ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00355342
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Osteoporosis Bone Mineral Density Osteopenia Chronic Obstructive Pulmonary Disease COPD
Sponsor: GlaxoSmithKline
Start date: 2004-04-28; Completion date: 2007-09-06
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms: arm 1: Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline. arm 2: Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication.
Interventions: intervention 1: Salmeterol 50 mcg BID intervention 2: Fluticasone Propionate/Salmeterol 250/50 mcg BID intervention 3: DISKUS inhaler
Intervention descriptions: intervention 1: Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening. intervention 2: Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening. intervention 3: Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period.

Protocol documents:
Clinical trial NCT00258206
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2004-12-01; Completion date: 2007-09-07
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with cyclophosphamide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with cyclophosphamide works in treating patients with high risk, refractory, or relapsed multiple myeloma.

Detailed description:
OBJECTIVES:

* Determine the effect of rituximab and high-dose cyclophosphamide on the growth of myeloma stem cells in patients with high-risk, refractory, or relapsed multiple myeloma.

OUTLINE: Patients receive rituximab IV on days -10 and -7; once weekly for 4 weeks (after completion of high-dose cyclophosphamide); and then once in months 3, 6, 9, and 12. Patients also receive high-dose cyclophosphamide on days -3 to 0.

PROJECTED ACCRUAL: Not specified.

Arms: arm 1: Rituximab 375 mg/m\^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m\^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m\^2 once each during months 3, 6, 9, and 12
Interventions: intervention 1: rituximab intervention 2: cyclophosphamide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00493831
Conditions: Cigarette Smoking
Keywords: smoking reduction inflammation harm reduction lipid biomarkers
Sponsor: University of Nebraska
Start date: 2005-08-23; Completion date: 2007-09-09
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this prospective, open-label, clinical trial is to establish the feasibility and validity of exhaled breath condensate (EBC) biomarkers for use in studies designed to evaluate harm reduction strategies of smoking. This will be accomplished by measuring selected markers in EBC believed related to the pathogenesis of lung disease before and after a smoking cessation intervention.

Detailed description:
Twenty subjects will be accrued in three groups based on smoking habit: 10-20, 20-30 and \>30 cigarettes/day. Eligibility criteria include male and female cigarette smokers ≥19 years of age, who are able to give informed consent, able to exhale into Eco Screen instrument for 15-20 minutes. All must be willing to make a serious quit attempt and be willing to use nicotine replacement therapy.

Subjects will be excluded if any of the following are present: regular use of anti-inflammatory medication; presence of any inflammatory disease of the respiratory tract including moderate or worse COPD (FEV1 \< 80% predicted and FEV1/FVC ratio \< 0.7). Subjects with normal lung function who meet criteria for diagnosis of chronic bronchitis will be excluded. Subjects with stable medical conditions, excluding inflammatory lung disease, will be permitted to participate, providing anti-inflammatory therapies are not used regularly and providing there has been no change in their clinical status in the two months prior to beginning the study.

Upon entering into the study, subjects will establish a quit date and will be treated with nicotine replacement therapy (NRT) products based on individual preference and will receive smoking cessation counseling. They will then be seen at 12 visits over the course of 25 weeks.

Evaluations will include vital signs, interval smoking history, food frequency questionnaire, exhaled carbon monoxide, blood drawn for chemistry and CBC, peripheral blood harvested and serum aliquoted and saved for future biochemical analysis, urine sample for isoprostane, pregnancy test for females, and exhaled breath condensate. Some visits may also include spirometry with and with out bronchodilators, 24 hour urine collections for NNAL and NNAL-glc quantification, health status assessed using St. George's Respiratory Questionnaire, the Functional Assessment of Chronic Illness Therapy - Fatigue, the Leicester Cough Questionnaire, the Clinical COPD Questionnaire and smoking related symptoms assessed using the Breathlessness, Cough, and Sputum Scale.

Arms: arm 1: any form of nicotine replacement would be allowed at subject discretion
Interventions: intervention 1: nicotine polacrilex, transdermal system or inhaler
Intervention descriptions: intervention 1: on label use of Nicotine replacement therapy (NRT)

Protocol documents:
Clinical trial NCT00197145
Conditions: Infection, Human Immunodeficiency Virus I
Keywords: HIV-1 GW873140 CCR5 antagonist experienced
Sponsor: ViiV Healthcare
Start date: 2005-07-21; Completion date: 2007-09-11
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist GW873140 or placebo in combination with an optimized background regimen in treatment-experienced HIV-infected subjects with R5-tropic virus

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: GW873140
Intervention descriptions: intervention 1: 400 mg twice daily

Protocol documents:
Clinical trial NCT00363480
Conditions: Asthma
Keywords: Asthma Asthma Control Test SERETIDE
Sponsor: GlaxoSmithKline
Start date: 2006-05-17; Completion date: 2007-09-14
Enrollment: 221 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test (ACT) will be used to detect differences in the level of asthma control during treatment. The study aims to show a correlation between improvements of ACT und the level of asthma control which will be reached by the patients.

The aim of the study is to show that most of symptomatic asthma patients can reach 'well controlled asthma' with SFC. We get information about ACT in daily practice and physicians are trained to use the asthma control test as a screening tool and for follow up of asthma management. Correlations are expected between the improvements in ACT, Quality of Life and asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.

Detailed description:

Arms: arm 1: Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Interventions: intervention 1: Salmeterol/Fluticasone 50/250 mcg intervention 2: Salbutamol 100 mcg intervention 3: DISKUS™ powder inhalers
Intervention descriptions: intervention 1: Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers. intervention 2: This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. intervention 3: Participant received salmeterol and fluticasone using DISKUS™ powder inhalers.

Protocol documents:
Clinical trial NCT00249821
Conditions: Small Gestational Age (SGA)
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2005-02-28; Completion date: 2007-09-30
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of Saizen® during 1 year to 1 group receiving 0.035 mg/kg/day (0.24 mg/kg/week) of Saizen® during 1 year after an initial 3-year treatment of recombinant human growth hormone (r-hGH) therapy with 0.057 mg/kg/day in both groups.

Detailed description:

Arms: arm 1: Subjects who met all inclusion/exclusion criteria were randomly assigned to 0.057 mg/kg/day in this multi-center study. Subjects were stratified at randomization according to the Height-Standard Deviation Score (H-SDS) at this time (less than \[\<\] -2 SDS or greater than \[\>\] -2 SDS) arm 2: Subjects who met all inclusion/exclusion criteria were randomly assigned to 0.035 mg/kg/day in this multi-center study. Subjects were stratified at randomization according to the H-SDS at this time (\< -2 SDS or \> -2 SDS)
Interventions: intervention 1: Saizen® intervention 2: Saizen®
Intervention descriptions: intervention 1: Saizen® \[somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. intervention 2: Saizen® \[somatropin (rDNA origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.

Protocol documents:
Clinical trial NCT00256126
Conditions: Growth Hormone Deficiency Turner Syndrome
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2005-05-31; Completion date: 2007-09-30
Enrollment: 318 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Saizen intervention 2: Saizen
Intervention descriptions: intervention 1: Subjects with TS will receive SAIZEN® as subcutaneous injection at a dose of 0.050 milligram per kilogram (mg/kg) of body weight per day (within the recommended dosage 0.045-0.050 mg/kg body weight) for a period of 1 month intervention 2: Subjects with GHD will receive SAIZEN® as subcutaneous injection at a dose of 0.035 mg/kg of body weight per day (within the recommended dosage 0.025-0.035 mg/kg body weight) for a period of 1 month.

Protocol documents:
Clinical trial NCT00251589
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Relapsed Non-Small-Cell Lung Cancer Refractory Non-Small-Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-01-01; Completion date: 2007-10-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib \[Tarceva (TM)\] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also be evaluated.

Detailed description:

Arms: arm 1: Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion arm 2: Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. arm 3: Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. arm 4: Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
Interventions: intervention 1: Vorinostat intervention 2: Vorinostat intervention 3: Vorinostat intervention 4: Vorinostat intervention 5: erlotinib
Intervention descriptions: intervention 1: Vorinostat 200 mg twice a day for 3 days a week. intervention 2: Vorinostat 300 mg once a day for 3 days a week. intervention 3: Vorinostat 300 mg twice a day for 3 days a week. intervention 4: Vorinostat 400 mg once a day for 21 out of 28 days. intervention 5: erlotinib 150 mg once a day.

Protocol documents:
Clinical trial NCT00401726
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder Depression Anxiety
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2006-06-01; Completion date: 2007-10-01
Enrollment: 537 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a patient management program, which aims to help patients achieve successful outcomes by reinforcing physician treatment efforts, providing feedback to treating physicians, and encouraging better physician-patient communications.

Detailed description:

Interventions: intervention 1: Venlafaxine ER intervention 2: Dialogues Time to Talk Program
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00087529
Conditions: Multiple Sclerosis
Keywords: PPMS Primary progressive MS Primary progressive multiple sclerosis Rituxan MS
Sponsor: Genentech, Inc.
Start date: 2004-06-01; Completion date: 2007-10-01
Enrollment: 439 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The study will enroll approximately 435 subjects at up to 60 sites in the United States and Canada.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: rituximab
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose

Protocol documents:
Clinical trial NCT00096941
Conditions: Solid Cancers
Keywords: Advanced solid cancers HER2 EGFR
Sponsor: Genentech, Inc.
Start date: 2005-05-01; Completion date: 2007-10-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, open label extension study. Subjects who have completed treatment in the parent study of pertuzumab, either alone or with a combination agent, and who received at least one dose of pertuzumab in the parent study are eligible for inclusion in this trial if they are continuing to receive clinical benefit.

Detailed description:

Arms: arm 1: Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.
Interventions: intervention 1: Pertuzumab
Intervention descriptions: intervention 1: Pertuzumab was supplied as a single-use liquid formulation.

Protocol documents:
Clinical trial NCT00104104
Conditions: Multiple Myeloma
Keywords: Z-MAX, multiple myeloma, zoledronic acid, bone metastases
Sponsor: Novartis Pharmaceuticals
Start date: 2004-10-01; Completion date: 2007-10-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to study the safety of treating patients with multiple myeloma and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.

Detailed description:

Arms: arm 1: Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks arm 2: Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
Interventions: intervention 1: zoledronic acid
Intervention descriptions: intervention 1: 4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.

Protocol documents:
Clinical trial NCT00118417
Conditions: Panic Disorder
Keywords: Selective serotonin reuptake inhibitor Anxiety Pharmacotherapy Cognitive behavioral therapy CBT
Sponsor: Massachusetts General Hospital
Start date: 1999-03-01; Completion date: 2007-10-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the effectiveness of different treatments for panic disorder symptoms in individuals who still have symptoms after initial treatment with medication.

Detailed description:
Panic disorder is a serious condition that may cause significant psychological and physical distress. Many patients with panic disorder remain symptomatic despite initial intervention. Unfortunately, little data is available to guide health care providers in "next-step" treatment approaches. This study will evaluate the effectiveness of treatments for individuals with panic disorder that is resistant to initial treatment with selective serotonin reuptake inhibitors (SSRIs).

This study will last 24 weeks and will comprise three phases. In Phase 1, participants will receive the SSRI sertraline for 6 weeks. Phase 1 will be used to determine participants' resistance to treatment. During Phase 1, participants will begin a medication schedule and symptom diary and will have weekly study visits to assess regimen adherence and any side effects they may be experiencing. In Phase 2, participants will be randomly assigned to 6 weeks of one of two treatments: sertraline at an elevated dose from that given in Phase 1 or a sertraline and placebo regimen. During Phase 2, participants will have 3 study visits. Self-report scales and diary entries will be used to assess panic disorder symptoms and medication side effects. In Phase 3, participants will be randomly assigned to receive either cognitive behavioral therapy (CBT) or sertraline and clonazepam for 12 weeks. All participants will have weekly study visits during Phase 3. Questionnaires and self-report scales will be used to assess participants at the end of Phase 3.

Study hypothesis: Combined selective serotonin reuptake inhibitors (SSRIs) and benzodiazepine treatment, increasing the dose of SSRI, and the addition of cognitive behavioral therapy (CBT) each may have benefits for patients with panic disorder who remain symptomatic after initial treatment with SSRIs.

Arms: arm 1: Participants in phase II will receive sertraline, or an equivalent medication, up to 100 mg plus a placebo pill. Participants in phase III will receive the same medication with cognitive behavioral therapy. arm 2: Participants in phase II will receive sertraline, or equivalent medication, up to 200 mg. Participants in phase III they will receive the same medication with flexible clonazepam augmentation.
Interventions: intervention 1: Clonazepam intervention 2: Sertraline intervention 3: Cognitive behavioral therapy
Intervention descriptions: intervention 1: Participants will receive clonazepam. intervention 2: Participants will receive sertraline. intervention 3: Participants will receive cognitive behavioral therapy

Protocol documents: