ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01312766
Conditions: Infertility
Sponsor: IBSA Institut Biochimique SA
Start date: 2011-02-01; Completion date: 2013-12-01
Enrollment: 270 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.

Detailed description:

Arms: arm 1: New hMG preparation. arm 2: None
Interventions: intervention 1: Menotropins intervention 2: Menotropins
Intervention descriptions: intervention 1: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. intervention 2: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.

Protocol documents:
Clinical trial NCT01315574
Conditions: Glaucoma
Keywords: Glaucoma Xalatan Travatan Z Latanoprost Travoprost Dry Eye
Sponsor: Massachusetts Eye and Ear Infirmary
Start date: 2011-02-01; Completion date: 2013-12-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the efficacy of FDA-approved Travoprost (Travatan Z) and Latanoprost (Xalatan)as anti-glaucoma treatment. Several studies indicate that glaucoma medications may be associated with decreased tear production and tear film break-up time (TBUT), and increased inflammatory cells in the conjunctiva (membrane lining of the eye lids and the covering of the eye) leading to dry eye. Normal tear film (coating of the eye) is continuous and blinking maintains the tear film continuity. If you keep your eyes open long enough without blinking, the tear film will start breaking up. Your eye will feel uncomfortable forcing you to blink. In patients with dry eyes, the tear film is unstable, and breaks up faster. Therefore the tear break up time in patients who have dry eyes is shorter.

In this study, the investigators will be comparing the two previously mentioned FDA-approved eye drops Latanoprost and Travoprost. The difference between the two medications is a preservative called benzalkonium chloride (BAK). Latanoprost contains BAK while Travoprost does not. The investigators will be comparing the efficacy of each medication in lowering IOP as well as trying to track the density of immune cells across the corneal surface by taking photos of your eye. The investigators will also be assessing whether either drop leads to symptoms of dry eye by comparing results from ocular surface exam tests such as TBUT.

Detailed description:
The purpose of the study is to compare the early effects of two anti-glaucoma eye drops on eye pressure and inflammation of the eye using a microscope. One of the eye drops contains a commonly used preservative, benzalkonium chloride (BAK), while the other is free of this preservative, instead it utilises a new ionic buffer system called SofZia. Prolonged use of BAK may be damaging to the eye surface and thus being investigated at a microscopic level in this study.

Specific aims are to assess the in vivo effect of topical BAK-containing and BAK-free prostaglandin analogue anti-glaucoma therapy on intraocular pressure (IOP), as well as on density and morphology of corneal immune cells, epithelial cells and sub-basal nerve plexus.

Arms: arm 1: 7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma. arm 2: 7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.
Interventions: intervention 1: Travoprost intervention 2: Latanoprost
Intervention descriptions: intervention 1: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily. intervention 2: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.

Protocol documents:
Clinical trial NCT01332721
Conditions: Adult Solid Tumor
Keywords: TRC105 CD105 Endoglin Solid Tumors Avastin Bevacizumab
Sponsor: Tracon Pharmaceuticals Inc.
Start date: 2011-04-01; Completion date: 2013-12-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate safety and tolerability and determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced solid tumors for which bevacizumab is indicated.

Detailed description:
Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor types. TRC105, a monoclonal antibody to CD105, is a novel angiogenesis inhibitor that complements bevacizumab in preclinical models. Together, these antibodies may result in more effective angiogenesis inhibition and improved clinical efficacy over that seen with bevacizumab alone. The purpose of the study is to evaluate safety and tolerability and determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced solid tumors for which bevacizumab is indicated.

Arms: arm 1: Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.
Interventions: intervention 1: TRC105 and Bevacizumab
Intervention descriptions: intervention 1: Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.

Protocol documents:
Clinical trial NCT01334229
Conditions: Type 2 Diabetes Mellitus
Keywords: sitagliptin diabetes apolipoprotein B48 and B100
Sponsor: Laval University
Start date: 2011-04-01; Completion date: 2013-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-IV), and has been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes mainly through incretin hormone-mediated improvements in islet function \[13\]. Although clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-IV inhibitor treatment \[14-16\], animal studies suggested that DPP-IV inhibition reduce intestinal triglycerides (TG) absorption and apolipoprotein (apo) production \[17\] and increased chylomicron catabolism \[18\]. Interestingly, a recent study supporting this hypothesis showed that vildagliptin therapy was able to reduce postprandial intestinal triglyceride-rich lipoproteins (TRL) particles in patients with type 2 diabetes \[19\]. Recently, our group has reported that sitagliptin treatment significantly reduced plasma apo B-48 and TG concentrations in the postprandial state. Moreover, animal studies showed that sitagliptin decreased intestinal secretion of intestinal apo B-48, mainly by increasing level of glucagon-like peptide (GLP)-1 \[20\]. Therefore, the present study was designed to examine the effects of sitagliptin on the kinetics of TRL apo B-48 and in patients with type 2 diabetes. A possible reduction in postprandial atherogenic TRL apo B-48-containing lipoprotein levels by sitagliptin would add to therapeutic utility of this DPP-4 inhibitor and suggest the potential to reduce cardiovascular risk in patients with type 2 diabetes.

Detailed description:

Arms: arm 1: Sitagliptin 100 mg/d for 6 weeks arm 2: Placebo for 6 weeks
Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Sitagliptin 100 mg/d for 6 weeks intervention 2: Placebo for 6 weeks

Protocol documents:
Clinical trial NCT01335867
Conditions: Alcoholism Cocaine Dependence
Sponsor: University of Pennsylvania
Start date: 2011-04-01; Completion date: 2013-12-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.

Detailed description:
The hypotheses in the proposed study will be tested with a 2-group design to assess the efficacy of vigabatrin compared to placebo. We will follow NIAAA's COMBINE Medical Management (MM) manual in weekly dispensing medications, safety checks and medication adherence. The psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 60 men and women with current DSM-IV diagnoses of both cocaine and alcohol dependence who will be randomized to vigabatrin or placebo (30 subjects per group). All subjects will receive weekly sessions of CBT. The study length for each subject is comprised of a1-3 weeks of screening and baseline evaluations, an 8-week double-blind, placebo-controlled trial with CBT (medication phase), and one follow-up visit 12 weeks after starting study medication.

Study medication will be initiated in Week 2. The research physician will explain the dosing regimen and subjects will be randomly assigned to receive either vigabatrin or identical placebo tablets. Subjects will receive 1 gram of vigabatrin or identical placebo tablets on medication days 1-3 then 1.5 grams or identical placebo tablets on days 4-7. The dose ids increased to 2 grams in week 2, 3 grams in weeks 4-7 and then reduced to 2 grams days 50-53, and to 1 gram on days 54-56

Arms: arm 1: Vigabatrin titrated to 3 grams daily for 8 weeks arm 2: Identical placebo daily for three weeks
Interventions: intervention 1: Vigabatrin intervention 2: Placebo
Intervention descriptions: intervention 1: Vigabatrin escalated to 3 grams daily for 8 weeks intervention 2: Placebo pills

Protocol documents:
Clinical trial NCT01337687
Conditions: Autism Spectrum Disorders
Keywords: Autism Autism Spectrum Disorders Oxytocin Hollander ASD Asperger Syndrome Asperger
Sponsor: Montefiore Medical Center
Start date: 2009-10-01; Completion date: 2013-12-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Autism Spectrum Disorder (ASD) is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning and repetitive behaviors and restricted interests. Oxytocin (OT) is peptide that is known for its peripheral effects on facilitating uterine contractions and milk let-down; however, studies, mainly with rodents and non-human primates, has found that OT is involved in affiliative behaviors, including sexual behavior, mother-infant and adult-adult pair-bond formation, separation distress, and other aspects of social attachment. Moreover, OT is known to play an important role in repetitive behaviors and stress reactivity. Given that repetitive behaviors and deficits in social interaction are core symptom domains of autism, and that OT is involved in the regulation of repetitive and affiliative behaviors, it is believed that OT may play a role in the etiology of autism. Moreover, preliminary data obtained by Hollander and colleagues suggests that OT may be of value in treating core autism symptoms. Specifically, synthetic oxytocin administered via intravenous infusion to adults with autism spectrum disorders (ASD) produced significant reductions in repetitive behaviors and facilitated social cognition/memory in a double-blind, placebo-controlled cross-over laboratory challenge.

Encouraged by these findings, the primary aim of this study is to investigate the safety and therapeutic efficacy of intranasal OT in treating repetitive behaviors and social functioning/cognitive deficits in adults with ASD. This research embraces a translational approach to develop a novel treatment for core ASD symptoms; given that there are currently no Food and Drug Administration (FDA) approved medication treatments for core ASD symptoms, this research addresses an important unmet need in the field. The goal of this study is to evaluate the safety and efficacy of repeated Intranasal Oxytocin Treatment (INOT)administration in adults with ASD.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Intranasal Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: Oxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day. intervention 2: Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.

Protocol documents:
Clinical trial NCT01342341
Conditions: Alcohol Abuse
Sponsor: University of California, San Francisco
Start date: 2011-04-01; Completion date: 2013-12-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The overall goals of this study are to (1) expand knowledge about interactions of chlorzoxazone with alcohol by assessing the effects of chlorzoxazone compared to placebo in moderate and heavy social alcohol users and (2) to compare the effects of chlorzoxazone on visual cue induced alcohol craving to placebo in moderate to heavy social alcohol users.

Detailed description:
The investigators propose a 45-day, double-blind, placebo-controlled crossover study in light to moderate and heavy alcohol users.

The specific aims are to:

1. Determine if chlorzoxazone alters daily alcohol consumption by comparing the mean drinks consumed per day during chlorzoxazone administration compared with the mean drinks per day consumed during placebo administration.
2. To determine if polymorphisms in genes encoding for neurotransmitters or receptors involved in alcohol reward, abuse, dependence, craving, or relapse may predict the level of response to chlorzoxazone's effects on alcohol consumption or craving.
3. To investigate any change in alcohol craving during a cue induced craving task where participants view and respond to a number of images.

Arms: arm 1: Experimental: Forty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (1st intervention; 14 days), followed by a washout (7 days), and then followed by placebo (2nd intervention; 14 days). arm 2: Experimental: Forty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive placebo (1st intervention; 14days) followed by a washout (7 days), and then followed by either 250 or 500 mg of chlorzoxazone BID (500 or 1000 mg/day) x 7 days followed by 500 or 1000 mg of chlorzoxazone BID (1000 or 2000 mg/day) x 7 days (2nd intervention; 14 days).
Interventions: intervention 1: Parafon Forte
Intervention descriptions: intervention 1: Drug: Parafon Forte administered at study visit

Other: Placebo administered at study visit

Protocol documents:
Clinical trial NCT01359943
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis RA secukinumab AIN457 inflammatory joints American College of Rheumatology ACR
Sponsor: Novartis Pharmaceuticals
Start date: 2011-10-01; Completion date: 2013-12-01
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite treatment with Methotrexate.

Detailed description:

Arms: arm 1: secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8 arm 2: secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8 arm 3: placebo at Weeks 0, 1, 2, 3, 4, 8 \& 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
Interventions: intervention 1: secukinumab (AIN457) intervention 2: placebo
Intervention descriptions: intervention 1: Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). intervention 2: Matching placebo to AIN457 i.v. and to AIN457 s.c..

Protocol documents:
Clinical trial NCT01364649
Conditions: Treatment Outcome
Keywords: Sexual Dysfunction, Physiological Depressive Disorder, Major Depression Antidepressive Agents Drug Therapy
Sponsor: Takeda
Start date: 2011-06-01; Completion date: 2013-12-01
Enrollment: 447 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Vortioxetine (Lu AA21004), once daily (QD), compared with escitalopram on sexual functioning.

Detailed description:
The drug being tested in this study is called Lu AA21004. Lu AA21004 is being tested to treat people who have major depressive disorder (MDD). This study will look at sexual function in people who take Lu AA21004.

The study will enroll approximately 440 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Lu AA21004 10 to 20 mg
* Escitalopram 10 to 20 mg - This is a comparator drug that is also used to treat MDD.

All participants will be asked to take one tablet at the same time each day throughout the study. All participants will be asked to answer questionnaires at each study visit.

This multi-centre trial will be conducted in the United States and Canada. The overall time to participate in this study is 14 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 21 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg, tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only. arm 2: Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only.
Interventions: intervention 1: Vortioxetine intervention 2: Escitalopram intervention 3: Placebo
Intervention descriptions: intervention 1: Vortioxetine tablets intervention 2: Escitalopram tablets intervention 3: Vortioxetine Placebo-matching capsules

Protocol documents:
Clinical trial NCT01383135
Conditions: Breast Cancer Non-Small-Cell Lung Cancer Glioblastoma Other Cancers
Keywords: Healthy volunteers
Sponsor: Stanford University
Start date: 2010-10-01; Completion date: 2013-12-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study was to conduct a pilot test of new tracers (\[18F\]FPRGD2 and \[18F\]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data.

The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.

Detailed description:
The tracer \[18F\]FPRGD2 was not evaluated in this study. The protocol title was never amended to reflect this.

Arms: arm 1: Normal volunteers to receive 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection. arm 2: Breast cancer patients to receive 4 to 11 mCi F18-FPPRGD2 by IV injection. arm 3: Glioblastoma multiform patients to receive 5 to14 mCi F18-FPPRGD2 by IV injection. arm 4: Lung cancer patients to receive X to XX mCi F18-FPPRGD2 by IV injection.
Interventions: intervention 1: F18-FPPRGD2
Intervention descriptions: intervention 1: Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).

Protocol documents:
Clinical trial NCT01386528
Conditions: Congenital Bleeding Disorder Haemophilia B
Sponsor: Novo Nordisk A/S
Start date: 2012-06-07; Completion date: 2013-12-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

Detailed description:

Arms: arm 1: New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial
Interventions: intervention 1: nonacog beta pegol
Intervention descriptions: intervention 1: The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).

Protocol documents:
Clinical trial NCT01391611
Conditions: Gastrointestinal Stromal Tumor (GIST)
Sponsor: Kristen Ganjoo
Start date: 2011-07-01; Completion date: 2013-12-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to gather information about the safety (any harmful effects) and effectiveness (usefulness) of Pazopanib in the treatment of Gastrointestinal Stroma Tumors (GIST) that cannot be treated by surgery or has spread to other organs. The Food and Drug Administration (FDA) have approved Pazopanib for the treatment of advanced kidney cancer but it is not approved for the treatment of GIST. The investigators hope to learn about the safety and usefulness (effectiveness) of Pazopanib for patients with GIST.

Primary Objective:

Non-progression rate based on RECIST criteria (CR+PR+SD)

Secondary Objectives:

* Response per Choi criteria
* 6 month progression-free survival
* Safety and tolerability

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: 800 mg; PO

Protocol documents: