bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a
Condition: Shigellosis
MeSH terms: Dysentery, Bacillary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, single-blind, randomized, placebo-controlled, single-center study in
      healthy subjects using a staggered approach to dosing.

      30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without
      adjuvant or placebo.
    

Detailed description: 
      A total of 30 subjects will be randomly assigned to one of 3 different arms in order to
      evaluate the safety, tolerability and immunogenicity of a candidate vaccine, formulated with
      or without adjuvant, and the outcome compared to a placebo control group.

      For each active treatment group, 12 subjects will be injected twice with 10 μg Flexyn2a
      candidate vaccine 4 weeks apart. A control group with 6 subjects will be injected following
      the same schedule with a placebo solution.
    

Intervention name(s): Flexyn2a; Placebo; Flexyn2a plus adjuvant
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular doses of 0.5 mL; Intramuscular doses of 0.5 mL; Intramuscular doses of 0.5 mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: bioconjugate vaccine; safety; immunogenicity; shigellosis
Study of Preoperative Docetaxel or Cisplatin (CDDP) + Docetaxel for C-stage IB-II Non-Small Cell Lung Cancer (NSCLC)
Condition: Pulmonary Neoplasms
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the preoperative
      docetaxel and docetaxel-cisplatin combination in c-stage IB/II NSCLC, and select the optimal
      preoperative therapy for phase III trials.
    

Detailed description: 
      Preoperative chemotherapy has substantial theoretical advantage. Several controlled trials
      are under way in early stage (clinical stage IB-II) nonsmall cell lung cancer (NSCLC). In
      each trial, platinum-based doublet chemotherapy is employed. Although platinum-based doublet
      is the treatment of choice for advanced NSCLC, risk/benefit balance might well be different
      in earlier stages. There have been no prospective randomized trials to choose an optimal
      preoperative chemotherapy in early stage NSCLC.

      Comparison: Preoperative cisplatin-docetaxel combination versus docetaxel monotherapy in
      clinical stage IB/II NSCLC.
    

Intervention name(s): Preoperative docetaxel-cisplatin combination chemotherapy; Preoperative docetaxel monotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Preoperative docetaxel-cisplatin combination chemotherapy; Preoperative docetaxel monotherapy
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pulmonary neoplasm; preoperative chemotherapy; cisplatin, docetaxel; randomized trial; clinical stage IB or II nonsmall cell lung cancer
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of XNW4107 Alone or in Combination With Imipenem/Cilastatin
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-part, first-in-human study to evaluate the safety, tolerability and
      pharmacokinetics of escalating doses of XNW4107 given as intravenous (IV) infusion in healthy
      male subjects. In part 1, subjects will receive a single dose of XNW4107. In part 2, subjects
      will receive XNW4107 for 7 days. In Part 3, subjects will receive XNW4107 in combination with
      imipenem/cilastatin for 14 days.
    


Intervention name(s): XNW4107
Intervention type(s): Drug
Intervention description(s): Single or multiple dose ascending study for XNW4107 alone or multiple dose study of XNW4107 in combination with imipenem/cilastatin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: XNW4107; Pharmacokinetics
Resistance Training in Patients With Parkinson's Disease.
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This is a controlled trial to assess the effects of resistance training on bradykinesia and
      physical function in patients with Parkinson's Disease. Forty patients diagnosed with
      Parkinson Disease stage 1 to 3 of the Hoehn and Yahr scale took part in the study and were
      allocated into 2 groups; Training Group performed a 9-week RT program twice a week while the
      Control Group attended lectures on the disease.
    


Intervention name(s): Resistance Training; Lectures on the disease
Intervention type(s): Other; Other
Intervention description(s): The TG performed the RT program using weight machines. Before the training period, participants underwent three weeks with eight familiarization sessions to ensure proper technique execution. The protocol aimed to workout major muscle groups and involved the following exercises: chest press, knee extension, hamstrings curl, leg press, and seated row. Training sessions lasted approximately 50-60 minutes with 2 sets of 10-12 repetitions until fatigue.; The control group attended an orientation program with lectures on health, quality of life and scientific update on disease.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to Nutrients
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to identify how certain parts of the brain that control appetite
      respond to changes in dietary carbohydrate and fat.
    

