bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Thymic Peptides in the Treatment of Hospitalized COVID-19 Patients in Honduras
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Thymic peptides
Intervention description: 250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: A participant-level comparison based on registry data from the Hospital de Santa Bárbara Integrado will be performed after propensity score matching.
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: SARS-CoV-2 Infection; COVID-19 Pandemic; 2019 Novel Coronavirus Disease; Thymic peptides; Thymus gland; Peptides; Honduras; Coronavirus Disease 2019; Coronavirus Disease-19; COVID-19 Virus Infection; 2019-nCoV Disease; 2019-nCoV Infection

Summary:

      This is a single-arm, open-label, phase II clinical study to evaluate the safety and efficacy
      of thymic peptides in the treatment of hospitalized COVID-19 patients in Honduras.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed case of COVID-19 by viral nucleic acid (RNA) detection, viral antigen
             detection, or detection of antibodies to the virus.

          -  Participants that require hospitalization under Honduran Ministry of Health Guidelines
             for Clinical Management of COVID-19 Adult Patients: Stage IIb, defined as a patient
             with or without risk factors that presents with warning signs (shortness of breath,
             tachypnea), and altered inflammatory parameters.

          -  Participants that present with at least one of the following: oxygen saturation level
             below 94 percent; complete blood count showing lymphopenia, neutrophilia, or both;
             positive C-reactive protein; chest radiography or CT scan with ground-glass opacities.

          -  Male or female at least 21 years old.

        Exclusion Criteria:

          -  COVID-19 patients that do not require hospitalization under Honduran Ministry of
             Health Guidelines for Clinical Management of COVID-19 Adult Patients: phase IA
             (asymptomatic), phase IB (mild symptoms without risk factors), or phase IC (mild
             symptoms with risk factors).

          -  Participants currently in other clinical trials evaluating experimental drugs.

          -  Known history of allergic reactions to thymic peptides or calf thymus acid lysate
             derivatives.

          -  Organ transplant recipients.

          -  Women who are pregnant or breast feeding.
Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Pegylated interferon alfa-2a plus nucleos(t)ide(s)
Intervention description: Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: chronic hepatitis B

Summary:

      A prospective, randomised, open-label phase IIb clinical trial assessing the effect of
      pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing
      nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B

      The primary objective of the trial is to investigate whether the add-on of pegylated
      interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the
      percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48
      weeks.

      170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an
      oral antiviral regimen and having a nondetectable viral load for at least 12 months are
      included.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis B, HBe antigen negative

          -  treatment with a stable oral antiviral treatment (not containing telbivudine) and a
             fully suppressed viral load for at least 12 months (below limit of detection in
             conventional HBV-PCR assays, i.e. <116 IU / ml).

          -  18-70 ys

          -  willingness and ability to give informed consent and to follow study procedures

          -  willingness to use adequate contraception

        Exclusion Criteria:

          -  contraindications against treatment with pegylated interferon, e.g. depression,
             uncontrolled epilepsy, autoimmune diseases, pregnancy, leukocytopenia or
             thrombocytopenia at screening, etc.

          -  active alcohol or drug abuse

          -  preexisting polyneuropathy
LifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia
Condition: Alzheimer's Disease; Dementia
MeSH terms: Alzheimer Disease; Dementia
Intervention: Lifezig
Intervention description: Personalized Reminiscence Video
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 242.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The LifeZig Project is a research study of a new reminiscence activity for individuals with
      Alzheimer's Disease (AD) and other types of dementia, based on the LifeZig system, with
      personalized video channels containing old photographs and music on television.

      The goal of the LifeZig study is to enhance the quality of life for dementia patients and
      their families/caregivers, decrease the burden of care, and contribute to positive
      interaction between dementia patients and families/caregivers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria for dementia patients:

               -  documented diagnosis of probable Alzheimer's or other type of dementia, medically
                  stable, and visual/hearing capabilities to watch television.

          -  Inclusion criteria for family members/caregivers:

               -  provide care or be a family member of dementia patient, have knowledge of the
                  person, and be able to provide old photographs of dementia patient.
A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lu AG09222; Placebo
Intervention description: Lu AG09222 will be administered per schedule specified in the arm.; Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine
      headaches for people who have not been helped by other treatments that are used to prevent
      migraines.

      People who join this trial have tried 2 to 4 other medications to prevent their migraines,
      but these medications have not helped them.

      When the trial is over, researchers will use this information to find out if the number of
      migraine days decreased more for the participants who got either dose of Lu AG09222 than for
      the participants who got the placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  The participant has a diagnosis of migraine as defined by International Classification
             of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening
             Visit.

          -  The participant has a history of migraine onset at least 12 months prior to the
             Screening Visit.

          -  The participant has a migraine onset at ≤50 years of age.

          -  The participant has documented evidence of treatment failure in the past 10 years of
             at least 2 to 4 (maximum) different migraine preventive medications.

        Key Exclusion Criteria:

          -  The participant has been previously dosed with an anti-pituitary adenylate
             cyclase-activating polypeptide (anti-PACAP) ligand-targeting antibody.

          -  The participant has confounding and clinically significant pain syndromes.

          -  The participant has a diagnosis of acute or active temporomandibular disorder.

          -  The participant has a history or diagnosis of confounding headaches.
Study to Asses Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of AZD0328 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: AZD0328; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of
      multiple ascending doses of AZD0328 in patients with schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia according to the DSM-IV (Diagnostic and Statistical Manual
             of Mental Disorders, 4th Edition)

          -  Low level of Extra-pyramidal symptoms

          -  No clinically significant findings on physical examination

        Exclusion Criteria:

          -  Diagnosis of schizoaffective or schizophreniform disorders

          -  Any significant psychiatric or neurological disease other than schizophrenia
Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Oxytocin; Placebo
Intervention description: spinal injection of oxytocin; spinal injection of placebo
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of intrathecal oxytocin on speed of
      reduction in pain for the first 60 days after hip surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for unilateral, primary total hip replacement

          -  American Society of Anesthesiologists physical status 1-3

        Exclusion Criteria:

          -  Pregnancy

          -  Currently Workman's Comp litigation related to hip replacement

          -  Taking greater than 100 milligrams of morphine (or equivalent)

          -  Suffering from a psychotic disorder or a recent psychiatric hospitalization
Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
Condition: Morphea
MeSH terms: Scleroderma, Localized
Intervention: Crisaborole
Intervention description: Apply Crisaborole 2% ointment to affected skin twice per day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Morphea, Localized Scleroderma

Summary:

      This is a pilot study to determine the safety and clinical efficacy of crisaborole 2%
      ointment in the treatment of morphea.
    

Eligibility criteria:

        Inclusion Criteria:

          1. >= 18 years of age

          2. Clinical diagnosis of morphea.

          3. <20% Total body surface area involvement.

          4. Does not require systemic immunosuppressive therapy for morphea.

          5. No immunosuppressive systemic therapy 1 month prior to starting the study
             (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide,
             prednisone >=10 mg PO daily).

          6. No immunomodulating topical therapy (topical steroids or topical calcineurin
             inhibitor), and no topical vitamin D analogue, 2 weeks prior to starting study.

          7. No allergy to crisaborole or vehicle.

          8. No known renal disease

          9. Able to give informed consent.

        Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for
        inclusion in this study.

          1. Clinical diagnosis of depression or history of suicidal ideation.

          2. Pregnant or breastfeeding women, with pregnant women being defined as the state of a
             female after conception until the termination of gestation, confirmed by a positive
             urine human chorionic gonadotropin (hCG) laboratory test. Women with a positive urine
             hCG at any time during the study will be withdrawn from the study.
Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement
Condition: Colorectal Cancer; Metastases
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Intervention: Cetuximab; Bevacizumab; Leucovorin; Oxaliplatin; Fluorouracil
Intervention MeSH terms: Leucovorin; Bevacizumab; Cetuximab; Fluorouracil; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colorectal Cancer; Metastasis; Neoadjuvant Therapy

Summary:

      The purpose of this study is to determine the effect of short-duration pre-operative FOLFOX
      based therapy on postoperative problems after liver surgery for patients with metastatic
      colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Synchronous or metachronous colorectal metastases

          -  Technically resectable liver metastases

               -  Four or fewer metastases

               -  No tumors in porta hepatis

               -  Resection of no more than 70% of liver needed

          -  Medically suitable candidate for major liver resection

          -  FDG-PET scan without metastatic disease outside the liver

        Exclusion Criteria:

          -  Near-obstructing or obstructing colon lesions in patients in whom combined resection
             is planned (as delay for preoperative chemotherapy would be medially impossible)

          -  Treatment with FOLFOX or cetuximab within 12 months

          -  Treatment with irinotecan within 12 months

          -  Abnormal liver function (ALT or AST > 5x ULN, bilirubin > 3x ULN)

          -  Body mass index >/= 35 kg/m² (as the risk for steatohepatitis is increased)

          -  Renal insufficiency (Cr > 2.5mg/dL)

          -  Interstitial lung disease (because cetuximab has been rarely associated with
             development of interstitial lung disease)

          -  ECOG performance score >/= 3

          -  Patients unable to give informed consent

          -  Pregnant patient (as cetuximab is a Class C drug)

          -  Peripheral neuropathy >/= grade II (as oxaliplatin causes neuropathy to worsen)
Open-Label Extension Study to Evaluate the Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
Condition: Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Intervention: SD-101 dermal cream (6%)
Intervention description: SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No
Keywords: Amicus Therapeutics; Scioderm, Inc.; Recessive Dystrophic; Junctional non-Herlitz; Epidermolysis Bullosa; Simplex; SD-101 6%; SD-101-6.0; Allantoin 6%; Zorblisa

Summary:

      The purpose of this study was to assess the continued safety of topical use of SD-101 cream
      (6%) in participants with Epidermolysis Bullosa (EB).

      Funding Source: FDA Office of Orphan Products Development
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent form signed by the participant or participant's legal representative;
             if the participant is under the age of 18 but capable of providing assent, signed
             assent from the participant.

          -  Participant (or caretaker) must be willing to comply with all protocol requirements.

          -  Participant must have successfully completed the SD-003 study.

        Exclusion Criteria:

          -  Participants who do not meet the inclusion criteria.

          -  Pregnancy or breastfeeding during the study. A urine pregnancy test will be performed
             at the final visit for SD-003 for female participants of childbearing potential.

          -  Females of childbearing potential who are not abstinent and not practicing a medically
             acceptable method of contraception.
Living With Hope Program for Rural Women Caregivers
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: Living with Hope Program
Intervention description: The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity "Stories of the Present". Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hope; quality of life; caregivers

Summary:

      Family caregivers of terminally ill persons describe hope as inner strength that will help
      them continue caregiving. Our research team has developed and pilot tested a Living with Hope
      Program (LWHP) for caregivers of family members with advanced cancer, with the goal of
      fostering hope and improving quality of life (www.usask.ca/nursing /research/livingwithhope).
      The caregivers involved in our pilot test found the LWHP easy to use and we found some
      evidence to suggest that the program may have increased their hope and improved their quality
      of life. We would like to further develop and test the LWHP by finding out more about how and
      how long it might work. We believe it will improve the quality of life of active and bereaved
      older rural women of persons with advanced cancer and may decrease the number of
      prescriptions and doctor visits over one year. Since rural women caring for persons with
      advanced cancer seem to have the least hope, we want to focus on them first before including
      other caregivers in our research. Two hundred rural women caring for a person with advanced
      cancer will be asked to take part in this study. Their feelings of control, loss and grief,
      quality of life and hope will be measured over a year. The numbers of time they visit their
      physician and how many prescriptions they have over the year will also be collected. This
      study will contribute to the refinement of a Living with Hope Program that may improve
      quality of life and personal health of older rural women caring for their spouse with
      advanced cancer and those who subsequently become bereaved.
    

Eligibility criteria:

        Inclusion Criteria:

          -  caring for a person who is diagnosed with advanced cancer, c) home address is outside
             of metropolitan areas.

        Exclusion Criteria:

          -  caring for a person with advanced cancer and dementia
Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
Condition: SARS-CoV-2 (COVID-19) Severe Pneumonia
MeSH terms: COVID-19; Pneumonia
Intervention: Efzofitimod 1 mg/kg; Efzofitimod 3 mg/kg; Placebo
Intervention description: Concentrate for solution for infusion; Concentrate for solution for infusion; Concentrate for solution for infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized 1:1:1 to a single intravenous (IV) dose of efzofitimod 1 mg/kg, efzofitimod 3 mg/kg, or placebo matched to efzofitimod.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The Investigator, Sponsor, and participant will be blinded to treatment assignment; study center pharmacy personnel will be unblinded.
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; CoV-2; ATYR1923 (efzofitimod); acute respiratory distress syndrome; ARDS; SARS-CoV-2 Infection; COVID-19; Severe Pneumonia

Summary:

      To evaluate the safety and preliminary efficacy of efzofitimod, compared to placebo matched
      to efzofitimod, in hospitalized participants with SARS-CoV-2 (COVID-19) severe pneumonia not
      requiring mechanical ventilation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmation of SARS-CoV-2 infection by polymerase chain reaction (PCR).

          -  Severe pneumonia related to SARS-CoV-2 infection, defined as fever or suspected
             respiratory infection with radiographic abnormalities suggestive of viral pneumonia,
             plus at least 1 of the following:

               -  Respiratory rate >30 breaths/minute;

               -  Severe respiratory distress, as determined by the Investigator;

               -  Oxygen saturation (SpO2) ≤93% on room air.

        Exclusion Criteria:

          -  Participant is intubated/mechanically ventilated.

          -  In the opinion of the Investigator, participant's progression to death is imminent.

          -  Treatment with immunosuppressant/immunotherapy drugs, including but not limited to
             interleukin (IL)-6 inhibitors, tumor necrosis factor-alpha (TNF-α) inhibitors,
             anti-IL-1 agents and janus kinase inhibitors within 5 half-lives or 30 days prior to
             Day 1.

          -  Use of chronic (>30 days) oral corticosteroids for a non-COVID-19-related condition in
             a dose higher than prednisone 10 mg or equivalent per day.

          -  Weight >165 kg or <40 kg.