bioihbjkbjnl/mcl2 huggingface dataset:
Study of orBec® as Monotherapy in the Treatment of Patients With Upper GI Symptoms Caused by Chronic Graft Versus Host Disease (GVHD)
Condition: Chronic Gastrointestinal Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Intervention: orBec; Placebo
Intervention MeSH terms: Beclomethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BDP; orBec; GVHD; beclomethasone dipropionate; bone marrow transplant; hematopoietic cell transplant; HCT; stem cell transplant; marrow transplant; SCT; beclomethasone 17,21-dipropionate

Summary:

      Use of an oral topically-active glucocorticoid with limited side effects may control the
      gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receipt of allogeneic hematopoietic cell transplant >100 days prior to consent

          -  Documented cGVHD as defined by the NIH consensus criteria in at least one organ system
             other than the GI tract (for example, cGVHD of the oral cavity would qualify as a
             criterion)

          -  Endoscopic findings consistent with GI GVHD

          -  Must be able to swallow tablets

          -  Must be able to read and understand informed consent

          -  Adequate birth control methods for the duration of the study

        Exclusion Criteria:

          -  >500 mL/day of diarrhea on any 1 day within 3 days prior to the first dose of study
             drug

          -  GI infection

          -  Multi-organ failure or other condition that, in the opinion of the investigator, would
             compromise the patient's ability to complete the study.

          -  HIV seropositivity

          -  Pregnant or nursing female

          -  Use of any investigational drug to treat chronic GVHD within 28 days of the first dose
             of study drug

          -  Evidence of recurrent or progressing malignant disorder that was the indication for
             HCT
Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Diclofenac Capsules low dose; Diclofenac Capsules high dose
Intervention MeSH terms: Diclofenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The purposes of this study are to evaluate the safety and tolerability and to model the
      single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children
      ages 6 to <17 years experiencing mild to moderate acute postoperative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight ≥18 kilograms.

          -  Mild to moderate acute pain requiring treatment with analgesic medication.

          -  Willing to have blood samples taken for PK sampling using an indwelling catheter.

          -  Must be able to swallow capsules and can tolerate oral medication.

          -  For females: is not of reproductive potential (defined as premenarchal) or is
             practicing an acceptable method of birth control

        Exclusion Criteria:

          -  Severe acute pain

          -  Chronic analgesic or glucocorticoid use for any condition within 6 months before
             dosing with study drug.

          -  Emergency surgery

          -  History of allergic reaction, hypersensitivity, or clinically significant intolerance
             to diclofenac, aspirin, codeine, acetaminophen, or any NSAID

          -  History of peptic ulcer disease or a GI event (eg, perforation, obstruction, or bleed)
             within 6 months before screening

          -  Current use of any medication that may cause a clinically significant drug interaction
             when co-administered with diclofenac

          -  Current use of any medication that might affect the pharmacokinetics of diclofenac

          -  History of bleeding disorders .

          -  Developmental delay or behavioral problems that would make it difficult to assess
             pain.

          -  Impaired liver function

          -  Clinically significant renal or cardiovascular disease

          -  Any medical condition that compromises ability to swallow, absorb, metabolize, or
             excrete the study drug

          -  Previously received any investigational product or device within 30 days before
             Screening or scheduled to receive an investigational device or another investigational
             drug (other than that in this study) during the course of this study.

          -  Previous participation in this clinical study or currently taking diclofenac.
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: PTH analog; Placebo; Forsteo (Teriparatide)
Intervention description: A recombinant 1-31 amino acid fragment of PTH.; A recombinant 1-34 amino acid fragment of PTH.
Intervention MeSH terms: Teriparatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 97.0
Sex: Female
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Bone Density Conservation Agents

Summary:

      This study is designed to provide information about the bone anabolic properties and
      absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of
      24 weeks to postmenopausal women with osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy postmenopausal women (45-80 years old) with a diagnosis of osteoporosis

        Exclusion Criteria:

          -  Use of estrogen or hormone replacement therapy

          -  Use of bisphosphonates, strontium ranelate or denosumab

          -  Use of parathyroid analogues or other bone metabolic agents

          -  Medical conditions which might alter bone metabolism

          -  Any known clinically significant disease affecting calcium metabolism or history of
             metabolic disorders including Paget's disease, osteogenesis imperfecta, or
             osteomalacia

          -  Impairment of thyroid function
Pemetrexed and Cisplatin Treatment Before Surgery in Non Small Cell Lung Cancer
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed; cisplatin
Intervention description: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles; 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To determine the response to this regimen for therapy prior surgery in patients with locally
      advanced disease or metastatic disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of non-small-cell carcinoma of the lung

          -  Patients with locally advanced disease or metastatic disease, candidates to surgery
             after evaluation by oncologist and thoracic surgeon

          -  Tumour with possibility of curative surgery

          -  At least one uni-dimensionally measurable lesion

          -  Adequate pulmonary function to perform the planned surgical resection

        Exclusion Criteria:

          -  Active infection (at the investigator's discretion)

          -  Pregnancy or breast-feeding

          -  Serious concomitant illness at the investigator's discretion

          -  Previous diagnosis of malignant disease

          -  They have received treatment during the last 30 days with a drug, other than the study
             drug, that has not received regulatory approval for any indication at the time of
             their entry in the study
Volumes of Administration for Intranasal Midazolam
Condition: Children Requiring Sedation to Facilitate Laceration Repair
MeSH terms: Lacerations
Intervention: Intranasal midazolam
Intervention description: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
Intervention MeSH terms: Midazolam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 1 Year
Maximum age: 7 Years
Healthy volunteers: No
Keywords: Sedation; Laceration repair; Children; Intranasal; Midazolam

Summary:

      The purpose of this study is to determine exactly how much drug volume should be administered
      into each nare, so that the drug absorption can be maximized and the amount that runs out of
      the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug
      given intranasally. The investigators will determine this ideal "volume of administration" by
      studying intranasal midazolam in children who require sedation to facilitate laceration
      repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic
      outcomes associated with each volume of administration. We will block randomize children to
      receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200
      microliters (mcL), 500 mcL, or 1000 mcL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1 to 7 years of age, inclusive.

          -  Require intranasal midazolam for minimal sedation to facilitate laceration repair.

        Exclusion Criteria:

          -  Weight less than 10 kg.

          -  Known allergy to midazolam.

          -  Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily
             cleared

          -  Inability to speak English or Spanish

          -  Developmental delay, psychiatric illness, neurologic impairment, or altered mental
             status; or illnesses associated with chronic pain (e.g. sickle cell disease,
             inﬂammatory bowel disease).

          -  Foster children or wards.
Cognitive Enhancement Through Transcranial Laser Therapy
Condition: Healthy Participants; Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Intervention: LLLT; Placebo
Intervention description: The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA).; The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA). However, the placebo group will receive approximately 1/12th of the cumulative energy density as the treatment group.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 91.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a mechanism-driven translational project to test the efficacy of transcranial
      low-level light/laser therapy (LLLT), for enhancing cognitive function in middle-aged and
      older adults and participants with Mild Cognitive Impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and postmenopausal women, aged 45 and older

          -  Participants with Mild Cognitive Impairment

        Exclusion Criteria:

          -  neurological disease (e.g., large vessel stroke, seizure disorder, Parkinson's
             disease, Alzheimer's disease, clinically significant traumatic brain injury with loss
             of consciousness > 30 minutes, multiple sclerosis, or brain infection/meningitis

          -  baseline IQ < 85 placing them below the average range of intellectual functioning

          -  major psychiatric illness (e.g., schizophrenia, bipolar disorder) or substance abuse
             (diagnosed abuse and/or previous hospitalization for substance abuse)

          -  severe cardiovascular disease (e.g., pacemaker), chronic obstructive pulmonary
             disease, liver or kidney disease, inflammatory illness
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
Condition: Fracture Healing
MeSH terms: Fractures, Bone
Intervention: Romosozumab; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Fracture Healing; Tibial Diaphyseal Fracture

Summary:

      The primary objective of this study is to investigate the effect of romosozumab compared with
      placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in
      the midsection of the shinbone).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Skeletally mature adults, age 18 to 85 years with radiographically closed growth
             plates

          -  Fresh unilateral closed or Gustilo type I or type II open tibial fracture

          -  Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open
             fractures only) intramedullary nailing

        Exclusion Criteria:

          -  Major polytrauma or significant axial trauma

          -  Associated lower extremity fracture that will delay subject's ability to bear weight
             beyond the normal time expected for a tibial shaft fracture

          -  Use of bone grafts at the time of fracture fixation

          -  Pathological fracture or metabolic or bone disease

          -  History of symptomatic spinal stenosis or facial nerve paralysis

          -  Malignancy within the last 5 years

          -  Evidence of the following (currently or within the past 5 years): elevated
             transaminases, significantly impaired renal function, current hyper- or hypocalcaemia

          -  Use of agents affecting bone metabolism

          -  Subject refuses to use appropriate methods of contraception
Rosiglitazone Effect on Mitochondria and Lipoatrophy
Condition: HIV Infections
MeSH terms: Lipodystrophy
Intervention: Rosiglitazone; Placebo
Intervention description: Rosiglitazone 4mg BID; Placebo for rosiglitazone
Intervention MeSH terms: Rosiglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mitochondria; HIV; lipoatrophy

Summary:

      The purpose of this study is to examine the effect of rosiglitazone on limb fat and
      mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that
      does not contain stavudine (d4T) or zidovudine (AZT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lipoatrophy

          -  Thymidine sparing ARV for at least 24 weeks

          -  Prior thymidine NRTIs for at least 12 months

        Exclusion Criteria:

          -  Diabetes

          -  Heart failure

          -  Liver disease

          -  Hormonal therapies
Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: olaparib; paclitaxel; Placebo
Intervention description: 100mg BID oral tablet continuous; iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle; 100mg BID oral tablet to match olaparib tablet
Intervention MeSH terms: Paclitaxel; Olaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Poly(ADP ribose); polymerase (PARP); Gastric cancer; olaparib; PARP inhibitor; ATM AZD2281; Ku0059436; Homologous Recombination deficiency (HRD); Recurrent gastric cancer; metastatic gastric cancer

Summary:

      To assess the efficacy of olaparib when given in combination with paclitaxel compared with
      paclitaxel alone as defined by progression-free survival (PFS), in all patients with
      recurrent and metastatic gastric cancer who progress following first-line therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent or metastatic gastric cancer that has progressed following first
             line-therapy

          -  Confirmed ATM protein status by IHC archival tumour sample

          -  At least one lesion (measurable and/or non-measurable) that can be accurately assessed
             by imaging (CT/MRI) at baseline and follow up visits

        Exclusion Criteria:

          -  More than one prior chemotherapy regimen for the treatment of gastric cancer in the
             metastatic or recurrent setting

          -  Any previous treatment with a PARP inhibitor, including olaparib

          -  Patients with second primary cancer, except; adequately treated non melanoma skin
             cancer, curatively treated in situ cancer of the cervix, or other solid tumours
             curatively treated with no evidence of disease for >5 years
Effect of OC000459 on Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: OC000459
Intervention description: Oral CRTH2 antagonist
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether OC000459 is in reducing disease severity
      and preventing flares in people with moderate to severe atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Atopic dermatitis as defined by a score of at least 9 on the Nottingham Eczema
             Severity Score, stratified into moderate (score 9 to 11 inclusive) and severe (score
             12 to 15 inclusive) disease.

          2. Fully documented history of the use of topical corticosteroids (TCS) and/or topical
             calcineurin inhibitors (TCI). Subjects without a fully documented history will be
             excluded from the study.

          3. Male and female subjects with moderate to severe atopic dermatitis treated with by TCS
             and/or TCI (with or without emollients) at the time of screening and over the previous
             month.

          4. Subjects must have had at least 1 AD flare in the previous 6 months.

        Exclusion Criteria:

          1. Receipt of any forbidden medication including over the counter preparations and herbal
             medicines within 14 days of the first dosing day with the exception of paracetamol up
             to a maximum of 2g daily.

          2. Use of systemic steroids within 4 weeks of the screening visit, light therapy or
             immunosuppressants within 2 months of the screening visit.

          3. Use of NSAIDs.

          4. Subjects initially diagnosed with AD aged 2 years or over will be excluded unless they
             have either coexisting or a history of asthma and/or allergic rhinoconjunctivitis.

          5. Subjects with contact dermatitis will be excluded.

          6. Subjects with acute skin infection or acute disease flares. Subjects with active
             flares during the screening to randomisation period (visits 1 to 2) may be managed
             according to normal clinical practice and be rescreened once their flares are no
             longer active.

             -
A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
Condition: HER-2 Gene Amplification; Esophagus Cancer; Gastroesophageal Junction Cancer; Stomach Cancer
MeSH terms: Stomach Neoplasms; Esophageal Neoplasms
Intervention: MM-111; Paclitaxel; Trastuzumab
Intervention description: MM-111 (IV); Paclitaxel (IV); Trastuzumab (IV)
Intervention MeSH terms: Paclitaxel; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER-2 Gene Amplification; Esophagus Cancer; Gastroesophageal Junction Cancer; Stomach Cancer; Her2 Positive; Her2+; Esophageal Cancer; Metastatic

Summary:

      To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more
      effective than paclitaxel and trastuzumab alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have documentation of histologically or cytologically confirmed
             metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or
             stomach

          -  Patients must have documentation of histologically or cytologically confirmed HER2
             expression

          -  Patients must be ≥18 years of age

          -  Patients must have ECOG PS of 0, 1, or 2

          -  Patients must have adequate hematologic status, renal and hepatic function

        Exclusion Criteria:

          -  Patients with known hypersensitivity to any of the components of MM-111

          -  Patients with a known history of hypersensitivity to paclitaxel or other drugs
             formulated in Cremophor® EL

          -  Patients with a known history of hypersensitivity to trastuzumab or any of its
             components (group 1 patients only)

          -  Patients with an active infection or with an unexplained fever >38.5°C