ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01061775
Conditions: Hypothalamic Obesity
Keywords: Hypothalamic Obesity Exenatide Byetta Craniopharyngioma
Sponsor: Children's Hospitals and Clinics of Minnesota
Start date: 2010-01-01; Completion date: 2019-03-15
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index) of children treated for craniopharyngioma that have developed hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that Exenatide given to hypothalamic obese children for 6 months will reduce their body mass index significantly from baseline.

Detailed description:
Hypothalamic obesity is when individuals suffer from acute weight gain after brain tumor treatment, involving secondary damage to the ventromedial nucleus of the hypothalamus, which may lead to obesity. The weight gain is uncontrolled and not receptive to diet and exercise interventions. The rate of long-term obesity in children diagnosed with craniopharyngioma can be as high as 50%. Exenatide, a drug indicated for diabetes, is an incretin mimicking agent that mimics the enhancement of glucose-dependent insulin secretion and several other antihyperglycemic actions of incretins has resulted in weight loss when given to diabetics. Exenatide shows potential to benefit patients suffering from hypothalamic obesity by slowing gastric emptying and therefore reducing food intake. Also increasing the glucagon-like peptide 1 (GLP-1) circulation, decreased due to obesity, at the already compromised GLP-1 receptor site of the hypothalamus could potentially help with regulation of appetite.

Arms: arm 1: 5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.
Interventions: intervention 1: Exenatide
Intervention descriptions: intervention 1: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.

Protocol documents:
Clinical trial NCT03664544
Conditions: Severe Hepatic Impairment Healthy
Keywords: Severe Hepatic Impairment Healthy
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2018-11-06; Completion date: 2019-03-25
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.

Detailed description:

Arms: arm 1: HP PK MCI-186 arm 2: NHV PK MCI-186
Interventions: intervention 1: MCI-186
Intervention descriptions: intervention 1: 30 mg MCI-186 will be administered intravenously over 60 minutes.

Protocol documents:
Prot_000.pdf: 





















































































































































SAP_001.pdf:
Clinical trial NCT03134703
Conditions: Neonatal Abstinence Syndrome
Sponsor: Johns Hopkins All Children's Hospital
Start date: 2017-02-27; Completion date: 2019-03-27
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a non-randomized, un-blinded feasibility study project comparing the Length of Stay (LOS) of Neonatal Intensive Care Unit (NICU) infants diagnosed with Neonatal Abstinence Syndrome (NAS) treated with methadone with historical data and a comparison group of NICU NAS infants treated with a different narcotic agent.

Detailed description:
For the time frame July 1, 2013 through September 30, 2014, 300 infants with NAS have been cared for in the JHACH NICU with an average length of stay of 30 days. Such a prolonged length of stay has a negative impact on maternal/infant bonding. In addition, infants suffering from NAS have poor regulatory mechanisms and are invariably hard to care for and difficult to console, and they provide an emotional challenge to their caretakers. This challenge becomes even more significant when the caretaker is the mother who is suffering from addiction and is already emotionally compromised by feelings of depression, anxiety, guilt or insecurity. Attachment is an ongoing process and the quality of the relationship between mother and her infant directly influences the structure of the child's affective ties and overall organization of responses to environment. This mother-infant bond sets the stage for understanding and identifying the infant's needs and reciprocal parental response to those needs. Maternal emotional unavailability has potentially serious effects on the long term mother-child relationship, and on the child's development.

This project provides a novel approach and an alternative care plan for infants with NAS. It is funded by the State of Florida and allows to: 1) educate and empower a specified population of mothers who are undergoing institutionalized rehabilitation and whose infant needs treatment for NAS; 2) safely transition the infants home for final wean of their pharmacologic treatment; 3) provide regular developmental follow up for these infants through our NICU follow up clinic, hence identifying and quickly responding to neuro-developmental delays.

Arms: arm 1: NAS infants treated for withdrawal symptoms with methadone arm 2: NAS infants treated for withdrawal symptoms with morphine (standard of care at Johns Hopkins All Children's Hospital)
Interventions: intervention 1: Methadone intervention 2: Morphine
Intervention descriptions: intervention 1: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS) intervention 2: Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)

Protocol documents:
Prot_SAP_000.pdf: 



























































ICF_001.pdf:
Clinical trial NCT02749617
Conditions: Anti-Xa Activity
Sponsor: University of British Columbia
Start date: 2016-08-09; Completion date: 2019-03-28
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study will investigate the impact of dexamethasone (DEX) on anti-Xa levels in participants taking apixaban 2.5 mg twice a day by mouth (PO BID). Investigators propose a prospective, cohort study of 24 participants with multiple myeloma, in whom a lenalidomide-dexamethasone (LEN-DEX)-based myeloma treatment regimen is indicated. Eligible participants will initiate thromboprophylaxis with apixaban prior to starting their DEX-containing regimen and continue until the end of cycle 3. Anti-Xa levels, D-Dimer and plasma drug concentration will be measured.

This pilot study looks to investigate this potential interaction between apixaban and dexamethasone to see if it warrants further investigation in a larger study.

The sample size of 24 provides 90% power to detect a primary outcome of ≥ 50% reduction in peak anti-Xa levels from baseline. Secondary outcomes include changes in plasma apixaban levels, D-dimer, and symptomatic venous thromboembolism (VTE) and bleeding during a 3-month treatment period.

Detailed description:
Study has terminated due to poor enrollment.

Arms: arm 1: apixaban 2.5 mg PO BID
Interventions: intervention 1: apixaban
Intervention descriptions: intervention 1: 2.5 mg PO BID

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT05343156
Conditions: Diabetic Macular Edema
Sponsor: Oculis
Start date: 2017-09-18; Completion date: 2019-03-28
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Anti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid and or vascular endothelial growth factor (VEGF) antibodies into the vitreous cavity or slow release drug capsules surgically implanted in the eyes run the risk of surgical complications including infections, hemorrhages and cataracts and place a huge demand on eye care resources significantly increase the risk of cardiovascular events and death.

A non-invasive drug delivery platform with steroid eye drops, reaching the back of the eye to treat DME and other retinal diseases would circumvent most of these problems.

A novel drug delivery platform is required for ocular therapy. Oculis ehf. has developed a drug delivery platform, which is based on cyclodextrin nanoparticles that dissolve in the tear fluid to form water-soluble drug/cyclodextrin complex nanoparticles. Animal and initial clinical testing has shown the potential for this technology to increase the drug concentration in the eye tissues including the retina and therefore treat retinal diseases like DME.

Detailed description:

Arms: arm 1: The study eye received 1 DexNP eye drop 3 times a day (every 8 hours) for 12 weeks. arm 2: The study eye received 1 vehicle eye drop 3 times a day (every 8 hours) for 12 weeks.
Interventions: intervention 1: Dexamethasone nanoparticles eye drops
Intervention descriptions: intervention 1: DexNP 15 mg/mL eye drops 3 times a day (every 8 hours) for 12 weeks

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00784303
Conditions: Thyroid Cancer
Keywords: Thyroid Cancer
Sponsor: Eisai Inc.
Start date: 2008-11-06; Completion date: 2019-03-29
Enrollment: 117 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and efficacy of oral lenvatinib in participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC), unresectable differentiated thyroid cancers, stratified by Histology.

Detailed description:
This study contained 3 Phases: the Pretreatment Phase, the Treatment Phase, and the Extension Phase. The Pretreatment Phase lasted no longer than 28 days. Informed consent was obtained and protocol eligibility and disease characteristics were established prior to treatment. The Treatment Phase consisted of a Treatment Period and a Follow-up Period. The Treatment Period of the Treatment Phase began at the time that the first participant began study drug administration and ended at the time when all participants enrolled completed 8 cycles of treatment or discontinued study treatment prior to the eighth cycle (ie, time of data cutoff for the primary study analysis \[Primary Completion Date\]). All participants then entered the Extension Phase. The Extension Phase consisted of a Treatment Period and a Follow-up Period. The Extension Phase began immediately after the Treatment Phase ended and included all participants that were either still receiving treatment or in follow-up. The time of data cutoff for the primary study analysis occurred when all subjects in the study completed 8 cycles of treatment or discontinued study treatment prior to the eighth cycle.

Arms: arm 1: This arm will enroll participants with radioiodine (131 I)-refractory/resistant differentiated thyroid cancer. arm 2: This arm will enroll participants with medullary thyroid cancer.
Interventions: intervention 1: Lenvatinib (DTC Cohort) intervention 2: Lenvatinib (MTC Cohort)
Intervention descriptions: intervention 1: 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily, or 10 mg lenvatinib orally twice daily (20 mg total). Out of 58 participants in the DTC cohort, 56 participants received 24 mg lenvatinib once daily and 2 participants received 10 mg lenvatinib twice daily (total 20 mg daily), given continuously in 28-day treatment cycles. intervention 2: 24 mg lenvatinib (two 10 mg tablets and one 4 mg tablet) given orally, once daily given continuously in 28-day treatment cycles.

Protocol documents:
Clinical trial NCT01345019
Conditions: Cancer Hematologic Malignancies Multiple Myeloma Oncology Bone Metastases Multiple Myeloma Bone Lesions
Keywords: zoledronic acid hematologic malignancies SRE skeletal-related event blood cancer lytic bone lesions bone metastases myeloma fractures spinal cord compression radiation to bone surgery to bone bisphosphonates Neoplasms, Plasma Cell Paraproteinemias Neoplasms Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Blood Protein Disorders Hematologic Diseases multiple myeloma denosumab Neoplastic Processes Bone Diseases Diphosphonates Bone Density Conservation Agents
Sponsor: Amgen
Start date: 2012-05-17; Completion date: 2019-03-29
Enrollment: 1718 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.

Detailed description:

Arms: arm 1: Zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaniously (SC) once every 4 weeks (Q4W) in the double-blind treatment period (Since denosumab was determined to have a positive benefit:risk profile in the primary analysis of the study, per protocol, participants who were still undergoing Q4W scheduled assessments were offered open-label denosumab 120 mg SC Q4W for up to 2 years) arm 2: Denosumab 120 mg subcutaniously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment period (Since denosumab was determined to have a positive benefit:risk profile in the primary analysis of the study, per protocol, participants who were still undergoing Q4W scheduled assessments were offered open-label denosumab 120 mg SC Q4W for up to 2 years)
Interventions: intervention 1: Denosumab intervention 2: Zoledronic acid intervention 3: Placebo to Denosumab intervention 4: Placebo to zoledronic acid intervention 5: Denosumab (for the open-label treatment phase)
Intervention descriptions: intervention 1: Administered by subcutaneous injection once every 4 weeks. intervention 2: Administered by intravenous infusion over 15 minutes once every 4 weeks intervention 3: Administered by subcutaneous injection once every 4 weeks. intervention 4: Administered by intravenous infusion over 15 minutes once every 4 weeks intervention 5: Administered by subcutaneous injection once every 4 weeks.

Protocol documents:
Clinical trial NCT00664326
Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Carcinoma
Sponsor: Bayer
Start date: 2008-04-30; Completion date: 2019-04-02
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC).

Detailed description:
The final analysis of efficacy will be performed after last patient has been treated for at least 6 months. Additional periodic safety and efficacy data reviews will be performed for any patients continuing to receive study drug afterwards.

Arms: arm 1: Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
Interventions: intervention 1: Regorafenib (Stivarga, BAY73-4506)
Intervention descriptions: intervention 1: Patients will be treated with BAY73-4506 160 mg po qd for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Patients will continue treatment with BAY73-4506 until disease progression, intolerable toxicity, or patient refusal to continue with the study or investigator decision to remove the patient from study.

Protocol documents:
Clinical trial NCT00129935
Conditions: Breast Cancer
Keywords: HER2 negative breast cancer Node positive breast cancer Adjuvant treatment Oral chemotherapy
Sponsor: Spanish Breast Cancer Research Group
Start date: 2004-02-01; Completion date: 2019-04-04
Enrollment: 1384 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 (HER2) negative, node positive breast cancer patients.

Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4 cycles of T 100 mg/m2 day 1 every 3 weeks.

Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by 4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period.

Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen after the end of chemotherapy.

Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or aromatase inhibitors (or both) after the end of chemotherapy.

Patients may receive radiotherapy when clinically indicated.

Detailed description:
Estimation of the 5-year disease-free survival in the control arm is 72%. The experimental arm is expected to increase the 5-year disease-free survival by 7% (up to 79%). With an alpha error of 0.05 and 80% power, 592 patients per arm are needed. Assuming a 17% post-randomization drop-out, 691 patients per arm are needed.

Arms: arm 1: Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles. arm 2: Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Interventions: intervention 1: Docetaxel intervention 2: Capecitabine intervention 3: Epirubicin intervention 4: Cyclophosphamide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01466660
Conditions: Lung Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2011-12-13; Completion date: 2019-04-12
Enrollment: 319 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.

Detailed description:

Arms: arm 1: afatinib once daily. arm 2: gefitinib once daily
Interventions: intervention 1: Afatinib intervention 2: gefitinib
Intervention descriptions: intervention 1: afatinib once daily intervention 2: Gefitinib once daily

Protocol documents:
Clinical trial NCT01271712
Conditions: Gastrointestinal Stromal Tumors
Keywords: Gastrointestinal stromal cancer GIST multikinase inhibitor
Sponsor: Bayer
Start date: 2011-01-04; Completion date: 2019-04-15
Enrollment: 199 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.

The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival Follow up Period.

Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive best supportive care which excludes any disease specific anti cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgery.

Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3 months (through month 6), and every 8 weeks until the end of treatment, or more frequently if clinically indicated. Tumor assessments include CT or MRI and will be performed until tumor progression is seen in a central radiology review.

Subjects receiving placebo who experience disease progression may be offered active treatment.

Subjects who experience progression during regorafenib treatment may continue open label treatment.

All subjects will enter the Survival Follow-up Period upon discontinuation of randomized study treatment.

Detailed description:

Arms: arm 1: Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks arm 2: Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
Interventions: intervention 1: Regorafenib (Stivarga, BAY73-4506) intervention 2: Placebo intervention 3: Best supportive care
Intervention descriptions: intervention 1: 160 mg po once daily (od), 3 weeks on/1 week off. Route of administration: oral intervention 2: once daily (od), 3 weeks on/1 week off. Route of administration: oral intervention 3: Best supportive care includes any method to preserve the comfort and dignity of the patients, and excludes any disease-specific anti-neoplastic therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgical intervention.

Protocol documents:
Clinical trial NCT01610284
Conditions: Breast Cancer
Keywords: Breast cancer Hormone receptor positive HER2-negative Metastatic Locally advanced PI3K Fulvestrant Refractory Aromatase inhibitor
Sponsor: Novartis Pharmaceuticals
Start date: 2012-08-07; Completion date: 2019-04-19
Enrollment: 1147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

Detailed description:
Patients were randomized (1:1) to receive buparlisib (100 mg/day) or placebo with fulvestrant (500 mg); randomization was stratified by PI3K pathway activation status (activated, non-activated, unknown determined in archival tumor tissue) and visceral disease status (present or absent). Tumor evaluation was performed 6 weeks after the randomization date and then every 8 weeks until radiological progression (based on Response Evaluation Criteria In Solid Tumors \[RECIST\] version 1.1).

Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program. Accordingly, on 19-Dec-2016, Novartis notified all the Investigators about the decision not to pursue further development of buparlisib in Breast Cancer. As a result, the CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last visit).

Arms: arm 1: BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol. arm 2: BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
Interventions: intervention 1: Fulvestrant intervention 2: BKM120 intervention 3: BKM120 matching placebo
Intervention descriptions: intervention 1: Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter) intervention 2: BKM120 100 mg once daily intervention 3: BKM120 matching placebo, once daily

Protocol documents: