ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01662115
Conditions: Post-operative Ileus
Keywords: ILEUS
Sponsor: The Cleveland Clinic
Start date: 2012-08-01; Completion date: 2014-06-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative period influences surgical outcome in patients undergoing colorectal surgery.

Detailed description:
The main hypothesis of this study is that use of nicotine gum after colorectal surgery will accelerate recovery of bowel function. Eligible patients include all patients undergoing segmental small bowel or large bowel resection with a planned primary anastomosis, planned removal of the nasogastric tube at the end of the surgery, and administration of clear liquids on post-operative day one. Patients who have an ileostomy or colostomy created will be excluded. Patients enrolled in the study will be randomized to one of three groups: nicotine gum, regular gum, or no gum. Patients randomized to nicotine gum or regular gum will chew the gum three times a day for 1 week. The main outcome measure is time to first bowel movement or flatus.

Arms: arm 1: 100 subjects who will actually get the intervention medication arm 2: 100 subjects who will be part of a control group arm 3: 100 subjects who will not get neither the intervention nor the placebo gum.
Interventions: intervention 1: Nicotine gum intervention 2: Regular chewing gum
Intervention descriptions: intervention 1: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first intervention 2: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first

Protocol documents:
Clinical trial NCT01664039
Conditions: Glaucoma Ocular Hypertension
Keywords: Glaucoma Ocular hypertension
Sponsor: Alcon Research
Start date: 2012-09-01; Completion date: 2014-06-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.

Detailed description:

Arms: arm 1: Travoprost 0.004% ophthalmic solution with Polyquad®, 1 drop to the study eye(s), once a day in the evening, for 6 months arm 2: Bimatoprost 0.01% ophthalmic solution with BAK, 1 drop to the study eye(s), once a day in the evening, for 6 months
Interventions: intervention 1: Travoprost 0.004% ophthalmic solution intervention 2: Bimatoprost 0.01% ophthalmic solution
Intervention descriptions: intervention 1: Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative intervention 2: Ophthalmic solution containing benzalkonium chloride (BAK)

Protocol documents:
Clinical trial NCT01667679
Conditions: Migraine Headaches
Keywords: Migraine Headaches Sumatriptan
Sponsor: Avanir Pharmaceuticals
Start date: 2012-08-01; Completion date: 2014-06-01
Enrollment: 275 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine headaches in 30 minutes after use.

Detailed description:
The primary objective for this study is to compare the proportion of attacks in which pain reduction (defined as a decrease in pain intensity of at least 1 point) is achieved at 30 minutes following 20 mg OPTINOSE SUMATRIPTAN treatment with 100 mg Sumatriptan Tablets

Arms: arm 1: 20 mg OPTINOSE SUMATRIPTAN Powder Delivered Intranasally With the Bi-directional Device nasally and Placebo Tablet arm 2: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
Interventions: intervention 1: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally intervention 2: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01667900
Conditions: Diabetes Mellitus, Type 2 Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-08-01; Completion date: 2014-06-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of dulaglutide in Chinese participants. The purpose of the study is to determine how the body processes dulaglutide and how dulaglutide affects the body. This study has 2 parts: Part A - single dose of dulaglutide administered to healthy participants in 2 of 3 study periods. There is a minimum 28-day washout between periods. Part A will last approximately 16 weeks. Part B - multiple doses of dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM). Part B will last approximately 15 weeks.

Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this study.

Detailed description:

Arms: arm 1: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods arm 2: 0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods arm 3: 1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods arm 4: Placebo administered once SQ to healthy participants in 1 of 3 treatment periods arm 5: 0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks arm 6: 0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks arm 7: 1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks arm 8: Placebo administered to participants with T2DM once weekly SQ for 4 weeks
Interventions: intervention 1: Dulaglutide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.

Protocol documents:
Clinical trial NCT01670019
Conditions: Major Depressive Disorder Without Psychotic Features
Keywords: Depression Antidepressant Antipsychotic
Sponsor: Duke University
Start date: 2012-10-01; Completion date: 2014-06-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing antidepressant treatment in patients with major depression who have not had a complete therapeutic response to treatment with the antidepressant alone.

The investigators hypothesize that added asenapine will produce greater reductions in depression than will added placebo.

Detailed description:
The investigators will undertake a 6-week, double-blind, randomized, parallel-group, placebo-controlled trial of adjunctive asenapine in 130 patients with MDD without psychosis who have had an incomplete therapeutic response to treatment with an antidepressant medication alone.

Arms: arm 1: Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability arm 2: Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability
Interventions: intervention 1: Asenapine 5-20 mg daily intervention 2: Placebo 1-4 tablets daily
Intervention descriptions: intervention 1: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID intervention 2: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID

Protocol documents:
Clinical trial NCT01674010
Conditions: Bipolar 1 Disorder
Sponsor: OPKO Health, Inc.
Start date: 2012-08-01; Completion date: 2014-06-01
Enrollment: 309 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.

Detailed description:

Arms: arm 1: Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks arm 2: Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks
Interventions: intervention 1: ELND005 intervention 2: Lamotrigine intervention 3: Valproic acid intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01675167
Conditions: Low Back Pain
Keywords: CLBP Chronic Low Back Pain Chronic Pain Back Pain
Sponsor: BioDelivery Sciences International
Start date: 2012-09-01; Completion date: 2014-06-01
Enrollment: 815 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-experienced subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.

Detailed description:

Arms: arm 1: Twice Daily Dosing arm 2: Twice Daily Dosing
Interventions: intervention 1: Buprenorphine intervention 2: Placebo
Intervention descriptions: intervention 1: Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily intervention 2: Matching Placebo Buccal Film twice daily

Protocol documents:
Clinical trial NCT01678911
Conditions: Irritable Bowel Syndrome Ulcerative Colitis Interstitial Cystitis Prostatitis Pelvic Pain
Keywords: Pelvic Pain Chronic Pelvic Pain Irritable Bowel Syndrome IBS Ulcerative Colitis UC Interstitial Cystitis IC Prostatitis Pain
Sponsor: Shirley Ryan AbilityLab
Start date: 2012-08-01; Completion date: 2014-06-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is done to investigate the pain relieving effects of the study drug Gralise (a novel long acting gabapentinoid) for people who experience chronic pelvic pain. Subjects with Irritable Bowel Syndrome, Interstitial Cystitis, Ulcerative Colitis, and Prostatitis will be recruited. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been reported to be well tolerated and effective in the treatment of various chronic pain conditions, particularly in neuropathic pain. About 36 subjects will take part in this study.

Detailed description:
As a participant in this study, you will be asked to come to the Rehabilitation Institute of Chicago (RIC), Center for Pain Studies (446 E Ontario St. Suite 1011, Chicago, IL 60611). Your part in this study will last for 15 weeks and will involve 4 visits to the Rehabilitation Institute of Chicago and anywhere from weekly phone calls to phone calls every other day.

If you are in this study, you will be placed in one of two study groups: one group will receive the study drug followed by a placebo and the second group will receive a placebo followed by the study drug. The amount of weeks on placebo versus the study drug will not be equal. You will be assigned a study group by chance using a process similar to the flip of a coin. This process is called randomization. Neither you nor the study staff will select the group you will be in. However, if you have a medical emergency, we can get this information. A placebo looks like the study drug but is an inactive substance that has no medication. Researchers use a placebo to see if the study drug works better or is safer than not taking anything.

Arms: arm 1: Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2. arm 2: Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
Interventions: intervention 1: Gralise
Intervention descriptions: intervention 1: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of "wash-out" before repeating the above procedure for the other arm of the study (placebo or medication).

Protocol documents:
Clinical trial NCT01682863
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QAB149, QVA149, indacaterol maleate, gylcopyrronium bromide
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-01; Completion date: 2014-06-01
Enrollment: 614 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

Detailed description:

Arms: arm 1: QVA149 27.5/12.5 μg capsules arm 2: QVA149 27.5/25 μg capsules arm 3: QAB149 75 μg capsules
Interventions: intervention 1: QVA149 intervention 2: QVA149 intervention 3: QAB149 intervention 4: Placebo
Intervention descriptions: intervention 1: QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI intervention 2: QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI intervention 3: QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI intervention 4: To mimic QAB149

Protocol documents:
Clinical trial NCT01684202
Conditions: Carcinomatous Edema
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2012-07-01; Completion date: 2014-06-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
OPC-41061 will be administered to patients with volume overload associated with cancer, first by dose-escalation and subsequently for 6 consecutive days at the fixed dose at which urine volume is increased to investigate efficacy, pharmacokinetics, pharmacodynamic effects, and safety and to determine the effective initial and maintenance doses of OPC-41061.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OPC-41061
Intervention descriptions: intervention 1: orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.

Protocol documents:
Clinical trial NCT01690000
Conditions: Osteoporosis
Sponsor: University of Aarhus
Start date: 2012-11-01; Completion date: 2014-06-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.

Detailed description:
Background: Melatonin is known for its regulation of circadian rhythm. The production falls with age, which explains why elderly may have disturbed sleep patterns. Laboratory study and animal experimental studies suggests that melatonin also may protect against bone loss through increased osteoblast- and inhibited osteoclast activity. However, so far human studies have not been performed.

Design and patients: Double blinded randomised controlled study. Eighty post-menopausal women (aged 55-75) with osteopenia are randomized to receive 1mg, 3mg or placebo (daily - at night time) for 12 months.

Methods and results: Effects of melatonin on BMD, bone- structure and mass will be assessed through DXA-scans, pQCT, and QCT. Quality of life, sleep, and activity level will be assessed though questionnaires. Calcium homeostasis will be analyzed through blood and urines samples. As safety parameters, balance and muscle function will also be performed.

Conclusion: Expected improvements in BMD, quality of life and sleep.

Arms: arm 1: 1 mg melatonin nightly arm 2: 3 mg melatonin given nightly arm 3: Identical placebo given nightly
Interventions: intervention 1: Melatonin
Intervention descriptions: intervention 1: 1 or 3 mg of melatonin PO each night for 12 months

Protocol documents:
Clinical trial NCT01699685
Conditions: Chronic Obstructive Pulmonary Disease: COPD
Keywords: Moderate to severe COPD patients are included NVA QAB
Sponsor: Novartis Pharmaceuticals
Start date: 2012-11-01; Completion date: 2014-06-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study purpose is to evaluate the effect of QAB149

* NVA237 vs. QAB149 on static lung hyperinflation.

Detailed description:
This is a multicenter, randomized, double-blinded, single-dose, cross-over, placebo-controlled study. The primary endpoint was chosen to demonstrate the superiority of a single-dose of the combined inhalation vs. the mono inhalation regarding the Inspiratory Capacity (IC) peak value. A total of 78 patients will be randomized to complete two visits with two single doses of treatment. Patients will be randomized in a cross-over manner. Treatment visits will be separated by a study medication wash-out period.Treatments will be administered in a blinded fashion.

The patients will be male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and \>10-pack years history of smoking, FEV1 \<80% and ≥30% of the predicted normal value.

Arms: arm 1: Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI arm 2: Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI
Interventions: intervention 1: QAB149 intervention 2: Placebo intervention 3: NVA237
Intervention descriptions: intervention 1: Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI intervention 2: Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI intervention 3: Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Protocol documents:
Clinical trial NCT01724190
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes Vitamin D Clinical Remission
Sponsor: Nationwide Children's Hospital
Start date: 2012-11-01; Completion date: 2014-06-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if supplementation with Vitamin D in children and adolescents with newly diagnosed type 1 diabetes increases the number of patients who enter the honeymoon period.

Detailed description:
Type 1 diabetes is an autoimmune disease characterized by destruction of the insulin secreting beta-cells of the pancreas. There is evidence that Vitamin D may play a role in the initial risk of development of autoimmune disease, including type 1 diabetes. However, Vitamin D may also play a role the natural progression of type 1 diabetes by altering innate insulin secretion and sensitivity and by influencing systemic inflammation, directly at the level of the beta-cell. Studies have shown that Vitamin D insufficiency or deficiency is frequently reported in children and adolescents with type 1 diabetes. A majority of newly diagnosed patients with type 1 diabetes enter a period of partial clinical remission, characterized by low or even absent insulin requirements, also known as a honeymoon period. This honeymoon period is associated with improved metabolic control, near normal insulin sensitivity, and recovery of beta-cell function leading to preservation of endogenous insulin secretion. We hypothesize that supplementation with Vitamin D in children and adolescents with newly diagnosed type 1 diabetes will halt the destructive process within the beta cell and improve beta-cell function by increasing endogenous insulin secretion and decreasing systemic inflammation, thereby increasing the rate of partial clinical remission.

Arms: arm 1: Subjects will receive oral vitamin D supplementation, 3000 IU daily over the course of 9 months. arm 2: Subjects will receive a placebo solution daily over the course of 9 months.
Interventions: intervention 1: Vitamin D intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01733472
Conditions: Osteoarthritis
Keywords: anaesthetic techniques subarachnoid analgesia
Sponsor: Region Skane
Start date: 2013-01-01; Completion date: 2014-06-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether general anaesthesia or regional anaesthesia is best for patients undergoing Total Hip Arthroplasty.

Detailed description:
A randomized controlled trial (RCT) with a follow up time of 48 hrs. Patients scheduled for primary Total Hip Arthroplasty. A total of 120 patients randomly assigned to one of the two alternatives (general anaesthesia (GA) or regional anaesthesia (RA)).

General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (LOS) for patients undergoing total hip arthroplasty (THA).

Primary endpoint:

LOS.

Secondary endpoints:

Postoperative pain? Postoperative orthostatic function (dizziness) Time until the patient meets the discharge criteria from PACU How many patients will need at least one urinary bladder catheterisation

Arms: arm 1: RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg arm 2: GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol
Interventions: intervention 1: GA-arm, remifentanil intervention 2: RA-arm
Intervention descriptions: intervention 1: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm intervention 2: Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.

Protocol documents: