bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In COPD Patients.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: GW642444M; GW642444H; placebo
Intervention description: drug; drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: pharmacodynamics,; Chronic Obstructive Pulmonary Disease (COPD); safety,; COPD patients; pharmacokinetics,; tolerability,; GW642444,

Summary:

      This study will involve the use of a new compound, GW642444 that is being developed for the
      treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on
      cells in the lungs, causing some of the muscles around the lungs to relax and open up better
      (bronchodilation), making breathing easier. When a medicine is made into a form ready to be
      given to patients, the active ingredient is often prepared in the form of a salt, and
      inactive ingredients (excipients) are often added. Inactive ingredients might be used to help
      a medicine work better, to make it easier to produce the medicine, or to make it easier to
      get an accurate dose of medicine. In previous studies the study drug has been given as a dry
      powder in the form of either the 'H' salt (with the excipient lactose), or in the form of the
      'M' salt (with the excipients lactose and cellobiose octaacetate). In this study the 'M' salt
      form of the study drug has been prepared with lactose and a new excipient called magnesium
      stearate (instead of cellobiose octaacetate). Participants in this study will receive both
      the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate. This
      study will be the first time the new 'M' salt form of the study drug will be given to COPD
      patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female (of non-childbearing potential) > or = 40 years

          -  History of COPD

          -  Smoker or ex-smoker

          -  Body weight > or = 50 kg with BMI 18-32 kg/m2

        Exclusion criteria:

          -  History of significant disease

          -  Subjects with a primary asthma diagnosis

          -  Alpha-1 antitrypsin deficiency as underlying cause of COPD

          -  Recent respiratory tract infection

          -  Poorly controlled COPD

          -  Blood potassium level < 3.5mmol/L

          -  Short-term or long tern oxygen therapy

          -  Recent participation in another trial

          -  History of drug or alcohol abuse

          -  Known allergies

          -  Recent blood donation

          -  ECG abnormalities
Translating Neuroprediction Into Precision Medicine Via Brain Priming
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Intervention: Oxytocin; Pivotal Response Treatment; Placebo
Intervention description: Oxytocin nasal spray.; An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.; Placebo nasal spray.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eighty children will be randomly assigned to receive PRT with either oxytocin (forty children) or a placebo (forty children).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 5 Years
Maximum age: 9 Years
Healthy volunteers: No

Summary:

      The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT)
      on the development of language, social, and play skills in young children with Autism
      Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an
      enhancer of response to PRT. Participants will be randomly assigned to either an intranasal
      OXT group or a placebo group. Neither the research team nor the participants will know or
      choose which group the participant is assigned to. Children in both groups will participate
      in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels
      of activity in and functional connectivity among certain PRT-response brain regions will
      benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of
      PRT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Fit the age requirement: age 5-9

          2. Have been diagnosed previously with an ASD and meet criteria for ASD when
             characterized by research team

          3. Be in good medical health

          4. Be cooperative with testing

          5. Speak English in the family

          6. Successfully complete an fMRI scan

          7. Full-scale intelligence quotient (IQ)>70

        Exclusion Criteria:

          1. Any metal or electromagnetic implants, including:

               1. Cardiac pacemaker

               2. Defibrillator

               3. Artificial heart valve

               4. Aneurysm clip

               5. Cochlear implants

               6. Shrapnel

               7. Neurostimulators

               8. History of metal fragments in eyes or skin

          2. Significant hearing loss or other severe sensory impairment

          3. A fragile health status.

          4. Current use of prescription psychotropic medications that may affect cognitive
             processes under study.

          5. A history of significant head trauma or serious brain or psychiatric illness
A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: capecitabine [Xeloda]; capecitabine [Xeloda]; bevacizumab [Avastin]; oxaliplatin; irinotecan
Intervention description: 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle; 1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle; 5 mg/kg taken intravenously on Day 1 of each 2 week cycle; 85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles; 135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of
      Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12
      cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were
      randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and
      oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to
      receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment
      was until disease progression, and the target sample size was 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥18 years of age

          -  Histologically confirmed adenocarcinoma of colon or rectum, with unresectable
             metastatic or locally advanced disease

          -  ≥1 measurable target lesion

          -  Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

        Exclusion Criteria:

          -  Prior systemic therapy for advanced or metastatic disease

          -  History of another malignancy within last 5 years, except cured basal cell cancer of
             skin or cured cancer in situ of the cervix

          -  Clinically significant cardiovascular disease

          -  Current or recent use of full dose oral warfarin or full dose parenteral
             anticoagulants or thrombolytic agents

          -  Chronic daily treatment with >325 mg/day aspirin
Afamelanotide in Patients Suffering With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Afamelanotide
Intervention description: Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.
Intervention MeSH terms: Afamelanotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate the effect of afamelanotide on the facial inflammatory
      acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability
      of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on
      quality of life in eligible patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an
             Investigator's global assessment (IGA) score of 2-3;

          -  Chronic course of acne vulgaris;

          -  Acne-related lesions both on the face, chest and back;

          -  Indication for treatment of acne vulgaris;

          -  Aged 18-30 years (inclusive);

          -  Fitzpatrick skin types I-III;

          -  Providing written Informed Consent prior to the performance of any study-specific
             procedure.

        Exclusion Criteria:

          -  Female subjects;

          -  Diagnosis of severe acne vulgaris;

          -  Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or
             other local anesthetic to be used during the administration of the implant;

          -  Use of topical acne medication such as retinoids, benzoyl peroxide or topical
             antibiotics within 2 weeks prior to the first dose;

          -  Use of oral antibiotics for acne within 4 weeks prior to the first dose;

          -  Use of topical corticosteroids on the face, chest and back or systemic corticosteroids
             within the past 4 weeks prior to the first dose;

          -  Use of systemic retinoids within 6 months prior to the first dose;

          -  Use of anti-androgenic agents such as finasteride within 4 weeks prior to the first
             dose;

          -  Use of phototherapy devices for acne such as ClearLight™ or Zenozapper within 1 week
             prior to the first dose;

          -  Use of tanning booths or lamps within 1 week prior to the first dose;

          -  Active skin disease that may interfere with evaluation;

          -  Other forms of acne such as acne rosacea, acne excoriée, chloracne, acne conglobata,
             acne fulminans, acne inversa or drug-induced acne;

          -  Participation in a clinical trial for an investigational agent within 30 days prior to
             the screening visit.
Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
Condition: Lymphoma, Follicular
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Sargramostim (Leukine); Rituximab
Intervention description: Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab; Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
Intervention MeSH terms: Rituximab; Molgramostim; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sargramostim; Leukine; NHL

Summary:

      The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim
      will be more effective than rituximab alone.
    

Eligibility criteria:

        Inclusion Criteria (abbreviated list):

          -  Relapsed follicular B-cell lymphoma

          -  One or more previous therapies for non-Hodgkin's

          -  At least one measurable tumor by CT scan or MRI

          -  Additional criteria to be determined at screening visit

        Exclusion Criteria (abbreviated list):

          -  Rituximab refractory (less than 6 months from last treatment with rituximab to
             relapse)

          -  Currently receiving treatment for another cancer

          -  Infection currently being treated

          -  Active Hepatitis B

          -  History of HIV infection

          -  Pregnant

          -  Additional criteria to be determined at screening visit
Toradol to Reduce Ureteroscopic Symptoms Trial
Condition: Urinary Lithiasis; Kidney Diseases; Kidney Stone; Pain, Postoperative
MeSH terms: Kidney Diseases; Kidney Calculi; Urolithiasis; Urinary Calculi; Pain, Postoperative; Lithiasis
Intervention: Toradol
Intervention description: IV toradol
Intervention MeSH terms: Ketorolac Tromethamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Double blinded randomized controlled clinical trial to assess the impact of intraoperative
      Toradol on post-operative pain scores for patients undergoing ureteroscopy for urinary stone
      management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing Ureteroscopy for kidney stone management between age 18-80.

        Exclusion Criteria:

          -  Unable to provide consent

          -  Contraindications to Toradol
Minocycline to Reduce Pain After Carpal Tunnel Release
Condition: Chronic Pain; Post-operative Pain
MeSH terms: Chronic Pain; Pain, Postoperative
Intervention: Minocycline; placebo
Intervention description: RCT blinded placebo trial; RCT blinded placebo trial
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators are looking at whether peri-operative minocycline will reduce the duration
      of pain after minor hand surgery: carpal tunnel release and trigger finger release.

      The investigators' hypothesis is that minocycline will reduce post-operative pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult, Veteran,

        Exclusion Criteria:

          -  Kidney failure, Liver failure, thrombocytopenia, ALS, SLE, Frailty, unable to
             understand survery
Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls
Condition: Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Empagliflozin; BI 10773
Intervention description: open label
Intervention MeSH terms: Empagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on
      kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus
      and healthy controls
    

Eligibility criteria:

        Inclusion criteria:

          1. T2DM patients and healthy controls aged =18 to <70 at Visit 1.

          2. Patients diagnosed with T2DM according to the American Diabetes Association criteria
             prior to informed consent who are drug-naïve

          3. T2DM patients on a stable dose of allowed concomitant medications (as determined by
             investigator) for 30 days prior to entering the study.

          4. T2DM patients with HbA1c between >7 and <10.0% (>53 mmol/mol and <86 mmol/mol) at
             Visit

        Exclusion criteria:

          1. Patients with type 1 diabetes mellitus.

          2. Patients with uncontrolled hyperglycemia with a fasting plasma glucose level greater
             than 240 mg/dl after an overnight fast.

          3. Patients with a history of clinically significant heart disease (New York Heart
             Classification greater than class 3; more than non-specific ST-T wave changes on the
             ECG), peripheral vascular disease (history of claudication), or pulmonary disease as
             determined by investigator.

          4. Medical history of cancer (except for basal cell carcinoma) and/or treatment for
             cancer within the last 5 years.
Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness
Condition: Vegetative State; Minimally Conscious State; Disorders of Consciousness
MeSH terms: Consciousness Disorders; Persistent Vegetative State
Intervention: Anodal tDCS; sham tDCS
Intervention description: patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised); Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 15 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: vegetative state; minimally conscious state; disorders of consciousness; transcranial direct current stimulation

Summary:

      Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to
      the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and
      attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised
      (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a
      double-blind sham-controlled experimental design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  post-comatose patients

          -  patients in vegetative/unresponsive or minimally conscious state

          -  patients with stable cardiorespiratory parameters

          -  patients free of sedative drugs and Na+ or Ca++ channel blockers (e.g., carbamazepine)
             or NMDA receptor antagonists (e.g., dextromethorphan)

        Exclusion Criteria:

          -  premorbit neurology antecedent

          -  patients in coma or <1week after the acute brain insult

          -  patients with a metallic cerebral implant or a pacemaker (in line with the safety
             criteria for tDCS in humans)
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: Elagolix; Placebo
Intervention description: Capsule administered orally; Capsule administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 118.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Polycystic Ovary Syndrome; Hormone; Elagolix

Summary:

      This study will assess the potential impact of elagolix on disordered pituitary and ovarian
      hormones in women with polycystic ovary syndrome (PCOS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with clinical diagnosis of PCOS.

          -  Participants with a body mass index (BMI) of 18.5 to 38 kg/m^2 at time of Screening.

        Exclusion Criteria:

          -  Participants with newly diagnosed medical condition requiring intervention that has
             not been stabilized at least 30 days prior to Baseline.

          -  Participants with a significant medical condition that require intervention during the
             course of study participation (such as anticipated major elective surgery).

          -  Participants with an unstable medical condition (including, but not limited to,
             uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable
             angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically
             significant infection or injury).
Prospective Trial Comparing Response to Hyperbaric Oxygen Treatment in Patients With Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: HBOT
Intervention description: HBOT
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: interstitial cystitis

Summary:

      To review the results of Hyperbaric Oxygen therapy (HBOT) on the symptoms of interstitial
      cystitis (IC). To determine if there is greater symptom improvement in the ulcerative vs the
      non-ulcerative patients with interstitial cystitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Interstitial cystitis.

          -  Urinary frequency of at least 8 times per 24 hours period.

          -  Patients with ulcerative IC must have undergone previous biopsy negative for cancer.

          -  Patients must agree to not begin any additional treatment for IC until study
             completion.

        Exclusion Criteria:

          -  Absolute or relative contraindication to hyperbaric oxygen treatment.

          -  Patients dependent on intermittent catheterization or indwelling catheter to empty
             bladder.

          -  Any imminent change in residence, which could compromise compliance.

          -  Unlikely to be compliant due to unmanaged medical or psychological problems.

          -  Severe debilitating concurrent medical conditions.

          -  A history of pelvic radiation, bladder stone, bladder cancer or cancer in situ, or
             urethral cancer.

          -  Precious bladder or neurologic surgery which has affected bladder function.

          -  Currently has an active urethral stone, ureteral stone or urethral diverticulum.

          -  Subject misses more than 10 treatments.

          -  Severe claustrophobia.