bioihbjkbjnl/mcl2 huggingface dataset:
Using D-cycloserine to Enhance the Benefits of Cognitive Behavioral Therapy for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: D-cycloserine; Cognitive Behavioral Therapy
Intervention description: Single, fixed 50-mg dose of D-cycloserine administered 1 hour prior to a CBT session; One-hour talk therapy session with a trained clinician aimed at increasing cognitive flexibility by examining alternative explanations to everyday situations
Intervention MeSH terms: Cycloserine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Paranoid Schizophrenia; Paranoid Delusions; CBT; D-Cycloserine

Summary:

      This study will examine whether pretreatment with D-cycloserine before cognitive behavioral
      therapy can reduce impairments still present in people with stable cases of schizophrenia as
      well as determine which traits make schizophrenics most likely to respond to D-cycloserine
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophrenia,
             paranoid subtype, based on chart review, Structured Clinical Interview for DSM-IV, and
             consultation with the patient's clinicians

          -  Medicated with an antipsychotic agent other than clozapine at a stable dose for at
             least 6 weeks

          -  Scores at least 3, or "moderate," on the Scale for the Assessment of Positive Symptoms
             global delusion rating

          -  Paranoid or referential delusional content

          -  Never engaged in formal CBT psychotherapy in the past

        Exclusion Criteria:

          -  Diagnosis of a comorbid Axis I disorder other than schizophrenia

          -  Active substance abuse or dependence within 6 months

          -  Significant suicidal ideation within 6 weeks

          -  Pregnant or nursing

          -  Unstable medical disorder

          -  impaired renal clearance (creatinine <60mg/dL/min)

          -  Suffering from dementia

          -  Suffering from seizure disorder
Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: Azelaic acid (Finacea, BAY39-6251); Metronidazole (Metrogel); Doxycycline (Oracea)
Intervention description: Participants received topical azelaic acid gel 15% twice daily for 12 weeks; Participants received topical metronidazole 1% gel once daily for 12 weeks; Participants received systemic doxycycline 40 mg once daily for 12 week
Intervention MeSH terms: Metronidazole; Doxycycline; Azelaic acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rosacea

Summary:

      Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15%
      gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole
      1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at
      total of twelve weeks to determine the rapidity of improvement, and the length of time to
      reach 25%, 50% and 75% clearing compared to baseline.
    

Eligibility criteria:

        Inclusion Criteria:

        - Moderate papulopustular rosacea (IGA>4) with a minimum of 10 and no more than 50
        inflammatory lesions and persistent erythema with or without telangiectasia

        Exclusion Criteria:

          -  Sensitivity to any of the treatments used

          -  Co-existing conditions that would unfavorably influence the course of the disease

          -  Pregnant or lactating women

          -  Severe rosacea
Postpartum Management of Gestational Hypertensive Disorders Using Furosemide
Condition: Hypertension, Pregnancy-Induced
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Intervention: furosemide; labetalol
Intervention description: five day course of furosemide 20mg QD; 200mg labetalol BID
Intervention MeSH terms: Labetalol; Furosemide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Masking description: randomized open label
Enrollment: 13.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: pregnancy induced hypertension; preeclampsia; furosemide

Summary:

      -  The main purpose of this study is to learn if incorporating a loop diuretic such as
           furosemide along with labetalol in the routine management of postpartum gestational
           hypertensive disorders could lower the need for additional anti-hypertensive agents to
           control blood pressures, improve blood pressures (as measured by systolic blood
           pressure, diastolic blood pressure and mean arterial blood pressures), shorten hospital
           stays and decrease readmissions for patients with gestational hypertensive disorders.

        -  Based on a study by Veena et al1, there is reason to believe that the addition of
           furosemide to other anti-hypertensives may help decrease the need to add or increase the
           dose of medication to control blood pressures. There may be potential to shorten
           hospital stays and decrease readmissions, as well. Collecting data will be done using a
           prospective, randomized 1:1 controlled study assigning postpartum patients with a
           gestational hypertensive diagnosis to either labetalol alone or labetalol plus
           furosemide.

        -  The study will be performed in the postpartum wing of Miami Valley Hospital Main Campus
           and would use patients who have consented to participate in the study with enrollees
           coming from the OB Staff population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postpartum women delivering at Miami Valley Hospital

          -  Diagnosis of gestational hypertension or preeclampsia

          -  Able to provide written informed consent

        Exclusion Criteria:

          -  Diagnosis of chronic hypertension

          -  Allergy to study medications

          -  Unable to understand English
Alternate Day Versus Daily Oral Iron Therapy in Adolescents
Condition: Iron Deficiency Anemia; Heavy Menstrual Bleeding; Abnormal Uterine Bleeding
MeSH terms: Uterine Hemorrhage; Menorrhagia; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Hemorrhage
Intervention: Ferrous sulfate
Intervention description: Alternate day dosing of ferrous sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Minimum age: 9 Years
Maximum age: 22 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Iron deficiency anemia affects over half of girls and young women with heavy periods and is
      the most common cause of anemia worldwide. Most girls with heavy periods who also have iron
      deficiency anemia are prescribed iron to take by mouth every day by their doctor. There are
      some studies showing that taking iron every other day may actually help the iron be absorbed
      into the bloodstream better. This study is trying to compare how taking iron every other day
      compares to taking iron daily for treatment of anemia.

      The goal of this clinical research study is to learn which of the two methods of care will be
      the best way for girls and young women with iron deficiency anemia to take iron
      supplementation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 9 years or greater and less than age 22 years

          2. Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score
             >100

          3. Iron deficiency anemia, defined as both hemoglobin <12 g/dL and ferritin <15 ng/mL
             within 7 days of enrollment.

        Exclusion Criteria:

          1. non-uterine cause of vaginal bleeding

          2. pregnancy

          3. chronic kidney disease

          4. serology confirmed celiac disease

          5. active gastrointestinal blood loss

          6. active malignancy

          7. inability to follow-up at Texas Children's Hospital

          8. receipt of intravenous iron within 30 days prior to enrollment

          9. allergy or known inability to tolerate oral iron
Epidural Morphine Following Vaginal Delivery
Condition: Pain
Intervention: Preservative-free epidural morphine; Placebo
Intervention description: One time dose of preservative-free epidural morphine 2.5 mg given within one hour following vaginal delivery; 5 ml of epidural preservative-free saline given within one hour following vaginal delivery
Intervention MeSH terms: Morphine; Narcotics
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 228.0
Sex: Female
Minimum age: 16 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Postpartum perineal pain; Epidural morphine; Randomised clinical trial

Summary:

      The investigators believe that pain management following a vaginal delivery can be improved.
      Many women receive epidural medication during labor and delivery, and the investigators felt
      that using the epidural following delivery might improve the first day pain. This study is to
      determine whether a single dose of epidural morphine given to mothers after a vaginal
      delivery will reduce the perineal pain in the postpartum period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy parturients (ASA 1 or 2) of > 34 weeks gestational age who chose epidural
             analgesia for labor, and deliver vaginally.

        Exclusion Criteria:

          -  Women whose labor is terminated by cesarean delivery

          -  Parturients with known morphine allergy

          -  Parturients with narcotic addiction past / present
The Effect of Protein on Calcium Absorption and Gastric Acid Production
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: esomeprazole; Placebo
Intervention description: 2 Interventions with esomeprazole 20 mg twice a day for 9 days vs. a placebo for 9 days while on a high protein diet; Placebo 20 mg twice a day for 9 days
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gastric acid; Dietary protein; Calcium; Intestinal absorption; Calcium sensing receptor

Summary:

      We have established that dietary protein is an important regulator of intestinal calcium
      absorption in humans. However, we do not understand the mechanism by which dietary protein is
      affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether
      dietary protein-induced changes in gastric acid secretion explain the observed changes in
      intestinal calcium absorption.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and women age 18-45 years

          -  Caucasian or Asian descent due to increased risk of Osteoporosis

        Exclusion Criteria:

          -  gastrointestinal diseases

          -  osteoporosis

          -  diabetes

          -  hypertension

          -  liver disease

          -  thyroid disorders

          -  kidney disease

          -  kidney stones

          -  cancer

          -  heart disease

          -  eating disorders

          -  obesity

          -  hypogonadism

          -  amenorrhea

          -  oligomenorrhea

          -  abnormal serum FSH or estradiol levels

          -  birth control medication or other hormone-altering medications

          -  pregnancy

          -  Lifestyle factors such as:

               -  smoking

               -  excessive exercise (although moderate exercise is allowed)

               -  prescription medications known to influence vitamin D or calcium metabolism or
                  gastric acid

               -  excessive body weight change during the past 6 months

               -  food allergies

               -  unusual eating habits or medically prescribed diets
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
Condition: Klinefelter Syndrome
MeSH terms: Klinefelter Syndrome; Syndrome
Intervention: testosterone cypionate 200mg/ml
Intervention description: Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: Male
Minimum age: 42 Days
Maximum age: 108 Days
Healthy volunteers: No
Keywords: body composition; Klinefelter syndrome; XXY; sex chromosome variation; sex chromsome aneuploidy

Summary:

      This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about
      body composition (muscle and fat) and male hormones and look at the effect of testosterone
      shots on body composition. The Investigators know that older boys and men with Klinefelter
      syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but
      we do not know if this difference is present at birth or develops over time. The
      Investigators will learn if body composition and motor skills are improved with testosterone
      treatment in infants with Klinefelter syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male infants with 47,XXY karyotype

        Exclusion Criteria:

          -  Gestational age at birth <36 weeks

          -  Birth weight <5%ile or >95% for gestational age

          -  History of thrombosis in a first degree relative

          -  Exposure to androgen therapy outside of the study protocol.
Surgical Pain Control With Ropivacaine by Atomized Delivery
Condition: Pain
Intervention: Intraperitoneal Ropivacaine (AIR); Atomized Intraperitoneal Saline (AIS)
Intervention description: Ropivacaine 2 mg/kg per lean body mass up to no more than 200mg total dose will be atomized and delivered into the peritoneal cavity at the completion of surgery.; Atomized saline will be administered to the peritoneal cavity at the completion of surgery.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Surgical Pain Management; Robotic surgery; Ropivacaine

Summary:

      The purpose of this trial is to determine the effect of spraying a local anesthetic called
      Ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. Ropivacaine is a
      local anesthetic used to block pain in the body. There are studies showing that Ropivacaine
      decreases the pain of surgery with minimally invasive (laparoscopic) appendix and gallbladder
      removal but has not been tried in robotic pelvic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consent to undergo robotic assisted gynecologic or urologic surgery

          -  Between the ages of 18 and 75

          -  Able to consent, fill out study documents, and complete all study procedures and
             follow-up visits

        Exclusion Criteria:

          -  Patients with an allergy to local anesthetics

          -  Patients with severe underlying cardiovascular, renal or hepatic disease

          -  Pregnant patients
Methadone Versus Morphine for Orthopedic Surgery Patients
Condition: Fracture; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Methadone; Morphine
Intervention description: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation; Patients will receive 0.2 mg/kg of morphine IV immediately after intubation
Intervention MeSH terms: Morphine; Methadone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Surgery, Orthopedic; Pain, Postoperative

Summary:

      The investigators propose to compare analgesia by methadone and ketamine with a combination
      of morphine and ketamine in orthopedic surgery patients with moderate to severe pain. The
      investigators hypothesize that when given with ketamine before surgical incision, methadone
      is more effective than morphine in reducing postoperative morphine consumption and reducing
      pain during movement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA I-III

          -  Ages 18-65 years

          -  Presenting for lower extremity orthopedic surgery involving fracture of long bones at
             University of Louisville Hospital

          -  Surgery expected to last more than one hour

          -  Patient expected to have moderate to severe post-operative pain

          -  Patient refused regional anesthesia or has a contraindication to regional anesthesia

        Exclusion Criteria:

          -  Any known contraindications to methadone including hypothyroidism, Addison's disease,
             prostatic hypertrophy, or urethral stricture.

          -  Difficulty or inability to understand the study or protocol

          -  Known renal or hepatic dysfunction

          -  BMI> 35

          -  Known respiratory or cardiovascular problems, such as obstructive sleep apnea or
             oxygen saturation of less than 92% on room air

          -  Taking any of the known drugs that induce or inhibit the cytochrome p450 enzyme
             systems. Common examples of these drugs are antifungal, antiretroviral, barbiturates,
             dexamethasone, and macrolide antibiotics.

          -  Pregnancy

          -  Taking preoperative opioids for more than 2 weeks before the surgery
Effect of Milnacipran on Pain in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Milnacipram
Intervention description: Titration to 200mg PO daily
Intervention MeSH terms: Milnacipran
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fibromyalgia; pain

Summary:

      The investigators want to study the effects of milnacipran treatment on neurotransmitter
      release in fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female age 18 or older

          -  Written informed consent and written release of health and research study information

          -  Diagnosis of Fibromyalgia

          -  Participant has pain greater than 4 on the NRS of 0 to 10 on average over the last
             week prior to initial evaluation that interferes with function most days per week

          -  Pain duration greater than 6 months

          -  Negative urine pregnancy test on experimental day 1 and 2 and on first day of
             treatment prior to administration of study medication and fluoroscopy

          -  Ability to speak and understand English, to follow instructions, and fill out study
             questionnaires

          -  Likely to complete all required visits

          -  Must be ambulatory and able to lay prone for 30 minutes

        Exclusion Criteria:

          -  Any condition or situation that in the investigator's opinion may put the participant
             at significant risk, confound the study results, or interfere significantly with the
             participant's participation in the study

          -  Serious, unstable medical illness that could lead to hospitalization over the next
             three months; and/or a DSM-IV diagnosis(es) with active problems within the last six
             months, such as: schizophrenia, bipolar disorder, antisocial personality disorder, or
             substance use disorder

          -  Known, uncontrolled, serious systemic disease, including: hypertension and/or
             tachyarrythmia

          -  Females who are pregnant, breast feeding, or who plan to become pregnant, or who may
             potentially become pregnant

          -  Allergy or sensitivity to any component of the study medication or to contrast dye

          -  Patients on coumadin, heparin, or any other known increase risk of bleeding

          -  Signs of increased intracranial pressure

          -  Patients who are unable to continue current pain medication

          -  Allergy or contraindication to acetaminophen

          -  Use of monoamine oxidase inhibitors

          -  Uncontrolled narrow-angle glaucoma