bioihbjkbjnl/mcl2 huggingface dataset:
Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
Condition: Diabetic Foot Ulcer; Amputation
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: TCM; Placebo
Intervention description: The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.
The formula consisted of 12 herbs, viz:
Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae; Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.
The placebo was made with starch and colouring materials.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Healthy volunteers: No
Keywords: Diabetic Foot Ulcer; Traditional Chinese Medicine

Summary:

      Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent
      elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super
      imposed infections, all contribute towards the chronicity and failure of treatment.
      Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer
      that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like
      to try all methods of healing before accepting amputation.

      Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for
      diabetic patients suffering from chronic foot ulcers may promote healing so that major leg
      amputation can be avoided.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Well Controlled diabetic state

          -  Presence of gangrene or non-healing ulcer in diabetic patients over the foot or feet.
             Infection should be well controlled.

          -  Good glycaemic control

        Exclusion Criteria:

          -  Pregnant women and women at risk of conception

          -  Patients taking digitalis glycosides

          -  Patients with abnormal liver function tests

          -  Patients with plasma creatinine great then 150 umol/l or unstable renal function

          -  Poorly controlled Diabetes Mellitus

          -  Uncontrolled infection

          -  History of adverse reaction to herbal medicine

          -  Unstable medical conditions

          -  Non-compliance with regime
A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Brexpiprazole; Sertraline; Brexpiprazole Matching Placebo; Sertraline Matching Placebo
Intervention description: Brexpiprazole oral tablets.; Sertraline oral capsules.; Brexpiprazole matching placebo oral tablets.; Sertraline matching placebo oral capsules.
Intervention MeSH terms: Sertraline; Brexpiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as
      monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants between the years of 18-65 with a diagnosis of PTSD
             (diagnosis can be made at screening)

        Exclusion Criteria:

          -  Index trauma event >15 years before screening

          -  Index trauma event at age <16

          -  Any traumatic event within 3 months of screening
A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Condition: Metastatic Castration Resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Rucaparib
Intervention description: Rucaparib will be administered daily
Intervention MeSH terms: Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 277.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CRPC; PARP inhibitor; PARPi; BRCA; ATM; HRD; TRITON; homologous recombination; DNA repair; DNA defect; DNA anomaly; BARD1; BRIP1; CDK12; CHEK2; FANCA; NBN; PALB2; RAD51; RAD51B; RAD51C; RAD51D; RAD54L; germline; somatic; mCRPC

Summary:

      The purpose of this study is to determine how patients with metastatic castration-resistant
      prostate cancer, and evidence of a homologous recombination gene deficiency, respond to
      treatment with rucaparib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 18 years old at the time the informed consent form is signed

          -  Have a histologically or cytologically confirmed adenocarcinoma or poorly
             differentiated carcinoma of the prostate

          -  Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL
             (1.73 nM)

          -  Experienced disease progression after having received at least 1 but no more than 2
             prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based
             chemotherapy, for castration-resistant disease

          -  Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other
             homologous recombination deficiency

        Exclusion Criteria:

          -  Active second malignancy, with the exception of curatively treated non-melanoma skin
             cancer, carcinoma in situ, or superficial bladder cancer

          -  Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any
             platinum-based chemotherapy

          -  Symptomatic and/or untreated central nervous system metastases

          -  Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would,
             in the opinion of the investigator, interfere with absorption of rucaparib
Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats
Condition: Ovarian; Breast; Prostate; Pancreatic; Advanced Tumours
Intervention: olaparib
Intervention description: Tablets Oral BID
Intervention MeSH terms: Olaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: olaparib; PARP inhibitors; genetic BRCA1 mutation; BRCA2 mutation; solid tumour refractory

Summary:

      To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed
      genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed documented deleterious or suspected deleterious BRCA mutation. (The presence
             of a loss-of-function germline mutation in the BRCA1 and/or BRCA2 gene must be
             confirmed prior to consent according to local practice).

