ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT05085834
Conditions: Inflammation Cardiovascular Diseases Zinc Deficiency
Keywords: Zinc inflammation Cardiovascular Diseases risk
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2020-01-22; Completion date: 2024-08-02
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among HIV infected patients on stable anti-retroviral therapy

Detailed description:
This study will focus on subjects with documented zinc deficiency (levels \<75 µg/dl) as group most likely to benefit from the zinc supplementation. The investigators also acknowledge that zinc may be beneficial in all HIV subjects, regardless of the plasma zinc level; however initial studies should be done in subjects with low zinc levels as they are more likely to benefit.

Arms: arm 1: Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks. arm 2: Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.
Interventions: intervention 1: Zinc Gluconate intervention 2: Placebo
Intervention descriptions: intervention 1: Two 45 mg capsules once daily intervention 2: Two placebo capsules once daily

Protocol documents:
Prot_SAP_000.pdf: 













































ICF_001.pdf:
Clinical trial NCT05966584
Conditions: Breast Cancer
Keywords: Alpelisib Benralizumab Metastatic HR-positive HER2-negative breast cancer Rash 22-276
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2023-07-06; Completion date: 2024-08-02
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib. Researchers think adding benralizumab to the standard-of-care hormone treatment and alpelisib may prevent the patient from getting a rash.

Detailed description:

Arms: arm 1: Patients will receive fulvestrant or AIs and PI3K inhibition (alpelisib) per SOC (fulvestrant on days 1, 15, 29 and monthly thereafter; Ais on a daily continuous basis). Participants will receive one injection of benralizumab 30mg subcutaneously on day -1.
Interventions: intervention 1: Benralizumab intervention 2: fulvestrant or AIs) and PI3K inhibition (alpelisib)
Intervention descriptions: intervention 1: Benralizumab 30mg subcutaneously on day -1. intervention 2: SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib)

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01078662
Conditions: Ovarian Breast Prostate Pancreatic Advanced Tumours
Keywords: olaparib PARP inhibitors genetic BRCA1 mutation BRCA2 mutation solid tumour refractory
Sponsor: AstraZeneca
Start date: 2010-02-21; Completion date: 2024-08-12
Enrollment: 298 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response

Detailed description:

Arms: arm 1: Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.
Interventions: intervention 1: olaparib
Intervention descriptions: intervention 1: Tablets Oral BID

Protocol documents:
Clinical trial NCT00470704
Conditions: Breast Cancer
Keywords: HER2-positive breast cancer Herceptin trastuzumab
Sponsor: Nancy Lin, MD
Start date: 2007-05-14; Completion date: 2024-08-20
Enrollment: 87 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this research study we are studying the effects of the combination of lapatinib plus Herceptin in subjects with breast cancer that has spread outside of the breast. We are also studying whether positron emission tomography (PET/CT) scans can predict which participants will benefit from the study treatment. Finally, we are studying genes and proteins in the tumor tissue that may lead to sensitivity or resistance to Herceptin, and to the combination of Herceptin plus lapatinib. Lapatinib is a compound that may stop cancer cells from growing. Other research studies suggest that lapatinib in combination with Herceptin may help to shrink or stabilize breast cancer.

Detailed description:
* Participants will be asked to undergo a biopsy of an area of the body where the cancer has spread.
* Participants will be given a study medication-dosing calendar for each treatment cycle. Each treatment cycle lasts four weeks during which time you will be taking lapatinib, once per day.
* Participants will receive Herceptin once every week or once every 3 weeks through a vein.
* During all treatment cycles a physical exam will be performed and questions about the participants general health will be asked. Blood tests including chemistry and hematology will be performed to measure additional effect of the study drug and disease status. Photographs may be taken of the tumor to assess the response of the tumor to treatment.
* CT scans will be repeated every 8 weeks to assess the effect of the study treatment on the cancer. Either a MUGA scan or echocardiogram will be performed 8 weeks and 16 weeks after the participant starts the study treatment.
* Participants will remain on this research study for as long as they are benefiting from the study treatment.

Arms: arm 1: This cohort is made up of participants without prior trastuzumab for MBC. Adjuvant or neoadjuvant trastuzumab was allowed, if the interval from trastuzumab completion to recurrence exceeded 1 year.

1000 mg daily Lapatinib

2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab arm 2: This cohort is made up of participants with one to two lines of chemotherapy for metastatic disease with at least one trastuzumab-containing regimen or patients who recurred within 12 months of adjuvant or neoadjuvant trastuzumab with up to one line of metastatic trastuzumab-based therapy

1000 mg daily Lapatinib

2 mg/kg weekly or 6 mg/kg every 3 week dose of trastuzumab
Interventions: intervention 1: Lapatinib intervention 2: Herceptin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02007512
Conditions: Breast Cancer
Keywords: advanced breast cancer enzalutamide MDV3100 Estrogen receptor positive (ER +) Progesterone receptor positive (PgR +) HER-2 normal
Sponsor: Pfizer
Start date: 2013-12-16; Completion date: 2024-08-23
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.

Detailed description:
This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2-Normal.

Arms: arm 1: Enzalutamide 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) once daily after food. arm 2: Placebo and exemestane 25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet without placebo after unblinding) once daily after food.
Interventions: intervention 1: Enzalutamide intervention 2: exemestane intervention 3: Placebo (for enzalutamide) intervention 4: exemestane
Intervention descriptions: intervention 1: 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food. intervention 2: 25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet after unblinding) by mouth once daily after food. intervention 3: Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food. intervention 4: 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) by mouth once daily after food.

Protocol documents:
Clinical trial NCT01909453
Conditions: Melanoma
Keywords: Melanoma Cutaneous melanoma Skin disease Skin cancer Skin Neoplasms Neoplasm Metastasis BRAF mutant BRAF V600E BRAF V600K Cancer LGX818 MEK162 vemurafenib combination BRAF inhibitor resistance The combination of a selective BRAF- and a MEK1/2-inhibitor Prior immunotherapy MEK inhibitor Phase III Combo 300, Combo 450
Sponsor: Pfizer
Start date: 2013-09-12; Completion date: 2024-09-03
Enrollment: 921 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.

Part 1:

Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:

1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm)
2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or
3. vemurafenib 960 mg BID (denoted as vemurafenib arm)

Part 2:

Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:

1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or
2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)

Detailed description:

Arms: arm 1: LGX818 450 mg QD + MEK162 45 mg BID arm 2: Vemurafenib 960 mg BID arm 3: LGX818 300 mg QD + MEK162 45 mg BID arm 4: LGX818 300 mg QD
Interventions: intervention 1: LGX818 intervention 2: MEK162 intervention 3: vemurafenib
Intervention descriptions: intervention 1: LGX818- Orally 100 mg and 50 mg capsules intervention 2: MEK162- Orally 15 mg tablets intervention 3: Tablets in bottles or blisters 240 mg

Protocol documents:
Clinical trial NCT05219968
Conditions: Chronic Sinusitis Chronic Rhinosinusitis (Diagnosis)
Sponsor: Lyra Therapeutics
Start date: 2022-01-27; Completion date: 2024-09-16
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.

Detailed description:
This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.

Arms: arm 1: Single administration of LYR-210 drug matrix (7500 μg) arm 2: Single mock administration procedure
Interventions: intervention 1: LYR-210 intervention 2: Sham procedure control intervention 3: Background Therapy
Intervention descriptions: intervention 1: LYR-210 drug matrix (mometasone furoate) intervention 2: Sham procedure control intervention 3: Daily Saline Irrigation

Protocol documents:
Prot_000.pdf: 



















































































































































SAP_001.pdf:
Clinical trial NCT00680901
Conditions: Neoplasms, Gastrointestinal Tract
Keywords: unresectable HER2 ErbB2 TYKERB capecitabine CapeOx gastric/esophageal cancer GE junction metastatic lapatinib oxaliplatin
Sponsor: Novartis Pharmaceuticals
Start date: 2008-06-04; Completion date: 2024-10-03
Enrollment: 545 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2) gene. The trial investigated whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extended the time to progression and overall survival. Tumor ErbB2 (HER2) status had to be known before trial entry. CapeOx was administered to all patients, and patients were randomly assigned to receive either lapatinib or placebo.

Detailed description:

Arms: arm 1: CapeOx plus Lapatinib arm 2: CapeOx plus Placebo
Interventions: intervention 1: Lapatinib intervention 2: Placebo intervention 3: Capecitabine intervention 4: Oxaliplatin
Intervention descriptions: intervention 1: 5 pills at 250mg each once daily intervention 2: 5 pills once daily intervention 3: 1700mg/m2/day in two daily doses intervention 4: 130mg/m2 on day 1

Protocol documents:
Clinical trial NCT00066703
Conditions: Breast Cancer
Keywords: stage II breast cancer stage IIIA breast cancer estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer stage IA breast cancer stage IB breast cancer
Sponsor: ETOP IBCSG Partners Foundation
Start date: 2003-11-03; Completion date: 2024-10-23
Enrollment: 2672 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.

Detailed description:
OBJECTIVES:

* Compare the disease-free survival, breast cancer-free interval, distant recurrence-free interval and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen.
* Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.

OUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.

Arms: arm 1: Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin. arm 2: Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Interventions: intervention 1: exemestane intervention 2: tamoxifen intervention 3: triptorelin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01615029
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Daratumumab Lenalidomide Dexamethasone Dose-escalation Relapsed multiple myeloma Relapsed and refractory multiple myeloma
Sponsor: Janssen Research & Development, LLC
Start date: 2012-06-26; Completion date: 2024-10-23
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).

Detailed description:
The study is conducted in two parts. The dose escalation portion of the trial (Part 1) participants are enrolled into cohorts at increasing dose levels of daratumumab in combination with Len/Dex in 28 day treatment cycles. Part 2, the cohort expansion part of the trial, will further explore the maximum tolerated dose (MTD) (or the maximum tested dose) of daratumumab as determined in Part 1.

Arms: arm 1: Participants will receive daratumumab along with Lenalidomide and dexamethasone.
Interventions: intervention 1: Part 1 (Dose Escalation): Daratumumab intervention 2: Part 2 (Dose Expansion): Daratumumab intervention 3: Lenalidomide intervention 4: Dexamethasone
Intervention descriptions: intervention 1: Participants will receive intravenous (injection of a substance into a vein) infusion of daratumumab in an increased fashion from 2 milligram per kilogram (mg/kg) up to maximum dose of 16 mg/kg. Considering the safety and efficacy of dose in Part 1, recommended phase 2 dose (RP2D) for Part 2 of the study will be decided. A predose infusion of 10 percent (%) of the full dose of daratumumab will be administered a day before the first full infusion of the first cycle. Participants will receive 4 weekly infusions in the first 2 treatment cycles. From cycles 3 to 6 infusions will be administered every alternate week and monthly infusions will be administered from cycle 7 until disease progression. intervention 2: Participants will receive RP2D as determined in Part 1 of the study. Participants will receive 4 weekly infusions of RP2D in the first 2 treatment cycles. From cycles 3 to 6 infusions will be administered every alternate week and monthly infusions will be administered from cycle 7 until disease progression. intervention 3: All participants (Part 1 and Part 2) will receive 25 mg lenalidomide orally (by mouth) from days 1 to 21 of each 28-day cycle until disease progression. intervention 4: All participants (Part 1 and Part 2) will receive 40 mg (20 mg intravenously \[injection of a substance into a vein\]) dexamethasone once weekly. Participants older than 75 years or underweight (body mass index \[BMI\] less than \[\<\] 18.5), the dexamethasone dose will be administered at a dose of 20 mg once weekly until disease progression.

Protocol documents:
Clinical trial NCT04218084
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease Transcranial Doppler Ultrasound (TCD)
Sponsor: Pfizer
Start date: 2020-11-11; Completion date: 2024-11-06
Enrollment: 236 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a Phase 3, randomized, double-blind, placebo-controlled study of voxelotor in pediatric participants, aged ≥ 2 to \< 15 years old, with Sickle Cell Disease. The primary objective is to evaluate the effect of voxelotor on the TCD (Transcranial Doppler Ultrasound) measurements in SCD participants in this age range.

Detailed description:
This study is a Phase 3, randomized, double-blind, placebo-controlled study of voxelotor in pediatric participants, aged ≥ 2 to \< 15 years old, with Sickle Cell Disease. The study will be conducted at approximately 50 international clinical sites, and will enroll approximately 224 participants. Participants will be randomized in a 1:1 ratio to receive voxelotor or placebo. All participants younger than 12 years of age and randomized to voxelotor will receive a dose based on their body weight, to provide exposure corresponding to the adult dose of 1500 mg/day.

Arms: arm 1: Voxelotor 1500mg or equivalent daily as a tablet, dispersible tablet, or as powder for oral suspension. arm 2: Matching placebo.
Interventions: intervention 1: Voxelotor intervention 2: Placebo
Intervention descriptions: intervention 1: Participants are randomized 1:1 to receive voxelotor or placebo. intervention 2: Matching placebo.

Protocol documents:
Prot_000.pdf: 













































































































































































SAP_001.pdf:
Clinical trial NCT00512070
Conditions: Schizophrenia Schizoaffective Disorder Bipolar Disorder Obesity Metabolic Syndrome
Keywords: schizophrenia schizoaffective disorder bipolar disorder olanzapine melatonin obesity metabolic syndrome
Sponsor: Seattle Institute for Biomedical and Clinical Research
Start date: 2007-07-01; Completion date: 2024-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Atypical antipsychotic medications, such as olanzapine, cause metabolic side effects, including weight gain, extra fat around the middle of the body, high blood sugar, and high cholesterol. One of the mechanisms by which these medications may cause these effects is by reducing plasma melatonin. This study is a pilot project to evaluate 1) the effect of olanzapine on melatonin secretion levels and 2) the effect of melatonin on olanzapine-induced changes in melatonin secretion in patients with schizophrenia, schizoaffective, or bipolar disorder.

Detailed description:
To investigate the relationship between olanzapine, melatonin, and metabolic functioning, this pilot study is evaluating 20 patients with schizophrenia, schizoaffective disorder, or bipolar disorder over 15 weeks under three experimental conditions: 1) baseline (two weeks treatment with already established antipsychotic medication other than olanzapine or clozapine), 2) six weeks treatment with olanzapine only, and 3) six weeks treatment with olanzapine and melatonin. Half of the patients will receive 0.3 mg of oral melatonin and half will receive 3.0 mg of melatonin. Nocturnal melatonin production, as estimated by assay of urinary 6-sulfatoxymelatonin(aMT6s) adjusted for creatinine, will be measured weekly. In addition, weekly measurements of weight and other metabolic indices, including waist and hip measurements, fasting glucose, serum insulin, cholesterol, triglycerides, and leptin will be taken. It is anticipated that there will be an olanzapine-induced decrease in melatonin production. Furthermore, it is expected that the decrease in melatonin production associated with olanzapine treatment will be reversed by administration of melatonin with olanzapine.

Arms: arm 1: 0.3mg day melatonin arm 2: 3.0 mg/day melatonin
Interventions: intervention 1: olanzapine and melatonin
Intervention descriptions: intervention 1: In treatment phase I, all subjects will receive olanzapine, 10-25 mg/day. In treatment phase II, all subjects will receive olanzapine (10-25 mg/day) plus melatonin. Subjects will be randomized at a ratio of 1:1 to receive melatonin, 0.3 mg/day or 3.0 mg/day. Group IIA will receive 0.3mg day melatonin. Group IIB will receive 3.0 mg/day melatonin.

Protocol documents: