ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00804713
Conditions: Latent Tuberculosis Infection
Keywords: TB tuberculosis diagnosis TB screening
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Start date: 2009-03-01; Completion date: 2022-08-01
Enrollment: 2017 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overall objective of this study is to assess the feasibility and potential impact of using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for latent tuberculosis (TB) infection (LTBI) among military recruits. The current policy of universal application of the Mantoux tuberculin skin test (TST) to screen for LTBI may result in many TST reactions among recruits who are at low risk for LTBI. The central hypothesis is that targeted testing by use of the questionnaire will reduce unnecessary testing of low-risk recruits without affecting the identification of higher-risk recruits. The secondary hypothesis is that many discordant results between the TST and IGRA may be explained by cross-reactivity to non-tuberculous mycobacteria (NTM) with the TST.

Detailed description:

Arms: arm 1: Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
Interventions: intervention 1: BST intervention 2: TST intervention 3: QFT intervention 4: T-spot
Intervention descriptions: intervention 1: 0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method. intervention 2: Administer TB Skin test (TST) intervention 3: Perform QFT TB test intervention 4: Perform T-Spot TB test

Protocol documents:
Clinical trial NCT03233633
Conditions: Pain
Keywords: pain management terminally ill
Sponsor: The Connecticut Hospice Inc.
Start date: 2017-05-10; Completion date: 2022-08-05
Enrollment: 66 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study Objectives: Primary reduction of pain and reduction in overall opioid utilization. Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting.

Study Rationale: To determine optimum use and dosing of medical marijuana (CBD:THC) for pain and symptom management.

Study Population: This study specifically will enroll cancer and non-cancer patients as a primary diagnosis suffering from pain and having a terminal illness (defined as having less than 6 months to live) requiring end of life care.

Detailed description:
Primary Endpoint: Primary reduction of pain and reduction in overall opioid utilization as evidenced by overall reduction in numeric pain scores and MME (Morphine Milliequivalents)

Secondary and Exploratory endpoints:Secondary improvement in overall patient well being, weight stabilization with increased appetite, improved oxygen saturation, improvement or prevention of nausea and vomiting. Endpoints evaluation will be based on change from Baseline using the Modified Edmonton Assessment Scale.

Study design: This will be an open-label study. Patients will choose to participate in a Marijuana adjuvant treatment group, receiving marijuana in combination with standard opioid therapy.

Subject number: Minimum 66 patients

Treatment Duration: Minimum 5 days

Duration of follow up: Patients' initial opioid dose, dosing schedule and numeric pain score will be recorded. For the duration of the study (at least five days) changes in opioid doses and numeric pain scores will be tracked daily.

Marijuana will be administered to the patient via oral route three times daily for at least five days. Patients will receive standardized CBD:THC product provided by NIDA.

On admission to the study, a modified Edmonton Symptom assessment scale to quantify baseline appetite, depression, nausea, vomiting, overall well-being, and anxiety.

Data Tracking: Primary objective tracking will include average numeric pain scores and number of opioid dosage increases and average daily opioid amount (mg equivalents of morphine). Secondary objectives include Weight, Appetite, N/V, O2 Saturation, Self-reported data points from the modified Edmonton Assessment Scale.

Arms: arm 1: marijuana adjuvant treatment group utilizing scheduled opioid therapy in inpatient hospice hospital setting
Interventions: intervention 1: Medical Marijuana
Intervention descriptions: intervention 1: oral capsule, high ratio CBD:THC

Protocol documents:
Prot_SAP_000.pdf: 













































ICF_001.pdf:
Clinical trial NCT01849874
Conditions: Low-grade Serous Ovarian Cancer Low-grade Serous Fallopian Tube Cancer Low-grade Serous Peritoneal Cancer
Sponsor: Pfizer
Start date: 2013-06-27; Completion date: 2022-08-23
Enrollment: 341 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MEK162, MEK inhibitor; oral intervention 2: Physician's choice chemotherapy
Intervention descriptions: intervention 1: multiple dose, single schedule intervention 2: Patients will receive one of the following chemotherapies as determined by the physician:

* Liposomal doxorubicin, anthracycline antibiotic; intravenous (multiple dose, single schedule)
* Paclitaxel, mitotic inhibitor; intravenous (multiple dose, single schedule)
* Topotecan, topoisomerase 1 inhibitor; intravenous (multiple dose, single schedule)

Protocol documents:
Clinical trial NCT01995513
Conditions: Prostate Cancer
Sponsor: Pfizer
Start date: 2013-10-22; Completion date: 2022-08-31
Enrollment: 509 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

Detailed description:

Arms: arm 1: Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily arm 2: Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily.
Interventions: intervention 1: Enzalutamide intervention 2: Abiraterone intervention 3: Placebo for Enzalutamide intervention 4: Prednisone
Intervention descriptions: intervention 1: 160 mg by mouth once daily intervention 2: 1000 mg by mouth once daily intervention 3: Sugar pill manufactured to mimic Enzalutamide 40 mg capsule intervention 4: 5 mg by mouth twice daily

Protocol documents:
Clinical trial NCT01940341
Conditions: HBeAg-negative Chronic Hepatitis B
Keywords: Hepatitis Tenofovir Viread
Sponsor: Gilead Sciences
Start date: 2013-09-12; Completion date: 2022-08-31
Enrollment: 426 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.

Detailed description:
Study GS-US-320-0108 is a multi-center clinical trial, planned to enroll participants in multiple countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study before China was able to participate. Therefore, details for the China cohort was registered separately (NCT02836236) on ClinicalTrials.gov as the China cohort will not be part of the main study analysis.

Arms: arm 1: TAF + TDF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3). arm 2: TDF + TAF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3). arm 3: All participants who complete the double-blind period (96 weeks or 144 weeks) will be eligible to receive open-label TAF until Week 384 of the study.

After the end of study treatment, participants can either switch to commercially available anti-HBV treatments in their country or will be followed every 4 weeks, for up to 24 weeks off treatment (treatment-free follow-up (TFFU)) for safety assessment.
Interventions: intervention 1: TAF intervention 2: TDF intervention 3: TAF Placebo intervention 4: TDF Placebo
Intervention descriptions: intervention 1: 25 mg tablet administered orally once daily intervention 2: 300 mg tablet administered orally once daily intervention 3: Tablet administered orally once daily intervention 4: Tablet administered orally once daily

Protocol documents:
Clinical trial NCT01739309
Conditions: Mantle Cell Lymphoma
Keywords: Non- Hodgkins Lymphoma
Sponsor: Eli Lilly and Company
Start date: 2013-03-20; Completion date: 2022-09-05
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to estimate the disease control rate with abemaciclib for relapsed or refractory mantle cell lymphoma.

Detailed description:

Arms: arm 1: 200 milligram (mg) abemaciclib administered orally every 12 hours on days 1 through 28 of a 28-day cycle
Interventions: intervention 1: Abemaciclib
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT05081167
Conditions: Major Depressive Disorder
Keywords: REL-1017
Sponsor: Relmada Therapeutics, Inc.
Start date: 2021-06-02; Completion date: 2022-09-14
Enrollment: 232 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as a monotherapy for Major Depressive Disorder.

Detailed description:

Arms: arm 1: A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017. arm 2: Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet.
Interventions: intervention 1: REL-1017 intervention 2: Placebo
Intervention descriptions: intervention 1: REL-1017 tablet intervention 2: Placebo tablet

Protocol documents:
Prot_SAP_000.pdf: 
Protocol Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-
Controlled Study to Assess the Efficacy and Safety of REL-1017 Monotherapy 
for Major Depressive Disorder 
(The RELIANCE-III Study) 
Protocol Number: REL-1017-303 
NCT Number 
NCT05081167 
Name of Investigational Product: 
REL-1017 
Phase of Development: 
3 
Indication: 
Major Depressive Disorder 
Sponsor: 
Relmada Therapeutics Inc. 
Protocol Date: 
August 03 2022 
Certain information within this protocol has been redacted to protect either personally 
identifiable information or company confidential information. 
This may include, but is not limited to, redaction of the following: 
•
Names, addresses, and other personally identifiable information
•
Proprietary information, such as scales or coding systems, which are considered 
confidential information.
•
Other information as needed to protect the trade secret and/or confidential information of 
Relmada Therapeutics






INVESTIGATOR SIGNATURE PAGE 
Protocol Title: 
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 
Study to Assess the Efficacy and Safety of REL-1017 Monotherapy for 
Major Depressive Disorder (The RELIANCE-III Study) 
Protocol Number: 
REL-1017-303 
Confidentiality and Current Good Clinical Practice (GCP)/E6(R2): 
I agree, as an Investigator conducting this study: 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
Name 
Investigator Signature 
Title 
Date (DD-Mmm-YYYY) 
Institution
Clinical trial NCT05137002
Conditions: Uncontrolled Hypertension
Sponsor: CinCor Pharma, Inc.
Start date: 2021-12-07; Completion date: 2022-10-10
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications.

Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.

Detailed description:

Arms: arm 1: Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks arm 2: Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks arm 3: Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control arm 4: Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks
Interventions: intervention 1: CIN-107 intervention 2: Placebo
Intervention descriptions: intervention 1: CIN-107 tablets by mouth once daily intervention 2: Placebo tablets by mouth once daily

Protocol documents:
Prot_000.pdf: 































































































































































SAP_001.pdf:
Clinical trial NCT01940471
Conditions: HBeAg-positive Chronic Hepatitis B
Keywords: Hepatitis Tenofovir Viread
Sponsor: Gilead Sciences
Start date: 2013-09-11; Completion date: 2022-10-13
Enrollment: 875 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection.

Detailed description:
This study GS-US-320-0110 is a multi-center clinical trial planned to enroll participants in multiple countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study before China was able to participate. Therefore, details for the China cohort are registered separately (NCT02836249) on ClinicalTrials.gov as this cohort will not be part of the main study analysis.

Arms: arm 1: TAF + TDF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3). arm 2: TDF + TAF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3). arm 3: All participants who complete the double-blind period (96 weeks or 144 weeks) will be eligible to receive open-label TAF until Week 384 of the study.

After the end of study treatment, participants can either switch to commercially available anti-HBV treatments in their country or will be followed every 4 weeks, for up to 24 weeks off treatment (treatment-free follow-up (TFFU)) for safety assessment.
Interventions: intervention 1: TAF intervention 2: TDF intervention 3: TAF Placebo intervention 4: TDF Placebo
Intervention descriptions: intervention 1: 25 mg tablet administered orally once daily intervention 2: 300 mg tablet administered orally once daily intervention 3: Tablet administered orally once daily intervention 4: Tablet administered orally once daily

Protocol documents:
Clinical trial NCT03720717
Conditions: Pain
Sponsor: University of Alabama at Birmingham
Start date: 2020-10-27; Completion date: 2022-10-28
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.

Detailed description:
Postoperative pain continues to be a significant clinical problem. Use of perioperative adjuvants has improved postoperative pain control. The GABA-B receptor agonist, baclofen, is an appropriate drug to trial as such an analgesic adjuvant. Therefore, the investigators will conduct a study designed to determine whether or not a single, oral dose of baclofen given to patients undergoing kidney stone surgery will reduce postoperative opioid requirements measured in the first 24 hours following surgery.

Arms: arm 1: Patients identified as opioid tolerant if they reported using daily opioids greater than one month. Randomized into baclofen (10 mg p.o.) group. Drug was given within 30 minutes of OR entry. Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. arm 2: Patients identified as opioid tolerant if they reported using daily opioids greater than one month. Randomized into placebo group with dummy pill administration. Pill was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. arm 3: Patients identified as opioid naive if they reported minimal preoperative use of opioids with a criteria of non-daily use and/or use less than one month. Randomized into baclofen (10 mg p.o.) group. Drug was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status. arm 4: Patients identified as opioid naive if they reported minimal preoperative use of opioids with a criteria of non-daily use and/or use less than one month. Randomized into placebo group with dummy pill administration. Pill was given within 30 minutes of OR entry.Although pseudo-randomization was planned to be initiated near the end of the trial in order to assure balance group numbers, the early termination of the study did not require this and so all randomized to either baclofen or placebo, independent of opioid status.
Interventions: intervention 1: Baclofen 10mg intervention 2: Placebo
Intervention descriptions: intervention 1: Baclofen administration pre-operatively intervention 2: Placebo administration

Protocol documents:
Prot_SAP_002.pdf: 





















ICF_004.pdf:
Clinical trial NCT01750281
Conditions: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Keywords: Mitogen-Activated Protein Kinase Kinase inhibitor Non Small Cell Lung Cancer Metastatic Second line treatment for Non Small Cell Lung Cancer
Sponsor: AstraZeneca
Start date: 2012-12-18; Completion date: 2022-10-31
Enrollment: 212 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

Detailed description:
A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)

Arms: arm 1: Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle. arm 2: Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 mg/m2 intravenously administered on day 1 of each 21 day cycle. arm 3: Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Interventions: intervention 1: Selumetinib 75 mg intervention 2: Docetaxel 75 mg/m2 intervention 3: Docetaxel 60 mg/m2 intervention 4: Placebo
Intervention descriptions: intervention 1: Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule. intervention 2: Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. intervention 3: Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. intervention 4: Three placebo capsules will be administered orally uninterrupted twice daily.

Protocol documents:
Clinical trial NCT05372315
Conditions: Cataract
Keywords: PCIOL CCI CE
Sponsor: Iworks Laser and Vision Center
Start date: 2022-06-15; Completion date: 2022-10-31
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Detailed description:
This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Arms: arm 1: DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use

Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR. arm 2: DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use

Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.
Interventions: intervention 1: Dextenza 0.4Mg Ophthalmic Insert
Intervention descriptions: intervention 1: (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.

Protocol documents:
Prot_SAP_000.pdf: