protein kinase 2 (HIPK2) has been shown to be a new androgen receptor
      regulator. HIPK2 and androgen were demonstrated to mediate kidney tubular epithelial cell
      injury and apoptosis.

      Informations on HIPK2 polymorphism about renal stone formation are newfound and inconclusive.
      Therefore, in this study, authors aimed to investigate whether HIPK2 polymorphism is
      associated with renal stone formation in Turkish population or not.
    

Intervention name(s): Genetic analysis
Intervention type(s): Genetic
Intervention description(s): he real-time PCR amplification was performed in a final volume of 20μL reaction mixture, including 10 ng of genomic DNA, 5 µL of TaqMan® Universal PCR Master Mix, and 0.5 µL of 40X TaqMan® assay. Thermal cycling conditions were as follows: initial denaturation at 94℃ for 3 min, 40 cycles of 94℃ for 15 s, and 60°C for 1 min. The Rotor-Gene Q Series Software Version Q 2.3.1 (Rotor-Gene Q Series, Ziagen) was used for allelic discrimination.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: KSD HIPK2 gene Polymorphism
Accommodative Relief for Uncomfortable Non-Presbyopes
Condition: Asthenopia
MeSH terms: Asthenopia
Study type: Interventional

Summary: 
      This study will determine how multifocal contact lens correction affects symptoms of
      discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age
      range (ages 30-40 years).
    

Detailed description: 
      The purpose of this study is to determine how multifocal contact lenses affect contact lens
      comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have
      symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will
      wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and
      a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will
      wear the single vision lens first, and half of the subjects will wear the multifocal lens
      first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess
      their vision and comfort which each lens, and ocular surface and accommodative/binocular
      vision status will be evaluated at the initial dispense and after wearing each lens for two
      weeks.
    

Intervention name(s): Multifocal Contact Lens; Single Vision Contact Lens
Intervention type(s): Device; Device
Intervention description(s): The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks; The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Contact Lens; Multifocal; Accommodation; Presbyopia
A Study of SHP655 (rADAMTS13) in Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      SHP655 is a medicine used to treat sickle cell disease (SCD). The main aim of the study is to
      measure the safety and tolerability of SHP655 in SCD participants.

      Study participants will receive SHP655 or placebo on Day 1. Their SCD will be treated by
      their doctor according to their doctor's usual clinical practice.

      During the study, participants will be asked to follow-up on 13 days following SHP655 or
      placebo administration for safety assessment. Maximum duration of participation is expected
      to be about 2 months
    


Intervention name(s): SHP655; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive SHP655 as a single IV infusion at one of the 3 dose levels of 40 IU/kg, 80 IU/kg, or 160 IU/kg.; Participants will receive placebo matched to SHP655 of the 3 dose levels of 40 IU/kg, 80 IU/kg, and 160 IU/kg as single IV infusion.
Other intervention name(s): recombinant ADAMTS13
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Quality of Vision After Bifocal and Extended Depth of Focus Intraocular Lens Implantation
Condition: Intraocular Lens
Study type: Observational

Summary: 
      To compare the visual performance of the extended depth of focus (EDOF) intraocular lens
      (IOL) to bifocal and spherical monofocal IOL
    

Detailed description: 
      This study was conducted from 2018 to 2020. This study included patients who were with
      presence of cataract in both eyes, age between 50 and 80 years, and corrected distance visual
      acuity (CDVA) of both eyes under 20/40. Phacoemulsification cataract surgery was arranged for
      both eyes for all patients. The study groups of IOL models include EDOF Symfony IOL (AMO,
      Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal
      Sensar AR40e IOL (AMO, Santa Ana, CA, USA). The patients were routinely examined
      preoperatively as well as 1 month after surgery for far and near visual acuity (in LogMAR
      unit). Contrast sensitivity, wavefront aberration and quality of vision questionnaire was
      measured at the 1-month postoperative visit. These aforementioned outcomes were recorded and
      compared between groups.
    

Intervention name(s): Clear corneal phacoemulsification and IOL implantation
Intervention type(s): Procedure
Intervention description(s): Clear corneal phacoemulsification and IOL implantation were performed by 2 surgeons (Chao-Kai Chang and Hung-Yuan Lin) by using an identical technique to minimize differences in surgically induced aberrations between groups. The surgical process involved topical anesthesia, a 3-step clear corneal incision (2.75 mm) at 180° (temporal in both eyes), a 5.0-mm continuous curvilinear capsulorhexis, phacoemulsification using the stop-and-chop technique, IOL implantation with an injector, IOL centration, and a sutureless incision. The study IOL models include EDOF Symfony IOL (AMO, Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal Sensar AR40e IOL (AMO, Santa Ana, CA, USA).
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study was conducted from 2018 to 2020 in the Taipei Nobel Eye Clinic and Universal Eye
        Center ophthalmology clinic. The research protocol was explained to all prospective
        participants, after which they provided written informed consent before participating. The
        study was approved by the Ethics Committee of Chunghua Christian Hospital, and the protocol
        accorded with the tenets of the Declaration of Helsinki.
GrafixCORE®: Open-Label Study to Evaluate the Safety and Efficacy of GrafixCORE® for Complex Diabetic Foot Wounds
Condition: Complex Diabetic Foot Wounds
MeSH terms: Diabetic Foot; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      A multicenter, open-label, single-arm study to evaluate the safety and efficacy of
      GrafixCORE® for the treatment of complex diabetic foot wounds with exposed tendon and/or
      bone.
    


Intervention name(s): Grafix®
Intervention type(s): Other
Intervention description(s): The treatment indication is for complex diabetic foot wounds with exposed tendon and/or bone that can accommodate up to three 5cm x 5cm pieces of Grafix®.
Patients will be treated for up to 16 weeks.
Patients will be evaluated at screening and then weekly throughout the study or until wound closure.
Other intervention name(s): Tissue; Allograft Tissue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Complex Wound; Diabetic Foot Ulcer; DFU; GrafixCORE; Exposed tendon; Exposed bone; Allograft tissue