ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01225835
Conditions: Infertility
Sponsor: Ferring Pharmaceuticals
Start date: 2010-10-01; Completion date: 2013-06-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is aimed to demonstrate that highly purified Menotrophin produces significant lower progesterone serum levels during the follicular phase in comparison to Follitropin alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and to investigate if the progesterone serum levels might be a useful predictor for the success rate of the ongoing pregnancy rates

Detailed description:

Arms: arm 1: Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. arm 2: Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
Interventions: intervention 1: Menotrophin intervention 2: Follitrophin alpha intervention 3: Cetrorelix intervention 4: Choriongonadotropin intervention 5: Progesterone
Intervention descriptions: intervention 1: Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. intervention 2: Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. intervention 3: Participants self-inject subcutaneously Cetrorelix in the morning at a daily dose of 0.25 mg/day from Day 5 of gonadotrophin administration on and continue throughout the period of gonadotrophin treatment up to day 12 as a maximum. The last dose of Cetrorelix is given on the day of ovulation induction. intervention 4: 10,000 IU administered by the Investigator or designated personnel in the evening of the day on which the hCG criterion is met (no later than Day 13). The criterion for hCG administration is three follicles \>+17 mm diameter as shown by pelvic ultrasound examination. intervention 5: Vaginal gel progesterone is used once daily at a dose of 90 mg for a period of 30 days starting on the day of oocyte retrieval (approximately Day 14).

Protocol documents:
Clinical trial NCT01225991
Conditions: Rheumatoid Arthritis
Keywords: Pain, Fatigue, Geriatric, Rheumatoid Arthritis, Milnacipran
Sponsor: University of California, Los Angeles
Start date: 2010-11-01; Completion date: 2013-06-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the effects of milnacipran for the treatment of pain in rheumatoid arthritis in older adults.

Detailed description:
This is a 12-week open-label trial of milnacipran for the treatment of pain in rheumatoid arthritis in older adults. The investigators are interested in the relationship of chronic pain to inflammation, resilience, fatigue, and physical and mental functioning. The investigators anticipate that effective pain reduction will result in improved fatigue, resilience, physical and mental functioning and reduced levels of inflammation. The investigators are seeking to examine this directly in 30 older adults (55 years of age or older) with rheumatoid arthritis who will be using milnacipran for treatment of pain in the absence of clinical major depression. This proposed trial will serve as a pilot study to estimate the effect of the drug on pain and functional outcomes, as well as aid in dose-finding in this population.

Arms: arm 1: All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day, or to their maximum tolerated dose in the course of the first week. The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
Interventions: intervention 1: Milnacipran
Intervention descriptions: intervention 1: All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day).

Protocol documents:
Clinical trial NCT01232504
Conditions: Mycoses
Keywords: Allo-HSCT rhGM-CSF Systemic fungal infection (SFI)
Sponsor: Xiamen Amoytop Biotech Co., Ltd.
Start date: 2009-09-01; Completion date: 2013-06-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.

Detailed description:
From Sept 2009 to Dec 2012, we recruited consecutive patients with hematological diseases undergoing allogeneic stem cell transplantation at 5 institutions in China. Recipients between ages of 14 to 60 years old were eligible. Eligible patients were randomized to receive once daily subcutaneous 5-7μg/kg/d GM-CSF (Molgramostim, TOPLEUCON®; Xiamen Amoytop Biotech Co., Ltd., China) (GM-CSF group), 5-7μg/kg/d G-CSF (G-CSF group), or a combination of 2-3μg/kg/d GM-CSF and 2-3μg/kg/d G-CSF each (G-CSF+GM-CSF group). Administration of CSFs was started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days). If absolute neutrophil count (ANC) decreased to \< 1.5×10(9)/L within 5 days after withdrawal of CSFs, the same CSF would be resumed until the absolute neutrophil count (ANC) reached 1.5×10(9)/L again. All patients received antimicrobial prophylaxis with oral levofloxacin 500 mg daily and antifungal prophylaxis with oral fluconazole 200 mg daily.

Arms: arm 1: subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily arm 2: a combination of 2-3μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) and 2-3μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) each arm 3: subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily
Interventions: intervention 1: rhGM-CSF group intervention 2: rhG-CSF+rhGM-CSF group intervention 3: rhG-CSF group
Intervention descriptions: intervention 1: subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days). intervention 2: a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days). intervention 3: subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[ANC\] \> 1.5×10(9)/L for 2 consecutive days).

Protocol documents:
Clinical trial NCT01241344
Conditions: Adenovirus Disease
Keywords: AdV Hematopoeitic Stem Cell Transplant HSCT
Sponsor: Chimerix
Start date: 2010-11-01; Completion date: 2013-06-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to assess the safety and efficacy of preemptive treatment with oral brincidofovir (BCV), as compared to placebo, for the prevention of adenovirus (AdV) disease in recipients of hematopoietic stem cell transplantation (HCT) with asymptomatic AdV viremia.

Detailed description:
This was a Phase 2, randomized, multicenter, placebo-controlled study for pediatric and adult subjects who had undergone hematopoietic stem cell transplantation (HCT) and who had been identified as having asymptomatic adenovirus (AdV) viremia \[i.e., had detectable AdV DNA in plasma based on polymerase chain reaction testing performed at the local laboratory with no AdV disease symptoms\]. The primary objectives of the study were to assess the safety and tolerability of oral brincidofovir (BCV), and to estimate the treatment failure rate based on an efficacy endpoint with 2 different dosing regimens of oral BCV versus placebo.

Arms: arm 1: * Adult subjects: 200mg BCV administered as 50mg tablets taken orally either once weekly (QW; 4 tablets) or twice weekly (BIW; 2 tablets).
* Pediatric subjects: 4mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally either QW (as 4 mg/kg) or BIW (as 2 mg/kg). arm 2: * Adult subjects: Matching placebo tablets taken orally either once weekly (QW; 4 tablets) or twice weekly (BIW; 2 tablets).
* Pediatric subjects: Matching liquid placebo taken orally either QW (as 4 mg/kg) or BIW (as 2 mg/kg).
Interventions: intervention 1: Brincidofovir intervention 2: Placebo
Intervention descriptions: intervention 1: * Adult subjects: 200mg BCV administered as 50mg tablets taken orally either once weekly (QW; 4 tablets) or twice weekly (BIW; 2 tablets).
* Pediatric subjects: 4mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally either QW (as 4 mg/kg) or BIW (as 2 mg/kg). intervention 2: Adult subjects: Matching placebo tablets taken orally either once weekly (QW; 4 tablets) or twice weekly (BIW; 2 tablets).

• Pediatric subjects: Matching liquid placebo taken orally either QW (as 4 mg/kg) or BIW (as 2 mg/kg).

Protocol documents:
Clinical trial NCT01252732
Conditions: Wound Infection Abscess Systemic Inflammation Cellulitis
Keywords: ABSSSI Skin Infection Abscess
Sponsor: Melinta Therapeutics, Inc.
Start date: 2010-12-01; Completion date: 2013-06-01
Enrollment: 1019 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase 3 trial is to evaluate the efficacy, safety, and tolerability of oritavancin in ABSSSIs, including those caused by MRSA and to evaluate the potential economic benefit of oritavancin administered as a single 1200 mg IV dose.

Detailed description:
This is a Phase 3, multicenter, randomized, double-blind, parallel, comparative efficacy and safety study of single-dose IV oritavancin/IV placebo versus IV vancomycin for 7 to 10 days in adults with acute bacterial skin and skin structure infection (ABSSSI) suspected or proven to be caused by Gram-positive pathogens. Approximately 960 patients will be randomized at 100 centers globally.

In addition, this study will characterize the PK and PK/PD properties of a single 1200 mg IV dose of oritavancin and evaluate the potential health economic benefits offered by this dosing strategy.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Single-Dose IV Oritavancin Diphosphate intervention 2: IV Vancomycin
Intervention descriptions: intervention 1: Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days. intervention 2: Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.

Protocol documents:
Clinical trial NCT01257698
Conditions: Macular Hole Retinal Detachment
Keywords: Vitrectomy Gas bubble Retinal detachment Macular hole Aqueous suppressant
Sponsor: Mid Atlantic Retina
Start date: 2010-02-01; Completion date: 2013-06-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if glaucoma eye drops (dorzolamide-timolol) have any effect on the duration of an intraocular gas bubble following pars plana vitrectomy.

Detailed description:
At the end of some retinal surgeries, a gas bubble is placed in the eye. In surgeries for retinal detachment, this gas bubble helps to keep the tear(s) in the retina sealed up while the eye is healing and prevent the retina from re-detaching. In macular hole surgeries (a defect in the center part of the retina), the gas bubble helps to seal up this hole in the center part of the retina. The gas bubble (sulfur hexafluoride) will slowly disappear from the eye over the course of approximately 2 weeks.

In some cases, the gas bubble disappears more quickly than the surgeon would wish. Several eye drops are currently available which help to lower the eye pressure in conditions such as glaucoma where the eye pressure is unacceptably elevated and is causing or may cause vision loss. These drops have been shown to keep the eye pressure controlled after surgery with injection of a gas bubble in the eye. However, little is known about the effect of these drops on the duration of the gas bubble. The goal of this study is to see if these glaucoma eye drops have any effect on the amount of time the gas bubble remains in the eye.

After surgery with a gas bubble (sulfur hexafluoride) is completed, patients will be randomly assigned (like a flip of a coin) to receive a glaucoma drop (dorzolamide-timolol) or no glaucoma drop. These drops are currently available from pharmacies with a prescription and are not "experimental." However, the use of these drops in this protocol is not to treat glaucoma but represents an "off-label" use. Patients assigned to receive a glaucoma drop will be provided with the medication. All patients will receive the standard post-operative drops regardless of which group they are assigned to. Patients will be taken care of before and after the surgery like any other patient undergoing this procedure. The investigators expect that you will be enrolled in this study for 3 months.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dorzolamide 2%-timolol 0.5% topical eyedrops
Intervention descriptions: intervention 1: Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.

Protocol documents:
Clinical trial NCT01270347
Conditions: Cystic Fibrosis
Sponsor: Amgen
Start date: 2011-01-01; Completion date: 2013-06-01
Enrollment: 282 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.

Detailed description:
This study will assess the comparative safety of MP-376 (Aeroquin) and Tobramycin Inhalation solution (TIS) \[TOBI® Novartis Pharmaceuticals\] over three consecutive cycles of 28-days treatment followed by 28-days off in stable CF patients with chronic P. aeruginosa lung infection. Efficacy data for MP-376 and TIS at the end of the first 28-day treatment period will also be compared, as well as explored over multiple treatment cycles.

Study patients participating in Mpex 209 will be given the option to participate in a six-month open label extension phase of the Mpex 209 protocol. The open label extension will allow enrolled patients to receive three additional courses of MP-376 (levofloxacin inhalation solution, Aeroquin™).

Study with completed results acquired from Horizon in 2024.

Arms: arm 1: Aeroquin, Inhaled Levofloxacin (MP-376) arm 2: Tobramycin Inhalation solution (TIS) \[TOBI® Novartis Pharmaceuticals\]
Interventions: intervention 1: MP-376 (Levofloxacin Solution for Inhalation) intervention 2: TIS (Tobramycin Inhalation Solution)
Intervention descriptions: intervention 1: MP-376 (Aeroquin, Levofloxacin solution for Inhalation) 240 mg administered BID for 28-days treatment followed by 28 days off treatment intervention 2: Tobramycin Inhalation Solution administered BID over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment

Protocol documents:
Clinical trial NCT01271244
Conditions: PTSD
Sponsor: VA Nebraska Western Iowa Health Care System
Start date: 2008-06-01; Completion date: 2013-06-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study looked at relationship between escitalopram and heart rate variability and QT variability in veterans with PTSD.

Detailed description:
The investigators are studying if taking escitalopram will normalize heart rate variability and a decrease (or no effect implying a lack of serious cardiac side effects) including QT variability in veterans with PTSD.

Arms: arm 1: Escitalopram 10-20 mg/day arm 2: Escitalopram 10-20 mg/day
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: 10-20mg daily for 12 weeks

Protocol documents:
Clinical trial NCT01292837
Conditions: Epilepsy Generalized Tonic-clonic Seizures
Keywords: Levetiracetam Epilepsy Generalized tonic-clonic seizures
Sponsor: UCB Japan Co. Ltd.
Start date: 2011-02-01; Completion date: 2013-06-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to \<16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).

Detailed description:

Arms: arm 1: Twice daily (morning and evening) orally
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.

Protocol documents:
Clinical trial NCT01294800
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-02-25; Completion date: 2013-06-01
Enrollment: 450 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the efficacy of a range of preladenant doses compared with placebo in participants with moderate to severe Parkinson's disease (PD) experiencing motor fluctuations and receiving a stable dose of levodopa (L-dopa), as measured by "off" time. Participants will continue to receive their stable regimen of L-dopa plus any adjunct medications during the study as prescribed by their physician. Several classes of adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase inhibitors, and dopamine agonists.

Primary Hypothesis: At least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 12 in the mean "off" time.

Detailed description:

Arms: arm 1: Participants will receive preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks. arm 2: Participants will receive preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks. arm 3: Participants will receive preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks. arm 4: Participants will receive a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Interventions: intervention 1: Preladenant intervention 2: Placebo tablet to match Preladenant
Intervention descriptions: intervention 1: 2, 5, or 10 mg tablets taken orally twice daily (BID) intervention 2: tablets taken orally BID

Protocol documents:
Clinical trial NCT01301963
Conditions: Refractory Multiple Myeloma
Sponsor: Case Comprehensive Cancer Center
Start date: 2011-07-01; Completion date: 2013-06-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored

Detailed description:
PRIMARY OBJECTIVES:

I. Ability to reach target collection of 5 x 10\^6 CD34+ cells/Kg with =\< 2 days of leukaphereses using one of two mobilization regimens.

SECONDARY OBJECTIVES:

I. Percentage of patients achieving target goal CD34+ cell dose (as above) in =\< 5 days of leukaphereses.

II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other.

III. Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive G-CSF subcutaneously (SC) once daily (QD) on days 1-8.

ARM II: Patients receive G-CSF SC QD on days 1-7 and plerixafor SC QD on days 4-7.

After completion of study treatment, patients are followed up at 14 days.

Arms: arm 1: Patients receive G-CSF SC QD on days 1-4. arm 2: Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
Interventions: intervention 1: plerixafor intervention 2: filgrastim
Intervention descriptions: intervention 1: Given SC intervention 2: Given SC

Protocol documents: