ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01791855
Conditions: Renal Insufficiency
Keywords: Subjects with Renal Impairment healthy
Sponsor: Pfizer
Start date: 2013-05-10; Completion date: 2013-09-03
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with renal impairment are the target population for PF-04634817. The clearance mechanism of this drug means that exposure may be increased in subjects with renal impairment. This study will investigate the effect of the drug in subjects with varying degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: PF-04634817 intervention 2: PF-04634817 intervention 3: PF-04634817 intervention 4: PF-04634817
Intervention descriptions: intervention 1: Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min) intervention 2: Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min) intervention 3: Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min) intervention 4: Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)

Protocol documents:
Clinical trial NCT01345929
Conditions: Complicated Urinary Tract Infection Pyelonephritis
Keywords: cUTI
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2011-06-20; Completion date: 2013-09-04
Enrollment: 558 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).

Detailed description:
Approximately 500 subjects will be enrolled into this study and randomized 1:1 to receive CXA-201 or comparator (levofloxacin) resulting in 250 subjects per treatment arm. Subject participation will require a minimum commitment of 35 days and a maximum of 42 days. Subjects will be hospitalized for the administration of all doses of IV study therapy. A test of cure visit will occur at 7 days after the last dose of study drug and a late follow-up evaluation or contact will occur a minimum of 28 days and a maximum of 35 days after the last dose of study drug.

Arms: arm 1: CXA-201 IV infusion (1500mg q8) for 7 days arm 2: Levofloxacin IV infusion (750mg qd) for 7 days
Interventions: intervention 1: CXA-201 intervention 2: Levofloxacin
Intervention descriptions: intervention 1: CXA-201 IV infusion (1500mg q8) for 7 days intervention 2: Levofloxacin IV infusion (750mg qd) for 7 days

Protocol documents:
Clinical trial NCT01763333
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-01-08; Completion date: 2013-09-04
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706

Detailed description:

Arms: arm 1: single rising doses of BI 1026706 arm 2: bioavailability part of BI 1026706
Interventions: intervention 1: BI 1026706 Placebo intervention 2: BI 1026706
Intervention descriptions: intervention 1: Placebo to BI 1026706 intervention 2: different dose formulations

Protocol documents:
Clinical trial NCT01033240
Conditions: Advanced Hepatocellular Carcinoma Liver Cancer Hepatic Cancer Liver Neoplasms
Keywords: Sorafenib CS-1008 Advanced Liver Cancer
Sponsor: Daiichi Sankyo
Start date: 2010-07-09; Completion date: 2013-09-09
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of CS-1008 in combination with sorafenib to sorafenib alone for treating liver cancer. Approximately 160 participants will take part in this study at approximately 22 sites (4 in the US, 8 in Japan, and 10 in Asia).

Detailed description:

Arms: arm 1: Combination of CS-1008 and sorafenib; CS-1008 (2 mg/kg per week) in combination with sorafenib (400 mg self-administered by mouth twice daily) over 4 weeks observation, and may continue treatment until progression. arm 2: Combination of CS-1008 and sorafenib; CS-1008 (4 mg/kg per week) in combination with sorafenib (400 mg self-administered by mouth twice daily) over 4 weeks observation, and may continue treatment until progression. arm 3: Combination of CS-1008 and sorafenib; CS-1008 (6 mg/kg per week) in combination with sorafenib (400 mg self-administered by mouth twice daily) over 4 weeks observation, and may continue treatment until progression. arm 4: Combination of CS-1008 and sorafenib. Treatment Group 1: CS-1008 (6 mg/kg \[or as determined\] loading, 2 mg/kg/week maintenance) + sorafenib twice daily (N=50) arm 5: Combination of CS-1008 and sorafenib. Treatment Group 2: CS-1008 (6 mg/kg \[or as determined\] loading, 6 mg/kg/week \[or maximum tolerated dose {MTD}\] maintenance) + sorafenib twice daily (N=50) arm 6: Sorafenib. Treatment Group 3: sorafenib twice daily (N=50)
Interventions: intervention 1: CS-1008 2 mg/kg intervention 2: Sorafenib intervention 3: CS-1008 6/2 mg/kg intervention 4: CS-1008 6/6 mg/kg intervention 5: CS-1008 4 mg/kg intervention 6: CS-1008 6 mg/kg
Intervention descriptions: intervention 1: On a once a week basis CS-1008 will be administered intravenously starting at 2 mg/kg. intervention 2: On a daily basis, one sorafenib tablet, 400 mg, is taken orally twice a day. The total daily dose of sorafenib is 800 mg. The sorafenib tablets are taken at least 1 hour before or 2 hours after a meal. intervention 3: A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 2 mg/kg/week maintenance dose on a once-a-week basis. intervention 4: A 6 mg/kg loading dose of CS-1008 will be administered intravenously, followed by a 6 mg/kg/week maintenance dose on a once-a-week basis. intervention 5: On a once a week basis CS-1008 will be administered intravenously at 4 mg/kg if tolerated. intervention 6: On a once a week basis CS-1008 will be administered intravenously at 6 mg/kg if tolerated.

Protocol documents:
Clinical trial NCT01494922
Conditions: Reduction in Severity of Skin Scarring
Keywords: Skin scarring cicatrix hypertrophic scar hypertrophic scar prevention
Sponsor: Pfizer
Start date: 2011-12-08; Completion date: 2013-09-10
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: EXC 001 (currently called PF-06473871)
Intervention descriptions: intervention 1: Single dose administered by injection at four different times

Protocol documents:
Clinical trial NCT01627782
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder Treatment-resistant depression Ketamine
Sponsor: Janssen Research & Development, LLC
Start date: 2012-08-06; Completion date: 2013-09-12
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression (TRD).

Detailed description:
This is a double-blind (patients and study personnel do not know the identity of the administered treatments), randomized (the drug is assigned by chance), placebo-controlled (placebo is a substance that appears identical to the treatment and has no active ingredients), parallel arm study (each group of patients will be treated at the same time). The study will consist of a screening phase of up to 4 weeks, a 4-week double-blind treatment phase (Day 1 to Day 29), and a 3-week post treatment (follow up) phase. In the double-blind phase, patients will receive over 4 weeks either intravenous (IV) infusions of placebo (2 or 3 times weekly) or IV infusions of ketamine (2 or 3 times weekly). The total study duration for each patient will be a maximum of 13 weeks.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: Ketamine
Intervention descriptions: intervention 1: Form= intravenous infusion, route= intravenous (IV) use. IV infusions of placebo 2 times weekly or IV infusions of placebo 3 times weekly. intervention 2: Type= exact number, unit= mg/kg, number= 0.5, form= intravenous infusion, route= intravenous (IV) use. IV infusions of ketamine 0.50 mg/kg, 2 times weekly or IV infusions of ketamine 0.50 mg/kg, 3 times weekly.

Protocol documents:
Clinical trial NCT01670656
Conditions: Dysmenorrhea
Sponsor: Organon and Co
Start date: 2013-01-21; Completion date: 2013-09-12
Enrollment: 439 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study investigates four vaginal ring groups with respect to relief of primary dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant treatment efficacy in relief of primary dysmenorrhea.

Detailed description:
The study investigates four vaginal ring groups with respect to relief of primary dysmenorrhea, and should identify at least one vaginal ring that shows clinically relevant treatment efficacy in relief of primary dysmenorrhea. The intake of ibuprofen rescue medication and the impact on daily life is investigated: change from baseline data of these two variables will be compared between each of the four active ring groups, separately, and the placebo ring group. Furthermore, the study assesses the measurement characteristics and psychometric properties of a newly developed Dysmenorrhea Daily Dairy. Vaginal bleeding pattern and general safety and tolerability will also be evaluated.

Arms: arm 1: NOMAC-E2 700/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 2: NOMAC-E2 900/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 3: ENG-E2 100/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 4: ENG-E2 125/300 mcg will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. arm 5: Placebo will be administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
Interventions: intervention 1: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR) intervention 2: Etonogestrel containing contraceptive vaginal ring (ENG-CVR) intervention 3: Placebo intervention 4: Ibuprofen
Intervention descriptions: intervention 1: Either 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles intervention 2: Either 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles intervention 3: Placebo to match vaginal ring, intravaginally for two 28-day cycles intervention 4: Ibuprofen 400 mg will be dispensed throughout the entire study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose is 3200 mg (8 tablets)

Protocol documents:
Clinical trial NCT01725126
Conditions: Obesity
Keywords: metformin diabetes obesity liraglutide
Sponsor: GlaxoSmithKline
Start date: 2013-02-10; Completion date: 2013-09-12
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is the first administration of GSK2890457 in humans. The study will be conducted in 3 parts: - Part A (conducted at a single investigative site) will determine the safety and tolerability of GSK2890457 alone in healthy subjects during six weeks of dosing, as well as evaluating the potential for a pharmacokinetic interaction with metformin. Part A consists of Screening, Treatment (6 weeks) and Follow-up periods. - Part B (conducted at multiple sites) will determine safety, tolerability, and pharmacodynamics (PD) in subjects with Type 2 diabetes (T2D) when co-dosed for six weeks with liraglutide (Victoza). Part B consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods. - Part C (conducted at multiple sites) will determine safety, tolerability, and PD in subjects with T2D when co-dosed for 6 weeks with metformin. Part C consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods.

Detailed description:

Arms: arm 1: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks arm 2: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks arm 3: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks arm 4: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks arm 5: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks arm 6: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks
Interventions: intervention 1: GSK2890457 intervention 2: Metformin intervention 3: Placebo intervention 4: Liraglutide
Intervention descriptions: intervention 1: Provided as powder and capsule. intervention 2: Tablet

Part A: Single doses on Day 1 and Day 42 orally

Part B: Subject continues usual metformin dose through Run-in, and resumes after Treatment Period completed

Part C: Subject continues usual metformin dose throughout study intervention 3: Provided as powder and Capsule. intervention 4: Provided as Injection. 6mg/mL, 3mL injector pen that permits doses of 0.6mg, 1.2mg, and 1.8mg

Subcutaneous injection 18 weeks dosing (Stabilization and Treatment Periods, Part B only

Protocol documents:
Clinical trial NCT00766142
Conditions: Colorectal Cancer Primary Peritoneal Cavity Cancer
Keywords: adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer adenocarcinoma of the rectum recurrent rectal cancer stage IV rectal cancer peritoneal carcinomatosis
Sponsor: Institut Bergonié
Start date: 2007-05-01; Completion date: 2013-09-17
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well chemotherapy given together with cetuximab works in treating patients undergoing surgery to remove peritoneal carcinomatosis from colorectal cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of systemic chemotherapy and cetuximab, in terms of progression-free survival at 3 years, in patients with completely resected peritoneal carcinomatosis of colorectal origin.

Secondary

* Determine the therapeutic strategy among patients who are or are not fit to receive chemotherapy.
* Determine progression-free survival at 5 years and overall survival at 3 and 5 years in these patients.
* Determine the overall tolerability (mortality, morbidity) of this regimen, including surgery, in these patients.

OUTLINE: This is a multicenter study.

Patients undergo complete resection of the peritoneal carcinomatosis. Beginning 4-8 weeks after surgery, patients receive cetuximab IV over 2.5 hours. Patients also receive FOLFOX chemotherapy comprising oxaliplatin IV and leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46 hours. Treatment repeats every 2 weeks for up to 12 courses.

After completion of study therapy, patients are followed every 4 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Surgery + Chemotherapy + Cetuximab
Interventions: intervention 1: cetuximab intervention 2: fluorouracil intervention 3: leucovorin calcium intervention 4: oxaliplatin intervention 5: adjuvant therapy intervention 6: therapeutic conventional surgery
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01165320
Conditions: Candidiasis, Esophageal Candidiasis, Invasive Aspergillosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-07-06; Completion date: 2013-09-17
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.

Detailed description:

Arms: arm 1: Candida infection is strongly suspected based on clinical symptoms and the participant's clinical course, white moss (plaque) is observed on the esophageal mucosa, and therapy via intravenous infusion is judged to be suitable for the present episode of esophageal candidiasis. MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively. arm 2: Candida infection is strongly suspected based on the presence of refractory fever not responding to an antibiotic agent, or clinical symptoms at the site of disease, or the participant's clinical course. In addition, at least 1 of the following criteria must be met: 1) Candida infection is strongly suspected based on radiographic imaging findings and positive serological test for fungus, 2) yeast is observed by direct microscopy or histopathological test of tissue biopsied from the site of disease, or 3) Candida species are observed by culture test of specimens sampled from the site of disease. MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively. arm 3: Aspergillus infection is strongly suspected based on clinical symptoms and the participant's clinical course, and characteristic radiographic imaging findings are observed. In addition, at least 1 of the following criteria must be met: 1) risk factors predisposing to an Aspergillus infection, 2) positive serological test for Aspergillus, 3) acute-branching mold with separated hyphae are observed by direct microscopy or histopathological test, or 4) Aspergillus species are observed by culture test. MK-0991 therapy as a single loading dose of 70 mg/m\^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m\^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
Interventions: intervention 1: Caspofungin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01277211
Conditions: Contraception
Keywords: Contraception NuvaRing
Sponsor: Organon and Co
Start date: 2011-09-19; Completion date: 2013-09-18
Enrollment: 983 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be assessed and compared with that of Yasmin.

Detailed description:
The purpose of this study is to assess the contraceptive efficacy of NuvaRing in fertile Chinese women; to assess vaginal bleeding pattern (cycle control), general safety, and acceptability of NuvaRing; and to evaluate the NuvaRing's effect on dysmenorrhea.

Arms: arm 1: Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE. arm 2: Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
Interventions: intervention 1: ENG 120 µg + EE 15 µg intravaginal ring intervention 2: DRSP 3 mg + EE 30 µg
Intervention descriptions: intervention 1: 13 cycles of ENG-EE (NuvaRing) vaginal ring use. Each cycle 28 days, with a 21-day active treatment period followed by 7-day ring-free period. One ring per cycle, each ring containing 11.7 mg ENG and 2.7 mg EE, and releasing on average 120 mcg/day of ENG and 15 mcg/day of EE. intervention 2: 13 cycles of DRSP-EE tablet use. Each cycle 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received total of 21 tablets per cycle, each tablet contained 3 mg DRSP and 30 μg EE.

Protocol documents: