ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00068601
Conditions: Breast Cancer Infertility Menopausal Symptoms
Keywords: infertility menopausal symptoms stage II breast cancer stage IIIA breast cancer stage IA breast cancer stage IB breast cancer estrogen receptor-negative breast cancer progesterone receptor-negative breast cancer
Sponsor: SWOG Cancer Research Network
Start date: 2003-10-01; Completion date: 2016-09-01
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Goserelin blocks hormone production in the ovaries. It is not yet known whether ovarian suppression using goserelin will prevent ovarian failure (early menopause) in women receiving chemotherapy for breast cancer.

PURPOSE: This randomized phase III trial is studying how well giving goserelin together with chemotherapy works compared with chemotherapy alone in preventing early menopause in women with stage I, stage II, or stage IIIA breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Compare the rate of premature ovarian failure in women with stage I-IIIA hormone receptor-negative breast cancer treated with chemotherapy with vs without goserelin.

Secondary

* Compare the rate of ovarian dysfunction in patients treated with these regimens.
* Compare ovarian reserve in patients treated with these regimens.
* Describe the pregnancy rates in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to age (under 40 vs 40 to 49) and planned chemotherapy regimen (3- to 4-month/course anthracycline-based vs 6- to 8-month/course anthracycline-based vs 3- to 4-month/course non-anthracycline-based vs 6- to 8-month/course non-anthracycline-based). Patients are randomized to 1 of 2 treatment arms.

* Arm 1: Patients receive cyclophosphamide-containing chemotherapy alone. Patients are followed at 1, 2, and 5 years.
* Arm 2: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 416 patients (208 per treatment arm) will be accrued for this study within 3 years.

Arms: arm 1: Patients receive cyclophosphamide-containing chemotherapy alone. arm 2: Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cyclophosphamide intervention 2: goserelin acetate
Intervention descriptions: intervention 1: Part of planned chemotherapy regimen intervention 2: Given subcutaneously

Protocol documents:
Clinical trial NCT00514449
Conditions: Schizophrenia Schizoaffective Disorder
Sponsor: Konasale Prasad
Start date: 2007-06-01; Completion date: 2016-09-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine whether antiviral medication will help improve psychotic symptoms and cognition in individuals early in the course of schizophrenia or schizoaffective disorder who are exposed to herpes simplex virus, type 1 (HSV 1), a virus that causes commonly occurring and recurrent cold sores.

Detailed description:
The main objective of the study is to evaluate the efficacy of add-on treatment of Valacyclovir (VAV), an antiviral medication, in the treatment of early course schizophrenia/schizoaffective disorder patients. Our main hypothesis is that the VAV add-on treatment will improve positive, negative and cognitive symptoms in herpes simplex virus (HSV) positive schizophrenia or schizoaffective disorder patients. We hypothesize that the grey matter reductions in specific brain regions (such as prefrontal regions) will improve in patients on VAV + antipsychotic compared to those on placebo + antipsychotic and the improvements in positive, negative and cognitive symptoms will be correlated with the grey matter changes.

Arms: arm 1: 1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks. arm 2: 2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
Interventions: intervention 1: Valacyclovir intervention 2: Placebo
Intervention descriptions: intervention 1: 1 g PO BID x 2 weeks after 2 weeks it goes up to 1.5 g PO BID x 16 weeks along with antipsychotic intervention 2: 2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic

Protocol documents:
Clinical trial NCT00540007
Conditions: Hodgkin Disease
Keywords: Hodgkin Lymphoma Lenalidomide Anti-neoplastic agents Thalidomide
Sponsor: Washington University School of Medicine
Start date: 2007-09-06; Completion date: 2016-09-01
Enrollment: 80 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy of lenalidomide in the treatment of relapsed or refractory classic Hodgkin lymphoma(cHL).

Detailed description:
Hodgkin lymphoma (HL), an uncommon but significant subtype of lymphoma, is divided into classical HL (cHL) and nodular lymphocyte predominant HL (NLPHL). Progress has been made in cHL therapy resulting in 5-year failure free survival rates between 61%-89% even in the setting of advanced stage or bulky disease. Patients who relapse however, have a variable prognosis ranging from a 8-year overall survival rate of less than 8% for patients who never achieve a remission to 54% for patients with a complete remission lasting greater than 12 months. High dose chemotherapy with autologous stem cell support is the standard of care for patients with relapsed cHL but for those that relapse despite aggressive salvage therapy 20 - 50%, with median remission durations of approximately 6 months. Furthermore, a subset of relapsed HL patients may not be candidates for aggressive salvage regimens. These novel salvage therapies are needed for relapsed/refractory cHL, especially agents without serious late toxicities are particularly attractive in this disease. Advances in the understanding of HL pathogenesis and lenalidomide's mechanisms of action provide substantial rationale for evaluating lenalidomide in HL patients.

Arms: arm 1: * The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-21 of a 28 day cycle. arm 2: * The first group of participants will be assigned to Cohort 1 and if no unacceptable toxicities occur in Cohort 1 then the second group of participants will be assigned to Cohort 2
* Lenalidomide 25 mg per day PO daily on days 1-28 of a 28 day cycle.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00611858
Conditions: Rectal Cancer
Keywords: 5-FU cetuximab radiation adenocarcinoma of the rectum neoadjuvant therapy
Sponsor: Dana-Farber Cancer Institute
Start date: 2008-05-01; Completion date: 2016-09-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The standard treatment for rectal cancer is to receive the chemotherapeutic drug 5-fluorouracil (5-FU) with radiation therapy before having surgery to remove the rectal cancer. This is known as neoadjuvant chemoradiotherapy. The purpose of this research study is to determine if Cetuximab improves the benefits of neoadjuvant chemoradiotherapy when given with 5-FU and radiation therapy.

Detailed description:
The epidermal growth factor receptor (EGFR) present in normal and tumor cells is involved in signaling pathways affecting cellular growth, differentiation, proliferation and programmed cell death. Overexpression of EGFR has been associated with poorer prognosis in colorectal cancer. Cetuximab targets and blocks EGFR and has been shown to be safe and effective in treating colorectal cancer and head and neck cancers.

The primary hypothesis is that cetuximab in combination with standard 5-FU and radiation as neoadjuvant therapy would improve pathological complete response (pCR) compared to the historical rate (30% versus 10%). The regimen would be considered promising if 5 or more of 25 evaluable participants achieve pCR. The probability of observing this outcome is 0.91 and 0.10 if the true pCR rate is 30% and 10%, respectively.

Arms: arm 1: Cetuximab: Participants first receive cetuximab at the initial dose of 400 mg/m2 intravenously (IV) administered over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Cetuximab is given as single agent during the first 3 weeks on study and then in combination with 5-FU and radiation.

Radiation: Radiation therapy given as standard of care is initiated after the 3rd dose of cetuximab with a total dose of 50.4 Gray (Gy) in 28 fractions over approximately 5.5 weeks.

5-FU: Participants receive 5-Fluorouracil (5-FU) continuous infusion through central venous access at 225 mg/m2/day given 7 days a week starting day 1 of radiation (no later than 3 days) and lasting the duration of radiation therapy.

Duration of neoadjuvant therapy is estimated to be 9 weeks. Surgery follows at week 13-17. Sigmoidoscopy is performed for biopsy prior to the 1st dose and after 3rd dose of cetuximab before the initiation of radiation and/or 5-FU.
Interventions: intervention 1: Cetuximab intervention 2: 5-Fluorouracil intervention 3: Radiation
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00776594
Conditions: Prostate Cancer
Keywords: Androgen deprivation therapy ADT bevacizumab
Sponsor: Dana-Farber Cancer Institute
Start date: 2008-10-01; Completion date: 2016-09-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).

Detailed description:
* Participants will be randomized into one of two study groups. The first group will receive Androgen Deprivation Therapy (ADT) plus bevacizumab. The second group will receive ADT alone.
* For the Androgen Deprivation therapy either (treating physician discretion)leuprolide or goserelin acetate (given as injections) every 3 months for a total of 6 months. Bicalutamide will also be taken orally daily for a total of 6 months.
* Bevacizumab will be given intravenously every three weeks for a total of 8 infusions over 6 months.
* Participants will be evaluated every 7-9 weeks with vitals, physical exam, PS, laboratories including PSA and testosterone.

Arms: arm 1: Androgen Deprivation Therapy Plus Bevacizumab arm 2: Androgen Deprivation Therapy Alone
Interventions: intervention 1: Androgen Deprivation Therapy intervention 2: bicalutamide intervention 3: bevacizumab
Intervention descriptions: intervention 1: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months intervention 2: 50mg orally daily for 6 months intervention 3: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Protocol documents:
Clinical trial NCT00777153
Conditions: Recurrent Glioblastoma
Keywords: Cancer Tumour Advanced Solid Tumour GBM Glioblastoma
Sponsor: AstraZeneca
Start date: 2008-10-01; Completion date: 2016-09-01
Enrollment: 423 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.

Detailed description:

Arms: arm 1: Cediranib 30mg arm 2: Cediranib 20mg + lomustine arm 3: Lomustine and Placebo Cediranib
Interventions: intervention 1: Cediranib intervention 2: Cediranib intervention 3: Lomustine Chemotherapy intervention 4: Placebo Cediranib
Intervention descriptions: intervention 1: 30 mg/day, oral, until progression intervention 2: 20 mg/day, oral, until progression intervention 3: 110 mg/m2 / Q6W, oral, until progression intervention 4: Oral, until progression

Protocol documents:
Clinical trial NCT00808639
Conditions: Bladder Cancer Muscle-invasive Bladder Cancer
Keywords: pegfilgrastim MVAC
Sponsor: Dana-Farber Cancer Institute
Start date: 2008-12-01; Completion date: 2016-09-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to test the effectiveness of neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) in combination with pegfilgrastim followed by radical surgery in patients with muscle-invasive urothelial carcinoma.

Detailed description:
* Participants will be given a study infusion schedule for each treatment cycle. Each treatment cycle lasts three weeks. The infusion of methotrexate will take place on the first day of each cycle. Infusions of vinblastine, doxorubicin and cisplatin will take place on the second day and an injection of pegfilgrastim will be given on the third day.
* During all treatment cycles participants will have a physical exam and will be asked questions about their general health and any problems they might be having and any medications they may be taking.
* Following completion of study treatment, but before surgery, participants will have an assessment of their tumor by CT scan of the chest and and MRI of the abdomen and pelvis.
* Following the participants surgery, we would like to keep track of their medical condition indefinitely, or until this study is officially completed. We would like to do this by calling the participants on the telephone once a year to see how they are doing.

Arms: arm 1: Chemo therapy with methotrexate, vinblastine, Adriamycin, Cisplatin
Interventions: intervention 1: Methotrexate intervention 2: Doxorubicin intervention 3: vinblastine intervention 4: cisplatin intervention 5: Pegfilgrastim
Intervention descriptions: intervention 1: intravenously 30mg/m2 over 30 minutes intervention 2: intravenously 30mg/ms over 15 minutes intervention 3: intravenously 3mg/m2 over 30 minutes intervention 4: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion intervention 5: Given subcutaneously 24 hours after last chemotherapy dose

Protocol documents:
Clinical trial NCT00887783
Conditions: Non-small Cell Lung Cancer
Keywords: Induction chemotherapy Non-small cell lung cancer Randomized phase II study Navelbine Oral (R) 3D-conformal radiotherapy Chemo-radiotherapy Local-regionally advanced non-small cell lung cancer
Sponsor: Odense University Hospital
Start date: 2009-05-01; Completion date: 2016-09-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consists of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients will be included in the study after completing the induction chemotherapy. Randomization will take place only if an acceptable dose plan can be obtained.

Detailed description:
This study was an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consisted of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients was included in the study after completing the induction chemotherapy. Randomization took place only if an acceptable dose plan could be obtained.

Primary endpoint: local recurrence free interval

Arms: arm 1: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 66 Gy (2 Gy x 30, 5 F á weeks).

Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization arm 2: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) Radiation technique: 3D, 4D og VMAT techniques. The patients all had 2 cycles of carboplatin and vinorelbine before randomization
Interventions: intervention 1: Navelbine intervention 2: 66 Gy/33F intervention 3: 60 Gy/30F
Intervention descriptions: intervention 1: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks intervention 2: irradiation to 66 Gy (2 Gy x 30, 5 F á weeks) intervention 3: irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)

Protocol documents:
Clinical trial NCT01008059
Conditions: Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A
Sponsor: Washington University School of Medicine
Start date: 2009-10-01; Completion date: 2016-09-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A activity.

Detailed description:

Arms: arm 1: Alfentanil (0.5-1 mg IV bolus) followed 3 hours later or simultaneously by 1-4 mg oral deuterium-labeled (d3) alfentanil on each study visit.
Interventions: intervention 1: Alfentanil
Intervention descriptions: intervention 1: No drug treatment before alfentanil

Protocol documents:
Clinical trial NCT01032239
Conditions: Severe Spasticity
Keywords: Severe spasticity in post-stroke patients
Sponsor: MedtronicNeuro
Start date: 2009-11-01; Completion date: 2016-09-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.

Detailed description:
This is a randomized, controlled open-label parallel group study to demonstrate the efficacy benefit of ITB Therapy over BMT in post-stroke patients with severe spasticity who have not reached their therapy goal with other treatment interventions.

In order to evaluate the efficacy benefit of ITB Therapy over BMT in post-stroke patients, a two-arm parallel group design will be applied. Patients will be equally randomized to one of two treatment arms:

1. ITB Therapy arm; or
2. BMT arm

The study consists of a run-in phase of 21 days for the BMT treatment arm and 2-25 days for the ITB Therapy treatment arm, followed by a 6 month active trial.

The BMT treatment arm will receive a combination of oral antispastic medication and physiotherapy. Patients must be prescribed at least one or a combination of the following oral antispastic medications: oral baclofen, tizanidine, diazepam (or other benzodiazepines) or dantrolene. Following the run-in phase, patients will enter the 6 month active trial.

The ITB Therapy treatment arm will receive a combination of ITB Therapy and physiotherapy. During the run-in phase, a test with intrathecal baclofen will be performed to evaluate the response of the patient. Patients fulfilling the test success criterium will be implanted with a Medtronic SynchroMed®II infusion system. Following implant, patients will enter into the 6 month active trial, which includes a 6 week titration phase, during which time oral antispastic medications must be gradually reduced with complete discontinuation by the end of the titration period.

During the 6 month active trial, patients will be assessed at 3 and 6 months. All primary and secondary endpoint assessments will be performed by a blinded assessor.

The total study duration is expected to be 60 months, including a 39 month enrollment period. The total duration per patient is approximately 7 months (approximately 1 month run-in period followed by 6 months active treatment).

Arms: arm 1: Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump) arm 2: Use one or a combination oral antispastic medication.
Interventions: intervention 1: intrathecal baclofen
Intervention descriptions: intervention 1: ITB test, implant, 6 months follow-up

Protocol documents:
Clinical trial NCT01136798
Conditions: Type 2 Diabetes Sleep Disordered Breathing
Keywords: slow wave sleep exenatide and sleep
Sponsor: University of Chicago
Start date: 2010-06-01; Completion date: 2016-09-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.

Detailed description:

Arms: arm 1: Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks. arm 2: Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Interventions: intervention 1: Exenatide intervention 2: Placebo
Intervention descriptions: intervention 1: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks intervention 2: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks

Protocol documents: