ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00884832
Conditions: Fecal Incontinence
Keywords: fecal incontinence stool leakage incontinence FI Urge predominant fecal incontinence
Sponsor: Mayo Clinic
Start date: 2008-10-01; Completion date: 2012-08-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic are doing a research study to assess the effects of a medication, clonidine, on fecal incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug Administration (FDA) for treating high blood pressure, but not for treating incontinence and rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence, increase rectal capacity and reduce rectal sensation to a greater extent than placebo in women.

Detailed description:
Available therapeutic options for idiopathic fecal incontinence (FI) are limited and unsatisfactory. In addition to weak anal sphincters, our data suggest that reduced rectal capacity may contribute to rectal hypersensitivity and the symptom of rectal urgency in FI. During a 4 week study, oral clonidine restored rectal capacity and improved fecal continence in women with urge-predominant FI. Clonidine improves fecal continence and stool consistency in diarrhea-predominant irritable bowel syndrome (IBS). Therefore, we now propose a placebo-controlled study of clonidine for FI. Our aims are to (i) compare the effects of clonidine and placebo, to be given for 4 weeks, on symptoms, anal pressures, rectal compliance and sensation in women with FI. Forty four women (18-75 y) with urge predominant "idiopathic" FI and ≥ 4 episodes of FI during a 4 week screening period will be recruited to this study. Thereafter, patients will be treated with clonidine or placebo for 4 weeks. Bowel symptoms will be recorded in a diary. Anal sphincter pressures, rectal compliance and sensation will be evaluated before and during treatment with clonidine.

Arms: arm 1: Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. arm 2: Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
Interventions: intervention 1: Clonidine intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks. intervention 2: Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.

Protocol documents:
Clinical trial NCT00887640
Conditions: Prostate Cancer
Keywords: metastatic Temsirolimus prostate cancer
Sponsor: Duke University
Start date: 2009-07-01; Completion date: 2012-08-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single arm study of 11 men with treatment refractory metastatic Castrate Resistant Prostate Cancer (CRPC) who will receive temsirolimus IV at a dose of 25 mg weekly until progression. Progression will not include Prostate Specific Antigen (PSA) progression; however, upon PSA progression, the addition of an anti-androgen will be permitted. The primary objective of the study is to evaluate change in circulating tumor cell (CTC) counts over time in men with metastatic treatment-refractory CRPC in response to temsirolimus therapy.

Detailed description:

Arms: arm 1: Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
Interventions: intervention 1: Temsirolimus intervention 2: Diphenhydramine
Intervention descriptions: intervention 1: dosage form: IV dosage, frequency and duration: 25mg weekly until clinical progression intervention 2: Dosage form: IV or PO Dosage, frequency and duration: 25-50mg, 30 minutes prior to Temsirolimus infusion

Protocol documents:
Clinical trial NCT00894517
Conditions: Benign Prostatic Hyperplasia
Sponsor: Allergan
Start date: 2009-08-01; Completion date: 2012-08-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 24 week study evaluating the effects of botulinum toxin Type A on semen quality in patients with signs and symptoms of Benign Prostatic Hyperplasia (BPH).

Detailed description:

Arms: arm 1: OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1. arm 2: Placebo (saline) injected into the prostate on Day 1.
Interventions: intervention 1: Botulinum Toxin Type A intervention 2: Placebo (saline)
Intervention descriptions: intervention 1: OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1. intervention 2: Saline injected into the prostate on Day 1.

Protocol documents:
Clinical trial NCT00901186
Conditions: Diabetic Macular Edema Visual Impairment
Keywords: Diabetic Macular Edema Ranibizumab Laser Treatment Visual impairment
Sponsor: Novartis Pharmaceuticals
Start date: 2009-11-01; Completion date: 2012-08-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.

Detailed description:

Arms: arm 1: RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved. arm 2: At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
Interventions: intervention 1: RFB002 intervention 2: Laser photocoagulation
Intervention descriptions: intervention 1: 0.5 mg intervention 2: None

Protocol documents:
Clinical trial NCT00924560
Conditions: Bone Mineral Density
Keywords: Adolescents Bone Mineral Density Oral Contraceptive
Sponsor: Duramed Research
Start date: 2009-06-01; Completion date: 2012-08-01
Enrollment: 1361 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a 28-day OC regimen on bone mineral density (BMD) in adolescent females.

Detailed description:
Participants will be randomized to either a 91-day OC or a 28-day OC. Participants not seeking hormonal contraception who meet eligibility criteria will serve as a control group. Duration of the study for each study participant will be approximately 13 months.

Arms: arm 1: Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles). arm 2: Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles). arm 3: Participants received no oral contraceptives during the study.
Interventions: intervention 1: 91-day Levonorgestrel Oral Contraceptive intervention 2: 28-day Levonorgestrel Oral Contraceptive
Intervention descriptions: intervention 1: Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.

Take 1 tablet daily intervention 2: Levonorgestrel/ethinyl estradiol 0.10/0.02 mg tablet and placebo. Take 1 tablet daily

Protocol documents:
Clinical trial NCT00935493
Conditions: Cognitive Aging
Keywords: guanfacine aging cognitive aging prefrontal cognitive function executive function prefrontal cortex
Sponsor: Yale University
Start date: 2009-06-01; Completion date: 2012-08-01
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This proposal aims to determine whether low does of the alpha-2A-adrenoceptor agonist guanfacine can improve deficits in prefrontally-mediated cognitive functions in healthy elderly subjects.

Detailed description:
Primary:

* To determine whether low does of the α2A-adrenoceptor agonist guanfacine can improve deficits in prefrontally-mediated working memory and executive control functions, in healthy elderly subjects. Subjects will be randomly assigned to receive placebo or guanfacine at one of two dose levels: 0.1 mg, or 0.5 mg daily at bedtime in double-blind fashion for twelve weeks.

Secondary:

* To determine whether guanfacine can favorably influence global status and quality of life (QOL) in healthy elderly subjects.
* To determine whether low-dose guanfacine is safe and well-tolerated in healthy elderly subjects.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Guanfacine intervention 2: Guanfacine intervention 3: Placebo
Intervention descriptions: intervention 1: Guanfacine 0.1 mg po qhs intervention 2: Guanfacine 0.5 mg po qhs intervention 3: Placebo po qhs

Protocol documents:
Clinical trial NCT00960661
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide Byetta insulin lispro Humalog insulin glargine Lantus Amylin Lilly
Sponsor: AstraZeneca
Start date: 2009-09-01; Completion date: 2012-08-01
Enrollment: 1036 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

Detailed description:

Arms: arm 1: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) arm 2: Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
Interventions: intervention 1: exenatide intervention 2: insulin lispro intervention 3: Metformin intervention 4: Insulin/ Glargine
Intervention descriptions: intervention 1: subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day intervention 2: titrated based on pre-meal glucose level; three times a day intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00989573
Conditions: Crohn's Disease
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-10-01; Completion date: 2012-08-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid \[5-ASA\] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active Crohn's disease.

Detailed description:

Arms: arm 1: oral administration of placebo once-daily for 8weeks arm 2: oral administration of OPC-6535 25 mg once-daily for 8 weeks arm 3: oral administration of OPC-6535 50mg once-daily for 8 weeks
Interventions: intervention 1: Placebo intervention 2: OPC-6535 intervention 3: OPC-6535
Intervention descriptions: intervention 1: oral administration of placebo once-daily for 8 weeks intervention 2: oral administration of OPC-6535 25 mg once-daily for 8 weeks intervention 3: oral administration of OPC-6535 50 mg once-daily for 8 weeks

Protocol documents:
Clinical trial NCT00998946
Conditions: Lymphoma, B-Cell
Keywords: Relapsed Refractory Non-Hodgkin's
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2009-09-01; Completion date: 2012-08-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of relapsed or refractory B-cell Non-Hodgkin's lymphoma (NHL). The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this participant population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this participant population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).

Detailed description:

Arms: arm 1: Participants received pralatrexate at an initial dose of 30 mg/m\^2, as IV push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline on Days 1, 8 and 15 of a 4-week cycle (weekly for 3 weeks with 1 week of rest) until criteria for discontinuation per protocol were met. The initial dose of 30 mg/m\^2 may be reduced to 20 mg/m\^2 weekly, permitted per protocol defined criteria. If pralatrexate 20 mg/m\^2/week was not tolerated, pralatrexate had to be discontinued. Dose re-escalation was not allowed once dose reduction was done.

Participants had dietary supplement of vitamin B12 and folic acid along with pralatrexate. Vitamin B12, given as 1mg IM, within 10 weeks of start of pralatrexate dosing, every 8-10 weeks throughout the study and for at least 30 days post last dose of pralatrexate. Folic acid was given 1mg daily, orally, for at least 7 days prior to start of pralatrexate, throughout the study and for at least 30 days post last dose of pralatrexate.
Interventions: intervention 1: Pralatrexate intervention 2: Vitamin B12 intervention 3: Folic Acid
Intervention descriptions: intervention 1: Pralatrexate injection administered as intravenous (IV) push intervention 2: 1 mg intramuscular (IM) injection intervention 3: Oral 1 mg tablet

Protocol documents:
Clinical trial NCT01010477
Conditions: Smoking Cessation Schizophrenia
Keywords: smoking cessation schizophrenia nicotine nasal spray behavioral counseling
Sponsor: Rutgers, The State University of New Jersey
Start date: 2009-08-01; Completion date: 2012-08-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The objectives of this study are to determine the efficacy of NNS with behavioral intervention for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of subjects who receive NNS and behavioral intervention will be significantly greater than the quit rate of the control group who will receive the placebo spray plus same behavioral intervention. Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million during these 4 weeks. The investigators will also assess abstinence rates at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been stopped. Since studies of this group suggest high relapse rates when treatments are discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the investigators will continue NNS treatment for a total of 20 weeks.

Detailed description:

Arms: arm 1: Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. . Nasal spray will be used from the TQD through the end of Week 20. arm 2: Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Nasal spray will be used from the TQD through the end of Week 20.
Interventions: intervention 1: Nicotine Nasal Spray intervention 2: Behavioral counseling
Intervention descriptions: intervention 1: minimum 8 doses of nasal spray per day; maximum of 5 doses per hour, no more than 40 doses per day intervention 2: Both groups will receive behavioral intervention designed for schizophrenia delivered as 15 individual counseling sessions over 26 weeks.

Protocol documents:
Clinical trial NCT01015807
Conditions: Hyperalgesia, Secondary
Keywords: postoperative hyperalgesia pain transversus abdominis plane block TAP block cesarean section
Sponsor: University of Washington
Start date: 2009-11-01; Completion date: 2012-08-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether a transversus abdominis plane (TAP) block with Clonidine added to the injectate (Clo-TAP) performed approximately 2hrs after the cesarean section (CS) will decrease the amount of postoperative hyperalgesia and ultimately reduce post-CS chronic pain.

Detailed description:
Acute severe pain after cesarean section (CS) occurs more often than is thought and 10-15% of the women having a cesarean section develop chronic pain (Kehlet et al. 2006). With over 1.3 million cesarean deliveries per year in the US, this is bound to create a significant health problem. One way to address this health burden is to refine techniques that may help control the pain women experience after CS and ultimately reduce the potential to develop chronic pain.

The purpose of this randomized, double-blinded study is to evaluate the ability of an established anesthetic technique called the transversus abdominis plane (TAP) block to reduce the amount of hyperalgesia women develop around their incision after CS. Measuring the amount of punctuate mechanical hyperalgesia is used as a tool to assess postoperative central sensitization (Lavand'homme et al. 2005), which contributes to postoperative acute pain. Since postoperative acute pain has been shown to be predictive of developing postoperative chronic pain (Eisenach et al. 2008; Yarnitsky et al. 2008), an effective TAP block could help diminish the incidence of chronic pain after CS. In addition, blood samples will be collected for future genetic analysis and we will test preoperatively for mechanical temporal summation (mTS) to evaluate CNS (central nervous system) sensitization and nociceptive system hyperexcitability and see if this correlates with the amount of hyperalgesia women develop around their incision after surgery.

The primary aim of this study is to evaluate the benefits of two different solutions injected by TAP block technique on postoperative peri-incisional hyperalgesia.

Arms: arm 1: Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo arm 2: 2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo arm 3: 2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine
Interventions: intervention 1: Bupivacaine Placebo intervention 2: Clonidine Placebo intervention 3: Bupivacaine intervention 4: Clonidine
Intervention descriptions: intervention 1: 2 x 20mL 0.9% NaCl intervention 2: 2 x 1mL 0.9% NaCl intervention 3: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine intervention 4: 2 x 1ml Clonidine = 150 µg Clonidine

Protocol documents:
Clinical trial NCT01017263
Conditions: Attention Deficit Hyperactivity Disorder Glucose Intolerance Obesity
Keywords: ADHD Glucose Intolerance Obesity Vyvanse
Sponsor: Duke University
Start date: 2009-12-01; Completion date: 2012-08-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study to assess the effects of chronic administration of Vyvanse (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are obese.

Detailed description:

Arms: arm 1: Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
Interventions: intervention 1: Lis-dexamphetamine
Intervention descriptions: intervention 1: Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.

Protocol documents:
Clinical trial NCT01034657
Conditions: Myelodysplastic Syndrome (MDS)
Keywords: MDS bone marrow anemia cytopenia transfusion dependance EPO ESA erythropoietin LBH589 Myelodysplastic Syndromes hematopoietic improvement IPSS Low IPSS Int-1 HI-E HDAC Inhibitor HDAC-I DAC-I Deacetylase-Inhibitor Histone Deacetylase-Inhibitor red blood cell transfusions
Sponsor: Novartis Pharmaceuticals
Start date: 2009-11-01; Completion date: 2012-08-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study assessed the efficacy and safety of LBH589 as single agent and in combination with ESA in red blood cell transfusion-dependent Low and Int-1 MDS patients being either refractory to ESA or with a low probability of response. The study had a non-randomized core phase followed by a randomized phase.

Detailed description:

Arms: arm 1: During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months. arm 2: During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
Interventions: intervention 1: LBH589 intervention 2: Epoetin Alfa
Intervention descriptions: intervention 1: LBH589 was supplied at dose strengths of 5 mg or 20 mg hard gelatin capsules. intervention 2: Epoetin alfa was supplied as 10000 IU/1 mL in a ready-to-use syringe.

Protocol documents: