ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00616577
Conditions: Inguinal Herniorrhaphy Orchiopexy
Keywords: Caudal Epidural Ropivacaine
Sponsor: Loma Linda University
Start date: 2007-10-01; Completion date: 2010-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Caudal epidural analgesia (caudal block) is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).

This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements.

Detailed description:

Arms: arm 1: Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision. arm 2: Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia. arm 3: Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.
Interventions: intervention 1: Ropivacaine intervention 2: Ropivacaine intervention 3: Ropivacaine
Intervention descriptions: intervention 1: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine intervention 2: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine intervention 3: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site

Protocol documents:
Clinical trial NCT00618748
Conditions: Bipolar I Disorder
Keywords: Bipolar
Sponsor: Eli Lilly and Company
Start date: 2008-02-01; Completion date: 2010-09-01
Enrollment: 101 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.

Detailed description:
This is an open-label, multi-center, long-term treatment study conducted only in Japanese sites. The subjects are patients who fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) (296.50=unspecified, 296.52=moderate severity, 296.53=severe without psychotic features, 296.54=severe with psychotic features), who have completed Study HGMP (NCT#00510146) and patients who did not participate in Study HGMP who have been recruited to participate in Study HGMS.

Arms: arm 1: Participants who received olanzapine 5-20 mg/day in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks. arm 2: Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks. arm 3: Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
Interventions: intervention 1: Olanzapine
Intervention descriptions: intervention 1: 5-20 mg/day, oral, daily

Protocol documents:
Clinical trial NCT00627705
Conditions: Autistic Disorder
Sponsor: Stanford University
Start date: 2008-02-01; Completion date: 2010-09-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism. NAC is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by internal toxins called "free radicals." It is possible that children with Autism tend to have lower levels of glutathione, an important compound in our bodies that helps combat the effects of toxic free radicals.

We hope that by studying the antioxidant system in more detail, we will increase our understanding of the reasons why people develop Autism so that we can design better ways to treat individuals with this condition. This study is meant to test the safety tolerability of NAC and its effectiveness in the treatment of behavioral difficulties in children with autism. It will also examine the possible benefit of this agent in improving the core deficits in autism such as social deficits.

Detailed description:

Arms: arm 1: active compound N-Acetyl Cysteine arm 2: Placebo or sugar pill
Interventions: intervention 1: N-Acetyl Cysteine intervention 2: Placebo - sugar pill
Intervention descriptions: intervention 1: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks

Entire intervention lasts for 12 weeks (drug administration is continuous). intervention 2: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks

Entire intervention lasts for 12 weeks (drug administration is continuous).

Protocol documents:
Clinical trial NCT00632125
Conditions: Chronic Kidney Disease
Keywords: CKD subjects with or without dialysis treatment
Sponsor: Sandoz
Start date: 2008-07-01; Completion date: 2010-09-01
Enrollment: 1695 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

Detailed description:
This study was a multi-center, multinational, prospective, single-arm clinical study with a 6-month treatment period. The primary objective was to extend the safety database of patients with CKD who receive i.v. HX575 epoetin alfa treatment and to monitor the adverse event (AE) profile under post-approval conditions.

Arms: arm 1: This post-authorization safety study was designed as a multi-center, multinational, prospective, single-arm clinical study with a 6-month HX575 (recombinant human) erythropoietin alfa treatment period. It was planned to include approximately 1,500 patients.
Interventions: intervention 1: HX575 recombinant human erythropoietin alfa
Intervention descriptions: intervention 1: HX575 epoetin alfa i.v. will be administered according to the SmPC

Protocol documents:
Clinical trial NCT00656669
Conditions: Breast Cancer
Keywords: newly diagnosed breast cancer neoadjuvant therapy
Sponsor: Indiana University
Start date: 2008-04-01; Completion date: 2010-09-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer. This treatment can help shrink the tumors so they can be removed to help prevent the cancer from spreading to other parts of the body. This study is being done to test the impact of adding sunitinib as a single-agent (Segment 1), followed by sunitinib plus paclitaxel (Segment 2), followed by doxorubicin and cyclophosphamide (Segment 3). We hope the addition of sunitinib will make the treatment more effective, but we don't know if this is true.

Detailed description:

Arms: arm 1: The study will be conducted in 3 sequential treatment segments.
Interventions: intervention 1: sunitinib alone intervention 2: sunitinib plus paclitaxel intervention 3: doxorubicin and cyclophosphamide
Intervention descriptions: intervention 1: sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks. intervention 2: sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. intervention 3: doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.

Protocol documents:
Clinical trial NCT00661726
Conditions: Thalassemia
Keywords: Thalassemia Intermedia
Sponsor: Carelon Research
Start date: 2008-01-01; Completion date: 2010-09-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Thalassemia intermedia (TI) is an inherited blood disorder that can cause anemia due to low levels of hemoglobin. Decitabine is a medication that may be effective at increasing hemoglobin levels. This study will evaluate the safety and effectiveness of decitabine at increasing hemoglobin levels in people with TI.

Detailed description:
Thalassemias are inherited blood disorders that are characterized by low levels of hemoglobin and healthy red blood cells, which can lead to anemia. There are many different types of thalassemias, and TI is one type. People with TI often have moderate to severe anemia and may have a shortened life span, organ damage, and a lower quality of life as a result of the disease. Decitabine is a medication used to treat people with diseases that affect bone marrow and blood cells. The medication may be an effective treatment for people with TI because it may have the ability to interact with a person's DNA and increase hemoglobin levels. Previous studies in people with anemia have shown that decitabine has increased hemoglobin levels in some participants. The purpose of this study is to evaluate the safety and effectiveness of decitabine at increasing hemoglobin levels in people with TI.

This study will enroll people with TI. Following an 8-week screening period, participants will attend a baseline study visit, which will include a blood collection, pregnancy test, physical exam, and echocardiogram heart imaging procedure. Decitabine will be injected under the skin in the abdomen, thigh, or upper arm. Participants will be observed for a minimum of 30 minutes after the injection to assess pain or adverse reactions. Participants will then receive low doses of decitabine twice a week, on consecutive days, for 12 weeks. They will be closely monitored and dosages will be adjusted or stopped as needed. Every 2 weeks, participants will undergo a blood collection for safety testing. Every 4 weeks, participants will attend a study visit for a pregnancy test, physical exam, blood collection, and review of medication effects. Additionally, at the Week 12 visit, a repeat echocardiogram will occur. During Weeks 12 to 24, participants will not receive decitabine injections but will attend monthly study visits for repeat testing. Study researchers will contact participants by phone every 3 months during Year 1 and then every 6 months for the duration of the study to collect long-term survival and medical information.

Arms: arm 1: Participants will receive injected decitabine for 12 weeks.
Interventions: intervention 1: Decitabine (USAN, INN)
Intervention descriptions: intervention 1: Participants will receive 0.2 mg/kg of decitabine subcutaneously twice a week for 12 weeks. The dose will be reduced for toxicities as needed. The maximum dose of decitabine to be given will be 0.2 mg/kg.

Protocol documents:
Clinical trial NCT00668863
Conditions: Unresectable or Metastatic Colorectal Cancer
Sponsor: Pfizer
Start date: 2008-05-01; Completion date: 2010-09-01
Enrollment: 71 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil) intervention 2: Sunitinib
Intervention descriptions: intervention 1: FOLFIRI treatment with Sunitinib on Day, Irinotecan 180M/M IV , l-Leucovorin 200M/M, 5FU 400M/M bolus and 2400M/M in 46-hour continuous infusion on Day1 each 42 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. intervention 2: 37.5mg daily P.O., 4 weeks On 2weeks Off each 42 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

Protocol documents:
Clinical trial NCT00669461
Conditions: Constipation Parkinson's Disease
Keywords: Constipation Parkinson's Disease
Sponsor: University of Arkansas
Start date: 2009-06-01; Completion date: 2010-09-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the potential to improve constipation in patients with PD with no subsequent adverse events on the control of the neurological manifestation of PD. So we hypothesize the following:

1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary)
2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary)
3. Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lubiprostone
Intervention descriptions: intervention 1: Lubiprostone 24 mcg BID orally for 4 weeks

Protocol documents:
Clinical trial NCT00677833
Conditions: Malaria, Falciparum
Keywords: P. Falciparum Malaria drug treatment clinical trial
Sponsor: Pfizer
Start date: 2008-06-01; Completion date: 2010-09-01
Enrollment: 361 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Azithromycin plus Chloroquine intervention 2: Artemether-lumefantrine
Intervention descriptions: intervention 1: Combination of Azithromycin plus Chloroquine Azithromycin (\~30 mg/kg) + chloroquine (\~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2) intervention 2: Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)

Protocol documents:
Clinical trial NCT00681889
Conditions: Corneal Neovascularization
Sponsor: Reza Dana, MD
Start date: 2008-04-01; Completion date: 2010-09-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.

Detailed description:
This is an open label, single site, uncontrolled, single group assignment, safety/efficacy, Phase I study of topical administered ranibizumab in subjects with corneal neovascularization. Ten eyes of patients with corneal neovascularization will be recruited. Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.

Arms: arm 1: 10 Patients will receive treatment (Ranibizumab)
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: 10 Patients will receive treatment (Ranibizumab)

Protocol documents:
Clinical trial NCT00692185
Conditions: Eating Disorders
Keywords: Anorexia Nervosa
Sponsor: New York State Psychiatric Institute
Start date: 2005-10-01; Completion date: 2010-09-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of the antipsychotic medication olanzapine in treating outpatients with anorexia nervosa.

Detailed description:
Anorexia nervosa (AN) is a disease of disordered eating and is characterized by self-starvation, extreme weight loss, and difficulty maintaining a normal weight. Symptoms and behaviors of AN may include distorted body image, obsessive exercise, lack of menstruation among women, binge and purge eating behaviors, and intense fear of weight gain. Furthermore, people with AN are at a high risk of other mental disorders, such as depression and anxiety, and medical complications, such as organ damage, heart failure, and osteoporosis. Current treatments for AN include nutrition counseling, psychotherapy, and medication. Although weight restoration is a treatment priority, no particular therapeutic approach for patients with AN has clear empirical support. Previous studies have suggested that certain medications usually used to treat schizophrenia, also known as atypical antipsychotic drugs, may be helpful in increasing appetite and reducing anxiety related to weight gain and eating in people with AN. Specifically, the atypical antipsychotic medication olanzapine may be effective in improving overall symptoms of AN and in restoring weight to normal levels. This study will compare the effectiveness of the antipsychotic medication olanzapine versus placebo in treating outpatients with AN.

Participation in this study will last 8 weeks. All participants will first undergo baseline assessments that will include questionnaires and interviews about AN symptoms, a physical exam, vital sign measurements, an electrocardiograph (EKG), and a blood draw. Participants will then be assigned randomly to 8 weeks of daily treatment with olanzapine or placebo. Participants will meet with a study doctor weekly over the 8 weeks of treatment. During these visits, the study doctor will monitor participants' progress, medication dosage, vital signs, and side effects. Participants will also fill out weekly questionnaires about the status of their condition and monthly repeat baseline questionnaires. In addition, participants will undergo blood draws every 2 weeks for the first month of the study and every 4 weeks for the remainder of the study. Upon completing the 8 weeks of treatment, participants will repeat the baseline assessments. During the next 5 years, participants may be contacted to complete a follow-up interview.

Arms: arm 1: Participants will take olanzapine. arm 2: Participants will take matched placebo.
Interventions: intervention 1: Olanzapine intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks. intervention 2: Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks.

Protocol documents:
Clinical trial NCT00713258
Conditions: Back Pain
Keywords: Postmenopausal women Back pain Osteoporosis related fracture
Sponsor: Nycomed
Start date: 2008-04-01; Completion date: 2010-09-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Detailed description:

Arms: arm 1: PTH (1-84) + placebo alendronate arm 2: PTH (1-84) placebo + alendronate
Interventions: intervention 1: Parathyroid hormone (PTH) (1-84) intervention 2: Alendronate
Intervention descriptions: intervention 1: 100 µg PTH(1-84) daily intervention 2: 70 mg alendronate weekly

Protocol documents:
Clinical trial NCT00722566
Conditions: Multiple Myeloma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2008-07-01; Completion date: 2010-09-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.

Detailed description:

Arms: arm 1: VELCADE administered by subcutaneous injection arm 2: VELCADE administered by intravenous infusion
Interventions: intervention 1: VELCADE Administered by subcutaneous injection intervention 2: VELCADE Administered by intravenous infusion
Intervention descriptions: intervention 1: Patients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle intervention 2: Patients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle.

Protocol documents: