ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00832520
Conditions: Advanced Cancer
Keywords: Advanced cancer weight loss Remeron body weight
Sponsor: New Mexico Cancer Research Alliance
Start date: 2008-11-01; Completion date: 2011-06-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if remeron, also called mirtazapine, can help you prevent weight loss while on treatment for your cancer. Remeron is currently used to treat depression and has not been approved by the Food and Drug Administration for use to treat weight loss.

Detailed description:
Weight loss in cancer patients can be the result of inadequate intake or absorption of nutrients and/or tumor-induced weight loss due to metabolic changes the tumor is creating in the body (1). Inadequate intake resulting in a starvation state can simply be the result of eating less due to depression, nausea/vomiting, feelings of fullness, and taste changes (2). Though not intentional the weight loss caused by these symptoms can be explained and reversed by increasing intake of nutrients. Unintentional weight loss induced by the tumor can be caused by multiple physiological factors that increase the catabolism of muscle and fat and increased nutrient intake alone may not reverse the weight loss. Unintentional weight loss can predict a poor prognosis in cancer patients which is most likely due to decreased doses of treatment (3-5).

Usual care for weight loss in cancer patients varies among practitioners and can include nutrition counseling by a registered dietitian or by the practitioner themselves. Treatment can vary from counseling patients to increase intake of nutrient dense foods to prescribing medications in order to improve appetite or mood, to decrease feelings of fullness, or to control nausea/vomiting, etc. (6). However, these interventions do not always work. For varied reasons not all patients are able to improve their oral intake of food items and in patients with tumor induced weight loss increased oral intake does not improve the metabolic changes.

Anti-depressant medications have weight related side effects (7-9). Mirtazapine has been shown to have side effects of increased appetite and increased weight in cancer subjects studied for use with depression and nausea. (10-13). These results appeared to range from changes in appetite to changes seen in metabolic processes such as changes in the cytokine system to reduce inflammation seen in cachectic patients. Therefore, using mirtazapine in cancer patients even without depression may help to stop unwanted weight loss and increase survival by allowing patient to complete prescribed treatment.

Arms: arm 1: Mirtazapine 15 mg orally at bed time for 8 weeks
Interventions: intervention 1: Remeron (mirtazapine)
Intervention descriptions: intervention 1: Mirtazapine 15 mg orally at bed time. Patients with a creatinine clearance \< 50% or a bilirubin or transaminases \> twice the upper limit of normal will take a 7.5 mg dose.

* Drug Administration: Drug will be administered orally, every day for a period of 8 weeks
* Dose modifications: None

Protocol documents:
Clinical trial NCT00856726
Conditions: Control
Sponsor: University of Miami
Start date: 2009-02-01; Completion date: 2011-06-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators aim to study potential racial differences in renal phosphorus handling by provocatively testing urinary phosphorus excretion using parathyroid hormone infusions in healthy white volunteers compared to healthy black volunteers.

Detailed description:

Arms: arm 1: (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours
Interventions: intervention 1: 1-34 parathyroid infusion
Intervention descriptions: intervention 1: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours

Protocol documents:
Clinical trial NCT00861341
Conditions: Diabetes Platelet Function Healthy
Keywords: Pioglitazone Thiazolidinediones Platelet Function Platelet aggregation Diabetic Aspirin.
Sponsor: University of Rochester
Start date: 2008-12-01; Completion date: 2011-06-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine how pioglitazone and aspirin affect platelets in the blood of diabetic and non-diabetic subjects. Platelets are small cells in the blood that help with blood clotting. Pioglitazone is a drug that is used to lower blood sugar and fats by helping the body to use insulin correctly. Pioglitazone is presently used to treat diabetes but has not been approved for non-diabetics. This study will determine whether pioglitazone reduces the activity of platelets in people who are or are not also taking aspirin.

Detailed description:
Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.

Arms: arm 1: Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
Interventions: intervention 1: Aspirin intervention 2: Pioglitazone
Intervention descriptions: intervention 1: 81 mg intervention 2: 30mg Pioglitazone x1

Protocol documents:
Clinical trial NCT00887315
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC Metastatic Stage IV NSCLC Limited Volume Stage IV Non-small Cell Lung Cancer
Sponsor: University of Chicago
Start date: 2009-04-01; Completion date: 2011-06-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary goal of the study is to assess the overall survival of the addition of hypofractionated image guided radiotherapy concurrently with Docetaxel and cisplatin. Survival will be assessed at 1 year from the date of study enrollment to date of death.

Detailed description:

Arms: arm 1: Chemotherapy only arm 2: Chemotherapy and hypofractionated image guided radiotherapy
Interventions: intervention 1: Docetaxel and cisplatin intervention 2: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy
Intervention descriptions: intervention 1: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV repeated every 21 days for 2 additional cycles. For patients randomized to group 1, the chemotherapy is identical to that administered for the first 2 cycles intervention 2: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV for 2 cycles along with hypofractionated radiotherapy to all known sites of disease

Protocol documents:
Clinical trial NCT00887549
Conditions: Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2009-04-01; Completion date: 2011-06-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this research is to determine if there is a link between TS production and how well patients respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much TS they produce.

Detailed description:
All patients on this study will receive 4 intravenous injections of the chemotherapy drugs pemetrexed and cisplatin (with each injection approximately 3 weeks apart). Patients who complete 4 such injections and respond well to their treatment may continue to receive an injection of chemotherapy drug pemetrexed (approximately every 3 weeks). In general terms, treatment will last until either the patient or the doctor decides that there is no clear benefit in continuing with the treatment.

TS levels will be measured from the tumour sample used to make the original diagnosis of NSCLC.

Arms: arm 1: None
Interventions: intervention 1: pemetrexed intervention 2: cisplatin
Intervention descriptions: intervention 1: Induction Therapy: 500 milligrams per square meter (mg/m\^2), intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: 500 milligrams per square meter (mg/m\^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs intervention 2: Induction Therapy: 75 mg/m\^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles

Protocol documents:
Clinical trial NCT00889421
Conditions: Uveitis
Keywords: uveitis apremilast
Sponsor: Oregon Health and Science University
Start date: 2009-11-01; Completion date: 2011-06-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.

Detailed description:

Arms: arm 1: Patients receiving apremilast.
Interventions: intervention 1: Apremilast
Intervention descriptions: intervention 1: oral dose of 30 mg BID for 6 months

Protocol documents:
Clinical trial NCT00903877
Conditions: Fibromyalgia
Sponsor: Stanford University
Start date: 2009-05-01; Completion date: 2011-06-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia. Determine the feasibility and promise of an appropriately powered future prospective randomized controlled study of using T3 (the active form of thyroid hormone) for the treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and promise of conducting a prospective controlled study in the future.

Detailed description:

Arms: arm 1: Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
Interventions: intervention 1: T3
Intervention descriptions: intervention 1: Patients receive T3 in a dose of 25mcg and 50mcg

Protocol documents:
Clinical trial NCT00913133
Conditions: Thrombosis
Keywords: Anticoagulation Prophylaxis Desirudin Direct thrombin inhibitor Heparin-induced thrombocytopenia
Sponsor: Canyon Pharmaceuticals, Inc.
Start date: 2010-03-01; Completion date: 2011-06-01
Enrollment: 516 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.

Detailed description:
Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.

Arms: arm 1: desirudin 15 mg twice daily for a minimum of 5 days
Interventions: intervention 1: Desirudin
Intervention descriptions: intervention 1: Desirudin SC 15mg q12h

Protocol documents:
Clinical trial NCT00915772
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2009-06-01; Completion date: 2011-06-01
Enrollment: 567 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46

Detailed description:

Arms: arm 1: Linagliptin low dose + metformin 500 mg, bid arm 2: Linagliptin low dose + metformin 1000 mg bid arm 3: Metformin 1000 mg bid
Interventions: intervention 1: Linagliptin + metformin intervention 2: Linagliptin+metformin intervention 3: Metformin
Intervention descriptions: intervention 1: Linagliptin tablet low dose + metformin tablet 500 mg bid intervention 2: Linagliptin low dose tablet + metformin 1000 mg tablet bid intervention 3: Metformin 1000 mg tablet bid

Protocol documents:
Clinical trial NCT00929162
Conditions: Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Keywords: ovarian cancer chemotherapy sensitive ZD4054
Sponsor: AstraZeneca
Start date: 2009-06-01; Completion date: 2011-06-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare progression-free survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination with carboplatin+paclitaxel.

Detailed description:

Arms: arm 1: ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks arm 2: Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
Interventions: intervention 1: ZD4054 Zibotentan intervention 2: Paclitaxel intervention 3: Carboplatin intervention 4: Placebo
Intervention descriptions: intervention 1: 10 mg oral tablets once daily intervention 2: 175mg/m2 IV on day 1 every 3 weeks intervention 3: Carboplatin AUC of 5.0 IV on day 1 every 3 weeks intervention 4: matching placebo for ZD4054 10 mg

Protocol documents:
Clinical trial NCT00934050
Conditions: Alzheimer's Disease
Sponsor: OPKO Health, Inc.
Start date: 2009-06-01; Completion date: 2011-06-01
Enrollment: 103 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ELND005 (scyllo-inositol)
Intervention descriptions: intervention 1: Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks

After 15Dec2009: ELND005 250 mg PO BID for 48 weeks

Protocol documents:
Clinical trial NCT00934947
Conditions: Burns Pain
Keywords: Burns Pain
Sponsor: University of North Carolina, Chapel Hill
Start date: 2009-07-01; Completion date: 2011-06-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the ability of propranolol to decrease pain and improve recovery in burn patients with a common genotype.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Propranolol intervention 2: Placebo intervention 3: Propanolol
Intervention descriptions: intervention 1: 40 mg intervention 2: sugar pill intervention 3: 120 mg twice per day

Protocol documents:
Clinical trial NCT00937495
Conditions: Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2009-06-01; Completion date: 2011-06-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with advanced soft tissue sarcoma. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the objective response rate in patients with advanced soft tissue sarcoma treated with vorinostat and bortezomib.

SECONDARY OBJECTIVES:

I. Characterize the toxicity of this regimen in these patients. II. Evaluate the progression-free survival and median overall survival of patients treated with this regimen.

OUTLINE:

Patients receive vorinostat orally (PO) once daily on days 1-14. Patients also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 6 months for up to 2 years. (As of Addendum 7, patient follow-up no longer required.)

Arms: arm 1: Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: vorinostat intervention 2: bortezomib
Intervention descriptions: intervention 1: 400 mg given PO intervention 2: 1.3 mg/m\^2 given IV

Protocol documents:
Clinical trial NCT00945672
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease amyloid imaging antibody
Sponsor: Pfizer
Start date: 2009-08-06; Completion date: 2011-06-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: PF-04360365 10 mg/kg intervention 2: PF-04360365 7.5 mg/kg intervention 3: placebo
Intervention descriptions: intervention 1: 10 mg/kg every 90 days (5 total doses) intervention 2: 10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses) intervention 3: placebo administered every 90 days or monthly to match experimental treatment arms.

Protocol documents:
Clinical trial NCT00947882
Conditions: Lower Urinary Tract Symptoms (LUTS)
Sponsor: Ferring Pharmaceuticals
Start date: 2009-08-01; Completion date: 2011-06-01
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Degarelix 10 mg intervention 3: Degarelix 20 mg intervention 4: Degarelix 30 mg
Intervention descriptions: intervention 1: Mannitol 50 mg/mL solution intervention 2: 10 mg degarelix, 40 mg/mL solution intervention 3: 20 mg degarelix, 40 mg/mL solution intervention 4: 30 mg degarelix, 40 mg/mL solution

Protocol documents:
Clinical trial NCT00952588
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukaemia, AML
Sponsor: AstraZeneca
Start date: 2009-07-01; Completion date: 2011-06-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.

Detailed description:

Arms: arm 1: AZD1152 1200 mg, iv, 7 day infusion monotherapy arm 2: LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
Interventions: intervention 1: AZD1152 intervention 2: LDAC
Intervention descriptions: intervention 1: 1200 mg, iv, 7 day infusion intervention 2: 20 mg, sc, bd, 10 days

Protocol documents:
Clinical trial NCT00955552
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis (OA) knee
Sponsor: Eurofarma Laboratorios S.A.
Start date: 2010-08-01; Completion date: 2011-06-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.

Detailed description:
To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form.

Some eligibility criteria:

Osteoarthritis of the knee confirmed by radiological examination; Visual analogue scale (VAS) \> 40 mm; Clinical diagnosis of pain and functional limitation

Arms: arm 1: glucosamine hydrochloride 500 mg and chondroitin sulfate 400 mg (Cosamin DS®, Nutramax Laboratories).

The medication was supplied as capsules, with the daily dose of 3 capsules. arm 2: Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal The medication was supplied as capsules, with the daily dose of 3 capsules.
Interventions: intervention 1: Glucosamine sulphate and chondroitin sulphate association intervention 2: Cosamin DS® (Nutramax)
Intervention descriptions: intervention 1: glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal intervention 2: oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days

Protocol documents:
Clinical trial NCT00983801
Conditions: Stomach Neoplasms
Sponsor: R-Pharm
Start date: 2009-11-01; Completion date: 2011-06-01
Enrollment: 58 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine whether ixabepilone is effective in the treatment of unresectable or metastatic gastric cancer in Asian participants.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ixabepilone
Intervention descriptions: intervention 1: Vial, Injection, Intravenous (IV), 40 mg/m\^2, Every 21 days, Up to 8 cycles or until disease progression or intolerable toxicity. Additional treatment was given in agreement by both the investigator and sponsor. Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day (3 week) cycle provided the participant met the retreatment criteria.

Protocol documents:
Clinical trial NCT00991276
Conditions: Restless Legs Syndrome
Keywords: restless legs syndrome RLS polysomnography PSG sleep disturbance patient reported outcome
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-12-01; Completion date: 2011-06-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: pregabalin intervention 2: placebo intervention 3: pramipexole
Intervention descriptions: intervention 1: capsules; 300 mg once-per-day; 4 weeks of treatment intervention 2: capsules; 0 mg once-per-day; 4 weeks of treatment intervention 3: capsules; 0.5 mg once-per-day; 4 weeks of treatment

Protocol documents: