ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01256424
Conditions: Cervical Intraepithelial Neoplasia
Keywords: CIN
Sponsor: Photocure
Start date: 2011-04-01; Completion date: 2012-12-01
Enrollment: 262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).

Detailed description:

Arms: arm 1: HAL PDT 5% arm 2: HAL PDT 1% arm 3: HAL PDT 0.2% arm 4: Placebo without illumination
Interventions: intervention 1: HAL 5% with illumination intervention 2: HAL 1% with illumination intervention 3: HAL 0.2% with illumination intervention 4: Placebo ointment without illumination
Intervention descriptions: intervention 1: Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation intervention 2: Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation intervention 3: Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation intervention 4: Treatment with a singe dose of 2g placebo ointment, no photoactivation

Protocol documents:
Clinical trial NCT01256671
Conditions: Vaginal Atrophy
Keywords: Vulvar/Vaginal Atrophy Atrophic Vaginitis Dehydroepiandrosterone DHEA Prasterone Vaginorm Menopause Intrarosa
Sponsor: EndoCeutics Inc.
Start date: 2010-12-01; Completion date: 2012-12-01
Enrollment: 530 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.

Detailed description:

Arms: arm 1: 0.5% DHEA (intravaginal)
Interventions: intervention 1: DHEA
Intervention descriptions: intervention 1: Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.

Protocol documents:
Clinical trial NCT01262287
Conditions: Alcoholism Alcohol Abuse Alcohol Dependence
Keywords: Randomized Trial Medication for Heavy Drinking Dutasteride Treatment
Sponsor: UConn Health
Start date: 2011-01-01; Completion date: 2012-12-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether dutasteride is safe and effective for reducing alcohol use in male drinkers who want to stop or reduce their drinking. The investigators hypothesize that at a dosage of 1mg/day, dutasteride will be well tolerated and that, compared to placebo treatment, dutasteride will result in a greater reduction in the amount of alcohol consumed per week. The study sample size is of a pilot scale and is designed to provide additional support for the study hypothesis and provide an estimate of likely effect sizes in order to design a more definitive study.

Detailed description:

Arms: arm 1: dutasteride (1 mg oral daily dose) for 8-week treatment period arm 2: placebo daily for 8-week treatment period
Interventions: intervention 1: Dutasteride intervention 2: Placebo
Intervention descriptions: intervention 1: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period intervention 2: placebo capsules in same number as active drug, daily for 8-week treatment period

Protocol documents:
Clinical trial NCT01266148
Conditions: Renal Function and Chronic Allograft Vasculopathy
Sponsor: Novartis Pharmaceuticals
Start date: 2009-11-01; Completion date: 2012-12-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A controlled, randomized, open-label, multicenter study evaluating if early initiation of everolimus and early elimination of cyclosporine in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy

Detailed description:
This was a prospective, multi-center, randomized, controlled, parallel group, open label study in de novo heart transplant recipients. Patients eligibility for randomization was assessed 5 days after heart transplant.. Patients fulfilling the inclusion and exclusion criteria were randomized to one of two treatment groups: either conventional treatment with Cyclosporine A (CsA), Mycophenolate mofetil (MMF), and corticosteroids (Group A), or low-dose CsA and everolimus, reduced dose MMF, and corticosteroids (Group B). After 7 to 11 weeks, CsA was discontinued in Group B, while the standard triple-drug immunosuppressive regimen was maintained in Group A.

Arms: arm 1: Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS. arm 2: Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
Interventions: intervention 1: Cyclosporine intervention 2: Mycophenolate mofetil intervention 3: Corticosteroids intervention 4: Everolimus intervention 5: Anti Thymocyte Globulin
Intervention descriptions: intervention 1: Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3) intervention 2: Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11 intervention 3: Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups. intervention 4: Everolimus 0.75 mg twice a day as starting dose up to a target blood level: 3-6 ng/mL (7-11 weeks) and 6-10 ng/mL for remaining of study intervention 5: Induction therapy, Anti Thymocyte Globulin (ATG): 1-2 mg/kg/day during 3-5 days for control and everolimus groups after transplant surgery and prior to randomization.

Protocol documents:
Clinical trial NCT01281202
Conditions: Cocaine Addiction Cocaine Dependence
Keywords: Cocaine Cocaine Addiction Treatment Cocaine Treatment Vigabatrin CPP-109 Catalyst National Institute on Drug Abuse
Sponsor: Catalyst Pharmaceuticals, Inc.
Start date: 2011-01-01; Completion date: 2012-12-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.

Detailed description:
The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.

There are 3 Phases to this study:

* a 2-4 week Screening/Baseline Phase during which eligibility to be included in the trial will be tested;
* a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets in addition to counseling; and
* a 15 week Follow-up Phase, during the first 4 weeks (Weeks 10-13) of which subjects will continue to receive counseling.

Arms: arm 1: Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase

During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks

Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13) arm 2: Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase

During treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks

Subjects were provided with on-site, supervised, standardized, manualized Indivdiual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)
Interventions: intervention 1: Vigabatrin intervention 2: Matching Placebo
Intervention descriptions: intervention 1: Tablets intervention 2: Tablets

Protocol documents:
Clinical trial NCT01290718
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-12-01; Completion date: 2012-12-01
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: capecitabine [Xeloda] intervention 2: trastuzumab [Herceptin]
Intervention descriptions: intervention 1: 900mg/m2 bid po on days 1-14 of each 3-week cycle intervention 2: 8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks

Protocol documents:
Clinical trial NCT01312922
Conditions: Major Depressive Disorder
Sponsor: PharmaNeuroBoost N.V.
Start date: 2011-09-01; Completion date: 2012-12-01
Enrollment: 555 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall objective of this trial is to demonstrate clinically relevant superior antidepressant efficacy of the fixed dose combination PNB01 (low dose pipamperone and citalopram) over reference antidepressant treatment with citalopram alone, and a low dose of psychoactive pipamperone alone in patients with moderate to severe Major Depressive Disorder.

This study was specifically designed to assess patient related outcome (PRO) parameters using an Interactive Voice Response System (IVRS) via telephone.

Detailed description:
This is an international, double-blind, centrally randomized (stratified), multicenter study in 555 patients suffering from moderate to severe MDD in up to 40 sites in the USA, Germany and Canada. Eligible out-patients will be treated once daily (QD) with a fixed dose of either PNB01 (PIP 15 mg / CIT 20 mg (Week 1) - PIP 15 mg / CIT 40 mg (Week 2-10)), CIT alone (CIT 20 mg (Week 1) - CIT 40 mg (Week 2-10) or PIP 15 mg alone (Week 1-10) in a 1:1:1 ratio in a double-blind fashion for 10 weeks. Study visits will be conducted 1, 2, 3, 4, 6, 8 and 10 weeks after study treatment initiation. Possible withdrawal effects will be assessed 1 week after study treatment withdrawal.

A blood sample for pharmacokinetic analysis will be collected when drawing blood for routine biochemistry. Patients who provided written informed consent to participate to the study will be asked to provide their consent to participate also to the non-mandatory pharmacogenetic study.

Patient related outcomes will be collected electronically (ePRO) at study visits prior to visiting the investigator by using an Interactive Voice Response System (IVRS) via telephone. Patients wishing or choosing to discontinue the study treatment prematurely will be encouraged to continue to provide their scores, safety data and medications taken, up to the scheduled study end, by telephone.

Arms: arm 1: oral, once daily administration arm 2: oral, once daily administration arm 3: oral, once daily administration
Interventions: intervention 1: PNB01 fixed dose combination of pipamperone and citalopram intervention 2: Citalopram intervention 3: Pipamperone
Intervention descriptions: intervention 1: oral once daily administration intervention 2: oral once daily administration intervention 3: oral once daily administration

Protocol documents:
Clinical trial NCT01316302
Conditions: Social Anxiety Disorder
Keywords: Social Anxiety Disorder Social Phobia SAD
Sponsor: The Medical Research Network
Start date: 2011-04-01; Completion date: 2012-12-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).

Detailed description:
Social Anxiety Disorder (SAD) is recognized as a prevalent, chronic and disabling condition. Lifetime prevalence has been estimated at 13% in the National Comorbidity Survey. There is good reason to think that Pristiq® would be effective in Social Anxiety Disorder. Effexor XR, which is mechanistically similar to Pristiq®, was found effective for subjects with Generalized Social Anxiety Disorder in all five of the placebo controlled trials in which it was studied.

Arms: arm 1: Flexible dose, 50-100mg QD arm 2: Matching placebo
Interventions: intervention 1: Pristiq intervention 2: Placebo
Intervention descriptions: intervention 1: Flexible dose, 50-100mg QD, for 12 weeks. intervention 2: Matching placebo, taken QD for 12 weeks.

Protocol documents:
Clinical trial NCT01326312
Conditions: Prostate Cancer
Sponsor: GTx
Start date: 2011-06-01; Completion date: 2012-12-01
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether GTx 758 is effective in achieving and maintaining castrate testosterone levels in men with advanced prostate cancer.

Detailed description:
Prostate cancer is one of the most frequently diagnosed noncutaneous cancers among men in the US and is the second most common cause of cancer deaths. Patients with advanced prostate cancer undergo androgen deprivation therapy (ADT), by either LHRH agonists, LHRH antagonists, DES and other nonselective estrogens, or by bilateral orchiectomy. ADT by LHRH agonists, LHRH antagonists, or bilateral orchiectomy not only reduces testosterone, but also substantially lowers estrogen levels as estrogen is derived from the aromatization of testosterone. ADT-induced estrogen deficiency causes significant side effects which include hot flushes, gynecomastia, bone loss, decreases in bone quality and strength, osteoporosis and life-threatening fractures, adverse lipid changes, increase in body fat composition, and higher cardiovascular disease and myocardial infarction, and depression and other mood changes.

GTx-758 is a nonsteroidal selective ER agonist that suppresses LH secretion by the pituitary by feedback inhibition of the hypothalamic-pituitary-gonadal axis to induce castrate levels of testosterone. However, because it is a selective ER agonist, GTx-758 may maintain bone, does not induce hot flushes, avoids adverse lipid changes and body fat composition changes, and does not have the acute testosterone surge that are associated with other forms of ADT.

Arms: arm 1: GTx-758/Experimental/ nonsteroidal selective ER alpha agonist arm 2: GTx-758/Experimental/ nonsteroidal selective ER alpha agonist arm 3: Luteinizing Hormone Releasing Hormone Agonist
Interventions: intervention 1: GTx-758 1000mg intervention 2: Lupron Depot intervention 3: GTx-758 2000mg
Intervention descriptions: intervention 1: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension intervention 2: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension intervention 3: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension

Protocol documents:
Clinical trial NCT01327482
Conditions: HIV
Keywords: Raltegravir Pharmacokinetics
Sponsor: University of Washington
Start date: 2011-10-01; Completion date: 2012-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an investigation of the pharmacokinetics of raltegravir in the tissue of the female genital tract to determine if twice-daily dosing of 400mg achieves adequate drug levels to prevent viral integration of HIV-1. The study will also assess whether drug levels change in the tissue across the different phases of the menstrual cycle.

* Hypothesis #1: Twice daily dosing with raltegravir 400mg will result in intracellular concentrations that should be sufficient to suppress HIV-1 replication throughout the menstrual cycle.
* Hypothesis #2: Intracellular genital raltegravir peaks will be lower and troughs higher compared to extracellular concentrations in the plasma and PMBCs (peripheral blood mononuclear cells).
* Hypothesis #3: Intracellular raltegravir concentrations will be slightly lower during the luteal phase of the menstrual cycle due to cellular pumps such as p-glycoprotein, which are present in higher numbers during periods of high progesterone.

Detailed description:
HIV-1 is shed in genital secretions which increase the risk of transmission between sexual partners and from mother to infant. Antiretroviral medication taken prior to exposure to HIV-1 can prevent viral transmission from a mother to her infant. Raltegravir (RAL), by blocking integration of viral cDNA into the host's genome, makes an excellent candidate for preventing HIV-1 infection. RAL is licensed for treatment with twice-daily dosing based on plasma trough concentrations; however, intracellular concentrations of RAL which are relevant to blocking infection of cells have not been previously studied. P-glycoprotein pumps, which are involved in regulating drug absorption and metabolism, can influence intracellular drug concentrations. P-glycoprotein concentrations appear to vary with menstrual cycle suggesting it may affect intracellular drug concentration of RAL in women.

Women will be enrolled in the study and followed during the course of a menstrual cycle while taking a dose of 400mg PO twice daily. An initial screening visit will be performed prior to enrollment and participation in the study. Review of medical history as well as blood and urine collection will occur during the screening visit. Once enrolled, participants will have blood and genital tract samples collected once a week for four weeks to assess intracellular concentrations of RAL in the blood and genital tract tissue.

Arms: arm 1: All patients were part of the intervention arm, as this was a pharmacokinetic study. All women took Raltegravir 400mg orally, twice daily for 3 weeks.
Interventions: intervention 1: Raltegravir
Intervention descriptions: intervention 1: Dosage: 400mg/PO (by mouth) Frequency: Twice daily Duration: During course of menstrual cycle (28 days)

Protocol documents:
Clinical trial NCT01335620
Conditions: HIV
Keywords: HIV Pharmatokinetic 60 years old Raltegravir
Sponsor: Imperial College London
Start date: 2011-04-01; Completion date: 2012-12-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.

Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to:

* tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
* raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.

Detailed description:
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.

Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence of previous HIV- resistance mutations on genotypic resistance testing.

At baseline, subjects will switch antiretroviral therapy to:

* tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
* raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.

Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits that will include standard safety parameters. Assessment of cardiac biomarkers at baseline and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and on day 180 will also be undertaken.

Following completion of this study, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.

Arms: arm 1: Single arm study

tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily
Interventions: intervention 1: Raltegravir intervention 2: Tenofovir intervention 3: Emtricitabine
Intervention descriptions: intervention 1: 400 mg twice daily intervention 2: 245 mg once daily intervention 3: 200mg once daily

Protocol documents:
Clinical trial NCT01338792
Conditions: Hormone-resistant Prostate Cancer Recurrent Prostate Cancer
Sponsor: University of Southern California
Start date: 2006-06-01; Completion date: 2012-12-01
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving oxaliplatin and pemetrexed disodium together works in treating patients with refractory hormone-resistant prostate cancer. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving oxaliplatin together with pemetrexed disodium may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES: I. To determine the response rate by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, prostate-specific antigen (PSA) response by the PSA Working Group criteria, and overall clinical benefit defined by summation of RECIST complete responses (CR) plus RECIST partial responses (PR) plus PSA PRs. SECONDARY OBJECTIVES: I. To determine time to progression in patients with hormone-refractory prostate cancer (HRPC) receiving oxaliplatin and pemetrexed. II. To describe the safety profile of this treatment. III. Pain response will be evaluated in an exploratory manner. IV. Undertake a pilot analysis of excision repair cross-complementing 1 (ERCC1) expression levels and polymorphisms, looking at their ability to predict response to platinum therapy. OUTLINE: Patients receive oxaliplatin intravenously (IV) over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.

Arms: arm 1: Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: oxaliplatin intervention 2: pemetrexed disodium intervention 3: questionnaire administration intervention 4: laboratory biomarker analysis intervention 5: reverse transcriptase-polymerase chain reaction intervention 6: polymorphism analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Ancillary studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies

Protocol documents: