ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02314117
Conditions: Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma
Sponsor: Eli Lilly and Company
Start date: 2015-01-20; Completion date: 2020-08-14
Enrollment: 645 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.

Detailed description:

Arms: arm 1: 8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m\^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m\^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m\^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle. arm 2: Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m\^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m\^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m\^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Interventions: intervention 1: Ramucirumab intervention 2: Capecitabine intervention 3: Cisplatin intervention 4: Placebo intervention 5: Fluorouracil
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered orally intervention 3: Administered IV intervention 4: Administered IV intervention 5: Administered IV

Protocol documents:
Clinical trial NCT04032327
Conditions: Postoperative Pain
Sponsor: Walter Reed National Military Medical Center
Start date: 2018-07-01; Completion date: 2020-08-25
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Effective post-surgical pain management is a crucial component of a patient's postoperative course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, literature regarding this medication specific to Urogynecology and Gynecology is limited.

The investigators propose a prospective, randomized, double blind, trial with 120 subjects recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic to study postsurgical pain control after posterior repair. There will be two arms in the study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®.

The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual postoperative pain control regimen. The investigators hypothesize a 30% difference in post-operative pain measurements between the two groups.

Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3 and any post-operative voiding and defecatory dysfunction, comparing the two groups

Detailed description:

Arms: arm 1: 20 mL of 0.25% plain bupivacaine arm 2: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Interventions: intervention 1: Exparel plus plain bupivacaine intervention 2: Bupivacaine
Intervention descriptions: intervention 1: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy intervention 2: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy

Protocol documents:
Prot_SAP_ICF_001.pdf:
Clinical trial NCT03831880
Conditions: Growth Hormone Deficiency
Sponsor: Pfizer
Start date: 2019-02-07; Completion date: 2020-08-28
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an open label randomized 24 week crossover trial assessing the treatment burden of a weekly growth hormone injection regimen (somatrogon) compared to a daily growth hormone injection regimen (Genotropin). Approximately 90 children with growth hormone deficiency who have been stable on treatment with daily Genotropin will be enrolled.

Detailed description:
Subjects will be randomized to one of two sequences, either 12 weeks of continued treatment with daily Genotropin followed by 12 weeks of treatment with weekly somatrogon, or 12 weeks of treatment with weekly somatrogon followed by 12 weeks of treatment with daily Genotropin. Subjects will have study visits at Baseline, Weeks 6, 12, 18, and 24. Subjects will also be followed up by phone 8 to 12 days after each treatment period begins (Week 1 and Week 13). Subjects and caregivers (as a Dyad) will complete questionnaires assessing treatment burden at baseline and at the end of each 12 week treatment period. All subjects/caregivers will receive a follow up phone call at Week 28.

Arms: arm 1: Genotropin to somatrogon arm 2: somatrogon to Genotropin
Interventions: intervention 1: Genotropin intervention 2: somatrogon
Intervention descriptions: intervention 1: Genotropin (dose \[mg\] at time of enrollment) given subcutaneously once daily intervention 2: 0.66 mg/kg/week given subcutaneously once weekly

Protocol documents:
Prot_000.pdf: 















































































































































































































SAP_001.pdf:
Clinical trial NCT00704730
Conditions: Thyroid Cancer
Keywords: Medullary Thyroid Cancer MTC
Sponsor: Exelixis
Start date: 2008-06-01; Completion date: 2020-09-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.

The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: XL184 intervention 2: Placebo
Intervention descriptions: intervention 1: Gelatin capsules supplied in 25-mg and 100-mg strengths administered orally daily intervention 2: Gelatin capsules color and size-matched to XL184 capsules administered orally daily

Protocol documents:
Clinical trial NCT01083316
Conditions: Amyloidosis
Keywords: Amyloid Amyloidosis AL Amyloidosis Primary Amyloidosis Stem Cell Transplant
Sponsor: Boston Medical Center
Start date: 2009-09-01; Completion date: 2020-09-04
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The drugs dexamethasone and bortezomib are both FDA-approved for the treatment of multiple myeloma, a disease very similar to amyloidosis. However, they are currently investigational for the treatment of amyloidosis.

We want to find out if the addition of dexamethasone and bortezomib to standard high dose chemotherapy and stem cell transplant can help improve response.

Standard treatment includes four steps: 1) Stem Cell Mobilization (standard) 2) Stem Cell Collection (standard) 3) Conditioning Regimen (Melphalan chemotherapy). The conditioning regimen helps to kill the abnormal cells in the body and makes room in the bone marrow for new blood stem cells to grow. 4) Stem Cell Infusion

Participants in this study will have an additional treatment step called "induction therapy", designed as the first step towards reducing the number of abnormal cells in the body. Two cycles of the investigational drugs bortezomib and dexamethasone will be given during induction therapy. In addition, bortezomib will given as part of the conditioning regimen, in addition to the standard melphalan chemotherapy.

Detailed description:
The drugs dexamethasone and bortezomib are both FDA-approved drugs for the treatment of multiple myeloma, a disease very similar to amyloidosis. However, they are currently investigational for the treatment of amyloidosis.

The investigators want to find out if the addition of dexamethasone and bortezomib to standard treatment of high dose chemotherapy and stem cell transplant can help improve response to treatment.

Arms: arm 1: Induction:

Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days

Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days

Conditioning:

Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4

Melphalan 70-100 mg/m2/day IV on days -2 and -1
Interventions: intervention 1: Bortezomib intervention 2: Dexamethasone intervention 3: Melphalan
Intervention descriptions: intervention 1: Induction:

Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days

Conditioning:

Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 intervention 2: Induction:

Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days intervention 3: Conditioning:

Melphalan 70-100 mg/m2/day IV on days -2 and -1

Protocol documents:
Clinical trial NCT02144077
Conditions: Basal Cell Carcinoma (BCC)
Keywords: Photodynamic Therapy PDT non-aggressive BCC
Sponsor: Biofrontera Bioscience GmbH
Start date: 2014-01-28; Completion date: 2020-09-09
Enrollment: 281 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to test the effectiveness and safety of the medicine Ameluz® (5-aminolevulinic acid) in comparison to methyl-aminolevulinate (MAL), used with photodynamic therapy (PDT), to treat thin, non-aggressive BCC (basal cell carcinoma).

Detailed description:
The treatment comprises of up to 2 PDT cycles, each with two PDT sessions one week apart.

If 12 weeks after the the second PDT all lesions are completely cleared the patient will enter the follow-up phase. In case of remaining lesions the patient will receive a second PDT cycle starting on the same day.

Arms: arm 1: Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin. arm 2: Topical application of Metvix creme containing 160 mg/g methyl-aminolevulinate. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin.
Interventions: intervention 1: BF-200 ALA intervention 2: methyl-aminolevulinate
Intervention descriptions: intervention 1: Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation) intervention 2: Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)

Protocol documents:
Clinical trial NCT02687451
Conditions: Post-Operative Pain Acute Pain
Keywords: Surgical Pain Acute Post-Surgical Pain
Sponsor: Endo Pharmaceuticals
Start date: 2016-04-01; Completion date: 2020-09-15
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy, tolerability, safety and pharmacokinetics of Oxymorphone HCl as an analgesic for acute moderate to severe post-operative pain in pediatric subjects.

Detailed description:

Arms: arm 1: Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; open-label, single-dose, dose selection phase. arm 2: Oxymorphone HCl Immediate Release Oral Liquid and Oxymorphone HCl Injection; placebo controlled, randomized, double-blinded multiple-dose phase. arm 3: Sodium Chloride 0.9% solution; comparator for multiple-dose phase.
Interventions: intervention 1: Oxymorphone HCl intervention 2: Placebo
Intervention descriptions: intervention 1: Oral liquid and injection; dose to be determined by Independent Data Monitoring Committee (IDMC). intervention 2: Placebo Comparator for the double-blinded, placebo-controlled multiple-dose phase.

Protocol documents:
Prot_000.pdf: 
This study was initiated at the request of the FDA as a class required Post-marketing Study in 
Pediatric Patients.



















































































































































































































SAP_001.pdf: 
This study was conducted at the request of the FDA as a class required Post Marketing
Study in pediatric patients.
Clinical trial NCT03137121
Conditions: Advanced Cancer
Keywords: nausea vomiting olanzapine
Sponsor: University of Alabama at Birmingham
Start date: 2017-07-12; Completion date: 2020-09-15
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the use of olanzapine for the treatment of cancer patients with chronic nausea and/or vomiting unrelated to chemotherapy or radiation in a randomized placebo-controlled pilot trial.

Detailed description:
Patients with advanced cancer experience a variety of physical and psychosocial symptoms that significantly affect the patients' quality of life. Chronic nausea is a particularly distressing symptom present in \>60% of patients with advanced cancer. A number of palliative care studies have evaluated treatments of nausea with limited success. Olanzapine with its unique formulation and decreased drug interactions compared to many other drugs appears to be a reasonable candidate for further evaluation. Olanzapine has significant potential for use in the prevention and treatment of nausea in a palliative care setting with a once-daily dosing.

Arms: arm 1: Patients will receive 5 mg olanzapine orally for 1 to 7 days daily. arm 2: Patients will receive a placebo orally for 1 to 7 days daily.
Interventions: intervention 1: Olanzapine intervention 2: Placebo
Intervention descriptions: intervention 1: Olanzapine is used as an anti-emetic. intervention 2: The placebo is a non-anti-emetic.

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02447328
Conditions: Locally Advanced or Metastatic Breast Cancer
Sponsor: AstraZeneca
Start date: 2015-05-29; Completion date: 2020-09-16
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm study aims to assess the safety and tolerability profile of Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events after Fulvestrant (Faslodex®) for about 6 months

Detailed description:
This study is a Phase 4, single-arm, safety and tolerability study of fulvestrant (Faslodex®) as 2nd line therapy in postmenopausal women with locally advanced or metastatic breast cancer.

All of enrolled patients in this study will be injected fulvestrant (Faslodex®). This study will be performed for about 3 years and approximately 100 patients(actual target will be 80 treated patients) will be enrolled in about 10 investigational sites.

After obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed.

Patients who meet the inclusion/exclusion criteria will be injected the fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection. The information of adverse events will be collected after the 1st dose of IP injection. In case that the evaluation of tumor response might be performed in regular clinical practice, those data will also be collected as well. The quality of life will also be measured.

Arms: arm 1: Faslodex treated in the study
Interventions: intervention 1: Fulvestrant
Intervention descriptions: intervention 1: fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.

Protocol documents:
Clinical trial NCT02175212
Conditions: Prostate Adenocarcinoma
Keywords: Patients with prostate adenocarcinoma
Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Start date: 2005-11-01; Completion date: 2020-09-24
Enrollment: 362 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present study is a phase III randomized and multicentric trial evaluating the potential additional impact effect of two years adjuvant androgen deprivation when combined with neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk prostate cancer patients. Stratification will be performed by prognostic factors and by participating institution.

Detailed description:

Arms: arm 1: * Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
* Bicalutamide 50 mg tablet every day for 2 months
* High dose conformal radiotherapy
* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy arm 2: * Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
* Bicalutamide 50 mg tablet every day for 2 months
* High dose conformal radiotherapy
Interventions: intervention 1: Short term androgen deprivation intervention 2: Long term androgen deprivation intervention 3: Short term androgen deprivation intervention 4: Long term androgen deprivation
Intervention descriptions: intervention 1: * Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
* Bicalutamide 50 mg tablet every day for 2 months intervention 2: * Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
* Bicalutamide 50 mg tablet every day for 2 months
* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy intervention 3: Minimum dose of 76 Gy (range 76-82 Gy) intervention 4: Minimum dose of 76 Gy (range 76-82 Gy)

Protocol documents:
Clinical trial NCT03176771
Conditions: Tardive Dyskinesia
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2017-06-21; Completion date: 2020-09-29
Enrollment: 256 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of MT-5199 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Detailed description:

Arms: arm 1: MT-5199 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning for 6 weeks. arm 2: Subjects randomized to the MT-5199 80 mg dose will receive MT-5199 40 mg for the first week (administered as one (1) 40 mg capsule and one (1) placebo capsule), followed by MT-5199 80 mg administered as two (2) 40 mg capsules, taken by mouth, every morning for 5 weeks. arm 3: Placebo administered as two (2) placebo capsules, taken by mouth, every morning for 6 weeks. arm 4: At the end of Week 6, subjects will enter a double-blind extension period for 42 weeks. Subjects who were initially randomized to placebo will be re-randomized (1:1) to receive either MT-5199 40 mg or 80 mg and subjects initially randomized to MT-5199 will continue with their current dose. arm 5: At the end of Week 6, subjects will enter a double-blind extension period for 42 weeks. Subjects who were initially randomized to placebo will be re-randomized (1:1) to receive either MT-5199 40 mg or 80 mg and subjects initially randomized to MT-5199 will continue with their current dose. Subjects re-randomized to receive MT-5199 80 mg will receive 40 mg for the first week.
Interventions: intervention 1: MT-5199 intervention 2: Placebo
Intervention descriptions: intervention 1: MT-5199 40 mg capsules intervention 2: MT-5199 placebo capsules

Protocol documents:
Prot_000.pdf: 























































































































































































































SAP_001.pdf:
Clinical trial NCT02759861
Conditions: Genotype 1 Hepatitis C Virus
Sponsor: University of Nebraska
Start date: 2016-08-01; Completion date: 2020-10-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection

Detailed description:
determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection

Arms: arm 1: patient will receive 8 or 12 weeks depending on clinical data
Interventions: intervention 1: harvoni
Intervention descriptions: intervention 1: 8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy

Protocol documents:
Prot_SAP_000.pdf: