bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
Condition: HIV Infections
MeSH terms: Smallpox
Intervention: IMVAMUNE (MVA-BN)
Intervention description: 2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 581.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; treatment experienced; treatment vaccinia naive

Summary:

      The purpose of this study is to gather information on the safety and immunogenicity of an
      investigational smallpox vaccine in HIV infected populations. Subjects will receive two
      vaccinations
    

Eligibility criteria:

        -  Genders eligible for Study: Both

          -  Age: between 18 and 55 years

          -  Healthy volunteers are accepted

        Inclusion Criteria:

          -  Subjects tested positive for HIV-1 infection (HIV-infected subjects).

          -  Subjects that are tested negative for HIV (Healthy subjects).

          -  Either on stable antiretroviral therapy or not on antiretroviral therapy.

          -  CD4 cells > = 200 - 750/µl.

          -  Subjects must be in good general health except for HIV infection.

          -  Women must not be pregnant and use an acceptable method of contraception.

        Exclusion Criteria:

          -  Impairment of immunologic function (other than HIV infection).

          -  History of coronary heart disease, myocardial infarction, angina, congestive heart
             failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood
             pressure.

          -  Uncontrolled serious infection.

          -  History of or active autoimmune disease.

          -  History or clinical manifestation of clinically significant and severe hematological,
             renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal
             disorders.

          -  History of an immediate family member (father, mother, brother, or sister) who has had
             onset of ischemic heart disease before the age of 50 years.

          -  High risk of developing a myocardial infarction or coronary death.

          -  History of intravenous drug abuse (within the last 12 months).

          -  Known allergy to egg or aminoglycoside (gentamicin).

          -  History of anaphylaxis or severe allergic reaction.

          -  Subjects undergoing treatment for tuberculosis infection or disease.

          -  Chronic administration of systemic immuno-suppressants.
A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
Condition: Pan Tumor
MeSH terms: Neoplasms
Intervention: Nivolumab; Ipilimumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 212.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: TMB-H

Summary:

      The purpose of this study is to demonstrate the clinical activity of nivolumab in combination
      with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a refractory, metastatic, or unresectable histologically or
             cytologically confirmed solid malignant tumor with high tumor mutational burden
             (TMB-H) who are refractory to standard local therapies, or for which no standard
             treatment is available.

          -  Must be able to provide tissue and blood TMB-H testing results

          -  Must have measurable disease for response assessment

        Exclusion Criteria:

          -  Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma
             (RCC) or hematological malignancy as primary site of disease

          -  Participants who received prior treatment with an anti-programmed death-1 (anti-PD-1),
             anti-programmed death ligand 1 (anti-PD-L1), anti-programmed death ligand 2
             (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4
             (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell
             co-stimulation or checkpoint pathways

          -  Treatment with any chemotherapy, radiation therapy, biologics for cancer, or
             investigational therapy within 28 days of first administration of study treatment

        Other protocol defined inclusion/exclusion criteria apply.
NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
Condition: Coronavirus; Covid19
MeSH terms: COVID-19
Intervention: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group; Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group
Intervention description: Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.; Participants will receive sham taVNS stimulation for weeks 1&2 and active stimulation for weeks 3&4 of the stimulation portion of this study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of the research is to test out a new form of treatment that examines stimulation
      of a nerve in the participant's ear. This is called transcutaneous (through the skin)
      auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive
      stimulation through the ear. The taVNS device looks like an ear bud used with a smart phone
      or computer. The study team is investigating whether or not taVNS can treat neurologic
      symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may
      experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue,
      irritability, etc. This study is entirely online and all assessments will be completed
      virtually.
    

Eligibility criteria:

        Inclusion Criteria:

          -  COVID positive

          -  At home

          -  Afebrile

          -  Anxiety

          -  Depression

          -  Vertigo

          -  Anosmia

          -  Headaches

          -  Irritability

          -  Cognitive Processing

        Exclusion Criteria:

          -  Damage to left ear anatomy

          -  Unstable hemodynamic effects

          -  Ischemic or hemorrhagic stroke after developing COVID

          -  Unable to give consent, follow instructions

          -  Unable to read or write or speak English

          -  No access to home WiFi
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Condition: Stage V Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Eculizumab
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized
      recipients of deceased donor kidney transplants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female participants ≥18 years old.

          2. Participants with Stage V chronic kidney disease who received a kidney transplant from
             a deceased donor to whom they were sensitized.

          3. History of prior exposure to HLA (human leukocyte antigen):

               -  Prior solid organ or tissue allograft

               -  Pregnancy

               -  Blood transfusion

               -  Prior exposure to specific donor's HLA

        Exclusion Criteria:

          1. Has received treatment with eculizumab at any time prior to enrolling in this study.

          2. Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased
             donor.

          3. History of severe cardiac disease.

          4. Prior splenectomy.
Effectiveness of Nucleoside Supplementation or Switch to Tenofovir in Reversing Fat Loss in HIV Infected Adults
Condition: HIV Infections; Lipodystrophy; Metabolic Diseases; Nutrition Disorders
MeSH terms: Lipodystrophy; Metabolic Diseases; Nutrition Disorders
Intervention: NucleomaxX; Tenofovir Disoproxil Fumarate
Intervention description: NucleomaxX 36 grams TID every other day; Switch of thymidine nucleoside reverse transcriptase inhibitors to Tenofovir Disoproxil Fumarate
Intervention MeSH terms: Tenofovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lipoatrophy; mitochondria; HIV; treatment experienced

Summary:

      HIV lipoatrophy is a condition marked by fat loss; it occurs in many patients taking
      antiretroviral (ARV) therapy that includes nucleoside reverse transcriptase inhibitors
      (NRTIs). Lipoatrophy may be related to mitochondrial toxicity, a condition that can damage
      the heart, nerves, muscles, kidneys, and liver, and can affect the body's ability to produce
      energy. NucleomaxX is a food supplement consisting of a sugar cane extract high in
      nucleosides, which are building blocks that may counteract the negative effects of NRTIs.
      Tenofovir disoproxil fumarate (TDF) is an NRTI that may cause less lipoatrophy than other
      drugs in its class, such as zidovudine (ZDV) or stavudine (d4T). The purpose of this study is
      to determine whether nucleoside supplementation with NucleomaxX and substitution of TDF for
      ZDV or d4T in an ARV regimen can reverse fat loss caused by mitochondrial toxicity in HIV
      infected adults.

      Study hypotheses: 1) The substitution of TDF for d4T or ZDV in patients with HIV lipoatrophy
      will result in an increase in mitochondrial DNA content in fat, skeletal muscle, and
      peripheral blood mononuclear cells (PBMCs), which in turn will lead to an improvement in
      mitochondrial function as assessed by electron transport chain (ETC) and oxidative
      phosphorylation pathway (OXPHOS) activity. The latter should lead to a decrease in fat
      apoptosis and in mitochondrial and lipid oxidative damage biomarkers. 2) Supplementation with
      uridine (via NucleomaxX) will increase mtDNA content in adipose tissue and increase body fat
      content.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of HIV lipoatrophy

          -  Receiving a stable stavudine- or zidovudine-containing ARV regimen

          -  HIV-1 RNA viral load less than 50 copies/ml

        Exclusion Criteria:

          -  Coagulopathies or other bleeding disorders

          -  Diabetes requiring medication

          -  Creatinine clearance less than 50 ml/min

          -  Pregnancy or breastfeeding
A Multi-center 12-week Study of HMS5552 in T2DM
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: HMS5552; HMS5552; HMS5552; HMS5552; Placebo
Intervention description: 75mgQD; 100mgQD; 50mgBID; 75mgBID; QD/BID
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 258.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GKA,T2DM,HMS5552

Summary:

      This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type
      2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will
      receive placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male & female, 40~75 years old

          2. T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3
             months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone

          3. HbA1c 7.5~10.5% at screening and pre-randomization

          4. Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening,
             and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization

          5. BMI: 19~30kg/m^2 & TG<5.5mmol/L

        Exclusion Criteria:

          1. T1D，secondary DM, pre-DM

          2. kidney diseases or eGFR MDRD<60ml/min/1.73m^2

          3. unstable CVDs

          4. liver diseases

          5. mental or CNS diseases
Efficacy and Safety of VDA-1102 Ointment in the Treatment of Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Placebo; 5% VDA-1102; 10% VDA-1102
Intervention description: 200 mg applied once-daily for 28 days; 200 mg applied once-daily for 28 days; 200 mg applied once-daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: topical ointment; skin; hexokinase; precancerous conditions; carcinoma, squamous cell

Summary:

      This Phase 2 clinical trial is a multi-center, randomized, double-blind, placebo-controlled,
      multiple-dose, parallel-cohort study to assess the efficacy, safety and tolerability of
      VDA-1102 in the treatment of actinic keratosis (AK) on the head of male and female adult
      subjects.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Subject has a minimum of 4 and a maximum of 8 discrete Grade 1-2 AK lesions within a
             single 25 square centimeter area of skin on their scalp or face

        Main Exclusion Criteria:

          -  Subject is: (a) pregnant; (b) lactating; (c) planning to become pregnant during the
             study, or (d) fertile and they or their fertile partner is unable or unwilling to use
             the required contraceptive methods

          -  Subject is immunosuppressed

          -  Subject has used any of the following topical treatments in the Treatment Field: (1)
             topical retinoids within 8 weeks of Screening or (2) micro-dermabrasion, laser
             ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod, ingenol, or
             other topical treatments for AK or that might impact AK within 12 weeks of Screening.

          -  Subject has used systemic retinoid therapy within 6 months of Screening Visit.
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.
A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Condition: Homozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: ALN-PCSSC; Standard of Care
Intervention description: ALN-PCSSC is a small interfering ribonucleic acid (siRNA) that inhibits PCSK9 synthesis and is given as SC injections.; Included maximally-tolerated statin therapy and/or other low density lipoprotein-cholesterol (LDL-C)-lowering therapies.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety, tolerability, and efficacy of ALN-PCSSC in
      participants with homozygous familial hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, ≥12 years of age with a diagnosis of homozygous familial
             hypercholesterolemia by genetic confirmation or a clinical diagnosis based on a
             history of an untreated low-density lipoprotein cholesterol (LDL-C) concentration >500
             mg/deciliter (dL) [13 millimoles/liter (mmol/L)] together with either xanthoma before
             10 years of age or evidence of heterozygous familial hypercholesterolemia in both
             parents.

          -  Stable on a low-fat diet.

          -  Stable on pre-existing, lipid-lowering therapies (such as statins,
             cholesterolabsorption inhibitors, bile-acid sequestrants, or combinations thereof) for
             at least 4 weeks with no planned medication or dose change for the duration of study
             participation.

          -  Fasting central lab LDL-C concentration >130 mg/dL (3.4 mmol/L) and triglyceride
             concentration <400 mg/dL (4.5 mmol/L).

          -  Body weight of 40 kilograms (kg) or greater at screening.

        Exclusion Criteria:

          -  LDL or plasma apheresis within 8 weeks prior to the screening visit, and no plan to
             receive it during the study because of the attendant difficulty in maintaining stable
             concentrations of LDL-C while receiving apheresis.

          -  Use of mipomersen or lomitapide therapy within 5 months of screening.

          -  Previous treatment with monoclonal antibodies directed towards PCSK9 within 8 weeks of
             screening.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Zinc to Treat Tinnitus in the Elderly
Condition: Tinnitus
MeSH terms: Tinnitus
Intervention: Zinc; Placebo oral capsule
Intervention description: Zinc taken once daily; Placebo capsules taken once daily
Intervention MeSH terms: Zinc; Zinc Sulfate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: placebo pill
Enrollment: 116.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: tinnitus, zinc

Summary:

      There is widespread belief and some evidence to indicate that zinc can successfully treat
      tinnitus. Zinc deficiency is more likely to occur in the elderly . The primary objective of
      this study is to establish the effectiveness of zinc for the treatment of tinnitus in
      individuals 60 years of age and older. Subjects will be randomly assigned to either receive
      zinc daily or a placebo. After 4 months and a 1-month wash-out, the subjects will be crossed
      over to the other group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  60 years of age or older

          -  Tinnitus for 6 months or more

          -  Normal copper levels

          -  Be generally healthy

        Exclusion Criteria:

          -  Have a treatable otological disorder

          -  Involved in litigation

          -  Have or are suspected of having a serious psychiatric problem

          -  Involved in other treatments for tinnitus

          -  Are taking drugs which might interact with zinc and result in tinnitus

          -  Have copper deficiency

          -  Have Zinc levels above normal

          -  Are cognitively impaired.