bioihbjkbjnl/mcl2 huggingface dataset:
A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Intervention: Risperidone; Placebo
Intervention description: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks.; Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: Female
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Anorexia Nervosa; Risperidone; Atypical Neuroleptics; Dopamine; Leptin; Body Image; Adolescents

Summary:

      The aim of this pilot study is to determine the safety and efficacy of risperidone for the
      treatment of anorexia nervosa.

      Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image
      distortion and Eating Disorder Inventory -2 scores than subjects on placebo.

      Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body
      weight sooner than controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary Diagnosis of Anorexia Nervosa

          -  Female, age 12-21

          -  Active in a level of care for AN at The Children's Hospital, Denver

          -  As long as there is a primary dx of AN, co-morbid diagnoses may be included.

          -  If taking an antidepressant, must be on a stable dose for 3 weeks prior to entering
             the study, and dose of antidepressant may not be changed during Phase 1 of the study.

          -  If choosing to discontinue antidepressant medication, must be off the medication for 3
             weeks prior to beginning the study.

          -  If sexually active, must use birth control during the study and have a monthly
             pregnancy test.

        Exclusion Criteria:

          -  Previous enrollment in this study on a prior admission

          -  Previous allergic reaction to risperidone or other atypical neuroleptic

          -  Positive pregnancy test

          -  Neurologic disorder other than benign essential tremor

          -  Taking a psychotropic medication other than antidepressant and discontinuing the
             medication is not recommended.

          -  Active hepatic or renal disease

          -  Wards of the state

          -  Males
Subcutaneous Rehydration Compared to Intravenous Rehydration
Condition: Dehydration
MeSH terms: Dehydration
Intervention: recombinant human hyaluronidase
Intervention description: 150 Units in 1 mL
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 30 Days
Maximum age: 10 Years
Healthy volunteers: No
Keywords: pediatric; hylenex; subcutaneous infusion; hyaluronidase; rHuPH20; recombinant human hyaluronidase

Summary:

      Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration
      in mildly to moderately dehydrated pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children of either gender from one month to ≤10 years of age.

          -  Patients with mild or moderate dehydration

          -  Healthy child except for the underlying etiology for dehydration

          -  Pre-dehydration body weight ≥ 5th percentile for age

          -  Parents or legal guardian(s) available to provide informed consent.

        Exclusion Criteria:

          -  Severe dehydration

          -  Shock or life-threatening situation (life expectancy < 10 days).

          -  Requirement for IV access for any indication other than for treatment of dehydration.

          -  Indwelling IV catheter, except for one intended only for collection of clinical
             laboratory specimens.

          -  Any condition precluding SC infusion or infusion site evaluation

          -  Any reason (prior to study enrollment) for a hospital admission or an extended stay in
             the ED for other than dehydration.

          -  Known hypersensitivity to hyaluronidase or hylenex.

          -  Known hyponatremia (< 130 milliequivalents per liter [mEq/L]) or hypernatremia (> 155
             mEq/L).

          -  Known hypokalemia (< 3.0 mEq/L).

          -  Any medical condition likely to interfere with the patient's ability to fully complete
             all protocol-specified interventions, the ability to undergo all protocol-specified
             assessments, or likely to prolong the patient's need for medical attention beyond that
             required for treatment of dehydration.

          -  Participation in an investigational drug or device study within 30 days prior to
             enrollment in this study.
Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients
Condition: Memory Impairment Due to Corticosteroid Use; Hypomania Due to Corticosteroid Use; Hippocampal Atrophy Due to Corticosteroid
MeSH terms: Mania
Intervention: Lamotrigine (Drug)
Intervention MeSH terms: Lamotrigine
Phase: Phase 4
Study type: Interventional
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: 65 Years

Summary:

      The purpose of this study is to determine if lamotrigine therapy is associated with
      improvement in mood, memory and hippocampal size and function in patients receiving chronic
      corticosteroid therapy. Standard care for mood changes associated with corticosteroid
      therapy, if severe, includes antidepressants or other medications which can influence mood.
      No therapies, other than dose reduction or discontinuation, are currently available for
      memory loss associated with corticosteroid treatment. However, very little information is
      available on the treatment of either mood or memory changes associated with corticosteroid
      treatment, thus the proposed project may improve standard care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current Corticosteroid Use of 7 mg or more for 6+ months

          -  18-65 years of age

        Exclusion Criteria:

          -  Primarily non-English speaking

          -  Pregnant/nursing woman

          -  Currently taking Depakote

          -  Currently taking Rifampin

          -  Has diagnosis of major depressive disorder, schizophrenia, PTSD, bipolar I or bipolar
             II (not related to corticosteroid use)

          -  Diseases with CNS involvement

          -  Is to start a brief steroid taper

          -  History of Alcohol/drug abuse/dependence
An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
Condition: Rhematoid Arthritis
MeSH terms: Arthritis
Intervention: Tofacitinib with methotrexate; Tofacitinib without methotrexate; Adalimumab with methotrexate
Intervention description: Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months; Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months; Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months
Intervention MeSH terms: Adalimumab; Methotrexate; Tofacitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as
      compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy
      compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes
      measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab.
      To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or
      adalimumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have moderate to severe rheumatoid arthritis

          -  On methotrexate but inadequately controlled

          -  Subjects must not have active tuberculosis or an inadequately treated tuberculosis
             infection

          -  Subjects must use contraception

        Exclusion Criteria:

          -  Subjects who have been previously treated with adalimumab or Tofacitinib

          -  Subjects with any current malignancy or a history of malignancy, with the exception of
             adequately treated or excised non metastatic basal cell or squamous cell cancer of the
             skin or cervical carcinoma in situ.

          -  Subjects with specific laboratory test abnormalities

          -  Subjects with specific types of infections
Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
Condition: Post-operative Craniotomy Patients; Carotid Endarterectomy and Carotid Artery Stenosis Patients; Post-op Spine Patients Admitted to the NCCU; Endovascular Patients Undergoing Intracranial Intervention; Traumatic Brain Injuries NPO for at Least 12 Hours
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Carotid Stenosis
Intervention: Intravenous acetaminophen; Placebo for IV acetaminophen
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Craniotomy

Summary:

      To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient
      pain.

      To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels
      in neurocritically ill patients.

      To assess the effect of an intravenous nonnarcotic pain medication on common side effects
      seen in patients taking other intravenous narcotic pain medication in the neurocritical care
      unit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  > 45 kg (amenable to adult dosing)

          -  all traumatic brain injuries NPO for at least 12 hours

          -  all post-operative craniotomy patients

          -  all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke
             patients

          -  all carotid endarterectomy and carotid artery stenosis patients

          -  all endovascular patients undergoing intracranial intervention

          -  all post-op spine patients admitted to the NCCU

        Exclusion Criteria:

          -  documented allergy to acetaminophen

          -  documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease
             (hepatitis)

          -  documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed
             prior to study procedures that will ensure patients do not have renal impairment.

          -  patients who are pregnant or breast feeding
Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation
Condition: DENT IMPLANTS; LASER
Intervention: Conventional mechanical therapy; Saline; Methylene Blue; Light emitting laser; Non-light emitting laser
Intervention description: Both experimental and sham arms will receive the Conventional mechanical therapy; Sham group will receive saline as a sham for methylene blue; Experimental arm will receive methylene blue; Experimental arm will receive Light emitting laser; Sham group will receive Non-light emitting laser
Intervention MeSH terms: Methylene Blue
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dental implants; Laser; Antimicrobial photodynamic therapy; Low level laser therapy; Peri-implant mucositis; Peri-implantitis

Summary:

      The purpose of this study is to compare clinical outcomes (change in bleeding sites (BOP) and
      probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites
      exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic
      therapy (aPDT) and assess the microbiologic profile of plaque samples before and after
      treatment with or without aPDT samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least one implant with peri-implant inflammation that requires non-surgical
             treatment.

          -  Peri-implant diseases included are peri-implant mucositis and peri-implantitis

        Criteria for diagnosis of peri-implant mucositis or peri-implantitis:

          1. Red, swollen gingival tissues surrounding the implant

          2. Presence of bleeding and/or suppuration on gentle probing around the implant

          3. Increased probing depth compared to probing depth after restoration of the implant
             (greater than 2mm increase in probing depth)

          4. May or may not have progressive bone loss in relation to radiographic bone levels
             assessed either 1 year following restoration of the implant OR ≥3mm of radiographic
             bone loss from the implant platform -systemically healthy or with controlled common
             systemic conditions, such as hypertension, that will not affect wound healing.

        Exclusion Criteria:

          -  current heavy smokers (>10 cigarettes/day)

          -  have diabetes or other systemic diseases that may comprise healing

          -  take antibiotics within 3 months before the procedure
Trial of Two Versus Three Doses of Human Papillomavirus (HPV) Vaccine in India
Condition: Cervical Cancer; Cervical Precancerous Lesions
MeSH terms: Uterine Cervical Neoplasms
Intervention: Prophylactic quadrivalent HPV vaccine Merck (Gardasil®)
Intervention description: The participants received either one, two or three doses of the avaccine. Each injection contains 20 microgram type 6, 40 microgram type 11, 40 microgram type 16, and 20 microgram type 18.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22729.0
Sex: Female
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary study hypothesis wasthat a two-dose human papillomavirus (HPV) vaccine regimen
      would offer similar immunogenicity and protection as that of a three-dose regimen to girls
      against persistent HPV infection and cervical neoplasia caused by HPV types included in the
      vaccine. The Government of India stopped vaccination in all the HPV vaccine trials in the
      country in April 2010 due to reasons not related to this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Apparently healthy, ambulant girls aged 10 - 18 years

          -  Unmarried girls

          -  Girls with intact uterus

          -  Resident in the villages chosen for the study

        Exclusion Criteria:

          -  Girls with any severe and/or debilitating illness

          -  Past history of allergy to any medication
Smartphone Intervention for Smoking Cessation and Adherence to Anti- Retroviral Therapy (ART) Among People Living With Human Immunodeficiency Virus (HIV)
Condition: Smoking; Smoking Cessation; HIV
Intervention: Nicoderm C-Q Transdermal Product; Adherence to Antiretroviral Therapy Counseling; Behavioral Smoking Cessation Counseling; "Crave-to-Quit" app; vDOT "emocha" app
Intervention description: 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT); Brief counseling on adhering to antiretroviral therapy with self-help materials.; One time face-to-face smoking cessation counseling and 2 follow-up phone calls.; Evidence-based mindfulness smoking cessation smartphone app ("Crave-to-Quit") adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.; Video Directly Observed Therapy (vDOT) smartphone app ("emocha") that allows participants to take a video of themselves taking medication to ensure adherence.
Intervention MeSH terms: Anti-Retroviral Agents; Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nicotine replacement therapy; antiretroviral; smartphone

Summary:

      The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app
      can help people quit smoking and stay on antiretroviral therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • ≥ 18 years old

          -  Diagnosed with HIV

          -  have been prescribed ART medication in the prior 6 months

          -  have smoked ≥ 5 cigarettes/day in the past year

          -  be interested in making a quit attempt in the next 30 days

          -  own a smartphone (apple/android)and plan to keep it active for the following 3 months

          -  read/speak English

          -  be able to provide consent

          -  have no plans to move in the next 3 months

          -  not pregnant or planning to be pregnant in the following 3 months

        Exclusion Criteria:

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Pregnant women

          -  Prisoners

          -  Those that regularly use tobacco products other than cigarettes

          -  Those that use drugs (methadone, alcohol, cocaine, marijuana) more than once-a-week.

          -  Have contraindication to NRT (past month myocardial infarction, history of serious
             arrhythmias/or unstable angina pectoris, dermatological disorder)

          -  Have cognitive/mental health impairment that inhibits mindfulness treatment

          -  Use other tobacco products regularly (which can interfere with biological verification
             of smoking cessation)

          -  Currently being treated for smoking cessation, alcoholism, or illicit drug use
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Tetany
Intervention: TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
Intervention description: 0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 600.0
Sex: All
Minimum age: 2 Months
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; Poliomyelitis; TETRAXIM™

Summary:

      The purpose of this study is to assess the safety of TETRAXIM™ administered in routine
      clinical practice according to Korea Food and Drug Administration Notification No. 2009-46
      "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are 2 months or more of age (as indicated in the currently approved local
             product labeling) and who are given the study vaccine at least one dose or more,
             during a routine health-care visit, as primary immunization or booster immunization
             for the prevention of diphtheria, tetanus, pertussis, poliomyelitis.

          -  Written informed consent obtained from the subject's parents/legal representative.
Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients
Condition: Perioperative Hypothermia
MeSH terms: Hypothermia
Intervention: Bair-Paws Warming Device; Bair-Hugger Warming Device
Intervention description: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.; Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if placement of a forced-air warming device prior
      to institution of regional anesthesia improves perioperative temperature control in patients
      undergoing total hip arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients undergoing total hip arthroplasty under neuraxial anesthesia,

          -  age 55-85,

          -  BMI 18-40

        Exclusion Criteria:

          -  allergy to local anesthetics,

          -  patients electing to have general anesthesia for their total hip arthroplasty,

          -  pregnancy,

          -  prisoners,

          -  patients unable to give informed consent,

          -  English as a second language,

          -  active infectious or febrile illness (measured temperature > 37.5 degrees Celsius).