bioihbjkbjnl/mcl2 huggingface dataset:
Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer
Condition: Locally Advanced Lung Cancer; Metastatic Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB-A317 in
      combination with standard platinum-based chemotherapy in participants with advanced NSCLC or
      SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort,
      squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Participants with a mixed
      adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on
      the predominant histopathological profile. (e.g., participants with adenocarcinoma component
      accounting for > 50% will be allocated to non-squamous NSCLC cohort.). Participants with
      squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by
      the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as
      Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A
      dose-expansion stage and Cohort B dose-expansion Stage.
    


Intervention name(s): Tislelizumab; Paclitaxel; Gemcitabine; Etoposide; Pemetrexed; Cisplatin; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered 200 mg intravenously (IV) as specified in the treatment arm; Administered 175 mg/m² IV as specified in the treatment arm; Administered 1250 mg/m² IV as specified in the treatment arm; Administered 100 mg/m2 IV as specified in the treatment arm; Administered 500 mg/m² IV as specified in the treatment arm; Administered 75 mg/m²/day IV as specified in the treatment arm; Administered AUC 5 as specified in the treatment arm
Other intervention name(s): BGB-A317
Intervention MeSH terms: Paclitaxel; Etoposide; Carboplatin; Gemcitabine; Pemetrexed; Tislelizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the pharmacokinetics (PK) of 3 different
      modified-release formulations of lersivirine and compare it to the PK of the
      immediate-release tablet. The effect of food on the PK of one of the modified-release tablets
      will also be assess along with the safety and tolerability of each treatment.
    


Intervention name(s): Lersivirine Immediate-Release (fasted); Lersivirine Modified-Release #1 (fasted); Lersivirine Modified-Release #2 (fasted); Lersivirine Modified-Release #3 (fasted); Lersivirine Modified-Release (fed)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg); Single 500 mg dose of Lersivirine Modified-Release Tablet #1; Single 500 mg dose of Lersivirine Modified-Release Tablet #2; Single 500 mg dose of Lersivirine Modified-Release Tablet #3; Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; Pharmacokinetics; Lersivirine; Modified-release
Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults
Condition: Prevention of Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety,
      tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza
      vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers
    

Detailed description: 
      1. Assessment of Safety

        2. Assessment of Immunogenicity

        3. Estimated Enrollment: 100
    

Intervention name(s): NBP607; Agrippal
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose, 0.5ml, Intramuscular (IM) injection; 1 dose, 0.5ml, Intramuscular (IM) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is
      more effective than placebo as a treatment for type 2 diabetic subjects who are not
      sufficiently controlled with diet and exercise
    

Detailed description: 
      All subjects will participate in a lead-in period, and qualifying subjects will continue into
      a short-term randomized treatment period. Subjects who complete the short-term period will be
      eligible to enter the long term extension period. Also, subjects in the short-term period who
      have an elevated blood sugar that requires additional medication for blood sugar control will
      be eligible to enter the long-term treatment extension period where they will receive
      metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c
      (A1C) > 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible
      to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label
      saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the
      long-term treatment extension period.Saxagliptin dose titration was not permitted.
    

Intervention name(s): Saxagliptin; Saxagliptin; Saxagliptin; Placebo matching Saxagliptin; Metformin; Placebo matching Metformin; Saxagliptin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT]); Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Tablets, Oral, 500 mg, daily (42 months LT); Tablets, Oral, 0 mg, daily (42 months LT); Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label; Tablets, Oral, 500-2000 mg (as needed for rescue)
Other intervention name(s): BMS-477118; BMS-477118; BMS-477118; BMS-477118
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Utilizing Patient-Reported and Radiographic Outcomes and Evaluating the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of
      lorecivivint injected intra-articularly (IA) into the target knee (most painful) joint of
      moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg
      lorecivivint per 2 mL injection. This study will utilize radiographs and patient reported
      outcomes (PROs) to evaluate the safety and efficacy of lorecivivint.
    


Intervention name(s): Lorecivivint; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Healthcare professional-administered intra-articular injection; performed on Day 1; Healthcare professional-administered intra-articular injection; performed on Day 1
Other intervention name(s): SM04690
Intervention MeSH terms: Lorecivivint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SM04690; Wnt pathway inhibitor; osteoarthritis; Samumed; lorecivivint
The Role of the Omentum in the Treatment of Morbid Obesity
Condition: Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this research is to determine some of the reasons that blood sugar and insulin
      levels improve after bariatric surgery but before weight loss begins, as well as why people
      respond differently to weight loss surgery. It will also examine whether removing the fat
      around the stomach and large intestine (the omentum) will improve weight loss. Finally, it
      will see why there are differences between Whites and African Americans who have weight loss
      surgery.
    

Detailed description: 
      The purpose of this research is to tease out the mechanisms related to changes in insulin
      sensitivity, metabolism, hormones, and body composition following bariatric surgery. Because
      preliminary data indicate differing responses to this surgery, both Caucasian and African
      American adults, scheduled for RYGB, are being recruited to participate. It is believed that
      the omentum contributes to hepatic insulin resistance, both because of the increased delivery
      of NEFAs via the portal vein, and the increased production of cytokines. Because of this, it
      is postulated that removing the omentum as part of bariatric surgery will speed up the
      reversal of insulin resistance and diminish racial differences in response to the surgery.

      Data are derived from tissue and blood samples obtained operatively (from individuals having
      bariatric surgery and other abdominal operations), as well as during
      hyperinsulinemic-euglycemic clamps, from indirect calorimetry, DEXA, Health-related Quality
      of Life surveys, and 24-hour urine samples. There were 66 participants randomized to
      omentectomy/no omentectomy. A post hoc data power analysis determined that this number of
      subjects is sufficient for data analysis.
    

Intervention name(s): omentectomy
Intervention type(s): Procedure
Intervention description(s): RYGB with omentectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Metabolic Signatures and Biomarkers in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      We plan to use a metabolomics lipid platform to map biochemical signatures in unmedicated
      schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug
      aripiprazole and compare that to lipid perturbations induced by risperidone. These drugs have
      inherently different risk for metabolic adverse effects and patients respond to them
      differently. Metabolic signatures for the drugs capture significant biochemical information
      that could explain part of the basis for varied drug response within individuals and will
      highlight pathways implicated in drug action and in disease pathogenesis possibly enabling
      new drug design strategies. In addition, we will compare patients to healthy controls at
      baseline in regard lipid profiles.
    

Detailed description: 
      Schizophrenia (SCH) is a devastating mental disease that affects the human population
      worldwide with an incidence of about 1%. Most individuals with this illness benefit from
      long-term pharmacotherapy, however, the therapeutic effects of antipsychotic treatment are
      inconsistent, incomplete, and often countered by significant side-effects associated with
      long-term physical morbidity (e.g., tardive dyskinesia, obesity, hyperglycemia,
      hyperlipidemia. Metabolomics is a powerful new technology that provides a snap shot of
      biochemical pathways at a particular point in time. It has been earmarked as an important
      area to develop under the NIH roadmap initiative. We plan to use this platform to map
      biochemical signatures in unmedicated schizophrenic patients prior to and 4 weeks post
      treatment with the antipsychotic drug aripiprazole and compare that to lipid perturbations
      induced by risperidone. These drugs have inherently different risk for metabolic adverse
      effects and patients respond to them differently. Metabolic signatures for the drugs capture
      significant biochemical information that could explain part of the basis for varied drug
      response within individuals and will highlight pathways implicated in drug action and in
      disease pathogenesis possibly enabling new drug design strategies.In addition, we will
      compare patients to healthy controls at baseline in regard lipid profiles, to assess whether
      lipid profiles differ between unmedicated schizophrenia patients and healthy controls.
    

Intervention name(s): Aripiprazole; Risperidone; Healthy volunteers
Intervention type(s): Drug; Drug; Other
Intervention description(s): Aripiprazole for 4 weeks; Subjects will be randomized to risperidone for 4 weeks; Healthy volunteers
Other intervention name(s): Abilify; Risperdal
Intervention MeSH terms: Risperidone; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Metabolomics
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the antitumor activity, toxicity, and effectiveness of the combination of
      goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with
      hormone receptor positive metastatic carcinoma of the breast.
    

Detailed description: 
      Pre-menopausal women with estrogen and/or progesterone receptor positive, metastatic or
      recurrent breast cancer were enrolled and treated with goserelin (Zoladex) monthly and began
      anastrozole (Arimidex) daily for 21 days following the first injection of goserelin.
      Participants continued on treatment until disease progression or unacceptable toxicity.
    

Intervention name(s): Anastrozole (Arimidex); Goserelin (Zoladex)
Intervention type(s): Drug; Drug
Intervention description(s): Anastrozole is a prescription hormonal treatment that helps fight breast cancer by lowering the amount of estrogen in the body. It is a non-steroidal aromatase inhibitor, which significantly lowers serum estradiol (estrogen) concentrations, without interfering with the formation of adrenal corticosteroids or aldosterone; Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women
Other intervention name(s): Arimidex; Zoladex
Intervention MeSH terms: Anastrozole; Goserelin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Sipjeondaebo-tang on Korean Patients With Cold Hypersensitivity in the Hands and Feet (SDT)
Condition: Cold Hypersensitivity
MeSH terms: Cryopyrin-Associated Periodic Syndromes; Hypersensitivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Gachon University, Gil Oriental Medicine Center
    


Intervention name(s): Sipjeondaebo-tang Granule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.; 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Other intervention name(s): Deciten Granule
Intervention MeSH terms: Juzentaihoto
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cold Hypersensitivity; Korean medicine; Sipjeondaebo-tang; Cold intolerance
Observation of Blood Orphanin and Norepinephrine Levels in Diabetic Patients Under Subarachnoid Anesthesia
Condition: Intraspinal Anesthesia
Study type: Observational

Summary: 
      This study aims to investigate the Influence of Intraspinal anesthesia to the concentrations
      of blood orphanin, norepinephrine in patients with diabetes mellitus. We hope to explain the
      relationship between sensory and sympathetic nerves in diabetic patients undergoing
      intraspinal anesthesia.
    


Intervention name(s): ELISA
Intervention type(s): Diagnostic Test
Intervention description(s): Detection of blood orphanin and norepinephrine in patients
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic
Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil
Condition: Gastrointestinal Problems
Study type: Interventional

Summary: 
      This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness,
      stool patterns and growth of two cow's milk-based beverages for children.
    


Intervention name(s): Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
Intervention type(s): Other
Intervention description(s): Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
The First-In-Man Pilot Study of Firehawk
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of
      Microport for the first time to assess the preliminary safety and feasibility used in the
      human body. And provide evidence for subsequent large-scale, multi-center, randomized
      controlled clinical trials, then provide the basis for the formal application of the product
      in China.
    


Intervention name(s): Rapamycin target-eluting Coronary Stent System
Intervention type(s): Device
Intervention description(s): Implantation of the rapamycin-eluting coronary stent system
Other intervention name(s): Firehawk
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sirolimus eluting stents; percutaneous coronary intervention; First in man
Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) and Influenza Treatment System With Machine Learning
Condition: COVID-19; Post-COVID-19 Syndrome; Influenza
MeSH terms: COVID-19; Influenza, Human; Post-Acute COVID-19 Syndrome
Study type: Observational [Patient Registry]

Summary: 
      This is an open-tabled, one-arm observatory trial to assess the effectiveness and safety of
      the Autonomous Treatment System Based on Machine Learning in patients with Covid-19,
      Post-Acute Sequelae of SARS-CoV-2 infection and influenza.
    

Detailed description: 
      This study has enrolled 27 patients diagnosed with Covid-19, Post-Acute Sequelae of
      SARS-CoV-2 infection, and influenza. Of these patients, 26 are outpatients, and 1 is
      hospitalized. After screening based on the inclusion and exclusion criteria, eligible
      patients will receive prescriptions recommended by the Autonomous Treatment System Based on
      Machine Learning in this observational trial.

      The objectives of this study are:

        1. To compare the classifications made by our machine learning system with those by
           physicians to assess the model's reliability and accuracy;

        2. To evaluate Covid-19-related hospitalizations or deaths from any cause through day 28;

        3. To determine if the machine learning system's recommended prescription alleviates
           symptoms of Covid-19, Post-Acute Sequelae of SARS-CoV-2 infection, and influenza;

        4. To monitor participants who tested positive for the Covid-19 for 28 days after
           initiating treatment, looking for potential rebound cases.

      Participants will use an online application to receive the recommended prescription results
      and will forward these results to a physician for verification. Patients are instructed to
      complete the online analysis every 3 days or whenever their symptoms change, whichever comes
      first. They are also asked to adhere to the prescribed medication regimen. Research
      physicians will conduct follow-ups with patients every 3 days via phone calls. The potential
      treatments patients may receive include any of the following Traditional Chinese Medicine
      formulas: LizCovidCure-1, LizCovidCure-2, LizCovidCure-3, LizCovidCure-4, and LizCovid-5.
    

Intervention name(s): Autonomous Treatment System for Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection and Influenza Based on Machine Learning
Intervention type(s): Other
Intervention description(s): A novel treatment recommendation system for Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection and Influenza, which is based on machine learning
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with active SARS-Cov-2 infection within 30 days patients with Post-Acute Sequelae
        of SARS-CoV-2 infection and patients with influenza.
A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease
Condition: Graves' Disease
MeSH terms: Graves Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      An open label study to evaluate the safety and efficacy of CFZ533 following 12 weeks
      treatment in patients with Graves' disease
    


Intervention name(s): CFZ533
Intervention type(s): Drug
Intervention description(s): CFZ533 intravenously over approximately one hour
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Graves' disease; Hyperthyroidism; CFZ533; TSH
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of
      multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and
      elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI
      425809 given in the morning and in the evening.
    


Intervention name(s): BI 425809; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; Tablets
Intervention MeSH terms: BI 425809
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment