bioihbjkbjnl/mcl2 huggingface dataset:
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study
Condition: PMS
MeSH terms: Premenstrual Syndrome
Intervention: escitalopram; placebo
Intervention description: 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.; Placebo tablets matched to drug
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: Female
Minimum age: 15 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: premenstrual syndrome; PMS; PMDD; treatment; SSRI

Summary:

      The purpose of this pilot study is to determine the efficacy and safety of escitalopram
      administered premenstrually (day 14 through day 2 of the menstrual cycle) for severe PMS in
      young women ages 15-19 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females 15-19 years of age

          -  Regular menstrual cycles of 22-35 days

          -  In general good health

          -  Medically approved birth control method if sexually active

          -  Evidence of ovulation

          -  Meeting all symptom criteria for PMS

          -  Signed informed consent

          -  Subjects under age 18 must also have signed parental consent

        Exclusion Criteria:

          -  Current use of any treatment for PMS.

          -  Psychotropic or other medications that may compromise the study drug.

          -  Pregnancy, intending pregnancy or breast feeding.

          -  Not using a medically approved birth control method if sexually active.

          -  Significant medical or gynecological abnormalities.

          -  Irregular menses, any gynecologic disorder.

          -  Any severe or unstable medical illness.

          -  Any current major psychiatric diagnosis or any history of a major psychiatric
             diagnosis.

          -  Any current or history of alcohol abuse, drug abuse, suicide attempt, bi-polar
             disorder, psychosis or severe personality disorder.

          -  Use of triptans (Imitrex, Zomig, Frova, Maxalt, Axert, Amerge, Relpax).

          -  Use of medicines that include dextromethorphan such as Tylenol or Vicks cough
             medicines.

          -  Use of the pain medication meperidine.

          -  Use of any herbal product such as St John's Wort that may increase serotonin.

          -  Use of monoamine oxidase inhibitors (MAOIs), pimozide or citalopram hydrobromide.

          -  Drugs metabolized by CYP2D6 or a combination of CYP3A4 and CYP2D6 inhibitors.

          -  Hypersensitivity to escitalopram or citalopram.
Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Losartan (+) amlodipine; Placebo to match losartan/amlodipine tablets; Amlodipine camsylate; Placebo to match amlodipine
Intervention description: One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.; One tablet containing placebo, orally, once daily, for 8 weeks.; 2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.; 2 tablets containing placebo, orally, once daily, for 8 weeks.
Intervention MeSH terms: Losartan; Amlodipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 334.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypertension; Uncontrolled hypertension; High blood pressure; Uncontrolled high blood pressure; Untreated high blood pressure; Untreated hypertension; Essential hypertension

Summary:

      This study will determine whether using losartan and amlodipine together will be non-inferior
      in lowering blood pressure than amlodipine alone.
    

Eligibility criteria:

        Inclusion criteria

          -  Participants with essential hypertension:

               -  who are on single drug therapy

               -  who are newly diagnosed and not yet taking any drug therapy, or have not had any
                  drug therapy for at least 2 weeks prior to entering study

               -  who have blood pressure readings of 90mmHg ≤ MSDBP < 110mmHg and 140mmHg ≤ MSSBP
                  <180mmHg after 2 weeks wash-out for patients on single agent.

          -  Randomization (Visit 3)

               -  After dosing of amlodipine 5mg for 6 weeks, blood pressure readings are:

                    -  90mmHg ≤ MSDBP < 110mmHg and 140mmHg ≤ MSSBP < 180mmHg.

        Exclusion criteria

          -  Participant with MSDBP ≥ 110mmHg or MSSBP ≥ 180mmHg.

          -  Participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose
             combination medicine should be counted as the number of active ingredients).

          -  Participant with known secondary hypertension of any etiology.

          -  Participant with malignant hypertension or current evidence of impending or active
             malignant hypertension, including headache, papilledema, cardiac ischemia, or
             pulmonary congestion precipitated by elevated blood pressure.

          -  Participant with known intolerance, contraindication or hypersensitivity to any
             component of dihydropyridines, angiotensin II receptor blockers.

          -  Participant showing positive in pregnancy test, lactating woman, or woman who intends
             to get pregnant during the study period.
Desensitization in Kidney Transplantation
Condition: HLA Sensitization
Intervention: plasmapheresis; Bortezomib; Rituximab; Methylprednisolone
Intervention description: Patients will receive plasmapheresis 1.5 x plasma volume prior to each Bortezomib dose. Plasma volume replacement will be per physician discretion.; Patients will receive bortezomib as described in protocol; Patients will receive rituximab as described in protocol; Each bortezomib dose will be preceded by intravenous methylprednisolone (100mg for first two doses and 50mg for following doses).
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Rituximab; Bortezomib; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alloantibody; Desensitization; Kidney Transplantation; Nephrology; Plasma Cells; Translational Research/Science

Summary:

      To determine if deletional strategies will provide effective desensitization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 65

          -  Voluntary written informed consent

          -  Patient on deceased donor wait list with a current or peak cytotoxic or calculated
             panel reactive antibody (PRA) > 20%

        Exclusion Criteria:

          -  Myocardial infarction within 6 months

          -  Patient received investigational drug within 14 days prior to initiation of study
             treatment

          -  Serious medical or psychological illness

          -  Diagnosed with malignancy within three years, except complete research of basal cell
             carcinoma or squamous cell carcinoma of skin, an insitu malignancy or low risk
             prostate cancer after curative therapy

          -  Absolute neutrophil count (ANC) < 1000

          -  Receipt of live vaccine within 4 weeks of study entry

          -  Female subject that is breast feeding
Effect of Mu-opioid Receptor Genetics on 3 Doses of Spinal Morphine for Postoperative Analgesia After Cesarean Section
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Morphine
Intervention description: Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
Intervention MeSH terms: 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: 169.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: cesarean; postoperative; morphine; genetics; opioid

Summary:

      HYPOTHESIS: The response to a given dose of morphine given via a spinal anesthetic for
      cesarean section will be affected by the genetics of the woman's mu-opioid receptor

      Most women undergoing elective cesarean section (CS) receive spinal anesthesia, and most
      receive a dose of preservative free morphine with the spinal anesthetic.
      Spinally-administered morphine provides 16-24 hours of high quality pain relief. The dose
      administered is usually 75-200 micrograms, but surprisingly few dose-response studies exist.

      The mu-opioid receptor (OPRM1 gene)is the site of action of endogenous opioid peptides and
      opioid analgesic drugs like morphine. There is a common genetic variant of this receptor at
      the 40th amino acid of the protein, with asparagine and asparate being present in different
      people. The less common variant (aspartate), present in 25-30% of the overall American
      population (higher in Asian populations, lower in Blacks) at codon 40 that has been shown in
      many studies to affect opioid analgesia.

      This will be a randomized, blinded study of 3 doses of spinal morphine (50, 100, 150
      micrograms) given to women undergoing elective cesarean section at term pregnancy. 300 women
      will be studied (100 per dose). Blood will be obtained for genotyping of OPRM1 and other
      genes that may affect pain and analgesic responses. The primary outcome will be the amount of
      intravenous morphine patients self-administer in the 24 hours postsurgery.

      The primary outcome (use of intravenous morphine) will be analyzed by dose, and within each
      dose group by genotype of OPRM1. Secondary outcomes will include pain scores every 6 hours,
      satisfaction with analgesia, side effects (itching, nausea/vomiting) by dose and genotype.

      It is anticipated that there will be an interim data analysis at 150 evaluable subjects for
      assessment of the dose response to morphine in the overall population; then a final analysis
      at 300 subjects for the genetic effect assessment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy women undergoing elective cesarean

        Exclusion Criteria:

          -  cardiovascular disease

          -  analgesic medications

          -  complications of pregnancy
Oral Sedation During Cervical Dilator Placement
Condition: Oral Sedation and Cervical Dilator Pain
Intervention: Oxycodone and Lorazepam (Active Comparator); Placebo Comparator
Intervention description: Oxycodone and Lorazepam; Placebo oral pills
Intervention MeSH terms: Oxycodone; Lorazepam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The participant, provider, and nursing staff will be blinded to the intervention. The pharmacy will prepare the treatment drugs and placebos.. Randomization will be stratified by gestational age (>= 20 weeks or <20 weeks) and the randomization allocation sequence will be computer-generated with a random number generator by a statistician. The pharmacist will be aware of the randomization sequence and will dispense the drugs as appropriate, while keeping track of which arms participants were randomized to.
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Oral Sedation; Lorazepam; Oxycodone

Summary:

      This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will
      be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on
      pain scores during cervical dilator placement prior to dilation and evacuation (D&E).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18-50 years

          -  English speaking

          -  With an intrauterine pregnancy (either viable or non-viable) between the gestational
             ages of 17w0d and 23w6d

          -  Have a support person present with participant

          -  Have a cell phone capable of text messaging (optional)

        Exclusion Criteria:

          -  Non-English-speaking

          -  Taking a daily benzodiazepine or opiate

          -  Have a known allergy or contraindication to NSAIDs, opiates, or benzodiazepines
D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions
Condition: Schizophrenia; Schizoaffective Disorder; Delusional Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Delusions; Schizophrenia, Paranoid
Intervention: D-Cycloserine; Placebo; Cognitive Behavioral Therapy
Intervention description: Participants will receive 10 administrations of 50 mg of D-Cycloserine by mouth one hour before CBT sessions, weekly, in weeks 3-12.; Participants will receive 12 weekly administrations of placebo by mouth 1 hour before CBT sessions, from weeks 1-12.; Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
Intervention MeSH terms: Cycloserine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No
Keywords: Schizophrenia; Delusions; D-Cycloserine; CBT

Summary:

      This study is a placebo-controlled 12 week trial of DCS augmentation of once-weekly CBT
      sessions in 60 schizophrenia subjects with antipsychotic-resistant delusions. In addition to
      testing efficacy, this trial will characterize DCS effects in terms of time course and
      persistence of response and will examine DCS effects on memory consolidation and cognitive
      flexibility as possible mediators of DCS enhancement of CBT for delusions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-68

          -  Diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder

          -  Treated with any antipsychotic except clozapine for at least 8 weeks or antipsychotic
             naive for lifetime

          -  Willing to participate in CBT

          -  Sufficient proficiency in English to complete assessments

          -  Score of at least 3 on the SAPS at two assessments, four weeks apart

        Exclusion Criteria:

          -  Current treatment with clozapine

          -  SSRI treatment

          -  Active alcohol or other substance abuse within six weeks

          -  Unstable medical illness

          -  Pregnant or nursing

          -  Anemia

          -  Renal insufficiency
A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women
Condition: Healthy Lactating Women
Intervention: pregabalin (Lyrica)
Intervention description: Subjects will receive a single 150 mg dose of pregabalin in the evening of Day 1, a 150 mg dose of pregabalin in the morning and evening of Day 2 and a 150 mg dose in the morning of Day 3.
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetic; pregabalin; lactation

Summary:

      This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in
      healthy lactating women. The objectives are to determine whether pregabalin is secreted in
      breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other
      objectives are to estimate potential infant exposure to pregabalin if administered to
      lactating women and to characterize the safety and tolerability of pregabalin in lactating
      women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy lactating females between the ages of 18 and 45 years (inclusive) who are
             actively breast-feeding or expressing breast milk and are at least 12 weeks post
             partum.

          -  Subjects must be willing to temporarily discontinue breast feeding their infants
             before the Day 1 evening dose through to 42 hours after the last dose

        Exclusion Criteria:

          -  History of significant adverse reaction to pregabalin or gabapentin.

          -  Subjects pregnant or unwilling or unable to comply with the Lifestyle guidelines
             presented in the protocol during the study period and through the follow-up visit.

          -  Subjects with evidence or history of clinically significant hematological, renal,
             endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric
             (including post natal depression), neurologic or allergic disease (including drug
             allergies, but excluding untreated asymptomatic, seasonal allergies at time of
             dosing).
Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty
Condition: Hip Osteoarthritis; Primary Total Hip Arthroplasty; Pain
MeSH terms: Osteoarthritis, Hip
Intervention: Suprainguinal fascia iliaca (SIFI) block; Sham block; Ropivacaine; Saline
Intervention description: An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.; An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.; Local anesthetic (numbing drug); Salt water placebo
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: suprainguinal fascia iliaca (SIFI); nerve block

Summary:

      The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection
      technique (also called a "nerve block") that numbs the nerves going to the side and front of
      the upper leg will improve pain control after surgery. The SIFI technique uses a numbing
      solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This
      block may affect movement in the leg and make the legs weak. The amount of leg weakness is
      not known and assessment of this will be included in the study. Many institutions use the
      SIFI block for patients having total hip replacements, with the hope of providing good pain
      relief combined with improved mobility after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English speaking

          -  between 18 and 75 years old

          -  American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip
             arthroplasty

        Exclusion Criteria:

          -  ASA 4 or 5

          -  revision hip arthroplasty

          -  diagnosis of chronic pain

          -  daily chronic opioid use (over 3 months of continuous opioid use)

          -  inability to communicate pain scores or need for analgesia

          -  acute hip fracture

          -  Infection at the site of block placement

          -  Age under 18 years old or greater than 75 years old

          -  Pregnant women

          -  Intolerance/allergy to local anesthetics

          -  Weight <50 kg

          -  Suspected, or known addiction to or abuse of illicit drug(s), prescription
             medicine(s), or alcohol within the past 2 years.

          -  Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the
             opinion of the investigator, may interfere with study assessments or compliance

          -  Current or historical evidence of any clinically significant disease or condition
             that, in the opinion of the investigator, may increase the risk of surgery or
             complicate the subject's postoperative course.
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Lastacaft ®; Tears Naturale ® (Placebo)
Intervention MeSH terms: Alcaftadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by
      In-Vivo Confocal Microscopy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a positive history of ocular allergies and a positive skin test to protocol
             defined allergens

          -  Have a positive CAC reaction at Visit 1

          -  Have a positive conjunctival inflammation score at Visit 1

        Exclusion Criteria:

          -  May not use disallowed medications in specified washout period

          -  May not have an ocular or system disease the investigator feels with impact subject
             safety or trial parameters

          -  May not have active ocular infection