bioihbjkbjnl/mcl2 huggingface dataset:
An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Condition: Hyperoxaluria, Primary
MeSH terms: Hyperoxaluria, Primary
Intervention: Oxabact OC5 - Oxalobacter formigenes Strain HC-1
Intervention description: Live, commensal bacteria
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label study in which all patients will receive Oxabact OC5
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No

Summary:

      Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent (as applicable for the age of the subject).

          2. Participation in and completion of study OC5-DB-02.

          3. Subjects who had received vitamin B6 during OC5-DB-02 study should maintain a stable
             dose. Subjects not receiving vitamin B6 during OC5-DB-02 must be willing to refrain
             from initiating pyridoxine during study participation.

        Exclusion Criteria:

          1. Inability to swallow size 4 capsules.

          2. Use of antibiotics to which O. formigenes is sensitive.

          3. Current treatment with a separate ascorbic acid preparation.

          4. Pregnant or lactating women (or women who are planning to become pregnant).

          5. Women of childbearing potential who are not using adequate contraceptive precautions.

          6. Presence of a medical condition that the Investigator considers likely to make the
             subject susceptible to adverse effect of study treatment or unable to follow study
             procedures or any condition that is likely to interfere with the study drug mechanism
             of action (such as abnormal GI function).

          7. Participation in any interventional study of another investigational product,
             biologic, device, or other agent or not willing to forego other forms of
             investigational treatment during this study.
A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BGF; GFF
Intervention description: Treatment with Budesonide/Glycopyrronium/FormoterolFumarate; Treatment with Glycopyrronium/Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to
      evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and
      Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject must be 40 years to ≤80 years of age inclusive, at the time of signing the informed
        consent form at Visit 1.

          -  COPD Diagnosis: Subjects with an established clinical history of COPD

          -  Screening clinical laboratory tests must be acceptable to the Investigator.

          -  Screening ECG must be acceptable to the Investigator

          -  Individual Compliance: Subjects must be willing to remain at the study center as
             required per protocol to complete all visit assessments

          -  Patients should be on scheduled maintenance treatment with one or more inhaled
             bronchodilator therapies.

        Exclusion Criteria:

          -  As judged by the investigator, any evidence of significant diseases other than COPD,
             i.e., disease or condition which, in the investigator's opinion makes it undesirable
             for the subject to participate in the trial.

          -  Spirometry Performance:

               1. Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS
                  acceptability criteria.

               2. Repeatability: Subjects who cannot perform technically acceptable spirometry in
                  accordance with ATS repeatability criteria

          -  Cancer: Subjects who have cancer that has not been in complete remission for at least
             five years.

          -  Substance Abuse: Subjects, who in the opinion of the Investigator, significantly abuse
             alcohol or drugs

          -  Subjects who in the opinion of the investigator are unable to abstain from prohibited
             medications including LABA/LAMAs/ICS
Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial
Condition: Haemophilia A
MeSH terms: Hemophilia A
Intervention: Turoctocog alfa
Intervention description: Intravenous (i.v., under the skin) administration.A maximum dose of 200 IU/kg daily.
The maximum treatment period for this trial is 24 months and the patient(s) will be called for visit to the clinic every 3rd month.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
      the trial is to evaluate safety of immune tolerance induction (ITI) treatment with turoctocog
      alfa (a recombinant factor VIII) in patients who have developed neutralising antibodies
      against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation
      in NN7170-4213 (NCT02994407)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in the NN7170-4213 trial (male, age at least 18 years (part A)
             and age at least 12 years (part B))

          -  Development of a confirmed high titre neutralising antibody towards factor VIII
             (greater than 5 Bethesda Unit) after exposure to subcutaneous turoctocog alfa pegol in
             the NN7170-4213 trial or development of a confirmed clinically relevant low titre
             inhibitor (at least 0.6 to below or equal to 5 Bethesda Unit), defined as factor VIII
             activity measures (recovery) and/or bleedpattern indicating a lack of clinical
             response to factor VIII treatment

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to trial product(s) or related products, defined
             as allergic reactions

          -  Participation in another clinical trial within 1 month before screening (except
             participation in NN7170-4213)

          -  Any disorder, except for conditions associated with Haemophilia A which in the
             investigator's opinion might jeopardise patients' safety or compliance with the
             protocol

          -  Currently receiving immune tolerance induction treatment with a factor VIII containing
             product other than turoctocog alfa
Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer
Condition: Breast Cancer; Metastases
MeSH terms: Breast Neoplasms
Intervention: vinflunine; Alkylating agent of physician choice registered in cancer
Intervention description: 280 mg/m2 on day 1 of each cycle every 3 weeks; cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin
Intervention MeSH terms: Alkylating Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 594.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      In metastatic breast cancer (MBC) patients who have already received anthracyclines, taxanes,
      antimetabolites and vinca-alkaloids and have developed drug resistance to these drugs,
      therapeutic options are very limited. Alkylating agents showed a modest activity in
      pretreated metastatic breast cancer. This phase III trial will compare the effectiveness and
      the safety profile of vinflunine to an alkylating agent of physician choice in MBC patients
      who have exhausted anthracyclines, taxanes, antimetabolites and vinca-alkaloids.
    

Eligibility criteria:

        Inclusion Criteria:(main conditions)

          -  Female patients 18 to 75 years of age with metastatic breast cancer
             histologically/cytologically confirmed not amenable to curative surgery or
             radiotherapy and who have received at least two prior chemotherapy regimens including
             anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate
             for these drugs,

          -  Karnofsky performance score of at least 70 %, adequate haematological, hepatic and
             renal functions and ECG without clinically relevant abnormality.

        Exclusion Criteria:

          -  Concurrent serious uncontrolled medical disorder,

          -  known or clinical evidence of brain metastases or leptomeningeal involvement,

          -  pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,

          -  history of second primary malignancy,

          -  HIV infection, preexisting neuropathy,

          -  pregnancy or breast feeding.
Efficacy and Safety of BIIB111 for the Treatment of Choroideremia
Condition: Choroideremia
MeSH terms: Choroideremia
Intervention: BIIB111
Intervention description: Administered as specified in the treatment arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 169.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NightstaRx; NSR-REP1; Gene Therapy; AAV; REP1; Timrepigene Emparvovec

Summary:

      The objective of the study is to evaluate the efficacy and safety of a single sub-retinal
      injection of BIIB111 in participants with choroideremia (CHM).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Are willing and able to give informed consent for participation in the study.

          -  Have a documented genetically-confirmed diagnosis of CHM.

          -  Have active disease clinically visible within the macular region in the study eye.

          -  Have a BCVA of 34-73 ETDRS letters (equivalent to worse than or equal to 6/12 or 20/40
             Snellen acuity, but better than or equal to 6/60 or 20/200 Snellen acuity) in the
             study eye.

        Key Exclusion Criteria:

          -  Have a history of amblyopia in the eligible eye.

          -  Have had previous intraocular surgery performed in the study eye within 3 months of
             Visit 1.

          -  Have any other significant ocular or non-ocular disease/disorder which, in the opinion
             of the investigator, may either put the participants at risk because of participation
             in the study, or may influence the results of the study, or the participant's ability
             to participate in the study.

          -  Have participated in another research study involving an investigational product in
             the past 12 weeks or received a gene/cell-based therapy at any time previously.

          -  Are unwilling to use barrier contraception methods, or abstain from sexual
             intercourse, for a period of 3 months, if treated with AAV2-REP1.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE)
Condition: Urge Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Intervention: Fesoterodine Fumarate
Intervention description: FDA approved anticholinergic medication used for treatment of urge urinary incontinence
Intervention MeSH terms: Fesoterodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: overactive bladder; urge urinary incontinence; pharmacogenetics

Summary:

      Urge urinary incontinence, characterized by unpredictable and embarrassing large volume urine
      leakage, is a major health issue for elderly women, as it is incredibly common and
      significantly impairs quality of life. Although anticholinergic medications are the most
      common therapy, the investigators are unable to predict an individual's response to a
      particular drug in terms of both effectiveness and side effects. Through genetic evaluation,
      the investigators have the potential to personalize and optimize drug therapy for millions of
      elderly women suffering from urge incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ≥ 50 years

          -  ≥ 3 UUI episodes on a 3-day voiding diary

          -  Urge-predominant incontinence, >50% of total incontinence episodes

          -  No history of failure to fesoterodine

          -  2-week washout period if currently on an anticholinergic for UUI

          -  Willingness to avoid off-protocol UUI therapy during the study period

          -  Post Void Residual (PVR) <150 mL

        Exclusion Criteria:

          -  Contraindications to fesoterodine (e.g., bladder outlet obstruction, narrow angle
             glaucoma, myasthenia gravis, severe hepatic or renal impairment)

          -  Inability to complete study-related items and visits - i.e., cognitive impairment
             based on Mini-Cog test score (exclude if score of 0 or 1-2 (Abnormal))

          -  Urinary retention requiring catheterization

          -  Symptomatic, untreated urinary tract infection not resolved prior to starting
             fesoterodine

          -  Botulinum toxin injection for UUI in the last year

          -  Current therapy with peripheral or sacral neuromodulation

          -  Neurologic conditions that may affect urinary function (stroke, multiple sclerosis,
             spinal cord injury, Parkinson's disease)

          -  Women taking potent CYP3A4 inhibitors
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
Condition: Sinusitis; Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections; Sinusitis
Intervention: Amoxicillin-clavulanate; Placebo
Intervention description: Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days); placebo made to match the study antibiotic given twice a day orally for 10 days
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 515.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: pediatrics; antibiotics; placebo

Summary:

      The objective of this trial is to determine whether certain subgroups of children with acute
      sinusitis exist in whom antibiotic therapy can be appropriately withheld.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets criteria for "persistent" or "worsening" presentations of sinusitis

          -  Baseline score ≥9 on the Pediatric Rhinosinusitis Symptom Scale

        Exclusion Criteria:

          -  Severe presentation (≥3 days of colored nasal discharge and fever ≥39°C

          -  Asthma/allergic rhinitis explains symptoms

          -  Allergy to amoxicillin-clavulanate

          -  Immotile cilia syndrome

          -  Cystic fibrosis

          -  Immunodeficiency

          -  Parental inability to read/write English or Spanish

          -  Other concurrent infection (e.g., pneumonia, acute otitis media, streptococcal
             pharyngitis)

          -  Systemic toxicity

          -  Wheezing on exam

          -  Antibiotic use within 15 days
A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Intervention: IPV; f-IPV
Intervention description: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID); Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 773.0
Sex: All
Minimum age: 5 Weeks
Maximum age: 7 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will assess and compare the immune response to full-dose inactivated polio vaccines
      (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated
      poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule
      combinations in the Expanded Program on Immunization (EPI) primary series.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Infants of 6 weeks of age (-7 to + 7 days) on date of enrollment.

          2. Healthy, as assessed from medical history and physical examination by a study
             physician,

          3. Written informed consent obtained from parents or legal representatives who have been
             properly informed about the study and are able to comply with planned study
             procedures.

        Exclusion Criteria:

          1. Vaccinated with any poliovirus vaccine prior to inclusion,

          2. A household contact with OPV vaccination history in the past 4 weeks,

          3. HIV infection or pharmacologic immunosuppression,

          4. Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde),

          5. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and
             intradermal injections,

          6. Acute severe febrile illness on day of vaccination deemed by the Investigator(s) to be
             a contraindication for vaccination,

          7. Not suitable for inclusion or is unlikely to comply with the protocol in the opinion
             of the investigator(s).
Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Intervention: Semaglutide; Placebo (semaglutide)
Intervention description: Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.; S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 611.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will look at the change in participant's body weight from the start to the end of
      the study. This is to compare the effect on body weight in people taking semaglutide (a new
      medicine) and people taking "dummy" medicine. Together with the medicine, the participant
      will also be part of an intensive lifestyle program where the participant will have talks
      with study staff about healthy food choices, what the participant can do to lose weight and
      be more physically active. The participant will either get semaglutide or "dummy" medicine -
      which treatment the participant gets is decided by chance. The participant will need to take
      1 injection once a week. The study medicine is injected with a thin needle in a skin fold in
      the stomach, thigh or upper arm. For the first 2 months the participant will be on a low
      calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for
      each day. The study will last for about 1.5 years. The participant will have 32 clinic visits
      with the study doctor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age more than or equal to 18 years at the time of signing informed
             consent

          -  Body mass index more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2
             with the presence of at least one of the following weight-related comorbidities
             (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or
             cardiovascular disease

          -  History of at least one self-reported unsuccessful dietary effort to lose body weight

        Exclusion Criteria:

          -  Hemoglobin A1c more than or equal to 48 mmol/mol (6.5%) as measured by the central
             laboratory at screening

          -  A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before
             screening irrespective of medical records