ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00847509
Conditions: Lung Cancer Head and Neck Cancer
Keywords: lung cancer head and neck cancer radiotherapy chemoradiotherapy radiation chemoradiation FLT [F-18]FLT FDG [F-18]FDG
Sponsor: Siemens Molecular Imaging
Start date: 2009-02-01; Completion date: 2010-09-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates for early assessment of tumor response to radiation or chemo-radiation combo.

Detailed description:
PHASE: II/III

OBJECTIVES:

Primary: To investigate the clinical value of serial quantitative \[F-18\] FLT positron image assessment of tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens (except with 5-fluorouracil) in comparison to serial quantitative \[F-18\] FDG images

Secondary: To gain additional clinical information and experience with \[F-18\]FLT to guide the design of a future, pivotal, Phase III trial where changes in tumor proliferation from pre-treatment baseline values can be used as a early indicator of response to therapy regimens.

DESIGN: Open label, nonrandomized, uncontrolled, single group assignment

DURATION: Pre treatment \[F-18\] FLT PET scan following a clinical \[F-18\] FDG PET scan followed by post treatment \[F-18\] FLT PET scan and a post treatment, clinical \[F-18\] FDG PET scan at 4 weeks (±1 week) to monitor radiotherapy or chemoradiotherapy.

PROCEDURES: Informed consent, collection of demographic information, medical history, physical examinations, vital signs, 12-lead ECGs, concomitant medication collection, monitor adverse events, pre treatment \[F-18\] FLT PET scan and post treatment \[F-18\] FLT PET scan

SUBJECTS: Approximately 60 patients will be enrolled with confirmed lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil) to be eligible. This allows for approximately 40 evaluable patients to complete this study at approximately four to eight sites and conducted in the United States.

Arms: arm 1: Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate \[F-18\] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard \[F-18\] FDG PET will be the active comparator.
Interventions: intervention 1: [F-18]FLT
Intervention descriptions: intervention 1: The individual doses of \[F-18\]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging.

Protocol documents:
Clinical trial NCT00862836
Conditions: Ovarian Cancer
Keywords: ZD6474 Vandetanib Zactima Ovarian Cancer Phase I Phase II Randomized Safety
Sponsor: Genzyme, a Sanofi Company
Start date: 2009-04-01; Completion date: 2010-09-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.

Detailed description:

Arms: arm 1: Vandetanib added to standard therapy (pegliposomal doxorubicin)
Interventions: intervention 1: Vandetanib
Intervention descriptions: intervention 1: 100mg doses orally, once daily

Protocol documents:
Clinical trial NCT00884039
Conditions: Transplant Intraocular Pressure
Keywords: cornea transplant intraocular pressure steroid response
Sponsor: Cornea Research Foundation of America
Start date: 2009-05-01; Completion date: 2010-09-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the use of anecortave acetate injection to reduce intraocular pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. Alternative methods of IOP control have been shown to entail serious risks. For example, reduction of topical steroids increases the risk of graft rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft failure. This study is designed to have sufficient power to detect whether a single injection can induce a clinically significant IOP reduction.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: anecortave acetate intervention 2: 30 mg anecortave acetate
Intervention descriptions: intervention 1: anterior juxtascleral depot of 15 mg anecortave acetate intervention 2: anterior juxtascleral depot of 30mg anecortave acetate

Protocol documents:
Clinical trial NCT00887679
Conditions: Anxiety Disorders HIV Infections
Keywords: Escitalopram Anxiety Disorder HIV and AIDS treatment experienced
Sponsor: Duke University
Start date: 2009-05-01; Completion date: 2010-09-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and effective in the treatment of HIV-infected patients with generalized anxiety disorder.

Detailed description:
Anxiety disorders are twice as prevalent among HIV-infected patients as they are in the general population. Approximately 25%-40% of HIV-infected patients have anxiety disorders; Generalized Anxiety Disorder, Panic disorder and post-traumatic Stress Disorder being the most frequent. Non-adherence to anti-retroviral medications is commonly seen in patients with HIV with GAD.The role of specific selective serotonin reuptake (SSRIs) in the treatment of HIV-patients with GAD is unclear. Escitalopram has been used in the treatment of GAD in the general population. It has been shown to be safe in HIV-patients with a tolerable side-effect profile. However, whether it can improve GAD in HIV-infected patients has not yet been investigated.

Arms: arm 1: Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Open label, rater-blinded, prospective, 6-week trial of escitalopram.Subjects received escitalopram 10-20mg. Escitalopram was started at 10mg per day and augmented weekly in 10mg per day increments, the maximum dose being 20mg per day.
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: 10-20 mg/day oral of Escitalopram for 6-weeks. Escitalopram flexible dose (10-20 mg/day). A forced escalation schedule of escitalopram was used to titrate it to the maximum tolerated dose. Drug was discontinued at the end of the study.

Protocol documents:
Clinical trial NCT00889707
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia BPH Enlarged Prostate
Sponsor: Sophiris Bio Corp
Start date: 2009-01-01; Completion date: 2010-09-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether PRX302 is safe and effective in the treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).

Detailed description:
This is a randomized, double-blinded, placebo-controlled study of transperineal intraprostatic injection of PRX302 under sonographic guidance. Subjects will be randomly assigned to the two treatment groups in a ratio of 2:1 between PRX302 and Placebo, stratified by prostate size and baseline IPSS.

Arms: arm 1: PRX302 arm 2: Placebo
Interventions: intervention 1: PRX302 intervention 2: Placebo
Intervention descriptions: intervention 1: PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit. intervention 2: PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and left lobes of the prostate, with a minimum of 1.0 mL per deposit.

Protocol documents:
Clinical trial NCT00891813
Conditions: Secondary Hyperparathyroidism Renal Insufficiency, Chronic Parathyroid Hormone Hemodialysis Hypercalcemia
Sponsor: Abbott
Start date: 2009-05-01; Completion date: 2010-09-01
Enrollment: 100 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.

Detailed description:
The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.

Arms: arm 1: None
Interventions: intervention 1: Zemplar (paricalcitol)
Intervention descriptions: intervention 1: Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.

Protocol documents:
Clinical trial NCT00892723
Conditions: Scar Prevention Scar Reduction
Keywords: AZX100 Patient and Observer Scar Assessment Scale POSAS Visual Analog Scale VAS Keloid Scarring Scar reduction Scar prevention
Sponsor: Capstone Therapeutics
Start date: 2009-05-01; Completion date: 2010-09-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: AZX100 Drug Product intervention 2: Placebo intervention 3: AZX100 Drug Product
Intervention descriptions: intervention 1: Subjects were administered AZX100 0.3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery. intervention 2: Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery. intervention 3: Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.

Protocol documents:
Clinical trial NCT00903383
Conditions: Rheumatoid Arthritis
Sponsor: Lexicon Pharmaceuticals
Start date: 2009-07-01; Completion date: 2010-09-01
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305 versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate therapy.

Detailed description:

Arms: arm 1: A low dose of LX3305; daily oral intake for 12 weeks arm 2: A mid dose of LX3305; daily oral intake for 12 weeks arm 3: A high dose of LX3305; daily oral intake for 12 weeks arm 4: Matching placebo dosing with daily oral intake for 12 weeks
Interventions: intervention 1: LX3305 low dose intervention 2: LX3305 mid dose intervention 3: LX3305 high dose intervention 4: Placebo
Intervention descriptions: intervention 1: A low dose of LX3305; daily oral intake for 12 weeks intervention 2: A mid dose of LX3305; daily oral intake for 12 weeks intervention 3: A high dose of LX3305; daily oral intake for 12 weeks intervention 4: Matching placebo dosing with daily oral intake for 12 weeks

Protocol documents:
Clinical trial NCT00911495
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Sponsor: GlycoMimetics Incorporated
Start date: 2009-05-01; Completion date: 2010-09-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular effects of intravenous GMI-1070 in the outpatient setting.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: GMI-1070
Intervention descriptions: intervention 1: Intravenous GMI-1070 given as two doses over the course of one day

Protocol documents:
Clinical trial NCT00930982
Conditions: Bronchiectasis
Keywords: Ciprofloxacin Airway infection Bronchiectasis
Sponsor: Bayer
Start date: 2009-06-01; Completion date: 2010-09-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.

Detailed description:
Safety issues are addressed in the AE section. There is no standardised and unanimously accepted definition of exacerbation in COPD; 4 definitions are widely used: (1) using a combination of 3 cardinal symptoms: increased dyspnea, sputum volume, and sputum purulence; (2) looking at the presence of the following patterns of symptoms during \>=2 consecutive days: either 2 or more of 3 major symptoms (increase in dyspnoea, sputum volume and sputum purulence); or any 1 major symptom together with any 1 minor symptom (increase in nasal discharge, wheeze, sore throat, cough or fever); (3) a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD; (4) a complex of respiratory events (i.e. cough, wheezing, dyspnoea or sputum production) lasting \>=3 days.

Arms: arm 1: 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily arm 2: Inhalation of matching placebo twice a day
Interventions: intervention 1: Ciprofloxacin (Cipro, BAYQ3939) intervention 2: Placebo
Intervention descriptions: intervention 1: Inhalation of 32,5mg Ciprofloxacin inhaled twice a day intervention 2: Inhalation of matching placebo twice a day

Protocol documents:
Clinical trial NCT00937391
Conditions: Magnetic Resonance Imaging
Keywords: MRI agents Magnevist
Sponsor: Bayer
Start date: 2010-01-01; Completion date: 2010-09-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to \< 2 years of age

Detailed description:
Safety issues are addressed in the AE section

Arms: arm 1: For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
Interventions: intervention 1: Gadopentetate dimeglumine (Magnevist, BAY86-6661)
Intervention descriptions: intervention 1: For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).

Protocol documents:
Clinical trial NCT00938717
Conditions: Irritable Bowel Syndrome With Constipation
Keywords: IBS
Sponsor: Ironwood Pharmaceuticals, Inc.
Start date: 2009-07-01; Completion date: 2010-09-01
Enrollment: 805 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Linaclotide or Matching Placebo
Intervention descriptions: intervention 1: Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial

Protocol documents:
Clinical trial NCT00975637
Conditions: Psoriasis
Sponsor: Bausch Health Americas, Inc.
Start date: 2009-12-01; Completion date: 2010-09-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.

Detailed description:
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio. Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and 8.

Arms: arm 1: 140 mg SC arm 2: 70 mg SC arm 3: 280 mg SC arm 4: 210 mg SC arm 5: Placebo
Interventions: intervention 1: 70 mg SC intervention 2: 210 mg SC intervention 3: 140 mg SC intervention 4: 280 mg SC intervention 5: Placebo
Intervention descriptions: intervention 1: 70 mg SC intervention 2: 210 mg SC intervention 3: 140 mg SC intervention 4: 280 mg SC intervention 5: Placebo SC

Protocol documents:
Clinical trial NCT00983073
Conditions: Chronic Pain Osteoarthritis
Keywords: Osteoarthritis Pain Assessment Tapentadol Centrally acting analgesic Chronic pain due to osteoarthritis
Sponsor: Grünenthal GmbH
Start date: 2009-09-01; Completion date: 2010-09-01
Enrollment: 224 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.

The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.

Detailed description:

Arms: arm 1: Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol IR tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.
Interventions: intervention 1: Tapentadol
Intervention descriptions: intervention 1: Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusting at 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed 500 mg of Tapentadol per day.

Maintenance Period: Participants continuing on the dose established in the previous period.

Protocol documents:
Clinical trial NCT00987727
Conditions: Dry Eye Syndromes Keratoconjunctivitis Sicca
Sponsor: Allergan
Start date: 2009-11-01; Completion date: 2010-09-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.

Detailed description:

Arms: arm 1: carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD) arm 2: sodium hyaluronate 0.18% (VISMED® Multi)
Interventions: intervention 1: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD) intervention 2: sodium hyaluronate 0.18% (VISMED® Multi)
Intervention descriptions: intervention 1: One drop in each eye three to six times daily, as needed intervention 2: One drop in each eye three to six times daily, as needed

Protocol documents:
Clinical trial NCT00992459
Conditions: Urea Cycle Disorders
Keywords: Urea Cycle Disorder (UCD) UCD hyperammonemia Buphenyl (NaPBA) glycerol phenylbutyrate (GPB) Sodium Phenylbutyrate (NaPBA)
Sponsor: Amgen
Start date: 2009-10-01; Completion date: 2010-09-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was a randomized, active-controlled, double-blind, cross-over study designed to enroll subjects with UCDs who are being treated with NaPBA.

Detailed description:
This was a randomized, active-controlled, double-blind, cross-over study designed to enroll subjects with UCDs who are being treated with NaPBA. Subjects were randomly assigned to receive either HPN-100 + NaPBA placebo or NaPBA + HPN 100 placebo for 2 weeks, and then crossed over to receive the other treatment for 2 weeks. Venous ammonia was the primary outcome measure. Subjects were admitted to the clinical research unit for 24 hours of pharmacokinetic (PK) blood and urine sampling (including an overnight stay) at the end of each treatment period, by which time the study drug had reached steady state.

Subjects followed a stable diet throughout the study as prescribed by the investigator and dietician. Throughout the study, diet diaries were completed by the subject and dietary protein intake were assessed by a dietician based on completed dietary diaries and consultation with the subject.

Subjects who completed this study and met the study entry criteria, were offered the opportunity to enroll in the HPN-100 open-label safety protocol (HPN-100-007).

Study acquired from Horizon in 2024.

Arms: arm 1: Subjects in Arm A were randomly assigned to receive NaPBA + HPN 100 placebo for 2 weeks and then crossed over to receive HPN 100 + NaPBA Placebo for 2 weeks. arm 2: Subjects in Arm B were randomly assigned to receive HPN-100 + NaPBA placebo for 2 weeks and then crossed over to receive NaPBA + HPN 100 placebo for 2 weeks.
Interventions: intervention 1: HPN-100 intervention 2: Buphenyl (NaPBA)
Intervention descriptions: intervention 1: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (\~17.4mL) delivers equivalent amount of PBA in 40 tablets of NaPBA. intervention 2: Buphenyl (NaPBA) will be the comparator drug to HPN-100 in this study.

Protocol documents: