ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01419119
Conditions: Vitamin D Deficiency
Keywords: vitamin D insufficiency Cholecalciferol D3 Parathyroid Hormone 25-hydroxyvitamin D3 RDA, recommended daily intake (nutrition policy) Vitamin D Hypovitaminosis-D Pharmacologic treatment
Sponsor: Umeå University
Start date: 2011-09-01; Completion date: 2012-10-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of different doses of vitamin D in persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.

Detailed description:
The participants in the study have taken part in a previous screening study. They are now asked to participate in this treatment study. At a screening visit blood samples for vitamin D3 and PTH are collected. Data regarding previous fractures, life style, exposure for sun, clothes, diet, smoking and physical activities are collected. The Vitamin D value predict the treatment dose.

Arms: arm 1: Vitamin D3, 10 000 IU daily. Treatment to patients with Serum-vitamin D levels below 25 nmol/L arm 2: Vitamin D3 2000 IU daily, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 nmol/l will be randomised to arm 3: Vitamin D3 2000 IU weekly, one of two arms that patients with Serum-vitamin D levels between 25 nmol/L and 49 mol/l will be randomised to arm 4: Vitamin D3, 2000 IU daily i.e. 3 drops orally once daily for 12 weeks, treatment to patients with Serum-vitamin D levels between 50 and 74 nmol/L
Interventions: intervention 1: Cholecalciferol high dose at Vitamin D deficiency intervention 2: Cholecalciferol median dose at Vitamin D insufficiency intervention 3: Cholecalciferol low dose at Vitamin D deficiency intervention 4: Cholecalciferol median dose at sufficient Vitamin D level
Intervention descriptions: intervention 1: 10 000 IU daily i.e. 15 drops orally once daily for 12 weeks intervention 2: 2000 IU daily i.e. 3 drops orally once a day for 12 weeks, intervention 3: 2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks, intervention 4: 2000 IU daily i.e. 3 drops orally once daily for 12 weeks

Protocol documents:
Clinical trial NCT01431950
Conditions: Asthma
Keywords: fluticasone furoate
Sponsor: GlaxoSmithKline
Start date: 2011-09-01; Completion date: 2012-10-01
Enrollment: 238 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.

Detailed description:
This will be a multi-centre, randomised, double-blind, parallel-group study. Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (screening visit) will enter a four week Run-In period during which they will remain on their baseline ICS medication. In addition, all subjects will be provided with albuterol/salbutamol for relief of asthma symptoms. Subjects failing screening will not be eligible for re-screening. During the Run-In and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening Peak Expiratory Flow (PEF), asthma symptom score and rescue albuterol/salbutamol use. Subjects will receive a contact (Phone Contact 1/optional office visit (1b)) during Run-In to reinforce compliance with Run-In medication and diary monitoring. Those subjects who meet the eligibility criteria at the end of the Run-In period will be stratified in an approximately 1:1 ratio according to their baseline FEV1 as a percentage of predicted normal - one stratum for those with FEV1 percent predicted ≥40% to ≤65% and one for those with FEV1 percent predicted \>65% to ≤90%. Once stratified, subjects will be randomised to one of the following treatments and enter into a 24 week double-blind treatment period:1) Fluticasone furoate 100mcg once daily in the evening or 2) Fluticasone furoate 200mcg once daily in the evening.

Subjects will then attend 6 on-treatment visits at Visits 3, 4, 5, 6, 7 and 8 (Weeks 2, 4, 8, 12, 18 and 24 respectively). All visits including Visit 1 must be conducted in the evening between 5 PM and 11 PM. Subjects will receive treatment for 24 weeks. Twenty four hour urinary cortisol assessments will be collected at the end of Run-In (Visit 2) and at end of treatment (Visit 8) visits. A follow-up contact will be performed 1-week after completing study medication (Visit 9). Subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). In addition, partially used NDPIs will be collected in a subset of subjects. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.

Arms: arm 1: Inhaled corticosteroid (ICS) arm 2: Inhaled corticosteroid
Interventions: intervention 1: fluticasone furoate intervention 2: albuterol/salbutamol
Intervention descriptions: intervention 1: Inhaled corticosteroid intervention 2: Provided as rescue relief of asthma symptoms

Protocol documents:
Clinical trial NCT01439126
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Sponsor: Concordia Pharmaceuticals Inc., Barbados
Start date: 2011-08-01; Completion date: 2012-10-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the long-term efficacy and safety of KAPVAY™ (clonidine hydrochloride) extended-release in children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD)

Detailed description:

Arms: arm 1: Subjects in the KAPVAY™ arm receive their optimal dose of KAPVAY™ for the 26-week randomized-withdrawal period (Period 3) arm 2: Subjects in placebo arm tapered off optimal dose of KAPVAY™ (ie, Period 2 Maintenance Dose) at weekly intervals in decrements of 0.1 mg/day until reaching dose of 0 mg/day; subjects then receive only placebo for the rest of the study
Interventions: intervention 1: clonidine hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, 0.3 mg, or 0.4 mg from Weeks 11-36 intervention 2: KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, or 0.3 mg at Week 11; KAPVAY™ 0.1 mg, KAPVAY™ 0.2 mg, or placebo at Week 12; KAPVAY™ 0.1 mg or placebo at Week 13; placebo from Weeks 14-36

Protocol documents:
Clinical trial NCT01442363
Conditions: Perianal Crohn's Disease
Keywords: Crohn's disease perianal inflammatory bowel disease fistula
Sponsor: Braintree Laboratories
Start date: 2011-11-01; Completion date: 2012-10-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is designed to determine the effects of BLI-1300 ointment on perianal pain associated with active Perianal Crohn's Disease (PCD).

Detailed description:

Arms: arm 1: Investigational Product (10%) Ointment arm 2: Investigational Product (20%) Ointment arm 3: Placebo Ointment
Interventions: intervention 1: BLI-1300 low dose intervention 2: BLI-1300 high dose intervention 3: placebo
Intervention descriptions: intervention 1: topical ointment intervention 2: topical ointment intervention 3: topical ointment

Protocol documents:
Clinical trial NCT01449708
Conditions: Postoperative Nausea and Vomiting
Keywords: Bariatric Surgery TIVA PONV non-opioid OSA
Sponsor: Coastal Anesthesiology Consultants
Start date: 2011-11-01; Completion date: 2012-10-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases.

Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication.

Our study hypothesis is that different types of anesthetics reduce PONV further.

Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA).

The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.

Detailed description:
See above

Arms: arm 1: Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. arm 2: Patients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine
Interventions: intervention 1: TIVA NoNarc
Intervention descriptions: intervention 1: * patients in both groups receive antiemetic prophylaxis
* patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
* postop management in both groups is similar in both groups

Protocol documents:
Clinical trial NCT01460342
Conditions: Benign Prostatic Hyperplasia
Keywords: Prostatic hyperplasia Benign prostatic hyperplasia Lower urinary tract
Sponsor: Eli Lilly and Company
Start date: 2011-12-01; Completion date: 2012-10-01
Enrollment: 610 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3, randomized, double-blind, placebo-controlled, parallel-design, multinational study to evaluate the efficacy and safety of tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia.

Detailed description:
Tadalafil is being investigated as a treatment for men with signs and symptoms of benign prostatic hyperplasia \[BPH; also referred to as urinary disturbance or BPH-LUTS (BPH-lower urinary tract symptoms)\] in Japan and overseas. Overseas studies and the Japanese dose-finding study LVIA (NCT00783094) identified tadalafil 5 mg once-daily as the recommended dose. The long-term safety and maintenance of effect was confirmed in the open-label extension of study LVIA. The risk-benefit profile was further studied in the Asian study LVHB (NCT00861757).

This study, LVJF, is to confirm the efficacy and safety of tadalafil 5 mg once-daily in Asian men with BPH-LUTS.

Arms: arm 1: Following the 4-week placebo lead-in period, this arm will consist of a 12-week placebo treatment period involving 2 x 2.5-milligram (mg) tadalafil placebo tablets taken orally once daily. arm 2: Following the 4-week placebo lead-in period, this arm will consist of a 12-week treatment period involving 2 x 2.5-mg tadalafil tablets taken orally once daily.
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg (2 x 2.5-mg tablets), given once daily as oral tablet intervention 2: 2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily.

Protocol documents:
Clinical trial NCT01461369
Conditions: Osteoarthritis
Sponsor: Iroko Pharmaceuticals, LLC
Start date: 2011-10-01; Completion date: 2012-10-01
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the hip or knee.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Diclofenac intervention 2: Diclofenac intervention 3: Placebo
Intervention descriptions: intervention 1: 35 mg bid Capsules intervention 2: 35 mg tid Capsules intervention 3: Capsules

Protocol documents:
Clinical trial NCT01473836
Conditions: Intra-abdominal Infections
Keywords: Metronidazole intra-abdominal infection pelvic inflammatory disease anaerobe
Sponsor: Pfizer
Start date: 2011-11-01; Completion date: 2012-10-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium.

Detailed description:

Arms: arm 1: Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium
Interventions: intervention 1: Metronidazole intervention 2: Ceftriaxone sodium
Intervention descriptions: intervention 1: Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) for 3 to 14 days, in principle. Treatment duration can be prolonged up to 21 days based on subject's condition. intervention 2: Ceftriaxone sodium will be administered at a daily dose of 2 g (strength) when metronidazole is administered TID or at a daily dose of 4 g (strength) when metronidazole is administered QID.

Protocol documents:
Clinical trial NCT01491490
Conditions: Schizophrenia
Keywords: Schizophrenia Functional psychosis Schizophreniform Acute psychosis
Sponsor: GW Research Ltd
Start date: 2011-10-01; Completion date: 2012-10-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Olanzapine is one of the most effective and best tolerated of the atypical antipsychotics, but it is also particularly associated with weight gain and metabolic problems.

This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of two medications GW42003 and GW42004 as a 40:1 ratio when combined with the subjects existing treatment of olanzapine in subjects with weight gain attributable to olanzapine treatment for functional psychosis. This is the first study to determine whether the study medications have a positive benefit for subjects on their cholesterol levels, body weight and other metabolic parameters, as well as a potential augmentation of the anti-psychotic effect of olanzapine.

This is a multi-centre randomised, double-blind, placebo-controlled, parallel-group pilot study. There will be two groups of subjects (GWP42003 plus GWP42004 (40:1 ratio) and placebo), with a treatment duration of 6 weeks as well as a baseline period of variable length and one week follow-up. The two treatment groups will be randomised equally.

In order to be eligible for enrollment in this study, subjects will need to be aged 18 years and above and be clinically diagnosed with functional psychosis and receiving olanzapine treatment for no more than 3 months with evidence of weight gain attributable to olanzapine treatment.

Eligible subjects will enter the study at a screening visit (Visit 1) and commence a baseline period. Subjects will also be assessed at Visit 2 for further weight gain during the baseline period. The baseline period is flexible in length to allow time for this weight gain to be achieved and also for the olanzapine dose to be stabilised. If eligible the subject will be randomised into the 6-week treatment phase. There are a total of 6 visits in the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: GWP42003 : GWP42004 (40:1) intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules taken once a day for 6 weeks intervention 2: Capsules taken once a day for 6 weeks

Protocol documents:
Clinical trial NCT01498185
Conditions: Type 1 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2012-02-01; Completion date: 2012-10-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)

Detailed description:
Study Classification : Safety, Pharmacokinetics and Pharmacodynamics

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo matching Dapagliflozin
Intervention descriptions: intervention 1: Tablets, Oral, 1 mg, Once daily, 14 days intervention 2: Tablets, Oral, 0 mg, Once daily, 14 days

Protocol documents:
Clinical trial NCT01508117
Conditions: Glioblastoma Multiforme
Keywords: GBM brain tumor
Sponsor: University of Cincinnati
Start date: 2011-08-01; Completion date: 2012-10-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.

Detailed description:
The addition of axitinib to standard treatment is experimental and has not been approved by the United States Food and Drug Administration (FDA). Axitinib works by preventing new blood vessels from forming, and tumors need to make new blood vessels in order to grow. The study will find out what effects, good or bad, axitinib has on the tumor. In addition, this study will try to determine whether the response to axitinib and the overall outcome depends on certain characteristics of your tumor.

Arms: arm 1: Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity
Interventions: intervention 1: Axitinib intervention 2: Radiation Therapy
Intervention descriptions: intervention 1: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity intervention 2: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy

Protocol documents:
Clinical trial NCT01509053
Conditions: Schizophrenia
Keywords: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2012-01-01; Completion date: 2012-10-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.

Detailed description:
Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients with schizophrenia, increasing hospitalization rates, hospitalization days, and hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly diagnosed illness and has the seventh longest mean duration of hospital stay in the US. Frequent relapses and hospitalization can affect quality of life in these patients. Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment adherence and increased quality of life for patients with schizophrenia.

Arms: arm 1: Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase, participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase. Oral aripiprazole was available as rescue medication if necessary.
Interventions: intervention 1: Aripiprazole (Abilify®) IM Depot Injection intervention 2: Oral aripiprazole
Intervention descriptions: intervention 1: 400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.

Number of injections: 6. Participants have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2014. intervention 2: Oral aripiprazole tablets 10-15 mg/day (up to 30 mg/day).

Protocol documents:
Clinical trial NCT01509638
Conditions: Retraction of Colostomy
Keywords: Ileostomy reversal
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2012-03-01; Completion date: 2012-10-01
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

Detailed description:
This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Arms: arm 1: IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump arm 2: bupivacaine liposome injectable suspension.
Interventions: intervention 1: Group 1 Standard of Care intervention 2: Group 2 EXPAREL
Intervention descriptions: intervention 1: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed. intervention 2: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

Protocol documents: