bioihbjkbjnl/mcl2 huggingface dataset:
The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
Condition: Infertility; Endometriosis
MeSH terms: Infertility; Endometriosis
Intervention: Zoladex
Intervention description: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment
Intervention MeSH terms: Goserelin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Maximum age: 38 Years
Healthy volunteers: No
Keywords: endometriosis; pregnancy; In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI); peritoneal implants; embryo quality

Summary:

      In this study of endometriosis patients we compare a common treatment of surgical therapy and
      medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In
      both cases they immediately start In Vitro Fertilization (IVF) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  laparoscopical vaporization of endometriosis

          -  1,2, 3e IVF cycle

          -  endometriosis stage I and II

          -  younger than 38 years

        Exclusion Criteria:

          -  endometriosis cysts

          -  uterine pathology

          -  endocrinological diseases and problems
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera/Rituxan]; methotrexate; methylprednisolone
Intervention description: 1000 mg iv infusion on days 1 and 15; 10-25 mg weekly (oral or parenteral); 100 mg iv prior to each rituximab infusion
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Rituximab; Methotrexate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in
      patients with active rheumatoid arthritis who have had an inadequate response to
      methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and
      background methotrexate (10-25mg po or sc weekly). After the initial study period of 24
      weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated
      time on study treatment is 1-2 years and target sample size is <50
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >/= 18 years of age

          -  rheumatoid arthritis DAS28 >/= 3.2

          -  receiving treatment on an outpatient basis

          -  experienced an inadequate response to previous or current treatment with methotrexate

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than RA, or significant systemic involvement
             secondary to RA

          -  history of or current inflammatory joint disease other than RA

          -  previous treatment with any cell-depleting therapies
Desipramine in Infantile Neuroaxonal Dystrophy (INAD).
Condition: Infantile Neuroaxonal Dystrophy
MeSH terms: Neuroaxonal Dystrophies
Intervention: Desipramine
Intervention description: Study drug (desipramine) provided in tablet form to be taken daily.
Intervention MeSH terms: Desipramine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric genetic disorder; cognitive function; neuro-muscular disorder; PLA2G6

Summary:

      This is a research study to find out if clinically prescribed desipramine is effective at
      improving the symptoms and slowing the progression of Infantile Neuroaxonal Dystrophy (INAD)
      in affected children.

      Participants will receive an initial oral dose of study drug once a day. This dose may be
      changed depending on response to study drug Clinically collected data will be recorded for up
      to 5 years. Investigators will also ask for participant permission to obtain a sample of
      child's skin biopsy from unused clinical sample previously collected for standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  03-17years.

          -  Any gender

          -  Confirmed homozygotes or compound heterozygotes of pathogenic mutation variant(s) in
             PLA2G6

          -  Confirmed homozygotes of pathogenic mutation in PLA2G6

          -  Documentation of clinical presentation (signs and symptoms of neurodegenerative
             process) of INAD

        Exclusion Criteria:

          -  Patient has sign and symptom suggesting an ongoing acute or chronic illness such as
             fever of unknown origin or infection.

          -  Patient has a second genetic condition

          -  Parents are unable or unwilling to return for continued care for up to 12 months
Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
Condition: Pain
Intervention: Ketamine; Morphine
Intervention MeSH terms: Ketamine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: pain management; ketamine; morphine; pediatrics; emergency medicine

Summary:

      The proposed trial is a prospective, double blinded, randomized control trial with the
      primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease
      the total narcotic requirements of pediatric patients requiring intravenous analgesia in an
      urban emergency department (ED) compared to a group of patients who receive morphine alone
      for pain management. Patients are randomized to receive either a single bolus of ketamine
      (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be
      accomplished using morphine. Patient, family member, and research staff pain scores will be
      recorded, until 3 hours post study medication administration. Family members are contacted
      via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for
      evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be
      calculated for up to 3 hours post study medication administration and compared between the
      ketamine and morphine groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 3-17 years old

          -  Condition (medical or trauma) requiring opioid pain management per standard of care

          -  Need to establish an IV per standard of care

          -  Treating physician agrees to manage the patient's pain with morphine following
             randomization.

        Exclusion Criteria:

          -  Trauma Team Activation

          -  Known allergy to ketamine

          -  Family member unable/unavailable to provide informed consent

          -  When appropriate, patient unwilling to provide assent

          -  High suspicion of injury related to child abuse

          -  Patient and/or family member is non-English speaking

          -  Patient is incarcerated
A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole Lauroxil
Intervention description: Monthly IM injection
Intervention MeSH terms: Aripiprazole; Aripiprazole lauroxil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alkermes; ARISTADA; Aripiprazole Lauroxil; Schizophrenia

Summary:

      This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as
      ARISTADA, ALKS 9070).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR
             has a history of tolerated use of aripiprazole

          -  Has a diagnosis of schizophrenia

          -  Is clinically stable

          -  Has received at least 3 doses of risperidone long acting injection (Risperdal Consta)
             or paliperidone palmitate (Invega Sustenna) prior to screening.

          -  Has no antipsychotic medication regimen change for 4 weeks prior to Day 1

          -  Agreed to abide by the contraceptive requirements o the protocol

          -  Resides in a stable living situation

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Is currently pregnant or breastfeeding, or is planning to become pregnant during the
             study

          -  Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6
             months of screening

          -  Has participated in a clinical trial involving any investigational product within the
             past 3 months, or is currently participating in a clinical trial involving an
             investigational product

          -  Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine,
             methadone, opiates, phencyclidine at screening

          -  Additional criteria may apply
Effect of Collagenase on Healing and Scarring
Condition: Scarring; Impaired Wound Healing
MeSH terms: Cicatrix
Intervention: Collagenase Santyl; Collagenase Santyl Vehicle
Intervention description: Dermatome-induced skin wounds treated with drug active.
Each subject serves as his own control receiving both treatments in parallel.; Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: wound healing; scarring; collagenase; Santyl

Summary:

      A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6
      and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment
      versus vehicle alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent

          2. Willing to attend all required study visits

        Exclusion Criteria:

          1. Known hypersensitivity to Clostridial collagenase

          2. Anticoagulants (blood thinners, including aspirin) within two weeks

          3. Congenital skin disorder which affects keratinocytes, elastin, or collagen

          4. Any dermatologic disease which may be aggravated or provoked by the wounding procedure

          5. Dark skin pigmentation to a degree which is very likely to obscure the assessment of
             vascularization post-wounding

          6. At risk of keloid or hypertrophic scar formation

          7. Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper
             arm area where the wound will be placed

          8. Any skin disorder which causes delayed healing

          9. Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed
             thoracic outlet syndrome

         10. Taking concomitant medications at doses which are known to interfere with healing,
             such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or
             immunosuppressive drugs
Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine
Intervention description: 1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: ADHD; Children; Stimulant; Atomoxetine; Adolescents

Summary:

      Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not
      tolerating or not responding well to stimulant therapy will be included in this study. Two
      different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10
      weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be
      compared between the two different switching approaches.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients between 6-16 years of age

          -  Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV)
             diagnostic criteria for ADHD must be met

          -  Normal laboratory and electrocardiogram (ECG) results

          -  Normal intelligence

          -  Must have unsatisfactory symptom response to stimulant therapy or experience of
             adverse events while on stimulant therapy

        Exclusion Criteria:

          -  Less than 20 kg or more than 70 kg at study entry

          -  Concomitant major psychiatry disorders, drug or alcohol abuse or serious suicide risk

          -  Medical conditions such as seizures, severe allergies, glaucoma, cardiovascular
             disease, hypertension, or acute or unstable medical conditions

          -  Taking of anticonvulsants, antihypertensive agents, medication with sympathomimetic
             activity, psychotropic medications, monoamine oxidase inhibitor

          -  Immediate need for stimulant discontinuation due to tolerability problems

          -  Previous participation in an atomoxetine study, or unresponsive to atomoxetine, or
             intolerable side effects to atomoxetine
Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus)
Condition: Asthma
MeSH terms: Asthma
Intervention: pMDI budesonide/formotrol 160/4.5 is in group 1; Symbicort 160/4.5 plus Aerochamber Plus included in group 2
Intervention description: The asthmatic subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI 2 inhalations used in conventional fashion, and have pulmonary function measured over 12 hours who are expected to show bronchodilation.; Symbicort 160/4.5 2 inhalations will be administered through a valved holding chamber, Aerochamber Plus, Pulmonary functions will be measured over 12 hours in asthmatic subjects who are expected to show bronchodilation.
Intervention MeSH terms: Budesonide; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Asthma; Formoterol; Long Acting Beta Adrenergic Bronchodilator; Symbicort; Aerochamber

Summary:

      This study will compare the amount of bronchial tube relaxation from the Formoterol medicine
      contained in the Symbicort pressure Metered Dose Inhaler(pMDI)(a combination of Budesonide, a
      steroid, and Formoterol, a drug which relaxes the bronchial smooth muscle. The comparison
      will be using the pMDI in the usual fashion to the pMDIs and a spacer which allows more time
      for breathing in the medication. Breathing tests will be measured over a 12 hour period for
      the comparison.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Asthma with 15% or more increase in Forced expiratory volume at 1 second (FEV-1) after
             180-360 mcg of albuterol pMDI

        Exclusion Criteria:

          -  Any illness or condition which might place subject at risk in the study;e.g. some
             cardiovascular disorders Inability to understand and sign informed consent
The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Levobupivacaine; Bupivacaine; placebo
Intervention description: local injection; local injection; local injection
Intervention MeSH terms: Bupivacaine; Levobupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: anaesthesia; local anaesthesia; hemodynamics; bupivacaine; levobupivacaine

Summary:

      Ninety American Society of Anesthesiologists (ASA) Physical Status classification system I-II
      patients were recruited for a randomised, placebo-controlled, double-blind study and were
      randomly divided into three groups to receive either 20 ml of 0.5% bupivacaine (Group B;
      n=30), 20 ml of 0.5% levobupivacaine (Group L; n=30) or saline as a placebo (Group C; n=30).
      Scalp block was performed 5 min before head pinning. The primary outcome of the study was
      mean arterial pressure (MAP) and secondary outcomes were heart rate (HR), visual analogue
      scale (VAS) scores, additional intraoperative and postoperative drug use. Postoperative pain
      was evaluated using a 10-cm visual analogue scale (VAS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Physical Status classification system 1-2

        Exclusion Criteria:

          -  Uncontrolled hypertension, arrhythmia, diabetes mellitus or coagulopathy, coronary
             artery disease or a proven or suspected allergy to bupivacaine or levobupivacaine
Antidepressant Response in Older Adults With Comorbid PTSD and MDD
Condition: Post Traumatic Stress Disorder; Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Escitalopram; Duloxetine
Intervention description: The participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.; Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg for the first 2 weeks, then, contingent on clinical assessment that the 30mg dose is sufficiently well tolerated, be increased to 60mg for the remaining 6 weeks of the study.
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 60 Years
Maximum age: 105 Years
Healthy volunteers: No

Summary:

      In the Investigator's ongoing studies of Posttraumatic Stress Disorder (PTSD) in older
      adults, it has been found that older adults with PTSD frequently meet the criteria for
      comorbid Major Depressive Disorder (MDD). Moreover, relative to trauma-exposed healthy
      controls (TEHCs), elders with PTSD manifest executive function deficits, fatigability, and
      mobility and physical function deficits that are consistent with what the investigator has
      observed in depressed older adults. Yet, the investigator has found that very few older
      adults with combined PTSD/MDD have received appropriate antidepressant treatment for their
      condition. These findings give rise to the questions of (1) how effective is antidepressant
      treatment for depressive symptoms in the context of PTSD/MDD and (2) are cognitive and
      physical function deficits in PTSD/MDD patients reversible with effective antidepressant
      treatment?
    

Eligibility criteria:

        Inclusion Criteria:

          1. Individual has completed IRB 7489

          2. Diagnosed with DSM 5 MDD

          3. HRSD >=18

          4. Willing to and capable of providing informed consent and complying with study
             procedures.

        Exclusion Criteria:

          1. History of allergic or adverse reaction to

          2. Non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20mg) and
             duloxetine (at least 4 weeks at dose of 60mg)during the current episode.

          3. Current treatment with psychotherapy, antidepressants, or other psychotropic
             medications.
A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Oseltamivir; Oseltamivir; Placebo
Intervention description: Oseltamivir capsules for participants ≥ 13 years.; Pediatric suspension for participants aged ≤ 12 years.; Matching placebo provided as capsules and as a suspension.
Intervention MeSH terms: Oseltamivir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 102.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the
      efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the
      safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza
      strain or influenza A are eligible for this study. Patients will be randomized to one of four
      treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg
      (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body
      weight-adjusted for pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric, adolescent and adult patients >/=1 year of age

          -  Fever >/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore
             throat, or rhinitis)

          -  Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24
             hours prior to the first dose of study drug

          -  </=96 hours between onset of influenza-like illness and first dose of oseltamivir

        Exclusion Criteria:

          -  Currently receiving any form of renal replacement therapy including hemodialysis,
             peritoneal dialysis, or hemofiltration

          -  History of chronic renal failure or clinical suspicion of renal failure at baseline

          -  Clinical evidence of hepatic compensation at the time of randomization

          -  Known HIV infection

          -  Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to
             first dose of study medication