ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00483717
Conditions: Migraine
Keywords: Migraine Ketorolac
Sponsor: Egalet Ltd
Start date: 2007-07-01; Completion date: 2008-01-01
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

Detailed description:
Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

Arms: arm 1: Intranasal Placebo arm 2: Intranasal ketorolac tromethamine
Interventions: intervention 1: Ketorolac tromethamine intervention 2: Placebo
Intervention descriptions: intervention 1: 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride) intervention 2: Intranasal (IN) placebo

Protocol documents:
Clinical trial NCT00485472
Conditions: Osteoarthritis
Keywords: Osteoarthritis lacosamide VIMPAT
Sponsor: UCB Pharma
Start date: 2007-03-01; Completion date: 2008-01-01
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.

Detailed description:
LCM is an investigational drug that is being studied as a treatment in male and female patients who are diagnosed with osteoarthritis of the knee and require therapeutic doses of NSAIDs, COX-2 NSAIDs and/or paracetamol. This trial will be conducted exclusively in Europe.

The study has an adaptive 3-stage group sequential design.

The trial will last a total of 17 weeks. There will be a 2 week period to wean off current medication, followed by a 4 week period where the patient will receive placebo (inactive drug) or gradually increasing doses of LCM up to the target dose of 400mg/day. The target dose or placebo will be maintained for 8 weeks followed by a 1 week reduction period then a 2 week safety follow up period.

The last subject is expected to be enrolled in December 2007.

The study was terminated based on the outcome of the planned first interim analysis, which was performed as defined in the protocol in a subset of patients. It was decided not to continue the trial. No safety concerns were identified.

Arms: arm 1: lacosamide (LCM) arm 2: Placebo
Interventions: intervention 1: lacosamide intervention 2: Placebo
Intervention descriptions: intervention 1: 50 or 100mg tablet, 400mg daily, for 12 weeks intervention 2: 50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide

Protocol documents:
Clinical trial NCT00493038
Conditions: Sinusitis Bacterial Infections
Keywords: Treatment of acute bacterial rhinosinusitis
Sponsor: Bayer
Start date: 2006-02-01; Completion date: 2008-01-01
Enrollment: 293 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis

Detailed description:

Arms: arm 1: Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID)for 10 days arm 2: Amoxicillin/clavulanate 1000 mg tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
Interventions: intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Amoxicillin/Clavulanate
Intervention descriptions: intervention 1: Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days intervention 2: Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days

Protocol documents:
Clinical trial NCT00510510
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD glycopyrronium bromide antimuscarinic
Sponsor: Novartis
Start date: 2007-08-01; Completion date: 2008-01-01
Enrollment: 281 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: NVA237 100 µg intervention 2: Placebo intervention 3: NVA237 200 µg
Intervention descriptions: intervention 1: Dry powder inhalation once a day for up to 28 days intervention 2: Placebo to NVA237 dry powder inhalation once a day for up to 28 days intervention 3: Dry powder inhalation once a day for up to 28 days

Protocol documents:
Clinical trial NCT00511355
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2006-10-01; Completion date: 2008-01-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.

Detailed description:

Arms: arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive arm 2: Levonorgestrel and Ethinyl Estradiol Tablets (LNG-EE), 150 mcg LNG and 30 mcg EE
Interventions: intervention 1: NOMAC-E2 intervention 2: Levonorgestrel and Ethinyl Estradiol
Intervention descriptions: intervention 1: Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles. intervention 2: Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.

Protocol documents:
Clinical trial NCT00511433
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2006-10-01; Completion date: 2008-01-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.

Detailed description:

Arms: arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive arm 2: Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive
Interventions: intervention 1: NOMAC-E2 intervention 2: DRSP-EE
Intervention descriptions: intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28

for 6 consecutive 28-day menstrual cycles. intervention 2: Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.

Protocol documents:
Clinical trial NCT00514852
Conditions: Dry Eye Syndrome
Sponsor: Allergan
Start date: 2007-10-01; Completion date: 2008-01-01
Enrollment: 316 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear

Detailed description:

Arms: arm 1: Carboxymethylcellulose and Glycerin based artificial tear arm 2: Carboxymethylcellulose
Interventions: intervention 1: Carboxymethylcellulose and Glycerin based artificial tear intervention 2: Carboxymethylcellulose
Intervention descriptions: intervention 1: 1 to 2 drops into each eye as needed but at least twice daily intervention 2: 1 to 2 drops into each eye as needed but at least twice daily

Protocol documents:
Clinical trial NCT00516906
Conditions: Catheterization
Sponsor: Solventum US LLC
Start date: 2007-10-01; Completion date: 2008-01-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing

Detailed description:
Prospective, controlled, randomized, clinical trial comparing the 3M™ TegadermTM CHG (Chlorhexidine Gluconate) IV Securement Dressing (3M Healthcare, St Paul, MN) to a standard transparent dressing.

Arms: arm 1: Standard of Care Non-Antimicrobial Transparent Adhesive Dressing arm 2: Chlorhexidine gluconate antimicrobial transparent adhesive dressing
Interventions: intervention 1: Chlorhexidine gluconate intervention 2: Transparent Adhesive Dressing
Intervention descriptions: intervention 1: 2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear intervention 2: Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear

Protocol documents:
Clinical trial NCT00523549
Conditions: Hypertension Diastolic Dysfunction
Keywords: Hypertension systolic blood pressure diastolic dysfunction valsartan amlodipine
Sponsor: Novartis Pharmaceuticals
Start date: 2006-11-01; Completion date: 2008-01-01
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of treatment with valsartan + amlodipine to a target systolic blood pressure (SBP)\<130 mmHg compared to the Joint National Commission on the Treatment of Hypertension 7 recommended target SBP of \<140 mmHg on the intrinsic diastolic properties of the myocardium in patients with hypertension and echocardiographic evidence of diastolic dysfunction.

Detailed description:

Arms: arm 1: (Valsartan + Amlodipine to target SBP of \< 140 mmHg) arm 2: (Valsartan + Amlodipine to target SBP \< 130 mm Hg)
Interventions: intervention 1: valsartan intervention 2: amlodipine
Intervention descriptions: intervention 1: 160 mg or 320 mg tablets once a day intervention 2: 5 mg or 10 mg tablets once a day

Protocol documents:
Clinical trial NCT00525044
Conditions: Pharyngitis
Sponsor: Boehringer Ingelheim
Start date: 2007-08-01; Completion date: 2008-01-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.

Detailed description:
Male and female ambulant patients complaining of a sore throat caused by acute viral pharyngitis. Every patient may be included in the trial only once. A total of 250 male and female ambulant patients between the ages of 18 and 65 years will be enrolled. Approximately 8 centers will be recruited each enrolling approximately 30-32 patients.

Study Hypothesis:

The two-sided test hypothesis, that the results of the active treatment group with 20 mg Ambroxol and the placebo group do not differ with regard to the primary endpoint (null hypothesis (H0) will be tested against the alternative (H1) that they are not equal.

Comparison(s):

PRIMARY ENDPOINT:

Indication of pain on the VRS (PI)-verbal rating scale (pain intensity)-in the first 3 hours (the patient rates his/her pain on a six-point verbal rating scale).

SECONDARY ENDPOINT (S):

1. Patient's assessment of effectiveness and tolerance. The patient assesses the effectiveness and the tolerance of the test medicine for treating his sore throat at the end of the first and second day of treatment, by means of a verbal rating scale.
2. Participating doctors assessment of tolerance.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ambroxol intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00534794
Conditions: Allergic Conjunctivitis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-10-01; Completion date: 2008-01-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Elestat intervention 2: Pataday
Intervention descriptions: intervention 1: Elestat BID for 2 days intervention 2: Pataday QD for 2 days

Protocol documents:
Clinical trial NCT00539994
Conditions: Infections, Bacterial
Keywords: Altabax SB-275833 retapamulin nasal colonization PK tolerability safety efficacy
Sponsor: GlaxoSmithKline
Start date: 2007-09-01; Completion date: 2008-01-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3 or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S. aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19 intermittent carriers complete the study. Each eligible subject will participate in three screening visits, a treatment period, and two follow-up visits. Each subject's participation in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit. Subjects will participate in up to three screening visits to determine S. aureus culture positivity and colonization status.

Detailed description:

Arms: arm 1: 200mg BID retapamulin 5 days arm 2: 200mg BID placebo 5 days arm 3: 200mg BID retapamulin 3 days and placebo BID 2 days for a total of 5 days
Interventions: intervention 1: retapamulin intervention 2: Retapamulin intervention 3: Placebo
Intervention descriptions: intervention 1: 200mg BID retapamulin 3 days intervention 2: 200mg BID retapamulin 5 days intervention 3: 200mg BID placebo 5 days

Protocol documents:
Clinical trial NCT00545363
Conditions: Postmenopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2006-04-01; Completion date: 2008-01-01
Enrollment: 716 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will assess the impact of bone marker feedback (BMF), using serum carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams \[mg\] per oral \[po\]) in women with post-menopausal osteoporosis supported by patient-relationship program (PRP). Participants will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms: arm 1: Postmenopausal women will receive ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants, in this arm, will receive BMF at Month 3. BMF will be given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A "BMF-form" will be provided to the physicians to allow offering the bone marker result in an easy way. Participants will be informed if their results are within or outside of the desired range. In addition, participants will also supported by PRP, to be carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake. arm 2: Postmenopausal women will receive ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants will be supported by PRP, to be carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.
Interventions: intervention 1: Ibandronate
Intervention descriptions: intervention 1: Participants will receive ibandronate 150 mg QM orally for 6 months.

Protocol documents:
Clinical trial NCT00545844
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2007-04-01; Completion date: 2008-01-01
Enrollment: 313 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.

Detailed description:

Arms: arm 1: montelukast sodium
Interventions: intervention 1: montelukast sodium
Intervention descriptions: intervention 1: montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment

Protocol documents:
Clinical trial NCT00546052
Conditions: Hypertension Metabolic Disorder
Sponsor: Organon and Co
Start date: 2005-09-01; Completion date: 2008-01-01
Enrollment: 1738 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.

Detailed description:

Arms: arm 1: Losartan (MK0954) / Losartan + HCTZ (MK0954A)
Interventions: intervention 1: losartan potassium (+) hydrochlorothiazide
Intervention descriptions: intervention 1: All patients received Losartan 50mg at Visit 2 titrated to Losartan 100mg (if target BP not achieved) titrated to Losartan 100mg + HCTZ 12.5mg (if necessary) up to Losartan 100mg + HCTZ 25mg. Duration of treatment was one year.

Protocol documents:
Clinical trial NCT00556140
Conditions: Psychotic Depression
Sponsor: Massachusetts General Hospital
Start date: 2003-06-01; Completion date: 2008-01-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with psychotic major depression.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Everyone in this study will receive aripiprazole and an antidepressant called a selective serotonin reuptake inhibitor (SSRI). There is only one arm for this study.

Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia.

You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications that will be determined by the study doctor and you: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day.

Protocol documents:
Clinical trial NCT00558831
Conditions: Acne Vulgaris
Keywords: Acne
Sponsor: Northwestern University
Start date: 2007-10-01; Completion date: 2008-01-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the efficacy of a benzoyl peroxide 2.5% cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for the treatment of acne vulgaris.

Detailed description:
The purpose of this study is to compare the safety and efficacy of a benzoyl peroxide 2.5% cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for mild to moderate acne vulgaris.

Arms: arm 1: Benzoyl Peroxide (BP) 2.5% arm 2: Benzyol Peroxide 2.5% plus moisturizing lotion
Interventions: intervention 1: Benzoyl Peroxide intervention 2: Moisturizing Lotion
Intervention descriptions: intervention 1: Benzoyl Peroxide 2.5% intervention 2: None

Protocol documents:
Clinical trial NCT00566735
Conditions: Major Depression Bipolar Depression Schizoaffective Disorder
Sponsor: Massachusetts General Hospital
Start date: 2004-07-01; Completion date: 2008-01-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat problems with thinking and memory caused by electroconvulsive therapy (ECT).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Razadyne intervention 2: Placebo
Intervention descriptions: intervention 1: The starting dose of study medication is 4 mg twice a day intervention 2: 4 mg, 2 times a day

Protocol documents:
Clinical trial NCT00569868
Conditions: MULTIPLE MYELOMA
Keywords: PLASMACYTOMA
Sponsor: University of Arkansas
Start date: 2005-08-01; Completion date: 2008-01-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.

Detailed description:
Cardiovascular complications during the treatment of patients with multiple myeloma are not uncommon, (10%) and the frequency clearly increases with the use of regimens containing thalidomide in combination with glucocorticosteroids or chemotherapy especially adriamycin. Even with prophylactic anticoagulation, DVT still occurs in 10% of such patients. The use of full anticoagulation raises considerable concern of bleeding especially during the post chemotherapy thrombocytopenic period. We observed no thromboembolic episodes when Velcade was added to thalidomide and adriamycin containing chemotherapy.

Therefore, we would like to investigate this protective antithrombotic effect of VELCADE in a malignancy associated with a hypercoagulable state in a group of 10 patients with Relapsed/Refractory Multiple Myeloma.

Arms: arm 1: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days. After you have gone off study, you will be followed every three months for approximately 2 years.

Each cycle will consist of 3 weeks (21 days) according to the schedule below.

DRUG ROUTE DOSE DAYS Velcade IV 1.3 mg/m2 1,4,8, and 11 This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a two cycles.
Interventions: intervention 1: Velcade
Intervention descriptions: intervention 1: Except for the two PCR-based genotyping assays, which will be conducted only on baseline samples, tests will be assessed at baseline, 1-3 hours after the first dose of Velcade day 1 and on day 11 of the first cycle of Velcade.

The platelet Aggregation Test will be done only if Platelet count is 100 000.

Protocol documents: