ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01222884
Conditions: Chronic Kidney Disease Stage 5 (Dialysis Dependent)
Sponsor: Pharmacosmos A/S
Start date: 2011-06-01; Completion date: 2013-12-01
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).

Detailed description:

Arms: arm 1: Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection arm 2: Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection
Interventions: intervention 1: Monofer intervention 2: Iron sucrose
Intervention descriptions: intervention 1: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes intervention 2: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics

Protocol documents:
Clinical trial NCT01227681
Conditions: Parkinson Disease
Sponsor: Buddhist Tzu Chi General Hospital
Start date: 2010-06-01; Completion date: 2013-12-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of neuroprotection from granulocyte colony-stimulating factor on Parkinson disease

Detailed description:
Parkinson's disease (PD) is the second most common neurodegenerative disease and the severity of PD still progress during the ensuing years. Currently, there is no promising medical or surgical treatment to abrogate the disease deterioration. Granulocyte colony-stimulating factor (G-CSF), one of hematopoietic growth factors, has been routinely used for hematologic disorders and stem cell harvest from normal subject. G-CSF also demonstrated neuroprotection for rodents PD model. We hypothesize G-CSF will exert the effectiveness of neuroprotection for PD patients.

Arms: arm 1: high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles) arm 2: low dose group: 1.65ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles) arm 3: Sodium Chloride (NaCl) 0.9 %
Interventions: intervention 1: G-CSF intervention 2: Placebo
Intervention descriptions: intervention 1: G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously intervention 2: Sodium Chloride (NaCl) 0.9 %

Protocol documents:
Clinical trial NCT01235234
Conditions: Keratoconjunctivitis Sicca
Keywords: Dry eye disease KCS Aqueous Deficient Dry Eye
Sponsor: Can-Fite BioPharma
Start date: 2011-07-01; Completion date: 2013-12-01
Enrollment: 236 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Eligible patients with dry eye will be treated with CF101 or placebo twice daily for 24 weeks. Disease activity will be assessed using evaluations of ocular surface integrity, tear production, and patient symptoms.

Detailed description:
Patients will be randomized to receive either CF101 0.1 mg, CF101 1.0 mg, or matching placebo, given orally twice daily (BID) for 24 weeks. A Screening Period of up to 4 weeks that includes a 2-week run-in period will precede a 24-week treatment period, followed by a 2-week follow-up period.

At a Screening Visit, patients will undergo complete medical and ophthalmologic history, medication history, physical examination (including height, weight, sitting blood pressure, pulse rate and temperature), ophthalmic examination, and clinical laboratory tests. Disease activity will be assessed using fluorescein staining, Schirmer test with and without anesthesia, Ocular Surface Disease Index©, and tear break-up time.

Eligible patients will begin a 2-week run-in period during the 4-week screening period, during which time they will be instructed to discontinue use of all topical ophthalmic medications except for REFRESH TEARS® Lubricant Eye Drops. At the Baseline Visit, patients who successfully complete the 2-week run-in period and re-qualify for entry will be randomized to their assigned medication (CF101 0.1 mg, CF101 1.0 mg, or matching placebo) to be taken orally twice daily BID for 24 weeks. Patients will return for assessments and a new supply of study medication at Weeks 2, 4, 8, 12, 16, and 20; at Week 24 for a final on-treatment assessment; and at Week 26 for the 2-week off-treatment follow-up visit.

Arms: arm 1: Subjects were randomized to receive CF 101 0.1mg, orally, twice daily for 24 weeks arm 2: Subjects were randomized to receive CF 101 1.0mg, orally, twice daily for 24 weeks arm 3: Subjects were randomized to receive matching placebo, orally, twice daily for 24 weeks
Interventions: intervention 1: CF101
Intervention descriptions: intervention 1: orally q12h

Protocol documents:
Clinical trial NCT01239680
Conditions: Hemorrhagic Shock
Keywords: hemorrhagic shock glutamine trauma resuscitation department of defense trauma
Sponsor: University of Missouri, Kansas City
Start date: 2011-01-01; Completion date: 2013-12-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Overall aim of this work is to evaluate new methods of resuscitation that can be applied by front-line responders on the battlefield, in civilian life, or which can be used during initial resuscitation in the first fixed facility to which the injured patient is brought.

Detailed description:
Shock is a leading cause of death among American forces in battle, with many trauma victims dying of early hemorrhagic shock or from late septic shock.1 Shock is defined as circulatory collapse, when the arterial blood pressure is too low to maintain an adequate supply of blood to the body's vital organs and tissues. Specifically, hemorrhagic shock results when blood vessels are physically damaged while septic shock results when microbes or microbial products enter the blood stream. Despite advances in medical science, including the development of improved antibiotics, treatments for hemorrhagic and septic shock have changed little in the past 30-40 years. A wounded soldier bleeding on the battlefield, or a trauma victim in the United States, is treated today largely as he or she would have been treated in 1970.

The overall aim of this work is to evaluate new methods of resuscitation that can be applied by front-line responders on the battlefield (medical corpsmen, combat medics), in civilian life (Emergency Medical System), or which can be used during initial resuscitation in the first fixed facility to which the injured patient is brought. This might be a Fire Support Specialist (FIST) team in a combat theater or a trauma center in the civilian health care system.

Arms: arm 1: Ringer's Lactate 1 liter once over 6 hours arm 2: Ringer's Lactate with 25 grams Glutamine (1 liter) once over 6 hours
Interventions: intervention 1: Glutamine intervention 2: Ringer's Lactate intervention 3: Placebo (for Glutamine)
Intervention descriptions: intervention 1: Intravenous 25 grams once over 6 hours intervention 2: Intravenous 1 liter once over 6 hours intervention 3: Given Intravenously in 1 liter Lactated Ringer's

Protocol documents:
Clinical trial NCT01257230
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2010-12-01; Completion date: 2013-12-01
Enrollment: 398 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health care resource utilisation an on the number of adverse events.

Detailed description:

Arms: arm 1: once daily, delivered with Respimat inhaler arm 2: once daily, delivered with Respimat inhaler arm 3: once daily, delivered with Respimat inhaler
Interventions: intervention 1: tiotropium Respimat low dose intervention 2: placebo Respimat intervention 3: tiotropium Respimat high dose
Intervention descriptions: intervention 1: IMP intervention 2: placebo representing comparator intervention 3: IMP

Protocol documents:
Clinical trial NCT01257503
Conditions: Upper Respiratory Tract Infections
Keywords: children upper respiratory tract infections homeopathy
Sponsor: University of Washington
Start date: 2010-12-01; Completion date: 2013-12-01
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized controlled trial of a commercially available homeopathic cold remedy will be conducted. A total of 400 children, 2-5 years old, diagnosed with an upper respiratory tract infection will be randomized to receive either the homeopathic remedy or placebo. Parents of study children will administer 5 ml of the study medication up to 6 times per day as needed to treat cold symptoms. One hour after giving a dose the parent will rate change in symptoms (for up to the first 10 doses). In addition, parents will rate their child's overall symptom severity and functional status over the first 3 days of the cold. It is postulated that children receiving the active homeopathic remedy will have better symptom relief and that their symptom severity and functional status will improve more rapidly than those receiving placebo.

Detailed description:

Arms: arm 1: 5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms arm 2: 5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms
Interventions: intervention 1: Hyland's Cold 'n Cough 4 kids intervention 2: placebo
Intervention descriptions: intervention 1: 5 ml PO q4h prn cold symptoms intervention 2: liquid made to look like the active homeopathic remedy

Protocol documents:
Clinical trial NCT01261000
Conditions: Acromegaly
Keywords: Acromegaly
Sponsor: Cedars-Sinai Medical Center
Start date: 2010-11-01; Completion date: 2013-12-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Acromegaly is a disease of the pituitary gland that involves overproduction of growth hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I levels in the blood. However, no studies have evaluated the effects of blocking GH receptors in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with pegvisomant.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Pegvisomant
Intervention descriptions: intervention 1: Pegvisomant used as indicated

Protocol documents:
Clinical trial NCT01266291
Conditions: Complex Partial Seizures
Keywords: Tuberous sclerosis TS Seizures
Sponsor: University of Pennsylvania
Start date: 2010-08-01; Completion date: 2013-12-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, phase 4 study to examine the safety and efficacy of vigabatrin (Sabril) in Tuberous Sclerosis patients, a subset of the larger refractory complex partial epilepsy population for which the drug is approved. While enrolled on this trial, subjects will continue to take all of their normally prescribed medications, including their other antiepileptic drugs (AEDs).

Alternatively, there is a prospective observational arm that subjects who are about to take Sabril as treatment for seizures associated with Tuberous Sclerosis may join. Subjects who join this arm will not have any study visits and will not be asked to do anything specifically for the study. The study team will collect all study data from subjects' medical records only.

Detailed description:

Arms: arm 1: This is a single arm study. All subjects who are eligible for treatment will begin taking vigabatrin (Sabril) during the third month of the study. Treatment will be in accordance with the FDA-approved prescribing information: upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
Interventions: intervention 1: vigabatrin
Intervention descriptions: intervention 1: Subjects will begin taking vigabatrin (Sabril) during the third month of the study. Upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.

Protocol documents:
Clinical trial NCT01290484
Conditions: Lymphangioma
Keywords: Lymphatic malformation, vascular malformation
Sponsor: Stanford University
Start date: 2010-12-01; Completion date: 2013-12-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
There is an unsatisfied medical need for a first-line treatment of lymphatic malformations with a good benefit/risk profile. Based on a patient experience in the institution, the investigators plan to verify whether or not the medication sildenafil has a beneficial effect on lymphatic malformations. The investigators plan to do this by treating patients with lymphatic malformations with the medication sildenafil for a 20 week period. This is an investigator initiated study funded by an Innovations in Patient Care grant and a SPARK grant.

Detailed description:
Lymphatic malformations can be challenging to treat. Mainstay interventions including surgery and sclerotherapy are invasive and can result in local recurrence and complications. We sought to assess the effect of 20 weeks of oral sildenafil on reducing lymphatic malformation volume and symptoms in children. Seven children (4 boys, 3 girls; ages 13-85 months) with lymphatic malformations were given oral sildenafil for 20 weeks in this open-label study. The volume of the lymphatic malformation was calculated blindly using magnetic resonance imaging performed before and after 20 weeks of sildenafil. Lymphatic malformations were assessed clinically on weeks 4, 12, 20, and 32. Both the physician and parents evaluated the lymphatic malformation in comparison with baseline. Sildenafil can reduce lymphatic malformation volume and symptoms in some children. ( J Am Acad Dermatol 2014;70:1050-7.)

Arms: arm 1: Sildenafil oral tablet three times daily
Interventions: intervention 1: Sildenafil
Intervention descriptions: intervention 1: Sildenafil oral tablet three times daily

Protocol documents:
Clinical trial NCT01293123
Conditions: HIV
Keywords: HIV raltegravir cerebrospinal fluid
Sponsor: University of California, San Diego
Start date: 2011-12-01; Completion date: 2013-12-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to determine the effects of the HIV integrase inhibitor, raltegravir, in cerebrospinal fluid (CSF). This will be accomplished by collecting CSF before and after initiation of either raltegravir or another antiretroviral, efavirenz, each in combination with two other antiretrovirals. Assessments will include HIV RNA levels (viral load), neuropsychological testing, mood assessments, and quality of life assessments.

Detailed description:
Cognitive disorders continue to be a common complication of HIV disease even though potent antiretroviral drugs can reduce HIV below detectable levels and restore immune function. Concentrations of most antiretrovirals in the nervous system are only a fraction of concentrations in blood. As a result, HIV can continue to be present in the nervous system when it is below detection in blood. A recently approved drug, raltegravir, reaches therapeutic concentrations in cerebrospinal fluid and may be effective at controlling HIV replication in the primary target cells in the brain, macrophages and microglia. Based on this, raltegravir may be a particularly effective drug for treating HIV disease in the nervous system. The purpose of this study is to determine the effects of raltegravir in the nervous system by measuring HIV in the CSF (via lumbar puncture, also known as spinal taps) before and after initiation of raltegravir-containing antiretroviral therapy. CSF is an accessible fluid that provides a window into brain processes, including HIV replication and inflammation. The potency of raltegravir will be estimated by calculating the change in HIV viral load in CSF over time. These changes will be compared to those following initiation an efavirenz-containing regimen in a separate group of individuals. Two additional drugs (tenofovir disoproxil fumarate, emtricitabine) will be combined with either raltegravir or efavirenz. Neuropsychological performance, mood, sleep and quality of life assessment will also be compared. Participants will be randomly assigned to either raltegravir- or efavirenz-containing therapy.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Raltegravir intervention 2: Efavirenz
Intervention descriptions: intervention 1: raltegravir 400 mg PO twice daily intervention 2: efavirenz 600 mg PO once daily

Protocol documents:
Clinical trial NCT01296815
Conditions: Kaposi´s Sarcoma
Keywords: Kaposi sarcoma HIV Bevacizumab
Sponsor: Centro de Investigación en. Enfermedades Infecciosas, Mexico
Start date: 2010-09-01; Completion date: 2013-12-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Kaposi sarcoma remains the most common malignancy among persons with HIV.

Lesions localized to the airway may cause bleeding, pain and dyspnea.

New therapeutic approaches for local disease are needed.

The purpose of this study is to compare the effectiveness of intralesional bevacizumab + HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with AIDS.

Detailed description:
Once disseminated disease is excluded, histologically confirmed HIV-positive patients with localized Kaposi's sarcoma of the airway will be randomized to receive HAART only or HAART + intralesional bevacizumab.

The primary outcome will be the size of lesions according to RECIST criteria. Patients in the HAART + bevacizumab arm will undergo series of 3 bevacizumab injections of 5 mg/cm3. Follow-up will be carried out through scheduled meetings for office setting examination every week for the first 8 weeks, then every 15 days for two months and finally every month for eight months.

Size of the lesions will be assessed by an independent observer and adverse events will be recorded.

Arms: arm 1: Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents arm 2: Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Patients received 3 intralesional injections of bevacizumab (Avastin, Genentech, San Francisco, California) in the target lesion every 2 weeks. Bevacizumab was injected using an insulin syringe in a submucosal plane. The volume injected was based on the size of the target lesion; the dose was 0.2 mL (5 mg) per cm2.
Interventions: intervention 1: Bevacizumab
Intervention descriptions: intervention 1: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3

Protocol documents:
Clinical trial NCT01299038
Conditions: Breast Cancer
Keywords: Crestor TFBP rosuvastatin
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2010-10-01; Completion date: 2013-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. Studies have demonstrated that increases in microparticles may contribute to the development of deep vein thrombosis in cancer patients. The purpose of this research study is to see if rosuvastatin lowers the number of tissue factor bearing microparticles in the blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis.

Detailed description:
* Since no one knows which of the study options are best, participants will be "randomized" into the following study groups: Group 1 (regular dose of rosuvastatin) or Group 2 (higher dose of rosuvastatin).
* Participants will take 1 pill of rosuvastatin every day for 4 weeks. Each 4 week period is called a cycle.
* Participants will have a physical exam at baseline, on day 1 of starting rosuvastatin, and 2 month visits. Laboratory tests will be taken at baseline, on day 1 of starting rosuvastatin, 6 weeks and 2 months.

Arms: arm 1: Rosuvastatin 20mg taken orally once a day for 4 weeks arm 2: Rosuvastatin 40mg taken orally once a day for 4 weeks
Interventions: intervention 1: rosuvastatin
Intervention descriptions: intervention 1: Taken orally once a day for 4 weeks

Protocol documents:
Clinical trial NCT01302366
Conditions: Myeloma
Keywords: multiple myeloma myeloma asymptomatic myeloma smoldering myeloma Asymptomatic (smoldering) myeloma
Sponsor: NYU Langone Health
Start date: 2011-02-01; Completion date: 2013-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study proposes to determine the clinical activity of this agent in patients with asymptomatic multiple myeloma. It is believed that TBL12 will help delay the onset of active multiple myeloma, with very few-if any- side effects.

Detailed description:
Multiple myeloma is a cancer that evolves from a state known as Monoclonal Gammopathy of Undetermined Significance (MGUS), defined by parameters of M spike and bone marrow. After evolution to myeloma, patients may be asymptomatic, that is, without any endorgan disease of hypercalcemia, renal insufficiency, anemia or bone lesions. In asymptomatic myeloma (ASxM), there is no standard therapy. Thalidomide has been tried in patients with ASxM but with significant toxicity. The patients with ASxM are evaluable in terms of paraprotein measurements.

TBL12 sea cucumber extract has been shown to have a number of antitumor properties preclinically, including antiangiogenesis and direct tumor cytotoxicity. TBL12 has been used by a number of patients as a food supplement without any toxicity detected. The investigators thus propose to determine the clinical activity of this agent in patients with ASxM. Patients will be given TBL12 at the dose of 2 units of 20 mL each twice per day daily until disease progression and the effects on the paraprotein noted. Clinical effects seen will be correlated with any in vitro changes in angiogenesis in patient bone marrow samples. The results of this trial may form the basis for the use of this nontoxic agent in patients with the prodrome of or with other early cancers.

Arms: arm 1: TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
Interventions: intervention 1: TBL12
Intervention descriptions: intervention 1: None

Protocol documents: