ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00759187
Conditions: Gingival Diseases
Sponsor: Colgate Palmolive
Start date: 2008-01-01; Completion date: 2008-04-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.

Detailed description:
The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Fluoride intervention 2: Triclosan/Fluoride intervention 3: Chlorhexidine Gluconate
Intervention descriptions: intervention 1: Brush twice daily intervention 2: Half mouth toothbrushing twice daily for 4 days intervention 3: Mouth rinsing twice a day for 4 days

Protocol documents:
Clinical trial NCT00763048
Conditions: Gingival Diseases
Sponsor: Colgate Palmolive
Start date: 2008-03-01; Completion date: 2008-04-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.

Detailed description:

Arms: arm 1: Fluoride toothpaste (Colgate Great Regular Flavor) is the control for this study. All study toothpastes contain fluoride. The study is evaluating the additional ingredients in the other toothpastes. arm 2: fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste)
Interventions: intervention 1: Fluoride intervention 2: Fluoride, triclosan
Intervention descriptions: intervention 1: Brush twice daily for 6 weeks intervention 2: Brush twice daily

Protocol documents:
Clinical trial NCT00763061
Conditions: Glaucoma
Keywords: Glaucoma
Sponsor: Alcon Research
Start date: 2006-05-01; Completion date: 2008-04-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Detailed description:
To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.

Arms: arm 1: Travoprost 0.004% arm 2: Timolol 0.5%
Interventions: intervention 1: Travoprost 0.004% Ophthalmic Solution (Travatan) intervention 2: Timolol 0.5% Ophthalmic Solution (Timoptic)
Intervention descriptions: intervention 1: Travoprost at 9 AM + Placebo \& 9 PM intervention 2: Timolol in each eye, twice daily at 9 AM \& 9 PM

Protocol documents:
Clinical trial NCT00845663
Conditions: Healthy
Keywords: certolizumab pegol Cimzia bioequivalence Comparison Bioequivalence Study
Sponsor: UCB Pharma
Start date: 2007-10-01; Completion date: 2008-04-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).

Detailed description:

Arms: arm 1: pre-filled syringe (reference) arm 2: Auto-injection device (test)
Interventions: intervention 1: Certolizumab pegol intervention 2: Certolizumab pegol
Intervention descriptions: intervention 1: Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections intervention 2: Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections

Protocol documents:
Clinical trial NCT00884650
Conditions: Cerebral Palsy
Keywords: Pain Pain management Cerebral Palsy
Sponsor: University of Colorado, Denver
Start date: 2005-06-01; Completion date: 2008-04-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine which pain management strategy continuous analgesic pump or orally-should be used in the management of children with cerebral palsy.

Detailed description:
A prospective randomized controlled trial will be performed on up to 150 subjects who will undergo a tendoachilles lengthening, Strayer's procedure, epiphysiodesis of the femur or femoral osteotomy metal work removal.

Subjects will be randomized into two groups: the first group will have an anesthetic pain pump device supplemented with oral analgesia and the second group will only receive oral analgesia. The anesthetic continuous device will be used continuously for 48 hours and with a flow rate of 2ml/hour of 0.25% bupivacaine diluted in accordance to patient weight. Subjects in both groups will receive oral analgesia according to their pain requirements. The amount of oral analgesia used will be documented over 12-hour intervals in a patient diary over a 4 day period. Subjects will have their pain score assessed daily with the use of the Non-Communicating Children's Pain Checklist-Postoperative Version. Their overall satisfaction with post-operative pain management will be assessed at the end of the study with the use of the Parent Total Quality Pain Management questionnaire.

Arms: arm 1: Group 1 will receive oral analgesic only arm 2: Group 2: anesthetic continuous-infusion device, e.g. intravenous analgesic per pump, with supplemental oral analgesia
Interventions: intervention 1: oral analgesic intervention 2: intravenous analgesic per pump
Intervention descriptions: intervention 1: per clinical standard of care intervention 2: per clinical standard of care

Protocol documents:
Clinical trial NCT00896168
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis, Rheumatoid Infliximab Methotrexate
Sponsor: Xian-Janssen Pharmaceutical Ltd.
Start date: 2007-06-01; Completion date: 2008-04-01
Enrollment: 234 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants with severe disease and to compare the efficacy and safety of the MTX subgroups.

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-center (study conducted in more than 1 center), prospective (study following participants forward in time) study comparing the American College of Rheumatology (ACR) scores of participants with moderate RA (defined as having a score greater than 3.2, but less than 5.1 on the Disease Activity Score 28 \[DAS 28\]) to those participants with severe RA (defined as having a score greater than 5.1 on the DAS 28 score) disease while being treated with infliximab and MTX. DAS evaluates RA activity by several parameters including the number of swollen and tender joints and the participant's own assessment of their pain. Participants will receive infliximab 3 milligram (mg) per kilogram (kg) intravenous infusion (drug given into a vein) (over no less than 2 hours) at Weeks 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 Weeks. Participants will have a follow-up visit on Week 26. Efficacy will primarily be assessed by the percentage of participants obtaining ACR20, ACR50 and ACR70 response at Week 26. Participants' safety will be assessed throughout the study.

Arms: arm 1: Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activity score \[DAS\] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX IN a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks. arm 2: Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (mg/week) equal to the dose used before participation in the study) for 22 weeks.
Interventions: intervention 1: Infliximab intervention 2: Methotrexate
Intervention descriptions: intervention 1: Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22. intervention 2: MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.

Protocol documents:
Clinical trial NCT00926029
Conditions: Dental Plaque
Sponsor: Colgate Palmolive
Start date: 2008-01-01; Completion date: 2008-04-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.

Detailed description:

Arms: arm 1: Winterfresh Gel arm 2: Positive control (Total toothpaste) arm 3: test toothpaste
Interventions: intervention 1: Fluoride intervention 2: Triclosan, fluoride intervention 3: Metal salt
Intervention descriptions: intervention 1: Brush twice daily intervention 2: Brush twice daily intervention 3: Brush twice daily

Protocol documents:
Clinical trial NCT00941863
Conditions: Carcinoma
Keywords: Sorafenib Advanced Solid Tumors Maximum tolerated dose Carboplatin and paclitaxel chemotherapy combination
Sponsor: Bayer
Start date: 2002-07-01; Completion date: 2008-04-01
Enrollment: 158 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors.

The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.

Detailed description:

Arms: arm 1: Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). arm 2: Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). arm 3: Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). arm 4: Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet). Treatment were planned until primary completion date (PCD). arm 5: Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion. Treatment were planned until primary completion date (PCD). 25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib until 18 Sep 2008.
Interventions: intervention 1: Sorafenib 100 mg (50-mg tablet) intervention 2: Sorafenib 200 mg (50-mg tablet) intervention 3: Sorafenib 400 mg (50-mg tablet) intervention 4: Sorafenib 400 mg (200-mg tablet) intervention 5: Sorafenib 400 mg (Expansion)
Intervention descriptions: intervention 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet) intervention 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet) intervention 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet) intervention 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) intervention 5: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion

Protocol documents:
Clinical trial NCT00953862
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Substance Use Disorder Residential Treatment Facility
Sponsor: NYU Langone Health
Start date: 2005-07-01; Completion date: 2008-04-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Although Attention Deficit/ Hyperactive Disorder (ADHD) is a common comorbidity in individuals diagnosed with Substance Use Disorder (SUD), little data currently exists on the utility of screening tools in large samples of adult patients with SUD in inpatient treatment. This was a 10-week, 2-phase, open label trial of atomoxetine for ADHD in adult patients being treated for a co-morbid SUD in a residential treatment facility (RTF). The primary objective of the study was to assess the efficacy of atomoxetine in adults with an SUD and ADHD. Secondary objects included assessment of the co-morbidity of ADHD and the safety and tolerability of atomoxetine in this population.

Detailed description:
Phase 1: Patients with SUD who were either newly admitted (abstinent for \<1 week) or in treatment in the RTF (abstinent \<3 months) were administered the Adult ADHD Self-Report Scale Symptom Checklist (ASRS) v. 1.1 Screener. Patients who screened positive(\>= 4 out 6 significant items) were then administered the Adult Clinician Diagnostic Scale (ACDS) v.1.2 to establish a diagnosis of ADHD and the Predictive Value Positive (PVP) in this population.

Phase II (Treatment): Participants who screened positive for ADHD on the ACDS were given informed consent and baseline evaluations for inclusion. Those meeting inclusion/exclusion criteria were treated with atomoxetine starting at 25 mg/day. The dose was adjusted based on clinical response and tolerability over a 4-week period up to 120 mg/day and held constant for the final six weeks of the trial.

Arms: arm 1: Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 120 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side-effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a \>=30% reduction in total AISRS scores from baseline.
Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant at the optimized level for the final 6 weeks of the trial.

Protocol documents:
Clinical trial NCT01024738
Conditions: Dental Plaque
Sponsor: Colgate Palmolive
Start date: 2008-03-01; Completion date: 2008-04-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse

Detailed description:
Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.

Arms: arm 1: negative control toothpaste arm 2: positive control toothpaste (Total toothpaste) arm 3: positive control oral rinse
Interventions: intervention 1: Fluoride intervention 2: Triclosan, fluoride intervention 3: Chlorhexidine Gluconate
Intervention descriptions: intervention 1: Brush half mouth twice daily for four days. intervention 2: Brush twice daily intervention 3: Rinse mouth twice a day

Protocol documents:
Clinical trial NCT01137955
Conditions: Celiac Disease
Keywords: Gastrointestinal Symptom Rating Scale (GSRS) Poorly responsive Refractory Small intestine bacterial overgrowth Breath test
Sponsor: Columbia University
Start date: 2006-10-01; Completion date: 2008-04-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Celiac disease is a condition in which the small intestine is damaged by gluten, the storage protein of wheat and similar proteins in barley and rye. The disease can cause different symptoms such as diarrhea, bloating, abdominal pain and weight loss. The majority of patients respond to a gluten-free diet. However some patients (5-30%) have persistent symptoms and are considered to be poor responders to the diet. Bacterial overgrowth in the small intestine accounts for some of the refractory patients.

This study seeks to determine if antibiotic therapy with rifaximin relieves the symptoms of patients who are poorly responsive to a gluten-free diet and whether this impacts their breath test results.

Detailed description:
A symptom questionnaire will be administered at study initiation, 2 weeks and 12 weeks. Patients will undergo a breath test which involves drinking a sugar (lactulose) solution and breathing into a machine. This technique will identify the presence of bacteria in the small intestine. They will be randomly selected to receive either an antibiotic (rifaximin) or placebo three times a day for 10 days to treat their bacterial overgrowth.

Arms: arm 1: Antibiotic ,Rifaximin 400mg, given 3 times a day for 10 days. arm 2: Placebo pills given 3 times a day for 10 days.
Interventions: intervention 1: Rifaximin intervention 2: Placebo
Intervention descriptions: intervention 1: Rifaximin 400mg orally three times a day for 10 days total intervention 2: Placebo orally three times a day for 10 days total

Protocol documents:
Clinical trial NCT01263483
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
Sponsor: Takeda
Start date: 2007-01-01; Completion date: 2008-04-01
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.

Detailed description:
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

In Japan, α-glucosidase inhibitors are widely used as a first-line treatment for type 2 diabetes mellitus. Because alogliptin has a different mechanism of action compared to α-glucosidase inhibitors, the study evaluated the efficacy and safety of alogliptin combined with an α-glucosidase inhibitor in type 2 diabetic patients with uncontrolled blood glucose while taking a α-glucosidase inhibitor and receiving diet and/or exercise therapies.

To evaluate the long-term safety and efficacy of the concomitant use of alogliptin and an α-glucosidase inhibitor, subjects who participated in the present study could enter a long-term extension study SYR-322/OCT-003 (NCT01263509) that was planned separately.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Alogliptin and voglibose intervention 2: Alogliptin and voglibose intervention 3: Voglibose
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.

Protocol documents:
Clinical trial NCT01606254
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone Palmitate JNS010
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2007-01-01; Completion date: 2008-04-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description:
This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), parallel-group (Each group of participants will be treated at the same time), comparison study to assess the pharmacokinetics and safety of paliperidone palmitate (study medication) in participants with schizophrenia. The study comprises a 64-day Treatment period and a 155-day Follow-up period. The participants will be randomly assigned to one of the four study groups. The study medication will be administered on Days 1, 8, 36 and 64. Pharmacokinetics of the study medication will be assessed as primary outcome. Participants' safety will be monitored throughout the study.

Arms: arm 1: Paliperidone palmitate 50 milligram (mg) intramuscular (into the muscle) injection on Days 1, 8, 36 and 64. arm 2: Paliperidone palmitate 100 mg intramuscular injection on Days 1, 8, 36 and 64. arm 3: Paliperidone palmitate 150 mg intramuscular injection on Days 1, 8, 36 and 64. arm 4: Paliperidone palmitate 150 mg intramuscular injection on Day 1 and paliperidone palmitate 50 mg intramuscular injection on Days 8, 36 and 64.
Interventions: intervention 1: Paliperidone palmitate
Intervention descriptions: intervention 1: Paliperidone palmitate aqueous suspension for injection 0.5, 1.0, 1.5 milliliter equivalent to 50, 100, 150 mg paliperidone respectively as intramuscular injection on Days 1, 8, 36 and 64.

Protocol documents:
Clinical trial NCT01628848
Conditions: Parkinson's Disease
Keywords: SPM 962 rotigotine Parkinson's disease concomitant use of L-dopa
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2006-08-01; Completion date: 2008-04-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.

Detailed description:

Arms: arm 1: SPM 962 transdermal patch arm 2: Placebo transdermal patch
Interventions: intervention 1: SPM 962 intervention 2: Placebo
Intervention descriptions: intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day intervention 2: Placebo transdermal patch

Protocol documents: