bioihbjkbjnl/mcl2 huggingface dataset:
Examining Tolerance to CNS Stimulants in ADHD
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate
Intervention description: Children will receive a double-blind assessment to determine their optimal starting dose of Concerta. Doses will be adjusted over the course of the school year and inceased if tolerance to the medication is detected.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 267.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Tolerance to stimulant medication

Summary:

      Although stimulant medication is a well-established treatment for ADHD, it is often necessary
      for doctors to increase the dose over time to maintain the benefits of the medication. While
      medication can be very effective for improving symptoms of ADHD during the first year of use,
      it has not been found to significantly improve the long term course of children with ADHD.
      For example, in large research studies, groups of children who take medication for ten years
      do not have consistently better academic grades than groups of children who never used
      medication (individual results will vary from child to child).

      In order to help children with ADHD achieve the best possible outcomes, it is important for
      doctors to study why this happens. One possible reason is development of tolerance to the
      medication. Tolerance means that a drug's effects decrease when it is taken consistently over
      time, so that an increased dose is needed to continue showing effects. Some doctors believe
      that children who take stimulant medication for ADHD develop tolerance to it which would
      explain why benefits may not persist over time, but no research studies have been done to
      measure whether this occurs. This study aims to see if children show a tolerance effect to
      stimulant medication and whether that tolerance can be prevented by taking short breaks from
      the medication called medication holidays.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of attention-deficit/hyperactivity disorder

          -  Full Scale IQ above 80

        Exclusion Criteria:

          -  Psychotropic medications for conditions other than ADHD

          -  Active medical or psychiatric conditions that could be worsened by stimulants

          -  Diagnosis of Autism or Asperger's Disorder

          -  Documented intolerance fo methylphenidate or failed trial of OROS MPH
Detemir: Role in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin Detemir mixed with RAI injection; Insulin Detemir and RAI injection
Intervention description: Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection; Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: blood sugar; glycemic

Summary:

      Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given
      insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no
      difference in the patterns of blood sugars when detemir is given in the same syringe or in
      separate syringes with rapid acting insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM)

          -  On insulin glargine for at least 3 months

          -  Age 10-25 years

          -  Not on medications that may affect glucose concentrations

          -  Hemoglobin A1C (HbA1C) of less than 9 %

          -  Body Mass Index (BMI) less than 95th % and more than 10th%

          -  Supportive family

        Exclusion Criteria:

          -  Subjects with undetermined diabetes or Type 2 Diabetes Mellitus (T2DM)

          -  Unable to adhere to insulin regimen

          -  Positive urine pregnancy test
Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome
Intervention: hCG; hCG
Intervention description: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger; Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger
Intervention MeSH terms: Chorionic Gonadotropin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: OHSS, GnRH agonist trigger, low dose hCG, PCOS, IVF

Summary:

      This a prospective randomized double blind study involving patients at high risk of OHSS
      development with peak serum E2 levels < 4,000 pg/ml comparing the ongoing pregnancy rates in
      patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant
      hCG 1,500 IU 35 hours after GnRH agonist trigger.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome
             (PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must
             have > 14 follicles of over 11 mm in diameter and with peak serum E2 levels < 4,000
             pg/mL on the day of trigger of oocyte maturation.

        Exclusion Criteria:

          -  Hypothalamic dysfunction, Patients with < 14 follicles < 11 mm in diameter, peak serum
             E2 levels >= 4,000 pg/mL.
Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain
Condition: Typical Facial Pain; Atypical Facial Pain
MeSH terms: Facies; Facial Pain
Intervention: Bupivacaine; Triamcinolone; Dexamethasone
Intervention description: 4 mL of 0.25% bupivacaine; 40 mg of Triamcinolone; 4 mg of Dexamethasone
Intervention MeSH terms: Dexamethasone; Triamcinolone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Trigeminal neuralgia is a craniofacial pain syndrome that is typically characterized by
      unilateral severe, recurrent, electrical pain in one or more distributions of the trigeminal
      nerve. Current treatment strategies include oral medications as first line therapy with
      surgical interventions reserved for those patients who are refractory to medications or
      unable to tolerate medication side effects. Despite these current treatment options, many
      patients continue to have symptoms. Ultrasound-guided trigeminal nerve block allows for fine
      adjustment of the needle tip and direct observation of the medicine.

      Local anesthetic and steroids have been successfully used for diagnostic and or therapeutic
      nerve pain with great success. Steroids can be short or long acting in duration with varying
      side effects. If there exists a difference in duration of action, using the longer acting
      drug will provide a greater period of symptom relief for the patient and may allow the
      patient to undergo fewer interventional procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients presenting to the Northwestern Pain Center who are eligible and scheduled
             to receive a ultrasound-guided trigeminal nerve block.

        Exclusion Criteria:

          -  Exclusion is the same for patients who are not eligible for ultrasound guided nerve
             blocks.
EC PK in Women With Normal and Obese BMI
Condition: Contraception
Intervention: LNG-EC; UPA-EC
Intervention description: FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg; FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel; Ulipristal acetate; Contraceptives, Postcoital
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Emergency contraception

Summary:

      A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed
      differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate
      emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The
      investigators propose a study to compare serum LNG and UPA levels after administration of a
      single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no
      difference in PK parameters between women with normal BMI and obese women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18-45 years

          -  English-speaking

          -  BMI 18.5-24.9 kg/m2 or obese BMI 30.0-39.9 kg/m2

          -  Regular menstrual cycles

          -  No use of medroxyprogesterone acetate at least 6 months prior to study enrollment,
             unless resumption of two menstrual cycles

          -  No use of levonorgestrel intrauterine system (levonorgestrel-IUS), etonogestrel
             implant or combined hormonal contraception at least one month prior to the study and
             resumption of one menstrual cycle

          -  Women who are postpartum or post-abortion will be included if they have had at least
             one menstrual cycle since their last pregnancy

        Exclusion Criteria:

          -  Prior allergic reaction to LNG-EC or UPA-EC

          -  Use of hormonal emergency contraception within the past month

          -  Women who are currently pregnant or who are currently breastfeeding

          -  History of cancer other than non-melanoma skin cancer

          -  Medical or surgical conditions or conditions requiring therapies known to impact sex
             steroid production or metabolism

               -  Use of HAART therapy for management of HIV infection

               -  Concomitant use of CYP3A4 inducers like rifampin, barbiturates, carbamazepine,
                  lamotrigine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St.
                  John's Wort and topiramate

          -  Current participation in any other trial of an investigational medicine or device in
             the three months leading up to this study
Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: zoledronic acid
Intervention description: Zoledronic acid concentrate (4 mg/5 milliliters [ml]) was diluted in 100 mL sterile 0.9% calcium-free sodium chloride or 5% dextrose injection, administered IV, either 4 or 12 weeks for 96 weeks.
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple myeloma; zoledronic acid; skeletal complications; bone

Summary:

      This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in
      preventing skeletal complications in multiple myeloma participants who have been on an
      intravenous (IV) bisphosphonate for about one to two years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of multiple myeloma

          -  Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been
             initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due
             to multiple myeloma

          -  Stable renal function

        Exclusion Criteria:

          -  Known sensitivity to bisphosphonates

          -  Receiving investigational drugs considered not safe for co-administration or have a
             significant effect on bone turnover

          -  Current active dental problems

          -  Had bone marrow transplant or blood stem cell transplant within 2 months before study
             entry or planned transplant within 2 months following enrollment

        Other protocol-defined inclusion/exclusion criteria may apply.
Delayed Start to Ovarian Stimulation
Condition: Diminished Ovarian Reserve; Infertility; In Vitro Fertilization
MeSH terms: Infertility
Intervention: Ganirelix acetate
Intervention description: Subjects will receive 7 days of pre-treatment with the GnRH antagonist
Intervention MeSH terms: Ganirelix
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DOR; Infertility; IVF; ART; GnRHa; GnRH Antagonist Protocol; Ganirelix

Summary:

      In couples with infertility secondary to Diminished Ovarian Reserve, the investigators
      hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist
      (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Antral Follicle Count (AFC) less than or equal to 4 as measured by transvaginal
             ultrasound (TVUS), or

          -  Cancellation of a prior IVF cycle due to poor ovarian response.

          -  Patients will receive an antagonist stimulation protocol for IVF, or IVF with
             Intracytoplasmic Sperm Injection (ICSI).

        Exclusion Criteria:

          -  Severe male factor infertility requiring surgical intervention to obtain sperm

          -  Major uterine abnormality,

          -  Preimplantation genetic diagnostic (PGD) testing,

          -  Planned cycles without embryo transfer (for example, freeze-all, donor, or surrogate
             cycles).
Study of Dual Trigger Ovulation in Oocyte Donors
Condition: Infertility
MeSH terms: Infertility
Intervention: HCG; Lupron Trigger; Dual Trigger
Intervention description: hCG Trigger; leuprolide acetate 2 mg SQ; a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: oocyte donor; oocyte recipient; ovulation trigger

Summary:

      The project is a randomized, controlled, prospective study of oocyte donors comparing the
      safety and efficacy of triggering ovulation using a combination of two drugs-GnRH agonist and
      very low dose hCG-versus triggering ovulation with a standard hCG dose alone or a standard
      GnRH trigger alone.
    

Eligibility criteria:

        Inclusion Criteria:

        Donors

          -  Young women, age 21 to 34, presenting to our facility with the desire to donate
             oocytes and meeting FDA and program requirements for donation.

        Recipients

          -  Women, age 21 to 55, presenting to our facility with the desire to donate oocytes and
             meeting FDA and program requirements to be recipients of donated eggs.

        Exclusion Criteria:

        Donors

          -  Less than 2 ovaries or any other significant ovarian abnormality

          -  Does not meet current FDA or program requirements for donation.

          -  A contraindication for the use of gonadotropins (e.g. tumors, pregnancy/lactation,
             undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)

          -  A contraindication for the use of oral contraceptive pills (h/o thromboembolism,
             breast cancer, undiagnosed vaginal bleeding)

          -  Known gene defects, genetic abnormalities or abnormal karyotype

          -  Contraindication or hypersensitivity to any of the concomitant medication prescribed
             as part of the treatment regimen in this protocol

          -  Inability to give informed consent

          -  Donors who, because of their place of residence or personal situation, would not be
             able to commit to all required time points including the one extra visit required by
             study participation.

          -  The subject has a recent history of/or current epilepsy, thrombophilia, diabetes,
             cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Fingolimod
Intervention description: Fingolimod 0.5 mg tablet
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: multiple sclerosis, fingolimod, adult, FTY720, inflammatory disease, demyelination, auto-inflammatory disease, relapsing-remitting MS, CFTY720D2406

Summary:

      This study will evaluate if patients who had a serious cardiovascular event upon initiation
      of fingolimod are at risk to delevop long term other cardiovascular events
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients participating in study FTY720D2406 who experienced a serious cardiovascular
             event during their fingolimod treatment initiation or re-initiation which led to
             overnight monitoring or met seriousness criteria.

          -  Patients still on fingolimod after the this first dose serious event

        Exclusion Criteria:

        -Treatment with any investigational drug unless it is received as part of a Novartis
        sponsored MS study lasting less than 1 month
Long-Acting Reversible Contraception
Condition: Contraception
Intervention: DMPA; oral contraceptives; Implanon®; ParaGard®; Mirena®
Intervention description: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.; Oral contraceptives (any variety of formulations are permitted); Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel); Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface); Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)
Intervention MeSH terms: Contraceptive Agents; Etonogestrel; Contraceptives, Oral
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Partially randomized patient preference trial
Masking: None (Open Label)
Enrollment: 916.0
Sex: Female
Minimum age: 18 Years
Maximum age: 29 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: AE-adverse event; FDA-(U.S.) Food and Drug Administration; GCP-Good Clinical Practice guidelines; ICH-International Committee on Harmonisation; IRB-Institutional Review Board; IU-International units; mg-milligram(s); mm3-cubic millimeter(s); LARC-Long-Acting reversible contraception; PPCNC-Planned Parenthood of North Carolina; SAE-serious adverse event; SARC-Short-Acting reversible contraception; µg-microgram; ULN-upper limit of the normal range; SubQ-subcutaneous

Summary:

      In the proposed study, women aged 18-29 seeking oral or injectable contraception will be
      offered an opportunity to try LARC instead; the FDA-approved options include two types of
      intrauterine products and one type of subdermal contraceptive implant. Over a 24 month
      period, the experiences of LARC users will be compared to the experiences of those opting for
      their initial short-acting method.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 29 years of age;

          -  sexually active;

          -  seeking oral or injectable contraception;

          -  working cell phone;

          -  working email account;

          -  willingness to be contacted by the clinic staff or study coordinators; and,

          -  willingness to complete questionnaires.

        Exclusion Criteria:

          -  currently pregnant;

          -  previous use of a long-acting reversible contraceptive (LARC) method; and,

          -  medical contraindications for oral contraceptives and injectables.