          -  Confirmed malignant solid tumours for which no standard treatment exists

          -  At least one lesion (measurable and/or non measurable) at baseline that can be
             accurately assessed by CT/MRI and is suitable for repeated assessment at follow up
             visits

        Exclusion Criteria:

          -  Any previous treatment with a PARP inhibitor, including olaparib

          -  Patients unable to swallow orally administered medication and patients with
             gastrointestinal disorders likely to interfere with absorption of the study medication

          -  Patients receiving any systematic chemotherapy, radiotherapy (except for palliative
             reasons) within 2 weeks from the last dose prior to study treatment (or a longer
             period depending on the defined characteristics of the agents used)
IVIG Treatment for Refractory Immune-Related Adult Epilepsy
Condition: Epilepsy, Cryptogenic; Epilepsy, Partial; Seizure Disorder; Autoimmune Diseases, Nervous System; Limbic Encephalitis
MeSH terms: Limbic Encephalitis; Epilepsy; Seizures; Encephalitis; Epilepsies, Partial; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases
Intervention: IVIG
Intervention description: IVIG 2 mg/kg in two divided doses with placebo crossover
Intervention MeSH terms: Immunoglobulins, Intravenous
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Refractory epilepsy; Cryptogenic epilepsy; Autoimmune disorders; IVIG; Immunomodulatory therapy; Autoantibodies

Summary:

      The purpose of the initial screening study is to find out if immune problems are an
      unrecognized cause of epilepsy in some patients. This study consists of a single blood
      sample, which will be tested for possible immune abnormalities. If enough patients are found
      who show immune abnormalities, those patients who are still having uncontrolled seizures will
      be invited to participate in a study of immune treatment with a compound called intravenous
      immunoglobulin (IVIG).

      The study hypothesis is that a significant proportion of the young-onset, refractory,
      image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and
      many of these patients will respond to immune therapies, including IVIG.

      At present, the importance of immune abnormalities in causing epilepsy, and the proper
      treatment when they are found, are both poorly understood. The investigators hope that this
      study will help us understand the cause of some cases that are difficult to treat.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of uncontrolled epilepsy with at least two seizures a month for three
             consecutive months.

          -  Age 18 to 50.

          -  Clinical semiology or electroencephalogram (EEG) consistent with partial onset
             epilepsy.

          -  Refractory to an adequate trial of two or more main-line anti-epileptic drugs.

          -  Ability to keep a seizure diary.

          -  Normal brain magnetic resonance imaging (MRI) - 3 Tesla, seizure protocol; with the
             exception of hippocampal sclerosis

        Exclusion Criteria:

          -  History of severe prematurity or neonatal distress, febrile seizures, moderate or
             sever traumatic brain injury, stroke, brain tumor, meningitis, encephalitis,
             neurocutaneous syndromes, or intracranial metal objects.

          -  Evidence of psychogenic epilepsy.

          -  History of convulsive status epilepticus.

          -  History of primary generalized epilepsy in a first degree relative.

          -  Known serious medical illness.
Varenicline In-Patient Study
Condition: Smoking Cessation
Intervention: Smoking cessation counseling; Placebo; Varenicline
Intervention description: Counseling sessions provided by a trained smoking counselor; Sugar pill without any active medication; Varenicline (an approved medication for smoking cessation)
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Varenicline; Placebo; Inpatient

Summary:

      This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study
      that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr)
      smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The sample, 40 women and 40 men, will be hospitalized patients recruited from Stanford
             Hospital and Clinics who report smoking at least 10 cigarettes per day prior to
             hospitalization, have confirmed tobacco use by cotinine testing, and an expected
             hospitalization of at least 3 days duration from the date of study enrollment.
             Intention to quit smoking will not be required for study participation.

        Exclusion Criteria:

        - Study exclusion criteria are: dementia or other brain injury precluding ability to
        participate; Alzheimer's Disease; Parkinson's Disease; Huntington's Disease; meningitis;
        seizure disorder of a sustained nature; delirium; brain surgery; drug and/or alcohol
        dependence; suicidal ideation; end-stage renal disease (i.e., on dialysis); hypertensive
        crisis; stroke; myocardial infarction (MI) with severe cardiac damage; pregnancy or
        breastfeeding; non-English speaking; complete homelessness; or currently engaged in tobacco
        treatment. Study staff will consult with clinical staff prior to approach for study
        enrollment. In cases of severe renal impairment (estimated creatinine clearance <30
        mL/min), medical staff will consult with participants' physician to assess the
        appropriateness for study enrollment.
Naltrexone for Individuals of East Asian Descent
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Naltrexone; Placebo
Intervention description: Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors; Sugar pill, matched to the active study medication in capsule size and color
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: alcohol use disorder; naltrexone; Asian American; pharmacogenetics; OPRM1 gene

Summary:

      This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene
      on biobehavioral and neural markers of response to naltrexone in individuals of East Asian
      descent, an ethnic group most likely to express the positive predictive allele.
    

Eligibility criteria:

        Inclusion Criteria:

          -  current (i.e., past month) alcohol dependence

          -  East Asian ethnicity (i.e., Chinese, Korean, or Japanese)

          -  Prospective genotyping for the A118G SNP of the mu opioid receptor (OPRM1) gene to
             allow for balanced groups on all three genotypes (AA, AG, GG)

        Exclusion Criteria:

          -  lifetime DSM-IV of drug dependence (other than alcohol or nicotine)

          -  current use of psychoactive drugs as determined by self-reports and verified using
             toxicology testing

          -  lifetime diagnosis of bipolar disorder or any psychotic disorder

          -  contraindications to an MRI scan (including left handedness)
A Study of LY2127399 in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399
Intervention description: Administered subcutaneously
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate how LY2127399 works in participants with rheumatoid arthritis
      (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399
      via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study
      procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA
      activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of adult onset RA disease according to revised 1987 American Rheumatism
             Association (ARA) criteria and currently have a documented history of positive for
             rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab)
             and have moderately to severely active RA despite ongoing methotrexate (MTX) therapy

          -  Have active RA defined as the presence of at least 8/68 tender and at least 8/66
             swollen joints, as determined by the tender joint count and swollen joint count
             assessment forms

          -  Have a screening C-reactive protein (CRP) measurement greater than 1.2 times upper
             limit of normal or erythrocyte sedimentation rate (ESR) greater than 28
             millimeters/hour (mm/hr)

          -  Have a clinically inflamed joint suitable for synovial biopsy procedure

        Exclusion Criteria:

          -  Have used an unstable dose of non-steroidal anti-inflammatory drugs (NSAIDs) within 6
             weeks prior to baseline

          -  Have used oral corticosteroids at average daily doses of >10 milligrams/day (mg/day)
             of prednisone or its equivalent within 6 weeks prior to baseline

          -  Have received any parenteral corticosteroid injection within 6 weeks of baseline

          -  Have used other disease-modifying anti-rheumatic drugs (DMARDs) other than MTX,
             hydroxychloroquine, and/or sulfasalazine in the 8 weeks prior to baseline
A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption
Condition: Acneiform Rash; Papulopustular Eruption
MeSH terms: Exanthema
Intervention: Triamcinolone
Intervention description: 6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.
Intervention MeSH terms: Triamcinolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, controlled, phase II clinical study is designed to assess the efficacy of
      preemptive treatment with topical steroids in preventing the papulopustular eruption induced
      by epidermal growth factor receptor inhibitor (EGFRI) treatment in cancer patients.
      Participants will be followed up for 6 weeks of twice daily application of triamcinolone
      cream to the face, chest, and back.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a histologically or cytologically confirmed cancer diagnosis for
             which EGFRI treatment is indicated

          -  Initiation of topical steroids or control treatment within 3 days of initiation of
             cetuximab, erlotinib, panitumumab, or afatinib

          -  Patients must be age ≥ 18 years.

          -  Life expectancy of greater than 6 weeks

          -  Patient able to use topical medications reliably and complete questionnaires with
             assistance if needed

          -  Patients must have the ability to understand and the willingness to sign a written
             informed consent prior to registration on study.

        Exclusion Criteria:

          -  Patients who have used systemic or topical steroids within 7 days of trial
             registration, or start systemic or topical steroids for reasons unrelated to trial
             during the 6-week follow up period

          -  Patients who have used antibiotics within 7 days of trial registration, or start
             antibiotics for other conditions during the 6-week follow up period

          -  History of allergic reactions to topical steroids

          -  Patients with any rash at the time of study registration

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Patients using any other topical medications in the treatment areas (face, chest, or
             back).
Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Multivalent; Prevnar 13
Intervention description: Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 565.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel
      design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal
      vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent
      pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent
      pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a
      single dose of multivalent pneumococcal conjugate vaccine (Group 3).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days)
             at the time of consent (the day of birth is considered day of life 1).

          -  Healthy infant determined by medical history, physical examination, and clinical
             judgment.

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational pneumococcal vaccine.

          -  Prior receipt of routine pediatric vaccines, with the exception of hepatitis B
             vaccine.

          -  Previous receipt of >1 dose of hepatitis B vaccine.

          -  Prior hepatitis B vaccine must have been administered at age <30 days.

          -  Major known congenital malformation or serious chronic disorder.

          -  Receipt of blood/plasma products or immunoglobulins.