ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00520676
Conditions: Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-10-01; Completion date: 2010-07-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the combination of pemetrexed and carboplatin with the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4 toxicity in previously untreated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: Drug: pemetrexed 500 milligrams per square meter (mg/m\^2), intravenous (IV), every (q) 21 days x 6 cycles maximum

Drug: carboplatin Area Under the Curve (AUC) 5 milligram\*minute/milliLiter (mg\*min/mL), IV, q 21 days x 6 cycles maximum arm 2: Drug: docetaxel 75 mg/m\^2, IV, q 21 days x 6 cycles maximum

Drug: carboplatin AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum
Interventions: intervention 1: pemetrexed intervention 2: docetaxel intervention 3: carboplatin
Intervention descriptions: intervention 1: 500 mg/m\^2, IV, q 21 days x 6 cycles maximum intervention 2: 75 mg/m\^2, IV, q 21 days x 6 cycles maximum intervention 3: AUC 5 mg\*min/mL, IV, q 21 days x 6 cycles maximum

Protocol documents:
Clinical trial NCT00523991
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2007-04-01; Completion date: 2010-07-01
Enrollment: 457 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

Detailed description:

Arms: arm 1: Oral inhalation once daily of placebo matching tiotropium via handihaler arm 2: Oral inhalation once daily of 18mcg tiotropium via handihaler
Interventions: intervention 1: tiotropium intervention 2: Placebo
Intervention descriptions: intervention 1: Oral inhalation once daily of 18mcg tiotropium via handihaler intervention 2: Oral inhalation once daily of placebo matching tiotropium via handihaler

Protocol documents:
Clinical trial NCT00528372
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2007-09-01; Completion date: 2010-07-01
Enrollment: 1067 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated with medication or have been taking medication for less than 24 weeks since their original diabetes diagnosis. The safety of this treatment will also be studied.

Detailed description:
All eligible participants will receive single-blind placebo medication during the 2-week lead-in period. All participants may receive additional open-label treatment with metformin, 500-2000 mg, as needed for rescue, based on protocol specific criteria.

Arms: arm 1: Participants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. arm 2: Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. arm 3: Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. arm 4: Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. arm 5: Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. arm 6: Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. arm 7: Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. arm 8: Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. arm 9: Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks.
Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin placebo intervention 3: Metformin
Intervention descriptions: intervention 1: Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks intervention 2: Tablets, oral, 0 mg, once daily in the morning or evening for up to 102 weeks intervention 3: None

Protocol documents:
Clinical trial NCT00529802
Conditions: Carcinoma, Renal Cell
Keywords: metastatic renal cell carcinoma cancer
Sponsor: University of Chicago
Start date: 2007-09-01; Completion date: 2010-07-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.

Detailed description:

Arms: arm 1: All patients were to receive 10mg everolimus (RAD001) daily.
Interventions: intervention 1: RAD001
Intervention descriptions: intervention 1: take 2 tablets of RAD001 once a day by mouth (10 mg per day)

Protocol documents:
Clinical trial NCT00537979
Conditions: Secondary Hyperparathyroidism Dialysis
Keywords: Dialysis Hyperparathyroidism Zemplar
Sponsor: Abbott
Start date: 2007-09-01; Completion date: 2010-07-01
Enrollment: 147 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.

Detailed description:

Arms: arm 1: ABT-358 Zemplar arm 2: ABT-358 Zemplar
Interventions: intervention 1: Paricalcitol injection intervention 2: Paricalcitol capsules
Intervention descriptions: intervention 1: Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly intervention 2: Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly

Protocol documents:
Clinical trial NCT00589667
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer GEMCITABINE PEMETREXED ALTIMA epidermoid/squamous cell carcinoma pharynx larynx paranasal sinus head/neck squamous cell carcinoma
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2006-09-01; Completion date: 2010-07-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the combination of 2 chemotherapy drugs called pemetrexed and gemcitabine might be effective treatment for head and neck squamous cell cancer. The researchers want to find out what effects, good and/or bad, that this treatment has on head and neck cancer.

Detailed description:
Pemetrexed (500 mg/m2) and gemcitabine (1250 mg/m2) will be given together on Days 1 and 15 of a 28 day cycle in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Patients will not have received more than 2 prior chemotherapy regimens in the recurrent/metastatic disease setting. Vitamin B12 and folate supplementation will be administered per standard guidelines for pemetrexed chemotherapy.

The primary endpoint is the objective radiologic response rate. Radiologic imaging of evaluable disease will take place after every 2 cycles. Patients may remain on study until progression of disease or unacceptable toxicity.

Arms: arm 1: Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
Interventions: intervention 1: Pemetrexed plus Gemcitabine
Intervention descriptions: intervention 1: Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle. Vitamin supplementation will be as follows: Vitamin B12: 1000 µg IM injection no less than 1 week prior to the first dose of pemetrexed, and continuing approximately every 9 weeks until 3 weeks after the last dose of pemetrexed.

Folic acid: The preferred oral daily dose of folic acid is 350 to 1000 µg. Daily folate supplementation begins no less than 1 week prior to the first dose of pemetrexed and continues until 3 weeks after the last dose of pemetrexed.

For rash prophylaxis, dexamethasone (4 mg po twice per day) should be taken on the day before, the day of, and the day after each dose of pemetrexed unless clinical contraindications exist.

Protocol documents:
Clinical trial NCT00590395
Conditions: Cholecystitis
Keywords: Cholecystitis FDG PET/CT HIDA scan
Sponsor: Alan D. Waxman, M.D.
Start date: 2007-07-01; Completion date: 2010-07-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot study to investigate the ability of fluorodeoxyglucose-positron emission tomography (FDG-PET) and Positron emission tomography-computed tomography (PET/CT) as a direct method of detecting infection and/or inflammation of the gallbladder.

Detailed description:
Hepatobiliary iminodiacetic acid (HIDA) scan scintigraphy is a nuclear medicine scan used to evaluate patients suspected of having acute cholecystitis (infection/inflammation of the gallbladder). Because it is an indirect test that looks for obstruction of the cystic duct structure, there are many causes for a false-positive HIDA study. There is a need for a more sensitive and specific test that can accurately assess gallbladder infection and/or inflammation.

The purpose of this study is to determine the effectiveness of fluorodeoxyglucose (FDG) as a direct means of detecting patients with acute cholecystitis. FDG is an imaging agent that has previously been shown to accumulate in areas of infection and/or inflammation. The location and intensity of FDG accumulation in the body can be detected with a camera system called a "positron emission tomography" (PET) camera. In theory, this test should be effective in detecting acute infection and/or inflammation of the gallbladder.

Consenting participants will receive injection of FDG one hour prior to the FDG-PET/CT examination. The participant will then be imaged using a PET/CT machine, which is a special camera system that is capable of performing both a PET and CT scan at the same time. A CT scan is an anatomical imaging test and, for this research study, will mainly be used to localize the area of 18FDG accumulation recorded by the PET scan. The examination will take approximately one hour.

Arms: arm 1: 19 patients with suspected acute cholecystitis and a positive HIDA will be included in the study. This is purposely a highly selective population which most likely will have surgical proof of the findings. Subjects will receive an FDG PET/CT exam to determine the presence of gallbladder inflammation/infection(cholecystitis). Please note that 18FDG is an FDA approved radiopharmaceutical.
Interventions: intervention 1: 18FDG (an FDA-approved radiopharmaceutical)
Intervention descriptions: intervention 1: Route: Intravenous, Dosage: 5-10mCi, frequency: Single Administration

Protocol documents:
Clinical trial NCT00610155
Conditions: Pain
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-09-01; Completion date: 2010-07-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is a methodology study designed to discover whether a brain imaging technology is a better way of compare the relative sensitivities of fMRI and subjective psychometric assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical study design.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: Pregabalin intervention 3: Tramadol SR
Intervention descriptions: intervention 1: BID intervention 2: Dose 75 mg titrated to 150 mg, bid intervention 3: Dose 50mg titrated to 200 mg, bid

Protocol documents:
Clinical trial NCT00618332
Conditions: Seasonal Allergic Rhinitis
Sponsor: University of Chicago
Start date: 2008-04-01; Completion date: 2010-07-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.

Detailed description:

Arms: arm 1: 2 weeks of treatment arm 2: 2 weeks of treatment
Interventions: intervention 1: mometasone furoate nasal spray intervention 2: placebo
Intervention descriptions: intervention 1: 2 puffs in each nostril once a day for 2 weeks intervention 2: 2 puffs in each nostril once a day for 2 weeks

Protocol documents:
Clinical trial NCT00641745
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Lurasidone Schizophrenia Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2008-03-01; Completion date: 2010-07-01
Enrollment: 629 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is safe and tolerable long term among clinically stable patients. The study will also assess the long term effectiveness of lurasidone as compared to an active comparator.

Detailed description:

Arms: arm 1: Lurasidone arm 2: Risperidone
Interventions: intervention 1: Lurasidone HCl intervention 2: Risperidone
Intervention descriptions: intervention 1: 40 - 120mg per day intervention 2: Risperidone

Protocol documents:
Clinical trial NCT00669279
Conditions: Hypertension
Sponsor: University of Florida
Start date: 2008-04-01; Completion date: 2010-07-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine whether atenolol or controlled release carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure measured in the aorta, a large blood vessel carrying blood away from the heart, may be a better measure of the harmful effects of high blood pressure on the body's organs. In the past, blood pressure has only been measured in the arms. However, blood pressure in the arms may not accurately reflect the blood pressure in the aorta and thus may mislead doctors treating high blood pressure. For this reason, we are testing whether two different medications for blood pressure, both in a class called beta blockers, have similar effects on blood pressure in the arm and aorta.

Detailed description:
Carvedilol reduces aortic wave reflection and improves left ventricular/vascular coupling: a comparison with atenolol (CENTRAL Study) is a prospective, open-label, comparative, randomized control trial that evaluated brachial and central hemodynamic profiles in patients taking atenolol or controlled-release carvedilol.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Carvedilol CR intervention 2: Atenolol
Intervention descriptions: intervention 1: Dose titration of 20mg by mouth once daily for 1 week, then 40mg by mouth once daily for 1 week, then 80mg by mouth once daily for 2 weeks intervention 2: Dose titration of 25mg by mouth once daily for 1 week, then 50mg by mouth once daily for 1 week, then 100mg by mouth once daily for 2 weeks

Protocol documents:
Clinical trial NCT00685880
Conditions: Thumb Carpometacarpal Joint Osteoarthritis
Keywords: thumb carpo metacarpal joint osteoarthritis prolotherapy intra articular steroid hand therapy
Sponsor: Mayo Clinic
Start date: 2008-05-01; Completion date: 2010-07-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.

Detailed description:
Dextrose prolotherapy has been shown to decrease anterior cruciate ligament (ACL) laxity and decrease knee joint pain. Similar to ACL laxity leading to knee osteoarthritis, laxity of the "beak" ligament can lead to worsening thumb CMC osteoarthritis. We hypothesize that dextrose intra-articular prolotherapy will have similar results in treating the pain and instability related to symptomatic thumb CMC osteoarthritis. This will be a prospective randomized double blind comparison study comparing Celestone to Dextrose intra-articular injections as adjuncts to hand therapy for the treatment of symptomatic thumb CMC osteoarthritis. Twenty patients will be randomized to each treatment arm to provide enough power to show a 20% change in visual analogue scale (VAS) for pain to be significant. We will utilize the ultrasound guided injection protocol described by the co-investigators for both treatment arms to ensure proper placement of the respective solutions. We will measure various grip strengths, and VAS pain scales prior to the first injection, prior to the second injection at 6 weeks and at the final visit at 6 months. A telephone follow-up with pain scale will be administered at 3 months. A Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire measuring upper extremity functional impairment will be obtained at initial and final visits.

Arms: arm 1: Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. arm 2: Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
Interventions: intervention 1: Prolotherapy (10% dextrose solution) intervention 2: Betamethasone
Intervention descriptions: intervention 1: Dextrose diluted with sterile water. intervention 2: CELESTONE® SOLUSPAN® \* (betamethasone injectable suspension) Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. Subjects will receive a 0.25 to 0.5 mL Celestone Soluspan injection.

Protocol documents:
Clinical trial NCT00687193
Conditions: Arthritis, Rheumatoid
Keywords: Phase 2 monotherapy in Japan
Sponsor: Pfizer
Start date: 2009-03-01; Completion date: 2010-07-01
Enrollment: 318 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Placebo intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550 intervention 6: CP-690,550
Intervention descriptions: intervention 1: Placebo BID, 3 blinded tablets administered BID for 12 weeks intervention 2: 10mg BID, 3 blinded tablets administered BID for 12 weeks intervention 3: 15mg BID, 3 blinded tablets administered BID for 12 weeks intervention 4: 1mg BID, 3 blinded tablets administered BID for 12 weeks intervention 5: 3mg BID, 3 blinded tablets administered BID for 12 weeks intervention 6: 5mg BID, 3 blinded tablets administered BID for 12 weeks

Protocol documents:
Clinical trial NCT00692913
Conditions: Osteoporosis
Sponsor: Organon and Co
Start date: 2008-06-01; Completion date: 2010-07-01
Enrollment: 515 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

Detailed description:

Arms: arm 1: alendronate sodium (+) cholecalciferol arm 2: Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Interventions: intervention 1: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol) intervention 2: Calcium Supplement 500 mg intervention 3: Referred-Care Model
Intervention descriptions: intervention 1: FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52). intervention 2: Calcium supplied locally by the investigator (containing 500 mg

calcium supplement) daily for 52 weeks (unless the patient's dietary intake of

calcium exceeds 1000 mg per day). intervention 3: Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

Protocol documents:
Clinical trial NCT00699348
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-07-01; Completion date: 2010-07-01
Enrollment: 351 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent \[ESA\] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Intervention descriptions: intervention 1: Intravenous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms every 4 weeks for 24 weeks.

Protocol documents: