ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00723229
Conditions: Genital Herpes
Sponsor: University of Washington
Start date: 2008-08-01; Completion date: 2011-09-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial. We hypothesize that short bursts of HSV-2 reactivation will not be suppressed by acyclovir.

Detailed description:
We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial.

We propose to perform this study in two study populations. Cohort 1 will be comprised of 25 HSV-2 seropositive, HIV seronegative adults, and Cohort 2 will be comprised of 25 HSV-2 seropositive, HIV seropositive adults with a CD4 count\>250 cells/mm3. As suppression of HSV-2 using acyclovir is currently being studied in large, multi-center, international clinical trials as an HIV prevention strategy, these results will have broad implications for public health around the world.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: acyclovir
Intervention descriptions: intervention 1: Acyclovir 400 mg PO BID for 28 days

Protocol documents:
Clinical trial NCT00760838
Conditions: Asthma
Keywords: Inadequately controlled severe asthma
Sponsor: University Hospital, Ghent
Start date: 2009-03-01; Completion date: 2011-09-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.

Detailed description:

Arms: arm 1: Azithromycin 250 mg

1x/day during 5 days 3x/week afterwards arm 2: Placebo

1x/day during 5 days 3x/week afterwards
Interventions: intervention 1: Azithromycin 250 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks intervention 2: Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks

Protocol documents:
Clinical trial NCT00762268
Conditions: Bipolar Disorder Depression Bipolar Depression
Keywords: SAMe alternative treatments bipolar disorder depression bipolar depression treatment-resistant depression
Sponsor: Mclean Hospital
Start date: 2008-09-01; Completion date: 2011-09-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
S-adenosyl-L-methionine (SAMe) is a dietary supplement with antidepressant properties. SAMe's mechanism of action remains unclear, but it appears to be distinct from that of conventional antidepressants. The purpose of this study is to examine the effect of these properties on the mood of bipolar subjects with persistent major depression that has been unresponsive to standard pharmacotherapy.

Detailed description:
Depression in bipolar disorder is a significant source of disease-related debility; with bipolar individuals typically spending three fold as much time depressed as manic or hypomanic. Clinicians treating bipolar disorder often struggle to provide relief from depressive symptoms that are more often treatment resistant than in unipolar depression. To complicate matters further, the risk/benefit ratio of currently available antidepressants is a source of debate within the field of psychiatry.

S-adenosyl-L-methionine (SAMe) is a dietary supplement with well-established antidepressant properties. SAMe's mechanism of action remains unclear, but it appears to be distinct from that of conventional antidepressants. The purpose of this study is to examine the effect of these properties on the mood of bipolar subjects with persistent major depression that has been unresponsive to standard pharmacotherapy.

An unusual aspect of the current study design is the schedule of SAMe dosing. SAMe tablets will be administered intermittently and in steadily increasing dosages. The purpose of this gradual and intermittent dosage titration is to lessen the risk of antidepressant-induced mania by seeking the minimum effective oral dose of SAMe.

Arms: arm 1: SAMe: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period. arm 2: Placebo: Placebo SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral pills for only 3 days per week, followed by a 4 day "rest-period", before the round. The apparent dosage will be progressively increased each week to mimic a maximum of 1600 mg per day over a 4-week period.
Interventions: intervention 1: SAMe intervention 2: Placebo
Intervention descriptions: intervention 1: SAMe tablets will be administered intermittently and in steadily increasing dosages. Subjects will receive oral SAMe for only 3 days per week, followed by a 4 day "rest-period", before the next dosage increase. SAMe dosage will be progressively increased each week to a maximum of 1600 mg per day over a 4-week period. intervention 2: None

Protocol documents:
Clinical trial NCT00785798
Conditions: Relapsed Lymphomas Refractory Lymphomas
Keywords: Relapsed Lymphomas Refractory Lymphomas
Sponsor: Yale University
Start date: 2009-01-01; Completion date: 2011-09-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study will be a dose-finding, phase I study of the combination of vorinostat and PLD in patients with advanced lymphoma refractory to at least one prior systemic therapy.

Detailed description:
The study will also be a dose-escalating study of vorinostat 200mg to 400 mg twice daily for 7 days with PLD 30mg/m2 on day 3 every 21 days, with intrapatient dose escalation.

Primary endpoint is progression. All endpoints are observational

Arms: arm 1: Escalating doses of vorinostat 200mg to 400mg twice daily on days 1-7, and fixed-dose IV PLD 30mg/m2 on day 3 of a 21-day cycle
Interventions: intervention 1: Vorinostat intervention 2: Pegylated Liposomal Doxorubicin (PLD), Doxil
Intervention descriptions: intervention 1: 200mg to 400 mg twice daily on days 1-7 intervention 2: IV 30mg/m2 on day 3 of a 21-day cycle

Protocol documents:
Clinical trial NCT00789685
Conditions: Acute Lung Injury Acute Respiratory Distress Syndrome
Keywords: Open label
Sponsor: Faron Pharmaceuticals Ltd
Start date: 2009-02-01; Completion date: 2011-09-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).

Detailed description:
This was a phase I/II open-label study to assess the safety, tolerability and preliminary efficacy of FP-1201 (IFN β-1a) in the treatment of patients with ALI and ARDS.

The primary objective in the study was to evaluate the safety and tolerability of FP-1201 in patients with ALI/ARDS and to assess the safety, tolerability and preliminary efficacy of the optimum tolerated dose (OTD) in patients likely to derive clinical benefit.

The study consisted of a dose escalation phase to determine the maximum tolerated dose (MTD) and OTD followed by a separate cohort expansion phase in which the OTD was administered.

Arms: arm 1: Interferon Beta
Interventions: intervention 1: Interferon Beta
Intervention descriptions: intervention 1: Interferon Beta administered intravenously daily for 6 days. Doses of 0.12 MIU, 1.2 MIU, 2.7 MIU or 6.0 MIU (dose escalation phase) or 2.7 MIU (dose expansion phase) were administered.

Protocol documents:
Clinical trial NCT00793650
Conditions: Cancer Multiple Myeloma
Keywords: Cancer Multiple Myeloma Peripheral Blood Stem Cell Transplant
Sponsor: Emory University
Start date: 2005-05-01; Completion date: 2011-09-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to evaluate the safety of melphalan and autologous PBSCT (peripheral blood stem cell transplantation - stem cells that come from your own body) in combination with bortezomib, a new FDA approved drug used to treat myeloma.

Detailed description:

Arms: arm 1: Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours before melphalan. arm 2: Enrolled patients were randomized to receive a single escalating dose of bortezomib (1.0, 1.3, or 1.6 mg/m2) 24 hours after melphalan.
Interventions: intervention 1: Bortezomib intervention 2: Melphalan intervention 3: Autologous PBSC Transplant
Intervention descriptions: intervention 1: Escalating doses of bortezomib 1.0, 1.3, or 1.6 mg/m2 in Arm A and Arm B. intervention 2: All patients received melphalan (100 mg/m\^2/day × 2; days

-3 and -2), for a total dose of 200 mg/m\^2. intervention 3: Day 0 consists of the stem cell infusion.

Protocol documents:
Clinical trial NCT00809965
Conditions: Acute Coronary Syndrome Myocardial Infarction Myocardial Ischemia Unstable Angina
Keywords: Rivaroxaban Acute Coronary Syndrome ACS Aspirin Thienopyridine Unstable Angina Myocardial Infarction Anticoagulation Clopidogrel (Plavix)
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2008-11-01; Completion date: 2011-09-01
Enrollment: 15526 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

Detailed description:
Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

Arms: arm 1: One 2.5 mg rivaroxaban tablet twice daily for up to 6 months arm 2: One 5 mg rivaroxaban tablet twice daily for up to 6 months arm 3: One placebo tablet twice daily for up to 6 months
Interventions: intervention 1: Rivaroxaban 2.5 mg intervention 2: Rivaroxaban 5 mg intervention 3: Placebo intervention 4: Standard of care
Intervention descriptions: intervention 1: One tablet twice daily intervention 2: One tablet twice daily intervention 3: One placebo tablet twice daily intervention 4: None

Protocol documents:
Clinical trial NCT00823082
Conditions: Acquired Antithrombin III Deficiency Coronary Artery Bypass
Keywords: antithrombin ATIII acquired deficiency anticoagulants cardiopulmonary bypass surgery complications postoperative outcomes
Sponsor: Instituto Grifols, S.A.
Start date: 2009-06-01; Completion date: 2011-09-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.

Detailed description:

Arms: arm 1: Preoperative ATIII supplementation administered immediately after anesthesia induction arm 2: No preoperative ATIII supplementation administered
Interventions: intervention 1: Antithrombin III
Intervention descriptions: intervention 1: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

Protocol documents:
Clinical trial NCT00823719
Conditions: Lymphoma, Large-Cell, Diffuse
Keywords: Salvage chemotherapy relapsed grade 3B follicular lymphoma efficacy safety DHAP ofatumumab refractory Non-Hodgkin's Lymphoma Diffuse Large B Cell Lymphoma (DLBCL) Oncology ICE Transformed follicular lymphoma
Sponsor: GlaxoSmithKline
Start date: 2009-05-01; Completion date: 2011-09-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ofatumumab used in combination with ifosfamide, carboplatin, etoposide (ICE) or dexamethasone, cytarabine, cisplatin (DHAP) salvage chemotherapy regimens in subjects with relapsed or refractory diffuse large B cell lymphoma (DLBCL) who are eligible for autologous stem cell transplant.

Detailed description:
Rituximab combined with anthracycline based chemotherapy is the most common first-line treatment for subjects with diffuse large B cell lymphoma (DLBCL). Subjects requiring second-line therapy will most often receive rituximab in combination with salvage chemotherapy as an induction therapy prior to autologous stem cell transplant. With rituximab being in first-line therapy, the response rates for subjects receiving rituximab plus salvage chemotherapy has significantly decreased. Treatment with ofatumumab may be able to overcome the resistance to rituximab in the second-line setting and offer improved response rates. The objective of this study is to evaluate the overall response rate of ofatumumab in combination with ICE or DHAP chemotherapy prior to autologous stem cell transplant. Additional objectives are to evaluate the complete response rate, ability to mobilize cluster of differentiation (CD)34+ cells, progression-free survival (PFS) and overall survival.

Arms: arm 1: This study is a single arm study, but the Investigators are required to prospectively choose to treat all of their subjects with either ICE or DHAP chemotherapy regimens in combination with ofatumumab. Regardless of whether the subject receives ICE or DHAP chemotherapy, all subjects will receive the same ofatumumab regimen and dose.
Interventions: intervention 1: ofatumumab + ICE intervention 2: ofatumumab + DHAP
Intervention descriptions: intervention 1: 3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 milligrams (mg); cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg

ICE regimen:

ifosfamide + mesna - 5 grams (g)/meters squared (m\^2)/24 hours (hrs) continuous on day 2 of dosing cycle; carboplatin - AUC 5 (800 mg maximum) on day 2 of dosing cycle; etoposide - 100 mg/m\^2 on days 1, 2 and 3 of dosing cycle. intervention 2: 3 cycles of treatment will be administered. Each cycle will last 21 days. ofatumumab dose: cycle 1, day 1 - 1000 mg; cycle 1, day 8 - 1000 mg; cycle 2, day 1 and cycle 3, day 1 - 1000 mg.

DHAP regimen:

dexamethasone - 40 mg on days 1, 2, 3, and 4 of dosing cycle; cisplatin - 100 mg/m\^2/24 hrs continuous on day 1 of dosing cycle; cytarabine - 2 g/m\^2 q12 hrs (2 doses) on day 2 of dosing cycle.

Protocol documents:
Clinical trial NCT00833248
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Start date: 2009-04-01; Completion date: 2011-09-01
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.

Detailed description:

Arms: arm 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. arm 2: On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).

On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Interventions: intervention 1: Degarelix intervention 2: Goserelin intervention 3: Bicalutamide
Intervention descriptions: intervention 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. intervention 2: Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 3. The second and third doses of goserelin were administered on Days 31 and 59, respectively. intervention 3: On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.

Protocol documents:
Clinical trial NCT00848107
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis scleroderma digital ulcers vasculopathy
Sponsor: United Therapeutics
Start date: 2009-09-01; Completion date: 2011-09-01
Enrollment: 115 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.

Detailed description:

Arms: arm 1: Treprostinil diethanolamine sustained release tablet initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
Interventions: intervention 1: treprostinil diethanolamine
Intervention descriptions: intervention 1: sustained release tablet; BID dosing; up to 16 mg BID

Protocol documents:
Clinical trial NCT00851903
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Start date: 2009-06-01; Completion date: 2011-09-01
Enrollment: 112 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was the extension of the LANTU\_C\_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled).

All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria.

The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period.

The objectives of this extension study were:

* To assess the glycemic control (HbA1c \<7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus either insulin glargine or sitagliptin.
* To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight and overall safety.

Detailed description:

Arms: arm 1: Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \< Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 \<FPG ≤ 5.5 mmol/L).

Sitagliptin: stable dose of 100 mg once a day administered with or without food.
Interventions: intervention 1: Insulin Glargine intervention 2: Sitagliptin intervention 3: Metformin
Intervention descriptions: intervention 1: Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL). intervention 2: Oral administration. 100mg film-coated tablets. intervention 3: Patients continued with metformin as usual oral anti-diabetic treatment.

Protocol documents:
Clinical trial NCT00868348
Conditions: Postoperative Pain
Keywords: Total Knee Arthroplasty
Sponsor: University of Aarhus
Start date: 2009-05-01; Completion date: 2011-09-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ketorolac intervention 2: Saline
Intervention descriptions: intervention 1: 30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac intervention 2: 1 ml infiltration 4 ml intraarticular bolus injection of placebo

Protocol documents: