bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo
Condition: Axial Spondyloarthrithis; Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients receive study drug for one year (Part A). If, after the initial run-in phase, a
      sustained remission is reached they will be randomly split into one of three dose groups for
      another year (Part B). The maintenance of the sustained remission will be analyzed.
    


Intervention name(s): Certolizumab Pegol; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Active substance: Certolizumab Pegol
Pharmaceutical form: Prefilled syringe
Concentration: 200 mg / ml
Route of Administration: Subcutaneous injection; Active substance: Placebo
Pharmaceutical form: Prefilled syringe
Concentration: 0.9 % Saline
Route of Administration: Subcutaneous injection
Other intervention name(s): Cimzia; CDP870
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Axial Spondyloarthritis; axSpA; Ankylosing Spondylitis; Anti TNF-alpha; Certolizumab Pegol; Remission; Spondylarthropathies; Arthritis; Spinal Diseases; Immunosuppressive Agents
Pentoxifylline and Endometriosis
Condition: Endometriosis-Associated Infertility
MeSH terms: Infertility; Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To prove efficacy of an immunomodulator called pentoxifylline in the treatment of
      endometriosis in infertile patients undergoing laparoscopy surgery
    


Intervention name(s): pentoxifylline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 800 mg daily for six months
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: endometriosis; immunomodulation; infertility; laparoscopic surgery; pentoxifylline
Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease
Condition: Chorea, Huntington
MeSH terms: Huntington Disease; Chorea
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the
      efficacy, safety, and tolerability of valbenazine to treat chorea in participants with
      Huntington disease.
    


Intervention name(s): Valbenazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): vesicular monoamine transporter 2 (VMAT2) inhibitor; non-active dosage form
Other intervention name(s): NBI-98854
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Huntington's; Huntington; Chorea; Movement disorder; Valbenazine; HD; Tetrabenazine; VMAT2-Inhibitor
Preoperative Hyperthermia in Major Abdominal Surgery Patients
Condition: Colon Cancer
MeSH terms: Hyperthermia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators hypothesize that preoperative hyperthermia improves postoperative
      complications and compare a placebo group with standard thermoregulatory management
      (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core
      temperature) in a randomized, single blinded, controlled trial.
    

Detailed description: 
      The investigators hypothesize that preoperative hyperthermia improves postoperative
      complications and compare a placebo group with standard thermoregulatory management
      (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core
      temperature) in a randomized, single blinded, controlled trial.
    

Intervention name(s): Normothermia; Hyperthermia
Intervention type(s): Procedure; Procedure
Intervention description(s): Warming without increase in core temperature; Core hyperthermia (39 °C) for 2,5 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Melphalan and Whole-Body Hyperthermia in Treating Patients With Advanced Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma; Hyperthermia
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. Hyperthermia therapy kills tumor cells by heating them to several
      degrees above body temperature. Combining hyperthermia with chemotherapy may kill more tumor
      cells.

      PURPOSE: Phase II trial to study the effectiveness of melphalan and whole-body hyperthermia
      in treating patients with advanced melanoma.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the combination of 41.8 degrees Celsius whole body hyperthermia (WBH)
      and melphalan (L-PAM) in patients with advanced melanoma. II. Assess the efficacy of this
      combination of therapy. III. Assess the clinical toxicity of WBH and L-PAM in these patients.
      IV. Obtain pilot data on the effect of WBH and L-PAM on cytokine induction in these patients.

      OUTLINE: The combination of whole body hyperthermia (WBH) and melphalan (L-PAM) is
      administered on week 1. The infusion of L-PAM is administered at a constant rate over
      approximately 10 minutes, beginning 20 minutes after achieving target temperature of 41.8
      degrees Celsius by esophageal or axillary temperature probe. WBH is continued for an
      additional 40 minutes for a total of 60 minutes. On week 5 or 6, patients receive another
      combination of WBH and L-PAM. Disease status is reevaluated at least every 2 courses.
      Patients without progressive disease continue therapy of WBH and L-PAM every 4 weeks for a
      maximum of 6 courses.

      PROJECTED ACCRUAL: Approximately 34 patients will be accrued for this study.
    

Intervention name(s): melphalan; hyperthermia treatment
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Melphalan
Primary purpose: Treatment
Keywords: stage III melanoma; stage IV melanoma; recurrent melanoma
A Study to Evaluate the Effects of ABX-1431 on Patients With Tourette Syndrome
Condition: Tourette Syndrome; Chronic Motor Tic Disorder
MeSH terms: Tourette Syndrome; Tic Disorders; Tics; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate the effects and the safety of a single-dose of ABX-1431 HCl on
      tics and other symptoms of Tourette Syndrome.

      During part 1 (periods 1 and 2) each patient will receive study drug once and placebo once.

      Patients who complete part 1 with adequate clinical safety will be offered the option to
      participate in part 2 (periods 3 and 4) and again willl receive study drug once and placebo
      once where, in contrast to part 1, administration will take place with a standard high fat
      meal.
    

Detailed description: 
      This is a single dose, double-blind, randomized, placebo-controlled, cross-over study. This
      study will assess the single dose effects of ABX-1431 HCl on tics and other symptoms of
      Tourette Syndrome.

      All patients will undergo a screening visit for enrollment criteria. Eligible patients will
      be treated with a single dose of ABX-1431 HCl or placebo followed by efficacy, safety and
      pharmacokinetics assessments. After a washout period of 1-3 weeks, patients will undergo
      identical procedures with the other treatment.

      Only patients who complete the first part of the study with adequate clinical safety will be
      offered the option to participate in an additional two period crossover, where ABX-1431 HCl
      or placebo is taken with a standard high fat meal. Again, efficacy, safety and
      pharmacokinetics assessments will be done. After a washout period of 1-3 weeks, patients will
      undergo identical procedures with the other treatment.

      This study will enroll 20 patients with a diagnosis of Tourette Syndrome OR chronic motor tic
      disorder.
    

Intervention name(s): ABX-1431; Placebo Comparator; ABX-1431
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ABX-1431, capsules, 40 mg in the fasting state; Matching Placebo; ABX-1431, capsules, 20 mg with a high fat meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor
Condition: Borderline Ovarian Tumors
MeSH terms: Ovarian Neoplasms
Study type: Observational

Summary: 
      Retrospective and prospective multi-center study

      Indication: Fertility-sparing surgery for patients with borderline ovarian tumor and
      fertility

      Objectives:

        -  Description of the characteristics of the patients of less than 45 years having a
           fertility-sparing surgery for borderline ovarian tumors, the modalities of care and
           their fertility.

        -  Validation of a nomogram as an information medium to the patients concerned on their
           chance of alive birth according to their personal characteristics

      Origin and nature of the specific data:

        -  Extraction from the database " Tumeurs Malignes Rares de l'Ovaire " (TMRO)

        -  Collection of retrospective further informations in the participating centers

        -  Data collection from the patients (questionnaires) The data will be identified by the
           TMRO number allocated to every participant of the TMRO study .

      Data traffic :

      TMRO database extraction for the patients with BOT and corresponding to the inclusion
      criteria, supplied by Arcagy-Gineco.

      The database will be managed by the coordination team in an anonymous way by means of the
      patient identifiers of the TMRO base.

      Enrichment of the base by the anonymous questionnaires filled by the patients and the
      complementary data transmissions of the centers on anonymised files.
    


Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Fertility-sparing surgery for patients with borderline ovarian tumor and fertility.
      
Keywords: Borderline Ovarian Tumor (BOT); Fertility-sparing surgery; Gynecology; Oncology
A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy
Condition: Glomerulonephritis, Membranous
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranous
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, open label, experimental medicine study to evaluate the efficacy, safety
      and mechanism of action of belimumab in subjects with antiphospholipase A2 receptor (PLA2R)
      autoantibody positive idiopathic membranous glomerulonephropathy (IMGN), and to profile the
      relationship between biomarkers, autoantibody status and clinical response. 10 milligrams per
      kilogram (mg/kg) belimumab intravenous (IV) will be administered at weeks 0, 2, and then
      every 4 weeks, over a 24-week treatment period in subjects with anti-PLA2R antibody positive
      IMGN followed by a further long term treatment period until subjects reach remission of
      proteinuria, up to a maximum of 2 years total treatment. All subjects will receive background
      supportive therapy throughout the study. The dosing frequency will be adjusted to every 2
      weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is
      greater than 1000 milligrams per millimole (mg/mmol) [greater than 10 grams(g)/24 hours (h)],
      to compensate for loss of belimumab in the urine. Effects on mechanistic markers will be
      measured by the level of proteinuria, levels of anti-PLA2R antibodies, and various other
      measures of kidney function. These will be compared to historical data. The pharmacokinetics
      of belimumab will be measured to confirm dosing in heavily proteinuric subjects.
      Pharmacodynamic (PD) markers, biomarkers and Quality of Life(QoL) in IMGN subjects will also
      be investigated. Safety will be assessed by adverse events (AE), clinical laboratory
      evaluations, and vital signs.
    


Intervention name(s): belimumab
Intervention type(s): Drug
Intervention description(s): 10mg/kg administered intravenously
Intervention MeSH terms: Belimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IMGN; anti-PLA2R antibodies; pharmacokinetics; belimumab; Benlysta; Idiopathic Membranous Glomerulonephropathy; safety; GSK1550188; Lymphostat-B; membrane attack complex
A Study of AB-106 in Chinese Healthy Adult Men Evaluated the Effects of Itraconazole and Rifampicin on AB-106 PK
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      AB-106-C110 is China-only study, for investigating the drug interaction between AB-106 and
      CYP3A4 inhibitor (Itraconazole)/CYP3A4 inducer (Rifampin)（n=56）
    


Intervention name(s): AB-106, Itraconazole; AB-106, Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): single dose AB-106 at Day1, Itraconazole QD at Day14~Day28, single dose AB-106 at Day17; single dose AB-106 at Day1, Itraconazole QD at Day14~Day32, single dose AB-106 at Day21
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Contribution and Reproducibility of Lung Ultrasound in the Diagnosis of Acute Heart Failure in the ED
Condition: Dyspnea; Cardiac
MeSH terms: Dyspnea; Heart Failure
Study type: Observational

Summary: 
      Discrimination between cardiac and non-cardiac causes of dyspnea can be challenging, causing
      excessive delay before adequate therapy. In clinical practice lung ultrasound (LUS) is
      becoming an easy and reliable noninvasive tool for the evaluation of dyspnea and can shorten
      the time to diagnosis .However the reproductibility of this test was not extensively studied.
    

Detailed description: 
      Dyspnea is one of the most distressing situations for the patient . Emergency cases do not
      always present in conditions that are ideal for immediate diagnosis, which sometimes
      compromises outcome. Physical examination, laboratory findings and radiography are imperfect,
      resulting in a need for sophisticated test results that delay management.

      Lung ultrasonography is becoming a standard tool in critical cases in the ED.

      the investigators aim to perform ultrasonography on consecutive patients admitted to the ICU
      with dyspnea, comparing lung ultrasonography results on initial presentation with the final
      diagnosis by the ICU team.

      Three items were assessed: artifacts (horizontal A lines or vertical B lines indicating
      interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion,
      these items were grouped to assess ultrasound profiles.

      This study assesses the potential of lung ultrasonography to diagnose heart failure.The
      second aim of this study was to evaluate the inter-observer reproducibility of LUS performed
      by ED residents in the evaluation of cardiac causes of acute dyspnea.

      Patients presenting to the ED with acute dyspnea will be prospectively enrolled in this
      study. In each patient, LUS was performed by two ED residents blinded to clinical diagnoses.

      AHF was determined on the base of clinical exam, chest x-ray , brain natriuretic peptide
      (BNP) and echocardiographic findings.

      A patient lung comet score (LCS) was obtained by summing the number of comets in each of the
      scanned spaces.

      Then the probability of AHF was defined as :

      low probability (LCS<15) intermediate probability (15 <LCS<30), and high probability (LCS>30
      ).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all patients admitted to the ED with acute dyspnea, with the final diagnosis of heart
        failure
      
Keywords: Lung ultrasound; heart failure; diagnosis
Effects of Bracing on Knee Osteoarthritis (OA)
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Knee osteoarthritis (OA) is characterized by complaints of knee pain, aching and stiffness
      that commonly alter the way one will climb stairs and walk reducing an individual's function
      and the activities they may perform on a day-to-day basis. Providing a person with a knee
      brace designed for OA can help unload the arthritic part of the knee, thereby reducing pain
      and lead to improved function. The purpose of this study is to determine if use of the Rebel
      Reliever knee brace manufactured by Townsend Design can reduce pain and stiffness, improve
      strength and balance, and enhance functional activities such as stair and level gait, and
      ultimately lead to increased participation in the community.
    


Intervention name(s): Knee OA Brace
Intervention type(s): Device
Other intervention name(s): Rebel Reliever by Townsend Design
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals who are currently living with Knee OA of one leg
      
Keywords: OA; arthritis; knee OA
A Smoking Prevention Program (ASPIRE) and Mentoring for Preventing Smoking Among High School Youths
Condition: Healthy Subject
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This early phase I trial studies how well A Smoking Prevention Interactive Experience
      (ASPIRE) program and mentorship works in preventing smoking in high school students. ASPIRE
      is an online-based, youth-centered tobacco prevention and cessation program. The goal of this
      research study is to learn if training eleventh grade high school students to be tobacco-free
      role models and mentors for ninth grade high school students is possible and will positively
      influence the younger peers.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To evaluate the feasibility of training selected eleventh grade high school student
      volunteers to provide an intervention involving mentoring combined with social support
      activities.

      II. To increase ninth grade high school student well-being, which would ultimately influence
      tobacco related knowledge and resistance skills regarding tobacco uptake among ninth grade
      high school program participants.

      EXPLORATORY OBJECTIVES:

      I. Mentor ability, confidence, and intention (ACI) to address tobacco use and dependence and
      providing anti-tobacco advice to mentees.

      II. To determine the scores on mentoring competencies. III. To determine the influences of
      social support and self-esteem by mentors. IV. To determine the quality and satisfaction with
      the relationships among mentors and mentees.

      V. To determine level of knowledge about nicotine and tobacco products among mentees.

      VI. To determine susceptibility to tobacco use among non-smokers. VII. To determine
      progression through stages of change among smokers.

      OUTLINE:

      Participants complete online ASPIRE course over 3.5-4 hours.

      HIGH SCHOOL MENTORS: Eleventh grade high school students receive mentor training over 4-5
      hours on how to mentor ninth grade students.

      ALL STUDENTS: Mentors and mentees are paired up so that eleventh grade high school students
      mentor the ninth grade high school students over 30 minutes for 7 sessions about the
      different types of tobacco products (such as cigarettes, cigars, hookah, and so on) and the
      dangers of these products.
    

Intervention name(s): Preventive Intervention; Questionnaire Administration
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participate in ASPIRE and mentorship program; Ancillary studies (pre and post questionnaire)
Other intervention name(s): PREVENTATIVE; Prevention; Prevention Measures; prophylaxis; PRYLX
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of Finerenone to Investigate a Paediatric Formulation in Healthy Male Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Finerenone is developed for the treatment of diabetic kidney disease (adults) and chronic
      kidney disease (children). The purpose of the proposed trial is to test the pharmacokinetics
      of a novel liquid formulation for the treatment of children in comparison to the adult tablet
      formulation.
    


Intervention name(s): Finerenone (BAY94-8862): 20 mg intact tablet; Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet; Finerenone (BAY94-8862): 20 mg suspension
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg intact finerenone immediate-release tablet; single dose in the fasting condition; 20 mg crushed and resuspended finerenone immediate-release tablet; single dose in the fasting condition; 20 mg finerenone suspension; single dose in the fasting condition or in the fed condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Validation of the Utility of an Intelligent Visual Acuity Diagnostic System for Children
Condition: Ophthalmopathy; Artificial Intelligence
MeSH terms: Eye Diseases
Study type: Interventional

Summary: 
      Visual development during early childhood is a vital process. Examining the visual acuity of
      children is essential for the early detection of visual abnormality, but performing such an
      assessment in children is challenging. Here, the investigators developed a human-in-the-loop
      artificial intelligence (AI) paradigm that combines traditional vision examination and AI
      with integrated software and hardware, thus making the vision examination easy to perform.
      The investigator also establish a entity intelligent visual acuity diagnostic system based on
      the paradigm, and conduct clinical trial to validate if the diagnostic system can offsetting
      the shortcomings of human doctors.
    


Intervention name(s): An intelligent visual acuity diagnostic system for children
Intervention type(s): Device
Intervention description(s): An artificial intelligence to make evaluation and of children's vision.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Vision Disorders