bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Intervention: Tralokinumab; Placebo
Intervention description: Subcutaneous Injection; Subcutaneous Injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Reactive Airways; Respiratory Tract Disease; Obstructive Tract Disease; Lung Diseases

Summary:

      A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2
      Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma
      Inadequately Controlled on Inhaled Corticosteroid.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 to 75 years

          2. Documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)

          3. Documented treatment with an asthma controller regimen requiring treatment with ICS
             (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents
             total daily dose) alone or in combination ≥ 6 months and that has been taken at a
             stable dose for at least 1 month prior to enrolment (v1)

          4. Additional maintenance asthma controller medications must be given at a stable dose
             for at least 1 month prior to v1.

          5. At enrolment (v1) the subject must have a predicted normal value (PNV) for the
             pre-bronchodilator (BD) FEV1>50% and more than 1L.

          6. Post-BD reversibility in FEV1 of ≥12% and ≥200 mL at enrolment (v1).

        Exclusion Criteria:

          1. History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or
             other clinically significant lung disease other than asthma.

          2. History of anaphylaxis following any biologic therapy.

          3. Hepatitis B, C or HIV

          4. Pregnant or breastfeeding

          5. History of cancer

          6. Current tobacco smoking or a history of tobacco smoking for >10 pack-years.

          7. Previous receipt of tralokinumab
New Technologies to Determine Carotid Plaque Vulnerability in Patients With Significant Carotid Plaques
Condition: Carotid Artery Plaque
MeSH terms: Carotid Stenosis
Intervention: Contrast-enhanced ultrasound; Shear Wave Elastography; Ultrasound Examination
Intervention description: Subjects will receive a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.; Shear wave elastography will be performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. In each plane 10 measurements will be made and the in-phase/quadrature (IQ) data will be saved for further analysis. The plaque area in the imaging plane will be user-defined to extract the wave velocity values for a ROI analysis.; A standard carotid US examination using Duplex imaging will performed using a linear array transducer to obtain longitudinal and transverse images. All ultrasound measurements will be made by a trained registered vascular technologist. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carotid Plaque; Contrast Enhanced Ultrasound; Shear Wave Elastography; Endarterectomy; Stenosis

Summary:

      The researchers are trying to determine if the characterization of "vulnerable" carotid
      artery plaques can be accomplished with ultrasound-based methods that look for vessels in the
      plaque and measure the plaque stiffness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has carotid plaque with > 50% stenosis

          -  Subject is able to understand the study procedure and provide informed consent

        Exclusion Criteria:

          -  Subject is pregnant or breast feeding

          -  Subject is unable to provide informed consent

          -  Subject has contraindication to the use of the Lumason contrast agent.
Convalescent Plasma for Patients With COVID-19
Condition: Coronavirus Infection; Coronavirus; COVID
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Convalescent plasma
Intervention description: One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19

Summary:

      Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in
      patients with COVID-19 respiratory disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age > 18 with one or more of the following: Dyspnea Respiratory rate >= 30 breaths/min
             Oxygen saturation <=93% PaO2/FiO2 <300 Bilateral airspace opacities on chest
             radiograph at 24 to 48 hours

        Exclusion Criteria:

          -  Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA
             ECMO
OK432 (Picibanil) in the Treatment of Lymphatic Malformations
Condition: Lymphatic Malformations
MeSH terms: Lymphangioma; Lymphatic Abnormalities; Congenital Abnormalities
Intervention: OK432
Intervention description: OK432 will be injected at dosage of 0.01 to 0.05 mg/mL 6-12 weeks apart up to 4 injections total.
Intervention MeSH terms: Picibanil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All eligible participants receive the actual drug.
Masking: None (Open Label)
Enrollment: 275.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Standard of care for Lymphatic Malformations has been surgical excision. We have been using
      OK432/Picibanil (generously supplied by Chugai Pharmaceuticals in Japan) since 1992 with
      great success for macrocystic disease.

      The objective of the study was to provide OK-432 immunotherapy to subjects with macrocystic
      or mixed (> 50% macrocystic) lymphatic malformations (LMs) and investigate the efficacy and
      safety of OK 432 as a treatment option in subjects with LMs.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible to receive OK432 immunotherapy

          -  Patients must be ages 6 months to 17 years

          -  Patients must have a macrocystic Lymphatic Malformation

          -  Patients may have had surgical treatment for their Lymphatic Malformation

          -  Patients must have an imaging study to confirm the diagnosis of a macrocystic or mixed
             Lymphatic Malformation An MRI is preferred over a CT scan (an ultrasound may be used
             between injections if warranted, however an MRI or CT should be done pre and post
             treatment)

        Exclusion Criteria:

          -  Penicillin allergy

          -  Women who are pregnant or nursing

          -  Patients who present with a temperature of 100.5 degrees F or greater

          -  Patients with mixed hemangioma-lymphangioma lesions

          -  Patients with a history OR a family history of rheumatic heart disease or
             post-streptococcal glomerulonephritis

          -  Patients with hemodynamic instability and respiratory failure

          -  Patients with a history OR a family history of obsessive-compulsive, tic disorders, or
             PANDA (pediatric autoimmune neuro-psychiatric disorder associated with streptococcal
             infections)

          -  Patients who demonstrate abnormalities in the history, physical examination or
             laboratory analysis which may indicate significant hepatic, hematologic, or renal
             disease

          -  Patients who are not in "good general health" (including patients with congenital
             disorders, chronic diseases, immunologic dysfunction, transplant recipients)
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
Condition: Diabetes
Intervention: Sodium nitrite; Placebo
Intervention description: Sustained release formulation of sodium nitrite; Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuropathy

Summary:

      In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks
      with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily.
      Primary endpoints will be safety and pharmacokinetics. Assessment of the study medications
      affects on pain following treatment will also be recorded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects must be post-menopausal, sterilized or using suitable birth control

          -  Diagnosis of diabetes (HbA1c > 6.0)

          -  Diagnosis of diabetic peripheral neuropathy pain in feet

          -  Presence of ongoing diabetic neuropathic for at least 3 months

          -  A pain score of greater than or equal to 4 on the Numerical Pain Rating Scale at
             screening

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Patients with fibromyalgia or regional pain caused by lumbar or cervical compression

          -  History or diagnosis of significant neurological disease

          -  History and diagnosis of clinically significant psychiatric diseases

          -  Serious liver disease

          -  Poorly controlled diabetes

          -  Hypersensitivity to sodium nitrite or related compounds

          -  Life expectancy < 6 months

          -  A chronic illness that may increase the risks associated with this study

          -  Active malignancy requiring active anti-neoplastic therapy that will, in the opinion
             of the investigator, interfere with study treatment or participation

          -  Pregnant or nursing women

          -  Current diagnosis of alcohol or other substance abuse

          -  Current use of sildenafil or other phosphodiesterase Type 5 Inhibitors

          -  History of methemoglobinemia, (met-Hb ≥ 15%)

          -  Subject is involved in litigation or receives worker's compensation

          -  Inability to speak English
Facilitation of NMDA Receptor Function in Patients With Schizophrenia and Co-morbid Alcoholism
Condition: Alcoholism; Schizophrenia
MeSH terms: Alcoholism; Schizophrenia
Intervention: Glycine; placebo
Intervention description: Glycine, 0.8 gr per kg given in two daily doses
Intervention MeSH terms: Glycine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: glycine; treatment; alcohol dependence; schizophrenia

Summary:

      This placebo-controlled study is designed to evaluate the efficacy of glycine, an agonist of
      the glycine-B co-agonist site of the NMDA receptor, on alcohol consumption and craving as
      well as negative symptoms in schizophrenia.

      Glycine will decrease the rewarding action of ethanol and reduce ethanol consumption. Also,
      glycine will improve negative symptoms and cognitive deficits in schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of schizophrenia or schizoaffective disorder

          -  DSM-IV diagnosis of alcohol dependence

          -  Stable treatment with typical or atypical antipsychotics

        Exclusion Criteria:

          -  Axis I diagnosis other than alcohol dependence, schizophrenia, schizoaffective
             disorder, OCD, and PTSD.

          -  current drug dependence

          -  evidence of significant hepatocellular injury evidence by abnormal SGOT or SGPT levels

          -  history of seizures

          -  diabetes and medical conditions that would alter glycine metabolism

          -  positive pregnancy test

          -  treatment with clozapine, naltrexone or disulfiram
Efficacy and Safety Study of Elagolix in Women With Endometriosis
Condition: Endometriosis, Pain
MeSH terms: Endometriosis
Intervention: Placebo; Elagolix
Intervention description: Matching placebo tablets taken orally once a day; Immediate release (IR) tablets taken orally once a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Pelvic Pain,NBI-56418,Endometriosis

Summary:

      The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its
      effects on endometriosis related pelvic pain and its safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be female, aged 18 to 49 years, inclusive.

          -  Have moderate to severe pelvic pain due to endometriosis.

          -  Have a history of regular menstrual cycles.

          -  Have been surgically (laparoscopy or laparotomy) diagnosed with endometriosis within 8
             years of the start of screening.

          -  Have a Body Mass Index (BMI) of 18 to 36 kg/m², inclusive.

          -  Agree to use two forms of non-hormonal contraception during the study.

        Exclusion Criteria:

          -  Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH
             antagonist other than NBI-56418, or danazol or have received any of these agents
             within 6 months of the start of screening.

          -  Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or
             intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these
             agents within 3 months of the start of screening.

          -  Are currently using hormonal contraception or other forms of hormonal therapy or
             received such treatment within the last month.

          -  Have had surgery for endometriosis within the last month.

          -  Have had a hysterectomy or bilateral oophorectomy.

          -  Are using systemic steroids on a chronic or regular basis within 3 months.

          -  Have uterine fibroids ≥ 3 cm in diameter.

          -  Have pelvic pain that is not caused by endometriosis.

          -  Have unstable medical condition or chronic disease.

          -  Have been pregnant within the last six months.

          -  Currently breast feeding.
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: Saline; Insulin detemir; Insulin
Intervention description: Saline, administered intranasally twice per day for a 16 week duration; 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day); 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Memory; Intranasal insulin; Alzheimer's disease; Mild Cognitive Impairment

Summary:

      The study will examine the effects of intranasally administered long-acting insulin detemir
      on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment
      (aMCI). The rationale for these studies is derived from growing evidence that insulin
      contributes to multiple brain functions, and that insulin dysregulation can contribute to AD
      pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have
      beneficial effects on brain function. Intranasal administration of insulin increases insulin
      signaling in the brain without raising peripheral levels and causing hypoglycemia. Insulin
      detemir is an insulin analogue that may have better action in brain than other insulin
      formulations because of its albumin binding properties. The investigators will test the
      therapeutic effects of intranasally-administered insulin detemir in a study in which
      participants will receive insulin detemir, regular insulin, or placebo over a four month
      period. The investigators will test the hypothesis that insulin and insulin detemir will both
      improve memory and daily functioning in persons with AD/aMCI compared with placebo, but that
      insulin detemir will have the greatest effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 50-89

          -  Diagnosed with mild cognitive impairment, or mild/moderate AD

        Exclusion Criteria:

          -  Excessively high or low blood pressure, heart rate

          -  Pre-existing diabetes not controlled by exercise/diet

          -  Previous/current use of insulin

          -  Significant elevations in lipids, liver enzymes

          -  Menstrual period within the last 12 months

          -  Significant neurological or medical disorder (other than AD)

          -  Significant use of nasal decongestants

          -  Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or
             sedative medications
Brexpiprazole in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Intervention: Rexulti; Placebo
Intervention description: Atypical antipsychotic; Pill that contains no medicine
Intervention MeSH terms: Brexpiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of the proposed study is to evaluate the safety and efficacy of
      Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be
      tested is that brexpiprazole will be more effective and well tolerated in adults with BPD
      compared to placebo. The proposed study will provide needed data on the treatment of a
      disabling disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women age 18-65;

          2. Primary diagnosis of BPD

          3. Zanarini scale score of at least 9 at baseline

          4. Ability to understand and sign the consent form.

        Exclusion Criteria:

          1. Unstable medical illness based on history or clinically significant abnormalities on
             baseline physical examination

          2. Subjects with schizophrenia or bipolar I disorder

          3. Subjects with an active substance use disorder

          4. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          5. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity
             rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)

          6. Illegal substance use based on urine toxicology screening

          7. Initiation of psychological interventions within 3 months of screening

          8. Use of any other psychotropic medication

          9. Previous treatment with Brexpiprazole

         10. Cognitive impairment that interferes with the capacity to understand and
             self-administer medication or provide written informed consent
Treatment of Anxiety and Anorexia Nervosa in Adolescents
Condition: Anxiety; Anorexia Nervosa
MeSH terms: Anorexia; Anxiety Disorders; Anorexia Nervosa
Intervention: Fish oil; Placebo pill
Intervention description: Participants will take 4 capsules daily; Participants will take 4 capsules daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Anxiety; Anorexia nervosa; Adolescents; Fish oil

Summary:

      Adolescents with anorexia nervosa frequently have associated anxiety, and standard
      medications used for anxiety are unhelpful when patients are malnourished. This is a 12 week
      trial examining the safety, tolerability, and effectiveness of fish oil nutritional
      supplements for anxiety in adolescents with anorexia nervosa.
    

Eligibility criteria:

        Inclusion Criteria:

        Females admitted to Nationwide Children's Hospital Eating Disorder Partial Hospitalization
        Program

        Exclusion Criteria:

          1. Inability to take pills

          2. Co-morbid medical conditions affecting appetite and weight (e.g., inflammatory bowel
             disease, cancer, cystic fibrosis)

          3. Co-morbid psychiatric conditions affecting appetite and weight (e.g., bipolar
             disorder, substance abuse)

          4. Currently taking fish oil supplements

          5. Inability to participate in study for 12 consecutive weeks.