Detailed description: 
      To measure fMRI signal change in hypothalamic and brainstem centers associated with control
      of food intake and energy expenditure in response to IV glucose, fructose, and saline. The
      fMRI response to these nutrients will then be compared in obese vs. lean subjects. Frequently
      timed blood samples will be obtained for measurement of nutrients (i.e., glucose) and blood
      levels of other factors (i.e., insulin, ghrelin, lactate) during these infusion protocols,
      and to test associations between these levels and the fMRI response.
    

Intervention name(s): glucose; fructose; saline
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 0.3mg/kg of glucose; fructose IV bolus; IV saline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will receive infusions of glucose, fructose, and saline in a randomized order.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Obesity
Development of an Empowerment Intervention for Young Women Living With HIV
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will develop/adapt a culturally appropriate secondary prevention intervention for
      young, Human Immunodeficiency Virus (HIV)-positive women through intervention groups,
      evaluate its acceptability and feasibility, make appropriate modifications, and manualize the
      intervention in preparation for a full-scale randomized trial.

      Once the intervention is developed/adapted, the sites will pilot the interventions twice to
      enable modifications. The intervention aims to address the following concerns: 1) reducing
      the risk of young women infected with HIV transmitting the virus to their sexual partners,
      and 2) preventing young women infected with HIV from re-infection with a new viral strain or
      co-infection with another sexually transmitted disease (STD). Data will be collected to
      assess the feasibility and acceptability of the newly developed intervention using both
      quantitative and qualitative methods at each iteration.
    


Intervention name(s): Evolution: Young Women Taking Charge and Growing Stronger
Intervention type(s): Behavioral
Intervention description(s): The intervention aims to address the following concerns: 1) reducing the risk of young women infected with HIV transmitting the virus to their sexual partners, and 2) preventing young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease (STD).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Adolescent Trials Network
Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases
Condition: Gastric Diseases,; Gastric Ulcer,; Gastric Polyps,; Early Gastric Cancer,; Chronic Gastritis
MeSH terms: Gastritis; Stomach Ulcer; Stomach Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's
      approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy
      of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging
      results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse
      and focal diseases in stomach, we performed this single-blinded multi-center prospective
      study compared MCE with gastroscopy in patients with gastric symptoms and indication for
      upper GI Endoscopy.
    


Intervention name(s): MCE; Standard gastroscopy
Intervention type(s): Device; Device
Other intervention name(s): magnetic-controlled capsule endoscopy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Pharmacokinetics of Metformin Intolerance
Condition: Diabetes Mellitus, Type 2; Metformin Adverse Reaction
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Pharmacokinetic study of metformin intolerance
    

Detailed description: 
      This pharmacokinetic study recruited white European individuals with type 2 diabetes, who had
      previously been exposed to metformin and met the criteria for tolerance or intolerance.
      Intolerance was defined as previous exposure to metformin (maximum of 1000mg once daily for
      up to 8 weeks) but discontinued treatment with patient reported or documentation of
      gastrointestinal upset, leading to discontinuation (Criterion 1). Alternatively, intolerance
      was defined as inability to increase metformin dose above 500mg without experiencing
      gastrointestinal side-effects, despite having an HbA1c >53mmol/mol (Criterion 2). Tolerant
      individuals were defined as those taking 2000mg metformin daily in divided doses, with no
      side effects. Ten tolerant and ten intolerant individuals were recruited.

      Participants gave written consent. They attended the research centre fasted from midnight. A
      baseline blood test was taken before a single dose of oral metformin was administered at
      0900, with further bloods taken at 11 time points over the following 24 hours. A 24 hour
      urine collection was completed.

      Blood samples were analysed for plasma metformin, and serum lactate concentrations.
    

Intervention name(s): Metformin Hydrochloride
Intervention type(s): Drug
Intervention description(s): Single dose of 500mg oral metformin
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arms - metformin tolerant and metformin intolerant. All participants given single dose of metformin.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Metformin; Intolerance; Pharmacokinetics
Etude 3000 ARTHROSES Symptomatic Knee and Hip Osteoarthritis Prevalence Survey
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Observational

Summary: 
      Nationwide descriptive epidemiology survey aiming to determine lower limb OA prevalence,
      based on a validated method previously used to assess inflammatory rheumatism (rheumatoid
      arthritis and spondylarthropathy) prevalence in France.
    

Detailed description: 
      Osteoarthritis (OA) is a degenerative disease progressively affecting joint cartilage and
      subchondral bone, leading to pain, limited range of motion and functional impairment. Knee
      and hip are the more frequently affected joints. There is no treatment able to cure OA or at
      least to slow down cartilage damage. Thus, when symptomatic treatments become ineffective,
      joint prosthetic replacement is the unique solution.

      There is a substantial lack of information about osteoarthritis (OA) epidemiology in France,
      as well as in other European countries, which becomes more and more critical with population
      aging. The need for additional knowledge was outlined in the law about public health
      priorities in France, published on August 9th, 2004. In this document, a specific call is
      made for additional investigation on functional limitations, disability and quality of life
      modification of people affected by OA.

      Up to now, available information is mainly limited to short- or medium-term studies,
      conducted in clinic-based samples. Thus, based on demography and public health conclusions,
      implementing population-based epidemiologic studies is required in order to improve
      scientific knowledge with regards to :

        -  prevalence of symptomatic OA,

        -  its natural history over years and potential prognostic factors influencing the disease,

        -  its impact in terms of quality of life changes, disability, lack of autonomy and health
           resource use.

      Our expert group, which has a substantial experience in osteoarthritis, epidemiology and
      health service research, has developed a 2-part research program aiming to help answering to
      OA-related public health questions:

        -  Part 1: a nationwide descriptive epidemiology survey aiming to determine lower limb OA
           prevalence, based on a validated method previously used to assess inflammatory
           rheumatism (rheumatoid arthritis and spondylarthropathy) prevalence in France.

        -  Part 2: the constitution of a population-based cohort of OA patients, aiming to collect
           clinical, biologic and radiological data about OA natural history, predictors of
           structural progression, consequences on quality of life, function and health resource
           use.

      The present study is the part 1 of the program
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        population based
      
Keywords: Osteoarthritis; knee; hip; population based
The Health Benefits of Indoor Air Filtration Among Children
Condition: Protective Effect of Air Purifier on Children's Health
Study type: Interventional

Summary: 
      This study aims to explore the health benefits of air purifier on the impact of air
      pollutants on children's health.
    

Detailed description: 
      From April 2021 to November 2021, researchers conduct a randomized double-blind crossover
      trial on 110 healthy children in Jiaozuo City, Henan Province. The children are divided into
      two groups according to their classes and alternated the use of true or sham purifiers
      devices, including air purifiers and fresh air system. Air purifiers are installed in the
      classroom and bedrooms of the children. Fresh air system are installed in the classroom. A
      total of 6 epidemiological surveys are conducted on the subjects, with an interval of 60 days
      or more. All participants and research staffs were blinded to the group assignment. In
      addition, air pollutant exposure monitoring, questionnaire surveys, physical examinations,
      and biological sample collection are conducted on the research subjects each time. The
      biological samples are further tested for the concentration levels of related biomarkers such
      as the respiratory system, cardiovascular system, metabolic system, and nervous system.
      Furthermore, comprehensive evaluation of children's behavioral ability is also carried out.
    

Intervention name(s): Air Purifiers; Sham Air Purifiers
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Students are divided into two groups: intervention group and control group. The intervention team places an air purifier in the indoor environment to intervene. All the indoor environment of the group use the same qualified air purifier, and all participants and research staffs are blinded to the group assignment.; The control group is also intervened. The intervention is to place a sham air purifier (remove the filter screen) in the indoor environment, and all the indoor environment use the same air purifier as the intervention group. All participants and research staffs are blinded to the group assignment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Early Treatment for Acute ACL Tear
Condition: Anterior Cruciate Ligament (ACL) Tears
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is the first of its kind and will allow health care professionals and
      researchers to answer many questions about the reasons why anterior cruciate ligament (ACL)
      injury leads to knee pain and disability and osteoarthritis. We also hope that this study
      will be the beginning of new, more powerful and safer drugs to help patients with ACL
      injuries heal sooner and return to sports or daily activities pain free. Study participants
      will be recruited from the University of Kentucky and Vanderbilt University.

      The purpose of this research is to gather information on how safe and effective Kenalog® is
      in alleviating knee pain following ACL rupture.
    

Detailed description: 
      Injury to the knee during sports participation often involves partial of full detachment of
      the ACL. ACL tears cause pain, swelling and inflammation. While the swelling and inflammation
      usually goes away in time, individuals with ACL injuries may experience pain and notice knee
      instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the
      joint, allowing individuals the ability to walk or run again pain free or participate in
      sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can
      occur in that same knee 10-20 years later for reasons which are not well understood.

      In this research study, we hope to prevent and reduce the initial post-operative pain. The
      reduction of pain will allow for earlier movement of the knee joint and preparation for
      surgery. It may also reduce the risk to develop osteoarthritis in individuals with ACL
      injuries by treating them within 1-2 days after their injury.
    

Intervention name(s): Kenalog or placebo; Kenalog then Placebo; Kenalog; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Drug: Kenalog; Other Names:; triamcinolone acetonide injectable suspension; Drug Placebo (for Kenalog); physiologic Saline solution; Drug: Kenalog; Other Names:; triamcinolone acetonide injectable suspension; Drug Placebo (for Kenalog); physiologic saline solution; Drug: Kenalog; Other Names:; triamcinolone acetonide injectable suspension; Drug Placebo (for Kenalog); physiologic saline solution
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Pharmaceutical Solutions; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8558 Monotherapy in Anti-Retroviral-Naïve HIV-1 Infected Participants (MK-8558-002)
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      anti-retroviral activity of MK-8558 monotherapy in anti-retroviral-naïve human
      immunodeficiency virus type 1 (HIV-1) infected participants. The primary hypothesis is that
      at a dose that exhibits an acceptable safety and tolerability profile, MK-8558 has superior
      anti-retroviral activity compared to historical placebo data.
    


Intervention name(s): MK-8558
Intervention type(s): Drug
Intervention description(s): Single dose of MK-8558 administered as a tablet at a dose up to 1600 mg.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Irinotecan in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who
      have metastatic or recurrent colorectal cancer.
    

Detailed description: 
      OBJECTIVES: I. Confirm the greater than 20% response rate to irinotecan in patients with
      metastatic or recurrent colorectal cancer who have not receive prior chemotherapy for their
      advanced disease. II. Characterize pharmacokinetic parameters of irinotecan and its
      metabolite SN-38 and their relationship to response and toxic effect. III. Characterize tumor
      samples for topoisomerase I activity, proliferative fraction (ki67 expression), and p53
      expression and determine whether clinical response is related to these tumor characteristics
      in patient population. IV. Determine the in vitro inhibition of topoisomerase I activity by
      irinotecan, SN-38, and other camptothecin analogs and evaluate whether the degree of in vitro
      sensitivity to irinotecan and/or SN-38 is associated with clinical response in these
      patients. VII. Determine the frequency of somatic mutations following irinotecan and
      correlate this with pharmacologic parameters.

      OUTLINE: Patients receive irinotecan IV at a starting dose weekly for 4 weeks followed by 2
      weeks of rest. Treatment continues in the absence of disease progression or unacceptable
      toxicity. Tumor status is reassessed every 12 weeks during study. Patients attaining a
      complete response may receive additional courses of treatment. Patients are followed until
      death.

      PROJECTED ACCRUAL: A total of 54 patients will be accrued into this study at a rate of 25
      patients per year.
    

Intervention name(s): irinotecan hydrochloride
Intervention type(s): Drug
Intervention description(s): Irinotecan IV at a starting dose weekly for 4 weeks followed by 2 weeks of rest. Treatment continues in the absence of disease progression or unacceptable toxicity. Tumor status is reassessed every 12 weeks during study. Patients attaining a complete response may receive additional courses of treatment. Patients are followed until death.
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum