ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02116803
Conditions: Solid Tumors
Keywords: solid tumors TKI258 Dovitinib fulvestrant cancers with a mass bulky tumor nodule lump cancer solid malignancies
Sponsor: Novartis Pharmaceuticals
Start date: 2014-05-28; Completion date: 2016-11-28
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a Novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator.

Detailed description:

Arms: arm 1: Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB). arm 2: Participants were given dovitinib and fulvestrant coadministration starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
Interventions: intervention 1: dovitinib intervention 2: fulvestrant
Intervention descriptions: intervention 1: Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally. intervention 2: Fulvestrant is generally available as solution for injection in pre-filled syringes containing 250 mg of fulvestrant in 5 mL solution.

Protocol documents:
Clinical trial NCT02558829
Conditions: Growth Hormone Deficiency With Pituitary Anomalies
Keywords: Adult Growth Hormone Deficiency
Sponsor: AEterna Zentaris
Start date: 2015-12-03; Completion date: 2016-11-29
Enrollment: 157 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial. The trial will include subjects suspected to have adult growth hormone deficiency (AGHD) and a group of healthy control subjects.

Detailed description:
Trial subjects will be assigned to groups of descending likelihood of having AGHD:

Group A, B, C: High, intermediate, and low likelihood of GHD, respectively; Group D: Healthy control subjects matching Group A subjects .

The sequential order of the GHSTs for suspected AGHD subjects (Group A-C) will be determined by stratified randomization; healthy control subjects (Group D) will be tested in the same sequence as the matched Group A subjects.

Serum concentrations of GH will be measured at pre-defined time points before and after GHST with macimorelin or insulin. A peak GH value below the GHST-specific cut-off value will be considered 'test positive'. The ITT will be considered as comparator (non-reference standard) to assess positive and negative agreement of both GHSTs, based on the predefined cut-off values.

The following cut-off values for simulated GH levels were used for both GHST tests to be compared: macimorelin-GHST: GH: 2.8 ng/mL, ITT: GH: 5.1 ng/mL.

Amendment no. 1 (repeatability extension): had been issued for selected sites in Europe to obtain exploratory data on the repeatability of the MAC in a subset of subjects (planned N=30, 10 per Group) that had completed the core study.

Arms: arm 1: 1st Macimorelin-GHST, 2nd Insulin Tolerance Test arm 2: 1st Insulin Tolerance Test, 2nd Macimorelin-GHST
Interventions: intervention 1: Macimorelin intervention 2: Insulin
Intervention descriptions: intervention 1: macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose intervention 2: Insulin, 0.10 U/kg (0.15 U/kg if BMI \> 30 kg/m2), intravenous injection, single dose

Protocol documents:
Clinical trial NCT02777827
Conditions: Asthma
Keywords: Abediterol Dry powder inhaler Pressured metered-dose inhaler Pharmacokinetic Pharmacodynamic Safety
Sponsor: AstraZeneca
Start date: 2016-06-21; Completion date: 2016-11-29
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the pharmacodynamics of single doses of abediterol given by 2 different devices in participants with asthma. Abediterol (AZD0548) is a potential for once daily treatment of asthma and chronic obstructive pulmonary disease (COPD) in fixed dose combination (FDC) with an inhaled corticosteroid (ICS) or a novel anti-inflammatory agent. The aim of the clinical studies is to enable further investigations in participants with asthma and COPD to evaluate and develop abediterol as an effective long acting bronchodilator with an acceptable safety profile compared to other inhaled bronchodilators on the market, for the treatment of asthma and COPD.

Detailed description:
This is a randomised, double-blinded, double-dummy, placebo-controlled, multi-centre, six-way William's design, crossover study to assess the pharmacodynamics, pharmacokinetics, and safety of abediterol single dose, given by dry powder inhaler or pressurised metered-dose inhaler, in patients with asthma, on inhaled corticosteroids. During the screening period, all patients will take their own baseline inhaled corticosteroid for 2 weeks. Patients on long-acting β2-agonist/ inhaled corticosteroids will be switched over to the respective inhaled corticosteroid monocomponent. Patients will be provided salbutamol as rescue medication for use throughout the study. Abediterol is an investigational product in early stages of clinical development, therefore individual participants in the clinical studies may not have a clinical benefit, especially in view of alternative therapies (bronchodilators) being available for the treatment of asthma and COPD.

Arms: arm 1: Dry powder for inhalation administered via dry powder inhaler 0.156 μg/inhalation; (1 inhalation) arm 2: Dry powder for inhalation, administered via dry powder, inhaler 2.5 μg/inhalation; (1 inhalation). arm 3: Pressurised metered-dose, inhaler 0.025 μg/puff; (2 puffs). arm 4: Pressurised metered-dose, inhaler 0.078 μg/puff; (2 puffs). arm 5: Pressurised metered-dose inhaler 1.25 μg/puff; (2 puffs). arm 6: Pressurised metered-dose inhaler (2 puffs) and Dry powder for inhalation administered via dry powder inhaler (1 inhalation).
Interventions: intervention 1: Abediterol 0.156 μg intervention 2: Abediterol 2.5 μg intervention 3: Abediterol 0.05 μg intervention 4: Abediterol 0.156 μg intervention 5: Abediterol 2.5 μg intervention 6: Placebo
Intervention descriptions: intervention 1: Dry powder for inhalation intervention 2: Dry powder for inhalation intervention 3: Pressurised metered-dose inhaler intervention 4: Pressurised metered-dose inhaler intervention 5: Pressurised metered-dose inhaler intervention 6: Pressurised metered-dose inhaler and dry powder for inhalation.

Protocol documents:
Clinical trial NCT01471340
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2012-01-09; Completion date: 2016-11-30
Enrollment: 11744 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.

Detailed description:
Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1.

Arms: arm 1: MF/F MDI BID (pooled MF/F MDI 200/10 mcg BID and MF/F MDI 400/10 mcg BID treatments) arm 2: MF MDI BID (pooled from MF MDI 200 mcg BID and MF MDI 400 mcg BID treatments)
Interventions: intervention 1: Mometasone Furoate/Formoterol MDI 100/5 mcg intervention 2: Mometasone Furoate/Formoterol MDI 200/5 mcg intervention 3: Mometasone Furoate MDI 100 mcg intervention 4: Mometasone Furoate MDI 200 mcg intervention 5: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI intervention 6: Prednisone/prednisolone
Intervention descriptions: intervention 1: two inhalations BID intervention 2: two inhalations BID intervention 3: two inhalations BID intervention 4: two inhalations BID intervention 5: use as needed for asthma symptoms intervention 6: Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator

Protocol documents:
Clinical trial NCT00641147
Conditions: Familial Adenomatous Polyposis
Sponsor: National Cancer Institute (NCI)
Start date: 2010-10-01; Completion date: 2016-11-30
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.

Detailed description:
Specific Aims:

I. To determine in a randomized, double-blinded, placebo-controlled study the tolerability and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in familial adenomatous polyposis patients with intact colons, ileorectal anastomosis surgery, or ileo-anal pullthrough (reservoir) surgery.

II. To measure markers of cell proliferation including colorectal mucosal levels of ornithine decarboxylase (ODC), polyamines, mucosal deoxyribonucleic acid (DNA) methylation, proliferative index (Ki67 antiproliferative cell nuclear antibody), apoptosis index, vascular density, mucosal prostaglandin, leukotriene levels, and activation of the nuclear factor kappa B (NFKB), and v-akt murine thymoma viral oncogene homolog 1 (Akt) survival pathways.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive curcumin orally (PO) twice daily (BID) for 12 months.

Arm II: Patients receive placebo PO BID for 12 months.

After completion of study treatment, patients are followed up at 4 months.

Arms: arm 1: Patients receive curcumin PO BID for 12 months. Laboratory Biomarker Analysis arm 2: Patients receive placebo PO BID for 12 months. Laboratory Biomarker Analysis
Interventions: intervention 1: Curcumin intervention 2: Laboratory Biomarker Analysis intervention 3: Placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Given PO

Protocol documents:
Clinical trial NCT01232283
Conditions: Plaque Psoriasis
Sponsor: Amgen
Start date: 2010-11-22; Completion date: 2016-11-30
Enrollment: 413 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

Detailed description:

Arms: arm 1: Participants were initially randomized 2:1 and received apremilast 30 mg twice a day (BID). Participants maintained dosing through Week 32. At Week 32, responders, those with a Psoriasis Area Severity Index response -≥75 (PASI-75) and partial responders (≥PASI-50) were re-randomized 1:1 to apremilast 30 mg BID or matching placebo (treatment withdrawal). Participants could resume apremilast 30 mg BID at the time of loss of 50% of improvement in PASI score response which was observed at Week 32 compared to baseline), and no later than Week 52. At Week 52, the non-responders (\<PASI-50) had the option of adding topical therapies and/or phototherapy to their treatment regimen. Those re-randomized to apremilast 30 mg BID continued dosing through Week 52. At Week 52, participants continued treatment with apremilast 30 mg BID. arm 2: Participants will be initially randomized to placebo, identically matching during Weeks 0-16. At Week 16, Placebo participants will be switched to receive apremilast 30 mg BID. All participants will maintain Apremilast dosing through Week 32. At Week 32, participants originally randomized to placebo at baseline (Week 0) and are considered non-responders i( \< PASI-50) will have the option of adding topical therapies and/or phototherapy to their Apremilast treatment regimen. At Week 52, all participants will continue treatment with apremilast 30 mg BID. Participants will be followed and evaluated for safety and efficacy for up to an additional 4 years (years 2 through 5).
Interventions: intervention 1: Apremilast intervention 2: Placebo intervention 3: Topical or Phototherapy Therapy
Intervention descriptions: intervention 1: Apremilast 30mg by mouth (PO) twice a day (BID) for 32 weeks intervention 2: Identically matching placebo by mouth BID for first 16 weeks. Placebo participants will be switched to receive apremilast 30 mg BID at Week 16-32. intervention 3: Topical therapies such as low-potency or weak corticosteroids or phototherapies such as light therapy are added for non-responders at Week 32, (\< PASI-50) and added to their treatment regimen. The decision to add these treatments during this phase can only be made at the Week 32 visit.

Protocol documents:
Clinical trial NCT01550341
Conditions: Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Opiate Addiction Drug Dependence
Keywords: HIV AIDS Opiate Addiction Drug Dependence Buprenorphine
Sponsor: Yale University
Start date: 2012-02-23; Completion date: 2016-11-30
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.

Detailed description:
Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months.

STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Buprenorphine/naloxone intervention 2: Placebo Oral Tablet
Intervention descriptions: intervention 1: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration. intervention 2: 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.

Protocol documents:
Clinical trial NCT02091921
Conditions: Critical Limb Ischemia
Keywords: Critical Limb Ischemia, ticagrelor, Brilinta
Sponsor: University of Southern California
Start date: 2014-02-16; Completion date: 2016-11-30
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a major cause of death and disability (secondary to myocardial infarction, stroke and amputation). The mortality in patients with CLI approaches 13-25% and 50% at one and five years respectively. High on-treatment platelet reactivity (HPR) in patients treated with aspirin and clopidogrel is associated with increased risk of recurrent cardiovascular events after percutaneous coronary interventions and coronary syndromes. Preliminary studies suggest that the prevalence of HPR in patients with critical limb ischemia treated with aspirin and clopidogrel is as high a 78.5%. In patients with coronary artery disease ticagrelor overcomes non-responsiveness to clopidogrel. However, the antiplatelet effect of ticagrelor in patients with critical limb ischemia is unknown.

Detailed description:
Study Aim: This pilot study aims to investigate platelet function after switching from clopidogrel to ticagrelor in patients with critical limb ischemia.

Fifty patients with diagnosis of CLI (Rutherford class IV-VI) treated with clopidogrel 75 mg and aspirin 81 mg daily will be tested for inhibition of platelet aggregation using the VerifyNow P2Y12 and VASP assays before and 6±1 hours after their daily clopidogrel dose. All patients will then be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and Vasodilator-Stimulated Phosphoprotein (VASP) platelet reactivity assays repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose. For exploratory analysis, patients will be divided in two groups based on the P2Y12 reaction units (PRU): Group 1. High on treatment platelet reactivity on clopidogrel (HPR), defined as P2Y12 reaction units (PRU) ≥208 and Group 2. Appropriate platelet inhibition on clopidogrel (API), defined as P2Y12 reaction units (PRU) \<208. If subjects are withdrawn from the study prior to completion due to the high co-morbidity rate of this population, additional subjects will be enrolled to reach a total of 50 completed subjects for data analysis.

Arms: arm 1: All subjects will receive Ticagrelor.
Interventions: intervention 1: Ticagrelor
Intervention descriptions: intervention 1: All patients will be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and VASP platelet reactivity assays repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose.

Protocol documents:
Clinical trial NCT02872935
Conditions: Nausea Vomiting
Sponsor: Kokila N Thenuwara
Start date: 2015-05-15; Completion date: 2016-11-30
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.

Detailed description:
The hypothesis of this study is as follows: In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.

The study group will receive phenylephrine infusion \[dilution 100micrograms /cc\] Rate of infusion 50micrograms /hour, approximately 30ml/hour To be started immediately after the placement of the spinal anesthetic Patient will also be given .4mg \[1cc of glycopyrrolate\], with the starting of the infusion

The control group, will receive phenylephrine infusion \[dilution 100micrograms /cc\] Rate of infusion 50micrograms /hour, approximately 30ml/hour To be started immediately after the placement of the spinal anesthetic Patient will also be given a placebo \[1cc of N saline\], with the starting of the infusion

Following the administration of the study drug/placebo, the patient will be monitored for severity of nausea , vomiting and pain at 5 minutes intervals from placement of the spinal to delivery of the baby, and then at 15 minutes intervals from delivery of the baby till the end of the surgery ( the cesarean section)

Arms: arm 1: 1ml of Normal Saline will be given intravenously with the administering of the spinal dose arm 2: 1ml of Glycopyrrolate ( .2mg /ml) will be given intravenously with the administering of the spinal dose
Interventions: intervention 1: Glycopyrrolate intervention 2: Normal Saline
Intervention descriptions: intervention 1: .2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose intervention 2: 1ml of normal saline will be given intravenously with the administration of the spinal dose

Protocol documents:
Clinical trial NCT02875028
Conditions: Healthy Volunteers
Keywords: Coagulations Platelets Inflammation endotoxemia vorapaxar
Sponsor: Medical University of Vienna
Start date: 2016-06-01; Completion date: 2016-11-30
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Vorapaxar is a recently approved protease activated receptor - 1 (PAR-1) inhibitor. Platelet inhibition may also exert positive results on coagulation activation and may beneficially influence the inflammatory response. Since vorapaxar is the first available substance of a new class of platelet inhibitors its effects on the human coagulation system and the inflammatory response will be assessed in the well-established human endotoxemia model.

Detailed description:
Vorapaxar is a novel platelet inhibitor inhibiting PAR-1. It is the first available substance of a new class of platelet inhibitors blocking the activation of platelets via thrombin or thrombin receptor activating peptides via PAR-1. As platelets contribute to the coagulation activation, i.e. by providing the surface for the assembly of the Tenase complex, and furthermore to the inflammatory response by releasing their stored granula containing promotors of both, inflammation and coagulation, we want to assess the effects of vorapaxar on these in the human endotoxemia model. Sixteen healthy volunteers will be included in this randomized, double-blind, placebo-controlled, single center, crossover trial with a washout period of 8 weeks. This wash out period was chosen based on the long elimination half-life of vorapaxar and to prevent any carry-over effects. After intake of 10mg vorapaxar (-24h) the degree of platelet inhibition will be assessed by whole bood aggregometry and, in case of insufficient platelet inhibition, subjects may receive another 10mg of vorapaxar. A bolus of 2ng/kg bodyweight lipopolysaccharide (LPS) will be infused and blood sampling will be performed at pre-defined time-points. After the washout-period the respective other treatment will be given to subjects.

Arms: arm 1: subjects will be treated with 4x2,5mg vorapaxar in empty lactose-starch capsules arm 2: subjects will be treated with 4 empty lactose-starch capsules
Interventions: intervention 1: Vorapaxar intervention 2: Placebo intervention 3: LPS
Intervention descriptions: intervention 1: 10mg-20mg vorapaxar to achieve \>80% thrombin-receptor activated peptide-6 (TRAP) induced platelet inhibition intervention 2: None intervention 3: 2ng/kg Lipopolysaccharide as a bolus infusion

Protocol documents: