ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02373371
Conditions: Actinic Keratoses
Sponsor: University Hospital, Limoges
Start date: 2015-03-25; Completion date: 2018-06-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy in subjects with mild actinic keratoses (intra-individual comparison)

Detailed description:

Arms: arm 1: Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline arm 2: Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline
Interventions: intervention 1: Metvix® intervention 2: Photodynamic Therapy Blue light intervention 3: Photodynamic Therapy Daylight
Intervention descriptions: intervention 1: None intervention 2: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug intervention 3: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug

Protocol documents:
Clinical trial NCT02498483
Conditions: Pain Circumcision
Keywords: Infant pain Acetaminophen Circumcision
Sponsor: Columbia University
Start date: 2015-09-01; Completion date: 2018-06-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Infants do not routinely receive acetaminophen for pain control after circumcision. This study will determine if acetaminophen is effective at controlling infant pain after circumcision using nerve block and oral dextrose. Infants will undergo the routine circumcision procedure, and half will be randomly selected to receive half acetaminophen immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate, respiratory rate, oxygen saturation), the neonatal infant pain scale (NIPS), and salivary cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated pain scoring system based on the appearance of the infant. A reduction in NIPS for those infants who receive acetaminophen versus nothing will be the primary outcome to determine if the study is significant.

Detailed description:
Male circumcision is a common surgical procedure performed in the newborn period. The American Academy of Pediatrics Task Force on Circumcision recently published an update on circumcision policy stating the benefits of male circumcision outweigh the risks. Given this update, the investigators anticipate a percentage of families who were previously undecided about circumcision will choose to have their newborn circumcised. A common concern for both parents and physicians is effective pain control. For intra-operative pain control, dorsal penile nerve block (DPNB) has been found to be the most effective when compared to EMLA (lidocaine-prilocaine) or placebo. Acetaminophen is a relatively safe, easy to administer analgesic. Prior studies have suggested that acetaminophen could be helpful in postoperative comfort. However, studies examining the effectiveness of acetaminophen for postoperative pain control in infants who received DPNB are lacking. In addition, prior studies have been incomplete in the assessment of neonatal pain.

Arms: arm 1: Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. arm 2: Routine circumcision without acetaminophen.
Interventions: intervention 1: Acetaminophen
Intervention descriptions: intervention 1: Infants will receive 15 mg/kg of acetaminophen.

Protocol documents:
Clinical trial NCT02962284
Conditions: Metastatic Prostate Cancer
Sponsor: Sun Pharmaceutical Industries Limited
Start date: 2016-11-01; Completion date: 2018-06-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single-arm, multi-center extension study to evaluate safety in patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid). Patients will have successfully completed an 84-day treatment with abiraterone acetate in a previous trial. Results from the final visit of the previous study will be used to determine patient's eligibility for this study. Patients in this study will be eligible to receive open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of serum testosterone and PSA levels will be monitored. Disease progression will be assessed by PCWG2 criteria.

Detailed description:

Arms: arm 1: Aberaterone Acetate 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)
Interventions: intervention 1: abiraterone acetate with Methylprednisolone
Intervention descriptions: intervention 1: YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00777101
Conditions: Advanced Breast Cancer Breast Cancer
Keywords: HER2 ErbB2 metastatic neratinib lapatinib capecitabine HKI-272 Nerlynx PB-272
Sponsor: Puma Biotechnology, Inc.
Start date: 2009-02-04; Completion date: 2018-06-03
Enrollment: 233 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Neratinib intervention 2: Lapatinib intervention 3: Capecitabine
Intervention descriptions: intervention 1: Tablets 240 mg orally once per day until disease progression or unacceptable toxicity intervention 2: Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity. intervention 3: Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00706030
Conditions: Breast Cancer Advanced Malignant Solid Tumors
Keywords: Metastatic breast cancer HKI-272 Neratinib Nerlynx PB-272
Sponsor: Puma Biotechnology, Inc.
Start date: 2008-04-29; Completion date: 2018-06-07
Enrollment: 92 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors.

The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.

Detailed description:

Arms: arm 1: neratinib 160 mg tablets administered daily by mouth, vinorelbine 25 mg/m\^2 administered IV on day 1 and day 8 of 21 day cycle arm 2: neratinib 240 mg tablets administered daily by mouth, vinorelbine 25 mg/m\^2 administered IV on day 1 and day 8 of 21 day cycle arm 3: neratinib 240 mg tablets administered daily by mouth, vinorelbine 25 mg/m\^2 administered IV on day 1 and day 8 of 21 day cycle arm 4: neratinib 240 mg tablets administered daily by mouth, vinorelbine 25 mg/m\^2 administered IV on day 1 and day 8 of 21 day cycle
Interventions: intervention 1: neratinib intervention 2: vinorelbine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01638559
Conditions: Liver Transplant Recipients Liver Transplantation Immunosuppression
Keywords: liver transplant allograft function anti-rejection immunosuppression withdrawal tolerance
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2012-08-14; Completion date: 2018-06-11
Enrollment: 161 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to assess the efficacy of immunosuppression withdrawal (ISW) in pediatric liver transplant (tx) recipients.

Detailed description:
Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ. Long-term use of these medicines places transplant recipients at higher risk of serious infections and certain types of cancer.

This study seeks to:

* Find out if it is safe to slowly reduce and then completely stop the immunosuppression taken by children who have received liver transplants. This process is called 'immunosuppression withdrawal'or ISW.
* Find blood or liver biopsy tests that can help transplant doctors in the future to predict if it is safe to decrease or stop immunosuppression drugs in children who have had a liver transplant.

Arms: arm 1: Gradual withdrawal of immunosuppressive treatment withdrawal as per protocol.
Interventions: intervention 1: Immunosuppression withdrawal
Intervention descriptions: intervention 1: Participants will undergo gradual ISW in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants will be followed for 48 months ensuring a minimum of 36 months of follow-up after successful ISW.

Protocol documents:
Clinical trial NCT01713400
Conditions: Graft vs. Host Disease
Keywords: Acute Graft vs. Host Disease (aGVHD) Graft vs. Host Disease (GVHD)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2013-02-25; Completion date: 2018-06-14
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).

Detailed description:
This is a comparative study to assess the biologic and clinical activity of the agent ustekinumab when given in concert with our established regimen of SIR/TAC. Patients will be randomly assigned between the standard regimen of tacrolimus/sirolimus (TAC/SIR + placebo) vs. the investigational regimen of tacrolimus/sirolimus/ustekinumab (TAC/SIR/U) in a 1:1 scheme.

Arms: arm 1: Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program. arm 2: Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
Interventions: intervention 1: Ustekinumab intervention 2: Placebo intervention 3: Tacrolimus (TAC) intervention 4: Sirolimus
Intervention descriptions: intervention 1: One subcutaneous injection administered on day -1 and repeated on day +20 after transplant intervention 2: Subcutaneous injection of sterile saline (identical volume to that of ustekinumab) administered via the identical route and schedule as ustekinumab. intervention 3: Administered starting day -3 according to Blood and Marrow Transplant (BMT) Program standard operating procedures. TAC levels to be monitored and maintained at a target range of 3-7 given concurrent administration with sirolimus. Specific dose adjustments within this therapeutic range to be determined by the treating physician. intervention 4: Administered initially as an oral loading dose on day -1. Thereafter, SIR to be administered as an oral regimen daily. The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program. SIR levels to be monitored according to standard procedures. Dose adjustments to be made according to drug levels, with target range of 5-14ng/mL (therapeutic range by Abbott Architect instrument at Moffitt).

Protocol documents:
Clinical trial NCT02283658
Conditions: Ovarian Endometrioid Adenocarcinoma Ovarian Seromucinous Carcinoma Ovarian Serous Cystadenocarcinoma Ovarian Serous Surface Papillary Adenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Ovarian Germ Cell Tumor Recurrent Primary Peritoneal Carcinoma Undifferentiated Ovarian Carcinoma
Sponsor: Mayo Clinic
Start date: 2014-11-14; Completion date: 2018-06-21
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot, phase II trial studies how well everolimus and letrozole work in treating patients with hormone receptor positive ovarian, fallopian tube, or primary peritoneal cavity cancer that has come back. Everolimus and letrozole may stop the growth of tumor cells by blocking some the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Demonstrate that the combination of letrozole and everolimus leads to a higher percentage of patients who are free of progression at 12 weeks (PFS 12) as compared with that observed in a previously reported phase 2 trial of letrozole alone for relapsed ovarian carcinomas.

SECONDARY OBJECTIVES:

I. Cancer antigen (CA)-125 response, progression-free survival (PFS), overall survival (OS), the confirmed response rate, and adverse events.

TERTIARY OBJECTIVES:

I. Identify molecular biomarkers associated with a response to treatment with letrozole and everolimus in patients with relapsed ovarian carcinomas.

II. Develop and determine if response rates to letrozole and everolimus in patient derived xenograft (PDX) avatars correlate to responses noted in the patients.

OUTLINE:

Patients receive everolimus orally (PO) once daily (QD) and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Arms: arm 1: Patients receive everolimus PO QD and letrozole PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Everolimus intervention 2: Laboratory Biomarker Analysis intervention 3: Letrozole
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Given PO

Protocol documents:
Clinical trial NCT01362127
Conditions: Carcinoma, Squamous Cell Adenocarcinoma of the Esophagus and Gastric Cardia
Keywords: Histologically confirmed squamos cell carcinoma or adenocarcinoma of the esophagus and gastric cardia.Suitable for surgery.
Sponsor: Karolinska University Hospital
Start date: 2006-10-01; Completion date: 2018-06-25
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a higher degree of complete histological response than neoadjuvant chemotherapy before surgery in patients undergoing treatment for cancer of the esophagus or cardia.

Detailed description:

Arms: arm 1: Arm I: Radiochemotherapy + Surgery arm 2: Arm II: Chemotherapy + surgery
Interventions: intervention 1: Chemotherapy intervention 2: Radiochemotherapy
Intervention descriptions: intervention 1: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values. intervention 2: Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.

Protocol documents:
Clinical trial NCT00295646
Conditions: Breast Cancer
Keywords: Austrian Breast & Colorectal Cancer Study Group (ABCSG) 12 Phase 3 breast cancer anastrozole tamoxifen zoledronic acid premenopausal hormone receptor-positive Stage I Stage II bone mineral density BMD bisphosphonate zoledronate
Sponsor: Austrian Breast & Colorectal Cancer Study Group
Start date: 1999-06-01; Completion date: 2018-06-26
Enrollment: 1803 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.

Detailed description:
The trial is conducted as an open multi-center phase III study, in a two-factorial study design and according to Good Clinical Practice (GCP) guidelines. Patients will be randomly assigned to a total of 4 study groups in a 1:1:1:1 assignment ratio. Several stratification criteria will be used in order to ensure balanced distribution of known risk factors.

A total of 1.803 patients will be enrolled in 4 arms. Patients will either be treated with anastrozole (1mg daily for 3 years) or tamoxifen (20mg daily for 3 years), and will additionally receive either zoledronate (8mg q4 weeks for 3 years) or no zoledronate (arm A: Nolvadex alone; arm B: Nolvadex plus zoledronate; arm C: Arimidex alone; arm D: Arimidex plus zoledronate).

Zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment period of 3 years. Five Bone Mineral Density (BMD) measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).

Arms: arm 1: Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid) arm 2: Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid) arm 3: Study Drug Arimidex (Anastrozole) arm 4: Study Drug Nolvadex (Tamoxifen)
Interventions: intervention 1: tamoxifen intervention 2: anastrozole intervention 3: zoledronic acid intervention 4: goserelin
Intervention descriptions: intervention 1: 20 mg/d intervention 2: 1 mg/d intervention 3: 4 mg q6m intervention 4: 3.6 mg goserelin subcutaneously every 28 days

Protocol documents:
Clinical trial NCT01698801
Conditions: Multiple Myeloma
Keywords: Lenalidomide dexamethasone newly diagnosed multiple myeloma
Sponsor: Celgene
Start date: 2012-10-01; Completion date: 2018-06-26
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the efficacy of lenalidomide in combination with low-dose dexamethasone in Japanese subjects with previously untreated multiple myeloma.

Detailed description:

Arms: arm 1: Lenalidomide plus low-dose dexamethasone
Interventions: intervention 1: Lenalidomide intervention 2: dexamethasone
Intervention descriptions: intervention 1: 25 mg oral lenalidomide once daily on Days 1-21 of each 28-day cycle intervention 2: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle

Protocol documents:
Clinical trial NCT02568449
Conditions: Recurrent Pleural Malignant Mesothelioma Stage IV Pleural Mesothelioma
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2016-03-15; Completion date: 2018-06-26
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well nintedanib works in treating patients with malignant pleural mesothelioma that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the 4-month progression-free survival (PFS) in patients with recurrent, unresectable malignant pleural mesothelioma (MAM) treated with nintedanib.

SECONDARY OBJECTIVES:

I. To assess response rate (confirmed and unconfirmed, complete and partial responses) and disease control rate (response or stable disease) in the subset of patients with measurable disease by both RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria and Modified RECIST criteria for pleural tumors.

II. To assess overall survival.

III. To evaluate the frequency and severity of toxicities associated with this treatment regimen.

IV. To collect tissue samples for future correlative studies related to overall study objectives.

OUTLINE:

Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Arms: arm 1: Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Nintedanib
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT00915018
Conditions: Breast Cancer
Keywords: ErbB-2 positive advanced breast cancer HKI-272 Neratinib Nerlynx HER2 PB-272 metastatic breast cancer
Sponsor: Puma Biotechnology, Inc.
Start date: 2009-08-21; Completion date: 2018-06-28
Enrollment: 479 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Neratinib intervention 2: Trastuzumab intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent. intervention 2: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent. intervention 3: Paclitaxel - 80 mg/m² IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.

Protocol documents: