ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00770874
Conditions: Cervical Cancer
Sponsor: Taiho Pharmaceutical Co., Ltd.
Start date: 2008-09-01; Completion date: 2016-04-01
Enrollment: 375 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is an open-label, multicenter, multinational, two-arm, parallel randomized Phase 3 study evaluating the efficacy and safety of S-1+Cisplatin versus single-agent Cisplatin in patients with stage IVB, recurrent or persistent carcinoma of the cervix.

Detailed description:
Japanese phase II study of S-1 in cervical cancer suggested promising response rate and good tolerability. Since recommended chemotherapy for metastatic or recurrent cervical carcinoma is either single-agent Cisplatin or Cisplatin-based combination chemotherapy, this is designed to evaluate the efficacy and safety of S-1 in combination with Cisplatin compared with single-agent Cisplatin.

Arms: arm 1: S-1 + Cisplatin (arm A) arm 2: Cisplatin (arm B)
Interventions: intervention 1: S-1 + Cisplatin (arm A) intervention 2: Cisplatin (arm B)
Intervention descriptions: intervention 1: S-1 will be administered orally, twice daily from Day 1 through Day 14 followed by a recovery period from Days 15 through Day 21. Initial dose of S-1 will be determined according to the patient's body surface area (80 to 120 mg/day). On Day 1, Cisplatin 50 mg/m2 will be administered intravenously (IV). This regimen is to be repeated every 3 weeks. intervention 2: Cisplatin 50 mg/m2 will be administered intravenously (IV) on Day 1, repeated every 3 weeks.

Protocol documents:
Clinical trial NCT00833755
Conditions: Pain Chronic Pain Hyperalgesia
Keywords: Pain Chronic pain Opioid induced hyperalgesia Opioid therapy
Sponsor: Massachusetts General Hospital
Start date: 2008-09-01; Completion date: 2016-04-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.

Detailed description:
We hypothesize that:

1. Chronic pain patients on chronic opioids would have a lower pain threshold and lower pain tolerance when compared to opioid naïve patients (patients with chronic pain with non-opioids treatment)., as measured by QST in a non-affected neutral limb;
2. Chronic pain patients on chronic opioids would have an increased response to painful stimulation, so called "windup" as demonstrated by QST;
3. Both "wind-up" and altered pain threshold and tolerance would be indicative of the presence of opioid-induced hyperalgesia;
4. Intravenous ketamine, an NMDA receptor antagonist, could be used to differentiate between opioid-induced hyperalgesia and opioid tolerance.

Arms: arm 1: This group consists of 16 subjects who have chronic pain conditions treated with an opioid regimen. Subjects were randomized to receive a ketamine treatment during the study. They were given an intravenous infusion of ketamine (0.05mg/kg) diluted in 50 ml normal saline over 30 minutes. arm 2: This group consists of 22 subjects who have chronic pain conditions but were not on an opioid regimen over the last 3 months. Subjects were randomized to receive a ketamine treatment during the study. They were given an intravenous infusion of ketamine (0.05mg/kg) diluted in 50 ml normal saline over 30 minutes. arm 3: This group consists of 18 subjects who have chronic pain conditions treated with an opioid regimen. Subjects were randomized to receive a placebo treatment during the study. They were given an intravenous infusion of 50 ml normal saline over 30 minutes. arm 4: This group consists of 23 subjects who have chronic pain conditions but were not on an opioid regimen over the last 3 months. Subjects were randomized to receive a placebo treatment during the study. They were given an intravenous infusion of 50 ml normal saline over 30 minutes.
Interventions: intervention 1: Ketamine intervention 2: Placebos
Intervention descriptions: intervention 1: To compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy. intervention 2: To compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.

Protocol documents:
Clinical trial NCT00921310
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Temsirolimus and pemetrexed for recurrent or refractory NSCLC
Sponsor: Washington University School of Medicine
Start date: 2009-09-01; Completion date: 2016-04-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combination of temsirolimus and pemetrexed, as well as the response rate. The starting dose (Dose Level 1) and schedule of pemetrexed will be 500 mg/m\^2 given every 3 weeks and the starting dose (Dose Level 1) for temsirolimus will be 15 mg given weekly for 3 weeks, to complete 1 cycle. In subsequent cohorts, dose will be escalated or de-escalated. Enrollment to each cohort is based on toxicity experienced at that dose level.

Detailed description:
* To determine the maximum tolerated dose (MTD) of temsirolimus that could be administered weekly in combination with pemetrexed.
* To determine the dose-limiting toxicity (DLT) of temsirolimus and pemetrexed as well as other toxicities of this combination therapy.
* To describe the response rate of the combination in patients with relapsed/refractory non-small cell lung cancer (NSCLC).
* To describe phospho-Akt and phospho-S6 levels in circulating mononuclear cells before and after treatment.
* To determine the response rates in patients with NSCLC when treated with temsirolimus and pemetrexed.
* To evaluate progression-free survival in patients with NSCLC when treated with temsirolimus and pemetrexed.
* To determine the one-year survival rates in patients with NSCLC when treated with temsirolimus and pemetrexed.
* To describe phospho-Akt and phospho-S6 levels in circulating mononuclear cells before and after treatment.

Arms: arm 1: -Dose Level 1

* Pemetrexed 500mg/m\^2 intravenous (IV) on Day 1 of each 21 day cycle
* Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle arm 2: * Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle arm 3: * Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.
* Pemetrexed (375 mg/m\^2) IV on Day 1 of each 21 day cycle
* Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle
Interventions: intervention 1: Pemetrexed intervention 2: Temsirolimus
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01000285
Conditions: Leukemia-Lymphoma, Adult T-Cell
Sponsor: Washington University School of Medicine
Start date: 2010-09-01; Completion date: 2016-04-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The rationale of the current study is to explore the use of combination chemotherapy together with antiretroviral agents in order to determine the efficacy and toxicity of this approach, while also examining markers of virus replication and expression, and tumor cell proliferation to gain understanding of the biological basis of this malignancy and to identify predictors of response.

Detailed description:
Primary Endpoint:

\- To determine the tolerability and efficacy (response rate) of dose adjusted bortezomib-EPOCH (DA B-EPOCH) chemotherapy combined with Raltegravir in patients with HTLV-1 associated leukemia/lymphoma (ATLL).

Secondary Endpoints:

* To evaluate the effects of DA B-EPOCH chemotherapy combined with Raltegravir on HTLV-1 DNA and RNA load, HTLV-1 integrase gene sequence, and HTLV-1 integration sites. To determine if relapsed or progressive disease is a result of renewed virus replication.
* To evaluate the relation of NFκB gene expression profile on response to DA B-EPOCH chemotherapy combined with Raltegravir.

Arms: arm 1: Bortezomib 1.0 mg/m2 intravenous (IV) Days 1-4

Etoposide 50 mg/m2/d 96 hour continuous intravenous infusion (CIVI) on Days 1-4

Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4

Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4

Prednisone 60 mg/m2/d PO on Days 1-5

Cyclophosphamide 375 mg/m2 IV on Day 5

Raltegravir 400 mg PO twice per day (BID) every day starting with cycle 2 therapy for the entire duration of the cycle.

Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles.
Interventions: intervention 1: Bortezomib intervention 2: Etoposide intervention 3: Vincristine intervention 4: Doxorubicin intervention 5: Prednisone intervention 6: Cyclophosphamide intervention 7: Raltegravir
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None

Protocol documents:
Clinical trial NCT01070316
Conditions: Epilepsy Tuberous Sclerosis Complex
Keywords: Epilepsy Tuberous Sclerosis Complex Everolimus RAD001 Mammalian Target of Rapamycin (MTOR)
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2010-01-01; Completion date: 2016-04-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to learn if the study drug RAD001 can reduced the number of epileptic seizures, and can be taken safety by people who have epilepsy associated with Tuberous Sclerosis Complex.

Detailed description:
Tuberous sclerosis complex (TSC) is a genetic disorder with an incidence at birth of 1 in 6000. This disorder is characterized by the development of benign tumors in multiple organ systems, including the brain. The primary neurological manifestations of TSC are epilepsy, mental retardation and autism. Epilepsy is most common, occurring in 80-90% of patients, and often the seizures are severe, unremitting, and uncontrolled by current anticonvulsant medications. It is generally accepted that the seizures arise from cortical and subcortical tubers and surrounding tissue in the brain. These tubers are caused by mutations in the tumor suppressor genes TSC1 or TSC2. The protein products of these genes, hamartin and tuberin, act as negative regulators of the PI3K/PKB(Akt)/mTOR signaling pathway that regulates cell growth and proliferation Everolimus is an immunosuppressant drug that also inhibits mTOR signaling and is capable of reversing aberrant mTOR-dependent effects that occur when hamartin or tuberin are absent or defective. Thus, we hypothesize that drugs like everolimus may be therapeutically useful for the treatment of refractory epilepsy in patients with TSC.

Arms: arm 1: Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.
Interventions: intervention 1: Everolimus
Intervention descriptions: intervention 1: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day

Protocol documents:
Clinical trial NCT01165021
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2010-11-01; Completion date: 2016-04-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Folic Acid intervention 4: Vitamin B12 intervention 5: Dexamethasone
Intervention descriptions: intervention 1: 500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles intervention 2: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles intervention 3: Administered orally. intervention 4: Administered Intramuscular injection. intervention 5: Administered orally.

Protocol documents:
Clinical trial NCT01204203
Conditions: Mesothelioma
Keywords: mesothelioma zoledronic acid zometa bisphosphonate therapy CT scan PET scan
Sponsor: University of Alabama at Birmingham
Start date: 2009-06-01; Completion date: 2016-04-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial is to determine the response rate of single agent zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria and the EORTC tumor response criteria for 18F-FDG PET scans.

Detailed description:
This pilot study will examine the effect of bisphosphonate (zoledronic acid) in patients with malignant mesothelioma. Evaluation will be limited to patients with standard (CT scans) and functional instruments (FDG PET Scans) of tumor assessment after the administration of standard doses of zoledronic acid (4 mg IV every 3 weeks). We will also explore the biologic effect of zoledronic acid in patients using new serum markers as well as several blood level markers.

Arms: arm 1: Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
Interventions: intervention 1: Zometa
Intervention descriptions: intervention 1: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.

Protocol documents:
Clinical trial NCT01204775
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2011-06-01; Completion date: 2016-04-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.

Detailed description:

Arms: arm 1: Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) arm 2: Placebo matching saxagliptin tablet
Interventions: intervention 1: Saxagliptin intervention 2: Placebo (Saxagliptin) intervention 3: Metformin IR intervention 4: Placebo (Metformin) intervention 5: Metformin (Active Rescue)
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks intervention 2: Tablets, Oral, Once daily, 1-16 weeks intervention 3: Tablets, Oral, 500 mg, Once Daily, 17-52 weeks intervention 4: Tablets, Oral, Once daily, 1-16 weeks intervention 5: Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks

Protocol documents:
Clinical trial NCT01342926
Conditions: Atrophy, Geographic
Keywords: age-related macular degeneration geographic atrophy dry AMD
Sponsor: GlaxoSmithKline
Start date: 2011-06-01; Completion date: 2016-04-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of GSK933776 in the treatment of geographic atrophy secondary to age-related macular degeneration.

Detailed description:
This is a Phase 2a proof of concept study designed to evaluate the safety and efficacy of GSK933776 for the treatment of geographic atrophy secondary to age-related macular degeneration. This is a placebo-controlled parallel-group study that is double masked.

Arms: arm 1: 3 mg/kg administration of GSK933776 via intravenous infusion arm 2: 6 mg/kg administration of GSK933776 via intravenous infusion arm 3: Placebo via intravenous infusion arm 4: 15 mg/kg administration of GSK933776 via intravenous infusion
Interventions: intervention 1: GSK933776 intervention 2: Placebo
Intervention descriptions: intervention 1: GSK933776 intervention 2: Placebo

Protocol documents:
Clinical trial NCT01343277
Conditions: Advanced Liposarcoma or Leiomyosarcoma
Keywords: Advanced Liposarcoma or Leiomyosarcoma Trabectedin Yondelis Dacarbazine Anthracycline L-sarcoma
Sponsor: Janssen Research & Development, LLC
Start date: 2011-06-01; Completion date: 2016-04-01
Enrollment: 579 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma).

Detailed description:
This is a randomized study (study drug assigned by chance) using a 2:1 randomization. It is an open-label (all people know study drug), active-controlled (comparing to a different drug used for the same condition), parallel-group (different treatment groups continue with separate treatments throughout the study), multicenter study. This study will be divided into 3 phases, screening, treatment, follow-up and optional extension phase (OEP). During screening, potential participants will be assessed for study eligibility after providing signed informed consent. Approximately 570 patients who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1 ratio to either the trabectedin (n=380) or dacarbazine (n=190) treatment groups. During the treatment phase, patients will receive study drug once every 3 weeks, until disease progression (defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] Version 1.1 criteria) or signs of toxicity. Assessments will be performed to evaluate the effectiveness of the drug, and patient safety will be monitored. During the follow-up phase, after the last dose of study drug, clinical outcomes for patients will be evaluated. Trabectedin will be administered at a dose of 1.5 milligram per square meters (mg/m\^2) through a catheter into a large vein as a 24-hour intravenous (IV) infusion, once every 3 weeks, until disease progression or signs of toxicity. Dacarbazine will be administered at a dose of 1.0 g/m\^2 as a 20-120 minute infusion, once every 3 weeks, until disease progression or signs of toxicity. In the OEP, participants who were previously randomized to the dacarbazine group will have the option to receive trabectedin at the discretion of the investigator.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Trabectedin intervention 2: Dacarbazine
Intervention descriptions: intervention 1: Type=exactly number, unit=mg/m2, number=1.5, form=intravenous infusion, route=intravenous use. Once every 3 weeks until disease progression or signs of toxicity. intervention 2: Type=exactly number, unit=g/m2, number=1, form=intravenous infusion, route=intravenous use. Once every 3 weeks until disease progression or signs of toxicity.

Protocol documents:
Clinical trial NCT01398956
Conditions: Epilepsy Generalized Tonic-clonic Seizures
Keywords: Levetiracetam Epilepsy Generalized tonic-clonic seizures
Sponsor: UCB Pharma
Start date: 2011-06-01; Completion date: 2016-04-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.

Detailed description:

Arms: arm 1: Twice daily (morning and evening) orally
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: formulation: tablet or dry syrup

strength: 250 mg tablet, 500 mg tablet, dry syrup 50%

dosage: Sb ≥16 years and ≥4 and \<16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and \<16 years (\<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day

frequency: twice daily

Protocol documents:
Clinical trial NCT01434186
Conditions: Diabetes Mellitus, Type 2
Sponsor: AstraZeneca
Start date: 2012-05-01; Completion date: 2016-04-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes

Detailed description:
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone or in Combination with Baseline Insulin Therapy

Arms: arm 1: Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg arm 2: Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
Interventions: intervention 1: Placebo matching with Saxagliptin intervention 2: Metformin IR intervention 3: Metformin XR intervention 4: Saxagliptin
Intervention descriptions: intervention 1: Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52 intervention 2: Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52 intervention 3: Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52 intervention 4: Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)

Protocol documents:
Clinical trial NCT01514448
Conditions: Metastatic Renal Cell Carcinoma (mRCC)
Keywords: Kidney cancer mRCC metastic renal cell carcinoma everolimus sunitinib pazopanib
Sponsor: Novartis Pharmaceuticals
Start date: 2012-05-21; Completion date: 2016-04-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was evaluated in these patients.

Detailed description:

Arms: arm 1: Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
Interventions: intervention 1: Everolimus (RAD001)
Intervention descriptions: intervention 1: Everolimus was used as commercially available formulated tablets of 10 mg strength

Protocol documents: