ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00841555
Conditions: Glioblastoma Multiforme/Anaplastic Astrocytoma
Keywords: adult giant cell glioblastoma adult gliosarcoma adult anaplastic astrocytoma adult glioblastoma GBM/AA
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2009-02-13; Completion date: 2014-11-25
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when given together with radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.

Detailed description:
OBJECTIVES:

Primary

* To determine the maximum tolerated dose of temozolomide when given in combination with hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma.

Secondary

* To determine the time to neuroradiological evidence of tumor recurrence or progression in patients treated with this regimen.
* To determine the survival time of patients treated with this regimen.
* To determine the time spent in a Karnofsky performance status of 60-100%.

OUTLINE: This is a dose-escalation study of temozolomide.

Beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once daily for 5 weeks. Beginning 1 week after starting temozolomide, patients also undergo hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a week for 3 weeks.

After completion of study treatment, patients are followed at 1 month, 2 months, and 3 months, and then every 3 months thereafter.

Arms: arm 1: Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
Interventions: intervention 1: temozolomide intervention 2: Hypofractionated radiation therapy intervention 3: Intensity-modulated radiation therapy
Intervention descriptions: intervention 1: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.

Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment intervention 2: Patients will undergo HIMRT intervention 3: Patients undergo HIMRT

Protocol documents:
Clinical trial NCT03587428
Conditions: Oral Health
Sponsor: GlaxoSmithKline
Start date: 2014-11-04; Completion date: 2014-11-27
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study investigated the ability of two zinc-containing toothpaste formulations (Zinc A and Zinc B) to reduce the level of bacteria in saliva in the two-hour period after their use, compared to the effect of rinsing with water alone.

Detailed description:
This was a single centre, three treatment, randomized, blinded, cross-over study which involved rinsing with slurries of two sodium fluoride-silica dentifrices containing zinc chloride and sodium citrate, and with water alone. The study consisted of four Visits: Visit 1 (Screening), Visit 2 (Treatment 1), Visit 3 (Treatment 2), Visit 4 (Treatment 3). There was a minimum two days wash out period before the first treatment visit and between treatment visits to avoid any treatment carry-over effect. During that time participants brushed as normal (twice-daily) at home with a washout toothpaste and a toothbrush which was provided at screening. Participants were required not to brush their teeth on the morning of the treatment visits and not to eat or drink for 2 hours prior to the treatment visits.

Arms: arm 1: In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry. arm 2: In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry. arm 3: In this arm, participants received mineral water.
Interventions: intervention 1: Zinc-A toothpaste intervention 2: Zinc-B toothpaste intervention 3: Mineral water
Intervention descriptions: intervention 1: Participants received 6.0 grams (g) \[± 0.3g\] of the Zinc-A toothpaste in the form of slurry, one day per treatment (with at least 2 \[generally 7\] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink. intervention 2: Participants received 6.0 grams (g) \[± 0.3g\] of the Zinc-B toothpaste in the form of slurry, one day per treatment (with at least 2 \[generally 7\] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink. intervention 3: Participants received 6.0g (±0.3g) of mineral water (by weighing out), one day per treatment (with at least 2 \[generally 7\] days between treatments). Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.

Protocol documents:
Clinical trial NCT01803074
Conditions: Infection, Human Immunodeficiency Virus HIV Infections
Sponsor: ViiV Healthcare
Start date: 2013-04-04; Completion date: 2014-11-29
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to study the safety and tolerability of a HIV drug and to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected patients

Detailed description:
Masking: Open-Part B. Double Blind-Parts A and C

Gender: Both female and male participants for Parts A and C. Male participants for Part B.

HIV = Human Immunodeficiency Virus RNA = Ribonucleic acid

Arms: arm 1: BMS-955176 5 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 2: BMS-955176 10 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 3: BMS-955176 20 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 4: BMS-955176 40 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 5: BMS-955176 40 mg solution by mouth once daily for 28 days

Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days arm 6: BMS-955176 40 mg solution by mouth once daily for 28 days

Atazanavir 1 x 300 mg capsules by mouth once daily for 28 days

Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days arm 7: Atazanavir 1 x 300 mg capsule by mouth once daily for 28 days

Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days

Tenofovir 1 x 300 mg tablet by mouth once daily for 28 days

Emtricitabine 1 x 200 mg capsule once daily for 28 days arm 8: BMS-955176 40 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 9: BMS-955176 80 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 10: BMS-955176 120 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days arm 11: BMS-955176 ≤120 mg solution by mouth once daily for 14 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 14 days arm 12: BMS-955176 80 mg solution by mouth once daily for 28 days

Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days arm 13: BMS-955176 120 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Interventions: intervention 1: BMS-955176 intervention 2: Placebo matching with BMS-955176 intervention 3: Atazanavir intervention 4: Ritonavir intervention 5: Tenofovir intervention 6: Emtricitabine
Intervention descriptions: intervention 1: BMS-955176 intervention 2: Placebo matching with BMS-955176 intervention 3: Atazanavir intervention 4: Ritonavir intervention 5: Tenofovir intervention 6: Emtricitabine

Protocol documents:
Clinical trial NCT01225172
Conditions: Breast Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2010-12-31; Completion date: 2014-11-30
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BMS-754807 intervention 2: letrozole
Intervention descriptions: intervention 1: Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity intervention 2: Tablets, Oral, 2.5 mg, Daily, Until disease progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00163189
Conditions: Growth Hormone Deficiency
Sponsor: Pfizer
Start date: 2005-01-01; Completion date: 2014-12-01
Enrollment: 98 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Somatropin
Intervention descriptions: intervention 1: Liquid, daily, during 3 years and extended to 5 years Dosage: 0,46 mg/kg/week - the maximum dose should not exceed 50 µg/kg/day

Protocol documents:
Clinical trial NCT01225562
Conditions: Myocardial Infarction Cardiovascular Death Atherothrombosis Stroke
Keywords: Heart attack Heart Disease Acute coronary syndrome ACS Cardiovascular Disease
Sponsor: AstraZeneca
Start date: 2010-10-01; Completion date: 2014-12-01
Enrollment: 21379 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

Detailed description:

Arms: arm 1: Oral Treatment arm 2: Oral Treatment arm 3: Oral Treatment
Interventions: intervention 1: Ticagrelor 90 mg intervention 2: Ticagrelor 60 mg intervention 3: Ticagrelor Placebo
Intervention descriptions: intervention 1: Oral dose twice a day intervention 2: Oral dose twice a day intervention 3: Oral dose twice a day

Protocol documents:
Clinical trial NCT01357356
Conditions: Nocturia
Sponsor: Serenity Pharmaceuticals, Inc.
Start date: 2011-05-01; Completion date: 2014-12-01
Enrollment: 750 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.

Detailed description:

Arms: arm 1: SER120 (750 ng/day) arm 2: SER120 (1000 ng/day) arm 3: SER120 (1500 ng/day) arm 4: Placebo
Interventions: intervention 1: SER120 (750 ng/day) intervention 2: SER120 (1000 ng/day) intervention 3: SER120 (1500 ng/day) intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: SER120 (1000 ng/day) intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01526785
Conditions: Pompe Disease
Sponsor: Genzyme, a Sanofi Company
Start date: 2012-03-01; Completion date: 2014-12-01
Enrollment: 113 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study was to evaluate the efficacy and safety of treatment with 4000 litre (L) alglucosidase alfa (Lumizyme®) in Pompe participants.

Detailed description:

Arms: arm 1: Alglucosidase alfa (4000 L scale) intravenous (IV) infusion administered for 52 weeks as per physician's routine practice.
Interventions: intervention 1: Alglucosidase alfa
Intervention descriptions: intervention 1: 4000 L alglucosidase alfa administered by IV infusion at the same dose and dose regimen used for the patient's routine treatment prior to the study for 52 weeks.

Protocol documents:
Clinical trial NCT01719003
Conditions: Diabetes Mellitus, Type 2 Hyperglycemia
Sponsor: Boehringer Ingelheim
Start date: 2012-10-01; Completion date: 2014-12-01
Enrollment: 1413 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

Detailed description:

Arms: arm 1: Empagliflozin low dose once daily arm 2: Empagliflozin high dose once daily arm 3: Open label empagliflozin high dose split twice daily + metformin 1000 mg twice daily - Patients are no longer enrolled into this arm because of change in the inclusion criteria in protocol version 2.0 all patients are now enrolled into remaining double-blind arms. Patients already enrolled in the open-label arm according to protocol version 1.0 can complete the study. arm 4: Empagliflozin low dose split twice daily + metformin 500 mg twice daily arm 5: Empagliflozin low dose split twice daily + metformin 1000 mg twice daily arm 6: Empagliflozin high dose split twice daily + metformin 500 mg twice daily arm 7: Empagliflozin high dose split twice daily + metformin 1000 mg twice daily arm 8: Metformin 500 mg twice daily arm 9: Metformin 1000 mg twice daily
Interventions: intervention 1: Metformin 500 mg bid intervention 2: Metformin 1000 mg bid intervention 3: Empagliflozin low dose qd intervention 4: Empagliflozin high dose qd intervention 5: Empagliflozin low dose bid intervention 6: Metformin 500 mg bid intervention 7: Empagliflozin high dose bid intervention 8: Empagliflozin low dose bid intervention 9: Metformin 1000 mg bid intervention 10: Metformin 500 mg bid intervention 11: Metformin 1000 mg bid intervention 12: Empagliflozin high dose bid intervention 13: Metformin 1000 mg bid intervention 14: Empagliflozin high dose bid
Intervention descriptions: intervention 1: Metformin 500 mg twice daily intervention 2: Metformin 1000 mg twice daily intervention 3: Empagliflozin low dose once daily intervention 4: Empagliflozin high dose once daily intervention 5: Empagliflozin low dose split twice daily intervention 6: Metformin 500 mg twice daily intervention 7: Empagliflozin high dose split twice daily intervention 8: Empagliflozin low dose split twice daily intervention 9: Metformin 1000 mg twice daily intervention 10: Metformin 500 mg twice daily intervention 11: Metformin 1000 mg twice daily intervention 12: Empagliflozin high dose split twice daily intervention 13: Metformin 1000 mg twice daily intervention 14: Empagliflozin high dose split twice daily

Protocol documents:
Clinical trial NCT01768559
Conditions: Type 2 Diabetes
Sponsor: Sanofi
Start date: 2013-01-01; Completion date: 2014-12-01
Enrollment: 894 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

\- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

\- To compare the treatments/regimens on:

* The percentage of participants reaching the target of HbA1c \<7% or ≤6.5%,
* Body weight,
* Self-Monitored Glucose profiles,
* Fasting Plasma Glucose (FPG),
* Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants),
* Daily doses of insulins,
* Safety and tolerability.

Detailed description:
Approximately 41 weeks including a 26 week treatment period.

Arms: arm 1: Lixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin. arm 2: Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin. arm 3: Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Insulin glulisine QD intervention 3: Insulin glulisine TID intervention 4: Insulin Glargine (Mandatory background drug) intervention 5: Metformin (Background drug)
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection 30 to 60 minutes before breakfast or dinner. intervention 2: Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before breakfast or dinner. The initial dose was 3-5 units and then individually titrated to obtain the SMPG value \>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before lunch (if administered at breakfast) or at bedtime (if administered at dinner). intervention 3: Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before each meal. The initial dose was 3-5 units for each meal and then individually titrated to obtain the SMPG value \>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before the next meal or at bedtime (for injection at dinner). intervention 4: Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL). intervention 5: Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.

Protocol documents:
Clinical trial NCT00004418
Conditions: Adrenoleukodystrophy
Keywords: adrenoleukodystrophy inborn errors of metabolism rare disease sphingolipidoses
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Start date: 1998-04-01; Completion date: 2014-12-01
Enrollment: 126 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
OBJECTIVES: I. Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy.

II. Compare the frequency and severity of neurological disability of study patients with untreated historical controls.

Detailed description:
PROTOCOL OUTLINE: This is an open label study. Patients must follow dietary instructions as provided by the investigator. Patients receive 2-4 tablespoons of a mixture of glyceryl trierucate and glyceryl trioleate oil once daily. Patients complete a neuropsychological scoring scale questionnaire to measure neurological disability. Patients undergo physical examinations including magnetic resonance imaging and magnetic resonance spectroscopy of the head.

Patients are followed monthly for 6 months, then every 3 months until they reach the age of 13 years or death.

Arms: arm 1: Treatment of all enrolled participants. Dosage form is a liquid oil taken orally. Dose is to provide 20% of daily calories. Daily for duration of trial
Interventions: intervention 1: glyceryl trierucate/glyceryl trioleate
Intervention descriptions: intervention 1: Administration of glyceryl trierucate/glyceryl trioleate

Protocol documents:
Clinical trial NCT00021255
Conditions: Breast Neoplasms
Sponsor: Sanofi
Start date: 2001-04-01; Completion date: 2014-12-01
Enrollment: 3222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective:

* Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin.

Secondary objective:

* Compare overall survival of participants treated with these regimens.
* Compare the toxic effects (including cardiac) of these regimens in these participants.
* Compare quality of life of participants treated with these regimens.
* Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants.
* For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens.

Detailed description:

Arms: arm 1: Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles. arm 2: Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. arm 3: Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Interventions: intervention 1: Doxorubicin intervention 2: Cyclophosphamide intervention 3: Docetaxel intervention 4: Herceptin intervention 5: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents: