ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00656370
Conditions: Healthy
Keywords: Hylenex subcutaneous infusion hyaluronidase rHuPH20 recombinant human hyaluronidase
Sponsor: Halozyme Therapeutics
Start date: 2007-12-01; Completion date: 2008-01-30
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units.

In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR) solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150 units of hylenex.

In Stage 2, the comparison will be NS solution and buffered NS solution.

Detailed description:
This Phase IV, randomized, double-blinded study in volunteer subjects to evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. The study will be conducted in two sequential stages.

In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.

Tolerability will be assessed based on the subject's self-assessment of discomfort on a visual analog scale (VAS). Safety will be assessed by physical examination targeted at infusion sites, vital signs, and adverse events. The amount of fluid infused will be assessed by weighing the infusion bag, fluid and tubing at designated time points, and allowing the determination of flow rate.

Stage 2 will be conducted only if the observed Stage 1 VAS mean maximum pain score is at least 25 mm higher for one solution compared to the other. Stage 2 will evaluate the tolerability, safety, and flow rates of subcutaneously infused NS solution and buffered NS solution.

Arms: arm 1: Normal Saline (NS) and Hylenex arm 2: Lactated Ringer's (LR) and Hylenex
Interventions: intervention 1: recombinant human hyaluronidase
Intervention descriptions: intervention 1: 150 Units in 1mL

Protocol documents:
Clinical trial NCT00391625
Conditions: Gaucher Disease
Keywords: Gaucher disease, Enzyme Replacement Therapy
Sponsor: Shire
Start date: 2004-09-13; Completion date: 2008-01-31
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular engorgement, organomegaly, and organ system dysfunction. The purpose of this study is to evaluate the long term safety of enzyme replacement therapy with DRX008A (VPRIV®, GA-GCB; velaglucerase alfa) in patients with type 1 Gaucher disease.

Detailed description:
Type 1 Gaucher disease, the most common form, accounts for more than 90% of all cases and does not involve the central nervous system (CNS). Typical manifestations of type 1 Gaucher disease include hepatomegaly, splenomegaly, thrombocytopenia, bleeding tendencies, anemia, hypermetabolism, skeletal pathology, growth retardation, pulmonary disease, and decreased quality of life. Gene-Activated® human glucocerebrosidase (the long term safety of enzyme replacement therapy with DRX008A (GA-GCB; velaglucerase alfa) is produced in a continuous human cell line using proprietary gene-activation technology and has an identical amino acid sequence to the naturally occurring human enzyme. GA-GCB (velaglucerase alfa) contains terminal mannose residues that target the enzyme to the macrophages-the primary target cells in Gaucher disease. This study was designed to evaluate the long term safety of GA-GCB (velaglucerase alfa) in patients with Type 1 Gaucher disease

Arms: arm 1: 15-60 U/kg every other week via intravenous infusion
Interventions: intervention 1: GA-GCB
Intervention descriptions: intervention 1: 15-60 U/kg every other week via intravenous infusion

Protocol documents:
Clinical trial NCT00399763
Conditions: Attention Deficit Hyperactivity Disorder Substance Abuse
Keywords: Adolescent ADHD SUD
Sponsor: Denver Health and Hospital Authority
Start date: 2005-09-01; Completion date: 2008-02-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out whether atomoxetine (also called Strattera) helps teenagers (12-19) with Attention Deficit Hyperactivity Disorder (ADHD) and drug/alcohol problems.

Detailed description:
Evidence-based psychosocial treatments have recently been developed. However, very little data exist on the use of pharmacotherapy for adolescents SUD (Substance Use Disorder). One promising pharmacotherapy approach is to treat co-occuring psychiatric disorders. A common co-occurring disorder in adolescent SUD is attention-deficit/hyperactivity disorder (ADHD). Fortunately, new ADHD medications, such as atomoxetine, that do not have addictive potential are now available. However, all controlled studies of atomoxetine have specifically excluded teens with SUD. Therefore, little data exist on the safety and efficacy of the medication in this population. This research project will address the important research gap with the specific aim: to conduct a randomized, placebo-controlled trial of atomoxetine for ADHD in teens with SUD.

Arms: arm 1: placebo plus individual cognitive behavioral therapy arm 2: atomoxetine plus individual cognitive behavioral therapy
Interventions: intervention 1: Atomoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Half of participants are randomized to atomoxetine plus individual cognitive behavioral therapy targeting substance use disorder intervention 2: Half of participants are randomized to placebo plus individual cognitive behavioral therapy targeting substance use disorder

Protocol documents:
Clinical trial NCT00535496
Conditions: Neuromuscular Blockade
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-09-01; Completion date: 2008-02-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the trial is to determine the relationship within a participant between the time to manual detection of the reappearance of the fourth twitch (T4) measured using a peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch (T4/T1) ratio to 0.9 measured using a Train Of Four (TOF)-Watch® SX, of 4.0 mg/kg sugammadex administered at 15 minutes after either a bolus dose of 0.6 mg/kg rocuronium or the last maintenance dose of 0.15 mg/kg rocuronium.

Detailed description:
The TOF-Watch® SX has been used for neuromuscular monitoring in all

clinical trials with sugammadex. In clinical practice however, a PNS is commonly

used in many hospitals worldwide. A disadvantage of a PNS is that it is not objective monitoring like the TOF-Watch® SX, and it can detect only the number of twitches. In this trial, the relationship between the time to reappearance of T4 using PNS (i.e. Ministim® model MS-IV) and the time to recovery of the T4/T1 ratio to 0.9 using the TOF-Watch® SX was determined after a dose of 4.0 mg/kg sugammadex was administered 15 minutes after the last dose of rocuronium. Determining this relationship will enable the provision of advice on when it is safe to extubate participants after administration of 4.0 mg/kg sugammadex for reversing neuromuscular block while using a PNS. The time to reappearance of T4 was assessed by a blinded PNS-assessor. This assessor was blinded for the dose of sugammadex used and for the TOF results measured with the TOF-Watch® SX.

Arms: arm 1: sugammadex 1.0 mg/kg, TOF-Watch® SX (dominant forearm) and PNS (non-dominant forearm) arm 2: sugammadex 1.0 mg/kg, TOF-Watch® SX (non-dominant forearm) and PNS (dominant forearm) arm 3: sugammadex 4.0 mg/kg, TOF-Watch® SX (dominant forearm) and PNS (non-dominant forearm) arm 4: sugammadex 4.0 mg/kg, TOF-Watch® SX (non-dominant forearm) and PNS (dominant forearm)
Interventions: intervention 1: sugammadex
Intervention descriptions: intervention 1: Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.

Protocol documents:
Clinical trial NCT00547586
Conditions: Constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2007-10-01; Completion date: 2008-02-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: N-methylnaltrexone bromide (MOA-728) intervention 2: placebo
Intervention descriptions: intervention 1: Oral intervention 2: placebo

Protocol documents:
Clinical trial NCT00856583
Conditions: Schizophrenia
Sponsor: H. Lundbeck A/S
Start date: 2002-07-01; Completion date: 2008-02-01
Enrollment: 9809 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.

Detailed description:
The Committee for Medicinal Products for Human Use (CHMP) requested a post-marketing study to ascertain that the favourable benefit-risk profile and low mortality rates seen in the clinical studies with sertindole would not be offset by higher mortality rates when sertindole was used under more normal conditions of use. It was recognised that, in a clinical trial setting, strict patient selection and monitoring could lead to higher compliance in patient management and thereby to a lower mortality rate. Study 99824 was therefore designed in collaboration with the CHMP as an open-label, randomised study with minimum study management that focused on mortality and general patient safety. The duration of the treatment period was not fixed. No efficacy measures were included.

Arms: arm 1: Normally in the range of 4 to 20 mg/day arm 2: Normally in the range of 2 to 8 mg/day
Interventions: intervention 1: Sertindole intervention 2: Risperidone
Intervention descriptions: intervention 1: Sertindole was supplied as 4, 12, 16, and 20 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national Summary of Product Characteristics (SPC) for sertindole; in countries where sertindole was not marketed, the European Union (EU) SPC applied (all national and EU SPCs were essentially identical). Recommended dose range: 12 to 20 mg/day. The investigators were instructed to contact H. Lundbeck A/S if they deemed it necessary to increase the dose of sertindole to 24 mg/day, which was allowed in exceptional cases intervention 2: Risperidone was supplied as 1, 2, 3, and 4 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national SPC for risperidone. Recommended dose range: 2 to 8 mg/day

Protocol documents:
Clinical trial NCT00003896
Conditions: Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer
Keywords: stage III ovarian epithelial cancer peritoneal cavity cancer fallopian tube cancer
Sponsor: SWOG Cancer Research Network
Start date: 1999-09-01; Completion date: 2008-02-01
Enrollment: 68 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed description:
OBJECTIVES:

* Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer.
* Determine the feasibility of and toxic effects associated with this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Arms: arm 1: paclitaxel, cisplatin and liposomal doxorubicin
Interventions: intervention 1: cisplatin intervention 2: liposomal doxorubicin intervention 3: paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00044512
Conditions: Carcinoma, Hepatocellular
Keywords: Cancer Liver Cancer Hepatocellular carcinoma (HCC)
Sponsor: Bayer
Start date: 2002-08-01; Completion date: 2008-02-01
Enrollment: 137 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.

Detailed description:
In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:

* Pharmacokinetics (PK) profile of Sorafenib
* Plasma and tissue tumor biomarkers

Arms: arm 1: Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006)
Intervention descriptions: intervention 1: Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

Protocol documents:
Clinical trial NCT00096538
Conditions: Sarcoma
Keywords: classic Kaposi sarcoma recurrent Kaposi sarcoma
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2004-04-01; Completion date: 2008-02-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Herpesvirus is found in the lesions of most patients with Kaposi's sarcoma, and may have a role in causing Kaposi's sarcoma. Valganciclovir is an antiviral drug that acts against many types of herpesviruses and may be an effective treatment for Kaposi's sarcoma.

PURPOSE: This clinical trial is studying how well valganciclovir works in treating patients with classic non-HIV-associated Kaposi's sarcoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the antitumor activity of valganciclovir in patients with classic non-HIV-associated Kaposi's sarcoma (KS).

Secondary

* Determine the effect of this drug on lytic and latent human herpesvirus-8 gene expression in KS lesions of these patients.
* Determine the effect of this drug on the markers of angiogenesis in KS lesions of these patients.
* Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a pilot study.

Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity.

All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.

Arms: arm 1: Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
Interventions: intervention 1: valganciclovir
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00100789
Conditions: Head and Neck Cancer
Keywords: Recurrent stage IV squamous cell carcinoma hypopharynx larynx lip oral cavity nasopharynx oropharynx paranasal nasal cavity metastatic neck cancer
Sponsor: SWOG Cancer Research Network
Start date: 2005-01-01; Completion date: 2008-02-01
Enrollment: 67 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

Detailed description:
OBJECTIVES:

* Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel.
* Determine the confirmed and unconfirmed response (partial and complete) probability in patients with measurable disease treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.

Patients are followed every 8 weeks until disease progression, every 6 month for 2 years, and then annually for 1 year.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 10-13 months.

Arms: arm 1: None
Interventions: intervention 1: gemcitabine intervention 2: paclitaxel
Intervention descriptions: intervention 1: 3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days). intervention 2: 150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine

Protocol documents:
Clinical trial NCT00107614
Conditions: Waldenstrom Macroglobulinemia
Keywords: Waldenstrom
Sponsor: University of Arkansas
Start date: 2002-11-01; Completion date: 2008-02-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what the response is and the side effects are with chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide) + Rituxan, followed by two autologous transplants.

Detailed description:
Approximately 25 patients, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at UAMS (University of Arkansas for Medical Sciences) only.

Participants will receive two courses of chemotherapy with a regimen called DT PACE + Rituxan. This regimen consists of 6 drugs: Dexamethasone, Thalidomide, cis-Platinum, Adriamycin, Cyclophosphamide, and Etoposide.

Arms: arm 1: None
Interventions: intervention 1: DT PACE + Rituxan
Intervention descriptions: intervention 1: INDUCTION PHASE DT PACE + Rituxan DT PACE + Rituxan + PBSC Collection Response Assessment TRANSPLANT PHASE Transplant 1 (MEL 200 (patients with \< 50% response to induction) OR MEL-DT PACE (Patients with \> 50% response to Induction) Transplant 2 (identical to the first, except patients with progressive or proliferative disease, will receive BEAM) MAINTENANCE PHASE Rituxan every 3 months x 1 year

Protocol documents:
Clinical trial NCT00118092
Conditions: Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage IV Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-01-01; Completion date: 2008-02-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well 17-AAG works in treating patients with metastatic prostate cancer that did not respond to previous hormone therapy. Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the prostate-specific antigen (PSA) response in patients with hormone-refractory metastatic prostate cancer treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).

SECONDARY OBJECTIVES:

I. Determine the overall survival and disease-free survival rate in patients treated with this drug.

II. Determine the safety profile of this drug in these patients. III. Determine the duration of PSA response and PSA control in patients treated with this drug.

IV. Determine the partial and complete response rates in patients with measurable disease treated with this drug.

V. Correlate changes in expression levels of interleukin-6, maspin, and NF-kappaB in serum and tissue with cancer and treatment-related outcomes in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses of treatment beyond documentation of CR.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 20 months.

Arms: arm 1: Patients receive 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses of treatment beyond documentation of CR.
Interventions: intervention 1: tanespimycin intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents: