bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
Condition: Mild to Moderately Active Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Polyphenon E®; Placebo Oral Tablet
Intervention description: Oral capsules; Oral tablet: placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Ulcerative colitis; EGCG; Green tea polyphenols; Inflammatory bowel disease; Colitis; IBD; Green tea

Summary:

      Green tea consists of several components, with most research focusing on the polyphenol
      fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied
      extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has
      been shown to effectively reduce the inflammation associated with animal models of
      inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the
      form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or female with mildly to moderately active ulcerative colitis

        Exclusion Criteria:

          -  Off prohibited medications for proscribed period of time

          -  Evidence of infectious colitis

          -  Labs outside of range

          -  Pregnancy or lactation
Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
Condition: Aphthous Stomatitis
MeSH terms: Stomatitis; Stomatitis, Aphthous
Intervention: Ibuprofen, Diphenhydramine and Aluminium MgS; Diphenhydramine and Aluminium MgS
Intervention description: 3 times daily for 3 days; 3 times daily for 3 days
Intervention MeSH terms: Diphenhydramine; Promethazine; Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Aphthous Stomatitis; Ibuprofen; treatment efficacy

Summary:

      The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and
      Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  possessing at least one painful aphthous ulcer in the last 3 days

          -  older than 10 years of age

        Exclusion Criteria:

          -  systemic disease or specific syndrome (such as Behcet's)

          -  pregnancy

          -  breastfeeding

          -  allergy to NSAIDs

          -  history of asthma, peptic ulcers, hepatic and renal failures and hemorrhagic disorders

          -  consumption of anti-inflammatory medications in the last 24 hours
Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing
Condition: Fracture
MeSH terms: Fractures, Bone
Intervention: Vitamin D3; Placebo
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Tibial Shaft; Tibia; Femoral Shaft; Femur; Vitamin D; Fracture Healing

Summary:

      The objective is to determine the effect of vitamin D3 supplementation on fracture healing at
      3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult men or women ages 18-50 years

          2. Closed or low grade open (Gustilo type I or II) tibial or femoral shaft fracture

          3. Fracture treated with a reamed, locked, intramedullary nail

          4. Acute fracture (enrolled within 7 days of injury)

          5. Provision of informed consent.

        Exclusion Criteria:

          1. Osteoporosis

          2. Stress fractures

          3. Elevated serum calcium (>10.5 mg/dL)

          4. Atypical femur fractures as defined by American Society for Bone and Mineral Research
             (ASBMR) criteria

          5. Pathological fractures secondary to neoplasm or other bone lesion

          6. Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's
             disease, osteomalacia, osteopetrosis, osteogenesis imperfecta etc.

          7. Patients with hyperhomocysteinemia

          8. Patients with an allergy to vitamin D or another contraindication to being prescribed
             vitamin D

          9. Patients currently taking an over the counter multivitamin that contains vitamin D and
             are unable or unwilling to discontinue its use for this study

         10. Patients who will likely have problems, in the judgment of the investigators, with
             maintaining follow-up

         11. Pregnancy

         12. Patients who are incarcerated

         13. Patients who are not expected to survive their injuries

         14. Other lower extremity injuries that prevent bilateral full weight-bearing by 6 weeks
             post-fracture.
An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: emollient (Cetaphil cream)
Intervention description: Cetaphil cream applied daily from birth
Intervention MeSH terms: Emollients
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Maximum age: 1 Month
Healthy volunteers: No
Keywords: Atopic Dermatitis; Prevention; Skin Barrier

Summary:

      The purpose of this study is to determine whether early use of a bland emollient in newborns,
      prior to the clinical signs of skin disease, will delay the onset or prevent the development
      of atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least one parent diagnosed with Atopic Dermatitis

          -  one parent or sibling with hayfever or asthma

        Exclusion Criteria:

          -  newborns with dermatitis at birth

          -  newborns born greater than four weeks prematurely

          -  newborns with medical problems necessitating prolonged hospitalization

          -  newborns diagnosed with any immune deficiency syndrome
Mucinex Exploratory Cold Study
Condition: Common Cold
MeSH terms: Common Cold
Intervention: guaifenesin (Mucinex); placebo
Intervention description: bid 7 days; bid 7 days
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 378.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: common cold

Summary:

      This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex
      in patients with colds. Patients will receive 7 days of treatment with either Mucinex or
      placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  common cold symptoms

          -  meet symptom severity

          -  females of child-bearing potential must have negative pregnancy test and use effective
             birth control

        Exclusion Criteria:

          -  chronic respiratory conditions

          -  significant heart, kidney, liver, or lung disease, uncontrolled hypertension or
             diabetes, cystic fibrosis, thyroid disorder

          -  pregnant or lactating

          -  known malignancy

          -  participation in any other clinical trial within 30 days of baseline

          -  related to another enrolled patient or persons involved directly or indirectly with
             the conduct of this study
CopiOs Posterolateral Fusion Procedure
Condition: Spondylolisthesis; Stenosis
MeSH terms: Spondylolisthesis
Intervention: Copios
Intervention description: Bone Void Filler
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 21 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: CopiOs; Degenerative spondylolisthesis,; stenosis with instability, or; degenerative disc disease as diagnosed by radicular signs and/or imaging studies

Summary:

      To compare radiographic data collection from patients undergoing instrumented PLF with
      CopiOs(R) BVF or instrumented PLF with autologous bone and to assess overall clinical
      outcomes. Patients will serve as self controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be skeletally mature; between the ages of 21 and 75

          -  Patients having degenerative spondylolisthesis, stenosis with instability, or
             degenerative disc disease as diagnosed by radicular signs and/or imaging studies

          -  Patients will be medically indicated for a single-level, instrumented PLF between L2
             and S1 per their surgeon

          -  Patient must be willing and able to comply with study requirements, including all
             necessary study related paperwork and follow-up visits

        Exclusion Criteria:

          -  Use of iliac crest bone graft;

          -  Any previous lumbar spinal surgeries at indicated level;

          -  Any medical or physical condition that would preclude the potential benefit of spinal
             surgery;

          -  Use of a dynamic stabilization systems;

          -  Sites where stresses on void will exceed the load strength of fixation of hardware;

          -  Segmental defects;

          -  Significantly impaired vascularity proximal to the surgical site;

          -  Sites in direct contact with articular space;

          -  Soft tissue deficit not allowing closure;

          -  Active systemic or local infection;

          -  Severe degenerative bone disease;

          -  Patients with osteoporosis who are actively under treatment;

          -  Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI>40 kg/m2);

          -  Active malignancy;

          -  Patients with a history of multiple allergies;

          -  Patients with known allergies to bovine collagen;

          -  Hypercalcemia;

          -  Pregnancy;

          -  Mental illness;

          -  Alcohol or drug abuse;

          -  Incarceration.
Translational Neuropsychopharmacology Research of Nicotine Addiction
Condition: Nicotine Dependence, Cigarettes
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline (VRN); N-Acetylcysteine (NAC); Placebo
Intervention description: VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.; NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment; Matched placebo
Intervention MeSH terms: Acetylcysteine; Varenicline; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will examine the effects of combining Varenicline (VRN) and N-acetylcysteine (NAC)
      on neural circuitry function and treating nicotine addiction. Healthy adult nicotine
      dependent cigarette smokers interested in quitting (n=110) will be randomized to one of four
      PBO-controlled conditions for 4 weeks: 1) VRN+NAC, 2) VRN+PBO, 3) NAC+PBO or 4) PBO+PBO.
      Following 1 week of medication, participants will be contingently reinforced for 3 days of
      smoking abstinence and be scanned using functional magnetic resonance imaging (fMRI)
      techniques, while nicotine deprived during a resting state and a cue-reactivity (CR) task.
      Participants will be followed over the next 3 weeks of treatment and clinical variables will
      be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 - 55

          2. Right Handed

          3. English fluency

          4. 20/20 vision with corrective lenses.

          5. Smoke ≥ 10 cigarettes/day for a minimum of two years and have an expired carbon
             monoxide (CO) concentration of ≥ 10 ppm (to confirm inhalation).

          6. Interest in quitting smoking or contemplating a quit attempt in the next 6 months

          7. If female, agreement to use birth control

        Exclusion Criteria:

          1. Past head injury or primary neurological disorder associated with MRI abnormalities,
             including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating
             diseases

          2. Any physical or intellectual disability affecting completion of assessments

          3. Any contraindication to MRI

          4. Positive urine drug screen for illicit substances (such as marijuana or cocaine).

          5. Current or past psychosis

          6. Electroconvulsive therapy in last 6 months

          7. Use of antidepressant medications or other psychotropic medications in the last month.

          8. Positive urine pregnancy test or current breast feeding status
A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel pre-filled syringes for weekly IV injections.; Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of
      Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who
      are at imminent risk of suicide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major Depressive episode of at least 4 weeks and not exceeding 24 months in
             duration at visit 1

          -  Have current, ongoing suicidality (ideation or behavior) of sufficient severity to
             warrant hospitalization based on the judgment of the investigator

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test.

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 1 month before Visit 1.

          -  Lifetime history or currently meet DSM-5 criteria for:

               1. Schizophrenia spectrum or other psychotic disorder

               2. Bipolar or related disorder

               3. Major neurocognitive disorder

               4. Neurodevelopmental disorder of greater than mild severity or of a severity that
                  impacts the participant's ability to consent, follow study directions, or
                  otherwise safely participate in the study.

               5. Dissociative disorder

               6. Posttraumatic stress disorder

               7. MDD with psychotic features

          -  Significant homicidal ideation or at imminent risk of injuring others or causing
             significant damage to property, as judged by the investigator.

          -  Prior participation in any investigational study of rapastinel/GLYX-13
A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: LY317615
Intervention description: 500 mg, oral, QD, up to six 28 day cycles
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will measure the effectiveness and any side effects of LY317615 in participants
      with diffuse large B-cell lymphoma (DLBCL: a sub-type of Non-Hodgkins Lymphoma).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of recurrent or refractory DLBCL.

          -  Adequate organ functions.

          -  Able to swallow capsules.

        Exclusion Criteria:

          -  More than 3 prior treatments for this disease.

          -  Serious heart problems.
The Influence of Postoperative Analgesia on Systemic Inflammatory Response and POCD After Femoral Fractures Surgery
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Femoral Fractures; Cognitive Dysfunction
Intervention: morphine; levobupivacaine
Intervention MeSH terms: Morphine; Levobupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: postoperative analgesia; postoperative cognitive disfunction

Summary:

      The purpose of this study is to determine whether epidural levobupivacaine applied for the
      purpose of post-operative analgesia compared to systemic analgesia with morphine leads to
      better pain control, stronger suppression of the inflammatory response and the production of
      inflammatory mediators, faster recovery of patients and consequently less incidence of
      postoperative cognitive dysfunction (POCD) in elderly patients after surgical treatment of
      femoral fractures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients age 65 and over

          -  fracture of the proximal femur

          -  preoperative assessment American Society of Anesthesiologists(ASA) score I - ASA III

          -  a written consent of the patient to participate in research

        Exclusion Criteria:

          -  patient non-compliance

          -  ASA status IV and IV above

          -  patients younger than 65 years

          -  dementia, Parkinson's disease, cerebrovascular accident history; simultaneous head
             injuries,the use of opioids and benzodiazepines longer than a month before the
             surgery; alcoholism; serious liver disease (class C according to Child-Pugh's
             classification); severe kidney disease that require dialysis

          -  result of MMSE test (Mini-Mental State Examination) under 17

          -  the existence of any contraindications for the implementation of regional anesthesia
             and one or other form of post-operative analgesia.
Re-boosting of HIV-1 Infected Subjects With Vacc-4x
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: Vacc-4x
Intervention description: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 63 Years
Healthy volunteers: No
Keywords: CD4; Clinical trial; Human immunodeficiency virus-1 (HIV-1); HIV; Immunomodulary; Infection; Phase II; Re-boost; Vaccine; Vacc-4x

Summary:

      During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced
      immunological response and eventually immune deficiency. Vacc-4x is a peptide-based HIV
      immunotherapy vaccine and is anticipated to strengthen the immune system's response to HIV.

      All patients participating in this trial have previously received the vacc-4x vaccine in
      order to reduce the amount of HIV-1 virus in the blood and increase the immune response. The
      primary objective of this study is to evaluate if a re-boost with Vacc-4x could further
      reduce the amount of HIV-1 virus and increase the immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed immunization regimen with Vacc-4x active and stopped ART (at Week 28) in the
             CT-BI Vacc-4x 2007/1 study. (No re-start of ART is required).

          2. Documented pre-study CD4 cell count ≥400x106/L.

          3. Documented pre-study viral load < 300 000copies/mL.

          4. Signed informed consent.

        Exclusion Criteria:

          1. Reported AIDS-defining illness within the previous year.

          2. Malignant disease.

          3. On chronic treatment with immune-suppressive therapy.

          4. Unacceptable values of the hematologic and clinical chemistry parameters, as judged by
             the Investigator, including creatinine values >1.5 x upper limit of normal (ULN), and
             AST, ALT and alkaline phosphatase (ALP) values >2.5 x ULN.

          5. Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis.

          6. Pregnant or breastfeeding women.

          7. Women of childbearing potential not using reliable and adequate contraceptive methods
             (defined as: use of oral, implanted, injectable, mechanical or barrier products for
             the prevention of pregnancy; practicing abstinence; sterile) during the 5 weeks
             re-boosting period including the DTH and for 2 weeks after the DTH test, or sexually
             active male subjects with partners of child bearing potential unwilling to practice
             effective contraception during the 5 weeks re-boosting period including the DTH and
             for 12 weeks after the DTH-test.

          8. Current participation in other clinical therapeutic studies.

          9. Incapability of compliance to treatment protocol, in the opinion of the Investigator.