ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03495713
Conditions: Hodgkin Lymphoma
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2018-11-02; Completion date: 2022-04-20
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II single-arm, single-site, open label clinical trial with r/r HL patients, aimed to determine whether a RadVax approach using low-dose RT added to nivolumab can improve response among patients who do not achieve a CR to nivolumab alone. The long-term goal is to develop an effective regimen for r/r HL patients.

Detailed description:
Nivolumab 3 mg/kg will be administered on day 1 (pre-response assessment week 0) and on day 1 and continued per standard of care and institutional practices. At the week 1 biomarker collection, research FDG PET/CT will be performed to assess for FDG "flare." At week 8-12, PET/CT will be performed for the first response assessment. If a complete anatomic response is seen, nivolumab monotherapy will be continued on day 1 and continued per standard of care and institutional practices.

By contrast, if at week 8 less than a complete anatomic response is seen, radiotherapy to 4 Gy x 2 fractions will be administered (post-response assessment week 0). The patient will be evaluated by a radiation oncologist while on treatment, and toxicities will be recorded. Nivolumab will be continued on day 1 and continued per standard of care and institutional practices.

In either scenario, a second response assessment will be conducted \~8-12 weeks after the first response assessment. In either scenario, nivolumab monotherapy will be continued at the discretion of the treating medical oncologist.

If there is less than CR post-RT and there is an additional untreated non-target lesion that can be followed, radiotherapy can again be administered when disease progresses to a previously untreated lesion, after which the patient will continue on the post-RT follow-up algorithm.

Arms: arm 1: Subjects will receive initial treatment with the immunomodulatory agent, nivolumab, followed by low-dose (4 Gy x 2) involved-site radiotherapy in subjects with less than an anatomic CR after the first restaging scan. Patients with anatomic CR will continue nivolumab alone without radiotherapy. Eligible patients will have r/r disease with at least 2 sites of measurable disease, and must be eligible for treatment with nivolumab.
Interventions: intervention 1: Nivolumab
Intervention descriptions: intervention 1: Nivolumab 3 mg/kg will be administered on day 1 (pre-response assessment week 0) and on day 1 and continued per standard of care and institutional practices. A

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT04711837
Conditions: Anesthesia
Keywords: Anesthesia Elective surgery Propofol
Sponsor: Haisco-USA Pharmaceuticals, Inc.
Start date: 2021-02-11; Completion date: 2022-04-20
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blinded, propofol-controlled, Phase 3 clinical study to evaluate the efficacy and safety of HSK3486 for induction of general anesthesia in adults undergoing elective surgery.

Detailed description:

Arms: arm 1: HSK3486 for induction of general anesthesia. arm 2: Propofol for induction of general anesthesia.
Interventions: intervention 1: HSK3486 intervention 2: Propofol
Intervention descriptions: intervention 1: HSK3486 for induction of general anesthesia. intervention 2: Propofol for induction of general anesthesia.

Protocol documents:
Prot_000.pdf: 
COVER PAGE – PROTOCOL V5.0 HSK3486-304 
 
TITLE OF STUDY: A Multicenter, Randomized, Double-blinded, Propofol-
controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HSK3486 
Injectable Emulsion for Induction of General Anesthesia in Adults Undergoing 
Elective Surgery 
 
NCT NUMBER: NCT04711837 
 
DOCUMENT DATE: 30 JULY 2021 



















































































































































































SAP_001.pdf: 
COVER PAGE – STATISTICAL ANALYSIS PLAN 
V1.0 HSK3486-304 
 
TITLE OF STUDY: A Multicenter, Randomized, Double-blinded, Propofol-
controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HSK3486 
Injectable Emulsion for Induction of General Anesthesia in Adults Undergoing 
Elective Surgery 
 
NCT NUMBER: NCT04711837 
 
DOCUMENT DATE: 22 NOVEMBER 2021
Clinical trial NCT00002874
Conditions: Prostate Cancer
Keywords: stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer recurrent prostate cancer
Sponsor: Radiation Therapy Oncology Group
Start date: 1998-02-01; Completion date: 2022-05-20
Enrollment: 840 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.

Detailed description:

Arms: arm 1: Radiation therapy + bicalutamide arm 2: Radiation therapy + placebo
Interventions: intervention 1: bicalutamide intervention 2: radiation therapy intervention 3: placebo
Intervention descriptions: intervention 1: One (150 mg) tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation. intervention 2: 64.8 Gy in 36 fractions (1.8 Gy in 5 daily sessions per week) to the original prostate volume, the tumor resection bed, and the proximal membranous urethra. intervention 3: One tablet by mouth daily for two years beginning immediately upon, or just prior to, the initiation of irradiation.

Protocol documents:
Clinical trial NCT01571635
Conditions: Beta Thalassemia Major Beta Thalassemia Intermedia
Keywords: Beta-Thalassaemia
Sponsor: Celgene
Start date: 2012-10-10; Completion date: 2022-05-24
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dose finding study to determine the safety and tolerability of Sotatercept (ACE-011) in adults with Beta (β)-Thalassemia

Detailed description:

Arms: arm 1: Experimental 0.1 mg/kg -Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period arm 2: Experimental 0.3 mg/kg - Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period arm 3: Experimental 0.5 mg/kg -Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period arm 4: Experimental 0.75 mg/kg - Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period arm 5: Experimental 1.0 mg/kg -Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period arm 6: Experimental 1.5 mg/kg -Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period
Interventions: intervention 1: SOTATERCEPT (ACE-011)
Intervention descriptions: intervention 1: 0.1 mg/kg to 1.5mg/kg Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period.

Protocol documents:
Clinical trial NCT04778592
Conditions: Lumbosacral Radiculopathy
Sponsor: Eliem Therapeutics (UK) Ltd.
Start date: 2021-01-19; Completion date: 2022-05-25
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain

Detailed description:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain

Arms: arm 1: Drug: ETX-018810 BID for 4 weeks arm 2: Matching Placebo BID for 4 weeks
Interventions: intervention 1: ETX-018810 intervention 2: Placebo
Intervention descriptions: intervention 1: Study Drug intervention 2: Placebo

Protocol documents:
Prot_SAP_000.pdf: 
Protocol ETX-018810-201 
 
ETX-018810 
 
 
Eliem Therapeutics (UK) Ltd 
 
Confidential 
Page 1 of 7 
Version 2.0, 24 May 2021 
 
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the 
Efficacy and Safety of ETX-018810 in Subjects with Lumbosacral Radicular Pain 
 
NCT Number: 04778592 
 
Document Date: 24th May 2021 
 












Protocol ETX-018810-201 
 
ETX-018810 
 
 
Eliem Therapeutics (UK) Ltd 
 
Confidential 
Page 7 of 7 
Version 2.0, 24 May 2021 
 
The treatment comparison for the change from baseline at Week 4 was estimated using a Mixed 
Model Repeated Measures (MMRM), which included the baseline score as a covariate; treatment 
group, visit (week), and the treatment-by-visit (week) as fixed effects; and a repeated structure 
that acknowledged the visits within a subject using an unstructured covariance structure. The 
Kenward-Rogers (1997) approximation was used to estimate the denominator degrees of 
freedom. The estimate, standard error, 90% CI, and associated p-value (2-sided) were presented.
Clinical trial NCT02041533
Conditions: Stage IV or Recurrent Non-Small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2014-03-27; Completion date: 2022-05-27
Enrollment: 541 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

Detailed description:

Arms: arm 1: Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure arm 2: Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first

Squamous subjects:

* Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or
* Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or
* Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle

Non-Squamous subjects:

* Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle
* Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle

Optional crossover:

* Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure
Interventions: intervention 1: Nivolumab intervention 2: Gemcitabine intervention 3: Cisplatin intervention 4: Carboplatin intervention 5: Paclitaxel intervention 6: Pemetrexed
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01781637
Conditions: Peanut Allergy Food Allergy
Keywords: Xolair omalizumab peanut oral desensitization
Sponsor: Boston Children's Hospital
Start date: 2013-01-01; Completion date: 2022-05-31
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.

Detailed description:
36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital.

Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.

Arms: arm 1: Patients will receive omalizumab. arm 2: Patients will receive placebo.
Interventions: intervention 1: Omalizumab intervention 2: placebo
Intervention descriptions: intervention 1: subcutaneous injection intervention 2: subcutaneous injection

Protocol documents:
Clinical trial NCT01160211
Conditions: Neoplasms, Breast
Keywords: 1st line MBC MBC hormone receptor positive lapatinib trastuzumab HER2 positive aromatase inhibitor
Sponsor: Novartis Pharmaceuticals
Start date: 2011-05-05; Completion date: 2022-06-06
Enrollment: 369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

Detailed description:
This Phase III, multicenter, open-label study randomized subjects to one of the three treatment arms:

1. Treatment group A: lapatinib 1000 mg PO once daily + trastuzumab (loading dose of 8 mg/kg) followed by the maintenance dose of 6 mg/kg IV q3weeks + an AI (either letrozole, anastrozole, or exemestane) of Investigator's choice PO once daily.
2. Treatment group B: trastuzumab (loading dose of 8 mg/kg) followed by maintenance dose of 6 mg/kg IV q3weeks + an AI (either letrozole, anastrozole, or exemestane) of Investigator's choice PO once daily.
3. Treatment group C: lapatinib 1500 mg PO once daily + an AI (either letrozole, anastrozole, or exemestane) of Investigator's choice PO once daily.

Treatment continued until disease progression, death, or unacceptable toxicities, whichever came first.

Subjects who discontinued study treatment for reasons other than disease progression were followed-up every 12 weeks until disease progression or death, until the start of post-study treatment anti-cancer therapy (including radiotherapy and surgery), withdrawal of consent, or lost to follow-up, whichever came first.

Arms: arm 1: Lapatinib 1000 mg PO once daily + Trastuzumab (loading dose of 8 mg/kg) followed by the maintenance dose of 6 mg/kg IV every 3 weeks (q3weeks) + an Aromatase Inhibitor (AI) of Investigator's choice PO once daily. arm 2: Trastuzumab (loading dose of 8 mg/kg) followed by maintenance dose of 6 mg/kg IV every 3 weeks (q3weeks) + an Aromatase Inhibitor (AI) of Investigator's choice PO once daily. arm 3: Lapatinib 1500 mg PO once daily + an Aromatase Inhibitor (AI) of Investigator's choice PO once daily.
Interventions: intervention 1: Lapatinib intervention 2: Trastuzumab intervention 3: Aromatase Inhibitor intervention 4: Lapatinib
Intervention descriptions: intervention 1: 1000 mg by mouth once a day intervention 2: Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks (q3weeks) intervention 3: Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily intervention 4: 1500 mg by mouth once daily

Protocol documents:
Clinical trial NCT04466215
Conditions: Alcohol Use Disorder
Keywords: Alcohol-Related Disorders
Sponsor: The Scripps Research Institute
Start date: 2021-04-15; Completion date: 2022-06-07
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or greater severity treated with CORT118335 will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.

Detailed description:

Arms: arm 1: 900 mg (6 x 150 mg) tablets daily taken orally for two weeks arm 2: Six placebo tablets taken orally for two weeks
Interventions: intervention 1: Miricorilant intervention 2: Placebo oral tablet
Intervention descriptions: intervention 1: 900 mg (6 x 150 mg) tablets taken orally once daily for two weeks intervention 2: Six placebo tablets taken orally once daily for two weeks

Protocol documents:
ICF_005.pdf: 























SAP_004.pdf: 



Prot_003.pdf:
Clinical trial NCT04136366
Conditions: Proliferative Vitreoretinopathy
Keywords: ADX-2191 recurrent retinal detachment open globe injury
Sponsor: Aldeyra Therapeutics, Inc.
Start date: 2019-11-15; Completion date: 2022-06-14
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The GUARD Trial is a multi-center, randomized, controlled, adaptive Phase 3 clinical trial of repeated intravitreal injections of ADX-2191 versus standard-of-care for the prevention of proliferative vitreoretinopathy.

Detailed description:

Arms: arm 1: ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks. arm 2: Standard procedure performed.
Interventions: intervention 1: ADX-2191 (intravitreal methotrexate 0.8%) intervention 2: Standard surgical care procedure
Intervention descriptions: intervention 1: ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy intervention 2: Standard surgical care performed upon completion of pars plana vitrectomy

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT00679783
Conditions: Ovarian Carcinoma Breast Cancer
Keywords: Breast cancer Ovarian cancer BRCA Triple negative Poly(ADP ribose) polymerases Known BRCA or Recurrent High Grade Serious/ Undifferentiated Tubo- Ovarian Carcinoma Known BRCA or Triple Negative Breast Cancer
Sponsor: AstraZeneca
Start date: 2008-07-08; Completion date: 2022-07-20
Enrollment: 99 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study

Detailed description:

Arms: arm 1: Triple negative breast Cancer with unknown BRCA mutation status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally

AZD2281, PARP inhibitor Olaparib tablets, oral arm 2: Known BRCA mutation positive breast cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) to be administered orally

AZD2281, PARP inhibitor Olaparib tablets, oral arm 3: High grade serous/undifferentiated tubo-ovarian carcinoma with unknown BRCA status: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally

AZD2281, PARP inhibitor Olaparib tablets, oral arm 4: Known BRCA mutation positive ovarian cancer: AZD2281 400 mg bid (capsules)/ 300 mg bid (tablets) administered orally

AZD2281, PARP inhibitor Olaparib tablets, oral
Interventions: intervention 1: AZD2281
Intervention descriptions: intervention 1: PARP inhibitor Olaparib tablets, oral

Protocol documents:
Clinical trial NCT04402489
Conditions: EPP XLP
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Start date: 2020-06-01; Completion date: 2022-07-26
Enrollment: 184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP aged 12-75.

Detailed description:

Arms: arm 1: Oral tablet of placebo once a day. arm 2: Oral tablet of MT-7117 Low Dose once a day. arm 3: Oral tablet of MT-7117 High Dose once a day.
Interventions: intervention 1: Placebo intervention 2: MT-7117 Low Dose intervention 3: MT-7117 High Dose
Intervention descriptions: intervention 1: Placebo intervention 2: MT-7117 Low Dose intervention 3: MT-7117 High Dose

Protocol documents:
Prot_000.pdf: 







































































































































































































































































































































































































































































































SAP_001.pdf:
Clinical trial NCT00667251
Conditions: Breast Cancer
Keywords: recurrent breast cancer HER2-positive breast cancer stage IV breast cancer
Sponsor: Novartis Pharmaceuticals
Start date: 2008-10-07; Completion date: 2022-07-27
Enrollment: 652 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented evidence of human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) (by local or central laboratory testing) who had received no prior chemotherapy or HER2 targeted therapy in the metastatic setting.

Detailed description:
Subjects were stratified by

* Prior (neo) adjuvant HER2/neu targeted therapy (yes, no)
* Prior (neo) adjuvant taxane chemotherapy (yes, no)
* Planned taxane treatment (once weekly paclitaxel versus docetaxel once every 3 weeks)
* Liver metastasis (yes, no)

Subjects were randomized 1:1 to the following treatments to a planned sample size of approximately 600 subjects (to achieve 536 centrally confirmed HER2 positive subjects):

* Taxane based chemotherapy plus lapatinib for 24 weeks followed by single agent lapatinib
* Taxane based chemotherapy plus trastuzumab for 24 weeks followed by single agent trastuzumab

The choice of taxane (once weekly paclitaxel versus docetaxel once every 3 weeks) was at the discretion of the treating physician and was specified at the time of subject randomization.

A protocol-specified interim analysis was conducted on 27-Apr-2012, following which the participants in the Lapatinib plus taxane based chemotherapy arm could cross over to Taxane based chemotherapy plus Trastuzumab.

Arms: arm 1: Plus taxane based chemotherapy arm 2: Plus taxane based chemotherapy.
Interventions: intervention 1: trastuzumab intervention 2: docetaxel intervention 3: lapatinib ditosylate intervention 4: paclitaxel
Intervention descriptions: intervention 1: IV q weekly (loading dose 4mg/kg; subsequent doses 2mg/kg) or IV q 3 weekly (loading dose 8mg/kg, subsequent doses 6mg/kg). intervention 2: 75mg/m2 IV q 3 weekly, day 1 of a 3 week cycle for 8 cycles plus G-CSF (when given together with lapatinib). intervention 3: 1250 mg once daily (while given with taxane). 1500mg once daily (when given alone after taxane completion). intervention 4: 80mg/m2 IV q weekly days 1, 8 and 15 of a 4-week cycle for 6 cycles.

Protocol documents: