ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02691416
Conditions: Cerebral Arterial Aneurysm
Sponsor: The Third Central Clinical College of Tianjin Medical University
Start date: 2014-07-01; Completion date: 2016-01-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate differences between propofol postconditioning and sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect.

Detailed description:
intracranial aneurysm surgery may lead to regional ischemic reperfusion injury. Propofol, as an antioxidative phenol, has been demonstrated that mitigate the brain I/R in rats.

As for sevoflurane, some investigation indicated that sevoflurane is able to reduce oxidative stress in cell(except neuronal cell lines ) and rodent models, but the antioxidant effect did not found in human minor incision surgeries, furthermore, oxidative stress was raised in the major surgeries including orthopedic surgeries, hysterectomy, cholecystectomy, and thoracotomy

Arms: arm 1: 1.2mg/L propofol arm 2: 0.5%-2% sevoflurane
Interventions: intervention 1: propofol postconditioning intervention 2: sevoflurane
Intervention descriptions: intervention 1: administrated Target Controlled Infusion(TCI) of propofol (Cp 1.2ug/ml) and decreased sevoflurane with a Bispectral index (BIS) value of 40-60 to maintain anesthesia after clamp removal intervention 2: 0.5%-2% sevoflurane with BIS 40-60

Protocol documents:
Clinical trial NCT02750332
Conditions: Hereditary Tyrosinemia, Type I
Keywords: HT-1 Tyrosinemia Nitisinone Bioavailability Healthy Volunteer Food-Effect
Sponsor: Cycle Pharmaceuticals Ltd.
Start date: 2015-11-01; Completion date: 2016-01-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions (food-effect).

Detailed description:
The specific aim is to conduct a randomized, single dose, two-period crossover bioavailability study in at least 16 healthy male and female subjects at a single study center to evaluate the in vivo performance of Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions.

The study in healthy male and female volunteers is designed to establish a pharmacokinetic (PK) profile under fed and fasting conditions for the orally administered Test Product, Nitisinone 10 mg Tablets.

A total of 20 healthy female and male volunteers (age 18 to 55 years old) will be entered into the study. Volunteers will be determined to be free of significant medical conditions as assessed by medical history, physical examination, and blood and urine tests. Volunteers will be randomly allocated to receive the Test Product under fasting or fed conditions.

There will be a minimum 23 calendar days washout between treatments. Blood samples will be collected at pre-dose (0 hours) and at 15 minutes, 30 minutes, 1 hour, 2 hours, 2 hours and 30 minutes, 3 hours, 3 hours and 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours and 120 hours post-dose (total: 21 samples per treatment period).

Arms: arm 1: Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fed conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period. arm 2: Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fasting conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fed conditions. Each treatment period will be separated by at least 23 calendar days of washout period.
Interventions: intervention 1: Nitisinone
Intervention descriptions: intervention 1: A single oral dose of Nitisinone 10 mg Tablet will be administered.

Protocol documents:
Clinical trial NCT02985827
Conditions: Dry Eye
Sponsor: ORA, Inc.
Start date: 2015-12-01; Completion date: 2016-01-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to analyze the sensation to eye drops containing menthol in people with healthy eyes and in people with dry eyes. This study also examines the temperature of your eye using an Infrared Camera.

Detailed description:
Dry eye disease (DED) has been defined as a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface1. An estimated 25 million Americans are reported to have dry eye disease (DED)2, which is a number that will only increase with the U.S. aging population3. The only treatment currently available in the U.S. targets inflammation on the ocular surface. Because dry eye is a complicated disease that encompasses many conditions of the eye, diversified ways to treating the disease are necessary. Some recent studies suggests that some Dry Eye symptoms are caused by corneal cold thermoreceptors (such as TRPM8) chronically firing at below-normal thresholds. It thus logically follows that dry eye patients could be distinguished from normal patients by possessing higher symptom responses secondary to topical application of menthol, a potent agonist of TRPM8. If dry eye patients indeed have lower threshold firing of TRPM8, agonizing TRPM8 with menthol will elicit a more severe symptom response, given equal concentrations across populations.

To fully elucidate this relationship between TRPM8 agonists, sensation, and tear film cooling, two dry eye populations will be tested - one population which has exhibited symptom response to a previous dry eye agent, and one population with no symptom response to the same agent.

Arms: arm 1: Menthol containing over the counter eyedrop arm 2: Non-Menthol containing over the counter eyedrop
Interventions: intervention 1: Rohto (r) Hydra intervention 2: Systane (r) Ultra
Intervention descriptions: intervention 1: Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose intervention 2: Systane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose

Protocol documents:
Clinical trial NCT01809210
Conditions: Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV
Keywords: MEK1/2 inhibitor, Non Small Cell Lung Cancer, metastatic, first line treatment for Non Small Cell Lung Cancer
Sponsor: AstraZeneca
Start date: 2013-04-04; Completion date: 2016-01-04
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase I, open label multicentre study of selumetinib administered orally in combination with first line chemotherapy regimens to patients with advanced/metastatic NSCLC. The study has been designed to allow an investigation of the optimal dose of selumetinib in combination with various standard first line double-platinum chemotherapy regimens. Initial assessment will be based on tolerability of selumetinib in combination with one or more selected regimens that are considered to be tolerated also being assessed for preliminary evidence of activity.

This study is a dose finding and optional cohort expansion; In addition all patients will be assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.

Detailed description:
A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination with First Line Chemotherapy Regimens in Patients with Non-Small Cell Lung Cancer (NSCLC)

Arms: arm 1: Selumetinib plus gemcitabine; or pemetrexed and cisplatin or carboplatin
Interventions: intervention 1: selumetinib intervention 2: gemcitabine intervention 3: cisplatin intervention 4: carboplatin intervention 5: pemetrexed
Intervention descriptions: intervention 1: 2 x 25mg capsules bd continuously in cohort 1 (with gemcitabine and cisplatin). If tolerated - next cohort 3 x 25mg capsules bd continuously. if higher doses are explored, required number of capsules will be provided. Option to administer on D2-19 of each 21 day cycle if required to assess tolerability of combinations with chemotherapy intervention 2: 1250 mg/m2 iv on Day 1 and 8 of each 21 day cycle. If combination not tolerated, option to give 1000 mg/m2 iv on Day 1 and Day 8 of each 21 day cycle intervention 3: 75 mg/m2 iv on Day 1 of each 21 day cycle. If combination not tolerated, option to give 50 mg/m2 iv on Day 1 or 25mg/m2 iv on Day 1 and Day 8 of each 21 day cycle intervention 4: If it is not possible to identify a tolerable combination of selumetinib, gemcitabine and cisplatin, cisplatin may be replaced with carboplatin (AUC5) iv on Day 1 of each 21 day cycle intervention 5: Gemcitabine may be replaced with pemetrexed 500 mg/m2 iv on Day 1 of each 21 day cycle.

Protocol documents:
Clinical trial NCT02382939
Conditions: Adult Growth Hormone Deficiency Growth Hormone Disorder
Sponsor: Novo Nordisk A/S
Start date: 2015-02-12; Completion date: 2016-01-04
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in previously human growth hormone (hGH) treated adults with growth hormone deficiency.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: somapacitan intervention 2: somatropin
Intervention descriptions: intervention 1: Administered subcutaneously (s.c., under the skin) with an investigational pen once weekly for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout. intervention 2: Administered subcutaneously (s.c., under the skin) with a prefilled pen (Norditropin® FlexPro®) daily for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.

Protocol documents:
Clinical trial NCT01349465
Conditions: Hepatitis C
Keywords: Hepatitis C Hepatitis TMC435 Liver disease Virus Infection
Sponsor: Janssen R&D Ireland
Start date: 2011-07-04; Completion date: 2016-01-05
Enrollment: 249 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.

Detailed description:
This is a 3-year follow-up study in patients who completed the last post-therapy follow-up visit of the previous Phase IIb \[NCT00882908, NCT00980330\] or Phase III \[NCT01289782, NCT01290679, NCT01281839\] study in which they received TMC435, in combination with pegylated interferon and ribavirin, for the treatment of hepatitis C infection. The entire study duration for each patients will be approximately 36 months. The medical follow-up of the patients will be performed according to the local standard of care. This study will evaluate the levels of hepatitis C virus in the blood circulation, as well as safety and alpha-fetoprotein testing and the change in sequence of HCV NS3/4A region over time in patients with confirmed detectable HCV RNA at last post-therapy follow-up visit of the previous TMC435 study. In this study the development of liver disease progression will also be assessed. No medication will be administered in this study.

Arms: arm 1: Patients with sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) \[Phase IIb or Phase III\] in which they received a TMC435-containing regimen for the treatment of HCV infection. arm 2: Patients with no sustained virologic response (SVR) who completed last post-therapy follow-up visit of the previous study (LPVPS) \[Phase IIb or Phase III\] in which they received a TMC435-containing regimen for the treatment of HCV infection.
Interventions: intervention 1: No treatment
Intervention descriptions: intervention 1: No treatment was given to patients during this study as this is a follow-up study of previous Phase IIb or Phase III in which they received a TMC435-containing regimen.

Protocol documents:
Clinical trial NCT01925209
Conditions: Sporadic Inclusion Body Myositis
Keywords: sporadic inclusion body myositis, myositis, muscle wasting, controlled clinical trial, randomized, body mass, muscle function, strength, performance, physical function
Sponsor: Novartis Pharmaceuticals
Start date: 2013-09-26; Completion date: 2016-01-06
Enrollment: 251 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).

Detailed description:

Arms: arm 1: Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks. arm 2: Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks. arm 3: Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks. arm 4: Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
Interventions: intervention 1: BYM338/bimagrumab intervention 2: Placebo
Intervention descriptions: intervention 1: BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps. intervention 2: Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.

Protocol documents:
Clinical trial NCT02601001
Conditions: Healthy Volunteer
Keywords: Heart failure
Sponsor: Cytokinetics
Start date: 2015-11-13; Completion date: 2016-01-06
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of omecamtiv mecarbil in healthy volunteers in Japan.

Detailed description:
This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Arms: arm 1: Participants received placebo tablets twice a day (BID) in dosing period 1 (days 1 to 8) and in dosing period 2 (days 20 to 27). arm 2: Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 25 mg or 37.5 mg BID in dosing period 2 (days 20 to 27) based on their day 8 predose omecamtiv mecarbil plasma concentration (Cpredose): If day 8 Cpredose was \< 200 ng/mL, participants received 37.5 mg BID; if day 8 Cpredose was ≥ 200 ng/mL or a day 8 PK value was not available participants continued to receive 25 mg BID. arm 3: Participants received omecamtiv mecarbil 25 mg BID in dosing period 1 (days 1 to 8) and 25 mg or 50 mg BID in dosing period 2 (days 20 to 27) based on their day 8 predose omecamtiv mecarbil plasma concentration (Cpredose): If day 8 Cpredose was \< 200 ng/mL, participants received 50 mg BID; if day 8 Cpredose was ≥ 200 ng/mL or a day 8 PK value was not available participants continued to receive 25 mg BID.
Interventions: intervention 1: Omecamtiv mecarbil intervention 2: Placebo
Intervention descriptions: intervention 1: Omecamtiv mecarbil tablets for oral administration intervention 2: Matching placebo tablets

Protocol documents:
Clinical trial NCT01466153
Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: Chronic lymphocytic leukemia; leukemia; B-Cell malignancy; anti-CD19; monoclonal antibody; CLL; Refractory; Relapse; Non-Hodgkin's Lymphoma
Sponsor: MedImmune LLC
Start date: 2012-02-07; Completion date: 2016-01-08
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.

Detailed description:

Arms: arm 1: Rituximab was administered by IV infusion as 375 mg/m\^2 on Day 2 of Cycle 1 and then 500 mg/m\^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle. arm 2: MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle. arm 3: MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
Interventions: intervention 1: Rituximab intervention 2: Bendamustine intervention 3: MEDI-551
Intervention descriptions: intervention 1: Rituximab was administered by IV infusion as a dose of 375 mg/m\^2 on Day 2 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of up to 5 subsequent 28-day cycles intervention 2: Bendamustine was administered by IV infusion as a dose of 70 mg/m\^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle. intervention 3: MEDI-551 was administered at 2 mg/kg or 4 mg/kg by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycles.

Protocol documents:
Clinical trial NCT01908816
Conditions: Choroidal Neovascularization Macular Edema Glaucoma, Neovascular Diabetic Retinopathy
Sponsor: Novartis Pharmaceuticals
Start date: 2013-09-26; Completion date: 2016-01-08
Enrollment: 270 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

Detailed description:

Arms: arm 1: 0.5 mg ranibizumab applied in an individualized regimen as IVT injection of 0.05 mL.
Interventions: intervention 1: ranibizumab
Intervention descriptions: intervention 1: One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)

Protocol documents:
Clinical trial NCT01912872
Conditions: Severe IgE-mediated Asthma
Sponsor: Novartis Pharmaceuticals
Start date: 2013-11-11; Completion date: 2016-01-08
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assess efficacy and safety of omalizumab treatment during 12 months in order to reduce the use of inhaled corticosteroid (ICS) in pediatric and adult participants with severe Immunoglobulin E (IgE)-mediated asthma inadequately controlled with high doses of corticosteroids.

Detailed description:
This was a multicentric, open label, randomized, parallel-group study with a 12-month treatment period. Participants were assigned to one of the 2 treatment groups, omalizumab plus budesonide/formoterol or budesonide/formoterol alone.

The study comprised 4 phases:

During the 4-week run-in phase adult participants received budesonide 800 mg and formoterol 24 mg. If a participant complied with all inclusion and exclusion criteria and had received the according-to-age run-in proposed doses during the last month, the participant continued to the stable-steroid phase.

During the 16-week stable-steroid phase, adult and pediatric eligible participants were randomized to one of the two treatment groups.

During the 8-week steroid-reduction phase, adult and pediatric participants reduced 25% of the budesonide baseline dose every 2 weeks, depending of the asthma control, until they reached a 100% reduction of the baseline dose. The clinical control of asthma was defined according to criteria (GINA 2012).

Arms: arm 1: Participants will receive Omalizumab every 2 or 4 weeks depending on IgE level and body weight and will also receive budesonide and formoterol according to maximum daily dose. arm 2: Participants will receive budesonide and formoterol according to maximum daily dose.
Interventions: intervention 1: Omalizumab intervention 2: Budesonide intervention 3: Formoterol intervention 4: Budesonide intervention 5: Formoterol
Intervention descriptions: intervention 1: Subcutaneous injection dose according to the IgE level and body weight. intervention 2: Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose. intervention 3: Formoterol 12ug tablets taken orally according to maximum daily dose. intervention 4: Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information. intervention 5: Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.

Protocol documents:
Clinical trial NCT02034513
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2014-01-05; Completion date: 2016-01-11
Enrollment: 501 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1 diabetes.

Detailed description:

Arms: arm 1: Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period arm 2: Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine intervention 3: insulin aspart
Intervention descriptions: intervention 1: Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted. intervention 2: Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted. intervention 3: Administered 2-4 times daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Protocol documents: