ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00585169
Conditions: Pathological Gambling
Keywords: Pathological Gambling Compulsive Gambling Gambling Addiction Gambling Treatment Memantine Pharmacology
Sponsor: Yale University
Start date: 2007-12-01; Completion date: 2011-12-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of the proposed study is to evaluate the efficacy and safety of the drug memantine in individuals with pathological gambling (PG). Thirty subjects with DSM-IV PG will receive 10 weeks of open-label treatment with memantine. The hypothesis to be tested is that memantine will be effective and well tolerated in patients with PG. We hypothesize that memantine will reduce the severity of gambling symptoms and improve patients' overall functioning. This study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Detailed description:

Arms: arm 1: 10 to 30 mg/day memantine. The study consisted of 10 weeks of open-label memantine. All eligible study subjects were started at 10 mg/day for 2 weeks. The dose was increased to 20 mg/day after 2 weeks and then to 30 mg/day after 4 weeks unless remission of PG symptoms was attained at a lower dose.
Interventions: intervention 1: Memantine Hydrochloride
Intervention descriptions: intervention 1: 10 mg/day for two weeks, dose increase to 20 mg at week 3, 30 mg at week 4 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks.

Protocol documents:
Clinical trial NCT00588666
Conditions: Myeloproliferative Disorder Urothelial Carcinoma Cancer
Keywords: Myeloproliferative Disorder urinary bladder Cancer ureter renal pelvis chemotherapy
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2006-05-01; Completion date: 2011-12-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Gemcitabine and carboplatin are two standard chemotherapy drugs used to treat tumors of the urothelial tract. These drugs do not shrink tumors in all patients and when they do, it is generally for a limited amount of time. This has led scientists to look for different ways to treat cancer.

New drugs have been developed to treat cancer that work differently than standard chemotherapy drugs. One new class of drugs are called 'angiogenesis-inhibitors'. These drugs attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing. Bevacizumab is an anti-angiogenic drug.

In some other cancers such as colon cancer and lung cancer, combining bevacizumab with standard chemotherapy shrinks tumors in a greater proportion of patients and makes patients live longer than using standard chemotherapy alone. This has never been tested in urothelial cancer and we do not know if bevacizumab will have the same effects in this disease. The purpose of this study is to find out what effects, good and/or bad, the combination of gemcitabine, carboplatin, and bevacizumab has on you and your cancer.

Detailed description:
This is a phase II trial of gemcitabine, carboplatin, and bevacizumab in chemotherapy naïve patients with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.

Arms: arm 1: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
Interventions: intervention 1: Bevacizumab intervention 2: Carboplatin intervention 3: Gemcitabine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00596466
Conditions: Epilepsy
Keywords: open-label extension study pregabalin partial epilepsy
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-04-01; Completion date: 2011-12-01
Enrollment: 75 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the long term safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy patients for the treatment of partial seizures. This is an extension study to a previous clinical trial.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pregabalin
Intervention descriptions: intervention 1: pregabalin

Protocol documents:
Clinical trial NCT00603941
Conditions: Anaplastic Thyroid Cancer
Keywords: Anaplastic Thyroid Cancer Neoplasm Tumor Anti-neoplastic Agent First-line treatment of advanced Anaplastic thyroid cancer
Sponsor: Daiichi Sankyo
Start date: 2008-01-01; Completion date: 2011-12-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The Phase I/II study will be conducted as an open label, multiple center study of CS-7017, an experimental drug and paclitaxel chemotherapy in subjects with advanced anaplastic thyroid cancer. Biopsies will be obtained from patients with accessible tumor at baseline, two-weeks after the first CS-7017 dosage (prior to the start of combination therapy) and at the end of the first study cycle (week 3 of combination therapy), in order to evaluate the effects of the study drug alone and in combination with the chemotherapy agent on the tumor. Treatment will continue until disease progression or the development of intolerable toxicities.

Detailed description:

Arms: arm 1: Participants who received 0.15 mg twice daily (BID) oral CS-7017 and 135 \[Dose Level 1a\] or 175 \[Dose Level 1b\] mg/m\^2 intravenous (IV) paclitaxel once every 3 weeks. arm 2: Participants who received 0.30 mg twice daily (BID) oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks. arm 3: Participants who received 0.50 mg twice daily (BID) oral CS-7017 and 175 mg/m\^2 IV paclitaxel once every 3 weeks.
Interventions: intervention 1: CS-7017 intervention 2: Paclitaxel
Intervention descriptions: intervention 1: At Phase 1, CS-7017 will be tested in combination with paclitaxel at the following dosage levels: 0.15, 0.30, or 0.50 mg BID. At Phase 2, CS-7017 will be administered at the recommended phase 2 dose (RP2D). intervention 2: Commercially available paclitaxel will be administrated as IV infusion over 3 hours once every 3 weeks.

Protocol documents:
Clinical trial NCT00619892
Conditions: Panic Disorder
Keywords: SSRI Resistant Seroquel SR Seroquel XR Panic Disorder Comorbid Panic Disorder Quetiapine SR Quetiapine XR
Sponsor: Indiana University
Start date: 2008-02-01; Completion date: 2011-12-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus placebo.

Detailed description:
This was a single-site, double-blind, placebo-controlled (PLAC), randomized, parallel group (2 groups), 8-week, quetiapine extended release (XR) coadministration trial. SSRI resistance was determined either historically or prospectively. Patients were randomized if they remained moderately ill (CGI-S score ≥ 4). Change in the PDSS scale total score was the primary efficacy outcome measure. Responders were identified as those with a ≥50 % decrease from their baseline PDSS score. In the early weeks of therapy, XR was flexibly and gradually titrated from 50 to 400 mg/day.

Conclusions: This proof-of-concept RCT did not support the efficacy of this treatment strategy for SSRI-resistant PD. Quetiapine XR was generally well-tolerated. Important limitations were the small sample size, and the relatively low average dose of quetiapine XR used.

Arms: arm 1: Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy \& the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, \& 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations). arm 2: Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).
Interventions: intervention 1: quetiapine XR intervention 2: placebo
Intervention descriptions: intervention 1: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg. intervention 2: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.

Protocol documents:
Clinical trial NCT00626444
Conditions: Non-Hodgkin Lymphoma
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2008-02-01; Completion date: 2011-12-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Eligible candidates will be adults with aggressive or very aggressive NHL (WHO classification diagnosis confirmed by histological tumor examination). Patients must have failed one or more prior NHL chemotherapy or antibody therapy with curative intent, and the disease must not have progressed within 60 days of last therapy. In addition, patients must not be candidates for potentially curative therapy, such as HSCT, or they must have refused these alternative therapies. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. Intravenous ascorbic acid will be given in a dose based on the plasma vitamin C level to reach a level in the range of 300 to 350 mg/dL. Vitamin C infusions will be given three times a week on a schedule that allows at least 24 hours between each infusion, for a total of ten weeks (30 infusions). If disease progression occurs before or at the ten week assessment, then we discontinue protocol, based on futility. Toxicity and adverse events also will result in immediate discontinuation (details available in full protocol). If there is lack of disease progression or disease improvement, proceed and reassess again at 10 week intervals, for a total of three 10 week intervals. Initial criteria are based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson et al., Report of an international workshop to standardize response criteria for non-Hodgkin's lymphoma, Journal of Clinical Oncology, 1999, Vol. 17, No4, 1244-1253); response for this study will utilize PET in accordance with revised criteria (Cheson et al. Revised response criteria for malignant lymphoma. J of Clin Oncol 2007; 25(5): 579-586). We select 20 patients as an appropriate study size to evaluate a true response rate to therapy, compared to just the observed response.

Detailed description:

Arms: arm 1: Intravenous vitamin C
Interventions: intervention 1: Intravenous vitamin C
Intervention descriptions: intervention 1: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.

Protocol documents:
Clinical trial NCT00627406
Conditions: OHSS (Ovarian Hyperstimulation)
Keywords: GnRH antagonist GnRH agonist hCG OHSS In vitro fertilization ovulation induction Clinical pregnancy rate
Sponsor: Regionshospitalet Viborg, Skive
Start date: 2009-01-01; Completion date: 2011-12-01
Enrollment: 384 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles

Detailed description:

Arms: arm 1: More than 14 follicles with a diameter of \> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) arm 2: More than 14 follicles with a diameter of \> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.) arm 3: 14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5) arm 4: 14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
Interventions: intervention 1: Buserelin and Pregnyl intervention 2: Pregnyl intervention 3: Buserelin and Pregnyl intervention 4: Pregnyl
Intervention descriptions: intervention 1: Subcutaneous injection 0.5 mg and 1500 IU intervention 2: Subcutaneous injection 5000 IU intervention 3: Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days intervention 4: Subcutaneous injection 5000 IU

Protocol documents:
Clinical trial NCT00640289
Conditions: Hemophilia Factor XIII Deficiency
Keywords: Factor XIII Deficiency Rare Bleeding Disorder Hemophilia Fibrogammin P
Sponsor: Children's Hospital of Orange County
Start date: 2000-01-01; Completion date: 2011-12-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Congenital deficiency of Factor XIII is a rare but potentially life threatening disorder. It is inherited in an autosomal recessive fashion. Infusion of Factor XIII has proved to be useful for prevention and treatment of bleeding episodes, especially of spontaneous intracranial bleedings. In this study, Fibrogammin P will be given to patients with congenital Factor XIII deficiency and congenital/acquired FXIII deficiency to prevent bleeding and to treat established bleeding episodes. For Factor XIII prophylaxis to prevent hemorrhages, the dosage will depend on the weight of the subject. The frequency of Factor XIII administration will be determined by the factor's circulating half-life. During the first month only, a Factor XIII pharmacokinetic study will be determined over a 4-week period. Safety data will include accrual of information on viral safety, liver function, complete blood counts and adverse events. Historical data concerning spontaneous bleeds will be collected whenever possible two years prior to treatment with Fibrogammin P.

Detailed description:

Arms: arm 1: Treatment
Interventions: intervention 1: Fibrogammin P
Intervention descriptions: intervention 1: Prophylaxis treatment

Protocol documents:
Clinical trial NCT00642746
Conditions: Metastatic Colorectal Cancer
Keywords: Colon Cancer Metastatic Colorectal
Sponsor: OHSU Knight Cancer Institute
Start date: 2008-03-01; Completion date: 2011-12-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if alternating chemotherapy with erlotinib increases tumor shrinkage in people with metastatic colorectal cancer. The investigator will also be studying the side effects (good and bad) of alternating chemotherapy with erlotinib on metastatic colorectal cancer.

Detailed description:

Arms: arm 1: Subjects received FOLFOX (Leucovorin, Fluorouracil, and Oxaliplatin) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFOX on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22. arm 2: Subjects received FOLFIRI (Leucovorin, Fluorouracil, and Irinotecan) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFIRI on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22.
Interventions: intervention 1: Erlotinib intervention 2: Fluorouracil intervention 3: Leucovorin intervention 4: Oxaliplatin intervention 5: Irinotecan
Intervention descriptions: intervention 1: Erlotinib oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. In addition to the active ingredient, erlotinib contains lactose (hydrous), microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, and magnesium stearate.

Tablets containing 25 mg, 100 mg, and 150 mg of erlotinib are available. Each bottle will contain 30 tablets, a quantity sufficient for 4 consecutive weeks of dosing, with overage. intervention 2: Antimetabolite used as a chemotherapy. Administered intravenously as a bolus injection at 400mg/m2 on Day 1 followed by 2400 mg/m2 continuously over 46 hours. intervention 3: Chemotherapy agent given as a supplement to Fluorouracil. Given intravenously 400mg/m2 in combination with Fluorouracil dosing. intervention 4: Platinum-based antineoplastic chemotherapy agent given intravenously at 85 mg/m2. intervention 5: Chemotherapy agent given intravenously at 180 mg/m2.

Protocol documents:
Clinical trial NCT00656019
Conditions: Breast Cancer
Sponsor: Stanford University
Start date: 2008-04-01; Completion date: 2011-12-01
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess whether levels of vitamin D impact the characteristics of a woman's breast cancer at diagnosis, and whether a short course of vitamin D in women with low levels of vitamin D changes the gene expression of their breast cancers.

Detailed description:
Patients undergoing core needle biopsy of breast abnormalities suspicious for breast cancer will be identified and enrolled in study. As well as those who have had a core needle biopsy demonstrating breast cancer, but who have not yet undergone local surgical treatment, chemotherapy, or hormonal therapy are also eligible. patients with breast cancer on core biopsy will be eligible.

Participants will be assigned to treatment (0, 2000, 4000, 6000 IU/day vitamin D by mouth) based solely on their serum vitamin D levels (Normal: \>40 ng/mL; Low-normal: 31-40 ng/mL; Low: 20-30 ng/mL; Very-low: \<20 ng/mL). Prior to definitive breast cancer surgery, vitamin D level, parathyroid level, and calcium will be reassessed. Samples of the patients original core biopsy and pathology specimen from their definitive surgical therapy will undergo gene expression profiling.

The ultimate plan is to correlate baseline vitamin D levels with classic prognostic and predictive markers to see if breast cancer biology is impacted by baseline vitamin D level and by vitamin D supplementation and to see if vitamin D supplementation results in gene expression changes similar to those of the vitamin D sufficient group.

Arms: arm 1: No additional Vitamin D administered arm 2: 2000 IU dose of Vitamin D per day administered orally arm 3: 4000 IU dose of Vitamin D per day administered orally arm 4: 6000 IU dose of Vitamin D per day administered orally
Interventions: intervention 1: Vitamin D
Intervention descriptions: intervention 1: 0, 2000, 4000, and 6000 IU per day orally

Protocol documents:
Clinical trial NCT00656175
Conditions: HIV Infections Lipodystrophy
Keywords: lipodystrophy fat visceral fat HIV women raltegravir ART anti HIV therapy NNRTI Protease inhibitor integrase inhibitor treatment experienced
Sponsor: University of California, Los Angeles
Start date: 2008-09-01; Completion date: 2011-12-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ritonavir-boosted protease inhibitor (PI) regimens have become a backbone for treatment of people with HIV. However, adverse drug effects, particularly lipodystrophy/lipoatrophy are closely associated with these regimens. Therefore, there is a need for a drug with comparable effectiveness to the ritonavir boosted PIs without the side effects of dyslipidemia, which has been associated with elevated cholesterol and cardiovascular disease

Raltegravir is an HIV integrase inhibitor in phase III clinical development. To date there are no approved drugs that target the same stage of the HIV-1 lifecycle. However, data from studies indicate that raltegravir is generally safe and well tolerated and has strong antiretroviral activity when used in combination with licensed antiretroviral medications.

This study aims to demonstrate that patients substituting raltegravir for a PI or NNRTI based antiretroviral regimen will be associated with a 10% reduction in body fat over 24 weeks.

The study will consist of a total of 10 subject visits over a period of 48 weeks. Approximately 40 female patients will participate in this study (approximately 10 at UCLA).

Detailed description:

Arms: arm 1: Immediate switch of PI or NNRTI to Raltegravir arm 2: Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
Interventions: intervention 1: raltegravir
Intervention descriptions: intervention 1: raltegravir

Protocol documents:
Clinical trial NCT00658411
Conditions: Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome
Keywords: AML ALL MDS iron overload deferoxamine
Sponsor: Dana-Farber Cancer Institute
Start date: 2008-08-01; Completion date: 2011-12-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this research study is to determine the safety and feasibility of chelation therapy with deferoxamine for patients with iron overload who are receiving a stem cell transplant. Patients who have iron overload prior to stem cell transplantation may have more toxicity from the transplantation procedure, and thus may benefit from an attempt at iron chelation pre- and peri-transplantation. In this study we are examining the use of deferoxamine starting 2 weeks to 3 months prior to transplantation and continuing through the preparative regimen.

Detailed description:
See above

Arms: arm 1: Deferoxamine for \>=2 weeks prior to stem cells
Interventions: intervention 1: deferoxamine
Intervention descriptions: intervention 1: Given intravenously or subcutaneously over 8-12 hours daily for at least three weeks prior to transplantation date and continue until the day before the participant receives their donor's stem cells.

Protocol documents: