ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01774760
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: 18F-EF5 PET/CT Reproducibility
Sponsor: Turku University Hospital
Start date: 2013-03-01; Completion date: 2016-09-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The results of previous studies suggest further development of \[18F\]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of \[18F\]EF5 intratumor distribution using repeated pretreatment PET/CT scans.

Detailed description:
All patients will undergo normal diagnostic and staging procedures, including a conventional 18F-FDG PET/CT scan for the purpose of RT or surgical planning. In addition to that, an 18F-EF5 PET/CT scan will be performed on a separate day. The patients receive intravenous injection of 250-350 MBq of \[18F\]EF5. After that, a venous blood sample will be obtained for measurement of plasma radioactivity. A low-dose CT (helical) will be performed for attenuation correction and anatomical reference. After that, a PET scan will be performed (starting at 3 h after injection). The second 18F-EF5 scan will be performed in a similar way 4-7 days after the first scan. A representative histologic sample of primary tumor is pre-condition for study and an effort is made to store part of fresh histologic material in liquid nitrogen for later use in immunohistochemical analysis.

Patients are scheduled to undergo preoperative or definitive chemoradiotherapy using current clinical standards after completion of the current protocol. Follow-up information (event-free survival and overall survival) will be gathered.

Arms: arm 1: 18F-EF5 PET/CT scan
Interventions: intervention 1: 18F-EF5 intervention 2: Pretreatment PET/CT-scan (performed two times)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01913340
Conditions: Hypoxic-ischemic Encephalopathy Neonatal Encephalopathy Birth Asphyxia
Keywords: erythropoietin therapeutic hypothermia
Sponsor: University of California, San Francisco
Start date: 2013-09-01; Completion date: 2016-09-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability. Cooling therapy (hypothermia) provides some protection, but about half of affected infants still have a poor outcome. This clinical trial will determine if the drug erythropoietin, given with hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic deficits after HIE.

Detailed description:
This phase I/II clinical trial is designed to demonstrate:

1. The feasibility of recruiting, enrolling and following 50 patients with moderate to severe HIE at 5 sites, while meeting specified recruitment and follow-up target goals.
2. The safety of high-dose Epo therapy in neonates with HIE with respect to systemic organ function and general growth parameters.
3. The value of brain MRI/MRS performed at 4-7 days of age as a biomarker of motor function at 12 months of age.

Arms: arm 1: 1000 U/kg/dose x 5 doses arm 2: None
Interventions: intervention 1: Erythropoietin intervention 2: Normal saline
Intervention descriptions: intervention 1: 1000 U/kg/dose IV x 5 doses intervention 2: placebo: NS IV x 5 doses

Protocol documents:
Clinical trial NCT01948388
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Sponsor: Gaylis, Norman B., M.D.
Start date: 2013-09-01; Completion date: 2016-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effect of the utilization of two doses of corticotrophin ( ACTH) as a treatment in patients with early onset rheumatoid arthritis as an alternative to conventional steroid therapy by evaluating the change from baseline in the clinical findings as well as the structural findings on Magnetic Resonance Imaging (MRI). Corticotrophin (ACTH) may prevent the well documented structural progression damage in RA patients using disease-modifying antirheumatic drug (DMARD) therapy alone.

Detailed description:
This is a Phase II 24-week open-label study to evaluate the efficacy and safety of H.P. Acthar Gel Respository Injection, Corticotrophin( ACTH) administered to newly diagnosed patients with rheumatoid arthritis in conjunction with methotrexate, folllowed by a 24 week follow-up period. There will be a total of twenty (20) patients and two (2) treatment groups with 10 patients in each treatment group

Arms: arm 1: Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) weekly arm 2: Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) twice a week
Interventions: intervention 1: corticotrophin 80 units
Intervention descriptions: intervention 1: Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin

Protocol documents:
Clinical trial NCT01972464
Conditions: Tobacco Use Disorder
Keywords: Progesterone Placebo Postpartum Tobacco Pregnancy
Sponsor: Yale University
Start date: 2013-11-01; Completion date: 2016-09-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Smoking is the main preventable cause of mortality in Western countries, contributing to over 430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women often decrease smoking in pregnancy, when progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop.

Data from preclinical and clinical studies suggest that progesterone may be effective in preventing relapse to smoking in non-postpartum women. Prior work has shown that progesterone decreases both craving for cigarettes and the subjective rewarding effects of smoking among recently abstinent female smokers. These findings led us to hypothesize that progesterone may have efficacy as a relapse prevention treatment for postpartum women.

We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of progesterone. This will be a feasibility study that will compare progesterone to placebo for relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety, including the potential effects on breastfeeding and infants exposed via breast milk, in addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at follow-up, 3-months after the end of the protocol.

Detailed description:

Arms: arm 1: In this group women will receive a placebo pill which will appear similar to progesterone and will be inert. arm 2: In this group women will receive oral micronized progesterone twice a day.
Interventions: intervention 1: Progesterone intervention 2: Placebo
Intervention descriptions: intervention 1: oral micronized progesterone intervention 2: None

Protocol documents:
Clinical trial NCT01972568
Conditions: Lupus Erythematosus, Systemic
Keywords: Atacicept Placebo
Sponsor: EMD Serono
Start date: 2013-12-01; Completion date: 2016-09-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, double-blind, randomized, Phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (SLE).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Atacicept 75 milligram (mg) intervention 2: Atacicept 150 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks. intervention 2: Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks. intervention 3: Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.

Protocol documents:
Clinical trial NCT01984268
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis ACTHAR Methotrexate Inadequate response
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2014-06-23; Completion date: 2016-09-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Adenocorticotrophic Hormone provides safe and effective treatment to induce disease remission in rheumatoid arthritis patients with active disease due to an inadequate response to methotrexate.

Detailed description:
The standard treatment for rheumatoid arthritis is using disease-modifying anti-rheumatic drugs such as methotrexate to control joint pain and swelling. Often times rheumatoid arthritis patients experience inadequate response to methotrexate with acute or persistent joint pain and swelling. In these patients, alternative or additional immunosuppressive therapy is needed to induce disease remission. In the present clinical trial, ACTHAR is being studied to induce disease remission on rheumatoid arthritis patients who have inadequate response to methotrexate therapy.

Arms: arm 1: Rheumatoid arthritis subjects with inadequate response to methotrexate will be randomized to receive twice a week dosing of ACTHAR for a period of four weeks. arm 2: Rheumatoid arthritis subjects with inadequate response to methotrexate will be randomized to receive twice a week dosing of ACTHAR for a period of twelve weeks.
Interventions: intervention 1: ACTHAR
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01990560
Conditions: Mild Hypercortisolism
Keywords: mild hypercortisolism Subclinical Cushing's Syndrome Preclinical Cushing's Syndrome
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2013-11-01; Completion date: 2016-09-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether mifepristone is an effective treatment for hyperglycemia due to mild hypercortisolism.

* To test the hypothesis that GR blockade with mifepristone will decrease the severity of metabolic syndrome features as measured by waist circumference, lipid profile, body mass index, blood pressure and insulin resistance, measured by HOMA-IR score.
* To test the hypothesis that GR blockade with mifepristone will improve QoL, depression and anxiety scores, measured by validated assessments, in patients with mild hypercortisolism.

Detailed description:

Arms: arm 1: Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response
Interventions: intervention 1: Mifepristone
Intervention descriptions: intervention 1: All patients in the study will receive daily Mifepristone for 6 months and primary and secondary outcomes will be assessed before and after the 6 month treatment period

Protocol documents:
Clinical trial NCT02013050
Conditions: Oral Mucositis
Sponsor: Soligenix
Start date: 2013-12-01; Completion date: 2016-09-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Detailed description:

Arms: arm 1: Control arm 2: Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg
Interventions: intervention 1: SGX942 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02046564
Conditions: Major Depressive Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2014-02-01; Completion date: 2016-09-01
Enrollment: 412 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and the safety of ASC-01 (aripiprazole/sertraline combination) compared to sertraline monotherapy in patients with major depressive disorders who have responded incompletely to sertraline monotherapy.

Detailed description:

Arms: arm 1: The dose of 3-12mg/100mg(Aripiprazole/Sertraline Combination)will be orally administered once daily arm 2: The dose of 0mg/100mg (Placebo/Sertraline Combination ）will be orally administered once daily
Interventions: intervention 1: ASC-01 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02069041
Conditions: Carcinoma, Hepatocellular
Sponsor: Eli Lilly and Company
Start date: 2014-04-01; Completion date: 2016-09-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to determine if the advised dose of ramucirumab is safe to be taken with chemotherapy treatment in participants with advanced liver tumors.

Detailed description:

Arms: arm 1: 8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:

FOLFOX4 every 2 weeks:

85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2

Participants may continue to receive treatment until discontinuation criteria are met.
Interventions: intervention 1: Ramucirumab intervention 2: FOLFOX4
Intervention descriptions: intervention 1: Administered IV. intervention 2: Administered IV.

Protocol documents:
Clinical trial NCT02114203
Conditions: Phase 1 Sickle Cell
Sponsor: Pfizer
Start date: 2014-12-01; Completion date: 2016-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This study is being conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational drug, PF-04447943, in subjects with stable sickle cell disease with and without co-administration with hydroxyurea. This study will also aid in selecting the doses for future studies and evaluation of substances in the blood which may help access the effectiveness of the drug.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: PDE9i intervention 2: PDE9i intervention 3: placebo for PDE9i intervention 4: PDE9i
Intervention descriptions: intervention 1: oral dose, every 12 hours for 28 days intervention 2: oral dose, every 12 hours for 28 days intervention 3: oral dose, every 12 hours for 28 days intervention 4: oral dose, every 12 hours for 28 days

Protocol documents:
Clinical trial NCT02135146
Conditions: Hypotension Kidney Injury
Keywords: Hypotension Kidney injury
Sponsor: University of Colorado, Denver
Start date: 2014-01-01; Completion date: 2016-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to conduct a prospective, randomized, controlled trial comparing a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive perioperative fluid has been retrospectively implicated in the development postoperative acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid restriction in these patients is not without risk and may compromise end organ perfusion (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic surgery patients will result in better end organ perfusion with fewer occasions of acute kidney injury (AKI) without causing an increase in postoperative acute lung injury or pulmonary edema.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Plasmalyte 3ml/kg/hr group intervention 2: Plasmalyte 6ml/kg/hr group
Intervention descriptions: intervention 1: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them intervention 2: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them

Protocol documents:
Clinical trial NCT02205983
Conditions: Healthy
Keywords: enrolling adult volunteers
Sponsor: University of Chicago
Start date: 2015-01-01; Completion date: 2016-09-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In this study, the investigators will examine the effects of hydromorphone, as compared to placebo, upon physiological, subjective, and hormonal responses to a stressful speech task and a non-stressful control task in healthy adults. There is strong evidence in support of the role of endogenous opioids and opiates in mediating social behavior in humans and other animals, and particularly, in social distress. The investigators have recently shown that buprenorphine, a partial mu-opioid agonist, reduces cortisol responses to stress. Here, the investigators propose to further explore the role of the opioid system in mediating stress responses in humans through the use of hydromorphone, a full mu opioid agonist, in addition to acetaminophen. The investigators hypothesize that like acetaminophen, hydromorphone will reduce both physiological and subjective measures of stress.

Detailed description:
Participants be randomly assigned to receive 1000 mg acetaminophen, 2mg hydromorphone, 4mg hydromorphone, or placebo at each of two sessions; one during which they well participate in a stressful speaking task, and one during which they'll participate in a nonstressful control task. Physiological and subjective measures will be taken throughout each session.

Arms: arm 1: Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion. arm 2: Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion arm 3: Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion. arm 4: Healthy adult volunteers will recieve Dextrose (placebo).
Interventions: intervention 1: 2 mg hydromorphone intervention 2: 1000 mg Acetaminophen intervention 3: 4 mg hydromorphone intervention 4: dextrose
Intervention descriptions: intervention 1: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task. intervention 2: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task. intervention 3: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task. intervention 4: We are administering dextrose to healthy volunteers for our placebo group.

Protocol documents:
Clinical trial NCT02228460
Conditions: Fabry Disease
Keywords: Venglustat
Sponsor: Genzyme, a Sanofi Company
Start date: 2014-11-01; Completion date: 2016-09-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male participants diagnosed with Fabry disease.

Detailed description:
The total duration of study per participant was 7 to 8 months for participants who entered a planned extension study and approximately 13 to 14 months for participants who did not enter a planned extension study. A 2-year extension study was planned for eligible participants.

Arms: arm 1: GZ/SAR402671 15 milligram (mg) once daily orally for 26 weeks.
Interventions: intervention 1: GZ/SAR402671
Intervention descriptions: intervention 1: Pharmaceutical form: Capsule; Route of administration: Oral

Protocol documents:
Clinical trial NCT02230332
Conditions: Asthma
Sponsor: Milton S. Hershey Medical Center
Start date: 2015-01-01; Completion date: 2016-09-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Beta-2-agonists are effective in reducing airway narrowing in asthma and protecting against stimuli that produce bronchoconstriction. The combination of long-acting beta agonists (LABA) and inhaled corticosteroids (ICS) has become the most commonly used asthma controller medication class in the United States, but unfortunately, even when LABAs are added to ICS and used regularly, 58-81% of patients with asthma fail to achieve total control. Regular use of beta-agonists, both short and long-acting, reduces the ability of these agents to protect against the airway narrowing that occurs in asthma in response to bronchoconstrictor stimuli. We refer to this reduced effect as loss of bronchoprotection. In this proof of concept trial we aim to determine if alendronate, which diminishes beta-2 adrenergic receptor internalization, can reduce the loss of bronchoprotection that occurs with regular use of LABAs, even when used in combination with ICS.

Detailed description:

Arms: arm 1: Alendronate in 10mg capsules taken once daily arm 2: Placebo capsule taken once daily
Interventions: intervention 1: Alendronate intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02237157
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer unresectable gemcitabine device local delivery chemoembolization
Sponsor: RenovoRx
Start date: 2015-03-01; Completion date: 2016-09-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
A dose escalation, safety study of local (intra-arterially) delivered gemcitabine to the pancreas using the RenovoCath R120 catheter to determine the maximum tolerated dose.

Detailed description:
Patients diagnosed with unresectable pancreatic cancer who may or may not have had prior chemotherapy or radiation therapy may be eligible to enroll in this dose escalation study to determine the maximum tolerated dose of gemcitabine to be delivered locally to the pancreatic tumors using the RenovoCath R120 catheter. Patients enrolled may receive up to 8 catheterizations for delivering gemcitabine directly to the pancreatic tumors starting at a reduced dose( 1/4 of standard i.v. gemcitabine dose), then every two doses, increase the dose by 25% if there are no toxicities up to a maximum dose of 1000 mg/m2. There are four cycles, with two doses per cycle. Imaging studies will be conducted as well as assessment for standard, myelosuppresive and gastric toxicities will be assessed. Pain will also be measured throughout the study.

Arms: arm 1: Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose arm 2: Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose arm 3: Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose arm 4: Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose
Interventions: intervention 1: Gemcitabine, local delivery
Intervention descriptions: intervention 1: Intra-arterial targeted drug delivery

Protocol documents: