ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00665392
Conditions: Head and Neck Cancer
Keywords: stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx tongue cancer
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Start date: 2008-02-01; Completion date: 2013-11-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* To determine the complete clinical response rate at 3 months in patients with stage III or IV nonmetastatic squamous cell carcinoma of the oropharynx treated with cetuximab, docetaxel, cisplatin, and fluorouracil.

Secondary

* To determine the rate of tumor response.
* To determine progression-free and overall survival.
* To determine the rate of complete pathological response.
* To assess the tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15; docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1; and fluorouracil IV continuously on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months for 1 year and every 3 months for 2 years.

Arms: arm 1: Cetuximab by intravenous (IV) infusion over 1-2 h on day
Interventions: intervention 1: cisplatin intervention 2: docetaxel intervention 3: fluorouracil intervention 4: Cetuximab
Intervention descriptions: intervention 1: 75 mg/m², day 1. 3 cycles intervention 2: 75 mg/m² Day 1. 3 cycles intervention 3: 750 mg/m² day 1 to day 5. 3 cycles intervention 4: 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.

Protocol documents:
Clinical trial NCT00711594
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2008-04-01; Completion date: 2013-11-01
Enrollment: 74 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the Phase I step is to estimate the MTD at a dose level up to 50 mg/day (i.e., overseas recommended Phase II dose) in patients with advanced NSCLC and to determine the recommended dose for the Phase II step.

The objective of the Phase II step is to estimate the efficacy of BIBW 2992 monotherapy in patients with first generation EGFR-TKI-resistant advanced NSCLC at the recommended dose determined in the Phase I step.

Detailed description:

Arms: arm 1: Phase I step: Find maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally. Escalating doses of BIBW 2992 starting at 20mg daily. arm 2: Phase II step: Patients start continuous once daily oral treatment of BIBW 2992 at high dose, until progression or undue Adverse Events (AEs) develop. Patients can be dose-reduced up to two times if needed after temporary discontinuation of treatment due to drug-related AEs.
Interventions: intervention 1: BIBW 2992 MA2 40mg/day intervention 2: BIBW 2992 MA2 50mg/day intervention 3: BIBW 2992 MA2 20mg/day intervention 4: BIBW 2992 QD
Intervention descriptions: intervention 1: Phase I step: Increased dose cohorts from low dose to MTD intervention 2: Phase I step: Increased dose cohorts from low dose to MTD intervention 3: Phase I step: Increased dose cohorts from low dose to MTD intervention 4: Phase II step: This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs.

Protocol documents:
Clinical trial NCT00775190
Conditions: Contraception
Keywords: birth control pills oral contraceptives brand name generic side effects oral contraceptive side effects dysfunctional uterine bleeding pre-menstrual symptoms
Sponsor: William Beaumont Hospitals
Start date: 2008-10-01; Completion date: 2013-11-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized control trial of Ortho tricyclen versus Trinessa (generic equivalent) to determine if they have similar effects. Women will be randomized to receive either Ortho tricyclen or Trinessa oral contraceptives and will be asked to keep a daily dairy of any symptoms or bleeding experienced. Once a month, participants will be asked to complete a survey.

The objective is to compare generic oral contraceptives (OCPs) and brand name OCPs with respect to side effect profiles including bleeding patterns, mood changes, nausea and vomiting, frequency of menstrual cramps, breast tenderness, elevation in blood pressure, stroke, blood clots and patient compliance.

Detailed description:
This is a double blind randomized controlled trial of Ortho tricyclen™ vs. Trinessa™ (generic equivalent) to determine if they have similar effects on bleeding patterns, namely days of menstrual flow, amount of bleeding, and intermenstrual bleeding. Women will score these parameters using a survey with objective measures for days of bleeding, amount of flow, and days of breakthrough bleeding. As secondary outcomes, we will compare the side effect profiles of each in regards to nausea, vomiting, breast tenderness, menstrual cramps, mood changes, and thromboembolic events.

Patients will record in their daily diary if one of the outcomes occurs or not. We will observe whether the events occur and the number of occurrences within the six month time period.

Arms: arm 1: Participant Randomized to Ortho tricyclen 1 tablet by mouth Daily arm 2: Participant Randomized to Trinessa 1 tablet by mouth Daily
Interventions: intervention 1: ortho tricyclen intervention 2: Trinessa
Intervention descriptions: intervention 1: brand name oral contraceptive intervention 2: generic oral contraceptive

Protocol documents:
Clinical trial NCT00779467
Conditions: Labor Pain
Keywords: non narcotic epidural labor pain Non narcotic treatment of labor pain
Sponsor: Wake Forest University
Start date: 2008-10-01; Completion date: 2013-11-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor.

Detailed description:
This study is examining the use of the non-narcotic medication, neostigmine, in combination with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl in providing pain relief with the fewest side effects in labor analgesia.

Arms: arm 1: STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML arm 2: STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML arm 3: STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML arm 4: Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
Interventions: intervention 1: Neostigmine intervention 2: Bupivacaine intervention 3: fentanyl
Intervention descriptions: intervention 1: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia. intervention 2: None intervention 3: fentanyl 2 mcg/ml

Protocol documents:
Clinical trial NCT00813293
Conditions: Hepatocellular Cancer
Keywords: Hepatocellular Cancer HCC Liver Cancer radiofrequency ablation RFA sorafenib nexavaar liver directed therapy interventional radiology
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2009-06-01; Completion date: 2013-11-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine if sorafenib improves the effectiveness of a procedure called radiofrequency ablation (RFA) for the treatment of hepatocellular cancer (HCC). Radiofrequency ablation has been used to treat many types of tumors, including hepatocellular cancers. During RFA a needle is inserted into the tumor tissue and heat is used to kill the tumor cells. Sorafenib has been approved by the FDA for the treatment of hepatocellular cancer that cannot be treated with surgery. Pre-clinical data suggests that sorafenib may improve the efficacy of RFA.

Detailed description:
Hepatocellular cancer (HCC) has a poor prognosis with increasing mortality in the United States. Because HCC generally develops in patients with underlying liver disease, resection is often not possible. Liver transplant improves survival for HCC patients but given the national organ donor shortage often patients have to wait a considerable time for transplant. Liver-directed therapies such as radiofrequency ablation (RFA) remain important tools to control tumor growth and to potentially "bridge" patients to liver transplant. However, liver-directed therapies for HCC tumors greater than 3cm in size are suboptimal, leaving a critical unmet need.

Antiangiogenic systemic agents, such as oral sorafenib, reduce tumor blood flow and have been shown to improve RFA efficacy in animal and in computer models.

Arms: arm 1: Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). arm 2: Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min).
Interventions: intervention 1: Sorafenib intervention 2: radiofrequency ablation
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00829283
Conditions: Obesity Binge Eating
Keywords: Experimental Comparator
Sponsor: Yale University
Start date: 2008-11-01; Completion date: 2013-11-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.

Detailed description:
The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change.

Arms: arm 1: Standard Care arm 2: Stepped-care
Interventions: intervention 1: Behavioral Weight Loss intervention 2: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy intervention 3: Placebo intervention 4: Sibutramine/Orlistat
Intervention descriptions: intervention 1: weekly individual sessions for 6 months intervention 2: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months intervention 3: One pill daily intervention 4: Sibutramine 15 mg daily or Orlistat 120mg TID

Protocol documents:
Clinical trial NCT00837148
Conditions: Sarcoma Synovial Sarcoma Leiomyosarcoma Malignant Peripheral Nerve Sheath Tumor
Keywords: Sarcoma Bone BAY 43-9006 (SORAFENIB) DACARBAZINE 08-068
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2009-02-01; Completion date: 2013-11-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects, good and/or bad, the combination of sorafenib and dacarbazine has on sarcoma. Recurrent sarcoma is difficult to treat. Standard chemotherapy drugs can be toxic, and the length of benefit is usually short. As a result, we need new treatments for sarcoma. Sorafenib is a new type of "targeted" chemotherapy that attacks specific proteins (including "raf" and "VEGF receptor") in cells. We hope that by blocking these proteins we can cause the tumor to shrink. Sorafenib is also known as BAY 43-9006 and by the trade name Nexavar®. The FDA approved sorafenib in December of 2005 to treat patients with kidney cancer and in November of 2007 to treat patients with liver cancer. This drug is not approved by the U.S. Food and Drug Administration (FDA) or any other licensing authority for the treatment of sarcoma and is therefore considered to be experimental in this setting.

Detailed description:

Arms: arm 1: This study is an open label, single arm, Simon two stage, phase 2 trial of continuous, daily oral sorafenib, with intravenous dacarbazine administered every three weeks for patients with synovial sarcoma, leiomyosarcoma and malignant peripheral nerve sheath tumor.
Interventions: intervention 1: Sorafenib and Dacarbazine
Intervention descriptions: intervention 1: Treatment will be administered on an outpatient basis. Sorafenib is supplied as 200-mg tablets. The starting dose of sorafenib will be 400 mg PO twice daily (every 12 hours) continuously. There is no planned treatment interruption between cycles.

All patients will receive dacarbazine as an open-label dose of 850 mg/m2 by IV infusion over 60 minutes, starting on Week 1 and repeated every 3 weeks until disease progression or intolerance.

Protocol documents:
Clinical trial NCT00855309
Conditions: Herpes Simplex
Keywords: chemotherapeutic agent toxicity renal toxicity infection neutropenia
Sponsor: Wake Forest University Health Sciences
Start date: 2008-11-01; Completion date: 2013-11-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia.

PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia.

Detailed description:
OBJECTIVES:

* To determine the difference in nephrotoxicity between low-dose and weight-based intravenous acyclovir sodium as herpes simplex virus infection prophylaxis in patients with neutropenia.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
* Arm II: Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. Treatment continues for approximately 2 weeks unless clinical herpes simplex virus infection is confirmed or the patient is no longer neutropenic.

Arms: arm 1: Patients receive weight-based IV acyclovir sodium every 8 or 12 hours. arm 2: Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Interventions: intervention 1: acyclovir sodium
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00889512
Conditions: Infertility Hypothalamic Amenorrhea Hyperprolactinemia
Sponsor: University Reproductive Associates
Start date: 2009-04-01; Completion date: 2013-11-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to develop a new protocol using two different types of fertility drugs that is more similar to the way the hormones act in a normal menstrual cycle (period).

We are recruiting women who are trying to get pregnant through In Vitro Fertilization (IVF) who either have a high prolactin level (a hormone normally found in your blood that is produced in the brain) or have a condition known as hypothalamic amenorrhea in which one does not get regular periods due to low hormone levels.

The ovaries can be stimulated with Follicle Stimulating Hormone (FSH) alone and with FSH and Luteinizing Hormone (LH). FSH causes eggs to be made while LH causes estrogen (hormone) production. The women in this study have low hormone levels and need both FSH and LH. Luveris® (LH hormone) is a new drug approved for egg production and is used in IVF. There is no set amount of LH nor a set protocol for LH use. Therefore, we are testing this new regimen. One group of women will receive a fixed dose of LH throughout their cycle while the other will decrease the dose of FSH while at the same time increasing the LH dose which is what happens in the natural menstrual cycle.

Detailed description:

Arms: arm 1: Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout. arm 2: Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.
Interventions: intervention 1: Luveris fixed dose intervention 2: Luveris increasing dose
Intervention descriptions: intervention 1: Luveris 75IU daily throughout ovarian stimulation intervention 2: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG

Protocol documents:
Clinical trial NCT00936884
Conditions: Constipation
Keywords: Opioid Induced Constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2009-07-01; Completion date: 2013-11-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in adult Asian subjects with opioid-induced constipation associated with advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) or chronic nonmalignant pain.

Detailed description:
Subjects received subcutaneous methylnaltrexone (also referred to as MOA-728 or MNTX) or placebo every other day beginning on Day 1 up to a maximum of 7 doses during the 2-week double-blind period.

Inclusion criteria for this study included subjects with advanced illness or subjects with chronic nonmalignant pain. The actual study population included only subjects with cancer-related advanced illness.

All subjects who completed the double-blind treatment phase of this study could elect to receive methylnaltrexone during a 12-week open-label extension study, provided eligibility criteria were met. Subjects who did not continue in the open-label extension study had a follow-up visit 2 weeks after their last dose of test article.

Arms: arm 1: Methylnaltrexone once every other day. arm 2: Placebo once every other day. arm 3: Subjects who completed the double-blind period had the option to receive methylnaltrexone once every other day during a 12-week, open-label extension period.
Interventions: intervention 1: Methylnaltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and \< 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and \<38 kg.

Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments). intervention 2: Subjects received matching placebo injections.

Study duration: 2 weeks double-blind period (placebo treatments) followed by 12 weeks open-label extension period (MNTX treatments).

Protocol documents:
Clinical trial NCT00943592
Conditions: Advanced Hematologic Malignancies Leukemia Preleukemia
Keywords: Melphalan Alemtuzumab Clofarabine
Sponsor: University of Chicago
Start date: 2006-03-01; Completion date: 2013-11-01
Enrollment: 82 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a clinical research study designed to evaluate whether a conditioning regimen consisting of the combination of three drugs named melphalan, alemtuzumab and clofarabine supported by donor blood cells will result in rapid recovery and a high rate of long-lasting remissions in patients with leukemia, lymphoma and myeloma.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Clofarabine intervention 2: Melphalan intervention 3: Campath intervention 4: Stem Cell Transplant
Intervention descriptions: intervention 1: Clofarabine will be administered as a 2-hour IV infusion on Days 1 through 5 at approximately the same time everyday (4 dose levels). intervention 2: Doses ranging from 100 to 140 mg/m2 intervention 3: 20mg/d x5 intervention 4: Infusion of donor, bone marrow and auto.

Protocol documents:
Clinical trial NCT00948688
Conditions: Pancreatic Cancer Adenocarcinoma of the Pancreas
Keywords: Zolinza
Sponsor: Massachusetts General Hospital
Start date: 2009-08-01; Completion date: 2013-11-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The durg vorinostat (Zolinza) is a type of drug called an histone deacetylase (HDAC) inhibitor. It inhibits a group of enzymes called histone deacetylases. These enzymes help cancer cells survive. By inhibiting these enzymes, vorinostat helps kill cancer cells. In this research study vorinostat will be given along with radiation therapy and the drug 5-FU. This is the first research study in which vorinostat will be given along with radiation therapy and 5-FU. The purpose of this research study is to find the highest dose of vorinostat that can be given safely along with radiation therapy and 5-FU. The investigators will also begin to get information about whether vorinostat combined with radiation and 5-FU may help to treat pancreatic cancer.

Detailed description:
* Since we are looking for the highest dose of vorinostat that can be administered safely without severe or unmanageable side effects, not everyone who participates will receive the same dose. The dose will depend upon the number of participants enrolled on the study and how well they have tolerated their doses.
* 5-FU will be given intravenously over 24 hours 7 days per week during each week of radiation therapy. In order for participants to be able to receive the 5-FU as an outpatient, they will need to have central line catheter placed.
* Radiation therapy will be given once per day, 5 days per week, for 6 weeks.
* Vorinostat is taken orally.
* Participants will be seen once per week during the 6 weeks that they are receiving 5-FU, radiation therapy and vorinostat.

Arms: arm 1: Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
Interventions: intervention 1: Radiation therapy intervention 2: 5-FU intervention 3: Vorinostat
Intervention descriptions: intervention 1: Once per day, 5 days a week for 6 weeks intervention 2: Intravenously over 24 hours, 7 days per week during each week of radiation therapy intervention 3: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug

Protocol documents: