ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01650545
Conditions: Disorder Related to Lung Transplantation Bronchiolitis Obliterans Decreased Immunologic Activity Chronic Rejection of Lung Transplant
Keywords: case-control study aerosolized liposomal cyclosporine A bronchiolitis obliterans syndrome Lung Transplantation Lung function
Sponsor: University of Maryland, Baltimore
Start date: 2012-07-01; Completion date: 2019-11-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A in the treatment of chronic rejection in lung transplant recipients with bronchiolitis obliterans syndrome (BOS).

The primary objective is to evaluate the efficacy of liposomal cyclosporine A in the treatment of chronic rejection. Pulmonary function and changes in BOS grade are the primary end points.

Detailed description:
This is a randomized single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) in the treatment of chronic rejection in lung transplant recipients with Grade 1 or 2 BOS.

The primary endpoints will include:

* Improvement or stabilization of pulmonary function test (FEV1) from baseline
* Stabilization of histology (no deterioration from baseline)
* Safety of the preparation

The secondary endpoints will include:

* Pharmacokinetics and distribution of CsA in blood -
* Change in cytokine levels from BAL specimens.

Arms: arm 1: Arm 1) Aerosol liposomal cyclosporine Open label randomized trial using experimental inhalational therapy with liposomal aerosol cyclosporine in addition to standard immune suppression (tacrolimus , mycophenolate mofetil and prednisone) for 6 month duration at inhalational doses (5mg and 10 mg bid), to be defined by transplant type respectively (single, double lung transplant ) arm 2: Arm 2) Standard immune suppression consisting of typical oral immune suppression for lung transplant recipients typically tacrolimus, mycophenolate mofetil and prednisone.

Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone rapamycin described in the subsequent section as well.
Interventions: intervention 1: Liposomal aerosol cyclosporine intervention 2: standard immune suppression, oral
Intervention descriptions: intervention 1: inhaled form of immune suppression intervention 2: conventional drug

Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin

Protocol documents:
Clinical trial NCT03848182
Conditions: Pancreatic Cancer
Keywords: T-cell responses Pancreatic cancer Gemcitabine Perforin Granzyme-B Myeloid-derived suppressor cells
Sponsor: Albert Einstein College of Medicine
Start date: 2017-07-21; Completion date: 2019-11-11
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigator is developing an immune therapy against pancreatic cancer. Immune cells, known as "T cells with tumor killing capacity", are involved in this immune therapy. In mice with pancreatic cance there is evidence that one tetanus toxoid (TT) vaccination (that patients receive from childhood) combined with Gemcitabine activates these killer T cells. (Gemcitabine improves T cell responses) These killer T cells are able to destroy tumor cells uploaded with TT protein (such studies are planned in future clinical trials). The goal of this study is to test whether one TT vaccination combined with Gemcitabine treatment activates the same T cells in pancreatic cancer patients.

Detailed description:
Treating PDAC patients with gemcitabine and one TT booster Gemcitabine will be delivered as is standard of care. However, doses may be modified by the treating physician based on patient tolerance. Patients diagnosed with PDAC will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT by Dr. Chuy as outlined in Fig 2. Gemcitabine will be administered on days 1, 8, 15 every 28 days, and one booster with the human TT childhood vaccine will be administered on day 8 (there must be 2 hrs between the TT booster and the Gemcitabine treatment). Blood will be drawn just before each Gemcitabine treatment, except on day 8 at least 2 hrs will be needed between the blood draw and Gemcitabine treatment because the TT booster needs to be given just after the blood draw but 2 hrs before the Gemcitabine treatment (Fig 2). Three tubes of 10 mls each with heparinized blood will be needed for the isolation of peripheral blood mononuclear cells (PBMC). Two tubes will be used to analyze the T cells and one tube for analyzing the MDSC. The memory T cells and MDSC will be analyzed in the laboratory of Dr. Gravekamp.

Arms: arm 1: Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT
Interventions: intervention 1: Gemcitabine intervention 2: TT vaccine booster
Intervention descriptions: intervention 1: Gemcitabine will be administered on days 1, 8, 15 every 28 days intervention 2: One human TT childhood vaccine booster will be administered on day 8

Protocol documents:
Prot_SAP_001.pdf: 
Analyzing Childhood Recall Antigens in Patients with 
Pancreatic Cancer
Protocol ID:  2016-7197
NCT03848182
Clinical trial NCT01491737
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2012-02-17; Completion date: 2019-11-14
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.

Detailed description:

Arms: arm 1: Participants will receive pertuzumab in combination with trastuzumab plus aromatase inhibitor (AI) until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion. arm 2: Participants will receive trastuzumab plus aromatase inhibitor (AI) until predefined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.
Interventions: intervention 1: Pertuzumab intervention 2: Trastuzumab intervention 3: Aromatase Inhibitor intervention 4: Induction Chemotherapy
Intervention descriptions: intervention 1: Participants will receive a loading dose of 840 milligrams (mg) as an intravenous infusion on Day 1 of first treatment cycle, followed by 420 mg on Day 1 or Day 2 of each subsequent 3-week cycle until disease progression or unacceptable toxicity. intervention 2: Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity. intervention 3: Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily. intervention 4: Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.

Protocol documents:
Clinical trial NCT03541200
Conditions: Vasomotor Symptoms (VMS)
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Start date: 2018-04-18; Completion date: 2019-11-15
Enrollment: 190 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open-label, long term extension study of MT-8554 in postmenopausal women experiencing moderate to severe vasomotor symptoms who completed Study MT-8554-A01

Detailed description:

Arms: arm 1: MT-8554
Interventions: intervention 1: MT-8554
Intervention descriptions: intervention 1: MT-8554 Oral

Protocol documents:
Prot_000.pdf: 

















































































































SAP_001.pdf:
Clinical trial NCT01544179
Conditions: Non-Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer Gefitinib Pemetrexed Treatment Beyond Progression
Sponsor: AstraZeneca
Start date: 2012-03-15; Completion date: 2019-11-20
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.

Detailed description:
A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSA 250 mg in addition to Chemotherapy versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have progressed on First Line IRESSA.

Arms: arm 1: Gefitinib and cisplatin plus pemetrexed combination chemotherapy arm 2: Placebo and cisplatin plus pemetrexed combination chemotherapy.
Interventions: intervention 1: Gefitinib intervention 2: Placebo intervention 3: Pemetrexed intervention 4: Cisplatin
Intervention descriptions: intervention 1: Investigational Drug intervention 2: Matching placebo as comparator intervention 3: Chemotherapy (concomitant therapy) intervention 4: Chemotherapy (concomitant therapy)

Protocol documents:
Clinical trial NCT01133275
Conditions: Myelodysplastic Syndrome MDS
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2010-04-28; Completion date: 2019-11-21
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research is to evaluate the use of lenalidomide and prednisone in people with Myelodysplastic Syndrome (MDS).

Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for people with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. As it is being used in this study it is considered an investigational use. An "investigational use" is a use that is being tested and is not approved by the FDA.

Prednisone is approved by the FDA to treat numerous conditions. In addition, prednisone is approved by the FDA to treat Low or Intermediate-1 IPSS Risk, non-del (5q) MDS.

"Study drug" refers to the combination of lenalidomide and prednisone.

Detailed description:
10 mg/day of lenalidomide will be taken by mouth on days 1 - 28 of cycles 1-6. Dosing will be in the morning at approximately the same time each day.

Planned prednisone dose:

* 30 mg by mouth daily, days 1-28 of cycle 1
* 20 mg by mouth daily, days 1-28 of cycle 2
* 10 mg by mouth daily, days 1-28 of cycle 3
* 10 mg by mouth every other day on days 1-28 of cycles 4-6
* 5 mg by mouth every other day for responders beyond cycle 6

Arms: arm 1: All participants received lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
Interventions: intervention 1: Prednisone intervention 2: Lenalidomide
Intervention descriptions: intervention 1: Prednisone therapy for 6 cycles (24 weeks). intervention 2: Lenalidomide therapy for 6 cycles (24 weeks).

Protocol documents:
Clinical trial NCT03068754
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS
Sponsor: Mallinckrodt
Start date: 2017-06-22; Completion date: 2019-11-25
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
About 213 people with ALS will participate in this study. There will be locations in North and South America.

During the first part, participants will be randomly assigned to a group (like by flipping a coin). Out of every 3:

* 2 will get the study drug
* 1 will get a look-alike with no drug in it (placebo)

During the second part, everyone will get the study drug.

Participation will help doctors find out if Acthar can help or slow down the symptoms of ALS better than placebo.

Detailed description:
This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult participants with ALS. Approximately 213 participants will be enrolled.

Following a screening period of up to 28 days, participants with ALS and symptom onset (defined as first muscle weakness or dysarthria) ≤ 2 years prior to the Screening Visit will be randomized on a 2:1 basis to receive subcutaneous (SC) Acthar 0.2 mL (16 Units \[U\]) daily (QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3-week taper.

Participants who complete the 36 week double-blind treatment period are eligible to enter an Open Label Extension phase in which all participants will receive Acthar 0.2 mL (16 U) daily.

Arms: arm 1: Participants receive one 0.2 mL subcutaneous (SC) injection (shot under the skin) of the study drug (Acthar), daily for up to 36 weeks.

Those who do not continue into the extension period will have 3 weeks of tapering off the drug, ending their participation by Week 39. arm 2: Participants receive one 0.2 mL SC injection that looks like Acthar, but has no drug in it (Matching Placebo), daily for up to 36 weeks.

Those who do not continue into the extension period will have 3 weeks of simulated tapering, ending their participation by Week 39. arm 3: Participants who receive Acthar during the treatment period and continue into the extension period do not go through the treatment-period tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months. arm 4: Participants who receive Placebo during the treatment period and continue into the extension period do not go through the treatment-period simulated tapering, but receive one 0.2 mL SC injection of Acthar, daily for up to 48 weeks, followed by 3 weeks of tapering off the drug, ending their participation within about 21 months.
Interventions: intervention 1: Acthar intervention 2: Placebo
Intervention descriptions: intervention 1: Repository corticotropin for subcutaneous injection intervention 2: Matching placebo for subcutaneous injection

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01412229
Conditions: Head and Neck Cancer
Keywords: Head and neck cancer Phase II Locally advanced Squamous Cell Carboplatin Nab-paclitaxel Abraxane Cetuximab Induction Chemotherapy
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2012-02-01; Completion date: 2019-12-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy.

Detailed description:
This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, nab-paclitaxel and cetuximab prior to scheduled concomitant chemoradiation. The study is designed to evaluate whether this induction regimen can result in an improved response rate (complete response (CR) + partial response (PR)) with less toxicity than the current standard induction docetaxel, cisplatin and 5-fluorouracil (TPF) regimen.

Arms: arm 1: * nab-paclitaxel 100mg/m2
* Carboplatin area under curve (AUC)2 (IV)
* Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
Interventions: intervention 1: Cetuximab intervention 2: Nab-paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. intervention 2: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. intervention 3: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.

Protocol documents:
Clinical trial NCT03005522
Conditions: Dental Research Pharmaceutical Preparations, Dental
Sponsor: University of Arizona
Start date: 2017-01-01; Completion date: 2019-12-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An individual's quality of life can be seriously affected by the severity of dental pain. The emergency department is a common place to find those seeking relief from their dental pain- often times seeking removal of the affected tooth, dental anesthetic injections or oral pain medications. There are a number of dental infections that cause this type of debilitating pain. One such dental infection is termed periapical abscess. This infection involves the tooth pulp. These infections can arise in three ways: introduction through a defect in the enamel and dentin; from a periodontal pocket or an adjacent tooth; or hematogenous seeding of the pulp from mechanical irritation. As this disease process continues there are a number of complications including chronic pain and, more seriously, the spread of infection into deep spaces which can be a life threatening condition.

The Emergency Department treatment of this infection includes pain control, antibiotics and dental referral for ultimate management of the infection.

The purpose of our study is to investigate whether the addition of oral steroids will alter the time until patient experiences improvement in their dental pain. Steroids are a commonly used anti-inflammatory that is used in the Emergency Departmentfor the purpose of pain relief from throat pain. As the pain from periapical infection is thought to be largely from the pressure we speculate that the anti-inflammatory effects of steroids may decrease the inflammation thus the pressure and may ultimately lead to a decrease in time until the patient experiences some relief from their pain.

Detailed description:

Arms: arm 1: dosed with placebo arm 2: 10mg oral dexamethasone
Interventions: intervention 1: oral dexamethasone intervention 2: Placebo Oral Capsule
Intervention descriptions: intervention 1: Patient will be dosed with either placebo or with the study drug, 10mg oral dexamethasone, to be administered by mouth one time in the ED intervention 2: dosed with placebo

Protocol documents:
Prot_SAP_000.pdf: 


Study
Protocol


Statistical 
Anaysis
Clinical trial NCT01261247
Conditions: Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma Nodal Marginal Zone B-cell Lymphoma Peripheral T-cell Lymphoma Post-transplant Lymphoproliferative Disorder Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Waldenstrom Macroglobulinemia
Sponsor: Mayo Clinic
Start date: 2011-01-17; Completion date: 2019-12-02
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well panobinostat works in treating patients with relapsed or refractory non-Hodgkin lymphoma

Detailed description:
PRIMARY OBJECTIVES: I. To evaluate the proportion of confirmed response of LBH589 in patients with relapsed or refractory non-Hodgkin lymphoma. SECONDARY OBJECTIVES: I. To describe the toxicities associated with LBH589 in patients with NHL. II. To evaluate overall survival, progression-free survival, and duration of response in patients treated with LBH589. TERTIARY OBJECTIVES: I. To evaluate the pharmacokinetics of LBH589. II. To assess the correlation between clinical (toxicity and/or tumor response or activity) effects with the pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative laboratory) results. OUTLINE: Patients receive oral panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 2 years.

Arms: arm 1: Patients receive oral panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: panobinostat intervention 2: laboratory biomarker analysis intervention 3: western blotting intervention 4: DNA analysis intervention 5: flow cytometry intervention 6: pharmacological study intervention 7: immunohistochemistry staining method
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies intervention 3: Correlative studies intervention 4: Correlative studies intervention 5: Correlative studies intervention 6: Correlative studies intervention 7: Optional correlative studies

Protocol documents: