ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00267956
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis CNTO 1275 Ustekinumab Interleukin-23, IL-12, IL-23 Monoclonal antibodies
Sponsor: Centocor, Inc.
Start date: 2005-12-01; Completion date: 2007-09-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.

Detailed description:
This study is a randomized (the study drug is assigned by chance), double-blind (neither physician nor the patient knows the treatment that the patient receives), parallel-group (each group of patients will be treated at the same time), multicenter study to evaluate the effectiveness and safety of CNTO 1275 compared to placebo in the treatment of patients with active psoriatic arthritis. Patients will be randomized in 1:1 ratio to 1 of 2 treatment groups (CNTO 1275 63 mg and placebo). Patients will be randomly assigned to receive study medication up to Week 12 and will be followed through Week 36 to monitor safety and efficacy. Patients randomly assigned to placebo will crossover to receive CNTO 1275 63 mg at Weeks 12 and 16. Patients randomly assigned to CNTO 1275 will receive placebo at Weeks 12 and 16 to maintain the blind. The duration of participation for an individual patient in the study will be up to 36 weeks.

Arms: arm 1: Group 1: Patients will receive CNTO 1275 63 mg at Weeks 0, 1, 2, and 3. At Weeks 12 and 16, patients will receive placebo to maintain the blind. arm 2: Group 2: Patients will receive placebo at Weeks 0, 1, 2, and 3. At Weeks 12 and 16, patients will receive CNTO 1275 63 mg.
Interventions: intervention 1: CNTO 1275 63 mg intervention 2: Placebo
Intervention descriptions: intervention 1: The patients will receive 90 mg (or 63 mg after filtration) subcutaneous injection on Weeks 0, 1, 2, and 3; Placebo subcutaneous injection on Weeks 12 and 16. intervention 2: The patients will receive placebo subcutaneous injection on Weeks 0, 1, 2, and 3; At weeks 12 and 16 the patients will receive CNTo1275 90 mg (or 63 mg after filtration) subcutaneous injection

Protocol documents:
Clinical trial NCT00317226
Conditions: Anemia
Keywords: Anemia CKD Chronic Kidney Disease Iron Maintenance Dose
Sponsor: American Regent, Inc.
Start date: 2005-06-01; Completion date: 2007-09-01
Enrollment: 145 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).

Detailed description:
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004.

In this study patients that complete protocol 1VIT 04004 or are discontinued will be offered to participate in this extension study.

Arms: arm 1: maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Interventions: intervention 1: Ferric Carboxymaltose (FCM)
Intervention descriptions: intervention 1: maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit

Protocol documents:
Clinical trial NCT00361569
Conditions: Menopause
Keywords: vaginal atrophy vaginal dryness vaginal itching vaginal pain
Sponsor: Duramed Research
Start date: 2006-08-01; Completion date: 2007-09-01
Enrollment: 622 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Detailed description:
The study will include a screening period up to 4 weeks and a 12- week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: DR-2041a intervention 2: DR-2041b intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter intervention 2: 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter intervention 3: 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter intervention 4: 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

Protocol documents:
Clinical trial NCT00384033
Conditions: Depressive Disorder, Major
Keywords: MDD Major Depressive Disorder Depression
Sponsor: Pfizer
Start date: 2006-09-01; Completion date: 2007-09-01
Enrollment: 638 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: Active control to assess assay sensitivity
Interventions: intervention 1: Desvenlafaxine Succinate Sustained-Release (DVS SR) intervention 2: Desvenlafaxine Succinate Sustained-Release (DVS SR) intervention 3: Placebo intervention 4: Duloxetine 60 mg/day
Intervention descriptions: intervention 1: 50 mg tablet, once daily dosing for 8 weeks intervention 2: 100 mg tablet, once daily dosing for 8 weeks intervention 3: Matching placebo tablets and capsules, once daily dosing for 8 weeks intervention 4: 60 mg capsule, once daily dosing for 8 weeks

Protocol documents:
Clinical trial NCT00392925
Conditions: Overweight Obesity
Keywords: overweight obesity pramlintide leptin Amylin
Sponsor: AstraZeneca
Start date: 2006-10-01; Completion date: 2007-09-01
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, tolerability, and effect on body weight of leptin, injected subcutaneously, in combination with pramlintide, injected subcutaneously.

Detailed description:

Arms: arm 1: Placebo-pramlintide 600 microliters (µL) twice a day (BID) and metreleptin (recombinant-methionyl human leptin) 5 milligram (mg) BID, 20 weeks arm 2: Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and placebo-metreleptin 1 mL BID, 20 weeks arm 3: Lead-in period: 2 weeks pramlintide acetate 180 mcg BID, then 2 weeks pramlintide acetate 360 mcg BID Study period: Pramlintide acetate 360 mcg BID and metreleptin (recombinant-methionyl human leptin) 5 mg BID, 20 weeks arm 4: During the Lead-In Period before a participant was randomized to a study arm, the participant received 180 mcg pramlintide acetate twice a day (BID) for 2 weeks, followed by 360 mcg pramlintide acetate BID for 2 weeks (total of 4 weeks in the Lead-In Period).
Interventions: intervention 1: pramlintide acetate 360 mcg intervention 2: metreleptin intervention 3: placebo-pramlintide 600 uL intervention 4: placebo-metreleptin 1 mL intervention 5: Pramlintide acetate 180 mcg
Intervention descriptions: intervention 1: subcutaneous injection, twice a day, 360mcg intervention 2: subcutaneous injection, twice a day, 5mg intervention 3: twice a day intervention 4: twice a day intervention 5: subcutaneous injection twice a day, 180 mcg

Protocol documents:
Clinical trial NCT00409409
Conditions: Allergy
Keywords: Sublingual immunotherapy Grass pollen tablet Allergic rhinoconjunctivitis
Sponsor: Stallergenes Greer
Start date: 2006-12-01; Completion date: 2007-09-01
Enrollment: 278 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.

Detailed description:

Arms: arm 1: 300 IR grass pollen allergen extract tablet arm 2: Placebo tablet
Interventions: intervention 1: 300 IR grass pollen allergen extract tablet intervention 2: Placebo tablet
Intervention descriptions: intervention 1: One sublingual tablet daily during 4 months before pollen season and during pollen season intervention 2: One sublingual tablet daily during 4 months before pollen season and during pollen season

Protocol documents:
Clinical trial NCT00419263
Conditions: Influenza
Keywords: influenza flu
Sponsor: BioCryst Pharmaceuticals
Start date: 2007-01-01; Completion date: 2007-09-01
Enrollment: 344 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to be seen 5 more times after they are enrolled in the study.

Detailed description:
Peramivir is a neuraminidase inhibitor that was previously shown to be effective in the treatment of human experimental influenza using an oral formulation. Parenteral formulations of peramivir (for intramuscular and intravenous injection) entered clinical development at the time of this Phase 2 study. A series of Phase 1 studies in human volunteers was completed that provided safety and pharmacokinetic results that supported the initiation of this Phase 2 multinational, randomized, double-mask study that compared the antiviral efficacy and safety of peramivir administered intramuscularly versus placebo in adults with uncomplicated acute influenza. Because of the unique pharmacokinetic and pharmacodynamic properties of peramivir - a long terminal half life in plasma and an extended duration of binding to the neuraminidase enzyme - subjects were randomized in a 1:1:1 ratio to receive a single dose of one of three treatments: peramivir 150 mg, peramivir 300 mg, and placebo. Study drug was administered as one 2-mL intramuscular injection in each gluteal muscle (total of 4 mL, injected in divided doses). This multinational study was originally to be conducted at approximately 80 sites in the US and Canada. When enrollment during the North American influenza season of 2006-2007 did not achieve the target, the study was extended to sites in Australia, New Zealand, South Africa, and Hong Kong.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Peramivir 150 mg intervention 2: Peramivir 300 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo). intervention 2: Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg). intervention 3: Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).

Protocol documents:
Clinical trial NCT00461682
Conditions: Irritable Colon
Keywords: TRPV1 antagonist Fecal Urgency rectal pain IBS
Sponsor: GlaxoSmithKline
Start date: 2007-01-26; Completion date: 2007-09-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
SB-705498 has demonstrated efficacy in several preclinical and human experimental pain models. This study will investigate the efficacy of SB-705498 in patients with rectal pain. This will be a double-blind, placebo-controlled, two-way crossover study. 21 patients with faecal urgency (Group 1), and 21 patients with IBS (Group 2) will complete this study.

Detailed description:

Interventions: intervention 1: SB-705498
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00493220
Conditions: Healthy
Keywords: ceftriaxone cephalosporins pharmacokinetics subcutaneous hyaluronoglucosaminidase hyaluronidase hyaluronan rHuPH20
Sponsor: Baxter Healthcare Corporation
Start date: 2007-06-01; Completion date: 2007-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this study are:

* to establish the safety of subcutaneous administration of ceftriaxone at different concentrations, with and without HYLENEX recombinant, and to determine the maximum tolerated concentration;
* and to establish the pharmacokinetic comparability of subcutaneous administration of ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX recombinant and to IV administration.

Detailed description:

Arms: arm 1: subcutaneous HYLENEX and ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention arm 2: subcutaneous HYLENEX and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention arm 3: subcutaneous placebo and ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, IV ceftriaxone as 3rd intervention arm 4: subcutaneous placebo and ceftriaxone as 1st intervention, IV ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention arm 5: IV ceftriaxone as 1st intervention, subcutaneous HYLENEX and ceftriaxone as 2nd intervention, subcutaneous placebo and ceftriaxone as 3rd intervention arm 6: IV ceftriaxone as 1st intervention, subcutaneous placebo and ceftriaxone as 2nd intervention, subcutaneous HYLENEX and ceftriaxone as 3rd intervention
Interventions: intervention 1: SC HYLENEX and Ceftriaxone intervention 2: SC Placebo and Ceftriaxone intervention 3: IV Ceftriaxone
Intervention descriptions: intervention 1: single, subcutaneous, 150 U dose of HYLENEX; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes) intervention 2: single, subcutaneous injection of 1 mL 0.9% sodium chloride solution; followed by single, subcutaneous, 1 gm dose of ceftriaxone (350 mg/mL solution administered at 2.5 mL/min over 1.14 minutes) intervention 3: single, intravenous infusion of 1 gm ceftriaxone (40 mg/mL solution administered at 0.83 mL/min over 30 minutes)

Protocol documents:
Clinical trial NCT00497198
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes anion-exchange resin
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2005-10-01; Completion date: 2007-09-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MCI-196 intervention 2: Placebo of MCI-196 Tablet
Intervention descriptions: intervention 1: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) intervention 2: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration

Protocol documents:
Clinical trial NCT00851630
Conditions: HIV Tuberculosis
Keywords: HIV Tuberculosis Treatment Naive
Sponsor: Duke University
Start date: 2004-06-01; Completion date: 2007-09-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is twofold: (1) to assess the feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV infected subjects with tuberculosis in a resource-limited setting, and (2) to assess the impact of delayed versus early initiation strategies for fixed dose combination zidovudine/lamivudine/abacavir on the rate of tuberculosis-associated immune reconstitution inflammatory syndromes.

Detailed description:

Arms: arm 1: Initiation of fixed dose combination zidovudine/lamivudine/abacavir 2 weeks after commencing antituberculous therapy arm 2: Initiation of fixed dose combination zidovudine/lamivudine/abacavir 8 weeks after commencing antituberculous therapy
Interventions: intervention 1: Fixed dose combination zidovudine/lamivudine/abacavir
Intervention descriptions: intervention 1: All subjects will receive fixed dose combination zidovudine(300 mg) / lamivudine (150 mg) / abacavir (300 mg) by mouth twice daily. Medications will be provided as long as deemed beneficial by the site investigator and study subject for up to two years. Toxicity substitutions are allowed per protocol.

Protocol documents:
Clinical trial NCT00934375
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Sponsor: Eisai Inc.
Start date: 2006-02-01; Completion date: 2007-09-01
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aricept (donepezil hydrochloride) intervention 2: placebo
Intervention descriptions: intervention 1: 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. intervention 2: None

Protocol documents:
Clinical trial NCT01157169
Conditions: Healthy
Keywords: Bioequivalence Healthy
Sponsor: Teva Pharmaceuticals USA
Start date: 2007-08-01; Completion date: 2007-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc. to an equivalent oral dose of the commercially available reference product, Subutex® manufactured by Reckitt Benckiser, following and overnight fast of at least 10 hours.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Arms: arm 1: Buprenorphine 8 mg Sublingual Tablets arm 2: Subutex® 8 mg Sublingual Tablets
Interventions: intervention 1: Buprenorphine intervention 2: Buprenorphine
Intervention descriptions: intervention 1: 8 mg Sublingual Tablets intervention 2: 8 mg Sublingual Tablets

Protocol documents:
Clinical trial NCT01172145
Conditions: Apathy Alzheimer's Disease
Keywords: apathy Alzheimer's disease activities of daily living performance caregiver burden
Sponsor: Brown University
Start date: 2005-07-01; Completion date: 2007-09-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's disease (AD).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks intervention 2: 100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks

Protocol documents:
Clinical trial NCT01253187
Conditions: Contraception
Sponsor: Bayer
Start date: 2006-10-01; Completion date: 2007-09-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not using hormonal contraception

Detailed description:

Arms: arm 1: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) arm 2: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium \[MTHF-Ca\]) arm 3: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium \[MTHF-Ca\])
Interventions: intervention 1: EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300) intervention 2: EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca) intervention 3: L-5-MTHF 0.451mg (Metafolin)
Intervention descriptions: intervention 1: Treatment group A: Single 1 film-coated tablet (Ethinylestradiol \[EE\] 0.02mg / Drospirenone \[DRSP\] 3mg) taken orally under fasting condition at intervals of at least one menstrual cycle. intervention 2: Treatment group B: Single 1 film-coated tablet (Ethinylestradiol \[EE\] 0.02mg / Drospirenone \[DRSP\] 3mg / L-5-methyltetrahydrofolate \[L-5-MTHF\] 0.451mg) taken orally under fasting condition at intervals of at least one menstrual cycle. intervention 3: Treatment group C: Single 1 coated tablet (L-5-methyltetrahydrofolate \[L-5-MTHF\] 0.451mg) taken orally under fasting condition at intervals of at least one menstrual cycle.

Protocol documents:
Clinical trial NCT00455689
Conditions: Hot Flashes
Keywords: Lupron Premenopausal Hot flashes
Sponsor: Massachusetts General Hospital
Start date: 2005-11-28; Completion date: 2007-09-02
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.

Detailed description:

Arms: arm 1: Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) arm 2: Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)
Interventions: intervention 1: Leuprolide acetate
Intervention descriptions: intervention 1: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection

Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women.

Protocol documents: