bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis
Condition: Non-alcholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK)
      activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1
      (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the
      development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some
      research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in
      SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of
      lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c.
      Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c
      pathway in liver.
    


Intervention name(s): Oltipraz 1 (90mg); Placebo; Oltipraz 2 (120mg)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Oltipraz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate if the blood levels of experimental medication
      BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects
      specific enzymes involved with the breakdown of BMS-986224.
    


Intervention name(s): Rifampin; BMS-986224
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reducing Depression-related Stigma and Increasing-treatment Seeking Among Black Adolescents
Condition: Depression; Racism
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purposes of this study are to:

        1. test among adolescent the utility of brief video-based interventions to reduce
           stigma-related attitudes and increase help-seeking intentions toward depression;

        2. examine the role of race (Black vs other) as an independent factor in the primary
           outcome.
    

Detailed description: 
      Intervention videos will each be of ~120-second duration and feature an underage female
      professional (age 16) acting as a simulated patient. All three videos will focus on her as an
      empowered presenter with depression sharing her personal story regarding depression and
      describe how social supports from family, friends, and community, as well as professional
      help assisted her in overcoming symptoms of the illness.

      Assessments will occur at baseline and post-intervention, and will include:

        1. Demographics (baseline only);

        2. Primary outcome: Depression-related stigma(Depression Stigma Scale [DSS]) summary score.

        3. Secondary outcomes: a. DSS individual items; b. Help-seeking (General Help-Seeking
           Questionnaire [GHSQ]) summary score and individual items; and bc Racial attitudes:
           feelings thermometers.

      The investigators intend to randomly assign ~1,000 individuals aged 14-18 as follows:

      Subjects oversampled for Black participants (50% Black; 50% other);

      Randomized, in equal proportions, and stratified by race, to view one of three ~120-second
      videos of a girl with:

        1. No depression control (Black; BC);

        2. Depression (Black, following same script as in our earlier study (Amsalem and Martin,
           2021), DB); and

        3. Depression adjusted (Black, with script adjusted based on input from focus group of
           Black girls and women; DBa).
    

Intervention name(s): Short videos
Intervention type(s): Behavioral
Intervention description(s): Intervention videos will each be of 90-second duration and feature two underage professionals (ages 16) acting as a simulated patient. All videos will focus on an empowered presenter with depression sharing her personal story regarding depression and describe how social supports from family, friends, and community, as well as professional help assisted her in overcoming symptoms of the illness. The actors will include a Black girl and a white girl.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure
      sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design
      ,a double blind randomized controlled clinical trial was conducted to compare the retention
      and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass ionomer
      sealant (FUJI). The study comprised of 120 government school children of 7-9 years age group.
      The glass-ionomer sealant and resin-based sealant were applied randomly on either side of the
      first mandibular permanent molars. They were recalled for assessment of sealant retention at
      intervals of 3, 6 and 12 months.
    


Intervention name(s): Application of the GIC based sealant; Resin based sealant
Intervention type(s): Other; Other
Intervention description(s): Application of the GIC based sealant was carried out according to the manufacturer's instructions.; Application of the resin based sealant on the occlusal surfaces was carried out as per the manufacturer s recommendations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and document appropriate clinical safety and
      performance of the Remon CHF Implantable Pressure Sensor including the corresponding delivery
      system, the Remon CHF Home Unit, the Remon CHF Clinic System devices and associated
      application software. It is a small clinical trial to determine the feasibility of the
      device. The primary outcome measure relates to feasibility and not to health outcomes.
    

Detailed description: 
      This study was a prospective feasibility, non-randomised, singlearm, multi-centre,
      interventional clinical investigation performed at 4 international sites. Patients were
      implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding
      delivering system. Measurements were taken with the Remon CHF Home Unit and the Remon CHF
      Clinic System. Follow-up visits took place at one, three and six months after implant.

      Per protocol, a minimum of 30 patients was required to demonstrate safety of the device.

      The study was conducted in accordance with ISO 14155:2003 (parts I and II), the Declaration
      of Helsinki and all applicable local and national regulations in the countries of submission.
    

Intervention name(s): Implant of Pressure sensor.
Intervention type(s): Device
Intervention description(s): Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Diet and Its Relationship With Couple Infertility
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      This case-control multicentric study involving fertile and infertile couples aims at
      evaluating the impact on conception rate of nutritional parameters (biologic, clinic,
      anthropometric, and food questionnaire).
    

Detailed description: 
      Infertility affects about 15% of couples. Many factors relating to lifestyle and environment
      are likely to influence fertility. As an adapted nutrition could prevent 30% of cancers, diet
      could be essential, but largely neglected, in the prevention of infertility.

      Some studies tried to explore the impact of diet on male or female fertility, but very few
      focused on both. The aim of our study is to assess the role of nutrition in both fertile and
      infertile couples, taking into account most of factors relating to lifestyle. Clinical,
      anthropometric (BMI, fat mass), biological markers (non specific - glycaemia, lipids,
      inflammation, electrolytes - and specific - vitamins E, A, C, D, B, including folates and
      MTHFR polymorphism) and semen analysis, will be combined with validated questionnaires
      (nutrition, drugs, alcohol, tobacco, physical activity, sleep and stress).

      The statistical analysis of correlations between nutritional and clinical data will provide
      information concerning the impact of nutrition on fertility.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Defined population after a screening in out-hospitalized patients in selected investigation
        sites
      
Biospecimen description: 
      Impact of genetic polymorphism on clinical and biological phenotypes linked to food behaviour
      in infertility context
    
Keywords: Infertility; Obesity; Dietary intake; Fertility; nutrition; diet; weight
Risk Factors for Post-Operative Respiratory Complications in Patients at Risk for OSA
Condition: Respiratory Complications
Study type: Observational

Summary: 
      This study investigates the incidence of postoperative respiratory complications (PRCs)
      including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery,
      and failure to wean from ventilator within 48 hours of surgery - in patients with and without
      risk factors for OSA undergoing elective, non-cardiac surgery (NCS).
    

Detailed description: 
      324 subjects will be enrolled into one of two groups: increased or not increased risk for
      OSA, n=162 patients per group. Preoperative assessments of OSA status, Mallampati score (an
      assessment for mouth and throat morphology), STOP-BANG test (assessment for risk of OSA), and
      medical history will be used to determine patient group assignment. All subjects will receive
      standard general anesthesia and monitoring as a part of standard of care whether or not
      she/he will participate in the study, including ECG, arterial pressure, SpO2, BIS, Blood
      pressure (BP), heart rate (HR), and respiratory rate (RR), all of which will be continuously
      recorded and data will be saved for every three minutes during induction using standard
      monitors. Standard monitoring assessments in PACU will be used, and patients with increased
      perioperative risk for OSA will be closely monitored for hypoxemia and other complications.
      The Nellcor Pulse Oximetry Sensor will be applied in PACU and continuously monitor the
      patient's oxygen saturation and respiratory rate for the first 48 hours postoperatively. At
      the end of the 48 hours, the device will be removed, and the de-identified data will be
      transferred to a computer with analysis software and examined for patterns in respiratory
      distress in both patient groups. Data collected from the Nellcor Bedside Respiratory Patient
      Monitoring System on pulse and oxygen saturation, as well as data on clinically significant
      events, such as PRCs, acute respiratory failure, tracheal reintubation, hypoxemia, CHF, MI,
      A-fib, and delirium will be analyzed to understand the effects of OSA on postoperative
      recovery
    

Intervention name(s): Pulse Oximetry
Intervention type(s): Device
Intervention description(s): Use of pulse oximetry device for 48 hours after surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients at Ohio State University Wexner Medical Center, aged between 18-75 years,
        with an American Society of Anesthesiologists (ASA) physical status of I (normal healthy
        patient), II (patients with mild systemic disease; no functional limitation) or III
        (patient with severe systemic disease; definite functional impairment - with relatively
        stable disease, but requiring therapy) who are scheduled to undergo elective surgeries
        under sevoflurane general anesthesia as a standard of care.
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus
      placebo during induction therapy in participants with moderately to severely active CD.
    


Intervention name(s): placebo for risankizumab IV; risankizumab SC; risankizumab IV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): placebo for risankizumab administered as intravenous (IV) infusion.; risankizumab administered by subcutaneous (SC) injection; risankizumab administered as intravenous (IV) infusion.
Other intervention name(s): ABBV-066 BI 655066; SKYRIZI; ABBV-066 BI 655066; SKYRIZI
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ABBV-066; BI 655066
Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women
Condition: HIV Infections
MeSH terms: HIV Infections; HIV Seropositivity
Study type: Observational

Summary: 
      This study is a Multicentre cohort study with inclusion throughout the full duration of the
      study.

      The primary objective is the study of human papillomavirus related genital pathology in HIV
      positive women.

      The secondary objective are:

        1. To study the characteristics of HPV infection and related disease in the context of long
           term HAART and HIV infection ;

        2. To study the characteristics of atypical cells of uncertain significance detected in Pap
           smears, whose prevalence has dramatically increased in the last years;

        3. To describe cervical cancers observed in the cohort

        4. To study the evolution of recurrent high-grade lesions after surgery

        5. To describe the evolution of vaginal lesions developed after hysterectomy for high-grade
           lesions ;

        6. To describe the specific aspects of surgery for the treatment of cervical lesions
           according to the specific localization in the endocervix in HIV-positive women ;

        7. To study the in situ T cell HPV specific response in cervical lesions and the
           relationship between virological and clinical parameters, host immune status and natural
           history of lesions ;

        8. To initiate a prospective study on anal HPV infection and related disease among women
           infected with HIV.

        9. To initiate a study on therapeutic and/or prophylactic HPV vaccines in the context of
           immunosuppression and a high rate of HPV infection ;
    

Detailed description: 
      Data were be collected into evaluate:

        -  Analysis of prognostic factors (CD4, antiviral therapy) of cervical lesions, using Cox
           models.

        -  Estimation of rates of Incidence of high grade lesions, of recurrence after surgical
           treatments using Kaplan Meier tests.

        -  Logistic regression analysis for the study of factors associated with complete excision
           after surgical treatment.

        -  SIR (standardised incidence rate) evaluation for cervical cancer

      Study procedures are Annual follow-up in case of normal Pap smear, biannual follow-up in case
      of cervical lesions. Surgical management of High grade lesions.
    

Intervention name(s): surgical management of high grade lesions
Intervention type(s): Procedure
Intervention description(s): Clinical, pathological and biological, data at diagnosis and during follow-up will be collected.
Surgical sample will be collected to study human papillomavirus related genital pathology.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Keywords: human papillomavirus; follow up
Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure
Condition: Anemia
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic
      Renal Failure.
    

Detailed description: 
      Despite impressive advances in the safety of the blood supply, the search for therapeutic
      alternatives to blood continues. Recombinant Human Erythropoietin (rHu-EPO), along with iron,
      vitamin B12, and folic acid, has been recommended as a specific medication that should be
      used instead of blood transfusion if the clinical condition of the patient permits sufficient
      time for these agents to promote erythropoiesis.

      In normal physiological conditions Erythropoietin is produced in the kidney and stimulates
      the division and differentiation of committed erythroid progenitors in the bone marrow.
      rHu-EPO is a glycoprotein which stimulates red blood cell production. Epoetin alfa, a 165
      amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological
      effects as endogenous rHu-EPO.
    

Intervention name(s): Recombinant Human Erythropoietin alpha
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anemia
Diagnostic Accuracy By Providers Study
Condition: Vaginitis
MeSH terms: Vaginitis
Study type: Observational

Summary: 
      The validation study is intended to provide comparative data on the diagnosis of vaginal
      infections as performed in primary care settings versus the diagnosis provided through
      standard diagnostic testing performed in a reference laboratory. The clinician and lab
      diagnoses will be compared to those obtained using the BD MAX Vaginal Panel on the BD MAX
      System.
    

Detailed description: 
      The primary goals of this study are to:

        1. Compare the level of agreement of clinician diagnosed bacterial vaginosis (BV) to
           vaginal swab samples evaluated for BV using Nugent's criteria and the BD MAX Vaginal
           Panel

        2. Compare the level of agreement of clinician diagnosed trichomonas vaginalis (TV) to the
           laboratory diagnosis of TV identified by quantitative PCR using the GeneXpert system by
           Cepheid and the BD MAX Vaginal Panel.

        3. Compare the level of agreement of clinician diagnosed yeast vaginitis to laboratory
           diagnosis of yeast identified with culture and the BD MAX Vaginal Panel.

      The secondary goals of this study include:

        1. Being able to describe the patterns of testing among clinicians in community practices
           providing routine care for women presenting with symptoms of vaginitis.

        2. Describe the treatments prescribed for women presenting with vaginitis and how these
           prescribed treatments are distributed in women with laboratory-confirmed diagnoses.
    

Intervention name(s): BDMax Vaginal Panel
Intervention type(s): Diagnostic Test
Intervention description(s): The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions
Other intervention name(s): Gram Stain/Nuget Criteria; yeast culture; Trichomonas vaginalis NAAT
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women presenting to primary care offices with symptoms of vaginitis
Comparison Between NCRT and NCT Followed by MIE for Treatment of Locally Advanced Resectable ESCC
Condition: Esophageal Squamous Cell Carcinoma Stage cT3-4aN0-1M0
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy versus
      neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients with
      locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).
    

Detailed description: 
      It is a prospective randomized phase III clinical trial sponsored by Shanghai Zhongshan
      Hospital with other eight hospitals in China participating in. 264 patients with locally
      advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0) are recruited and
      randomly assigned into the neoadjuvant chemoradiotherapy group (NCRT group) and the
      neoadjuvant chemotherapy group (NCT group) according to the proportion of 1:1.The
      safety,efficacy of protocols and prognosis of patients are compared between the two regimens.
    

Intervention name(s): Neoadjuvant Chemoradiotherapy; Neoadjuvant Chemotherapy; Minimally Invasive Esophagectomy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Before surgery, patients in this group receive neoadjuvant chemoradiotherapy. A total dose of 40 Gy is delivered in 20 fractions (5 fractions per week) for 4 weeks. Chemotherapy is delivered concomitantly and composed of four cycles of paclitaxel 50mg per square meter of body-surface area and cisplatin 25mg per square meter of body-surface area weekly at the intervals of radiotherapy. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.; Before surgery, patients in this group receive neoadjuvant chemotherapy. Chemotherapy is delivered and composed of two cycles of paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 4 weeks. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.; After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy
Other intervention name(s): Preoperative Chemoradiotherapy; Preoperative Chemotherapy; MIE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoadjuvant Chemoradiotherapy; Neoadjuvant Chemotherapy; Minimally Invasive Esophagectomy; Esophageal Squamous Cell Carcinoma（cT3-4aN0-1M0）